Xvivo Perfusion AB (publ)

Thank you so much and welcome to Xvivo's earning call for the first quarter of 2024. Today we will start the presentation with the front picture. The slide in front of you right now is a picture of Alex from Australia. She received a heart transplant thanks to Xvivo's heart technology. I think it's important reminder to why we actually are here and it's to make sure that no one dies waiting for a new organ. And with that, we go to the next slide, which is just today's presenters. And that's me, Kristoffer Rosenblatt, CEO. And to the left of me today in the same room, for once, I have my CFO, Kristoffer Nordström.

Hi, everyone.

And with that, we go over to slide three, which is just a quick glance on Q1. I'm both proud and happy to report the strongest quarter in Exviva's history and that Q1 shows improvement in all three business areas. Sales came in at a record of 186 million Swedish kronor. The gross margins are continuing to show strength, so also in Q1. I again want to highlight that abdominal gross margin where we are closing into the 2027 strategic goal of 70% gross margin already now. This quarter we show 67% for disposable products, which is a slight improvement from 2023 full year margin, which was 66%. We plan to improve abdominal gross margin further when we reach economies of scale in production. The adjusted EBITDA shows an improvement to 20%, and I will let Kristoffer Nordström, our CFO, get more into the details on sales gross margin and profit later in the presentation quickly on the growth of thorax is picking up and that mainly come from higher xps xps activity during the quarter we have historically seen solid growth in europe on the xps but with more feet on the ground in the us we see an increasing activity there as well for example we have one active xps customer added during this quarter in the US. The abdominal portfolio continues to grow fast as well. Growth on disposable came in at 46% growth. We also see higher sales quarter on quarter, which means that we have enabled higher quantities from production this quarter versus the previous quarter. Since the limiting factor for high growth in the abdominal segment is production capacity of disposables right now. for longer term is also regulatory approval for labor in the US. As you can see, the production capacity is gradually improving, and we invest to scale up volumes times 10 of today's volume for disposables over time. And with that introduction, we go into the highlights, which is slide four, and we go into slide five after that. We of course have to start the highlight section with the report from this year's ISHT conference in Prague, which was a great success for Xvivo. The ISHT conference is the largest and by far the most important conference for heart and lung transplantation, and Xvivo received a warm welcome from all participants. As one example, Xvivo was the most selected exhibitor. The result from the EU study NIHP 2019 with Exviva Heart Technology was the most selected scientific session in the whole program during the week in Prague. The science from the Exviva Heart Technology shows there is the potential to change the paradigm of heart transplantation and it's great to show the transplant community how far we actually have come. Exvivo also held two extremely well attended industry symposia during the conference. This symposia itself and the abilities for the audience to see what the Exvivo technology can accomplish in the future was very well appreciated by the TransLang community. And many surgeons came up to me afterwards and said that those were the two best parts of the ISSRT. because of the good climate for discussion during the industry symposia. We will talk more about the ISHLT on the next slide, which is slide number six, where we will go more into the heart trial and the results from it. The presentation by Professor Philip Rieger attracted by far the most interest And I do believe that the fantastic top line result was the reason it did. There are three key takeaways. Number one, this is to our knowledge, the first randomized controlled trial with a superiority design in heart and lung transplantation. And this shows the confidence the clinicians have in the X-Viva heart technology. Number two, the HOPE group, in other words, the one pumped with FxViva technology, showed an improvement of 61% for severe PDD versus the control group. This is highly important as an improvement provided that PDD is the leading cause of early mortality after heart transplantation. And it's accepted that PGD also negatively affects long-term survival. The third key takeaway from this seminar is that all whole parts were deemed transplantable after perfusion. This is important to highlight since cold perfusion offers safety advantage during especially transportation of an organ. And with that news, we go to the next slide, which is slide number Seven, which is another groundbreaking result from the heart technology and our heart team. And we did press release this, you heard about it. And it's about the truly groundbreaking transatlantic flight that was published in Lancet during the quarter. Professor LeBreton has accomplished the first out of seven patients in the Pegasus trial. and that is designed to investigate very long transport times. This case was amazing, not only because it was the first and historic transatlantic flight of a donated heart, also the time outside the body of more than 12 hours is truly impressive. Since we have to compare this to the general accepted time on static cold storage, which is approximately four hours. Given that it was a comparably old donor and a comparably old recipient, it makes the achievement even more impressive. And it's also important to point out what Le Breton said that the heart regain normal function directly after transplantation, which is a great achievement and testament that the technology really works. Lastly, I want to mention that the fact that the transport was made on a normal commercial flight is also historical. and something we will work more on over time. So all in all, last year, the Australian study showed that we can safely increase transport time to 89 hours, and all patients in the study showed zero third-day mortality. In animal studies, Aarhus University recently published that ex vivo heart technology should good result even after 24 hours. This should be mentioned in animal studies. But this body of evidence, start to show that safe usage of more hearts at greater distances is possible. This will also open up for more heart transplants and better matching between donor recipients with good patient outcome. And as I stated that the commercial air transport is also important because over time it will also open up for cost saving for a transplant procedure if you can use standard modes of transportation. normal flights, cars and trains rather than expensive mode of transportation that we normally see heart transplant is needed for heart transplant today. And with that news we will go over to next slide which is slide number eight and the recent abdominal milestones. During the last year we have seen more than 20 publications on the liver assist technology showing improved patient outcome on both dbd and dcd graphs after transplantation but today i want to highlight and speak to another benefit of this technology and that is the ability to plan transplants to daytime surgery the background is that no one really wants to work too many nights in a row but for a transplant team that is business as usual After this publication for liver transplant teams we believe this could be about to change. The recent Lancet publication from Groningen shows that liver can safely be perfused up to 20 hours and hence eliminate the need of nine type liver transplants. By offering a better work-life balance a transplant team can more easily attract the right competence. This is not only good for fact that we can plan more or plan transplants in a better way but it's also very important so we can attract the right type of competence to hospitals that perform transplants and the last point is and we said it before sales for abdominal products right now are mainly limited by supply constraints and the production scale up of times 10 is progressing according to plans We have invested in machinery and the validation is currently performed. As also stated earlier, and I can mention again, the kidneys' transport is growing fast in the two markets we launched it in. Next launch market is the US. And as communicated in the last call in January, the target for full launch in the US is June 4, 2024, if you continue to follow the production scale-up plan as we do now. And with that, we turn our attention to the lung business. And 2024 definitely got a great start for lungs. We see high interest from clinics to start EBLP programs with XPS. In the US, we have a new sales force that is gradually picking up and gearing up. And as one example, we have one more active XPS customer. It was added during the quarter. And the interest from new customers the sales pipeline on both sides of the Atlantic is definitely there. So we will keep our sales team busy over the next year and further from that as well. We see a high interest from customers to start EVIP programs. The high interest comes from mainly from the ability to safely use more DCD lung with the XPS, which is something we are truly grateful for. That's what the XPS and STEN solution is designed for. This will enable more organs to be used for transplant. And lastly, we will continue to invest to serve our customers in the best possible way. We will invest mainly in clinical expertise and capacity during this year. to increase the utilization of AVLP. And the next slide will be the services and the audio recovery service. Christopher Nordström will later in this call give you more details on the service development. I will give you the key highlights here on this slide. Number one, all existing contracts are renewed. I truly want to highlight this. During HLT, Dr. Hormuz gave a great speech on the benefits of third-party organ recovery. It was very well received and appreciated by the audience and I am sure that this will open up business opportunities in the future. Three, we continue to get great feedback from customers regarding quality of the organ recovery service and the ability that they can grow their programs with great outcome using our service. So that's something we're very grateful for. Four, I want to state this because this is also important. Every day we continue to improve our service offering and searching capacity to meet the need on the US market. So now we are having a great service that we are investing behind and I'm sure we will see great interest in the future for this service. And with that, we will come in to the last part of the highlights and the clinical pipeline. So we go to first slide 11, the clinical pipeline, and then more to slide 12, where we will see the regulatory review. Nothing has actually changed or nothing majorly has changed since last time we met. So I will mainly repeat what I said in January. But in the U.S., the heart trial is progressing according to plan, and our clinical team in the U.S. is working very, very hard to include all clinics into the trial. At the moment, we have 10 clinics out of 20 that are initiated into the trial. And as you can imagine, after ISHLT, the interest is extremely high to be part of this U.S. trial. In Europe, We have handed in our technical documentation for review and everything is going according to the time plan. We are aiming for CMARC in Europe in Q4 2024. Very important to mention is that we can't affect the review time to 100%. The good news is that the notified body has been very responsive, even though we know they have high workload under MDR. Also, the Swedish MPA is responsive and deliver on time. The insecurity we face still, as reported last time, is how fast EMA, the European Medical Agency can handle their part of the review. But key is that we have done what we can. We handed in the product and clinical files with good quality on time. In Australia and New Zealand we continue to see high usage of the product. The regulatory approval will be pending the CMARC in Europe. So from a regulatory view there is nothing more to add for Australia. But since they use this product regularly the regulatory approval is not the key here. If we turn our attention to the liver in the US, we have reported earlier that the liver assist had been granted breakthrough device designation by the FDA. This means that we get a faster route through the FDA PMA process. And important to mention is also quality stamp and that the products are innovative and fulfill a need on the market. We have invested and are continuing to invest in the organization to run the study. and prepare the FDA documentation. And the aim is to hand in the IDE application at the end of 2024. And with that, I will hand over to our CFO, Kristoffer Nordström, who will present the financial performance during Q1. And we can go straight to slide 14.