Xvivo Perfusion AB (publ)

Thank you. And dear all, I welcome you all to the Exvivo's earning call for the third quarter of 2023. Today's presenters are me, Kristoffer Rosenblatt, CEO, calling in from Gothenburg, Sweden. And we have also Kristoffer Nordström, the company CFO, calling in from Philadelphia. And we go to the next slide, which is slide number three, and Q3 financial at the glance. I'm both very proud and happy to report that Q3 was another strong quarter with improvement in performance in line with the last four quarters we have seen. It's also very encouraging to see that our scaling up our business model showed an improved adjusted EBITDA that actually came in almost three times higher versus Q3 last year in terms of Swedish kronor. As you see on the slide sales came in at 147 million SEK and we posted the third consecutive high organic growth quarter with 37% in Q3. The gross margin and the adjusted EBITDA margins are continuously improving and we see that also happening in this quarter. On top of that, we're also very, very pleased to see that the integration of our three latest acquisitions has progressed according to plan, and they continue to significantly contribute to the high growth we see in the quarter. The recovery service in the U.S. is now organizationally and brand-wise fully integrated. The services are very high quality, appreciated by our customers, and the next steps are to start acquiring new contracts and pilot the product service model in a few clinics to start with. I also want to mention the abdominal portfolio, which is growing very fast for disposables. We can see 100% organic growth during the quarter. In liver, it's really encouraging to see that we see strong growth in all major markets in Europe. I especially want to mention France, where we now have full reimbursement, and that obviously helps growth a lot. But now I also want to start to mention the kidney loss, which is now gearing up, and we start to even see that in the numbers. The limiting factor for increased growth in the abdominal segment is production capacity of disposables and regulatory approval for liver in the US. The production capacity is gradually improving, and we will invest to scale up volumes. During the presentation we will go further into the details regarding our plan forward for all areas mentioned and especially production and regulatory approvals. Then we go to slide four which is the next slide where I want to give you the same picture but for the first three quarters of the year or YTD. And the key takeaway from this slide is that the progress shows similar pattern as we saw in Q3, and it's not isolated to one quarter. And when we look back at the first nine months of this year, we can conclude that not only the numbers in our current land business and abdominal business in Europe are pointing in the right direction, but also that we have passed many, many important milestones. And for example, we have heart Australia usage We have the US Heart Study that includes DCD and now has started. I also want to make integration and performance of our two service acquisitions, which has been truly amazing. And also the overwhelming positive feedback from both our liver and kidney customers, both in terms of clinical results and in terms of user experience and easy to use. We can also conclude. looking back at the nine first months of 2023 that the market is growing fast and especially in the US it is accelerating in 2023. This is a result of new technology coming to the market but also maybe more important political pressure that comes from the high alternative cost to a transplant for patients with end-stage organ diseases. So the passing of those important milestones together with an organization with a razor sharp focus to deliver and an underlying positive market fundamentals lies behind the number we see in front of us. I won't go into them in great detail here, but later in the presentation, our CFO will give you further details to both the numbers and the drivers behind the numbers. And with that, we change slide to slide. And we look into the Q3 highlights. This quarter, we will focus on progress for the heart technology, the kidney launch, and lastly, the very successful capital raise of 440 million sec aimed at increasing production capacity and obtain regulatory approval for heart-inclusive DCD and liver in the US. So with that, we go to slide, next slide, which is slide number six on the slide deck. And we start with the U.S. heart update. As we reported last quarter, the FDA granted us an IDE, including both the DBD and DCD donor heart. This meant that we could start a regular trial in the U.S. And as you saw already in mid-October, we have already had the first patient in to the study at the very reputable Duke University Hospital. As we have stated before, we can include a maximum of 20 sites to enroll 141 patients into the study. I want to especially mention again that the opportunity to include DCD into the trial design was very important. The DCD portion of the donor pool in the US was approximately one third last year in 2022, and DCD is growing very fast. Having the opportunity to also produce DCD hearts prior to transplantation will be key to save more hearts in the US and hence give the opportunity to more patients with end-stage heart disease a chance to a longer and healthier life. And if we look at the last bullet on the slide, I'm sure that many of you have already seen this or read it in major newspapers in the world. And the news was that Maryland performed their second seno heart transplant during the quarter. And we in Exviva are both very proud and humbled to be part of this groundbreaking science. Proud that our heart technology enables seno transplants, which is a more complicated heart preservation. And we're also very humbled by the fact that we work with very competent partners that maybe one day can change the future of transplantation. However, I do want to mention from an investor standpoint, the key takeaway is that Xvivo, together with Xtend and Legolas, has developed extremely innovative technology that can not only improve ordinary transplants, but also more advanced transplant models. It underlines the fact that Xvivo is the innovation leader in our field, However from a financial contribution standpoint there will be a limited financial contribution both in the near and midterm future. And with that we will change slide to number seven and we will take a look at an update on the European and Australian heart experience. As we reported, we have in Europe finalized inclusion of the regulatory study during Q2, and we are now entering the one-year follow-up phase. We have a very good initial feedback from the participating clinics. We have already submitted the technical documentation to Notified Body for regulatory approval or CE mark for the heart technology. In the meantime, we have applied for compassionate use. We will target three to four countries in Europe to enable compassionate use prior to regulatory approval in Europe. In Australia, we see that compassionate use cases, in other words before regulatory approval, in Q3 continue at a high level and represent approximately 30% of all heart transplants. in Australia, New Zealand. We are present at all clinics. And during the quarter, we have actually broken the record out of body time with one minute compared to the old one. So now it's a total of 48 minutes. And the fact that we are not allowed to market the heart products in Australia and New Zealand but see high usage is a testament that the need for the product is very high. And the reason for this is as I would say as always that the clinical data is convincing so far and that seeing is believing. Many of the surgeons we talked to say that to see the heart is in better condition after being on our heart box and even though we pushed out about the time to almost double of the generally accepted four hours and that is very encouraging. And the percentage clinical survival data is also truly, truly impressive with zero third-day mortality, even though the out-of-body time was more than double of the generally accepted four hours, and that is from the Australian study. With that, we leave the update on the heart side for the quarter, and we go into next slide, which is slide eight. and this time we want to give an update on the kidney assist transport launch update. We can now see that with production of kidney assist transport disposable kits when they are gradually increasing we see that we are also gradually increasing sales on the product and we can see that the selective launch is gearing up. The kidney cyst transport is now fully launched in the Netherlands, where we already produce all DCD kidneys in the Netherlands. And this is a very important both milestone and proof point for the future, since we know that almost one third of the donor pool in the US was DCD during 2022. And we know DCD is growing very fast. It's encouraging to see that success in the launch. is early and as I said we had a selective launch where we have selectively launched the kidney assist transport in the US, Australia, Sweden and Spain with very good initial customer response and the response we get is one it confirms the clinical result we have seen published in Lancet for example and two we get a confirmation that the kidney assist transport device is easy to use And that is very important to get into really high use rates for a product. I also want to point out that we have now installed the first kidney assist transport in an OPO in the US. OPOs are today performing a majority of kidney perfusions in the US. And of course, the OPOs will be a very important target group for the future launch of kidney assist transports. If we look at the operational scale up, as I mentioned, the limiting factor to an increased growth pace right now is production of kidney assist transport disposable sets. It is gradually building up both production and sales but right now demand greatly outpaced supply and hence that's why we choose for selective launch. During last quarter Q2 it was communicated from us and the company that the key focus right now is to build up production capacity for kidney assist transport in particular, but also for liver and heart, where we see great demand in the next couple of years coming. Even though the production quantity is gradually increasing month by month, there will be important milestones along the road. The first one we're aiming to is to having component production fully up and running in a good and automated clean room environment. And this milestone we hope to pass during Q2 next year. And when we pass that milestone, we'll increase production output dramatically for primarily the kidney assist transport. As of next summer, we will gradually scale up assembly and sterilization capacity. We aim to have full production capacity up and running in latest Q2 2025 for heart, liver, and kidney disposables. For lung, we make a judgment that there are no hurdles going forward because it's already fully set up. And with that initial highlight, I will change slide to slide number And I hand over the word to our CFO, Christoph Nordström, that will tell you more about the recent capital race.

Yes, thank you, Christopher. So in mid-September, we could proudly announce the carryout of a successful capital race, where both international and Swedish long-term very high-quality investors participated. We're very happy over that. Obviously, the 440 million SEC directed share issue took place at a zero discount, and the interest from both current but also new investors was solid, and we are very grateful for the trust and support, of course. The proceeds, worth emphasizing, will be earmarked to secure three strategic objectives that together will enable us to become the global leading oil organ company. So first of all, to finance a first class clinical trial and regulatory PMA process for the heart in the U.S. Second, to enable our liver PMA process in the U.S. to be conducted more in parallel with heart, hence reduce time to the U.S. market. And third, to finance the scale up, as Christopher mentioned, of disposable production times 10 over the next few years. So with this capital racing, we're now fully founded to capture the great market opportunities and, of course, to bring our life saving innovations to all major markets. I will leave the word back to you again, Christopher, and jump in when we come to the next financial section. So here you go.

Great. Thank you. The next slide is slide number 10, which is a quick clinical and regulatory timeline review. And we can actually skip or go over to the main slide, which is slide 11. By the way, we have clear focus areas, which is the current business, the kidney assist transport launch. then also regulatory approvals for heart and liver and that's the two last focus areas we will talk about on this slide. As mentioned in the US trial we had our first patient in and I'm very proud of the team that they could both include DCD into the trial design and and get the first patient in with almost no delay at all, which is a fantastic achievement. I know that the clinical team in the US is working extremely hard right now to enable more sites to participate in the clinical trial for heart in the US. As mentioned before, if we go to the next point, which is Europe, heart. We have handed in our technical documentation for review according to our time plan. We are aiming for a launch in Europe during Q2 2024. I still want to say that we have handed in our technical file in good quality and we handed in on time but it's always hard to predict exactly when you get a regulatory approval in time. Especially that we know that notified bodies are under a high work pressure with MDR but this time now we have and we are at this point confident that we will reach it. We have touched the Australia New Zealand experience at many times. We have high usage. The regulatory strategy for Australia and New Zealand is that we will. have commercial laws pending CMARC in Europe first so that hence Australia and New Zealand will be regularly approved after Europe in the timeline what it looks like right now. Then Kristoffer Nordström just mentioned that we raise some capital and one of the aims for that capital is that we will enable to run both the heart U.S. trial and the liver U.S. trial are more in parallel than what we could have done before. And this is great news. We have previously also reported that liver assist has been granted breakthrough device designation by the FDA. This means that we will get a faster route through the FDA PMA process. It is also quality stamped that products are innovative and fulfill a need on the market. And the global level team is actually, as we speak, meeting in Groningen in the Netherlands to design the US study and compiling both the quality file for an ID application and talk about trial designs. We have already started to invest in an organization to run the study. During this year, we see a great number of publications being released with overwhelming evidence that DeliverAssist and its protocol showing superior clinical results versus what is available today. We see that reflected in our sales numbers, and it also strengthens us in our belief that the US clinics should get access to this technology. The US study planning will be done during this quarter. And we aim for an ID approval late next year, 2024. And ID approval means that we have approval to start a regulatory trial in the US. And with that, we go to the next slide, which is financial performance and I give the word back to Kristoffer Nordström who will present financial performance.