Xvivo Perfusion AB (publ)

And welcome to Xvivo's earning call for the third quarter of 2024. On the first slide, today's presentation, sitting in the same room, Kristoffer Rosenblad, CEO, and besides me, Kristoffer Nordström, CFO of Xvivo Perfusion. And with that, we turn to slide two, the Q3 finances at a glance. And I'm proud and happy to report that Q3 shows improvement on top line as well as EBITDA. last year even though we continued and we will continue to invest in the organization for future growth. Sales came in at 191 million SEK which is a 41% organic growth and EBITDA shows an improvement to 21%. The growth for Thorax is mainly coming from higher XPS activity during the quarter. Another growth that we see in this quarter is the US Heart Trial, where we have seen very high interest to join the trial, as well as very high activity in the trial during the summer months. And Kristoffer Nordström, our CFO, will get into the details on sales, gross margin, EBITDA, and the numbers later in the presentation. So with that, we go to the next slide, which is slide three. And we see a similar picture in the Y2D numbers. Key takeaway from the first nine months are that growth is still mainly coming from an increased activity in existing customers and the stronger market. For hearts and lungs, we see a very high interest from new customers, especially after ISHRT in April, that we gradually start to see being converted to new sales from new customers. We can also conclude that sales from products is picking up faster than sales from services, even though we have a fantastic service offering with a very good quality. Regarding EBITDA, even though we have invested heavily in mainly commercial and field force, we can now see that the revenue model is scalable. In other words, sales is converted to economies of scale on gross margin as well as EBITDA level. Lastly and most important to mention is that the projects are progressing according to plan. The HART project is on time and budget. The production capacity project where we invest to scale up volumes times 10 of today's volume for disposables are running in line with communicated timelines. The first milestones for kidney assist transport and liver assist are completed, and we will have, and we have production volume to satisfy current market demand. As communicated earlier, the full scale of production of disposable for heart, liver, and kidney is estimated to be completed at the end of Q2 2025. But as I said, we have enough volumes for the need for the next year. And with that, we will go into the highlights of the quarter. So first, our business overview on slide four, which we can actually turn directly to slide five. And we will start with heart and news in heart. This slideshow is the summary of the heart trial. That was presented at the ISHCT conference in April in Prague this year. And I showed it before, but we start with those key takeaways. And the reason I show it again is that because it's very good data, we want to repeat it. And number one is that this is, to our knowledge, the first randomized controlled trial superiority design in heart and lung transplantation ever performed, which shows the confidence that clinicians have indexed with heart technology. Two, the HOPE group, in other words, pumped with the ex vivo technology, showed an improvement of PDD with 61% versus the control group, which is highly important, provided that PDD is the leading cause of early and late mortality in heart transplantation. Three, and also very, very important, is that all HOPE parts were deemed transplanted after perfusion. This is important to highlight since cold perfusion offers safety advantages during transportation. that we go over to slide six and the news during the quarter for for heart that was presented in NASA during quarter and we are now after this publication we are now more convinced than ever that this is this product has the ability to share the paradigm of heart transplantation and I want to highlight two key takeaways. And the first one is that when we just for minor difference between the 15 trial sites, we saw that the result was even better. We saw that the primary endpoint had a 49% risk reduction that was well within the statistical significance threshold. The other very interesting fact we see when we dig into the data is that During the seven analysis of PDD, we saw that severe PDD showed an even higher risk reduction with 76% for the hope group, i.e. pump with ex vivo technology versus the control group. And this is very important and very encouraging since severe PDD is highly linked to mortality of the transplantation. Some sources say that severe PDD is associated with nearly an eightfold increase in probability of one year mortality. It is obvious that we with this new knowledge look forward to the one-year follow-up of the data including the one-year survival data points that will be presented during ISHCT in Boston and that will take place in April in 2025. And with that we turn to slide seven. We have talked about DCD heart before, and now we will increase our efforts. To start with, we know that the portion of the donor pool that are coming from DCD is comparatively large in some countries and is growing fast. If you want to substantially increase the number of transplants, we need to prove that DCD hearts can be transplanted in a safe, cost-efficient, and practically feasible way with good patient outcomes. And the study we are now running in Benelux, Belgium and Netherlands is decided to show exactly that. The experience we have from liver and kidney hope shows very good clinical outcome. So the concept is proven. We have also seen in the preclinical settings on hearts that using the Xvivo heart technology and DCD drive procurement shows very good results. We have now reported the first three DCD cases and they had very good and encouraging results. This study together with the regulatory study in the US have decided to demonstrate safety and efficacy for DCD hearts. The company hopes and believes that we will have good evidence when the two studies are concluded. Besides this, I also want to mention the Pegasus in English, study by Professor Louboutin is progressing. The study is done with transatlantic flights on commercial airlines to show that more than 12 hours transport is safe and feasible in the practical setting. When this trial is concluded, we believe that it can revolutionize how heart transplant logistics are performed. And this is the first proof that our technology can enable both patient benefits and cost benefit for the healthcare systems around the world. With the body of evidence pointing towards the Xvivo heart technology to be gold standard in the future, the company works towards that goal. However, until further evidence is presented and accepted, the EU launch will still target approximately 50% of donated hearts that are either old model donors, typical long transportation times, or complicated implant procedures that will manage the longer out-of-body time for the donated heart. But that being said, that's the current hypothesis for the launch. But we believe over time that this has the ability to become gold standard. In other words, all heart should be transported on the Xvivo device. And going from heart, we go over to the next slide, which is slide eight, and we go into lung. strong body of evidence and is getting accepted as a tool to safely increase the number of lung transplants and decrease weightless mortality. So without going into details, we can now conclude that EVLP is a clinically proven accepted method to reduce weightless mortality with good clinical outcome. And with that, I go into the next slide, which is the slide nine. And this is to show that if we have good clinical evidence over time, it is translated to good performance on the market. So we see that the EVP growth is high, especially in the US, where we see doubling this Q3 versus last. And there are many factors behind the growth. We see, for example, the pressure from the American political system to increase the number of transplants has a positive impact on EVLP for lungs. We also see the hub models or centralized perfusion models help to drive growth. The other trend we see is that with a positive IHSDT and more feet on the ground, we see an increased interest for EVLP. And this interest is directly translated into increased number of lung EVPs, and hence more patients getting a chance of lung transplant. So key takeaway from the two lung slides are that innovative products with good clinical outcomes sooner or later translate into increased activity and shorter waiting lists for transplant patients in need of a new organ. And with that, we go to slide number 10 where we have even more exciting news and evidence and this is the liver product we have liver assist where we see the same level of evidence or or almost better and where we deem our liver assist hope technology is now clinically proven 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 grafts after transplantation. I choose to highlight three of those publications, and they are listed on this slide. And the first one, or the top one, I would say is the most important, where we see 1,200 livers using HOPE in a real-world setting trial. And the results showing five-year graph survival at 91% in the hope group versus 81% in standard of care. In the publications will state that hope treatment now reach ideal D stage four, which means in more normal English that it's proven in a real world setting and not only in clinical trials. And this is the, let's say, the highest level of support. And this supports that implementation of liver assist and hope could be a routine practice for liver transplantation. And that's something we work with in liver to get to the gold standard position where we have regulatory approval for liver assist. Secondly, also very encouraging data on the second one, long-term data. We can conclude that the more marginal donated livers, the higher need for liver assist and hope published data on extended criteria dbd liver shows that five-year outcome of 87 percent organ survival which is very very strong in itself but if compared to for example the expected one in the in the publication above using standard care was only 81 percent for good livers but the result becomes evident when we compare the 7% graft survival in the liver cyst group, and we compared to the control group where the result was 52%. The last publication I want to highlight that is important if we want to become gold standard within liver transplantation is the recent Lancet publication that shows that liver safely can be perfused after 20 hours and eliminate the need of nighttime liver transplant. And this is again a great example where we can improve graph survival and also improve work-life balance for our customers. Lastly, I stated earlier the production scale up times 10 is progressing according to plan. We reached our first milestone and we deem we have enough production capacity to bridge the gap until next year, where we will have full-scale production running. And with that, we go to slide 11, which is the last slide on the quality business update. And that's the recent acquisition of Flowhawk, which is a unique communication platform for the transplant process. The background is that with an increased organ office in the US, the complexity for OPOs and transplant center has increased dramatically. Three-step burden, HIPAA compliant, easy to use, communication tool is needed and the best solution on the market is Flowhawk. Flowhawk is already today used by leading transplant clinics and with combined forces we will strengthen the extreme offer to clinics and OPOs in the future. We will also over time integrate our product remote monitoring system into Flowhawk for a seamless customer experience. So we believe this is a very important strategic step for xvivo to be a provider to of easy to use products for our customers in the future and with that we're going to our clinical pipeline And we go to slide 12, and then we can skip right away to slide 13 for regulatory review. And again, I would say nothing has changed since last time we met. I will repeat what I said in July. In the US, the heart trial is progressing according to plan, and our clinical team in the US is working very hard to include all clinics into the trial. The interest is very high, I would say extremely high, to be part of the trial. And we are doing our utmost to make sure that we can meet that interest from US clinics. We have approval for up to 26 sites. We have activated 13 sites and 12 are, as we speak, including patients into the trial. As also mentioned before, in Europe, we have handed in our technical documentation for review according to our time plan. We are aiming for a CMARC in Europe end of this year. Important to mention, is that we can't fully affect that review timeline. The good news is that we have a notified body lined up and they've been very responsive, even though they have a very high workload under MDR. The security in the time now we still face is how fast EMA, European Maker Agency, and the Swedish MPA can handle the review. We have really done what we can to hand in our files on time and both when it comes to product and clinical files with very good quality but i want to highlight that that's slightly out of our hands uh in australia new zealand we have as mentioned before high usage of the product the regulator approval will be pending the c mark in europe so That is. Then we go over to liver. We have previously reported a liver system regretting breakthrough device designation by the FDA. And this means that we get a faster route through the FDA PMA process. I also want to say it's a quality of stamp that the products are innovative and fulfill a need on the market. We have invested in organization to run the study and prepare the FDA documentation. We are in close contact with the FDA for the final ID application that we aim to do before the end of this quarter. And with the clinical and regulatory review, we go over to, I hand over to my CFO, Christopher Nordstrom, who will present the financial performance during the quarter and the year so far. Yes, thank you, Christopher.

Yes, so been presented Q3 was yet another solid quarter for Exvivo. Net sales came in at 198 million SEC representing an organic growth of 41%. Overall gross margin 75%, that's 2% units better than last year due to product mix. Continued improvements on EBIT and EBITDA, so EBIT in Q3 adjusted for M&A costs of 5 million SEC was 13% versus 10% last year, mainly driven by increased sales and strong gross margins from our thoracic business area. Adjusted EBITDA in Q3, similar adjustments, M&A costs was 21% versus 19% last year. Looking at the year-to-date numbers, we are close to 600 million SEK in sales, representing a growth of 36% in local currencies, and a nice trend on EBIT and EBIT as well, so EBIT 13% and EBIT 22%. We'll look in a little bit deeper on each business area, so next slide here, starting with Thoracic. Yet another good quarter with sales coming in at 141 million SEK, the same number as the previous quarter actually on the dot, which means that Thoracic kept the train rolling, so to say, also during the summer months. Organic growth for disposables in Q3 was strong, 54%. Main drivers, Christopher mentioned before, EVLP in the US specifically, where we saw EVLP sales grow 110% in value versus last year. So the momentum for EVLP sales during the whole 2024 has been very tangible. Year to date, we have grown our EVLP business in the US, as an example, 80% in terms of sold units versus last year. During the year we have activated new transplant clinics and now most recently in the third quarter in the US, a very prominent OPO, which we are very excited for. We also had one XPS sale in Germany in the quarter. um on the sales side also great to share that we continue to see um good sales from heart 19 million sec in q3 and this is primarily from the revenue under our u.s trial where we have cms reimbursement in place gross margin on disposables in q2 very good at 85 and in line with the previous years moving over to abdominal Net sales 39 million SEK, which is 8 million SEK less than sales in Q2. As communicated during the Q2 earnings call, we expected somewhat weaker transplant activities over the summer months, especially in Europe, which is still the home turf for our abdominal business area. And the weaker sales in abdominal can primarily be explained by the summer effect, so to say. Organic growth in disposables was 13%. The mix between liver and kidney, we recognize that ratio from previous quarters as well. So about one third of our sales are kidney related and two thirds are liver. Kidney sales, kidney transport came in again above 10 million SEK and we're up to 35 million SEK year to date. Kristoffer mentioned it, but I will emphasize. So in terms of supply on kidney assist transport, we are now in a position where we can meet current customer demand, but also start approaching new customers. Focus for Q4 and Q5 is to continue to scale up the commercial organization and also to start acquiring clinical data on US patients and donors to continue to build clinical evidence supporting hope in the US. In 2024, for example, we've had a good start where there has been presentations by physicians at two transplant conferences and both presentations on U.S. data. And both presentations indicate improved labor function on extended criteria donors using HOPE. versus cold static storage. So it will be important for us to continue to build clinical evidence also in the US. And this will lead us to high market penetration and to establish reimbursement over time. Gross margin 62% from disposable versus 61% last year. Moving over to services, our third business area. Sales in Q3, 18 million SEK from 96 recovery cases. This represents a decrease of sales actually, minus 7% versus last year. During 2024, if you take the bigger picture, we have reorganized our commercial organization in the US. As you know, which together with our significant growth within EVLP have stolen some focus from this business area. And moving into 2024, we need to start to organize ourselves better around services and in a more focused way. We have continued to strengthen our recovery quality program in 2024. We take a lot of pride in that and we get a lot of good customer feedback. And now we have an opportunity to integrate our Flowhawk platform into the customer offering, starting in Q4. And this will give us an even stronger service offering going into 2025, that's for sure. I also want to mention another initiative that we will look into, and that is to see if we can start to include our service, our organ recovery service model into our clinical trials so our heart centers and also eventually our upcoming liver trials so I mean there is a great there is a great interest of combining our products with our service model but of course we would like to have the sites trying that before that the product is commercially launched hence already within the trial so that is something Moving over to my two last slides. EBITDA, 21% in the quarter. I mean, we have a continued good positive trend in rolling 12. We're at 20%, so that trend develops nicely. We have stated it before. Our ambition is, of course, to continue to improve EBITDA year on year, but we will do that step by step. Of course, we also want to invest heavily in this organization so we can grasp the market opportunities, but still improve our profitability. I think that is it on that slide. Moving over to my last one. So cash flow and financial position. Q3, once again, cash positive from operating activities, plus 23 million SEK. Investments primarily in our U.S. clinical trials amounted to 41 million SEK. That leads us to a total cash flow of around minus 21 million. We ended this quarter with a solid cash position of 450 million SEK. And this was everything for me. I will hand the word over to Kristoffer again and look forward to Q&A when we wrap up.

Thank you so much. The last couple of slides are on the outlook. And as always, I will start with a long-term outlook because it's important to remember why we're here. The demand for transplant are 10 times higher than today's supplies. And that's the whole reason for Xvivo being a company and existing. It's also interesting to mention that the sales value of machine perfusion versus cold static storage is also around a time 10 value component. So we're looking at the market that will in the future be a lot bigger than the one we see today. Machine perfusion service model have proven to increase the number of organs used for transplantation. I think you've seen a lot of that proof today in this presentation. I also want to mention that Exviva has unique, innovative and world leading products on the market or in the R&D pipeline, which we want to take to market as soon as we can. With the recent acquisition of Flowhawk and superior clinical results for our product, we have also started a long term goal to be sustainable for the community as a whole. We aim to build a sustainable transplant process for patients. In other words, better access to organs at the highest survival rate. We want to offer our customer a sustainable work-life balance. That is not always the case right now. We also want to offer sustainable economics for the healthcare system. By reducing the use of private jets, we believe we can offer a sustainable future for the planet and environment as well. With that, we go over to a little bit shorter outlook, which is 2025 mainly. And the two first points are important that we will continue to invest in commercial capability and organization capability that can handle growth and high growth. Especially now when we have two product launches, Kinesis Transport India, United States and Europe currently ongoing. And then as soon as we have CMR product, we will have a launch of heart in Europe. If we look more to the detail per product line, it means that we have seen for lungs, there is a great interest from customers to start EVLP programs, and we will invest to capture that one, continue to do that. For HART, the 2025 guidance is that we will launch our products in Europe and Pacific. We will actually start to investigate if we can launch them in Canada as well. We will continue to build the U.S. regulatory and clinical file during next year based on the good data and the high interest we see from the clinical trial in the U.S. For liver, we can see that we have, and you've seen it today, excellent clinical data published, and we will invest in commercial capabilities to capture the opportunity. We will mainly invest in Europe, and we also aim to start a clinical trial in the U.S. next year, pending the ID approval by the FDA. Now with kidney production up and running, we will turn our focus to commercial capabilities and to build a US clinical file. And lastly, we will integrate FlowHawk into our offering and continue to improve the service offering that will be very important for our heart launch in the United States. So with that little bit shorter term outlook, we will say thank you for listening today. And we open up the line for questions.

If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Ulrich Trattner from Carnegie. Please go ahead.

Hi, Christoph and Christopher. A few questions on my end. I'm perhaps starting off with the extraordinary growth in lung and EVLP in the U.S. And how much of this would you attribute it to the new allocation system in the U.S.? We have seen long outgrowing rest of Oregon throughout 24 and just trying to grasp the trend here, as well as where have we moved in terms of EVLT penetration in the US over the year? That would be my first question, please.

Thank you for that question, Ulrik. I would say we are now at an inflection point when it comes to EVLP. The interest is very high and I would say the new allocation system is only one part of the pressure the US Congress put on the transplant system in the US that is very positive for us. So we see that we are at an inflection point and there's a couple of factors that coexist and help us here. One is that the the results from evlp is now accepted that it's a tool that you can increase your the number of transplants in the transplant center we also came to a point where there is enough clinics used to actually perform evp and and how to read the data so the more standardized out the reading of the data becomes the easier it is to make a decision and we now see that we reach that point so it's a couple of Factors coexisting that leads to a good both market sentiment and a good uptake for the XPS in the United States right now. I don't have the exact numbers right now on where we are on penetration in the US, but it's definitely increasing because EVLP is growing at the fact that there is more than times 10 versus the underlying market growth.

I can provide some details on that. So you have around 2,500 lung transplants in And if you look at the number of EVLPs that we have made available by selling, that's around 500. So it means, from that perspective, we have made available a penetration of 20%. Not all of those sales have, of course, resulted in a transplant in the end, but that at least

Okay, so essentially based on the clinical data on the XPS and EVLP, that number could easily double in the next five years.

It's always hard to predict the future because it's the future, but the market sentiment we feel right now, it's very positive. That's as much as we know. Then it will depend a lot on us, how many feet we can put on the ground, how well-trained they are, how fast we can get new clinics up and running, et cetera. So we definitely have to run very fast to capture this market opportunity we see in front of us.

Yeah, great. And since you mentioned feet on the ground, and you also mentioned in the report increased commercial activity in the U.S. and advertising expanded in Canada already by Q4, uh can you elaborate what this entails what investments has been done in q3 and what's up for q4 i know that you you hired mark during q3 but but beyond that what type of commercial activities has been scaled up or what's in the plans for the next quarter or two uh we will we will emphasize a lot of our investments around the united states and canada in the next year so we are currently hiring uh

skilled marketing team. We are scaling up our feet on the ground in the United States, and we are starting to hire our first person into Canada. I would say we have had a successful MD-SAP audit, which will enable us to apply for market approval, but Health Canada, of course, is giving market approval now. So we don't have approval to sell in Canada yet, but we will start invest into Canada already Q4. And then we come back during the next quarterly meeting how that investment is progressing and turning into sales. But the North American team spent a week in Canada last week and they reported back to me that there is a very high interest for our products in Canada as we speak. They especially mentioned the liver assist and the extremely good result they have seen from Europe. When you can prove in a real-life setting when everybody's tired and working and it's not a controlled environment, then we can prove such extremely good improvement for livers using our technology. I think that has inspired a lot of interest from the regions where it is or can be regulatory approved pretty soon.

Okay, great. And if we were to look at kidney assist transport and then staying in the U.S., I know that you're ramping up production. I know there's still some production capacity left before you can deliver on OPO contracts. But beyond purely production capacity, is there any further sort of adoptions to the system that you feel is needed for it to go wide in the US? And you mentioned additional trials in the US and if you can elaborate on the necessity of these trials and if there's any major difference between the dynamics of a kidney in the US versus Europe.

There is no real difference between the kidney in Europe and the U.S. However, that's not how the world works. So a U.S. clinician want to see U.S. data based on a U.S. opioid system and U.S. patients to adopt that. They also want to see socioeconomic data that it's actually that we can get more kidneys allocated with our kidneys, his transport, et cetera. So that's what we are building up. We had two very good presentation during seminars in this quarter or last quarter Q3. So we are acquiring that body of data now, but we do also realize that this will take some time to both design and actually run trials and get the data presented So that's one thing. We have a few minor tweaks to make the Kinesis transport fit into the U.S. transplant system that we will work on during this and also part of next year. And then we will also scale up our commercial capabilities in the U.S. towards launching this product. I believe the team are doing a great job, but I think there are definitely a few learnings here to be really successful because this is the first quarter they could actually go out and sell the product. And we saw some good early signs, but I think we can be a lot better at selling the kidney in the US as well with training and more experience. So there are a few steps still to be done, and it's something we work very hard on internally, something I follow up on a weekly basis, our progress on kidney, especially in the US.

Great. And if we're to stay in the US, and we're approaching finalization of the hard trial, and it seems like it's been running at really full steam here, close to a year in, and we're almost done. So what's the plan here from Q1 onwards? Where are we in terms of planning for feeding trials? Is there any potential for pediatric use? Or how should we expect the continued use among the already activated sites?

That's a great question. And that's something we work together with FDA right now as we speak. So the interest is very high. And the interest for going into requiring more data around pediatric, DCD, etc. is extremely high. So we will pursue those efforts, and also to have a continuous access protocol for the trial sites. We will also pursue those roads, so to say. And we are in negotiation with the FDA right now, and we will come back when we have more to report on that, or let's say when the FDA has approved those efforts, but I believe and hope they will because the pressure from clinicians in the US is pretty high to use this our product because they are overwhelmed with the good results they see on the heart side when using it compared to what is available today in the US. So it's an overwhelming experience for them. So I believe that we will hopefully have some positive news to come back. But right now we are in discussion and negotiation with the FDA and it's of course pending their approval what we can do and not do on on the US soil.

Great and last question on my end relating to the heart and commercialization here in Europe that is coming up soon. Can you give us some timeline on expected reimbursement of the hard device? I'm guessing it will take at least half a year or a year before you get reimbursement. And how will clinics across Europe be able to find some cost cover for the device?

Yeah, that's a good question. And there are almost as many answers as there are countries in Europe for that. There will be different country by country. Some will be quicker and some will be slower. The typical example is that France is normally quite quick. And we estimate that the reimbursement process for ABM is approximately a year there in France. We've seen that on EVLP, for example, where France was the quickest one. Also Benelux or at least Netherlands are quite quick. We know that UK are normally quite slow, so to say. Germany is normally quite slow country, but we got some positive feedback from Germany now. So we might put that one on front burner. So before we have reimbursement, there will be, let's say, separate budgets. where they have to argue for using this technology for a subset of hearts in their transplant programs country by country. It will look a little bit different country by country. In some countries, there is more money available for new technology than in others, so to say. So we will focus our European launch on a few three to four European countries the first year. to not, one, spread ourselves thin, and two, to not, we will go where there is money in the healthcare system during the first year until we have a better picture on the reimbursement.

Great. Thank you for taking all my questions, and I'll get back into the queue.

Thank you, Henrik.

The next question comes from Jacob Lemka from SEB. Please go ahead.

Hi and good afternoon. Starting with abdominal and assuming in our liver here in Q3, it seems like growth decelerated a bit compared to recent quarters. Is there anything behind this other than the summer effect?

To our knowledge, no. We had a very slow summer on abdominal. It's mainly explained by Southern Europe, where we saw, to be truly honest, very slow liver and kidney activities, so abdominal activity in Europe. We can see early signs that it is picking up now, let's say from mid-September and onwards now in October. So we of course have to see a full q4 and and and maybe bit into q1 to fully answer that question But what I heard from the sales team was that it was a very very slow summer so to say so they were they were surprised himself how slow it was and And we hope that the early signs we see now in the last four to five weeks will continue to the rest of the quarter Okay

Just to follow up on earlier questions on Kidney, is it possible to get some sort of guidance on what growth expectations we should have here in Q4 and also into next year?

I'm sitting right now with both the team in the US and the team in Europe to really nail down activities we need to do and get that. We will be finished in mid-November with that exercise and after that I will have a better picture on what we can expect and can give more of a fair guidance than I can do right now. So I have to wait. Maybe we can take that question in general and I will have a better picture.

Okay but this is still fair to assume that it should grow here since you are able to produce more now?

Absolutely. I mean, to be truly honest, there is no excuse if we don't grow very fast in kidney. Absolutely. I mean, we know we have a couple of herders, especially in the U.S., too, when it comes to clinical data acquired on U.S. soil and scaling up and get the feet on the ground, get them ready. So definitely, there are a couple of challenges here. But yeah, this is not the growth rate we want to see from kidney with full-scale production or with enough production, so to say, to satisfy current demand. We want to see higher growth rates.

OK. And moving on then to a question more directed online. I mean, last year you talked about transact activities sort of slowing down towards the end of the year. And I guess my question is then based on what you're seeing now and what you're hearing from customers, do you expect to see sort of similar pattern this year or do you expect to see more, you know, full throttle throughout the end of the year?

The answer is very straight. We don't expect to see the same slowdown we saw last year. However, Q4 is always tricky because it depends on a few factors. And what happened last year was that OPTN had a goal, which they have already realized and reached that one already after Q3. And I assume, a little bit guessing from my side, that a few of the centers took a little bit longer Thanksgiving and Christmas holiday when they could actually still reach the goals. I know that OPTN has a higher goal this year, and therefore I don't expect the same downturn, at least not for the same reason. And we haven't seen any signs of slowdown so far versus the activity that we have seen. But it's not until we get into, let's say, holiday seasons here in the United States, we will have a better picture on that one. But we don't expect it, but Q4 is always tricky in that sense. You never really know.

Okay, but I guess then it's still fair to assume that we see the sort of usual historical sales pattern with Q4 being the clearly strongest quarter for you.

That's our expectation right now. Historically, as always, last year was... was a bit of an outlier in terms of of q4 um the other 11 years i worked here has q4 has been the strongest but uh yeah hard to speculate on that one but uh if we should if we should follow the normal pattern it should be stronger yes okay and then on on services uh i mean given the

sequential decline here in volumes in Q3. I'm wondering if you have lost any customers and also when do you expect services to sort of return to meaningful growth?

Yes. We touched upon this at the beginning of the year in one of the calls that we lost two customers in 2023, which was high volume, and we still suffer from that loss, so to say. The reason for the decline in this quarter was due to lower volumes at the current centers over the summer months. We have a few customers and if a few of them decrease their volumes, there is an impact on the numbers. Same thing here as for Kidney. I mean, we have all the reasons to expect this business to grow. We have an excellent platform built and we strengthen it now as we mentioned with Flowhawk. We continue to improve our communication and our integration with our customers. So we should expect an increase. However, I would say that the kind of infliction point here and and the and the real booster will be when we have a a transportable device to combine with our service offering and that is the heart box so that is when i think that the real synergies will come from this long-term strategic acquisition that we did okay very clear and then it's finally

It was a bit unclear earlier, but did you say that you will get continued access protocol on HART or are you working on getting that? And also, if you get that, what sort of volumes would that be in line with what you do today in the study or anything would be helpful?

Hard to speculate on the volume. Of course, we have not approved that. We are in negotiation with the FDA, but if you follow the history, how the FDA have treated other trials such as ours, they have granted continuous access protocol. The volume or the number of cases they have granted has typically been two-thirds of the Oh, sorry, three quarters of the trial volume. So that's the best estimate I can give today.

Okay, that's very good. Thank you very much.

Thank you.

The next question comes from Johan Aniris from Red Eye. Please go ahead.

Great. Thanks for taking our questions. Only a few mainly follow-up type of questions. On the heart study in the centers involved, it looks hopeful that you will sort of succeed to get a continuous access and support in place. FDA has been very supportive and rather proactive earlier on this side for you. Any reason why they should be slower in this case?

No, no, absolutely. There's no reason. It's just that dealing with the FDA, the FDA, how do you say, sets the rules. So I'm always very humble and cautious when I talk about the FDA because at the end of the day, they decide. I have no reason to believe that we should not get a positive treatment, so to say. But it's always good to be humble and make sure you do your homework when you're dealing with FDA.

Yes. And you are benefiting from some sales support related to the use of your solutions already at the trial stage. Is it possible to give an flavor of that level of support for example during Q3?

You mean in terms of number? Yes. We won't go out with detailed numbers during the trial but we know that the cost of recovery is 32,000 US dollar and we know that the majority of heart sales came from the US in Q3 but we won't because it's a clinical trial we won't go out with exact numbers how many were performed in each quarter. There is a high level of patient safety, we should keep that in mind. So we don't comment exactly on the trial, but we do see very good progress during the third quarter.

Yeah, that's useful. And on the services side, which has obviously underperformed now for some quarters, Should we expect any sort of organizational changes or anything like that? And what about, can you provide us in favor of the sort of pipeline of new accounts or transactions?

So I would say organizational, no. We are overall strengthening and we continue to strengthen our U.S. organization. And with Mark Reed on board, we will work know diligently on on a us service strategy uh that will be a high participation for us in 2025 um but i mean the foundation is there you know with excellent skill skilled surgeons uh we have turned this company profitable last year that was the main uh purpose um in terms of uh Customers, yes, there is a pipeline, we're working on that. We will also look into other types of services as well. It's early days, but we know that there is a big interest in perfusion services at hospitals as well. That's one thing we will look into, for example. As we have mentioned before, we have started one or two pilot projects within NRP with centers as well. So there are, you know, we need to define maybe a bit clearer our strategy, but there are definitely a lot of market opportunities.

Yeah, I can just mention on that. I mean, we're not happy at all with the progress in services. And of course, we will integrate Flowhawk. And during that integration, we will also try to understand what more feet on the ground would do for the integrated let's say digital and service business so that there might be more resources needed in our go-to-market model because we have a good service that is obviously not taking off so we're doing something wrong when it comes to go to market and we need to fix that.

Yeah I mean it's of course important to support with integrated services even if the absolute numbers are still modest. And another reflection is that some of these launch processes takes a bit longer to get up fully to speed. Q3 is perhaps a good example of what you that you can still achieve very good growth, very good growth indeed. But you will also be more exposed to and rely on some of the core existing solutions like Lung and Torex. What about Outlook? Can you expect healthy good support during this time ahead of the launch of other solutions?

I mean, we are in an interesting inflection point as a company where we have, of course, succeeded with PerfectX before and now we succeed with EVLP. And now we want to take those learning and to succeed in heart in Europe and liver. We want to take the learnings to our combined service digital offering in the US and the learnings to our kidney assist transport launch here in the US. So definitely there is an interesting point where we have to be fast and learn fast. So definitely, it's there. I don't want to be rude, but we have another meeting right now, both me and Kristoffer, and I see there are two written questions. I will read them and answer them. The first one is, could you give some more color on the possible Canadian law? Is that based on US data or EU data? The Canadian laws will be based on European regulatory approvals and therefore mainly European data to answer that question. The next question is, in short, has there been any notable slowdown in volume so far this quarter due to recent hurricanes that hit the United States, especially in the southern regions around Florida and Georgia and South Carolina? To my knowledge, there has been a few CASL transplants because you can't fly in a hurricane. But so far, there has been no huge impact on the overall numbers of transplants in the United States, to my knowledge. So with that, I want to say thank you to everyone listening in. And I hope to see you back end of January when we report the full year of 2024. And until then, have a nice day.