Xvivo Perfusion AB

STO:XVIVO

Earnings Call Analysis

Company Boosts Production, Profits Triple

In the latest quarter, Q2 2025, the company focused on increasing production capacity, especially for the high-demand Kidney Assist Transport. They plan to dramatically boost production rates by Q2 of next year, with full capacity expected by Q2 2025. Despite an 8% decrease in lung transplant volume and related disposable sales in the U.S., the company still achieved a record gross margin of 86% for disposables driven by strong PERFADEX Plus sales, its highest margin product. Sequential growth in Europe was observed in liver perfusion sales, resulting in a new all-time high. Services expanded with a 68% growth. EBITDA for Q3 tripled year-on-year to SEK 28 million due to increased sales and gross margins, and the cash position is robust at SEK 600 million. For the future, the company eyes growth through service hubs, regulatory approvals, and increased production, aiming to lead the market in organ perfusion services. Though current market share numbers for liver perfusion in Europe are not exact, the company considers itself the market leader.

Key Product Installations and Production Expansion Underway

The company successfully installed the first Kidney Assist Transport in the United States, marking a significant achievement, especially considering the current high demand outpacing supply. This product is crucial as it serves Organ Procurement Organizations (OPOs) that handle the majority of U.S. kidney perfusions. The company variously focuses on scaling production to accelerate the adoption of Kidney Assist Transport, alongside capacity for liver and heart disposables, expected to be in full swing by Q2 2025.

Capital Infusion to Accelerate Strategic Vision

Recent capital raising efforts have been successful, with high-quality investors participating, resulting in a directed share issue bringing in SEK 440 million. This capital will underpin three strategic goals, invoking confidence, as the firm aims to become the leading global all-organ company.

Financial Performance Indicators

The company's net sales increased by 51% year-over-year to SEK 147 million, bolstered by robust organic growth of 37%. Profits surged with gross profit reaching SEK 108 million and gross margin expanding by 1% to 73%. Both EBIT and EBITDA strengthened, with adjusted EBIT margin hitting 10% and adjusted EBITDA margin reaching an impressive 19%.

Disposables Drive Remarkable Sales Growth

Disposables sales achieved a new high at SEK 35 million, illustrating a substantial increase of 129% in local currencies, wholly derived from organic growth, which suggests strong market traction for these products.

Organizational Investment to Forge Growth

In 2023, the company spotlighted strengthening organizational structure and logistics efficiency in preparation for integration with the broader Xvivo system. Enhancements made position the firm to better handle demand surges with an adjusted EBITDA margin in Q3 of 19%.

Quarterly Production Capacity Uptick Anticipated

Production capacity is projected to rise each month until Q2 2024. This gradual scale-up is crucial as component manufacturing is a current bottleneck. The Q2 milestone is eagerly awaited, as it will enable significant capacity expansion, particularly for Kidney Assist Transport.

U.S. Organ Procurement Organizations as Key Targets

The company is focused on incrementally launching its Kidney Assist Transports within U.S. OPOs, which dominate kidney transplants in the country. Full-scale product launches are anticipated once production constraints are alleviated.

PERFADEX as a Performance Indicator

PERFADEX, widely used in lung transplants and indicative of the company's market performance, showed a sequential decrease from Q2, as reflected in sales figures. This remains a critical metric for evaluating overall company activity.

Australian Market Penetration and Revenue Realization

Australia showed a remarkable 30% penetration rate. The sales trajectory indicates some initial stocking by clinics, with subsequent quarters displaying stable or improving sales. Revenue impacts from this region are expected as early as Q4, marking a positive trend.

Price Increases Strategy and Market Dominance

The company plans to implement price increases in line with previous years, targeting products and regions where it adds most value and has been historically underpriced. Additionally, the firm enjoys exclusivity as the sole supplier of EVLP to key European hubs.

Strong ASP Improvement Across Business Segments

The company has placed a heightened emphasis on improving average selling prices (ASPs). As a result, thoracic EVLP this year experienced an ASP growth of 12%, signalling effective pricing strategies and market strength.

Long-term Growth Dependent on Scaling Production

Production capacity remains the linchpin for future growth. The company is on track to mitigate production constraints by Q2 2024, with enhanced delivery to the U.S. market earmarked as a potential game-changer for business expansion.

Earnings Call Transcript 2023-Q3

[Operator]

Welcome to Xvivo Q3 report for 2023. [Operator Instructions] Now I will hand the conference over to CEO, Christoffer Rosenblad, and CFO, Kristoffer Nordstrom. Please go ahead.

[Christoffer Rosenblad, executive]

Thank you, and welcome you all to the Xvivo's earning call for the third quarter of 2023. Today's presenters are me, Christoffer Rosenblad, CEO, calling in from Gothenburg, Sweden, and we have also Kristoffer Nordstrom, the company CFO, calling in from Philadelphia. And we go to the next slide, which is Slide #3 and Q3 financial at a 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 4 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 3x higher versus Q3 last years in terms of Swedish krona. As you see on the slide, sales came in at SEK 147 million, 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 3 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 service is of a 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 launch, 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 U.S. 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, sorry, we go to Slide 4 which is the next slide where I want to give you the same picture, but for the first 3 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 is not isolated to 1 quarter. And when we look back at the first 9 months of this year, we can conclude that not only the numbers in our current lung 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 U.S. heart study that includes DCD and now has started. I also want to make -- integration and performance our two service acquisitions, which has been truly amazing. And also we're developing 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 after looking back at the 9 first months of 2023 that the market is growing fast and especially in the U.S. 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 5 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 capture raise of SEK 440 million aimed at increasing production capacity and obtain regulatory approval for heart, inclusive DCD and liver in the U.S.So with that we go to slide, next slide, which is Slide #6 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 DBD and DCD donor heart, this meant that we could start the regulatory 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 U.S. was approximately 1/3 last year in 2022. And DCD is growing very fast. Having the opportunity to also pursue DCD hearts prior to transplantation will be key to save more hearts in the U.S. and hence give the opportunity to more patients with end-stage heart disease, a chance to 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 senior heart transplant during the quarter. And we in Xvivo are both very proud and humbled to be part of this groundbreaking science. Proud that our heart technology enables senior transplant, which is more, let's say, a complicated heart preservation. And we also very humble by the fact that we work with very competent partners that that maybe one day can change the future of transplantation. I however though want to mention from an investor standpoint, the key takeaway is that Xvivo together with [indiscernible] has developed extremely innovative technology that can not only approve ordinary transplants but also more advanced transplant models. It underlies the fact that Xvivo is the innovation leader in our field. However, from a financial contribution standpoint that there will be a limited financial contribution both in the near and midterm future.And with that, we will change slide to number, Slide #7, 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 1 year follow-up phase. We have a very good initial feedback from the participating clinics, and 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 3 to 4 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 represents 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 1 minute compared to the old one. So now it's a total of 8 hour, 48 minutes. And the fact that we are not allowed to market the heart products in Australia and New Zealand, but the high usage is the 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 they see the heart is in better condition after being on our Heart Box and -- even though we pushed out-of-body time to almost double of the generally accepted 4 hours, and that is very [indiscernible]. And the percentage clinical survival data is also truly, truly impressive with zero 30-day mortality, even though the out-of-body time was more than double of the generally accepted 4 hours in -- and that is from the Australia study.With that, we leave the update on the heart side for the quarter and we go into next slide, which is Slide 8. And this time I 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 assist transport is now fully launched in the Netherlands where we already [indiscernible] 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 1/3 of the donor pool in the U.S. was DCD during 2022. And we know DCD is growing very fast. It's encouraging to see that success in the launch this early.And as I said, we had a selective launch where we have selectively launched the Kidney Assist Transport in the U.S., 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 that is very important to get into really high use rates for product.I also want to point out that we have now installed the first Kidney Assist Transport in an OPO in the U.S. OPOs are today performing a majority of kidney perfusions in the U.S. and of course the OPOs will be a very important target group for the future launch of Kidney Assist Transports. And if we look at 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 a selective launch.During last quarter, Q2, it was communicated from us and the company that 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 milestone along the road. The first one we are aiming to is as 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 will increase production output dramatically for primarily the Kidney Assist Transport prospect.As of next summer, we will gradually scale up assembly and sterilization capacity with 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 #9 and I hand over the word to our CFO, Kristoffer Nordstrom that will tell you more about the recent capital raise.

[Kristoffer Nordstrom, executive]

Yes. Thank you, Christoffer. Yes. So in mid-September, we could probably announce the carryout of a successful capital raise where both international and Swedish long-term, very high quality investors participated. We're very happy of that, obviously. The SEK 440 million directed share issue took place at 0 discount, and the interest from both current and -- but also new investors was solid, and we are very grateful for the trust and support of course. The proceeds worth to emphasize will be earmarked to secure 3 strategic objectives that together will enable us to become the global leading all 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 Christoffer mentioned, of disposable production 10x over the next few years.So with this capital raising, we are now fully funded 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, Christoffer, and jump in when we come to the next financial section. So here you go.

[Christoffer Rosenblad, executive]

Great. Thank you. The next slide is Slide #10, which is a quick clinical and regulatory time line 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 and then also regulatory approvals for heart and liver. And that's the 2 last focus areas we will talk about on this slide. As mentioned in the U.S., the U.S. 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 get the first patient in with almost no delay at all, which is a fantastic achievement. I know that the clinical team in the U.S. is working extremely hard right now to enable more sites to participate in the clinical trial for heart in the U.S.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. And we are aiming for a launch in Europe to Q2 2024. I want to, still want to say that we have handed in, I would say, a file in good quality, and we hand it in on time, but it's always hard to predict exactly when we get a regulatory approval in time, especially that we know that notified bodies are under a high work pressure with MDR, but this time that we have, and we are at this point confident that we will reach it.We have [indiscernible] 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 or pending CE-mark in Europe first. So that hence Australia [indiscernible] regulatory approved after Europe in the time line, what it looks like right now.Then Kristoffer also just mentioned that we raised 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 mean that we will get it faster through the FDA PMA process. It is also quality stamped that the products are innovative and fulfilling a need in the market. And the global liver team is actually, as we speak, meeting in Groningen, The Netherlands to design the U.S. 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 the Liver Assist and its protocol is showing superior clinical results versus what is available today. We see that reflected in our sales numbers. And it has also strengthened us in our belief that the U.S. clinic should get access to this technology. The U.S. study planning will be done during this quarter, and we aim for an IDE approval late next year in '24. And IDE approval means that we have approval to start a regulatory trial in the U.S.And with that, we go to the next slide, which is financial performance, and I give the word back to Kristoffer Nordstrom, who will present financial performance.

[Kristoffer Nordstrom, executive]

Thank you. So yes, overall, Q3 was a strong quarter financially, where we not only see continued sales growth versus last year, but also a significant improved cash flow and profitability. So net sales came in on SEK 147 million, and that's a 51% increase year-on-year, where organic growth came in on 37%. And this was primarily driven by the continued use of machine perfusion at our centers globally. Gross profit increased SEK 39 million to SEK 108 million, and the total gross margin grew 1% unit to 73%.As I mentioned, both EBIT and EBITDA were strengthened significantly where EBITDA tripled versus last year. So the adjusted EBIT margin was 10%, adjusted EBITDA margin, 19%. And these adjustments that we are -- we have made are all related to the year-to-date integration costs, which we have previously communicated. And this project has now, as we enter the fourth quarter, been finalized. So in Q3 you had around SEK 12 million that were included in the marketing and sales costs driving that part of P&L OpEx up a bit. Year-to-date sales amounted to SEK 442 million, and that's a growth of 56% where 39% is organic and adjusted EBIT year-to-date 9% and adjusted EBITDA 18%. So overall, we're proud of delivering yet another growth quarter, and we are now entering the fourth quarter with confidence.Moving over to the business area slides starting with thoracic Q3. Once again, a solid quarter with sales of SEK 91 million and an organic growth of 20% for disposables. Here I think it's worth mentioning that third quarter is usually impacted by a lower level of transplant activity at clinics during the summer months. And we could see this also this year, where an example in the U.S., the lung transplant volumes in Q3 decreased 8% versus Q2 this year. And this relation was actually also mirrored in our sales, where we also saw our disposable sales declining 8% versus Q2 this year. But overall, we still feel that we have a very strong momentum and something to continue to build on. So with this said, the development in Q3 this year was strong.We continue to see heart sales in the quarter, SEK 4 million in Australia, which we are of course happy over. The gross margin for disposables were record high, 86%. And here we continue to work hard on our ASP development where we have been successful this year. We also had strong sales of PERFADEX Plus in the quarter, which is our highest margin products, and that contributed to this record level of disposables for this quarter isolated.As a final remark, we're happy to announce that in the third quarter, we saw 2 new hub models in the Europe that were established. So one is a Nordic initiative where a Copenhagen Hospital, the Danish Rigshospitalet will perform EVLP services to 1 Swedish Hospital to start with. And this is the first EVLP collaboration across national borders in Europe. The second one is a collaboration between 2 hospitals in France who recently performed the first EVLP in their project. So great initiatives that we are very curious and happen and we'll continue to support in the future.Moving over to abdominal, we continue to see a sequential growth over the quarters. And this is primarily driven by continued momentum in Europe for liver. Net sales amounted to SEK 35 million, which is a new all-time high. The growth of disposables was once again very significant, 129% in local currencies where 100% was organic. Similar ratio to 2 previous quarters in terms of liver, kidney. So liver sales, 69% and kidney 29%. Gross margin came in on 61%, which is a significant increase from last year's H1. We did not manage to repeat the 70% record level from Q2 this year, and that was because of a lower portion of sales from Italy. But the year-to-date margin increase from 53% to 65% is of course very solid and we're very happy about that.Final business area, moving over to services, a very busy quarter with the integration of -- into the Xvivo. So this is our organ recovery business in the U.S. Q3 sales were SEK 21 million, which means a 68% growth versus last year. Cases in line with Q2. So 148 cases were performed. And year-to-date we have grown 23% in case volume.2023 has been a year where we have put high focus on strengthening our organization and logistics efficiency and this in order to optimize our service offering and to prepare for the new -- for the business integration with the broader Xvivo. And as we have previously announced, STAR Teams is now fully integrated with Xvivo. And by that, we have established a really, really solid platform for growth that is designed to meet the increasing demand for this kind of service. So focus over the next years -- sorry, next quarters is quite simple. I mean, we will continue to renegotiate current contracts and right-size them in terms of profitability. We will recruit more surgeons, that's a high priority, in order to be able to secure new contracts. As we have expressed earlier, the demand is very strong.Moving over to EBITDA. So Q3 delivered sound profitability, I must say. EBITDA adjusted for integration costs were SEK 28 million, and that corresponds to a margin of 19%. And, yes, as mentioned, in comparison to last year, EBITDA tripled. The rolling 12 months trend looks good as well, and EBITDA margin now reached 18%, representing SEK 102 million. And this positive development is primarily a result of the increased sales and strength in gross margins. And as we have highlighted many times before, I mean, we will continue to seek a healthy balance between profitability and investments in OpEx also over the next upcoming quarters here.My final slide, cash flow. Q3 was strong from a cash flow perspective. Operating cash flow gave SEK 25 million, which is the lighting as to continue to build stock, shouldn't forget about that, in the quarter to meet the demand. Operating cash flow rolling 12 months is SEK 51 million now. Investments amounted to SEK 28 million and was primarily invested in our regulatory approval projects such as the heart trial. And this was in line with Q2, if you exclude milestone payments related to previous acquisitions that happened in Q2. And as I mentioned, we carried out the successful capital raise that gave SEK 430 million after transaction costs, which leaves us at a cash position at the end of the period of roughly SEK 600 million, which is of course very good for the future. And that was all for me. And over to you again, Christoffer.

[Christoffer Rosenblad, executive]

Thank you so much. That will bring us into the end of the presentation, which is looking a little bit into the future, the outlook as we turn to Page 19. And after that, we turn to Page 20, and we start with the long-term outlook.Yes, I always think it's important to establish the long-term picture why we're here. We are right now only scratching the surface of this huge opportunity. So it's good to remind ourselves that according to the WHO, the demand for transplants are 10x of today's supply of donated organs. The other thing we should remember is that the sales value of machine perfusion is roughly 10x versus cold static storage. Hence, we're looking at a market opportunity that is very big. The third point which is very important is that now we have a solution to this deficit of organs and resources in the transplant unit first. And that is machine perfusion and service models that have proven to increase number of organs to be used for transplantation. I would say especially in the fast-growing DCD organ pool. The main growth drivers are clinical results from machine perfusion and the fact that service models reduce complexity and time for the transplant clinic. So hence, machine perfusion service models on both normal DBD and standard and extended criteria as well as DCD grafts will drive growth in the near future, which is the next 5 to 10 years.Lastly, on the bigger picture, we also want to mention that to grow all the way 10x in number of transplants, the company believes it's possible to do that with current human donors. However, over time, innovative sources of organs will probably be used. One example is xenograft. And I think the key takeaway here is that for both machine perfusion and new resource of organ or new sources of organs, Xvivo has a proven product pipeline. And this puts Xvivo in a unique position on the market today.So from the bigger picture and the 5- to 10-year outlook, we go into the next year outlook for 2024. We will continue to build machine perfusion through hub and service models. You know that the next step is to integrate service products and establish more service hubs, both in Europe and the United States. For heart, the Heart Box we will prepare for both the European and Australian launch. We have started the U.S. PMA trial and the key aim here is to finalize trial inclusion as soon as possible. And that will be a key focus for the U.S. heart trial next year.For liver, we are aiming for ID submission to the U.S. FDA. And as I mentioned many times during this call and a lot internally in the company, our key priority is to increase production capacity by at least 10x. We will reach an important milestone in -- it will happen gradually but an important milestone in Q2 next year, and then we will have full capacity without any capacity constraints as of Q2 2025 for all products in our pipeline.Then we went through the Kidney Assist Transport launch today. We see encouraging results from the initial launch, and we will focus even more on this opportunity both in Europe and in the U.S. Here what is hampering us right now is the production capacity at the moment. At the moment, the introduction has been from a customer viewpoint, great. So it's all about gearing up production and increasing the sales footprint in mainly in the U.S.So with that, the last point is that we will keep a razor-sharp focus on our key priorities during 2024 to deliver the cornerstone of our long-term strategy.Thank you so much for listening today. With that, we turn to the last slide, Slide 22, and we open up for questions.

[Operator]

[Operator Instructions] The next question comes from Ulrik Trattner from Carnegie.

[Ulrik Trattner, analyst]

A few questions on my end. If I could start off talking or asking about revenues and start with abdominal and what is happening with liver in Europe? What is explaining this high growth beyond reimbursement in France? Just to get some understanding on the higher level of growth that we're seeing in Q3?

[Christoffer Rosenblad, executive]

Thank you, Ulrik. I will start to give an overview of what is happening, and then I will hand over to Nordstrom if he has something to add. But a few things has happened. Number one is that a number of clinical trials has come out lately and been published showing the superiority of both our product and the protocol we use -- so that's one thing we see. So the interest for liver perfusion in, I would say, especially DCD, but we also see convincing results in DBD has been very good results, and then the interest is increasing. That's the number one. We have also a very good sales force in Europe that is working very close to customers and have done under a number of years, and we see -- we start to see that result. So the results we see now in Q3 is not country-specific, but it's more European specific. So we see high growth in France, definitely driven by reimbursement, but we also see high growth in Germany, Belgium, Spain, et cetera. So it's more of all major countries in Europe type of growth we can see.

[Ulrik Trattner, analyst]

And perhaps I can split in another follow-up, what's your estimated market share in liver right now in Europe?

[Christoffer Rosenblad, executive]

That's a good question. We don't have an exact number. We know we are the market leader in liver in Europe, but we don't have an exact number, and it's something we will start to measure over time. But we know we are by far the market leader in terms of machine perfusion for liver in Europe.

[Ulrik Trattner, analyst]

Okay. Great. And staying on abdominal, you're seeing kidney now gearing up, I get around 2 million, 3 million [indiscernible] in sales in Q3. And I know that you're expanding your disposable capacity and expecting that to be sort of gradually stepped up. But is it around 2 million, 3 million that we should anticipate going forward as well that your current capacity and just how we should view to get past ramp up? I know that you're stating that by '25, it should be full operational 10x of what you currently are able to produce, but if you can help us tie that along the way until '25, what we are -- should be able to anticipate.

[Christoffer Rosenblad, executive]

That is a great question. I think what we see now going forward is a gradual ramp-up of our production capacity in quantities being shipped to customers where we will go to have more countries where we fully launch the product [indiscernible]. So that will happen gradually until Q2 next year, 2024. Then we will have, according to the time plan we have, we will have the components manufacturing full scale up and running. That will -- we have 2 positive effects. It will free up some time also in assembly. So we will free up some resources for both liver and kidney downstream in the production. And that will also take away the main capacity constraints we have right now. It's mainly linked to components manufacturing at the moment. So I think the first milestone we look to right now is a gradual uptake month-by-month, quarter-by-quarter until Q2 next year. And then we will see more of a say, lack of capacity constraints, then we know that the need will far outpace also the clean room and the sterilization capacity we have. So that's the next project that we start then during the summer, next summer, where we will scale up that as well to have what we hope is no capacity constraints at all because you should do also -- once we set up this supply chain, it should also be a scalable supply chain. Hence, if we want to grow up from 10x to 20x, that should also be possible with other products and sterilization validations we will perform. I hope you answered the question.

[Ulrik Trattner, analyst]

It did. It did. And how are you prioritizing customers? You mentioned that you just obtained sort of contracts on the first OPO in the U.S. I'm guessing here that is the kind of thing that you would like to prioritize to getting into more OPOs given the price points and the share volume of transplants performed of OPOs in the U.S. Just how are you planning to allocate this increased capacity over the next quarter until full production?

[Christoffer Rosenblad, executive]

In the next, let's say, 3 quarters, we will definitely target OPOs in the U.S. that because they are producing the bulk or the majority of kidneys in the U.S. We will continue to selectively launch in as many OPOs as we can during that period, knowing that there will be constraints, but we will try to get our foot into few during this period until we can, let's say, go full-scale launch also in the U.S. And this is one OPO, there are 55 more, of course. But the good thing is also that the OPOs, they talk to lot of clinics. So the world will spread over time, that one OPO will talk to clinics and those clinics talk to other OPOs, et cetera. So it will have a positive effect over time the more OPOs we come in to.

[Ulrik Trattner, analyst]

Great. And on the thoracic side, think we'll start off with lung and any reason for the strong performance of PERFADEX Plus? Because I see the same numbers that you are seeing on number of lung transplantations performed in the U.S. and seeing a small decline sequentially Q2 into Q3. And if I remember correctly, Q3 last year was not a weak quarter for cold perfusion. So what is driving excess growth of PERFADEX Plus?

[Christoffer Rosenblad, executive]

Maybe I'll start off and then hand over for the detailed numbers to Nordstrom. But our PERFADEX sale is normally a good market indicator because we know that is clinically used approximately the same amount. So -- and since we have a dominating market share in the world on PERFADEX we see that, that's a good indicator on how many lung transplants we made during the quarter. There could be some stocking effects in some quarters. But I believe that, that is a quite limited explanation at least this quarter. The fact is that in the U.S., there is very little stock on PERFADEX [ ultra ] clinics. We have next-day delivery. So if they call us before noon, they have it before 10:00 next morning, so they keep quite low stock. So I believe at least since U.S. is majority of sales, and I believe that's probably not an explanation for this quarter. So we see sequentially it's going down from Q2, and we can see that in our numbers. But we can see year-on-year that volumes are increasing Q3 this year versus last year. Nordstrom, do you want to add something to that?

[Kristoffer Nordstrom, executive]

No, just that it is a bit hard to look at isolated quarters still given the size of the company and the nature of the business. Usually, as you said, it is a good, how do you say, indicator on where the market and the next quarter is leading.

[Ulrik Trattner, analyst]

Okay. Great. And on heart sales, I know there's a slight slowdown in revenues, just shy of 4 million, if I'm getting the math right, in Q3. I know it's limited sales, and I know it's not under full approval. But is this something that is stable volumes or seasonal trend that you mentioned, you have the summer months during this time frame. If there's something that we should look out for in regards to the heart sales. A follow-up to that is it's very positive and encouraging to see that you have included the first patients in the heart trial in the U.S. And I remember that you're getting reimbursement for these patients. Are these patients to be recognized as revenue in Q4 already? Or is that something that we should anticipate first in 2024.

[Kristoffer Nordstrom, executive]

That's correct that there is reimbursement in place approved in the U.S., which we are happy over. And we will be able to build the clinics patient by patient. So you will see revenue already in Q4 that will be ramped up as we include and activate more centers, of course. Christoffer, maybe you have more insight to the Australia sales.

[Christoffer Rosenblad, executive]

Yes.

[Kristoffer Nordstrom, executive]

But I think the good thing of course is that we see that we are on 30% penetration, which is truly amazing. Might mean that there were some stocking, extra stocking in the beginning of the year because they got their -- the last patients included in Q4 last year, and it's in summer, et cetera, but please add Christoffer to brief that more.

[Christoffer Rosenblad, executive]

Yes. No, I can confirm that, that is correct. In terms of -- if you compare it to the U.S., in Australia we don't have next-day delivery. Hence, they need to keep stock at the site in order to have enough supply to perform heart transplant with our heart technology. Hence, that could -- the sales could shift quarter-on-quarter. I think the important is that the underlying usage is still similar to what we have seen and even a little bit more. And the sales pipe we saw in Q1 was driven by definitely some stocking up at all clinics in Australia. So that is the explanation why we see some sales going up and down for heart quarter-on-quarter. But the underlying usage is what is important here, and that is stable and even improving a little bit or increasing.

[Ulrik Trattner, analyst]

Absolutely. Yes. Absolutely. Do you know anything about your current stock levels? And if they follow the same general trend as the rest of the market, where we could potentially see some stocking up here in Q4 or when they are ending their budgets?

[Christoffer Rosenblad, executive]

That's a great question. We are not privy to that information right now, but it's something I will ask our head of Australia, if he has more knowledge on that. But we don't have any -- that information right now, unfortunately.

[Ulrik Trattner, analyst]

Okay. Great. Few more questions on revenue and 1 on OpEx, if I may. Price increases, if I remember it correctly, you tend to increase prices in the U.S. in November and in Europe by the early part of this year. Is this something that you're planning to do for 2024 as well here in November or closing in on November right now? And to what extent are you planning to increase prices?

[Christoffer Rosenblad, executive]

Yes, we are planning to increase prices, similar to what we have seen in previous years, similar amount. We will look at it a bit selectively where we add the most value, and we are, let's say, more underpriced than in some products and some geographies versus others. But we are aiming at increased prices according to -- yes, same procedures last year.

[Ulrik Trattner, analyst]

Great. And then one quick question on 2 European hubs. If I remember correctly, Denmark and France, right? And a quick question is just, are you the only supplier of EVLP to those sites?

[Christoffer Rosenblad, executive]

Yes is the answer to that question.

[Ulrik Trattner, analyst]

Great. And last question, that is on the OpEx side and what happened with personnel costs in Q3, it looks very low, even if including the integration charges that you took here in the quarter. Is there any reason for that? I believe it was at 9% of sales or something like that. Is there something that has been shifted to other sort of places in the OpEx? Or what's --

[Kristoffer Nordstrom, executive]

Are you referring to the admin cost?

[Ulrik Trattner, analyst]

Yes, the admin cost, correct, correct.

[Kristoffer Nordstrom, executive]

Okay. It's a little bit lower than before. It's a natural effect of summer holidays, vacation impact on costs, et cetera, minor reduction of costs due to employees leaving. But overall, looking -- if you give all the -- sorry, in the one-offs and the adjustment costs, we are at 10% of total sales year-to-date, which -- yes, I think that is the level where we are currently where we should be given the sales that we see and predict for the full year.

[Operator]

The next question comes from Jakob Lembke from SEB.

[Jakob Lembke, analyst]

I have a few questions. Starting on thoracic machine perfusion. I think the growth looks sort of lower than previous quarters. Is there anything behind this?

[Christoffer Rosenblad, executive]

I can answer that one. We can see some kind of shift between quarters. We can see YTD gives a better number. But if we compare this Q2 2023 was comparably quite strong and the same with last year Q3 in terms of Lung EVLP were also comparably strong. So comparably high comparable and a little bit stronger Q2 is what we have seen. So I think a more correct view is the YTD in terms of the YTD performance.

[Jakob Lembke, analyst]

Okay. And then just wondering if it's possible to sort of quantify the price increases you've had this year in the different products or business areas.

[Kristoffer Nordstrom, executive]

Yes. So first of all, this is a high focus for a few years now, we have really worked on improving our ASPs, and we've been very successful. If you look at thoracic, the EVLP this year, the ASP growth was 12%. And PERFADEX Plus close to 10%. And these are global numbers. Abdominal, liver sales in Europe, actually 20% increase this year, excluding Italy. So here we have really worked hard and been successful. When we expand to new countries, we have an option to come in on a good price level. When we expand to new customers it's the same thing. So 10% roughly on liver.

[Jakob Lembke, analyst]

Okay. And then on abdominal, I think it's a very impressive growth. You see that you can hold up this kind of high growth when you look into next year. Or is there anything like structurally that we should be aware of looking into the future?

[Christoffer Rosenblad, executive]

Thank you for that question. It's a very good question. I mean we have mentioned production capacity, that will be the main driver of increased growth. Once we scale up production, we will see also growth scaling up. So that's number one. I think if we look at the long-term picture, to have delivery in the U.S. will, of course, be a game changer. So to having the right focus on that project will be key of course. And but besides that, we don't see bottlenecks, so to say, besides the fact that there could be sometimes an effect between supply and sales that when we have supply it takes maybe a month or 2 before sales are really gearing up and meeting the right amount of customers to include them and train them on our products. So we have to work a little bit before the curve with the sales team. So they start training and product training and launching the product into new customers a little bit before so we are ready when the production scale-up comes. I hope that answered the question.

[Jakob Lembke, analyst]

Got it. That's good. Just a final question then on Kidney Assist Transport. I understand that you are sort of moving production facility and unfortunately also for the consumables. Can you give any sort of guidance or help on when this will be done? As I understand that, that will be the main sort of, yes, you losing factor for higher production.

[Christoffer Rosenblad, executive]

Yes. Did you say that the Kidney Assist Transport kits.

[Jakob Lembke, analyst]

Yes.

[Christoffer Rosenblad, executive]

Yes, as I said before, yes, that would be key. The first milestone we look into is components. And the first milestone we have is Q2 2024 to reach that one. After that, we should have less of capacity constraints going forward.

[Operator]

The next question comes from Johan Unnerus from Redeye.

[Johan Unnerus, analyst]

Just a few. The first one, you're clearly investing in services, which is also integrated part of the offer, of course, when -- how should we, over the next 12 months, should we assume that you're sort of investing ahead of the curve, so to speak, you have some pressure on the margin, and of course, you don't capitalize on that side, I suppose.

[Christoffer Rosenblad, executive]

Sorry, one more time, you want --

[Johan Unnerus, analyst]

Yes. You're investing in the services offer quite significantly. And that's of course also an integrated part of the solution offer. And as a result of your investments, I could say to you that is being ahead of the curve, there is also some pressure on the margins. You don't capitalize anything on that side. Should we expect you to step up the offer ahead of the curve also for the next 12 months?

[Christoffer Rosenblad, executive]

Yes. I mean the general question is yes, we will step up there. Service will be very important. It's also very profitable over time because we are solving a real problem at the customers, which is time and resource constraints. So that's something we definitely will scale up. I think we have proven in at least the last 11 years I've been here that we are scaling up with control -- we have a control scale up when we do it. We don't spend a lot of money and normally make huge losses. We had at one, one last quarter that was Q2 2020. So we will gradually increase. Now we have the right people on board, highly qualified people, both in Italy and the U.S. We have mailed the, let's call it revenue model and how we should perform the service, we have very, very good customer interactions where at least the customer feedback I got has been that they're very, very happy with the service and think it is of highest quality. So now it's obviously time to scale up that. And that will happen as poise gradually, where we invest while we grow. Then I think the really interesting part will be when we integrate product and service because then we truly solve all the customer wishes, which would be very important.

[Johan Unnerus, analyst]

And also the ability to secure access to train senior professional surgeons, is that a bottleneck?

[Christoffer Rosenblad, executive]

Nordstrom, you know this better than me, of course.

[Kristoffer Nordstrom, executive]

It's not a bottleneck, but it is of course a difficult factor. I am very pleased working with our recovery service now for several months to hear and to see how of a good reputation we have and our surgeons have. So this is very much asserted to surgeon recommendation referral strategy that I think will be successful, and we are, yes, currently working on it. And I think we'll be able, at least from a surgeon perspective, not need to invest heavily in ahead of a curve but rather work on par as we bring on more contracts in a controlled manner.

[Johan Unnerus, analyst]

Yes. And heart Europe, you alluded to that there is some -- could be some delays in the submission. I mean there's never zero risk. Is that something you can expand on? And when can -- when can you provide some feedback on the submission?

[Christoffer Rosenblad, executive]

No, no. Other way around. There is no delays in submission. We have submitted. So it's all done. And the initial feedback was that it was very good quality. We've got very good -- or very few questions and feedback on the files we have sent so far. So we are definitely on time. I just want to point out that [indiscernible] MDR is that we aim for launch Q2. We still do that. But you never know, so to say. They are under a lot of work pressure. But we are definitely doing our part of the equation, so to say. And what we can do is to hand in on time. So they have a window for checking the files and hand them in at the best quality. So it's very clear for them what they are considering for approval. So far, there is no signs of any delays, but I know from a fact that all notified bodies in Europe are under high workload, so to say. And we can't affect that. I want to be very transparent, not more than that. So I don't want to -- no alarm bells, but I want to be transparent here.

[Johan Unnerus, analyst]

Yes. And you also confirm that you are aiming to secure compassionate use in some selected markets in Europe? And when can we get feedback and clarification on that?

[Christoffer Rosenblad, executive]

We will get feedback and clarification on that hopefully during this quarter. We have obtained in some geographies in Europe. And we are currently discussing that in the heart team right now, how much resources and where we should put on compassionate use in Europe. So we will act during next quarter.

[Johan Unnerus, analyst]

And finally, study publication from Australia and New Zealand, the sort of very expensive publication. Is that, do you see them or --

[Christoffer Rosenblad, executive]

That's a good question. I don't know exactly when in time it is. So I will ask my CMO and we see when in time that will form because that will obviously be a high-impact publication. Indeed.

[Operator]

[Operator Instructions].

[Christoffer Rosenblad, executive]

I think that there is -- is there any more questions? We are 9 minutes or 10 minutes over time. If there are maybe one last.

[Operator]

The next question comes from Ulrik Trattner from Carnegie.

[Ulrik Trattner, analyst]

One question on my side. Just a quick one on STAR and if we should expect sales? And what's your view on the latest sort of integration and expansion in the U.S.? And if you're seeing more contracts being signed and growth expecting to accelerate from here? Or what's the current trend for the STAR now?

[Christoffer Rosenblad, executive]

Basically where we are is that we have right-sized the organization and worked very hard with integration. That has now been completed end of Q3. So going forward, we will be there for new contracts, so to say. It's hard to say exactly where we will end up, but we will work very hard to sell our services, both in the geographies where we are present, where we have the hubs, which is eastern United States. If you take from Chicago down to Texas and you go East. We will also expand our service network to the western part of the U.S. But we see high interest for our service model. We see a very high interest for a combined service product offering. So we don't feel that there are any type of constraints there. It's all to scale it up within -- that we scale it with control scale. That's what it's all about now because it's a service, you take care of somebody's organ for clinics. You have to do it with the best, best, best quality you can.

[Ulrik Trattner, analyst]

Okay. So you have by extension more sites, than mean more contracts, which should mean another step in terms of the revenue.

[Kristoffer Nordstrom, executive]

Yes. Correct.

[Christoffer Rosenblad, executive]

I see there's one more question.

[Unknown Analyst]

I just have a quick question on the installed base for the XPS system. Last quarter, if I remember correctly, there was 1 additional system installed, but you didn't state any data on this for this quarter? Do you have any additional insights?

[Christoffer Rosenblad, executive]

That's a good question. Nordstrom, who has that knowledge has actually just jumped off the call because he had another meeting. The model going forward is that we go more for a hub model. So we do install systems in new geographies mainly. But in existing geographies, we try to pull the EVLPs to existing XPSs. So the most important news this quarter was the hub model in Copenhagen and the hub model in France, that we are hence not placing a new XPS there, but we have a new clinic that we connect to an already existing XPS.

[Operator]

There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

[Christoffer Rosenblad, executive]

So much for all your questions and for listening in to the Q3 2023 interim report earnings call. I hope to see you back in January where we will report the full year 2023 and Q4 as well. So until then, I wish you a good day. Thank you.