Ladies and gentlemen, welcome to the XVIVO Group Interim Report Q3 2022. For the first part of this call, all participants will be in a listen-only mode. Now afterwards, there will be a question and answer session. I will now hand over to Christoffer Rosenblad, acting CEO. Please go ahead.
Thank you so much. Welcome to you all to XVIVO's earnings call for the third quarter of 2022. I move over to slide number 2 on the slide deck. Today's presenters are myself, Christoffer Rosenblad, acting CEO for XVIVO, and Kristoffer Nordström, CFO that you met before. As you all know, our CEO, Dag Andersson, passed away a month ago, and I assumed the role as acting CEO immediately. Our thoughts are with Dag's family. For the ones on the call that don't know me, this is actually my 34th quarter earnings call, but my first as acting CEO. I worked for XVIVO for 10 years, where 8 as CFO and 2 years as CEO and business development director. I was CEO for North America during 2016 to 2017, and I've been serving as deputy CEO since 2017 until now.
Let's move over to slide number three in the deck. Here we see the finances at a glance. I'm proud and very happy to report that Q3 was the strongest quarter ever posted by XVIVO, with sales of 97 million SEK and an organic growth of 35%. We are also very pleased to see both high growth and high growth margin for disposable products. Our CFO will give you more details on our financial performance later in the presentation. Which brings us into slide number four, and that's the Q3 highlights. We move fast on to slide number five. Let's start the highlights with our sharpened strategy presented at our Capital Market Day, a little bit more than a month ago. Our vision is still that nobody should die waiting for an organ.
This is a very strong vision that comes from the organization, and I dare say if you wake up anybody in XVIVO in the middle of the night, and you ask them what's our vision, they will answer this. We know that today only 1 out of 10 that needs a new organ actually get transplanted, so there are still a lot to be done to fulfill our vision. Our financial goal is to gradually improve EBITDA levels to above 30% in the strategy period. The economic engine is unchanged, it's revenue per installed machine. The strategic focus areas are in all essence the same, but developed and sharpened this year. The updated strategy put more emphasis on acceleration of our market leadership in lung, as well as a broader definition of new market expansion.
For example, Brazil has proven to be a future important market for XVIVO. We have a large part of our portfolio already approved in Brazil, and it is the third-largest abdominal market in the world, as well as being the largest insurance market outside the US. With that, we move to slide number six, and I wanted to update you on our latest acquisition, which is the Avionord Machines & Perfusion. They are today our distributor in Italy, so this is a forward integration case. If we move into slide seven, I will explain where it fits in the value chain of the transplant process. As you see, Avionord fits very well into the XVIVO offering. They have perfusionists employed. They are offering expertise and support during machine perfusion.
Together with this acquisition, XVIVO now offer all parts of the transplant process where an organ is outside the body. With that, we move to slide 8, some more details on the acquisition. In short, Avionord Machines & Perfusion has adopted a revenue model that is based on revenue per procedure rather than only revenue per kit, and that is highly appreciated by its customers. As you can see, in Italy, they are active in 15 out of 22 liver clinics today. The acquisition is financed to a 60% share and 40% cash, and this will make the owner family of Avionord Machines & Perfusion shareholder in XVIVO, which we think is very good. The acquisition is estimated to be completed in the next couple of weeks.
If we move to slide nine, we see the strategic rationale. The main reason for the acquisition is that it clearly supports our strategy, seen on the right side of the presentation. The long-term opportunity for XVIVO's products with Avionord's business model is fantastic. The deal rationale is that we secure Italy, which is Europe's largest liver market. We also get an option for an organ transport port called GISTO. It's developed after the transplant process and could be used long-term in more countries than Italy, obviously. More importantly, the business model of Avionord Machines & Perfusion is interesting because of three main reasons. The first one is it increases the machine and perfusion market penetration. For example, today in Europe, the liver market penetration is approximately 5% for machine perfusion.
It's a little bit different country by country, but roughly there. In Italy, it's between 20-25%. The second reason is that it gives high customer satisfaction since it removes customers' resource hurdles. If we, as Avionord Machines & Perfusion, can take care of machines and running it optimally, the clinic can focus on the transplants, which is what they do best. The third reason is that the gross margin is higher for this type of business model. We will see that in going into 2023 next year that we will come closer to our abdominal gross margin target of 70% over next year. That was the latest acquisition. With that we move over to our core business on slide ten. This is thoracic business. We can skip over to slide eleven very quickly.
On slide eleven, we can continue to see a very good momentum for EVLP. I'm very happy to announce that we have eight new XPS machines installed this year, and that's a new record. The XPS machines are mainly sold to customers, but as we said before, we can sometimes place them for a higher price per kit, or there is a leasing contract. As we see the activity on EVLP is increasing after COVID, and we show strong growth. We can YTD is 40% organic growth, and in the quarter alone, Q3 alone, we can see that 104%, which is very high. Albeit we should say it was a quite low comparable Q3 last year. On the other hand, we see quite high comparable Q4 2021.
We're still very happy with the year-to-date number, and we are very happy that we can see that we're out of COVID. The next part in the dark blue is that we are pursuing hub models, and we can see that newly published study shows that that is the correct way forward. For example, this study that was recently posted in The Journal of Heart and Lung Transplantation showed that we can use not accepted lungs, but after EVLP being usable for transplantation with similar results as pristine lungs in the control group. The study also confirms what we knew before, but that the use of EVLP increases the use of DCD organs. DCD organs is the fastest-growing donor pool today, both in the U.S. and outside the U.S.
Naturally we go over to slide number twelve to take a look at the market in number of transplants. This picture confirms what we said before, that COVID is now losing its grip on the transplant market, and we can see that in American transplant data. We see gradual recovery of total lung and lung transplants Q-on-Q and year-on-year. We're not 100% back to where we were in 2019, but when we talk to clinics, they believe that we will be there very soon and hopefully already in 2023. That was the thoracic business, and we move to slide thirteen, where we have the abdominal business. Go to that.
We skip ahead to slide fourteen, where, to start with, very happy to announce that our abdominal products, Kidney Assist Transport and Liver Assist, both cleared in the EU. We have therefore secured the product for sales and marketing in Europe for the future. An enormous amount of resources and effort has gone into this task, and I'm very thankful to our abdominal team down in Groningen, as well as our QA/RA team on a global level. They've done a fantastic job here. I'm also very, very pleased to report that the Liver Assist has been granted breakthrough device designation by the FDA. This will mean that we get a faster way through the FDA PMA process. It's also a quality stamp that the products are innovative and fulfill the need on the market.
With that, we move to slide sixteen, which is the Kidney Assist Transport update. The Kidney Assist Transport with oxygenated perfusion has, as we earlier reported, shown great results compared to what is available on the market today. For example, the Kidney Assist Transport showed 97% one-year graft survival versus only 90% in the control group for DCD kidneys of donors older than 50 years. We got 510(k) approval in Q1 and have during the year received great interest from American clinics and OPOs. During the year, we collected American user feedback and improved the product. We are also in the process of ramping up production on machines to satisfy the demand we see. We prepare for an accelerated launch in both the US and Europe during Q1 2023.
That will bring us to the last part of the business update, which is our clinical pipeline on slide number sixteen. We go over to slide seventeen right away, where we see the studies we are currently running. To start with, the heart preservation product is a truly innovative and a paradigm-shifting product. They have, among other things, enabled DCD transplants, as well as pushed the out-of-body time to almost 9 hours with very good results. That should be measured to what is standard of care today is roughly 4 hours out of body time today. As I reported earlier, the product consists of a machine and disposable and a new innovative perfusion solution that is very important for reaching those results.
The studies we are conducting are for the HeartBox are currently two to prove benefit and get market approval. In Europe, we have now included 75% of our patients in the study. We are still aiming to launch in Europe in the beginning of 2024. The Australian study is almost finalized inclusion, and the data will soon be featured in scientific journals around the world. The clinics we talked to are very happy with the HeartBox. As you heard Professor Macdonald say during our Capital Markets Day, the results are very good, and it would be considered unethical to not use it for transportation of hearts, which is probably the best results you can get from and hear from the HeartBox during the study.
In the US, we have submitted our IDE application, and as usual, there are discussions with the FDA. It is very encouraging that we have a great team assembled. It's high interest from really the best clinics in the US, high volume, high impact center, and they have also committed to be part of the study. We will start the study as soon as we get the green light from the FDA. We don't know exactly when that is, but feel we are definitely closer now than before. Lastly, our PRIM-PERF study and our PrimeMed product. It's a very interesting product. It's a CE-marked product, actually. We don't sell it today, but it is CE-marked. We could sell it. It has shown very good results in a smaller 40 + 40 patient study.
What we're doing now is that we are doing a larger study on a smaller patient group, and we aim to finalize inclusion during 2023. We are very happy that it's up and running again after some COVID restrictions have been hampering the inclusion rate. With that, I move over to slide eightee, which is the financial performance. With that, I also hand over to our CFO, Kristoffer Nordström, who will present the financial performance. Thank you so much.
Thank you for that, Christoffer. Yes. First some overall comments on our P&L, and then I will present the highlights for each business area as usual. XVIVO follows up Q1 and Q2 with a solid third quarter, proving especially that the good momentum within disposables continues and more so, especially within thoracic. Net sales Q3 amounted to SEK 97 million. We are getting closer to 100 million SEK, which will be a great milestone for us, and a 76% increase versus Q3 last year. Organic growth in local currencies, most importantly, was 35%. Acquired growth, 22% comprised by Star Teams, and currency effect was 19%. As you all know, we are in favor of a strong US dollar. Q3 gross margin was 72%, an improvement versus 69% last year.
Both EBIT and EBITDA was strengthened in Q3 versus last year. EBITDA margin was 10%. The margin would have been 14% if we were to exclude some one-offs related to organizational cost of sale. I'll come to that at a later slide here. Year to date, we present an organic growth of 35%, and a significant gross margin improvement on disposables. That is of course both pleasing and promising. Moving over to the next slide, which is the thoracic business area and Q3 highlights. Thoracic delivered another strong quarter and continues to deliver growth. Net sales amounted to 71 million SEK and the organic growth was 45% in local currencies. Our growth comes from where it should come from, right? Increased sales of EVLP.
EVLP sales in Q3 more than doubled versus last year, and the growth year-to-date is about 40% versus last year. Our focus on price increases, we feel that that's paid off, representing around 12% of growth. As you can see, in the donut, so to say, in the middle here, US was particularly strong in Q3, which is delightful since it is our most important market. Three XPS machines was delivered, two in the US at very interesting centers, and one in Italy. We have now delivered 8 machines during the year. As Kristoffer said, that is a record, and we're very, very proud over that. Gross margin disposables continues to be good, 84%. That's 5 percentage points better than last year.
Thoracic, as you know, that's more of a mature business for us. We see strong margins, also due to economies of scale. Okay, moving over to abdominal on slide 21. Net sales came in at 14 million SEK. Sales were mostly comprised of liver sales in Europe. Growth of disposables, most importantly, was good, 32% versus last year. Total growth was 8%. Organic growth in total, 1%. The reason for that, for the kind of low growth, is the fact that the machines were delivered in the quarter without invoicing them. As you know, that is part of our new strategy of placing machines up to the volume commitments and higher prices on the kits. You don't really see any machine sales in the non-prescribed quarter. There was a handful of placements.
Most important here, 32% growth versus last year on disposables. Gross margin on disposables was 51% versus 63% last year. The decrease there is primarily due to a high portion of distributor sales within this quarter. That is a fact that we most likely will not see in the future because Avionord acquisition. As you know, Avionord is 25% of our total abdominal sales at the moment. With them not being a distributor in the future, that will have significant impact on our gross margins. Looking year to date, gross margins in abdominal have increased from 51% to 53%. That's good. Abdominal, as you know, is not yet a mature market for us. For that reason, we don't yet see economies of scale, but that will come.
As communicated on our capital markets day, our margins within abdominal will increase in the next few years, fueled by the introduction of service models such as Avionord model, but also the launch of Kidney Assist Transport in the US where the pricing points are much higher, as you know. Moving over to services. Services consists of STAR Teams and their organ recovery business in the US. We acquired STAR Teams in November 2021. This was the third full quarter including this business. As Kristoffer said, there is a big interest in the US for this service model with outsourced organ recovery. One new contract was secured in Q3, and we will see that come into effect in Q4. We have a handful of other leads out at the customers and discussed with the customers.
In parallel with this, we will focus to invest in the organization to find more surgeons, especially, in order to secure future capacity. The integration with Star Teams' product offering has not yet started. There are really no synergies in these numbers at the moment, but we expect to start this and to see this during 2022. Net sales was SEK 12 million, and that represented a sales growth of 23%. Moving over to profitability and EBITDA. Rolling twelve EBITDA margin is 13%, representing SEK 46 million. Our gross profit has increased with increased sales, but during the last twelve months, we have also invested heavily in the organization and also in initiatives to support growth and to continue to build the market for machine perfusion. Adjusted EBITDA in the quarter was 10%.
Excluding some one-offs for organizational costs, EBITDA was 14%. We had some organizational costs, primarily legal costs, for a case that is now closed and with a positive outcome for XVIVO. This was just another quarter with a positive EBITDA. In terms of increasing EBITDA, we foresee this to happen gradually, year by year, during the strategy period, as communicated on the capital market day. Moving over to my last slide for this session. The financial position and cash flow.
Operating cash flow Q3 was positive, was good, plus SEK 17 million, and that was mainly a result of the increased sales that we have seen now, both in Q2 and Q3, but also a very, very good work from my colleagues at the finance department in collecting payments from customers. We reduced the working capital quite a lot. Investment amounted to SEK 34 million, primarily spending in our clinical projects, and that led to a total cash flow of minus SEK 18 million. Finally, just a heads-up on the Avionord acquisition. We expect this transaction, as Christopher said, to be closed in Q4. The purchase price is maximum EUR 12 million, and there is an initial purchase price that is maximum EUR 9.6 million.
40% of this, so SEK 3.8 million, will be paid in cash, the rest in new share issue. There will be a cash effect of roughly SEK 4 million in Q4. There is also an additional purchase price, an earn-out of a maximum EUR 2.4 million, and that is expected to be paid out in Q1 or Q2 2024. That was all from me now, and I'll hand over to you again, Christopher, and you will talk a little bit about our outlook.
Thank you so much, Kristoffer, for your view on the financials. We will take a look at first the helicopter view on the big picture and then the outlook for the next 12 to 14 months. If we move over to slide number twenty six, it's a more helicopter view, which I think is good to always start the outlook with. I mean, the demand for transplants is still ten times the supply today, which we have mentioned earlier. It's also good to note that the sales value of machine perfusion versus cold static storage is roughly 10 times as well. I think a great example is lungs, for example, Perfadex is bought for a box and some ice. It's roughly around $3,000 and then even the XPS is roughly around $30,000.
That is roughly where it is. Machine perfusion has also proven to increase the number of organs used for transplantation, especially the fast-growing DCD pool, which is the future source of, let's say, new organs as well as DBD organs not used today. That's all we can see, that we have a great opportunity to use machine perfusion to improve the life for many patients that today unfortunately die on the waiting list. Over to XVIVO. We have a unique and innovative and world-leading products on the market or in the R&D pipeline as you have today. We also have a strong management team and a strong organization in place. We are ready to deliver on the strategy presented in September during our Capital Market Day.
With that, I move over to the little bit closer outlook on the next 12-14 months on slide number twenty seven. The fourth key point we focus on is one, is machine perfusion, our core business. We see continued momentum through our hubs and service models. The next thing we would do is to integrate Avionord in Q4. Of course, we have our Kidney Assist Transport, where we will have scale-up production. With that, the very good customer feedback we have, we now will be ready to ramp up in 2023, both in the US and actually launch the new Kidney Assist Transport in Europe. Focus. We put a lot of focus on our Heart Box, which is a truly innovative product that can change the paradigm of transplantation as we know today.
During this and next year, we will prepare for commercial launches in Europe and Australia, New Zealand. We also aim to start the PMA study in the US as already communicated. The last point, number four, continued price increases. You can see that we are underpriced versus competition. We also know that we find ourselves together with all other companies in the world in an inflationary environment. This leads us to continue to increase prices where we have true uniqueness on our products and where we can save money for the healthcare system as a whole, which our product can do. With that, we move to slide 28. Thank you very much for listening today. With that, we open up the lines for questions.
Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad now. Once again, that is zero one to register for a question. Our first question comes from the line of Ulrik Trattner from Carnegie. Please go ahead. Your line is now open.
Great. Thank you very much. Good day, Christoffer and Kristoffer. First of all, my condolences regarding Dag. I would like to start off with the Avionord acquisition, if I may, and I'm sorry if I missed this, but when is the acquisition planned to be completed here during Q4? Just to get a rough idea how much to include for Q4 numbers.
Well, that's a good question. There were two conditions precedent that are one we passed, one we hope to clear in the next couple of days. That's the last I heard. There will of course be some days to actually complete the acquisition. We hope that we can do it in mid-November.
Okay.
The legal, some legal days.
Great. Again, sort of regarding Avionord, Italy seems to be quite a unique market when it comes to relationships between businesses and especially in the field of healthcare. I know obviously there's good penetration in Italy. How, sort of how many markets have you identified elsewhere in Europe where that you can replicate the same type of forward integration and expecting the same type of results?
That's a very good question. Today, there are in Europe very few companies similar to Avionord. But we have identified a few markets in Europe where we could build or replicate the model, which is open for it. Typically you can see, Benelux is such a market, where they have opened up for it. Switzerland is a similar market, where we think this model would work. I think for me, the biggest market where this would have an interest is obviously the U.S., where there are already service models in place.
You wouldn't be afraid that that would infringe with your current collaboration with Lung Bioengineering?
It depends product to product. I mean, in terms of abdominal, Lung Bioengineering is not present today in kidney, for example.
If we were to keep on the topic of services, are you happy with the development of Star Teams, 23% growth here? I note that you're adding some additional sort of recurring revenue clinics to the portfolio, but are you happy with the development of Star Teams and what are sort of the main limitation for growth in that business? As well as, you previously talked about expanding the product portfolio to abdominal. Do you have a time point for when that is about to happen? As well, this might be a long shot, but is there any possibility at all that the Heart Box under the PMA route in the U.S. would in any way be used by Star Teams in a clinical trial setting?
Is this way too optimistic to assume?
Thank you for your questions. To start with, we would have hoped for higher growth on the service model. For sure there is a market for it. We are currently on a shortage of surgeons actually that's what's hampering the growth, not the customer demand at this moment. We will investigate. All your other questions, we will need to view together with Star Teams and XVIVO for, let's say, a strategy going forward. We have previously chosen not to integrate the two companies to let Star Teams grow. We now see that there are greater opportunities for integration than we earlier anticipated.
For example, what you mentioned with the heart trial in the U.S. is a great example where I know there are interest among our clients that Star will, well, trial clients, trial clinics, that there is an interest that Star do the retrievals of them and actually do the machine perfusion. So we will come back with a more precise answer to your questions after our mid-November strategy meeting, XVIVO and Star together, where we will define, let's say, development plan going forward. You can expect a further integration between the two companies because there are a lot more commonalities than we initially anticipated between the two revenue models.
Great. On abdominal Kidney Assist Transport, it looks like there's been a slow sales ramp up since it was approved. If I'm not mistaken, just taking out the US sales from abdominal, it's slightly below SEK 1 million in sales for Q3. Could you give us any indication on when you're really planning to do a wide commercial launch of this, as well as could you give us an indication on how many systems that have been placed thus far?
Thank you. Yeah, I think I wrote that in the CEO word as well. We can expect the reason there hasn't been a wide launch yet is the production capacity. We are currently working very hard with ramping up the production capacity and we hope to have finalized that end of year. We expect a ramp-up launch, if we call it that, during Q1, both here in Europe, where we have the whole Kidney Assist and in the US as well. We have a limited because we can still produce it, though lower volumes.
We have a limited number of chosen customers in the US where we have performed a pre-launch type where we collect customer feedback and try to improve the product while we ramp up production. That is the reason why we haven't seen a faster product take up. Interest is very high and I know we have a very frustrated sales director in US who really want to sell this product because both clinics and OPOs really like the product. It has great clinical results, especially on the DCD side. It's a very good product overall. I'm really looking forward to next year when we can see the real impact of this product.
Hope that answers your question.
Yeah, absolutely. Just regarding the production capacity, because if I'm not mistaken, now all products are approved in Brazil. Obviously Brazil is a huge market for abdominal transplantation. I'm guessing that the Kidney Assist Transport is going to be an important product on that market. Do you believe that there will be sufficient production capacity to serve both the U.S. market and
The Brazilian market from 2023, and are we to expect any meaningful revenue contribution from Brazil in 2023?
To answer the first question, we will not launch a chemotherapy transport in Brazil in June 2022. We will focus on Europe and the US, mainly. There might also be a need in Australia for it. Regarding Brazil, yes. We focus on that, as I say, the first growth market outside Europe and the US, because of the regulatory situation. I think that we will start to see meaningful revenue in the beginning of 2023 from Brazil, yes. That we will gradually ramp up year on year.
Great. Last question on my end. Is there any updates regarding XPS approval in China?
No, I don't have any updates right now on the XPS approval route. I need to come back to you on the next call. The only thing I know is it's looking good, but I don't know. I heard that before, so I don't know exactly where they are in the process, but I will figure out, and during the next call you will know.
Yeah. Timing in China is always uncertain. That was all my questions for now. Thank you very much, and I'll get back into the queue. Thank you.
Thank you.
Thank you. Our next question comes from the line of Dylan van Haaften from Bryan Garnier & Co . Please go ahead. Your line is open.
Excellent. Thank you guys, and congrats on the quarter. My condolences as well. Perhaps staying on that topic of Dag's very large shoes, maybe as a first question to you, Christoffer. Is taking on the CEO role something that is in a more permanent fashion? Is that something that's on the cards?
To answer that's obviously the board's decision. I mean, their main job is to hire and fire the CEO. It's something you have to ask them. Yeah, of course, it's in the cards, so to say. It's their sole decision to take, and not mine to have an opinion of.
Understood. Maybe then to move on to one of the other things on the XPS placements this year. I think you've done very well. Are these add-ons, new installs, replacements or new centers? Could you qualify that a little bit?
Jens, do you wanna take this question?
Yeah. Yeah, yeah. Sure. 3 new XPS machines in the quarter. 1 was sold, 2 was placed. 2 very exciting machines in the US. The first one is. It's an Oklahoma clinic, as you wrote in the report. With support from Cleveland Clinic who is the one of the, as you know, one of the hospitals with an absolutely great EVLP programs in the US. They will support and share the knowledge so that they can build a regional hub in Oklahoma. So that is, of course, very promising, and they have great ambition. The second one is Brigham and Women's Hospital in Massachusetts, who is also a very prominent hospital who will kinda restart their EVLP program.
They took a hit during COVID, and they have also now great ambition. We also have it seems very promising. Third one is an Italian one, Padova. It's a smaller volume center, but with our relations and support also from Avionord, we believe that can also be very interesting in the future.
Excellent.
Thank you.
Super exciting. Maybe then a question on, and I'm not sure if you guys can answer that, but just obviously everybody's waiting for the sort of the approval of the IDE plan. Could you perhaps remind everybody on the planned centers and enrollment targets and potential timings we could think about once the IDE approval comes in?
For the Heart Box in the US,
Sorry, yeah, for the Heart Box.
I mean, yeah. We will try to focus on a few high impact centers who can enroll at a fast pace in this trial. We hope as soon as we get the IDE and can get started, we believe we can start more or less right away because we have geared up with the right organization behind it. It's always hard to estimate your inclusion rates in the study. Given the clinics we have on board for the study, we believe it can be comparatively quite quick to the earlier studies we have had in the U.S. or in Europe.
Understood. Maybe just a final question from my side. Just on Star Teams, I felt there is definitely sort of a sense of improvement there sequentially. Could you tell us a little bit about if you have changed anything in your initial strategy from when you've acquired the company, and what you're kinda seeing in the marketplace and how you guys are sort of meshing with the Star Teams team over in U.S. right now?
Yeah, that's a great question. I mean, to start, we see huge interest for a service model in the U.S. For many reasons, but one is that the transplant teams want to increase their capacity and do more transplants. They see that, for example, retrieval of organs is something they can outsource to actually do more transplants because they all want to do transplantation. We did change lately since, let's say, only a month or two ago. I had many discussions with our team CEOs, Dr. Magnus Nilsson said, about integration. I mean, from the beginning, we thought that we would give it three years to build up the service model alone.
Now we see that we can reap the benefits of an integration a lot faster. That's what we decided to do. We will initiate that work in here during November. We all know an integration take longer than a month or two. It will probably take a year to fully reap the benefits. We do see great results from the kind of start of integration we have done already. We did a soft start from kind of mid-August on a few issues like logistics that could be more helpful.
We do see that we can reap more sales revenues, and also some, let's say, cost revenues and combined product service model integration benefits from having a faster pace on the integration. That's where we are right now, where we will initiate that work here mid-November. Excellent. Thank you so much. Those were all my questions. I'll hop back in the queue. Have a great day, guys. Thank you. Thank you so much for your questions. Thank you.
Thank you. Our next question comes from the line of Peter Östling from Pareto Securities. Please go ahead, your line is open.
Yes. Thank you, guys. Of course, I provide my condolences as well for Dag's shocking departure. Thank you. A couple of questions. Start off with, you said that with this placing of the 1 XPS machine in Oklahoma, you are aiming to expand this hub-like model in the US. I was just wondering how Lung Bioengineering would react to that. I mean, You take it, Jonathan. My comment here, I mean, I would say as XVIVO Lung Bioengineering, I mean, we share the same vision that nobody should die waiting for a new organ. It's in their interest that that vision will be fulfilled to their max, so to say.
They also have ambitions to start and establish more hubs as well, looking further west in the U.S. I don't think we experience that there is any concerns from their side. Yeah. Well, maybe have you discussed expanding the hub system together? Yes. Christoffer Rosenblad. Yes, it's something we discussed with them on a let's say ongoing basis. I think both we in XVIVO and everybody in Lung Bioengineering realize that it's not gonna be one player pulling this off. It's a huge market having in front of us. Very big to fulfill times 10 of today in terms of number of transplants. It's a huge task.
I think we all realize that there will need to be more players, and we need to do this together, if we are to succeed. Okay. Keeping on the hub topic, but moving to another part of the world, can you give us a brief update about the situation in the U.K.? If you take Europe in general, we can see the same trend as in the U.S., that interest for hub models is increasing. We are seeing that more and more hubs are to be set up in Europe. We are in the U.K., the center that will lead the hub there are still in negotiation with NHS.
Right now, they have come back to us and said, "Yeah, we might wanna start anyway because we can't always wait." We are still in, let's say, a mode where we want to maybe go ahead anyway. That's where the fever is in the UK. The interest is really, really high. There are unfortunately some red tape need to be cut together with NHS. The clinics in the UK want to start now.
Do you know what might be the concerns from the NHS? Because I, as I remember, NICE has put out some positive recommendations regarding the use of XPS.
Yes
in the U.K.
Yes, that's correct. I haven't seen exactly what they said. From what I understood, it's more of a cutting red tape issue right now, which take longer time than the clinical investigation.
Moving over to the Avionord acquisition. At the time of the acquisition, you were going to issue some shares at a significantly higher value than where the shares trade today. Is the number of shares fixed? Is that the swing factor for maximum, or will you release more shares now, when the share price has declined quite significantly from the SEK 222 that was mentioned in the press release?
No, no. Thank you. Thank you, Peter, for a good question. No, we have press released the number of shares and that can't change, so to say. It's based on the 10-day feedback before the signing of the deal.
The signing of the deal, that was done in April then.
August. Yeah, August.
August.
Very long.
August. Sorry. Okay. Sorry.
Yeah.
The price of that portion is more or less fixed.
Yes. We will see that in the press release.
Just finally, back on the service model in the US. Have you seen any effect on sales related to the expansion of this national OCS program that TransMedics is pursuing?
We have heard about the program, and we have, let's say, to date, not seen an effect of it. We know TransMedics are quite aggressive on the U.S. market right now. That would be.
Okay. You haven't seen any effects on your service model because I guess when you see how they want to pursue it's a similar kind of model that they want to integrate the entire chain from the donor to the recipient.
Yeah, that is true. I mean, we haven't seen any effect on our sales, so to say, from that model. We are aware of what they're doing and they're obviously, since their last capital raise, quite aggressive on the American market. We don't see a direct effect right now. To be honest, we go after slightly different customers with very different models, so to say.
Even though on the first look, it looks very similar, but the Star offering is more of a retrieval service, while the TransMedics model is more they go after organs, that, let's say, the clinics would not go for. I think where we would see, for example, if we have a perfusion hub and the Star model together, that then our two models would be in more competition. Let's say Star-based model, it's quite little competition from TransMedics to date. It might increase in the future, but that's what we see today. While definitely, if we would go after the same type of organs, for sure, for machine perfusion model in a hub, then there might be more of a competition.
Yeah. As you have alluded to, that's you want to integrate the XPS and the Star Teams model more, and then it would be more similar to the NOP-
Yes
That TransMedics. Okay. Can I just ask a short one finally. When you received the breakthrough medical device designation for the Liver Assist, did you get any kind of feedback from the FDA regarding the two liver machines that are already approved in the U.S., the OrganOx and the OCS Liver?
Um, there's no-
How your Liver Assist would compare to those machines?
To start with, it's a slightly different approach. The two ones approved today are for warm perfusion of livers while we are pursuing a cold perfusion model for livers. It's slightly different, but the good news is that when there is something approved by the FDA, it does help to be, let's say, number two and number three. We've seen that very clearly with lungs where we were number one and had to pave the road for everybody else. That's a lot more of a task than being number two and three. We think that the two prior approvals will be of great benefit.
Well, I acknowledge that you use cold and then they use warm, but I believe the aim is still to expand the number of available organs. That's why I asked the question.
Yeah. Yes. Yes. I mean, definitely that's the aim of it and especially to that, as well as improve organ quality and graft survival, are the main aims for both, let's say, all of our models. That's why we're here on the market.
Okay. Okay. Thanks, guys.
Thank you so much.
Thank you. As we currently have no more questions registered, I hand back to our speakers.
Thank you so much. The clock is actually coming very close to 3:00 P.M. Central European Time, and this call is over. I thank you so much for listening to this quarterly earnings call with XVIVO. Thank you very much for all the good questions. I hope to see you in January for the Q4 earnings call. Thank you so much.
Thank you.
This now concludes our presentation. Thank you all for attending. You may now disconnect.