Ladies and gentlemen, welcome to the XVIVO report on operations 2022. For the first part of this call, all participants will be in a listen-only mode. Afterwards, there will be a question and answer session. I will now hand over to Christoffer Rosenblad, CEO. Please go ahead.
Thank you so much, welcome to you all to XVIVO's earnings call for the Q4 of 2022, and also on the report and operation for the full year 2022. With that, we go to the next slide. Today's presenter are myself, Christoffer Rosenblad. I'm CEO of XVIVO. On the side, I have Kristoffer Nordström, CFO, who will give you a deep dive into the financials. With that, we start the actual presentation. On slide three, we find the financials for Q4 at a glance, and I'm both very proud and happy to report that Q4 was the strongest quarter we ever had, posted by XVIVO. Sales reached SEK 132 million, and we have an organic growth of 27%.
The total growth of 53%, where we had some good tailwind from currency effects as well as acquired growth. Very stable EBITDA on 15%. We can also see that we show good growth on disposable sales for all product areas as well as good growth margins. We see growth, stable growth, high growth in all our areas where we invest in, which we're very happy with. If we go to the next slide, we will see the same picture for the year 2022. Again, very proud and happy that we set a new sales record of about 400 million SEK and strong growth of about 60%, whereof acquired growth was 15%, organic 30%. We see local currency growth in all product areas being very strong.
You can see definitely disposable sales are driving our growth, overall growth, organic. Good EBITDA level for the full year. We are still very happy with this 2022, where we passed many milestones and still managed to show growth and profitability. We see that. Oh, sorry. Our CFO will give you more details on the financial performance later on, and I will go into on the next slide the highlights and the milestone passed during 2022, which are, I think, even more impressive than the financial performance. We tells a picture of what we can see in the future. We go directly to slide six. The first point I wanna make here is that now life transplant business is starting again after Two COVID years.
We can see that we are back to 2019 levels, and we see good growth, both quarter on quarter and year on year. We see a good picture. We can also see that in all organs actually, even the ones not severely hit by COVID, we can see that there is definitely solid growth year on year, for all our, all areas of transplantation where we have products. This is positive for us going forward. If we go to the next slide, we are finally now accelerating the launch of Kidney Assist Transport, which we're very happy with. We have started to install the new device and train clinics on the machine already. The early experience is very good.
We have many testimonials from customers starting to using it now, and we can see that one customer, for example, did a trial on a porcine kidney pair, where one kidney went on the XVIVO Kidney Assist Transport and one kidney was transported with a standard machine used today. The result was very encouraging. The XVIVO kidney produced urine within two minutes. The standard of care machine took more than 30 minutes to produce urine. This made the choice very easy for the customer which one to use. We have very strong scientific results behind us already. For example, the last study that showed that if you use our Kidney Assist Transport, we have a 97% one-year graft survival versus only 90% in the control group.
That being the standard of care today, that standard of care machine to date. This was done on DCD kidneys, donors older 50 years. We are now gradually ramping up the launch in parallel with our ramping up of production, and we are now ramping up during Q1 to increase availability of machines. During Q2, we will have two new molds and after they are fully installed and up and running, we deem that we can satisfy the long-term market need on the Kidney Assist machines. With that, we can say that the initial customer feedback during 2022 and early on in the 2023 launch has been very encouraging, in line with what we have seen in clinical studies.
We look forward to 2023 to make a difference for patients, clinicians, and also to save money for the healthcare systems around the world, where we can... if we can use more of the kidneys donated, and they have longer survival in the patient, that will save a lot on the other side with lower cost for the healthcare systems in the world. Our next milestone on slide eight is that we have obtained MDR certifications for our abdominal products. We normally talk a lot about the FDA. The U.S. market is very, very important. But I would deem now with the new MDR regulation in place that approval in Europe is equally hard to obtain. Therefore, we're very, very pleased and proud that we have obtained it for our abdominal portfolio during 2022.
There's been an enormous amount of resources effort going into this task, of course. With this important milestone passed, we will now focus on commercial efforts. Together with our new acquisition, Avionord Machine Perfusion, we will accelerate sales in Europe of abdominal products. Next slide is slide nine. A very important product for us is the Liver Assist. We have, as I mentioned previously, cleared the MDR hurdle, and now we can definitely focus on the customer need for this product and satisfy it as much as possible. If we turn to U.S., we have been granted Breakthrough Device designation by the FDA during 2022. We have seen already in 2021 in The New England Journal of Medicine, very encouraging results on the Liver Assist usage. We have good clinical outcomes.
We have breakthrough designation obtained. We will now pursue the market opportunities through the PMA route for the Liver Assist in the U.S. We're working hard on this right now. We will come back when we have more information on this product. If we turn to the next slide, a very important milestone during 2022 that was quite recently integrated in 1st of December, is the Avionord Machine Perfusion acquisition. We have said it in a previous call that the main reason for the acquisition is that it clearly supports our strategy. The long-term opportunity of XVIVO's products with Avionord business model is fantastic. The deal rationale is that we secure Italy. This is Europe's biggest liver market. We also get an option for an organ transport box called Giotto, developed after transplant process.
We also believe that this Giotto and similar products will be important for transportation of all organs. If it keeps, it is according to the transplant process, and we'll simplify it. More importantly, the business model of Avionord Machine Perfusion is interesting because of mainly three reasons. The one is that it increases machine perfusion market penetration. I think the best example is the Liver Assist in Europe today, where we can see typically we have a 5% market penetration, different country by country, but on average. In Italy, it is between 20%-25% usage, which means that out of all liver transplant, 20%-25% is actually done with the Liver Assist. Number two, high customer satisfaction seems to remove customer resource hurdles.
The customer needs to keep their whole team trained on machine perfusion, but if we can actually help them with that, and we can keep personnel trained and support them with machine perfusion personnel resources, that will reduce a huge hurdle. My belief is that this is the main reason that we see higher penetration ratio for liver perfusion in Italy. Lastly, which is equally important for us, is that the gross margin is a lot higher in Italy and this acquisition will help us coming closer to our abdominal target of 70% which we're working towards. This will definitely be part of it.
Just to explain it again, what Avionord is, machine and perfusion, and why it fits so well with XVIVO offering is that Avionord machine and perfusion have perfusionists employed. They are 24/7 available for the clinicians to run the machine. They can also offer expertise on the machine run and support physically and being there actually during the machine run, sometimes over the teams or very often physically in the actual clinic to do it. Together with the STAR acquisition, XVIVO will now offer all parts of the transplant process where an organ is outside the body. We have started the integration already. We started that in 1st of December already. It's interesting, the commercial integration is more or less finished. It's done and it's working very well.
The admin and the integration is ongoing, and we have gone very far and we have very positive mindset from working together. With that, we go to the next milestone, which is, I think, the key milestone from the year 2022 on slide 11, and that's the XVIVO heart technology and the experience from Australia, New Zealand. The heart preservation product is a truly innovative and paradigm-shifting product. Among others, it has enabled Xenotransplants as well as pushed out-of-body time, as you see now, almost nine hours with good results. We should compare those nine hours to what we see today is typically four hours out-of-body time during a heart transplant. The product consists of a machine, a disposable, and a new innovative patented solution.
The Australian study that is now finalized and the data is being presented, we always thought the data would be good, but we actually never expected this good. We can see from the first 20 patients with an average of seven hours out-of-body time, we see 100% survival and 0% left ventricular PGD, which is very impressive. What is even more impressive is the feedback we get from clinicians using it. You heard during our Capital Markets Day in September that Professor McGiffin, he said that the results are good, and he deemed it even unethical to not use it for all transportation of hearts. In other words, he said if it's an intra-hospital, he could consider not using it, but if it's going from one hospital to another, he would use it.
The reality is that after the study was completed, in mid-December, that is a little bit more than one month, six cases, six clinical cases has been done in Australia and New Zealand. We should compare those six cases to an average monthly heart transplant volume in Australia and New Zealand somewhere between 12 and 15 cases per month on a yearly basis or on a monthly basis in average year. It is very encouraging that we see cases securing that they use the machine. What is even more encouraging is that this was not a single center, this was four different clinics who used it in Australia and New Zealand. We can say that it's widely accepted on the Pacific market. This is very, very important milestone for XVIVO going forward.
With that, we go to the last important, also very important milestone that we passed during 2022, and that's the first Xenotransplant ever performed. We have two advanced teams in the world. They are Maryland and Munich, and they are both deemed it absolutely important that we have the heart technology for Xeno. It is a necessity, and they have told me both that we can't do Xeno without it and that actually we have to guarantee supply to them. This is really interesting because everyone I met, until before this case, Xeno is always 10 years away. The heart technology then together with some other technologies in gene therapy and immunosuppressant has shown that it's actually possible already now. Last week, I spent time in the U.S.
We met clinicians in heart and kidney Xeno. There is an increasing interest for Xeno in the U.S. right now. And we see that many clinics wanna start Xeno programs, and they come to XVIVO for the product. The interest is increasing very fast. Even though we don't think that we will have a huge sales impact in 2023 already, but it does show that the XVIVO technology is in the forefront, is sought after by clinicians, and it also shows that the product portfolio of XVIVO has secured not only the current market opportunities with DBD and DCD organs, it has also secured future market opportunities in Xeno. We go to the next slide, we will go into the clinical pipeline, and we can go directly to slide 14 for an overview.
I've said it before, the heart technology is the paradigm shift in technology on the transplant market today. It enabled Xeno. It pushed out-of-body time with good results to almost nine hours. We are seeing this as the crown of the XVIVO product portfolio. We are conducting multiple trials to prove benefit and to gain market approval in the world. We have if you start with Europe, we have included 80% of patients in the study. We are aiming to launch in the Q1 of 2024. Again, what is encouraging is that the initial feedback we get from Europe is similar to that we got in Australia, that if they use the product, they say, "We wanna use it now.
We wanna use it today. XVIVO team is working very hard to accommodate usage already in 2023 through compassionate use, where they can use a product before market approval. We still forecast the study to be finalized inclusion fairly soon. We aim it to be Q2 2023 and launch it as soon as possible after that. As you know, in the U.S., we submitted the IDE application, and we are in a discussion with the FDA for starting the study. Again, when I was in the U.S. last week, we met clinicians, we met our team, and we have a very good team in place. We have very good clinics that will enroll patients to the study, high volume, high impact, centers.
When we talk to them, they are very encouraged by what they have seen so far, and it's an overwhelming feedback. They ask. They say, "Yeah, if we get it in our hands, we'll use it. What can we do to get the product approved as soon as possible? We want it in our program. We've seen what it's done, and we wanna do it now." The sentiment I got is really that if we can manage to get it approved, they will use it. Lastly, we went through the Australian study. I think key takeaway there is that we did expect usage definitely after the trial, compassionate use between trial and approval. The amount surprises us that it's so high.
It really shows that this is a product that makes a difference for clinicians. With that, we go over to slide 15, hand over to our CFO, Kristoffer Nordström, who will present the financial performance for Q4 and the year. Thank you so much for this session. I come back in the closing words.
Thank you, Kristoffer, for this very encouraging status update. Let's move over to the financial section. Overall, as Kristoffer has highlighted, we are very satisfied with the way we end the year. We end on a high, really. Q4 was by far our strongest quarter so far. Also pleasing that we see that we perform strongly in all three business areas, but also in both key Geographics, North America and Europe. Good across the board. Net sales Q4, SEK 132 million. That's a 53% increase year-on-year and a significant step up from quarterly sales earlier this year, which have been around SEK 90 million, right? Organic growth was 27%, acquired growth 7%. Then we have, as you know, some currency effect from a strong dollar, primarily, 90%.
Solid gross margins in the quarter, 72% all in all. Both EBIT and EBITDA were strengthened versus last year. EBITDA margin 15% and EBIT 6%. Looking at the full year, we hit SEK 415 million, passing the 400 million milestone. Sales grew 61% year-on-year, whereas 30% was organic growth. EBITDA for the full year, 14%, EBIT 3%. I'll move over to the next slide here, and we go into the respective business areas. If you start with thoracic. Thoracic performed a strong quarter and continues to deliver a solid growth. Net sales amounted to SEK 88 million. Organic growth was 26% in local currencies. We see that the machine perfusion trend is still strong.
There is definitely a recovery, and activity was good both in the U.S., in Europe, which is extra delighting. Over 30 customers actually purchased EVLP kits in the quarter, whereof LB is 1 of them, of course, but they serve more than 15 clinics. We should remember that. A very good uptake on EVLP is what we are experiencing at the moment. 1 XPS system was delivered to a French clinic. This was also 1 of the records for the year, actually, that we delivered nine XPS systems during the year. In Q1, Q2 in 2023, we will phase out our very last LS systems on the European market.
Not sure if every one of you remember, LS was the lung machines that we got when we acquired the small Swedish company Vivoline Medical AB in 2016. The main purpose of that acquisition was, of course, the heart project, but we also got some LS systems. We talk about a handful of LS systems, primarily in the Southern Europe region, who will be converted to XPS systems and XPS protocols in 2023, which we look forward to. Gross margin continues to be great, 85%. That's a 2% unit better than last year. If we move over to abdominal. Net sales came in on SEK 27 million, which is definitely an all-time high. We knew that the comparison quarter last year, we foresee that that could be a little bit hard to hit.
That was SEK 20 million sales, 2021 last year. Yes, as you can see, we came over, significantly over that, which is very pleasing. Organic growth, 27%, mostly comprised by liver sales in Europe still. As Christoffer said, we have not yet fully accelerated our launch of Kidney Assist. I guess you can say more or less all sales were liver and Europe. Growth of disposables was good, 37%, and gross margins were 64% in line with last year. We move over to our last business area, services. We were pleased to see that this business area grew in Q4. Services consist of STAR Teams and their organ recovery business in the U.S., and they were acquired by XVIVO in November last year, 2021.
This was the fourth whole quarter, including their business. There is a very big interest for organ recovery services in the U.S., and this is reflected in the good numbers that we're seeing in Q4. 44% growth in Q4 and 39% for the full year, 2022. In 2022, STAR Teams performed close to 500 cases, recovery cases. Not every case represents a transplant eventually. To put this into perspective, 500 cases is about 7% of all heart and lung transplants that were performed in the U.S. combined in 2022. It's a great platform for us to continue to build on. Sales in Q4 were SEK 16 million, an increase of 44%.
The reason for the increase is that we included a handful of new contracts in the quarter. I guess you can say SEK 16 million is therefore the base that we go into in 2023. A quarter, I should say. Moving over to profitability and EBITDA. We continue to deliver a solid EBITDA, and the trend is positive. The rolling 12-month EBITDA margin is 14%, representing SEK 56 million. The adjusted EBITDA in the quarter was 15% and full year, 14%. The adjustment we refer to is primarily mergers and acquisition-related costs. It was SEK 6 million in Q4 and SEK 8 million for the full year. In the quarter, we saw increased costs for marketing and sales, driven by the increase of sales. That's natural.
If we increase sales, we see increased freight costs and also some increased marketing activities. But we also had costs from activities such as the Liver Master Class event. It's important also to mention that we are investing a bit in front of the curve, especially talking about organization. If we look at our European organization, we are more or less fully invested after the last additions we made in Q4. Very good platform. There will be further investment in the U.S., and we will take that carefully step by step as we see that particularly the kidneys transport sales will grow.
R&D costs also increased in the quarter, primarily due to some regulatory costs that were consolidated to the Q4, and that we do not see will be the same case in Q1 next year. In terms of increasing EBITDA, we foresee this to happen gradually, as I mentioned before, year by year during the strategy period. Overall, we continue to deliver a top-line growth, good gross margins, and also a stable EBITDA level. Moving on to my final slide for this presentation, then I will hand over to Christoffer again. Financial position and cash flow. Operating cash flow in Q4 was strong, +22 million SEK, and that was a good follow-up on a very strong Q3 operating cash flow as well, 17 million.
This is an effect of, I would say, basically the increased sales that we see in Q3 and Q4. We have also worked on reducing our working capital. Investments amounted to 77 million in the quarter, where of a significant part of that was a payment for the Avionord acquisition, where we paid 40% in cash, equaling 42 million SEK. The rest, about 35 million SEK, was invested in our clinical projects and of course, primarily our heart trials. As a result of this, even though the operating cash flow was strong, 22 million SEK, there was a negative total cash flow of 58 million SEK. We end the year with around 250 million SEK in cash.
Also finally, just a heads-up on the Avionord acquisition, where there will be an additional purchase price of maximum EUR 2.4 million, so roughly SEK 24 million. Happy to pay that out, and it is expected to be paid out in Q2 2023. That was all for me summarizing a strong quarter, and I'll hand over to you again, Christoffer. Thank you.
Thank you. Briefly, we will have two slides on the outlook. We go directly to slide 23, where we have the long-term outlook. I think it's important to understand why we're here and the market opportunity and actually how big it is. Because the matter of fact is that the demand for transplants are today 10 times the supply. Also the sales value, what we are doing, machine perfusion, is approximately a little bit different organ for organ, but it's approximately 10 times higher than static cold storage, which today is often a beer cooler with ice and the solution. Machine perfusion has proven to increase the number of organs to be used for transplantation, especially in the fast-growing DCD organ pool.
To increase the number of transplants, the survival after transplant, et cetera, we know the machine perfusion will be an important part, an integral part. We therefore know that machine perfusion will be both normal and DCD grafts will drive the growth in the, in the near future. Our belief is if we're gonna grow all the way to 10 times the number of transplants today, we need not only new innovative products, but we also need new innovative sources of organs to be used. One example of that is Xenograft. And both for machine perfusions of the current used organs and also for new source of organ. XVIVO has a proven product pipeline on the market or in clinical studies for market approval. This really puts XVIVO in a unique position on the market today.
Also worth to be added in the long-term view of XVIVO and why we're here is that during the last two years, we have built a very strong leadership team as well as a strong organization, and we are now ready and committed that no one should die waiting for an organ. With that, we go to the next slide, which is slide 24, which brings us to the more near-term outlook of XVIVO and the 2023 and next 12 months. First we can see the machine perfusion is growing. We see continued momentum. We see that especially hub models and service models such as Avionord Machine Perfusion is supporting machine perfusion, and we see faster growth with those models. Number two is obviously Kidney Assist Transport.
We launch in U.S. and Europe, as I reported, we have very good customer feedback using our device, very strong clinical results backing it up. What we hear is that it's also easy to use, and they love to use the product. Number three is the heart. We will continue to prepare for European and Australian launch, and we want to start the PMA study in the U.S. For the liver product, we will prepare for the trial submission in the U.S. during the year, and we're working hard on this right now, and we'll come back when we have more information. Lastly, but not least, we can see that we live in a very inflationary environment.
We still see that we are underpriced, especially if you look at the clinical trial results versus the competition we see on the market today. We see that there is room to continue to increase prices for unique products. Thank you for listening on this quarterly call today, with that, we'll open up the line for questions. Thank you so much.
Thank you. If you would like to ask a question at this point, please press star one one on your telephone keypad and wait for your name to be announced. There'll be a brief pause while questions are being registered. Okay, the first question comes from the line of Peter Östling. Your line is now open. Please ask the question.
Very much, congrats for extremely strong quarter, especially the top line. It was impressive. I will start with my standard question, and that is your annual outlook. When will you start to make more solid financial outlooks instead of just descriptive outlooks? Your closest peer has done that from the start, so I don't see any reason why you shouldn't do that also or couldn't do that also.
Thank you, Peter. I appreciate the question. It's a very good question. What we have said now internally is that we want to have more granularity into the heart launch and the liver launch in the U.S., at least being closer to launch and have more of a full understanding of the opportunity there, because that will obviously affect both the top and bottom line results a lot. We want to have when we have more granularity on those two products, especially on the U.S. market, we will come back with financial guidance.
Okay, great. Your price increases, how many, how big, and where will those price increases be during 2023? Can you say anything?
Yeah, that's a good question. Yes, we definitely can say
Something around that. I mean, we are a global company and our customers are even if they are doing transplants regionally or in clinic, they do talk to each other. We will have global price increases to start with. We are in the process of defining the size of it and to be truly honest, we will do it normally, we price increase this beginning of Q3. In some jurisdictions due to contract reason, it's at the beginning of the year or first of January. We are now looking closely at especially inflation in numbers to see how we have to price it to adjust for inflation. We will come back on the number.
Okay. Okay. Fair, fair enough. Just on your last slide, you're mentioning this hub and service model. Can you say anything about the development in the U.K. where you have very good recommendations from NICE?
Yes.
How the work is proceeding there?
Yes. I can.
Yeah.
The work is proceeding very, very good. The main driver for the hub, the customer is basically a little bit frustrated with the support from the U.K. Health Administration that it's not good enough. We have hired a person in the U.K. that will start very soon to support this process. They basically said they would start the hub no matter what during 2023. We see an increase and you can see it also in other jurisdictions in the world or in Europe that there is an interest for hub solution, regional hub solutions. We do see that this could be an increasing, you can call it.
Which.
revenue model.
Which hospital did you end up with? I believe there has been several hospitals involved in being the actual hub.
Yeah.
Which one did you end up with?
Let me double-check this. I realize there has been several and I have to double-check with our commercial director where we ended up at the end of the day.
Okay.
It will be of course around London area, I think.
Okay. The MDR work that you have done maybe for several years, can you say anything about the cost of that program and if that will be, will lead to lower cost in 2023 or if you will reinvest that in your commercial operations ahead of the CAP launch and also the big heart launch in Q1 next year?
Yeah, it's a very good question. I don't have an exact number, but it has added a substantial workload and actually also a substantial cost to our P&L during the last 2-3 years. What will happen is some costs will of course go down, but they are quite marginal, typical application costs for MDR, et cetera. The main impact would be that now we can get the resources that we tied up in MDR and actually focus them on more customer flow development or commercial activities. We believe that passing the milestone of MDR that we will have more sales in our customer relations.
Okay.
That would be the main part.
Okay. Can you say anything about what kind of investments you need to do in your commercial operations ahead of the heart launch in Europe a year from now? Can you use your existing... I mean, the other Christoffer alluded to that the European organization is more like, more or less, fully staffed right now.
That is correct. We will in general, and if you look at all products, we are good staffed in Europe. We have a very strong where we have all products except heart now approved, but we have a good staff level in Europe, very competent people working very good together, selling our products. We will focus more on, let's say, operation production equipment to scale up production and investing in that. Then over time, we need to do the same investments we have done in Europe, also in the U.S. when we see more products nearing the market there.
Okay. Just finally before I jump back into the queue, was there any stocking to talk about in Q4 that maybe would affect Q1 sales?
The there is, let's say always certain amount of stocking level in Q4.
Mm-hmm.
I would say that it was nothing out of the normal this year. It was more driven by increased activity that you can see in the U.S. transplant numbers.
Yeah.
We do see that the trend of more transplants taking place, we can see that also going into the new year. We don't believe there was a strong stocking effect.
Okay.
Not more than normal. There is always-
Okay. Yep. I understand. Thank you. I jump back into the queue. Thank you.
Thanks, Peter.
Thank you. A reminder that if you would like to ask a question, please press star one one on your telephone keypad and wait for your name to be announced. Our next question comes from Johan Unnérus. Your line is now open. Please ask your question.
Thank you for taking my questions. Yet again, congratulations. I can start with a follow-up to Peter's excellent questions. on the, when we can expect some more detail from the financial, targets, put it that way, perhaps already 2023. Can we expect that ahead of the actual, launch of heart delivery or should we wait, expect that after the launch?
Good question. I think we should expect it after the launch, and we should expect it when we have more granularity into the U.S. user experience, because that will affect, obviously, the top line guidance.
Okay, that's good to know. Also, of course, second guessing or the FDA is always difficult and dangerous also. When is it possible to say anything about the timelines when we can expect sort of the structure for the U.S. study heart study?
Yeah. As you say, the last thing I should do is trying to forecast what the FDA will say. That given said, we have a good dialogue with them. We have a hope that we should be able to finalize that dialogue during the first half of 2023. Then we believe that we are very much in agreement with the FDA. That's at least our view on the, on the dialogue.
Excellent. Be looking forward to that as well. Sort of more of a less perhaps significant aspect, but it's our understanding that the bond for U.S. services and the STAR team is robust and high. There is a challenge, I believe, in actually recruiting these often senior experienced surgeons. How's that going?
It's going good. We do believe, I mean, getting good people is always the most difficult task in any business area or for any position within XVIVO. I just came back from traveling the U.S. for two weeks now. One thing that struck me is that XVIVO has a very strong brand in the U.S. being part of the transplant market, and I think that definitely helps in this process. We see that if you're in the transplant field, we do see that there is a wish to work with XVIVO. When we meet clinicians, we see that there is a wish to cooperate with XVIVO and support us. Logically, XVIVO said we will support you with training of, and certification of surgeons, et cetera.
We have a very good relations with both our customer clinicians and with other people in the field today. I'm most, I shouldn't say surprised because I knew it, but I was overwhelmed by the strong support and the very strong brand XVIVO has in the U.S. market.
You're fairly confident that you will find resources that meet, demand in that way.
Yes, we are. We are confident that over time we will. Again, I mean, getting the right people in the right place is difficult. I have to be humble here. Given the, the strong and the known brand of XVIVO, it makes me more confident.
Excellent. Also follow up, the price review. You're clearly looking into the impact of inflation and, on the cost side, I suppose. Earlier you had, also an, it was an aspect of rather not aggressive, but progressive price review, approaching a more sort of, reaching a more normal or competitive price level. Is that process going to continue or is it more about sort of protecting and, reacting to cost inflation or do you still see scope for more progressive price increases?
Depending really product to product. I do see that in some areas we are, let's say, underpriced, and there we see a more aggressive because we can see that the benefits for the health system that will save an enormous amount of money to the health system, we can see that we support, and there we see a great opportunity. It's a different product. Definitely we will look into both inflation and the other side of the equation, which is the, let's say, the opportunity to save costs where we have unique products.
Are you confident in giving examples of solutions where you are, so to say, underpriced?
Let me finish the job first really go through inflationary pressure and product to product. We can see in some service areas, in some product areas, we are underpriced today. It's something we need to adjust.
Is that process, expected to be completed or completed by Q1?
During Q1, probably mid Q2, we finalize that product.
Okay. Finally, on the R&D side, of course, you have exciting opportunities and will increase the R&D. That's obvious. Can you give us any flavor of that, sort of dynamic for 2023?
One more time. The dynamic for the R&D pipeline or the dynamic.
Oh, yeah, the R&D cost increases because, of course, you're supporting these studies that are ongoing and increasing and also hopefully starting some new studies and perhaps other activities as well.
Yeah.
Can you provide any sort of more precise or specific feel for the level of increase in 23?
Okay. Thank you. I mean, in terms of R&D, we will over time, we will have add a position where needed, but we don't foresee any drastic cost increases in 2023 on the R&D side. There are some gaps where we don't have positions today when we see more and more products coming to market, and we need to maintain them. As I stated earlier, we have worked very hard on MDR. We will use more and more of the, let's say, that time and that resources to actually work on improving our products on the development side. We don't foresee any dramatic increases on the R&D side, at least during 2023.
I could also add, Christoffer, here that in terms of investment, if you skip the P&L for a while and look at our cash flow, for 2023, in terms of investment R&D, we will basically. Yeah, I will expect more or less the same spend that we have had this year. Yes, we will start the U.S. trial, but we will also have a European trial that has now been concluded. The European heart trial will hopefully be concluded as well. Give or take, we talk about the same R&D spend, also on our balance sheet.
Thank you. That's very useful.
Thank you very much. Our next question comes from the line of Ulrik Trattner. Your line is now open. Please ask your question.
Thank you very much, good afternoon. I had some technical issues, I apologize in advance if I'm repeating any questions already answered. I'll start off with the high growth in warm perfusion. Is there a function of increased penetration or an adoption of warm perfusion in the U.S., or should we view this as a continuous trend of the nine XPS systems that have been placed in during the year?
Thank you, Ulrik, for your question. It has not been asked before. Actually, it's a bit of all of above there. What we see now is that when more and more personnel return from, let's say, COVID, take care of COVID, that we can see an increase in EVLP activity. It's actually something we see all over the world. Obviously, when I say the world, I mainly mean the U.S. and Europe. We can also see a higher interest for starting EVLP program, where you can see the 9 XPS last year, which is a record for a year. We see it's generally an increasing interest for XPS and EVLP.
I think part of that interest also comes from the fact that we can now look forward after COVID. That's my view on it for that.
Okay, great. Since we now are approaching an accelerated launch of the Kidney Assist Transport in the U.S., could you just help us decipher the gross margin profile going forward? I'm looking at Q4, seeing machine gross margin being very nice. I'm guessing that is partly related to the integration of Avionord for one month. If I remember it correctly, in the U.S., it's going to be placed more or less at cost, and you're going to have higher gross margin on the disposables. If you can give us some guidance on those two metrics, that would be very helpful.
Nordström, can you take this question?
Yep. Sure. You are correct, Ulrik. Our approach in the U.S. will be to place machines. That's our primarily model. In Europe it will look a little bit different depending on market. In terms of our disposables, we will go in with a price level in the U.S., that ensures that we are seeing a gross margin level of 70% initially, and that we will, of course, follow that closely and see if there is room for price increases as well. That's the initial model for the U.S..
That of course means that if U.S. Sales, when that takes off, it will contribute significantly to the gross margin of the business area, abdominal, and the global gross margin that we see. Also, as we mentioned, the Avionord effect. I mean, it is 20% of our European market today, where we go in with their prices and their margins, the prices are more or less the double of what we have seen before in XVIVO. That will also contribute. Yes, there will be a significant growth for the gross margins in abdominal in 2023 already. Go ahead, Julian.
Yeah, great. Thanks. Thanks for that. Two more questions on the gross margin side and perhaps one on Avionord. On the gross margin side, on disposables, do you see the potential of abdominal disposables in the U.S., like over time, more approaching the gross margin that you have in the thoracic or like in lung or is sort of 70% a sort of area or margin where you feel quite comfortable? On, on Avionord, and you might have mentioned this already, I'm getting that Avionord generated EUR 6 million in sales for one month in December. That sounds like really good progress. Do you have any sort of reference numbers for us what the sort of full year sales was for Avionord? That would be my second question.
Um.
Thank you. If I can take the first question, then I will leave the second question to Nordström. I mean, we said the initial goal of 70%, we will work towards that. It's a very good question. If you actually look at the U.S., you look at the health economics of our products within this transport and what it can do for the U.S. market, of course, dialysis costs roughly $80,000 per year. The average age or average survival on dialysis is pretty much 10 years. We talk about $800,000.
If we can get higher graft survival, which we have seen in The Lancet study, and we have seen that in the initial experiment, then we can of course, see that higher margins on the kidney side and as well as the liver going forward would be possible. We have decided that we first focus on the 70% and then we look into what is possible after that. Nordström, can you take the question about Avionord?
Yeah, I will need to come back with that information. The SEK 5, 6 million that you referred to in December, that was correct. It was a strong month for them, so it was not SEK 5, 6 million times 12. I wish. I would need to get back to you, Ulrik.
I can comment very quickly on it. I think we see they have a very, very good business model. I think I agree SEK 5-6 million is probably. There was probably more activity in December versus a previous month. There is no stocking effect on Avionord, just to be very clear, that they are a per procedure, so they don't sell kits to do procedures. We do see that the business model is working very, very good in Italy. We foresee that the interesting part is really how over time, how this business model can affect other area. For 2023, we haven't guided anything else that it will affect only the Avionord and the growth from the Italian market.
Okay. That's great. Two more questions on my end, perhaps a shorter one and one that you can perhaps elaborate a little bit about. First on the capitalized R&D in the quarter and going forward. If you could help us decipher at least how much of the capitalized R&D is allocated to the heart machine, which is obviously not on the market in any market, just so we can sort of decipher if the remaining part of the business is generating a free cash flow.
Yes. If you look at the in Q4, total investments were SEK 77 million. 39 of those were related to the acquisition, so the payment, cash part of Avionord. That's a separate thing. The capitalized expense of R&D were SEK 26 million.
Roughly 15 of those were on the heart project. Right?
Okay. you essentially generated a free cash flow of around like SEK 10 million in Q4, if we were to exclude the heart.
If we were to exclude the heart, exactly. 26 minus 50. Yeah. Mm-hmm.
Perfect. That's essentially what I was aiming at. Last question on my end would be just recent comments from TransMedics on them commenting on advancing and accelerating in the U.S. and perhaps looking more into lung and just how worried are you regarding their situation? They last year they did a capital raise, so they are quite well-funded. They don't seem to be worried that much about profits. Just how worried are you on the competition evolving in the U.S. from TransMedics?
A very good question. I think I said it before, and I will say it again, that with the market potentially being 100 times bigger than it is today, we realize that we can't build that ourselves. We need competition such as TransMedics to support us building that. In terms of clinical results, and outcome, we are very confident that the products we have and the personnel we have today giving service to our customers, meeting customers, and supporting them are of highest quality. To be honest, we are not worried. We are thankful they are there, of course, we think we have better products and better closer customer connections. You should never underestimate competition.
In this case, I think we need competition to grow the market faster than we could do ourselves.
Great. Thank you, Kristoffer and Christoffer. It's very helpful and congratulations on a good progress in Q4.
Thank you very much.
Thank you. We have no further questions at this time. Please continue.
Thank you so much. I think with that, we can conclude the report on operation quarterly call or the Q4 2022 quarterly call. We look forward to report the Q1 2023 report on the 24th of April. Hope to see you then. Thank you so much, everyone.
Thank you. That does conclude our conference call today. Thank you all for your participation. You may now disconnect.