Xvivo Perfusion AB (publ) (STO:XVIVO)
Sweden flag Sweden · Delayed Price · Currency is SEK
268.80
-5.20 (-1.90%)
May 5, 2026, 4:17 PM CET
← View all transcripts

Earnings Call: Q1 2023

Apr 24, 2023

Operator

Welcome to XVIVO Q1 report for 2023. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now I will hand the conference over to Chief Executive Officer, Christoffer Rosenblad and Chief Financial Officer, Kristoffer Nordström. Please go ahead.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Thank you so much. Welcome to XVIVO's earnings call for the first quarter of 2023. Today's presenters are myself, Christoffer Rosenblad, Chief Executive Officer for XVIVO, and Kristoffer Nordström, Chief Financial Officer. On slide three, you can see the financial at a glance. I'm very happy and proud to report that Q1 was the strongest quarter ever posted by XVIVO. We saw sales of SEK 141 million, organic growth of 34% and an adjusted EBITDA of 18%. We're also very pleased to see continued high organic constant currency growth and improving gross margin for disposable products for all segments. Also content that the integration of our three latest acquisition had progressed according to plan, and they have significantly contributed to the high growth during the quarter.

An opportunity to further integrate the STAR Teams recovery service in the U.S. with our product and the possible Avionord model is currently under investigation. We come back as soon as we have a result of that investigation. The Kidney Assist Transport has been launched during the quarter with mainly delivery and installations of machines in the U.S., the Netherlands and Italy. Therefore, we had mainly sales in Liver Assist in the quarter, and we're expecting to see a ramp-up of kidney sales during the year with increasing production capacity. I also wanna say that in terms of numbers and drivers behind the numbers, our Chief Financial Officer will give you further details later in the presentation. Next slide. slide four is the highlights.

In this conference call, we will focus on progress for the heart technology, the recent ISHLT conference, which is the largest annual conference for heart and lung transplantation, and the recent clinical publication strengthening the evidence for our product portfolio. On slide five, we start with that Australian experience. The first important thing to point out is that we have pre-started commercially with compassionate use in Australia and New Zealand. Very encouraging is that during Q1, roughly 25% of all heart transplants in Australia and New Zealand were performed under compassionate use with our heart technology. This is above our expectation and very impressive, and to my knowledge, at least such high usage before approval is uncommon or unheard of.

As you also see on the slide, all five clinics participated have continued to use the device, which is encouraging. We have also seen clinical data coming in. The reason for the high compassionate use is probably because the clinical data is convincing. The data was featured in three presentation during the recent ISHLT. Key takeaway was that the seeing is believing. After experience the box, the clinician want to use it more. The survival data is also impressive with no 30-day mortality, even though the out-of-body time was more than double from what is generally accepted, which is roughly four hours. The early experience is also that the heart function of the transplantation is very good. This is important for many reasons, but mainly three.

The first one is, that's the seeing is believing, it gives confidence to surgeons around the world that the heart technology works. Number two, normally, it's an indicator of longer-term survival. We haven't seen the data yet since it's a new technology, but we are looking forward to long-term survival data with high confidence. three, which is also very important, and the feedback I get more and more is that if you show good heart function after transplantation, it's normally correlated to lower aftercare for the patients, and especially as you know, we're coming in after COVID pandemic, and there is a shortage of qualified nurses especially.

This is an indication, not a final proof, but it's an indication that the heart technology could be a solution to reduce nursing time, both during organ recovery because the heart box is a very easy to use product and also, aftercare after the actual transplant where a large number of patients, especially from DCD end up in ECMO or other high working burden for qualified nurses, treatments. We're very happy with those results from the Australian, New Zealand experience, and we're happy with the flying start to that in that market. With that, we go over to next slide, which is slide number 6. I just came back from ISHLT, which was last week and had a very good experience from that week.

The interest for XVIVO and both the lung and heart technology, it was very high. Our booth, as you see in the picture, featuring the products was full more or less during the whole conference, which lasted for four days. The presentation industry symposiums from XVIVO was crowded with people standing against the walls, with very, very high interest. In terms of the heart, everybody I met asked if they could be part of trial in the U.S. It was a good week, as I said, the key takeaways from ISHLT is that machine perfusion is here to stay and fulfill an important role in transplantation today. DCD and use of extended criteria organs are growing rapidly, with that, the use of machine perfusion.

Lastly, that services and simplification for the user is important for the market acceptance. Here I'm confident that the Star acquisition, the Avionord acquisition with the Star in the U.S. and our very easy-to-use machines in both heart transplantation and kidney transplantation will support the market needs that we saw clearly during ISHLT. With that, we go to the next slide, which is slide seven. We also very proud and happy that we have strong clinical data, preclinical data, published during the first quarter of the year that will strengthen our go-to-market strategy for both liver and heart. The first one is the Liver Assist.

As you know, it was featured in The New England Journal of Medicine in 2021, showing that it's used for DCD livers, which for transplantation has significant positive impact post-transplant clinical outcome. In Q1, a publication in Journal of Hepatology showed positive results also for DBD livers, so it will open up new markets for our liver product. The last one at the bottom of this slide is very, very encouraging and says something about the future. In Q1, The Journal of Heart and Lung Transplantation published an article showing benefits of XVIVO heart preservation. That's the heart technology used after DCD donation, in a large animal model. In short, it demonstrated that our heart technology can be used both in direct procurement and after use of normothermic regional perfusion.

This result, if proven and mimic in a clinical setting, could open up a very large market potential for the XVIVO heart technology, which we're looking forward to. With that, we go over to our clinical pipeline, and we can skip direct actually to the slide 9 for a review of our status of clinical trial. As a company, we focus on mainly four things, the current business, the Kidney Assist Transport launch, and the regulatory approval trials for heart and liver. During this slide, we will focus on the last two focus areas. I'm happy to say that in Europe, we're almost finished with the clinical trial. We expect it to be finished during the second quarter, so this quarter. We are in process also of handing in documentation for the CE mark.

We hope it's always hard to guess when we will receive and when the CE mark and could have commercial launch, but we still aim in Q1 2024. For U.S. heart, we have just in the middle of April, handed in our ID application to the FDA. We know that FDA has 30 days to respond, so we expect an answer in May. If we get a positive answer, we aim to start the clinical trial in the end of Q3 when we have enrolled and trained all participants in the trials. Again, I can report from a dinner at ISHLT with the best of the best in heart transplant in the United States. We saw a very high interest.

We have the right centers, including the trial, high impact KOLs that will be very important for this trial. As I said before, the interest is very high. I think everyone we met asked to be part of this trial, we have today limited to 15. The last focus area is, as I said, the Liver Assist PMA. We have reported before that the Liver Assist is granted Breakthrough Device Designation during 2022. This will mean that we get a faster route through the FDA PMA process. It's also quality stamp that the products are innovative and fulfill the need on the market.

We are currently designing the U.S. study and compiling the quality file for an IDE application. We have also already actually started to invest in organization to run the study based on the high interest we have seen in the U.S. as well. We have seen now from the very strong numbers on liver that Kristoffer Nordström will show you more later in this presentation. We now encourage that we should invest in the Liver Assist to get to the market also in the U.S. With that, we go to the next slide, which is a partisan slide. With that one, I will hand over to our Chief Financial Officer, Kristoffer Nordström, who will present the financial performance during the quarter and deep dive into the details.

Kristoffer Nordström
CFO, XVIVO Perfusion

Thank you so much. As Mr. Rosenblad has emphasized here, Q1 was a strong quarter financially that we are very happy about, the whole organization. We presented strong sales, strong sales growth in all three business areas across the board, strengthened gross margins, which led to an improved EBIT and EBITDA. Net sales in Q1 came in on SEK 141 million, which means a 52% increase year-on-year. Organic growth was 34%, acquired growth 5%, and currency effect 13%. We delivered a strengthened gross margin 75% versus 70% last year. Gross margin on disposables improved 2 percentage for the company as a whole, and we'll dig into the details in each business area as we go here. From 79% to 81%, which is a very good number.

The primary reason for the improved gross margin is the development that we have seen in our abdominal business area this quarter. Both EBIT and EBITDA were strengthened versus last year, and an EBITDA margin of 18% was presented. If we move over to the different business areas, we start with thoracic. Thoracic performed a yet good quarter and continues to deliver growth. Net sales amounted to SEK 91 million. Organic growth was 23% in local currencies. The good machine perfusion trend continues. Activity was good both in the U.S. and Europe. In connection to Q4, we flagged for potential stock taking, stock building effect from the customers. We didn't really experience this in Q1, and we don't experience it in the beginning of Q2 either.

It seems like the volumes we see now are true and that there is a good momentum out there. As we have said before, in Q2, we plan to phase out the last LS machine systems in, on the European market. We have a handful of LS machines that will be converted to Express systems and Express protocols. That is very good. There are some strategic sites out there that we're working closely with, such as Copenhagen, for example. We hope to provide you with some good information about that process on the next earnings call here as well. Q1 thoracic sales include sales of heart preservation systems for the first time.

We have sold some disposables, as Christoffer said, in Australia and New Zealand, and also had some research related sales in the U.S. as well. Total heart number was on disposable side, SEK 7 million. Disposable grew 32%, where lung accounted for 25%. Here we are extra pleased that the EVLP sales grew 40% versus Q1 last year. Gross margin on disposables was especially strong, 86%, and that's 2 percent units better than last year, mainly driven by an increased ASP on PERFADEX Plus and EVLP on RTP markets. Moving over to business area, abdominal. Abdominal came in on SEK 31 million, which means once again, an all-time high quarter.

Growth in local currencies was 85% in total, growth on disposables was specifically good, 123% in local currencies year-over-year, where 82% was organic. 41% was acquired, with this we mean, it's represented by the former distributor margin in Italy. Sales were mostly comprised by liver sales in Europe still, approximately 78% of the total sales. Gross margin disposables were 65%, which is a significant jump up from last year's 53%. This is a result primarily of two aspects. First of all, the added margin from our perfusion service model in Italy brings up the gross margin. Second, an overall good progress on the ASP prices on liver in Europe. Moving over to the services segment, which is our STAR Teams ' organ recovery business in the U.S.

Here as well, Q1, a financially good quarter. Sales of SEK 19 million was recorded in the quarter, comprising a 82% increase versus last year. This increase was mostly a result of customers coming in at the end of last year. We also had some, what we call one-off recoveries performed in Q1, and that's for customers that don't yet have a contract. It also means that we have had a chance to prove our excellent service. And are in a very good position to start contract negotiations also with these sites. Hopefully they will result in additional contracts as the year proceeds. STAR Teams performed close to 500 cases last year, and in Q1, they started intensive with another 146 cases, a 24% increase versus last year.

Key for future growth within services is to continue to invest in the organization in both headcounts, but also in quality assurance. Focus in the coming quarters to bring on more surgeons and coordinators to ensure we are well prepared to meet the surgeon demand in the organ recovery services in the U.S. Moving over to EBITDA and profitability. Q1 delivered an improved EBITDA. Adjusted EBITDA was SEK 25 million, representing a margin of 18%. This was primarily a result of our increased sales and our strength and gross margins. Rolling 12 month EBITDA margin of 14.5% that represents SEK 66 million. The trend the last quarters has been good, with profitability levels that are increasing as sales are growing.

We will continue to aim for a balance between profitability and investments in the coming quarters. We will invest where it makes sense and continue to build our business model and organization as we go. Moving over to my last slide, the financial position and cash flow. Operating cash flow Q1 was negative SEK 12 million, which has been a trend for us in Q1 early years as well. This quarter was a result of increased working capital, mostly due to our increased sales and also payment of employee bonus liabilities that always are executed in Q1 every year. Cash flow from operating activities before changes in net working capital were positive SEK 22 million. Investments amounted to SEK 34 million, consisting of investments in our R&D projects, mainly our different heart projects.

Finally, just a heads up, on the Avionord acquisition, an additional purchase price of maximum SEK 25 million will be paid out in Q2, 2023, since they reached their milestone, whereof SEK 10 million will be in cash, and the rest will be in a new share issue. That was all from me, Christoffer, until the Q&A. Leaving the word over to you again.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Thank you. We will go over to the outlook, and we start on slide 18 with a longer term outlook. We are very, very pleased with this quarter. It's, of course, very good, but we're here for the long term. It's important to point out that the demand for transplant today is still 10 times higher than the supply of organs. Also the sales value of machine perfusion versus static cold storage is roughly times 10, a little bit different organ per organ. What we see in front of us is a market that is 100 times higher than we see today. I think that we have seen the beginning of that market expansion in the last quarter.

Also important to point out is the machine perfusion has proven to increase the number of organs to be used for transplantation, especially in the fast-growing DCD organ pool. Hence, machine perfusion, both normal, extended criteria, and DCD grafts will drive growth in the near future. As probably to go all the way to times 10 of today's numbers, the company at least believe that innovative sources of organ need to be used, for example, xenografts. For both machine perfusion and new source of organ, XVIVO has a proven product pipeline on the market, or we are in clinical studies for market approval. This puts us in a unique position on the market today.

Lastly, I think it's important to point out for long term is that during the last couple of years and we have invested in a strong leadership team, a strong organization, and we are now ready to deliver on our strategy and our focus areas to make sure that we can capture this very big or even huge market opportunity. If we go to the next slide 19, it's more of a shorter term outlook. That's what we're gonna do this year. We're gonna focus on, we said, our current business, and that's mainly machine perfusion. We see continued momentum through especially hub and service models.

That could also be said from ISHLT that it was a high interest for, from clinician to hub models and service models, so they don't need to keep all their, all their knowledge in-house that we could support them with that. I'm also happy to report that the integration with Avionord was record fast. We bought them in December 2022, 1st of December, and more or less from January 1, we executed as an integrated company, beating revenue budget, et c.. Very happy to see that and very impressive from the Avionord and European team. Number two, we will focus on the Kidney Assist Transport launch. It's the key focus area for us. We have launched in U.S. and Europe.

We have mainly installed machines during the quarter, and we're now looking forward to more usage on the product. We are continuously ramping up production on this product to make sure we can satisfy the high need. We talked a lot about heart today, and we will continue to work hard to get this product out. The message I get from clinicians is just get it approved, we will use it. We work very hard for commercial launch in Europe and Australia and New Zealand. We hope to start the trial in United States as soon as possible with a positive IDE application. Last focus area is that we will focus to prepare the liver application for the PMA approval in the U.S.

We will hopefully have an IDE application as soon as possible for the U.S. market. The last point is that we continue to see that we are underpriced versus competition, and we find ourselves in a high inflation environment. We will continue to increase prices on our unique products to make sure that cost increases from our suppliers and inflation is carried forward in the value chain when there are our reimbursement system to take care of them. With that, we can go to the last slide 20. I thank you for listening to us today. As you see, that's our vision that we work hard for. Nobody should die waiting for new organ, and we continue work hard every day. With that, we open up the lines for questions. Thank you.

Operator

If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Ulrik Trattner from Carnegie. Please go ahead.

Ulrik Trattner
Equity Research Analyst, Carnegie Investment Bank

Great. Thank you very much. Good afternoon, Christoffer and Kristoffer, and congratulations on a great quarter. I have a few questions, if I may, and very intrigued to see that you started to generate sales in heart. I was wondering if you can elaborate a bit on margins and pricing of those revenues, and it looks like it's not dilutive to thoracic sales in terms of the gross margin side. If you can just help to confirm that would be my first question.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Yes. We can confirm that we have a unique technology and we will not dilute margins on the ThorEx side with the heart launch.

Ulrik Trattner
Equity Research Analyst, Carnegie Investment Bank

Just in terms of are you able to take a full price being compassionate use or for the sites that have already been participating in the study? I'm guessing you will be giving them some type of discount or how does that work?

Christoffer Rosenblad
CEO, XVIVO Perfusion

Yeah, that is correct. We have a discount during compassionate use in Australia. We plan to do the same in Europe and if possible also later on in the U.S. There will be a before regulatory approval price for sure. We can't take full price.

Ulrik Trattner
Equity Research Analyst, Carnegie Investment Bank

Okay, great. A follow-up on heart and bridging into the PMA study in the U.S. We talked about this before, do you believe that Star will be able to participate in and/or to be included in the PMA study, given that they are part of the infrastructure for heart transportation?

Kristoffer Nordström
CFO, XVIVO Perfusion

Yes. It has been very clear, from several of the centers that they are interested in the STAR Teams' model as part of the study. That is something we would be, you know, would love to be able to support them with as well. That is definitely something we are looking into at the moment.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Yeah. To add to that question, Ulrik, we can. I've seen now in doing ISHLT that there is a need for service support. Of course, it's up to the clinician himself or the clinical team to make that decision. If we can help, we will help from the STAR Teams side.

Ulrik Trattner
Equity Research Analyst, Carnegie Investment Bank

Sure. Sure. On STAR Teams, you mentioned in the report that you're looking at improved margins. I'm guessing you're looking at the gross margin side of STAR Teams. Is this purely based on number of contracts obtained, or is there any volume component or any tweaking in terms of the revenue model in STAR Teams that should drive margins higher for that segment going forward here over the next six-12 months?

Kristoffer Nordström
CFO, XVIVO Perfusion

Yes. We are currently looking over the revenue model for STAR Teams. I think this is it's two-folded here. The contracts that we have, they are renegotiated on a yearly basis. We will have several opportunities during the year here to renegotiate contracts and with a new model in place ensure that they get even more profitable for us. The second thing I think is a little also up to us, but more internally that if we can be more strategic on where new customers are located, that could also give us economies of scale. Because we have learned now during this year that it's a lot about efficiency.

If we can have customers located in, where it makes geographically sense, and we can have our surgeons there, then we can kind of, cover more contracts with less surgeons, let's say.

Ulrik Trattner
Equity Research Analyst, Carnegie Investment Bank

Sure. Makes sense. Since we're talking about profitability, you highlighted improved growth margin, seeing that as well. The, the strong jump here in margins year-over-year, is it purely leverage on the current operation or is there anything in the numbers that we should be aware of, or is it contribution from Avionord and Star, which holds higher margins already, or is it just all of the above?

Kristoffer Nordström
CFO, XVIVO Perfusion

I would say, if we look at the business area per business area, so on the thoracic side, there we have constantly improved, you know, small steps at a time, mostly driven by our increased ASPs from the pricing increases that we have had now for a couple of years. That together with, to be fully transparent, some currency effects as well. On the abdominal side, we flagged on the capital markets day last year that our midterm goal is to reach above 70% in gross margin. We highlighted that there are two key drivers to that. The first one is the improved margins from the perfusion model in Italy.

I think that as long as Italy, as of today, is our biggest abdominal market, that is a big contributor. The second one is that, which we haven't seen the effects of yet, is when we get full steam ahead on the Kidney Assist Transport sales in the U.S., that will come in with a gross margin, I think about 70%, directly, which will also help out. We believe that the 65% you see this quarter is kind of what we should expect in short term now in abdominal.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Also to mention on that, Ulrik, you know, building a med tech company, it's, you have a lot of fixed costs. If it is around SEK 400 million-SEK 500 million, you can see economies of scale kicking in from your R&D, your quality department, your admin department, et c., etc. , your sales force. We will see economies of scale kick in over time. And that mention before we, and Kristoffer Nordström mentioned it, that we have a market opportunity that is 100 times larger than today's market. We will try to balance investments versus profits in the next quarters and years to come.

Ulrik Trattner
Equity Research Analyst, Carnegie Investment Bank

That's great. On abdominal, you mentioned it, that the gross margin was high in the quarter. As I'm looking at abdominal gross margin for machine, it was really high this quarter, which leads me to believe that, and obviously in your presentation, that sales from America was really low. What's left besides the fact that you stated that you need to increase production capacity, but what's left before Kidney Assist Transport takes off and have meaningful revenue contribution in the U.S.?

Christoffer Rosenblad
CEO, XVIVO Perfusion

I think we will see that gradually coming through the year. We will see an uptick quarter-on-quarter. We have, albeit small, a sales force there that have a great customer experience. When they do head-to-head with the current, generally accepted market practice on kidney transport, we see that our product comes out better, both in kidney function, in clinical trials we have seen it, but also in user friendliness, which is very important because again, the less easier to use, the less personnel you need to run it. We have confidence in the product and the clinical outcome of Kidney Assist. If we have the ramp-up of the production, we are confident that it will be also a same success.

Ulrik Trattner
Equity Research Analyst, Carnegie Investment Bank

Okay, great. One last question on my end, and I'll get back into the queue. Price increase, and you talk about still being vastly underpriced versus what's out there today. What type of price increases are we to expect throughout 2023 for each of the segments?

Christoffer Rosenblad
CEO, XVIVO Perfusion

We are compiling that work right now, so it would be prematurely to state the number. We have seen recent price increases and we think that the inflation is in line. At least it has not gone down too much right now. You could extrapolate the numbers yourself.

Ulrik Trattner
Equity Research Analyst, Carnegie Investment Bank

Great. Well, thank you very much, Christoffer and Kristoffer, and once again, congratulations on a great quarter.

Kristoffer Nordström
CFO, XVIVO Perfusion

Thank you.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Thank you, Ulrik, for questions.

Operator

The next question comes from Peter Öhling from Pareto Securities. Please go ahead.

Peter Öhling
Equity Research Analyst, Pareto Securities

Yes. Good afternoon, and also a very congratulations to extremely good quarter. I have a couple of quick questions. First, going back to the Australian experience. Can you say more specifically how large the discount is now when you're selling the product under compassionate use?

Christoffer Rosenblad
CEO, XVIVO Perfusion

No, unfortunately, we cannot comment on exact numbers. It's there, but we cannot comment on the exact discount. The final price will also depend on future reimbursement systems in different regions, where all the work has not been done yet. It would be also wrong to mention a number.

Peter Öhling
Equity Research Analyst, Pareto Securities

Okay. When it comes to the Kidney Assist Transport, you had some teething problems initially, when you launched a year ago. Have all those been solved now so you can go full speed ahead in your continued launch?

Christoffer Rosenblad
CEO, XVIVO Perfusion

Yes. To my knowledge, everything has been solved. We are still experience some issues with ramping up parts of the production of the machines, especially. We have the right number of machines there, including service machines, et c.. From what I heard, we should be able to wrap it up further in Q2 and then even more in Q3, et c.. We are quite confident. Also now we have installed a couple of machines during Q1, and they will start to generate revenue during Q2.

Peter Öhling
Equity Research Analyst, Pareto Securities

Okay. How will you, specifically related to the Kidney Assist Transport, how will you report the continued development when it comes to machines and usage? Will you just bake them into the abdominal area as you have now, or will you be more specific when it comes to numbers of machines sold and so forth?

Christoffer Rosenblad
CEO, XVIVO Perfusion

Two answers. One, we will not have more segments, so to say. Yeah, during the launch, we will be more specific in when we write in the abdominal segments of the quarter report on the progress of the launch.

Peter Öhling
Equity Research Analyst, Pareto Securities

Okay. You said that you that, a large part of the growth is stemming from your increased average sales price. I was just wondering, when will you see the volume factor also come in to play more significantly?

Kristoffer Nordström
CFO, XVIVO Perfusion

On, on abdominal? Are you asking about the abdominal side?

Peter Öhling
Equity Research Analyst, Pareto Securities

Well, I'm talking in general, since you mentioned the average sales price increase as an important component for the growth.

Kristoffer Nordström
CFO, XVIVO Perfusion

It's an important component of the gross margin growth, I would say. If you look on the abdominal growth, for example, that's very much volume-related.

Peter Öhling
Equity Research Analyst, Pareto Securities

Okay

Kristoffer Nordström
CFO, XVIVO Perfusion

W here we see a good progress on liver in Europe. Many clinics are really up to speed now. Looking at lung as well, not a number we discussed in the report, but the EVLP revenues in comparison with Q1 last year was up 40%, where of, I would say two-thirds are volume-related.

Peter Öhling
Equity Research Analyst, Pareto Securities

Okay, okay.

Christoffer Rosenblad
CEO, XVIVO Perfusion

The abdominal was up 82%, constant currency, excluding the Avionord effect, where the absolute majority is volume.

Peter Öhling
Equity Research Analyst, Pareto Securities

Yeah.

Christoffer Rosenblad
CEO, XVIVO Perfusion

It's getting used more.

Peter Öhling
Equity Research Analyst, Pareto Securities

Yeah. I hear you. Lastly, you had the symposia at the conference last week regarding EVLP. I think if I'm correct, about the title that it was something around how you will tear down the barriers for using EVLP even more in the future. I was just a little bit interesting what the conclusion from that symposia was?

Christoffer Rosenblad
CEO, XVIVO Perfusion

It was to start with a very good symposium. The conclusion is that the need for hub and service model will increase in the future to, yeah, what we said, bring down barriers.

Peter Öhling
Equity Research Analyst, Pareto Securities

Mm-hmm

Christoffer Rosenblad
CEO, XVIVO Perfusion

Fuel growth, within EVLP.

Peter Öhling
Equity Research Analyst, Pareto Securities

Okay

Christoffer Rosenblad
CEO, XVIVO Perfusion

Everybody agreed on that, and that was the way forward.

Peter Öhling
Equity Research Analyst, Pareto Securities

Yes

Christoffer Rosenblad
CEO, XVIVO Perfusion

I would say everybody's working very hard on that in many regions in Europe, as well as in the U.S., more locally, in the U.S. We see that the hub models, the ones that are used to using the XPS tend to use it a lot more because it's a knowledge, a knowledge hurdle, so to say. And once you go over that hurdle, it's a lot easier to use the product.

Peter Öhling
Equity Research Analyst, Pareto Securities

What is your expectation when it comes to time span? Are we talking about three to five- years, something like that? Could it go even faster?

Christoffer Rosenblad
CEO, XVIVO Perfusion

You mean at uptake in EVLP?

Peter Öhling
Equity Research Analyst, Pareto Securities

No. Well, introducing this hub and service model, which will be a critical factor to increase the usage of EVLP.

Christoffer Rosenblad
CEO, XVIVO Perfusion

I think I mean, it's happening while we're speaking, and there are hub models working in the U.S.

Peter Öhling
Equity Research Analyst, Pareto Securities

Yeah. You have the Lung Bioengineering, of course.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Yeah, for example.

Peter Öhling
Equity Research Analyst, Pareto Securities

Yeah.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Cleveland is also having a hub. You can see also regions in Europe or countries or regions in Europe are starting. I would say the hurdle right now is rather very practical to get approval or agree on the logistics around it. Everybody is continued to work in high pace to have that. Once we have, let's say, fully European and U.S., Canadian, where every center is at least covered by one hub, that might take a few more years, yes. It will happen gradually, not overnight.

Peter Öhling
Equity Research Analyst, Pareto Securities

Oh. Of course. Okay. I get back into the queue. Thank you, gents.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Thank you.

Kristoffer Nordström
CFO, XVIVO Perfusion

Thank you for the questions.

Operator

As a reminder, if you wish to ask a question, please dial star five on your telephone keypad. The next question comes from Alex Cogut from Bryan, Garnier & Co.

Alex Cogut
Head of Healthcare Equity Research, Bryan, Garnier

Well, hi, guys. Good afternoon. Thanks for taking my questions. I was just wondering if there are any major differences in the U.S. liver and heart trials compared to what you've done in Europe and Australia, and whether it's different at all from how TransMedics rendered trial?

Christoffer Rosenblad
CEO, XVIVO Perfusion

Thank you for a very good question. In terms of liver, we are designing it right now. My guess right now is that there will be very little difference in liver between how it's used in Europe and the trial design in the U.S., but that is remained to be seen. In terms of heart, there are a little bit different lengths we go for, where in Australia, for example, we went for the long, really long transportation times, and above what is used. In Europe, we have focused on the, let's say, the normal hearts, more or less, and occasionally if we go out of what is considered a standard criteria heart. In the U.S., we will focus on the extended criteria.

That could be high donor age, it could be expected transportation time, et c., etc ., It's a little bit different design region per region, but the three trials together will cover the full usage of the heart product.

Alex Cogut
Head of Healthcare Equity Research, Bryan, Garnier

Got it. As a second question, are you looking to leverage the Italian on the star model in other geographies as well?

Christoffer Rosenblad
CEO, XVIVO Perfusion

Yeah, we are investigating that right now. it's a very interesting question because it is. I'm more convinced now after ISRT, that there is the need for that model in more regions, more European countries or regions as well as the U.S., where the cost for a clinic to keep those very valuable nurses trained on different platform is quite high and something that we would like to get away from. If we could offer that as a service, that would be highly appreciated, I think. We are investigating right now which European countries would be fitted to it, because also the reimbursement system has to be covered. We know already now that in the U.S., reimbursement systems are typically cover this type of services in the cost report.

That would be an obvious market. We have not taken decision yet on a full integration of Star with our product portfolio and our VNO model, but it's something we are investigating right now. We will come back as soon as that investigation is finished.

Alex Cogut
Head of Healthcare Equity Research, Bryan, Garnier

Okay. Thank you so much. That's it for me.

Christoffer Rosenblad
CEO, XVIVO Perfusion

Thank you.

Peter Öhling
Equity Research Analyst, Pareto Securities

Thank you.

Operator

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

Christoffer Rosenblad
CEO, XVIVO Perfusion

Much for listening to the conference call for Q1. I will hope you will listen in to our conference call for Q2, which will be in the second week of July. With that, I thank you all and hope to see you again.

Powered by