Thank you so much. Good morning and good afternoon, everyone, and welcome to XVIVO's earnings call for the third quarter of 2026.

We can go to slide number 2. Joining me today are Kristoffer Nordström, our CFO, calling in from Denver in Colorado, and myself, Christoffer Rosenblad, CEO, joining from Stockholm, Sweden today.

With that, we can go to slide number 3, which is the Q3 financials at a glance. We delivered another solid quarter with sales in line with the first half of the year and organic growth of 32% compared with the third quarter of 2025.

EBITDA remained strong, supporting healthy operating cash flow. For the fourth consecutive quarter, total cash flow was close to neutral, resulting in a stable cash position.

Our CFO will later in this call provide more details on sales, gross margin, and EBITDA later in the presentation. Looking at the business, Thoracic continued to perform very well across both North America and Europe.

The positive market trends we saw towards the end of last year continued through the quarter, supported by strong growth in the lung market and our expanding commercial presence. Kidney also delivered strong growth driven by increased commercial coverage in Europe and growing interest in the US market.

Against this backdrop, sales development this quarter and over the coming quarters will be impacted by the transition to upgraded core components. While this creates a temporary headwind, it does not change our positive view on the underlying market opportunity and business momentum.

Turning to slide 4, which is the year-to-date performance. The first 9 months of the year show a similar picture to the quarter.

We continue to deliver strong and consistent growth driven by robust performance in Thoracic and healthy growth in Abdominal. Throughout the year, we have continued to invest in our commercial organization, scalable production capabilities, and regulatory approvals to support future growth.

Sales amount to 730 million SEK, corresponding to an organic growth of 30%. Key takeaway from the past 2 years is that we have demonstrated scalability of our business model.

With only a few months remaining of 2026, we are now increasingly focused on the opportunities ahead. The next 2 years will be important for XVIVO as we continue building the company toward our ambition of becoming the preferred partner in the transplant process.

Among the most exciting commercial opportunities are the launch of XVIVO Heart Assist Transport in Europe and our planned expansion into Canada and Australia. In Australia, the XVIVO Heart Assist Transport has already established a strong position through compassionate use and has already now become standard of care, which took only 3 years.

With that, we move over to the next slide, slide 5, and the key business highlights from the quarter on the next following slide, 6 and 7. Turning to slide 6 and the key highlights from the quarter.

Q3 was an important quarter for XVIVO marked by seven milestones across our business. First, with EU approval of XVIVO Heart Assist Transport, we can now begin supplying this life-saving technology to patients across Europe.

The approval covers all heart-donated and all heart transplant recipients, including all age groups as well as both DBD and DCD donors. Clinical data demonstrated a 76% risk reduction in severe PGD, the leading cause of early mortality following heart transplantation.

As a result, 6 additional patients per 100 survived to their 1-year follow-up date. This represents a significant benefit for this vulnerable patient population.

In addition, XVIVO Heart Assist also has demonstrated the ability to safely extend preservation and transportation times. This gives transplant teams greater flexibility in planning procedure, enabling surgery to be performed under more controlled conditions with rested transplant teams, while also having the potential to reduce overall cost of the transplant process.

Second, we reached another important milestone with the submission of the PMA application for XVIVO Heart Assist Transport in the United States. We are equally committed to patients with end-stage heart failure in the US and to enabling heart transplant teams to perform surgery with rested teams and in a less stressful and more controlled environment.

By extending transportation capabilities, XVIVO Heart Assist has the potential to make more donor hearts available for transplantation while reducing transportation costs, ultimately lowering the overall cost of the transplant procedure. Third, our OPO EVLP hub pilot is now successfully up and running, contributing to the strong lung sales development we have seen this year.

We are now seeing three distinct EVLP models emerging in the US market: advanced transplant centers, centralized EVLP providers, and OPO-based programs. Our strategy is to support all three models, helping more donor lungs reach transplantation and ultimately ensure that nobody dies waiting for a lung.

To support this development, we continue to invest in our commercial organization and strengthen relationships with an expanding network of EVLP partners across the United States. Finally, four, despite making significant investments in scalable manufacturing, regulatory initiatives, and commercial expansion, we continue to maintain a healthy financial position.

We believe this is the right time to invest in long-term growth opportunities ahead of us and continue building XVIVO for the future. With that, we're turning to slide 7, an update on the European heart launch of XVIVO Heart Assist Transport.

During the quarter, our primary focus was on preparing the market launch country-by-country and clinic-by-clinic across Europe. We are executing a structured three-tier launch strategy.

The first phase is now in place, enabling active transplant centers to begin using the Xhat under derogation or compassionate use while local listing processes are completed. We now turn to tier 2, and our current focus is targeting 33 transplant centers across four priority markets where reimbursement is already established.

These centers, together with the first eight, represent almost 40% of all heart transplant clinics in Europe. In parallel, in tier 3, our commercial and market access teams are working closely together to identify patient segments where the clinical value proposition is particularly strong, including DCD hearts, long-distance organ transportation, pediatric transplantation, and complex patients with prior LVAD support.

With very strong clinical evidence base already established, the focus is increasingly shifting towards health economics and reimbursement in Europe. From our perspective, the question is no longer whether the XVIVO Heart Assist can become the gold standard of future heart transplantation.

The key question is how quickly reimbursement can be established to ensure broader patient access across Europe. Ultimately, our ambition is clear: to make this technology available to more patients, enabling more heart transplants and bringing us one step closer to the future where nobody actually dies waiting for a heart.

That was the key milestone of this quarter. As custom, we turn to slide 8 and the regulatory and clinical update.

As more products receive approval and enter the market, the list of ongoing regulatory milestones continues to get shorter. With that, we can turn to slide 9 to show that picture.

The CE mark for XVIVO Heart Assist in Europe serves as a foundation for our regulatory application in both Australia and Canada. In addition to the clinical data generated in Australia, the European clinical trial provides strong supporting evidence.

It was the first randomized controlled trial with a superiority endpoint conducted in the field of heart transplantation. Beyond the strong clinical outcome, the trial was also the first to establish a link between preservation method, which is the Xhat, the risk reduction of severe PGD, which was 76%, and improved 1-year survival of 6 percentage points.

For heart in the US and liver in the US, I will return to the more deep dive into the following slides. With that, we turn to slide 10, which is the regulatory status of XVIVO Heart Assist Transport in the United States.

The US heart trial was fully enrolled in record time, completing enrollment in 13 months compared to the original plan of 30 months, and delivering results consistent with those we've seen in Europe. The study met its predefined safety and efficacy endpoints, while analysis of secondary endpoints showed a severe PGD rate of only 7.9%.

We also reached an important milestone with submission of the PMA application for XVIVO Heart Assist Transport. The submission has been accepted by the FDA in September, and the review process is now ongoing.

During the quarter, the extension of the continuous access protocol, or the CAP, was also approved, providing access to this really innovative and life-saving technology for an additional 60 patients at the participating trial centers in the United States. The Breakthrough Device designation supports an efficient PMA review process, and we are targeting commercial launch in late 2027.

This is subject to FDA review process time, as well as an approval. It should be mentioned that the Breakthrough Device designation allows us to have a dialogue with the FDA during the process, so that should facilitate the process.

Though I have to mention, as always, FDA review timelines are determined by the agency themselves and remain difficult to predict. We'll continue to provide regular updates to the investor community on the progress of the XVIVO Heart review process during quarterly calls.

With that, we turn to slide 11 and the US liver regulatory opportunity. Before I go in there, let me start with an overview of the clinical evidence supporting XVIVO Liver Assist.

XVIVO Liver Assist is approaching standard of care for liver transplantation in several European markets, and is supported by one of the largest body of clinical evidence in the transplant field, if not the largest body of evidence we have seen in the transplant field so far. The evidence base includes more than 100 peer-reviewed publications and covers a broad range of outcomes, from improved patient outcomes in both DCD and DBD liver transplantation to meaningful operational and economic benefits for transplant teams.

Clinical studies have demonstrated improved utilization of donor livers, improved post-transplant outcomes, and reduced complications. At the same time, machine perfusion has enabled transplant centers to work with greater flexibility and predictability, supporting both the teams and the hospital operations.

Taken together, we believe XVIVO Liver Assist has established one of the strongest clinical and health economic evidence bases in transplantation, and provides a solid foundation for our regulatory and commercial ambitions in the United States. With that, we go to slide 12 and a more specific update on the US regulatory pathway for the Liver Assist.

Following a reevaluation of our US regulatory strategy last year, interest in the Liver Assist has continued to grow among transplant centers in the United States. We are increasingly being approached by centers and clinics that would like to get access to Liver Assist, recognizing both its clinical benefits and its potential to improve workflow and quality of life for transplant teams.

There's a clear demand in the United States for cost-efficient solutions that can improve outcomes while supporting a more sustainable transplant practice. Against this backdrop, our regulatory team is actively preparing the submission package for the FDA.

We're targeting a 510(k) submission in the first half of 2027, and subject again to regulatory timelines, commercial launch in early 2028. We believe the US represents a significant long-term opportunity for Liver Assist, supported by both the strong clinical evidence base we just showed you and a growing market interest.

With that, I turn over to slide 13 and hand over to our CFO, Kristoffer Nordström, for the next segment of this quarterly call.

Thank you, Christoffer. Turning to the financial performance of the third quarter, and this was another stable quarter for XVIVO, as Kristoffer already mentioned.

Net sales reached 253 million SEK, corresponding to an organic growth of 32% in local currencies. Growth was led by Thoracic, our largest business area, while also Abdominal continued to show positive momentum.

EBITDA amounted to 52 million SEK, corresponding to a margin of 21% compared with 19% last year. This improvement was supported primarily by the strong sales, but also somewhat seasonally lower activity levels on the cost side over the summer months.

Gross margin worth a comment. Gross margin was 70% compared with 75% last year.

The year-on-year decrease reflected lower margins in Services primarily, as well as product mix and some inventory write-down within Thoracic. Excluding Services, where we have made deliberate investments over P&L for some time now, the product gross margin was 75% both in the quarter and year-to-date.

Moving over to our largest business area, Thoracic. Thoracic delivered a very strong quarter with net sales of 177 million SEK, an organic growth of 51%.

Lung sales amounted to 155 million SEK, and EVLP disposable growth was 67% in the quarter, reflecting the continued adoption that we see and the strong activity amongst our larger customers. We mentioned it in the report, Thoracic also benefited from approximately 19 million SEK of tailwinds towards the end of the quarter.

We had a 8.5 million SEK adjustment, you can say, based on IFRS and the treatment of lease contracts, and that refers to the three OPOs where we delivered XPSs earlier in the year. Now when you do that, you need to take the revenue and the COGS upfront, and that lesson we learned here in the quarter, so that's why you see that a bit of a one-time effect in this quarter isolated.

That's how we're going to treat those contracts going forward as well when we onboard new OPOs. There was also approximately 10 million SEK of inventory build-up by our largest customer in the US.

Heart sales, positive, amounted to 22 million SEK compared with 10 million SEK last year. The CAP study has started.

I think we had three patients included in Q3, it contributed with 1 million SEK, which means that the rest, the 21 million SEK, comes from Europe and it comes from Australia where we continue to see a very strong interest and good adoption of the technology. Gross margin was 80% compared with 89% last year.

As I mentioned, the decrease mainly explained by the product mix, hence a larger portion of this XPS revenue and also of inventory write-downs. Excluding these events, the gross margin would have been 85% for Thoracic, that's kind of the level we recognize from earlier quarters as well.

Moving over to Abdominal. Net sales of 62 million SEK, corresponding to an organic growth of 12%.

Liver sales were 40 million SEK and grew 9% in local currencies. Growth was somewhat lower than last year, reflecting temporary implications from the manufacturing transfer that has been going on, and somewhat softer activity in a few European markets over the summer.

We remain encouraged by the long-term opportunity supported by continued adoption in our core markets and the broader DCD utilization that continues, but also more long-term the reimbursement developments and those opportunities. Kidney sales amounted to 22 million SEK and grew 19% in local currencies.

Growth in the quarter was affected by seasonality and implications from the manufacturing transfer as well, and we believe that will continue into Q4. We do expect growth at current customers and with the current design to continue to return to higher levels of growth from the beginning of 2027.

Gross margin was 61% compared with 60% last year. Turning to Services, our final business area.

Net sales were 14 million SEK. That means a negative growth of 28%.

The decline was again primarily explained by lower organ recovery volumes. We remain optimistic about the pipeline of prospective customers.

We have several contract processes currently underway, so that's very encouraging. However, these processes continue to take longer time than we anticipated to convert into revenue.

Gross margin was negative 19% compared with 37% last year, and the decrease, it reflects the lower recovery volumes combined with our investment in expanding the surgical team to position us for winning new contracts in new geographies and for building capacity ahead of the US heart launch later on. As recovery volumes increase and the new capacity is utilized, we expect the gross margins to recover significantly.

EBITDA. Looking at 52 million SEK in EBITDA in Q3 compared with 36 million SEK last year, and the EBITDA margin improved to 21% from 19%.

Year-to-date EBITDA was 148 million SEK, and the margin was 20% compared to 17% last year, an improvement there. Rolling 12, we're at 21%.

The margin improvement in the quarter was supported by the strong sales, but also the seasonally lower summer activity while we continue to invest in commercial expansion, as we talked about, regulatory activities, and also the infrastructure to support future growth. Final slide, cash flow.

Cash flow from operating activities was strong, 53 million SEK positive in the quarter compared with 21 million SEK last year. The improvement was primarily driven by the strong sales development.

For the first 9 months, our operating cash flow amounted to 182 million SEK compared with only 14 million SEK last year, a significant improvement on the cash flow this year, which I am very proud of. Cash flow from investing activities was minus 49 million SEK, and whereof 39 of those were invested into our regulatory approval processes and clinical trials, primarily related to heart.

Over the three past three quarters, we have generated positive operating cash flows that has been sufficient to fund both our operating and our investing activities. We end the quarter with a cash position of 313 million SEK, and in addition, we have an unutilized part of our credit facility of €12 million.

We believe that we will enter next year with a solid cash position. With those comments, Christoffer, I will hand over to you again.

Thank you.

Thank you for that. We are now at the last section of the presentation, the outlook session, and looking into the next couple of years.

We can turn to slide 21, our outlook for the remainder of 2026 and the next 2 years. Over the past 4 years, we have invested heavily in building XVIVO into the company we are today.

Today we are number one, second to none, in innovation. We are number one in customer support and clinical evidence within transplantation.

We've built a strong position. Combining those with the close partnership with transplant teams around the world, this has created a strong foundation for very high continued growth into the future.

All of our major product platforms are now approved in Europe, and we are making good progress toward achieving the same in the US. As we look ahead, our focus increasingly shifts from building capabilities to expand access and driving adoption of our products.

Our ambition is to become the preferred partner in the transplant process. To achieve that, we have identified four key pillars or four key priorities.

Number one is to secure market access for heart and liver in the US through regulatory approval, reimbursement, continued generation of US clinical evidence, and further development of decision support parameters for both heart and livers with the HOPE method. Number two, the exciting XVIVO Heart launch in Europe.

Our aim is to establish the XVIVO Heart Assist Transport as the standard of care for modern transplantation. Third, we'll continue to strengthen our leadership position in EVLP for lungs.

We will continue to work closely with transplant centers to advance the science of lung transplantation. We'll continue to support pump centers, and we'll continue to support OPOs and centralized evaluation hubs in increasing access to donor lungs for transplant programs across the United States.

Finally, four, we'll continue to invest in the robust and scalable supply chain, maintaining the highest standards of quality across our products and processes. We are growing very fast, and we have to make sure that our supply chain run equally fast.

In addition, to maintain our number one position in perceived quality of customer support, we will continue investing in our commercial capability and in the partnerships that are critical to success of transplant programs across the world. The opportunities we see ahead of us are significant.

We have a strong product portfolio, growing clinical evidence, and dedicated teams around the world. We believe that XVIVO is well-positioned for the next phase of our growth journey.

With that, we can turn to the slide 22 in our longer-term outlook. Because if we look at the longer-term, the fundamental picture remain unchanged, and in many ways this is also the reason we're all here today.

According to the WHO, the demand for organ transplantation remains approximately 10 times greater than the available supply of donor organs. At the same time, the value created through machine perfusion is significantly higher than with traditional static cold storage.

Clinical evidence and real-world experience have demonstrated that machine perfusion as a service model can increase organ utilization, particularly within the rapidly growing DCD donor pool. The key drivers are superior clinical outcomes, increased utilization of donor organs, and simplified workflows for the transplant center.

As a result, we believe machine perfusion and service-based models for both DBD and DCD organs will continue to drive growth in transplantations for many years to come. At XVIVO, our ambition is to change the paradigm of transplantation through innovation.

We are committed to improving life after transplantation, making more organs available for patients in need, and providing transplant teams with technology that enables surgery to be performed under the best possible conditions. Therefore, our vision remains unchanged that nobody should die waiting for an organ.

With that, we can turn to slide 23. Before we open up for questions, I just want to touch base on our dream, and what we have been working the last 10 years to achieve is for transplantation to become a standard procedure, and that organ transportation can be performed using ordinary mode of transportation, and that it should be done by rested transplant teams with the best possible patient outcome.

Again, next time when you are flying, I hope that you are seated to one of our devices on a flight. Remember then, it's not just a device being transported, it's a donor heart going to a patient whose life is about to change.

I want to thank you all for supporting this journey with us. With that, I want to also thank you for listening today, and we will now open up the line for questioning.

Yes, hi, and good afternoon. My first question is on heart, and maybe shortly if you could share the split between Europe and Australia for the Q3 sales, and then also if you could comment yeah, if you already now started to drive adoption among these sort of tier 1 compassionate centers, and also when you will start to onboard new customers in that sort of tier 2 category?

Thank you. I will start with the second question.

We are listing the product, we are targeting to onboard new customers in December of this year. We know the listing process is 3 to 4 months.

Right now, the sales we see on heart is still coming from derogation, compassionate use, etc.

I can follow up Christoffer on the first question. In Q3, heart sales was as following: so Australia, New Zealand, 9 million SEK; Europe, 11 million SEK; and US CAP study, 1 million SEK.

Thank you.

Good. Just if I understand, are you growing your volumes with these existing customers right now, or are those sort of stable right now?

That's a good question. The majority of centers are growing, but we still believe that the real growth from both new centers and existing centers will come with the listing of the product and selling under CE mark and with reimbursement kicking in.

Hence, as of December.

Very clear. Then on liver in the US, very good that you are targeting a faster launch here.

I'm wondering sort of how you see the long-term prospects in the US market. On the one hand, you are already strong in Europe, but the US market is also more crowded and there are already, yeah, two warm perfusion players and one cold perfusion.

Would be interesting to hear what you think about the long term in the US.

That is a great question. From customer feedback, it has been very clear that they need an alternative in the US.

When they all meet, all transplant surgeons and transplant coordinator, all meet on the larger global conference, when they see Europe, it's clear that they see a extremely good product, very stable product with the best clinical result in the world. Of course, they want to get a hands on that one.

We are realizing it's a more crowded field, and I think the success rate of it will depend partly on how fast we can afford to scale up sales and support function to the Liver Assist, which will be key to be successful in the United States, as well as partnership within the let's call it logistic/perfusionist area so we can support OPOs in pumping the greatest number of livers as possible. There will be some investment needed and some partnership discussion needed to have the greatest possible success.

Do you think will you mainly sort of convert customers that today are on warm perfusion solutions or would it be those that don't use perfusion at all or converting those now maybe on cold perfusion? Do you have an assumption of that, which would be your main opportunity?

We are doing that job right now to look in what will be the main opportunity. I think that we will see opportunities in all of the above.

Then depending on how fast we can change current behavior, that will be the leading cause to where we will get the highest uptake of our technology. As always, when you launch a product, I think the majority of sales in the beginning will come from KOLs, the visionaries, the ones who want to change, and over time that will trickle down to the majority market.

Good. Then I also have a question on this stocking you mentioned to your large customer in the US.

Just to understand, is this an order you otherwise could have expected in Q4 that now came in Q3, or is it that sales stands out as unusually high to the customer? Just some more color on that, please.

Given our insight into the volumes, this was more of a top-up as we see it. We are afraid that it could mean that sales in Q4 to this customer might be slightly less than we expected, but still solid and contribute to growth in Q4.

Short comment on that one. Sometimes when we get orders, it can fall on the last day in one quarter or the first day in one quarter.

This fell in the last day. It happens.

It's not unusual. We just want to be very transparent.

Good. That's very helpful.

Then final question from my end is on kidney, and if you can elaborate a bit on what you mean by sort of more moderate growth. Let's say, do you still see some growth?

Will you grow with existing accounts or will you also take some new accounts, or just how should we look at that?

No, that's a good question. That needs some clarification.

We see high growth opportunities in the US coming from both existing, but primarily new accounts in the United States, as well as Europe. We are talking about moderate growth probably around 30%, but the opportunity is much higher if I look into the pipeline of new kidney customers, especially in the US market, but also in Europe, where we had so far, I think we had far above 60% growth here in Europe.

Due to some component changes where there are a shortage situation, we need to allocate them wisely. We would not be able to fulfill the full demand of the market next year in kidney.

That's our best estimation. It will still be a solid growth, still okay, but unfortunately not to its true potential, which we would have hoped.

That's very helpful. Thank you very much for taking my questions.

Thank you.

Hopefully you can hear me better now.

Yes. Perfect.

I would like to start on this big US lung customer, and you're of course mentioning again in the report that they are planning to switch to at least partly to their own EVLP platform here in 2027. Just for our benefit, to help us think about the dynamics in that switch, will this be from one day to another?

Will it be more a gradual shift? Because I'm thinking that some of the customers can stick maybe to your platform given that they have experience working with it.

Any color on that dynamic would be helpful.

Thank you. We will try our best.

You have a point that there is an end customer who has a say in this one, and it's very clear that the end customer decides. Just to be very clear, we've been partners for more than 10 years, and we are in constant dialogue around how to increase the lung utilization rate in the United States.

Today's around 20%, it should be 50%. The jump between 20% to 50% is why you build EVLP, because that's what it's developed for.

We are looking into those opportunities at the same time. We are in a phase in the dialogue where we can't go into exactly how the dynamic of pricing will develop.

We will, as soon as we know, we will inform the investor community, and at the latest in the quarterly report for Q4. That's clear.

All right.

Maybe a bit of a conceptual question, but when we are looking into next year and on lung specifically, okay, we have this, let's call it a headwind, potentially from this big customer, but you had a very strong placement year last year of XPS systems, the OPO model is starting to bear fruit. Is it sort of plausible for those initiatives to counteract to a full extent the potential headwind from the biggest customer, or is the magnitude too big to counteract, you think?

Or yeah, how we should think about the whole lung franchise next year in terms of growth rates, just maybe high-level takes from your end?

Right. You will get a high-level answer to that one, and we need to come back with a more detailed answer.

We do see fast growth in our new customers, and we do believe that that will hopefully cover any shortfall. That is our strategy, and we need to, of course, come back and update you regularly every quarter next year of the case, but that is the working hypothesis right now.

Lovely. Maybe my final one on services, are you evaluating any type of restructuring of that business, or any similar initiatives?

Do you think it will be or is it crucial for XVIVO to have an in-house service capability over time? Would it maybe be better and more cost-effective to work with a partner instead, or what's your thinking about that business area right now?

If I answer more general, we are continuously evaluating our strategy and go-to-market strategy for all of our products. As we have mentioned many, many times, this was bought as an option for the US heart launch, and we're now nearing US heart launch.

Of course, we are looking into what is the best possible way. We have the, I would say, the best quality organ recovery service, and it's a great asset that we will use in the heart launch in either way.

Of course, we are looking into any strategic opportunities constantly to see what is the best way forward.

I also want to comment that on the restructuring, as you said, that is what has happened. That's also why we see that we have invested into this business, and that's currently what's weighting down the margins of that business.

It has been a deliberate decision, and the restructuring has been attracting very talented surgeons in strategic geographies to position us for winning new contracts and to be on a good spot when we launch the heart launch. I'm very excited about the contract in discussions we have at the moment, and I just wish it went faster, to say, but we will get there.

Understood. Perfect.

Thank you very much.

Hi, good afternoon. Got a few questions today.

I think I'll start on liver. I'm a bit curious on the submission now in the US, what exactly it takes before you can submit it.

You targeted now on 2027, what are you going to do until that? Is it mostly just writing it up, or will you need to get any sort of clinical data?

I think you had it on the slide that you're only going to submit it based on data outside the US, do you have everything you need currently or yeah?

Thank you for that question. Of course, setting up the file and application will take some time, and that we will spend the time on.

Our current strategy is that we will have outside data. Still, the usability validation need to be done in the United States, but that's not a clinical trial.

It's more of usability trial, so that also takes some time. That is what we will spend the majority of time until submission.

Okay. I think you've spoken before because the predicate device you're relying on now is just HOPE, but you have most of your data in D-HOPE.

You have sufficient data for a submission, it seems like then.

Yes, we believe that. We have data both on HOPE and D-HOPE.

Good. Very simple answer then.

I was just then on service. You've spoken about that you've anticipated some kind of turnaround, but it hasn't turned up yet, and it seems to be contracts taking longer time.

Are there any reason to be more optimistic now in 2027? You said you have some in the pipe, but how reasonable is it to show growth not just ever, would you say?

It's very reasonable to expect growth in 2027, not necessarily in Q4, because it takes some time with contracting with legal and IT and all that stuff. We're very far on very interesting opportunities.

I'm confident we will see growth in 2027.

Thank you. Perhaps last question for me just around the cost next year.

Now you will have the US heart launch toward the end of next year, and then you also have liver in the US, and you're continue ramping up heart. How should we think about costs ramping up next year?

Do you think you will be able to defend the margin that you have this year, or how should we think about it?

That is a great question. It's slightly depending on timing of approvals.

We will invest in especially larger sales force prior to approval. We do through the study and through the continuous access protocol, we have already customers up and running, to say, in the United States.

We believe that over time, over quite short period of time, we will regain that one. We would need to invest a little bit before approval so everybody's up and running and we can do a great launch.

Fast recovery of those costs. How we invest that will depend on timing of approval.

If the current plan then plays out as you believe with heart launch and liver launch beginning of 2028, I suppose you will have to invest next year, but do you think you can defend the margin that you have this year then?

I think that we will see a slight margin dip during the second half of the year for the investment to increase sales force for both heart and liver.

Good. I'll take that answer.

Thanks very much. That was all for me.

Yes, good afternoon. Thanks for taking my questions.

I want to start with another one on heart. Similar to one that's already been asked, but I guess a little bit different.

About the tier 1 and tier 2 centers that you were talking about. If I got it correctly, you're currently as of today still running on the compassionate use, but as I understood that you still are fully up and running with the tier 1 centers.

The first question is around the tier 1 centers: do you view them to be fully up and running in terms of what their capacity is, or do you see more growth on each center going forward? Second question on this topic would be how long you expect the initial tier 2 rollout to take?

Basically, sort of from the day you start with the tier 2s to the day you've reached the first group.

Thank you for that question. If we look at the tier 1, no, they're not fully up and running.

There's a lot of potential in each account in each of the eight still. If I parallel that to the Australian launch where we had year 1, at the end of year 1 after launch, I think we had 30% penetration going into year 2, 40%, then year 3 up to 50% and above.

We actually up to in a few centers more than 60%. We will see a similar development in each account in Europe as well.

The question of how fast, it will be at this point, we are modeling this one, but it will be quite center-dependent on how they will approach it and how fast the reimbursement kick in. As I said in the call, we at XVIVO believe that this will become the gold standard.

This is how you transport hearts, but it will depend on reimbursement in every country. We are more looking into how fast we can establish reimbursement.

We haven't heard any customer so far who said, "We don't want to use this product." It's more that, "When it's reimbursed, I will use it for half of my hearts or all of my hearts."

That's the conversations we have.

Got it. Thank you.

Then one more on lung. You have been talking about and mentioning the inventory build-up from your large customer, but I'm just thinking bridging into Q4 here.

If we assume a sort of underlying lung pace and just adjusting for this inventory build-up in Q3, should that take us close to what was reasonable to expect for Q4, or are there other moving parts that we should be aware of when it comes to the sequential development here?

To my knowledge, there are no other moving parts for Q4.

Great. Then my final question on this leasing effect that we saw in the quarter.

Could you just give us some more color about the timing here, because I thought that OPOs have been up for a few quarters before this. Basically what is the reason for the timing to hit now?

Was this something that has been in the numbers before, but you just mentioned it for the first time now?

Yes, valid question. This relates to the OPO model where we are not selling a device, but we're placing a device with a lease contract over 2 years to our perfusion partner.

When I think we placed the first OPO in Q4 last year, and since it was a very small business then, we took the revenue on a monthly basis in connection with our invoicing. Now when these business have grown, we have looked into it further with our auditors, and it has been clear that this qualifies as a lease agreement, a financial lease agreement, where you should take the full value of the contract on day 1.

Since we didn't do that retroactively now, we needed to take revenue for these three OPO placements in one quarter retrospectively with the associated COGS as well. That's the reason.

It's a catch-up so to say. In the future, when we have a new OPO placement, you will see a full revenue of I think it's around 4 million SEK in that quarter.

Is that clear?

It's clear. Just to make sure we get the full picture, is this contract and the value that you account for, is that for the machine?

When they continue to use the machine, that will be sales in

Oh yeah. It's a razor blade model as always, but so this is only for the machine.

This was the leftover revenue for three machines that we placed earlier in the year.

To be clear, we try to communicate the underlying revenue, EVLP kits or kidney kits, etc. This IFRS and if it is an operational financial lease, I honestly don't care.

It's every time we use the machine, we save another life, and we take away somebody from the waiting list. That's what we communicate around.

For transparency reasons, we want to be very transparent around this change from operation to financial lease, but it's more of an IFRS thing and has nothing to do with underlying business.

No, of course. Appreciate the transparency, and it's very clear now.

Thank you. That's all for me.

Thank you.

Good afternoon, Kristoffer and Kristoffer. I have just two questions.

There's been a lot already, but perhaps going into more on the OPO model. You say you have three OPOs online now, and I believe you in Q2 talked about additional OPOs that you have line of sight in regarding this model.

Can you just maybe elaborate a little bit on how that pipeline is developing and how we should expect the kind of number of OPOs to progress the coming quarters?

Thank you. That's a great question.

We have identified five further or more OPOs in the pipeline that we will gradually introduce to this concept. The interest is very high.

It simplifies the process. It reduces the overall cost, and it helps the OPOs to improve their metrics, which is use rate of lungs.

It's a great method. The key here is to do the implementation flawlessly so you can be up and running as soon as possible.

It will be, if you call it, a controlled build-up of the pipeline in the next couple of quarters to make sure we have the best success we possibly can.

Great. Thank you.

Then maybe you touched upon it previously. You've talked a lot about liver during the call, but I guess I want to hear kind of more on your rationale behind going for a 510(k) with the kind of more narrow HOPE label compared to D-HOPE, given the kind of the fact that you also have the heart launch in the US up and running.

How should we think on the degree to which you invest in liver on a HOPE label basis in the US also coupled with the fact that there is an approved HOPE product there and that competitor has raised money recently and will probably put into their commercialization. How should we kind of view those competitive dynamics for liver?

We acknowledge that liver is definitely a competitive market. We believe that the body of evidence we have is second to none for liver, we believe we have a bit of a head start there.

We also have an abdominal team up and running already with kidney. We do think that there are investments, but compared to the investments we've seen other parties done, we don't think we even close to needing that type of investment to be very successful in this market.

Great. Maybe just a final one from me.

Apart from your largest US lung customer having their model approved, there is also another company that had their device for EVLP approved, it's been a couple of months now. I guess it's still early days for that company, but can you comment a little bit on whether or not that has affected competitive dynamics within lung in the US?

Far, we haven't seen that the competitive dynamics have changed in a large way. It's still early days.

We do expect if we look at the numbers, approximately 20% of all lungs are used, and today 2% to 3% of those come from EVLP. We know we're going to grow from 20% to 50%, the market opportunity is another 30 percentage points, and they will all come from EVLP because they need evaluation.

There is a lot of work to be done. Having more enters into the market has two effects: there is some competition, but there is also more people or more companies talking about the ability to evaluate more lungs for transportation.

We do believe that the market growth will increase over time due to more players in this field.

Great. Thank you.

I think that was all from my side. Thank you for taking my questions.

Thank you so much. We are nearing the end of this meeting.

Are there any questions left?

Hi there. Thanks for taking my questions.

I'll keep it short. I think I misheard on the quantifying the largest US customer share.

If you could break that down, that would be helpful. Then sort of looking forward, sort of excluding that customer, how should we think about the disposable growth, sort of the contribution from OPOs versus existing accounts?

Thanks.

Great. Thank you.

To start with, I will answer the second question, and Nordström, you can answer the first one. We see very solid growth from let's say all the customers.

I think YTD we are at 92% on, and now we talk about disposables, and not IFRS effects or anything else or stocking. We see a solid growth.

We think that will continue with addition of more accounts and with growth within existing accounts. We do see both a solid pipeline, a great interest, and that is converted into high sales growth.

Looking in the annual report from last year as we speak, we disclosed there under revenue that the largest customer last year was totaled 132 million SEK in 2025. I think that's a good measure stock for the magnitude.

Perfect. Thank you very much.

Thank you, Ed. Did you have any more questions?

I guess maybe just one more on sort of the static cold storage growth, and I know we talked a lot about EVLP, but sort of your expectations for this going forward.

Yeah. We have a dominant market share in static cold storage for lungs.

It is the gold standard. It's used by more or less every account in the world today, except where we choose to not sell it for ethical reasons.

We expect to grow with market growth, that if I remember correctly, we have in our plans right now is roughly 5% for next year.

Quite clear. Thank you very much.

Thank you so much. With that, we unfortunately have to end this call, and we are inviting you back for the year-end report 2026, and that call will be held on January 28, 2027.

Until then, I wish you a very good time, and hope to see you back for the Q4 or year-end report. Thank you, everyone.