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

To get started, we go to slide 2, and today's presenters are me, Christoffer Rosenblad, CEO, calling in from Gothenburg, Sweden, and Kristoffer Nordström, CFO, calling in from Denver in Colorado. With that, we can go over to slide 3, which is the Q2 financials at a glance.

The Q2 shows the sales amount in line with the previous quarter Q1 and with a 36% organic top-line growth compared to the same quarter last year. EBITDA was kept at a healthy level, resulting in a good operating cash flow.

For the third consecutive quarter, the total cash flow was neutral, and hence the cash position is stable. Kristoffer Nordström, our CFO, will get into the details on sales, gross margin, cash flow, and EBITDA later in this presentation.

If we look into the segments, both the thoracic and abdominal segments are growing rapidly in both regions, North America and Europe. The lung market trend from Q4 last year continued into 2026 with a good lung market growth.

I'm also very pleased with the strong kidney sales in the quarter fueled by a larger sales footprint in Europe and a growing sales force, and most importantly, growing interest from clinicians in the United States. We will come back later in the presentation on the progress for the service segment, the actions taken, and how we will execute to become the preferred partner in the transplant process.

With that, we can go over to next slide, which is slide number 4, which is the same picture, but for the first six months of the year. It shows a similar picture as the quarter.

Good, stable overall growth comes from strong thoracic growth and healthy abdominal growth. During this year, we have continued to invest mainly in sales force, scalable production structures, as well as regulatory approval.

Sales came in at 480 million Swedish kronor with a 29% organic growth. If we look into the segments, we can see that for heart, the main hurdle is regulatory approval.

Once the Heartbox is used, the feedback is overwhelmingly positive. We continue to build evidence, and more than 600 patients now have been successfully transplanted with the Heartbox.

The best testament to success is Australia, where the heart penetration year one was approximately 30%, year two it increased to 40% of DBD hearts in 2025. This year, we already see an increase to approximately 50% penetration of all transplanted hearts in Australia.

I also want to mention that our projects are progressing according to plan. Regulatory timelines are hard to predict, but clinical trial, submission file, and the development progress are progressing according to timelines we have previously agreed internally.

The full-scale production of disposables for heart, liver, and kidney will be extremely important to capture future growth potential for all three products. With that project coming to an end, we will now focus on reducing cost per disposable, setting up dual production where deemed necessary, as well as improving our machine production setup.

This project will also include our lung portfolio. Lastly and most important to mention is that this quarter again shows that the business model is scalable.

With increased sales, we see that turning into an improved EBITDA and an improved underlying cash flow. With that, we can go over to slide 5, and we will come back later to the financial numbers in that section.

We can go into the Q2 highlights on slide 5, and those we will see on the slide 6 and 7, we can go straight to number 6. One key is that we definitely start to see that with a larger sales force, we meet more customers, and we see an increased adoption of our technologies across the line.

Number two, we mentioned before that the lung market is back, and we very importantly are running an OPO EVLP hub pilot. That is successfully now up and running, and that explains partly the increased lung sales during the quarter.

Far, the progress is in line with plan, and we have identified 4 to 5 OPOs in the rollout pipeline, whereof the third OPO was onboarded last week. We are continuously investing in more feet on the ground in the US to enable closer customer relations with a growing number of EVLP partners.

If we look three, look into heart. As I just stated, in Australia, we saw a fast pickup of usage early on, and it increases year by year.

Now we see a similar interest in Europe, and it translated into usage under derogation or compassionate use. It's interesting, we hear more and more testimonials from customers who say that the XVIVO Heartbox changed not only the ability to transplant more patients with a higher patient survival rate, but it also reduced stress level in the transplant team and increased the confidence in heart transplantation.

In the US, the interest in our XVIVO heart technology is equally high, and we have recently submitted the extension of the CAP, or continuous access protocol, to the FDA. Mentioned in the last quarterly call, but will mention again, after spending time at the ISHLT 2026 in Toronto, it's clear that XVIVO is by far the innovation leader in the field of both lung and heart transplantation.

If we look into number 4, we saw increased sales from the Kidney Assist Transport, and we also see an increased interest and momentum from customers using the Kidney Assist Transport. This is based on more and more clinical evidence being available to clinicians that supports the use of Kidney Assist Transport, as well as a larger commercial footprint in both regions, Europe and the US.

In parallel, we are working hard to develop the product to meet US OPO needs, as well as lowering the cost per disposable to increase margins over time. With that, we continue on highlights on slide number 7.

Point five, what is very encouraging is to see that where we put commercial capabilities and increase our sales force, we grow typically between 30% and 60%. With future approvals expected and coming in, as well as our product improvement, we will continue to see this leverage of commercial sales force turning into increased sales at a good return on investment.

Even though I wish to have point six here, even though I wish to have had great news, we have seen great progress in all our regulatory processes, as well as we have stated, we worked hard on the derogation and compassionate use here in Europe. We see take it up in Australia.

Now we see that we have what I deem as good progress in the regulatory processes. I will shed more light on where we are on each approval in the next section of the call, the regulatory and clinical update, but I just want to conclude here that we are pleased with what we have seen so far.

If we look at point seven, very important point, to start with, we are very pleased with the growth and the cash flow we saw during the first half of the year, but we invest heavily in future growth. The majority of the investment, of course, goes into regulatory application for heart globally and liver in the US.

Besides that, we continue to invest heavily in building commercial capability and the production scale-up to enable higher volume than we have today. We are also investing in quality capabilities to support the growth we will see that we believes will be 10 10x in volume versus what we see today.

Lastly, number 8, that capture I think the first half-year is that we have a scalable business model. We do invest to capture that opportunity, and we see increased sales turn into EBITDA, that turn into an improved operating cash flow that we then can invest into regulatory approvals of our future sales drivers, which is heart globally, liver in the United States.

With that nice segue, we can go into the regulatory update, slide number 8, but we can actually quickly go to slide number 9 to go into the regulatory processes we have. This is the usual overview that we show every quarter on slide 9.

We now see more and more evidence for the Heartbox globally. In Europe, we ran the first randomized control trial with superior endpoint that was performed in the field of heart transplantation.

The clinical outcome was great, with an additional six lives saved per approximately 100 patients. It is also the first clinical trial to establish a link between preservation method, severe PGD reduction, and reduced one-year mortality.

In the analysis of the trial data, it was noted that the XVIVO group had a reduction of severe PGD by 76%, which is a lot. In comparable number, the severe PGD was 20% in the control group, which is expected, but only 5% in the XVIVO group.

It was further noted that the mortality after severe PGD was approximately 40% in both groups, leading to an increased survival of 6 percentage points in the XVIVO group versus the control group. The US heart trial was fully included in record time.

It showed the same picture. The severe PGD rate there was only 7.9%, and we are now finalizing the submission for the FDA for their review.

The team is working very hard. We are expected to hand in the submission file to the FDA during this quarter after we are waiting for some validation and product aging data before we can finally submit it.

In Europe, the CE-marking process for Europe is ongoing, and at a late stage now is my best judgment. Stated earlier, the Heartbox and disposable part of the product is already CE-marked.

The solution has passed EMA consultation, and we're now waiting for consultation at the sub-medic agency for the one part of the product. During Q2, we received a few questions of clarification nature, which we turned around in less than a week.

We are now waiting for feedback on that additional information, where we unfortunately don't have an exact timeline, but we expect feedback during this quarter Q3. As we stated earlier, the uptake of Heartbox is good in Europe under derogation and compassionate use, and we are ready to launch when the product is fully approved.

Hence, the launch plan is ready, we have staff recruited, and they are meeting customers today under derogation to support them with everything they need. The interest from clinics is very high in Europe, as it is in the rest of the world.

I still want to mention that even though the use under derogation and compassionate use is increasing and appreciated by our customer, we need to mention that the European heart clinics are suffering badly from lack of alternatives to the XVIVO Heartbox. In both United States and Canada, the regulatory approval will be pending the CE-mark in Europe, we are waiting for that one until we will seek for approval in those two regions.

The last point, liver in the United States, I will come back with an update on the next slide, slide 10, and the Liver Assist regulatory status in the United States. We have previously reported that the Liver Assist has been granted breakthrough device designation by the FDA with an approved IDE and CMS funding approved.

We could have started a trial Q3 already last year, at this point pretty much one year ago. We did decide to temporarily pause the activities for the liver PMA process to investigate alternative regulatory routes possible, and we are preparing for the FDA Q-Sub meeting, where the possible regulatory route will be decided by the FDA.

We have recently opted to focus the majority of the resources we have on the heart US submission. That being said, we have very high interest from US clinics that are supporting the US liver submission, and we are in good dialogue with clinics to prepare ourselves for the Q-Sub meeting with FDA.

We will inform all investors of the next steps in the US liver regulatory investigation latest in the Q3 report if we don't feel the need to do it before that. With that, I conclude the first section of the Q2 presentation, and I will hand over to our CFO, Kristoffer Nordström, who will present the financial performance.

Yes, thank you, Christoffer. Turning to the financial performance for the second quarter then.

This was another strong quarter for XVIVO. Strong momentum we saw in the first quarter continued into Q2, as you have seen, and we delivered net sales of 239 million SEK, which corresponds to an organic growth of 36% in local currencies.

Importantly, growth was broad-based across our portfolio and driven by continued adoption of our technologies in all major organ areas. Pleased to see that.

At the same time, we continued to invest in commercial capabilities, regulatory activities, and operational scale-up initiatives while maintaining a solid profitability. EBITDA amounted to 45 million SEK, and that's around 19% in EBITDA margin.

We believe that this demonstrates both the strength and the scalability of our business model. I will get back to that.

Gross margin was 71%. Thoracic margins remained strong, while gross margins in abdominal and services continued to impact the overall mix, and I will come back to that as well in a moment here.

Going over to next slide, which is the largest business area today for XVIVO, thoracic. Thoracic delivered a positive quarter with net sales of 158 million SEK and an organic growth of 53%.

Adjusted for heart trial revenue, we're still at 52% organic growth, very good. The momentum in lung continued to strengthen.

EVLP disposable sales grew 69% in the quarter, and we continued to see expansion beyond our largest customer accounts. Activity remained strong both among leading transplant centers, but also within our growing OPO strategy.

During the quarter, as an example, two additional XPS systems were installed at OPOs in the United States and are expected to become operational in the second half of the year. Heart, Christoffer touched upon it.

We're very pleased, very proud to see that we delivered a particularly strong quarter on heart, generating sales of 24 million SEK, and primarily from Europe and Australia. We continue to see increase in use under compassionate use and derogation in wait for our regulatory approvals.

With approximately 600 hearts transplants with our technology, we continue to build both clinical experience and commercial momentum ahead of our future approvals, which will be very important. Gross margin on thoracic was 83%, remaining at a very attractive level despite the increasing contribution from heart sales that we should remember is still at pre-launch pricing.

Moving over to abdominal. Abdominal delivered another strong quarter and reported net sales of 65 million SEK, corresponding to 26% organic growth.

Liver sales grew 11% in local currencies, while kidney contributed and was the primary gross driver with a growth of 72%. We are particularly encouraged by the continued adoption of Kidney Assist Transport both in Europe and North America as more centers gain experience with the early adoption of this technology.

Gross margin was 57%, an improvement from Q1, but less than the 68% last year. The decrease was primarily driven by product mix, with kidney representing a larger share of sales, as well as pricing conditions in certain markets.

While this impacts margins in the short term, we remain very confident in the long-term margin opportunity within abdominal. As adoption increases in the US where pricing levels are structurally higher, and as we continue implementing manufacturing and sourcing improvements, we expect margins to improve over time.

Overall, we remain satisfied with the growth trajectory in abdominal and the increasing adoption of both our liver and kidney technologies. Turning to services, our third business area.

Net sales were 15 million SEK, corresponding to negative growth of 25%. The development continues to be explained mainly by lower organ recovery volumes, while FlowHawk delivers another strong quarter.

FlowHawk grew 48% organically and continues to gain traction among transplant programs across the United States. We remain convinced that the digital workflow solutions will become an increasingly important part of transplant infrastructure and customer integration for XVIVO over time.

Within organ recovery, volumes remained below our expectations yet another quarter. However, following the investments we have made into the organization, the talent that we have attracted, we feel that we are getting closer to growing our customer base.

We have a firm focus on returning to growth here in the second half of the year, and I think we should see some results, especially in the back end of the year. Gross margin was 10%, and that's purely reflecting the lower organ recovery volumes combined with our investments in capacity.

As volumes recover, the margins should naturally improve. Switching gear from sales and going into EBITDA and profitability.

Despite continued investments, as we talk a lot about, in commercial expansion, regulatory activities, and scaling the organization for future growth, EBITDA remained strong at 19% in the quarter and 20% year-to-date, and on a rolling 12-month basis, EBITDA has now improved to 21%. Many companies can deliver high growth, and many companies can deliver profitability, and we're thinking that delivering 29% organic growth during the first half-year of the year while sustaining around 20% EBITDA margins and generating positive cash flow demonstrates the quality of our business model and this already at a very early phase of our growth journey, we're very proud of that.

As we have said previously, XVIVO's business model is highly scalable. We will continue to invest where we see clear long-term commercial opportunities, particularly in North America, but we will also maintain disciplined cost control across the organization.

My final slide, cash flow. One of the most encouraging aspects of the quarter, we think, was the continued improvement in cash generation.

Operating cash flow amounted to 63 million SEK in the quarter and 129 million SEK year-to-date. This should be compared with a negative operating cash flow during the first half of the year last year.

This reflects both the stronger commercial performance and the continued focus on working capital management. Cash flow from investments amounted to -68 million SEK in the quarter and relates primarily to regulatory and product development activities, especially within heart.

What we think is particularly important is that over the past three quarters, we have demonstrated our ability to largely self-fund both our operating investments, but also our growth investments, our capex. Despite continued investments into future growth, total cash flow for the first half of the year was essentially break-even, and we ended the quarter with a strong cash position of 305 million SEK.

With those comments, I will hand it over to you again, Christoffer. Thank you.

Thank you, Nordström. We will round off this presentation with outlook for the rest of the year and then a little bit longer-term outlook.

We start with slide 19 and the outlook for 2026, our focus areas. We will continue to build sales force and build new partnerships in the US to enable OPO and other clinics to recover more lungs by EVLP adoption through a combination of service models and staying very close to customers.

In parallel, we increase our service offering to better tailor customer needs, especially offering FlowHawk and NRP from a hopefully increased footprint, or we have an increased surgical footprint, we should also have an increased contract footprint. We will continue to work closely with our competent authorities in Europe with the aim of obtaining the CE-mark of heart, of course.

We are aiming to submit the regulatory heart file to the FDA for their review during this quarter, as well as deciding the regulatory pathway for Liver Assist in the United States with the aim of giving US surgeons the same opportunity we now see here in Europe using the Liver Assist, where European clinical teams saves hundred of lives every quarter thanks to Liver Assist. If we turn from this year outlook to a little bit longer term, which is I think it's important to keep in mind while we're here, is that the demand for transplant is still 10 times higher than the supply of organs.

We should also remember that the sales value for machine perfusion is approximately 10 times higher versus what is used today, to a large extent static cold storage or a beer cooler box-type with ice. Machine perfusion and our service model have proven to increase the number of organs to be used for transplantation, especially in the fast-growing DCD organ pool, where the main growth drivers are superior clinical results from machine perfusion and the fact that we can reduce complexity and add time for the transplant clinic in order to reduce stress.

In conclusion, we know that machine perfusion and good service models on normal and DCD graft will drive growth in the near and the long-term future. Lastly, XVIVO want to change the paradigm for transplantation by innovation.

We are convinced and committed to increasing patient lives after transplantation, making sure that no one dies waiting for an organ, and making sure that we have rested transplant teams performing surgery at a lower cost than what we see today in the transplant chain. We hope that you, dear listener, in the future when you fly, you might be seated near to an XVIVO Heartbox with a heart being transported to a patient whose life is about to change soon.

If you see that XVIVO heart device on your flight, you should know that it's not just a heart traveling, it's a hope for a new and a better life for the patient and his/her family. I want to thank you for supporting us on this journey to change the transplant system forever through superior innovation.

With those last words, I also want to thank you for listening today. With that, we will open up the lines for questions.

Good afternoon, everyone. A few questions from me, and I would like to start on the strong heart print that you mentioned.

Would it be fair to assume that sales in this quarter was maybe a bit boosted by a lot of new placement of the boxes, or were revenues mainly stemming from existing clients already sort of using consumables and yeah, more of sort of a basic run rate for the business, or just how we should think about the dynamics of the business model here in the beginning of the launch, if you will, and if we should extrapolate anything into second half?

Thank you, Simon. It's a great question.

We are scaling up in Europe. There were limited Heartbox sales both in Q1 and Q2, the main sales coming from disposables.

We should remember that once you get started, you have a few kits as safety stock, so that has affected half year one to some extent. We see definitely increasing uptake in Europe from using heart.

Great.

Great. The second question was on EVLP, I believe you have three OPOs, yeah, signed now soon online as well.

It sounds like more also in the pipeline, hopefully, for the remainder of the year. If you could help us understand the potential of these OPOs when it comes to revenue.

I guess you have data on their current volumes and growth rates, etc. Just trying to understand what 3 to 5 OPOs can do for you in, let's say, next fiscal year, what's the magnitude we're talking about?

We are in pilot phase, we do need to come back in probably six months to answer that question properly and with more exact data. What we do see is that the opportunity to evaluate in lungs on the OPO side is vastly outnumber the one on the clinical side due to their access to extended criteria lungs that is there, and also the fact that it simplified the whole process.

We have seen in one OPO, we saw a fairly fast uptake. We need to replicate that 3 to 4 times more to come back with exact numbers coming into next year.

Far, it looks good, and according to our own plans, it's according to those at least.

Okay. Makes sense.

The final one was on sort of further or coming investments in sales force when we're approaching a heart launch both in Europe and in the US, right, into next year. Could you give us any help or ballpark estimate on how many more salespersons, support persons do you need to really cater and to meet the demand and to make it a successful launch here for the heart product?

What's the magnitude of investments basically that we should expect here in, yeah, next year maybe?

Yeah. In Europe, we have invested.

There will be add-on investments when the more customers come on, the more field force we need, to say, ranging from customer support to technical support, to clinical support, to sales reps. That is more of a scaling-up exercise.

In the US, we will start to, during next year, scale up. We depending on a little bit on the timing, but we do believe that we need an approximately 10 to 13 extra commercial headcounts ranging from sales reps again to customer support, technical support, and increased clinical training/support.

Okay. That sounds fair.

Thank you so much. I'll get back in line.

Thank you.

Yes, hi and good afternoon. My first question is on the OPO customer channel.

I'm wondering, the first OPO that you won here earlier in the year, if you can elaborate on how that has sort of developed and ramped up here through the first half of 2026?

I can go on that one. You're right, Jakob.

We acquired that OPO in the back end of last year, and they became active very early this year. I would say they have a strong ambition at the OPO, and it's a mutual ambition, on par with volume-wise for EVLP, on par with, let's say, the top-five centers in the US.

We talk about fairly larger volumes. This is a new method, and we are three parties that needs to collaborate, it's XVIVO, and it's PSI, our perfusionist partner, and the OPO.

There are learnings in the making. We believe that we have a proof of concept.

To provide some more color, I think they are now close to, let's say, 20 EVLPs for the first half-year, and their ambition is higher than that when they are fully up and running. We consider that a very strong start, and now we want to replicate that on coming up at the OPOs as well.

I think you will see a variety of slightly lower volumes than this one, but also perhaps higher for other OPOs as well. It's a good start.

This, let's say, 20 in the first half, is that a reasonable assumption for this second two you won now in Q2 for H2 2026? Yeah.

No,

I think you will see I think the ramp-up time could vary a little bit on these two OPOs. One is smaller and one is bigger.

It's a little bit too early to say, I think. A lesson is that it takes at least a quarter, I think, to come up to speed for them.

That sounds fair. Then I have a question on the heart sales in Europe here in Q2, if you can elaborate on what countries are contributing to that?

Yeah.

As Christoffer said, we are very, very happy now with the footprint that we have in Europe. Naturally, there's some background noise here.

Not sure if it's you, Jakob, but naturally, these are sites that has participated in the European clinical trial. We talked about France, as we sent out the press release this year about the derogation, they are contributors.

You have the Benelux countries, Germany, Sweden, and Denmark, if I remember correctly. We think that's a very good starting point here for Q2.

Okay. Then

on the CE process for heart in Europe, I understand that it's tough for you, and it's hard for you to make predictions, but it sounds based on your commentary that we're unlikely to get it within the sort of one-year horizon from the press release you sent out in, yeah, August last year?

Yeah. That's our best guestimate at this moment based on where we are in let's say level of clarification.

That being said, it's hard to predict regulatory timelines, especially during the summer, but, yes, that's our best guestimate.

It's still reasonable to expect it in 2026, perhaps?

I certainly hope so.

It's tough, I get it. Then a question on liver, which had a bit slower growth here for the second quarter in a row, and I'm wondering if there's something that has changed there, or if it's only sort of, yeah, normal fluctuations?

I think that we had a fairly strong liver quarter last year to start with, we have fairly strong comparables. We do have a good liver pipeline still in Europe.

We believe that the majority of market penetration from here and after will come from both increased sales in let's say newer European countries, where we have, for example, really high penetration in Benelux, and we can see an increased penetration in other countries, Italy there. We believe that a large part besides new countries will also come from improved service models here in Europe as well.

If we look at the pipeline, it looks positive for liver as well.

Okay. Just on liver, I know there's one competitor that is talking about expanding more into Europe, and there's another competitor that I know is growing a lot.

You're not seeing any sort of increased competition from those in the short term?

We do see increased competition in Europe to some extent, absolutely. We believe we have a strong track record, very strong clinical proof, good customer relations, to say.

We so far haven't seen that strong competition coming in. I believe that most of let's say how successful we are lies in our hands and how successful we are to implement good service models.

When I talk to customers in liver, that applies to all organs, but in liver especially, they are looking for support in reimbursement, but especially in service model due to shortage of staff. If we can support them with that, I'm sure that we will become the preferred partner to a lot of clinics in Europe over time.

That's all for me. Thank you.

Hi, I've got a couple of questions, but I'll take them one by one, I think. The first one is around the largest customer that you have in lung.

You had another strong quarter here, I'm wondering what your expectations are now for the coming quarters and what kind of visibility that you have there? Also if your projections have changed at all following their own approval?

Thank you. In general, we stay close to all our customers, and especially the large ones.

We are part of their approval, and we will continue to see increasing quantities. We're convinced of that.

The sales value will, of course, be smaller compared to today. We have visibility approximately six months, good visibility, and for the six months, it looks good.

For after that, we have less visibility to say so, and we are in good dialogue to have a better understanding of how the future will be shaped together. We need to come back on a more detailed answer to that question.

Okay. Thanks.

I think in connection with the last report in Q1, you mentioned it was fair to assume that was a new baseline for the EVLP numbers, and this seems to have been true in Q2. It sounds like you still have the confidence around that statement now looking forward as well?

We are confident for the next six months, to say. We are also very confident that we together will increase the number of EVLP so we can make sure that nobody dies waiting for a lung at one point, and that we will do together.

We are convinced and committed to increase the volume and the number of EVLPs going forward. Exact how that will shape into US dollar is something we need to come back with if we look into 2027, 2028, 2029.

That's all right. Thank you.

Then a question on heart. You now plan for the PMA submission after the summer.

Now how large would you say the uncertainty is around the exact timeline for that? Do you have all the clear steps that you need to take now going forward until that submission?

Are you able to provide some more details around what that exactly is and what is remaining before you are ready for the submission?

The main, let's say, bottleneck is that we have had some changes of components with the product. That happens, we need to verify product aging for let's say the final product.

That is what we're waiting for now during the summer. It's a large clinical file, a large let's say product file, and animal file as well that needs to be submission.

That we have a great team on board. I sat with them for a week.

The clinical results fantastic, I am confident. If nothing goes wrong, I'm extremely confident.

Then with product aging or something out of our control, but if it comes to submission, the file is set for. I'm 100% convinced that we will do that on time.

Then it's more the unknown unknowns or that I don't know, but for the rest, I'm 100% confident that we will hit that timeline if nothing out of the ordinary happens.

Very good. Lastly from me around the CAP in the US, you submitted it, I think you said, earlier.

How long time does it take before the FDA can grant approval for that then, and when can we expect transplants to start again in the US?

The straight answer is I don't know 100% sure, but it's a fairly easy turnaround, to say, for the FDA to do. My best guestimate would be approximately 30 days turnaround time, hence it should be able to start somewhere here in Q3 if everything goes all right.

Perfect. Thanks, that was all for me.

Thank you.

Thank you, and good afternoon. I have two questions, I think.

I want to start with going back to what was discussed earlier here with the investments in sales force. When we think about OpEx and scalability going into next year, is the big driver of higher OpEx the investments in sales force, or is there anything else we should also keep in mind?

It's a great question. Thank you for asking that one.

With a growing company and growing machine fleet, you also need to scale up quality and technical product management, let's say the back end of the company to take care of the growing fleet and be able to return answers to customers very fast. Those investments are in comparison to commercial capabilities limited, so that's why we normally talk more about commercial capabilities, because that's where the bulk of investments will be funneled.

You're right, in general you also need to scale up let's say the back end of the company in order to enable higher growth rates. In terms of production, we don't see that we need to scale up because we are relying on the majority on third-party manufacturing, etc.

That's more improvement projects, lowering COGS over time, efficient processes, but we have the right people on board doing a fantastic job, I don't see a large scale-up there. Definitely quality side, technical product management side, there is a need.

Compared to commercial force, it's smaller and limited.

Just to follow up on that, is it fair to expect that to grow in line with sales growth?

In the beginning, it will be a larger, to say, investment, let's say, approximately six months before launch and 12 months after launch, but once that has stabilized, growth will far outpace those type of investments. It's more of a

Got it. Thank you for that.

Great. Then a question on abdominal, I guess.

You mentioned in the report that you had some pricing conditions in I believe undisclosed markets. Could you elaborate a bit on this, if possible to say what kind of pricing conditions, what markets are affected, and is this for the entire abdominal segment, or is it more towards liver or kidney?

I can take that one. This relates to Europe primarily.

If you look at certain countries in Europe, you have East Europe, you have certain South European countries where there's not enough money in the systems, and so pricing has to be lower. It's at those markets, where we do see competition from competitors implementing lower prices.

We believe that we will need to ask ourselves if those markets are at the moment attractive for us. If you look at the more important markets and what historically have been our main markets, you don't see that pricing pressure, and you see an increased utilization, especially DCD, and now looking into DBD as well, and we see less of competition today.

That might change. I would say last year, we were very good at coming into those markets, Eastern Europe and certain other countries, but it comes with lower margin.

That's not where you will see the growth either for XVIVO going forward. I'm not worried from that perspective.

It's just an effect we have at the moment.

Just to be clear, was this something that started or that you started seeing during Q2?

No, the volumes at those markets has picked up for us during this year due to our successful installations of our devices last year. If you look at Q2 specifically, I would rather say it's the fact that we have been very successful on kidney, and kidney sales globally are at lower margins.

That's how the market looks today. Then with reimbursement long term, we hope that we can improve that.

Also, we touched upon it, but I want to mention that one of the good outcomes of the manufacturing project that we have run now for two years moving manufacturing from Netherlands to Sweden is that we will see a lower COGS on especially our abdominal portfolio. I would say perhaps not this year, but starting from mid next year, we should start to see that coming in.

Thank you. Then just a final question for me, please, also on the COGS.

Besides what you just mentioned, you've also previously been speaking about for kidney in specific that volumes have been too low, and that's why the gross margin has been lower. Besides the initiatives and the move of production that you mentioned, how much higher volumes do you think is needed to see higher gross margins for the kidney sales?

I can answer that to some extent. We need to see three things.

One is a geography mix. I should also mention it's partly by choice where we choose to gather more DBD data on kidney in countries with a little bit lower margins, but you get very good data.

It makes economically sense because we don't have to pay for it, to say, but we pay for it through slightly lower margin. We think that that will be very useful data going forward in approximately one to one and a half year.

It's a geography mix when we grow more in high-margin countries, it will so to say look better picture. Then it's definitely a cost per kit, and there are two components there to look at.

One is the component cost where we need to reduce that and also get a better process. Then lastly, we have seen that when you come up to, let's say, stable production, it's not exactly a quantity, because we don't have a pricing with our production suppliers that is based on how much we purchase, we don't get lower if we purchase more.

It's more that the process get improved over time, and then you year by year reduce a little bit of cost every year because of better processes and higher scale, pretty much. It's a combination of those three factors that I think will take one to one and a half year to get out of the system.

Once we do that, we will have very healthy margin on our full product line.

Very clear. Thank you so much.

Good afternoon. Thank you very much for taking my questions.

I have a couple here. The first one would be on lung and the OPOs.

I guess if we look into H2, sort of how much do you view that is driving growth? Maybe more specifically in Europe, sort of and the EVLP momentum you've seen there, do you see that sort of continuing into the rest of the year?

Yeah. Looking into forecast, yes, we do believe that that momentum will continue.

We do see an increasing interest for lungs in general, EVLP in particular. The donor pool is becoming more and more extended criteria, to put it that way.

Hence, there is a larger portion of DCD. There is more TA-NRP done, which potentially harm the lungs, etc.

There is an increased insecurity coming from donor lungs. We see an increased interest, and we believe that if we are staying close to customers and do our job right, we believe that that momentum will continue through the rest of the year, yes, both in Europe and United States.

Perfect, that's really clear. Then maybe just more of a Q3 question, but obviously we've seen the typical seasonality in the US for lung.

I was just wondering to hear your thoughts on it for this year, sort of given dynamics like phasing of revenues, and obviously this growing OPO strength. Is there anything to upset that seasonality?

In general, doing this for 14 years, Q3 is typically a bit of a weaker quarter, very much depending on where the majority of people take vacation, and that applies, of course, to transplant teams as well. Last year was a bit of an anomaly with an extremely weak Q2 and actually July, August, and then we saw volumes picking up in September.

That has more to do with United States and the economy behind transplantation, more resource in the transplant system. If I look at a normal year, I would say Q3 is seasonally a bit weaker, and then Q1 to Q4 is typically a little bit stronger.

Perfect. This year, there's nothing to upset the last 14 years that you've experienced?

No, we haven't seen any sign of that so far.

Okay. No, that's really clear.

Then just my last question would be on FlowHawk, and I appreciate it's a small part of your service business, but obviously it looks like it's growing really well, and it's a SaaS, I assume quite a high gross margin contribution. I just want to try and understand sort of how big could this be, both in terms of sort of your revenue, I guess who's using it now.

I'd just be curious to understand a little bit more about this business.

Yeah. I agree with you.

We have high hopes for FlowHawk, and it's still a very unique communication and transplant administration tool. We will paint this picture more deeply for you guys during the rest of the year here as we move into our strategy work at XVIVO.

We see it as an air traffic control tower, more or less, that could be used by all OPOs, all transplant centers. We believe that in the near future here, you should be able to integrate our technologies with FlowHawk, which will create stickiness at the centers and so on, and it can also potentially make us come even closer to the customers at the organ offering stage, and so on.

It's in the early innings, but that's why we're also happy to see that we have this growth now, and it comes from both renewals from happy customers, but also additional centers coming on board. It's definitely a product for the future for us.

Perfect. That's really clear.

Thanks a lot.

Thank you. I see we have one more question left.

We are nearing the end of this call, but of course, we will allow one more question. Elvin, please.

Yes, good afternoon, thank you. I appreciate you taking the questions even though we are pretty much out of time.

I will just have two ones and see if we can manage both. Perhaps beginning a bit on the gross margin dynamics in the thoracic segment.

They're strong, but they're still down a bit year-over-year, and you mentioned mix effects in the quarter, and I guess it's because of the EVLP outgrowing Perfadex year-over-year, but I guess also a bit on heart. I guess my question is what is the kind of current gross margin that you're operating with in the heart business, and how would you expect this to kind of evolve from where you are now in the kind of 12 months post a European approval?

How should we think of that?

I can take that one. Heart coming from a clinical trial supply chain setup has lower gross margin compared to the rest of the product portfolio.

I think that it will take a couple of years post-launch until we are, let's say, up and running, but we will see definitely 12 months after European launch, we will see improvements, and then you need typically those changes, since it's a PMA in the United States and a Class III device here in Europe, there are quite long regulatory timelines for all production and product improvements projects. I would say we need probably a couple of years to get up to both scale and optimize production before we see the really high margins we see on more mature products.

Great. Thank you.

Just one more from me. Looking at cash R&D costs here in the quarter, it took quite a noticeable step up in Q2 versus Q1 and I guess also versus Q2 last year.

I acknowledge, of course, that you have the kind of intensive work with both the PMA submission and the European approval. Are there any kind of sort of extra temporary effects that are specific to Q2 now that will start to abate once we have a potential approval in Europe, or how should we look at R&D when we include capitalized development as well?

Yeah. It's it's a glad you asked that question there.

It's been a a busy quarter, as we have talked about, with a high focus on on our regulatory processes, primarily in the US. Naturally, the the capex and the the R&D spend in Q2 was higher.

We will see that go down the second half of the year, and and especially as we And what will happen is that when when we get the CE-mark, we will start to amortize the the the capex tied to the CE-mark, to say. I've disclosed that before, and it's around 25 million SEK per year in in amortization.

Despite this, we we still believe that we should be able to end the year If we track sales-wise, we should be able to end the year being cash positive for 2026, which would be which will be the first time in XVIVO's history.

Great. Thank you so much for taking my questions here in the last minute of time.

I will get out of the queue. Thank you.

Thank you so much. With that, I want to conclude this quarterly Q2 report, and I hope to see you all back on October 22 for the Q3 report as well.

Thank you very much for good questions, and thank you everyone for listening and being part of the journey of making sure that nobody dies waiting for an organ.