Welcome to Devyser Diagnostics Q4 Report 2025 presentation. During the Q&A session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now, I will hand the conference over to the speakers, CEO Jan Wahlström, CFO Sabina Berlin, and CCO Theis Kipling. Please go ahead.
Good day, and welcome to the Devyser Q4 2025 Earnings Call. I'm Jan Wahlström, CEO of Devyser, and would like to thank everyone for joining our call today. Today's presenters, and on the call today, we have, in addition to myself, also our CFO, Sabina Berlin, and our CCO, Theis Kipling. I will start with a short summary of our quarterly result and then recap our recent activities that resulted in a record profitable quarter, as well as a record sales quarter. I will give you an update on the recent product launches and present some additional highlights from the quarter before handing over to Sabina for a more detailed review of our financial results in Q4 2025, and then to Theis for an update on our recent commercial activities.
As headlines, I would say that we have started a new journey in the beginning of this year and focused the company towards profitable growth. For the full year, we now deliver EBIT profitability, and we will continue to focus on costs at the same time as we drive the growth at a high pace. Looking at the fourth quarter highlights, we are turning the company around on a path to profitability. We had another record quarter based on revenue with SEK 72 million in sales, it representing a growth of 20% compared to Q4 last year in local currencies. In reported currency, it was lower as we are facing currency headwinds. Gross margins came in at 79%. It's a disappointment, and we will continue to work on improving the margins in 2026.
What we are most satisfied with in the report is that EBIT came in at SEK 18 million, delivering 25% EBIT margin in the last quarter. Last year, EBIT was -3.7 million. Our cash position is now SEK 77.5 million. If I then move over to year-to-date financials. Sales year-to-date reached SEK 250.5 million, up 15.5% overall or 20.2% in local currencies. Gross margin exceeded our target on 80%. The February reorganization we did, supported ongoing improvements to costs and sustainable growth, giving us an EBIT for the year with SEK 10.1 million compared to last year's -SEK 62 million.
In the second half, we have maintained strong growth, we have controlled costs through new and had new product launches, as well as signed recent agreements with partners like Quest and Illumina. This quarter, EBIT exceeded 20%. Our collaboration with Thermo remains robust, showing positive trends in both the sales and lead development, and we've also seen in Italy, our largest market, achieving double-digit growth and continue to gain market share. As you might have seen, yesterday we announced that Devyser has entered into agreement to acquire 100% of the shares in Cybergene AB, a Swedish company within the Level Bio AB group. The acquisition is subject to Devyser obtaining customary regulatory clearance, and the purchase price was SEK 12 million, based on an enterprise value of SEK 8.9 million.
Cybergene is a Stockholm-based diagnostic company and has operated in the same markets as Devyser for many years, providing Devyser with an in-depth knowledge of Cybergene's products and customers. Cybergene has demonstrated steady growth, driven by a strong product offering and consistent market expansion, and will contribute positively to our gross profit as well as our gross margin. The transaction is scheduled for completion on April first of this year, and I expect transition and integration to be a smooth process. We then move over to product launches in Q4 and full year. During Q4, we introduced CFTR IVDR, our most significant internal project so far. Not only did we secure IVDR approval for an important product, but we also established a solid foundation to replicate this process for several other products.
The products that we launched in Q2, genomic blood typing and HLA loss, have performed well in the market, and Theis will provide further detail on this later in the call. Finally, on the highlights, I would like to add a couple of other activities from the quarter. Work continues on the MolDX evaluation for a post-transplant test in the U.S. We got feedback on our application at the end of October and requested additional supporting data. This required more clinical data that we have now gathered since November, and we are now analyzing those clinical samples. We expect to be able to file a new application to MolDX after the summer. At the same time, we continue to work on our FDA project in transplantation, and we have very positive development in this work.
We now have six, six sites in U.S. where we gather patient data, and we'll continue to do so during 2026 and 2027, to be able to file in 2028, if everything develops in a positive way. With that, I would like to hand over to Sabina to share more details on our financial results for Q4 2025.
Thank you, Jan. I will then continue with some more details on the financials for Q4. Revenue for the period October to December, as Jan said, came in at SEK 72 million, compared to the SEK 64 million in the same quarter of last year. That amounts to a quarter-over-quarter growth of 12%, equaling 21% in local currency. This quarter has been heavily impacted by FX, as has the past year, but we could still present our strongest quarter ever in this report. Our sales growth continues to be clear in the rolling 12 curve. Q2 and Q4 quarters tend to be stronger based on our distributor purchasing patterns, so a 12-month rolling view is always, interesting and relevant to highlight for us. We have a stable underlying growth that is very clear when we work with our growth numbers, in local currency.
EMEA had a good Q4, with 20% growth, with most of our direct markets contributing strong together with the Q4 order from Thermo. The Americas doubled in the full year, combining revenue from partner sales, our kit business, and our CLIA Lab. The region is continuing to, step by step, make up a larger portion of our business. The lower sales number in Q4 compared to last year is due to Thermo ordering their year-end inventory to Europe instead of U.S. So that is a phasing only. APAC continues to be an interesting future market with high potential, but still less of a focus for us in the short term. Q4 saw direct sales grow by 19% during the quarter and 11% during full year.
Distributor sales had a strong Q4, both this year and last year, and we saw a healthy annual growth during the full year. Gross margin in the isolated quarter was 79.5%, supported by the large sales growth, but also impacted by a lower than average number of hours booked into inventory due to production scheduling. Year to date was 80.6%, above our financial target. Our EBIT for the quarter was SEK 18 million positive, taking the full year to EBIT positive at SEK 10 million. The strong EBIT was driven by a combination of the strong revenue in the quarter and the lowered cost run rate, driven by the right sizing of our cost structure that we started a year ago and have continued to maintain since.
I see this as a strong indication of our ability to run Devyser as a long-term, sustainable, cash flow positive business. We closed the quarter with SEK 77 million in cash. The Thermo order we received in Q4 came in quite late in the quarter, and we received payment on this side of the new year. Cash flow from operating activity was SEK 12 million positive for the quarter and SEK 8 million for the full year. And, with that, I hand over to Theis.
Thank you, Sabina, and good morning from Italy. I'm very pleased to share several promising highlights from our strong Q4, which was another record quarter on several fronts. When I joined Devyser four years back, we reported full year 2021 revenues of roughly SEK 90 million , and we really didn't have much of a commercial organization, neither a platform for growth. Looking back today, I see a company that is completely transformed and is recognized by our customers, competitors, and strategic partners as a strong and serious company that they really are keeping a close eye on. During 2025, we delivered many breakthroughs, and not least, by delivering on our EBIT financial target during the past quarter.
We also made considerable progress on our new customer lead generation, which drove a large number of new customers recently onboarded, with whom we are diligently working on supporting them to reach their full potential. Our growth in North America continued, and in the past year, doubled versus 2024, driven by a consistent incremental onboarding of new customers as well. The growth in Europe, in Europe is also continuing as per plan, with several highlights. And to repeat what we also said in our Q3 earnings call, we have some very strong fundamentals in Devyser. We have a wide, strong, workflow-efficient product portfolio. We have a very strong regulatory capacity and are leading in Europe when it comes to IVDR. This new regulation is a structural change to the market, and we are very strongly positioned to exploit this.
We have multiple strong growth drivers, including transplantation across the largest markets of the world, but spearheaded by U.S. with our CLIA Lab, the FDA program, and naturally, the partnership with Thermo Fisher, and now also Illumina. On January 28, we announced the news of Devyser being a systems integrator with Illumina as we entered into a collaboration framework agreement. Illumina is by far the market leader when it comes to DNA sequencing, and despite the entry of several new instrument manufacturers, I'm confident that they will remain being a market leader for decades ahead. We have all our NGS products validated on the Illumina MiSeq platform, which has significant instrument coverage across the globe. This is important for Devyser, since this lowers the entry barriers into new accounts.
The new agreement enables Devyser to place their newly launched MiSeq i100 product family in the markets that we serve. Devyser was carefully chosen as a partner to Illumina for several reasons, but one of the key reasons is our strong regulatory position when it comes to IVDR in Europe. The old Illumina MiSeq platform is being discontinued and will be replaced the coming years with the new MiSeq i100 platform. This need to replace the old platform with the new platform in the years of having IVDR being implemented is expected to be a strong growth opportunity for Devyser to leverage, and thus, we do expect to be placing a considerable number of instruments the next years. The way this work is Devyser buying the instrument and consumables from Illumina and placing them under a multi-year aid and rental agreement with the customers.
The customer benefit is that they don't need to allocate a significant amount of upfront capital for the instrument acquisition, but instead can pay through a higher price on the Devyser products. In a similar manner, as it's seen with most leasing arrangements today in other markets. The benefits for Devyser are the increased revenues driven by the higher product prices, which will drive up margins and not least, increase customer stickiness. This is a proven model in many markets and the mostly used business model in the pathology segment, which is the segment that I came from at Agilent, and I'm confident that this will be a successful model also for Devyser. Moving on to an update on our partnership with Thermo Fisher. Q4 was, as expected, very strong quarter, and we're pleased to see a continued growth and onboarding of new customers.
As mentioned earlier already, we do expect lumpiness, but also the lumpiness to gradually level out over the years. Our transplantation business continues to shape our company and will remain a significant potential and growth driver for the company future. We have some very exciting milestones ahead of us this year, both when it comes to MoIDX and the FDA program, and we are very pleased with the consistent customer onboarding pace that we are seeing from Thermo Fisher. North America had another strong quarter and double revenues on full year basis versus 2024. We now have both Quest Diagnostics live in the U.S. with our RHD test, and as of January this year, Canadian Blood Services went live with the tests in Canada.
We don't expect an immediate massive uptake on either of them, but rather to see a consistent growth over the coming years. It takes time to build such a market. The collaboration with Cyted is developing well and is expected to grow further during the coming years. Jan and I visited Cyted last week in Cambridge, and both sides are pleased with the collaboration and the outlook. It's definitely an exciting time also for Cyted, with a unique product offering that they are taking to the U.S. patients. Moving on to Europe, I'm pleased to share that Italy continued to deliver well and show double-digit growth in a market where we already have a significant market share position. Across Europe, the IVDR regulation is being adopted, and we are seeing consistently increasing demand, which is expected to further accelerate as we get closer to the full implementation deadline.
Recently, we attended the Festival of Genomics conference in London, where a new customer of ours from Oslo in Norway presented data for our cystic fibrosis test and clearly underlined the workflow and regulatory status of the product, which, as he said in his own words, enabled their laboratory to reduce the turnaround time from two days to just one hour. With the IVDR status, it's an easy onboarding of new customers, which, combined with our new instrument placement ability, created a lot of positive interest in our booth. While having been direct for more than a year already, we have kept the relation with our distributors in Spain. We are cautiously, we've been cautiously transitioning from distributor managed to directly managing the customers, which we are now fully taking over as of January 1, 2024.
The Spanish market is very similar to our Italian market, and hence, we will be applying the same way of working as in Italy. Many of the customers that we have in Spain have historically been on our Fragment Analysis portfolio, which in recent years have gradually been expanded to also cover our NGS portfolio. However, limited by how Illumina have had their channel partnership structure in the Spanish market. With our new agreement with Illumina, we expect that we can open up new pathways to win over new customers in Spain, which is equally a very significant market as in Italy... and aiming to repeat the same success story as we have had with us from Italy. With that, Jan, I hand it back over to you.
Thank you, Theis and Sabina. Devyser have delivered, we have delivered our best quarter yet, with EBIT exceeding 20%, demonstrating the effectiveness of our strategy and this year's effort. We introduced new products and solutions to the market, including the HLA loss in Q2 and IVDR projects like CFTR in Q4, and we're progressing towards our long-term goals by investing in innovation and forming collaborations, most recently, the great collaboration that Theis talked about with Illumina. Our focus remains on continuous improvement and increased profitability, alongside strong top-line growth. We're moving towards positive cash flow, and with this report, our trajectory has definitely improved. With that, I would like to open to questions.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Ulrik Trattner from Carnegie. Please go ahead.
Thank you very much, and a few questions on my end. And if we'll just start off with the quite impressive sort of cost reduction that has been achieved here throughout 2025 and the level we are at, like in the second half of the year in absolute terms. How comfortable are you that you can maintain this level as the company grows? Obviously, you have new product launches, you're advancing forward with FDA trials, MolDX reimbursement. So how much should we extrapolate sort of this OpEx level that we are at currently?
Thank you, Ulrik, for the question. As you say, we have done a quite significant job on the cost side for 2025 and put ourselves in a position where I see that we have a good structure on when it comes to cost and for the type of business we run. I believe that we can continue staying on a similar cost level going forward. Of course, in the longer run, when our growth continues to improve, we will at some point need to start to invest into the commercial organization, but that's not something that we see in the next quarters coming.
We see that we have a good foundation that we can grow the business on.
That's great. And kind of building into your sort of investments here, a few questions on that, please. First, this acquisition that you announced late yesterday. My impression has been that mainly infertility has been part of your portfolio historically, but not potentially the most prioritized segment. Is this a new vertical that you have identified that you want to expand within? If you can give us the rationale, and I had a look late last night, and it looked like a PCR test and not an NGS test. So, like, how this fits into, like, your transitioning from PCR to NGS portfolios?
Thank you, Ulrik. I leave that question to Theis.
Yes, Ulrik, let me answer that one. You're right, that it's, it's this is not a portfolio that is on the NGS technology, but we're very happy that it's, it, it is as it is, relying on, on PCR and fragment analysis, which complements our compact and, and complete and extensive product portfolio really, really well. And, and those products in our portfolio are the longest standing, and we have a very broad coverage. And the way we tactically and strategically will, will use, use this and how we value the deal here, is that this gives us broader reach, because we've been, you know, they've been around since several years. They're doing really well. It's a company we have been up against in many, competitive situations, and we've been watching them with full, full admiration.
So they will actually complement our footprint nicely. As an example, their largest market is France, which is a market that we're quite rapidly penetrating, and the way it usually works is that we go in with some of those more simple tests, lower priced, and then we convert them to NGS when the account is capable and ready. And that is remaining to be the strategy of Devyser. So this is a future-proofing part of this portfolio and helped by also the agreement we now have with Illumina, which we believe that there will be an increased adoption coming ahead of us.
Okay. That's great, and kind of transitions me into my next question regarding the collaboration with Illumina. Based on your sort of the face value of what you present, it looks like you will build some capital, holding on to some capital with Illumina when you are buying these systems. And from purely a P&L, a financial perspective, it looks like this will initially hamper your margin profile. So just curious on how you will disclose system sales and margins going forward with this new Illumina collaboration?
I can take that one. I understand your concern that this will be weighing down our capital structure, but it will not, as these are long-term lease through a third party. So it will not have an impact on our cash flow. We will not be disclosing margins specifically for this partnership, as we don't do that for any of our partnerships. But we will be sure to keep the market updated on a level where you can feel comfortable as we do, that this is something that's contributing and in no way weighing down our business. So the structure of the customer agreements versus our lease structure is to the benefit on us.
Okay, that's fine. So just also to get some sense or clarity, like, is it fair to assume that we would estimate limited revenue contribution from the Illumina machines themselves, whereas you would make higher sort of profits on the reagents on the actual system that you place? i.e., from a sort of purely from a accounting perspective, it will be close to a zero-sum game in terms of the actual NGS instrument.
Theis, do you want to take that one?
Yeah, I can do that. Yeah, I think that's a reasonable assumption, Ulrik. But it will obviously drive, as you say, on our individual products an uplift, both in terms of prices and hence also margins. But we're not opening up a new business segment where we will be selling instruments and gaining a lot of margins from this.
Yeah.
This is an enabler to accelerate business-
Yeah
-in general.
That sounds fair. Last question on my end. In the U.S., like, obviously, in relative terms, you're growing. In absolute terms, it looks like very sort of minor contribution. You sound forward-leaning. You have Quest, you have Thermo Fisher. Should we assume that it would be continuous, very sort of minor in terms of percentage of group sales until you actually have the MolDX reimbursement in place? And what is sort of the near-term triggers that we have beyond MolDX in terms of accelerating American sales?
Theis, for you as well.
Yeah, I mean, I think, to... On the first part of the question, we will see a, you know, a gradual, continuously upward going growth line curve in the U.S. from the customers that we have just onboarded, and we are continuing quite a number of new customers, right? So U.S. actually is where when we look in the lead funnel, currently, we have the biggest funnel, right? And the most traction. So, that I expect a lot of from, in, you know, this year and the years ahead, also. On MolDX, I mean, that goes back to Jan's commentary earlier, with the timing, and naturally, this will be accelerating growth quite much once we get that positive approval.
Great. Is there anything else that would essentially trigger an acceleration in sales beyond sort of, like, the underlying traction that you have in your sales funnel and MultiX?
I would say to comment on that, we. You know, there's no one trick, right? I mean, I think what you're seeing we're doing is building out a very strong foundation of a company that has multiple different ways to grow, and we are accelerating all those verticals in a very, I'd say, very strong way. The partnership with Illumina is the first of its kind. Illumina have never made a Pan-European agreement like they have here. So and I think that is unique, right? Just from that one, I think we will see us strengthening our position in various markets. We, we are gaining really market trust, so you can see these just strategic partnerships are coming in, whether it's Quest, Thermo, Illumina, whoever they...
That is something I will expect to continue as we are now increasing our credibility in the market, and we are really strengthening the position we have here. As always, you know me, Ulrik, I'm always on the bullish side, but because I rely on what we have done, right? More so than, you know, words. Look at the actions.
Yeah, absolutely. I was kind of more aiming towards if you could tease us with the new product launches, potentially more or specifically more within the transplantation field, expansion into more solid organs here in the near term, offering to the U.S. market.
I think we have shared, shared those insights already, also from the 2024 capital markets day with the, the indications that are coming, right? With the moving beyond kidney to also include heart, liver, and lung, taking those through IVDR. And there's a pathway also in the U.S. at some point, right? To, to, to do that, but, we, in the U.S., it's, it's, it's initially focusing on, on kidney, both for the MultiX and the FDA application. But again, go back to the capital markets day, there were a number of additional products in the transplantation space that are still being worked on in the R&D department, and, you know, will be quite, intriguing once they will hit the market.
That's great. Thanks for taking my questions, and I'll get back into the queue.
The next question comes from Ludvig Lundgren from Nordea. Please go ahead.
Yes. Hi, and thank you for taking my questions. So I have two. I'm starting off on the gross margin here. If you can just elaborate a bit more on why it was on the softer side here in the quarter, and whether there were some mix effects that was somewhat of a one-off or how we should think about this moving forward?
Well, I can answer that. We do have some lumpiness over the year in individual quarters in our gross margins, the way our production is structured. So it's important to always look at gross margin over a longer period, either full year or 12 months rolling. The reason is that our production of diagnostics kits is very much based on how the raw material comes structured to us, the oligos that make up the majority of the kits. So batch can be sometimes needing 3 x more hours than the previous batch of the same kit, meaning that we're very dependent on like how our production is scheduled over the year in terms of bringing hours into inventory.
And this is a mix that we are trying to solve still within the IFRS framework. Unfortunately, IFRS bookkeeping is designed for production environments where everything takes the same amount of time every time. So this is not sort of leakage in our production, but it's very much how scheduling matches the budgeted scheduling that we have. So yes, this is a weaker quarter, but we also had a very strong quarter a year ago, looking back. So this is not a concern per se, in the ways that we're not above 80%, but it's something we need to fix to make sure that the market receives much more clearer reporting and much more stability over the year, and it's what we're working on.
I can add to that as well-
Okay.
I can just add to that as well, and then from me, Jan, here, that we're working on internal efficiencies in production, and we believe that that will be able to improve our gross margin in the year to come.
Okay, great. Thank you. Very clear. And then jumping over to operating expenses, which was a bit lower than I expected, at least here in the quarter. So, maybe starting off on the R&D side, I think gross R&D was around the lowest level for the year. Like, was there any type of one-offs in here, or is this just, you know, you slowing down the R&D investments a bit, sequentially?
Well, we're slowing down R&D cash flow, but not working speed. So part of the reorg that we did last year, we have restructured the R&D department and kept as much of the efficiency as possible while reducing costs. So, there's no specific one-off that reduces the R&D run rate, but rather, being at a level that fits our customer.
Okay, great. And just a follow-up on R&D. So capitalization rate was, I guess, a bit higher than usual here, with quite only SEK 2 million in the P&L on R&D side. Like, is this something to extrapolate ahead?
I don't think you ever should look at individual quarters, but the past few quarters have given a pretty reasonable assumptions on where our run rate for capitalization will be over the coming period.
Okay, great. Thank you. Yeah, yeah. I'll jump back into queue. Thank you.
Thank you.
The next question comes from Filip Wiberg, from Pareto Securities. Please go ahead.
Hi, good morning. I've got a few questions, and I think I'll start off with a follow-up on the acquisition that you did here. So I just had a quick look on the product portfolio last night, and it seems to have a very significant overlap with what you already have. So both on what the actual tests are and the technology. So I think you touched upon this a little bit, but it's also to get the reach. But can you just talk a little bit about the reasons why you did this acquisition?
Theis, do you want to take that?
Yes, I can do that. Filip, you're absolutely right. It is quite an overlap with the existing portfolio. But we see that as a strong component to what we just did here. Their products are also quite well ahead and in good place to become IVDR. So that means there's a long horizon for how long these products can remain on the market, and it really strengthens our total position within aneuploidy and male infertility. And we are taking on quite a number of additional accounts, new accounts that we are not in today, which is right on strategy. We want to be, you know, maximizing that, and we saw an opportunity here that would accelerate that quite a lot.
As I've said before, the strategy, we have a very complementary portfolio in many of these paths with the NGS overlap. So once we get, now we want to get a broader share of wallet with these accounts and then gradually help them to adopt the NGS technologies, which will significantly increase the average selling price. And not only will it increase the stickiness by placing these. For example, now we can place the instruments on five-year contracts. But the fact is that usually these instruments, they sit with the account for a lot longer than the initial contract period. So but that's the logic behind the deal.
Okay, thanks for that. Perhaps then on just the distributor sales here. So rebounding Q4, but still quite modest growth. So I think you touched upon this as well, but can you elaborate a little bit on how you view the continued growth opportunities from Thermo in 2026, specifically?
Theis?
Yeah. So if we take overall distributor channel performance, and then I'll come to the Thermo component in a second. But overall, going back 18 to 24 months, we have in various ways restructured the distributor channel, which was, in the day, very reliant on pure PCR fragment analysis. Now we have added quite a number of new distributors on the NGS, and those distributors usually are strong on either one of them. So... And that has been helping us well, and I think we are a much stronger and more future-proof channel when it comes to the distribution business, and we're opening up gradually a lot in many new markets also. So that, excluding instrumentation, super strong, going really well. Transplantation and the partnership with Thermo Fisher, equally so.
So as we have always said, we are very happy with the partnership, and they continue to deliver. And we recently got visibility to the accounts that they have onboarded the past year, and we were all very, very pleased by seeing that. So there is a commitment, as it has always been since the inception of the partnership, and I think we will see that that will be built upon here in the future as well. Did that answer, Filip?
Okay, thanks. Absolutely. Yes, very good. Thanks. Perhaps I can just continue. So, so you're getting a little bit better visibility into this, but, but we still have the quarterly variations, and I suppose they're going to, to stick around in next year as well. And I know you don't want to give, like, overall guidance on this, but, but could you provide some info around the quarterly variation that you expect in 2026? Is it like a similar pattern as in, in 2025, or?
I can take that one. I think that what we did say is that we will most likely see a similar pattern, but we believe that the lumpiness in that will even out more this year and even more so in the future. But a similar pattern is the most probable one, as you've seen this year, Filip.
Okay, very good. And then just last question, more of a general one on the growth going forward. So you've had quite high growth rate during several years now, going back, but during that period, you've also had quite significant investments in the organizations. And now you've pulled the brake a little bit in 2025. You have a big focus on the profitability, and we have also seen the growth rate now coming down in 2025. So profitability remains in focus. So, you know, given that, could you talk a little bit around how this affects your possibilities to grow?
Like, are there any opportunities that you feel right now that you have to not pursue, or like any opportunities that should have been able to drive growth, but you're currently holding back due to this profitability target?
We still have a very clear growth focus, and I believe that we are still investing heavily into that growth within our R&D department, as well as in our collaborations with companies like Illumina and other collaborations we sign up. So we continue to drive towards a high growth number going forward, and we are not happy with the staying on the lower growth path, but we want to continue with the high number on that one. I don't know if you want to comment more on that, Theis.
Yeah, I would, I would say two things. I mean, going back to the fundamentals of the business, also direct business growing really well. I think you had the, the growth, some mid-20s. I think that is pretty solid, and that's excluding instrumentation. I think we, as we also shared in the earnings call back in 2024, the U.S. will be what, you know, unlocks the next level of growth, and here we're waiting for the MolDX approval, which is going along well. And you can also now follow the progress on the FDA program, and, you know, those are two very significant levers, right, for, you know, fueling growth. But even without that, the underlying fundamentals of the business is growing well... very well still.
Okay, thank you. I'll stop there for now.
The next question comes from Oscar Bergman from Redeye. Please go ahead.
Hi, guys. Congrats on a very strong report. It seems like the market sentiment is, yeah, very strange at the moment, so not really recognized in the share price. I just have a few follow-up questions. The first one being, if you can just give me a sentence or two on the prospects for Spain to impact sales during 2026.
Theis?
Yeah. For Spain, I mean, I think this is, we can't give you any specific guidance, but I hope that you will see that we are making a very clearly defined play here, and we expect to have this not only for 2026, but for the many coming years to drive a lot of additional growth, and we are essentially replicating the way of working from Italy. It's also Virginio, who is the leader and he was the guy building Italy. He's still heading up and overseeing the Spanish market. We're relying on the same back office team when it comes to how to run excellence in applying to tenders. So there's a lot of things that will benefit the overall growth and drive acceleration, specifically in Spain.
Mm-hmm.
I can add to that comment as well, Oscar, that Spain is one of the top five countries in market size in Europe, and it's about the same size as Italy in the total market size.
Okay, thanks. And if I can just give a follow-up question also on Thermo Fisher. I believe in Q2, you mentioned that you expected a more quarter by quarter revenue build-up, and perhaps even less lumpiness, but it seems like you are now emphasizing that we should expect a lumpiness going forward. I'm just wondering if I have understood this correctly, and if you have seen anything change from Q2 that now makes you expect a more lumpiness for this collaboration.
Theis, do you want to take that?
Yeah. No, no. I mean, I think what we said, both myself and also Jan, is that there will be lumpiness, but it will be gradually reduced, you know, this year and moving ahead, right? So and I think we are risk that we are also seeing that, when from my chair here. So I'm hopeful that the lumpiness will be gradually reduced.
Okay, so what you're saying is that maybe we should expect, smaller sales, or sorry, smaller orders in every quarter rather than every other quarter?
I think that's the outcome, ideally, also, and I think that's also what Thermo will do. But to give you some context to the situation, they insist on keeping inventory on their own premises. They have two distribution warehouses, one in Europe and one in the U.S., so that they can ship and deliver orders overnight, essentially. As demand grows, obviously, that inventory that they keep will deplete faster, right? And that will trigger increased number of orders through Devyser, which will obviously—that's why we're seeing already now that lumpiness is definitely reducing, and it's being reduced because we are getting more and more customers onboarding. And those that have been onboarded a year ago have, you know, starting to now finalize their internal validations, are reaching full clinical routine.
That's just the sequence of things here. But you will have, you will see our lumpiness still moving forward. The question is when will that end? I cannot give you an answer.
Mm-hmm.
It's a good sign that it is being reduced because it means more and more customers are repeating the repurchasing, which is what we want.
Okay. And then just a final question on my end. You're targeting to submit this supplementary data set to MolDX after the summer, but what review time should we then maybe expect, after that, before a decision has been made?
The review time that MolDX has, correct me if I'm wrong there, Theis, is 60 days.
Correct.
Okay. Great, so before year-end, then, it should be a, a fair assessment.
Yeah, that's a fair assessment, I guess.
Okay, thank you.
The next question comes from Ludvig Lundgren from Nordea. Please go ahead.
Yes, hi. I just had a follow-up on the U.S. I think you previously highlighted that you are able to onboard transplant centers if they handle, like, internal validation of the kits themselves. Like, have you seen any progress here, and do these types of customers already contribute to sales in the region?
Theis?
Yeah, I can answer that one. Yes, I mean, that correctly understood, and also correct that we are seeing some of those accounts gradually coming on board and also will limit the lumpiness, right, as they get fully ramped. It is a longer validation process, but I think it's actually we have shared in the past also, we have, through Thermo Fisher, and it's quite some prominent institutions in the U.S. that has and holds a lot of volume. So, we're supporting everything that we possibly can to make sure that they reach their clinical full potential at the earliest.
Okay. But I assume these are quite low or like only a small share of the total sales in Americas currently. Is that fair?
I'm not sure we can actually comment on that.
Okay, fair enough. Yeah, thank you very much.
There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
So thanks, again, for everyone joining our call today, and looking forward to the next time. Thank you.