Thank you very much. Thank you very much out there for dialing in for CellaVision's quarterly report Q4 2025, which obviously also includes the consolidated results from the entire 2025.

A lot of good things have happened, and first of all, I want to formally welcome our newly appointed CFO, Monica Jönsson, who is with me today to participate and, of course, explain our business. Monica has been with us since autumn, and she was formally appointed CFO with CellaVision on December 12th.

That was the first good news. Hopping into the quarter in brief, the Q4 in brief, we have entitled our quarterly report as a solid quarter driven by strong performance in Americas.

It's particularly in Americas, however, we also see pretty strong performance in EMEA, while the quarter has been somewhat soft in APAC, and we will unfold that throughout today's call. We landed the quarter with net sales that increased by 5.6% to a revenue stream of 197 million SEK, which translate into an organic growth of 12.2% given our headwind on the FX of minus 6.6%.

Double-digit growth throughout this quarter. This translate into an EBITDA contribution of 65 million SEK, equivalent to 33 percentage points.

In terms of the business, we will go into the business and explain both our P&L, our regional split, give some highlights there, and, of course, also cut it across the different product families. I also want to give a little bit of insights as to our progress on our strategic direction.

We accomplished a key milestone by getting CE mark for our new application for bone marrow aspirates. This is a Class C product that is now registered according to the EU IVDR, which allows us to start launching the product this year or pretty much in the in the quarter we're in.

We can talk more about this a little bit later. We have also, as we've noticed in in our latest report, we've also been working on a significant software upgrade for our hematology instruments.

This has been successfully validated at a customer site. This really allows to operate our fleet with a modern and user-friendly interface, some new features including also higher speed on the new DI-60s that that comes out.

Furthermore, I also want to emphasize that the since we are coming to the year-end, the Board of Directors proposes to increase our dividend from 2.5 last year to 2.75 Swedish krona per share. This is what will be proposed at the Annual General Meeting taking place on the 28th of April.

If we zoom in on the financial development for for Q4, I've mentioned our revenue, and then if we hop in, on the left-hand side we have the quarter we are reporting today, the comparable quarter, and then we've consolidated the entire full-year report with a compare for 2024 to the very right-hand side. For for the quarter, our gross margin was 67%.

A little bit lower than normal, a little bit hit by by software, especially from APAC, but also FX also takes us down a little bit here. Operating expenses landed at 39%, and EBITDA, I've talked about the 65, that is 33%, which is above our target of 30%.

Then we on the R&D side, which is really very strategic for us, we've increased our R&D spend over the within this strategic period. We're at 19%, and up against the compare, it drops from 22.

It's it's actually 37 million in in in total R&D spend. Maybe I I can ask you, Monica, to comment on our capitalization and also maybe also our principles for capitalization.

That might be appropriate.

Sure. During the quarter, we capitalized 15 million SEK in R&D cost.

As you can see then that we capitalized more or less half of the R&D spend. What is not capitalized is mainly related to projects that are in an early stage and also product care.

You will see during 2026 that we will start capitalizing some of the projects that are maturing and also start depreciating some projects that we are launching products such as bone marrow.

Excellent. On the cash flow side, operating cash flow of 51, slightly increased with 5 million versus our comparable quarter, and a total cash flow of 30 million SEK.

Going from the operating to the total, the majority of that is really the cash that we invest and capitalize in R&D. That's what sits there.

We have very low financing activities, we have hardly any debt. We end the year with a balance sheet that contains a cash position of 180 million SEK—188 million SEK, sorry.

All right. I could say that here we are also showing the full-year results, we landed the year of 759 million SEK, which is an organic growth of 9% over the year, and a gross margin of 68%.

That provides a total cash flow of 40 million SEK. Obviously, we've paid our dividends, and we have also capitalized a considerable amount of R&D cost of 67 million throughout the year.

That is the main components that brings us to this total cash flow of 40 million. Right.

Let's move on. Let's try and look at the regional performance across the three regions: Americas, North and South; EMEA, including the Middle East; and APAC.

Our performance was very strong in Americas, in fact, all-time high with 90 million SEK. That is an organic growth of 50 throughout the quarter, also 50%, but then the headwind of currency effects, organic 58%.

Very strong momentum in Americas, especially in the US, which you may also is by Sysmex in their last couple of reports, Sysmex being our main strategic partner. That is kind of the business that is elevated due to our joint momentum.

It is fair to say that it's extremely high, and that is also due to a [stop?] at the presidential election in Q4.

I think that's a fair comment to provide the full picture. For EMEA, there we also saw an increase both in small and large systems, and we obviously also had a contribution from reagents, but they actually impacted negatively this quarter.

That is a euro business, we are primarily impacted by currency, and then there's a little bit of phasing on reagents there. I can talk more to reagent in a second.

On APAC, we typically in APAC, we have high fluctuations, depending on whether we ship to APAC, in particular China, or not. Here we landed in a pretty reasonable quarter, 28 million.

However, it does represent an organic decline or growth of minus 40%. That is also due to a strong comparable quarter.

You may recall that we had a let's call it a one-off tender delivery for New South Wales in Q4 last year, which is why we organically decline so much. Because it's a reasonable quarter where we've seen deliverables going both to China and to Southeast Asia, a little bit spread.

Then we continue to see growth of our expansion into APAC throughout a lot of countries, of course smaller volumes, but we are building our position with RAL stains across APAC. If I cut the same numbers per product family, instruments, reagents, software, and others, here you do see that our total instrument revenue was 126 million, and we talked about the US and the other elements, but it gives us an organic growth of 8%.

For reagents, we actually were flat or minus 2% on the total business for the quarter, which translate into 6% growth on the year, organically around 9%. EMEA decreased slightly, and as I said, that is primarily currency.

I would say, though, that our hematology, which is the growing portfolio we have, what does not relate to the hematology labs, and then the hematology reagents, which is the bulk of the business, like two-thirds of the business, it grows 10% for the majority of it, which is for Europe. Then APAC, where we've started to expand with our hematology reagents, there we also had solid growth, but though smaller numbers, but we grew on the quarter from 1.4 million to 2 million up against the comparable, and that pretty much more than doubled our revenue in APAC on the year.

For software and others, we had declining growth. I should say software and others, it contains both spare parts, as of course software, and also consumables such as oil, but it also entails the currency effect, which impacted our numbers considerable from a comparable position here.

Specifically on the software, we were low in the compare, and there was a major contribution from APAC due to the large tender we provided last year where that also entailed a considerable amount of software. This is also why we see the decline.

Key takeaways, as we say, the fourth quarter is driven by strong performance in Americas. We said we landed our year with 9% organic growth.

In fact, if I really look at where we work and how we work with our strategic partner organizations, our core strategy, it works. We are growing double-digit with these both partner organizations across the world.

However, we have some product lines like non-hematology other products that has taken our organic growth a little bit down, but our direction is paying off. That also applies to our Power of Focus strategy that we communicated in 2022.

Here we invested a very ambitious investment program in R&D and innovation. One of the levers was a new lever of entering what we call the specialty analysis arena, more applications to assist the hematology labs out there to diagnose blood-based disorders.

The first product is out. That is the product for bone marrow, as I initially said.

We do believe that now we can start building the market for assisting the lymphoma [formers?] and leukemias out there in the hematology lab and adjacent labs where they utilize this hematology solution or this bone marrow solution.

We're starting to launch first campaign-wise. There will be training of our partner organizations.

There will be building of a funnel, and then there will be evaluations of, and really, for the healthcare professionals to see how it assists their workflows. Then we do expect that we in the let's say the second half of the year, we will start seeing revenues from this product from Europe.

Then we're, of course, also on that note, aiming for getting into the US, but more about that later. As mentioned also when we teed off the call, we have a major milestone in launching the software upgrade that delivers this faster and smarter workflow and cutting-edge user experience for the hematology labs, and actually for the new DI-60 systems that is integrated with the hematology line of Sysmex.

It offers an improved integration, but it also entails an improved throughput, the number of blood samples that can be deployed will increase on the new DI-60s. We believe we're well positioned to continue our journey in assisting the mid- and high-volume labs here.

Very important key takeaway is repeating back to our Power of Focus, where we in early 2020 or in spring 2022, we acquired the IP rights to a patent portfolio that was invented by Caltech. We have deployed and further developed our technology in our hands.

As you can see in the way we communicate, we're extremely confident that this will really support our next generation hematology analyzers that are part of this major investment program that CellaVision has gone through and is going through. Furthermore, we are also very clear on our ambition to expand and deploy our capabilities for adjacent areas.

Here we're also confident to say that we truly believe that the way we go about pursuing our vision of really pushing the evolution of microscopy, we have a disruptive microscopy solution in our hands, and we believe that that is something we will continue to invest in, and we will also pursue future partnerships that can help us commercialize these technologies in the future. With that, taken together, I do believe we ended 2025 on a pretty strong note with 9% organic growth given everything that happens.

I'm actually very proud of the team given the fact that we've done this with our existing portfolio, and we are seeing now that our innovation program pays off, and we're starting to start launching all of these new opportunities, which we're very confident will be a profound platform for future growth. With that, we will close this session and enter the Q&A.

Thank you very much, and a few questions on my end. I apologize, I struggle a little bit with the sound, maybe it was just me, it might be things that you already addressed.

If I can start off with the DC-1 and the DC-1 momentum particularly in the US, and you sound like current trading and what you did see throughout Q4 was really improving. What do you derive that from?

Are you seeing that there is sort of increased capacity from the labs to expand and invest versus last year, or the reasoning behind the current sort of situation and demand flow?

No, fair, and thanks for your question, Ulrik. I think we see a momentum also given the softness we experienced a year ago, then gradually over the last half of 2025.

We've seen positive momentum communicated externally by Sysmex and how the market is operating on the large lab segment, and we've seen that translate into that also entails our solution, our integrated solution. At the same time, we have seen the interest, let's say, come back on the DC-1.

I think what is happening, and this is also something we are really starting to position, the targeted opportunities for the integrated health networks in the US. There, having the labs that can digitize the satellite labs, that is the value proposition.

There's one story around the workflow for the individual labs, but then what we are really seeing resonates in the US because they are digitized to a relatively high degree, that is attaching these IHNs, all the integrated health networks, the distant satellite hospitals. This is where we believe there is a market that is, I shouldn't say untouched, because we have certainly placed DC-1s, but the opportunities is much larger than what we have placed so far.

Hey, that's great. For the last few years, we have seen this prolonged order-to-installation trend.

Has there been any shifts sort of in that being shortened here, or is it still the same situation?

No, I think typically from orders are placed, let's say in the US, it is our believe and understanding that that is pretty much a face of two to six month. Then we have been in a situation where it's probably was longer, and now it seems like we're somewhat back to that up to half a year.

That's because hospital places the order with Sysmex, and then there is an installation project starting up. That means that everyone, IT, etc., has to come together, and then all the equipment, the cell counter including CellaVision's cell morphology analyzer, needs to be in place.

This is why from the orders of Sysmex to that, that is about this up to half a year. Then it varies.

We saw the tender we talked about in Australia, that took five years, it does vary. There are deviations to this rule of thumb.

You touched upon this now with sort of the software, denoted as sort of software and others in your report, a bit of weakness here in Q4, affecting the product mix. As you alluded to the sort of larger tendering in Australia, now you're rolling out an updated version.

What to expect from that segment? I guess you would assume some big price increases for software heading into '26 versus '25.

Actually, that's not how we position this. We position this solution as part of both the new DI-60s, we want to be competitive and protect the installed base, also the replacement market.

This is not an upgrade where we charge, it's part of the DI-60 system. What it does, it also allows the health networks, if you take a given hospital with satellite hospitals, etc., if they upgrade to this software version called 7.2, then all their entire fleet, including the old instruments, will all of a sudden be utilizing a new user interface with the improvements that we are launching in the software.

This is a way to really provide additional customer experience prior to our next generation coming out. We have sort of considered that's a better proposition as opposed to starting a price.

We would rather increase price when we come out with new hardware.

That would entail that there's no price increase of the DI-60 either. It's just...

No, there will be regular price increases on the instruments, but we will not sort of take the route of just charging for software. We believe we will capture the growth from the instrument placement instead.

Then just on an accounting question here, and just to double-check if my sort of maths sort of aligned with yours, because capitalized R&D historically has had an effect on the gross margin side. Now when you're rolling out the bone marrow application, I'm approximately at a one percentage point headwind on the gross margin on the back of starting to depreciate that.

Does that sound fair?

Yes, that sounds reasonable.

Great. A short answer, I like it.

Then, last question on my end before going back into the queue, if you can provide some more granularity on the rollout of the bone marrow application and the methanol-free reagents throughout sort of 2026? Going to the bone marrow, I know that you say that you will do a launch here in Q1, but is there any conferences here in the near term where you're going to do more of a broad-based launch, as well as how does the training of Sysmex personnel going?

Great question. For the bone marrow, you're absolutely right.

We'll start sort of the slowly campaign in this quarter in March. We are in the process of training the Sysmex reps, and once that is done, then we will, of course, start to position our solutions in Europe across the different countries.

There will be demos in the different individual labs, and then it's commercially available. With regards to conferences, we'll do the big launch at the ISLH later in May.

That's in May. That's the big conference where we sort of give the splash.

Then we will also be present at the EHA later in the year. ISLH is the biggest launch sort of event.

Coming back to the quarter here in Q4, I just want to express my appreciation also for our partner organization who has been with us on site here with Sysmex, where we have presented the bone marrows, and then we actually obtained the bone marrow CE mark just before Christmas, as opposed to Q1 as we had appointed. That is kudos to the team to actually driving this to be in our hands a little bit earlier, but also to Sysmex, who are really welcoming this significant product.

On the methanol-free, Ulrik, you also asked about methanol-free, right?

Yes. Yeah.

Yeah. The story around the methanol-free stain is that our reagent revenues is primarily the classic stains.

Now we have this methanol-free stain, we've had it for years in fact, but now there's an opportunity for the methanol-free to be running on the SP-50, the smearing and staining device of Sysmex. That has opened up for the opportunity to globalize methanol-free.

This is available in Europe, but this is also the opportunity to enter the US, where we have hardly been selling any reagents. This is obviously the plan.

In the US, we're currently, let's say, tweaking the protocol so the actual stain resembles what is preferred in the American market, Wright-Giemsa stains. It's still methanol-free, but there's a little bit of tweak going on there, and then we plan to launch it this year.

This is the plan together with Sysmex. That is the game plan to get into Americas, or the US.

Great. Thanks you for taking my questions, Simon and Monica, and I'll get back into the queue.

Thanks, Ulrik.

Yes, hi, and thank you for taking my questions. I have a few and I take them one by one.

Starting off on order intake, I believe you say that you have very strong order intake in Americas from the networks. I just wonder if it's possible to in some way quantify the book-to-bill here in the quarter, and whether this strong order intake, is it fair to expect this to translate to strong instrument placements also in H1 '26?

Yes, and in general, there's a momentum in the Americas, and especially in the US. It's early days, and we don't typically disclose our order book for the current quarter.

Having said that, I see no reason why the momentum for Americas should vanish. I think we're in a reasonable, solid situation there from what we hear from the market situation.

Great, thank you. Then I had a question on gross margins as well, a bit of a follow-up.

Softer here in the quarter, and I just wonder if it's possible to quantify how much of this relates to FX, and how much of this relates to the softer software sales and the weaker product mix from that, in rough terms would be great.

Yeah. Comparing to last year, it's a lot of FX, and somewhat product mix.

Exact relation here, I will not disclose, but a little more FX than product mix.

Great. Thank you.

Then final one from my side on gross R&D. You talked a bit about it here, but I just wonder, it was down to 37 million, down 9% year-over-year, I believe.

Why was it down this quarter, and how should we think about this gross R&D level looking into '26? Is 37 million a reasonable level to extrapolate?

Yeah. Actually, we see some decline in R&D spending in Q3 and Q4 versus last year's Q4, Q1, and Q2, and that is mainly due to the phase of the of one of our biggest projects where we had a lot of buying of consumables during Q4, Q1, and Q2, and then due to the the phase of the project, we do not have that in Q3 and Q4.

Then also, we have released some consultants that worked on the software upgrade project after the Q2. What we see going forward, we will see a continued high R&D cost actually in 2026.

We have many interesting projects that we are working on, I would expect more in line with Q1, Q2, Q3 levels also during 2026. Q4 is not significant and what what you will expect for the next year, for this year actually.

Understood. More in line with the quarters.

Yes, and just follow-up on that, what is a fair capitalization rate to expect on these projects then in '26?

More or less at the same level as...

Higher or lower? Okay.

Probably the same level. The projects that Monica elaborate to, some of them will be early stage, which means that we don't capitalize, and then some of them will actually make it throughout our development model, then they will cross the line and start being capitalized.

There's a little bit of balance.

Then we have a few that were capitalized up until Q4 that are now depreciating, so that is then evening out.

Yeah.

Great. Thank you very much.

I'll jump back into the queue.

Thanks, Ludvig.

Yes, hello everyone. I think most of the questions have been asked and answered already, but maybe just to clarify, did you say that we should expect, Simon, some contribution from the bone marrow application in EU here during the fiscal year in H2?

Was that correct?

We're building out the funnel, but the question is how long time does it take for the lab to evaluate it before they place the order and we ship to Sysmex. However, we are positive that we should start selling and see invoices, to speak, in the second half and in particular in Q4.

That's our ambition, definitely.

Yeah. I think also this was touched upon before, but on the methanol-free reagents, obviously now available in EU with Sysmex, is this more also a second-half thing, or can we see something here already in first half?

I'd say for EU, I think the methanol-free stain represents a growth opportunity in general because it's a better value proposition. However, given the market share we have on the RAL, and there's markets where we have a very low market share where there's plenty to do, and there's markets where we have very high market share, but we will cannibalize a little bit in Europe.

That's my point, that we may transfer certain classic stain customers to methanol-free in Europe. In the US, we expect that we will gain share as we start pushing this because there we have zero market share.

We own the market together with Sysmex, but reagent-wise, this is when we start with the methanol-free. There we will gradually gain customers as they convert their engines and the line is down, then we expect to place methanol-free stains gradually.

That contribution for 2026 is probably somewhat limited because it's also dependent on the launch, and then there's a phase where the customer would like to try it out. Therefore, we would be a little bit conservative on estimates for contribution from methanol-free in the US.

I hope that explains the situation, Simon.

No, definitely. Could you remind us roughly the difference in price between the methanol-free stain and the legacy stains from RAL?

Just, in the case of cannibalization, what, a

percentage or... No, I'm not going to go to the pricing piece also for competitive reasons, but there will be a little bit of a lift.

I would say, remember the hematology reagents are a little bit commoditized. It's high volume, but it's not sophisticated chemistry.

We will raise the price, but you cannot go for extra top margins in this market.

No, no, that's understood. My final question relates to the FPM technology.

You sound quite upbeat in the CEO letter, I think, around it and the prospects. I was just a bit curious to learn about sort of what a potential partner could look like.

Do you expect that to happen within the hematology market where you're present already today with your current existing partners, or could this also be, yeah, a new partner in an adjacent area, just high level if you could say anything about that?

No, I think, yeah, high level, I'd say definitely the position we have where we lead the hematology space, we are very confident, and I'm glad that I transmit the positive and confident attitude because that's what we have. We are now at a stage where we are confident to protect and grow our business in the hematology arena.

The adjacent areas, this is where we've also throughout 2025 matured the technology to a level so that we've talked about cytology, we've talked about pathology. We're confident that we can actually build instruments for those segments.

There are other adjacent areas in the clinical space and in the research space where we believe that the FPM technology, given the image quality, given also the speed, but the depth of focus, and there are a number of features where we believe we can disrupt those segments. Those will be players in the microbiology arena, in the pathology, cytology arena, and in the life science space.

Now we're in a situation where we can engage more, let's say, fundamental and more substantially with partners because they can see what we can, and it's not just IP rights that we've acquired. That's why we're pushing our communication a little bit further because we're confident that we sit on a disruptive microscopy solution here.

Okay. That makes sense.

Thanks a lot, and that was all I had.

Of course, we are looking forward to disclose partners or improvements as we go along. That's of course our goal.

Yes, thank you for taking my question. I have one follow-up regarding the order intake.

You mentioned that you reached record levels in the quarter from larger integrated networks in the US. Did you deliver most of it in Q4?

Yeah. That may be worthwhile sort of communicating that the order intake, it is also shipped.

Then we believe we still have momentum for Americas. Yes, what you see is what is shipped.

That's what we book for Q4. That is correct.

All right. Do you see any risk of inventory build-up impacting Q1 in the US?

In the US, I'd say, roughly speaking, maybe a little bit for smaller instruments, but not necessary for the larger instruments.

All right. Could you please give us some comment on the outlook in the other regions regarding the instruments?

I think that's along the lines of what we've said with the momentum we've seen in the different regions. We believe that translates into orders.

Now the business is fluctuating a little bit, and for Americas, we have relatively good visibility. It's a little bit harder for us for Europe because it's a consolidation of orders that comes from multiple countries via the supply chain of Sysmex, and then it comes to us.

There we actually have less visibility. What we hear is that there is, and this is what we communicate, and we have seen it over the last couple of years, that there's a fundamental interest for our solutions.

We see no reason why that shouldn't stop. Then, of course, we may have some fluctuations per quarter.

Fundamentally, we believe we're in a pretty good situation, also now that we're launching new software, etc. That makes us believe in the future.

APAC, I would say we think we have good opportunities, incremental business in Australia and New Zealand. There could be some opportunities also in Japan.

Then, as we are now manufacturing our integrated system in China. That allows us to participate in domestic tenders where you have to be a domestic player, and our products is registered in China as coming from a Chinese legal entity.

Over time, we still believe in China. However, we also know that this is where our competitors strong.

We're up against that in China, but it's a huge market. We believe that there's certainly a position for Sysmex CellaVision out there.

Okay. Thank you very much.

Thanks, Christian.

Yes, hi. Just another follow-up on the reagent side.

That was a bit weaker here in Q4 when comparing to Q3, but Q3 was of course very strong. I just wonder, is an average of these a fair assumption going ahead, or what would you say is the run rate of reagents currently?

No, I agree. I think Q4 was a little bit weak both on the hematology side, even it was 10% organically, but we were flat if not negative on the non-hematology proportion.

We had a big tender where we've been working on that throughout the year where we didn't ship products, we were a little bit negative on that. I think Q4 stands out as a somewhat of a soft quarter on the regions, and we expect it to bounce back, especially with the growth coming from the hematology which represent approximately two-thirds of our reagent business.

Great. Follow-up to that, what is a fair growth rate that you would expect for the hematology business?

Can this grow double-digits?

Historically we've been landing it at probably lower double-digit for the hematology. It's a considerable business, it takes more to change the growth so to speak.

However, with the gradual increase, we've seen the 80% growth we have on the hematology side in APAC, however, it's small contribution obviously. Total revenue out there this year was 9 million.

Still, it's growing, and then as we start over the next coming years to get into the US, I think that's where we can probably even more ambitious of getting higher growth rates for the company in the revenue bucket because this is really incremental growth that comes in while we still believe that we have opportunities to grow double-digit in Europe, where we have a profound footprint. It's really a big thing for us that we can finally enter the US given the fact that the Sysmex smearing device can now host the methanol-free stain.

It is exciting for the coming years to start and build that market.

Would you expect some incremental sales in the US already in '26 from this?

I would expect it, but I don't want to overdo it. I would say that if I can see traction from the ones starting to use methanol-free, that would be really our goal.

It will translate into some revenue, but it's at the end of the year I would expect. That would put us in a situation where it's confirmed in the market, and that gives us a good platform for growth contribution in '27.

I think that's the way to look at it.

Perfect. Very clear.

Thank you very much.

Pleasure.

Thank you very much, and again thank you everybody who called in, and not the least to the good questions that gave us a meaningful report out here today for 2025. I want to sort of finish up the call by saying that I think what we've demonstrated throughout the previous year both on commercial arena, but also on our investments and the organization's ability to translate the investments to meet very, very crucial strategic milestones.

That means we're set up to continue our position of leading digital morphology into the future. Thanks to our team for the relentless effort that you all do, but also thanks to our strategic partner organizations spanning from Japan and all across all regions around the world.

I think that is key, and then finally I also want to send my sincere thanks to our entire group of hematology professionals who are actually using our solutions on a daily basis. Amongst that segment, a special thanks to the ones who are providing us with feedback to our development programs or who has participated in our clinical validations, which has been a considerable part of the investments.

Again, the good example is the bone marrow CE mark that we, of course, want to leverage for a global product. Really a big thanks to our employees, our partners, and our professionals that we work with as customers.

With that, thanks for dialing in, and we're looking forward to actually be back with the interim report on the 24th of April, and then we have our Annual General Meeting for the April 28th. Thank you very much.