CellaVision AB (publ)

Thank you very much, and thanks to everyone taking the time to listen in to our quarterly report that we've launched this morning for our third quarter. I'm happy to say that I also have our Interim CFO, Monica Jonsson, with me, and we'll be happy to also answer any questions you may have when we get to that part of the session.

So, the quarter in brief. So, we have named our quarterly report softer quarter with mixed regional performance, and this is also related to currency effects.

We saw Americas and EMEA had some quarterly variations resulting in modest growth, which we are highlighting here. We are coming out with a quarter here where we are reporting net sales decreased by 1.7 percentage points to SEK 176 million.

However, due to the FX headwind of minus 4.3%, then sales increased organically by 2.6% during this quarter versus the comparable quarter last year. On the EBITDA side, we increased our EBITDA to SEK 50 million.

So, we increased by SEK 1 million, and this relates to -- or corresponds to an EBITDA margin of 28%, also a small increase. In terms of what we want to highlight with regards to our strategic direction and our progress, we actually see a lot of progress.

It's a very exciting time for the company and our partner. We're highlighting the fact that we've completed our clinical trial.

We've submitted our documentation to receive the CE Marking for our bone marrow application. So, we do expect this one to be done according to plan and obtain the CE mark by here we say, early 2026.

I think we've said Q1, so that's still in line. But we are positively optimistic around it, even though there are, of course, always risks with anything, but this is an exciting time.

So now we are really looking into training and the commercial launch activities for 2026. Another big chunk of our investment has gone into an upgraded software for our platforms where we've done the verification that has been completed and now being installed at customer sites for final validation before we roll it out, which is planned for next quarter, which is this quarter here in November.

All right, here we go. And then a slide around the financial development.

So, it's a busy slide, but what you have here is our Q3 numbers reported fresh at the very left-hand side, the comparable quarter and then the year-to-date numbers for 2025 in the middle, followed by the compare last year and then the full year 2024 on the very right-hand side. So, I talked about the organic growth and the revenue of SEK 176 million.

If we sort of peel the onion and then work our way through the P&L, that translates into a gross margin of 69%. So, we increased the gross margin by 1 percentage point.

We had full impact from our price increases during Q3, and we had a little bit of a product mix. So that was a positive contribution.

On the operating expense side of things, we invested SEK 82 million, went down with -- as compared to last year, a little bit on sales, a little bit on admin and according to plan, invested a little bit more on the R&D side. So that actually translated into a growth of EBITDA of around 2 percentage points.

So, from SEK 49 million to SEK 50 million despite the negative decline in revenue. On the R&D side, as you can see, 24% so we have -- of sales is what we have invested into R&D, of course, slightly affected by sales.

However, really, the investments are following our plan, and we've capitalized a little bit less than normal, only SEK 14 million this quarter, which is primarily due to the vacation piece and partly also completion of the software upgrade, which also had a little bit of an impact on how much we capitalized. On the cash flow side of things, we had a cash flow before the working capital items of SEK 52 million.

And then the working capital adjustments or impact was actually minus SEK 22 million, and the majority of that was from accounts receivable since we had quite a number of orders being placed in September. So, this is why our accounts receivable increased.

So, we had an operating cash flow of SEK 29.6 million, SEK 30 million. And on the investment side, we invested SEK 22 million, both on the capitalized R&D activities, as I said, but also investments into data storage was a significant chunk this year to serve our capacity for some of our new technologies.

And then after subtracting our SEK 4 million of finance activities, the cash flow that were related with that, we ended up with a total cash flow of SEK 4 million. So that's really the story around our P&L.

Let's take a look at the regional highlights. So, in Americas, we had 68 million on the top line coming from the Americas region, South and Northern America, which is equivalent to an organic growth of 4%.

So, we also had currency effect there, of course. I'd say, in general, it was carried by -- it came from really good traction on the large instrument platforms and less from the smaller instruments, where we saw a modest decrease.

However, we also saw good traction in Latin America. So that is also positive for future growth.

In general, I'd say our sort of also when we look at our leading indicator in collaboration with our strategic partner. We believe that we have an increasing potential in the U.S., which was also confirmed in the half year report of Sysmex launched yesterday.

In EMEA, likewise, sales amounted to SEK 96 million versus the SEK 98 million last year. That is an organic growth of 1%.

I think this was actually acceptable also in the light that we were up against a pretty tough compare since we had inventory buildup in the comparable quarter last year. So, a decent single-digit growth in reality.

We had reagents growth as well, quite a bit from EMEA. However, on the hematology side, it was modest -- very modest with only 1%.

So, there is some phasing of orders on the hematology side there. But generally, a good 14% growth on the reagent business.

For APAC, I'd highlight that it was a soft quarter, SEK 13 million, so 10% growth, but of course, on a very low base. This was also what we hinted in our previous quarterly report where we had some inventory shipping since we are entering our program where we are manufacturing out of China.

So, we ship quite a number of parts and instrument modules to China, which impacted sales, but this was the main contributor to a soft sales across APAC. We sold also outside of China.

So, we do see momentum in pockets across Southeast Asia and Australia. So that is a positive outlook there.

And then I also want to emphasize that we are seeing a good traction, 5x improvement of revenue sales from our reagent in APAC. Of course, it's small numbers in APAC, but it gives us the confidence that we -- that our penetration and expansion in APAC on the reagent side is on the right track.

If we cut the numbers in terms of sales per product group. So same numbers but sliced per product category.

We have SEK 93 million versus SEK 102 million on the instrument category. And again, contribution from the large instruments was important.

And then as I just alluded to on the Made in China initiative, it is very important for us to be able to participate in the market in China by manufacturing our instrument in China. So that is a project that is also coming to the end as part of our strategy.

On the reagent side, I mentioned the growth of SEK 40 million in revenue versus the SEK 35 million. So that's the 14% growth.

So good to see also that our -- what we define as non-hematology is actually contributing with a decent sort of single-digit healthy growth this quarter here. So that is really good.

And then finally, on the software side, SEK 43 million. So -- and that is also a correlation up against how we're doing on the instrument side, but it is actually a decent software revenue we accomplished.

And also, we had a contribution coming from spare parts and consumables worth SEK 23 million. So, the key takeaways is that, as we say, yes, we've had somewhat softer quarter with some different variation across the regions.

But the underlying is a healthy business, which is supported by the gradually expanding strategic partnership, which is advancing across multiple dimensions on internal processes, on the -- now the focus also on launching the products. This is another thing that the power of focus strategy that we launched in June 2022, it is starting to provide the output, both from what you see when we decided to enter the specialty arena or specialty analysis with the bone marrow that is expected to come out.

So, our focus and activities are really on training and commercial launch activities, and so they will be here as we start the new calendar year. I also emphasized the software upgrade without going into details prior to launch, then I would say that it is delivering a faster, smarter workflow, and it does have a new cutting-edge user experience.

In terms of our fifth pillar in our strategic direction or strategy, the power of focus, we also have these new areas where we expand beyond hematology, which is really the focus of deploying our full Ptychographic Microscopy technology, the FPM technology. And we have reported that we are lifting this into our next-generation hematology analyzer.

And that is really proceeding according to plan. And based on this development, we are now also able to really scan different sample formats in the context of cytology and pathology as an example.

And that is also an exciting area where we are having discussions with partners -- potential partners playing in those field. So taken together, a solid quarter.

We worked hard, but also on the R&D and now on the marketing side is ramping up. So, it's a pleasure to present the results today.

And with that, I think we should open the floor for questions. Any questions are, of course, welcome.

Thanks.

I'd like to maybe kick off with a question on the software upgrade you announced here it's rolling out. Should we expect any financial impact from the rollout here already in Q4?

And will this be sold as an option to the customers? Will it be mandatory?

How will you charge for it? Just any more color on the software upgrade would be helpful.

Sure. The software upgrade is seen as an upgrade on our instruments, both on the usability and the performance to improve the workflow.

We have decided to -- that this will be part of the package when you purchase the blood line, [indiscernible] as an example, then this will not come with an additional fee for the end user. So, this is really a means of differentiation.

So, you should see this as a growth contributor by keep on being relevant in the labs and demonstrating our innovation muscle prior to our next-generation system. That's how you should look at it.

Okay. That's very clear.

And also, on the R&D CapEx here going forward, I think roughly the levels now, I'd say, like SEK 70 million per year capitalized. Should we expect this to decline here going forward as the software product is now rolling out, bone marrow is coming out.

Of course, we're still investing in the next-generation instruments, I suppose. But how should -- how do you believe we should look at the capitalized R&D here in the coming, let's say, 1 or 2 years?

Should it decline more to a historic level, or should it be kept roughly at the same level?

Yes, see, our aspiration is really to maintain focus on us being an innovator -- innovation company. I think we are at a pretty decent level here.

On the capitalization, we have a portfolio of projects we want to start -- so this is also a bandwidth question for us. I think we're at a reasonable level.

But as we see more of our projects being terminated, it is a balance as to how mature are new projects? Are we capitalizing or are they more immature than that.

So, you may see some changes in our capitalization, but our intention is actually to keep on investing in the R&D phase. We expect that as we see more changes also throughout next year, we'll probably give more sort of guidance or update on how we see it as we've come to the end of the power of focus.

So, we will certainly be more specific around this particular question as we enter 2026.

I think that would be a good idea. I think just as you're now sort of finishing up a few of these bigger projects, it would be good to help us understand how we should look at this going forward.

Maybe the final one from my end. You mentioned, I think, that the cash flow was a bit held back by an increased amount of orders placed during the end of the Q3 quarter.

Could we expect that sort of this dynamic to sort of has continued into Q4, i.e., that sort of how you enter Q4 is looking sort of good on that same trajectory? Or was it just a matter of timing that it sort of ended up in the late Q3 here order intake and delivery?

That is simply just the nature of the payment terms when we receive the orders throughout September, then that's why you see this fluctuation on accounts receivable this time around. It's not a systemic thing per se.

It's really a timing thing.

A few questions on my end. Starting off with the product mix and the gross margin, and you say you've had a favorable product mix here in the quarter, improving margins.

But regardless of the mix, some portions here in your profile are increasing its gross margin sequentially, systems software or reagents. And because the margins are a bit higher than it's been before, and you're still sort of affected by negative FX in the quarter.

So, can you help us decipher what segment is improving its margins?

I think -- so pricing was one element. In terms of mix thing, we still have -- we have 14% growth on the reagent side.

That actually pulls down the margin. We have a little bit lower margin on the reagent side versus instruments and software.

But that was still -- despite that, we had sort of solid growth on the large instruments, which kind of contributed to the 1% increase versus the last year.

Still sort of when I sort of -- any way you look at it, if you split it up into 2 segments, like cell morphology systems or morphology systems and reagents, some of these segments have improved its gross margin sequentially and year-over-year.

Yes. So, help me out here.

What are you looking for specifically which product group is it that you're...

I'm just trying to figure out sort of what in the product mix have increased the margin. Regardless of the mix, some of your system or reagents have increased its margins sequentially.

And I'm just trying to figure out whether sort of which part of it is moving the needle.

I think maybe this time around, I think we had probably more contribution from large systems versus the small. So that has been a contributor -- positively contributing to the overall gross margin.

I'd say that's probably the driver you're looking for.

Yes, That’s great. And the software upgrades live here in November enables you to commercialize wider sort of the MCDh reagents.

Have you received any feedback from customers? And can you just give us sort of the highlights here of how you intend to commercialize it sort of near term?

Will it be initial sort of customer feedback then gradual ramp-up? Or how should we view this?

Yes. That’s a great question.

No, you're absolutely right that the software upgrade also comes with the opportunity, you can say, changes on the steering and staining device by Sysmex, which is called SP-50. So that has also been upgraded so they can host our methanol-free stain.

That's an important part of this integrated software upgrade. So that allows us now to actually start positioning methanol-free stains or Sysmex to position the methanol-free stains to be used on the SP-50, which is a major milestone.

So, we're in the phase of evaluating the stain with customers. I believe that Europe will be first.

This is where we have the majority of our business on the [indiscernible], the classic stains. So, there will -- there can be some conversion, but obviously, the value proposition of methanol-free is strong.

So, we can -- that can still contribute in Europe. And then it's also an enabler for the U.S.

And we expect the launch in 2026 for the U.S. Here, there's both customer assessments and a little bit of, you can say, regional preferences that we are working on finalizing, but we expect the launch to be happening next year.

That's kind of where we are for the U.S.

And if we were to look at sort of China, and you've been working here and we can read in the reports on sort of transferring systems. And I guess it's Sysmex that is trying to build up manufacturing in China in order to participate in local tenders.

So where are they in terms of operations in China?

They have a fixed site in China where we work together. So, we are doing our manufacturing of our Chinese devices within China, in their plant as part of that.

And they also have cell counters manufactured out of China. And as you say, rightfully, that allows us to actually participate in hospital tenders or deals where it's a prerequisite that you have Chinese manufactured instruments.

So, this is why this strategic initiative has been an important enabler for us to continue to compete in a more competitive market as opposed to other elsewhere.

And are we to expect any effects from that initiative or...

Sorry, can you repeat that, Ulrik?

Are we supposed to expect any acceleration in China sales from this initiative in the near term?

I think it's fair to be mindful also, if you read the report that came out yesterday from Sysmex, it is obvious that China is a fierce competitive market to be in. However, this gives us the opportunity to actually compete in collaboration with China in that market.

So, protecting the market share that they report they have, and of course, aiming for growth via differentiation, is our game plan. But it is fierce that we all know that both on the pricing side and on the competitive side with local players, it is a difficult market, but it is relatively sizable out of our APAC numbers, which is also why we have invested in this program to protect our position.

Okay. Great.

And last question on my building a little bit more on the capitalized R&D. It's down quite a lot sequentially.

And as you highlighted sort of summer months and reported R&D is up. To what degree is this sort of just summer months in prioritization?

And how much of this is pipeline maturing? The bone marrow application has now been submitted.

What is left in terms of R&D spend for bone marrow application and as well sort of the software upgrade, is also now a commercial product. So, I guess that will not run you that much R&D.

No, that's true. I think after Q2, we also released some consultant costs or some consultants, which is also reflected in the less capitalization.

And as you say, of course, also the amount capitalized is equal to what we did last year, but coming from a higher base. So that is really because we are also releasing some consultants.

Having said that, we are an innovation company. And I think that's super important, which is also what I tried to elaborate to Simon in the previous questions that were posed there.

So, we are seeking for opportunities to invest and maintain our strategic focus of differentiating. We cannot disclose what are those programs.

That would be unwise from a competitive position. But our intention is to really pursue our direction.

And back to -- part of your question was also related to bone marrow. We are confident, as report, of course, there are risks, but we are confident that we are getting the CE mark for Europe.

We still have investments to do to complete our trials and the work that we do to also enter the U.S., So we're not fully at harbor, so to speak, with the investments related to bone marrow.

The first one is regarding the instrument sales that declined year-on-year, but your tone remains optimistic and especially for the larger systems. So, should we view this as an indication that demand strength will translate into stronger instrument sales in Q4 already?

I probably defer to sort of be super specific on what happens in Q4. However, I do note that our leading indicators are positive.

I do note that Sysmex for the past 2 quarters, so including the quarter they completed, or they reported yesterday, so their Q1 and Q2 equivalent to calendar year Q2, Q3. I do note that they are signaling, or they are reporting instrument growth of 10% in the U.S.

and 4% in Europe. And I think there is a healthy environment.

This is also what we see. So, we're positively optimistic.

So, you read my tone correctly, but I will defer for being super specific until we've seen what orders we get in and so forth.

Okay. Perfect.

And demand for smaller instruments appears a bit softer than for the larger ones. Do you view this as a temporary situation?

And what factors do you believe could drive a recovery in the near term?

Yes. No, I think it's temporarily.

I think we, together with our partner, has pushed a concept which included both -- for the small labs, which included both the smearing and staining, and our DC-1 instruments. Prior to this, we had very healthy double-digit growth on the DC-1 instrument sold by itself.

And then we positioned this instrument package called the DIFF-Line. And it is no secret that we had some operational performance issues with the SmearBox.

So, I truly believe that part of the issue is not the market demand. It's our product issue that we had.

And now we do have another simple solution that can substitute. So, it's a matter of getting aligned and getting back and really working with the opportunities as opposed to -- because we have seen a glitch in the pipeline that we built up due to this.

But I really trust that it's a temporary thing. The demand is there.

And also, if I look at it, especially in the U.S. All the IHNs are set up for our solution.

And I do believe we're the only company who can actually serve that segment in a networked manner, from small labs integrated with the connectivity and our software solution to cater and be managed and decided upon from a diagnostic perspective at the large labs. So, it's temporary, Christian.

Okay. Great.

My final question, Reagents performed really well with strong momentum in APAC. Do you see any risk of inventory buildup in the reagents that could dampen sales in the fourth quarter?

No, you're right. I'd say inventory buildup, then I'm thinking specifically around China.

And the challenge there when you build up an own manufacturing is that, first of all, the line, we are selling a lot into China, that is then sitting in the manufacturing line. And then after that, you have a layer of 60 to 70 distributors below.

So, there is a very little transparency to the end user in China. So, from that perspective, I would probably answer that, yes, there is a risk of some inventory buildup for the time being because it's very hard to translate how much is actually entering the end users for the time being.

So, there's a little bit of risk for that, specifically related to target.

So I wanted to continue a bit on this last question with APAC instrument sales. So of course, it was lower in Q3 with some inventory destocking following the large Q2 order.

But given that you now have local assembly in China, as I understand it, like will this lead to APAC instruments even more lumpy ahead? It has been lumpy historically as well, but could it be even further enhanced now?

I think the lumpiness is primarily driven for China and not APAC as a whole. So that's for China specifically, I would say.

But temporarily, I can certainly not guarantee that there will not be some lumpiness. China -- sorry, APAC has always been quite lumpy and also because China is the biggest market that we serve.

However, I do see opportunities both when we look at Japan and when we look at Southeast Asia, not the least in Australia and New Zealand. So, some lumpiness can occur.

And that cannot be sort of neglected, so to speak. But still, I think it's positive that we're actually seeing opportunities both on the instrument side and then also on the reagent side, where we believe there is a good opportunity to actually bundle our offerings because we are the only provider who can actually provide both instrument software and reagents.

Okay. Great.

So yes, just a follow-up to that. So, you saw this SEK 3 million reagent sales in APAC in Q3.

Like we have seen some spikes in reagent sales historic as well. Like is this to be considered somewhat of a one-off, this level?

Or does it rather reflect that you are seeing a significant increase in reagent customers in the region?

No, you're right. It's not a continuous sort of flow.

There is lumpiness if you look at the revenue for APAC reagents per se. However, we do believe that the shipments that we send, they go to multiple markets.

So, you should see it as a sign of us starting to actually grow the base of RAL reagents being consumed across multiple markets in APAC. I think that's the positive thing.

And then also, we're also working on our logistics setup to serve the reagent market in APAC, which is another driver that can also help us facilitate and provide the reagents. So, you should expect growth, but I cannot guarantee that there will not be this lumpiness because it is a matter of -- it's large shipments that goes when they go and sometimes, they don't go.

So that's how you should look at it.

Okay. I understand.

Very clear. And then another follow-up.

Just like looking at the instrument sales in APAC. So, on a rolling 12-month basis, I guess it has stabilized now around SEK 25 million, SEK 27 million, something like that.

Like is this a fair level to extrapolate ahead? Or do you expect this to grow example, looking into '26?

For example, the last part, I didn't hear that.

Yes, for 2026, like do you expect to have a similar type of -- or similar amount of quarterly deliveries on an average level?

Yes. It's always tricky with the average question.

I think it's a decent level. Having said that, there are specific opportunities, I'd say that when we look into and we discuss with our partner, there are specific opportunities sitting in APAC that are significant.

And if they don't come, then you end up with this relatively flat look. However, the spikes can certainly come because we have some good opportunities across network hospitals, both in Australia, New Zealand, but also in Japan.

And if they materialize, then I think we should certainly expect growth when you do your math over the 2026.

Okay. Great.

And like -- because I think last year, we saw quite a significant spike in APAC instrument deliveries in Q4. Like is there any seasonal component to that, that customers trying to fill their budgets?

Or was that more of a one-off so to say?

We compare that with last year, what I recall was that we had to serve -- we were obligated to serve a specific tender that was 5 years old type of thing. So that happens in the comparable quarter, Q4 last year.

I don't expect there to be much -- you can call it seasonality per se. It's more a function of where the specific opportunities materialize rather than seasonality.

Okay. And then final question, like you have talked a bit before about reagent sales in the U.S.

and the potential there. Like any updates on that?

And if we could start to see this starting to ramp into '26? Or yes, just how to think about that?

Yes. No, I think about it in a way where we've been also at our Capital Market Day when we launched the Power of Focus, we were really emphasizing that MCDh, the methanol-free stain is the enabler to go and penetrate the reagent market in the U.S.

That assumption has not changed. But now we've progressed much further.

So we're actually able to bring MCDh onto the Sysmex smearing and staining device that is consuming our methanol-free stain. So, I think we've come a long way on the development side.

So now it's about getting some customer feedback on the stain, whether there are any last tweaks for U.S., I do expect it to materialize, let's say, mid-2026, which, of course, means that the contribution from the reagent in 2026 U.S. is not enormously, but milestone-wise and the fact that we start launching this has enormous impact also on how we work with the team over there to actually position our total solution now also including instruments.

So, by the end of the day, very exciting times for us.

Thank you very much. And first of all, thanks to all of you taking the time to listen in and staying with us throughout the Q&A.

In my closure comment, I want to thank especially our strategic partners, the partner organizations all across the regions and the different functions. I really see gradual constant progress here 1.5 year after we especially launched the strategic alliance agreement with the Sysmex Corporation team.

I also, in particular, I want to thank our own team, our staff. It's been extremely probably more than usual a tough quarter, and I think they know what I referred to on the internal lines.

However, the dedication and the focus seems to take no ends all across our functions. So really a heartfelt piece of appreciation here.

And then finally, I want to emphasize that on February 5, 2026, this is when we announce and present our year-end bulletin for 2025. So that will be published, and we are looking very much forward to present the results.

And with that, I thank you for your attention and your interest in CellaVision. Thank you.