DiaSorin S.p.A.

DiaSorin S.p.A.

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Q4 FY2025 · Earnings Call TranscriptMarch 20, 2026

Operator

Good afternoon. This is the Chorus Call conference operator.

Welcome and thank you for joining the DiaSorin full year 2025 results conference call. As a reminder, all participants are in a listen-only mode.

After the presentation, there will be an opportunity to ask questions. Should anyone need assistance during the conference call, they may signal an operator by pressing star and 0 on their telephone.

At this time, I would like to turn the conference over to Mr. Carlo Rosa, CEO of DiaSorin.

Please go ahead, sir.

Carlo Rosa

Thank you, operator. Ladies and gentlemen, good afternoon and welcome to the DiaSorin full year results.

Today, we have a busy agenda. I'm going to make some business remarks, then our current CFO, Mr.

Pedron, is going to take us through the 2025 financials. Our future CFO, Mr.

Alberto, is going to discuss about guidance 2026, and then collectively we're going to take questions. Let me start from 2025 business comments.

2025, I think, marked a year of good achievement for our company, with success for our strategy in the different technologies, with Immuno delivering a 7% growth, Molecular Diagnostics year-on-year flat—and we'll see later primarily related to the fact that the flu season this year has been very weak—and then LTG delivering to expectation, flattish compared to previous year. Again, as we will discuss later, primarily due to the fact that on the Life Science segment, as I think is very well known by everybody, 2025 has not been an exciting year.

Let me now turn to the specific technologies. Let's start from Immuno.

It's very clear that Immuno, we always talk about the success of our hospital strategy. In the US, we have delivered the number of hospitals that was targeted, and actually, if I go back and think about the 2023 plan, LTP, what was when we deliver our targets for the hospital strategy, what the company was looking for is to get to 600 hospitals by 2027.

Actually, I believe we're going to get to 600 hospitals by the end of 2026. This strategy has been extremely successful.

By the same token, we continue to launch specialty assays. Hepatitis Delta, together with Gilead, we are the first and only company to have an FDA-approved Hepatitis Delta assay, which is a great opportunity in light of the expected approval of the new Hepatitis Delta drug.

The TRAB, which is an autoimmune assay, very specialist. We continue to fuel globally our Immuno franchise with specialty products.

When it comes to Molecular Diagnostics, I will be more specific later, but we continue with the increasing and launch of the different panels on the Plex platform. Today, we have four approved, and GI is submitted and expected to be approved in the next 60 to 90 days.

We are, as I remind everybody, as far as of today, we are focusing our effort just in the US market, when I will talk about Plex, just remember, it's only the US. We continue to deliver the customizable mini panel strategy.

When it comes to NES, which is the small platform, as discussed already, we have got approval of our respiratory panel. We have submitted our GAS panel on NES, and we expect approval within H1 of 2026.

We built a dedicated sales force in the US of around 30 people, with an investment with annualized is estimated to be around $10 million, that will allow us to launch efficiently and effectively NES in the non-acute and acute space in the US. In parallel, we have signed up two major distributors: Fisher Scientific, that will work with our direct sales force in the acute hospital segment, and McKesson—I think the press release went out yesterday—that is taking the exclusive distribution of our LIAISON NES in the non-acute in the US, together with, again, the dedicated 30 people that we have hired to support the business.

Commercial launch is expected to be April 1st. Moving forward with the business, from a footprint organization, we have pretty much completed the phase-out of our industrial plant in Germany, again, to streamline our manufacturing footprint.

The all products manufacturing has been moved to Italy, and we are practically at the end of the process, and I would like to thank all our German employees that have been extremely collaborative and professionals in allowing the company to close the plant in good order and not to provide any disruption of supply to the customers. When it comes to Chicago and Cyprus, which are the two sites where we manufacture Plex and NES, we have completed all the investments, which have been in the order of $30 million, and now we have the capacity in place to sustain the launch of the two platforms.

When it comes to China, we have we believe that we continue to see that the macro environment in China is actually not improving, to say the least. VBP policy now is adopted in all the provinces, but what we are seeing is that even in Shanghai and Beijing, that supposedly were not touched by VBP, now clearly, VBP is also de facto applied into this very large markets, and so the effect of VBP will hit China in its entirety.

Because of that, and because of the fact that we honestly don't see for DiaSorin a space as a supplier of commodity, non-specialty assays in China, we decided to close our manufacturing site in Shanghai and discontinue the local manufacturing project. Unfortunately, and funny enough, Murphy's law, we we're making that decision when we just got approval of all the products.

I think that, again, our view on the Chinese market continues to be very negative, and the ability to compete in that market with me-too products, I don't think is there. Although, as I think we have discussed, we are now resorting to a different strategy, which is the specialty strategy in two areas: one is TB, where we are successful globally together with QIAGEN, and the other one is on the GI immune strategy.

We expect the TB product to be approved by the summer, we will start our TB campaign in the summer, and the calprotectin assay to be approved within 2026, beginning of 2027. Again, China, we are redirecting the effort.

We are taking away all costs associated with being a non-specialist player and investing to become a specialty player in that market, which we honestly believe is the only way for a company like DiaSorin to continue to survive and make good business in the Chinese market. When it comes to 2025, again, we have been experiencing, I think, overall headwinds and tailwinds.

Let me remind everybody what happened last year. Tariffs clearly have been impacting the P&L last year, although we believe that those tariffs, which is in the range of $9 million—again, I'm talking about the cash component—will be able to get them back sometimes in 2026, but last year, they did impact our P&L.

The NIH funding cuts did impact the business of our partners in Life Science, and in fact, and this is the reason why we have a flat overall LTG business, which, as we have discussed a few times, is a combination of high single-digit growth of the diagnostic component, but high single-digit decline of the Life Science. We have been experiencing volume normalization in Europe, testing volume, and I'm using Germany as an example.

Germany used to grow on an annualized rate around 6% to 7% from volume testing perspective at the end of '24, beginning of '25, and we actually saw that by the end of 2025, that is more around 1%. I'm using Germany because it's a very large market, but I believe that this problem is actually replicating around Europe.

Again, it's normalization, clearly, after the COVID effect, in my opinion. Then, last but not least, the flu season.

No need to comment, but the flu season has been very poor in 2025, and also Q1 of '26, we continue to see the same effect. Because of the fact that a good chunk of our business for Molecular is flu, clearly, we are tactically suffering from lack of revenues in this segment.

From a tailwind perspective, clearly, PAMA implementation has been delayed post-2026, and this has lowered the level of pressure on our customers, and so I believe that from a pricing perspective, we do not foresee an impact coming from PAMA. Now, let's deep a little bit more into the numbers, and let's look into Immuno.

Our Immuno franchise, we like to look at total, and then take out what we believe are the one-off effects. If you look at Immuno franchise, full year growth 7%.

If we take away two effects, which are China, the China decline, which was almost 18%, and the outbreak effect that we commented a few times, then the growth of the franchise would have been 9%, which so it means that solid, healthy growth of our Immuno business. North America continues to be one of the leading market for DiaSorin.

We had full year growth of 15%, but if you look at quarter to quarter, Q3 14%, Q4 14%. Is the performance of North America is clearly extremely solid there.

Europe, we saw that by year end, it's mid-single-digit, which I think it's okay when it comes to the European market, which does have dynamics, as we know, of growth expectation which are very different from the rest of the world. China has been very negative, and overall, during the year, we lost €8 million in China in revenues, which is minus 19% versus prior year.

Clearly, we saw these effects softening in Q4, but what we are seeing moving forward, though, is that this VBP effect, I think, will continue now into provinces that so far were not really touched by this. My view when it comes to 2026 certainly is not positive about this.

If we look at Molecular, as our Molecular business is fundamentally flat year-on-year, but with different components. Looking at the three different legs of the business, as let me remind you, we look at the business as the what we call targeted, which is our Molecular franchise that came in original from DiaSorin and Focus.

We have the franchise which is the multiplexing franchise, and then we will have the NES. If we now talk about the targeted franchise, we see that which I mean overall is close to $100 million.

There are three different segments into this. We have what we call the specialty, the specialty targeted, which closed at around €40 million annualized with a growth rate full year '25 of over 35%, and by the way, fairly constant quarter-to-quarter, this continue to drive the growth of the franchise.

By the same token, we have a respiratory component, which is 40% down compared to last year. The good news is that now is becoming very small, is between €10 million to €15 million, but the seasonal effect was has been so far very heavy because of respiratory season.

Finally, we have what we call ASR, which is, again, roughly €40 million, very profitable business, which are reagents that we sell to laboratory in the US, roughly 200 customers, to do LTD assays in the US, which is flat, and not expected clearly to be a significant growth driver, but is a very significant profit and very profitable business for DiaSorin. On top of that, is allowing us typically to launch as LDTs some of the specialty assays, and then meanwhile file with run clinicals and get the FDA approval that then will allow us to move to the full the full kit.

This franchise, I believe, is solid, and will continue to deliver the growth transforming this the business from very dependent on respiratory to fundamentally very to be very dependent from the growth of specialties. The second segment is the multiplexing.

The multiplexing for us is the combination of Verigene I plus the LIAISON PLEX. Full year growth of this business all in has been around 9%.

Clearly, there has been an effect here which has to do a lot again with flu and the flu season in two ways. The business that we had with Verigene I had a flu component, but more than anything else, all the LIAISON PLEX business that we actually are building, it's all respiratory, for a very simple reason that we just got blood in mid of 2025.

It's very clear that we have a double-whammy situation in this case. If we look at LIAISON PLEX per se, we had an objective to close 150 customers in the US, and in fact, we closed 147, which so we are at target.

We have placed roughly 1,000 systems with these customers in the US. Again, this is US-only because we did not make this platform available outside the US.

40% of the contracts that we close are fixed, and 60% are flex, which means now that and the weight of the flex business is increasing, clearly, because all the new placements we are making are fundamentally based on flexibility on building the mini panels. If we look at customer split, 90% are hospitals and 10% are commercial labs.

Clearly, if we look at the revenue contribution so far, commercial labs represents a little bit over 50% of the business, and this is because of the fact that we closed some very large contracts in commercial, and namely, the one that was made public was the Quest agreement, where Quest now has transitioned to the LIAISON PLEX platform for all the respiratory business. GI panel clearance, as said, expected in the next 60 to 90 days, and this clearly will accelerate penetration in the US in US hospitals, also because the GI panel is the one that allows to the full extent the use of the mini panel, customized mini panel concept.

When it comes to the non-automated business, which is the legacy business left, clearly is left unattended, is declining, minus 6% full year, and is supposed to continue to decline simply because this is a business that we're not invested in, is a cash cow, and but still very profitable with like all the cash cow businesses. LTG, we spoke about the LTG before, is a very so is a 50-50 business, as you know.

The split is 50% diagnostic, 50% Life Science. When it comes to the diagnostic business, grew 9% last year, and but when it comes to the Life Science business, it actually declined 9%, and that and this is why it made the LTG business fundamentally flat.

We'll talk about expectations for this business in 2026, but I believe that in 2026, we are expecting moderate growth, primarily driven by the fact that there are initial signals that the Life Science business is going to do better than last year, also because, in full honesty, last year was, for everybody in the business, a terrible year, right? Recovery of that business is mathematically expected.

At this point, I believe that I will let PG take care of comments on the financials, and then I'll make some further remarks. PG, please.

Piergiorgio Pedron

Thank you, Carlo, and welcome, everyone, as Carlo said, to our 2025 fourth quarter earnings conference call. As usual, during the next few minutes, I will provide an overview of our financial performance for the full year, after which, as Carlo just reminded us, he and Alberto will cover 2026 guidance, and we will then proceed to the usual Q&A session.

So 2025 full year revenues were just short of €1.2 billion, reflecting a 1% or €10 million increase compared to the same period last year. This performance was achieved notwithstanding a €13 million reduction in COVID-related sales, once again, as expected, and a €34 million negative impact from foreign exchange rate, primarily due to the depreciation of the US dollar against the euro, as we have discussed many times during our last earnings calls.

Excluding COVID and at constant exchange rate, our core business has achieved a 5% full year growth, therefore in line with the guidance. Carlo previously outlined the factors contributing to this performance: robust results from the Immuno franchise despite the challenges in China and the outbreaks in Europe in 2024; normalization within the LTG franchise following a favorable phasing in the first half of 2025; and a stable trajectory for the overall Molecular business, which has been negatively impacted by a very mild start of the flu season and, as you might remember, the discontinuation of the Aries platform.

2025 adjusted gross profit at €778 million accounted for 65% of our revenues. This represents a decrease of €4 million or 1% compared to 2024, mainly driven by tariff impact, which at the P&L level in the year accounted for €4 million, a different product mix, and the negative FX impact.

At constant exchange rate, the adjusted gross profit would have increased by almost €20 million or 2%. Adjusted operating expenses for the full year were €474 million, marking a 1% decrease from the previous period, whereas at constant exchange rate, the expenses increased by 1%.

As a percentage of revenues, OpEx declined to 39%, down from 40% in 2024. The small rise in absolute value at constant exchange rate was mainly due to the higher labor costs from the annual salary review and increased depreciation tied to the recent product and platform launches, including the LIAISON PLEX, which had been previously in development.

This minimal increase reflects our disciplined approach to cost management. I'd also like to address the reported statutory operating expenses, which in Q4 have been impacted by the initiation of the divestiture plan of our manufacturing site in China that Carlo just talked about.

This project will be completed by the end of 2026. This initiative, which was prompted by material change in the Chinese market, as we heard, is consistent with DiaSorin's ongoing strategy to optimize our global manufacturing footprint, previous actions such as the divestiture of our Irish and South African facilities and the commissioning of our manufacturing site in Germany.

These steps demonstrate our continued effort to adapt to the evolving macroeconomic conditions and enhance our long-term competitiveness. We anticipate that the one-off charge related to the full scope of this initiative will not exceed €22 million, €20 million of which has been booked in Q4 '25, with the vast majority being non-cash costs, primarily intangible and fixed assets write-off.

The monetary total impact will be less than €3 million. We estimate that this initiative will bring an annualized savings, once completed, of about €6 million.

As a result of these dynamics, 2025 adjusted EBIT reached €304 million, representing 25% of revenues, confirming the profitability we had in 2024. This reflects an increase at constant exchange rate of €13 million or 4% compared to the same period last year, whereas the result at current FX is in line with 2024.

Adjusted interest expenses for the full year were slightly above €1 million, compared to an income of €4 million in 2024. The primary factor behind this variance was a reduction in our cash balances and investment yields, reflecting the decline in interest rates.

As discussed in previous earnings calls, the normalized tax rate has adjusted to 25% following the conclusion of the Patent Box regime for our Italian legal entity. For the full year 2025, the tax rate is about 29%, and this is due to a couple of one-off events that occurred in the fourth quarter.

The most significant impact resulting from the withholding tax on dividends from the US subsidiary, and the impact of not accrued taxes deduction of the impairment costs related to the divestiture of the Chinese manufacturing site, in light of the limited visibility on future taxable profits in our Chinese legal entity. These items are not expected to occur again in 2026, we will go back to a normalized tax rate of 25% in 2026.

2025 adjusted net results at €223 million or 19% of revenues is lower than '24 by €13 million or 6% as a combination of a negative FX impact, accounting for €12 million, and higher interest and tax rate expenses. The adjusted EBITDA for the full year 2025 is €394 million, accounting for 33% of total revenues, therefore in line both in absolute with the absolute figure and revenue ratio recorded in 2024.

At constant FX, adjusted EBITDA reports an increase over 2024 by €15 million or 4%, with the margin slightly exceeding 33% and in line with the annual guidance. Q4 '25 profitability at constant exchange rate, just short of 32%, is about 140 basis points lower than the corresponding period in 2024, mainly due to the variations in product mix and the impact of the tariffs, which accounted for €2 million or thereabout in the quarter.

Before turning to the net financial position, let me share a brief comment on the tariff situation in the US. On March the 5th, the US Court of International Trade, so-called CIT, issued a nationwide order requiring US Customs and Border Protection to refund IEEPA-based tariffs, following the US Supreme Court's February 20th ruling that the IEEPA does not authorize tariff actions.

The order applies to all importers, therefore to DiaSorin as well. The Court of International Trade has given Customs Border Protection 45 days to prepare the system for this activity.

We will keep on monitoring the evolution of this very complicated situation and update investors consequently. As of today, the potential P&L upside related to 2025 tariffs is about €4 million, as we said, plus €1 million to €2 million for the first two months of 2026.

From March on, IEEPA tariffs have been replaced by the new tariff scheme imposed under Section 122, which is included in our 2026 guidance. Turning to our net financial position, we closed 2025 with a net debt amounting to €580 million, with an improvement of €38 million compared to the same to the end of 2024.

This reflects a solid free cash flow of just short of €210 million, compensated by cash outflows, including €97 million in payments to shareholders exercising withdrawal rights after the recent implementation of the enhanced voting rights mechanism, as well as €63 million distributed as dividends to our shareholders. Before Carlo and Alberto present the 2026 guidance, I'd like to share a few personal remarks.

As you might know, this is going to be my last earnings call in DiaSorin, since in April, I'll be moving to a different professional chapter of my life. As I wrap up my time here, I just want to say a big thank you to all my DiaSorin colleagues, my super amazing team, Carlo, obviously, and the whole board.

The last 15 years have been an incredible ride, full of teamwork, growth, achievements that I will always remember. DiaSorin has been like a second home to me throughout these years, and I have every confidence that it will continue to excel and accomplish even greater things in the future.

I'm also certain that Alberto, who has been an integral part of my team since I joined DiaSorin, will be an outstanding CFO. To all the analysts and investors I've gotten to know over the years, it's been a real pleasure interacting with you.

Thank you for your insights and open and constructive dialogue. I wish you guys the best going forward.

Carlo Rosa

Thank you, PG. Clearly, this is a very emotional moment for everybody here.

PG reminded me today that when he joined DiaSorin 15 years ago, our revenues were less than our OpEx today, which clearly shows that the company grew significantly, and PG was very instrumental to work with us during these very interesting times. By the same token, I would like to welcome Alberto Donati, who is stepping in effectively today as the CFO of this organization, and as all the CFOs, is going to be his duty and honor now to help us out to understand the guidance for 2026.

Alberto.

Alberto Donati

Thank you, Carlo, and thank you, PG. Good morning and good afternoon, everyone.

I will now walk you through our guidance for 2026, which, as usual, will be expressed at a constant exchange rate using 2025 as a reference here. Now, before getting into the numbers, allow me to briefly frame the macroeconomic environment we are operating in, as 2026 will be characterized by some headwinds in the first part of the year.

Specifically, we do expect a slower start of the year in the United States, and this is because they're partly impacted by the critical weather conditions in the first quarter, as well as a much weaker flu season, as has already been reported by many of our peers, and which is weighing on our respiratory testing in the early part of the year. We also see a continued normalization of the volume in Europe, which is consistent with the trend already observed in the second half of 2025.

With all of this being said, for the full year of 2026, we expect the group revenues to grow between 5% and 6% at a constant exchange rate. As a reminder, this includes COVID sales, which were included in the 4% growth of 2025, 5% for 2025 was excluding COVID.

We are now giving the guidance including COVID, but we do expect COVID sales to continue to deteriorate. From a quarterly standpoint, 2026 will be back-end loaded.

We expect a softer first half, primarily explained by two factors: First, the LTG business was significantly front-loaded in 2025, as mentioned during last year conference calls, and as reminded by Carlo early on, resulted in a tough comparison in the early part of 2026. Secondly, the flu season has been especially weak in the first quarter of 2026, which while we have embedded in our numbers a normal season for the second half of 2026.

Additionally, considering the NES, LIAISON NES with the launch of the ABCR panel, and the LIAISON PLEX having the complete panel available in the second half with GI, those will primarily contribute in the second half of the year, which naturally shifting a meaningful portion of the Molecular Diagnostics growth towards the back end of the year. From a profitability standpoint, we expect the group to deliver an adjusted EBITDA margin between 32% and 33% in 2026, and again, as usual, this is at constant exchange rates.

This reflects the combination of a softer first half driven by business phasing and product timing, and the commercial investments we made to ensure the successful launch of the NES platform, again, as mentioned by Carlo early, north of $10 million. We do expect that the progressive improvement in the second half of the year supported by the volume recovery, the operating leverage, and the contribution from the new product launches.

Please consider that 2026 guidance does not take into account any potential negative impact related to the ongoing military conflict in the Middle East, which could affect the group sales in the region. It also excludes any possible indirect effect of the conflict, including the increasing logistical and distribution complexities potentially extending to the Asia Pacific region, as well as inflationary pressures on cost.

Before concluding, let me just reiterate that DiaSorin remains highly exposed to the USD with approximately 50% of the group revenues which are denominated in USD. As a reminder, a rule of thumb is that every $0.01 movement of the USD versus euro has an impact of approximately €6 million to €7 million on an annualized revenues, and €2 million to €3 million on our adjusted EBITDA.

I will now turn it to the operator for the Q&A.

Operator

This is the Chorus Call conference operator. We will now begin the question and answer session.

Anyone who wishes to ask a question may press star and 1 on their touch-tone telephone. To remove yourself from the question queue, please press star and 2.

We kindly ask you to pick up your phone when asking questions. Anyone who has a question may press star and 1 at this time.

The first question is from Aisyah Noor, Morgan Stanley. Please go ahead.

Aisyah Noor

Hi, good evening, everyone. Thanks for taking my question.

My first one is on the immunodiagnostics guidance of mid-single-digit growth for 2026, which is a slowdown from 2025 of 7%. Can you explain why this is a slowdown if the China VBP impact is smaller year-over-year?

Then my second question is on the McKesson partnership that you signed yesterday. What do you think will incentivize McKesson to push your products more strongly versus the competitor, SPOTFIRE?

Are you pricing it competitively? Is there higher fees to this partner?

Basically, how do you ensure the success of this partnership? Then I'll have a follow-up after.

Carlo Rosa

Thank you, Aisyah. Let me take the two questions.

The immunoassay projection in 2026 forsees a normalization of testing volumes. As I said, we saw it progressively softening during 2025, and I'm talking about Europe, and therefore, we expect that this will have an effect in 2026, meaning that this is going to be the normal volume effect that we would expect in immunoassay.

Please consider that Europe is 50% of the immunoassay revenues, it does have an impact. Second question on McKesson.

Look, these distributor platforms, they carry instruments from different companies. That that is true.

Although I believe that when we look at the POL market, there is what we, and we mapped all the POLs in the US by size. We believe today that there is a great opportunity provided by the fact that in the low-mid volume POLs, there is no platform today, and I'm talking about modern platform, that can serve that segment.

We're talking about customers that are consuming between 500 to 1,500 tests, total flu tests per year. We also saw in the market that the positioning of the SPOTFIRE actually is on the higher segment of the market, including where you find Cepheid, where you find also Abbott ID NOW, whereas in the lower, smaller side of this business, you find ID NOW, and you know that today ID NOW is the platform every everybody's going after because it's a very, very old technology, and really is not serving the purpose of this market.

To be honest with you, when we went to McKesson, we're learning this space. This is not a traditional space for DiaSorin, and we actually understood that the way we look at the market, positioning of the product in a certain segment, is exactly the reason why McKesson was looking at getting our platform exclusively for distribution.

We have an exclusive relationship with them, clearly with a minimum commitment that they need to guarantee for for retaining the the exclusivity. You asked for about McKesson, right?

Not Fisher. That's the answer for McKesson.

Aisyah Noor

Yes. Yes, I did.

Thanks. Just to follow up, maybe a question for Alberto, could you give us some guidance on the FX impact on sales and EBITDA margin for the 2026 fiscal year?

Alberto Donati

Yep. From a EBITDA perspective, just as a reminder, we did give the guidance at a constant exchange rate.

What do we expect? We expect, as as I reminded before, the impact for us is €2 million to €3 million every $0.01 movement that we have.

Now, in 2025, the impact on our top line was €35 million, and at the bottom line was around €15 million in 2025. Allows us some flexibility in 2026, as we don't know where the dollar is going to be given the uncertainties of the market.

At the moment, the guidance is at constant exchange rate, knowing that for every $0.01 movement, we have a €2 million to €3 million impact on our adjusted EBITDA.

Piergiorgio Pedron

Aisyah, if I can step in. If you look at the latest Bloomberg consensus for the FX rate for 2026, and again, a lot of things are happening, but what you find today is 1.18, right?

Since the average exchange rate for 2025 was 1.13, applying the rule that Alberto told you about, you would expect a negative FX impact on the top line of €35 million, right? Which is the difference from 1.18 to 1.13 times seven, which is the €6 million, €7 million Alberto was talking about on the top line.

I believe this is important for you guys to understand and master, otherwise it's going to create some complications when you will be working on your model and, defining your consensus. Whereas if you go to the EBITDA level, again, it's €2 million, €3 million times this five we were talking about, you get to top €15 million.

At the end of the day, if you believe Bloomberg forecast for 2026, eventually the FX impact on 2026 vis-à-vis 2025 is going to be similar to what we experienced in 2025 vis-à-vis 2024.

Aisyah Noor

Okay. Thank you so much, PG.

All the best, PG.

Operator

The next question is from Odysseas Manesiotis, BNP Paribas Exane. Please go ahead.

Odysseas Manesiotis

Hi, thanks for taking my questions. Firstly, I wanted to get a bit of a feeling of what was the main driver for your growth expectations to be lower than what they were in Q3.

I remember you saying high single-digit growth was possible in '26 in Q3. I want to get a feeling of the key drivers of lowering your expectations there.

Was it I'm thinking is there a bit of a small delay on the Calpro 3 launch, lower expectations on the NES, or further pressure in China, Germany, and Europe, sort of what are the main drivers here? Then I have a follow-up.

Listen,

Carlo Rosa

if I understood correctly, you are talking about the comment on high single-digit total business growth 2026 expectations, correct?

Odysseas Manesiotis

Yes.

Carlo Rosa

Okay. I I made a comment before.

Two things: We are starting Q1 with a very, very low respiratory season, which is not what were clearly built in the expectation Q3 last year when we were commenting the 2026 numbers. You saw that some you saw it from from comments and commentaries which have been made by some of our competitors that the flu season is 25% to 50% lower than last year.

Very significant, which was not built in, clearly, in our expectations. The second one is the fact that in the European volume, we saw it decreasing also in Q4.

As I told you, I gave you a number. Now we are at average 1% growth.

We were sitting mid-year with annualized around 3.5%, right? There is a normalization so-called of volumes that now we have seen, and we expect to see moving forward.

Last but not least, and again, I'm referring to commentaries which have been made by some of the large US operators, namely Quest and Labcorp, Q1 volumes, testing volume in the US have been particularly low, and this is because of a very severe weather situation. Please go and listen to what Quest and Labcorp mentioned about quarter one that are still affected today.

Those volumes is still affecting some of the US business these days. This is why we believe that high single-digit is not achievable, and 5% 5% and 6% are are more realistic.

With all due respect, though, guys, I think that Alberto made a made a good point. We are where we are, as we sit in Q1, in after 20 days of war.

Making a projection of what is going to happen at this point on from a costing point of view, it's mission impossible. Okay?

From what we understand today, we believe that the business is going to grow 5% to 5% to 6%, and we believe, as Alberto clearly explained, is back-loaded as a combination of mathematics on LTG, tough comp, H1 versus H1, and the fact that H1 will completely miss the flu numbers.

Odysseas Manesiotis

Thank you very much. That's very clear, Carlo.

On energy and logistics, I understand, as you said, it's a bit mission impossible to give specific guidance including these, but just to get a sense of how bad this may get for you. Your consumables, are these largely made of oil-based plastics?

Historically, in times of higher energy prices, were you able to pass through costs comfortably to customers? I remember that may have not been the case.

Is that correct?

Carlo Rosa

Listen, I'm going to give you a rule of thumb. If the cost of energy stays where it is today, right, with oil being over $100, to us, the impact on energy and logistics is around $5 million.

Okay? My problem, to be honest with you, is not necessarily with energy and logistics, because the logistics issue, if it doesn't solve, I think that we have a whole set of different problems, right?

Today, the logistics issue is that we cannot ship through Dubai, and we were shipping pretty much not only Middle East, but we're shipping Asia through Dubai, but that will be solved. To me, the real problem is the inflation on the raw material, as we all know, and that is a complete different order of magnitude, because it has to do with all the plastic and all the oil derivatives that everybody in this industry is using, right?

To make a projection there, it's really mission impossible. Again, energy and logistics is around $5 million.

Odysseas Manesiotis

Thanks a lot for the clarity, Carlo. PG, it was great working with you.

I wish you all the best with the new role.

Piergiorgio Pedron

Thank you, Odysseas, likewise. Great working with you.

Operator

The next question is from Jan Koch, Deutsche Bank. Please go ahead.

Jan Koch

Good evening. Thanks for taking my questions.

Thanks for providing the comments on the sales phasing in 2026, but what about profitability? Margins have been usually higher in H1 than in H2.

Is this still the case in 2026? Then secondly, you provided the growth rates of your automated multiplexing business in recent quarters.

Could you provide that comment for Q4 as well? Finally, one housekeeping question: Could you help us with the expected D&A ratio in 2026 in view of the upcoming Plex and NES placements?

Carlo Rosa

Can you repeat the last question?

Jan Koch

D&A ratio in 2026, I guess. The depreciation and amortization, I guess.

Odysseas Manesiotis

D&A. Absolutely.

Carlo Rosa

Okay. First two questions.

Odysseas Manesiotis

First one was profitability phasing. Alberto can take it.

Alberto Donati

Yeah. As we mentioned before, within the 32% to 33%, we have to take into consideration a few effects: First is that we do have a full year effect on the tariffs.

We do also have a mix effect, since we know that the molecular growth growing low double-digit brings lower marginality, which is dilutive to the gross margin. The NES investment, Carlo mentioned it before, north of $10 million, which brings us a natural under-absorption in the year of the launch, plus the further deterioration of China due to the VBP and the continuous pressure from locals and on pricing is posing us pressure on the EBITDA margin overall, but especially considering the tough comparison of the LTG in the first half, we do expect to see the EBITDA to be softer in the first half as a function of fundamentally the lower sales on LTG and the operating leverage.

We then expect the EBITDA to recover in the second half as a improvement supported by the volumes that is recovering, again, as I mentioned, the operating leverage, and the contribution of the new product launches.

Piergiorgio Pedron

I guess the second question was growth rate automated in Q4, the automated multiplex. Right, Jan?

Jan Koch

Absolutely, the growth rate.

Carlo Rosa

The growth rate in Q4, as said, was, I believe, slightly negative, -5%... -4%,

Piergiorgio Pedron

-5%, yeah. ...but

Carlo Rosa

it's all flu. It's all flu volume.

It's all related because placements, I give you a number of placements, but you can assume that the placements develop regularly. From a revenue perspective, -3%...

Piergiorgio Pedron

-2%. It's -2%, Carlo, the right number.

It's on the presentation.

Carlo Rosa

So -2%, but fundamentally it's all respiratory-driven. It's a volume effect.

Alberto Donati

D&A 2026. Jan, the last question related to the depreciation and amortization, if I understand correctly.

That we've been launching two platforms in between 2025 and 2026, we do see a start an increase of the depreciation and amortization linked to the start of the depreciation of all the tangible and intangible that are linked to the launch of the NES platform.

Jan Koch

Thank you. All the best, PG.

Piergiorgio Pedron

Thank you, Jan. To you as well.

Operator

The next question is from Kavya Deshpande, UBS. Please go ahead.

Kavya Deshpande

Hi, Carlo, PG, and hi, Alberto. Thank you for taking my questions.

My first one was just on the revenue guidance. You've been very clear about the headwinds that get you to the 5% scenario.

I was just wondering the top end of that, the 6% growth scenario, is that including what in your view is sort of the full contribution of all the potential product tailwinds you've got from the Plex panels, from I guess to a lesser extent NES, because it's early, and from Quantiferon Gold Plus, etc.? Then, Carlo, actually, one for you on China.

You've made a big step in terms of changing your strategy here, but I suppose what are you seeing on the ground that's making you think this is kind of a still an attractive market for DiaSorin to stay in? Also, would it be possible to specify the exact China headwind you expect for 2026?

I understand if not, but I thought I'd try.

Carlo Rosa

Specifying the exact headwind, look, as I said, in 2025 was around €8 million, right? Kavya, I believe in 2026, it could be in the order of magnitude of €5 million.

Again, it's a toss of a coin, because the truth of the matter is that we were expecting VBP to be done and over with fundamentally, and now what's happening is that VBP de facto is also hitting Shanghai and Beijing. Shanghai and Beijing are clearly, as you can imagine, big business opportunity for us.

If you're asking me, is there an opportunity for DiaSorin in China? I believe is a very tactical short-term.

I see a market that is becoming extremely competitive, but competitive meaning, as that when you have the market leader that is leaving on the ground 500 million Swiss francs in revenues in one year, which is 20% down, I think, of the total revenues, the market is becoming a terrible market, where everybody is chasing all the opportunities with desperation on price. This VBP concept, it's fundamentally has been driving all companies to go after all the business with a very low price.

This is why I'm saying we came to the conclusion that what we were thinking in 2019, when all this started and nothing of this was there, and there was a very large, significant, profitable opportunity with mainstream products, evaporated. Now, since the only opportunity for us is to become a specialty company, and there are a couple of areas where the specialty is significant, you are left now with the fact that now manufacturing a specialty in China is dangerous, because as nobody is guaranteeing you know-how.

By the same token, is not needed, because at that point, a specialty being a specialty, if there's no VBP, there is no very high local competition. The added value of being local manufacturer is not there.

It would be only increase the risk of losing control of your technology. This is China.

On the revenue guidance, Kavya, you said on the 6%. I believe that we have high 2026 is a very important year for DiaSorin because we have the launch of NES, okay?

We will discuss in May about expectations, strategical expectation on NES for DiaSorin. As you can imagine, as you saw from bioMérieux as well, the expectation is very relevant for us because the market opportunity is very relevant, because the window, I believe, is the right window, because an opportunity within the next three years to get to the market also with the STI and tap into that business as well.

Certainly the 6% includes the fact that there is an additional technology and product line that will help us drive revenues next year. As said, by the same token, it does foresee that the volume effect that we experienced in different geographies is fundamentally it went back to where it used to be pre-COVID.

Operator

The next question is from Charles Pitman-King, Barclays. Please go ahead.

Charles Pitman-King

Hi, guys. Thanks so much for taking my questions.

I have two, please. Maybe just firstly, just wondering around how you're thinking in your guidance around the outlook for your LTP revenues, given Roche is expected to launch in this space soon, and that I believe is expected to bring in some pricing pressure.

If you can just quantify again what revenue you're currently generating from TB and how you expect it can continue to grow through this over 2026. Then just secondly, coming back to your LTG revenues, you kind of highlighted that we've seen improving commentary for Life Science peers, but obviously '25 was a bit of a balance of Life Science down, diagnostics up.

Just wondering how you expect diagnostics to also be improving, and whether or not you think that will be where both end markets will improve to drive better growth for LTG this year. Thank you.

Carlo Rosa

Okay. Listen, clearly, we are not going to disclose what are the revenue of LTB, of tuberculosis.

That's confidential information, especially in light of the fact that Roche supposedly launching the product. How do I sort the question is what is your expectation about Roche on the market?

I don't know, because I don't know when they're launching, if they're launching, and what they're launching. Hold your thoughts until May 13th, because May 12th, Roche is going to have their Analyst Day, and they're going to talk about the good, bad, and ugly about diagnostics, right?

We're going a week later on the 20th, we're going to talk about LTP, and there you're going to hear about what we assume about the Roche effect. Just one comment: Remember that the only thing that Roche said is that they're not going to lower price.

Keep that in mind when we will see what happens when they hit the market. Okay?

If you go to their market day, ask them if it is true that they don't plan into lower the price. LTG.

LTG, our diagnostic business is very healthy and somehow decorrelated from what you've seen in diagnostics, because we are serving a couple of players that dominate their space. In One Lambda, which is one of our customers today in diagnostic multiplexing, they have 80% market share in transplant.

That business is a solid business that is growing single-digit, simply because the transplant number is growing. This is why I'm saying I'm not expecting to see a negative effect on the diagnostic side.

By the same token, you know the Life Science business, as you very well know, was so poor in 2020 2025, right? We see that all that and fundamentally was driven by the US market, and fundamentally was driven by these NIH mumbo-jumbo.

At least the NIH situation has been clarified. We know that funding has been guaranteed.

We know that customers are applying for funding. What we know is that investments, if you look at 2025, we were hit most on equipment, right?

This is simply because with this uncertainty on funds, labs and academia was not buying systems. What we are seeing is that the funnel on instruments is actually coming back, okay, from a very poor situation.

This is why I'm saying my LTG expectation from in 2026 is that we're going to have a moderate growth, but please listen to what the Thermo, the Millipore, the Bio-Techne, and all these guys are saying, because they're all DiaSorin Luminex customers.

Charles Pitman-King

That's great. Thanks so much.

All the best, PG.

Carlo Rosa

Thank you.

Operator

The next question is from Natalia Webster, RBC. Please go ahead.

Natalia Webster

Hi, thanks for taking my questions. I have three, please.

The first is a follow-up on margins, appreciating the various effects like tariffs in China to consider in 2026, but what else has changed from your previous expectations to reach the 36% to 37% level by 2027? Do you still expect margin expansion beyond 2026 with the continued dilution from the Molecular growth?

My second question is on the Immuno guidance of the mid-single digits in 2026. Again, looking beyond this, once the European volumes have normalized, do you see potential for this to pick up back to the high single-digit levels that you've seen previously?

Do you see that double-digit growth in North America specifically as sustainable going forwards, considering there's a couple of delays on a couple of the key specialty tests that you called out previously? Then finally, on your Plex platform, are you able to talk a bit more about what you're seeing in the competitive landscape here?

You've talked about the GI panel being important for more adoption in inpatient settings. Is this the main barrier there?

Have you seen any pushback on other areas like the longer time to result versus competitors? Thank you.

Carlo Rosa

I'll take the last one, okay, right, on Plex. If I understood correctly, you want to understand the competitive landscape.

In my very humble opinion, the competitive landscape did not change at all, meaning that you have bioMérieux that is dominating this space with and now we're talking about the acute space or the hospital market, because Plex goes on the acute space. From a competitive space, we are where we are.

We honestly don't see in the US QIAGEN today as a competitor, also because QIAGEN so far has been very active and successful outside the US, and they're building, I believe, their presence in the US market. The competitor you need to go after and displace is always bioMérieux.

On the time to result in this space, one hour, two hours doesn't make any difference, to be honest with you, because you're talking about hospitalized patients, or you're talking about commercial labs, right? A commercial lab is a send-out sample, and so it does so they collect, they get the result, and they ship back in within one shift.

One hour, two hours doesn't make a bit of difference. Clearly, I'm not referring now to the SPOTFIRE, which is a 30-minutes assay, but that goes into a different segment, and there is where we compete with the LIAISON NES, that does have same or better time to first result.

On the GI, I'm saying that, as I think I always commented, that when it comes to the adoption of mini panels, the ability actually not to run all the 20-some analytes, but build mini panels, GI is where you have most variability of panels, because of the use of these different panels, which can be associated with dietary, which can be associated to infections, which can be associated with travel, the bugs or bugs that you get into funny countries during travel. We estimate that, in that sense, you have seven, eight different panels that you really need to build in order to segment the different clinical situations that a doctor would have to face when it comes to GI infections.

When volume, I believe your question is, do you see volume going up? My answer is no, I don't.

I believe that we're going to go back to where volume was prior to COVID and whatever happened after COVID, and primarily, in my opinion, driven by a combination of things: One is an economic situation. Volume typically reflects because there is a portion of this diagnostic procedure that is paid directly by patients out of pocket everywhere in the world.

I have in mind Italy, where of if the healthcare budget is €140 billion, the government pays for €110 billion and people chip in for €30 billion. The viability of patients to pay out-of-pocket really is very well-correlated to how economies are doing, and I don't think that moving forward, from what we see today, economies are going to do great, right?

I don't see that incentive more out-of-pocket to drive up volume. Again, we're going back to where we were in prior to COVID, where it was expected that in the developed market, on average, volume would grow around 1% to 2%, which is where fundamentally we are today.

On margins, Alberto, can you please comment?

Alberto Donati

Thank you, Carlo. Natalia, Alberto speaking.

On your question on EBITDA and the comparison with the 2023 plan of getting to 36% in 2027, please consider that we are fundamentally living in a different world, and I'm specifically referring to the macroeconomic and industry events, some of which are outside of DiaSorin control. Specifically, let me start with China VBP.

Carlo mentioned the impact that we had, which is around 1% of our top line, and this is primarily due to price reductions, which go directly to the bottom line. The second one is the NIH funding, which is affecting the growth of the LTG, not only on instruments at the beginning, but then as a consequence, also on the other product lines of the franchise, being the consumables and the royalties, for a franchise that has a high marginality.

Tariffs, and additionally also the company has decided to increase the spending and the investment of NES in order to ensure the success of the launch. Taking all of the above into consideration, the business is at the moment delivering the marginality that we were expecting, but for 2027 onward, please wait for the Capital Market Day when we were going to give our view until 2030.

Natalia Webster

Could

Carlo Rosa

you please wait for May, because we're going to go through all the drivers of growth. Overall, I believe that North America, again, growth of North America, if you think about it, has been driven by hospital strategy plus high penetration in the big labs, right?

Which is today our business TB certainly has been a growth driver for the company, and TB growth went high double-digit today to whatever number QIAGEN is saying, because I keep saying, it's a QIAGEN business, right? I would recommend that as far as TB, you wait for QIAGEN to comment, and what they say clearly is applicable to DiaSorin.

As far as the hospital strategy, we will continue to deliver the hospital strategy. As said, as far as the big laboratory business, I recommend that you listen to what they say, generally speaking, about their volumes, because again, their volume is our testing volume in that segment.

In order to get a more strategic qualified by product line and expectations, I believe you need to wait for the May discussion.

Natalia Webster

Understood. Thank you, and all the best, PG.

Piergiorgio Pedron

Thank you.

Operator

Gentlemen, there are no more questions registered at this time. I turn the conference back to you for any closing remarks.

Carlo Rosa

Thank you, operator. I think we are done.

Thanks.

Operator

Ladies and gentlemen, thank you for joining. The conference is now over, and you may disconnect your telephones.