DiaSorin S.p.A.

Thank you, Operator. Ladies and gentlemen, good afternoon, and welcome to the Quarter 3 DSO Conference Call. As usual, I will make some qualitative and quantitative comments on the quarter, and then I will turn to our CFO, Mr. Pedron, for the comments on the financial results. Let me start with some general notes on the two main businesses that we have, immunodiagnostic and molecular diagnostic. With immunodiagnostic, the strategy continues, also in Q3, as we have been discussing now for a few quarters, and I would say in the last two years. So we have a development strategy in the U.S., as we know, enlarging our footprint in hospitals, and as it happened last year, we foresee from the result that we have seen in the first nine months, including Q3, that we will hit our target of roughly 90 new hospitals, and we confirm that. our ambition to reach 600 new hospitals by 2027. Meanwhile, we continue to develop content on the Liaison platform. We have developed a new version of the Quantiferon assay for TB. It's called high throughput that we are ready to launch in Europe, and we have submitted to the FDA for approval, and this is to continue to offer better and improved solution to high-volume accounts around the globe, again, together with our partner, QIAGEN. We have launched a new assay, a specialty assay, which is the TSH receptor assay, and this is in continuation with our strategy of continuing to enrich the catalog of the liaison Excel. with new and specialty products. MIMED, there has been new evidence which has been presented at the ACID meeting in 2025 and so we continue to, or MIMED continues to deliver on its promise to fund clinical study that prove the clinical use of their algorithm for differential diagnosis between bacterial and viral infection. And so we continue to believe in this program, and we continue to support MIMED deployment in the U.S. and key markets using the Eliason XL and also the key system of MIMED that we have in distribution in the key markets. From cost perspective, Point of view, we have announced that we're going to consolidate our manufacturing in Europe. Closing our German plant and consolidating all our volumes into the Italian and UK plant and the project is ongoing as expected and will be concluded as expected. If we now turn into molecular diagnostic, where we have three platforms, and I will comment more on the cell result of the three platforms, although when it comes to menu activities and major achievement, for the liaison MDX, as you have seen in the press release, we got finally approval of our FluA, DRSV, and COVID assay, which we were missing from our arsenal, and this should give us the opportunity to stabilize our MDX respiratory franchise that has been suffering, and we will see later, both from increased competition with the fourplex, but also clearly decreasing volume due to the very late start of the respiratory season. On the EliaZone MDX, we continue to develop strategically new assays, and the Candida auris, which has been very successfully launched in the U.S., now has also been made available in Europe through CE marking. If you move to the EliaZone Plex, we have launched the blood panel, GranPos, GranMeg, and ISC. We have been completed the clinical study for GI that we plan to submit by the end of this month, assuming that the FDA will open up because today the FDA is working on current applications but not on new filings. So as soon as they reopen, We are ready to file the gastroenteric, and we expect clearance by H1 next year, and this will complete the fundamental stream of products needed to be competitive on Plex. On the liaison Plex, as we are pressing this, we signed a major agreement with Quest. Quest is a very trustworthy partner of the assorting, and we have initiated deployment of Plex for the RSP panel in all the Quest Labs. This is going to be completed and validated by rent, and we will start to generate revenue starting from Q1 of next year. We have launched a fully customized base panel as part of our flexing strategy in the U.S., and I will comment later on the success of Plex But we see adoption of the FLEX algorithm in half of the installations that we achieved in the U.S. Now, when it comes to LiaisonNet, which is our third strategic platform, we submitted in July for the four-plex respiratory panel. The interaction with the agency is continuing without hiccup or anything unexpected, and we expect to get clearance by year end of early 2026. So let me just now move to discussing the quarterly revenue, as usual, at constant exchange rate. So in quarter three, our business ex-COVID grew by 3%, driven primarily by immuno, which delivered a 6% growth, with molecular diagnostic, where the overall molecular diagnostic franchise declined by 1% and LTG declined by 6%. I'm going to comment later on each of these elements. This means that nine months into the year, Ex-COVID, the assortment grew 6% with immuno leading at 7% and molecular at 3% and LTG at 4%. To fully understand the quarter three result, we will provide more data and deeper segmentation across the three business lines. So I'm going to talk about immuno, molecular, and LTG. So let's start from immuno. In immuno, let me remind you that in H125, so in the first six months, the franchise grew 8%. If you look at this growth, taking out for one second China and the outbreaks event, which we did comment before, growth has been 11% in H1. With the North America growing 16%, the rest of the world, including Europe, ex-China, growing by 9%, and China declining by almost 20%. What happened in quarter three? In quarter three, total immunosuppressants grew by 6%. If you look at the total immunosuppressants without China, the outbreak effect in quarter three has been very minimalistic. The base business without China grew 9%, so strong growth. If we now look at the major geographies, U.S. continues to grow very strongly at 14% in the quarter. The rest of the world, including Europe, meet single-digit growth 6%, and there is a very specific element that did impact Europe, and I'm going to comment later, and China. because of the implementation of the BB2 that now is covering all the oncology products, took a hit, very severe hit in the quarter, minus 30%. Now let's look at what happened in the main geographies. Not discuss North America because North America continue to deliver hospitals are in line with the expectation and growth in the quarter has been 14%. So let's take that off the table. When it comes to Europe, we see immunodiagnostic testing volumes decelerated in quarter three versus H1. And this specifically has been reported in two main markets for the Azorean. One is Germany and one is Italy. So, again, we saw a deceleration of testing volumes in these two markets. This is explainable by the fact that there has been a new reform that has been implemented and now we feel is taking effect in Germany where the denial rate in commercial labs as a result of the recent health care reform is increasing. What does it mean? It means that the government is controlling diagnostic volume growth rates in two ways. One, which is historical, providing to general doctors, general practitioners, a budget for diagnostic. But now, assigning also to the hospital and the laboratory the responsibility over the budget, which fundamentally means that over a certain budget, private labs and hospital are denied by the government, by the different states, of the reimbursement. And this is, again, to control a volume growth that has been explosive in Germany in the post-COVID time. Italy is not subject to any specific reform, but we saw the Italian volume becoming seasonal again. What does it mean? Historically, pre-COVID, we always have experienced that volumes were growing each one and seasonally declining in H2. That didn't happen in the last five years, and this has to do with the fact that there was a continued testing volume increase that has been interpreted like a post-COVID catch-up. We saw that 2025 is going back to historical seasonality, which in my opinion means that in Italy we are going back. There has been a complete catch-up. in testing, and we're going back to what it used to be. So you expect to be more front-loaded in H1 than in the second part of the year. China, we did comment, so it's minus 25% in the quarter, but it's due to the effect of VBP2. We expect that starting from next quarter, this effect in China will start to smooth out. Now let's talk about molecular. And I'm going to comment on molecular looking at the three different platforms that today the assortment is serving to the market. The MDX, the multiplex franchise, and then I'm going to make some specific comments on the NAS. When it comes to the MDX franchise, Let me remind everybody that the MDX is the platform that we sell to hospitals, and we provide, it does have a limited multiplexing capability up to four, and it is the DeSorin platform for specialty products. The revenue, total annualized revenue of the MDX franchise is roughly 100 million euros. and it is split in three segments. We have 15% of these revenues, so roughly 15 million, which are respiratory. So it's extremely seasonal, and it is actually a market that the assortment has not been able to hold post-COVID because of the fact that we were lacking as a combination of two things. The market was actually shifted by CFA to a fourplex market, And we didn't have the fourplex. We had the triplex. The fourplex was just approved last week. The second thing is that this platform was never intended to be a platform for respiratory. It's always been, again, intended, even at the beginning, as a platform for specialty. So now we have the respiratory, which is, again, as I said, roughly 15% of total revenue for the MDX. That has been declining severely. in the last quarter and in the current quarter. Second cluster of products is the targeted, and this is where this platform becomes strategic for the Osorin, is roughly 40% of total MDX franchise, so roughly 40 million euro. And on this franchise, we've been experiencing in Q1, Q2, and Q3, growth of 35% to 40% per quarter. This is driven by all the specialty, the congenital CMV, the C-auris, and the HSV testing for meningitis, which continue to be very successful and drive placement in the U.S. market of this platform. So this is the future of the franchise. And this is actually the reason why the SORIN has developed also the follow-up platform, which is going to be the MDX Plus that will actually continue to give life to this strategy. And then we have the third bucket, which again is roughly 40 million euros that runs on the MDX and is the ASR. The ASR business is a very profitable business that the Asurion has inherited with the focus acquisition from Quest. It's clearly a business that does not provide strong growth because it has to do with the fact that certain hospitals in the U.S. market are developing NTDs on this platform for certain applications. Let me say the more difficult application, those that companies don't take through the FDA. And typically you would expect from this franchise to provide low single-digit growth, which in fact this has been doing every quarter in the last few years. Again, this is not a strategic portion of our portfolio, but a very profitable portfolio and is one that we continue to keep and nurture with the development of LTD And this also is giving us the opportunity sometimes to launch certain products, see the uptake, and then decide to move them from an LDT to a fully validated 510K product as it happened with the C hours. So the total franchise for MDX in H1 grew 9%. In Quarter 3, it grew 4%. primarily driven by the seasonality effect of influenza. And in the nine months, it grew by 7%. Now let's now move to the multiplexing franchise. Our multiplexing franchise, we look at this business in two buckets. What we call the non-automated multiplexing. which is an old technology that fits very well certain markets actually. It's adopted more in Europe than in the U.S. It's a franchise that continues to decline, clearly, because labs have been moving to more automated solutions. It is still relevant for the assortment, around $35 million, annually extremely profitable, so we continue to keep it. We use it opportunistically in Europe in certain markets, but certainly it cannot be a strategic franchise for the company. Although it does represent roughly 35% of the total multiplexing franchise. So the total multiplexing franchise... It's around 110 million euros for the company. Of these assets, around 35 would be non-automated. The rest is a combination of Virgin One and Deliazone Plex. I'm going to comment specifically on the on the Virgin One and the liaison plaque. So it's very clear that the Virgin One represents a very interesting install base sitting roughly on 200-300 customers in the U.S. of different size between commercial labs and hospitals. It does have... Part of this business, of every virgin one, is still respiratory, although a good chunk of this business actually is more blood and sepsis because this is how this technology was launched by Luminex at the time. It does offer for the soaring also clearly an opportunity strategically to replace this Virgin 1 with the liaison plex. We have not announced and we don't have any intention to announce in the near future that we are going to stop making the Virgin 1, but certainly we make an effort to transition some of these accounts to the liaison plex. You will see later that every time we transition these accounts from one technology to the other, that drives a price increase in the range of 20% to 25%. Let's talk now on the liaison Plex. First, let me remind everybody that we launched the liaison Plex just in the U.S. Second, we have... today closed approximately 100 customers in the U.S. Split by, if you look at this 100 users, 80% of these customers are hospitals and 20% are commercial labs. Although if we look at the RSP revenue contribution, and again, I will not comment on blood because blood has been just launched, so it's not relevant when it comes to the quarter results. So if we look at the revenue contribution of this base of Plex, 65% of revenues are coming from commercial labs and roughly 35% are coming from hospital labs. What does it mean? It means by definition that the majority of the respiratory revenue that we get on the Plex are outpatients by definition and not inpatient. And this is exposing our Plex business more than other competitors to seasonality, right? Because we don't have the inpatient component that it gives more stability across season to this business. And again, this explains why, since the season is late, we are particularly hit on our multiplexing revenues, again, because of this dependency. If now we look at the usage of these accounts between flex and fixed, so between offering the total panel versus using mini panels or credits, 60% of the customers adopted flex as a combination of mini panels and or credits, and 40% adopted the fix, right? So it's almost 50-50, although if we look at – Hospitals versus commercial labs, we clearly see more adoption of flex into hospitals than the commercial labs. What does it mean? It means that these 100 customers, if we look at the contracted yearly business, so annualized business, clearly on an average season, right, because it's a lot of respiratory, is above $30 million. With half is brand new business, half is conversion from Virgin One to Plex with an average price increase of, as I said before, 20% to 25%. So if I look at the overall Plex launch, I believe it has been very successful. I believe that more than what we discussed before and by some of the competitors, the market is veering toward flexing as a combination of mini panel adoption where, again, the difference between our positioning and competitor position of mini panel is that we allow the customer to fully customize their mini-panels, whereas competitors offer fixed mini-panels. And we believe that there is a competitive advantage in offering full flexibility versus fixed mini-panels. Now, let me just conclude with the liaison NES. As said before, we submitted clear the liaison NES is intended to serve hospitals and POL So at launch, we will offer this platform in hospitals and POS in the U.S. Submission is gone as expected, and as said, we expect clearance by year-end or beginning of 2026. As far as commercial readiness is concerned, we are hiring, as we speak, a dedicated commercial team that will be in place by Q1 2026, assuring readiness for a successful U.S. launch. And we are also working on the selection of a distributor or a couple of distributors which will complement our direct self-force. and we expect this distribution network to be in place by H1-2026. Let me now comment briefly on our LTG. If you remember, in H1, LTG provided a growth which was double-digit. We clearly explained that we could not expect due to the situation with the life science market, we could not expect that growth certainly to continue. And we were driving the market to low single digit ERN growth. And in fact, in quarter three, and this is because of the seasonality of this business, you know, we actually supply and our end user customers are actually the major life science companies and then package our reagent and instrument into their own offering. So if you look at quarter three results, minus 6% is very much expected in order to drive year-end results, again, at around low single-digit growth. Although, if you remember, this business is actually a business that is by half of it, roughly, is directed toward companies that use the technology to develop diagnostic tests. And half of it is actually we are supplying companies that develop products for research, academia, and biopharma. And it's very interesting that if now we look at how these businesses perform, right, and, again, we need to look at the seasonalization here is driven – not necessarily by an inducer seasonalization, but again by how their supply chain is scheduling, ordering, and inventory. We continue to see, even in quarter three, that the diagnostic business continues to grow low single digit, although life science, we continue to see a steep decline. So minus 15% of the life science business in the quarter, indicating that This life science market stabilization is not in sight yet. If we look inside this decline or this instability of life science, what we really see is that the instrument component of this is almost completely frozen, whereas the reagent side continues a modest growth or a low single-digit decline. indicating that the issue today in this segment of the market is that academia and researchers clearly do not have capex availability to buy instruments, but they continue to buy reagents to feed the current installed base of systems that they have. Now, before turning to the CFO to comment, one on PAMA and the result tax, We continue to get questions from analysts and investors about PAMA and how this will affect the business. And just to summarize where we are, the Congress now is pushing the adoption for PAMA, but the timing is very uncertain. And today the government, is trying to understand through a better survey than the one that was originally done in 2015, better understand what is today the differential in reimbursement or price reimbursement actually between what private prepayers reimburse for certain tests versus what the Medicare does. And the reason is a result of a discussion between the different stakeholders. The Results Act has been issued, and now the CMS is collecting new data to really understand, to define the differential between private payers and Medicare. So long story short, there is an effort ongoing. We believe that PAMA will eventually be able to hit the diagnostic players. It's very difficult for anybody to predict when and to which extent. So this is what, at best, this is what we can tell, but certainly it's not at 2025, and we are not sure if it's going to be at 2026. but I believe all the players are going to keep the investors updated on what's happening. Last comment I want to make is on tariff. Mr. Pedro is going to comment on tariff better, but from a business perspective, I believe the majority of the industry has decided that in the U.S., for the time being, tariffs are not going to be pushed through the channel to the customers. And so everybody has been keeping tariffs in their balance sheet for a series of different reasons. And same thing has happened for the assortment. So today we anticipate when it comes to 2025 roughly a $5 million increase negative contribution on tariff debt on a full year basis will impact our profitability by roughly $11 million. So nothing astronomical, but to the contrary of what we were thinking before, we don't believe that in 2025 or 2026 we will be able to push this to our customers. So now, Mr. Pedron is going to drive you through the numbers.

Thank you, Carlo. Good day, everyone. Thank you for attending the Assuring Q3 2025 earnings call. During the next few minutes, I will provide an overview of the Assuring financial performance for the first nine months of the year. Following my remarks, as usual, we will proceed with the Q&A session. So, year-to-date revenues for 2025 reached €900 million, reflecting a 3% increase of €23 million growth compared to the same period last year. This performance was achieved notwithstanding an €11 million reduction in COVID sales and a €19 million negative impact from foreign exchange, primarily due to the depreciation of the US dollar against the euro exchange. as previously discussed during our last earnings call. To this note, let me please remind you that on a full year basis, each one cent movement in the U.S. euro-dollar exchange rate usually affects the Australian revenues by about 6 to 8 million euros and adjusts the EBITDA by 2 to 3 million euros. Considering that the average USD, Euro exchange rate in Q4 of last year was around 1.07, we anticipate a continued foreign exchange headwind into the latter part of 2025. Excluding COVID impacts and the constant exchange rate, our core business has achieved a 6% year-to-date growth. Carlo has already covered all the different elements. In the third quarter, revenues at current exchange rate declined by 2%, representing a reduction of €7 million compared to 2024. In contrast, the performance excluding COVID effects and the constant exchange rate, as we just showed, was plus 3%, with a negative effect in the quarter of €12 million. So out of the €19-20 million I was discussing about for the full nine months of the year, €12 million were in Q3. Gross profit for the first nine months of 2025 totaled €587 million, accounting for 65% of revenues. broadly consistent with the 2024. This represents an increase of $9 million, or 2%, compared to the same period in the previous year, but withstanding a tariff impact of about $2 million, as we just discussed. For the third quarter, the gross profit margin remained stable at 65% of revenues, aligning with Q3 2024 and continuing the trend we saw over the past year. previous quarters, despite the negative tariffs effect that we've just mentioned. Year-to-date adjusted operating expenses at €346 million represented a 1% increase compared to the prior year, or about a 3% constant exchange rate. Adjusted OPEX as a percentage of revenues declined to 38%, down from 39% in 2024. The increase in absolute value in operating expenses relative to 2024 was mainly driven by higher labor costs from the annual salary review cycle, as well as an increased depreciation related to the recent product and platform launches previously in development phase, such as the liaison place. Excluding the impact of this increased depreciation, I think it's interesting to notice that adjusted operating expenses at constant exchange rate would have risen by only 1%, indicating a very disciplined management of our cost base. Adjusted operating expenses for the first nine months of 2025 were negative by €8 million, €1 million better than the same period in 2024. As a result of the dynamics we just described, September year-to-date adjusted EBIT reached €233 million, representing 26% of revenues, confirming the profitability we had in 2024. Adjusted interest expenses for the first three quarters were just under €1 million, compared to an income of €3 million in the same period of 2024. The primary factor behind this variance was a reduction in our cash balance and investment yields, reflecting the reduction of our debt and the decline in interest rates. The adjusted tax rate increased from 23% to 25%, mainly due to the termination of the patent box regime for our Italian legal entity, as we discussed in H1. Year-to-date adjusted net income amounted to €174 million, accounting for 19% of revenues. In the first nine months of the year, adjusted EBITDA reached €302 million, marking an increase of 10 million, or 3%, over the same period the last year at current exchange rate and 7% at constant exchange rate. The EBITDA margin was 34%, both at current and constant exchange rate, an improvement from the 33% we had in 2024. At constant exchange rate, Q3 EBITDA margin stood at 32%, remaining broadly consistent with the same period in 2024. Turning now to our net financial position, we closed Q3 2025 with a net debt amounting to €670 million, in line with the position at the end of 2024. This reflects a solid free cash flow of €161 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. Let me now close with our revised outlook for the full year 2025. Taking into account the factors mentioned by Carlo that are affecting our overall top line, Our guidance has been revised as follows. Revenue ex-COVID to grow by about 5%, with COVID-related revenues projected at around €10 million, adjusted EBITDA margin at about 33%. As always, these figures are at constant exchange rate, assuming a USD-EUR rate of 1.08, which was 2024 as a reference. I would like to emphasize that despite the headwind affecting our revenue and impact of tariffs, we have managed to review the adjusted EBITDA margin by only 100 basis points. I believe this outcome reflects, as I was saying before, the very disciplined approach we have applied to managing our core space. With that, I will now turn the line over to the operator to begin the Q&A session. Thank you.

Thank you. 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 the touch-tone telephone. To remove yourself from the question queue, please press star and 2. Please pick up the receiver when asking questions. Anyone who has a question may press star and 1 at this time. First question is from Anca Verma, JP Morgan.

Hi, good afternoon. I have two questions, please. The first one, can you provide us an update with the divisional guidance for FY25, given the revised guidance for the group? Are you still comfortable with 8% for amino? And on the molecular side, above 8 seems quite challenging. So what would be a realistic guide? And essentially, just want to understand how you see the recovery in the top line. And while it's still early, are you able to provide any comments around the trajectory into FY26? And then the second question is, just looking at the last couple of years of performance and today's revised guidance, the path to midterm targets, How confident are you in those, in the high single-digit to low double-digit CAGR for the top line and 36% to 37% EBITDA margins by 2027? Could you potentially hold a capital market day next year and revisit the mid-term targets?

Hi, this is P.G. speaking. I will try to take all of your questions. So we are not providing guidance for 2026 yet, right? but I'd like to underline that a few, I would say most of the things that Carlo discussed about that affected the last quarter, that will be affecting the last quarter of 2025, and we saw it in Q3 of 2023, so a lot of those headwinds will not be there in 2026. And so we do still feel comfortable with the 2027 guidance we put out there at the end of 2023, which was calling, as you just rightly said, for a growth of the top line of high single, low double. Obviously, considering what has happened, we believe that the high single digit growth is for the top line is, I would say, more likely. And, yes, we will be reviewing in a dedicated event in 2026, I believe towards the end of Q2, we will be renewing and reviewing our plan because, you know, the previous plan was coming during 2027, so we felt like it was the right time to go in front of investors and the market and to next year to tell the market how we see the business developing from 2027 onwards. Let me please remind you that when we put in front of the market the guidance for long-term guidance for 2027, it was back in December 23, and we had not launched yet the liaison Plex and the liaison Nest platforms yet. which by the next capital market day, you know, will have been brought to the market. So it will be also, let me see, we'll have more real life data to project the future. For 2026, as I was telling you, you know, the guidance for 2026 is going to be released when we will be discussing about year-end results for 2025. But building again on what Carlo was saying, I would say that it wouldn't be unreasonable to think about a number which in 2026 vis-à-vis 2025 will show a top-line increase of high single-digit. Again, the precise number would be given March 2026. But these high single digit, I believe, is a very reasonable number.

Thanks, Siji. That's helpful. I was just going to follow up on the divisional guide for 2025, please.

When you say divisional guidance, exactly what do you mean? Because we have not issued for 2025 a divisional guidance. We have issued the guidance for the overall guidance top line of the story. And then if you are referring to the documents we put in front of investors back in 2025, where we told investors, you know, how we saw the progression of the three main technologies we have, immunomolecular and LTG, you know, that is not the guidance that we gave in 2024, not in 2025, right? But the main trajectory is a standard, meaning that the immuno franchise should expect to see a growth of, let me say, mid to high single digit. And the molecular franchise is going to show a growth of, let me say, mid to high teens. Let me put it in that way. Coming from, once again, the full effect of the liaison plexus, now you're going to see the gastrointestinal panel being available on the market, plus, you know, all the, let me say, the full effect of the 100 customers Carlo was mentioning, was discussing about, plus, once again, the NAS, for which I believe Carlo shared a few details in terms of sales organization and contract with distributors. But again, in 2025, we did not issue a specific guidance as such for the three different franchises.

Sorry, I just wanted to make a comment on the need of a new view. If you think about it, in the last 12 months, 12 to 18 months of the world, changed dramatically, right, with consequences to the business. Think about all the discussion about life science, where is it going, and funding, and the fact that certain projects will be funded, others will not going to be funded, the effect on vaccines, funding, which, by the way, does impact our business. And by the same token, the Chinese situation is very much new, right? So if you really look at the business model and all the assumptions that we developed in 2023, projecting 2027 and forward, all these assumptions, I believe, change one way or another. Some are positives, some are negatives. For example, in our plan, there was a small component of the Liaison S. Today, the Liaison S is almost a product. I'm crossing fingers. It's going to be a product approved in the U.S. very soon. We have developed a five-year review. for the liaison net, so we now have an understanding of the potential of that market with its segmentation. And so we really feel the need to go back to, first, our self-investors, and I put myself as an investor, to the board and to the other stakeholders, and explaining this new environment of the company, see growth and the opportunity. And this is why PG is saying, we're going to anticipate our revised LTP into 2026 rather than waiting for the full year 26 and then do it in 2027. Thanks, Carlo.

That's very helpful. Thanks, Vicky. That was very helpful as well. The only division guide I was referring to was the soft comments you had made around immuno being around the 8% initial guide. and molecular being above that. But I'm happy to jump back in the queue. That was really helpful. Thank you.

Next question is from Odisseas Manisotti, BNP Paribas.

Hi, thanks for taking my questions. And Carla, thanks a lot for your call today. That has been very helpful to get our heads around the current dynamics. I had one on the point you made about PAMAS. Could you give us some color on your exposure on the routine testing targets for your Immunase franchise, just for us to get a sense of how this risk may be quantified for you?

Hi, this is Luca. It's very, very difficult for me, but let me make a couple of comments. Back then, 2016, 2015, when all this really initiated, we had a very significant exposure to this, primarily with vitamin D, because back then vitamin D was a big, big portion of the U.S. revenues, and we actually knew that clearly vitamin D, the reimbursement that Medicare versus private was different magnitude. In today's environment, our U.S. business completely shifted away from that more into specialty, right? And therefore, you know, if typically in a laboratory, you know, And I think Question Lab will comment on that. Medicare does represent 30% of their revenue, give or take. Today, our revenues, our portfolio, I think that is way less than that when it comes to the Medicare contribution versus others. For example, if you take TB, which is... which is certainly relevant for the soaring in the U.S., primarily that business is driven by routine testing of healthcare workers, which has nothing to do with Medicare, right? So didn't do a very specific analysis and happy to give more flavor when we are going to do the LTPs. But let me say compared to what we were back then at Palma, I believe that Palma today will have a much, not necessarily a big effect on our revenue. And I keep saying that at the end of the story, even if I look at the vitamin D story, what is changing dramatically, the environment is competition more than government cutting reimbursement, right? And again, if you look at vitamin D, the availability of more than one player dropped the price from $8 to $0.80, which is the reality of today. So take it with a grain of salt, but I honestly believe that our exposure is not going to be dramatic.

Thank you. That's very helpful. And a follow-up maybe on the points made around the new reforms in Germany. I might understand that this may be one of the factors, let's say, that also becomes a pressure into next year. And could you help us quantify your exposure into the country and how bad can it get simply just to get heads around how much of a pressure that can be?

No, don't read too much into it. This has nothing to do with the exposure in the country. Actually, funny enough, most of the progress manufacturing in Germany were directed toward the Chinese market, right? Because in Germany we were making Me Too products for oncology and thyroid that we don't sell much, of which we don't sell much in Europe. It's more for export market and China, right? As far as the exposure, our exposure in Germany, if you don't mind, can comment on it because this is really, it would be good for competitors to know, but just for information, it is the second largest market for us after Italy.

Sorry, to clarify, I meant on the reforms that had an impact on testing volumes there in Q3 that you mentioned, whether we should expect to have a pressure that may accelerate or become more since 2026. Sorry if it wasn't clear.

To me, just to give you an order of magnitude, if in 2023 testing volume in Germany was overhauled, was growing high single digit, right? And that was the effect of the post-COVID catch-up. What we are seeing today later in H2, so in quarter three, so second part of the year, is going more close to low single digit, so 2, 2.5%. So there's a magnitude of the effect. So we don't see a decline in volume. We see much less growth. This is important to understand. The volume is declining. It's not growing as much as it used to grow.

Got it. Thank you.

Next question is from Dylan Van Aften, Stiefel.

Hey guys, good evening. So just a couple of clarifications from my side. So maybe firstly, just on the molecular business, if we kind of look into next year, can we just kind of reflect on what will happen with, you know, the composition of, you know, the low plex respiratory We also kind of think about what could happen with ASR and also how the Plex side will look once the GI panel is there. And let's say if we do the same exercise you guys did on the slides, if we kind of look into next year, you know, how would that look? So, for instance, I understand that with Plex in the hospital side, the lack of a gastrointestinal panel kind of hurts you guys right now. That might look different next year. Also, Roche will be in the market then with the GI panel. Maybe just a mental exercise if we could do that. My second question would just be on NESS and if you guys have decided on a distributor or if there's also going to be a direct component to the marketing. And then thirdly, is there any update on the Lyme detect assay? And if you've seen any change in the interaction with the FDA.

Thank you. Okay. Because there are three different questions, I believe. So when it comes to Ness, as I said before, we are hiring, as we speak, our own selfers, around 20, 25 people that are going to be dedicated to serve some of the direct customers in the segment, so the larger PRLs, whereas by the same token, driving the distributor. And again, this is nothing new is what typically you do in this sector. with a sales regional rep that is more business development than a sales rep, right? Because utilizing different channels. No, the answer is no, we've not selected the distributor yet. We're working as to, we're talking to the distributors to understand which one makes sense for the assortment in light of the fact that one of them is already fully engaged with a competitor. And so we are looking at other possibilities, right? And as I said, our objective is to have in place the distribution network by H1 of next year. Now, when it talks about Lyme detect, we are reflecting, as I said, with Cajun and talking to a major lab to understand if – we can introduce this product to the market as an LDT. Meanwhile, we are understanding how to get a clear path for clearance with the SEA. Now, when it comes to 2026, look, I'm going to leave it to Pidgey, but please take into consideration that we don't have a budget for 2026 discussed or approved with the board, so it's very difficult for us. to make any specific comment on 2026.

Yeah, I will try. Hey, Dylan, I will try to take it from a qualitative perspective, right? And all the trends, I believe, are very similar to what Carlo described in his initial remarks. So for the respiratory, I believe it's fair to say that you shouldn't expect a negative, let me say, a headwind, as we did in this year. Obviously, it all depends on the flu season, but the remaining business that we have is smaller. As Carlos said, now we have, we just press released the fact that we have the four packs, which will allow us to fortify and to better defend the remaining business we have, which is not a strategic business, but I would say it's fair to say from a qualitative perspective that directional perspective that you should not expect and had been the strongest, the one we saw this year. The molecular targeted assays, on the contrary, should keep growing, you know, at a very nice clip. We have a few assays for which we are the only game in town. Candida auris, as you know, is the only assay which is FDA approved. We have congenital CMVs. We have HSV with a cerebral spinal application, cerebral spinal fluid application. So we have a very nice position in there. So I would say, again, they're actually expecting, you know, a double-digit growth next year is fair. ASR, again, Carol spoke about ASR a few minutes ago. He said you should expect, in his remarks, he said that, low to mid-single-digit growth on the ESR business. That's what this business usually provides to us. You are not going to have, obviously, the negative headwind from ARIES. ARIES in the first nine months of the year was, you know, minus 5 million, and that is going to go away simply because it's a different perimeter of consolidation. for the non-automated multiplex said, you know, that is not a strategic business. It's a business which is more material in Europe than in the U.S., but there you should expect, you know, single-digit, low, mid-single-digit decline. Again, directionally, this is not a budget. Eventually, discussing about multiplex automated, so the liaisonplex and the Virgin One, I go back to what I said previously to Anshar, right? So this is one of the engines of our growth. Obviously, we said that we closed business for $30 million, and we still have months to go before the end of the year. You will see the full effect of that business next year, plus the contribution of GI and the blood panel, the three blood panels, right? So all combined, obviously, this brings you to a double-digit growth for this franchise. And this is as much as I can say now, since as Carlo just reminded everybody, we still need to go to our board approval for the budget. But there actually, I believe, you know, you have a good indication of where the business should go. Excellent. Thanks, Carlo. Thanks, BG.

Next question is from Aisha Noor, Morgan Stanley.

Hi, good evening. Thanks for taking my question. My first one is on molecular. So I would love to unpack a little bit, Carlo, the numbers you've disclosed today on the liaison Plex business. Apologies for the naivety of this question, but of the 100 customers you talked about, does Quest count as one customer or eight labs or 24 systems? And of those, you know, we'd just like to understand whether or not you think you are taking market share in the quarter. My second question is on immuno. So between China, Germany, and Italy, which are I think the three regions you called out as the weaker regions, which did you least expect to impact you in the third quarter from a growth perspective? Because I think our thinking this whole year, Carlo, was that China was VBP minus 5 million or so. And so this seems like it's gotten worse than you perhaps anticipated. So I just would like to know, A, the ranking of the headwinds, and B, maybe how long you expect of these three regions, how long these headwinds are expected to persist. Thank you.

First, obviously, and sorry for the naivety of my answer, but Quest is one, not 24. Otherwise, it would not be fair. Quest is one account, right? Then, as you've seen from the press release, we are replacing different systems in different labs because they are decentralized testing within the facilities. Now, talking now about the different regions, look, China, the problem is that the fuller effect of China is going to be, I don't know, 7, 8 million, whatever it is. But 3 million were just Q4. Sorry, Q3, right? So Q3 fundamentally was in one, we got it in one quarter the same way we got it in H1, right? This is why it's more skewed toward Q3. Q4, is it going to be stabilized? Not yet, but I think the, Most of the damage actually has been done in the first nine months, and my expectation is that moving into 2026, we're not going to see 30% decline in China any longer. Are we going to see a flat China, which would be a great result? I don't know, but probably we're going to see a more reasonable decline. low single-digit decline, which again in these days in China means a stabilization, right? As said, and as we will discuss moving forward, the problem for us in China is that we had a business which 75% was Me Too. And as a Me Too essay, we were hit by competition, VDP, full-blown. Moving forward... The residual business is still partially me too, but now the full hit has been taken. But then we have the specialty component, which now is more relevant. And again, I think as we discussed already, specialty for us in the future has to do with two products, TB, which is not registered yet in China. And we expect, we filed the clinicals around the discussion and We expect to get it approved next year, so TB will be available in China. And the second product is more calprotecting and inflammatory, where we are starting registration clinicals, and it's going to be at 2027. But that will move fundamentally our business away from a Me Too, BBP kind of business. Now, Germany and Italy, I think it's very different. Certainly Italy is double the size of Germany, so any effect you have in Italy is different. bigger than Germany. But by the same token, if I look at Italy, the overall performance, right, so the full year performance, is not that far from what we expected in the budget. The problem is that we had a tremendous H1 because the volume growth was very significant. And now we see that, like what I call seasonalization, I see now that H2 is going to be lighter, which still provides for Italy low single-digit growth. So it's not a declining market. It's simply you don't have that effect of volume growth that was pushing that market from a low single-digit to a high single-digit. Germany is a completely different story, and I believe it's more difficult to predict. Again, in Germany, you don't have declining volume. You have a volume that... volume growth that is stabilizing back to what it used to be prior to the COVID time and all this turmoil that really happened over the last five years. For your reference, if you look at the EDMA data and you look at the market, so the total market growth in Europe, major markets, is 2%. So if I do have in Germany a volume increase, that is growing around low single digit, we are going back to pre-COVID times. This is what I'm saying. So the true damage, if you call it as a damage, is that H1 was skewed by the fact that all these effects are going to hit H2 more than H1. That's it. And was it foreseeable? Not really. This is the problem. And I think we have been commenting several times about the fact that in Europe, For now, several quarters, our industry has been enjoying an extra volume push, which was difficult to quantify and was very difficult, actually, to forecast how long this has lasted. And I'm keenly interested. I didn't follow, actually, reporting by other companies, and I really want to understand in Q3 and Q4 how other companies that are very much dependent on Me Too's and other and in this market, how they're going to comment the performance of Europe.

Okay, thanks so much. And just to follow up on a comment you made earlier on the molecular market, you mentioned a market shift to four-plex testing against three-plex testing. I'm just curious how you know that this shift happened if you didn't sell the four-plex test before. Is it because you actively had customers requesting the four-plex? Or did you actually see customers deactivate the three-plex usage with you? Just some color there on this comment.

Listen, I'm simply reading the press release of Danager and Cepheid. If you remember the story, Cepheid was the first one actually to launch on the platform the four-plex. And actually, they forced during COVID times, at the end of the COVID time, right, they force all the customers to move away from the COVID only to the fourplex, right? So they launch it and they force that market to move. And it has been a very smart and winning move because it moved the market away from COVID or COVID flu into the fourplex, which was, and they were the only company to really supply it. This business for the Azoran has always been, forget the COVID component, which was huge, obviously, but the flu COVID has been a good franchise for the Azoran, has been declining over time because we lost some of it, again, because of COVID per se. Now we are back into the regular use of fourplex in the market, which is the new reality. In fact, if you look at the Amazon Nest, the liaisonness is a fourplex assay. And if you go back to what we were discussing about why we delayed the liaisonness, it was because we had developing ready to go to clinical with the flu A, flu B, and COVID. And we realized very rapidly that the market actually moved away from that into the fourplex. So we actually redid clinicals with a new product, and now we are launching the right product. But if history... and is driven by what Safe Aid has been very acutely able to do in this market.

Understood. Thanks so much for your comments.

Next question is from Kavya Deshpande, USB.

Hi, Colleen. Hi, PG. Thank you for taking my questions. PG, I think you said that earlier, most of the headwinds impacting Q4 this year won't continue into 2026. Would you be able to break down in a bit more detail which ones continue and which ones don't? And then for the ones that do continue, what is the quantum? Are they kind of unwinding or are they accelerating? And then just another quick question on the sort of outlook for the multiplexing franchise as a whole. Carlo, I think previously you talked about 200 million euros as a target for sales by 2028. I mean, in terms of the Plex respiratory revenue exposure, perhaps making it lean more towards outpatient and making those revenues a bit more sensitive to flu fluctuations. Had you baked that into the 200 million euro revenue outlook? And does that still hold? Thank you.

Hey, Carly, I will try to take the first one and I guess also the second one, and maybe Carlo can chime in if I would be missing anything. So if not yet, I understand why you guys want to have an understanding of 2026, but you need to be patient because we need to go through the board approval and then 2026 guidance is going to be released next year. But I will try once again from a qualitative perspective to help you out to kind of understand the main moving pieces. I believe Carlos said a few seconds ago we are not expecting headwind from China or a very limited headwind from China in 2026. So that is not going to be there. ARIES 5, 6 million euro headwind is not going to be there. in 2026 and onwards, obviously. This headwind we experienced on the MDX platform is not going to be there for two reasons. One, the business now is very limited in size, and so it's not material. And second, because of the availability of the new product, we think we will be able to better defend the remaining business, which is, once again, not material. The outbreak, we've not discussed a ton about the outbreak. By the end of the day, by the end of the year, the outbreak impact that we had in 2024 is going to be 6 million, which is not going to be there. And if you just take China and the outbreak together, you have one percentage point of our total sales, which are not going to be there. If we move to LTG, you guys have not made a ton of questions about LTG, but LTG, as Carlo said during his remarks, is playing against us because it's a B2B business. We see a very nice growth on the diagnostic part of the business, but on the life science part, what our customers, and it's the big names of the life science, telling us that is that, you know, they're struggling as well to sell instruments. Instruments represent one-third, give or take, of our life science franchise in the LTG business. And we had, you know, a material headwind, which we think is not going to go away in Q4. What's going to happen next year, very difficult to tell you. It depends on, you know, it's a business we don't control. It's a business to business. It depends on NIH. It depends on, you know, funding. and we will see there what our customers will tell us. Going to the molecular part of the business, I believe I've already covered it discussing with Dylan, and those are the, let me say, drivers that you should expect in 2026 and onward. Then discussing about the Plex, the fact that most of the Plex business now is in a reference lab, so it's outpatient. It's driven by the fact that we have, up until a few weeks ago, one panel available, which is the respiratory panel. And so that limitation is going to go away completely when we will have the GI, but let me say a very strategic part of our offering and strategy is to go to hospitals. That is where we want to play. And we also see possibilities of cross-selling to our immunocustomers, molecular products. So the short answer to your question is yes. You know, in the number that we gave for 2028, we already included the fact that part of that number is going to be respiratory cells. But the majority of that number, we believe, is going to come from the gastro and from the blood, as it is for the very Gen 1 offering, as we speak.

Thank you very much.

Next question is from Ian Koch, Deutsche Bank.

Good evening. Thanks for taking my two quick questions. The first one is on your new guidance. Does your new guidance assume any meaningful impact from the government shutdown in the U.S. in Q4? And then secondly, on your supply chain, do you face any negative impact from the supply chain issues that one of your key suppliers has currently?

I think the second question, because I'm not sure I understood the first. When it comes to the second question, the answer is no. So whatever strategy issued as for magnets, I don't know what I'm talking about, but certainly it's not to do with anything that has to do with the supply of the aliazonic cell. First question.

I'm not sure I got it. If you can please clarify your question, Ian, or the one on the guide, I think.

On your guidance, essentially for LTG, do you expect any kind of incremental negative impact in Q4 on the back of the government shutdown in the U.S.?

No, I don't think the government shutdown per se is creating an issue with the instrument. The real issue, again, has been the lack of funding or the redirection of funding or the freeze of funding. to academia that has frozen completely the instrument market so far. What is going to happen in quarter four? Again, in order to understand how we will do in this business, please listen to what Thermo Fisher and the other players are saying about the space. because whatever they say about that space is going to be reflected on the way our life science business will perform, because Thermo, Minipore, Biotechnique, I mean, these are the companies that are buying systems and distributing systems for us in that segment. So I did not really follow their latest reports, but please refer to that, and you will have a better understanding of what that business will do.

If I can add a comment here on the RTG just again, but it's just, you know, reasoning around with available data, right? If you look at the nine-month data we provided for you, obviously what Carlo said about the life science part of the RTG business tends, but if you look at the diagnostic part of the business in the first nine months of the year, you see a plus 20%, right? which is unusual, right, because it means that our customers, diagnosis customers, would have been growing their business by 20%. So there, remember, as we always said, there is a phasing of these big orders, bulk orders that we got from our diagnostic customers, meaning that you should expect a Q4 for the diagnostic part of our LTG business, which eventually will deliver full year for a diagnostic growth, which is usually, let me say, mid to high single digit. But this is just, you know, what we always said. So it's just looking into the numbers and information that we've already discussed.

Understood. Thank you.

Next question is from Natalia Webster, RBC. Hi there. Thanks for taking my questions. First, A confirmatory question on Plex. You mentioned that you now have 100 users in the US. Do you still see your previous target of 150 active users by the year end as achievable? And then secondly, in terms of that mix, you mentioned that the GI panel could help you increase your mix of inpatients. I was just wondering if you're expecting that GI panel introduction to also increase the number of customers that are using the flex versus the fixed option. And then thirdly, a question on NES. You mentioned that you're looking for clearance towards year end or early 2026 and an agreement for distribution by H1. So is it reasonable to assume revenue contribution from Q3, Q4, 2026? And also just trying to understand how you plan to differentiate yourself here, given the market has become increasingly competitive? Thank you.

Okay, let me start from the last. So, yes, we expect to see contribution from H2, from this. Okay, but... If you don't mind, we're going to give more color on this, certainly when we talk about 2026 budget, but very much so during the capital market day that we're going to do by 2026 summer. When it comes to FLEX, I believe that what PG said is as follows. The more we complete the menu, the more the market will develop into the hospital because commercial labs have enough volume to justify multiple placements of systems with one parameter. But when you need to penetrate the hospital market, clearly you need more than one. even if quite often these hospitals have multiple platforms, right, you need to be able at least to take away one, which typically runs on one or two panels. So my take is that moving forward with flex blood, with respiratory blood and GI, we're going to penetrate the hospital market also because, by the way, GI is a hospital product. market panel. And more than that, a comment I would like to make is that as we discussed, I think, previously, GI is almost the perfect example for the mini panel. Because at that point, the combination of mini panel that the hospital can make is very large. You can go seasonal. You can go depending on where the patient is coming from. You can go by outbreak. You can go in many different ways. And so I expect that, as said, today 50% or 60% of our customers are using already Flex with respiratory, in which the number will increase significantly, again, because of the nature of the disease. When it comes to the first questions, you said 150 accounts. We are at 100 today. I believe we're going to get close to 150. I see the funnel. I see the number of accounts we have in the funnel. But I believe that, again, counting Quest as one, we are going to get close to that number.

Great. Thank you.

Mr. Rosa, there are no more questions registered at this time.

Thank you, Operator. Good night.

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