Good afternoon. This is the Chorus Call conference operator. Welcome. Thank you for joining the DiaSorin First Quarter 2026 Results Conference Call. As a reminder, all participants are in 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 zero 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.
Thank you, operator. Ladies and gentlemen, good afternoon and welcome to the Q1 conference call. As usual, I will give some color to the financial results, and then I will let our CFO, Alberto Donati, to take you through the numbers. I'm gonna make my comments at constant exchange rate. In Q1 2026, as anticipated during our full year result call, the quarter registered a slightly negative performance, -3%, mainly as a result of the following factors. First, as reported by all our competitors, the softness of the flu season with the declining volume by roughly 25%.
This clearly has affected the performance of our molecular diagnostics platforms, since a good chunk of business today, especially multiplexing, is related to products in the respiratory area. As far as LTG, if we did comment before a tough comparison with the same period of last year's last year. In this case, we expect that by in the second half of the year, the trend will revert. Last but not least, the QuantiFERON-TB performance that in the U.S. has been driven by the reduction of immigration-related testing, which specifically for us resulted into a one-off event of destocking of some of the large commercial labs in the U.S. that where typically this testing happens.
I will now deep dive into the three business lines. The immuno grew 1% compared to last year. Molecular diagnostics declined 12%, LTG declined 7%. Now let's go one by one. When it comes to immuno, as said, it grew 1% over last year. If we exclude China, the growth was 2%. North America was growing 1%, the rest of the world, including Europe, 2%. China declined, continues to decline 22% as the effect of VBP broadens and now also is hitting the performance of the company in Shanghai and Beijing that until last quarter was not actually affected by VBP. When it comes to QuantiFERON, the performance on QuantiFERON globally was weaker than the previous quarters.
The QuantiFERON franchise grew globally 6%. This is due to a one-off destocking event of the QuantiFERON product in some large commercial labs, and this has been driven by a decline in demand for TB testing, which is required for immigration for the visa issuance. We expect this to recover already starting from Q2, because I said this is related to the fact that some of the large labs have canceled orders in Q1 because they are to bring their inventory level back to where is needed. We continue to see stable double-digit growth in U.S. and in Europe outside the commercial labs, and this has been driven by the launch of the new high-throughput version of the LIAISON QuantiFERON-TB Gold Plus II test, which has been recently FDA cleared.
As QIAGEN reported, we see no changes in pricing or competition. QuantiFERON continues to grow double digits in hospital market, continues to grow double digits in Europe. We saw again this slowdown in the commercial lab in the U.S. Net of this impact. Sorry, let me just add a couple of things. We also experienced in January and February, but with a recovery in March of general softness of U.S testing volume, as reported by some of the commercial labs due to the severe weather conditions in the U.S., as said, which affected some testing volumes at the states. We saw recovery of this started from March and in April.
The third element, when it comes to diagnostics, is that we continue to see the normalization of testing volume in Europe, as we have been anticipated in previous calls. Net of these impacts, our immuno-based business continues to grow steadily and perform strongly, as discussed before. The U.S. hospital strategy continues to be on track, and we are now approaching close to 750 hospitals by midyear. By year-end, we should get to the mark of the 600 hospitals, which actually was part of our 2023-2027 plan. We are one year ahead of expectations for this strategy. Again, it's working very well. The second element of this is that our specialty testing, which clearly goes into this installed base of systems in hospitals in the U.S., continues to grow.
There's a strong momentum in areas like gastroenterology and other, and some of the infectious disease specialty areas. If we look outside U.S. and Europe, as said before, the only geography where we are experiencing slowdown is China. China continues to decline again in the quarter, 22%. What we saw is that on top of the VBP that is hitting the industry, now we see that some of the provinces and cities that supposedly were not supposed to be hit by VBP now, as a combination of price policies driven by competition and/or the fact that hospitals do apply the VBP policy anyway. We see that the price erosion continues to be very strong in China. Again, this, I believe, has been reported by everybody that operates in this sector.
When it comes to our direct business, ex-U.S. and ex-China, so we are talking about Australia, India, Mexico, and Brazil, we continue to see mid-to-high single-digit growth. These markets continue to perform very well for the company. Last but not least, our export business is displaying results in line with expectation, with clearly the exception of the Middle East region that has been impacted by the current war. We estimated that the effect in the quarter is close to EUR 1 million. Let's move to the molecular diagnostic. The molecular diagnostic total franchise declined 12%. As said before, this is fundamentally driven by the very weak respiratory season.
As we have discussed previously, I will comment the different segments, the different platforms, the LIAISON MDx franchise, and then I will talk about our multiplexing franchise and make a few comments about the LIAISON NES. Let's talk about the LIAISON MDx franchise, which annually represents roughly EUR 100 million of revenues. The franchise declined 7%, but as we have discussed, there are different trends in this product line. We have the respiratory, which is declining 40%. Again, it's all volume-driven. We have the targeted specialty, which is growing 41%. And this has to do with the fact that we continue to benefit on the uniqueness of our product offering. Today, the targeted specialty represents roughly EUR 45 million, so is almost half of this franchise. And then we have the ASR.
ASR is for us a relevant business. It represents 40% of this basket. It's these are reagents that we provide to hospitals and commercial labs to develop their LDT. It is highly affected by ordering patterns, and because clearly hospitals do buy these reagents in bulk. In Q1, the business declined 10% versus last year, but we expect that this will normalize and get annualized to a small growth starting from Q2 this year. Let's move to molecular multiplexing franchise, which is approximately, again, EUR 100 million annual revenues.
In Q1, it's flat. It is flat notwithstanding the fact that there is a good portion of this business, which is respiratory, which clearly is very negative, but it's counterbalanced by the fact that we are growing the PLEX customer base. We have additional business and additional respiratory business, although it's again, from a volume perspective, is not where it's supposed to be due to the weak season. We have launched the blood and the new panels, which clearly are not seasonal, and they contribute to the net growth.
If we look at the performance of this segment, which again, strategic, is Plex-based, is flat, but it's also the matter there is a strong growth, which is compensating the decline of the respiratory component of this business. When it comes to customer split, which is an information I believe we have been starting to provide to the market by now, 90% of the customer type are hospitals and 10% are commercial labs. Clearly, we expect this to shift even more toward hospitals, which is the fundamental market for this technology. When it comes to the contribution, though, to the total revenues, 30% of the contribution comes from commercial labs and 70% comes from hospital labs.
This has to do with the fact that, as we have press released, we have signed up and now installed our LIAISON PLEX in some of the major large commercial labs in the U.S. We expect the GI panel clearance within days, so I hope that we'll be able to provide some good updates, good news during our analyst day, which is going to happen on the 20th. Now, I was going to give some qualitative comments about the LIAISON NES because it's been just launched on April 1st. We have both distributors, Thermo Fisher and McKesson, now operating in the U.S. with the LIAISON NES.
Because of the way this business works, there is in the next few months, we expect to install systems, and then these systems clearly going to generate reagent revenues during the flu season. Starting from late Q3 and beginning of Q4. We're going to give way more color during the meeting on the 20th, but I am happy to report that the launch has been so far very successful. Last remark on LTG. As you all know, the LTG business for DiaSorin is a B2B business. It's always related to bulk orders that are coming from our diagnostic clients as well as the life science clients.
Because of the way of the ordering pattern in 2025 versus 2026, we expect that H1 is gonna be lighter than last year. We expect H2 to show strong growth compared to last year. Overall, we confirm our expectation that LTG will deliver low to mid-single digit growth in 2026. One element that I would like to comment on is that we see an improvement of the life science sector, I think as reported by some of our clients in their comments of Q1. Whereas the diagnostic business has always been traditionally very strong and clearly more predictable. I'll now comment on the Investor Day. Everybody is invited to attend to our Investor Day, which is gonna happen on May 20th.
We're gonna host our Capital Market Day at our innovation hub in Milan, where we're going to unveil our 2027, 2030 strategic plan. This event clearly will offer a unique opportunity to experience our innovation presence, including live demonstration of all our platforms, which will be led by either R&D or our marketing team. The session will then continue with a comprehensive presentation of the new plan. I warmly invite everybody to join us either in person or connected through the web. I'm turning the microphone to Alberto, who is gonna take you through the numbers. Thank you, Alberto.
Thank you, Carlo.
Good morning and good afternoon, everybody. Thank you again for joining the DiaSorin Q1 2026 Earnings Call. Also for the continuous interest that you're all showing in our company. In the next few minutes, I'm going to walk you through the financial performance of the first quarter of the year. Then I will turn the line to the operator for the usual Q&A session. As we navigate through these results, you'll see that while we face some expected headwinds this quarter, we also remain confident that we're gonna be achieving our full year guidance. Let me start from the revenues.
Q1 2026 total revenues came in at EUR 287 million, which is down 3% at constant exchange rates compared to Q1 2025, which is in line with the trend and guidance we shared in the previous conference call, as Carlo just outlined. At current exchange rates, revenue declined 8%, reflecting a significant Forex headwind of around EUR 17 million. As a reminder, Q1 2025 benefited from an extraordinarily strong U.S dollar with an average of around 1.05 compared to an approximately 1.17 in Q1 2026, which is a difference of more than ten cents. Overall, Q1 2026 was particularly impacted by the exchange rates even. Given a very tough year-on-year comparison.
Moving to profitability, Q1 2026 adjusted pro- gross profit came in at EUR 186 million, down 5% at constant exchange rates compared to Q1 2025. At current exchange rates, the decline was 9% with a headwind of EUR 10 million due to the Forex, to the exchange rate. The adjusted gross margin remained, however, quite stable at around 65% at both constant and current exchange rates, slightly down from the 66% of 2025. This is primarily due to the negative impact of the tariffs in Q1 2026, which, as you all know, were not yet present in Q1 2025. This is also despite the unfavorable leverage of fixed cost, which is also demonstrating the continuous capability of the company to deliver a diligent and rigorous cost management measures in order to maintain profitability.
The Q1 2026 adjusted operating expenses were EUR 119 million that are substantially flat compared to 2025, with a ratio of revenues of 41% vis-a-vis a 39% of last year. This increase at constant exchange rate is around 4% as a result of a normal increase of expenses and most notably the commercial investment for the launch of the LIAISON NES platform, which we commented during the last call and accounts for north of EUR 10 million for the full year. Q1 2026 adjusted EBIT came at EUR 67 million, which is down 17% at constant exchange rate, while at current exchange rate, the decline was 20% because of a Forex headwind of EUR 3 million. The margin, the EBIT margin, was 24% at current exchange rates and 23% at constant exchange rates.
The adjusted interest expenses at EUR 2 million are compared to an income of EUR 1 million in 2025, and this is a difference of EUR 3 million, mainly because of the lower yield on our cash balance, which is coming from not only the reduction of interest rates, but most importantly to the lower cash balance due to the share buyback. Year-to-date adjusted net result came in at EUR 49 million, which is 17% of revenues and decreased by EUR 16 million or 25% compared to the previous year. Now let me move to the EBITDA. Q1 2026 adjusted EBITDA totaled EUR 90 million, which is around 31% at both constant and current exchange rates.
This decrease compared to last year reflects some of the headwinds that were previously mentioned, namely the VBP tariffs as well as the decision of investing for the success of the next commercial launch, but most importantly and significantly, the unfavorable operating leverage due to the lower revenues in the quarter. Turning to the balance sheet and the cash flow performance, we delivered a solid result despite the challenging revenue and macro environment. Our net financial position showed net debt of EUR 711 million at the end of Q1 compared to EUR 580 million at the end of 2025. This is a variance of EUR 131 million that primarily reflects, on one side, the good operating cash generation, and the free cash flow came in for Q1 at EUR 32 million.
On the other hand, this was more than offset by EUR 154 million for the cash outflow to support our share buyback program that is, you know, aimed at the shareholder remuneration. As a reminder, within the authorization approved by the shareholder meeting on January 27th, the board of directors approved the launch of a share buyback program for shareholder remunerations for a total cash outflow not exceeding EUR 250 million.
As of today, the company purchased over 3 million shares, completing roughly likely above 80% of the total program. In light of the Q1 results, we are confirming our full year 2026 guidance at constant exchange rates for 2025. We continue to expect revenues to grow between approximately 5% and 6% with adjusted EBITDA margin in the range of 32%-33%. Please note that as we mentioned already last, during the last call, this guidance does not account for further potential negative impacts from the prolonged military conflict in the Middle East, which could further impact the group. Specifically, it excludes the possibly indirect effect of extended logistical and distribution difficulties, and most importantly, the potential future inflationary effect on material cost on one side and supply chain on the other, which were not significant in Q1.
Now before turning to the operator, allow me a quick update on tariffs, because as you all know, the U.S. government adopted an exceptional tariff framework in 2025, while in 2026, in early 2026, the legal landscape shifted significantly. On one side, the U.S. court ruled the termination of the APA duties and also a nationwide order for customs to refund eligible amounts, while at the same time, the administration introduced also, you all know, a temporary 10% global tariffs under the Section 122. As a result, DiaSorin initiated a refund actions through the newly established mechanism, we are now closely monitoring the situation, and we expect to have updates from customs within the next 90 days at the latest. I will now hand it over to the operator for the Q&A session.
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 one on their touchtone telephone. To remove yourself from the question queue, please press star and two. We kindly ask to use handsets when asking questions. Anyone who has a question may press star and one at this time. The first question comes from Aisyah Noor with Morgan Stanley. Please go ahead.
Hi. Good evening, Carlo and Alberto. Thank you for taking my question. My first one is on QuantiFERON, which you mentioned on the call was growing 6% globally. From my understanding is, QIAGEN last week reported a 5% decline in their QuantiFERON franchise. What is explaining this difference? Could you quantify the impact of the destocking effect for QuantiFERON in the quarter for you? My second question is on the diagnostics market outlook. We heard from bioMérieux a few weeks ago that the instrument sales development in the market has been weaker than expected due to cost pressures in IVD. Just wondering if you are seeing a similar dynamic and if you could remind us what the split in sales or what was the development of instrument sales versus consumables for you. Thank you.
Okay, I'll take the call. I'll take the question. On the QuantiFERON, unfortunately, you cannot really compare our revenues to the QIAGEN revenues for two reasons. First one is that they report CLIA, and they report ELISA. When they see the overall franchise, when they show a decline, and I think they've been talking about the effect of tenders in the Middle East, they clearly refer more to the ELISA technology. Therefore, this has been really impacting the overall franchise, whereas we only see the pure CLIA effect, we don't suffer from that. Typically, if you remember, our QuantiFERON franchise was growing 15%.
Now this slowdown, as we discussed, is primarily driven by commercial lab segment in the U.S. and destocking. North America has been soft in that sense, it's been declining. QuantiFERON -3% as a combination of that effect. I cannot give you the destocking value, but I give you enough data that you can do the math yourself. My observation is that, starting from the beginning of Q2, which is what we experienced so far, we see that there is a normalization in QuantiFERON volume.
This has been, again, some of the large labs that are actually doing all this LIAISON testing that had a lot of inventory that they decided to consume, so they stopped ordering for almost a quarter, and now they started again. When it comes to the instrumental comment of your earlier, and again, I believe, I don't know, I believe you are referring to the Spotfire, correct? Is it the Spotfire?
I think the comment was on broader instruments, appetite for instrument CapEx in the diagnostics market overall. This would also be relevant for the immunodiagnostics business.
Look, I would say that the vast majority of our business today is only reagent rental, both in certainly across all the European countries. In the U.S., there was After COVID, I believe, we went back to the normal course of business. I would say that 80% of our placements today are all reagent rental. The sales really make a small portion of our revenues. On the LIAISON NES, granted, I have four weeks under my belt, not enough experience. We actually had surveyed the market pretty well, the POL market, which is where this system goes.
What it was very clear to us is that if during COVID and, I would say until 2023, 2024, there was availability, cash availability by these customers to buy the systems. Today is 90% reagent rental because for a very simple reason. The customers cannot predict the revenues that they're gonna be generating because it's seasonal. Think about this season, right? For these customers in POLs, testing for respiratory is actually a revenue line for them. They don't feel comfortable about projecting the revenue line because they're dependent, as we are, on the season. They, I think, revert back to what was the typical model in this space pre-COVID, which has always been reagent rental.
Okay. Thank you so much.
The next question comes from Odysseas Manesiotis with BNP Paribas. Please go ahead.
Hi. Thank you for taking my questions. Firstly, on the cost lines, I mean, considering sales seem to have come a touch below by EBITDA, seems a bit above. Could you give us a bit of color on how the different cost lines moved and why you stopped disclosing them? Secondly, on the NES changes so far, Carlo I understand you don't have a lot of weeks under your belt to get a good feel of the interest so far. From the few clients that you might have gotten a feeling, what are the few disappointing differentiation of the platform that have been appreciated the most so far?
Yeah. I will take the second question, and I will leave to Alberto the first one. I think he has just one clarifying question for you to be able to answer. Second, you're asking about NES and why we think NES is different. I hope you're gonna be in Milan next week, but actually, two weeks. I will show you why NES is different. NES is a very simple platform. It's really like a Lavazza coffee machine to be chauvinist. You just put inside the cartridge. You push a button, get the result. If you look at the Spotfire, for example, there is hands-on.
It's been a very successful platform, by the way, but there is hands-on time. Hands-on that, I mean, customers have to do it. The POL space, again, four weeks under my belt, but it's a very unsophisticated space. I believe that the advantage that we have today compared to some of the legacy systems, Abbott is a good example, or even more recent systems, is that we are really hands-free. Let me remind you that this system was designed originally for Walgreens. When we started this, it was a Walgreens system for pharmacies. I believe that today what customers experience is two things versus eight. Pretty much, it takes 17 minutes versus 40, 38. Versus other competition that provide results in similar timeframe, it's simplicity. Okay.
I hope you're gonna be in Milan next week, and I'll show it to you, Alberto.
Odysseas, good afternoon. Allow me just to clarify whether you were asking for the split of the cost line, so the OpEx split or d id I misunderstand your question?
Yes. I was looking for a feeling of how the cost lines moved in the quarter, and, yes, a feeling of whether there were substantial decreases in any of them to justify the stronger margin than their expectations.
Okay. Okay. Let me start from the cost line. As I mentioned before, the growth in our operating expenses was 4% compared to previous year. This is the combination of fundamentally two things. On one side, the salary increase that as we discussed and commented in the past, we in the inaudible it is done in July every year. In Q1, we had an impact, roughly 1/3 of the increase, of the overall increase is simply given the salary increase, the carryover effect of the salary increase that we had in Q3 of the previous year. The second element, as I mentioned before, in terms of OpEx, is the investment for NES launch, which again, $10 million, north of $10 million for the full year.
We started very early with investments since the beginning of the year. We hired the full team since the beginning. That contributed around 1/3 of the increase, 1/3 is purely driven by the normal inflation increase of expenses that we usually have. From a gross margin standpoint, as I said, we have a gross margin that is substantially flat and similar to previous year. We closed 2025 adjusted gross profit at 66%, while we closed Q1 this year at 65%. The 1% difference is fundamentally driven by the tariffs, while at the same time we were able, with strong cost management, to offset the negative operating leverage. From a gross margin standpoint, in Q1, we were substantially in line with our expectation.
Thank you. Are you gonna continue not disclosing the lines going forward? Could you give me a feeling of whether anything changed on the R&D side for you?
In terms of disclosure of data, we're gonna be consistent with what we have disclosed so far. You're gonna receive the same level of information and data that we've been providing. From an R&D standpoint.
From an R&D standpoint, let me just make a comment. We've been investing a lot in our platforms in the last three years. There has been a surge in R&D spending, which has been very significant in clinical spending because we've been taking to the market three platforms. What you have to expect, and I think what you will start to see, from second half, is that there is gonna be a normalization of R&D expenses, which doesn't mean that we're not gonna be developing products, because you will see during our investor day next week, what we commit to in terms of new product development. But certainly not to the intensity and level which was necessary to develop three platforms in the last three years. Again, normalization starting from H2.
I'm very clear. Thanks for the call.
The next question comes from Kavya Deshpande with UBS. Please go ahead.
Good evening, Carlo and Alberto. Thanks for taking my questions. My first one is just around the reiteration of guidance. It implies slightly faster revenue growth than previously over the rest of the year, if I'm not wrong, it still looks like it's implying flat margin over the next three quarters versus last year. Alberto, you were very clear on the pressures you faced on margins in Q1. I guess something underlying feels like it was better, whether it was cost controls or the benefit of the German factory closure. I was wondering whether you could elaborate on those key terms and whether you expect them to continue over the rest of the year.
Carlo, just on your expectations for China, given everything that's going on there, on the last call, I think you said you were expecting a EUR 5 million decline there. Is that expectation also reiterated as part of your guidance? Thank you.
Let me take China first, Kavya, and then I'll let Alberto discuss about the rest. Look, I am, you need to concede that we have been very clear about China a while ago when everybody else was a little bit ginger about it. I'm telling you, the situation is not improving. It's not improving as a combination of a couple of things. A, we all thought and hoped that the VBP would actually stay within certain provinces. We all thought that we would be sheltered in some very large markets in China. I'm telling you, it's not happening. It's not happening as a consequence of two things. A, some of these hospital administrators do implement VBP anyway.
Second, I know when you have companies, very large companies leaving on the table hundreds of millions of dollars in price, as some of the very large players have reported, the market become nasty. Nasty means that, in order to preserve the business that everybody has, then, we kill ourselves with pricing that, in my opinion, doesn't make sense. I believe we're very fortunate with the fact that, if it's not EUR 5 million, it's gonna be EUR 7 million. Okay? But it's a relatively small damage. I believe that, when it comes to the whole industry, there is gonna be another level of pain that will surface in this market moving forward. Is a combination of 3 things. The market becoming again very aggressive, VBP being extended.
Last but not least, I believe I'm starting to see Chinese players that now are moving not only out of clinical chemistry, hematology and immunoassays, but they're also getting a more specialty segment.
Understood. Thank you.
Thank you, Carlo. Going back to your first questions related to gross margin and what is our expectation. Allow me to start from the end, and then I'll walk you through some of the elements. Fundamentally, yes, we do expect our gross margin to be stable and then the EBITDA to improve, so that we go back within the guidance range of 32%-33% as the effect of the operating leverage. Let me now further clarify. We do have positive and negative elements affecting our gross margin.
On the side of the negative elements, of course, we are going to foresee a negative, unfavorable mix coming from the growth of the molecular franchise that, as we know and we discussed in the past, is dilutive in terms of margin for our group. The growth of the revenues in that franchise is going to be slightly dilutive for our gross margin, as well as Carlo already mentioned, a further deterioration on China. We plan to offset those thanks to, you mentioned it as well, Germany, the closure of the Germany, so the optimization of our industrial footprint.
The fact also that in the second half we're gonna have a lower impact on tariffs compared to what we had in the H2 of last year, and simply the positive effect of the operating leverage.
Thank you. If I could just clarify on the German factory closure, I think Gigi had previously said you expected a EUR 6 million- EUR 8 million benefit. Is that still the expectation?
Yes, indeed.
Thank you.
The next question comes from Jan Koch with Deutsche Bank. Please go ahead.
Good evening. Thanks for taking my questions. You mentioned in your press release that you expect several headwinds to ease from Q2 onwards. What gives you confidence that this actually happens? Secondly, on QuantiFERON, and sorry if I missed that, but how much of your QuantiFERON revenue is exposed to immigration testing in the U.S. and in the Middle East region? Finally, on the phasing of your sales growth this year, do you think that you can already be in line with the full year guidance range in Q2?
I'll start from the guidance. When we disclosed the guidance last month, we already showed the progression. We show the progression quarter-over-quarter, and you can see that while we were expecting for Q1 to be slightly negative, we also expect Q2 to be slightly positive. We're gonna be within guidance by the end of the year, thanks to the contribution of the second half. By the time we close H1, we're not gonna be yet within the 5%-6% growth.
I think the question is different. Look, I understand what you're saying, so what you're asking, what are the headwinds that you're not gonna have? I think primarily two. One is an assumption that I think everybody is making that we're gonna have a normal flu season in Q4, right? Second element is to do with the LTG. As explained last year, if I remember correctly, LTG grew 15% in H1. It declined 14% in H2, and eventually the growth was around 1%. We expect that overall by year-end the business will grow low single digit to mid single digit. It really depends how life science will perform. But growth anyway. Q1 we I think it grows with - 7%. You know again which is all to do with the ordering pattern.
This is going really to carry an effect on the H2 performance versus H1. Let me also remind you that the LTG, the fact that LTG carries more weight in H2, is really contributing also to the growth of the margins because it's a very profitable business for us. It will contribute to an improvement all of the mix. Next. Sorry, did you have another question?
Yeah, on QuantiFERON and exposure to immigration testing.
Look, as you know, as you very well know, QuantiFERON is a QIAGEN business, and so I cannot really comment too much on QuantiFERON. I know that Thierry had a QuantiFERON day yesterday, and unfortunately, I didn't have time to listen to it. I don't know what they discussed about integration, whether he quantified, but I really invite you to actually refer to what QIAGEN discussed yesterday.
Got it. One follow-up, if I may, on the commercial investments for the NES launch. How much of the planned EUR 10 million investments were already booked in Q1?
Less than two.
Okay.
Within two.
The next question comes from Anna Ractliffe with Bank of America. Please go ahead.
Hi. Thank you for taking the question. I wanted to ask about the reiterated guidance in the context of the slightly softer quarter. Do you still see a pathway to the high end or should we be thinking more about the low end for this year? Also appreciate you aren't including Middle East impact in your guidance, but if you could help us directionally with the exposures. I think last quarter you said every month the price of oil is above $100 , that's a EUR 5 million impact. Is that still the right way to think about it and do you have any levers to offset that impact? Thanks again for taking the questions.
Anne, look, believe me, I'm not in a position now to say high end, low end. I'm saying that we feel as comfortable that we're gonna hit the range, and I believe that let's see what happens in Q2 , and then we may comment differently about which side of the range we're gonna be. Related to your second question about the effect of oil, I think Alberto is gonna shed some light.
Thank you, Carlo. Yes, indeed. As we mentioned before and during the last call. During the last call, Carlo already mentioned that there are, we've estimated at least EUR 5 million of potential increase between the supply chain cost and also a further potential increase on materials that we have not quantified coming from the increase in material cost due to the increase in plastics. This is not included. EUR 5 million annualized.
Annual.
Absolutely. This is not included in our guidance because it was not material, not significant in Q1, and we cannot make an estimation of what it could be the impact within 2026 yet.
Just one clarification, there was no impact in Q1, correct?
Yeah.
Okay. Yep.
The next question comes from Natalia Webster with RBC. Please go ahead.
Hi there. Thanks for taking my questions. I have three, please. The first is on the Immuno business. Just following up on Immuno U.S. growth. Appreciate the numbers around QuantiFERON, but are you able to provide the level of impact that you saw from the adverse weather in Q1, and then what the underlying U.S. growth looked like excluding both of these effects? I'm interested to hear on what you're expecting for both QuantiFERON growth and underlying U.S. growth for the remainder of the year. My second question is on Immuno growth in Europe. You previously talked to normalization in volumes and specifically mentioned that German testing volumes fell to around 1% in 2025. Has this stabilized in Q1 or do you see further downside risk here?
Then thirdly, just following up on that last question on the Middle East impact. Appreciate you say that the impacts weren't material in Q1, but are there certain mitigation measures that won't necessarily continue going forward? Are you able to just help us a bit around the potential exposure if you're not able to offset these in the longer term? Thank you.
Let me start from the last. We know for sure that our business in Iran most likely is gonna suffer from this situation, right? Roughly Iran did represent for us EUR 3 million-EUR 4 million and so far clearly we're not able to ship anything to the country, nor we know what is gonna happen at the end of this because we had a distributor there and honestly we don't know where the distributor is these days. That is an element. The rest of the region we assume that the problem today is more to do with the logistics.
Actually, we know it's logistics because Dubai was our port of entry for many of these countries, and with slowdowns, distributors have been working with the inventory that they had. Depending on how long this will continue, clearly it's gonna get to a point where they're gonna run out of inventory and then that is gonna be a problem. Today, I don't know, it can be temporary or you can have an effect, an effect moving forward. When it comes to the volume, look, today, what we see when we say normalization in Europe it means that we continue to experience quarter-to-quarter growth which sits as low as 0.5%, as high as 2%.
Clearly, again, it's a bit difficult on a monthly basis and this is why I'm saying, we are saying, it's around 1 1/2. Really compares to last year where we were around 6%, right. In certain quarters. This is why I'm saying we believe that we go fundamentally reading these numbers, we are back to pre-COVID time, where the European market was growing to these levels. I don't know, didn't pay attention, I don't know if any of our competitors gave any indication about volume. U.S. growth, let me make it simple for you. If you strip out the two effects, which is the destocking plus the weather effect.
The weather effect again did hit some of the states because others were no problem. Unfortunately, some of the state like the East Coast, we have very large customers. I would say that if I look at March pretty much normalized. Therefore, if you strip out QuantiFERON and you strip out the weather factor, the rest of the business has been delivering in line with what we have seen in the previous quarters.
Thank you. Just on the QuantiFERON growth going forwards, are you expecting this to improve into Q2 and H2?
Listen, I said before, don't shoot the messenger. I believe you should be talking to and listening to QIAGEN and just following their indication about what they expect QuantiFERON to be. Again, the only thing you need to be cautious is that they have an ELISA component to it, which clearly is sold in a certain environment, whereas we only have CLIA. Our business is fundamentally U.S. and Europe, whereas their business is global because in many geographies they sell ELISA. When you talk to them, you I think you need to ask from them more color on the geographies in case you're interested.
Okay. Thank you.
The last question comes from Philip Omnou with JP Morgan. Please go ahead.
Hi, guys. Thank you for taking my questions. Just one more technical one. The D&A charge in Q1 are a bit lower, at least versus what we expected. I know you guys have spoke to higher D&A given the launch of NES. Can you give us a bit more color on what we should expect as a runway going forward from here? Second question, just on QuantiFERON again. I know you guys don't wanna talk too much given it's a QIAGEN business, but it would help us understand if there's anything baked into the full year guidance re sort of incoming competition in the TB testing area.
I'll take the second one. We honestly are eagerly waiting to see what Roche is gonna say, I think, in their diagnostic day. To be honest with you, I don't expect any material competition in 2026. Our guidance does not take into effect any effect from the launch of
Passcode has been confirmed. Please wait while you are joined to the conference.
First question.
Yep
You take care of it.
Yep.
No, I'll do it.
Thank you, Carlo. From a D&A perspective, we can confirm the expectation of growth in the H2 . Just please, you mentioned two components, the launch of the new products, which for us is in two components, the NES and the Plex. Why do I mention both? Because on one side, NES was officially launched on the 1st of April, so you don't see the full impact and the full effect in the Q1 . Second, because we do have also the expectation for the GI panel to be registered and launched in a matter of weeks and days. We will also start the depreciation amortization of those panels. This is from an intangible standpoint.
from a tangible standpoint, again, given the fact that the NES has just been launched, the installation of instruments is gonna happen in the coming weeks and months. we do expect that with the success of the platform, you're gonna see also an increase of the depreciation amortization related to the instruments that we will be placing on reagent rental.
Okay. Thank you t hat's it c lear.
Mr. Rosa, gentlemen, there are no more questions registered at this time.
Thank you. Bye. Take care.
Ladies and gentlemen, thank you for joining. The conference is now over. You may disconnect your telephones. Thank you.