DiaSorin S.p.A. (DIA) Earnings Call Transcript & Summary

May 6, 2025

Borsa Italiana IT Health Care Health Care Equipment and Supplies earnings 50 min

Earnings Call Speaker Segments

Operator

operator
#1

Good afternoon. This is the Chorus Call conference operator. Welcome, and thank you for joining the DiaSorin First Quarter 2025 Results Conference Call. [Operator Instructions] At this time, I would like to turn the conference over to Mr. Carlo Rosa, CEO of DiaSorin. Please go ahead, sir.

Carlo Rosa

executive
#2

Yes. Thank you, operator. Good afternoon, and welcome to the quarter 1 results for DiaSorin. As usual, I'm going to make some general comments about the quarter. And then Mr. Pedron, our CFO, will drive you through the numbers. So quarter 1 was a very good quarter for DiaSorin. We had revenues of almost EUR 310 million, 7% growth versus Q1 '24. If you look at the base business, excluding COVID, it's 9%, in line with expectation. COVID revenues, EUR 5 million in the quarter. I'll remind you that the guidance for '25 was EUR 20 million. So we are in line with guidance for COVID as well. EBITDA margin, 34%, a very solid start to the year with underlying growth despite macro headwinds. The immuno is back to high single-digit growth. The molecular respiratory did benefit from a pickup of the flu season in Q1. And it's a very good start of the year for our multiplexing that grew 25%, and I will comment later. And also for our targeted single-target specialties in molecular, which is growing now 14%. And then as far as LTG, we had a very strong quarter, 13% up versus last year. Although, I will comment later, let's make sure that we understand, there is a phasing effect of certain bulk orders in Q1 that made this quarter extraordinary in terms of growth. And our quarter 1 performance confirms our guidance for full year of 8% growth of base business revenue and 34% of EBITDA margin. Now let's get into the different segments. Let's start from the immunodiagnostics. The immunodiagnostics, ex COVID, grew 8%, in line with expectations and confirming the strong positive trend of immuno, notwithstanding headwind in China. If we look at CLIA, that does represent the majority of revenues in immuno, it grew overall 9% in the quarter driven by the excellent performance of clearly our specialty menu and our U.S. hospital strategy that continues to deliver according to expectation. Clearly, all this is partially offset by the impact in China of VBP. But by the same token, we just got approval in China of our LIAISON XL, manufacturing the instrument there. So we expect in the next few quarters that we will be able to react to this negative impact. I will comment more specifically China later. Let's look at North America, plus 18%, so it continues to be the engine of growth for DiaSorin. The CLIA grew 19%, again, driven by the success of the U.S. hospital strategy. And the quarter 1 placements are in line with full year expectation and consistent with the 2025 target of achieving roughly 600 placements or 600 hospitals in the U.S. And again, as in the previous quarter, this has been possible by the increased commercial footprint following the Luminex acquisition. As far as Europe is concerned, plus 5% (sic) [ 4% ] in quarter 1; driven by CLIA, plus 6%. And the result is partially offset by what we discussed, I think, outbreaks in mycoplasma and parvovirus that we experienced in 2024 in some of the European countries. So strong growth even if the comparison quarter-to-quarter was unfavorable because, again, of outbreaks that happened in '24 and did not happen in '25. Export pretty much grew in all geographies, in line with the overall business growth in DiaSorin, so not diluted. China with a minus 18% in the quarter, most of the impact is due to the VBP. The overall effect of VBP full year is around EUR 5 million. So this is in line with our expectations. China continues to be a very difficult market. There's a combination of, again, VBP price pressure and also competition by local players. Although DiaSorin in China represents less than 3% of revenue, so the impact for the company is fairly limited. And again, last comment, as far as immunodiagnostics is concerned, QuantiFERON continues to be a driver of growth together with stool panel. And in both cases, we registered double-digit growth. And we also have a good performance of all the other infectious disease assays. As far as MeMed is concerned, our ambition for 2025 is to have 25 new customers ending -- by year-end, ending with approximately 100 signed customers by the end of '25. And in Q1, we signed 25. So we are in line with achieving as well the target for MeMed in number of customers by year-end. So we see an acceleration of MeMed, which is a combination of the good result that were published on June, plus increased adoption due to all the marketing activities that together with MeMed, we did in the last 2 years. When it comes to now molecular diagnostics, let's move to molecular diagnostics. Molecular Diagnostics, ex COVID, grew 7%. If we exclude ARIES, ARIES is a platform that was developed by Luminex and we did sunset at the end of last year, if we exclude the effect of the ARIES sunsetting, which is roughly EUR 5.5 million that happened in H1 '24 and we don't see it any longer in '25, so ex ARIES, the growth go from 7% of molecular to 12%, so double-digit growth. Multiplexing quarter 1 growth of 25%, in line with full year expectation. I remind everybody that we shared with the market our target to grow the business, the full multiplex business, by 25% from EUR 60 million to EUR 75 million. So Q1, we are in line with that. As far as the LIAISON PLEX, very good performance in terms of placements, notwithstanding the fact that this happened during the flu season. So now we expect an acceleration of placements during off-flu season to get ready for the next flu season by the end of 2025. One more comment in molecular has to do with our targeted molecular business, I call the old DiaSorin brand, which is not multiplexing, it's single plex, and we continue to have a very strong growth in this segment due to our specialty offering. And I remind everybody that Candida Auris, which was approved a couple of months ago, that is really driving new placements of LIAISON MDX in the U.S. market. We are the only company with an FDA-cleared assay for Candida Auris. PLEX submissions in line with what we have projected and discussed during our Analyst Day/Market Day in 2023. So respiratory, as you know, has been approved last year; blood culture, BCY, was approved in '24; BCN, approved in April a month ago; and we expect BCP to be approved within the next 8 weeks. And we are done with the clinical studies for GI, and we will submit GI by the end of 2025. So we are in line with expectation and in line with our plan that we shared with the market again in 2023. As far as customers for PLEX placements, noticeable is the fact that we now place more systems with the flex approach rather than fixed. Now 60% of customers are using flex and 40% are using fixed. But the trend is certainly that placements and adoption is going to move toward the flexible panel, which is the real innovation that DiaSorin is bringing to the market. And as far as split of labs, 20% of placements are in commercial labs; and 80% in hospital labs, which is expected with respiratory since the majority of the market actually sits in the hospital segment. And VERIGENE, other panels are stable as expected. On the LIAISON NES, we have concluded the clinical studies in the U.S. And we are on track for filing the LIAISON NES, which is our decentralization platform for flu A to B, COVID and RSV. We are on track for filing in July 2025 and again, in fact, in line with the time line that was communicated during our Analyst Day in 2023. Next panel to come that is currently under clinical is Group A strep, and we expect that we're going to wrap up clinical, and submission is expected by quarter 4 of 2025, again, in line with what was communicated to the market. Last, but not least, the LTG, the licensed technology, is a very solid result in the quarter, 13%. And the strong performance is due to the fact that in diagnostics, growth continues to be strong as well as in pharma customers, and this has been partially offset by the result of life science partners, which are more linked to the academia and funding and everything that is happening these days in the U.S. Again, the result is also affected by the fact that we had some bulk shipments in Q1 that will not repeat in the second quarter. So we reiterate that our expectation is that LTG, by year-end, will grow low single digits. A couple of comments, and Mr. Pedron is going to go through it, U.S. tariffs. And now we're talking about the tariffs and counter-tariffs, which have been now raised primarily between U.S. and China because, as you know, there are no tariffs as of today for medical products made in U.S. and exported to Europe. The impact for the group is negligible, not material. We expect that in 2025, the impact at the EBITDA level is going to be below EUR 5 million. So to the contrary of other companies, what has been reported by other companies, because of the fact that we do have a footprint that is local for local, so a lot of U.S. products are actually manufactured in the U.S. for the U.S. market, we are not exposed to the tariff. At this point, I'm going to turn the microphone to Mr. Pedron, and he's going to take you through the numbers.

Piergiorgio Pedron

executive
#3

Yes, Carlo. Good morning, good afternoon, everybody. Thank you for joining DiaSorin Q1 '25 earnings call and for the interest you are showing in our company. In the next few minutes, I'm going to walk you through the financial performance of the first quarter, and then I will turn the line to the operator for the Q&A session. Q1 '25 total revenues at EUR 313 million are above last year by 8% and, despite the expected decrease in COVID sales, down by EUR 4 million or almost 50%. The business, ex COVID, is growing in the quarter at constant exchange rate by 9%, therefore, a touch better than the full year guidance because of the solid performance of immuno and molecular businesses in combination with some tailwind coming from a couple of back-orders of LTG customers, net of which we would have been in line with the guidance. The FX impact in the quarter is positive for about EUR 4 million. Talking about exchange rate, let me please remind you that since our business is exposed to USD-euro fluctuations, we might see some FX headwind for the remainder part of the year, considering where the U.S. dollar is trading now compared with the last 9 months of 2024, which saw an average exchange rate of about USD 1.08 per euro. As a rule of thumb, let me please remind you, as I've done several times in the past, that for every $0.01 movement of the dollar against the euro, DiaSorin revenues move by about EUR 6 million to EUR 8 million on a yearly basis and that the adjusted EBITDA moves by about EUR 2 million to EUR 3 million, again, on a yearly basis. First quarter adjusted gross profit at EUR 205 million, 65% of revenues, is better than last year by 7%, with a ratio of the revenues, which is substantially in line with 2024, which closed at 66%. Q1 '25 adjusted operating expenses at EUR 118 million increased by 3% compared to 2024, with a ratio of the revenues of 38% vis-a-vis 40% last year. The increase at constant exchange rate is just a touch above 1%; and the improvement of the operating leverage, about 200 basis points in Q1, will be the main driver of our margin expansion, as discussed several times over the last quarter calls and during the Capital Markets Day we had back at the end of December '23. Other adjusted operating expenses, negative EUR 4 million, are substantially in line with 2024. As a result of what was just described, Q1 '25 adjusted EBIT at EUR 83 million or 27% of revenues is better than previous year by 13% or EUR 9 million. Adjusted interest income at EUR 1 million is slightly lower than last year, which closed at EUR 2 million, mainly because of lower yield on our cash balance coming mainly from a reduction of interest rate; whereas the adjusted tax rate increased from 23% to 24%, mostly because of the termination of the Patent Box regime in our Italian legal entity. This measure has not been renewed by the Italian fiscal authority, as expected and shared with investors during the last Capital Markets Day. Year-to-date adjusted net result at EUR 64 million or 20% of revenues have increased by EUR 5 million or 9% compared to 2024. And lastly, Q1 '25 adjusted EBITDA at EUR 107 million or 34% of revenues is better than last year by EUR 10 million or 10% with a margin of 34%, in line with our full year guidance. The EBITDA margin at constant exchange rate has increased by about 100 basis points compared to Q1 2024. Let me now move to the net financial position. We closed Q1 '25 with a net debt of EUR 672 million, EUR 55 million more than the end of 2024. This variance is largely driven by the combined effect of a very sound free cash flow generation, EUR 42 million in the quarter, more than offset by EUR 97 million debt towards those shareholders who have exercised their withdrawal rights in connection with the recent adoption of the announcement of the increased voting rights mechanism. Lastly, we confirm 2025 guidance, which is calling at previous year exchange rates for revenues, ex COVID, to grow by about 8%, with COVID sales around EUR 20 million, and an adjusted EBITDA margin at about 34%. Please note that this guidance includes the expected impact of the tariffs recently introduced in the different geographies where we do business. We all acknowledge that the overall scenario is still in flux, but considering what we know today and the mitigation actions we have already introduced and are about to implement, the estimated impact on our profitability is deemed not material. With that said, let me please turn the line to the operator to open the Q&A session. Thank you.

Operator

operator
#4

[Operator Instructions] The first question comes from Kavya Deshpande of UBS.

Kavya Deshpande

analyst
#5

The first one was just on your tariff estimate. So I completely understood that it's a very low exposure, I think you said about EUR 5 million of EBITDA. Could I please double-check what this estimate covers? For instance, does it cover raw materials and component shipments as well as finished goods? And then my second question was on immunodiagnostics. So clearly, the U.S. hospital strategy has been accelerating for nearly 18 months now. Are you seeing any material growth in the menu consumption and revenue pull-through of hospitals that have been customers for a year now? Or is revenue growth here really being driven by new customer wins and new LIAISON placements?

Piergiorgio Pedron

executive
#6

Okay. I will start. Kavya, this is P.G. speaking. I will take the question on tariffs. So what it includes is all the imports from country of origin, let me say, Europe and U.K., into the U.S., which are subject to 10% tariffs. Whereas goods from the U.S. -- our goods, I mean, reagents and med tech goods coming from U.S. to Europe, are not subject to any kind of tariffs. So it's 10% on our exports from European countries into U.S. and goods moving from the U.S. to China, which are subject to 125% tariffs. So this value, the lower than EUR 5 million impact to our EBITDA that Carlos was mentioning, refer to these two flows of goods. I'd like also to say, though, that if we look at what's really happening on the ground in China to this 125% tariffs is that in reality, even though the tariffs are there, what we see when we clear customs is that, more often than not, no tariffs are really applied. And this is, we understand, not an exception for DiaSorin. We understand this is happening more broadly for reagent goods, for diagnostics reagent goods entering into China, which means that if what we are observing now eventually will become a reality, and we know that the Chinese government is talking to the U.S. government about these tariffs, eventually, this EUR 5 million impact can be slightly diminished.

Carlo Rosa

executive
#7

Kavya, I'll talk about now the growth. As I said, this has been an outstanding program. And still, we have a long runway to go. I would say that growth is driven as a combination of new placements. As I said, it's 100 new customers that we added to the funnel every year, plus the fact that typically, in our business, we have an add-on policy. And so we actually go and sell more products to beef up the menu on the existing base. I really cannot tell you the combination -- I mean, the weight of these two effects, but I would assume that placements clearly is at least 70% of growth and then add-on represents probably around 30%.

Operator

operator
#8

The next question is from Jan Koch of Deutsche Bank.

Jan Koch

analyst
#9

I have two, please. The first one is on your multiplex business. I was surprised that this business didn't grow above your full year expectations of 25% in Q1 given the strong flu season and the seasonal effect. Should we expect a weaker growth in Q2 and Q3 given the lack of the flu season? And then secondly, on the planned launch of the NES, could you share your point-of-care strategy? And are you planning to provide placement numbers of this instrument once you have launched it?

Carlo Rosa

executive
#10

Jan, listen, you need to understand that to the contrary of other companies, we don't provide flu, we provide the overall multiplexing base. And we do have a multiplexing business today that the majority of which today is not respiratory, okay? Because traditionally, our VERIGENE I business, which still makes the bulk, obviously, in quarter 1, is nonrespiratory-driven, it was more blood and GI. Therefore, we expect clearly, since we are building a base of respiratory business, we expect that during the next respiratory season, the weight of respiratory is going to be higher, right, than what has been in Q1, for this reason, because we are building a base now of placements of PLEX, which are de facto driven by respiratory. We are going to get approval of the last blood panel, as I said, within the next couple of months. We do have expectations of placements revenues coming from blood, but very limited in 2025, okay, simply because we're building again the base for blood in 2025. So to me, 25% of Q1 is exactly what we were expecting in order to make the overall growth by year-end.

Piergiorgio Pedron

executive
#11

If I can add a comment, Jan, just building on what Carlo said, I believe in the past, we shared with investors that differently from our -- from different players in this space, our respiratory panel, let me call it that way, is about 30% of our multiplex sales. So considering that we have the remaining part of the multiplex business, which, as Carlo said, diverging, I mean, one, it's not growing, you understand that the 25%, including it all, is really what you should expect in order to get the 25% at year-end. So we are where we wanted to be at the end of Q1.

Carlo Rosa

executive
#12

Now your second question about LIAISON NES, I'm a little bit confused because we are 1 year away from commercialization. So we'll talk about LIAISON NES at the right time. Today, in terms of how we're going to be reporting the systems, I'm not really sure where to go on placements. But again, too early to say. Today, what we are focusing on, our effort clearly is to ramp up and submit, and we are on time for the submission, on plan. And then we're working on the distribution strategy that, as you know, it's for LIAISON NES, we always stated that there are 2 markets. One market is pure POL. The other market in the U.S. is within IDN systems where you have a hub-and-spoke model. So for the hub-and-spoke model, the hospital market, we do have the sales force to serve that market. For POL, we don't have the sales force. And as everybody else, we are selecting a distributor to partner with.

Jan Koch

analyst
#13

Makes sense. One follow-up, if I may, on LT (sic) [ LTG ]. Could you help us a bit with the phasing of this business for 2025, given that, yes, you benefited from some phasing in Q1?

Piergiorgio Pedron

executive
#14

So I believe our expectation for the LTG business full year growth is low to mid-single digit. This is where we guided the market. I believe at the end of last quarter call, I said that if you break down the 8% base business growth that we are expecting for 2025, directionally, you should expect molecular to grow overall a little bit faster than 8%; immuno, around 8%; and LTG, below 8%, so this low to mid-single digit. It's difficult to make projection because as you, I guess, might have seen from what other life science companies reported, these cuts to NIH funding in the U.S. might have an impact there. So I believe we will understand better over the next few quarters. Please don't forget, though, that give or take, 50% of our LTG business is going to a diagnostics company. So that part of the business is not going to be exposed to these cuts that we see happening in the U.S.

Operator

operator
#15

The next question is from Maja Stephanie Pataki of Kepler Cheuvreux.

Maja Pataki

analyst
#16

I would just like to follow up a bit about the question that Jan posted on the seasonality of the LIAISON PLEX, VERIGENE business. Now thank you very much for providing again or reminding us again that respiratory is only around 30% of the multiplexing franchise so far. But are you expecting that the high respiratory season in Q1 will be compensated by the number of placements that you're posting in the market, and therefore, you're not expecting to see seasonality impact throughout the year? Or how shall we think about that just to be sure that we don't get into miscalculations? That's point number one. And then point number two, when it comes to the ARIES discontinuation and the impact on the molecular business, you've highlighted 7% growth. Excluding the wind-down of the business, it would have been double-digit growth. Is that how we should think about the business throughout the year? Or what kind of phasing are we to expect in that business?

Piergiorgio Pedron

executive
#17

Maja, this is P.G. speaking. I believe, as I just said, if you need to think about the growth of the overall molecular franchise over 2025, you should expect a number which is -- and that's not a guidance, but it's just if you break down our drivers, the 3 main franchises, a number which is higher than the 8% overall growth. So call it 10%, 11%, 12%. But that is the ballpark of the number you should expect. And if you look at Q1 without ARIES, I believe Carlo said 12%, which is in the ballpark number we would have expected. I'm not sure I understood your question on the miscalculation on VERIGENE and PLEX. I believe what we said is that we closed last year with EUR 60 million. We were targeting EUR 75 million for the full of 2025. If I look at Q1 absolute number, we are absolutely in line with the EUR 75 million target we gave, also considering the phasing. So you should expect, for respiratory obviously, some higher sales in Q1 and Q4. But considering what we source for VERIGENE in the past, we don't expect that to be massive.

Maja Pataki

analyst
#18

Okay. Great. P.G., can I just quickly double-check? When you say like indicative the 8% growth for -- or higher than the 8% growth on the molecular franchise for the full year, this is including the discontinuation, right? This compares to the 7% reported.

Piergiorgio Pedron

executive
#19

Yes.

Maja Pataki

analyst
#20

Okay. So you're anticipating an acceleration throughout the year based on the placement.

Piergiorgio Pedron

executive
#21

Also because the effect of ARIES is going to go away in the second part of the year, right? So yes, also because of that effect, you're going to see some acceleration. And then don't forget, we just got approval of the second panel of blood. The third one is coming. So we're also expecting to have some LIAISON PLEX blood sales in the last part of the year.

Maja Pataki

analyst
#22

Great. And then, Carlo, just very quickly, I'm sorry, my line has been really, really bad, I keep losing the call, did you say that you're a year away from the commercialization of the NES platform?

Carlo Rosa

executive
#23

Yes. What we said is that we are submitting in July, and we are submitting for the CLIA waiver as well. So we expect that before next summer, we're going to have the system approved. The CLIA waiver takes a tad longer than just the 510(k). But this is in line with our plan. So we're going to be working for the -- to start catching the 2025 season -- sorry, '26 season.

Maja Pataki

analyst
#24

'26, right? Okay.

Carlo Rosa

executive
#25

Yes, '26 season.

Operator

operator
#26

The next question is from Aisyah Noor of Morgan Stanley.

Aisyah Noor

analyst
#27

Two left from my side, the first one was on immunodiagnostics. The differential growth between North America of 15% is quite dramatic versus Europe of 4%. Did you see some outsized benefits from the outbreaks in the U.S., for example, which could also continue in Q2? Or was it a combination of the hospital strategy, QuantiFERON, stool and everything else? Just trying to explain the differential growth between the 2 regions. And then a follow-up to P.G. on FX. So just to clarify, based on current spot rates, what is your estimate of the U.S. dollar kind of weakest impact on sales and EBITDA for the full year?

Carlo Rosa

executive
#28

I will take the first one. Look, we have seen a difference in growth between Europe and the U.S. consistently over the last years. And this is because of the fact that in U.S., we have an aggressive strategy, which allow us to make a lot of new placements, again, hospital strategy. Whereas in Europe, for us, is a more mature market. So it's not driven necessarily by placements, it's driven by add-on and new assays. So we always stated that our expectation is that Europe, on a normal year, should grow mid- to high single digit. Now what happened last year, we had clear growth double digit because we had an effect of outbreaks, which we could not foresee. This year, without the outbreaks, but with a continuous volume improvement, which is a phenomenon that we see in Europe and continue to see in Europe and we don't see in the U.S., now we have a 5%, 6% growth, okay? So you should not be surprised as it happened in the last several quarters to see the strong growth in U.S. and more stability in the European market for immuno.

Piergiorgio Pedron

executive
#29

Aisyah, so if I -- in Q1, we had a positive FX impact on our top line, as we said. If I look at the last 3 quarters of 2024, we have had an average exchange rate of $108 per EUR 1. Now we are at $113. We were at $115 in end of April and May. So if I take, let me say, an average of $114, $115 for the last 9 months of the year, I'm expecting a headwind over the full year, right, which is going to wipe out the benefit we had in Q1, of EUR 30 million to EUR 35 million at top line level coming from exchange rate, which is just the usual -- $108 minus $115, $114 times EUR 7 million annualized, and you need to take out the positive effect we had in Q1, and you get to EUR 30 million, EUR 35 million headwind on the top line coming from FX.

Operator

operator
#30

The next question is from Shubhangi Gupta of HSBC.

Shubhangi Gupta

analyst
#31

So my first question is on China. You saw a decline in revenues in China. So could you explain, was it down to volume? So there were more ASP cuts in China? And which segments were impacted more? And yes, I'll follow up with a second question.

Carlo Rosa

executive
#32

Listen, China has nothing to do with volume. China has to do with a terrible situation in China, a double-whammy situation, where you are hit on price severely by VBP and you're hit on your ability to compete against the Chinese local players that today are the preferred suppliers by the Chinese hospitals. That's it. Nothing to do with testing volume. Testing volume actually in China continues to grow around 2%, 3% as we have seen historically, right? So I kept saying now for quarter-to-quarter that China, unfortunately, in my very humble opinion, in the short, midterm is not a growth opportunity at all. It's just limiting damages, hoping for the future. And what's the hope for DiaSorin is that this market will move to a specialist market. Because today, for DiaSorin, what you see, the residual revenues we have are primarily me-too, high-throughput assays that today are noncompetitive and they're becoming very cheap, okay? So the DiaSorin strategy is to resist being there, to activate our manufacturing site and transition our menu to a couple of opportunities that we see. TB is one. We have just submitted, together with QIAGEN, the LIAISON TB to the Chinese authorities, and we expect to get approval in 12 months. So we're going to have a TB strategy with LIAISON that today we don't have, and stool. But if that doesn't happen, so if the market does not transition to a specialty market, I see no good news coming from anybody that today is not Chinese and is not offering distinctive products. Because the Chinese today are very fierce competitors, and they are favored by the local hospitals.

Shubhangi Gupta

analyst
#33

My second question is on MeMed. So I believe there was expectation of JUPITER study results in H1 of this year. Is there any update on it? And what is the update on reimbursement levels for MeMed?

Carlo Rosa

executive
#34

There is no reimbursement. There is no update on reimbursement. As you remember, actually, MeMed itself is taking care of it. And the expectation on reimbursement is not in '25, if I remember, it's more in '26. As far as the study, JUNO, I think -- JUPITER, sorry, they said that because of the great results of the JUNO study, which was actually published last year, they decided to increase the number of certain populations that they were collecting. So they delayed the JUPITER to the second half of 2025. It is because they want to beef up certain populations in order to make the data that already look great on JUNO even stronger statistically. This is the update we have from MeMed.

Operator

operator
#35

The next question is from Natalia Webster of RBC Capital Markets.

Natalia Webster

analyst
#36

Two follow-ups for me, please. The first on the respiratory season and the impact on molecular. Specifically for the targeted sort of legacy molecular business that's exposed to respiratory, are you able to give us an idea of the contribution from the higher flu season here? Is it still the case that around 30% of this business is exposed? And then my second question is just a follow-up on the MeMed BV. Can you remind us how many people are dedicated to pushing this test in the U.S. and what you're expecting in terms of continued marketing investment here?

Carlo Rosa

executive
#37

Sorry, on the MeMed, I cannot take the question or give you an answer on the MeMed because we have a competitor to come. And any of this information, we consider confidential to the business and to the company. We are keeping -- the information I can give you is that we have a dedicated team, which is dedicated now not to develop more business, but to bring home the pipeline that we've been working on, so a number of hospitals that we already met several times in order to educate on the use of the product. So today, our effort is to close all these accounts and get to the 75, 100 accounts closed by year-end, which is our primary target. Meanwhile, we are still working in digital campaigns. The dollar amount, I cannot share. I'm a little bit -- I don't understand the question on respiratory. Can you just repeat it?

Natalia Webster

analyst
#38

Sure. It was just around, you mentioned before, around the multiplex exposure to the respiratory season. I just wanted to follow up on the targeted molecular business and how much that's benefited from the higher flu season in Q1?

Carlo Rosa

executive
#39

I think we said 30%.

Piergiorgio Pedron

executive
#40

Right, more or less. More or less, what we said is that if I look at the past, VERIGENE I, right, because we just launched PLEX -- by the way, Natalia, this is P.G. speaking, obviously. What we said in a few occasions is that different from other players in this space, our business, multiplex business, was kind of less exposed to respiratory season. We said around 30%. And what we also said in the past is that we did not observe, considering our customer base, very material fluctuations of respiratory panel sales from quarter-to-quarter. We had obviously some little pickup in Q1 and Q4, but nothing super material.

Natalia Webster

analyst
#41

Okay. And just a follow-up on MeMed, given the delay in the JUPITER study and the plans for reimbursement there, is it fair to say that we should really see an acceleration in 2026 onwards from the contribution there?

Carlo Rosa

executive
#42

I think so. I think that it's all relative, right? Our immuno is an EUR 800 million franchise. And so acceleration clearly is all relative to the size of the business. Now if you talk about in absolute values, so MeMed growth per se, yes, absolutely. But it's very important for us. What we're really looking, to be honest with you, are two things at the MeMed business, the adoption, so number of hospitals. This is why we are fixated between closing 75 to 100 accounts by year-end; and the volume, the testing volume. Because what we noticed is that when the hospitals are starting using it, then you see an increased adoption, right? Today, our statistic is limited because we have a limited number of accounts. So for us, it's very, very important to demonstrate at year-end that not only we have a base now, but we also have a base that is consuming more of the assay because they learn how to use it.

Natalia Webster

analyst
#43

Great. Sorry, just one quick follow-up as well. On LymeDetect, is there any updates on the progress there towards FDA approval?

Carlo Rosa

executive
#44

LymeDetect, as I think has been disclosed by QIAGEN, but I'm not sure about this, so we are in discussion with the FDA about the clinical study and how to classify patients vis-a-vis the comparator study. So we don't need to do more clinical study at this point, we need to get together more clinical information on the patient sets that we've already run. So stay tuned.

Operator

operator
#45

The last question is from Marianne Bulot of Bank of America.

Marianne Bulot

analyst
#46

I hope you can hear me. The first one is on immunodiagnostic and on the geographies, just wondering how do you expect the different geographies to play out for the rest of the year? Wondering if there were tougher comps in Europe for the full year or if you see some more quarters -- some quarters more impacted by the tougher comps. And my second question is on the tariff, just wondering if you have tried to estimate what could be the impact if there was going to be a tariff from Europe onto goods manufactured into the U.S.

Carlo Rosa

executive
#47

Look, on the tariff questions from now Europe, we're not spending time, to be honest with you, trying to play scenarios because, as you have seen, scenarios are changing by the day. And also if you think about the Chinese, all these announcements about massive tariffs and then shipments today of medical goods are not subject to tariffs. I mean the last shipment for us was clearly 2 days ago. So it's a waste of time. So wait and see. Clearly, the only exercise we did was what is known and may be there to stay, which is the U.S. tariff. And there, as I said, we gave an estimate, which is -- so tariff for us, fortunately, are relatively material. It was very difficult to hear your first question. I think you're asking about immunoassay and trends moving forward and if in the second part of the year, we see that there is less in terms of the effect of outbreaks, if it makes a difference. Actually, the Q2, if I remember correctly, by Q2, beginning of Q3, the outbreak of parvovirus and myco was primarily gone. And so I believe that this effect will ease up in Q4. So Q4, you should see a cleaner effect versus last year. U.S., there was no effect, to be honest with you. There were no outbreaks. The outbreaks were primarily European. So it's a regular trend as far as it is concerned. And then that's it. I think that was the question, I hope.

Marianne Bulot

analyst
#48

Yes, that was the question.

Operator

operator
#49

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

Carlo Rosa

executive
#50

Thank you, operator. Take care. Bye.

Piergiorgio Pedron

executive
#51

Bye.

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