DiaSorin S.p.A. (BIT:DIA)
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Earnings Call: Q1 2025

May 6, 2025

Moderator

Everyone, this is the Chorus Call conference operator. Welcome, and thank you for joining the DiaSorin First Quarter 2025 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.

Carlo Rosa
CEO, DiaSorin

Yes, thank you, operator. Good afternoon, and welcome to the quarter one 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. Quarter one was a very good quarter for DiaSorin. We had revenues of almost EUR 110 million, 7% growth versus Q1 2024. 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 remind you that the guidance for 2025 was EUR 20 million, so we are in line with guidance for COVID as well. EBITDA margin, 34%, is a very solid start of the year, with underlying growth despite micro headwinds. The immuno is back to high single-digit growth.

The molecular respiratory did benefit from the kick-off of the flu season in Q1, and it's a very good start of the year for our multiplexing that grew 25%. I will comment later. Also for our targeted single target specialties in molecular, which is growing now 14%. 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. Our quarter one performance confirms our guidance for four years of 8% growth of base business revenue and 34% EBITDA margin. Now, let's get into the different segments. Let's start from the immunodiagnostic.

The immunodiagnostic ex-COVID should grow 8%, in line with expectations and confirming the strong positive trend of immuno, notwithstanding headwind in China. If you 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. By the same token, we just got approval in China of our LIAISON XL manufacturing unit 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 on China later. Let's look at North America, plus 18%. It continues to be the engine of growth for DiaSorin.

CLIA grew 19%, again, driven by the success of the U.S. hospital strategy. The Quarter One placements are in line with full-year expectation and consistent with the 2025 target of achieving roughly 600 placements of 600 hospitals in the U.S. 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% in Quarter One, driven by CLIA, plus 6%. 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. Strong growth, even if the comparison quarter-to-quarter was unfavorable because, again, of outbreaks that happened in 2024 and did not happen in 2025. 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 the VBP full year is around EUR 5 million. This is in line with our expectations. China continues to be a very difficult market. There is a combination of, again, VBP plus pressure and also competition by local players. Although for DiaSorin, China represents less than 3% of revenue, so the impact for the company is very limited. Last comment, as far as immunodiagnostics is concerned, QuantiFERON continues to be a driver of growth together with the stool panel. In both cases, we registered double-digit growth. We also have a good performance of all the other infectious disease assays.

As far as needed is concerned, our ambition for 2025 is to have 25 new customers ending by year-end, ending with approximately 100 signed customers at the end of 2025. In Q1, we signed 25, so we are in line with achieving as well the target for needed in number of customers by year-end. We see an acceleration of needed, which is a combination of the good result that we published on Juno, plus increased adoption due to all the marketing activities that, together with Luminex, we did in the last two 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 some set at the end of last year.

If we exclude the effect of the ARIES some setting, which is roughly €5.5 million that happened in H1 2024, and we do not see it any longer in 2025. Ex-ARIES, the growth goes from 7% of molecular to 12%, so double-digit growth. Multiplexing, quarter one growth of 25%, in line with full-year expectation. I remind everybody that we share with the market our target to grow the business, the full multiplexing business, by 25% from €60 million-€75 million. Q1, we are in line. 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. 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 to do with our targeted molecular business is the, I call the old DiaSorin brand, which is not multiplexing, it's single- plex. We continue to have a very strong growth in this segment due to our specialty offering. 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 and Market Day in 2023. Respiratory immunoadmin approved last year, blood culture BCY was approved in 2024, BCN approved in April a month ago. We expect BCP to be approved within the next eight weeks.

We are done with the clinical studies for GI, and we will submit GI by the end of 2025. We are in line with expectation and in line with our plans that we share with the market, again, in 2023. As far as customers for PLEX placements, it's noticeable the fact that we now place more systems with flex approach rather than fixed. It's now 60% of customers are using flex, and 40% are using fixed. The trend is certainly that placement and adoption is going to move toward the flexible panel, which is the real innovation that DiaSorin is bringing to the market. 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.

The VERIGENE other panels are stable as expected. On the LIAISON NES , we have concluded the clinical studies in the U.S. We are on track for filing the LIAISON NES , which is our decentralization platform for A to B, COVID, and RSV. We are on track for filing in July 2025, and again, in line with the timeline that was communicated during our Analyst Day in 2023. Next panel to come that is currently under clinical is Group A Strep. We expect that we're going to wrap up clinical, and submission is expected by quarter four 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%.

The strong performance is due to the fact that the immunodiagnostic growth continues to be strong, as well as in pharma customers. This has been partially offset by the result of life science partners, which are more linked to 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 have some bulk shipments in Q1 that will not repeat in the second quarter. We reiterate that our expectation is that LTG by year-end will grow lots of digits. Couple of comments, and Mr. Pedron is going to go through it. U.S. tariffs. Now we're talking about tariffs and counter tariffs, which have been now raised primarily between the U.S. and China because, as you know, there are no tariffs as of today for medical products made in the U.S. and exported to Europe.

The impact for the group is negligible, non-material. We expect that in 2025, the impact at the EBITDA level is going to be below EUR 5 million. 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. A lot of U.S. products are actually manufactured in the U.S. for the U.S. market. We are not exposed to the tariffs. 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
CFO, DiaSorin

Dear Carlo , good morning. Good afternoon, everybody. Thank you for joining DiaSorin Q1 2025 earnings call and for the interest you're 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 training session. Q1 2025 total revenues of EUR 330 million are above last year by 8%, 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, it's much better than the full-year guidance because of a solid performance of immune and molecular businesses in combination with some tailwind coming from a couple of bulk orders of LTG customers, methods 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/EUR fluctuations, we might see some FX headwinds for the remainder part of the year. Considering where the US dollar is trading now, compare with the last nine months of 2024, which saw an average exchange rate of about $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 one cent movement of the dollar against the euro, DiaSorin revenues moved by about EUR 6 million-EUR 8 million on a yearly basis, and that the adjusted EBITDA moved by about EUR 2 million-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 revenues which is substantially in line with 2024, which closed at 66%. Q1 2025 adjusted operating expenses at EUR 180 million increased by 3% compared to 2024, with a ratio of revenues of 38% vis-à-vis 40% last year. The increase at constant exchange rate is just a touch above 1%. The improvement of the operating leverage, about 200 basis points in Q1, would be the main driver of our margin expansion, as discussed several times over the last quarter calls and during the capital market day we had back at the end of December 2023. Other adjusted operating expenses, negative for EUR 4 million, are substantially in line with 2024.

As a result of what just described, Q1 2025 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 market day. Yesterday, adjusted net result at EUR 64 million, 20% of revenues, had increased by EUR 5 million, 9% compared to 2024.

Lastly, Q1 2025 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 2025 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.

Moderator

Thank you, sir. This is the course call conference operator. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the touchtone telephone. To remove your question, please press star and two. We kindly ask you to pick up the phone when asking questions. The first question comes from Kavya Deshpande of UBS.

Kavya Deshpande
Director and Equity Research Analyst, UBS

Hi, Carlo. Hi, PG. Thank you for taking my questions. The first one was just on your tariff estimates. Completely understood that it is 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? My second question was on immunodiagnostics. Clearly, the U.S. hospital strategy has been accelerating for nearly 18 months now. Are you seeing any material growth in 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? Thank you.

Piergiorgio Pedron
CFO, DiaSorin

Okay. I will start. Hi, Kavya. This is PG speaking. I will take the question on tariffs. What it includes is all the imports from countries 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 the agents and MedTech goods coming from U.S. to Europe are not subject to any kind of tariff. It is 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. This value, the lower than EUR 5 million impact to our EBITDA, as Carlo was mentioning, is referred 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 these 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. That this is, we understand, not an exception for DiaSorin. We understand this is happening more broadly for reagent goods, for diagnostic 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
CEO, DiaSorin

Hey, Kavya, I'll talk about the growth. As you 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 said, it is 100 new customers that we add to the funnel every year, plus the fact that it is typical 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%.

Kavya Deshpande
Director and Equity Research Analyst, UBS

Understood. That is super helpful. Thank you very much.

Moderator

The next question is from Jan Koch of Deutsche Bank.

Jan Koch
VP and Equity Research Analyst, Deutsche Bank

Good afternoon, and thanks for taking my questions. I have two, please. The first one is on your multiplex business.

I was surprised that this business didn't go 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? Secondly, on the planned launch of the NES, could you share your point of care strategy? Are you planning to provide placement numbers of this instrument once you have launched it?

Carlo Rosa
CEO, DiaSorin

Listen, you need to understand that to the contrary of other companies, we don't provide flu. We provide the overall multiplexing base. We do have multiplexing business today, the majority of which today is not respiratory, okay? Because traditionally, our VERIGENE 1 business, which still makes the bulk of business in quarter one, is non-respiratory driven, was more blood and NGR.

Therefore, we expect clearly, since we are building a base of respiratory business, we expect that during the next respiratory season, the weight of the 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 said, within the next couple of months. We do have expectations of placements and revenues coming from blood, but very limited in 2025, okay, simply because we're building, again, the base for blood in 2025. To me, 25% of Q1 is exactly what we are expecting in order to make the overall growth by year-end.

Piergiorgio Pedron
CFO, DiaSorin

If I can add a comment, Jan, just building on what Carlo said, I believe in the past we showed investors that differently from different players in this space, our respiratory panel, let me call it in that way, is about 30% of our multiplex sales. Considering that we have the remaining part of the multiplex business, which, as Carlo said, the VERIGENE 1 , is not growing, you understand that the 25%, including it all, is really what you should expect in order to get 25% of TRN. We are where we wanted to be at the end of Q1.

Carlo Rosa
CEO, DiaSorin

Now, your second question about LIAISON NES, I'm a little bit confused because we are one year away from commercialization. We talk about LIAISON NES at the right time today in terms of how we're going to be reporting the systems.

I am not really sure I'm going to go on placements, but again, too early to say. Today, what we are focusing on, our effort clearly is to wrap up and submit, and we are on time for the submission on plan. We are working on the distribution strategy. As you know, for the LIAISON NES, we always stated that there are two 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. For the hub-and-spoke model, the hospital market, we do have the sale force to serve this market. For here, we don't have the sale force. As everybody else, we are selecting a distributor to partner with.

Jan Koch
VP and Equity Research Analyst, Deutsche Bank

Makes sense. Thank you. One follow-up, if I may, on LT.

Could you help us a bit with the phasing of this business for 2025, given that, yeah, you benefited from some phasing in Q1?

Piergiorgio Pedron
CFO, DiaSorin

I believe our expectation for the LTG business full-year growth is low to mid-single digit. This is where we gather the market. I believe at the end of last quarter, Carlo said that we should break down the 8% base business growth that we are expecting for 2025. Directionally, we should expect molecular to grow a little bit faster than 8, immuno around 8, and LTG below 8. This is low to mid-single digit. Difficult to make projections because, as you know, and as you, I guess, might have seen from what other life science companies reported, these caps to NIH funding in the U.S. might have an impact there. 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 diagnostic companies. So that part of the business is not going to be exposed to these caps that we see happening in the U.S.

Jan Koch
VP and Equity Research Analyst, Deutsche Bank

Understood. Thank you.

Moderator

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

Maja S. Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Hi. Good evening. I would just like to follow up a bit about the question that Jan posted on the seasonality of the LIAISON PLEX, VERIGENE in 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 impacts throughout the year?

How shall we think about that just to be sure that we do not get into miscalculations? That is point number one. Then point number two, when it comes to the ARIES discontinuation and the impact on the molecular business, you have highlighted 70% growth, excluding the wipe 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? Thank you.

Piergiorgio Pedron
CFO, DiaSorin

Hey, Maja, this is PG 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 is not a guidance, but it is just if you break down our drivers, the three main franchises, a number which is higher than the 8% overall growth.

Call it 10, 11, 12. I mean, but that is the ballpark, the number you should expect. If you look at Q1 without ARIES, I believe Carlo said the 12%, which is in the ballpark number we would have expected. I'm not sure I understood your question on miscalculation on very genuine plaques. 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. You should expect some correct respiratory offices with some higher sales in Q1 and Q4. Considering what we saw for very good in the past, we do not expect that to be massive.

Maja S. Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Okay, great. Thank you. PG, can I just quickly double-check?

When you say indicative the 8% growth 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
CFO, DiaSorin

Yes.

Maja S. Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Okay. You are anticipating an acceleration throughout the year based on the placement.

Piergiorgio Pedron
CFO, DiaSorin

Also because the effect of the ARIES is going to go away in the second part of the year, right? Yes. Also because of that effect, you are going to see some acceleration. Do not forget that we just got approval of the second panel of blood. The third one is coming. We are also expecting to have some LIAISON PLEX blood phase in the last part of the year.

Maja S. Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Great. Carlo, just very quickly before, my line has been really, really bad and I keep losing the call.

Did you say that you're a year away from the commercialization of the NES platform?

Carlo Rosa
CEO, DiaSorin

Yep. What he 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 510(k) . But this is in line with our plan. So we're going to be working to start catching the 2025 season. Sorry, 2026 season.

Maja S. Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

2026, right? Okay. 2026 season. Yeah, yeah. Right. Thank you very much for that.

Carlo Rosa
CEO, DiaSorin

Yep.

Moderator

The next question is from Aisyah Noor of Morgan Stanley.

Aisyah Noor
VP of Equity Research, Morgan Stanley

Hi. Good evening. Thanks for taking my question. 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 two regions. A follow-up to PG on FX. Just to clarify, based on current spot rates, what is your estimate of the US dollar kind of weakness impact on sales and EBITDA for the full year? Thank you.

Carlo Rosa
CEO, DiaSorin

Okay. Sure. 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. This is because of the fact that in the U.S., we have an aggressive strategy, which allows us to make a lot of new placements.

Again, hospital strategy, whereas in Europe, for us, is a more mature market. It is not driven necessarily by placements. It is driven by add-on and new assets. 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. We do not see in the U.S. Now we have a 5-6% growth. Okay? You should not be surprised, as it happened in the last several quarters, to see that the strong growth in the U.S. and more stability in the European market for immuno.

Piergiorgio Pedron
CFO, DiaSorin

Hey, Aisyah.

If I Q1, we had a positive effect, impact on our top line, as we said. If I look at the last three quarters of 2024, we have had an average exchange rate of $1.08 per EUR 1. Now we are at $1.13. We were at $1.15 at end of April, in May. If I take, let me say, an average of $1.14-$1.15 for the last nine months of the year, I'm expecting net wins over the full year, right, which is going to wipe out the benefit we had in Q1 of EUR 30 million-EUR 35 million at top line level coming from exchange rate, which is just the usual $1.08 minus $1.15, $1.14 times EUR 7 million annualized. You need to take out the positive effect we had in Q1.

You get to EUR 30 million-EUR 35 million headwind on the top line coming from the FX.

Aisyah Noor
VP of Equity Research, Morgan Stanley

Okay. Thank you very much.

Piergiorgio Pedron
CFO, DiaSorin

Thank you.

Moderator

The next question is from Shubhangi Gupta of HSBC.

Shubhangi Gupta
Associate Director and Equity Research Analyst of Healthcare, HSBC

Hi. Thanks for taking my question. This last question is on China. You saw a decline in revenues in China. Could you explain what was it down to, volume? There were more ASB cuts in China and which segments were impacted more? I'll follow up with the second question.

Carlo Rosa
CEO, DiaSorin

Listen, China is nothing to do with volume. China is to do with a terrible situation in China, double whammy situation where you are hit on price severely by VBP, and you are hit on your ability to compete against Chinese local players that today are preferred as 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? I kept saying now for quarter to quarter that China, unfortunately, in my very humble opinion, in short term is not a growth opportunity at all. It's just limiting damages, hoping for the future. What's the hope for the authority is that this market will move to a specialist market. Because today, for the authority, what you see, the residual revenues we have are primarily mid to high throughput assets that today are non-competitive and they're becoming very cheap. Okay? The authority strategy is to resist being there to activate our manufacturing site and then 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. We are going to have a TB strategy with the LIAISON. Today, we do not have any stool. If that does not happen, if the market does not transition to specialty market, I see no good news coming from anybody that today is not Chinese and is not offering distinctive products. The Chinese today are very fierce competitors, and they are favored by the local hospitals.

Shubhangi Gupta
Associate Director and Equity Research Analyst of Healthcare, HSBC

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

Carlo Rosa
CEO, DiaSorin

There is no reimbursement. There is no update on reimbursement. As you remember, actually, MeMed itself is taking care of it.

The expectation of reimbursement is not in 2025, if I remember, it is more on 2026. As far as the study Juno, I think Jupiter, sorry, they said that because of the great result of the Juno study, which was actually published last year, they decided to increase the number of certain populations that they were collecting. 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 looked great on Juno even stronger statistically. This is the update we have from MeMed.

Shubhangi Gupta
Associate Director and Equity Research Analyst of Healthcare, HSBC

Thank you.

Moderator

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

Natalia Webster
European Healthcare Analyst, RBC Capital Markets

Hi. Thanks for taking my questions. 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? 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? Thank you.

Carlo Rosa
CEO, DiaSorin

Sorry. On the MeMed, I cannot take the question or give an answer on the MeMed because we have a competitor to come. Any of this information we consider confidential to the business, to the company. 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.

A number of hospitals that we already met several times in order to educate on the use of the products. Today, what I've heard is to close all these accounts and get to the 75-100 accounts closed by year-end, which is our primary target. Meanwhile, we're still working in digital campaigns. The dollar amount, I cannot share. I'm a little bit, I don't understand the question on the respiratory. Can you just repeat it?

Natalia Webster
European Healthcare Analyst, RBC Capital Markets

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 benefited from the higher flu season in Q1.

Carlo Rosa
CEO, DiaSorin

I think we said 30%, right?

Piergiorgio Pedron
CFO, DiaSorin

Yeah, more or less. More or less, what we said is that if I look at the facts, VERIGENE 1 right, because we just launched PLEX.

Hey, by the way, hi, Natalia. This is PG speaking obviously. What we said in a few occasions is that differently from other players in this space, our multiplex business was kind of less exposed to respiratory season. We said around 30%. 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, super material.

Natalia Webster
European Healthcare Analyst, RBC Capital Markets

Okay. Thank you. Just to 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
CEO, DiaSorin

I think so. I think that it's all relative, right? Our immuno is an EUR 800 million franchise.

Acceleration clearly is all relative to the size of the business. If you talk about in absolute values, MeMed growth per se, yes, absolutely. It is very important for us. What we are really looking, to be honest with you, are two things in the MeMed business: the adoption, so number of hospitals. This is why we are fixated between closing 75-100 accounts by year-end and the testing volume. What we noticed is that when the hospitals start using it, you see increased adoption, right? Today, our statistic is limited because we have a limited number of accounts. For us, it is very, very important to demonstrate year-end that not only do 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
European Healthcare Analyst, RBC Capital Markets

Okay. Thank you. Sorry.

Just one quick follow-up as well. On Lyme Detect, is there any updates on the progress there towards FDA approval?

Carlo Rosa
CEO, DiaSorin

On Lyme Detect, I think it's being disclosed by QIAGEN, but I'm not sure about this. We are in discussion with the FDA about the clinical study and how to classify patients with a better comparator study so we don't need to do more clinical study. At this point, we need to get together more clinical information from the patient sets that we've already run. Stay tuned.

Natalia Webster
European Healthcare Analyst, RBC Capital Markets

Okay. Thank you.

Moderator

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

Marianne Bulot
Analyst, Bank of America

Yeah. Good evening and thank you very much for taking my question. 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 borders more impacted by the tougher comps. 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. Thank you very much.

Carlo Rosa
CEO, DiaSorin

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've seen, scenarios are changing by the day. Also the change, it's not about the Chinese. All these announcements about massive tariffs and then shipments today are not of medical goods, are not subject to tariffs. The last shipment for us was here two days ago. It's a waste of time. Wait and see.

Clearly, the only exercise we did was what is known and maybe dare to say, which is the U.S. tariffs. Dare said we gave an estimate, which is, so tariffs for us, fortunately, are relatively material. It was very difficult to hear your first question. I think you're asking about immuno assay and trends moving forward. If in the second part of the year, we see that there is less in terms of the special outbreaks, it makes a difference. Actually, the Q2, if I remember correctly, by Q2, beginning of Q3, the outbreak of parvovirus and micro was primarily gone. I believe that this effect will ease up in Q4. 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.

It is a regular trend as far as this is concerned. And then that's it, right? I think that was the question, I hope.

Marianne Bulot
Analyst, Bank of America

Yes, that was the question. Thank you very much.

Carlo Rosa
CEO, DiaSorin

Okay. Thank you.

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

Thank you, operator. Take care. Bye-bye.

Piergiorgio Pedron
CFO, DiaSorin

Thank you. Bye.

Moderator

Ladies and gentlemen, thank you for joining the conference. Now, will there any of these disconnect your telephone?

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