Good afternoon, this is the conference call operator. Welcome, and thank you for joining the DiaSorin second quarter 2024 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. Good morning, good afternoon to everybody, and welcome to the quarter two 2024 results. I'm gonna make some introductory comments first at the constant exchange rate, and then I'm gonna leave Mr. Pedron, the CFO of the company, to go through the numbers in more detail. So let's start from the top line. It was a strong quarter. The company ex-COVID grew 7%, and there is an acceleration in quarter two compared to quarter one. When it comes to the COVID business, EUR 5 million and in the quarter, so far in line with our full year guidance of EUR 30 million.
It said is a very strong quarter, and it's a combination of, immunoassay that is growing 11%, with CLIA, which is the major component of this business, growing 13% in the quarter. And this is due to the fact that, US and Europe, as we will see later, continue to provide strong results. China is not still impacted by VBP, even if in the second quarter, we had no growth. But Molecular, +5%, it would have been, as we did comment, before, we lost a contract last year, that has been impacting, first half. Without the effect of this contract, our molecular franchise, they would have grown 8%, and there is no impact of Plex yet, but I'm gonna comment on Plex later.
LTG, in the quarter, -7% deceleration, although I think we need to be more analytical about this result. We see growth in consumable, we see growth in royalties, and we see we continue to see a strong decline in instrumentation as a result of the fact that in the life science sector, our customers placing systems. So the performance in this business, I remind everybody, is fundamentally reflecting what the major biotech and med tech companies that are distributing our products are doing globally. Now, let's dive in into the different segments. So let's start from immunodiagnostic. As said, immunodiagnostic ex COVID, +11%. There is a very strong positive trend on CLIA, so on the LIAISON, also in this quarter, which is the result of the performance of two main geographies, Europe and the U.S.
When it comes to the U.S., as we have seen in the last few quarters, the hospital strategy is working well. We are keeping expanding our presence in the U.S. hospitals, and this is very relevant also for our molecular business, and I will comment on this later. We are well on track to deliver our 2027 plan with 600 hospitals. So far, we are over 300, within H1 we closed 50 new accounts. I remind everybody that the target for 2024 was 100 hospitals, and we are on track to deliver also the growth this year.
Clearly, this has been possible, as I did comment before, on the increased commercial footprint, thanks to the Luminex acquisition and to our menu, which is a combination of specialty products that well fit this segment of the market. When it comes to Europe, very strong performance is around +12% in the quarter, in spite of some headwind with some legacy products like vitamin D. When it comes to Europe, the performance is supported by the fact that we continue to see growth in testing volumes in all the main European geographies, and we see no headwind in front of us when it comes to this volume contribution.
If we now move to China, if you remember, quarter one, we had a positive result, but I warned the market that that was because of an easy comparable to Q1 2023, when there was still low testing volume because of COVID. In quarter two, we in China experienced a high single-digit decrease that makes the H1 almost flat. We don't see the VBP effect yet, but we continue to see headwinds when it comes to the strong competition due to local suppliers and the fact that there is today, I would call it more persuasion coming from the government to buy more and more Chinese-made products. I remind everybody that China does represent today less than 3% of the overall business, so there is not a significant impact on the company results.
However, we continue to stay in China and working to the transformation of the business from a me-too product catalog, which is what we sell today, to a specialistic or specialty business, which is what is gonna be coming with the registration of the QuantiFERON product and the stool product that today are not distributed in China yet. When it comes to other geographies, we are delivering very good results in all the geographies where we are working direct. Australia notwithstanding, we have a very high penetration is growing almost 15% in the quarter and high single digit growth in more established market, Mexico and Brazil, where we have a solid business.
The only area where we are suffering is the Middle East and specifically in Iran, because we had a strong business and because of the local, the current situation, we have not been able to ship products in H1 of 2024. So overall, immunodiagnostics is doing great. When it comes to new products, I want to discuss MeMed and Lyme. Lyme is in line with the plan. We received, remember, we have submitted to the FDA our additional clinical results, and we have received from the agency comments, and we are collecting data for a final resubmission in September. So we are on track to get our product approved by 2025 as per planned.
We are also finishing up discussions with a large lab in the US that is gonna help us to educate the market, because as I understand, we need to make sure that we move the market from current testing into the adoption of the T-cell component. MeMed, the JUPITER study is confirmed to be completed in quarter one of next year, and in quarter three, quarter four, there is gonna be an initial set of data that are gonna be made public. By the end, it continues to be a door opener for us for discussions with hospitals in the US, and we continue the education campaign to [audio distortion] .
So overall, the franchise is doing fantastic in all different geographies, and we are very comfortable with the sustainability of this business mid long term. Now, let's move to molecular diagnostics. As I said, ex-COVID +5% in the quarter without the effect of the lost business last year is 8% growth. And again, there is no contribution whatsoever of Plex, that we just launched two months ago. The legacy, the sort of molecular business, what we call the targeted business or multiplexing, is growing double digits. The Verigene business is holding pretty well, and we—I’m gonna comment on the customer base of Verigene shortly. We have sunsetted the Aries as per planned, and we are transitioning the Aries business to our MDX platform, and it is moving forward as expected.
We continue to see growth in the respiratory. Also, a high single-digit growth in quarter two. This has nothing to do with the respiratory season. That is, you know, will start in twenty... late in Q3, Q4. But it's more to do with the fact that we do have a presence in this business, and we have other infections happening outside the season that are making this business strong. And overall, we have a very good performance both in Europe and in North America. Now, let me make a couple of comments on LIAISON Plex and LIAISON NES. When it comes to the LIAISON Plex, we have a very good start with a strong interest for the LIAISON Plex concept.
I remind everybody that, as we discussed previously, the adoption of Plex testing in the regular customer in the U.S. would grant saving in the range of 30%-35% compared to what they are spending today. Certainly in the current environment in the U.S., it is very well appreciated. We have a customer base in the U.S. of over 800 customers that we have access to. These are existing DiaSorin customers. Three hundred are Verigene users, and then over 300 are hospitals that we serve with our immuno business and are not buying from DiaSorin molecular, and they represent a relevant base to market the new platform. Today is an important day.
We are here in Chicago, in our manufacturing site, and we are hosting an event for investor and analysts to review the strategy and explain the technology, and we are extremely positive about the launch of this platform. LIAISON NES we have conducted and almost wrapped up a preclinical study in Australia with the new assay, the flu, RSV, and COVID. So the complex assay that we have developed on the platform, we are very happy with the results. We have tested the platform in a CLIA-waived environment, and we are ready to start clinicals in October, as we have discussed.
So when it comes to molecular, we're excited and, very excited because, we have a strong business, and we have two very nice platforms, very innovative, that, are hitting the market, now and, within the next couple of quarters. Now, let's move to LTG. LTG, I remind everybody, our LTG franchise is a combination of, diagnostic partners and, life science partners. Diagnostic partners are doing very well, reflecting, the fact that the diagnostic, market worldwide, is experiencing strong growth. In the life science technology, we have, we have partners that today are experiencing, as we all know from public information, single- to double-digit, decline. Net, net result is that, we see an increase in consumable.
We see an increase in royalties, which are the relevant part of this business, and clearly, we see a strong decline in the instrument placements. Because the market fundamentally is frozen due to the fact that there is CapEx restriction in the R&D in university environment. So we continue to monitor the market. I believe some of the partners are highlighting the fact that they expect the life science component to bounce back in the second half. But as far as margins are concerned, clearly the fact that consumables and royalties continue to increase is actually positive for DiaSorin, so it's positive for the company. Now, I'm gonna pass the mic to Mr. Pedron, who is gonna go through the numbers, and then we're gonna make sure this is in.
Good morning. Good afternoon, everybody. Thank you for joining DiaSorin H1 2024 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 DiaSorin during the first half, and I will then turn the line to the operator for the usual Q&A session. H1 2024 total revenues at EUR 589 million are above last year by 2% or EUR 30 million, despite the expected decrease in COVID sales, down by EUR 21 million, and the different perimeter of consolidation coming from the carve-out of the flow cytometry business in Q1 2023. Business ex COVID is growing in H1 at constant exchange rate by 6%, 7% excluding the flow business, therefore in line with a higher range of the full year guidance.
H1 COVID sales in the quarter accounted for EUR 14 million, vis-à-vis EUR 35 million in 2023, confirming our 2024 outlook, which is calling for nearly 30 million. The FX impact in the quarter is not material at all. Q2 revenues ex COVID, constant exchange rate, grew vis-à-vis 2023 by north of 7% to EUR 20 million, thus recording an acceleration toward Q1, which grew 5%. This variance, as we just heard, has been driven by a better performance of both the immune and the molecular franchises, partially offset by the LTG business, because of the generalized softness of the life science market, and in particular, to instrument sales. H1 gross profit at EUR 390 million, or 66% of revenues, is better than last year by EUR 11 million or 3%.
Q2 gross margin ratio at 66% of revenues as well is slightly better than last year, which closed at 65%. All the initiatives aimed at improving operation processes and containing costs, alongside a more structured approach to pricing, which we discussed in the past, allowed us to preserve margins, despite the inflationary pressure experienced in the last 18 months, now muted, and the manufacturing costs we are incurring into to set up our new plant in Shanghai, which has not started production yet. I believe this to be a remarkable indicator of the success of the relentless efforts we put in place to safeguard our profitability. H1 2024 adjusted operating expenses at EUR 229 million are basically in line with 2023, with a ratio of the revenues of 39%, vis-à-vis 40% of last year.
The fact that operating expenses have not increased despite the investment to support the MeMed acceleration program in the US, and the physiological yearly labor cost rise is a clear demonstration of our discipline in managing the cost base, and the result of the synergies delivered after Luminex acquisition, and marks a clear path to increasing profitability in line with the plan presented during the last capital market day. Adjusted H1 adjusted operating expenses are higher than last year by EUR 4 million. This increase is driven by many moving parts, among which I'd like to mention a new tax introduced in 2024 by the Italian government on medical devices companies, equal to 0.75% of sales made to laboratories covered under the Italian National Health System. The yearly impact of this levy should be around EUR 1 million.
Please be aware that this is different, and on top of the Italian payback mechanism we have discussed many times in the past, and that I will cover in a few minutes because there are some news there. As a result of what just described, H1 2024 adjusted EBITDA at EUR 153 million, 26% of revenues, is higher than last year by EUR 9 million or 6%, whereas, the increase in Q2 is 14% or EUR 10 million. Half year adjusted interest income at EUR 2 million is in line with last year, and the same is true for the adjusted tax rate, which closed the first six months of the year at 23%.
Moving now to the year-to-date adjusted net result, we see EUR 120 million, or 20% of revenues, which is better than 2023 by EUR 7 million or 6%, whereas the increase in Q2 is 12%. Lastly, H1 2024 adjusted EBITDA, just short of EUR 200 million or 34% of revenues, is better than 2023 by EUR 8 million or 4%, whereas the increase in the second quarter accelerated to 10%, with a profitability of 34%, vis-a-vis 32% of Q2 2023. Let me now move to the net financial position. We closed June 2024 with a net debt of EUR 781 million, basically in line with the end of 2023.
The free cash flow generated in H1 has been offset by the payment of dividends to our shareholders, some share buyback to support the equity compensation plan for the certain employees, plus some minor moving parts. Before discussing 2024 guidance and opening the Q&A session, let me update you on the so-called Italian payback, which, as I think you will all remember, is a request for companies to pay back part of the regional budget overspending on medical devices covered by the Italian National Health Service. A few days ago, and precisely on July 22, the Italian Constitutional Court ruled in favor of the legitimacy of the law that introduced this mechanism back in 2015. At the same time, though, stating the possibility for each company to settle the amounts due for the period 2015-2018, by paying 48% of the original ask.
Nevertheless, the payment is currently suspended and only upon a new request made by the regions that must recalculate what originally due in the light of the ruling, imposing the reduction to 48%, the amount should become payable. On top of this, to make things even more complicated, the trial will continue before the Administrative Regional Court in Rome, that will judge on the other objections, besides the constitutionality issue raised by the claimants last year. To confuse this saga even further, some operators are considering bringing this case before the European Court of Justice for the alleged violation of EU rules. Now, let's move to what this means for us, for DiaSorin. As you might remember, we have built over the last few years in our balance sheet, a provision against this risk.
Therefore, the latest legal developments are not going to have any impact to our PNL, whereas in the settlement scenario, we would have a net cash out of about EUR 7 million. We are assessing with our legal team and with the Association of Italian Diagnostic Companies, how to move forward, meaning if to settle or keep on litigating, since many things are not clear and determined yet. As usual, we will provide you with an update as things progress. Let me now finish my remarks moving to the outlook. Considering the strong start of the year, we are increasing the 2024 guidance, aligning with the higher range of what previously reported, both for revenues and profitability. To be more specific, the new outlook is calling at previous year exchange rate for revenues excluded to grow between 6% and 7%.
with COVID sales at about EUR 30 million, that is not going to change, and an adjusted EBITDA margin at about 33%. With that said, let me please turn the line to the operator to open the Q&A session. Thank you.
Thank you. This is the conference operator. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their touchtone telephone. To remove yourself from the question queue, please press star and two. We kindly ask you to pick up your phone when asking questions. Anyone who has a question may press star and one at this time. The first question is from Kavya Deshpande with UBS. Please go ahead.
Hi, Carlo. Hi, PG. Thanks for taking my questions. I've got two, please. So the first was just on the U.S. hospital strategy. So I know in the past you flagged that there was only very little overlap between your hospital customers and Luminex's when you acquired it. I was just curious as to the new accounts that you've been adding, have those mainly been from the Luminex pool that you're now bringing over to the immunoassay franchise, or are there brand new accounts here as well that you're gaining traction with? And then my second question was around LIAISON. So you called out MDX as one of the drivers of outperformance here. Was that mainly the respiratory portfolio in MDX, or more balanced between that and the specialty and other tests as well? Thank you.
Hi, Kavya. No, when it comes to the first question about the US hospitals, I would say that the vast majority of accounts are new accounts, and this is because the size of the hospitals served by Luminex was more mid-small. And therefore, when it comes to our current strategy on the LIAISON XL, we are going to mid mid-high volume accounts, which actually you see the effect on the revenue of the US CLIA business is actually growing almost 20%. So the long story short, today, we are really focusing on new accounts, completing new accounts.
As I did comment before, we see Luminex, for the time being, not as a strong contributor to revenues, but as a very relevant asset, to initiate discussions with these hospitals. Second, on the MDX, what we call the targeted, is a combination of two businesses. As you remember, there is an ASR business which continue to thrive as a combination of the fact that we keep launching new products in that segment. And, in the last few years, there are really few players left, in this space. And, we actually inherited this business when we bought Focus from Quest, because it was the outfit that Quest was using to develop the full LDT business.
So it's a very, very nice business, and it's growing double digits for us. The rest of the catalog on the MDX, you know, we have been focusing most of this business in the specialty. And actually this is paying, it's paying off clearly, because we don't have competition in that space. And we are really... We are extremely excited for the Candida auris, because it's been a de novo. It's a de novo FDA case. It's been a long clinical study. We are the only one in the U.S. market to get this product approved. It's raising concern.
So, long story short, we really believe that turning the MDX into a specialty program strategically was a good decision and continue to support the growth of this business.
Thank you very much.
The next question is from Marianne Bulot with Bank of America. Please go ahead.
Thank you very much, and thank you for taking my questions. I have two as well. So the first one is: we've seen obviously very strong performance in North America, driven by the hospital strategy. And so I was wondering if you could give maybe a little bit more colors in terms of profitability impacts from this, this strategy, especially. And the second question is more on your guidance and, the fading into this year. Obviously, you had a strong H1 at 34%, which is above the upgraded range of 33%. So if you could give a little bit of color on the phasing for the rest of the year and if there is anything that could be a slowdown into H2. Thank you.
Hey, Marianne, this is PG speaking. Thanks for your questions. I will start with the guidance one. You know, if you go back and look at the performance of our business over the last few years, what you would, what you would see is that typically in H2, OpEx, so H2 over H1 of every single year, OpEx are kind of increasing for two reasons that we see happening year-over-year. The first one is that we have our salary increase kicking off in July, right? And as you might remember, 65% of our OpEx is in reality labor cost, right?
We expect that this impact to be give or take EUR 5 million additional cost in H2 compared to H1. On top of that, if you look at the phasing of some discretionary spending, we have some of those, let me put, projects, which are, you know, gaining some speed or traction in H2. And my estimation is that from that, we will have an additional five million, give or take, of additional what Carlo was telling you. And it's interesting, if you go back and look at 2023, and you do the same exercise, once you would take out the fact that in H1 2023, we had the immunoassay business, you would see a similar increase.
So, long story short, if you wish, what we see in H2 is slightly more than 32% EBITDA margin with, you know, a similar gross margin and, you know, one point, let me say, give or take, of profitability invested in OpEx, if you can use this word. So we feel pretty comfortable with the 33%. As usual, you know, we like to deliver on what we commit, and this is, I believe, the story about guidance and of the guidance for 2024. In terms of profitability of the hospital business, usually we don't like and we don't disclose profitability by customer segments, right?
As you know, the immuno business is one of the businesses which for us carry, you know, one of the highest margins, so to say, definitely higher than the molecular one. So you have obviously some kind of positive impact coming from that. But also, if you look at the margins of H1, now we have a positive impact coming from the fact that we had a lower, as Carlo was commenting, lower instrument sales in the LTG business and lower export sales, which usually come with a lower margin. So once again, many moving parts, but, you know, the general statement is that immuno business carry very good margins, and hospitals pricing in the U.S. allow us to, let me say, have a margin advantage in sales.
Okay, thank you very much.
The next question is from Odysseas Manesiotis with Berenberg. Please go ahead.
Hello, thanks for taking my question. Sorry, the line is breaking a bit. It's not great here, but one on MeMed, please. Regarding the inclusion of MeMed in some U.S. coastal guidelines, could you please talk about how exactly MeMed was included in the guidelines? As in, is there a first line test in septic patients with respiratory infection? Just want to get, you know, how does it there. And secondly, can you give us, that might be, I might have not heard that because the line is not great, but could you give us a bit more color on the strength of the immunoassay as in the particular test that did well in the second quarter? And may I squeeze in one last one?
So the margin, you're going after the molecular market for growth, not margin, so also taking into account VBP and DRG becoming more of a problem in 2025, is it fair to assume that the 2027 margin should be very back end, as in not seeing much expansion next year? That's it. Thanks.
Hi, Odysseas. So the first question on MeMed was on guideline, not guidance, right? Guideline meaning clinical guideline?
No, it was included in clinical guidelines of hospitals, as in for the ones that have started doing that already. How is it in the first line test or for pediatric patients or?
Yeah, yeah, yeah. Yeah, I think we did comment this before, and I don't think that we have any specific update on that. And again, in short summary, the customers that we have up and running between us and MeMed, this assay, are all customers that have taken the time to implement the testing with, of, MeMed, of the algorithm, B versus V, in a certain patient population that, as we discussed in the past, it really depends from hospital to hospital. Some do decide to start with children, others do open it up to different age groups. And what we see is a variability in the way that different hospitals are actually approaching the problem.
But, I believe that two things are very relevant. The JUPITER study is important because it will remove potential issue of reimbursement. Although today, the assays are reimbursed by the insurance policies, insurance companies, using generic codes, we don't think, believe that this is sustainable long-term, but today we don't see necessarily denials in that area. And including the fact that, as we discussed a few times, MeMed is covered under DRG, right? So it's part of the lump sum that hospitals do get for outpatients. So we're gonna give, as we have discussed, more color on MeMed by year-end, because we will have one year experience in the U.S. and Italy, and I think it's gonna be a very interesting discussion.
What's noteworthy is that also by the end of the year, MeMed is gonna release a subset of data to the JUPITER study, and so the market will have an indication of how things are actually doing clinically with that study. The strength of the immunoassay, which I think was your second question, it goes back again to our specialty strategy, and it's stool, it's the QuantiFERON that certainly are the number one, number two products these days in terms of door openers.
But also the rest of the menu of infectious disease we are experiencing as a result. We do have an infectious disease in most of the European countries. We have market shares of 30%, 40%, and we are experiencing increasing increased intestine volume. So now we see the whole portfolio of products really kicking in. And as we discussed a few times, China is at this point minor damage and it's damage control, and so it does not really influence our inaudible. Okay?
There was one on margin.
One on margin that I think that PG's gonna take.
Yeah. Hey, Mauricio, good to talk to you. You know, I, I believe what we said during the capital market day is that our increase in EBITDA margin is mainly an operating leverage play. I believe you can see it very clearly in Q2, whereby revenues increased by 5% and OpEx didn't increase at all. This meaning that we already have a setup, when I think about our OpEx, which will allow to sustain the growth coming from all the new platforms which are gonna hit the market. We asked ourselves, after Luminex acquisition, you know, what are we gonna do? Do we wanna keep on investing in the commercial organization, waiting for the new products to come? Do we wanna pause?
Eventually we said it was more wise, you know, to keep on investing on our commercial footprint, especially in the US, waiting for the products to come. Now, the products are coming, the Plex hit the market. As Carlos said, XS is doing just great. So, as soon as we will have those products in the market, you will see that, let me say, operating leverage play hitting our PNL. So, I would say, that is fair. Obviously, you know, there are many moving parts. Here is your story, right? My disclaimer, allow me some flexibility, but this is, this is the story. Which is also true, if you wish, if you look at, the guidance for the year, right?
You know, we started with a guidance which was 32%-33%, and after the result of the first half, we felt comfortable enough to raise to raise the guidance. I believe this is what I can, you know, comment and share about, margins and margins development.
Very good. Thank you.
The next question is from Shubhangi Gupta with HSBC. Please go ahead.
Hi, thanks for taking my question. I have one on Plex, please. Can you update the growth momentum in Plex? What is the feedback from customers, and how does it compare to the other instruments and syndromic testing that already exist?
Okay, so the audio was not great, so I think you're asking for Plex, and how does it compare with other existing systems? Is it correct?
Yeah. Yeah.
Okay. As we, I think I've discussed a few times in the past, and we're gonna be covering today, again, as I said, we are here in Chicago. We're very excited. We have a lot of analysts participating and a lot of US investors. So, when it comes to Plex, the fundamental difference between us and competition has to do with ease of use in comparison with bioMérieux, with BioFire, because understandably so, the BioFire has been a very successful platform, but the technology is a little old, and so there is a lot of hands-on time that more modern systems don't have. But fundamentally, the distinctive offering of the LIAISON is with the Plex.
So the ability to flex the panel, depending, optimizing, let me say, the panel with the population, the seasonal test tested by a lab. I'm giving you a very simple example. During the respiratory season, if you look at the prevalence of the viruses, well, first, the majority of the infections are virus-related and not bacteria-related. The second, if you look at the prevalence, you take the top seven viruses, which may vary depending on the population tested, so there is a certain prevalence on kids that you don't see in adults. But with just seven out of potential nineteen targets, you cover 90% of the infections, okay? This is giving you the power of flexing.
If you apply these algorithms that every hospital will be set free to decide, because we offer a basic 7-targets panel that can be and those targets are pretty much decided by each individual customer. If you just do the math, and you look at the prevalence, and you look at what customers are paying today for the full panel of 19 versus flex, you're talking about saving a significant amount of money, 35%-40% to what you're paying today. And the second data point, which I think is very interesting, is that if you look at the respiratory market, just respiratory market in the U.S., that does represent 70% of the total syndromic business.
You look at what an average hospital system is actually spending in respiratory syndromic, you're talking about $350,000-$400,000. So you understand that savings are significant. You're not talking about tens of thousand. You're talking about $100,000-$150,000, which certainly is attracting the interest of many stakeholders in the hospital system. If you now go behind respiratory, and you go to blood, for example, because there is another concept which I think is very important for everybody to understand. Plex is not only relevant for respiratory, Plex is relevant for all different application.
If you look at blood, which is gonna be the second panel that we are gonna launch, we just got the FDA approved, and we are on track to file by September the other two blood panel for approval in the U.S. Right there, you can actually use the panels according to the current guidelines, without forcing customers to use a full panel, a gram-neg or gram-positive patient, which is what they are forced to do today.
So and if you go now to GI, which is the last bucket, that is even more relevant, because when it comes to GI infection, you have stools, you have geographical differences, you have people that are actually traveling in exotic locations and coming back, and therefore you're not forced to do all and everything that is on mother Earth. But you can tailor-made these panels depending on geography. So it's a very powerful positioning for the company. And we just launched it two months ago. We have a respiratory as we speak, and we have a lot of traction coming from customers because of what we discussed. So there is a financial incentive, certainly, to look into this technology. We have closed the first accounts, so we have real-time users of the technology.
We have a good funnel. The last element, which I think I did provide during my opening remark, we have in the US, where we launched the system, by the way, does everybody understand that we just did a US launch for the time being. We have an installed base of roughly 800 customers that are DiaSorin customers, either immuno or Verigene or molecular, doing molecular, not doing multiplexing, that we can address and present this new technology. Vast majority of this would be certainly hospitals, which are either hospitals managed by the very large labs or independent hospitals.
And as you know, when it comes to hospitals managed by very large, by the very large labs, we do have a relationship with the large lab that is allowing us to discuss overarching contracts. Last but not least, the opportunity in this space for DiaSorin clearly is in the conversion, right? As said, we have a sizable Verigene business that certainly we will have to convert. But every time there is a conversion, there is a price increase because of the positioning of the Verigene one. So all in all, clearly, the jury's out, the system is on the market, and I think we're gonna provide more colors coming the next few quarters.
Thank you. Just a quick follow-up. Do you have a number on the install base for Verigene?
... Yes, we do, but, as you can appreciate, we don't disclose. What we have said is that roughly in the US, we have 300 customers using the Verigene one panels, blood, respiratory, and GI. The majority of these customers are non-respiratory, and simply because, the respiratory business, which makes the lion's share of the market, requires the handling of volumes, and, clearly, the Verigene one that is more on hands-on technology did not fit that market. But, and therefore, our Verigene customer base is primarily GI and blood.
Thank you.
The next question is from Aisyah Noor with Morgan Stanley. Please go ahead.
Hi, good afternoon, or I guess good morning to both of you. Thanks for taking my question. My first one is on the immuno growth. I mean, you've had a few quarters of very strong growth already. And I think, you know, you mentioned in the press release, it's 22% growth in the North America immuno business, which is pretty strong. How sustainable do you think this is as you look out into the second half of the year and even 2025? And if you could disclose what the pricing levels are in this business, in the immuno business, relative to historical levels, that would be super helpful. And then the second question is on the LIAISON Plex. What do you think is the...
Well, actually, you mentioned at the beginning of the launch, you were hoping to replace or upgrade as much as possible your installed base of Verigene 1. How far along are you in that replacement phase now, and where are you hoping to be by the flu season in Q4?
I don't remember saying that we wanna replace the existing install base. I said that we're gonna be balancing new customers with the existing install base. Clearly, I'm not gonna provide any data in what we are doing today when it comes to the mix between the Verigene one accounts and what we do with the plex. On the immunoassay, to be honest with you, I don't understand the question, because you're asking if I think this is sustainable long term. I think that we provided the answer in the past few times, because we said that we have 2,200 customers that have been mapped, and they constitute a base that we can work on, primarily U.S. hospitals.
Today, we are really at the beginning of the runway, so I believe that this strategy is clearly sound. Now, we have been pushing in this segment for almost three years, and we continue to see the strong success. Pricing, as you can imagine, I'm not gonna comment on pricing. It is, though, very well known that because of the size of the accounts, the hospital market is a richer market than the traditional commercial segment.
The next question is from Hugo Solvet with BNP Paribas. Please go ahead.
Hi, hello. Thanks for taking my questions. I have a few, please. First on the LIAISON Plex. You guys had the approval of a blood panel last month. Just want to clarify the commercial rollout for blood panels here. Will you be gradually rolling out this one, or wait for the two next ones to be approved before to maximize the commercial opportunity? Just to follow up on that, maybe with six months into the year, seven now, actually, you can help us understand what's baked into the guidance in terms of LIAISON Plex sales, as you likely have some strong links now that you've started to engage with U.S. customers. And lastly, Piergiorgio, you mentioned some operating leverage with new platform.
Just a quick clarification, would you expect that as soon as you launch the new platforms, or will you need to reach scale for operating leverage to be triggered? Thank you.
I will take the first question. Clearly, we need the full panel, so it was the first product that we went through, it did have strategic value for us, because we have negotiated with the FDA how to present the data. And actually, this panel went through, as you noticed, very smoothly. So now we have a framework for gram-positive gram-neg. But certainly, we are not... As we speak, we are focusing on respiratory, and we are not working on blood, because we need the completion on the panel. Then I'll leave the other two questions to PG.
Yeah, I will start with the operating leverage. I believe what I was trying to convey is that, you know, basically, in our projection, the top line is gonna grow faster, much faster than operating expenses. And you already saw it in Q2, and this is what is gonna drive and increase in our EBITDA margins. And when I talked about the launch of new platforms, what I meant is that since we will expand our offerings-
... thanks to the fact that, Plex just reached the market, we're gonna expand the menu, we're gonna obviously launch the product. The next is gonna come, LIAISON, MeMed, you know, all of those programs that we discussed about during our capital markets day, are gonna be very nice contributor to our already existing solid top line growth. As a combination of those, you know, new products platform here in the market, building on the existing, revenue growth and, on a, tight management of our costs, that is gonna, that is what is going to deliver the increase in margins. In terms of, if I got your second question right, you know, I believe you asked guidance on Plex sales. You know, we are not, we are not gonna give any guidance on Plex sales.
I mean, obviously, this is a sensitive topic from a competition perspective. You will see our Plex sales, you know, reported in our total molecular sales. We will give some color, we will try to explain you guys, you know, how the things are going, but don't expect from us a very specific number.
Thank you.
The next question is from Maja Stephanie Pataki with Kepler Cheuvreux. Please go ahead.
Hi, good afternoon. Thanks for taking my questions. I would have three, please. Carlo, you have been commenting on strong European volume growth now for a couple of quarters. Can you maybe provide a bit more insight, what you think is driving the increased volume growth in Europe, and how long is that sustainable, from a market perspective? My second question relates to your commentary around the seven pathogens covering 90% of all reasons for the infection. Is it any seven pathogens that are covering 90%? And are you basically defining the first seven pathogens that need to be tested, or how do I think about that?
Then lastly, just to confirm, the flexibility is not only going to be on respi and gastro, but it's also going to be on blood culture and later on, on the meningitis encephalitis. Thank you.
Hi, Maja. Look, when it comes to the European growth, it's very difficult for me to dissect this number. Because, first, we play fundamentally in infectious disease, right? We are not in oncology, thyroid, I mean, the more mainstream. So I really don't know, first, if this is an overall volume increase or not. I assume looking at, for example, I saw Roche reporting, and they play in that segment, and they had an outstanding result in their immuno franchise. So I assume that you also see a volume increase overall in this more me-too balance. When it comes to infectious disease, it's across the line and across the board, so you see prenatal, you see hepatitis, you see all these assays going up.
When we talk to customers, and these are across geographies, by the way, so it's not just one, it's pretty much everywhere, including countries where like Germany, where typically it's you know, testing is very well controlled from a reimbursement point of view. The customers are saying that as a result of the COVID, there is a resurgence or more attention to overall infectious disease testing. Okay, this is as much as I can tell you. Is this sustainable? I don't know. I think that we are talking about, just to put in perspective, we are talking about a volume growth of probably 3%-4%, versus what traditionally was more into the 1%, because you always see volume increase, but not to this level.
By the same token, I believe that, PG made a good point. We do have now a process in place to control pricing much better than before. We were able—we now see also the effect of this price increase that we negotiated across different geographies with customers, because everybody recognizes that there has been an inf—there is an inflationary effect, effect on the, on the market. Now, if I move to the, to the, to, to, to Plex, yes, Plex is gonna be across the different balance. And I'm gonna make a comment about it later. But when it comes to the seven targets, I'm not deciding the seven targets. The customer is deciding, is deciding the seven targets.
What we are presenting today here in Chicago is the fact that the seven targets, which are primarily viral targets, really depends on the mix of population that in the season. Okay, for example, in the RSV season, it makes sense to include RSV. In the non-RSV season, or, you know, RSV is a particularly widespread between kids and elderlies. And, so when you if you test someone that is more my age, I don't consider myself an old guy, yet it would not make sense to run RSV, for example, if I show up with symptoms, at least as a primary screening. So, but again, just to make it clear, we are not deciding which are the targets.
We are just saying pick seven, and the hospitals clearly have the ability to do what they want. One last comment on flexibility. I believe flexibility is very relevant for the existing panels, but is super relevant also for the future panels. Because if you think, for example, tick-borne is an area where we are present, we are very strong, we are present with Lyme today, where we dominate the market. We are investing with changing in this area, and certainly there is a need of a molecular component to it. Not to Lyme specifically, but to all the other tick-bornes, where we are present with our ASR.
In that case, again, tick-borne, you have ticks, diffusion in different geographies, so it would not make sense to have a fixed panel for that. But customers should be able to adopt depending on season, depending on geography, and depending where actually the patient is coming from. Okay, so to me, flexibility in this environment, I believe that not offering flexibility is a nonsense, is a medical nonsense. And I think financially also is a great incentive for customers. This is the feedback I'm getting so far from the launch of Plex.
Okay, thank you very much.
The next question is from Anna Payne with Barclays. Please go ahead.
Hi there. Thanks. Congrats, guys. Yeah, on the line on behalf of Gaurav Jain here. Just a quick one from me on Plex. You mentioned sort of, I think, over 300 U.S. immuno customers as a potential sort of cross-sell target market for Plex. Just wanted to clarify, do you feel like these customers are existing molecular customers who are with a competitor? Or is this Blue Ocean strategy addressing, you know, new targets to molecular market that can be tapped into as a result of your lower price point? Related to that, just a question on your sales and marketing. You know, I, I'm keen to understand, you know, the extent to which there's cross-selling within, you know, immuno to molecular.
And I guess, sort of, you know, based on that as well, I guess a couple of months into the launch of Plex, do you remain comfortable that your sort of existing level of sales force is sufficient for the rollout of Plex in line with your guidance? Thanks, guys.
When it comes to the 300 existing hospitals, and it's over 300, by the way, these are hospitals that do, all of them clearly do molecular testing, because they are mid-large institutions, hospital systems. Today, remember, when we go and with our immunoassay platform, fundamentally the menu is an infectious disease menu, because you have QuantiFERON, you have stool testing, which is also infectious disease. Then we have the traditional panels for all the prenatal infections. We are an infectious disease company, and this is why molecular fits very well with our existing customer base in the U.S. and in Europe, huh?
Unfortunately, in Europe, we feel that the market for multiplexing is not so developed for many different reasons, and we want to focus today just on the US market. Sales and marketing today, if you look at the funnel, moving forward for Plex, initial funnel, we just started. But there is already cross-selling happening, so 10% of the funnel today are hospitals doing immuno and not doing molecular. Okay? So I see this is why I was referring during the call to a potential installed base of 800 hospitals and commercial labs in the US, and we can reach with our Plex, either because they are Verigene accounts or they are infectious disease people, labs, they do know us, and we can access with Plex.
The next question is from Giorgio Tavolini with Intermonte SIM. Please go ahead.
Hi, good evening or good morning, everyone. Regarding your revenue guidance, is it correct to assume that the improvement is essentially linked to the growth of molecular diagnostic, since after the 4% growth in H1 and 5% in the second quarter? So I was wondering if the original target of a flattish molecular revenue growth should be now understood as flat to low single digit? I don't know. The second question is on the QuantiFERON platform. We have seen the new U.S. guidance recommending the use of the latent TB test in pediatric population.
I was wondering if you are seeing any acceleration in the adoption of this test, and if you see any new developments from the latent TB test. Thank you.
... Look, the new guideline just hit the street, when it comes to TB. And therefore, certainly there is an increased awareness of TB testing in the U.S. I think QIAGEN has been doing a fantastic job in educating this market, and we continue to see an uptake in volumes for this product line. Okay? And I'm leaving to then PG to answer to your first question.
Ciao, Giorgio. On the guidance, you're right. I mean, I think you are looking at the capital market day data, where we said that you know in 2024 we would have expected a flattish molecular growth. In reality, what is happening is that both for the molecular franchise and the immune franchise, we are seeing better numbers than what we originally budgeted for. And for molecular, I believe Carlo said very clearly that you know we are enjoying a very nice growth on the not only on the legacy DiaSorin business, if you wish, the specialty business with ASRs and you know the products such as the HSV, the VZV, all of those high specialty products, high price.
But also, you know, the legacy if you wish, Luminex business, so the Verigene, and the what we call non-automated assays, is doing slightly better than what we originally expected. And that has been able to more than offset the softness that we are seeing on the LTG business, right? Because we are not expecting the life science business to be eating the LTG business. I mean, eventually capable of offsetting the increase we saw on the diagnostic part of the business. So long story short, the answer is molecular, both legacy and legacy Luminex and legacy DiaSorin, and immune business, which grow to such an extent to more than offset the softness we are seeing on the LTG business.
Many thanks, Carlo and Piergiorgio.
Thank you, Giorgio.
See you.
Gentlemen, there are no more questions registered at this time.
Thank you, operator.
Ladies and gentlemen, thank you for joining. The conference is now over. You may disconnect your telephones.