Good afternoon. This is the Chorus Call conference operator. Welcome, and thank you for joining the DiaSorin first quarter 2022 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, and ladies and gentlemen, good morning, good afternoon. This weekend, I will make some few comments. As usual, at constant exchange rate. The CFO, Mr. Pedron, is gonna take you through the numbers. Okay. First, as you know, we have been slightly changing our reporting system after the acquisition of Luminex. Now we have the business, which is divided in three buckets. We have the immuno side. In the immuno side, we have all the technologies that start from CLIA, the ELISA technologies. We have the molecular bucket, and then we have the licensed technology bucket. Let me start to talk about immuno.
Immuno, we look at the ex-COVID part of the business, so clearly ex-COVID, and then we look at the COVID part. Let me clarify first the COVID. COVID, if you remember on immuno, it was the antibody test after vaccination to monitor the antibody titer. Then we had a high-throughput antigen test to be used in hospital settings, when they wanted to have cheaper technology, cheaper than molecular to test personnel. Well, this side of the business is declining sharply. This is fundamentally because there has been no adoption of the serology test or less than what it should be done. This is something.
The fact that government has been fighting the adoption of serology as a way to control immune response against the vaccine because the problem there was to convince the population to get vaccinated rather than the sophistication of the follow-up. We still have a business that is a good business for us, but it's 50% below what it was one year ago, mainly driven by CLIA ex-COVID. When we look at CLIA now, the overall DiaSorin business, we have the CLIA ex vitamin D component, which is growing strongly, 13% in the quarter. We have vitamin D, which is declining a little bit, -5%. That is much more stable than certainly than before.
On the CLIA XD performance, if we look at the geographies, we have the U.S. growing 13%, and we have Europe growing 9%, and we have China, which is flattish, just growing 3%. I'm gonna comment on China later in the presentation. Now, if we now switch to molecular, we have the COVID bucket, and we have the ex-COVID bucket. I understand that when it comes to molecular, numbers are clearly affected by the change in the perimeter that happened after the Luminex acquisition. So I will try to digest the numbers for you. When it comes now to the COVID component, okay, which is molecular COVID, we see 15% decline on average compared to the peak of last year.
This is certainly to do with the fact that with Omicron, we had a very high January and then a sharp decline. The peak of testing, as you have seen reported by different operators in this field, this peak now is much sharper than what it was in 2021. When it comes to the ex-COVID, we have overall a single-digit growth. We've got ex-COVID is a combination of the old of the MDX technology coming from DiaSorin. Clearly, you have all the multiplexing different technologies coming from Luminex. Overall, this bucket is a single-digit growth. Certainly, there is a negative growth in the respiratory and the consequence clearly of COVID. Then we have a growth in non-respiratory.
Primarily, we're talking the gastro panel for the VERIGENE I, the blood culture panel for the VERIGENE I, and then the MDX assays, which, if you remember, were primarily on the non-respiratory side, was for transplantation. We have very nice ASR business that has been used by labs to develop their own LDT. Overall, this bucket of ex-COVID COVID is a single-digit growth component. If we move to what we call licensed technologies, okay. Licensed technologies has to do with the business that Luminex developed when the company was started. Overall, it is around annually a $20 million franchise.
This business, if you remember, it's another business where we have partnerships with some of the main players in the life science business that are actually using our instrumentation and our technology to build their own products, primarily in the space of life science research, basic research, but also specifically there is one player, very important player which dominates the transplantation market, and that player is using our technology. Overall, this bucket, which in terms of profitability is accretive vis-a-vis our overall business, this bucket is growing 14%, okay? That is a consequence of the fact that a good quantity of money is being poured into life science research.
It's a combination of pharma investment, but especially as a combination of grants coming from the governments both in U.S. and in Europe that after pandemic decided to foster the sector, really increasing the number of public spending in this sector. We are benefiting from that trend. Last but not least, the flow cytometry. Flow cytometry, which is a relatively small business for us, it's less than $50 million annually, it's flat. It's a combination of that business actually is split in two. We have some really high complex flow cytometer plus imaging system, and that piece of the business is actually growing. Then we have a more mature set of technologies, a small piece of equipment that are sold to smaller labs. That one is more flat.
In the very specific case, in quarter one, we had problems with delivering some of the system because of the supply chain and unavailability of certain electronic components, which is interesting because so far it's the only area in the company where we're experiencing supply issues with this component. One remark when it comes to the LTG growth, if you remember that last year we launched the INTELLIFLEX, which is the new platform that was developed by Luminex for this sector, and the adoption of this platform by partners is far greater than expected. We had a solid Q1 and we have a strong funnel for quarter two. Which makes us optimistic about the performance of this business moving forward.
Now, if I may make some comments when it comes to different geographies, and I wanna start with the U.S. As you know, today, the U.S. is the primary market for the company. It does represent 50% of our overall revenues. If you look at the strategy in the U.S., we started, as you saw in 2019, really investing in a capillary sales force or a bigger sales force to try to increase our presence in the hospital market. We went through COVID, and certainly COVID did somehow help in the hospital penetration at the time when serology there was a hype of serology in Q2 last year.
At the same time, also it slowed down the installation of some of the systems simply because hospitals were very busy and so in certain cases they could not literally see our technicians in the lab. Overall, as a combination of pause and net, we made our plan. The idea was to create additional 150 hospitals in the network in the U.S., which we are perfectly in line to achieve by year-end. It's very clear when it comes to our product portfolio today, as a combination of what is available with the LIAISON XS, the QuantiFERON, and now the very exciting MeMed opportunity, which is clearly a hospital test.
It's very clear that what we are reflecting is on further investment in our ability to reach this segment of the market, which for us is extremely promising. As a combination of certainly better pricing and better and much interest in tests like, again, the MeMed and the upcoming on the DiaSorin QuantiFERON test for Lyme with high clinical value. Right. Today, what is really paying out is the fact that the company continues certainly to develop its commercial presence, but we are expanding very rapidly into the hospital segment.
The growth you see in the U.S. is driven by a combination of success in commercial lab, but also, again, as I said, expansion in this segment. This is very important because the next generation platforms that are coming on the molecular side, which is the LIAISON NES and the LIAISON PLEX, have been designed for that segment. Okay, it all fits perfectly. You have a funnel of product for that segment, and you have expansion of the customer base and expansion of infrastructure to serve that segment. When it comes to Europe, which today is 33% of revenues, we have solid single-digit growth. We have discussed a few times that for us, Europe clearly is a mature market.
We continue to fuel that market with continuous product, with product that we continue to bring to that market. QuantiFERON was the last one. MeMed BV has been launched in Europe. Clearly, it is not contributing yet to revenues because we are in a phase where we have clinical evaluations which are happening in the major hospitals. The initial response from the hospital and the clinicians is very positive. We are actually running some regional clinical studies because, as you know, every country in Europe fortunately or unfortunately needs their own opinion leader to bless the algorithm and the product.
There is a continuous effort in 2022 in Europe that is gonna be mainly focused in generating this data and promote again the adoption of this product, in the hospital sector. Now, last but not least, is China. China is complicated. China today, for DiaSorin represents, around 5% of revenues. I would say very gladly, we have diluted the Chinese risk. China short term, we see it as a burden and not as an opportunity as a consequence of declining prices as an effect of these very large tenders, provincial tenders that now are in place and are driving price down on average 30%.
The second effect clearly is the fact that there is a priority, official or unofficial priority, call it as you like, to the local manufacturer versus imported products. We believe that as said already in the previous quarter, we continue with the strategy we have. We continue with the set up of the manufacturing site, where clearly we have been hampered by the COVID with the shutdown of COVID in the last month or so. We are in Shanghai, and in Shanghai, as you know, everything has been locked down, so we cannot move forward with what we were foreseeing for the manufacturing site. You know, we believe that this situation is temporary and we will set up. We'll continue the set up of the manufacturing site.
The overall investment in China is over EUR 30 million that we have forecasted to get there. Because we believe that 1.4 billion people market has to be served. The short-term view is negative. I believe that the mid long-term view has to be positive, especially for a company like DiaSorin, which is thriving off some of the specialty products. Okay. Last but not least, I would like to make a comment on the announcement about the fact that we finally found a president for the Luminex business.
Angelo Rago is an American executive from Chicago, 30+ year experience in med tech space, where he has been working in imaging and first and then ophthalmology and later, and has a very specific experience on the issue of the decentralization and the point-of-care setting. That to us was key because Angelo, you know, Luminex moving forward will continue to serve the hospital market, but that's traditional in our sense because we've been there with our products for a long time. By the same token, we need to tackle the decentralization mode and get our products on the NHS to the POL and to the pharmacies.
Angelo's experience is very much welcome to help us out to set up the strategy for the launch of the LIAISON NES. Okay. PG, please go ahead with numbers, and then we're gonna move to the Q&A session.
Thank you, Carlo. Good morning and good afternoon, everybody. In the next few minutes, I'm going to walk you through the financial performance of DiaSorin during the first quarter of 2022. Consistently with work done last quarter, and in order to better understand the performance of the business, I will refer to adjusted P&L items. Therefore, sterilizing the impact of the following, Luminex deal, related elements. The one-off acquisition and integration costs, the effect of the purchase price allocation that we had covered last quarter, the cost of financing, and lastly, the fiscal impact of all of these components. The financial review is available on our website, we are providing a line-by-line bridge between adjusted and IFRS items. That is usual. I'd like to start with what I believe are the main highlights of the quarter.
Q1 2022 total revenues at constant exchange rate grew by 28%. The immunodiagnostic franchise, ex-COVID, grew by 7%, driven by a 13% increase in the CLIA ex vitamin D franchise, which, as Carlo just said, is being partially offset by the expected slightly negative performance of vitamin D, ELISA, and the instruments business, according to the new reporting structure. The molecular business ex-COVID growth is mainly driven by the inclusion of the Luminex in the perimeter of consolidation on top of all of those elements that Carlo covered. Whereas the licensed technology franchise variance year-over-year is obviously all due to the different perimeter of consolidation, but Carlo covered the performance of the business, so I believe we should be fine there.
COVID-19 sales did better in the quarter than originally expected when we set the 2022 guidance, mainly because of the impact of the Omicron variant. Those sales have decreased at constant exchange rate compared to 2021 by 10% or EUR 10 million. Q1 adjusted EBITDA records an increase at constant exchange rate of 10% compared to last year, with a margin of 42% of the revenues. The margin has been positively affected by the COVID sales of the quarter and by a positive one-off of about EUR 2 million that we booked in the other operating expenses. Lastly, we keep confirming our ability to generate a very healthy free cash flow. EUR 160 million in the quarter, with an increase compared to Q1 2021 of EUR 36 million or 46%.
The net financial position is negative for EUR 860 million, with a ratio over 2021 adjusted EBITDA of 1.5%. Let me now please go through the main items of the P&L. Total revenues at EUR 358 million grew by 34% at current exchange rate or EUR 91 million compared to last year. Luminex products revenues in the quarter amount to EUR 97 million. COVID revenues amount to EUR 97 million as well, vis-a-vis EUR 102 million of Q1 2021. The quarter has seen some EUR 16 million FX tailwind, mainly driven by the USD appreciation. Considering 2021 USD euro exchange rate and the current trend, I think it is fair to expect that this positive tailwind will continue for the remainder of 2022.
Q1 2022 adjusted gross profit at EUR 237 million, grew by 28% compared to last year, closing the first quarter with a ratio of the revenues of 66% vis-à-vis 69% of the same period of last year, and in line with the Q4 2021. The difference with Q1 2021 is mainly driven by the inclusion of Luminex in the scope of consolidation. This variance is in line with our expectations and modeling, and is reflected in 2022 outlook. Adjusted operating expenses at EUR 109 million, grew by 61% compared to the same period of 2021, with a ratio of the revenues of 31% vis-à-vis 25% of last year. This increase is in line with our expectations, is once again mainly driven by the different perimeter of consolidation.
We are expecting synergies to reach the level discussed during the Investor Day back in December, as the integration process will move forward. Adjusted other operating expenses are better than last year by EUR 1 million. As said, this difference is due to a favorable one-off of about a couple of million euro that we booked during the quarter. As a result of what I just described, the adjusted EBIT at EUR 126 million or 35% of revenues, has increased compared to 2021 by 10% or EUR 11 million. The income and expenses at EUR 2 million is substantially in line with last year. Adjusted tax rate at 23% is in line with the 2021 as well.
The net result at EUR 96 million or 27% of revenues is higher than previous year by EUR 9 million or 11%. Lastly, adjusted EBITDA at EUR 150 million or 42% of revenues is higher than 2021 by 16% or EUR 20 million. The variance at constant exchange rate is positive by 10% with a ratio of the revenues of 42%. Difference with Q1 2021, which closed at 49%, is slightly better than our expectation and almost entirely driven by the change in perimeter of consolidation. Lastly, let me move to 2022 full year guidance. As usual, in previous year, constant exchange rate. Because of the peak of COVID sales during the quarter, mainly driven by the Omicron variant of the virus, the outlook of the year has been increased.
Specifically, the updated guidance is calling for total revenues substantially in line with 2021, between -2% and +1% to be precise, and revenues ex-COVID to grow by about 24%. In COVID sales set between EUR 150 million and EUR 180 million. Adjusted EBITDA margin between 35% and 37%. Before concluding, please remember that our financials are highly exposed to U.S. dollar, as we said, and even more so now that North America represent about 50% of the total group sales. Therefore, as a rule of thumb, consider that for every 1 cent movement of the dollar against the euro, our revenues move by about EUR 6 million-EUR 7 million on a yearly basis. Now let me please turn the line to the operator to open the Q&A session. Thank you.
This is the Chorus Call conference operator. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their touchtone telephone. To remove yourself from the question queue, please press star and two. Please pick up the receiver when asking questions. Anyone who has a question may press star and one at this time. The first question is from Maja Pataki of Kepler. Please go ahead.
Hi. Good afternoon or good evening to everyone. I have a couple of questions. It's mostly probably clarification to understand results and what comments have been. First of all, congrats on the results. I mean, great results. I'm trying to understand the increase in EBITDA margin guidance. I mean, yes, you are increasing COVID revenues a bit, the upfront, probably the FX is helping as well, but it would be great if you could help us bridge a bit this sudden move from 35%-37%, given that only six weeks have passed since your full year results. That would be my first question. My second question is, can you help us understand organic growth?
Because, I mean, it would be interesting to see what is organic growth or what was organic growth in the quarter, fully ex Luminex, and what was organic growth ex-COVID to understand what the business was. Carlo, just a quick question. I'm not sure I heard it right. Did you talk about the NES instrument, that it will target the hospital base? Did I get that? I'm sorry if I misunderstood something. It would be great to have some clarification. Then just maybe a point to make. It would be really helpful for us if we would have some comparables, either get the quarterly sales figures broken down by the new reporting structure or to get in addition the old reporting structure, because it makes it a bit difficult to follow what is really happening. Thank you very much.
Hey, Maya. Listen, I'll take the... Well, first on the last recommendation, I understand it's complicated, but by the same token, the business has changed, right? The portfolio today is completely different from what we had. We're gonna try to make an effort to make it simpler. In my opinion, it's gonna become more understandable for you when after July, now you're gonna be comparing at constant perimeter. Okay. When it comes to NES, I mean, you know, NES, fundamentally, for NES, there are two markets, two segments of the market.
One is within the hospital, and this is simply because within the hospital, there is a need for decentralization anyway, because on one side there is a core lab, concentration of testing, and then, within the hospital, especially hospital chains, now you have the necessity to take these point-of-care platforms and decentralize in emergency rooms and certain settings, to actually make more efficient the flow. That is no problem because that's the hospital market, is where we operate, is where we are investing, we have infrastructure and that goes along very well with the plex and goes well, goes very well with VNET because, you know, this is all eventually one setting.
In the U.S., what is very interesting is that the buyer, eventually the IHN, they're now owning more and more hospital chains. They actually contract with us the full package, the full portfolio, right? You also give them one contract for molecular, immuno and everything is inside. Clearly, when it comes to this contractual relationship, which are traditionally very difficult with these buyers, unless you have something that is unique. With the fact that we bring to the market specialties like the QuantiFERON, like the VERIGENE, allow us to get into the door and then from there get a portfolio approved, including also the me-too product. Okay, so very no problem there.
Where the problem started, the problem meaning that what's new for DiaSorin clearly now is to take the NES out of that setting and more into the retail pharmacy. If I can make a comment, I believe that, as we have discussed many times, there is a U.S. situation and there is non-U.S. or European situation, let me put it that way. I rule out China completely because as we speak, China is unaffordable anyway for molecular because prices are very, very low, and by the same token, they are going toward their own solutions.
When it comes to the U.S., the POL market these days is concentrating, but by the same token, is also being consolidated within the hospital chain because the IHN see the POL as a way to really get control of the patients. Again, you're gonna find yourself contracting with the IHN and selling through the IHN to the POL. That in a sense is simplifying it. Certainly, capillary will need a distributor, I believe, to serve that market. That is relatively simpler. You have the pharmacy market. Okay, the pharmacy market, in my very humble opinion, the jury's out on what is gonna be that market after COVID, because we know what it is for COVID, which is plenty of money.
You've seen, recently I was following the Walgreens report, and they clearly said they did benefit significantly from COVID testing. Now, are they now going to adopt diagnostics as part of the services provided? From what I'm seeing so far, I believe that when it comes to CVS and the clinic model, that decision strategically has been made. When it comes to Walgreens, I believe that the jury is still out, okay? We need to see. When it comes to the European setting, for pharmacies, the problem there is price, because for most of the relevant European geographies, the government, so the social system does not cover for the test, so it's out of pocket.
What we still need to understand, certainly the out-of-pocket, so the EUR 20 that we think a citizen in Europe is available to spend on diagnostic procedures is good enough to use lateral flow. That is certain, and with the lateral flow cost structure, I believe you can make money there. Jury's still out whether individuals, patients, will be available now to pay more than EUR 20 because there is no way you can make money, in my opinion, selling point of care in pharmacies, for EUR 20 when it comes to molecular. There is where I believe we need to understand better.
The good news is that as a result of COVID, in many countries where in Europe today you could not test, pharmacies could not do any testing, you know, COVID was made as an exception. Now, they are changing the law and testing is allowed. Italy is a very good example where literally yesterday the government is approving a new decree that allows testing in the pharmacies for respiratory illnesses. Now the, you know, the market is open, which is very interesting. We need to understand the pricing situation because reimbursement is not there. Now, PG, can you take. I'm gonna take care of the EBITDA and organic.
Absolutely. Hey, Maja. Good to talk to you. When we try to dissect what's happening to the EBITDA margin for Q1, I believe we need to consider two main factors. The first one is that, in Q1, as said, we had very good COVID revenue. Because COVID revenues are EUR 90 million or so. The one-off effect of the EUR 2 million was mentioned about in my remarks. That is what is explaining basically the 42% EBITDA margin. If you just use the Q1 numbers and you try to, let me say, normalize the COVID sales, saying, Okay, you know what?
Next, for the next nine months, the new guidance top range is calling for, you know, EUR 30 million revenues per quarter. So if you do the math and reverse engineering, Q1 with EUR 30 million of COVID revenues, you would get to an EBITDA margin of 35%, without considering the one-off. Which is exactly where our guidance was. Why now we raised the EBITDA margin guidance? I mean, we had a range now, at least from 35%-37%. Well, the answer is all in the additional COVID revenues that we think we might see in the remaining remainder of the year compared to, you know, our original guidance that, as you know, was set before the Omicron variant and before the Capital Markets Day.
Long story short, the main driver behind the increase, potential increase in the EBITDA margin in the guidance for the full year of 2022 is higher COVID sales. Indeed, we kept the guidance for the ex-COVID sales at 24%. Once again, if you did, you know, if you try to reverse engineer the year to go from now until the end of the year, you would see that in order to meet the 37% EBITDA margin guidance, we are expecting for the nine months we have in front of us, a 35%-ish EBITDA margin. I would move to the organic growth now.
I understand it's kind of more complex now because we bought Luminex, but what we are trying to do is to report sales according to what we did in the Capital Markets Day, when we set, if you want, the new way to look at the business. Three main buckets, as Carlo said, immunodiagnostics, which is absolutely comparable because it's, if you wish, the legacy DiaSorin business, and there we said 7% growth.
Which if you look at the guidance we gave you on the Capital Markets Day, because we broke it down by technologies exactly in line with that guidance, which is calling for 7% growth in 2022. Even by vitamin D, you know, all the things that Carlo explained. I believe that not a lot of complexity there to understand the immunodiagnostic growth, which is, by definition, constant perimeter. If we look at the other two buckets of our sales, molecular diagnostic and license technology. For license technology, it's only delta perimeter of consolidation. I think Carlo made a couple of comments, compared to, let me recall, you know, the revenues that Luminex generated prior to the acquisition.
Carlo said that, you know, in the Licensed Technologies Group you have two components, the so-called Licensed Technologies Group, and this is where we have all the complexity that we're trying to simplify. You know, he said in that bucket, you have what Luminex used to call the Licensed Technologies Group. And there you have a very nice growth of 14%, and then you have, which is the vast majority of that bucket. You move to the complex part, which is the molecular. Because now molecular is a combination of DiaSorin's existing business plus the Luminex business, which is made up of multiplex business and the ARIES platform.
Again, a lot of moving parts there, and I'm making all of these comments without considering COVID. What you see there, as Carlo said, you know, is single-digit growth, whereby you have all those panels which are not respiratory, which are growing nicely, and you have a little bit of negative number for the respiratory panels. Again, I understand it's complex, a lot of different elements, but we think that the right way to look at the business now is, you know, to split it out in those three main buckets, and we will help you out, you know, as long as we will not get too brave to understand the main drivers behind those variances.
Okay. Since you can't give me an organic growth number excluding COVID for the business, can you help me understand the EUR 97 million in COVID revenues that you're booking in the quarter, which part was Luminex, which part was DiaSorin, and within DiaSorin, how much was in immunoassay? The second part that I'm still a bit puzzled about is, look, I know you had strong COVID revenues, but that should not have really been a super surprise in March. I mean, what... It's a bit difficult to understand the strong beat that it's really only down to COVID. I mean, right, I mean, we had an Omicron wave. We had the peak in 2022 in January. You talked about it. And you had numbers fairly late in the quarter. I'm still a bit puzzled to understand, can it really only be COVID?
What was your assumption really for Q1 when you were setting the guidance?
Let me take the COVID part. I'm puzzled myself because we made a very clear comment when we gave the EUR 150 million guidance. The concept is we really have no idea what is gonna be H2. By the way, it's not only us saying that, it's everybody saying that, right? Today, what I'm saying is that compared to my own assumption, I believe that Q1, but more importantly, February and March, because January, everybody was here. You saw a very sharp decline, especially in the U.S., for February and March. Okay. What we are seeing is that the business is holding up better than what we expected. This is why we feel that there is an opportunity to overachieve that number. Okay?
Is it gonna be what we said? Is it gonna be more than that? I don't know. I keep saying I think we all need to wake up in June and look at the H2 scenario at this point, look at what is the adoption of COVID testing. Because look, what is very interesting today, and to my own surprise, is that antigen testing is holding up. Fundamentally because there is a ton of self-testing that is going on, and people don't wanna do molecular fundamentally for a very simple reason, because molecular is more sensitive. And that means that the quarantine period is gonna be much more elongated, to the point that even the government are saying, "Just do antigen testing." Right?
This is in, especially in countries, in the European country, where still when you're quarantined, then you cannot leave your house, you cannot go to work. Second thing is that, so the question is, who is gonna do molecular? Today what we see is that, hospitals continue, for example, to use molecular testing, which is really predictive of, infection activity of the patient for admissions, for healthcare monitoring and so forth. Will this continue? I don't know. If this continue, I think that is gonna be the core business off-season COVID business, because, remember, now we're talking about off-season procedure. Nothing to do with peaks and non-peaks. Now we're gonna be facing the respiratory season.
When it comes to the respiratory season, the big, big question is differential diagnosis. Okay, you're gonna sneeze, and you wanna know whether you have flu or COVID, and you're gonna be sent now by your doc to do a differentiating test. There I believe that molecular is gonna be the choice. You know, you're vaccinated, eventually you got Omicron already because there has been a ton of people that got Omicron, so you have natural vaccination. Then you really are not gonna do testing with the exception of the project population pockets of patients. Nobody knows. I think the industry is saying, I believe we will understand much better in H2 what the number is gonna be. Now, when it comes to the fact that the extra growth may come from the better performance of the current business, I honestly don't think so. PG, please.
No, absolutely. I mean, as I said, the guidance has not changed for the business ex-COVID, which is +24%. You are right, when we commented year-end results, you know, we were at the beginning of March, so we had the visibility of the two months. Now, with the visibility of the four months, which is the double of two, it is very simple. You know, we feel more comfortable now to say that we might end up with EUR 180 million revenues of COVID in 2022 compared to the visibility we had back at the beginning of March. Going to the breakdown of COVID sales, yes, I can help you out there. In Q1 2021, new diagnostic COVID sales were around EUR 24 million-EUR 25 million.
Q1 2022 is EUR 12 million, so half of what we saw in Q1 2021. The Luminex contribution to Q1 2022 COVID revenues and with total molecular, it's around EUR 14 million-EUR 15 million. The remainder to get to the EUR 92 million or EUR 93 million, I can't remember off the top of my head, is all molecular DiaSorin. Which is a recorded decrease of 15% same remainder, molecular DiaSorin, compared to Q1 2021. I believe that's covering your questions.
The next question is from Hugo Solvet of BNP Paribas Exane. Please go ahead.
Hi, thank you for taking my question. Couple on my side. First on the LIAISON XS vitamin D business, strong growth across the board. Can you give us a bit more granularity on what is exactly driving that, gastro tuberculosis, or is the global ongoing? That would be very helpful. Thank you. Second question on pricing, how many price increase would you expect to pass this year? What's the net impact of that, and how your clients are taking them? Any even qualitative comments would prove very helpful.
Last one on my end and on the guidance, so we understand that the guidance is being driven by extra COVID sales in Q1. However, over the past six weeks, since you gave the 2022 guidance, we have had a significantly worsening macro environment. What makes you, I would say, so confident that DiaSorin will not feel any impact from worsening macro in the remainder of the year, and that you will be able to deliver on that guide? Thank you.
Okay, let me take some of the questions. Pricing increase is a very simple situation. There is no price increase. Unfortunately, in our business, very hardly you can pass through your customers your inflation. This is because good chunk of the business is driven by tenders with fixed pricing, by contracts, multi-year contracts with fixed pricing. Very few exceptions, we cannot pass on to customers additional costs. We find or finance the increase of costs with more efficiencies, and this is what we have been done consistently over the years. Keep also in mind that what is working in our favor is that the product lines that are actually growing, so the mix is favorable.
Because the CLIA is certainly much more profitable than the declining ELISA and instrument revenues, so that favors it. The mix within CLIA, selling [multipherum, selling stool and the specialty is clearly affecting positively the overall CLIA margin. That is where in terms of DiaSorin has always been able to safeguard margin notwithstanding price pressure. When it comes to the LIAISON XL, the XL vitamin D growth, to me it's very simple. It has to do with a combination of legacy products, or let me say, not legacy product, but new products which I would call relatively smaller market opportunity of higher price, like hepatitis C, for example, that we launched last year. Clearly high price, high margin, low competition, very small competition.
It's really affecting, contributing to the growth. Plus, two very large buckets of product. One is the, again, the stool diagnostic products. Adoption of some of these products like Calprotectin, for example, continues to improve, 25% year-on-year growth. And we are investing a lot in clinical studies to foster and this growth. Also keep in mind that in the U.S., pretty much for a product like Calprotectin, we, with the product offering we have, and we are unique, and we don't really see competition from smaller caps or smaller players, and/or the big players try to do transitioning.
Trying to transition some of this assay to the chemiluminescence, which failed because of quality and because of the handling of oxygen. That I hope. Clearly with the QuantiFERON franchise, because it's a product that we share with our good friends from QIAGEN. You have seen that they reported good growth in that line, and we can clearly extrapolate. If they're growing nicely on that product line, we are growing nicely as well, because a lot of the growth comes from the fact that we are working together, expanding the customer base and adoption of these assays. Also we are moving from send-outs to in-house testing in hospitals, especially in the U.S., and that really drives, for example. These are the two factors. On the last question.
Yeah, on the macroeconomics, I believe we did consider the changes in the macroeconomic environment we're seeing. You know, to be more specific, if you think about the inflation pressures that we're all seeing and we're talking about, we already you know made some assumptions when we did our budget. We recently reviewed our numbers, and we factored in EUR 7 million-EUR 8 million more on the cost side. In our assumption, which we believe will be covering, safeguarding the margins with all those initiatives that Carlo discussed about. So, with the visibility we have now, because the situation is changing every minute, but with the visibility we have now, I believe we feel comfortable with the guidance we just gave to the street.
Okay, thank you. Just to clarify, the EUR 7 million-EUR 8 million more, is that a change from the initial 2022 guidance to the upgraded guidance?
It's included in the 35%-37% EBITDA margin that we just shared.
Okay.
It's in there. It's included.
Okay, thank you very much.
Thank you. Thank you.
The next question is from Peter Welford of Jefferies. Please go ahead.
Oh, hi. Thank you. Most of it, just really a few quick points of clarity, if you don't mind. Just firstly on COVID, could you possibly just. You've given us a lot of color, but could you possibly just give us also some visibility by geography, if possible? Just trying to understand from the point of view of when we think about the trends, going obviously forwards, but also as well going back in the winter season. If you possibly just in quantifying terms of how much of those COVID sales are U.S., presumably the bulk of Luminex's, and also how much of it is potentially then from Europe. Also then just on serology for COVID, interested to hear that you said that that's down about 60%, year- on- year.
I guess back at the sort of capital markets event, you were a lot more confident, it felt, that that was probably a more durable business at about sort of EUR 10 million-EUR 15 million or something or even EUR 15 million a quarter. I guess, could you talk briefly about what's changed to make governments, I assume, and other academics, less interested in that? I mean, is that a business basically just faded to zero at this point? Then just the other one, quick one, just on MeMed. I think that was filed in the U.S. I guess any commentary at all. I know FDA is very busy and obviously trying to sort out a backlog. Is there any update at all on the potential timing of a possible approval by FDA of MeMed in the U.S., please? Thank you.
Hey, Peter, listen, MeMed, on the FDA approval, I don't feel comfortable making any assumption, to be honest with you, because as you said, today it's impossible to understand their schedule. The very good news, though, on that side is that quite often these days when the FDA is busy, they don't assign a reviewer, so you're kind of put in a queue. Today, we already had a reviewer assigned three months ago, almost right away after the submission, and there is a continuous dialogue with them, with the reviewer. So it's a very active process, which in my opinion, in these days is a very good news. Now, when it comes to serology, I can give you my two cents, to be honest with you, of what is happening.
The first thing I believe that the governments have spent an awful amount of time telling people, "Don't test, just vaccinate." Because testing would add confusion, especially in the U.S., CDC and the FDA. The FDA never, ever allowed anybody, by the way, including ourselves, to report in the packaging set all the data about follow-up studies. I mean, studies about follow-up after vaccination, which we have in the European product. Not allowed in the U.S. product. What they say is that we're gonna be allowing you to report this data, you meaning us, everybody else, only the day that you're gonna show me what is the protective cutoff, you know, which is a very smart way to say forget about it.
When it comes, now, I believe to Omicron. Omicron, I am triple vaccinated, and I got Omicron in a heartbeat. I believe that notwithstanding data that are really proving that, if you are vaccinated versus not vaccinated, the especially for the, you know, fragile population, you get less severity of the infection. I believe that now people, if you talk to the regular people, they see that, okay, you get vaccine, but you're gonna get Omicron, but it's not a big deal. Okay? It's like it's washed out, like, okay, it's another flu and couple of days I'm back in business. People don't wanna hear about follow-up testing and all that jazz. It remains, today measuring antibody titers done academically, by.. On a certain population because people really want to understand what is, I mean, how long these antibodies will last.
Last but not least, if you remember, which is very interesting, until a few months ago, everybody was talking about a fourth shot with a new vaccine, with Omicron variant. I don't know about you, but I've not heard anything new on that side. It is, you know, even on the vaccine industry, there is not an effort any longer to go after this new variant. Long story short, this is what we are seeing. We see a core business that continues. It's mostly with academic clinical studies, large hospitals that are following a certain patient set, but this business is clearly not growing.
Now, when it comes to COVID trend by geography, which I believe, Peter, was your last question, I believe that we see today what we already saw before in the last wave. U.S. declining much faster than Europe. This also has to do, in our case, with positioning of systems, because in Europe, as we have discussed in few conference calls, all our MDX systems are placed within hospitals for hospital admissions and confirmatory of positives that from the high throughput systems. That testing volume is more resilient. There in Europe, we see a 35% decline so far, whereas in the U.S. it's, I mean, we're following the market, it's 70% down, okay? This is it.
That's great. Thank you.
The next question is from Giorgio Tavolini of Intermonte. Please go ahead.
Hi, good evening, or good morning, everyone, and thanks for taking my questions. I was wondering if you could provide us more color on your multiplexing business that you acquired from Luminex. On the cost synergies with Luminex, if you started with some cost synergies in the quarter and the progression for this year. Thank you.
If I may, I think we gave a lot of color on multiplexing business. I believe in a nutshell, as said. We bought a multiplexing company, and there is a business today that is based on older technologies that is resilient, but certainly cannot be grown until the new technology, the Plex, will reach market. Okay. Again, there is appreciation from these technologies, but certainly they are today, they're not allowing much new customers adoption. Today, fundamentally for multiplexing is the respiratory part of the business is becoming relatively small. It spiked because of COVID, but then it's going back to really small numbers. Whereas, what's resilient is more the gastro and the blood culture testing, which is, we think has been a bread and butter of the VERIGENE I business since the beginning. Now, that was the question. What was the second question? About synergies?
Cost synergies.
Please.
If you want, Carlo, I can take it. Yeah. Giorgio, I believe we said during the Capital Markets Day that the overall cost synergies we were committing to were $60 million by 2025. I would say we are very pleased with how the program is moving along. We have initiatives, we have projects, we have owners, we have due date, we have timelines, we have an IMO program, which is, I would say, very well managed. You know, again, I can say is that everything is moving along according to the plan, and you start seeing, you know, again, as planned, as modeled, the impact on our financials.
Okay, thank you.
As a reminder, if you wish to register for a question, please press star and one on your telephone. The next question is from Maja Pataki of Kepler. Please go ahead. Ms. Pataki, your line is open.
Yes, sorry, I was on mute. Just two questions from my side. First of all, can you maybe talk a bit about the instrument placements that you've seen in the quarter? I must have missed that in the press release. Maybe just talk about the, you know, the legacy business, how that is being progressing and then the molecular franchise business. Then just quickly come back to the numbers that you have given me. If I do the math, I see that on my calculations, ex-COVID organic growth was around 2%-3%, and I cannot consolidate that with your very strong and positive notes about all the business lines.
Is it ELISA that has been declining more, or is it China specifically that has been, you know, more of a drag on the organic side? It would be really helpful if you can help me understand what's been going on. Thank you.
I'll take the organic growth. Again, I don't know exactly how the model you're looking at is built. But what I can tell you to add more color is that, you know, on the previous Capital Markets Day, before Luminex acquisition, I believe we said the growth mid- to high-single-digit. This was before COVID, different world. If I look at how we closed the numbers, constant exchange rate, DiaSorin only, without Luminex, I would say that we are there. We are in the range of 5%-6% growth, immuno, and it's the overall DiaSorin business without COVID. More than that, I believe it's difficult to say, we already sliced and diced the numbers in, you know, in two different ways. I believe that's all I can share with you.
Okay, Maja, I think your question is on the installed base, I believe. Right?
Yes, the trend-
I believe.
...in the Q1.
Okay. The trend on the Q1 is that, you know, typically in the Q1, we have a lower number of installations than happens in the other quarters. Last year, the comparison to last year is unfair for the LIAISON XL because in Q1 last year, we installed almost 30 systems.
Yes.
In a very large U.S. lab for the QuantiFERON business, okay? That was one of the peaks that, you know, was made a Q1 hit as an outlier. When it comes to the LIAISON XLs, we are actually starting the placements in the U.S., and I think the overall budget for this year is around 100 systems that we have. When you look at the LIAISON MDX, it is around 15 systems, which is in line with what we are projecting. Clearly we had completely different numbers during the COVID time.
The COVID time in this very specific case is over, and now as far as the NES is concerned, the game here is to defend the base first because you have a lot of crowded labs with a ton of capacity, and now they're gonna make decisions, they're making decisions about which platforms that they're gonna keep and the one that they're not gonna use any longer. All your installed base, clearly now they have the time, because they didn't have the time before, to get more juice. Differentiate the product offering away from just COVID. All in all, I mean, trends for quarter one are in line with our budget expectations.
Thank you very much for that.
The next question is from Hugo Solvet of BNP Paribas Exane. Please go ahead.
Hi, thanks for the follow-up. Just wanted to come back on the supply chain issues and problem in sourcing electronic components, which you mentioned earlier in the call. Just wondering, within your new 2022 guidance, how long do you think those supply chain issues will last? Thank you.
At first, Hugo, I was talking about a very specific case for one system that we offer in flow cytometry, and that is with actually a cable that we are getting from Vietnam and the supply there is, let me say, not certainly solid. Overall, I have to say notwithstanding all the issues you hear from different businesses, our business specifically has, and touch wood, not really suffered that much from availability of components. Also STRATEC, our supplier, did not report so far any issue with the supply chain. There is a cost issue, which is different, and has to do with inflation, which PG, I think, has already discussed about.
The other issue with supply chain that we discussed is the complication of shipping products to China. That is clearly an issue, especially people like us that have their warehouse system in Shanghai and everything is locked down. Again, I think it's black and white, to me. Either in the next two to three weeks, they're gonna open up, or I think we're gonna have bigger problems, and not only us, than what we're seeing today, because Shanghai and also now the Beijing airport are all closed. Especially for people in pharma industry that everybody that has to ship within the cold chain now is stopped, okay?
You know, I'm an optimistic guy, and I believe that this cannot continue for too long.
Okay, thank you for the clarification.
Mr. Rosa, there are no more questions registered at this time.
Thank you. Have a good day to you.
Ladies and gentlemen, thank you for joining. The conference is now over. You may disconnect your telephones. Thank you.