Good afternoon. This is the Chorus Call conference operator. Welcome. Thank you for joining the DiaSorin First Half 2023 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.
Thank you, operator. Good morning, good afternoon, and welcome to the DiaSorin H1 conference call. As usual, I'm gonna go through some comments about the business, and then I will allow the CFO, Mr. Pedron, to go through the numbers. As usual, I'm gonna comment all the numbers at constant exchange rates. We had very good quarter. A quarter with an acceleration of revenues compared to Q1. In fact, the quarter closed at +5% versus Q1 at +3%. That is clearly excluding COVID. I am going to now briefly comment the three legs, so the way we look at the business, immune diagnostic, molecular, and the LTG. Let's start from the immune diagnostic.
The immune diagnostic franchise, ex-COVID, closed in H1 at +7%, with a very strong quarter two, with growth over 8%. There has been a very strong performance of our CLIA franchise, that net of Vitamin D in the first half has grown over 13%. If we look at the different geographies starting from Europe, Europe quarter two was +6%. Ex-Vitamin D CLIA was +11%. Fundamentally, in Europe, what we continue to see is increase in volume, most likely due to rebounding of testing after COVID. We saw this positive effect in Q1, we continue to see this effect in quarter two in all the different European geographies. When it comes to North America, very strong results. In H1, 13% up.
If we exclude Vitamin D, is 19% up. In the quarter two, specifically, 15% over last year, if we exclude Vitamin D, is plus 22%. As you all know, in North America, the program has been mainly focused on the hospital segment. In 2022, we heavily invested in doubling our sales force. We completed the hiring end of last year. Effective Q1, we now have a very complete sales force that is serving the market segment of the hospitals. We have an ambition to close in the next three years, over 250 hospitals, doubling our hospital presence in the US.
As we have discussed many times, we are very successful as a combination of the two systems we have, the LIAISON XL and recently, the LIAISON XS and the products. Mainly, I would like to mention clearly the QuantiFERON together with our stool franchise. These products together are actually driving interest of customers that typically in this segment, have been sending out products. With the viability of our, of these products and the systems we provide, we can in source and making clearly this testing profit center for the hospital. It, it's working very well.
We look outside of Europe and North America and the rest of the world, I believe that the good news is that China, that has been real driving in quarter one, did actually stabilize in quarter two. In quarter two, for the first time, we have seen a modest growth in CLIA, this is certainly very positive. I think that we continue to be very cautious about near-term opportunities in China because of the current very rapidly shifting policy towards China-made product, as we continue to become more and more popular in our customer base.
Although, it is certainly true that we have invested significantly in turning our commercial sales force with new leadership and changing our distribution network in China, and I think we start to see the first positive effects. The other element, which I believe is very important, is that now that we are close to opening our manufacturing site, is very clear to the customer, the direction that DiaSorin is taking in China to become China-based. Indeed, I believe it's certainly helping the business. Again, I'm very cautious about the future because as we did comment a few times, China is unpredictable in the short term. Let's see how it goes, but certainly a good news.
In all the other geographies, where we are direct, Brazil, Mexico, and Australia, we are enjoying strong growth in the immuno assay franchise, and clearly related mainly to our traditional infectious disease product line. The other thing that I think is very relevant to discuss is the fact that for the first time in the post-COVID era, we've been launching new products. Specifically in Q2, we launched two new products from the LIAISON XL, the new general test, and the MR-proADM, a very interesting product that has been developed together with Thermo Fisher Scientific, with a license coming from Thermo Fisher Scientific. I think finally, after two very difficult years of COVID has consumed our R&D resources in 2020 and 2021.
Now, starting from 2022, we restarted the development, and now you see a few new products that are hitting the market, taking us back to where we were prior to the COVID pandemic time. This is, I think, great. The other thing I would like to mention is that, with specifically related to the U.S., we really start to see the effect of the critical mass that we were able to build as a consequence of the Luminex acquisition. As I think we have discussed strategically, DiaSorin wants to improve the footprint in the U.S., and sees itself as a U.S. company when it comes to the future.
It's very clear that the Luminex acquisition gave us the brand, the visibility, the footprint, and the resources which are now very useful is now in launching all the new products that they will bring into the market. As a intangible or tangible value from acquisition, critical mass clearly is paying out. Last but not least, when it comes to Luminex, as we have discussed, I think in the last conference call, we decided to increase our spending in marketing and providing commercial coverage for the launch of the product. We have hired the dedicated clinical reps that are needed to go and solicit demand with the clinicians.
The dedicated new sales force now is staffed, being trained, and started from COVID, and we start to hit the market together with other tools like the digital campaign, in order to create demand for this very interesting product. Now, if we move to molecular diagnostic, ex COVID, the franchise in the first half is relatively flat. Is a combination of low growth in respiratory, and we have a very good performance in the syndromic panel with Verigene , which is partially affect offset by the flu-only test that we carry on the NES. I remind you that this is an effect of the last few seasons, that was really strong in quarter one, and therefore, relatively weak. Sorry, relatively strong in quarter four, and so relatively weak in quarter one.
In the non-respiratory, we are a decline of roughly 5%, but it is primarily due to the fact that, as we have discussed, we lost a contract with a very large lab for CF, and now in the Q2, we start to feel almost a full loss of the revenues related to this product. Cystic fibrosis, the growth is low single digits. Considering the fact that our molecular, our molecular business today, when it comes to the syndromic, still relies on technologies which are very solid, but certainly they are showing sign of time, to put it that way. This business is extremely resilient.
Certainly, we are waiting for the Plex for now to invert from a stable business and go back to growth. When it comes to the Plex, we have completed the clinical studies for the respiratory panel, and we expect a filing in Q4, and approval by the next by next year respiratory season. When it comes to the LIAISON NES, same thing. Clinical study started in Australia, because now, as you know, flu season will continue in the U.S., and we expect a filing in the U.S. of the ADC, so the flu and COVID product at the end of the coming respiratory season. Last but not least, is our Licensed Technologies business. I think we all need to remind ourselves the fact that quarter one was very weak.
We did comment last time that Q1 was weak because we had a backorder, significant backorder, still of instruments due to the supply chain issues that we still encounter till the end of last year. Quarter two is completely different. As you had seen, we had double-digit growth at 10%. This is primarily due to the fact that we were able to close our gap, and now we have availability of spare parts. We are able to make systems and, we ship all the instruments that were in backorder. I believe that, as you have seen from other competitors, when it comes to the life, the Life Science business, we see initial signs of slowdown.
Therefore, a little caution that the double-digit growth in quarter two should not be intended to be what we believe this business can continue to perform in Q3 and Q4. We really need to understand, I remind everybody, this is a B2B business, so we actually sell, relatively small portion of these revenues come from direct sales to customers. Most of the revenues in this business come from B2B with, some of the largest, life science companies in the U.S. We are waiting to see the way that, they're going to be forecasting Q3 and Q4, then to provide an expectation to what we believe is going to be around the beginning of next year. Just be cautious. Don't take the +10% of Q2, of quarter two as a, as a true running rate.
Couple of comments. very good news, we actually received from the FDA on the closing of the warning letter. This was a significant effort by the company, and couple of years of solid work by our quality assurance team and regulatory brought us to, again, brought the FDA to close the warning letter. we are going back to the regular business, where we made significant investments in the quality system of Luminex. We remember the DiaSorin quality system, and therefore, we are confident that moving forward, we are gonna be able to work in an FDA environment, also at Luminex, according to the most recent standards.
Last but not least, when it comes to the synergy and integration plan, glad to report that we are on time, and we expect by 2023, a running rate between EUR 50 million and EUR 55 million in cost synergies as provided in our long-term plan. At this point, I'm going to turn the microphone to Mr. Pedron, and then I'll take questions after him. Please go ahead.
Thank you, Carlo. Good morning. Good afternoon, everybody. In the next few minutes, I'm going to walk you through the financial performance of DiaSorin during the first half of 2023. I will make some remarks on the contribution of the Q2. Let me please remind you all that consistently with what we did over the last earning calls, to better understand the performance of the business, I will refer to Adjusted PNL items, therefore sterilizing the impact of the Luminex deal-related elements. As we did over the last few quarters, I would like to start with what I believe are the main highlights of the period.
H-one twenty-three total revenues at constant exchange rate decreased by 16%, whereas the reduction at constant perimeter of consolidation, which means without the contribution of the flow cytometry business that we carved out in February 2023, has been 14%. This result, which is in line with the full year guidance, is a combination of the expected fall in COVID sales, the carve-out of the flow business, partially offset by a growth in the ex-COVID business of around 4%.
To be more precise, ex-COVID revenues at constant exchange rate and perimeter of consolidation, without the contribution of the molecular respiratory business, grew by 4.2%, with a contribution of very good performance of the immuno franchise, plus 7% in Q2, which saw an acceleration compared to what we achieved in Q1, moving from the 60% of the Q1 to 8% of the second. A recovery of the LTG business, which closed Q2 2023 with an increase of 8, 10%, therefore, ending the half year with a growth of 2% compared to 2022. Lastly, a slightly negative performance of the molecular franchise, net of the respiratory business, driven by the budgeted loss of the cystic fibrosis business that Carlo just mentioned.
The molecular business, respiratory business, recorded in the first six months of the year, a performance substantially in line with 2022, +2%, to be precise, as a combination of an increase in the Verigene I respiratory panel, which offset a decrease in the flu and flu-only molecular testing for the reasons that Carlo just commented. H1 Adjusted EBITDA at EUR 190 million, or 33% of revenues, is substantially in line with the full-year guidance. The decrease compared to last year, EUR 79 million, 29%, is mostly driven to the drop in COVID sales, therefore, to the corresponding worsening of operating leverage. We generated EUR 104 million of free cash flow in the first six months of 2023, down EUR 34 million compared to last year.
The variance, once again, is mainly driven by the falling COVID sales, whereas the non-recurring saving events, which I talked about during Q1 2023 earning calls, have mostly been offset by the expected strong performance of Q2 2023, which grew to the free cash flow generation of EUR 76 million. Now, before moving to the PNL, let me provide you an update on the so-called payback system for medical devices in Italy. As you might remember from the previous earning calls, this measure originally introduced in 2015 by the Italian government and never implemented since then, has been eventually reactivated in September 2022. With the goal of rationalizing public medical devices spending, this scheme requires companies to pay back any sum exceeding the budget allocated by the central government to the Italian regions.
Specifically, the law obliges vendors to return to the regions about 50% of the turnover exceeding the medical devices cap, fixed for the period 2015, 2018. Please note that even if the September 2022 law decree covers only four years, as said, 2015 to 2018, the payback could be potentially extended in the future to the subsequent years. What has happened? Practically, all the operators, including DiaSorin, have filed a legal appeal to the competent courts to challenge the decree covering the years 2015, 2018. In particular, the Administrative Regional Court in Rome has been charged with more than 1,800 recourses to suspend and annul the payback regulations.
The payment due date, originally set for January 2023, after being postponed a few times, was set for the end of July. Based on the most recent news, might be postponed even further till the end of October. Moving from this very complex situation, reach of legal controversies, the government recently issued a law introducing the faculty for each company to settle disputes relating to the period 2015, 2018, by paying 48% of the total amount requested by the region. By renouncing any pending legal litigation. We are assessing the possibility to adhere to this settlement. No final decision has been taken yet. Please note that before September 2022, reactivation of the payback mechanism, DiaSorin had already built in its balance sheet a provision based on information available back then. It's a relative risk assessment.
Therefore, the potential settlement, as we just discussed about, would be covered with the provision booked in the past and would not have any impact to the PNL of this year. Pending more clarity on the legal front for the years following 2019 and the amount already booked for in our balance sheet in the past, we have not changed our provision for the period 2019-2022, and we have not accrued anything for 2023. We will keep on monitoring the evolution of this very complex and daily changing situation and update you during the next quarter course. Moving on to the PNL, H1 2023 total revenues at EUR 576 million, as we said, decreased by 16% or EUR 109 million compared to last year.
This variance, completely due to lower COVID sales, which in the first half are down by EUR 150 million, or 77% compared to last year, and the disposal of the flow cytometry business. I think it is worth noticing that the Q2 recovered some EUR 6 million FX headwind, mainly driven by the US dollar depreciation compared to the euro. Considering the current exchange rate and what we had in H2 2022, I believe it is fair to expect this negative FX impact to continue in the second part of the year. First half, adjusted gross profit at EUR 379 million, decreased by 16% compared to last year, with a ratio of the revenues of 66%, in line with the same period of 2022.
The carve-out of the flow cytometry business, alongside all the initiatives aimed at improving operations, processes, and containing costs, some of which part of our broader cost synergy plan, allowed us to preserve margins despite the reduction in COVID revenues and the tail of the inflationary pressure we talked about in 2022. I believe this to be a remarkable indicator of the relentless efforts we put in place to safeguard profitability. Which has been confirmed by Q2 '23, which goes with a gross margin ratio over revenues of 65%. H1 '23, adjusted operating expenses at EUR 230 million, grew by 2% compared to last year, with a ratio of revenues of 40%, vis-a-vis 33% of 2022. The worsening of the operating leverage ratio is entirely due to the reduction in COVID sales.
Moving to Q2 '23, adjusted OpEx decreased compared to last year by 1% or EUR 1 million, with a ratio of revenues of 40%, vis-a-vis 36% of last year. This OpEx reduction is the result of all the initiatives we implemented to control cost, the impact of the cost synergy plan that also Carlo just mentioned, and the disposal, obviously, of the flow cytometry business. Adjusted other operating expenses at negative EUR 4 million are substantially in line in absolute value with 2022. As a result of what we just described, H1 '23 Adjusted EBIT at EUR 144 million, or 25% of revenues, has decreased compared to 2022 by 35%.
Adjusted interest income at positive EUR 2 million, is better than last year by EUR 6 million, mainly because of improved yield on our cash investment, whereas the adjusted tax rate at 23% is in line with 2022. Year to date, adjusted net result at EUR 113 million, or 20% of revenues, is lower than previous year by 33%. Let me now move to the net debt position. At the end of June, the net debt was negative for EUR 861 million, vis-a-vis negative EUR 907 million at the end of 2022.
This improvement has been mostly driven by the operating cash generated in the first six months of the year, partially offset by the payment of just short of EUR 60 million dividend to our shareholders in May 2023, and EUR 23 million of treasury shares to buy back. Lastly, we confirm 2023 guidance, as usual, expressed at previous year exchange rate. Let me finally please remind you that we have, built in our assumption, an average respiratory season, and the 2023 guidance, as I just said, does not include any possible impact from the payback mechanism in Italy. Since the whole situation is in flux, and the most recent news, which has personally been positive and pointing in the right direction, has made even more difficult to make any reliable prediction on what is going to happen.
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 the touchtone telephone. To remove yourself from the question queue, please press star and two. We kindly ask you to pick up the handset when asking questions. Anyone with a question may press star and one at this time. The first question is from Supriya Gupta from HSBC. Please go ahead.
Hi, thanks for taking my question. Are you seeing any impact from biotech funding cuts? Can you please shed some light on that? Secondly, is it possible to give a margin according to the business, like, how does molecular diagnostic margins compare to immunodiagnostics and Licensed Technologies? Third, on MeMed, maybe, are you seeing any resistance from physicians in adopting the test, and what is the workflow for that? Thank you.
Could you want to take the margin question first?
I will. Sure. We don't disclose, the exact number, you know, the different margins between the 3 business franchises that we are, immunodiagnostic, molecular diagnostic, and LPG. Ballpark number, you should consider that immunodiagnostic and LPG have a higher margin compared to molecular diagnostics, and this is kind of a standard in the industry. You can, let me say again, broadly consider a difference between those two franchises, immuno and LPG, very similar margins compared to molecular, which are slightly lower, but we don't disclose the exact margins by product line.
Okay, I will take a minute on the biotech. I think that it should be clear to you that we don't, we don't sell to the end user customer. We sell, again, to the very large biotech company that then serve that market. I see that if you listen to what Thermo Fisher Scientific has been saying yesterday, reporting yesterday, I believe, it is, it's gonna give you part of the story. I think there is a slowdown in some of the segments, we don't see it yet.... that we may see it in the, in the following 2 quarters, and this is why we're cautious about projecting double-digit growth of our LTG franchise.
Another effect that we have seen is destocking, this is certainly true, because some of the partners, which traditionally have been relying on six to nine months of inventory, are reducing inventory, and this has to do with, clearly increased cost of capital and need to manage the working capital, right? Diana, you know, I believe the LTG will continue to be a solid business. I believe that sooner than later, all the funding that has been made available in the US, and in Europe, through the new initiatives, will support growth, especially in the academic environment. Again, I'm just cautious about Q3 and possible Q4.
When it comes to MeMed, I think it's a little early, meaning that so far we have seen that there is significant enthusiasm by the clinicians because the data that MeMed has been supplying and have been used for the registration of the product, also with the FDA, this data are extremely convincing. The value of the assay ruling out the bacterial infections, I think is so far all the clinical studies done also by local hospitals, have demonstrated that the value is there.
I believe next step, especially in the U.S., is to find a budget, because today, as you know, this test is not reimbursed by the payers, otherwise is will be part of the DRG funds that each hospital get for the emergency room visits. I believe the jury is out, but what I've seen, and again, is an initial effort, is that the physicians clearly see the value. Now is the administration has to, two things have to happen. The administration will have to accept investment, and there are some of reason to do so, because there is a significant saving in the fact that if antibiotic treatment and also hospitalization of patients.
Clearly, now MeMed and DiaSorin are working heavily with payers in order to conclude a clinical study that is ongoing to provide evidence then for the payer to provide a dedicated reimbursement for the essay. That event, I think, if met, would unlock the full potential of this product.
Thank you. The next question is from Maja Pataki, from Kepler Cheuvreux. Please go ahead.
Hi, thanks for taking my question. Carlo, just to start maybe with your last comment around MeMed, as you said, you believe that, you know, getting the reimbursement would unlock significant potential. Do you have any feeling for a potential timeline? Are we looking at 6 months, or is it 12 months from now when you expect to have the reimbursement that could start to drive the growth there? My first question. My second question is a bit of the full year guidance and the margin side. You guys Adjusted EBITDA margin of around 34%. You were around 33% in the first half of the year.
Is it the synergies that start to come through, more and more, that are going to drive the margin profile in the second half of the year? Or is there anything from a revenue mix that is going to start to drive margins up? Lastly, on the Italian payback system, and I'm fully aware of the fact that there are a lot of unknowns there, did you actually commented that there is this proposal that you could pay 48% of the current request, financial request. Would you. Therefore you would have to sign that you know, you step back from all claims, would that also mean that you would, in the future, not be able to appeal against it?
Would that basically mean, like, every time something is introduced, it's a fair new game and you could do whatever, you know, whatever happens? Thank you.
If you really make a one page, I'll comment on the payback, and then let's see if that would be enough. This payback story is a typical Italian soap opera, because the government went back, if I may. Being Italian, you know, I cannot be accused of not being chauvinistic, but it's very confusing, and I think it's an attempt to get resources when needed by the healthcare system, but it's the wrong, wrong way to do it. This 48% seemed very palatable because it was until a few hours ago, because it was a way to seal a deal, pay 48%, and forget about it, right?
It would be without a course, so you will not be able to then go back and claim the money, and claim your money back. I think it would really change the situation has been the ruling of this TAR of Lazio, right? which pretty much said without saying that there are doubts about the fact that this is even possible under the Constitution. I believe that if prior to a few hours ago, I think the world was split in two. Some of the large companies that were inclined to pay, and clearly all the small companies that would have would suffer from strong financial impact, not available, really, to pay or to agree to the 48%. This ruling, I think, moved pretty much everybody toward the meeting, okay?
This is what most likely we are going to do ourselves. As said, it's an Italian soap opera. We have seen this many times. I believe that in the future, if well conceived, this is something that can be set in place, and we will have to understand how to deal with it. To go back and claw back from the past, I think is unfair, but very complicated, okay? I'm relatively positive about this payback, but stay tuned because we need to understand how they're going to organize it moving forward. Second thing on MeMed, on the reimbursement. Look, Maja, you know and I know that in the US, to the contrary of the European model, it's the system is profit-driven, okay?
I'm not saying it's only profit-driven, but certainly coverage of reimbursement does help in a situation where most of the hospitals are maybe not going back to the pre-COVID situation, which means they're losing money. We will MeMed, agreed to spend a significant amount of money in a clinical study intended to provide all the evidence to the payers. The study started, and is going to take, I believe, without being too optimistic or pessimistic, around 12 months to be completed, then you have the filing. I would say that no later than 18 months before you get a ruling from some of the main payers, okay?
For the next foreseeable future, we will need to live with the clinical value and the fact that the hospital receives a DRG reimbursement, and they see value in bringing the test in. Clearly, what I've seen, Maja Pataki, and it's counterintuitive, you know, right? When you go to the very large institutions, where you do have a very strong clinical group, the adoption rate is not as fast as you would think, because in the very large clinical institutions, they want to generate their own data, right? Yes, the administration is weaker, but by the same token, all these clinicians, they want to do their own, their own studies, and takes time. They also have plenty of technology for standard of care, okay? It's not that they are lacking tools.
They have all the tools, that are more expensive, and they would see this clearly as a way to simplify their life. If you go in the periphery, if you go in the in smaller institutions where they do not have the technology and they're not so sophisticated, this is. The adoption rate actually is way, way faster. Okay. Today, you are forced to go to some of the institutions to create scientific interest, but the real market is actually in the periphery. Again, driven by the fact that they need some cheap tools to serve these patients. I hope that, you know, it's been specific enough, but no, no, no later than 18 months to get money, to get a reimbursement.
Okay, great. Thank you much.
I will, hey, Maja, this is CG speaking. I will take the one on margin. I guess, that's how you want to call it.
Yeah, please, go ahead.
We closed the half with a Adjusted EBITDA margin, and Q2 with a Adjusted EBITDA margin. In the quarter, though, in the first part of the year, to be more precise, we had some extraordinary legal costs related to the whole legal issue we had with the Italian Market Authority that we discussed in the past. We believe we are done there, at the light of the most recent news, basically done. There is gonna be, let me say, a tailwind in the second part of the year. Then obviously, we have a few other elements that we need to consider.
Starting from the assumption, the Bloomberg is a crystal ball, obviously, but at the same time, you know, the immunoassays franchise is going pretty, pretty well, and we are seeing, as we commented, a very nice growth in the U.S., where we are enjoying higher margins. In a sense, through there are some uncertainty in China, as Carlo commented, but, you know, we might see some.
Hopefully good news, there as well. There are some assumptions on the flu season. We said that, you know, in our guidance, so we have a regular flu season assumption. There is gonna be another factor which we are, you know, building into our projection for H2. Eventually, last but not least, there are also some as Carlo commented, some assumptions were made on the Licensed Technologies business, where we are seeing some indication which are telling us that potentially H2 is not gonna grow rightly, I would say, at the same speed that we saw in Q2.
Many moving elements, but, when we consider them all, I believe that, shooting for 34% EBITDA margin for the year is still what, you know, we have in our line of sight.
Great. Thanks a lot. That's super helpful. Just a quick question, could you provide us with the Q2 growth on like for like basis, ex-COVID, if you were to adjust it for the contract that you lost in specific diagnosis?
You know, I'm not sure we can disclose the contract that we lost, the amount for CPIC.
Okay.
I don't think I can do that.
Don't worry. Don't worry, it's fine. Thanks a lot.
The next question is from Noor Aiza from Morgan Stanley. Please, go ahead.
Good afternoon, Carlo and PG. Thank you for taking my question. My question is on China. There's been some very mixed feedback from your competitors this week around the trajectory of growth, and some are saying it's worsened in the quarter. Can you talk a bit more about what you're seeing and why, you know, you know, seeing some moderate growth already in Q2? Is it because you're exposed to kind of specific pockets of growth, do you think you're gaining market share? How does this also compare versus your expectation about pricing and potential pricing declines in China from the VBP developments that would be helpful.
The second question is on MeMed. This is probably in response to their clinical data that we shared at their ACC this week. I believe you mentioned before about targeting 100 hospitals in the first wave of the program. Just curious to see how far along you are and how many hospitals you targeted versus this 100 target. Would there be scope to increase that once you start seeing more positive readouts from the hospitals in the coming months? You know, the third one, I guess, is a more broader question about your mid-term guidance and whether you have any new thoughts about when you'd like to revisit that or, or perhaps revisit that with the investors in the capital markets in the coming 6 months. Thank you.
Okay, I will take the China, and then MeMed, and then I leave PG with the guidance. Look, as said, China is extremely volatile, so it looks like that, as far as we are concerned, and in the immunosuppressed segment, we saw volumes in the provinces where we operate to bounce back. That really did help in the quarter two. It looks like from our own projections that we may have moderate, very moderate, or no growth in Q3 and Q4, but without really seeing the level of losses that we have seen before. This is, again, because of the COVID volume, pre-COVID volume coming back. Everything else that everybody is discussing is still there.
You have pricing going down 30% in regional tenders, more Chinese preference toward Chinese products, and da, da, da, da, da. Even when saying, you know, good Q2, Q3 and Q4, they are not gonna be a drag when it comes to next year. I think we need to close the year, and then we're gonna see what happens. In parallel, though, I am comfortable because I think we turned the corner, and when it comes to the manufacturing site, and this section of DiaSorin become more Chinese, that, as you know, rarely happen because we are starting to make first validation lots in our manufacturing site in Shanghai. That's very good.
When it comes to MeMed, I think as you have, I believe you have discussed yesterday at the American College of Cardiology, and you have seen. Well, you've been at the event, and you have seen the clinical data, very impressive, that we are presenting yesterday. Our, clearly, our the people that we hired are going to go and target customers, hospitals in different regions where we have an existing system because we do want to, we want to accelerate revenues, and we don't want, we want to actually have placement of new system dedicated. You know, volumes of this set are relatively low. We are talking about between 2 to 7 tests per day, so from a volume perspective, it's, it's, it's nothing. Clearly, with the pricing effect, then it becomes a significant business.
As I think, we may have discussed yesterday, we go to the installed base primarily on the East Coast, some very selected areas in California. TG?
Yeah, the question on the midterm guidance. I believe that as we previously discussed, we will be hosting an event where we will be updating the financial guidance, the midterm financial guidance. Said that, all the strategic projects and trajectories that we discussed about at the end of 2021 are all valid. Considering the latest events, the filing of the Plex, the filing of the Nest, the take-up rate of MeMed, what's gonna happen in China, the paybacks, you know, all of those elements, for which is kind of more challenging, making a projection.
I believe that by year-end, some of those data points, some of those elements will be clear, and that will allow us to review, refresh the financial midterm guidance. Once again, said that all the strategic projects and trajectories are exactly the one that we discussed about at the end of 2021 during our Capital Markets Day.
Thank you very much.
The next question is from Hugo Solvet , from BNP Paribas. Please go ahead.
Hi. Hello. Thanks for taking questions. I have a couple follow-ups. First, on latent TB testing, we have had some discussions about large European diagnostic players potentially entering the TB testing market sometime next year. Can you confirm that, and what's your volume price mix expectation within the long-term guide? Second, on molecular diagnostics, I think you were about to complete some of the respiratory studies around now, to file in Q3 or Q4 2023. Can you confirm the timeline here, and any update on the gastrointestinal panel? Thank you.
Okay, well, I will not certainly comment about what other players are gonna be doing with their LTB. It's a large market. We expect people to look at this market, bioMérieux, as you know, already did it. They had to withdraw the product. The product so is not a simple product to make. Also, QIAGEN developed the CD4/CD8, the two tubes, which is certainly differentiating. QIAGEN has been on this, in this market for 15 years with gazillion publications supporting the product. That doesn't say that somebody will show up and try to make a run at this market. I have no information whatsoever, except for ton of gossips, and I'm really sick and tired of gossips about who is coming to the market.
Said that, wait and see, and when the very famous large player is gonna show up, let's see what they have. When it comes to molecular diagnostic, you may missed what I said before. Yes, we completed the Plex, respiratory, clinical, and yes, we're gonna submit in Q4. GI, I'm not available as we speak, to give any date on GI or blood. Understandably, we believe that blood is gonna be actually the panel that we saw the suit, realizing that with a very big one in the U.S., we have almost 30% market share in this segment. In the segment we certainly know well. Was there another question? No. Anything else?
The next question is from Louise Barwell, from Jefferies . Please go ahead.
Thank you for taking my question. I have a couple of follow-up, if I may. Two, on the financials first. I was looking at Adjusted EBITDA margin. You mentioned 32% in Q2. Could you run us through kind of a bridge, what do you think are the triggers to go up to 35 in order to over Q3 and Q4, in order to achieve the 33%, 34%, sorry, over the two year? The second one, on finance is about your payback issue. I was wondering, you mentioned that the provision were in line with what you could have to pay for the 2015, 2018 period. Could you give us a number there and maybe an estimation for 2023?
I'd stop there and maybe, come back to my other next question later.
Okay, Louise. This is TG speaking. I'm not gonna provide you a specific bridge from Q2.
Which closed at 32% EBITDA margin, which is said to get to the 34% guidance. I believe a few minutes ago, I tried to explain, I think it was to Maja, why I believe 34% for the full year is still in our line of sight, and that's why we're confirming our guidance. I just refer to you, you know, to what I just said to Maja, because that's the reason why we see 34%. In terms of payback, we have a provision in our books, which we deem in line with the maximum the risk we might have coming from the payback.
Please bear in mind, the law is covering the period 2015, 2018, right? That is the period for which we are kind of assessing the possibility to settle. That settlement, if we decided to do so, it's gonna be just short of EUR 10 million, which once again, have been fully provided for in our balance sheet. The law is completely silent for periods after that 2015 to 2018 timeframe. The thing is that even if we decided to settle, and it's a big if, as Carlo was saying, that even if we decided to settle, we would still have the possibility that would not prevent us the possibility to fight back, to challenge legally any potential additional claim from the government for the period after 2018.
As the decision we will take once again for the period 15/18, is not gonna impact in any shape or form, what we might want to do for the period after 2018. Said that, the situation is really in a flux. It's changing literally every day, and unfortunately, I do agree with Carlo. This is an Italian soap opera or saga, but let's wait and see what's gonna happen.
Okay. Thanks for those elements. My other question were about the strategic program. You mentioned earlier in this call, do you maybe have some more information than us on what they are doing to reach private insurance reimbursement? The amendment of the BOG, we talked about, we said maybe in a year. Do you have some data point we may miss on this one?
Yes, I do. Unfortunately, this is a confidential information to the company, and therefore I won't be able to disclose. The only thing I can tell you is that in order to get the reimbursement of the payers, there has been a clinical study which has been negotiated with payers, which is in process. If, when completed, it's gonna be filed to the payers, to support their decision on reimbursement. Okay? Any more, any more of that, I can't disclose.
Okay, thank you. Maybe just to finish, to confirmation of what you said earlier, you mentioned an update of your financial guidance during potential Capital Markets Day or something by the end of the year. Could you remind us what you have now as information that was not integrated into your former guidance? Finally, about the Plex, you mentioned that you finished the clinical tests on the respiratory line, and that you want to be submitting Q4. Could you just explain to us why not Q3?
I'm laughing because I just had 2 days of reviews with the regulatory people, I'm trying to represent their interest. You need to understand that a clinical study for these kind of panels is like 19 clinical studies together. The FDA is seeing each individual, let's say, as an essay, so it's like filing 19 filing cases. That takes a lot of time to compile all these 19 filing case and file with FDA, and therefore, the testing was completed at the end of the respiratory season, and now the team is working in compiling all together. This is why I'm saying I feel comfortable with the fact that Q4 is the real timeline for the submission.
Yeah, regarding the midterm guidance, once again, now we have a midterm guidance out there. I believe, during the Q4 call, if I remember, you know, we've commented on that guidance, many moving elements, which are the ones that we just mentioned, the MeMed and China and the payback, and the respiratory season, and you name it. So that is the official guidance we have out there, but we have to build in some flexibility as again, I said, a few quarters ago, considering all the most recent news. That's why we said we will revisit the financial guidance of the numbers, not the programs and the projects, by year-end.
Excluding the respiratory season, it's only bad news, right? We made China and payback.
Say again, please.
I said, like excluding respiratory season, it's only on the negative side, right? We had delayed China, we had unexpected and payback was obviously rather decreased than more.
No, no.
No, no, it is sorry. We didn't say no, on the negative side.
Absolutely.
What we said is that, we get better visibility on certain strategic problems and market conditions, which, you need a crystal ball to really understand, a few quarters ago, what would happen to China. This is the end limit, and this is why we said we're gonna sit with investors and share with them how we view with better clarity now, the next 2, 3 years. I don't understand why you're saying the negative side.
Just because my understanding was that you had a delayed on, on reimbursement, that China was weaker than expected, and obviously the payback conditions, you were not aware when you made the, the former guidance. My understanding was that on those three topics, you unfortunately only had a negative incremental move since last guidance, but you, you're saying it's not the case.
What I'm saying is that, life is always a mix of things that go better than what you expect, and things that are worse than you expect. This is the time I think there are many goals in the year. I believe that year-end is the time to make a summary of the top 10 negative and give a view to the market.
Okay, there's positive. That's good. Thank you very much for your answer.
Thank you.
The next question is from Odysseus Mamioti, from Berenberg. Please go ahead.
Hi there. Thanks for taking my questions. I got one on the CLIA ex-COVID growth this quarter, and particularly the acceleration in Q2 over Q1. I understand QFT and still have been doing good, but could you give us some color on whether this is more of an issue of post-COVID type environment recovery or more of a new wins with hospitals here, helped by your sales force? A second one, please. Could you give us an update on pricing on your molecular and immunodiagnostics divisions? I remember you were looking to this earlier this year. Would you have an expectation of the magnitude of the price increase that you could take doing this too? Thank you.
Okay. I'll make a comment on the, on the first question. As I see honestly, two effects. I see that in the U.S. is, it's only business, because we are in an expansion mode, in the U.S., getting more customers through the, through the hospital program, employ the right resources, we have platforms, we have systems, we have products. U.S. is customer expansion and getting business, a combination of, gaining business from competition and/or, in-sourcing versus, send outs, which is working very well. When it comes to Europe, I think that there is an effect today of, of a very important effect of volume, which, volume is going back, in more different regions, where, where it should be.
Especially for some of the specialty products with infectious disease, I think we did comment over COVID, that prenatal testing, we were severely hit during COVID, and now we see all the volume actually going back. Short answer, U.S., all new growth, and when it comes to Europe, there is an effect of volume, which if I need to estimate, is probably around 40% of the growth that you see, but don't necessarily quote me on that because I'm giving you my rule of thumb estimation.
Yeah, regarding the pricing, what you said, hello, hi. I believe what you're referring to is the program, we just started at the beginning of the year. We hired an advisor there to help us out, to review the possibility for the group to our pricing strategy, if I can say it in that way, because, you know, we came from an environment without inflation, whereby in the past, we very seldom, in very few occasions, in very few geographies, had an active policy of increasing prices year-over-year into customers.
You know, inflation came, and we started that program aimed at being more, let me say, smart in a sense, considering the new market condition, the way in which we were managing our pricing strategy and trying to eventually go back to customers, and increase pricing on a current basis. The exercise that we did is almost over. Our commercial organization is going into execution mode. We will start seeing something in the second part of the year, and the bigger impact will come over the following years.
These initiatives does not cover only pricing, but we are also considering the possibility to ask customers as many peers are doing, to contribute, for example, to shipping costs, distribution, you name it. This is one of the several initiatives I was referring to when I said that, you know, we are putting in place programs to keep on safeguard our margins. But so far in H1, you really, you know, almost nothing, I would say nothing.
All very clear. I also have a follow-up. Thanks for your answer so far. I mean, I understand you might not be able to disclose that, but perhaps to try. On the clinical study with MeMed, that you mentioned, has been negotiated with payers, could you broadly talk about the endpoints here? Are they your typical cost and specificity, endpoints?
No, I cannot. Just to be clear, you said it's been negotiated. The clinical for the protocol has been negotiated. The clinical study is ongoing, and again, confidential to the companies can disclose, especially in an environment, with this test, it is becoming more competitive, whereas, you know, there is another player today that got a license, so can't be more specific. Sorry.
Understood. That's fine. Thank you very much.
The next question is a follow-up from Maja Pataki from Kepler Cheuvreux. Please go ahead.
Hi, me again. I'm sorry, just a quick follow-up question. Carlo, you have been talking about this enforcing of stool testing, you know, driving solid growth in the immunoassay business, and of course, there still is room for this to go. Like moving to the long term, what is the growth rate for the stool testing market? Are we looking at the similar like molecular growth or is it a market that stands out with higher growth rate?
Extremely higher than I would-...
Higher.
Oh, yeah. You're talking about, around on average, between 5% growth today.
Wow!
Keep in mind that we do have a full panel of products. It took years to set it in place. Fundamentally, we have two areas of interest. The first one is, you know, we have an H. pylori test. That's one growth. The other one is the calprotectin and elastase-1 , which is becoming extremely interesting because of, you know, irritable bowel disease. If you go to the US and you just switch on your TV and you watch commercials, I mean, you see how much Crohn's disease and all these new set of drugs, biologicals, that have been developed and now they hit the market in the US.
What is very interesting, and I would like to tell you that it, it was all well-planned and thought, but it was not. All these biologicals actually require TB testing for eligibility, and the typical market that is used for Crohn's is Calprotectin in Elastase-1. Right. It's a very interesting position that the company put together in this very much growing segment.
Sorry, that's obviously extending the follow-up question, but just, could you provide some indication of how big the stool testing share is of the immunoassay franchise?
No, Maja, I cannot. I realize that, we can providing all these numbers, grow the appetite of competitors that are lurking around.
Okay.
I can't.
Okay, fine.
There are two things that I think you should understand. First, it took years to develop because it's a complex matrix, and overall, the 2 total panel is 6 products. The second thing is that when it comes to specifically Calprotectin, we have research. We've been researching to add more markers to Calprotectin to actually increase the clinical specificity. I think we have some very interesting assays coming over. It's a franchise where DiaSorin has been investing over the last 10 years, and now we are really reaping the benefit of the full menu and the products to come.
Understood. Thank you much.
Mr. Rosa, just remember, there are no more questions registered at this time.
Okay, thank you, Operator. Bye-bye.
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