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Earnings Call: Q4 2021

Mar 16, 2022

Operator

Good afternoon. This is the Chorus Call Conference Operator. Welcome, and thank you for joining the DiaSorin Full- Year 2021 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, Chief Executive Officer of DiaSorin. Please go ahead, sir.

Carlo Rosa
Chief Executive Officer, DiaSorin

Thank you, operator. Good morning, good afternoon to everybody, and welcome to the year-end results call for DiaSorin. I'm gonna briefly comment quarter four as usual at constant exchange rate 2020, and then Mr. Pedron will take you through the numbers. It is noteworthy that Q4 represented a fully recovered quarter from a revenue perspective. It's very interesting that I will compare results to Q4 of last year, and this will in my opinion give an indication of how the business is performing. Starting from this quarter after the Luminex acquisition, I will provide comments in three different buckets that now we are using to represent the business of two different technology groups.

First, I will talk about COVID-19, which includes immuno and molecular, including also the Luminex COVID-19 business. Second bucket is immuno ex-COVID. The third bucket is LTG or licensed technology, which has to do with all those technologies that Luminex developed and licenses through partnership, primarily in the research space. Let's start from COVID-19. When it comes to COVID-19, Q4 revenues were roughly EUR 100 million, of which 17 million were COVID-19 products coming from Luminex. If we compare, as I said, to Q4 2020 revenues, if we look at the DiaSorin product alone, so excluding the Luminex component, revenues were down 20%. This is as expected, related to the fact that Q4 volume, testing volume of COVID-19 compared to previous year was roughly down by the same number.

We continue to have an extensive installed base of customers that are using our molecular product, although we are certainly today suffering from shift up or down in volume. From a price perspective of COVID-19, what I have to report is that we don't see price pressure in any of the major markets where we operate. If we look at the Omicron effect, I think it's noteworthy that compared to 2020, Omicron has created a much narrower peak of testing, which has been concentrated primarily in December, January, with a very sharp decline that we start to notice in the last few weeks. On the Omicron peak compared to the Delta peak, they look very different. Overall, we continue to stand on our COVID-19 projection.

We need to wait and see what is gonna happen in 2021, in the next few months about adoption of testing. Then certainly we need to understand what is gonna happen in the second half. I don't think anybody wants to see that, but we want to understand how the next season is gonna look like starting from after the summer. I have COVID-19, by the way, and this is why I need to speak a little slowly today. On the immuno side, Q4 was largely in line with Q4 of 2020. Let's talk about immuno non-COVID.

Q4 was up 12%, with CLIA XL growing 19% year-on-year, and CLIA Vitamin D flat, notwithstanding the loss of Quest in 2021, which certainly has been well compensated by the surge in vitamin D testing due to COVID-19. CLIA grew double digits in all geographies, actually on average, well above 25%, with the exception of China that continues to show a decline due to the known issues related to the lockdowns and strong price declines, which are driven by the adoption, as has been discussed a few times, of regional tenders, which are really affecting price, especially on the me-too products like thyroid, fertility, so the high volume products. Our CLIA business is solid and is certainly driven, as in the past, by specialties.

In 2021, notwithstanding I said, the weakness of China, we achieve another record year of LIAISON XL placements, over 550 systems worldwide. With a record amount in the U.S. Notwithstanding the fact that China, which traditionally has been driven XL placement, has been very soft in 2021, we really succeeded with Immuno and the XL in the other two main geographies. Primarily in the U.S., where the hospital strategy that was initiated two years ago now is really paying out its dividend, and we continue to gain share in this very strategic and important market. Last comment I would like to make on Immuno has to do with MeMed. We launched the product on the LIAISON XL in Europe, and we submitted the file to the FDA in mid-December.

This assay for me is a great fit to the DiaSorin portfolio, as we discussed at the Investor Day meeting. Because it's a specialty, it goes naturally on our installed base, and it completes our infectious disease portfolio. We have great expectations about the success of this product. Our partner, MeMed, is raising its ability to educate physicians. We're gonna keep you updated throughout 2021. Again, I really believe that this assay will very well fit our growing installed base in the hospital market. Let's now discuss LTG. Please remember that this business is primarily driven by our strategic partners who have adopted Luminex technology to develop either research or IVD products. Year-over-year, the business grew 20%.

This is even more significant if we compare 2021, not to 2020, that clearly 2020 dive because of the pandemic effect. If we now compare 2021 to 2019, still, we have a double-digit growth of this business, indicating that this is a very solid opportunity and is gonna be a contributor, both from a margin perspective as well as top line growth to the growth of DiaSorin. Last but not least, in this space, we launched the new platform. The INTELLIFLEX is the new multiplexing platform for research, and the book of orders exceeded by far our expectations. When it comes to LTG, it is a very nice addition to the traditional DiaSorin IVD business. Before leaving the podium to Mr.

Pedron, excuse me, one more comment, and it has to do with the LIAISON PLEX or VERIGENE II, as Luminex used to call it. We continue the validation effort to bring on the manufacturing line for the high-volume manufacturing in Chicago. We are focusing on, as we have discussed during Investor Day, the Gastrointestinal Pathogen Panel and the three blood panels: the Gram-positive, Gram-negative, and yeast. As discussed, we expect to start clinical studies for IVDR submission in the second part of 2022. We expect to start initial placements in Europe for customer usability in the early fall. Meanwhile, our traditional multiplexing business, which is mainly driven by the VERIGENE I, is relatively stable, with ups and downs, clearly in the respiratory panel due to the COVID-19 business.

We continue to maintain a very solid install base, and we continue to invest in the multiplexing business, developing some of the manual application. O ur manual technology for multiplexing is called NxTAG, and we have launched recently a new updated Gastrointestinal Pathogen Panel for the European market. Now I'm gonna leave the podium to Mr. Pedron, who is gonna drive you through the numbers. PG, please.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Thank you. 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 in 2021. I will also make some comments on the contribution of the fourth quarter and on the impact of the Luminex business, whose acquisition was completed, as you might remember, on July the fourteenth of last year. To better understand the performance of the business, I will refer to adjusted P&L items, therefore sterilizing the impact of the following, so to say, Luminex deal-related elements. So the one-off acquisition and integration costs, the effect of the purchase price allocation, costs of financing, and lastly, the fiscal impact of all of these components. Both in the presentation uploaded in our website and in the press release, we are providing a line-by-line bridge between adjusted and IFRS items.

said that, as usual, let me please start with what I believe are the main highlights of 2021. We closed the Luminex transaction in July for a total equity value of approximately $1.8 billion. Starting from Q3 2021, Luminex financials are consolidated into DiaSorin. 2021 total revenues at constant exchange rate grew by 41% in the year, therefore doing slightly better than the full year outlook, which was calling for a 40% progression. Q4 2021 grew by 36% vis-à-vis 2020 at constant exchange rate. Luminex contribution to the top line at current exchange rate was EUR 195 million in the year and EUR 104 million in the quarter. This performance is slightly better than what we originally expected, with the overage mainly driven by the Luminex molecular business.

The COVID-19 contribution at current exchange rate was EUR 378 million in the year and EUR 102 million in the quarter, compared respectively to EUR 266 million and EUR 101 million in 2020. 2021 full- year adjusted EBITDA at EUR 543 million or 44% of sales is slightly better than the outlook, which was set at 43% margin, mainly because of the higher top line we just discussed about. We completed the Luminex purchase price allocation, and as a result, in Q4 2021, we booked a EUR 24 million hit to our P&L, of which EUR 80 million of intangibles depreciation and EUR 6 million of higher costs of goods sold, the latter coming from the revaluation at fair value of Luminex inventory, as dictated by IFRS principles.

The quarterly run rate hitting our P&L from Q1 2022 onward in the intangible depreciation line coming from the PPA is going to be EUR 9 million. You might notice that this number is different from the one we shared during the Capital Market Day, which was forty million euro. The difference is coming from the fact that now we have completed the PPA exercise, whereas back in December, it was still an estimate. We keep confirming our ability to generate a very healthy free cash flow, EUR 301 million in the year. The net financial position is negative for EUR 986 million, with EUR 403 million cash, and the net debt leverage 1.8x adjusted EBITDA .

Finally, the board of directors approved to propose to the annual general meeting to be held at the end of April, the distribution of an ordinary dividend of about EUR 57 million, equal to EUR 1.05 per outstanding share, and a buyback plan for up to 1.5 million shares to support the potential settlement of the outstanding convertible bond and the management equity plan. Let's now go through the main items of the P&L. 2021 revenues closed just above EUR 1.2 billion, compared to EUR 881 million in 2020, therefore recording a growth of 40%, both in the year and in the quarter. The year has seen some EUR 6 million FX headwind, net of which, the growth would have been 41%.

The growth at constant exchange rate and scope of consolidation, meaning excluding Luminex, is 19% in the year, and therefore slightly better than the guidance, which was set at 18%, and flattish in the quarter because of lower DiaSorin COVID-19 sales, which Carlo just said, moved from EUR 101 million in Q4 2020 to EUR 81 million in Q4 2021. Q4 2021 ex-COVID, again, same perimeter of consolidation, so without Luminex, recorded a solid growth of 10% at constant exchange rate compared to 2020, and 7% compared to Q4 2019, mainly fueled by a very strong performance of our CLIA ex-vitamin D franchise, which grew by 19% in the quarter and 22% compared to Q4 2019. H2 2021 Luminex pro forma sales grew nicely vis-a-vis 2020.

Let me remind you that we didn't consolidate obviously in 2020 Luminex sales. That's why I'm saying pro forma. As a result of a good performance of the combination of the ARIES and VERIGENE molecular platforms, paired with a very strong licensed technology business, with a joint growth of about 20%, partially offset by the so-called non-automated assays, which recorded exceptional COVID-driven sales back in 2020, when the supply of COVID-19 testing in the market was somehow limited and greatly overcome by demand. Full- year 2021 adjusted gross margin at EUR 831 million grew by 38% compared to last year, with a ratio of our revenues slightly below 2020. 66%-67% vis-à-vis 68%.

This difference is mainly driven by the inclusion of Luminex in the scope of consolidation, and that is even more clear when we consider the adjusted gross margin ratio of the quarter, which closed at 66% compared to 68% of 2020. This variance is in line with our expectations and modeling and is reflected in the guidance we gave last December during the Capital Market Day. 2021 adjusted operating expenses at EUR 357 million grew by 34% compared to 2020, with a ratio over revenues of 29% vis-a-vis 30% of the previous year. The increase in the adjusted OPEX ratio of the fourth quarter from 26% of last year to 30% of 2021 is due to the very same reason highlighted for the gross margin, Luminex consolidation into DiaSorin numbers.

Once again, this is in line with our plans and the guidance we gave during the Capital Market Day. We are expecting synergies to reach the level discussed during the Investor Day as the integration process will move forward. Full- year adjusted other operating expenses at EUR 9 million decreased by EUR 3 million compared to last year. As a result of what just described, 2021 adjusted EBIT at EUR 465 million or 38% of revenues has increased, I'm sorry, compared to 2020 by 43% or EUR 141 million. Adjusted interest income and expenses at EUR 4 million is substantially in line with 2020, and the adjusted tax rate at 23% is in line with 2020 as well.

2021 adjusted net result at EUR 357 million or 29% of revenues is higher than previous year by EUR 109 million or 44%. Lastly, 2021 adjusted EBITDA at EUR 543 million or 44% of revenues is higher than 2020 by 41% or EUR 158 million. The variance at constant exchange rate is positive by 42% with a ratio over revenues of 44%. The adjusted EBITDA ratio in the quarter at 43% is lower than 2020, which closed at 47% because of the expected dilutive, slightly dilutive effect deriving from the consolidation of the Luminex business, the very same reason we just discussed a while ago. Now let me please move to the free cash flow.

In the course of 2021, the group generated EUR 301 million free cash flow vis-à-vis EUR 232 million of 2020, therefore booking an increase of 29% or EUR 68 million. As discussed back in July, I believe it is worth underlining that in 2021 we've had much higher tax cash out compared to 2020, EUR 118 million vis-à-vis EUR 37 million. This difference has been mainly driven by two elements, a different phasing and higher profit compared to previous year. Lastly, let's move to 2022 full- year guidance.

As usual, at previous year constant exchange rate, the outlook is in line with what reported during our recent Capital Market Day and is calling for revenues ex-COVID to grow by about 24%, total revenues marginally lower than 2021, -2% to be precise, because of a reduction of COVID-19 sales, for which 2022 outlook is about EUR 150 million compared to around EUR 380 million in 2021, and an adjusted EBITDA margin at around 35%. Before concluding, please remember that DiaSorin financials are highly exposed to the U.S. dollar, and even more so now that North America represents about 50% of the total group sales. Therefore, as a rule of thumb, consider that for every 1- cent movement of the U.S dollar against the euro, DiaSorin revenues move by about EUR 6 million on a yearly basis.

Now let me please turn the line back to the operator to open the Q&A session. Thank you.

Operator

Excuse me. 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 touch-tone telephone. To remove your question, please press star and two. Please pick up the receiver when asking questions. We pause one moment while participants join the queue. The first question is from Emanuele Gallazzi of Equita. Please go ahead.

Emanuele Gallazzi
Analyst, Equita SIM

Yes, good afternoon, everybody. Thank you for taking my questions. I have three questions. The first one is on the cost inflation. Can you discuss, let's say, in more details what you are seeing now in terms of cost inflation, and how are you dealing with it? The second one is on the QuantiFERON tuberculosis test. If you can just help us understanding the contribution of this test on 2021 revenues and, I would say any color on your expectation for 2022 will be useful. My last one is on the platform, and in particular on new placement made in 2021. Can you give us an idea of the split between new clients and let's say a replacement? Thank you.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Carlo, do you want me to take it since you know, since you have COVID-19? Maybe it's easier for me, and then please just jump in.

Hugo Solvet
Equity Research Analyst, BNP Paribas SA

Yes, please.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

If, uh-

Hugo Solvet
Equity Research Analyst, BNP Paribas SA

Yeah, go ahead, please.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Okay. Thanks. Thanks, Emanuele. I will start with the cost inflation. We built in our model some cost inflation assumptions when we presented our numbers to the Capital Market Day back in December. Please remember that our business is not very much exposed to energy costs. If I look and if I think through the bill of material of our products, most of the costs are labor driven, and then I will touch labor. Then we have obviously our raw materials and the, if you want, the energy driven part is the plastic, which is not, as I said, the majority of the cost of our products. We built in our assumptions when we prepared the plan some cost inflation there.

When we did the plan, obviously, we had no clue about what was gonna happen with the Ukraine and the Russia conflict, which is likely in the future pose some additional question mark, which is very difficult to forecast now. We are seeing this inflation. You know, it's very clear when we look at transportation costs and energy costs for our manufacturing site, which again are not that material compared to other costs. I'm talking about labor. I guess now we have to understand what's gonna happen in the next few months, as I said, with the crisis in Ukraine. So far on top of what I've just said, meaning transportation and some energy, we are not seeing much else.

Considering the materiality, I believe we should be able to cope with it. Regarding the latent tuberculosis contribution in 2021 and 2022, I believe I cannot give you the exact number. As you know, this product is a product that has been developed in partnership with QIAGEN. What I believe I can tell you is that by all means, this is, as expected, one of the contributor to our growth. As we disclosed during the Capital Market Day, most of the growth is coming from the U.S. market where the product was launched after the European one, simply because it was approved later compared to Europe.

We still have a room to go, a lot of room to go for in 2022 with this product, with the latent tuberculosis. I believe we have disclosed to the market that we also got Labcorp as a customer for which we are very proud of. This product together with all the other specialty products, and very likely MeMed as soon as we will get a registration from the U.S., will be one of the drivers of our hospital strategy in the U.S. By all means, if I think about our CLIA Vitamin D franchise, latent tuberculosis will play a key role also in 2022. The last question regarding the platform. The installments that we quoted are net installments, meaning new installments.

Not a replacement of existing machine. I mean, if you place a new machine and you take out one from the market, it's zero. It's not included in the number that Carlo was quoting. Meaning that all of that number is coming either from a new business, I mean, in new customers, or from new business in existing customers, simply because volume and menu is increasing. I believe we don't want to disclose exactly, you know, how much of those 555, I believe that's the number Carlo quoted, instruments are coming from new customer, how much is new business.

You know, as Carlo said, it's very clear that the big driver of this new placement is coming from the U.S., where our hospital strategy is already, you know, is already delivering very nicely for us. And so we're already seeing the results of the investments we made a couple of years ago there.

Hugo Solvet
Equity Research Analyst, BNP Paribas SA

Very clear. Thank you very much.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

The next question is from Peter Welford of Jefferies. Please go ahead, sir.

Peter Welford
Senior Equity Research Analyst, Jefferies

Hi. Yes. Thanks for taking my questions. First, if I could just ask a question on the COVID-19 dynamics that you're seeing. You mentioned that there was a sharp decrease in the last few weeks. I'm curious if you can just comment with regards to whether this is a very U.S.-focused comment, or are you also seeing similar trends in other geographies. Can you just talk a little bit about perhaps which platforms it is in particular you're seeing that, or is it across all the platforms. I guess I'm just curious with regards to, you know, what sort of type of test in particular you're seeing a change. Are you still seeing roughly stable COVID-19—I appreciate it's small—but COVID-19 antibody testing business, which I think historically you've said has been relatively robust.

Secondly, just on China, wonder if you can just comment with regards to what you're seeing in China. We obviously hear a lot of reports about further lockdowns, obviously a big COVID-19 wave at the moment going on there as well. I guess understanding you don't have much exposure, I don't think, to COVID-19 testing in China. So is there still, from your point of view, considerable disruption likely to the Chinese business this year? And I wonder if you can just comment a little bit on what you're seeing there and any change at all to what I think is already a challenging environment.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Just perhaps ask two financial quick questions. One, just can you possibly provide the outlook for the total depreciation and amortization we should be thinking about for 2022, just to get the EBITDA from an EBIT number? Secondly, also the financial expenses, any, I guess insights you could provide into what sort of finance costs in the P&L we should be thinking for 2022. Thank you.

Carlo Rosa
Chief Executive Officer, DiaSorin

PG, I will take the COVID-19 in China, okay? You take the other two. When it comes to COVID-19, the comment we have seen already last year that the U.S. is following a completely different perspective in terms of volume drops or volume rise versus Europe, especially for us. This has a lot to do with the different positioning of the systems in Europe and in the U.S. In Europe, typically, we are not so sensitive to volume drops, and this is because our systems in Europe have been positioned in hospitals for hospital admission and/or for confirmatory assays for antigen positivity and so forth.

Therefore, typically we don't see such a swing, and also now we are not seeing such a dramatic swing in Europe. In the U.S. it's completely different, because our systems are a platform used in mid-sized hospitals as one of the primary platforms, and therefore we are clearly subject to the volume fluctuation. As you have seen from all the different statistics, and as I discussed before, there was a surge in Omicron testing which happened in December and January, and then it's really going away. Therefore we see this sharper decline. As far as China is concerned, the problem with China, I think, has to do with two different elements.

The first one certainly has to do with lockdowns because which is something we don't experience in Europe any longer. It did affect the business when it did happen. Since I think the end of 2020 we have not seen a pandemic really affecting so dramatically testing volume. In China, we still see that, and it's very obvious from the different provinces where that happens, and all of a sudden volume goes almost to nil, and it can last for weeks. The second element, this I assume is gonna go away as soon as these lockdown policies will not be set in place any longer.

The second element which I believe though is more structural about China is the fact that, we like it or not, the government is pushing hard on these provincial tenders and adoption of these provincial tenders. The net effect is that you see price decrease in the range of 30%-50%, to the point that I think Western companies decided in certain tenders not to even participate because it doesn't really make any sense. You see more and more of local suppliers which are able to cope with the cost structure, price structure, and I have to say in some cases, quality. It is what it is.

Hospitals are forced to buy local, not only because of price but as you know, also because of the fact that quite often they are forced to explain if they don't use local, why they're not using local suppliers. Okay? All said and done, this makes China near future very, very complex. We will continue our effort to stay in China with a manufacturing site. We are, as I said, on track with that venture. How the market is gonna shape midterm, long-term, I don't think anybody knows at this stage. I'm very happy today, to be honest with you, that China does represent less than 5% of our turnover. PG, you wanna take care of the financial questions?

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Thank you. Yes, sure. Thank you, Carlo. Hi, Peter. Let's start from. I believe the third question, which was the one about the depreciation. I believe the right way to look at it is the following. You should consider EUR 9 million per quarter of depreciation coming from the purchase price allocation, mainly in intangible depreciation, to which you should add more or less EUR 25 million run rate of the depreciation of everything else. If you wanna sum up the two is roughly EUR 35 million per quarter. Obviously, the part of depreciation coming from the PPA is fixed now that we have completed the purchase price allocation exercise.

The one coming from the depreciation of all the other elements is obviously subject to change considering what's gonna happen to our investments. I believe that, you know, it's a good run rate that you can also see in Q4. If you look at interest expenses, I believe we need to distinguish between 2 big buckets. One is the convertible bond interest, which is a non-monetary items based on how the accounting of convertible bonds works. We are, you know, anyway booking interest to our P&L negative interest, obviously, even though it's a zero coupon convertible bond. We booked in the first seven months of the year EUR 5 million give or take. If you wanna have a ballpark for 2022, you can give or take double it.

When you look at the term loan, so the other part of, you know, the financing structure we put in place when we bought Luminex, where we booked in the first months of the year, EUR 7 million. That amount obviously is declining, considering, you know, the fact that the amount, the principal on which we're paying interest is decreasing as we pay back as we reimburse the the loan. Again, if you wanna have a ballpark number for your modeling, you can take the EUR 7 million and make it EUR 12 million for 2022.

Maja Pataki
Analyst, Kepler

That's great. Thank you.

Operator

The next question is from Hugo Solvet, BNP Paribas Exane. Please go ahead.

Hugo Solvet
Equity Research Analyst, BNP Paribas SA

Hi. Hello. Thank you for taking my question. Quick follow-up on Luminex. You have received a Form 483 in the U.S. from an inspection in October at the end of last year. Can you maybe discuss the issue here and anything probably out of the scope of what you identified when visiting the site back in Q3 or in September last year? Second, on Luminex, you mentioned, Carlo, if I'm not mistaken, but correct me if I got it wrong, that you will start the clinical trials for submission later in the year.

What's actually the level of confidence you have in getting the VERIGENE II on the U.S. market before the end of 2023, given extended review timelines from the FDA. Last question on the long-term guidance that you gave us at the Capital Market Day. Can you maybe discuss the sensitivity of especially the EBITDA guidance to sustained and potentially sustained cost inflation? Thank you very much.

Carlo Rosa
Chief Executive Officer, DiaSorin

Okay. I'll take the Luminex, Form 483 and the clinical studies. 483 is exactly what we did in due diligence and this is how we expect the Form 483 to move forward. We have agreed upon with the agency to enter Luminex into a program that is gonna last 18 months, where we're gonna work with the FDA. It's a pilot program. There are nine companies, I think, in the U.S. who joined. Luminex is one of them. The FDA with external consultants are gonna work with the company in the implementation of all the corrective actions that has been identified by the Form 483 and by the company.

I'm very comfortable with the way this is going, and I'm quite comfortable that within 18 months the issue is gonna be completely resolved. By the same token, this is not affecting the ability of the company today to make product or submit product through the agency. There are no surprises to be honest with you there. When it comes to the clinical studies and the FDA, look, when it comes to the FDA, when you submit and you don't know when you get out of it. That's certainly a general statement. However, what we have seen so far is that pressure on FDA because of COVID-19 has been released.

The FDA is going back to regular course of business and is looking at files. Today, we have several products at the agency waiting for approval. We have investigators by the agencies that have been allocated to work with us on the file. I'm seeing that they are going back to normal. That means that when it comes to panels like the one we discussed, which are fighting case, you would expect typical three to six months approval time. I feel comfortable at this stage with the fact that in 2023, we should see some of these panels starting in the U.S. market. On the EBITDA, I leave it to PG.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Thank you, Carlo. Yes, as I said, when we put together the long-term plan, we made some assumptions based on the information we knew back then. Those information did not include obviously what's happening now with Ukraine and what we are seeing with the price of oil and, you know, everything which is derived from those increases, the energy and you name it. W e are monitoring very closely the situation. I believe it's very early for everybody to make projections because we don't know what's gonna happen. Most, as I said, of our cost base is labor based, but we know that also there obviously you might have some impact on inflation coming starting from oil. Early to say, Hugo.

I believe, again, the assumptions we gave when we gave the long-term guidance, took into account some cost inflation by all means. Those assumptions were based on information we had up until November, December last year. What's gonna happen and what is gonna be the impact of what we are seeing, in Ukraine, I believe it's very early to say.

Hugo Solvet
Equity Research Analyst, BNP Paribas SA

Okay, thank you very much.

Operator

The last question is from Maja Pataki of Kepler. Please go ahead.

Maja Pataki
Analyst, Kepler

Yeah, good evening, everyone. Last question. Carlo, first to you, swift recovery. I hope you don't feel too bad. And then PG, just a quick question. I'm sorry, I will have to ask again about the cost inflation because, you know, obviously the world has been changing very fast last three weeks, and we don't know how this is going to be, you know, impacting raw materials, but it would be really helpful for us to know what kind of wage inflation you have baked in, into the, 35% adjusted EBITDA margin. Because we've seen companies left and right coming out surprising us with wage inflation, saying that inflation isn't transitory and therefore, they had to adjust wages. It was just for us to know or to make our own assessment on where the world could move. That would be super helpful.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Yeah, Maja, it's very difficult because when we did our exercise, we made some assumptions in terms of wage inflation for each and every country where we do business. That is part of our usual budget forecasting planning process. That assumption is based on market data that we get from the different geographies where we do operate. On the top of my head, I believe that, for example, for the U.S. market, we were just below, I believe 3.5%, 4%. That's the assumption we made on the top of my head. But I might be wrong because again, it was back in November, as I said. Usually, we've never gone far when we put those numbers in our plans.

What's gonna happen now in the last three weeks, as you said, I don't know. It's very difficult to say. As you know, we have plans to streamline our cost base. We have synergies that we presented to the market community. I can say that we are going, you know, pretty well, according to the plan that we put in front of ourselves and in front of the market. It's very difficult for me to say what's gonna happen, as a result of what we've seen in the last three weeks.

Maja Pataki
Analyst, Kepler

Okay. Would it be a fair assessment to say if things, you know, stay status quo or get even worse than additional wage inflation would probably be in the books? Is that the right way to think about it?

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Say again, if things stay status quo?

Maja Pataki
Analyst, Kepler

Yeah. If you know, I mean, if inflation stays here or goes further up, then it's fair to assume that you would have to make some adjustment on wages during the year. Would that be a fair assessment?

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

We compete in a market, and we have to deal with the market reality, right?

Maja Pataki
Analyst, Kepler

Yeah. Yeah. Okay. Fine.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

But at the same time, as you know, we are very diligent in the way in which we manage our cost base. What I can tell you is that we will use all the leverages that we have in order to compensate any potential uptick in terms of wage inflation, which was not considered in our original plan.

Maja Pataki
Analyst, Kepler

Okay. Maybe just quickly, last question. You stated Russia, Ukraine is a small, it's not important for you. But are you still shipping to Russia or have you stopped shipments?

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Yeah. We, for us, the Russian business is not very material. I believe that if we combine both the Luminex and the DiaSorin business in our budget, on the top of my head, the number was well below EUR 10 million, to give you a sense of, you know, the business we have there.

Maja Pataki
Analyst, Kepler

Mm-hmm. Okay.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Thanks.

Carlo Rosa
Chief Executive Officer, DiaSorin

Listen, Maja, we continue to ship for the time being. Certainly, you know there is a list of companies, blacklisted companies and banks that so far are not preventing us to do business. We are just waiting. We decided that we're gonna follow whatever AdvaMed and MedTech Europe are gonna decide, right? We're not gonna make a decision ourself. The real problem moving forward, really is not, in my opinion, to make business, but to collect the money.

Maja Pataki
Analyst, Kepler

Okay.

Carlo Rosa
Chief Executive Officer, DiaSorin

What can be the killer here is the collection. If I can go back one second to your question about the cost. Look, what worries me the most, to be honest with you, today is shipping cost. Because of the complexities of shipping around the globe, which actually brings us back to the pandemic times. Certainly, we do have a cost of labor increase in the U.S., which is certainly much more than in Europe. It's certainly true that we now have an important cost base in the U.S. I believe that in a way that we can manage, as PG said.

Don't forget, we're in 2022 also we expect synergies too. So that I believe that a little bit more synergies could actually compensate for a little bit more cost, right? I'm giving you rule of thumb explanation here, but the shipping cost is what really we need to understand. Plastic raw material, usually is relatively small, so relatively immaterial.

Speaker 10

Okay. Thank you very much.

Operator

The next question is from Giorgio Tavolini of Intermonte. Please go ahead. Mr. Tavolini, your line is open, sir. Perhaps you have your phone on mute.

Giorgio Tavolini
Analyst, Intermonte

Yes. Do you hear me? Sorry. Hi, good evening. Thanks for taking my questions. I was wondering if you could provide more visibility on the LTG line that represented roughly 8% of sales in 2021. If you are still confident on doubling the contribution from this line for this year. The second one is on the indications. If you have any indication on first quarter trends related to the COVID-19 business. What we should expect, trends in line with the exit of 2021. Thank you.

Carlo Rosa
Chief Executive Officer, DiaSorin

P.G., do you wanna take it?

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Sure. Yes, the first question regarding the licensed technology business, I believe, Giorgio, you are referring to the guide that we gave you on the Capital Market Day. Yes, I mean, that is still our assumption. As Carlo said, during his remarks, that the business is doing very, very well. We're very positive there. Absolutely, we, you know, we confirm what we said during our Capital Market Day. On the top of my head, I believe we said that, obviously also because of change in perimeter, but we said that from 2021 to 2022, that franchise was going to grow by 115%-120% on the top of my head. I believe your second question was regarding COVID-19 in Q1 2022.

Is that what you asked, Giorgio? I'm sorry, the line was a little bit kind of.

Speaker 10

Yes. No, sorry. Actually the ex-COVID business. If you are still if you see a similar pace in terms of growth like in Q4 for also in Q1.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Yeah, I mean, absolutely. I mean, as we said, when you say, you know, ex-COVID business, now we are much more complex reality. We have several different pieces. We have the CLIA ex Vitamin D, we have , all the rest of the immuno panel, we have molecular, and we have the licensed technology business that we just discussed about. I would say that the trend we saw in Q4 2021 overall in the business and all of its components will be confirmed in Q1 2022, and those are the basis for our guide for 2022, overall guide, which is 24% growth, ex-COVID.

Speaker 10

Thank you very much.

Operator

The next question is from Andrea Balloni of Mediobanca. Please go ahead.

Andrea Balloni
Equity Analyst, Mediobanca

Yes, good afternoon, everybody, and thanks for taking my question. First of all, thanks Carlo for taking part of the call, and take care of yourself. A couple of short questions first of all about COVID-19 sales. You've mentioned around EUR 378 million sales from COVID-19. If you can give us the amount of molecular compared to the other COVID-19 test sales. My second question is about the P&L below gross profit. If we consider the adjusted number, stripping out one-off costs, we see marketing and commercial costs, which are around 17% of sales in H2 and R&D expenses of P&L, which are around 5.5%- 5.8%.

Speaker 10

My question is, can we consider this percentage as quite stable over the business plan period?

Carlo Rosa
Chief Executive Officer, DiaSorin

PG, go ahead.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Ciao, Andrea. Let me start with the first one regarding COVID-19. COVID-19 sales for 2021. Out of the EUR 380 million or so sales, we have, let me say EUR 70 million to EUR 75 million, which are immunodiagnostic driven, and the rest is molecular. When I say molecular, is a combination obviously of our own solution and the solution provided by Luminex. When you look at the P&L and you strip out the adjustments, as you said, I believe if you want to have an idea of the rate, you should look at Q4, not at the full- year, because in the full- year, it's a kind of a mixed bag. You have 12 months of DiaSorin and six months of Luminex.

I believe you really need to look at Q4, and I don't have those percentage on the top of my mind. Those are the percentage that give or take should fairly represent what we expect during 2022. Yeah.

Speaker 10

Okay. Thank you, PG.

Operator

Gentlemen, at this time, there are no more questions registered.

Carlo Rosa
Chief Executive Officer, DiaSorin

Thank you, operator. Good night.

Piergiorgio Pedron
Chief Financial Officer, DiaSorin

Yes. Thank you. Goodbye. Take care.

Operator

Ladies and gentlemen, thank you for joining. The conference is now over, and you may disconnect your telephones.

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