DiaSorin S.p.A.

Good afternoon. This is the Corsco Conference Operator. Welcome and thank you for joining the diasoring third quarter and nine months 2020 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 the telephone at this time i would like to turn the conference over to mr carlo rosa ceo of diasorin please go ahead sir yes uh thank you operator and uh good morning good afternoon to everybody welcome to the 43 conference call

I think this time we are going to make some short comments and then I'm going to leave Mr. Pedron to go to the numbers and then we're going to leave ample time for Q&A because I think there are lots of questions, not I believe necessarily related to the results, but to the environment ecosystem after the Pfizer announcement a couple of days ago. I would start and comment on revenues. As you have seen, the quarter has been a very strong quarter. I think in line with what we have seen also from other players in diagnostic. And we need to look at the revenue from perspective of COVID opportunity and from what the rest of the business is doing. The rest of the business is recovering better than expected. We were coming in Q2 from a minus 35%, and that was pretty much generalized in all the different geographies. In quarter three, now we are at minus 7%. With a different mix, we have U.S. and Europe with strong recovery, We are almost close to where we were last year, whereas China is still lagging behind, and I'm going to make some comments about China specifically. U.S. and Europe, we have seen constantly that testing volumes in the major geographies in major countries in Europe are going back to last year levels pretty much, and this for us is a combination of Regular prescriptions that we see, again, going back to normality, and then combination of new business that we closed last year and growth of our product lines. The gastroenteric line is, notwithstanding the COVID situation, is growing over 20% year-on-year, which is phenomenal. And then the TB program that certainly is fully incremental for us, and it's firing up. It did fire up well in Europe, and it has been firing up in the U.S. as well. So in U.S. and Europe, a combination of recovering of testing volume and our traditional programs firing up, we see the traditional business doing okay. When it comes to China, we still have a red flag in China, and I think I heard also other diagnostic companies making similar comments. And the reason we believe is the fact that, as you know, in China there is no, so medicine is practiced right at the hospital sites, and so hospital sites additionally are extremely crowded, and I believe still the general population does not want to go to see their doctors except for emergency cases because they don't want to be exposed to the risk of, of infection, and this is the only way I think all of us can explain why, notwithstanding what is happening in the rest of the world, China is still lagging behind vis-a-vis volumes. And so we will watch carefully what happens in quarter four, and we hope that eventually volume is going to go back. But so far, I don't think we have lost visibility. Now, let's talk about COVID. certainly the business is doing extremely well. And we need to look at two components of COVID, on one side serology and on the other side molecular. Serology Q2 was phenomenal and this was because there was lots of excitement about the adoption of serology for epidemiological studies and then the viability of serology to support lack of testing capacity from a molecular side. So lots of hype that eventually died pretty fast. And if you have seen comments from the major labs in the U.S. as well as other competitors, the spike really lasted two, three months. And then serology went back to where I think it deserved. which is an interesting tool to follow up at this point, all the patients that are hospitalized. So more clinical use than general use. In quarter two, I remind everybody that we had roughly 45 million euro revenues on serology. This is in quarter three, is not there, certainly is not there anymore. I think that our projection of C serology more around, you know, between 8 and 10 million per quarter, which is what we believe is physiological use of serological tools, especially in those countries like Brazil, India, and some of the export countries where lack of swabs and molecular testing is somehow compensated by the use of IgG and IgMs, which is an assay that we have launched a couple of months ago. As far as the molecular is concerned, look, today I think everybody is in the same situation. There is growing, growing demand of molecular testing. And molecular is considered, as we all know, the gold standard. And it is used both for clinical use, so to diagnose the acute phase, and also today to try to identify the asymptomatic carriers. Sales are proportional to manufacturing capacity. In Q3 we had versus Q2 50% growth rate of our molecular testing, which is pretty much in line with increased manufacturing capacity. We are a little bit far ahead compared to what we said was our goal. If you remember, we said we would have a million tests of molecules per month. capacity by the end of the year, and I think we were able to anticipate a couple of months that capacity, so we are enjoying good, good growth. Price is stable. We have positioned our assay as a specialty product for triage in admission. We have a relatively small system, our MDX, that has been very successful into the hospital setting, so where we enjoy specific positioning as well as a price premium, because we sell the ability to triage within 45 minutes, so you are able to triage patients and properly redirect the COVID positive and COVID negative patients. So far, as far as the installed base is concerned, we have We've been able to place roughly 500 additional systems for molecular. A good chunk of it is in Europe. Prior to COVID, as you can imagine, our installed base was primarily U.S.-driven. After COVID, the installed base has been growing significantly in those countries where we have elected to sell the product. Certainly we had to make certain decisions in terms of priorities and as I think we have stated from the beginning, US, Italy were the primary markets that we decided to serve, followed certainly by Spain and France and few other placements in other European countries. So COVID is doing fine. The positioning, I believe the correct positioning, and we now have another goal, which is to get to 1.2 million tests around the February timeframe, which would be the next step of increased capacity. At the same time, we have also launched our flu assay, which now is compatible with COVID, so we can follow the trend of differential diagnosis in patients that do show up with the same symptoms, although I think as we have seen in Australia, now it's also fairly clear in the US and in Canada, where we have a big install base, the influenza season looks like it's going to be fairly mild. And I believe that this is the consequence of all the social distancing and hygiene measures that were adopted because of COVID. The results in Australia that I've seen were unbelievable. Whereas last year in June, there were 7,000 cases a month of reported flu. I think it went down to 50 a month. And so it clearly showed that this influenza season is going to be very mild, which is a living space to actually manufacture more COVID. And so we are actually balancing today our manufacturing more toward COVID than flu. There is another program that for us is very strategic, is antigen testing. Antigen testing was clearly made available a couple of weeks ago, so it's not part of the quarter three results. However, these antigen tests that we launched, I believe is a very strategic product, has been the first one And so far the only one to be launched with certain characteristics is, you know, as public information is ortho clinical and is Diasorin the only two high throughput assay launch. Our assay though is different than ortho because it's quantitative and allows the determination of the viral load, which we believe is a very relevant characteristic of this product. And by the same token, the positioning is specific because, you know, there are a lot of point of care antigen tests available out there that have been deployed in different settings to be used. This product, which is a high throughput and is actually run on our liaison platform, has a better clinical performance than some of these rapid antigen testing, and that's This comes without saying because the chemiluminescence technology is a much more powerful technology than this laminar flow. It guarantees traceability, which is something that some of the laminar flow point of care assays don't do today. This is key in my opinion. Increased sensitivity and traceability is very relevant in order to allow the identification of asymptomatic carriers. For diagnostic, there are fundamentally two uses. One, the swab, the molecular testing is used more for clinical identification and for diagnosis and to release patients to guarantee that they're not infectious any longer, whereas the antigen testing would be, the use of it would be a widespread use in the community to identify hotspots and asymptomatic carriers. Our assay, because of the sensitivity that it has, does allow certainly the identification of asymptomatic, and this is how we are positioning it. So we expect, we launched it 10 days ago, it's doing very fine, and now we are commercializing it in the U.S. under EUN and submitted for EUA approval, which we expect to come in the next few weeks. Last but not least, we are working on a new product, which is a new serological assay that we intend to submit to the agency in the next few weeks. And this assay is intended to be a post-vaccination test. And the idea shortly is to use the same protein that has been used by the vaccine companies, which is a very specific spike protein, and then use that protein to understand the vaccine, the response of the patients or the vaccinated individual to the vaccine. It's a bet, certainly, because today there are no guidelines that do recommend post-vaccination testing. But if that comes and there is going to be a utilization of serology, We believe that this assay is superior to what's existing on the market because it's been specifically designed with, again, the same protein, S protein, that has been used as a candidate for most of the vaccine programs. At this point, I'm going to leave the mic to Mr. Pedron. He's going to take you through the numbers, and then we're going to take questions shortly thereafter.

Thank you, Carlo, and good morning, good afternoon, everybody. In the next few minutes, like usual, I'm going to walk you through the financial performance of Diasorin during the first nine months of 2020, and I will also make some remarks on the contribution of the third quarter. So we close September here to date with an increase in revenues at constant exchange rate of 17% or 91 million euros. As a result, if you might remember, a soft Q1, mainly driven by a volume reduction in China due to COVID, and a very good second and third quarter. Specifically, Q3 saw an increase in revenues of comparable FX of 34% of €60 million. Carlo has already discussed at length the reasons behind these variances. As expected and anticipated during last quarter call, Q3 20 gross margin ratio at 68.3% of revenues is below what we see in Q1 20 and Q2 20, which closed at 69.1%, mainly because of higher sales of COVID molecular tests. Year-to-date gross margin, though at 68.8%, is just slightly lower than 2019, which closed at 69.1%. September year-to-date EBITDA at €258 million records an increase at constant exchange rate compared to last year of almost 25%. Year-to-date EBITDA margin, always at comparable rate, is 42.3%, vis-à-vis 39.8% of 2019. Q320 EBITDA at €104 million, or almost a 46% margin, registers a record performance with an increase of 54% at comparable rates. Lastly, we confirm our ability to generate a very healthy and predictable free cash flow, €153 million in the first nine months of the year, thus bringing the net financial position of the group to positive €256 million. Let's now dip a little bit into the main items of the P&L. We said that the year-to-date revenues at €610 million grew by 16% or €85 million compared to last year. The growth at constant exchange rate is 17%. The impact of COVID revenues, again at comparable rates, has been €166 million year-to-date and €73 million in the quarter. As expected, the appreciation of the euro against almost all the currencies in which the group operates has caused some material effects headwind in the quarter, therefore offsetting the tailwind we saw during the first half of the year. Considering where the U.S. dollar is trending now compared to 2019, I believe it is fair to say that we will experience a similar 7 million euro or thereabout negative currency effect also in the last quarter of the year. Gross margin at 420 million euro grew by almost 16% compared to last year, closing the first nine months of 2020 with a ratio of 68.8%. Q3 gross margin increased compared to 2019 by almost 30%, with a ratio of revenues of 68.3%, vis-a-vis, as I said, 69.1% of H120. This slightly decrease in the quarter gross margin ratio compared to the first two quarters of this year is mainly the result of a different product mix. To be more precise, lower clear sales and higher molecular sales. which enjoy, as we have discussed several times, lesser margin, slightly lesser margin. The increase of the molecular franchise, 34% of the total quarter sales, has been mainly driven by COVID testing. Total year-to-date operating expenses at €195 million of 32% of revenues have increased by less than 2% of €3 million compared to last year. The OPEX ratio of revenues is 32% vis-à-vis 36.5% of 2019. Here we have two effects of opposite sign. On one side, we have had a slowdown of activities and a consequent reduction in costs caused by the widespread lockdown measures that interested all the geographies in which we operate. On the other side, we have had sustained and increasing costs mainly driven by the investments we made in the U.S. commercial team aimed at supporting our hospital strategy, again as discussed a few times during these calls. Year-to-date other operating expenses at 11 million euros increased compared to 2019 by 5 million euros. As discussed, the biggest driver of this variance is an unforecasted loss we suffered in our South African subsidiary during the shutdown process. for which we have activated our group insurance policy. And we are hopeful that the old claim process will be completed within the next 18 months. As a result of what just described, year-to-date EBIT at €214 million, or 35% of revenues, has increased compared to 2019 by almost 29%. Q320 closed at €90 million, with an increase of 62%. or 34 million euro compared to last year. September to date tax rate is in line with 2019. This brings us to net results of the first nine months at 163 million euro or 26.6% of revenues, which is higher than previous year by 36 million euro or 28%. The increase in the quarter is almost 60% or 25 million euro. Lastly, September year-to-date EBITDA at €258 million is better than last year by €49 million. EBITDA rational revenues is 42.3% at constant effects vis-à-vis 39.8% of 2019. Q3 closed at €104 million, or 45.7% of revenues. The substantial margin improvement toward last year, both in the year-to-date but even more so in the quarter, is driven by the operating leverage resulting from the increase in revenues amplified by a muted increase in operating expenses. Let me now please move to the net financial position and the free cash flow. We close the period with a positive net financial position of €256 million and €284 million cash. In the first nine months of the year, the group generated €152 million free cash flow vis-à-vis €138 million of 2019. The year-to-date free cash flow has been affected by an increase in working capital, mainly driven by higher accounts receivable and higher inventory to sustain the COVID testing volume and sales, higher capex, driven by the acquisition of the TTP license and higher installment of our platforms, and all of these just partially offset by lower tax cash out, mainly coming from a positive phasing, and the one-off of €6 million exit tax we paid in 2019 when we closed our Irish manufacturing site. Lastly, the full-year 2020 guidance at 2019 exchange rates. We expect revenues to increase at around 25% and an EBITDA ratio at around 43% of revenues, all at 2019 exchange rate. Please remember that the assuring financials are highly exposed to the U.S. dollar, and even more so now that the United States represents more than 40% of the total sales of the group. Therefore, as a rule of thumb, consider that for every one cent movement of the dollar against the euro, the Australian revenues move by about 3.54 million euro on a yearly basis. Now let me please turn the line to the operator to open the Q&A session. Thank you.

Excuse me, this is the Corfu Conference operator. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and 1 on their touch-tone telephone. To remove yourself from the question queue, please press star and 2. Please pick up the receiver when asking questions. Anyone who has a question may press star and 1 at this time. The first question is from Catherine Tennyson of Bank of America. Please go ahead.

Hi, thank you. I have two questions, if I may. So firstly, can you just help us understand what are your expectations for the phasing of the antigen testing opportunities into 2021? And secondly, obviously after this exciting new flow, what are your expectations for how that vaccine impacts your business into 2021 as well? Thank you.

Catherine, sorry, the line was not the greatest, so I hope I was very, you were very choppy, so very difficult to understand. So if I understand correctly, you want to understand the antigen opportunity in 2021 and the effect of the viability of vaccination on the business. Is this correct?

Yes, that's the start and I'll have a quick follow up after this.

OK. As far as antigen testing is concerned, as said, antigen testing, I believe, is going to be used fundamentally to trace asymptomatic in the population. And today, you know, this requires lots of volume, lots of testing volume. And today, because of the lack of capacity for the molecular swab, this cannot be done using the molecular test. So I believe that as long as there will be a need to pick up asymptomatic individuals in the general population, there is going to be a substantial demand of antigen testing. How long is this going to last, which I think ties to the second question. I think that anybody honest in the industry will tell you no idea. And we have no idea, in my opinion, simply because I was very surprised last night when without any scientific data made available, a statement was actually made by the vaccine industry saying, hey, we have 90% protection. But already today, lots of people are asking, really show the data and let's understand exactly what the vaccine is, how it works, how effective it is. And there are lots of questions that I don't think we will have an answer to by the time the vaccine is going to be launched. And one of which is for how long is this protection going to last? And then the other question, I believe, is going to be adoption, adoption rate. You know, today I am a I'm amazed to read the statistics both in U.S. and Europe that says that half of the population does not want to get vaccinated. Okay. So to make a long story short, I have no idea of what would be the impact of the vaccine because we don't know what kind of vaccine we have. We have no idea in terms of how long this is going to last, and we have no idea about the deployment. Okay. So I think we need to understand, and we're going to understand later in the year, I think by mid-next year, when we are going to be presented with data, more secure data, about efficacy of the vaccine. All said and done, I just want to make sure you understand that personally, I hope that this vaccine will have 100% efficacy so that COVID goes away. I'm tired of spending my weekend in a lockdown on my balcony in Milan, as I already said a few times. But all said and done, very difficult today, in my opinion, to make a projection. Antigen testing is a very good tool as long as you need to pick up asymptomatic people, is also a very good tool when it comes to secondary geographies, and we've already seen in India and in Brazil and in Mexico, some of these geographies where there is a capacity issue with molecular, then IgM and serology was used, and then antigen testing will become a very nice and better way, improved way to actually also diagnose the acute infection. So we see an opportunity on the couple of thousand systems that we have today installed in the secondary market. As far as molecular, as said, today we don't have enough. I believe that what will happen eventually when the pool of testing is going to shrink, the first one to go is going to be the antigen testing. And the molecular will continue to be there because the gold standard is the same clearly more sensitive than any antigen testing and it is going to be used and it's going to be extremely relevant in my opinion until the virus is going to be completely eradicated for a differential diagnosis because don't forget what you need to do right after the vaccine is going to be made available is still to identify hotspots and as soon as they have been identified then you need to proceed with lockdown and lots of testing in that particular population. And it will be used again next season, next flu season for differential diagnosis. We'll still be there. By then, I don't think that the virus is going to be eradicated, so you're going to have symptomatic people that will show up with symptoms, and you still want to know is it COVID or flu. And in fact, I project that next year there's going to be a lot, much more use of flu and COVID combined than what we have seen in this season. But to be honest with you, this is as much as I can tell you because I don't have a crystal ball.

That's helpful. If I could just squeeze in a very quick one. Now in Europe, we're seeing the second wave pick up again and we're seeing localized lockdowns. From what you're seeing in your communications with hospitals, can you see that as an impediment to the recovery of the base business back to flat in Q4? And also just a reminder, in case I missed you at the start of the call, what does your failure guide imply for the recovery of the base business? Thank you.

Again, today we don't see it as an impediment because I think that hospitals are much better organized in terms of their ability to first triage at the entrance. So they have what they call the clean side of the hospital and the COVID side of the hospital. And therefore a viability of testing right there triaging is allowed immediately to separate the different patients and then admit patients in the clean air and keep it clean. And I think that today has been understood by patients and we don't see right now a problem with testing volume. Okay, anything can change. Okay, but so far, if I need to look at October and November, we still continue to see the recovery of the base business.

Super, thank you so much.

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

Yes, good afternoon, everybody, and thanks for taking my question. Congratulations for a strong set of results at The first question is a very general one. I understood your type of crystal ball, but in any case, how do you suppose 2021 could evolve quarter by quarter, assuming vaccine in terms of your three COVID-19 texts, I mean, molecular, antigen, and serology? What should we expect, not in terms of guidance, absolutely, but just in terms of general market trend? And my second question is about the antigen and molecular test. I don't understand why I shouldn't assume that antigen test may at least partially erode some market share to the molecular one. I mean, for example, if I believe to have flu before doing a molecular test, I may try an antigen test. And if this is negative, in the end, I don't do any molecular test anymore. And my last question is about the routine test. I didn't get your answer to the previous question. Which kind of recovery do you expect for next year? Is it feasible to assume volume returning to 2019 level?

Okay, I start from the last, going to the first. As far as next year recovery, I believe that for sure the availability of vaccine is going to make the recovery faster. The general level of confidence, I believe, is going to return back, and this could be a problem, but there is a strong expectation by people that the availability of vaccine is going to address the problem. So even psychologically, I think that people will feel better about going to the doctor, going to the hospital, and so forth. So I think when we look at 2021 projection, we projected that volumes are going to go back to what they were in 2019. As far as antigen testing and why it does not cannibalize, because the use is completely different. Today, the PCR assay, which is the gold standard, is used for clinical diagnosis. But it's not enough. I keep saying, look at the U.S. The U.S. has said that today they do a million PCR a month, so 30 million a day, so 30 million PCR a month. And they say that in order to coexist and reopen certain activities, fly, and being able to go to watch football, you need to do much more testing. And that cannot be done by molecular because it's too complex and is too expensive, by the way. And it should be done by a cheaper alternative, which is the antigen testing. By the way, you said if I do an antigen test in a negative, I feel comfortable. I wouldn't, to be honest with you, because one of the issues with the antigen test is sensitivity. And today there has been a work that has been published by the French health authorities, which so far I found it to be the best evaluation ever that I've seen on antigen testing. And what they prove is that antigen testing sensitivities compared to PCR is 75%. Okay, so 75% means that you're going to be missing one out of four, which is good enough. if you want to use it for testing of asymptomatic in areas with relatively high prevalence. But then if you go to the individuals and you want to rule out with symptoms, rule out whether it is or it is not, COVID is not good enough. You need to do PCR. This is why I'm saying the first one to go away is going to be antigen. First, all antigen testing is going to disappear, in my opinion. in when the vaccination is going to be widely available. And again, I'm remarking widely available because you need to reduce the pool of negative patients to the virus. And then PCR eventually is going to go away, meaning that the PCR will be used still for differential diagnosis with symptoms when people show up, especially during the peak season. So what you will see eventually is that you're going to have a surge in volumes during the flu season and that is going to revert more to less volume during the summer. That is the signal that will tell you that COVID is going away because it's just becoming another diagnostic test for differential diagnosis and making sure that the symptomatic patient that shows up is is a flu patient and not a COVID patient. And also that one is going to disappear when then the virus is going to be eradicated. Okay. But think about it. Even today, I think 20 years, 30 years after the measles vaccine has been made available in 90% of the population, whenever a 95% is vaccinated against measles, you still have the measles outbreaks. Last year, for us was a record year, 2019 was a record year on measles because there were outbreaks throughout the United States. So you really need to be careful about projecting. In my humble opinion, today it is very difficult to make a projection until you really understand what the vaccine is all about.

Okay, thank you.

The next question is from Maya Pataki of Kepler-Chevreux. Please go ahead.

Great. Thanks for taking my question. Actually, Carla, I'm sorry, but I'm going to ask you again to look into a crystal ball, which you might not have. But it is a very clear statement from your side on what you believe might happen, that antigen testing will be first to go away. Well, if you look at the PCR market as a total, there is a substantial volume of more manual-related PCR tests today that are helping to address the demand. Do you think the more manual PCR tests will go away after the antigen tests? and then a second question is at some point in time there is probably going to be over capacity in the market on the on the pcr manufacturing site do you believe there is going to be a harsh pricing competition in the in the code space and do you think it could actually extend to the other to the other pcr testing areas thank you maya

I think you made a very astute comment, and thanks for bringing this up. Yes, indeed. You know, to me what's outstanding today, go out and look at how is it possible that still in the U.S. they can do 30 million PCR a month, and also Italy. In Italy today they are doing 1 million. They're doing 200,000 a day, which means 6 million per month. And when you go and talk to customers, you find that it's a very interesting story. It's a combination of IVD products, and so us, Abbott, Roche, you know, the usual suspects, the usual companies that have C-mark products as well as EUA products, versus a plethora of LDTs, which have been developed by hospitals that don't get enough PCR reagent from industries, buying fundamentally reagents left and right and setting up their own assays on typically thermal fissure open platforms or bio-ride open platforms. At the end of the story, if you think about it, you need the CDC protocol, you need an extraction system, and you need just a PCR instrument to do a PCR test, right? I think, and you're very right, that the first one to go will be these old plethora of LDT assays because they carry liability. They are very time-consuming, by the way, because there is no level of automation whatsoever. And it's very interesting. If you look at one of the most recent publications that has been issued by the FDA, and what they did was they pretty much tracked down all the assays that received EUA approval, and there were 162 And believe me, I don't remember that there are 160 molecular diagnostic companies in the world, right? So there are a lot of these products, a lot of these assays and methodologies that have been fundamentally developed like LDTs and filed as EUA, which is no problem because when you want to get your EUA, the burden of getting EUA is relatively small, right? And this is why they have an EUA because it's a short track to registration. Now, we are completing our 510 , because we see that now the world is going to move from EUA to 510 . And just to give you an understanding, the cost of filing an EUA, which is a combination of clinical, the clinical study which is now required for a 510 and the filing itself is $1.5 million. Okay, so now I want to see whether 160 companies that, you know, they came from nowhere, a lot of them, are they going to invest $1.5 million to get a fighting game? That itself is going to clean up the list of suppliers. So, in fact, you're right. I think antigen goes down. Then I think that the – the LDT is going to disappear, and then last, the IVD companies, then when the volume then declines, then the IVD volume certainly is going to go down. From a price point of view, look, it's inevitable that eventually everything resorts to price, also because today there are subsidies which are very specific for the reimbursement I'm talking about in the U.S., very specific for COVID-19. And I believe that when things are going to go to normal again and there's not going to be so much pressure on volume, I think that also the reimbursement by definition is going to, which is very generous today on purpose to push all companies to invest in research and development and bring forward all these essays, also the reimbursement is going to go down. But this is part of life, right? It's nothing unheard of. What I don't think is going to happen is that all this scenario is a 2021 scenario. So we feel overall pretty comfortable vis-à-vis what is the opportunity in 2021. I think that when you talk to 2022, there is going to be lots of uncertainty, but again, It all depends what kind of vaccine are we going to have in front of us. And as of today, we don't know enough. And when the vaccine is going to be launched, we still are going to have lots of questions because nobody will be able to tell for how long the protection will last. Okay.

Understood. Thank you very much, Carla. Two follow-up. One is, do you think that the pricing pressure, because there is going to be such a big overcapacity from the big guys, could be extended to other PCR tests as well? And then, just quickly, can you give us an update on the saliva test? You haven't really spoken about that, so just wondering if there is any update that you can share.

Maya, I don't think so. Because again, everything else, the regular course of business of molecular is properly priced and the pricing will come from competition and properly reimbursed. Actually, I see something completely different. I see that thousands of systems have been now acquired by hospitals. And it's very interesting and you see it also in our results as well. Because of the fact that lots of emergency funds have been unleashed, every company is reporting that if in 2019 we were actually 70% of our placements were going through reagent rental and 30% were actually sold. In 2020, what you're seeing is that it's completely reversed. So 70% of the equipment is purchased by hospitals and 30% is leased. And they are doing so because they have lots of money. They are called emergency funds. Now you're going to have all these thousands of equipment that is going to be owned by hospitals. What I think is going to be the effect is that hospitals will be encouraged at that point to decrease the send-out and increase the assays that they're going to do in-house, and especially in the U.S., And so I think that there are going to be lots of incentives for these hospitals not to, you know, engage anymore with the big private labs but do more testing themselves. And by the way, this is what we see ourselves because one of the net results of the adoption of serology in the U.S. and not necessarily by testing volume but by the fact that every hospital is still doing serology. We are talking about, you know, on average, 1,000, 2,000 tests a month. This has pushed the installation of lots of liaison Excel as well in the proper segment, which is the hospital segment. Remember, we had a hospital strategy. And what we are seeing is that now these hospitals that have the Excel are saying, okay, let's, you know, faster adoption of TB. TB is the designated victim. Rather than sending it out to Quest, LabCorp, Sonic, we're going to do it ourselves because now we have the Excel. GI, same story. It was in a relatively small mid-volume, not worth taking it itself, but now that we have the box and we have TB, now let's do also the calprotectin, the H. pylori, and all the rest. And I think this is true for all the diagnostic companies. So what you will see is going to be that there is going to be a lot of insourcing of testing and less of send-out. And this, I think, should be a concern of some of the big laboratory chains in the U.S. And if I'm not mistaken, some of the CEOs already did comment on the fact that the next challenge in the U.S. market for them is going to be the fact that hospitals will tend to insource.

Fantastic. And the saliva test?

Saliva test, you need to stay tuned because we launched it with NPS and NS, and we're now doing the clinical studies to validate saliva. As you know, we were able to validate saliva on our molecular test. We have it CMARC, the only company with a CMARC saliva claim on molecular. Very proud of it. And now we are doing the clinical for the antigen. The real problem, to be honest with you, is that when you, since the FDA is asking for symptomatic and asymptomatic patients, one of the problems with symptomatic patients is that they have no saliva, unfortunately. And this is because of the respiratory condition, but also the fact that everybody is under oxygen. And one of the effects of this oxygen is that it dries up completely your mucosa. So the clinical study is longer than expected, more on the symptomatic, but, you know, we're working on it, and we're going to keep you updated within the next four to six weeks.

Fantastic. Thank you so much.

The next question is from Scott Bardo of Barenburg. Please go ahead.

Yeah, thanks very much for taking the questions, and congratulations again on great results today. I guess with the new flow on what appears to be quite an effective vaccine, investors are increasingly focusing on the new normal for Diosorin and where you land post this crisis. So I wonder if you could please share some thoughts as to has the recent experience that you've seen with COVID-19 installed base, tremendous growth and margins and so forth. Changed in any way your longer term perspectives for the business pre-COVID, which was for mid to high single digit growth and slightly over 38% or so margin. So I wonder if you could talk a little bit to that and when potentially we could see a more normalized type growth profile for the company. So that's the first question, please. Second question. Pleasing to see you have a laboratory antigen test, which I think looks to be a good one. Siemens Healthineers recently pouring a lot of cold water on the notion of laboratory-based antigen tests, suggesting there's not really an opportunity there because of the logistical considerations. Can you highlight why you would disagree? And also, again, your comments on androgen going away relatively quickly after full vaccination. Is it unfair to suggest that you move into the more numerous and bigger lateral flow opportunity at a time when the market is already starting to peter away? Thank you.

Okay. You know, let me just make a joke. You always say that the test is not needed when you don't have it. So, I didn't hear Siemens making the statement, to be honest with you. I heard Roche saying that they are coming in December. That I heard loud and clear. And I think that Roche made pretty much the same comment we made. It's very important. The utilization of the assays is completely different. The point of care does carry lots of benefit if you want to go deep down in the community, if you want to provide. to the family doctor with a tool to rapidly identify whether an asymptomatic patient that shows up is COVID or non-COVID, and then send the patient to avoid that all these patients rush to the emergency room and they get congested fundamentally, the emergency room, which is something we are experiencing these days. However, there is a trade-off. And the trade-off that we see is performance. You saw Quidel yesterday had actually an FDA warning letter, a public warning letter on the performance of the product. Because the lateral flow technology is a good technology, but does carry certain limitations in terms of sensitivity and specificity. We all know. But it's a good trade-off because it's exportable. So you can actually decentralize testing lateral flow. I believe that when you take that assay and you put it into a liaison format, chemiluminescence, call it liaison, call it Roche, call it Siemens if they are able to do it, it would be fundamental. You go back to the typical performance of analytical performance of a chemiluminescent assay that from our experience you gain minimum log insensitivity. And this actually allows you, I believe, to get closer to the sensitivity of PCR. And on this one, you know, Scott, you are technical enough to understand my comment. You know that today there is lots of debate about the fact that PCR is too sensitive. And now there are indications, again, indications and not guidelines to the fact that, you know, if you run a PCR assay and you are over 33 CT, so you're positive. but over 33 CTs, well, you have detectable virus, but you're not necessarily infectious. And so everybody is indicating that the clinical relevance for infectivity is up to 33 CTs. And if you see some of the antigen tests have been actually tested, the FDA asks you to look through the spectrum, but fundamentally the clinical claim is up to 33 CTs. With our assay and the sensitivity that is provided by the chemiluminescence technology, any chemiluminescence technology, so I'm sure Arosh is going to get that as well, you are getting to the level where up to 33 CTs you pretty much match the result of the PCR, give or take, with chemiluminescence. This is why I'm saying that I see a need of an antigen test done and managed by the central lab. And I've seen how customers that have adopted rapidly this assay are using it. And an example is one of the, in an Italian region, I cannot name the hospital of the region, they use it to rule out all the asymptomatic. Right, and because they have a gazillion asymptomatic patients that are coming over because they are relatives to people that have been diagnosed, and then you need to understand that they're positive or negative, the quarantine, all that jazz and story. And the hospital today is using it to immediately, very fast, to rule out the asymptomatic and free them up versus then get themselves into the quarantine. And today, lots of volume actually is going in that direction. This is why I'm saying there is a need for this antigen test. It is going to go away because eventually when you will be able to choose, you're going to be choosing for clinical, again, diagnostic specification, you're going to go for a gold standard. And gold standard, undeniably, is the PCR, let's say. Now, let's talk about the post-COVID. post-COVID world. Okay, let me just state, I don't know when the post-COVID world is going to start. Okay, I think, I hope it's going to start in 2022. Post-COVID for us, if you listen, well, I know that you listen, and unfortunately, some of other investors did not. They were too much focused on COVID, but we started to talk about the post-COVID world three months ago. And to me, the best move was NEMED. And we talk about MIMED and nobody listened because everybody was enthusiastic about COVID. But MIMED for us was the beginning of a new post-COVID world where certainly we have an installed base in hospitals because of COVID. And MIMED is a fantastic opportunity because it's innovative, is very much welcomed clinically by physicians. MIMED, the company itself, spent a gazillion amount of dollars in into the clinical validation of the concept, and we expect that very rapidly they're going to have also the FDA approval so that we can use their assay as a medical device. So MIME to me is the post-COVID word that will lead to the assortment of three things, in my opinion. Brand recognition because we have been faithful and loyally serving our customer base without a single day of backorder, and this has been recognized by everybody. Uninstalled base. that we were able to establish on molecular and immuno. And last but not least, COVID will translate to everybody into lots of cash, right? And now the next question, I'm going to reply before you ask the question. The question is, you need to take that cash and then rightfully invest it in order to strengthen the company. And certainly M&A plays a role. And we do have a plan, as you know. We've been always careful buyers. We believe that the post-COVID time is going to be a good momentum to look into M&A opportunities, and we are certainly focused on that.

Thanks very much, and maybe just a quick follow-up if I can. So you're right, I was going to ask a question on M&A. But just to understand, you know, it may be too difficult to answer, but the profile for the business pre-COVID as compared to post-COVID, is it still relevant, mid to high single digit, you know, sort of high 30s margin? And maybe to answer the M&A, ask the M&A question slightly differently, you know, with DSR in set to, you know, exceed approach the 1 billion sales mark, do you feel confident that that is a level and watermark approach that you can sustain along with M&A going forward?

Listen, again, I pull out my crystal ball, I look into it, and I say yes, because nothing changed. Okay? So Diasoring has always been a profitable company because of the nature of the business we run, which is extremely specialized. And again, sorry if I go back to it, look at MIMET. We didn't get ourselves into another TSH. We got ourselves into far-front technology, clinical technology, MIMET, which is high-value products and hopefully high-profit products. Certainly, we need to invest in marketing and promotion, but it's a good bet because it's a phenomenal clinical tool that everybody is welcoming. So if I look at the crystal ball post-COVID, I think that we will continue our trajectory, hopefully reinforced strategically by the proper acquisition that will give us sustainable critical mass over a billion.

Okay, thanks so much, Dave.

Mr. Rosa? There are no more questions registered at this time.

Thank you, operator. Bye-bye.