Good day, welcome to the bioMérieux yearly business review conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Franck Admant. Please go ahead. Thank you, Mary. Good day, everyone, and thank you for joining us to review bioMérieux performance for 2020 and our objective for 2021. Before leaving the floor to Alexandre Mérieux, Chairman and Chief Executive Officer, and Guillaume Bouhours, our CFO, I will just make a very short introduction to provide you couple of information. First of all, our press release will go out to this morning at 7:00 A.M. This press release can be found on the homepage of our website. In addition, please note that the slides of this meeting will be available on the homepage of our website and can be downloaded directly from the webcast. From here till the call, the webcast and the call will be available in replay on our website. Going to the presentation contents. After reviewing our 2020 performance and 2021 objectives, we will hold a Q and A session. Questions can come from the conference call and from the chat of the webcast. If you wish to ask a question, please make sure to identify yourself, name and company. A very last word before starting the presentation. I will not read the slide which is currently projected, but I recommend you to take note of its content that reminds the usual disclaimer about the forward-looking statement. I now hand the call over to Alexandre Mérieux. Thank you, Franck. Thank you, everyone, for joining this webcast on our 2020 results and the outlook for 2021. As you all know, 2020 has been a special year for all of us around the world, and it has also been a special year for bioMérieux. As a dedicated company to clinical diagnostic of infectious disease, we have been able to play a key role in the fight against COVID-19, thanks to the portfolio of our solutions that we developed and also thanks to the engagement of our teams. You can see, I believe, on the slide, the performance of bioMérieux in 2020, which has been remarkable. First, looking maybe at the sales growth. We grew nearly by 20% organically. We are now a EUR 3 billion company. More than that, a EUR 3.180 million revenue for 2020. Our profitability has increased also. We are in 2020 at 19.6% of contributive EBIT versus 14.5% in 2019. You see also that this year was a good year in terms of cash generation. We have a free cash flow of EUR 328 million, and we are a debt-free company. You see the growth this year. It has been contrasted, I would say that the surge of molecular and BIOFIRE was the key growth driver for us, BIOFIRE being the key solution. We see that all the ranges have been impacted, like for other clinical IVD companies. Mainly in Q2, linked also to the slowdown of traffic in the hospitals, we see some signals of a recovery. Moving now to what happened in 2019. As you know, we have started at the early days of the crisis to really put the focus on the development of a COVID-19 test solution on our range, and it has proven to be well-adapted. We were able first to have the extraction. We were able then to develop on the ARGENE range, monoplex testing and now low-plex testing. Of course, now with the FILMARRAY, with the RP2.1, we have been able to add COVID to the respiratory panel that was already existing and has been a booster of growth. Using the VIDAS range, we have been able to develop two serological tests, IgG and IgM, on the VIDAS platform. We have been able to develop a comprehensive portfolio of solution using also the wide range of technology available in bioMérieux. Looking now at the specific ranges. As I said, BIOFIRE has proven to be a key diagnostic solution in the fight against COVID, with an impressive growth of around 80%. We're noticing that the install base in term of units has really increased now from around 10,000 to now 17,300 units worldwide. It's a major achievement. The key facts of the year have been at the launch of RP 2.1. We have also launched a solution called BCID2 for blood culture identification. The pipeline is still very active, and we should launch in 2021 the BIOFIRE Joint Infection Panel, and also we'll upgrade the FILMARRAY panel adding COVID-19 test in the panel. The basis for us to grow is around the evolution of the BIOFIRE instruments, the large install base, which could be in the future an important potential for us. Even if we had a nice growth in the U.S., we keep on growing internationally with now having sales outside of the U.S. for BIOFIRE, representing 23% of the total revenue of BIOFIRE. We have also a way to satisfy the demand, has been to work to increase the manufacturing capacity of BIOFIRE, which is being produced in Salt Lake. As you see now, we have been able this year, we were around 750,000 capacity production of kits per month. We should be able this year to produce around 1.2 million kits per month in our Salt Lake sites. Knowing that we are invested in a new manufacturing building, we are making progress on the automation project that we have, and also we put the organization around 24/7. Looking at the other ranges, as we said, there was some impact this year because everything was at least at the hospital or the lab. A lot of focus was on COVID-19 and not so much on the other pathologies. You see clinical micro at - 5% and immunoassay at - 7%. What I told you and what we told you, that there is a signal of a recovery in Q3 and Q4 on these ranges, on the culture for microbiology and also on the immunoassay. We are recovering, and we get for this also, we start to have an impact from the serology test starts COVID that we developed on VIDAS. Pipeline for 2021 or so should be fueled by first an evolution of our mass spectrometry system that we are working on. Also in the field of immunoassay, we have already launched NEPHROCHECK, which is for- AKI. Acute kidney injury, every time. Acute kidney injury. We're about to launch our solution for tuberculosis, TB-IGRA on VIDAS, and also dengue. We're also preparing launches of chikungunya test and also traumatic brain injury test for 2022. Now talking about the industry business. The performance of industry was at 2% in 2020. Different type of growth depending, we address two market segments. One is healthcare, the other one is food. On the healthcare side we had a good momentum, should quite a strong resilience in line, I would say, with the pharmaceutical industry in 2020. For food, we were a bit impacted by the lockdown measure also on the fact that we serve the food service business, which has been impacted along the year. I would say that we still have solid fundamentals, good recovery in Q4 on this industry business. The signal demands should be important for this year. Worth noticing also that in the healthcare business now, bioMérieux is positioned to do the quality control of sterility. With the surge in the vaccine production, we should be part of the player who are able to test for this increase of production in the vaccine world. With this being said as introduction, I will now leave the floor to Guillaume Bouhours, who will introduce the financial results. Thank you, Alexandre. Hello, everyone. Let's start by reviewing our organic growth of 19.7% by application, and this exceptional performance in 2020. For the first time, molecular is actually our first range of product, representing almost 40% of group sales. This +84% organic for molecular is made of 79% organic growth for bioMérieux, as Alexandre mentioned, and more than doubling actually for the other molecular ranges in this part. Microbiology at -5% as Alexandre already commented. We have, let's say, a clear recovery for blood culture in the last quarter of the year, a bit softer recovery for the ID/AST at this stage. Immunoassay -7%, but again, with a really good trend of recovery in Q3 and even stronger in Q4. Almost stable actually versus 2019 in Q4. Finally, industry at +2%, which includes food segments being stable in the year and healthcare really solid, resilient growth at +5%. Just to be noted in the others, you have this gray part of EUR 78 million. This includes the BIOFIRE Defense with the singleplex for the significant growth this year. By geography now, of course, a momentum that reflects the exposure and the positioning of bioMérieux in molecular in the different regions. Super strong in Americas, North America +40%, Latin America, excellent performance as well, +21%. Obviously our first region and first country with the U.S. EMEA, a bit more contrasted at +8% overall. Strong performance in France, in Northern Europe, in Spain, in Italy. A slowdown in Middle East and Africa, which are our usual growth driver. This year, in 2020, we are more impacted as they are more on routine parameters. In Asia Pacific, overall +1% organic growth. Much lower than the past years. Very contrasted as well. China is very slightly negative. We have an exceptional performance in Japan, where I remind you that we entered with FILMARRAY at the end of 2019, which was really good timing, super performance, and breakthrough in 2020. Good performances as well in Australia and India that we can mention here. Moving to the overall view of 2020 sales. A major FX impact, especially accelerated in Q4. Of course, the US dollar at one was 1.19 actually versus euro in Q4 is having a significant impact on revenues. We'll come back to FX sensitivity in a few minutes. We can now turn to the P&L, profit and loss. Beyond the sales growth of 19.7%, I would like to highlight the gross margin improvement from 54.8% in 2019 to 56.2% in 2020. A significant improvement. That's linked to the positive product mix as we often highlighted BIOFIRE FILMARRAY has, let's say, above-average margins, and of course, was growing above average this year. Also a volume effect on the part of fixed costs that are above gross profits. SG&A grew 7.5% overall at constant rates. That includes, I would say, a lot of exceptional positives and exceptional negatives. What I mean is that we had exceptional savings this year on travel, on congress, and advertising, due to, again, the situation. We also had in these lines exceptional costs. With a strong sales performance, we had additional sales bonus, additional profit sharing, and variable compensation. I would say all this are close to offset each other, the exceptional plus and exceptional minus in these lines. Moving to R&D, 8% increase. We end the year at 12.8% of R&D over sales, which is slightly below our usual percentage, but of course, linked to the volume. We accelerated our COVID developments this year. We also maintained our efforts and our investments in other programs as the launches and the pipeline that Alexandre mentioned highlight. Overall, contributive EBIT of EUR 613 million, like-for-like increase, very impressive, of 66%, reflecting the strong operational leverage on the additional sales. We can look on the next slide at, let's say, a few elements of bridge on the contributive operating income. We highlighted here the COVID impact. The COVID impact on operating income is estimated, of course, it's estimated of EUR 170 million. That's a result of a net additional revenues net that we estimate at around EUR 320 million. All the elements that I mentioned earlier of exceptional savings, travel, congress, and exceptional additional costs, especially profit sharing and variable comp. All this ends into EUR 174 million. Apart from that operational improvement of more than EUR 100 million EBIT. Some small, let's say, differences versus last year on the U.S. pension settlement, where we had the freeze of the U.S. pension in 2019 for + EUR 11 million, and the termination of these plans in 2024 -EUR 4 million. Our famous, let's say, Phantom shares plans, which remember, are bonus in the U.S. for U.S. teams linked to the share price of bioMérieux. That actually were an expense of EUR 44 million in 2020, and that's 9 million more than the 2019 expense on this Phantom shares piece. Last comment on this slide, EUR 30 million FX effect on the CEBIT, which again reflects our exposure. I remind everyone, we are very much with expenses in euro and dollar and exporting worldwide in other currencies. Now looking at the P&L below operating income, we have, as usual, let's say, amortization of BIOFIRE acquisition price, stable, EUR 18 million per year. The second line is, I would say, new element, this -EUR 42 million reflects a non-current element for the exceptional solidarity actions decided by bioMérieux with EUR 42 million of, let's say, philanthropy expenses, EUR 22 million that we announced in H1, where we added also EUR 20 million for a new corporate endowment fund, let's say, fond de dotation, of bioMérieux. The initial, let's say, donation was EUR 20 million in 2020. The spend will be over three years for this philanthropy part. Net financial expense at EUR 29 million compared to EUR 23 million last year. Income tax of 23%. I will come back to that in a minute, effective tax rate. Overall, net income group share EUR 404 million, up 48%. On this basis, the board decided to propose a dividend of EUR 0.62 per share, meaning a payout ratio of 18% of this net income for the dividend to shareholders. A quick snapshot on the tax rate, that's the tax proof starting from the French tax rate of 32% in 2020. As usual, we have our country mix and tax credits. We would have a recurring effective tax rate of 22.2%. We have a few non-recurring items that overall are negative on the tax rate and increase it to 23%. Among these non-recurring items, we can mention the philanthropy actions, solidarity actions, where we actually are above the deductibility threshold for that kind of expenses in France. Coming to the cash flow statement now, a very strong increase of EBITDA in line with the operating income as mentioned earlier. Working capital consumption was -EUR 86 million in 2020, with an increase of inventory of EUR 83 million, especially linked to the very strong ramp-up of activity in molecular, of course. Payables +EUR 5 million. We accelerated to support our suppliers on these payments. Receivables, very stable in terms of days. Last element there, social debt, that actually reflects an increase, that reflects the higher profit sharing and variable compensation linked to this, let's say, exceptional financial performance. CapEx ended the year at 9% of sales, but still a strong level of investments, especially in our manufacturing capacity for molecular in Salt Lake, but not only. Overall, as Alexandre explained, a very strong free cash flow, EUR 328 million compared to EUR 150 million last year. That is now leaving our net debt overall at EUR 92 million, which includes EUR 97 million for IFRS 16. Therefore, we mentioned that our net financial debt is actually debt-free. A small point about the exposure to foreign currencies, especially important in this environment. We wanted to update you on this. On this table, you have in the first column our exposure based on 2020 on the revenues. A very strong U.S. dollar exposure on revenues, but this sales exposure on U..S dollar is, of course, offset by our strong cost base in the U.S., therefore it's a lower exposure on operating profit, always important to keep in mind. You see the different levels. Actually, when we look at the current rates and these exposures for 2021, you will see that we have an impact of EUR 30 million-EUR 35 million at the current visibility on rates included in our EBIT guidance for this year, 2021. With this, I hand over back to Alexandre. Thank you, Guillaume. I propose to now is able to talk with you a bit about our CSR ambition for bioMérieux, because we have always done CSR, but I would say that we have formalized a new CSR ambition for bioMérieux, supporting our long-term vision, but also I would say are very much included into our roadmap. This ambition relies on side panel that you see, health, planet, healthcare ecosystem, employees, and extended company. I won't give you too much detail, but just to give you a few KPIs. When we talk about health, it's of course about the public health mission of bioMérieux to keep on, as we do since the beginning of the company, to lead the fight against infectious disease through innovation, with this tech committee, I would say, to investment in R&D, and also be the leader in the fight against AMR, which is antimicrobial resistance. Of course, today it's a lot about COVID, but we believe that short, mid, long-term AMR is a key public health threat also in terms of infectious disease. Planet, we have also adopted some targets to reduce the greenhouse gas emissions. Another topic which is important and will be important is also our commitment to do eco design for our system and work more on, I would say, on the product life cycle optimization of our solution. Healthcare ecosystem is the way how we interact ethically with key stakeholders such as patient community, and make sure that the different stakeholders are integrated into our consulting governance. Employees, key asset of bioMérieux. Also there are a few objectives. I would say one of them is around the safety of our employees, and to make sure we can reduce by half the incident rate that we see on our sites, and so keeping progressing on this front, even if we have made a lot of progress recently. Working also on diversity and inclusion at all levels of the company, including diversity in terms of more position of women in corporate leadership team, and also more position of international teams in our leadership teams, also with some key KPIs to start with for 2025. Extended company, it's a bit how we interact also with our ecosystem and partners. One key topic will be around to increase the proximity we have with the suppliers, proximity both from a geographical standpoint, but also how we build partnership with our suppliers. Also, as introduced by Guillaume, philanthropy, which is quite much into the DNA of the group. We have announced, in addition of what we do in terms of supporting initiatives all over the world, we have announced the creation of an endowment fund for EUR 20 million. As you know, we are living in a sanitary crisis, but it's starting to have social and economic consequences. We felt, with bioMérieux leadership team and with the board, that creating this fund will be there to support solidarity initiatives outside of the field of health and supporting topics such as education, training, NGOs, and to do it also on a worldwide basis, making sure that the 45 subsidiaries where bioMérieux is present, our teams will be able to support and follow interesting initiatives in the field of territorial solidarity. With this being said, I can now move to the outlook for 2021. As you see, it's quite of an uncertain world right now, linked to the evolution of the pandemic and also the positive impact of vaccines. I would say in this environment, where diagnostic is key, we project, we estimate that the growth of the company in term of revenue should be between 5%-8% in term of organic growth. We have strong signals early this year, so we believe that the first half growth should be quite strong, maybe in line with the Q4 trend that we displayed. Regarding the financial performance of the company and the contribution to operating income, we target estimates to be aligned with the 2020 performance. Having in mind a negative FX impact of EUR 30 million- EUR 35 million. We will do also MyShare plan, keep on having our employees being shareholder of the company. We should see the end of the PSOP Phantom share by the end of April. Tax rate, we estimate to be around 23%, and there is still maybe some uncertainty on the U.S. tax rate, what will happen. This is our estimate. CapEx around 10%, and we will keep on investing in capacity production, R&D, and everything which there will be that we need to do to serve the market. Maybe with this being said, 2020 was a special year, as I said, lots of engagement from bioMérieux. Lots of recognition, also the value of diagnostic. I believe the company and our people are engaged more than ever, feeling very useful. I believe also that having a comprehensive set of technologies and solution, it's microbiology, it's molecular biology, it's immunoassay, it's service, it's data, it's a key strength to continue to be at the forefront of the fight against infectious disease. Of course, COVID is here. COVID is here also to stay, which will be part of, for the long term, of our restricted panel and our portfolio of solution. Infectious disease go beyond, and there are also many important topics, as I mentioned, such as antimicrobial resistance, sepsis management, quality control for the food and the pharma industry, which are key topics linked to infectious disease that we are addressing. We are on the right topics. We are doing, I believe, the right investment with a long-term view. Also linked to the good result that we had this year, we have a solid financial structure that allows us to support growth and investments to continue to develop the company in the right way. With this being said, I propose that we open the floor to the Q and A. Thank you. If you wish to ask a question at this time, please signal by pressing star one on your telephone keypad. Please ensure the mute function on your telephone is switched off to allow your signal to reach our equipment. Again, please press star one to ask a question. We can now take our first question from Alex Gibson of Morgan Stanley. Please go ahead. Great. Thanks. Good afternoon. Thanks for taking my questions. I've three. The first one is just on your guidance around the first half growth being on trend with Q4 2020. Can you provide some context around this, if this means you expect 20% growth in the first half? If that's the case, how much is coming from BIOFIRE, where the comps start to get difficult? Second question is on the EBIT contribution from COVID. Thank you for providing the EUR 174 contribution in 2020. How much of that are you incorporating into your EBIT guidance for 2021? My last question is just looking towards the end of 2021 and into 2022, balancing the slowdown probably that's going to happen in H2 with the ramp-up of utilization of BIOFIRE placements. Do you actually see the molecular business growing in 2022? Is it going to be a decline? Thank you. Thank you. I will answer some of your questions, and with Guillaume, we'll do a back and forth. 2022, i t's really difficult to predict 2021 because a lot of things will depend on the pandemic, if it continues or if it slows down. What I can tell you, maybe your question is into H2 also, that today we still have a strong demand signal for testing for COVID. We believe it will still be a key contributing factor for Q1 and H1. It's a projection we do. H2, I believe, we will see. We all expect COVID to go down. We all want COVID to go down. If it's the case, maybe it will have an impact. As you know, BIOFIRE, now we have a very strong installed base of 17,000 instruments. With FILMARRAY, we don't do only respiratory. We do GI, we do meningitis, we do BCID, we'll do soon brinjal infection. It's also a base to grow for the future, by adding the new panels that we have, either already developed or that we have in development. Another maybe something which may be difficult to quantify at this stage, but less COVID would also mean for us, a better, stronger recovery of the business, such as microbiology, immunoassay and industry. I'm sorry to say, we'll see. I will say that the perspective, the one we have today, the good thing to see that FILMARRAY has grown, so it's a good base for growth for the future. The recovery of the non-COVID business also should impact positively the growth of bioMérieux. I don't know if I answered all your question, or Guillaume, if you want to add. On guidance, I think your question was how close it is to the Q4. We said similar to Q4 trend. We mean the percentage of growth, to be precise. It doesn't mean exactly 20%, of course, it can be slightly below or maybe slightly above. Difficult to know at this stage. Around this figure. EBIT contribution of COVID-19, I think your question was on what to be, let's say, kept for 2021. On sales, as you understand rightly, we are really looking at the current trends that we see. As I just explained for H1, and as Alexandre explained, the lack of visibility for H2. On the cost side, I would say, as I explained, the exceptional savings and the exceptional costs, we expect most of this to, let's say, not be recurring. The exceptional variable compensation, exceptional profit sharing, all these parts on additional costs should disappear. Not everything. For example, freight costs were much higher since March, April, of course, we have in our guidance still higher than normal, let's say, freight costs. On the other side, the savings a big part of the savings will disappear. Again, some will stay, for example, travel obviously like today, like everyone, we have a lot of travel reduction. We'll see in H1 for sure. We'll see later in the year. Okay, Sorry? All that I just said is factored in. Yeah. Yeah. Okay. That's great. Could I just get one clarification on the EUR 174 million, do you think that level could be sustained, so you could see EUR 174 million net impact again in 2021? It's not as if you're baking in that amount reducing. Again, I have difficulties to look at it this way because of the revenue part, which is, of course, the biggest part of this, EUR 174 million. I don't think we analyze it this way. Again, in 2020, it was exceptional plus, and some exceptional negatives from Q2, and then to the next quarters. This year, we know that the start of the year is still on the same trend, and we don't really know for H2. Difficult to measure in this way. That's why I try to give you more insights on the cost side. Yeah. Thank you. I'll go back in the queue. We can now take our next question from Catherine Tennyson of Bank of America. Please go ahead. Hi. Thanks for taking my question. I have three, if I may. I guess we're already starting to see testing numbers in the U.S. start to drop off. For you personally, how are you seeing the demand as you progress through Q1 and into Q2 in that region? If we look at the full-year guidance, and we assume a relatively close run rate to Q4, we're looking at a - 5% organic growth outlook for H2. Could you just give me an idea of the components of that? What are your assumptions for H2 2021 for base business growth or recovery, and also COVID testing volumes? Finally on Q4, specifically your 1,400 BIOFIRE placements, can you give us an update of the geographical mix of those? Also what portion of those were just adding capacity into existing accounts as opposed to making headways into greenfield sites? Thanks. Thanks very much. On the install base, happy to share. The increase of almost 7,000 during the year was, let's say, roughly half on existing customers and half on new customers on the number of units that were additionally installed. The split of additions is about 2/3 U.S. and 1/3 outside of the U.S. in Q4, which is quite similar to what we had throughout the year. Yes. I think that answers your question on geography and type of customers. In terms of trends for H2, again, that's really difficult to say and to share. I think the key message on our side is that we lack visibility. It's super uncertain for us for H2. Yeah. I don't think we have strong assumptions to share in details for H2. U.S. testing, again, we don't give in this call or the figures of the last few weeks. What we can tell you is, as we said, we see the trends that are overall quite similar to Q4, with both still a strong demand on molecular and recovery on some of the ranges that we mentioned had a good recovery, immunoassay, big part of the microbiology in Q4. That's really helpful. Thanks. We can now take our next question from Hugo Solvet of Exane BNP Paribas. Please go ahead. Hi. Thanks for taking the question. A couple of my side. On longer term competitive environment in immunoassays, two large competitors have announced that they are about or will launch low to mid throughput automated platforms. What are your expectations around pricing in this context? On the contribution of serology COVID testing to the recovery of immunoassay, what does it mean for the base business and its trend? Lastly, with a 0.1 x net debt to EBITDA ratio, should we think about reinvestment for bioMérieux's future growth? Is that more M&A or R&D? On R&D, can you please share some of the progresses that you've made recently and give more details on the timing of launch for the TB test in Europe and in the U.S.? Thank you. Lots of question around the immunoassay. VIDAS, as you know, this year was impacted by less testing in immunoassay. I believe there's been a global trend in the IVD world. VIDAS, our strategy is to have a mix of strategy for developing countries and for mature country. The push for high medical value markers is a strategy that we have, and we mentioned that we just launched NEPHROCHECK for acute kidney injury. To your last question, we should launch soon this year, TB-IGRA in Europe. There will be competition, but we still believe that the VIDAS is a platform which is well suited for high medical value markers. I believe you had another question that I cannot read myself, in fact, sorry. The debt level. On the debt level. Yes, we'll use this money to keep on, I would say, investing in our pipeline. In term of M&A, it's sure that things might happen. I would stay open to new technologies which have the potential impact to either reduce time to result or be disruptive on the field that we address, either respiratory, AST or food and pharma type of a quality control business. You had a question also on serology and how it will work with vaccines. Yes? Was the question, or not at all? The contribution of serology COVID testing to the recovery of immunoassays that we've seen in Q4, and how is the base business ex-COVID trending? No, it helps to recover. I would say I'm not sure we give the figures on serology, it helps also to recover on Q3 and Q4. It's not super clear yet how much serology will be used in line with the vaccination campaigns which are happening. We saw demand. On the double immunoassay, yeah, we saw the demand being back in some countries, in some parts of the world where COVID has gone. To your question, it's not so much serology versus base. It's really more, as Alexandre explained, high medical value markers in our menu for immunoassay versus more, let's say, routine markers. Whereas the routine was really severely impacted, again with the lower hospital number of patients everywhere in the world. The high medical value markers performed well and recovered strongly at the end of the year. It's serology, but it's also PCT. It's a parameter like D-dimer that are used in the care for COVID patients, et cetera. That's really the big difference in the 2020 trend. We can now take our next question from Maja Pataki of Kepler. Please go ahead. Yes. Good afternoon. Two questions from my side. First, on R&D spend. We've seen it go down as a percentage of revenues, obviously, since you've seen this strong growth in 2020. Since we're expecting to see growth going forward, how shall we think about R&D? That it's going to go back towards the levels we had before, or that it will stay around the 13% going forward? And the question to that would really be that, could you tell us what are the key areas for your R&D projects, particularly if you expect to spend more again? The second question, with regards to the new customers that you've placed the BIOFIRE instruments in 2020, have you already started to talk to those customers about additional panels, or is it still far too early because hospitals are just too busy with COVID-19? Thank you. They have been very busy with COVID-19. We know we communicate today around the joint infection, around the pneumonia V2. The BCID2 has been known for last year. It was not, I would say, maybe adequately promoted because of the COVID pandemic. So no, we communicate around the pipeline. On to the R&D, it's for us, yes, this year it's because the sales increased very much and we increased R&D. Not to the same level. In fact, it will depend a bit on the project. We'll keep the company focusing on innovation. That's really the nature of the game in our space. What we can communicate today, it's more around the menu enrichment on all of our key platforms. When we'll be closer to launching new platforms, it will be time to discuss. At this stage, we mainly invest in a menu improvement, evolution of our systems. Perfect. Thank you. Just a follow-up question on that. Alexandre, can you remind me, please, what the split was of the consumable sales in BIOFIRE in 2019 when it comes to respiratory, GI, pneumonia? Just to have a feeling of what the mix could look like going into 2022. I'm looking at the report. What we have said is in 2019, RP was just above half of the reagent sales. Actually in 2020, it was more three quarters of the reagent sales. Thank you. The remaining 45% or whatever it was, 40%, can you tell us what the split was for those? Just roughly. It was number two GI, number three pneumonia? Yes, number two GI. Number two, GI and meningitis. Meningitis, yeah. Great. Thank you so much. We can now take our next question from Scott Bardo, Berenberg. Please go ahead. Yeah, thanks very much for taking my question. The first question, just a clarification on guidance fees. Apologies, I joined the call a little bit late, so I just wanted to make sure I had in my mind your statements on EBIT development or expectation for 2021. First of all, appreciate you giving guidance in uncertain times. Am I to understand correctly that this similar levels of contributive EBIT around EUR 613 million or so, your statements are that we should deduct currency of around EUR 30 million, EUR 35 million and also net off around EUR 10 million from share-based compensation? Basically, the guidance is implicit at EUR 570 million. Did I get that correct? If you could please clarify, I would be much appreciated. The second question to Alexandre, please. Alexandre, obviously, a tremendous year for BIOFIRE and bioMérieux with respect to placements and expanding the customer base. We have noted a similar, very strong dynamic for other alternative technologies like low-plex systems, where some of the placement numbers have been even more impressive over the course of 2020. In your opinion, is there any friction or any competition that you're now starting to see in multi-analyte testing? Of course, this was an environment where bioMérieux is and was particularly strong. Now seems that other alternatives are in the market. I just wonder if you could share some thoughts there. Last question for me, please. Alexandre, I appreciate, again, lots of moving parts here. Is it possible to help outline a little bit the bioMérieux story post-COVID? We've been in a situation where the companies have very good growth and some modest but successive margin improvement. We now sort of entering this year with a very high margin and maybe some abnormal revenues for COVID. I just wonder if you could help us outline what the midterm story looks like for bioMérieux, both from a sort of growth and a margin perspective. That would be very helpful. Thank you. Okay. Question around syndromic and the competition with the low-plex. If I look at syndromic, I really try not to be arrogant, but I really believe that we led the race this year on the syndromic approach. Of course, other players grew, but it's now a EUR 1 billion business, syndromic. Of course, COVID has helped a lot. I really believe that thanks to the menu, thanks to the international network, we have really pushed our advantage on the syndromic front. low-plex is there also, as you mentioned, and also we have a low-plex solution with ARGENE, now with a smaller ARGENE. It's also there. I believe there will be room for different type of testing approaches, depending on the setting, depending on the criticality of care for the patient. It depends if you are at the hospital or if you are ambulatory. I believe there will be room for the syndromic and also for the low-plex approach. Today, our objective, our goal is really to reinforce our leadership in syndromic. There is room for others, and COVID has proven that there was room for low-plex, for antigenic for any type of solution. The space has changed. The IVD space has changed and many trends have pushed further. Your question around the long-term profitability of bioMérieux, and it's true that COVID has been a booster of growth and of performance for us. I believe that we will stay to the commitment that I took a few years ago as to keep on working on a steady improvement of the performance of the company, and to have a profitable growth. This is what we'll work on. In a post-COVID world, if there is a post-COVID world, we will update you on this, but we are committed to steadily improve the performance of the company. I guess I forgot another question, which was part of it. bioMérieux story beyond. bioMérieux story beyond COVID. First, I believe COVID is here to stay. COVID, not as a pandemic, hopefully, but COVID will be there in the menu of bioMérieux both in Immunoassay, in BIOFIRE, and with ARGENE. I believe that the fight against infectious disease and the recognition of diagnostic has been great this year. Diagnostic is really part of the continuum of care. There is prevention, there is diagnostic, there is treatment. I believe we are part of the solution. It was a strong recognition of the value we bring. It will be up to us, up to the competitors also to keep on working on this recognition, bringing innovation and infectious disease threat. Again, it goes beyond COVID. AMR, the link with the zoonotic disease. I think we have to learn from what happened and to be ready for other challenges. Hopefully not this critical. Back to your questions about more specifically the EBIT guidance for 2021. To be precise, the guidance is to be aligned at current rates. Let's say around EUR 600 million at current rates. When I say current, I mean that the - EUR 30 million-EUR 35 million of ForEx as well as the MyShare plan are all included in this figure. Correct. Okay. Thank you. Thanks for the clarification. Maybe just a last very minor point, if I may. Again, the placement rates for both have been phenomenal throughout the course of the year. It was a little bit surprising to me in Q4, given the escalation of this crisis, and the very high levels of testing that your placement rates were the lowest of the year in the fourth quarter. Is there any reason for that? Was it capacity issue that you had, or was there anything particularly else underpinning why your placement rates for modules were lower than in Q1 at the beginning of the year? Yeah. One of the big reasons that actually we have not discussed on this call yet, but we are still on back order on reagents, despite our very strong increase of capacity as we explained and as we showed. We are still on a significant few weeks of back order on the reagents. That's a reason for us also to self-limit the delivery of new instruments, so that then, of course, customers with instruments, we are able to provide them with reagents. Very clear. Thanks very much indeed. We can now take our next question from Peter Welford of Jefferies. Please go ahead. Oh, hi. Thanks for taking my questions. I've got a few. I'll stick with BIOFIRE, if you don't mind, please. Firstly, thanks for giving the breakdown of the placements between new and existing and the geographic. That's very helpful. Can we just understand a little bit more about the customers, if possible? In the sense that, particularly in the U.S., what proportion of these customers is typically a hospital sort of emergency department, versus on the other hand, perhaps a hospital lab or alternatively a physician office or that sort of environment. I guess you're just trying to sort of help us understand where you are within the typical COVID testing landscape. Then just a clarity as well on the ex-U.S., I think you said 23%. Is that 23%, was that the fourth quarter sales? Or was that of the 2020 sales overall were 23% ex-U.S.? Just finally on, again, the ex-U.S., I just wondered if you could talk a little bit about which countries you've managed to gain traction in so far, which countries are proving more challenging. I guess just trying to understand, are there certain countries that represent the majority of that, and there's still other countries that are largely untapped? Is it more that it's a sort of steady growth across many of the developed world's countries? Just trying to help us understand the dynamics there. Thank you. Okay. I think that the total ex-U.S. numbers were on the year, on the 2020. 23% is for the full year. Traction around the FILMARRAY, it's a bit global also. As stated by Guillaume, we also had to do choices sometimes between who we serve and who we don't serve. We of course served our customers and we gained other customers. In terms of traction, there was a good traction in the U.S., of course, in Europe, I would say also. Japan, mentioned by Guillaume, we got the reimbursement and the geo pro or RP early on last year. This is a good success for us to be in Japanese market. We are not in China yet. We're still not registered in China with FILMARRAY. This is also why you saw that maybe in Asia Pacific, we had less exposure to molecular and to bioMérieux. This is maybe where this is a region which contributed less, maybe except from Japan to the growth of FILMARRAY. Your question around the split of customers in the U.S. I'm not sure we did it, to be frank. FILMARRAY is used in many, many settings, hospitals, of course, but also a big lab chain. I'm not sure there is a big difference. I think especially in COVID-19 times, I think everybody needed a testing solution and FILMARRAY was part of it. I would say again, it's an innovative platform which can fit many needs. Thank you. We can now take our next question from Christophe Ganet at ODDO. Please go ahead. Yeah, absolutely. Thank you for taking my questions. Actually, I have two. Three, sorry. Just to be clear and clarified on the exceptional cost, can you just summarize the amounts of what you would consider that are exceptional costs, non-recurring for 2021, and exceptional savings on the other side? Secondly, can you talk a little about the price projections you have for 2021, notably for the COVID family of tests? Third is about immunology. Is it possible to share the percentage of the routine tests now on the 2020 figures, plus the perception you have of the rate of penetration of serological tests, and notably on which market do you think there is a high potential for those tests? Thanks. Guillaume, you take the cost, exceptional cost? I mean, yes. No? Yeah. Okay. Start with that. Actually, your question is about, let's say, what makes the exceptional COVID impact, EUR 174 million of operating income impact in terms of savings and cost. To give you a bit more color, let's say, the savings, and here we talk about travel, about congress, marketing costs, is overall about magnitude of EUR 60 million. The additional cost, we have about EUR 90 million of additional cost, including the phantom share part. That's a big part. Phantom shares, variable compensation, sales bonus, et cetera. Another about roughly EUR 30 million of operational cost. One of which is, I mentioned earlier, the freight cost, the transport cost of our product, which are much higher, let's say, since COVID. As you know, air freight is much more expensive specifically. I think that gives you a bit more, let's say, color and precision. Price projections for 2021. No major difference, actually. There's no basically stability of ASP and the prices, yeah. I think your third question was on the routine on the immuno. Basically, roughly a third of our revenues is routine and about two-third is high medical value in a broad sense. It's about serology, proPCT, D-dimer, et cetera, that kind of parameters. Routine was impacted. Routine was impacted, whereas as I mentioned earlier, high medical value was especially well recovering in H2. Regarding the ramp-up of the serological tests, which country should be concerned? You said it has already been launched, right? I think it has been launched. Maybe the ramp-up was, to be frank, I'm not sure. I believe that maybe it's more Europe in the first days, because this is where we have the strongest base. I'll deep dive. It was. Thanks. We can now take our next question from Alex Gibson of Morgan Stanley. Please go ahead. Great. Thanks for taking the follow-up. I just had three hopefully quick ones. On the placement of BIOFIRE systems in 2021, what are you budgeting for here? Will you place systems with customers that just want to use it for COVID, or do you now want to focus more on the customers that may want to use the broader menu? Second question on the panel capacity. You said you're moving to, I think it's 1.2 million per month. Will you have any plans to increase that further in 2021 if you see conversion rates improve? Then lastly, bigger picture, longer term, the BIOFIRE multiplex reimbursement across Europe. It still seems to be pretty limited. Can you give us an update on when you expect to gain reimbursement codes for syndromic testing in European countries, and what that could mean in terms of accelerating growth and placements, utilizations of your systems? Thanks. Maybe the production, the EUR 1.2 million budget that we gave you are the monthly target for production. Agreed. Average target for 2021. These are the figures we communicate on. Of course, depending on the demand, that will attach. It's really big work being done by the teams to increase the capacity. Its capacity. It doesn't mean sales. Again, as I explained earlier, we are on backorder at this stage. We expect, and it's really we need to be out of backorder so that we can deliver customers as they request. Potentially, we would expect to rebuild our inventory levels, which would be normal by the end of the year, especially for the next winter season. Again, it's capacity level, manufacturing capacity. It doesn't mean exactly sales. Your question on the sales of FILMARRAY this year will answer to the demand. COVID is COVID, but for us, FILMARRAY, it's a menu play. It's a large panel. I mention again, respiratory, gastrointestinal, meningitis, BCID2, pneumonia, soon joint infection. It's a menu play, and it will depend on circumstances. It's a big push for COVID, but this platform is meant for syndromic testing of different types of pathologies. From the reimbursement in Europe? Th ere is no major change on the reimbursement. We don't foresee major changes. We are able to do business. It doesn't mean there is no reimbursement. It means that of course we are part of DRT, diagnostics-related DRG, diagnostic-related group for inpatients, and it's for the hospital to see how they allocate their resources and their spend for treatment and diagnostics. That's the way we handle the business in Europe, and again, it really proved successful in 2020. Yeah. Okay. It just seems that last point could be very helpful because speaking to some people, it seems like FILMARRAY is a cost-minus type of reimbursement today, and if you could get a code, maybe it could be a cost plus, and you would see better adoption than you currently are. I'm just trying to understand, is reimbursement changes likely to occur over the next one to two years in Europe, or is there something that's just not going to be pushed through? We are promoting the value of FILMARRAY. The value is, of course, the medical value, but also its benefit for the healthcare system, reducing the length of stay for the patient. That's the approach that we are developing. Things are moving faster in some countries than others, and it will be our job also to promote this value, but sometimes things are moving slower in some parts of Europe. Okay. Thank you. We can now take our next question. Mary? Apologies. Go ahead. I have some questions from the website, if you let me go through them. Good. Okay, I have a question from Louise Boyer, Societe Generale. No, Stifel. She's asking for the G&A evolution. Shall we consider the 270 basis points improvement over the year are sustainable? Again, the percentage of sales on SG&A, of course, is very much driven by the volume, as we wrote and explained. What I think you need more to consider is that we will continue to especially invest in our sales and marketing, try to maintain, of course, G&A at a reasonable level, even though we invest also in transformation programs of the company, especially on the digital front, and that's part of G&A. In the basis of 2020, again, there are a lot of exceptional costs and exceptional savings that kind of offset each other. We can expect to, let's say, to rebuild from this basis for the coming years. Another one from Louise as well. How much of the new 70,000 units of Alpha and Salbe have been placed versus sold? I think we answered already to the question, but what protection do you have against the drop in reagents volume on placed units? What kind of contract do you have? The percentage is 75% sold, and the rest more placements for the BIOFIRE part for the new ones in 2020. In terms of protection, I wouldn't say we have specific protection. Again, as Alexandre explained, it's about our menu, about the value and the medical value of FILMARRAY. There's no specific protection or specific guarantee. Even though, of course, on some placements, we have volume commitment. Again, we should not consider that as a specific overall protection. A question from Delphine Le Louet, Societe Generale. EUR 42 million allocated to non-recurring and philanthropic actions. How should we see that amount evolving in the future? It's a bit specific for this year. The dividend, but also the endowment fund, which is in the account this year, but for three to four years. It's a bit special, as I mentioned, we had a good performance, bioMérieux. I don't think we are lucky to be in this business because we worked hard to deliver the solution. We believe that it's also the duty sometimes of companies who are performing well to take care of the local community. As I stated, there will be consequences from the COVID-19 beyond sanitary consequences. We believe it's a good thing if we can afford it, and to support solidarity initiatives. It will be handled not only by the corporate. It will be handled by the different subs that we have in the world. It's a bit specific to the situation. When you have good performance, we believe it's good to give back. That's all. Marie, please go ahead. Thank you. We can now take our next question from Maja Pataki of Kepler. Please go ahead. Yes, thank you. Three follow-up questions if I may please. The first one, Alexandre, I believe it was at the H1 call where you increased your guidance, or you delivered a very strong EBIT performance for the first half, and you cautioned that we should not assume this going forward to be a sustainable level. Your 2021 guidance is very confident, and I'm wondering if you could tell us what has changed in the environment, why you turned more positive or confident. The second question is with regards to the BIOFIRE CLIA panels. I believe a couple of years back you tried to place or to sell the respiratory panel, CLIA waived panels in the U.S. to physician offices. Has that been part of your success in 2020 in the U.S.? The last question is with regards to China. BIOFIRE hasn't been approved yet, but as I understand, for the first two years, once a diagnostic test is being approved, it is out-of-pocket payment. Do you believe that it will be a very slow ramp-up in China once it is approved, based on the fact that it will not be reimbursed in the beginning? Thank you. For China, first we need to approve it, then we'll see. It takes a lot of time. There are a lot of constraints, regulatory hurdles, I would say, sometimes to go back and forth. I don't know yet. We are first working on this. I believe syndromic is a solution that fits needs all over the healthcare setting. First I would like to get a better confidence about the registration in China. Sorry, I keep forgetting the question. The number two question. CLIA waived. Yeah. Sorry. I'm not efficient. No worries. Yes, we have the strategy to test a bit the market for CLIA, and it has proven, yes, to be a step. In the numbers you see, it doesn't make a big difference, but I think there is traction. There is traction with this solution. That goes in line, I don't want to be too philosophical, but I believe COVID testing has changed many things. It has changed the push for molecular. It has also pushed maybe the need for more decentralization. I believe these are trends that we have to monitor or to follow. Yes, there was good traction on this this year. On my level of confidence, I'm known to be quite cautious. No, we feel engaged, and we see the dynamics. These are predictions. I insist on the uncertainty, but this is the prediction that we see today. The dynamic infectious disease is there for the long term, and then again, it can also go beyond COVID, and the recovery of the other solutions could help. Thank you. Thank you. Once again, as a reminder, please press star one to ask a question. We can now take our next question from Scott Bardo of Berenberg. Please go ahead. Thanks very much for the follow-ups and the extended Q and A today. I think, certainly a lot of the discussions I've been having with investors in diagnostics, there's a lot of focus on the post-COVID landscape. I appreciate, Alexandre, you don't think COVID's going away. I accept that. The landscape after this near-term abnormal demand that we see for the pandemic. Question is, Alexandre, do you think the time has now come for bioMérieux to provide some sort of mid-term strategy and mid-term financial targets, which a lot of your leading peers do? Is that now something in your thinking that we should come to expect from bioMérieux? The second question, please. Again, bioMérieux being a global leading upper respiratory disease company, or certainly leading in that area of testing. Lots of debates, I think, about the influenza season and the respiratory seasons going forwards. There's been negligible flu season this year, and indeed, lots of government vaccination programs, not just for COVID, but for flu as well. Have you considered or caught any feedback in the industry that indeed, going forward, there may actually be lower respiratory season, even including COVID, because of these aggressive actions for new vaccines and therapeutics? I guess the nature of the question is, has the market changed in this post-COVID environment? Your thoughts around that would be greatly appreciated. The last question, if I may, Alexandre. Please help us understand where we are within the innovation journey for BIOFIRE. Obviously, you've been first to the market with lots of new tests. I think six or seven tests on the platform. Where are we in that journey? Is there still some significant unmet medical needs to come on this system? Is the product portfolio now more full? Thank you. Okay. You have big questions. Maybe the second one on the flu season. I'm sorry. I love to say a lot I don't know this year in general with COVID. It will depend. It is true there was no flu. There was no real flu this winter because we all wear masks and clean our hands, and we don't meet any more people. I hope that we go back to a normal life. We'll see. I don't know. Flu is like a coronavirus, and it can mutate, so we never know. It is very difficult to predict. What I know, again, is that syndromic is the right solution if flu comes back, depending on which level. Because we want to know, do I have a flu A? Do I have a flu B? Do I have neuro? Do I have corona? I still believe that low flu, high flu season, syndromic will be a key solution to differentiate the type of infection. It's very difficult to predict what will happen. I believe that infectious disease will remain a key topic. This crisis has proven other things, and it's not only about human, it's also about One Health approach and the link between veterinary and the human and ecosystem. Okay, it should help us to react a bit in a CSR way, but I cannot predict the future. To your first question about long-term guidance. Of course, in bioMérieux, we have long-term planning. We decide our investment for the long term alone. I'm not used to give long-term guidance because I think sometimes it's a bit risky. The world is changing, and I'm not sure I will do it in a time of pandemic where the uncertainty is quite strong. Maybe one day we'll give more guidance around the strategy, the big, long-term roadmap. On the figure side, I don't think that's something I would do at this stage, at least. On the, again, the sub-question. Innovation journey on BIOFIRE. It's a menu play. You can also see that since the acquisition of BIOFIRE by bioMérieux, we already launched two different platform. We launched the FILMARRAY 2.0. We launched the TORCH platform. Some tests have moved from 60-minute testing to 45-minutes testing. This is an innovative platform. That's how we see the things with this technology. Maybe more to come on the menu, on time to results. These are the things we are working on. Very good. Maybe just last quick one, if I may. You made the acquisition of NEPHROCHECK a few years ago, which I thought was a very clever acquisition, a good product for unmet medical need. I now note that product is now approved. Can you help us understand, will this be a big contributor to group growth of the immunoassay business, or is this going to be a bit of a slow and steady burn? If you could help there, that would be appreciated. It's too early to say. It's a test with lots of medical value. It will take time to ramp it up, because we have to keep on investing in the clinical studies, in a real-world evidence type of thing. It's a good test. We are very pleased to own it. Now we have to build the market around it with the KOL and the real-world evidence. It's here to stay. Thank you. Mary, last question? We have no further questions over the phone. Oh, okay. I have no question on the web chat as well. Thank you very much for this discussion or question with you. I think it was one hour and 20 minutes this time. I guess the activity is interesting. Thank you very much. We stay in touch. I guess there will be a communication with the Q1 results. Next week. In April. Thank you. Thank you. Thank you very much. Bye-bye. Ladies and gentlemen, this concludes today's call. Thank you for your participation. You may now disconnect.