Ladies and gentlemen, please stand by. Good day, and welcome to the bioMérieux First Quarter 2022 Sales Results Conference Call. Today's conference is being recorded. Now, at this time, I would like to turn the conference over to Franck Admant. Please go ahead.
Thank you. Good afternoon, and thank you for joining us to review bioMérieux's performance for this first quarter of 2022. As usual, I am online with Alexandre Mérieux, Chairman and CEO, as well as Guillaume Bouhours, CFO. Before handing the call over to Alexandre for preliminary remarks, please note that this conference call will include forward-looking statements. I would like to remind you of the usual disclaimer saying that forward-looking statements are based entirely or partially on assessments or judgments that may change or be modified due to uncertainties and risks related to the company's environment, notably those described in the 2021 universal registration document, including but not limited to economic conditions, financial exposure to currency exchange fluctuations, change in government policies or regulations, third-party reimbursement policies, timing of the onset, length, and severity of flu season and competition.
Accordingly, we cannot give any assurance as to whether we will achieve these objectives. I will also add that Mark Miller, our Chief Medical Officer, will join us on the call today. I also remind you that today's call is being recorded and that replay will be available on our website. I now hand over the call to Alexandre Mérieux, and then we will open the call to discussion and questions.
Thank you, Franck. Thank you everyone for joining this call. I will start with a quick review of the activity for the first quarter, and then we'll take time, of course, to go through the announcement today on the acquisition of Specific Diagnostics. If I start with Q1, we recorded sales of EUR 803.337 million as compared to EUR 845 million a year before, which was an organic evolution of -4.5%. The reported evolution was -0.9%, mainly due to USD currency fluctuations year on year. This evolution has been driven by a solid performance both in industrial applications at +6% and in clinical microbiology at +5%.
While BioFire's panel sales have been stable as expected, and our immune assay franchise has been affected by the headwinds that we mentioned in our call one month ago, referring to the lower COVID-related assay demand versus last year in the first quarter. Now let's dig more into more details for each range of products. I will start with on the molecular front. BioFire FilmArray panel sales have been stable at EUR 273 million, booked over the quarter, and the respiratory panel's demand remained strong in Q1. However, due to impacts from COVID on the essential workforce in January and February, we were unable to completely fulfill the backlog. Respiratory panels, representing a significant part of our sales at 70%, were still increasing mid-single digit versus last year first quarter.
This growth has been compensated by an exceptionally high basis of comparison for non-RP panel last year. This one was still increasing in Europe, Middle East, APAC, and Latin America, while respiratory panels registered also a strong increase in Asia Pacific and LATAM. Instrument sales have been decreasing as expected, and still our installed base kept on growing with +500 units, 40% of them outside of the U.S., mainly in APAC and Europe, and the total installed base amounts now to a solid 22,500 units worldwide. To conclude on this molecular chapter, other molecular ranges, including the DNA, RNA extraction and ARGENE ranges, have stepped back, but versus also exceptionally high volumes in the previous year. No surprise on the immune assay front.
Remember, commenting on last year's performance, we mentioned tailwinds linked to COVID-related assays such as D-dimer and ferritin, and those tailwinds are creating a very high basis of comparison that explain mainly the decrease registered this quarter. The other factor affecting also the immunoassay is the continued erosion in the U.S. of the PCT test. We remain confident for the rest of the year regarding the immunoassay. We have a healthy pipeline of new solutions which have been launched. Tingobria test should be launched as expected. We are still forecasting a CE mark submission of the TBI and the new VIDAS platform.
In microbiology, we showed a very solid performance at about 5% growth, and this growth was fueled by a robust reagent sales growth in the ranges such as VITEK and the BACT/ALERT ranges, and I would say in all the regions for bioMérieux. In Q1, the equipment sales has been lower than the one we had in Q1 2021. Lastly, the industry unit demonstrated a strong start of the year with a +6% growth versus first quarter 2021. Here again the growth was fueled by very robust reagent sales above single digits, especially in the U.S. The performance has been solid in both food and healthcare businesses.
As a conclusion, the start of the year is well aligned with our expectation, and still there are uncertainties in the world remaining to COVID evolution, for example, in Asia. We have also a question mark around inflation and geopolitics. At this stage we maintain our 2022 outlook as stated in our market communication on both sales and EBIT. With this short introduction coming on the Q1 result, I propose now that we move into a big topic, which is the acquisition of Specific Diagnostics that we have just announced. I will start by giving you a snapshot, a review on Specific Diagnostics. I think everybody has a link to the slide. It's a company which was founded 11 years ago.
This is based in California, in the San Jose area. It's a company which was funded and developed by Paul Rose, a scientist and entrepreneur, which has been focusing on developing a fast and smart solution for fast detection of antibiotic susceptibility testing. It's a company that we know well because we joined, we invested in this company in 2019. Last year also we started a co-distribution agreement in Europe between bioMérieux and Specific Diagnostics. Companies that we know quite well, and we're very pleased that we have been able to have Specific joining bioMérieux.
Because as you know, they are addressing an important topic, very important, I would say clinical unmet need, which is a fast result for antibiotic susceptibility testing. We know that AMR, antimicrobial resistance, is a key public health topic. It's a flagship fight for bioMérieux since the inception of the company. We call AMR being the silent pandemic. Having fast result for AST is key. Timing is of essence when you are fighting sepsis. Sepsis which is linked to severe blood infections.
This company has developed a very interesting and promising system called the SPECIFIC REVEAL, which is really, I would say, providing actionable results for, at this stage, gram-negative bacteria, giving after positive blood culture results in an average of 5 hours. Basically providing fast results for positive blood culture actionable results, giving the right information to the biologist and to the physician to action the right antibiotic treatment. This is also a platform solution with very lots of ease of use. This is Specific's proprietary technology based on small-molecule sensors, with each sensor generating a colorimetric, meaning a color change reaction, to the metabolic volatiles released by organism during the growth.
This is a smart, innovative and proprietary technology giving, I would say, accurate information. Maybe Guillaume, I can leave you the floor to discuss the key terms of the transaction.
Yes, with pleasure. Hello, everyone. I'm very pleased to explain the key terms of this core acquisition. The acquisition price for 100% of the company is $425 million. I say 100% because you know that we have a minority stake. We will pay the acquisition price mostly in cash, but also partly in shares. The reason for partly in shares is that the founder, Mr. Paul Rose, asked to have a share actually, which is probably a proof of his confidence in the future and the synergies between Specific and bioMérieux.
The approximately 1% share dilution from this payment in shares we intend to offset for existing shareholders through a share buyback and cancellation program that we will launch, of course, after closing of the acquisition. In terms of revenues, to give you a ballpark, of course it's minimal revenues today. We expect to ramp up revenues probably above $60 million in year five, so 2022 being year one. As the company is in a product launch stage, remind you that it's CE marked, not yet FDA approved. Still a product launch stage, and mainly focused on R&D. It will be a dilutive impact on our operating income. We estimate about $10 million impact for 2022, about $15 million impact in 2023.
To become a positive contribution, accretive from 2025. All these figures are before any PPA or purchase price accounting impact. Final point, we still have some work because it's signing. We expect to close the acquisition in Q2 of this year. With that, I hand over to Mark Miller, our Chief Medical Officer, on the key elements of what this technology brings.
Thank you very much, Guillaume. Hello, everybody. I'm pleased and excited to tell you why SPECIFIC REVEAL is so important to bioMérieux and also to patients and the medical value that it brings to the medical healthcare community and to patients themselves. When you look at blood cultures, the current methodology in most labs, which is unoptimized, gives results in about 60 hours. That's about two and a half days to wait for an AST or an antibiotic susceptibility result. When you look at what bioMérieux can add to this, we reduce this time for gram-positives.
Excluding the SPECIFIC REVEAL right now, but for gram-positive organisms with the VIRTUO system, which already is the fastest blood culture system on the market, we can reduce time with the VIRTUO blood culture system and then adding on VITEK MS and VITEK 2, we can bring this down to about 42 hours, which is good, but we are always looking for faster AST results in order to really direct specific patient care, to fight drug-resistant infections.
If you look at what we can do with Specific Reveal and gram-negative organisms, again, the faster blood cultures on the VIRTUO system, then we add in our gram staining and our molecular solution with BioFire BCID for identification and the Specific Reveal, which can give results in about 5-6 hours, and we can now bring down results to the same day within the same shift in most instances, almost all instances. This means that from the time of a positive blood culture, the clinician knows exactly which antibiotic to give, same day, same shift, in order to either escalate or to de-escalate, both of which are very important for patient care. Now I hand it over back to Alexandre.
Thank you. Thank you, Mark. Yeah, just to tell you that we are very, very pleased with this acquisition. It perfectly fits, I would say, the strategic agenda of bioMérieux. As stated also by Mark, it will provide very important medical outcome for the patients. With this acquisition, I would say that we are reinforcing our leadership in microbiology. You see the full portfolio of solution. This is very complementary to our ranges. Also, again, we are there to reinforce our leadership also in the fight against antimicrobial resistance, which is a key public health issue where timing is of essence. We are very, very pleased to have also the team of Specific joining bioMérieux.
It's a team of talented people dedicated also to public health and to science. With this being said, now we are in the early days, so we'll keep up, I would say, pushing the collaboration we have in Europe. As mentioned by Guillaume, the product is not still FDA approved, but the clinical trials have started. We know well the technology, we know well the people, and it's a technology with lots of potential and promises, I would say, for the benefit of the patient and the fight against antimicrobial resistance. With this being said, maybe, Franck, we can open the floor to questions.
Ladies and gentlemen, if you'd like to ask a question, you can signal by pressing star one on your telephone keypad. Do keep in mind, if you're using a speakerphone, please make sure your mute function is released so your signal can reach our equipment. Once again, star one for questions. We will begin with Maja Pataki with Kepler.
Yes, good afternoon, and thank you for taking my questions. I have several as usual. I would like to start with the Q1 results. I think, you know, the biggest surprise with Q1 was obviously the close to 16% decline in immunoassay. You have flagged that there is this COVID headwind coming in that business. But can you help us understand, you know, how much are the individual product groups? I understand that you can't say whether D-dimer is being used with COVID patients or not, but it would be helpful to get a bit of a split of the immunoassay franchise in PCT US or PCT in general, then D-dimer and ferritin, just to have an idea how we can model that going forward.
Then my second question with regards to Specific Diagnostics, it doesn't really come probably much as of a surprise that you've integrated the company, but what I'm trying to understand is if I look at the total number of sepsis patients admitted to hospitals in the U.S. but also in Europe annually. If I look at the, you know, hospital labs in the U.S. and in rest of the world, your EUR 60 million revenue in five years seems to be not very exciting. I'm sure it has a big impact on patient lives, but just from a financial perspective, is it the typical bioMérieux conservatism that you're applying here? Or are there obvious things that we need to keep in mind, like, which will slow down the uptake or have an impact on the financials?
Lastly, on the FDA approval, when do you think this would come through? Thank you.
Okay. I can start with Specific. I believe. First, I think it's, at this stage, this is the CE mark. We believe that the FDA submission will be done in H2, and then we have to wait for the FDA feedback. I don't know otherwise, if to say that we are bioMérieux, and we are, say, cautious as usual. We believe there's a strong clinical demand for this solution. That will need some time to do the ramp-up. Yeah, we might have better surprises, I would say.
This is what we prefer at this stage to mention that we'll be able to reach to be above $60 million in 2026. That's what we prefer to say at this stage for this. This is early on. Even if we know that, I would say, the expectations coming from the physicians and the patients will be important. Your first question was on immuno. You wanna take it, Guillaume?
Yes, of course. You were asking, I think, a bit more details about the split of the immuno portfolio. I think we mentioned a number of times that the PCT is roughly a third of the reagents portfolio. If we take all the, let's say, COVID-related parameters, so it means SARS-CoV-2, D-dimer, and a few others that were used as emergency for COVID-related patients monitoring, it's about 15%-20% of the portfolio this year. But this part is, of course, the part that is a significant decrease versus last year, when we had a very strong demand in Q1 and in Q2 last year specifically for these COVID-related immunoassay parameters. If you go, Laure.
Yeah.
Laure has some
Okay.
Alexandre, can I just quickly ask, since you have been distributing Specific in Europe now for a couple of months, can you talk about what the feedback is from the labs and how this is, you know, how often is it integrated? When people try it, is it really every time integrated or how should we think about that?
Yeah. I think the feedback is obviously very positive from the hospital and on the lab. This is also why we are doing this acquisition. I would say yes, the performance of the test in terms of the nice coverage we have for Gram-negative plus the time to results. That's really also we knew this company. The feedback is very positive from the users, I would say, and this is also what motivated us to go further. I think most of the are still, I would say, in evaluation mode, but the feedback is positive. Again, I think this solution's answering a very important clinical unmet need.
The platform is ease of use is there. I think you know what I would say, checking many of the boxes that we were looking for to address phase III for after positive results. Positive feedback, which led us to move further.
Okay, thank you. I'll go back into the queue.
We'll now move to our next caller, which will be Hugo Solvet with BNP Paribas.
Hi, guys. Thank you for taking my questions. I have a few. First on the sales for BioFire that are being held back by COVID impacting employees in production. Can you give us, please, an idea of the amount of sales that have been held back? Should we think that it's just delayed bookings leaping into Q2 or just missed sales opportunity for you? Second, on the placement trend for BioFire instruments back to 500, which is similar to pre-COVID level. Is it just that hospitals, urgent care centers are putting investments into new products on pause or an increased competitive environment?
On the competitive environment, can you please give us a bit more detail on whether or not you're seeing pricing pressure at the moment or just more competition against you? That'd be all for now. Thank you.
Okay. Maybe I can take the first one on BioFire, and Guillaume can take the next one. So regarding BioFire the sales, so it was an installation of more than 500 units in Q1. To be frank, for me, from the numbers are okay. It means that we have doubled the installed base in the last two years. As we said, now we hope to enter into an endemic world of COVID. Now for the challenge that I would say rather the opportunity for us is now that we have doubled the installed base to be able to promote the non-respiratory panels that we have, such as GI, meningitis, BCID, and pneumonia.
Regarding competition, no specific moves or pressure to report linked to the acquisition movement that we have seen last year. I believe that everybody has been busy satisfying the market and the demand. Nothing to report regarding, I would say, price pressure today on the respiratory panels. Guillaume, I can let you answer on the sales held back.
Yes, of course. Coming back, the event is that the COVID wave itself impacted our manufacturing teams in Salt Lake City end of December, January, and even some part of February, which then, of course, impacted our capacity to produce and our overall build-up. We were on allocations from mid to end of January on backorders. We definitely missed sales. The evaluation is at least several tens of millions of dollars of missed sales, probably potentially above $50 million. It's always difficult to...
To assess, because we see orders, but again, between orders that are for consumption or for inventory buildup, it's difficult to say. That's our estimate. We are very cautious on the, let's say to be conservative is probably missed sales, yeah. We're very cautious on the backlog or the back order conversion potential.
Okay. Thank you very much. Just one quick follow-up on the price increase topic. Can you please give us more details on how many price increase will you be passing or trying to pass this year in total? Or how much would that be compared to what you have historically been doing? Thank you.
Yeah. Price increases, it's not so much waves of price increases like, I don't know, companies maybe with more catalog approach would potentially do. It's more that we go customer by customer and segment per segment. We are definitely in this approach to see where we can pass through some of the inflation that we have actually in our salary, in our raw material. That's going on through the year. It's not, again, it's not specific to waves. Also due to the fact that we have, as you understand, contracts that are multi-year contracts with or without inflation clause, and that needs to be adapted.
Thank you.
Now moving to our next caller, and we'll hear from Delphine Le Louet with Societe Generale .
Yes. Hi. Can you hear me well?
Yes.
Yeah. Perfect. Yeah. I have a question on the long term, a more strategic question for you, Alexandre. When you think about the next five years, you've been activated on the, let's say, on the corporate side, which is, to my point of view, a very good news, with the Specific Diagnostics. It's effectively, as Maja said, very tiny part of the revenue in five years, just 1%, 1.2% of our future revenue in five years from now. How should we think about the acquisition strategy going forward, both in terms of volume, meaning price, and how much you can put on the table, and also in terms of accretion to the revenue? Do we have to settle for 1%-2% on a yearly basis?
Is it really spot on, meaning that as traditionally speaking, doing some acquisition very sporadically, or can we see more of external integration coming up in the future? First thing, and second thing, dealing specifically with the sepsis, can you tell us or give us the idea of how big today is sepsis within the VITEK, VIDAS and BioFire, and how much should that be in the five-year time, given the EUR 60 million additional revenue? Thank you.
Okay. Bold question, but, when you look at us, first, I think we are very pleased to have done this acquisition 'cause it's what we like to do. It's a strategic acquisition. We acquire key technology for the long term. We bring on board talented teams, scientific entrepreneurs and experts. I would say this is quite in the DNA of bioMérieux. When we do something like this, it's for the long term. I believe that this solution will have a great future in the portfolio of bioMérieux. You can say we are cautious or not, but I think this solution is here to stay for the long term. It's a very nice complement to our solution.
When I look at the long term of the growth of bioMérieux, we'll stay open to strategic acquisition and partnership. It's something we have always done. You have to know that you know that we invest in R&D, close to 13%. I think also that our internal pipeline of solutions is quite nice, quite busy. We still have this. We want to reinforce our leadership in microbiology, and Specific will be a key component of this strategy. BioFire is still there for the long-term goals of bioMérieux. You know also that we have announced that we did the FDA filing of a new decentralized solution for BioFire.
This one also will help us to fuel the goals of the company. I would say the pipeline will be the first marker of goals for us. By the way, we announced last month that we have a VITEK MS, which has been FDA approved. This is I would say a highly differentiated mass spectrometry instrument which is there for the long term. It will be a combination of a healthy pipeline with key attributes in terms of performance and medical value. We stay open also to strategic acquisition and partnership for the long term.
Sorry, that's a bit of my answer, but we remain ambitious, I would say, to keep on leading the rest in microbiology and also in the syndromic approach. Regarding sepsis for us, it's part of the AMR strategy that we have. It's difficult for me to tell you what is the specific revenue we do with the sepsis application. But this is a key component of our strategy against AMR. It's not only VITEK like that, BioFire, I would say it's the full range of bioMérieux solution, which is aiming at tackling this issue. But I don't have specific numbers for sepsis.
We know sepsis is a key of key importance because this is where you need to action it fast results. But that's embedded, I would say, in our AMR strategy.
Okay.
We have a follow-up from Maja Pataki with Kepler.
Yeah. Thank you very much. Back again with questions. I have three this time, I think. The first is, so we're talking now gram-negative bacteria. How difficult is it to replicate that for gram-positive bacteria? Second of all, I think one obvious question obviously is what is the cannibalization effect of Specific Diagnostics of your existing portfolio? Then, you know, the third question is with regards to the continuous bleeding on your PCT franchise.
Can you help us understand, is it a question of pricing pressure, a question of volume decline because competitors are more aggressive on pricing, or is it a question of the fact that your VIDAS is still not the, you know, it's still a low throughput instrument and therefore, as the PCT acceptance is growing in the market, you just are not offering a sufficient throughput to satisfy the market? Thank you.
Thank you. I will maybe answer to PCT and maybe Mark, after maybe if you wanna take the one on gram-negative bacteria. Yeah. PCT, yes, we are seeing continued pressure on price and volume, maybe not to the same level that we saw maybe three years ago when all the key players arrived. Yes, the limitation is due to the fact that there are more players, that PCT is becoming, I would say, more relevant as an indication, and that it's moving to higher throughput platform. Then again, VIDAS, this is where we see an impact in developed settings where the market is quite centralized.
In areas which are developing settings, where VIDAS is still quite adapted to the throughput of the laboratory, there is still a potential there. Mark, you okay to talk about the importance of gram-negative bacteria?
Sure. It's very important to notice the difference between gram-positive and gram-negative in terms of their resistance and the implications for patients. For gram-positive bacteria, and this explains why the prioritization was on gram-negatives by Specific, and why we will continue that direction. Gram-positive organisms, there's only about three or four mechanisms of resistance, and they can be detected by other methods quite easily, either molecular methods or other methods, and they don't pose the same difficulty in treatment to clinicians as gram-negatives. Gram-negative organisms, on the other hand, have hundreds of different mechanisms of resistance. It is very difficult, based on gene analysis or molecular methods, to determine the exact sensitivity or resistance of gram-negatives, and that's why phenotypic or growth-based AST is so important.
Hence, that's why Specific, and we agree, has prioritized gram-negative organisms for the SPECIFIC REVEAL system. It doesn't mean that gram-positives don't work on this system. It just means that the prioritization has been for gram-negatives because of the incredible medical value that it brings to the clinicians and to the patients, because they're so difficult to treat and much more difficult than gram-positives. That explains why the focus right now has been on gram-negatives. There's still gram-negative infections are still 50%-60% of all positive blood cultures. This is very significant, and they are the most difficult to treat by far.
Okay. Understood. Sorry, Alexandre. Yeah?
Yeah. Sorry, Maja, to answer your question on cannibalization, which I think we did not answer. One of the strength of this acquisition is actually cannibalization is not a big topic. The reason for that is that the vast majority of samples on VITEK are not blood samples. Blood samples are probably around 10% of the samples. As Mark just said, on top of that, inside the blood samples, about Mark said maybe 30-40% are gram-positive. You see all in, today, the gram-negative Reveal is applicable for, let's say, 5-6% of the volumes that would go to VITEK.
The beauty that is this 5%-6% are the one where the time, the fast time to result, the fast AST has the biggest medical value as Mark just explained.
Understood. Just quickly a follow-up, Alexandre. On the PCT, does the launch of the new VIDAS modular system, do you think that's going to have an impact on the growth going forward or the deterioration of PCT market shares going forward?
It will be a revamping of the VIDAS platform. It won't be specifically addressing, I would say, PCT. You have to see the next platform of VIDAS as a smart, I would say, lifecycle management of the instrument. I cannot say if it will have a positive impact on PCT.
Thank you very much.
We had two questions online that we maybe can take from Lawrence. We indicated mid-single-digit growth in RP BioFire sales. Question is on the total BioFire panel sales in Q1 and the decline in instrument sales. Total panel sales were stable in Q1, and the decline in instrument sales was pretty strong. It's about -60% of instrument revenues, but remember that last year, at the beginning of the year, it was still a very high increase in the equipment phase for the labs. The second question is, as Specific seems to leverage the BioFire system, should the addition of Specific strengthen BioFire overall customer proposition?
I would say maybe Alexandre wants to add that actually it strengthen our whole portfolio, which as you understand it strengthen the microbiology offering as well as the VITEK MS PRIME as well as the BIOFIRE BCID2 Panel for blood culture. It's a very complementary to our portfolio.
Yep, you said it right.
We do have another phone question. We have a follow-up from Hugo Solvet with BNP Paribas.
Hi. Hello. Thanks very much. Sorry, Guillaume, to make you repeat, line broke on the last question. Can you repeat, please, the split that is the respiratory and non-respiratory panel test sales and, the growth trend for them? Thank you.
Yes. What I mentioned is that the overall reagent sales are stable in Q1 with, as Alexandre mentioned, mid-single digit growth in respiratory, and about, roughly 10% decrease in non-respiratory. The 10% decrease might seem a bit unusual, and it is, and the reason is not that the trend didn't change. It's mainly the high comp basis, 'cause last year when we got out of backorder, for BioFire in March, we suddenly had a very strong catch-up effect on non-respiratory backorder actually. We sold a lot of non-respiratory in March last year. The Q1 basis is a bit, let's say, inflated by this effect on non-respiratory last year. We are still very confident on the non-RP trend overall.
I mentioned, I don't know if the line broke, the question was on equipment BioFire sales in H1, which were down 60% in Q1, sorry.
Okay. That's helpful. Thank you. Just the split of the percentage of reagent sales between RP and non-RP in Q1. Can you share that number?
Yes, of course. In Q1, respiratory was 70% of reagents sales. Remember, this figure last year was 72%, and this figure pre-pandemic was 56% of the reagent sales from RP.
Okay. Thank you very much.
We do have another follow-up from Delphine Le Louet with Société Générale.
Yeah. Thank you. Have you seen any change in orders regarding the order book at the end of the quarter compared to the beginning of the quarter? If yes, can you specify it on a regional basis, please?
Regarding respiratory panels?
Yeah, ordering pattern. Yeah.
We see the demand remains quite important at this stage. You know, remember that last year, I think we saw a sharp decrease or drop in demand in March, I believe. Now we still see at this stage that the demand remains quite strong.
Thank you.
At this time, we do not have any additional questions in our queue. I will turn the call back to your host for any additional or closing remarks.
Sorry, we have a question on the line regarding the valuation of the deal. Why doing it now instead of waiting for FDA approval? The question follows with the total addressable market that could be expected, and is the negative impact on EBIT included in the guidance? So maybe I can take part of that. Of course, it's always a balance of timing for an acquisition. Not too early to make sure that new technology is, let's say, proven and its market access also is kind of demonstrated, but also not too late so that the price remains, let's say, reasonable. So we believe we have found the right balance because we are at the moment where the technology is proven.
We've been able to test it, even to test it with customers, as Alexandre Mérieux explained. We have customer feedback. We know the company for two, three years. We believe it's very good timing, and FDA approval is not that far away, as mentioned already. The negative impact on EBIT is not included in our guidance. We will see, but at this stage, we don't change the guidance. We will see throughout the year. Obviously, it was not included in the guidance of two, three months ago. At this stage, there is no more question on the chat, neither on the phone. Could you confirm?
Actually, we did have another question come back on the queue. We have Maja back in the queue with Kepler. Go ahead.
Yeah. Last question. On the 500 instruments that you placed, or roughly 500 instruments, can you give us a split, how much is with new customers and how much is with existing customers, if there are any existing customers who wanna continue to place additional instruments? Thank you.
Yes, thank you. Sorry for that because we, as you understand, we advanced the Q1 sales release compared to our usual timing. Actually at this stage, we don't have this precise information. I believe the trend is quite similar to the trend that we have discussed for the end of last year. But I don't have the precise figures. Again, we advanced the release also so that we could announce the specific acquisition at the same time.
Okay. Understood. Thank you.
Now confirming no more questions in the queue on the phone.
Okay. Thank you. Thanks to all for your participation to this call and for your questions. Just to remind you that our next formal release will be on August thirty-first with a webcast to present bioMérieux half year results covering both sales review and financial performance. By then, we remain at your disposal if you have any more questions. Thank you very much.
Thank you.
Bye.
Bye.
Thank you.
Ladies and gentlemen, this will conclude your conference for today. Thank you for your participation and you may now disconnect.