bioMérieux S.A. (EPA:BIM)
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Earnings Call: Q3 2024

Oct 30, 2024

Operator

Good day, and welcome to the bioMérieux Third Quarter Sales Performance Conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Aymeric Fichet. Please go ahead.

Aymeric Fichet
Head of Investor Relations, bioMérieux

Thank you, Mélissa. Good afternoon, everyone, and thank you for joining us to review bioMérieux's performance for this Q3 2024 sales performance. I'm online with Pierre Boulud, CEO, together with Guillaume Bouhours, CFO. Before handing the call over to Pierre for preliminary remarks, please note that this conference call will include forward-looking statements that may change or be modified due to uncertainties and risks related to the company's environment. Accordingly, we cannot give any assurance as to whether we will achieve these objectives. I also remind you that today's call is being recorded and that a replay will be available on our website, www.bioMérieux-finance.com. I will now hand over the call to Pierre, and then we will have some additional comments from Guillaume, and then we will open the call for discussion and questions. Pierre?

Pierre Boulud
CEO, bioMérieux

Thank you, Aymeric. And good day, everyone. So very glad to share with you a review of commercial performance in Q3 for bioMérieux. So as you could see, we had another solid sales performance in Q3, reaching EUR 969 million, an organic growth accelerating at 11% over the quarter, so slightly improving year-to-date sales growth to 10.3% organically. So a few messages, first of all, on the growth drivers that we've selected in the context of GO28, and they are all very positive. So let me start with SPOTFIRE. Very happy with the installations with SPOTFIRE. There was a little bit of concern in the past quarter on the 250 installations. We are very glad to report 600 installations, which is the record number of installations we had done in any quarter since the launch in Q3.

Very positive performance, together with very strong support from a partnership, McKesson, which is now full speed. Very positive outcome for Q3. Obviously, positioning us very well at the very beginning of the respiratory season with what we believe is the most comprehensive respiratory panel on the market. I'll come back to that. The second growth driver, non-respiratory panels for BioFire, is also showing again in Q3, and it's a little bit less sensitive to epidemiologies and respiratory panel. Very good performance in Q3. Guillaume will come back to the detailed numbers, but I'd like to share with you a data point which is also very positive, which is we've increased the proportion of BioFire customers using at least three panels. It is now 51% and improving from 48% at the end of 2023.

So three additional percentage points, again demonstrating the benefit of having a very comprehensive menu of panels available in the market. And finally, the two additional growth drivers, microbiology and industrial applications. We are seeing for both a very solid demand that translates into good volume growth, but also for both microbiology and industrial applications, we keep passing good price increase. So pricing power is again demonstrated in Q3, which is very positive in commercial performance. Now, if I follow on with the rest of the elements, maybe less financially speaking, but our capacity to deliver innovation in the market, which is very important. We call it an innovation powerhouse. Three pieces of good news that happened in Q3. SPOTFIRE, again, we are now following the FDA approval in August in the U.S. We launched the Sore Throat Panel, which gives us three elements of differentiation.

Again, a 5-plex and 15-plex panel that allows us to cover the needs in a very broad way from the physicians. Two, it allows us to have Strep A into a mini panel, which is, as you know, highly valued by the clinicians in terms of selection of antibiotic treatments. And finally, it also gives us the opportunity, together with SPOTFIRE, to propose to the patients a throat panel, not a nasopharyngeal panel. So that's also a benefit in terms of complementing a SPOTFIRE solution. It's being launched in August, right in time for the respiratory season. We are also launching, following the FDA approval, VITEK REVEAL in the US. So busy days. It will now be marketed in the US. We're starting a commercial launch in August, in, sorry, September. And finally, VIDAS B12.

As you know, we have, with VIDAS, two businesses: the PCT business that is going down and the routine business that is going up. B12 will allow us to complement the menu of more than 100 assays that we have and hopefully fulfill medical needs in many geographies. That's for the innovation powerhouse. GO Simple. We keep seeing good traction, and we are in the implementation phase of many of the initiatives that we have identified and shared with you. Corporate social responsibility, very much on track to reach our 2024 targets. We expect to fulfill expectations there. Finally, going stronger, the engagement of the teams. Just to report back that we have now fully updated a long-term incentive plan so that they are fully aligned with the GO28 objectives, and they are now shared with the senior leaders in the organization.

So with all of that, and based on those good Q3 numbers, we are very confident to reach the 2024 annual guidance that we revised as of the 5th of September. There is a slight improvement on FX impact that we also wanted to share with you as we are sharing a Q3 commercial performance. And with this, I hand over to Guillaume, who will share with you more details on our Q3 performance.

Guillaume Bouhours
CFO, bioMérieux

Thank you, Pierre. Hello, everyone. And now, let me provide you some more details on the Q3 sales performance. So overall, EUR 969 million, an organic growth of 11% in the third quarter. You can note that we had a negative currency effect, EUR 26 million on sales over the quarter that makes up to EUR 76 million year-to-date negative effects on the sales. In the quarter, it was driven by Argentina, peso, Turkey, Asian currencies, and, I would say, to a lesser extent, the US dollar. The organic performance was driven really by our GO28 four growth drivers that together were up 10%, as well as by the BioFire respiratory panel. In detail, and talking about organic growth, BioFire non-RP delivered non-respiratory panels that delivered a robust performance, plus 16% in the quarter on a pretty high comp basis. Double-digit growth in every region, notably strong in EMEA and Asia-Pacific.

All the panels were growing double-digits. So actually, very balanced, strong, and balanced growth. Non-RP panels represented 44% of the BioFire revenue sales during the quarter. SPOTFIRE now, as you saw, EUR 20 million sales in Q3. As Pierre mentioned, it's the key news, so I can repeat it: strong acceleration in instrument placement, instrument installation, with 600 new installations at customers over the quarter, with our install base now reaching 2,100 instruments. McKesson partnership actually delivered the large majority of these instrument installations in Q3 in the U.S. And now we have the SPOTFIRE instruments that are installed in nine countries. So it's not only a U.S. story. It's beyond that. We believe we are on track to reach our year-end sales target for SPOTFIRE, which I remind everyone is EUR 80 million for 2024. Turning to microbiology, very nice 10% organic growth in Q3.

Prices increased by 4 percentage points during this quarter. Overall, reagents were really strong overall, plus 12%, notably on our VITEK ID/AST, as well as our blood culture BacT/ALERT product line, both at double digits on reagents. Fourth growth driver of GO28 are the industrial applications. The quarter was dynamic for industrial applications, with sales at 12%. Both segments, so it means pharma segment as well as the food segment, grew double digits. As Pierre mentioned on the prices, this is also a segment where we are able to pass prices through with 5 percentage points of price increases. So overall, very strong dynamic on reagents, plus 14%, and positive, back to positive on instruments, even though, of course, less positive than reagents. On top of our fourth growth driver of GO28, the BioFire respiratory panel delivered a very good performance, up 14% over the quarter.

Of course, this is thanks to a high epidemiology, sorry, epidemiology, so number of cases of these different respiratory pathogens compared to 2023 at the same period. I'll come back to that when talking about the guidance. Finally, immunoassays were slightly negative performance with mixed trends. We continue to see a pretty negative trend on our procalcitonin PCT sales, down 11%. They represent about 25% of the immunoassay sales and about flat performance for the other assays and equipment, so the rest of the immunoassay portfolio. So overall, this really solid Q3 performance on top of a solid H1 makes us confident, as Pierre mentioned, in achieving our 2024 revised guidance. As a reminder, this guidance that was revised up early September includes sales growth between 8% and 10% on an organic basis, EBIT growth 12%-17% on an organic basis.

Of course, to be at these levels, the main uncertainty are the respiratory sales in Q4. And we assume at this stage a slight decrease in respiratory sales in Q424 versus Q423. So just a reminder that Q423 was actually a high start of the winter season at the end of last year. So far, a bit too early. We have no indication yet on what will be the respiratory season. So these are really assumptions. They are not derived from what we could see in the last few weeks. A comment on the foreign exchange impact, so on CEBIT that we slightly revised, so it's an improvement in the region of -€60 million for the full year. The previous estimate was around -€70 million.

We saw mainly in the last few months moves on the US dollar, on the Japanese yen, on the UK pound, as well as we implemented internal actions to reduce our exposure on intercompany positions. And I just mentioned FX impact that was, I mentioned already, €26 million negative in Q3, and we estimate more or less the same impact around minus €25 million on sales in Q4 to help in your modeling. And with this, I propose we move to the Q&A session.

Operator

Thank you. If you would like to ask a question, please signal by pressing star one on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, that is star one to ask a question. We'll pause for just a moment to allow everyone an opportunity to signal. Our first question will come from Hugo Solvet with BNP Paribas.

Hugo Solvet
Executive Director, BNP Paribas

Hi, guys. Thanks for taking my questions and congrats on the prints. I have a few things. First, on the guidance, the low end of your 2024 sales growth guidance implies 2% growth only in Q4 despite an easing comp basis. So Guillaume, I'm fully aware that you mentioned the high comp base for respiratory sales in December, in particular last year. But could you maybe help us understand if that lower respiratory sales only implies BioFire sales? Because to me, there should be an offset from SPOTFIRE coming in strongly in Q4. So just keen to have your view here. Second, on SPOTFIRE, how sustainable do you see the 600 placement number? Should we expect this to accelerate in Q4, and what would be the run rate?

Also follow up on that in terms of pull-through, which is obviously optically lower, given the higher placement number this quarter. What would be a good pull-through going forward? And third question on BioFire, 150 placements is a bit soft or softer than what we are used to. Can you maybe elaborate a bit here on the different dynamics, if it's competition, cannibalization, deactivation, and/or can you be sure that there is no increased competition? Thank you.

Guillaume Bouhours
CFO, bioMérieux

Thank you, Hugo. Thanks very much. So on the guidance, yes, definitely, for us, the uncertainty is the strength of the winter season in Q4 and the respiratory panels' sales. On the rest, we are very confident, and we have no major topic. So we try to factor in this range the uncertainty. You're right. It's quite a broad uncertainty. Our median assumption is a decrease, again, because last year, decrease of respiratory panel sales in Q4. Last year was a very strong season, so we don't assume it will be a strong season. Let's see. And yeah, it's probably, I think, around -5% to -20% on respiratory panel sales in Q4. Probably, let's say, factor the upper part or lower part of the guidance.

Pierre Boulud
CEO, bioMérieux

Okay. And I'll take your good day, Hugo. I'll take your two additional questions. So SPOTFIRE, we don't communicate on projections for SPOTFIRE. So we are seeing what we commented in September is still very true. There is a seasonality dimension for us in both the reagent consumption and installations. So we were not at all worried with Q2 installations, and we are very happy with the installations in Q3, but we don't comment for the future quarters. And on Torch placements, so you're right to say it's a little bit lower than it was in Q2. Maybe a general comment first. We are seeing overall a little bit of softness in new instruments in general for us. It's true in microbiology, VITEK, BacT. It's true on VIDAS, immunoassays. It's true in industrial applications. And Torch is not immune to that.

So we're seeing a little bit of softness, which may be due to the fact that 2023 was actually very stronger in terms of new installations. So there is a bit of a general softness in the market in terms of new installations that we're seeing a little bit more in Q3. With regards to Torch, more specifically, I mean, I know you know it, but I still remind it. When we say 150, it's net net. It means it's the sum of the customers we win and together of the customers we lose. So it means that in Q3, we have actually increased our install base by 150 units, which, by the way, is 850 year-to-date on a total install base of 25,000 instruments. So it's still an increase of install base that bodes well for future reagent sales.

In terms of reagents, we are seeing very strong consumption of reagents on our install base. So Guillaume was mentioning a 16% growth on non-respiratory panel. It's the highest quarter ever in the history of bioMérieux with BioFire of non-RP sales. So we're seeing actually an improvement in terms of use rate of the install base beyond the addition of new instruments to the install base. So we are seeing more a bit of market softness, but overall, a very strong competitive position. We think we're holding it. We don't have any negative signs in that regard.

Hugo Solvet
Executive Director, BNP Paribas

Okay. Thank you very much.

Guillaume Bouhours
CFO, bioMérieux

Thank you.

Operator

Thank you. Our next question comes from Marianne Bulot with Bank of America.

Marianne Bulot
Analyst, Bank of America

Thank you very much, and good afternoon. I was wondering if I could follow up on the question that Hugo just asked. On the BioFire placements, you mentioned a net number. I was wondering if you could maybe provide a little bit of color on in terms of new machine this quarter versus last year and the one that maybe you lost this quarter versus the last one.

And then second question, you had some other peers in your space mentioning a pull-forward of demand for respiratory from Q4 to Q3, saying that maybe some of their customers order a bit more into this quarter to make sure they kind of had a security of supply for the next respiratory season. So just wondering if it's something that you have seen as well and if you could provide a bit more color in terms of contribution to your growth for this quarter? Thank you.

Pierre Boulud
CEO, bioMérieux

Thank you for the question. So I'll take your two questions. So the first one, we don't give the details between new installations, the customers who win, the customer who lose. We give the net net, which I think is actually amongst the players. I'm not sure everybody is giving that much information. So we're very happy to share the information, but it's actually a significant piece of information. We feel it's very useful for you and for us from a transparency perspective, but we don't go into more details. Obviously, we'll look into it internally, but it's not something we disclose externally. Sorry for that.

And with regards to the kind of potential stocking impact, respiratory Q3 into Q4, we don't have evidence of that. We haven't seen it. I mean, even though we are discussing Q3 numbers today, we don't see in October any impact of stocking in September, to be transparent with you. So no impact from our perspective in our Q3 performance for RP related to stocking.

Marianne Bulot
Analyst, Bank of America

Okay. Thank you very much.

Operator

Thank you. Our next question comes from Maja Pataki with Kepler Cheuvreux.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Yes. Good afternoon. I am going to go back and dig into the same, poke into the same question that Hugo asked and Marianne asked before. I fully understand that you don't want to give us the exact data on how many clients you lost and how many clients you signed on. But can you just tell us maybe from a sentiment perspective, whether you've seen this quarter more customers that you've lost versus quarters before, or whether it's just more of a softer placement quarter for instrumentation? Because that would help us understand how much you're seeing competition. And also, when you are kind of losing the instruments or the customers for BioFire, is it something where you say, "Oh, actually, we're placing some of our SPOTFIREs in there," or is it really going to competitive accounts?

Because as we know, there is increased competition in the US, and it will be very helpful for us to understand that point. Second point is, could you clarify, please, for the group level, how much was pricing contribution to growth in Q3 and what you're kind of expecting for Q4? And then lastly, Guillaume, could you just remind us of the absolute EUR million number of respiratory sales in Q4 2023? Thank you.

Pierre Boulud
CEO, bioMérieux

Okay. I'll start with the first question. Maya, good day, and Guillaume will follow up with pricing impact and your first question. So no, I can give you a more qualitative perspective. I was actually in the U.S. two weeks ago. We spent a bit of time together with the teams. It's a qualitative answer, but we don't see, to your point, the competition dynamics changing in the U.S. or, by the way, outside of the U.S. versus what we've seen and experienced in the previous quarters. We don't see it from a pricing perspective in our numbers. We don't see it from an installation perspective. So it's really not that we are losing more customers. It's more that the overall movement of installations was softer. So obviously, we want to be very careful. It's early days, but we don't see major customer losses, if that's your question.

That's basically where we stand with regards to the competitive environment with BioFire. We're, again, seeing very positive traction, and we're seeing the BioFire solution on RP and non-RP as holding a very strong competitive situation in the U.S. and outside of the U.S.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Great. That's very helpful. Pierre, maybe just to follow up, are you seeing some of your customers that are saying, "Okay, instead of taking one additional BioFire instrument, we're going to add a SPOTFIRE"?

Pierre Boulud
CEO, bioMérieux

Yeah. Yeah. So cannibalization of.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Whether it is cannibalization or maybe just a different way to ultimately, it probably is cannibalization. But are you seeing somewhere they say, "This makes sense for us to have the full range of covering all patients that walk in from the easy one to the immunocompromised"? Is that something that you're seeing happening a lot in the U.S. or elsewhere?

Pierre Boulud
CEO, bioMérieux

What we're seeing is really a segment of frontline testing, which comes together with point of care where you have solutions that allow to do patient triage at the entry of the hospital, patients who are not necessarily very sick, and where there is a need for respiratory testing. That's a significant segment where BioFire is not very significantly present because with our RP2 panel, we are actually mostly inpatients for patients who have comorbidities, very sick, and that's very much a second-line testing, which is the bulk of the sales we are doing with BioFire. What we're seeing when we are selling SPOTFIRE into IDNs or into hospitals is that it is positioned in frontline testing. What makes it an attractive opportunity in frontline testing is time to result, 15 minutes. It's having a lower plex, five-plex panel, and ease of use.

Those are the elements that we see that help us being competitive in this segment of the market. There are some clients who actually ask for both frontline and second-line testing. So we are seeing very much the two segments, obviously, being consistent and kind of connected, but as two segments in the market.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Thank you.

Guillaume Bouhours
CFO, bioMérieux

On pricing, so contribution to growth is actually the same in Q3, very close to 2.5%-2.5%, which was exactly the same level at the end of June. Actually, the quarter is in exactly the same trend as H1 was.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

That's what you're expecting to be able to pull through in Q4 as well?

Guillaume Bouhours
CFO, bioMérieux

Again, globally, the trends should remain quite similar. Yeah. We don't give an exact guidance on this, but.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

No, no, no, of course. But whether there is an analysis or something.

Guillaume Bouhours
CFO, bioMérieux

It should remain the same. Yeah, it should remain the same ballpark, of course. Yeah. There are questions on the.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Respi sales?

Guillaume Bouhours
CFO, bioMérieux

Respi sales, as mentioned, so I don't know if the question is that, but the respiratory panels, 56% of sales versus 44% for non-RP sales, so respi, actually, in absolute figure, is EUR 180 million without.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

For Q4 2023, I'm sorry. Last year.

Guillaume Bouhours
CFO, bioMérieux

sorry.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

For the prior space. Yeah, yeah. Yeah.

Guillaume Bouhours
CFO, bioMérieux

Sorry, what's the question?

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

I was wondering if you could share with us the absolute number of respiratory sales in Q4 2023, the comparison base that we're looking at for 2024?

Guillaume Bouhours
CFO, bioMérieux

We need to check, but we will come back during the.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Okay. Great. Thank you.

Guillaume Bouhours
CFO, bioMérieux

You're good then, Maja.

Maja Pataki
Head of Medical Devices Sector and Deputy Head of Swiss Research, Kepler Cheuvreux

Perfect. Yeah.

Operator

Thank you. Our next question will come from Ayesha Noor with Morgan Stanley.

Ayesha Noor
Associate, Morgan Stanley

Hi. Good afternoon. Thanks for taking my question. My first one is on the BioFire midterm guidance of 10% non-RP sales growth and flat RP sales growth. What level of placements did that guidance assume? And can you still deliver it if your BioFire placements remain at 150 or lower per quarter going out to 2028? Just some broader thoughts there would be useful. The second question is a bigger question on the flu season. So for the nine-month period this year, your respiratory growth is now tracking at 14%. This is meaningfully above the midterm guidance of flat. If we look at the CDC WHO data, flu cases are not trending significantly above average. And your competitors are also growing quite well, so no one appears to be losing share. So my question for you is, what do you think's going on? Are we over-testing?

Are lab volumes just shifting very quickly to the hospital setting? Just based on your utilization levels, customer ordering patterns, just try to get a read of how sustainable this mid-teens growth is going out to and how much we can extrapolate for 2025. My final question is just on SPOTFIRE. Could you provide the sales mix between 5-plex and 15-plex and how that shapes your views on the gross margin outlook for 2025? Thank you.

Pierre Boulud
CEO, bioMérieux

Thank you. So I think I'm the one who is going to take your questions. So the first one and the midterm guidance, you're right to say we have midterm guidance for non-RP, 10% for RP, 0%. We didn't share a guidance on install base. To be honest with you, we don't have a very detailed number of that. We've made some assumptions, but there are many components into the calculation. So we don't. This is not a number that we communicated from a guidance perspective. But the 10% for non-RP and the 0% for RP is obviously still very clearly a guidance that we confirm for the years to come. Your second question on respiratory, you're totally right. I think most players are reporting good numbers with regard to respiratory testing. Our understanding of the situation is related is really an epidemiology answer.

What we're seeing is more cases, more patients, so more tests, so the good news is we don't believe we're losing any market share, but the hard truth is I'm not sure we are getting much market share with that 14%. It's really what's driving the performance. Very happy to have it, and your related question to that is in terms of extrapolation. It's actually, unfortunately, very much related to epidemiology in that context, the market share that moves that much, and that's the reason why we have a Q4 that we assume to be softer because we, at this stage, and it's, again, as Guillaume was saying, it's a pure assumption.

We don't have a crystal ball on what the respiratory season is going to look like in Q4, but we assume that the respiratory season in Q4 would be lower. Hence, as it would be lower, we would have lower sales in Q4 than in Q3. The team is still looking into Q4 respiratory sales.

Guillaume Bouhours
CFO, bioMérieux

We have it.

Pierre Boulud
CEO, bioMérieux

But before we give it to you, I can give you the split: 15-plex and 5-plex. So in value, it's around 50/50, the 15-plex and the 5-plex.

Guillaume Bouhours
CFO, bioMérieux

Year-to-date.

Pierre Boulud
CEO, bioMérieux

Year-to-date.

Guillaume Bouhours
CFO, bioMérieux

% over the years.

Pierre Boulud
CEO, bioMérieux

Very similar to what we've seen so far. 50/50, the high-plex 15-plex and the low-plex 5-plex. Q4 respi sales.

Guillaume Bouhours
CFO, bioMérieux

Q4 respiratory sales in 2023 were around EUR 240 million. You go, Maja.

Operator

Thank you. Our next question will come from Kavya Deshpande with UBS.

Kavya Deshpande
Director, UBS

Good afternoon. Thank you for taking my questions. I've got two, please. So the first is on SPOTFIRE installation. So 600 instruments, obviously very impressive. Based on our discussions, people were expecting quite a bit less than that. So just curious to see with some testing running at full speed this quarter, were there any sort of device stocking effects here or any one-offs that you'd flag? Did this truly reflect in-quarter demand? That's my first question.

And then my second question would be, when you look at the placements and where they're going, are these mainly going to settings that have never had a point-of-care instrument before, so like true white space? Are they going to settings that maybe use your competitors' devices and are looking to add capacity on the ground with SPOTFIRE? Or is this active share-taking where these settings are actively replacing your competitor devices with SPOTFIRE? Thank you.

Pierre Boulud
CEO, bioMérieux

Thank you for your questions. So on your first question on potential one-off in Q3 with regards to 600, no, there is none. The deal we have with McKesson, they don't stock, actually. We directly place at the customer. It's a direct shipment to the customer. So there is no stock impact with McKesson. And for obvious reasons, the clients don't want to stock instruments that they don't use. So they're actually, as soon as they're placed and they're properly calibrated, they run reagents in a matter of days. So the 600 instruments are by now all up and alive and running reagents. So that answers to your first question.

The second question, is it market share or is it growing the market? It's mostly market share. The immense majority of the placements and the sales we make with SPOTFIRE are actually competitive wins. So very, very, very few customers starting with point-of-care. Most of them, I don't want to say 100%, but most of them were actually using point-of-care solutions.

Kavya Deshpande
Director, UBS

Actually, that's very clear. And if I could ask a quick follow-up, please, just in terms of the regional split of your 600 instruments placed this quarter, when we think of how many went to the U.S. and how many went to Japan, is that split sort of broadly similar to what we've seen in previous quarters? Anything to flag there?

Pierre Boulud
CEO, bioMérieux

Yeah. We don't give the numbers generally, but it's fair to say that Japan is the second biggest geography for us. And we had a good performance year-to-date, Q2 and Q3. So we don't have the exact numbers here, but definitely, Japan is the second biggest market for us after the U.S. And we are now live in seven countries with SPOTFIRE.

Guillaume Bouhours
CFO, bioMérieux

Nine.

Pierre Boulud
CEO, bioMérieux

Nine, sorry. Nine countries with SPOTFIRE. So we expect to see some traction outside of the US and Japan in the coming months.

Kavya Deshpande
Director, UBS

Thank you very much.

Operator

Thank you. Our next question comes from Dylan Van Haaften with Stifel.

Dylan van Haaften
Director of Healthcare Equity Research, Stifel

Hi, guys. Thank you for taking my questions. Just firstly, another follow-up just on BioFire versus SPOTFIRE. Are there any differences in the pricing structure between the two, for instance, with some older BioFire contract structures versus the newer SPOTFIRE contract structures, mostly because you mentioned they were competitive? Just want to get a sense if things kind of shift if you have structurally higher SPOTFIRE installed base growth. Maybe second question would then just be, could you give us a flavor for the respiratory season so far? Sort of what are you seeing? Are you, let's say, somewhat enthused by what we're seeing in terms of the start, even though it's starting in two days? That'd be great. Just a final question. Could you just remind us just on procalcitonin when the downtrend started and what percentage of immunoassays it is today? Thank you.

Pierre Boulud
CEO, bioMérieux

Okay. I start with BioFire versus SPOTFIRE. So we are very much trying to make them non-competitive. It's important to us because, as I was saying before, SPOTFIRE, most of the installations that we see are actually in point-of-care where there is competition. So it's really not against BioFire. The pricing, I think we shared around $100 for the 15-plex and around $70 for the 5-plex panel. And very much the spirit of the positioning and what we believe is really a winning combination is to have SPOTFIRE for point-of-care/frontline testing for patients who actually need a diagnostic solution with a very short time to result, very easy to use, and also to orient the patient.

And the BioFire solution, and I'm talking RP here, is really for the second-line testing for the patients who are hospitalized, who are sick, and you don't want to take a chance in terms of making sure that you have the right treatment for those patients. So we are seeing the two segments of the business very complementary, actually, even from the software solutions. We are connecting them so that the labs have full access to the data and not much competition.

The main contract difference is that SPOTFIRE is obviously the vast majority placement market. So it's investment for us and CapEx for us. Whereas BioFire, especially in the U.S., was actually a majority sold market. So that's, I would say, the main difference in terms of structure of the contract, as you were asking.

To your second question on respiratory season, as we said, it's a bit of the pain of having a fiscal year that ends at the end of December, which is actually in the middle of the respiratory season. We don't have solid reliable projections for respiratory season. So basically, we are making assumptions every year. That's also the reason why we revise the guidance at the end of Q2, because we knew that at the end of Q3, we would not know much more or much better. Honestly, at this stage, it could still be an average respiratory season, a very high respiratory season, or a very low respiratory season.

And that's why we give this range of 8%-10% of the sales growth. We assume a normal respiratory season a bit lower than we had last year in the period October to December. To be totally honest, we may be wrong, but we believe that the 8%-10% gives us a very range that gives us a very solid forecast for the three months to come.

Guillaume Bouhours
CFO, bioMérieux

Regarding PCT, competition really entered in the U.S. back in 2017 around. And so from there, we started to lose market share to the high-throughput platforms and competition. And today, PCT, Procalcitonin is about 25% of our immunoassay sales. Immunoassay sales are 10% of the total, around 10% of the total sales.

Dylan van Haaften
Director of Healthcare Equity Research, Stifel

Excellent. Thank you very much.

Guillaume Bouhours
CFO, bioMérieux

Thank you.

Operator

Thank you. Our next question comes from Jan Koch with Deutsche Bank.

Jan Koch
VP of Equity Research, Deutsche Bank

Good afternoon. Thanks for taking my questions. I also have three, if I may. I would like to come back to your 2024 guidance. I'm assuming that your growth drivers continue the strong performance in Q4. The midpoint of your sales guidance implies that your respiratory business in Q4 is on a slightly lower level than in Q3 or Q2 in absolute numbers. I understand that there are still some uncertainties regarding the flu season, but do you think it is likely that Q4 could be lower than Q3 and Q2?

And secondly, on SPOTFIRE and here on your guidance as well, your guidance implies only EUR 27 million of revenue in Q4 compared to EUR 60 million last year. In the meantime, you have tripled your installed base and you expanded your test menu. And we're wondering if there could be some upside potential here as well. Then lastly, how's the launch of your MS PRIME progressing? What are your thoughts here for the next year? There has been some noise in the market, so any color would be helpful.

Pierre Boulud
CEO, bioMérieux

So on the 2024 guidance, thank you for this opportunity to clarify. So yes, we have included RP slightly lower than Q4 last year, again on a high basis. But I'm not sure about the calculation. It's not lower than Q3 this year. I think that's what you said. We don't expect RP to be lower in Q4 than in Q3. And just to give the figures again, in Q3, we sold EUR 180 million of RP panels. And last year, Q4 was a base of around EUR 240 million. So there's a really significant gap. Okay.

Second question, it's a fair comment. SPOTFIRE, we have a significantly bigger installed base than we had a year ago, and we have two more panels, Sore Throat, 5-plex, and 15-plex. The challenge with SPOTFIRE Q4 sales is beyond the installed base, beyond the offering. Again, the epidemiology is going to play a big role, right? If there is no epidemiology, there will be little consumption. There may be an opportunity for an upside if the respiratory season is high, given the installed base that we have, but probably too early to call this. We'll report that back at the end of the respiratory season when we close the year. Your third question.

Guillaume Bouhours
CFO, bioMérieux

MS PRIME.

Pierre Boulud
CEO, bioMérieux

MS PRIME and the dynamics of VITEK MS PRIME. Yes, there was a bit of noise because we are in the process of internalizing the manufacturing of VITEK MS PRIME. It was outsourced, actually, some elements of the development together with the manufacturing based on the success that we've seen and based on the capabilities that we have. And it's also on our side, part of the GO28, GoSimple plan to actually reduce our cost. We have decided to accelerate the internalization of the manufacturing of VITEK MS PRIME. It will be actually manufactured on two sites at bioMérieux, Florence, Italy, and St. Louis in the US. It will come together with, we hope, improvements from a supply chain perspective and also cost of goods reduction. So that led to a reduction of ordering to our existing supplier, KMC. The dynamics are still very positive.

We're seeing very good traction in the market, and we expect a very solid performance in 2025, and we are building actually a manufacturing plant internally to complement the KMC offering in 2025.

Aymeric Fichet
Head of Investor Relations, bioMérieux

Okay. Melissa, just we have some written questions. So the first one from Arnaud Cadart. When will you be able to communicate on the conclusion of the audit of the U.S. activities? Maybe for you, Pierre?

Pierre Boulud
CEO, bioMérieux

Yes. So first of all, nothing new on this front. As you know, we have actually already communicated in the subsequent events for H1 press release. So we have basically done a copy and paste of that information into a Q3 press release because it's now a Q3 element. The verifications are ongoing. We are working also on remediation plans for internal control. It's progressing very well, and we are very confident to reach the revised guidance that we communicated for 2024. What we said is we plan to be in a position to reach conclusions on the verifications before the closing of 2024, and we are very much on track to do so.

Aymeric Fichet
Head of Investor Relations, bioMérieux

Okay. Thanks, Pierre. Another question from Thibault Bouly, Midcap regarding microbiology. Did you see any positive impact during the quarter of the Becton Dickinson supply problems that appeared to be solved at the end of September? Could you give us more color on VITEK REVEAL sales?

Pierre Boulud
CEO, bioMérieux

Yeah. So blood culture supply. So first element, most contracts with the clients are multi-year contracts, so it's not changing from one year to another. The second element of context is we're actually sharing raw materials to one supplier together with Becton Dickinson. We have diversified our sources of supply with additional suppliers. So we are significantly less exposed than BD's than they were in the context of supply. So we are very confident that we keep supplying our customers. As we mentioned and Guillaume highlighted, we have very strong dynamic volume growth and pricing improvements in microbiology. So we are working hard to make sure that our clients are still happy with us, and hopefully, if we can take some share, we'll take some share, but no change of dynamics as we speak. With regards to VITEK REVEAL, we're very excited with the launch in the US.

Obviously, it's a big event for us. A significant share of the market is in the U.S. As I said, we've just launched commercially, so it's a little bit early to give you more color. But probably, I don't know, we need to give ourselves a few months, right? But in the next six to nine months, we should be able to give you a bit more perspective on the uptake on VITEK REVEAL and where we stand with regards to new instruments and the uptake of the laboratories and clients.

Aymeric Fichet
Head of Investor Relations, bioMérieux

Okay. And maybe one last question. Can you give more color on actions taken to reduce FX negative imp act at CEBIT level? Is there more to come to be less dependent on FX devaluation in some countries? So maybe for you, Guillaume. Yeah, of course. So we took action on what is actually a small part of our FX exposure, which is intercompany outstanding payables. And so we notably through capital increase of local subs that then can repay intercompany payables. It gives less volatility, variability on those outstandings, which is good. Yet the big exposure, the biggest exposure is not on this. The biggest exposure is a conversion of contributed EBITs of foreign entities into euro accounts.

And that cannot be hedged and is a bit structural in our accounts and in the structure of bioMérieux being an exporter from US dollar and euro base into many, many countries in the world. So we'll keep significant exposure, but we are trying to work on the different possible levels to reduce it as much as possible. Okay. Coming back to you, Melissa.

Operator

Wonderful. We have another question from Hugo Solvet with BNP Paribas.

Hugo Solvet
Executive Director, BNP Paribas

Hi, me again. Thanks for taking my follow-up. Just here, you mentioned the majority of placements for SPOTFIRE being market share gain. Just can you elaborate a bit on that, whether it's from Roche about any other players that would be helpful? Second, Guillaume, I think back on the Q2 call, you committed to deliver the long-term guide, 7% sales growth and above 10% EBIT growth even next year despite the higher starting point. With Q3 in the bag, the starting point is even higher now. So do you still commit to deliver that into next year? Thank you.

Pierre Boulud
CEO, bioMérieux

Market share gains, I'll start with this to give you a guidance question. Market share gains on SPOTFIRE. Yes, again, it's actually a market with formidable players. Roche with cobas Liat. We're seeing Abbott with ID NOW, and we're seeing Danaher, Cepheid with GeneXpert. And I'm glad to say that we have actually competitive wins against all three players. We see our solution attractive. We have very positive feedback, to be honest. What's resonating very well is the 5-plex being capable to diagnose 5-plex instead of two to four in the competition is perceived as very valuable. The opportunity to have the 15-plex, I shared earlier that for us, it's a positive. Close to 50% of our sales with 15-plex is also showing that the opportunity to have not only 5-plex, but a broader plexing option is very valued.

The third element which we see getting traction is time to result, 15 minutes. It's close to half the time for GeneXpert. It's also perceived as very valuable from a workflow perspective for the point-of-care clinics, but also in frontline testing. So those elements help us to get share. But it's definitely, I don't know if it's good or bad, it's really building on a market that is already existing. We are not shaping the market as we used to do with BioFire RP and non-respiratory panels. The guidance, Guillaume?

Guillaume Bouhours
CFO, bioMérieux

Yes, on our commitments. Of course, we are fully committed to what was our target in the Capital Markets Day, which is a midterm target as part of our GO28 plan, so let me rephrase the financial targets of GO28. We committed to 7% compounded annual growth rate on the sales on an organic basis over the five years, which means, because it's compounded, that it's not exactly every year. It can be slightly higher certain years and slightly lower other years. That's on the sales.

On the CEBIT, our commitment is to improve the margin from 16.5%-20%, which on an organic basis, and as it's not so easy to follow year on year with the, I would say, the starting average rates, we committed on top to have every year, so this one is every year, a minimum of 10% organic growth of our contributed EBIT. So we can confirm that for next year, again, we are committing to the 7% CAGR on sales and the minimum 10% annual on CEBIT.

Hugo Solvet
Executive Director, BNP Paribas

Okay. Thank you for the clarification.

Operator

Thank you. And our last question can come from Marianne Bulot with Bank of America.

Marianne Bulot
Analyst, Bank of America

Thank you very much, and thank you for taking a follow-up. I just wanted to come back quickly on your comment of the overall softness in the market for new instruments. If you look at the BioFire placement, do you think that was the reason for the lower placement versus history, or would you say that was maybe more because you had some customers that didn't renew the contracts? If you had to pick a bigger driver between the two, if there is one, that would be useful. Thank you.

Pierre Boulud
CEO, bioMérieux

No, thank you for your question. Our analysis of Q3 is definitely the former. It's more a market that has been a little bit slower in Q3. We don't see any reluctance from customers renewing contracts or, as I said earlier, enhanced competitive environments. We are not seeing that. Obviously, to be followed in the context of multiple activities from the competition, but Q3 numbers actually reflect, from a commercial performance perspective, very strong competitive position for BioFire, both in the U.S. and outside of the U.S.

Marianne Bulot
Analyst, Bank of America

Okay. Thank you very much.

Pierre Boulud
CEO, bioMérieux

Thank you.

Operator

It appears there are no further questions over the phone.

Aymeric Fichet
Head of Investor Relations, bioMérieux

Okay. On our side, Melissa, some very short one coming from Christophe Raphael. Would it be possible to think about expanding geographically your deal with McKesson in LATAM, for example?

Pierre Boulud
CEO, bioMérieux

So the short answer is no. McKesson is a very strong player in the U.S. Outside of the U.S., we actually believe we have what it takes to commercialize SPOTFIRE. We don't need a distributor. Of course, it could be a case-by-case basis, but the plans, as we speak, are to only use McKesson in the U.S., which, by the way, as we said, we are very happy with the collaboration and moving in the very right direction in Q3.

Aymeric Fichet
Head of Investor Relations, bioMérieux

And we are good.

Pierre Boulud
CEO, bioMérieux

Okay. So thanks a lot, everyone, and our next call will be on March 7th next year for the full year 2024 results. Thanks a lot. Have a nice afternoon and a good day for our U.S. colleagues and U.S. investors.

Guillaume Bouhours
CFO, bioMérieux

Thank you very much. Bye-bye.

Operator

This concludes today's call. Thank you for your participation. You may now.

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