Good day, and welcome to the bioMérieux FY 2023 results webcast. Today's web conference is being recorded. At this time, I'd like to turn the conference over to Mr. Aymeric Fichet. Please go ahead.
Thanks a lot. Good afternoon, everyone, and thank you for joining us to review the bioMérieux performance of the 2023 full year results. I'm online with Pierre Boulud, CEO, and Guillaume Bouhours, CFO. Please note that this conference call will include forward-looking statements, which 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 2022 universal registration document. I also remind you that today's call is being recorded, and that a replay will be available on our website, www.biomerieux-finance.com. I will now hand the call over to Pierre, and then we'll open the call to discussion and questions. Pierre, the floor is yours.
Hello, everybody. Good to have you all on the phone. We will share together with you today. I'll start with a few words on our 2023 business performance. Then I will hand over to Guillaume, who will deep dive into the financial performance. A nd I will close the presentation with 2024 business outlook before we go into the Q&A. 2023 highlights. A few elements to share with you. The first one is, as you've seen, we are reporting a sales growth of 6.6% sales growth, ahead on top of our 4%-6% sales guidance.
That is, mostly driven with overperformance by a very strong performance of our business, excluding respiratory panel, that we guided between 8%-10%. A nd at the end of the year, we've managed to achieve 11% sales growth outside of the respiratory panel, so not impacted by a COVID epidemiology decrease. Profitability-wise, we've grown EBIT by 2% at constant exchange rates and constant scope, which is actually a performance in the high end of the range, unfortunately impacted by higher than expected foreign exchange headwinds in the region of EUR 55 million. Finally, in 2023, we are very satisfied that beyond the strong commercial performance, we have also been able to launch important innovation that will also support our growth in the next few years.
Be it SPOTFIRE in the summer of 2023. B e it VITEK REVEAL. Be it VIDAS KUBE. B e it 3P for our industry business, and MAESTRIA as a software solution. So if we go a little bit more granular into the different franchises that we have, as you can see, a solid performance of BIOFIRE product range, driven by three elements. The first one, very strong growth of a non-respiratory panel, +24%. That is very much driving the performance of BIOFIRE product range and leveraging the install base that we have. 75% of our customers now use at least two panels, which has been increasing in 2023. The second growth driver is install base.
We've managed to expand our install base by 1,900 instruments, close to 2,000, which is significantly more than we did in 1,500. So an acceleration of new installations and close to 10% of our total installed base. Final growth driver, internationalization of the sales outside of the U.S. As you know, it's been a key component of our strategy in the last couple of years. We have now close to 40% of the install base that is installed outside of the U.S., and close to 27% of our reagent sales outside of the U.S. So three growth drivers for BIOFIRE: non-RP, install base growth, internationalization of the sales. If we move to SPOTFIRE, that has been the entry for bioMérieux into the point-of-care market in 2023.
As you know, we believe we have a very competitive solution. 15 minutes time to results, CLIA-waived, two panels, 5-plex, and 15-plex that allow to maximize the opportunity for the clinicians to adapt the testing to the patients. We have now 800 instruments installed by the end of the year. We are both an installed base in the point-of-care setting, but also in a more classical hospital segments. We have also managed to introduce the product outside of the U.S., so we are now present in seven countries, with first clients in seven countries. As you know, in 2023, we've also agreed with McKesson for them to distribute our product in the U.S.
We have filed to the FDA an expansion of the menu to bring beyond the 5-plex and 15-plex panel for respiratory, a sore throat panel, hopefully in the next few months. Next slide relates to microbiology performance. I am very satisfied with the performance in microbiology, close to 14% sales growth in 2023. Very homogeneous performance in the different regions, very much leveraging the increased awareness around antimicrobial stewardship and the importance of high-quality diagnostics to support the fight against antibiotic resistance. We have a very renewed portfolio of instruments. As you know, we have launched VITEK REVEAL and filed to the FDA in the U.S. We have launched a new software solution, MAESTRIA, that supports our efforts in terms of antimicrobial stewardship.
We also aim at complementing our solution with sequencing solution. As you know, we've entered the R&D project and an equity stage with Oxford Nanopore to bring sequencing solutions into clinical use in the next few years. Let's us, let b efore last, immunoassay slide, on immunoassay's performance, mostly VIDAS performance. We are back to growth in 2023 with a routine testing that is mostly designed to fit the needs of developing settings. So we've been growing 6% in 2023. We've also launched to support this immunoassay product range, VIDAS KUBE. That is a new platform where every test is actually available on this new platform where it's launched. We have a good commercial launch with close to 400 instruments installed by the end of December 2023.
We've also launched for the developed setting, a new parameter, traumatic brain injury. It's approved in Europe. W e're filing in the U.S. Unfortunately, as you know, we are still suffering the pressure of procalcitonin that is still decreasing, representing less and less, obviously, in our total sales. A nd largely compensated by the growth that we have on our routine performance. Last slide, industrial applications. As we've shared with you along the year in 2023, very solid performance, 9% sales growth for our industrial applications. T hat cover both, food and pharma clients. Very much driven by one very strong performance in pharma, driven by cell and gene therapy, where we have a very high market share for quality control of, in this industry, and significant price increases. Guillaume will further expand on that topic.
We've managed to pass significant price increases in those applications that supports the excellent sales performance that we've witnessed in 2023. With this, I hand over to Guillaume, who will share with you more details on the financial performance.
Thank you, Pierre. Hello, everyone. So starting with sales, here is a recap of what Pierre presented business by business. So overall, the 6.6%, as Pierre mentioned, above our guidance, which was 4%-6%, and above also on the overall non-RP, 11% growth versus 8%-10% guidance. So molecular definitely remains our first range of product with 39% of the sales, EUR 1.4 billion of sales. Pierre commented on the three subsegments of molecular. By the way, I take this opportunity to mention that we plan now to, let's say, report to you externally with these three subsegments with BIOFIRE non-RP and BIOFIRE RP, both being the menu that we have on the TORCH, let's say, equipment.
With of course, we report separately because they have different trends. To report separately, the SPOTFIRE, as it is a different market segment, the point-of-care. On SPOTFIRE, I can mention that the overall revenues in 2023 are EUR 20 million. S lightly above EUR 20 million, of which EUR 18 million are reagents, which we see as a very good performance in only six months to seven months of commercial launch. Moving to microbiology, Pierre said it. S o overall, 34% of the group sales, as you can see. Important to note that part of this record 14% growth, that we are proud of, about 4% is the price increase contribution to pass through inflation to our customers, and the rest is already a very good volume increase of about 10%.
Immunoassay, Pierre commented, so overall -3%, of which -2% is VIDAS' main range. Industry, 9% overall, with growth that is driven by pharma on the volume part, and a very nice performance on the price increase. We've been able to pass through more than 6%, to, to our customers, pretty steady on the pharma and food segments, overall. With that, I propose to make a few comments by geography. N ot many details on this slide, but a few comments, maybe color. So Americas, overall, 4.5%, it's actually a bit lower than that on North America.
North America was very dynamic on the microbiology as well and non, as non-respiratory. B ut of course, a decrease on the respiratory with a lower, lower, flu season and respiratory season, I should say. And of course, the continued decrease of, immuno with the procalcitonin, in the immunoassay portfolio that is specifically, strong, about -20% in North America. Latin America is a smaller region for us, but definitely a very good growss contributor, super dynamic, over 20% growth overall, and really over the different ranges. EMEA, 8.5% growth, which includes a superb non-RP performance, even significantly above group at 28% growth of non-RP in Europe. I think it's...
Nice to highlight, and also, a double-digit in microbiology, which is not so easy in markets where that are both mature and where we have already stronger positions. Asia Pacific, 9% growth, with, let's say, slightly different trends. China, clinical important to note, excluding Hybiome, and I'll come back in a minute to Hybiome. So I'll say historical, mainly microbiology business performed very well in a year of recovery of the China market. Now, you remember that 2022 was still under lockdowns and disruptions. So in this year of recovery, we grew more than 15% in China clinical. Japan was down, mainly due to its respiratory BIOFIRE exposure with a lower, of course, COVID respiratory. And India is performing very well, above 20% growth.
Again, that testifies of our strong positioning in emerging. India is all ranges, but we can note that immunoassays is growing in India. Just to mention as last comment on the geography, U.S. remains, of course, our first market, 43% of group sales. China remains the second market with 8% of group sales. A nd then it's countries like France, for example, is 6%. Now turning to the profit and loss count. You can read on this slide the, let's say, the variations, and on the last column on the right, the like-for-like changes. With the 16.6% organic growth of sales, you can see that we were able to improve the gross profit on the like-for-like.
So actually, the gross profit margin improved by 50 basis points, which is actually factoring the fact that our price increases, of course, stronger on microbiology and industrial applications, were good enough to offset a significant part of the inflation. And we also benefited from lower transport costs as the market, especially on sea freight, started to normalize. Looking at SG&A, sales, marketing, G&A, 10% growth overall, including let's say, one-off impact of EUR 10 million on the MyShare employee ownership plan, which we do every two years, usually. That is really mainly factoring normalization of the sales and marketing activities.
So return to normal trend of events, customer shows and activities and travel that goes with it, which of course, we see very positively because we need to promote with our customers our many product launches and innovations. R&D, I think the highlights here is mainly in the column of percentage of sales. You see that we maintain a high percentage of sales at 12.5% of sales. V ery much in line with our bioMérieux target, to be significantly above the market and to invest for the long term. Contributive operating income lands at 2% like-for-like growth, so at a constant FX and scope, which is actually above our expectations. So we are pretty pleased, as Pierre mentioned already, with this result. It's slightly above our expectations. We performed well.
What is less positive I would say, is of course, the FX impact, which was more headwind than we expected. We end the year at -EUR 55 million. I can mention very late in the year with the Argentine peso, a huge devaluation, and I think it was early December after the elections. But there are a number of impacts that are... Just to mention, and we can come back in the Q&A, but some are linked to, let's say, hyperinflation countries like Argentina, like Turkey. Some are also linked to the fact that the euro is pretty strong against many currencies, for example, against Chinese renminbi or Japanese yen, much stronger than it used to. So turning to the EBIT to net income, the very major comment there is actually in the line of amortization of acquired intangibles.
As you see, this line is pretty heavy, with a major impairment that we had to take on the Hybiome acquisition. So for everyone, I remind you that Hybiome is a small immunoassay company, about EUR 25 million sales. So, I mean, in terms of sales and overall contribution, it's pretty small. So the acquisition, we took control back in 2018- 2019, with minority investors still in the capital. The company underperformed throughout the COVID period. We were expecting a rebound post-COVID, and basically, we did not see any—we did not see a rebound in 2023. Quite, quite the opposite, and we had to take, let's say, yeah, a view on the depreciation of the value.
We also decided to, after a review of strategic options, to actually take out some of the minority investors, change the management. So we have a new manager in charge, and we will look at turning around this small Chinese company. That being said, not major comments on the other line. Net financial expenses slightly improving, of course, thanks to higher interest income, as well as lower hedging costs. The effective tax rate, if you exclude the Hybiome impact, which of course is a non-deductible impairment, is actually very much in line with our historical and guidance around 23.4%, excluding this impact. And net income, of course, is impacted by Hybiome impairment again, but excluding the Hybiome impairment would be down 2%.
So yeah, let's say almost stable on the net income, excluding this, exceptional one-off. On the cash flow statement, so the major elements here to mention is the working capital. As you can see, a major increase on the working capital side that, fully comes from inventory. We had, several effects in inventory. First, to rebuild some inventory, especially on the BIOFIRE respiratory. You can remember that we ended 2022 or, or started 2023 with extremely low inventory. Actually, we were on back order on, BIOFIRE RP, so we rebuilt the inventory. With the growth of non-RPs BIOFIRE as well, of course, we have to follow with, inventory as well.
Another effect is the many, many new product launches, such as SPOTFIRE, for which, of course, we need to build inventory to be able to serve our clients in the launches. So quite significant, let's say, investment in inventory part this year. CapEx was very much in line with expectation. Overall, investing in our capacity, mainly for the future, which overall makes the free cash flow at EUR 150 million, slightly lower than last year. In the financing activities, you can note the 7% stake in Oxford Nanopore, which weighs about EUR 150 million.
And so overall, not commenting on all the rest, we end up the year with EUR 166 million of net debt, very low leverage of 0.2x. A nd still, since Pierre mentioned it, a very high headroom for investments and M&A, if we need and wish to. I can make a few comments on the CSR roadmap. So you remember that this is the roadmap we announced two years ago on five pillars. Health, planet, healthier ecosystem, the way we care for employees and team, and the extended company. Overall, with these, let's say, roughly 10 KPIs to follow progress. So maybe not to comment on each of them. I'm happy to answer comments.
I think the main message in here is that we feel we are on track with our, let's say, more midterm and sometime long-term for the greenhouse gas emission midterm and long-term targets. Overall on track. And with that, I now go back to Pierre on the outlook.
Thank you, Guillaume. Moving to 2024 and our guidance for 2024. First, slide on the growth drivers that we expect to see in 2024. We have four of them. First one is obviously our BIOFIRE product range that we expect to keep growing in 2024, mostly driven by our non-respiratory panels, based on the very significant success that we've seen in the last 12 months- 18 months. We expect to grow around 15%. For respiratory panel, it's obviously related to the impact of the respiratory season. S o we plan for a medium respiratory season. With regards to SPOTFIRE, the second growth driver, we expect to ramp up in the U.S.
I've talked about international launch. S o launching outside of the U.S., and we also expect to see the benefit from having the approval on the sore throat panel. So we have a target of EUR 80 million sales in 2024, to be compared with the EUR 20 million that Guillaume was mentioning for 2023. Microbiology, we plan to keep increasing market share, growing faster than the market. A nd benefiting from the new instrument that we've launched in the last two years, VITEK MS PRIME and VITEK REVEAL. Finally, industrial applications. We expect our industry applications to be a growth driver in 2024, with a combination of price effects and the pharma segments growing a little bit faster than food.
So when you put all those growth drivers together, that gives the guidance that we shared with you this morning of 6%-8%, organic, including respiratory, for 2024. From a profitability perspective, we expect to grow at constant exchange rate by at least 10% EBIT, so that we generate profitable sales growth. Obviously, there is an exchange rate impact that we estimate at this stage of the year at around EUR 50 million. And finally, we keep investing into manufacturing and the future of bioMérieux with capacity and SPOTFIRE placements, that's 10%-11% of expected sales. Last word before we open for the Q&A, we are very pleased and excited to invite you to Capital Markets Day that we plan to organize on April 9th.
It was an ask from the financial community that we give you a bit more visibility beyond the next few months on our medium-term plans. It's been also since I was appointed first of July, we've worked together with the management team on refining and stabilizing our business perspective for the next few years. So it will be an opportunity for us, together for me, together with the management team to share with you both top and bottom line expectations for the years to come, and also an opportunity to showcase our solutions, because there will be also a showroom next to the meeting for the presentation. So looking forward to seeing as many of you as possible on April 9th in Paris. With this, I think we can close the presentation and open the Q&A.
Thank you. If you dialed in via the telephone and would like to ask a question, please signal by pressing star one on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, press star one to ask a question. If you are in the event via the web interface and would like to ask a question, simply type your question in the Ask a Question box and click Send. We'll go first to Odysseas Manesiotis with Berenberg.
Hi, thanks for taking my questions. Firstly, could you please explain the details around the recent FDA recalls for the BIOFIRE GI panels that were yielding false positives and negatives? Have you accounted for any impact from this to your non-respiratory sales panel sales growth guidance? And secondly, on your EUR 80 million revenue guidance for SPOTFIRE this year, what utilization or revenue per instrument does this assume for instruments you place in 2023? And what are your thoughts on how high this can get when you eventually also add some bloodborne virus panels in there? Thank you.
So let me answer your first question on the GI panel. You're right to say we had a quality concern with the GI panel on one out of the 22 targets. So, obviously, we take quality matters very seriously. It's a big topic for us, so we are in constant dialogue and discussion with the FDA, most notably, on these topics. So, where do we stand? We've done a field corrective action that is basically around informing our customer that on this single target, when they have positive results, they need a confirmation, actually. So for you to know field corrective actions, I mean, it's really day-to-day business for us, right? We do, unfortunately, something like 30 field corrective actions a year.
So this is one of them on all the product ranges. We are very much used to that. We again take it very seriously. We're obviously investigating the topic. We are informing the clients. Just to clarify, we don't ask the customers to return their GI panels to us. We don't have a stop shipment, so we keep shipping the products. They are just informed. We don't see, and we don't expect any commercial impact, if any, to be honest, it would be more an acceleration that we are witnessing. So really, business as usual, unfortunately, right? I mean, when I say business as usual, it may sound a bit strange, right? Obviously, we have dedicated team working on addressing the challenge, discussing with the FDA.
It's a top priority to make sure that we find good corrections to this one parameter that we have, but no major changes and absolutely no change of commercial expectations on our side.
Your second question was on the SPOTFIRE in 2024 utilization rate. So basically, we try to give you, without entering into a detailed model, I would say, our best, expectation at this, stage and the ability to look at it. That's why we gave you this, EUR 20 million or actually EUR 18 million on the reagents for six months. Of course, six months of ramp up throughout 2023. We were commercial in the U.S. from June, and of course, we ramped up to about 800 instruments in the field from June to December generating this EUR 18 million. And when we try to...
Of course, you understand. We don't have a lot of, let's say, look-back and experience. B ut when we try to look at further ramp up of the instruments in 2024, and what it generates in terms of revenues of overall this, we get to this target of EUR 80 million. Keep in mind, obviously, that it means mainly revenues in Q1 and Q4. We expect Q2- Q3 to be much lower by essence of the respiratory product at this stage. Not sure exactly what you target about the bloodborne virus. What we- but maybe to answer more broadly on the pipeline.
So at this stage, we have mentioned for SPOTFIRE, the RP sore throat, where we expect approval sometime in 2024, and therefore being commercial sometime in 2024. Beyond this panel, we would like to actually invite you to the Capital Markets Day, where we'll also give more, let's say, visibility on our pipelines for the different products and regions and, and platforms. So let's share on April 9.
Understood. Thank you for the clear answers. Can I squeeze one more in, please? So very quick one. Could you elaborate on how you arrived to the EUR 50 million FX cEBIT impact for 2024, to what extent is there any temporary hedging costs included in that?
So yeah. W e're pleased to elaborate because it's an important impact, so it's probably important to discuss. Thank you for asking. So first, on the methodology, hedging costs are actually, well, first, they are not that big. It's a few million EUR per year, and it's part of the financial results. So below EBITDA and below EBIT, in the financial result line, the hedging costs are there. And they are pretty stable, usually quite stable year-on-year. No, the impact is mainly an impact of, let's say, conversion and translation of exposure in foreign currencies. The very major impacts are, of course, in the most in the currencies that have high devaluations. So the top ones are clearly the Argentine peso again.
It again, it's strange because our exposure to Argentina is not that huge, right? So it's a small country for us, but yet the impacts in terms of devaluation are so huge that it does impact overall. So Argentina, Turkey, Egypt are among the big devaluation countries. And you know, on top of that, we have the strength of the euro that is against, let's say, more stable currencies, but euro is being pretty strong. So typically, there are additional impacts against Chinese renminbi, Japanese yen, many of the Latin America currencies. And when you add EUR 2 million-EUR 3 million for each of those, at the end, it's a big big figure. Yeah.
Very clear. Thank you.
We'll go next to Hugo Solvet with BNP Paribas.
Hi. Hello. Thank you for taking my questions. I have two. First, on margin, should we consider the 50 basis points margin improvement at a constant exchange rate for 2024 as a floor? Can you maybe elaborate on the depth into context of the 6%-8% organic g rowth? And second, on industrial applications, how confident are you you can keep up with a strong growth rate? I mean, pricing was about 2/3 of the growth this year. Or should we think about that going forward? Thank you.
On the first one, I'll take that, Guillaume. Yes, but definitely, that's why we say, in our guidance, more than 10% and at least 50 basis points. So yes-
Sorry, yes.
You rephrase it very well, Hugo. Thank you. Yes, we consider it a floor of our commitment. Yes, definitely.
To your second question, Hugo, industrial applications and our confidence to generate 9%, it's actually relatively high. We believe there is. I mean, it's also the benefit of having a strong market share. We believe we still have pricing power, so we're working on keeping the price increase. As we shared with you in 2023, we had a significant growth in pharma, significantly less in food. We're seeing the food volumes to recover in 2024. That would also help to secure the 9% target that we have.
I mean, I'm not going to say it's an easy target because the teams would hate me. B ut we are confident in our capacity to grow at that pace in 2024 for industrial applications.
Okay, thank you.
Does that answer your question?
Yes, it does. Thank you. Just going back on the first question, should growth be 8% or above, should we think about margin up, you know, 100 basis points or higher? And longer term, probably, the growth that we have this year, 6%-8%, and margin improving 50 basis points. G iven all of the accelerating moving parts in the portfolio and leverage, should we think about 2024 guidance as a base from which you should accelerate going forward?
But it's a very good question, and we believe it's a very good topic as well. We definitely want to address the profitability improvement. It's definitely a topic for you and for us. And I would, again, I think it's one of the key topics, not the only one. One of the key topics we want to take more time to explain at the Capital Markets Day, how we see that over a slightly longer period than one year. A nd give you more visibility in the medium term on our ambition to improve to improve margin step by step.
Thank you.
We'll go next to Aisyah Noor with Morgan Stanley.
Hi, good afternoon. Thanks for taking my questions. I have two, please. The first one is on the 2024 guidance for RP sales, which you mentioned in the press release to slightly slow down in the year. Could you define what slightly slow down means? Is that less positive or is it negative? And could you elaborate the drivers of this slowdown, and how much you've assumed from a lower flu season? how much from negative pricing, and I guess to what extent does this outlook embed some competitive headwinds from four, possibly five, newcomers in the multiplex market in the U.S. this year? And then I'll leave that for the next one.
Yes. Hi, Aisyah. Thank you for the question. So yes, the slight slowdown is actually a decrease in our, let's say, guidance overall. So to make a round figure, it's factored, let's say, around -5%. And it includes definitely when we say medium pre-season, we consider that the Q4 2023 was above medium. That's why we mentioned that we beat at the end of the year our guidance with 6.6% instead of maybe 4%-6%. So it was quite strong.
And on top of that, yes, it does include a very slight price pressure, so low single digit, but slight price pressure, 1%-2% is included in our view for 2024 as well.
Okay. And then the second one was just on the, you mentioned in the press release. An investment in SpinChip Diagnostics. If you could elaborate, what is the value of this investment? And could you talk a bit about the competitive strengths of this technology versus, the existing point-of-care immuno platforms in the market? As I understand, this market is quite saturated, at least on the single plex side.
Yeah, thank you for the question. I can take it. So, we've made an investment of EUR 10 million into this Norwegian company. It's a startup. They have, t o your point, it's a market where there are lots of solutions available. What we're seeing in SpinChip is a very interesting technology that allows to give very quality, a very good level of performance, very sensitive results, especially for cardiac markers. So, we feel they have a promising technology. That's the reason why we invested in them. The rationale, strategic rationale for us is, as you understand, we've entered now this point-of-care market with SPOTFIRE. So, we are very active at looking for opportunities to complement the portfolio in the point-of-care setting.
And definitely, beyond molecular point-of-care solution, we believe that we could nicely complement our portfolio with obviously, well-differentiated immunoassays point-of-care solution. So that's the strategic rationale for the investment.
Okay, understood. Thank you so much.
Thank you.
Maybe to take some questions, I take one or two from the line, and thank you for also raising questions by writing. There's one about the effort on inventories in 2023, what you expect in 2024 and 2025? Actually, we give some idea on the CapEx, but we don't give really a guidance on the inventory or the cash flow. We can see if that's something we can do or not, Capital Markets. Let's see, but no specific guidance today on this. You want to add something, Pierre, no?
Yeah, I mean, what's for sure is that in 2023, we rebuilt the stock that we didn't have at the end of 2022. So there was, as Guillaume was saying, in 2023, there is a negative event which we were in backorder, especially on BIOFIRE. A nd we've rebuilt the stock to be able to meet the demand during the respiratory season, which, by the way, we did. We are not in backorder anymore. So this rebuilding of stock is not going to happen twice. But we don't give specific guidance on cash flows just to reassure that the rebuilding of stock is not going to happen every year, hopefully.
There's a question on the split by country of SPOTFIRE, of the install base. It's actually vastly U.S.
U.S., 90%.
Yeah, more than 90%. We are present again in seven countries, but the second is Japan.
The second biggest country is Japan.
It's Japan, but really far from the U.S. base. Maybe taking questions online.
We'll go next to Maja Pataki with Kepler.
Yes, good afternoon. Thank you for taking my question. First, quickly on SPOTFIRE, can you elaborate a bit on the reagents? Was it mainly the low-plex, the sort of the 5-plex panel, or did you also see demand for the 15-plex? Can you provide us an update where you stand with regards to the reimbursement for the 15-plex? And then, on BIOFIRE, the guidance that you're providing on the non-respiratory, so you're looking for a marked slowdown in non-respiratory sales growth. Is that related to the expectation that some of your competitors are going to be present in the U.S. market with non-respiratory panels? Or what is the reason why you're seeing this dramatic slowdown?
How much, you know, is it, is it volume slowdown, and how much is pricing impact in there? Thank you.
So I take your three questions. So SPOTFIRE reagents, thank you for raising it. Good question. Actually, it's early days, right? Because we've been in the market for just a few months, and we've seen the beginning of the respiratory season. By the end of 2023, it was 60% of the volumes with a 5-plex panel and 40% with the 15-plex panel, which is sold at a higher price. So for us, it was. It shows, in a way, the value of having the combination of 5-plex and 15-plex. It also shows that, obviously, the reimbursement is less convenient to your second question on 15-plex than 5-plex.
It shows that the medical value of the 15-plex is proving good enough to justify the use by the clinicians. The third question relates to the evolution of non-RP. And yes, I mean, we guide for 15% while we've experienced 24%. We don't expect price decrease, more on the contrary, but we are basically we kind of factor in, yes, of course, a little bit of competitive pressure. B ut it's more that the market. We don't expect the market to keep expanding 25% every year, right? So, in French, we say, the trees don't grow to the sky.
So, yes, we expect that growth rates, even though we are working on it, to decline a little bit, but mostly driven by the fact that the market capacity to grow at that pace is going to be challenged at some point. So that's the rationale for this 24% moving into 15.
Okay. Can I just double-check what you mean with less favorable on the 15-plex? It doesn't mean you don't have the reimbursement yet. Is that what you're saying here? And if that's the case, w-en do you expect the reimbursement to come through? And on your commentary that there is not a price increase from the non-respi, well, do you anticipate similar pricing pressure like you mentioned for the respi side of the business?
So, on your first follow-up question, that the reimbursements. No, the 15-plex panel, to make it simple, it reimburses the very same way for the clinicians, the way BIOFIRE RP panel is reimbursed. So we have limitations and conditions with that relate to 15-plex, but that apply the very same way. So it is reimbursed, but definitely in a point-of-care setting, it's less convenient. For instance, you have HMOs that limit the use if you're far away from the hospital or for immunodepressed patients. So there are conditions that are depends by payer that limit a little bit the reimbursement conditions for the 15-plex. But the 15-plex is reimbursed, it's a coverage matter.
It depends on the patient profile and yes, the circumstances of the testing being done. The 5-plex panel, as you know, between 3-plex and 5-plex, the conditions of reimbursements and the coverage is much higher, so that makes it significantly easier to use 5-plex panel for the clinicians. Does it answer your question?
Okay, got it. Thank you very much. Yeah, yeah, thanks. Thanks a lot, Pierre.
We don't anticipate, we believe, with regard to the pricing evolution for the non-RP panels, we don't anticipate price pressure. We don't, we don't believe there will be any. We believe we have very competitive solutions, and at this stage, we don't see any price pressure. So, this is, this is not in the 24-15 evolution.
Got it. Thank you.
We'll go next to Shubhangi Gupta with HSBC.
Hello?
Call, your line is open. You may be on mute.
Hello. Uh-
Hello.
I have three questions. The first on the industrial solution, what is the level of price increases we should expect in 2024? Second, on your, for your FY 2024 outlook, have you included any impact of volume-based procurement-related ASP cuts in your guidance? And, are you seeing any price cuts in China? And then third, on the U.S. market, so a lot of competitors are also present at the point of care testing. So do you see any scope of expansion into retail pharmacy clinics for diagnostic testing?
I'll start with the second one, which relates to a volume-based pricing tendency in China. Our business is not impacted in 2024. It's a significant share of our sales is done in microbiology, where there is no volume-based pricing. The business that is in immunoassays is not impacted either, because it's mostly procalcitonin that is not part of the scope of volume-based pricing. It doesn't mean we are immune to price cuts in China, but so far, for 2024, we don't expect any negative pricing impacts on our business for bioMérieux in China. Pricing evolution for industrial applications, I don't know if we give any color on that.
I'm getting the body language of Guillaume, who say no. We don't give color. It's a combination of volume and price. We don't expect as much as what we had in 2023.
Yes.
That was 6%-
Yes.
- if my recollection is correct. So not as much as 6%. B ut still significant, and that helps with the 9% target that we have. Your third question, I'm not sure I got it actually. Do you mind saying it again?
Yeah, yeah, sure. Thanks for the first two. For my third question, so there's a lot of competition in point of care testing in the U.S., which is the major market for point of care right now. So do you also see expansion of this diagnostic testing in retail pharmacy clinics like CVS and Walgreens?
Sorry, yeah. Got you. Very good question, actually. It's a very good question again. At this stage, we don't have any of that into our target for, which is EUR 80 million for 2024. It may be an opportunity, but at this stage, this is not put into calculations. But, obviously, it's a business opportunity. If and when retail pharmacies decide to incorporate the diagnostic solution point of care, we would be delighted to have those discussions with them, with SPOTFIRE. We have very high-level discussions, nothing concrete and specific at this moment.
Thank you.
Thank you. Maybe taking a few questions from the chat. So we have one question on Specific Diagnostics loss in 2023. We had guided on EUR 25 million when we acquired. And the question, will it be breakeven in 2024? So this—and actually, there's a related question on the performance in 2023. So, first thing to say that definitely the ramp-up in Europe is slower than we expected. It takes more, let's say, effort to convince and to get the sales ramp up. And on top of that, in the U.S., we are still, as you know, in the FDA review process. We are confident, but we are later than we expected, eighteen...
Two years ago at the acquisition time. So, definitely this delay on European ramp-up and U.S. registration, filing, approval makes the revenues lower in 2023. Therefore, the loss is definitely higher than the 2025. It's a bit overall delayed, and the breakeven as well that we mentioned in 2024 will be delayed. We are still very confident on the value of the platform, on its, let's say, commercial potential, but definitely in a delayed timeline.
Maybe to complement Guillaume's answer on VITEK REVEAL, you have to understand that, for us now, VITEK REVEAL and the Specific Diagnostics teams are fully integrated into bioMérieux. So, we actually, for instance, when we look at the investment in R&D, that are at 12.4%-12.5%, they fully integrate VITEK REVEAL Specific Diagnostics R&D investment. So we reallocate the R&D investments to make sure that, we cover the needs for Specific Diagnostics, but reduce the cost of the investment in R&D on some other areas. So at some point, looking at VITEK or Specific Diagnostics as a single entity within bioMérieux won't make much sense. The microbiology teams sell VITEK REVEAL. The R&D teams in microbiology work on VITEK REVEAL.
So, it's now part of the solution, part of the integrated solution that we propose in the field of microbiology, and that's how we look at it, moving forward.
There are two questions on the Oxford Nanopore about situation seems to depend. I'm not sure what you mean, maybe it's the share price, or and you say concerned about the investment. More importantly, then related, there's a question on the: Do we expect to increase our stake? Is there a sensitivity agreement? So maybe if I, we can complement, but clearly on the stake, we know we took 7%. We don't expect it to re-increase. We have, as you know, an R&D agreement. We have regular contacts at the CEO, CFO, and R&D levels to follow both the R&D partnership, as well as the overall Oxford, let's say, situation, as we are one of their main, let's say, investor.
Yeah, and maybe to bring a little bit of color to it, we are very happy with the quality of the relationship we have with Oxford Nanopore. We are very excited by the technology, and it's a long-term investment, so the very recent share price evolution for us is not a challenge, because we invested in Oxford Nanopore for with a more medium to long-term perspective. So, so no specific concern on our side.
Another question on the chat is about the EUR 400 million target for SPOTFIRE. So definitely, yes, we do confirm. We give you more color with last year and this year, let's say, guidance, and we believe this is on track for the EUR 400 million. 2027 is still a long way, but definitely on track at this stage, at this early stage, for this target. There's an additional question on the pricing pressure on BIOFIRE. S o not SPOTFIRE, but BIOFIRE. We mentioned earlier, -1%-2% on the RP. So that's what we... Yes, sorry, we said that for 2024, but that's what we saw in 2023.
So yes, it's what we saw and what we expect additionally in 2024 is triggered by, I mean, not only the direct competition of the direct syndromic, Qiagen, GenMark, et cetera, but also the indirect competition of low-plex and the pressure from, let's say, customers also to manage their own cost post-COVID, probably with more focus on this part post-COVID.
...More, more questions on the phone, maybe?
On the phone?
Yes. We'll go next to Christ Ganet with ODDO .
Yeah, absolutely. Can you hear me?
Yes, yes, we can.
Good afternoon. Thank you for taking my question. Actually, two. One is on the point of care situation and environment. I'd like to hear you, but the reaction, potential reaction of Cepheid on the field. Have you seen any change in terms of strategy, in terms of keeping their clients, in terms of client policy? That's the first one, and the second one is on SPOTFIRE. Can you help us understand the utilization as well concerning, for example, the reorders, the pace of reorders, the potential feedback, notably in terms of lack of panels, if there is? Is there a specific disadvantage now that they are using it, comparing all the machines, do they see a specific reason to give back the machine?
Or, and about the pace of placements, probably giving us some contrast with the 400 systems placed during the last quarter. Thanks.
Okay. So I take it, competitive situation. Do we see any specific reaction from Cepheid? Or, you know, obviously, it's probably more a better question for a colleague from Danaher. They have a remarkable position in this field of point of care. They are a very strong competitor, so we don't take them lightly. Beyond Cepheid, we have also Roche with Liat, we have also Abbott with ID NOW. So, we are very much trying to be... But we believe we are very competitive. Obviously, every player is reacting its own different way. But no specific competitive intelligence to share at this stage, which also depends on the market. So, so, yeah, no, no, no, no specific reaction.
If only, we are not only competing against Cepheid, we also have Roche and Abbott that are in this market of point-of-care testing. The other question is to have a little bit of qualitative feedback from some reply to your question on first clients for SPOTFIRE. It's actually very positive so far. We don't have any clients that I'm aware of returning their instruments. They are using the reagents. They like the 15 minutes, the time to result, they like the ease of use. What we're also hearing is they like the double panel, 5-plex and 15-plex. What else can I share? Menu, it was—it's a good question.
In point of care, I mean, the respiratory and sore throat are really the big elements. So, the menu is obviously important, and we plan to enrich the menu that is available on SPOTFIRE. But, the two big components where we need to be present are really respiratory and sore throat. So what we expect is that in 2024, with hopefully the approval of the sore throat panel in the U.S., we'll be in a very strong position to be very competitive in the market. We don't give guidance on placements, new instruments.
As we are talking about SPOTFIRE, there's a question on the chat on the split between outpatient, POC, and hospitals.
So I can give that feedback. So, again, early days. B ut what we are seeing today is 80% of the instruments installed are in a point-of-care setting, and 20% in a hospital setting. So, as we expected, there is an opportunity for a point-of-care solution into IDNs and hospitals, and it's proving to be correct. And we're starting to see, it's early days, but installations. You have to understand that in this specific segment, the purchasing process takes a little bit more time, because you go through a full purchasing process with the finance and so on and so forth. But the opportunities are also bigger, because when they buy, they buy for multiple installations at once. We're starting to see good traction also on this segment. But today, if we look at the installations, they are 80% into point-of-care setting.
I'll take the additional question on the FX. Sorry, back to that, but thank you for the question, of course. So the question mentions that there are, of course, big differences that are very visible on the exchange rates of Argentine peso, Turkish lira, and it's not mentioned in the question, but I can add Egyptian pound. But that it's not so visible that they are the headwind for other currencies. Just to mention that our policy is to hedge for one year the currencies that we can hedge, so not the most volatile. Which means that we hedge in Q4 for the year after.
So when we look at it, it's actually the difference of, let's say, maybe throughout Q4. S o let's say average Q4 rates to make it simple, rates or forward rates, compared to average Q4 the year after. And when you do that, it's a reality that renminbi for China, again, for Japan and I don't know, I mentioned South America, so the Colombia, Mexico, et cetera, are definitely headwinds. And when you add, I mentioned earlier, EUR 1 million, EUR 2 million, EUR 3 million for each of these currencies, at the end, it adds up to the big amounts of Argentina, Turkey, Egypt to this, let's say, around. And of course, it's so an estimate with humility at this stage of the year, the currencies move one direction or the other. It's the estimate that we have at this stage of the year.
Back to SPOTFIRE, there is a question on the chat on risk of cannibalization between BIOFIRE and SPOTFIRE. So, the answer is no. Very limited. We are super excited with the sales perspective for SPOTFIRE because there is very limited cannibalization. So as I said, 80% of installation in point-of-care setting, so by construction, zero competition with BIOFIRE. And even when we sell to IDNs or integrated distribution networks, what we're seeing is, back to the earlier question. We are actually, the SPOTFIRE purchasing process is more against Cepheid, Liat, ID NOW than against the BIOFIRE. They use SPOTFIRE for frontline testing, and they keep BIOFIRE in touch for second line testing.
We are actually seeing more of a synergistic approach than cannibalization by being capable to market both SPOTFIRE and BIOFIRE.
And we can take additional questions online. There are a few additional?
Yes, we'll go to Hugo Solvet with BNP Paribas Exane.
Hi, thanks for taking the follow-up. Actually, I have two. Circling back on your comments from slower growth traction of SPECIFIC REVEAL. Do you see on the other end, pockets of upside risk to other platforms that could help offset that longer term? Second, you mentioned, Guillaume, that you have an underutilized balance sheet. So, what's your thinking around M&A? Maybe you can expand a bit on large acquisitions versus probably smaller bolt-on deals that you've historically been doing. Thank you.
So SPECIFIC REVEAL, yes, we're seeing a bit of a slower than expected sale growth in Europe. Mostly related actually to, there is a very strong medical need, very strong technical, validation by the hospitals and financing challenging, because we are basically, as we did with BIOFIRE. W e are creating, generating a new market segment with Fast AST, that, today is not necessarily into the tenders and the budget from the labs. So, we are working on that. We are very confident, it will, it will, bring a ton of value to bioMérieux, and it's a, it's a long and, complicated process, as we experienced, by the way, with syndromic testing with BIOFIRE.
The second element is that relates to SPECIFIC REVEAL, is we are actually seeing a very halo impact on the rest of our microbiology offering, because definitely we're bringing innovation. So it rejuvenates the interest for the entire suite of microbiology solution that we have, be it VIRTUO. We have very strong growth in hemoculture, be it VITEK, very strong growth in ID AST counts, be it VITEK MS PRIME. So, it's obviously complicated to measure, right? But it contributes to the very strong performance that we're seeing in microbiology, and we don't see, to your question, any potential risk on downside, more the contrary, actually, on the rest of the microbiology offering.
And for your second question, Hugo, which is really about M&A, pretty simple. We very much like to share, in the Capital Markets Day, our, let's say, our philosophy, or the way we could look at it. I don't expect that we announce in a big acquisition on April 9th. That's not the topic. But definitely to share, how we see, using our, find the ways we could use our balance sheet and clearly invest for the growth of bioMérieux in the future. This will be among topics on April 9th. Any more questions on the phone?
At this time, there are no further questions.
Okay. So I think we're anyway running out of time. So, thank you, everybody, for a very interactive session. Looking forward to hopefully seeing or talking to you on April 9th for the Capital Markets Day. And thank you very much.
Thank you.
This does conclude today's conference. We thank you for your participation.