bioMerieux SA

bioMerieux SA

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Q2 FY2026 · Earnings Call TranscriptJuly 28, 2026

Operator

Hello and welcome to the bioMérieux half-year 2026 financial performance call. Please note this webcast is being recorded, and for the first part, participants' lines will be in listen-only mode.

You will have the opportunity to ask questions at the end of the presentation. This can be done by pressing pound key 5 on your telephone keypad.

I will now hand the conference over to Aymeric Fichet, Head of Investor Relations.

Aymeric Fichet

Thank you. Hello everyone, good afternoon, and thank you for joining this call.

I am with Pierre Boulud, CEO, together with Guillaume Bouhours, CFO. 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.biomerieux-finance.com.

I will now hand the call over to Pierre, and then we will open the call to questions. Pierre?

Pierre Boulud

Hello everyone, good afternoon. A couple of words on the agenda first.

I'll, first of all, share a few highlights on the business for the first half of the year, then hand over to Guillaume, who will go into more details around the financial performance and 2026 outlook, and I'll finish the call with a few words on ambitions for 2027 and 2028. You've heard the disclaimers from Aymeric.

Moving on the H1 highlights. As you've seen, we are reporting a sales growth that accelerated in Q2, plus 5%, 7.3% excluding respiratory panel sales, that is compensating a lower Q1 that was at 3.9% of decline, significantly impacted by the low respiratory epidemiology.

Our CEBIT at the end of H1 declined by 5% organically, reflecting especially the modest sales evolution that we had in Q1. We kept a sustained focus on innovation, I'll come back to that, with multiple product launches in H1, and we're delivering very strong cash generation.

Almost €300 million of free cash flow generated in H1, growing 76% versus H1 2025. Guillaume, again, will share more details on this cash flow generation.

To give you a bit more color on the financial performance, I would like to give a bit more qualitative comments on the different pillars of the GO•28 initiatives. I already mentioned multiple launches.

Q2 was heavy actually in terms of innovation. We have filed in June revised panel for BIOFIRE Gastrointestinal Panel that improves its performance and its relevance in the market.

With regards to point of care, we are accelerating with the filing of Vaginitis Panel to the FDA and to the European authorities. We are very happy to get the approval in June of SpinChip, the first test on SpinChip, the immunoassay platform that we acquired last year for high sensitive troponin.

Finally, in industry, a couple of launches I would like to highlight: Gene-Up Typer for Salmonella, very common contamination that we see in the food industry that allows to better identify the source of the contamination, and Axilics acquisition that is further strengthening our offering in pharma quality control. With regards to GO•SIMPLE, making also good progress in Q2.

Headcount evolution is very much under control. We actually have 200 headcount less at the end of June versus end of December, managing our costs efficiently.

Especially we've implemented the reduction of workforce in China, following difficult 2025 that we have gone through, and also decided to accelerate the closing of the Saint-Beauzire site by one quarter. We're progressing also on SG&A efficiency and implementing the different operating model that we have engineered.

With regards to COGS improvement, I would like to highlight two elements: automation for BIOFIRE, we're now at 60% of BIOFIRE pouches 100% automated, and with regards to procurement, additional savings above €10 million. With regards to GO•STRONGER, we've conducted our Voice of Employee, and we're for the third year in a row within the top 25% of the healthcare industry in terms of engagement.

With regards to our sustainability objectives, we're very much on track with CSR ambition. At the end of June, we have reduced by 31% our greenhouse gas absolute emissions.

Moving into business highlights, I would like to highlight Q2 performance. As I said, very strong performance actually in Q2.

GO•28 growth drivers have grown 8.5% in Q2. If you allow me to start with BIOFIRE non-respiratory, we've grown 7% in Q2 with a further increase of our installed base.

We keep increasing the number of instruments that are in the market and leveraging cross-selling strategy. With regards to SPOTFIRE, very strong performance.

If I look at reagent sales only, in Q2 it's grown 40% in a context of low epidemiology, and 400 instruments installed in Q2 with no specific one-off, neither in Japan or in the US. It's actually strongest Q2 since launch, further demonstrating good commercial uptake.

We're now at 7,200 instruments, our installed base is 60% bigger than it was in June 2025. In microbiology, very much in line with the 2026 guidance.

We've seen improvements in China. We've also seen improvements in instrument sales, as you know were slow in Q1, and very solid dynamics in blood culture.

Finally, industrial applications: very strong 9% sales growth with very strong performance for reagents growing double-digit, with price increase and strong dynamics in the pharma segment. BIOFIRE respiratory panels have been declining 6%, a little bit of price erosion, very similar to what we've experienced in the past, 2 to 3 percentage points, and even though it impacts us less than in Q1, a couple of points, but lower respiratory epidemiology.

Immunoassays almost flat with good dynamics on VIDAS Kube. Now with this, I wanted to highlight Q2, but I'm handing over to Guillaume to share with you performance for H1.

Guillaume Bouhours

Thank you, Pierre. Hello, everyone.

Let's look at the H1 organic growth. Overall plus 0.2% organic thanks to the 5% in Q2 that Pierre just highlighted.

Overall on H1, we see the following trends: BIOFIRE non-RP at plus 5.5% with, again, low epidemiology impacting pneumonia there in Q1 and a solid plus 7% in Q2; BIOFIRE RP, okay, we discussed it on much lower epidemiology than last year; SPOTFIRE, Pierre highlighted the 400 instruments in Q2, but I think it's important to highlight reagents overall in H1 plus 35% despite, as you all know, much lower epidemiology in H1 '26 than H1 '25; microbiology, overall plus 4% in H1, notably very strong dynamic on BACT/ALERT, our blood culture reagents, and I think Pierre mentioned the positive price increase that we were able to deliver in microbiology; immunoassay minus 3%, but actually when we exclude and look at the trends of China and procalcitonin, PCT, when we exclude those two, we are on a slight growth path, positive; and industry applications continuing to deliver well, as Pierre mentioned, with acceleration even in Q2, plus 7% overall in H1, with reagent sales up double-digit, including also there some price increases between 1% and 2%. If we turn now to the view of H1 by geography, a few comments there.

North America, overall minus 1%. Of course, it's a region that is most exposed in our portfolio to respiratory, with BIOFIRE RP and SPOTFIRE.

Yet, we saw in the region solid growth in industry applications, in non-respiratory panels, and in microbiology. Latin America continued on a super good dynamic, overall plus 11% organic in H1, and actually solid on all product lines in LatAm.

EMEA, as you can see, plus 2% organic, notably good growth on BIOFIRE non-RP, industry applications, and microbiology. Asia Pacific delivers minus 3%, but it's actually a very contrasted picture inside Asia Pacific, where China was down 6% overall in H1, and I remind you the bulk of it is microbiology for us.

We also had a negative trend in Japan that's a bit new, and that was mainly due to changes expected in the regulatory coverage population for SPOTFIRE in Japan. On the other hand, in Asia Pacific, we saw very strong growth in India and a very good level of growth in South Korea, balancing China and Japan overall.

With that, let's look to our income statement. I will comment mainly on the organic, it's called the change like-for-like on the right column.

As said, we said up 0.2% organic. We deliver the gross profit slightly down, minus 1%, and actually margin on an organic basis minus 70 basis points.

This is due to a slightly unfavorable product mix, of course with a lower share of BIOFIRE RP, one of our high-profit products; also an increase in our manufacturing projects spend; and the impact of the Middle East events twofold: one that you can expect on the transport cost of our products from the oil prices, but also some raw materials that are plastic-based that also saw some increase. Important to note, in terms of tariffs, I'm talking about the US tariffs, they were quite neutral year on year from H1 '25 to H1 '26 as we had the new tariffs applied in H1 '26, which were not in place in H1 '25, but that these were offset by the fact that we were able to apply for reimbursement of 2025 extra tariffs, the one that were let's say rebuffed by the Supreme Court, and that we received the reimbursements for more or less similar amounts to the tariffs we paid for H1.

Moving to SG&A, our sales, general, and administrative costs were overall, as you can see, down 2% in H1 due to lower variable compensation for our teams, and also the effect of GO•28 efficiency initiatives and additional new cost measures, we'll come back to that, to adapt to the slightly slower growth. R&D expenses plus 5% in H1, leading to 13% of R&D over sales.

Overall, as Pierre said, CEBIT is down 5% on a like-for-like basis, with a margin of 15.9%. The margin itself is down 100 basis points on an organic basis.

When we look at the reported impact, negative minus €35 million, and the effect of change of scope, acquisitions, of minus €5 million. With that, we can have a look at the income statement below CEBIT.

First, the line of amortization of acquired intangibles came back to a normalized level at minus €14 million for H1 after a very significant impact last year, which was the partial impairment of Specific technology. Our net financial expense moved to minus €5 million in H1.

The slight move compared to last year is due to the evolution of foreign exchange on our cash pooling positions. Income tax on the P&L is, let's say, pretty stable in terms of effective tax rate, 23.4%, overall delivering an adjusted EPS that is down minus 4% organic, pretty similar to the evolution organic of CEBIT, and minus 17% in terms of reported, also similar to the reported CEBIT evolution.

We can move to the cash flow. BioMérieux delivered a very strong cash flow in H1.

From an EBITDA of €440 million, slightly down, we had actually a cash generation from working capital thanks to a good management of receivables, with notably a good cash collection from customers in the US. Inventory is actually down, so that's positive, thanks to raw material optimization in terms of inventory.

The other key element in the cash flow is definitely tax payments. Just to remind you that the US tax reform, whereas it has no specific impact in the P&L, but has a cash impact, a timing impact, very favorable for bioMérieux.

That's what you see in the downturn of cash payments from €123 million last year H1 to €28 million this year H1. CapEx at 7% of sales, very slightly down in million euros.

Two-thirds of it is manufacturing, mainly for capacity, automation, about one-third for placement of new instruments, mainly SPOTFIRE, for our customers. Overall, a free cash flow at a very nice level of almost €300 million, compared to €170 million last year, and it puts bioMérieux balance sheet at a strong position of a net cash of €236 million on the balance sheet at the end of June.

With that, a few words on our 2026 outlook that we actually would like to reiterate and confirm. Based on the solid Q2 2026, as Pierre has detailed, and we must highlight a lower comp basis in H2 last year, which was at 3% versus plus 9% in H1 last year, we confirm the 2026 sales guidance for plus 3% to plus 5% organic sales evolution in '26, and CEBIT guidance of 0% to 10% organic growth of CEBIT.

That being said, I would like to maybe preempt, and I'm sure you have the usual question on what's the underlying assumption on the respiratory season. Basically, if Q4 2026 respiratory season is in line with Q4 2025, which itself was 10% below Q4 2024, we would expect full-year '26 sales growth to stand more towards the bottom of the annual guidance range.

On the opposite, if there is a strong epidemiology in Q4, this would have a positive impact on respiratory panels, SPOTFIRE sales, and pneumonia panel sales. On CEBIT, it's important to mention that we see a slight improvement in the prospects of foreign exchange impacts for the year, that now we revise to minus €40 million to minus €50 million.

I remind you that we had an impact of minus €35 million in H1, we took the bulk of it in H1. CapEx, we also revised slightly down from initially 9% of sales to more around 8% of sales.

With that, I would like to hand over back to Pierre for the outlook of 2027 and 2028.

Pierre Boulud

Thank you, Guillaume. Let's move now towards the mid-term outlook.

What we wanted to share with you is what we see that since 2024, the world has changed. We've seen worsening of geopolitical environment that translates into higher focus on defense and military spend that comes in many countries at the expense of the healthcare budget, and that translates into financial pressure on our clients.

These evolutions make GO•28 plan even more relevant, since we target to be more agile, more customer-focused, more efficient in order to better serve customers. Q1, as we shared, was heavily impacted by the epidemiology and the respiratory season.

This impact has now faded into Q2, and we have now a clearer understanding of the dynamics into our different businesses. To reflect this new environment, and now that we're seeing better the situation following the epidemiology impact of Q1, and we think this environment will stay in the next two years, we have decided to adjust our financial perspectives for 2027 and 2028.

With regards to sales growth, we now aim at 3% to 6% annual sales growth at constant exchange rate and scope for 2027 and 2028, with the very same focus on the growth drivers that were identified for GO•28, I'll come back to that. We also continue the implementation of all the initiatives that we have in the GO•SIMPLE plan, and from profitability perspective, we now aim to grow our CEBIT higher than the organic sales growth that we just revised for 2027 and 2028 at constant exchange rates and scope.

With regards to GOING STRONGER and GOING RESPONSIBLE, we've actually kept the objectives unchanged. If we go into the GO FOR GROWTH and the respective growth drivers, this is a kind of summary slide of what supports this revised objective of 3% to 6% annual organic sales growth in 2027 and 2028.

With regards to high-plex, actually the assumptions that we've made at the end of '23, beginning of 2024 with regards to pricing erosion, market share evolution are very consistent with what we're seeing now and actually very much in line with the plan. We have adjusted to a market growth that is slower than what we expected, especially for non-respiratory.

We were expecting a market to grow 10% to 15%. In that very dynamic market to grow 10%, we're seeing the market growing slower than that because of the financial constraints.

In that slower market growth, our new ambition is to grow from 4% to 8%. SPOTFIRE, we've adjusted to take into account the fact that we were giving an objective in euros, but at 2023 euro exchange rate, and also take into account the fact that with the success of SPOTFIRE, we have now more dependence on the respiratory season, and Guillaume was mentioning it for 2026.

It's actually a very similar objective to the objectives that we had, but we give it in terms of percentage of growth in 2027 and 2028, that goes between 25% to 40% growth versus what we've seen in 2026. Microbiology, the adjustment relates to China.

When we communicated the plan in early 2024, we did not expect China to decline close to 15% in 2025. Guillaume said it's progressing a bit with a sales decline of 6% in H1, but still, since China stands for 10% of global microbiology sales, we've kept all the other assumptions unchanged actually in terms of price evolution, market share evolution, but that translates into a microbiology sales growth evolution of 3% to 5%.

Immunoassays very similar to what we were sharing until now, and industrial applications is actually the same. If we go one by one on the different segments, for non-respiratory panels, we still believe in spite of the competitive announcements that we have the best-in-class solutions, be it in terms of time to result, there is no better solution in the market today, even though they were more recently launched in terms of time to result.

We still have the largest menu in the market. With FireWorks, we're actually capable to give epidemiology data to our clients on a very regular basis, and by the way, the Cyclospora outbreak in the US is a clear demonstration that having Cyclospora into the high-plex panel allows to do real-time surveillance of what's happening in the US in terms of outbreak.

The fourth element I would like to mention is we're still growing our installed base. Since 2023, we've grown our installed base by 3,000 units in two years between end of 2023 and the end of 2025.

We've increased our installed base by close to 12%, that is further supporting the sales growth in terms of reagents, and very high level customer service that is highly acknowledged by and recognized by our customers. Together with best-in-class solutions, we keep bringing up-to-date panels.

GI Med was launched in 2025. We've just communicated that we are updating our GI panel to make it even more competitive.

We're planning to launch a new Meningitis Panel in 2027 to keep up to speed in terms of performance. SPOTFIRE, so as I said, very similar ambition versus what we were sharing earlier.

We are uniquely positioned with 100% of the assays that were launched that are CLIA-waived, that really truly allows us to address the point of care market. We have still the fastest time to result and most comprehensive respiratory menu.

As I shared, very strong traction and dynamics, 7,200 instruments since launch, 400 additional instruments in Q2 only. It's very exciting, we're starting to expand the SPOTFIRE menu outside of the respiratory infections with the Vaginitis Panel launch in Q2 2026, as we committed to in 2024.

We're also preparing for STI launch in 2028 and Meningitis Panel launch in 2028, so that will allow to further expand SPOTFIRE success beyond respiratory disease. Microbiology, maybe a few highlights here.

First, blood culture practice is normalizing after the challenges from a major competitor with regards to bottle supply. We're seeing very dynamic sales in blood culture in 2026 that will further support the growth in the years to come.

We are the only player that is capable to have a fully integrated offer from identification to antibiogram, and the only one that is capable to provide fast identification with BIOFIRE BCID, but also fast antibiogram with Vitek Reveal. We keep bringing innovation.

We've already launched the small Vitek replacement, Vitek Compact Pro. We are ramping up Vitek Reveal.

We are going to launch Vitek Pro, which is a big Vitek, in 2027, and planning to launch the small Virtuo, BACT/ALERT 3D, in 2028. As I said, China is a big deal in microbiology, 10% of the microbiology sales.

As we are not expecting the market to grow as it used to be, we are localizing manufacturing for instruments to make sure that we can tap into the Chinese market evolution in the years to come. Industry, as I said, we've kept the ambition similar to what we said beginning of 2024.

We're seeing a strong need for quality control, both in food and in pharma. Strong traction in pharma, especially with regards to cell and gene therapy.

We've launched Gene-Up for mycoplasma. We are launching SPOTFIRE for mycoplasma for pharma quality control.

We've just invested into Axilics, that is an additional cytometry solution for pharma quality control. We're seeing a strong traction that we are planning to keep in the years to come.

The two additional segments that are not growth drivers, but obviously have an impact on our total sales evolution, are BIOFIRE respiratory panel and immunoassays. BIOFIRE respiratory panel, what we're seeing, as I said, is this high-plex market to not grow as fast as we expected.

It used to be flat sales for respiratory. We're now expecting minus 5%, which is a combination of a slow price erosion in the range of what we've been seeing in the last couple of years, 1% to 3%, and a bit of epidemiology reduction of volumes, knowing that, of course, what is a in-driver for RP sales is epidemiology.

We've seen it in Q1 2024, very strong sales growth. We've seen it unfortunately in Q1 2026 with very strong decline.

That's the main driver for the evolution of our RP panel. Immunoassays, very similar evolutions.

The only addition here is that we will include into immunoassays evolution the launch of SpinChip, and we'll come back to you when we are closer to launch, possibly Q4. Launch is now expected in Europe in September.

That's for the GO FOR GROWTH drivers for the next two years. With regards to GO•SIMPLE, a couple of comments here.

In 2024 and 2025, we've actually overdelivered in terms of CEBIT improvements, we've demonstrated that the different initiatives were actually translating into actual improvements and operational leverage. Now in the context of a sales growth that we expect to be a bit slower than we initially ambitioned, we are looking into accelerating some initiatives and adding some new ones to make sure that we're capable to bring our CEBIT to a growth that is higher than our organic sales growth.

It will take additional efforts from the organization that we are working on for 2027 and 2028. The last two dimensions of the plan, GOING STRONGER.

We're still very active. This is a very important topic for us that relates to deployment of core behaviors, core processes simplification.

We still aim to be in the first quartile. We've been there in the last three years, and we're still working to make sure that we continue to strengthen team members engagement.

The last dimension of the GO•28 plan is the sustainability dimension and CSR roadmap. We've updated this roadmap at the beginning actually of 2026, we've kept it unchanged.

What probably most noticeable is we've added an ambition to decline our Scope 3 emissions by 35% in 2034. The teams are actively working on this, and so far, we're very much in line with the target.

Now closing the call before we get into the Q&A, key takeaways to share: As you've heard, we're seeing a solid Q2 2026 performance, posting 5% organic sales growth. That allows us to confirm the 2026 guidance, sales expected to grow between 3% and 5%, CEBIT expected to grow between 0% and 10%, slight positive adjustment on FX impact, €40 million to €50 million, most of it has impacted unfortunately H1.

We're taking the opportunity of this Q2 communication and the stabilization of our performance to update and adjust 2027 and 2028 financial perspectives. We now plan an organic sales growth to be between 3% and 6%, and a CEBIT growth to be higher than organic sales growth.

While we're doing this, we keep investing into the future, that translate into the hopefully soon approval of SPOTFIRE Vaginitis, BIOFIRE GI new version of our panel, the launch of SpinChip, and new instruments in microbiology, as well as the update of the industrial application solutions with Gene-Up Typer. With this, I think we go for Q&A.

Aymeric Fichet

Yeah.

Operator

If you wish to register for a question, please dial pound key 5 on your telephone keypad or submit a question through the chat. If you wish to withdraw your question, please dial pound key 6.

The next question comes from Odysseas Manasiotis from BNP Paribas. Please go ahead.

Odysseas Manasiotis

Hi, thank you for taking my questions. Firstly on your new '27-'28 targets, they imply pretty much to a deceleration in growth from what the midpoint of your '26 guide implies for H2.

You're essentially going from around 7% to 8% to around 4.5%. Could you touch on areas where you may have been particularly conservative, and is there anything else other than market-wide factors that you mentioned on spending that are driving this in terms of competition, price pressure, even let's say Cepheid's upcoming high-plex launch?

That's the first question. The second one, regarding what backs your growth ambitions after '28, you've touched on a few drivers here with SPOTFIRE STI, SpinChip, the smaller Virtuo instrument.

I'm thinking, should we be thinking about a reacceleration after '28? Is this a bit of a time where you won't be taking as many product launches as usual or should we be viewing that '28 plus growth trend similar to what we're seeing to '28?

Thank you.

Pierre Boulud

Thank you, Odysseas. Let me take your two questions in order.

The first one that relates to sales growth ambition for 2027-'28, I think the right way to look at it is if you want to triangulate this ambition, I would triangulate with Q2. Obviously Q1 was very much, as I said, very much impacted by the epidemiology.

We still have a low epidemiology in Q2, but it feels like a more solid basis. In Q2, our sales growth is 5%.

It's actually very close to the midpoint of our long-term guidance. That's the way I would look at the next few years.

Not in the spirit of deceleration, but more in a spirit of continuing the trajectory that we've seen in Q2. Of course, there are upsides and downsides versus Q2.

A lot of things will happen, but I think it's a solid guidance in a context where we are capable to generate 5% sales growth in Q2. Your second question relates to evolution of our sales after 2028.

That would be the object probably of a new Capital Market Day. Today we really want to focus on giving you better perspectives on how we're seeing 2027 and 2028.

Of course, the investment that we make in innovation in 2026 to '28 will have an impact, hopefully, in the years to come. Too early to say how it translates in terms of sales dynamics, but the idea is to continue to grow faster than the market in the years to come.

Operator

The next question comes from Aisyah Noor from Morgan Stanley. Please go ahead.

Aisyah Noor

Hi, good afternoon, Pierre and Guillaume. Thanks for the question.

I'd love to start with SPOTFIRE. Your new guidance of 25% to 40% using 2026 as the jump-off point would imply something like €400 million to €410 million or so of sales by 2028 versus your prior target of €450 million.

Would be great to know what the main drivers of this change are. Is it just flu, or do you see the need to embed more pricing and competition from newcomers to the market?

Then my second question is on instrument sales. In the last quarter you called out multiple headwinds from geopolitical uncertainty, pressure on hospital budgets, delays in capital investment decisions.

Do you think that the instrument purchasing this quarter was somewhat of a release of that pent-up or pressured demand last quarter and we're still kind of in a weak demand environment? If you could give us an update on the instrument outlook embedded in your guide, that would be great.

Guillaume Bouhours

Maybe I can start with the equipment sales. Thank you, Aisyah.

Equipment sales, actually we saw a good pickup in Q2 at plus 5% overall on equipment sales, which still leads to an overall H1 equipment sales at minus 7.5%, because, again, as you rightly pointed, Q1 was very much down. Yes, it's improving.

It's also one of the elements that helps, among others, of course, as Pierre mentioned, to see clearer thanks on the base of Q2 for the market trend and the future.

Pierre Boulud

To come back to your first question on SPOTFIRE, you're right to say that when you apply the midpoint more or less based on our 2026 target, that leads to a little bit more than €400 million, €410 million in 2028. The main difference is actually exchange rate impact, which, as we've kept saying in the last couple of years, the euro has been evaluated.

It was the only guidance that we were giving in euros, it was starting to be a bit misleading to give a euro target based on 2023 exchange rate. To make it simpler and easier to forecast for you guys, we give a progression in percentage like we're doing for the other product ranges.

Aisyah Noor

Perfect, understood. If I could just follow up, could you elaborate a little bit on this change in Japan reimbursement or policy change, and whether that's a one-off quarter dynamic, or do you expect it to continue in the second half?

Pierre Boulud

I can take it. It's actually very illustrative of the worsening of the market conditions I was talking about.

We're very successful with SPOTFIRE and BIOFIRE in Japan, by the way, very limited competition from other high-plex competitors, it's not a market share challenge. It's actually the Japanese authorities have decided to restrict the use of SPOTFIRE Respiratory Panel to, quote, "high-risk patients," unquote.

It limits the use of this very valuable, we think, of course we are biased, but very valuable panels to a smaller patient population, hence having an impact. It's unfortunately structural, on one hand.

On the other hand, the authorities, together with the clinical associations, are still in the process of defining what a high-risk patient means. There was a preliminary understanding that was, for instance, it's only children under 5 years age, but it's not specified in the guidance.

Actually, there are high-risk patients, the pediatric association is actually claiming that there are high-risk patients that are above 5 years that should be taken into account. There is a bit of a wait-and-see period that is impacted short-term sales evolution in Japan that will hopefully be clarified in the coming months.

The bad news is still there: there is a more restrictive use and coverage of SPOTFIRE panels in Japan. By the way, while we were seeing this, our overall SPOTFIRE reagent sales have grown 40%, huh.

It was a negative, but overall we still have very strong performance on SPOTFIRE. Overall.

Double. Yeah.

Aisyah Noor

Understood. Thank you very much.

Operator

The next question comes from Anna Radcliffe from Bank of America. Please go ahead.

Aymeric Fichet

Anna? Anna, we don't hear you.

Maybe you are on mute? No.

So... Operator, yeah, yeah.

Operator

The next question comes from Kavya Deshpande from UBS. Please go ahead.

Kavya Deshpande

Good afternoon, Pierre and Guillaume. Thank you for taking my questions.

My first was on the 2026 guidance for respiratory panels. If I heard correct, Guillaume, I think you said the bottom end of the range is likely if the Q4 season this year is in line with last year.

From the outpatient data we have, it looks like volumes are still below last year, even as the comparators have become a lot weaker in the past few weeks. Is there something that you are seeing in your specific inpatient data that is giving you confidence that the Q4 flu season will be at least in line or grow versus last year?

Then my second question was around the non-respiratory guidance for this year. It seems to now imply an acceleration from about 5.5% in the first half to over 10% in H2.

It's obviously also a lot stronger than your medium-term guidance for this franchise. Just curious to know what is driving that and whether that's the new GI panel or something else giving you that confidence there?

Thank you.

Guillaume Bouhours

Thank you, Kavya. Maybe coming back on the '26 guidance on RP just to repeat, because you're right, it's an important point.

If the Q4, the season at the end of the year, Q4 '26 is at the same level as Q4 '25, we would expect our our sales to be at the bottom end of the guidance. It's an important precision overall on the on the range.

I don't think we, as there are always this debate on data during the summer, especially, Southern Hemisphere, et cetera, we don't believe that much can be actually derived from from summer data in any way to the to the winter season. We more look at it in a, how should I say, simple way and taking assumptions.

That's why we give you if it's at the same level of last year, which was, by the way, special as well. Last year was actually low October, November, super high December.

Overall, that's top Q4, Q4 overall, and that's that's the, let's say, the color we we can give. We will see all together if the the epidemiology becomes average or or stronger by the end of the year, but at this stage, we don't know.

Non-RP does imply, you're right, I think your calculation is correct, maybe a bit a bit lower than 10% for H2, and we've seen this acceleration from Q1 to Q2, and Q2 was pretty solid at 7%. Yes, you're right, it does imply a slight acceleration beyond 7% if you want to be at this at this level.

Pierre Boulud

It's worth mentioning on non-RP that the Cyclospora outbreak in the US is actually detected with the high-plex panel, Kavya, not with mid-plex panels available in the market. We're seeing a very significant uptick.

We don't know for how long, but in the US, we're seeing very strong evolution of GI panel. Of course, non-RP is also depending upon circulation of parasites, bacteria, and viruses, but just to give a little bit of color on what we're seeing in July.

Guillaume Bouhours

Everyone knows that Cyclospora is a pretty severe gastro syndrome, parasite, which currently, as Pierre mentioned, is an outbreak in the US. They are talking about more than 5,000 cases now, 5,000 to 10,000, which is the highest outbreak of this kind for many, many years.

Again, as Pierre said, high-plex is helping to diagnosis, not low-plex.

Kavya Deshpande

Understood. Thank you very much.

Operator

The next question comes from Charles Pitman-King from Barclays. Please go ahead.

Charles Pitman-King

Hi guys, thanks so much for taking my questions. Two, if I may.

Firstly, maybe just with respect to the FY '27-'28, thank you very much for the divisional breakdown in the presentation, but I'm just wondering if you could give us a little bit more detail on how you think about the gross margin mix development over the period given these new growth mix and tariff expectations, just how you think about that directionally. Then just on a SPOTFIRE, a couple of quick clarifications.

Can you just confirm there were no one-offs for SPOTFIRE in 2Q supporting that 400? Can you confirm that meningitis is coming in '28 versus what I understood was a '27 launch?

Just any further comments you can give on the Liaison NES, any impact from launch initially given that this was a concern of investors after their launch in April? Thank you.

Pierre Boulud

I can take the SPOTFIRE questions, and Guillaume will answer on the gross margin. SPOTFIRE, first question, yes.

Yes, and confirmation that there is no one-off in the 400. As and we commented a little bit in Q1, we had significant one-offs in Japan and in the US with bigger deals.

In Q2, none of this, the 400 is normalized number. Meningitis, good pick.

We're now looking into 2028 versus 2027. To be honest, it's still tentative.

Maybe it can be accelerated, maybe it can be a bit delayed, so that's why we give overall years. Actually the test is ready.

What is generating the uncertainty is the speed of the clinical trial. A bit early, but the latest plan we have is more a launch in 2028.

With regards to the competition of Liaison NES, what we said when it was announced is it's actually a pretty crowded market already. There are multiple competitors.

We have low market share. Of course, a lot of respect for the launch of this new system, and it doesn't dramatically change the competitive environment.

We're still seeing, and actually Q2 is proving, we're still seeing SPOTFIRE as a very competitive solution, and there is definitely room for every solution in the market, hopefully a little bit more for SPOTFIRE.

Guillaume Bouhours

For the gross margin? For the gross margin, thank you, Charles, for the question, but I don't think we, at this stage, give details on the line by line.

What I can say, and I think it's important to restate what Pierre has already mentioned, is our commitments to deliver on the cost side to have this new guidelines of organic CEBIT growing organically faster than sales growth. For that, we commit to deliver on GO•28 initiatives and to launch new efficiency and cost initiatives.

We are looking as we speak on different fronts, and as you can understand, some will impact gross margin, some will impact sales and marketing, G&A, and even pretty likely some will impact R&D. It's difficult yet to say at this stage, exactly depending on choices, how gross margin specifically will evolve.

I think the most important is our global commitment.

Charles Pitman-King

Thank you very much. Appreciate it.

Operator

The next question comes from David Westenberg from Piper Sandler. Please go ahead.

David Westenberg

Thank you for taking the question. I wanted to talk maybe on SpotFire, how did it do

Aymeric Fichet

in Q2? David, David, the line is super bad.

Can you do something on your side?

David Westenberg

I'm trying. Better now?

No?

Aymeric Fichet

No. Maybe closer to the mic?

David Westenberg

All right, on my mic now. I want to talk about SpotFire and how it did in Q2.

Can you talk about maybe new customer wins versus cannibalization, what characteristics do you think it's going to make it better than competitors in the coming quarters, where's the lowest fruit, and how should we think about instruments in 2026 and the impact on '27 and 2028 guidance, if you can hear me.

Pierre Boulud

SpotFire. I understand your question is on SpotFire evolution of install base.

There is no cannibalization, as because we are primarily in the point of care segment, we are not seeing any cannibalization with BIOFIRE product range in the hospital setting. It's all new customers.

It's also all competitive wins, because in most, 99% of the cases, those clients were already equipped with a point of care solution. That's for Q2 and H1.

We don't give guidance on the evolutions, number of instruments. Usually what we see is stronger actually Q3, really the very end of Q3, it's really September, and actually the big quarter for us in terms of installation, because it's in the market dynamics, is more in Q4, preparation for the following respiratory season.

We do expect very similar trend to what we've seen.

David Westenberg

Got it. Just on the follow-up on the 2027, 2027 or 2027, 2028 guide, you mentioned you do expect for gross CEBIT higher than revenue.

You have been growing R&D, but you've been cutting on the SG&A front in the near term. What levers do you have theoretically if you're coming in at the lower end of the guidance in terms of '27, '28, what kind of levers do you think you would use on the OpEx line to make sure that you still can grow CEBIT above revenue?

Thank you.

Guillaume Bouhours

Yes, at the lower end of the sales guidance to answer rapidly your question, probably it would take more time to go into details, but if we're at the lower end of the section, it's still 3% to 4% sales growth. We believe at 3% to 4% sales growth, we still have operating leverage that we can deploy and that would allow to grow profitability faster than sales.

As we are going to prepare for 2027 budget and 2028, maybe we'll give a little bit more color into what we're planning to do for 2027. We believe, and that's the reason why we communicated this guidance, that even at the low end of the guidance in terms of sales growth, we are capable to bring profitability improvements together with a lower sales growth.

David Westenberg

Thank you.

Operator

The next question comes from Jan Koch from Deutsche Bank. Please go ahead.

Jan Koch

Good afternoon, thanks for taking my questions. My first one is on microbiology.

Could you speak about the improvements you have seen in China? Have hospitals started to use more blood culture bottles again?

What are your expectations for China for H2 here? Secondly, on BIOFIRE, Danaher announced plans to enter the high-plex market with its third-generation system.

Given their large installed base, how do you view the competitive risk, and have you included that in your new 2027, 2028 targets? Then finally, one clarification on tariffs.

Sorry if I missed that, but does your H1 CEBIT include any positive impact from tariff refunds?

Pierre Boulud

Thank you, Jan. Maybe this is Guillaume, I'll take the last one first, on tariffs.

Guillaume Bouhours

Yes, to clarify, we did apply for reimbursement of 2025 tariffs that became, I think they say, non-constitutional in the US. We did apply, and we got the reimbursement, actually cash-wise.

P&L-wise as well, we have about €30 million of positive impact in our H1 P&L. Yet, I mentioned it's neutral if you compare to 2025, because in H1 2025, the tariffs were not yet in place, and we paid in H1 2026 the 15%, mainly the 15% on imports, mainly from Europe into the US.

Between the H1 '26 paid and the H2 '25 reimbursed, it was overall neutral, and neutral compared to last year '25. Just remind everyone, talking about tariffs, that we are actually manufacturing in the US about 85% of what we sell in the US, which of course gives relatively low exposure of bioMérieux to US tariffs.

With that, maybe, Pierre, on China?

Pierre Boulud

Yes, maybe China to give a bit of color. Guillaume highlighted we had a decline of sales by 6%, which is still negative, and yet much better than 2025, as you pointed out.

Two elements: the first one is, and we said it when we commented 2025, it was not so much pricing or market share, it was very much market deceleration. We've seen a lot of stock reduction at hospital and distributor level that are a bit of one-offs.

Now it's part of the improvements. We don't have that additional effect that we had in 2025.

The other element is the localization of instrument is working. We have localized the manufacturing of our two BACT/ALERT that are available.

We're planning to have Virtuo very soon approved in terms of localization in 2026. We've also localized the Vitek Compact Pro in China, and we already manufacture locally blood culture bottles.

All of this together has also helped to recover better and be more dynamic in the market. We are very much in line with the plan that was mid-single-digit decline in China, that's what we've seen in H1, that's what we expect in H2 2026.

Your second question relates to BIOFIRE, the announcements from Danaher, Cepheid on their new system. It kind of demonstrates the value of high-plex testing in the eyes of Danaher, Cepheid.

We are very happy to see that having high-plex molecular solution is acknowledged and recognized by a big player like Danaher. They've announced a new system, actually, to be able to launch high-plex solution.

We still need to see, beyond the system, what are the panels with which performance and targets they plan to have. They haven't communicated any, as far as I know, beyond the system, any new panel launch.

When we know better from them, we'll be able to give you more color on how we plan to be competitive against this new system.

Jan Koch

Great, thank you.

Pierre Boulud

Thank you.

Operator

The next question comes from Philip Omnou from JP Morgan. Please go ahead.

Philip Omnou

Thanks guys for taking my question. Just on your '26 guidance for your organic growth for 3% to 5%, that assumes a pretty big step-up in the second half to around 8%.

Firstly, are you able to share whether you expect Q3 to be within that 3% to 5% or could it be higher, and therefore how back-end loaded are you assuming the phasing of the organic growth for the year to be? Then secondly, when it comes to your confidence or your visibility in the rest of the business outside of respiratory, how much confidence or visibility do you have in order to hit the low end if flu was below or at the same level as 2025?

Then just a quick clarification on the tariff refunds piece, can you confirm that the benefit that you saw in this quarter is the full amount that you paid in 2025 and therefore we shouldn't expect any more tariff refunds to come through in Q3 or Q4? Thanks.

Guillaume Bouhours

Yes, maybe I'll start with tariffs. Yes, it's almost the full amount of the reimbursement.

There's a very small amount, below €2 million, that is left to be reimbursed probably in H2, we hope for that. The bulk of it, as I mentioned, €30 million was actually reimbursed and paid and recognized in the P&L in H1 for the US tariffs of 2025.

Then if we move to the '26 sales guidance, again, I think the most important is to restate what I said. Again, we are mainly on the trend of the Q2 solid performance.

That is what gives us confidence on the way we will deliver in H2. Respiratory, which of course is the main uncertainty, if we factor a Q4 '26 at the similar level of epidemiology as Q4 '25, we would be around the bottom of the guidance.

Let's see where it gets. It can also be stronger, and again, stronger would mean for us an uptick on respiratory panels, but also pneumonia and also SPOTFIRE, obviously.

Philip Omnou

Great, thanks guys.

Aymeric Fichet

Okay. I'm going to read the question from Anna from Royal Bank of Scotland because she has an issue with her headset.

She would like to have an update comment on your view on competitive positioning on both BIOFIRE and SPOTFIRE across both technologies. It seems like competition is increasing.

Second question: looking beyond 2028, specifically for SPOTFIRE, how do you see the balance of increasing competition versus your non-RP launches driving an acceleration in growth? The last question is for the mid-term CEBIT downgrade, is that just from operating leverage or are you also factoring in some additional pressure from inflation, oil prices that would be at high levels for the mid-term?

Pierre Boulud

Let me start with the first one, competitive positioning, and then I'll talk about the beyond '28, and Guillaume will take the CEBIT evolution. Competitive positioning, it's a broad question.

Let me say it this way: what we're seeing for BIOFIRE, and I said it a little bit when we were sharing the perspective, was that we're not seeing a significant degradation of a market share in respiratory panels or in non-respiratory panels. We're seeing price erosion.

We're seeing market share erosion, but the assumptions that we had in 2024 are actually proving to be very correct at end of June 2026. I know it's been a very regular question and challenge raised in the context of competitive launches.

We're actually seeing a very decent performance, and actually what drives the evolution of our sales is very much related to epidemiology for respiratory more than competitive challenges. That's what I would say for BIOFIRE.

Of course, we've tried to integrate the evolution of the competition in the revised guidance. It's our best estimate of what we're seeing, but for non-RP, we're still expecting to grow 4% to 8% in the years to come, given what we believe is the superior system in the market with the broadest menu and very strong installed base that, by the way, keeps increasing in H1 2026.

With regards to SPOTFIRE, again, very different picture, because in this case, we don't have a high market share to protect, we're actually taking share. As I said, the competitive environment is a little bit less sensitive to us, because we're more in market share uptake.

As I said, we are very much in line with the plan. As you pointed out, there are new competitors in the market, but it's a huge market, with the region of €3 billion to €4 billion market.

We're still a very marginal player in this market, we believe there is ample room for growth in this market, with the caveat of we're getting more and more dependent upon the respiratory season, because it's mostly respiratory sales. Which is a good segue to your second question, post-2028.

Probably would be if and when we do a new Capital Market Day, it would be a good topic. As we said, until 2028, the impact of vaginitis, STI, meningitis is included in the guidance for 2028, but is not very significant yet.

Of course, as we move forward, and we believe and we aim to bring very differentiated solutions for vaginitis, for STI, for meningitis, we hope to take share in this point of care market, so that is aiming at derisking, if you wish, our sales from respiratory season on SPOTFIRE in the years to come. I'm not in a situation to give you now any order of magnitude of number beyond 2028.

Mid-term CEBIT evolution, Guillaume?

Guillaume Bouhours

On the CEBIT evolution, lower than the previous targets of the plan, top line is definitely a major impact, of course, especially in a high-margin businesses as we have. Of course, 3% to 6% growth has a major impact on CEBIT compared to middle above average 7% CAGR.

Also, you're right that, as we mentioned, the macro environment is not the same as it was back in 2024. Tariffs, just to mention tariffs in the US of 15% were not present at the time.

We base our case on the current, and that's very difficult, the current oil price, which is slightly below $100 a barrel, and it was absolutely not the same environment before that. We can mention on inflation also the chips, electronics, we say crisis, which is actually the drag of AI data centers on the whole world of chips, which makes it more difficult to source and much more expensive to source as well for own equipments.

I can continue like that. I think our new guidance takes into account this new context as we know it today.

Of course, we don't factor any new macro environment, or new, I don't know, war or anything like that, but at least the environment as we know it today that is so different, as I just mentioned on the cost side as well, from what we saw and we had back in 20 early 2024. Just

Aymeric Fichet

Anna, just one follow-up question for 2026. For the 0% to 10% CEBIT evolution in 2026, are you able to comment on what will drive you closer to the upper or lower end of the range?

How much will it be dependent on operating leverage, mix, or respiratory season?

Pierre Boulud

The main dependency, as usual at this stage of the year, is definitely on the strength of the respiratory season. This is, as we explained, what drives the top line in the range, and definitely that's what will drive the bottom line.

If you do the mathematical calculation, which obviously is a bit limited, but still not irrelevant, if H2 equals Q2, i.e. if we grow 5% in H2, we would be at 3% sales growth for the full year.

That kind of builds a bit the bottom of the guidance, if you wish, and to Guillaume's point, then of course we are very dependent upon the respiratory season. As we said, respiratory season 2026 Q4 equals respiratory season Q4 '25 would give us 3%.

Guillaume Bouhours

To take one question from written questions, a question from Christophe Rafalovitch on price. The question is on industrial applications, but I'll be a bit broader to recap on pricing effects.

Industrial applications, to your question, was able to increase price by slightly less than 2% in H1. We also are able to increase price in microbiology by around 2%, which actually makes price increases in about 50% of our overall portfolio and sales, whereas on BIOFIRE, we decrease about 1% prices on non-respiratory overall, and slightly less than 3%, less than 3% price erosion on respiratory panels on BIOFIRE.

Again, 50% with price increases, but 40% of the portfolio with slight price decreases. By the way, when you look at the whole overall price effect on bioMérieux, it's therefore pretty neutral in H1.

Aymeric Fichet

Let's go for maybe three extra written questions. The question is, is the 3% to 6% annual growth a target or an ambition?

Pierre Boulud

I think it's important to restate actually the way we wrote it in the press release is that we are aiming at delivering 3% to 6% organic annual growth, and then that's our wording, yeah.

Aymeric Fichet

Maybe one question from Arnaud Cadart from CIC. As you mention with the revised guidance for '27 and '28, the market is less responsive to innovation.

Why maintaining intact the R&D initiatives?

Pierre Boulud

Actually we don't keep them intact, we keep reviewing R&D portfolio to make sure that we adjust the innovation that we launch to the market conditions. Our objective is clearly to reach by the end of 2028, very much in line with the GO•28 plan, 12% of our sales in research and development.

Now it's more what is it that we bring in terms of innovation that will resonate best in terms of market acceptance and affordability from the market. It's obviously a big topic for us, and of course, we're looking at a portfolio of innovation, taking into account this new environment.

Aymeric Fichet

Maybe just a second question from Arnaud: could you update us on the launch of SpotFire in France?

Pierre Boulud

Yes, so as in France there is not a point of care market that is formally organized. What we are capable to do is to launch SpotFire in the hospital environment, it's mostly available through emergency departments.

There are two new news. The first one is we've actually got the approval for Europe of the low-plex SpotFire for respiratory that was not available in Europe yet, was launched in Q2, we'll expect it to further expand in Europe and, of course, in France.

The second new news that relates to France is there was a decree that allows to do elderly houses or Maison de Santé in French, I don't know to say it in English, the decree is out, but there is no funding. As we speak, we are working together with authorities to see how we can organize for a proper reimbursement for that kind of solutions outside of the hospital setting.

Aymeric Fichet

Maybe the very last question from Thibault Voiellamache from Allinvest: should investors expect bioMérieux to play a more active role in industry consolidation in order to strengthen its medium-term growth profile?

Pierre Boulud

Our view on M&A stays unchanged. One, we keep looking at what we call bolt-on opportunities to further strengthen our portfolio of solutions in the core strategic segments where we operate.

Axilics or SpinChip are recent illustrations of what we do from an M&A perspective. Of course, if and when we see adjacencies, additional segments where we believe we can acquire strong position, this is something that we keep exploring, but they need to be strategically and financially reasonable, no pressure that relates to this evolution of mid-term guidance.

Aymeric Fichet

Okay. Thanks a lot.

Thanks for your questions and your participation to this call, and our next touch point will be on October 30th for our Q3 sales performance.

Pierre Boulud

Thank you, everyone. Have a good day.

Aymeric Fichet

Bye-bye. A

Pierre Boulud

good summer break.