Bonesupport Holding AB (publ)

Bonesupport Holding AB (publ)

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Q2 FY2026 · Earnings Call TranscriptJuly 16, 2026

APIChatGPT

Operator

Welcome to BONESUPPORT Q2 2026. For the first part of the conference call, the participants will be in listen-only mode.

During the questions and answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now I will hand the conference over to CEO Torbjörn Sköld and CFO Håkan Johansson.

Please go ahead.

Operator

Torbjörn Sköld

Thank you, operator. Welcome, everyone, to BONESUPPORT's Q2 2026 results call.

My name is Torbjörn Sköld, CEO of BONESUPPORT. With me here today is our CFO, Håkan Johansson, and together we will use the next 25 minutes to guide you through the Q2 presentation and then open the line for questions.

Before starting the presentation, I would like to draw your attention to the disclaimers covering any forward-looking statements we will make today. Let's look at the financial and operational highlights of the quarter.

Q2 reflected solid execution across the business. Net sales came in at SEK 356 million, corresponding to a growth at constant exchange rates of 30% versus Q2 2025.

Reported growth was 25%, showing that the currency impact on our figures for the quarter has decreased compared to the previous quarters. Our adjusted operating result, excluding incentive program effects, was SEK 104 million, corresponding to an adjusted operating margin of 29%.

Reported operating result was SEK 90 million. We saw another quarter of solid cash generation, with operating cash flows reaching SEK 67 million.

After completing a share buyback of SEK 83 million, this resulted in a cash position of SEK 434 million at quarter end. After a period of significant commercial investments, it's encouraging to see the strong operating margin together with continued strong cash flows as confirmation of the scalability of our business model.

We continue to see strong traction for CERAMENT in the U.S., with sales reaching SEK 295 million for the quarter, compared with SEK 236 million in Q2 2025. In Europe and rest of the world, we saw solid momentum across all markets with a growth of 26% at constant exchange rates compared to Q2 2025.

During the quarter, the regulatory process for CERAMENT V progressed according to plan within the framework of the De Novo process. If granted market authorization, CERAMENT V will constitute an entirely new product category, like CERAMENT G in 2022.

Just as in the review of the De Novo application for CERAMENT G, both CDER, Center for Drug Evaluation and Research, and CDRH, Center for Devices and Radiological Health, are involved, and the lead review team, which sorts under CDRH, remains the same as during the 510 process. BONESUPPORT has continued the constructive dialogue with FDA within the scope of the De Novo process and is working purposefully to address the requested details and clarifications.

Responses are to be submitted no later than end of August. Progress on CERAMENT for spine continues to be solid.

The CERAMENT BVF launch is on track, and the preparations for the studies on antibiotic-eluting CERAMENT follow plan, an important step as we continue expanding our portfolio of indications and applications. In Q2, U.S.

CMS proposed improved reimbursement for the use of CERAMENT G in complex orthopedic infection surgery and more specific identification codes for CERAMENT G. Let's move to the sales development.

Next slide, please. This chart shows total last 12 months reported sales in SEK by quarter since 2019 in stacked bars per region and product category.

As you can see, the launch momentum for CERAMENT G in the U.S. is strong.

Given that we keep bringing new strong clinical studies and opening up new market segments, new indications, a product like CERAMENT G will remain in launch phase for many years to come. Throughout 2025 and in the first half of 2026, we've seen strong influence from the U.S.

dollar to Swedish krona depreciation, which influences the optics of the graph, but not the in-market performance, as you will see in Håkan's slides later in the presentation. Last 12 months growth in Q2 of 21% in the graph corresponds to an even stronger 32% at constant exchange rates.

U.S. CERAMENT BVF last 12 months sales was flat year-over-year at constant exchange rates.

In total, antibiotic-eluting CERAMENT grew with 40% last 12 months in the quarter at constant exchange rates. Next slide, please.

In U.S., sales amounted to SEK 295 million, representing a growth of 31% at constant exchange rates. Growth of CERAMENT G was slightly lower than expected due to a handful of customers implementing restrictions in their usage of CERAMENT, so-called pre-approvals.

This reduced the growth rate somewhat in the quarter. It's not new for customers who started using CERAMENT G more recently to temporarily limit usage while awaiting results.

The restrictions is set by hospital administration to keep short-term costs down. The demand and the need among treating clinicians remains intact and is growing.

We've seen this pattern before. When customers accelerate their use of CERAMENT G, hospital administrations may, as a cost-driven response, introduce temporary restrictions, so-called go-stop-go.

These hospitals continue to use CERAMENT G, albeit at the reduced level, which creates a good foundation for increasing usage, again, using health economic arguments. The proposed changes to DRG codes announced by CMS during the quarter, with expected implementation in the fourth quarter, add further strength to these dialogues.

Excluding the impact from these customers mentioned, we continue to experience strong growth of CERAMENT G, driven by both increased access through new accounts and new surgeons, as well as wider adoption among existing users. We see growth from all three prioritized platforms, foot and ankle, trauma, and arthroplasty.

As part of our ambition to modernize an outdated standard of care in the U.S., we have opened one market segment after another, starting with foot and ankle, followed by trauma, and now moving into revision arthroplasty. Our market research presented at our capital markets day indicates that around 60% of the revision arthroplasties receive some form of local antibiotics, mainly from PMMA and antibiotic powder.

It also indicates that 80% of the surgeons in the survey found CERAMENT G appealing to highly appealing. Interest continues to grow for CERAMENT G in revision arthroplasty and periprosthetic joint infections, where the clinical needs remain substantial and the evidence supporting our antibiotic-eluting technology has resonated strongly with surgeons.

We've built a solid foundation for our spine strategy over the past quarters by establishing distributor coverage and preparing the market. In Q2, we continued the early-stage launch of CERAMENT BVF in spinal procedures, with distributors actively engaging spine surgeons across both existing and new partnerships.

The surgeon access and early stages of adoption in spine follow plan and indicate the strength and potential of this segment. As this is a new clinical segment for us, more clinical data is needed to support broader market penetration.

Importantly, the performance of CERAMENT BVF in spine will help confirm the value proposition for the CERAMENT platform, which will pave the way for future antibiotic-eluting CERAMENT launch. Our market research, also presented at our Capital Markets Day in April, points to strong clinical and market rationale for antibiotic-eluting CERAMENT in spinal procedures.

Infection and reinfection prevention remain major unmet needs in spine surgery. 75% of surgeons already use local antibiotics for surgical treatment, and 86% use them for prophylaxis in at least some patients.

The current standard applying antibiotic powder without controlled delivery, often called dumping, is used by roughly 78% of the surgeons. Yet 82% consider that this approach is suboptimal, pointing to a clear gap between current practice and what surgeons believe is the right solution.

In Q2, U.S. CMS, Centers for Medicare & Medicaid Services, announced a proposed ruling, full year 2027 IPPS, including changes that improve payments for the use of CERAMENT G in the treatment of complex orthopedic infections, such as periprosthetic joint infection, fracture-related infection, and diabetes-related bone infection.

In parallel, CMS proposes the introduction of more specific procedure and identification codes for CERAMENT G. Although this is a proposed ruling, this is very positive for BONESUPPORT, as it validates the uniqueness and value CERAMENT brings and reduces potential barriers for using CERAMENT in daily clinical practice.

The company submitted additional clarifications to the CMS during the public comment period, aiming to tie the extra reimbursement specifically to on-label use of approved products in this category, where we currently hold the only approval, strengthening our competitive moat. In parallel, we've prepared a roll-up plan with supporting education and communication materials to fully capitalize on the ruling.

A final decision from CMS is expected in late summer 2026, and the ruling expected to come into effect as of October 1st, 2026. Let's turn to Europe.

Next slide, please. Sales in Euro came in at SEK 61 million, representing 26% growth at constant exchange rates.

While part of this reflects a softer comparison base in Q2 2025, it was still a very strong quarter. We saw strong development across our three market structures: direct, hybrid, and distributor markets.

This model is well-suited to the early stage the company is currently in. In our direct markets, the market conditions in Germany have stabilized, and healthcare providers have adapted to the new normal following last year's market reforms.

Our investments in hybrid markets developed well, underlying continued potential ahead. In our distributor markets, we see large potential to increase our footprint by entering more countries.

Meanwhile, the CERAMENT launch in India, with a focus on the private market, is going according to plan. We note volatility in the Middle East, where geopolitical unrest is affecting market presence and logistics in the short term.

I'll leave a deep dive into the numbers to Håkan.

Torbjörn Sköld

Håkan Johansson

Thank you, Torbjörn. Net sales improved from SEK 284 million to SEK 356 million, equaling a growth of 25% in reported sales growth or 30% in constant exchange rates.

Torbjörn has already spoken about the performance in especially the U.S. and the major drivers behind the sales growth.

As the large movement in US dollars over time somewhat hides the true trajectory in the U.S., I would like to share the U.S. sales performance in US dollars.

Having CERAMENT G as the growth driver in the U.S., this slide shows the quarterly CERAMENT G sales in the U.S. in US dollars, with continued solid performance despite the isolated headwinds already covered by Torbjörn.

The contribution from the U.S. segment improved by $35.8 million versus Q2 2025 and amounted to $140.2 million.

The improved contribution relates to increased sales after the effect of increased costs. Selling and marketing expenses during the quarter amounted to SEK 135.3 million, compared with SEK 117.8 million previous year, of which sales commissions to distributors' fees amounted to SEK 94.5 million, compared with SEK 78.5 million in the same quarter last year.

From the graph at the bottom of the screen showing net sales as bars and gross margin as the orange marker, it can be noted that the gross margin remains stable and strong at 93.8%, with a decline in the quarter, mainly following the impact from tariffs, impacted with SEK 1.5 million in comparison with the same quarter last year. In Europe and rest of the world, a contribution of SEK 16.8 million was reported, compared with SEK 13.6 million previous year.

Selling and marketing expenses increased by SEK 5.3 million, mainly related to the previously communicated commercial investments in the so-called EUROW Booster Program. From the lower graph and orange marker, a minor movement in gross margin can be noted, mainly impacted by market mix.

Selling expenses, excluding sales commission and fees, increased by SEK 16.2 million compared with previous year, following the commercial investments in both the U.S. and Europe.

Investments aimed at future sales growth, driven both by market opportunities and by sustained high marketing activity. R&D remained at a stable level and focused on strategic initiatives such as the market authorization submission for CERAMENT V in the U.S., the research and studies in spine, and also future portfolio innovation.

Administrative expenses, excluding the effects from the long-term incentive programs, remaining stable with an increase of SEK 1.3 million in the quarter. The adjusted operating result amounted to SEK 104.1 million, with only minor currency effects impacting.

I will come back to this on a later slide. Gross margin is down following a SEK 2.7 million inventory write-down regarding components and materials, as well as continued impact from U.S.

tariffs. As mentioned previously, a SEK 1.5 million impact compared with the same period last year.

The difference between adjusted and reported operating result is cost related to our long-term incentive programs, amounting to an expense of SEK 14.5 million in the quarter, compared with an expense of SEK 7.6 million previous year, as you could see from the previous slide. The increase in expense include SEK 1.6 million relating to the long-term incentive program approved by the AGM in May 2025, which was included from the beginning of this year.

Operating cash flows were strong in the quarter. Net cash is down following the executed share buyback totaling SEK 83 million.

During the quarter, the Swedish krona has experienced volatility and weakened against US dollars, among others, with only minor exchange gains and losses reported as other operating income and expenses. This graph on this slide shows with gray bars how the relationship between the US dollar closing rate and the Swedish krona has varied over time.

This is read out on the Y-axis. The blue dotted line read out on the Y-axis shows adjusted operating result.

The adjusted operating result Excluding translation exchange effects is the orange line and gives a more comparable view of the underlying trend. In the table below the graph, you can see that the FX-adjusted operating margin of 28% in the quarter, compared with 26% in the same quarter last year.

In the shorter term, the operating margin has been impacted by the commercial investments made in both Europe and U.S. This quarter shows a return to a gradually improved operating margin.

As already mentioned, a solid cash conversion has been reported continuously since Q3 2024, with an average cash conversion of 79%, visible as the dotted line in this graph. Q2 this year reports a solid 67% cash conversion.

With this, I hand back over to you, Torbjörn.

Håkan Johansson

Torbjörn Sköld

Thank you, Håkan. To summarize Q2 2026, sales grew 30% at constant exchange rates, reflecting steady and consistent progress.

Highlights were EUROW growth versus prior year of 26% at constant exchange rates and strong adjusted operating margin of 29%, and solid cash flow underscoring the strength of the business and its scalability. As a result of the first half of the year's sales growth of 31% in constant exchange rates, we estimate full-year sales growth to be between 33% and 36% in constant exchange rates.

Our confidence in this estimate is based on the underlying run rate coming out of Q2, the new account pipeline that we see with both IDNs as well as distributors, and on top of that, we see the potential positive triggers of the CMS ruling, the SOLARIO study publication, and a CERAMENT V approval. The quarter confirms that the company's position has strengthened and continues to be characterized by relatively low but rapidly increasing market penetration, creating significant room for expansion for many years to come.

Let's open the line for questions.

Torbjörn Sköld

Operator

If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad.

The next question comes from Erik Cassel from Danske Bank. Please go ahead.

Operator

Erik Cassel

Hello. Good morning.

I wanted some clarification on the, as you call it, go-stop-go dynamic that you talked about in the U.S., on those sort of accounts. Is it possible to say if they have some sort of special characteristics?

Are they mainly, say, inpatient, outpatient? Do they do any sort of special procedures?

Are they atypical in the, say, amount of procedures that they do? I think any color on how, say, general or niche these accounts are would be helpful to pencil out the outlook and if it applies to everything, basically.

Erik Cassel

Torbjörn Sköld

Yeah. What we can see is that it's a handful number of accounts.

All the accounts are among the, let's say, the top 50 accounts that we have. We don't see anything related to that they are in a special niche or only in one of the three categories.

We also see that they are unrelated to each other. We don't see a common trend or anything like that.

What is also very important is that all of these accounts continue to use our products at a relatively high volume level. Albeit at a slightly reduced level compared to Q2 2025.

We have ongoing conversations with all of them to provide arguments for why they should come back to the previous levels. Also, not only that, grow from there.

That's what we can say about those accounts. I don't know if there's anything else, Håkan, that I'm missing on that one.

Torbjörn Sköld

Håkan Johansson

No, I think that somehow it's fair to say that somehow if we look at that category of large customers and we exclude the handful where we now experience this situation, there is a solid underlying growth among these accounts.

Håkan Johansson

Torbjörn Sköld

Correct.

Torbjörn Sköld

Erik Cassel

Okay. Thank you.

My assumption has been that all the clinical data and cost benefit, et cetera, is being assessed during the VAC approvals to sort of get into hospital to begin with. Can you share some light on the arguments that you need to have with hospitals to get them to resume that higher usage and basically not have restrictions?

Do they request more clinical data, or are their own, say, clinical outcomes not really reflecting the sort of data that you have produced already? What's the actual pushback from them?

Erik Cassel

Torbjörn Sköld

No, typically what we see is that the access comes at different levels of the hospital. It's not that we have convinced one group of administrators and they change their minds.

It has to do with that we increase the volume of usage, either in the hospital or a group of hospitals, and they see the increasing number of invoices and the volumes and the amount of money that they spend of CERAMENT. It's not necessarily a new type of argument or new evidence that is required.

It is just to make sure that we get access on more and more levels as we grow the adoption within the accounts.

Torbjörn Sköld

Erik Cassel

Okay, thank you. Last question.

Is it possible to, in some way, quantify what it could have been if it wasn't for this sort of dynamic, if those accounts would have performed, say, as the other cohorts that did not see this dynamic? What would the overall growth have been in that case?

That ties into, can you somehow proactively prevent this dynamic by actively, before that happens, showing the hospital administration, maybe by yourself providing more data or perhaps seeing those codes come into effect by October? Is there something to do on that?

Erik Cassel

Torbjörn Sköld

Great questions. Thank you, Erik.

On the first point, we're not going to give you a number, but high level, if it wasn't for these handful of accounts, we would be perfectly on plan, exactly in line with what we planned for. That's what we can say.

On the second piece is a really good topic, we have invested over the last couple of quarters in our medical education, in our national accounts, in our health economics teams, et cetera. We're building that capabilities.

We have done so, and we will continue to do so. What we saw in the second quarter is that's exactly the right thing to do.

Exactly to your point that also being more proactive when we enter accounts to make sure that we don't enter into this go-stop-go, that we have more of a linear and solid progression. We have to always convince the clinical stakeholders first.

That's just a given in the business that we're in. Also that we early on engage them more proactively using the data that we have.

I think there are two aspects in the short term that will really strengthen our case on this one. One is clearly that you mentioned, the CMS ruling.

It will be seen, assuming that it comes into play, it will be seen very positive. It should be very positive.

That's number one. Of course, we're preparing a lot of work on that to make sure that we have solid material and a rollout plan, and educating not just our users and the clinicians, but also the administrators and the coders at the hospital so that they fully understand and can leverage this.

That's number one. Another point is, for example, the upcoming and expected publication of the SOLARIO study.

That's a really good piece of evidence that really supports the usage and also the higher cost of CERAMENT compared to alternatives. I think that's how I would answer those two questions, Erik, if that makes sense.

Torbjörn Sköld

Erik Cassel

Yeah. Great.

Thank you so much. I'll jump back in queue.

Erik Cassel

Operator

The next question comes from Kristofer Liljeberg from DNB Carnegie. Please go ahead.

Operator

Kristofer Liljeberg

Yeah, thank you. Three questions.

First, on the same topic, could you maybe provide a figure what's your success rate historically has been turning around this type of administrative restrictions? I guess this is not something completely new.

Secondly, you touched upon the reimbursement changes. Is it too early or have you received any type of feedback in conversation with customers how positive this could actually be?

My final question is more for Håkan on the selling expenses that were now flat sequentially after having been up quite significantly in the previous two quarters. Should we expect it to remain at this level now for some time here coming quarters, or are you planning additional hiring short term that will drive up costs further?

Thank you.

Kristofer Liljeberg

Torbjörn Sköld

Thank you, Kristofer. Good questions.

The first question on the success rate. We've been pretty successful with this historically.

Not 100%, but definitely more than 50%. I think it is somewhere between 50%-100% in terms of the success rate.

What is positive here is that the dialogues are ongoing. That's the answer to your first question.

Reimbursement changes, I think it's a combination between very positive to too early to tell, honestly, because it's still a proposed ruling. It's not been decided yet.

The limited feedback that we have is very positive, but I think it's too early to draw any conclusions on that. Those were the two answers to the two first questions.

What about selling expenses?

Torbjörn Sköld

Håkan Johansson

About selling expenses, will this be flattening out? I think that it is evident, given the market potential that remains, that we will continue to invest commercially.

Do we see and do we have plans that will make big impacts in the shorter term? No.

Again, over time, I am sure that we will report and you would see gradually increasing selling expenses.

Håkan Johansson

Kristofer Liljeberg

Yes, coming back to that. The reason I'm asking is because if we looked at the fourth quarter and first quarter, the sequential increase in operating profit was pretty limited despite continued strong sales growth.

Just wonder if we could expect this, as we saw this quarter, more operational leverage momentum for the remainder of the year sequentially.

Kristofer Liljeberg

Håkan Johansson

I think that's what you can expect is that selling expenses as a percentage to sales will continue to come down, and by that then support improved operating leverage going forward.

Håkan Johansson

Kristofer Liljeberg

Great. Thank you very much.

Kristofer Liljeberg

Operator

The next question comes from Mattias Vadsten from SEB. Please go ahead.

Operator

Mattias Vadsten

Hi. Thank you for taking my questions.

Some of them have been asked already, I will continue a bit on the go-stop-go dynamics. When you say that they are applying restriction and awaiting results, just to be clear, is this results of patient outcomes or health economic outcomes or both?

That's the first one.

Mattias Vadsten

Torbjörn Sköld

Okay, good. The go-stop-go typically applies to two parts.

One is the clinical, that's early phase. That is not what we saw in Q2.

Go-stop-go can apply to a clinician wanting to try the product, tries the product in a number of patients, then stops to see the clinical results. That's one aspect of go-stop-go.

That is not what we see in Q2. The other aspect is simply that clinician starts using the product, but the approvals at higher levels in the administration, and it can be at several different levels depending on the amounts of money that they spend of CERAMENT.

There, it's not so much they want to see the results of the health economic benefits. As Erik Cassel pointed out earlier, it could be a Value Analysis Committee.

There are many different natures of these in U.S. hospitals.

They want to see the health economic results of it. Number one, from other clinics, number two, sometimes in their own clinic.

That's the answer to that question, Mattias.

Torbjörn Sköld

Mattias Vadsten

I guess that takes a bit of time because the major benefit is, of course, that the patients do not return with infections and so forth, I guess.

Mattias Vadsten

Torbjörn Sköld

Well, most of the time, it's enough that you have a good meeting with the administrators supported by local key opinion leaders, regional key opinion leaders, and ourselves. That's the most.

Actually, I wouldn't say it would necessarily take a lot of time, but for sure, weeks, months to establish these meetings and get the rulings in our favor. That's the timing aspect that I have in mind.

Torbjörn Sköld

Håkan Johansson

I think, Mattias

Håkan Johansson

Mattias Vadsten

Thanks so much

Mattias Vadsten

Håkan Johansson

We not forget is that we are talking to high volume customers. That means that there are plentiful of documentation from patients treated at these hospitals that we can benefit from in these discussions.

Håkan Johansson

Mattias Vadsten

Great. That's a clear answer.

Next question is, did you see this dynamic of those handful key accounts change anything through the quarter, or was it the same environment the whole Q2 quarter?

Mattias Vadsten

Torbjörn Sköld

I think it's fair to say, that's also to the last comment that I made in the presentation when we talk about the confidence in delivering the 33%-36%. I think if we look at the run rate coming out of Q2, it looks very positive.

There's no doubt about that. I think the dynamic changed gradually during the quarter to the positive.

Again, as we saw in the quarter, it fluctuates, and it will fluctuate going forward. We have good confidence in this going forward.

It's not the first time that it happens, and it's not the last time that it happens. It's simply nature of the business that we're in.

We're growing 30%, 30%-40% in the U.S. That means that the hospitals spend a lot more money on CERAMENT.

We keep our pricing very, very stable, and we want to be disciplined around that. We don't want to take shortcuts reducing price just to get an easy approval.

We want to maintain that price level and go-stop-go, we've seen in the past, we saw it in Q2, and we will continue to see it going forward.

Torbjörn Sköld

Mattias Vadsten

Perfect. Thank you.

I was going to the last one. There have been some news this week from a major private hospital in the U.S.

citing lower surgery volumes in the second quarter. I'm just asking here, did you experience any impact in the quarter from a lower overall procedure volume in orthopedics in the U.S.

during Q2, or is this not a factor for you? Thank you.

Mattias Vadsten

Torbjörn Sköld

Great question. Yes, we've noted the data points from several different external sources.

When we look at market data that sort of is applicable to the indications that we are in, we also see the same data points. To say that we see it in our numbers and to explain our numbers with that, I think it's difficult to confirm that that's a factor, and it's also difficult to reject that that's a factor simply because We're so small.

We're growing 30%, in the U.S., even more. To say that our results is because of a slight reduction in volume, I don't think it would be intellectually honest to say that.

It could be the case, but it could not also be the case. We don't really see it that way.

Torbjörn Sköld

Mattias Vadsten

Thank you so much for all the answers.

Mattias Vadsten

Operator

The next question comes from Sten Gustafsson from ABG Sundal Collier. Please go ahead.

Operator

Sten Gustafsson

Good morning. You already answered a lot of questions about the U.S.

market, but I just want to confirm if I heard you correctly when you said that the momentum during the quarter improved gradually. Is that correct, that the growth trend was stronger in June compared to the start of the quarter?

Sten Gustafsson

Torbjörn Sköld

I think it's fair to say that when we look at our estimates for the remainder of the year, how do we come to the 33%-36%? I think there are a couple of factors.

One was the run rate that we saw coming out of Q2. That's number one.

Yes, is the answer to your questions. That's not the only thing, of course.

What is also very important is to look at what do we have in the pipeline of conversions, customers, IDNs, and also, equally important, new distributors that we sign up. I would say those two factors are most key underlying points in our confidence in the 33%-36%.

On top of that, you have those CMS rulings, the SOLARIO study, and certain V approval.

Torbjörn Sköld

Sten Gustafsson

Have you heard anything about publication of SOLARIO study, when that will come?

Sten Gustafsson

Torbjörn Sköld

We have the same information that we've given previously, meaning that it has been approved for publication, and we have no new news to that. We expect a publication in the near term, that's what we said in the last quarterly call, and I hope it's the last quarterly call I say this, you never know with these scientific journals.

It's out of our control, and it's out of the author's control as well. We'll see how it plays out.

Torbjörn Sköld

Sten Gustafsson

Sure. Turning to Europe and Rest of the World, obviously, it's great to see the growth rate there.

Could you highlight some of the markets where you see particularly strong growth rate? How is the U.K.

and Germany, which I assume are the largest parts contributing to that growth and also the new markets where you recently entered into like India and Canada and so forth?

Sten Gustafsson

Torbjörn Sköld

Sure. I think what's very positive with EUROW is that it's broad across direct hybrid distributors.

It's also broad within the respected countries. I will not quote any numbers.

I leave that to Håkan to do if he wants to. I think high level, Germany, we saw recovery from last year.

Both the healthcare market there as well as ourselves have sort of adopted and found our way in this new normal. I think U.K.

is more neutral. We saw some recover early in the year, and in Q2 was more neutral.

India follows plan, but it's still so small, so it's not a material driver of the growth in EUROW. It's more that most of the other countries just tick in the right way, and we gradually improve in all of them.

Also, I think when you look at the EUROW number, you should have taken into account that we came from a, relatively speaking, lower base last year. When we adjust for that, it's still a very solid and good growth.

We're very pleased with the performance. I don't know, Håkan, if you have anything else you want to add.

Torbjörn Sköld

Håkan Johansson

No, I think to your last point, I think that, again, we know that we have self-comparables, but despite Easter in early April, the EUROW delivered a good sequential growth to Q1 and delivered strong confirmations around stability in the U.K. Also, really the stabilization in Germany, stable growth in all our direct markets, solid growth numbers, high growth numbers in the markets where we have been investing.

I think that gives a lot of confidence around our strategies outside U.S. going forward.

Håkan Johansson

Sten Gustafsson

Thank you.

Sten Gustafsson

Operator

The next question comes from Edward Hall from Stifel. Please go ahead.

Operator

Edward Hall

Good morning, guys. Thank you for taking my questions.

Apologies for sticking on the U.S. topic.

I just wanted to understand the customer concentration in the U.S. and maybe sort of the number of accounts that have this dynamic.

Like what channel were they in, and is this any way related to the Affordable Care Act subsidy expiring? That would be my first question.

Edward Hall

Torbjörn Sköld

The number of accounts that we saw the impact in Q2, it is a relatively small number. We say a handful of accounts in the report, and we do not provide more specifics than that.

That is number one. In terms of the channels, no.

We pretty much only have one channel. It is an independent sales rep channel, and there was no sort of pattern there that there was only related to one independent sales rep channel or the other.

It is no pattern there. We do not have any information that this sort of round of go-stop-go in the U.S.

can be correlated to anything related to the Affordable Care Act. Again, we cannot confirm it, and we cannot reject it.

That would be my answer to it.

Torbjörn Sköld

Edward Hall

No, that's really clear. Thanks.

I guess maybe just on the updated guidance, I would just like to hear your thoughts as we go into H2, and I appreciate it's easier comps, but obviously there's still an underlying acceleration. I just wanted to understand what sort of underpins your confidence for this guidance now.

Is it sort of the easier comps? Is it a real clear acceleration that you're seeing?

Any commentary there would be really helpful.

Edward Hall

Torbjörn Sköld

Yeah, sure. It goes back to what I said earlier around why do we feel very confident in the 33%-36% range?

It is how we came out of Q2. It is the trend that we saw in Q2.

It is the absolute level that we sort of had in terms of run rates. It's also in terms of the product mix.

That's number one. Number two is also when we look at the pipeline of, call it new accounts, new IDNs, it looks very healthy compared to our historic numbers.

Also, when we look at the pipeline of new distributors, that looks also very healthy. Those are the three key points to that.

On top of that, if you overlay, but this is sort of out of our control and it's difficult to sort of get the timing on it, but those first three things, those are within our control. Out of our control is the CMS ruling.

It is the publication of the SOLARIO study, and it is also the CERAMENT V approval in that order of, we'll call it magnitude of potential impact in second half of the year. That is sort of what is building our confidence in the new guidance.

Torbjörn Sköld

Edward Hall

Perfect. No, that makes a lot of sense.

Maybe just finally, just again, back on the U.S., sort of the three U.S. segments that you've broken out, could you talk about which segments are maybe for the first half of the year really performing above expectations or in line with expectations?

Or maybe put it another way, sort of what's really driving the prints today?

Edward Hall

Torbjörn Sköld

I'm going to give the boring answer on this one. I think all three segments deliver in line with plan when we look at the numbers, the product mix.

We see and hear a lot of positive feedback on the fact that we are entering, still at a very early stage, but that we're entering revision arthroplasty. That's more the, call it noise, qualitative feedback.

In terms of the numbers in the quarter, all three segments delivered according to plan. Spine also delivered according to plan, but it's such a small number, so it doesn't really change the overall picture.

Torbjörn Sköld

Edward Hall

Perfect. Thanks very much and congrats.

Edward Hall

Operator

As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Kristofer Liljeberg from DNB Carnegie.

Please go ahead.

Operator

Kristofer Liljeberg

Two additional questions if there is time. First on, cash flow continues to be strong.

Just wondering how you view the share buyback mandate you have and the need to keep a lot of cash on the balance sheet. The second question is, Germany, is that market back to growth, or is just that it has stabilized at the lower level?

Thank you.

Kristofer Liljeberg

Håkan Johansson

Thank you, Kristofer, I'll start with the first question. Again, as we could see, it's positive to see a continued underlying positive cash flow, giving us both necessary funds to continue reinvesting in the business.

We talked about continued commercial investments, et cetera. Again, also open up for a more utilization of the mandate that was given by the AGM in May to continue buying back shares.

Håkan Johansson

Torbjörn Sköld

Good. Since you stopped, I assume I will take the second question.

Thank you.

Torbjörn Sköld

Håkan Johansson

Of course.

Håkan Johansson

Torbjörn Sköld

It's good. On Germany, I would categorize it more as stabilizing than growing, clearly going in the right direction, of course, as you sort of develop month-over-month, it's not black and white, we're still more in the stabilization phase than the growth phase.

Torbjörn Sköld

Kristofer Liljeberg

Great. Thank you.

Kristofer Liljeberg

Operator

There are no more phone questions at this time. I hand the conference back to the speakers for any written questions and closing comments.

Operator

Håkan Johansson

We have a few questions on the web, and most of them have been answered already, but there is one question that has not been covered in the call, and that is now back to the communication we made on Level I trauma centers and how they are progressing after the increase in access in 2025. Torbjörn, a few words on that one?

Håkan Johansson

Torbjörn Sköld

Sure. No, I think progress is solid according to plan, really.

We focus on more to increase the adoption in these that we managed to get access to, rather than necessarily go for more. We're progressing well, and we're pleased with the performance.

Again, very early phase. I think that's one question, right, from the web.

What is this one? There's another one.

"What triggered the downgrade of your guidance for this year?" I would say it's more a reflection that we have now two quarters in the books.

We grew 31% in the first half year compared to first half year in 2025, where we grew 40%. It is really to be as transparent and granular with the market on what we see, what we feel, and what we think for the remainder of the year.

That's really the background for the updated guidance. Should we take this one?

What is this? "If the De Novo process continues as planned, when do you expect to be able to make first sales of CERAMENT V in the U.S.?

Is that included in the guidance?" Okay, great.

We plan to submit our answers to FDA no later than end August. It's really up to FDA to say yes, no, or something in between.

Given that, let's say that we submit in end August, it is going to have very little impact on our numbers for this year. We have not taken into account any CERAMENT V in the updated guidance.

Is that all?

Torbjörn Sköld

Håkan Johansson

That's all.

Håkan Johansson

Torbjörn Sköld

No further questions?

Torbjörn Sköld

Håkan Johansson

No further questions.

Håkan Johansson

Torbjörn Sköld

No, nothing on the chat?

Torbjörn Sköld

Håkan Johansson

Nope.

Håkan Johansson

Torbjörn Sköld

Okay. With that, thank you all for your attention.

We wish you a great rest of the day and a fantastic summer for those of you who have vacations. Thank you very much.