10/23/2025

speaker
Torbjörn Skrold
CEO

Welcome everyone to Bonesupport's Q3 2025 results call. My name is Torbjörn Skrold and since September 1st, I'm the CEO of Bonesupport. With me here today is our CFO, Håkan Johansson, and together the two of us will use the next 25 minutes to guide you through the Q2 report and then open the line for any questions. Before starting the presentation, I would like to draw your attention to the disclaimers covering any forward-looking statements that we will make today. Next slide, please. So let's look at the financial and operational highlights from the quarter. Q3 was another strong quarter with solid execution across the business. Net sales came in at 294 million, corresponding to a growth of 24% versus Q3 2024. Sales growth at constant exchange rate was 34%, showing that there's continued strong currency impact on our figures for the quarter. Our operating results excluding incentive program effects was 79 million, corresponding to an adjusted operating margin of 27%. Reported operating results was 65 million, and we saw strong cash generation with operating cash 379 million. One highlight in the quarter was the publication of the long-awaited Serahip study, which now kicks off our market penetration efforts in this market segment, revision orthoplasty. We will look deeper into this later in the presentation. We continue to see strong traction for SeraMed-G in the US, where both new accounts and increased use among current users contributed to the strong progress. CerementG sales in the U.S. reached 192 million for the quarter. Furthermore, the proposed NTAP for CerementG in open trauma has now been decided upon, as well as a 6% general increase in Cerement relevant DRG codes by CMS for orthopedics. So all in all, an eventful and a successful quarter. As I've transitioned into my new role and reflect on the business, I find our strategy sound and that the business develops very well. What really stands out is the solid evidence base supporting the CEREMENT platform and the significant long-term opportunity of CEREMENT globally in several clinical segments. This spring, we're planning to host a Capital Markets Day where we'll share a structured overview of our key initiatives and our path forward. We'll follow up with more details and the official dates later.

speaker
Moderator
Moderator

Hi, this is your moderator speaking. We're having some technical issues, but we are going to try to get the speakers back as soon as possible.

speaker
Håkan Johansson
CFO

So the speakers have connected again. Can the moderator please confirm whether the sound and technology is up again?

speaker
Moderator
Moderator

Yes, everything is great.

speaker
Torbjörn Skrold
CEO

Thank you very much. Thank you, moderator. Moderator, can you please inform us how long did you listen to us?

speaker
Moderator
Moderator

We came to... You were as likely the third slide in the third quarter report.

speaker
Torbjörn Skrold
CEO

Okay, I assume that we've gone through slide three and we move over to the sales development. This short shows the last 12 months sales in Swedish Krona by quarters since 2019 in stacked bars by region by product category. As you can see, the launch momentum for Cermon G in the US is exceptionally strong. However, in the last two quarters, we've seen strong influence from the US dollar to Swedish crown depreciation. Last 12 months growth in Q3 of 37% in the graph corresponds to an even stronger 41% at constant exchange rates. So most of this quarter over quarter slowdown in last 12 months sales is due to the strong currency impact. Ceramide BVF last 12 months dropped 2% year over year in constant currency. In total, antibiotic elutin ceramide grew with 59% last 12 months in the quarter in constant currency. Next slide, please. In US, sales amounted to 246 million, representing a growth of 40% at constant exchange rates. There was some general variability during the quarter due to the usual stop and go dynamics, a reflection of the strong pace of new customer recruitment over the past six to eight months. As part of our mission to modernize an outdated standard of care in the US, we have successfully opened one market segment after another. We started with foot and ankle, then we followed with trauma, and now we're moving into revision arthroplasty. Revision arthroplasty and the subset segment of periprosthetic joint infections are areas we have not specifically focused on in the past. Each year, approximately 1.5 million primary joint replacements are performed in the U.S. with just over 70,000 revision procedures requiring bone graft. The center hip results are groundbreaking. Although the study is not very large, patients have been followed for an average of 3.3 years with no infections reported. I'll speak more about CERAHIP on the next slide. We have expanded our U.S. organization, and we plan to recruit additional team members with specialized expertise in revision arthroplasty to support the market entry and the medical education programs. We are expanding our presence in the market to introduce CERAMEN, for use in spinal procedures in Q4 2025. Several distributors are now in place to begin engaging with spine surgeons. Some of these distributors are already our partners today on the extremity side, while others represent new collaborations. The spine segment is new for us, and we will begin generating clinical data during 2026, soon to establish a foundation for further market penetration. We've also made strong progress in evaluating and preparing the regulatory pathway for introducing Cerament G into the spine segment. We have reached a stage where guidance from the FDA on the regulatory path is required. We plan to meet with the FDA at the beginning of 2026. The path forward will be shared and communicated at the Capital Markets Day this spring in 2026. The team has been working diligently with assembling data in reply to FDA's question on Cerament V, and we expect to send in the supplementary data pack in November. The material relates mostly to clarifications and making sure that the evidence is presented in the way that FDA wants to have it. Being a pioneer technology, there's no template as how to bring forward the evidence. The thoroughness of the process testifies to the rigor of solid data required to qualify a product into the unique category of antibiotic eluting bone graft. And we should remember that this category is defined by another CERAMENT product, namely CERAMENT G. So let's start to Europe. Next slide, please. Sales performance in Europe continues to be influenced by the same dynamics observed in G2. The third quarter typically shows some volatility due to seasonal factors. Additionally, the contraction and disruption in Germany have persisted as anticipated. Sales in Euro came in at 48 million, representing 5% year-over-year growth and 7% at constant exchange rates. Hybrid markets in Southern Europe, Australia and Canada are performing strongly. We're beginning to see positive traction from the investments made during the first half of 2025, reflected in improved sales performance. In the UK, the previously announced prioritization of hip and knee surgeries is gradually restoring procedure volumes, which bodes well for the future of bone support in the UK. However, the pace of recovery varies by region and is largely dependent on staffing levels. During the quarter, the European Bone and Joint Infection Society held its annual meeting. Several podium presentations and posters highlighted the efficacy of Sermon G and Sermon V in single-stage procedures and demonstrated improvements in patient outcomes. A poster presentation by Dr. Meller from Charité showcasing results from the CERAHIP study attracted significant interest and a large audience. We'll review the detailed findings from the now-published study on the next slide. Also, Professor Ferreira from University Hospital Stellenbosch presented results from his study involving 103 trauma patients with bone infections. These patients were treated with a single-stage procedure using CERAMENT-G or CERAMENT-B, After an average follow-up of 11 months, 96% remained infection-free and no amputation is done.

speaker
Moderator
Moderator

Sorry, we're having some technical issues again. The speakers will be back as soon as possible.

speaker
Torbjörn Skrold
CEO

The annual meeting of the American Association of Hip and Knee Surges, AUKUS, in Texas, which last year attracted over 5,100 participants. In fact, our US team is actively preparing for the event at this very moment as it kicks off today. Now, I'll leave a deep dive into the numbers to Håkan. Håkan, please.

speaker
Håkan Johansson
CFO

Thank you, Torbjörn. And again, sorry for what seems to be a day of technical disruptions, and hopefully somehow everything stabilizes. So into the financials. Well, net sales improved from 237 to 294 million, equaling a growth of 24%, reported sales growth of 34% in constant exchange rate. Torbjörn has already spoken about the solid performance in especially the U.S. and the major drivers behind the sales growth. But as the weak U.S. dollar somewhat hides a continued strong trajectory in the U.S., I would like to share the U.S. sales performance in U.S. dollar. This slide shows the quarterly sales in the U.S. and U.S. dollar with continued solid performance quarter to quarter. The growth in dollar in the quarter of 40% should be viewed in perspective of volatility on BVF sales being 1.7% below same quarter last year, whilst S&M and GE continue to show solid performance with a growth of 59.2%. The contribution from the U.S. segment improved with 31.9 million and amounted to 111.2 million. The improved contribution relates to increased sales after the effect from increased costs. Sales and marketing expenses during the quarter amounted to $123.6 million compared with $102.6 million previous year, of which sales commissions, the distributors and fees amounted to $84.2 million compared with $65 million in the same quarter last year. From the lower graph showing net sales as bars and gross margin as the orange marker, it can be noted that the gross margin remains stable and strong around 95%. In Europe and rest of the world, a contribution of 12.5 million was reported to be compared with 15.6 million previous year. Sales and marketing expenses increase with 4.6 million, including 2 million related to the previously communicated commercial investment in the euro booster program. From the lower graph and orange marker, the minor drop in gross margin is noted, mainly impacted by market mix. The flat selling expenses compared with the same quarter previous year is due to a depreciated US dollar, but also an effect of seasonality. As mentioned previously, the quarter also included 2 million related to the Eurobooster program. R&D remained focused on the execution of strategic initiatives, such as the application studies in spine procedures and the market authorization submission for Sermon B in the US. These initiatives have been progressing well during the quarter and among others leading up to the launch of our product, Sarment BVF, in Spain later this year. And administration expenses, excluding the effects from the long-term incentive programs, remain on a stable level. The reported operating result amounted to 65.4 million, despite unfavorable currency effects totaling 5.7 million. And I will come back to this in a following slide. The newly introduced tariffs in the United States are not expected to have a material impact on cost in 2025 due to high safety inventory. The full effect of the current 15% tariff equals a 0.8% impact on U.S. gross margins and will come gradually with full effect from 2027. The difference between adjusted and reported operating results are costs regarding the long-term incentive programs, amounting to an expense of $13.2 million in the quarter compared with $7.3 million previous year, as you could see from the previous slide. Cash conversion remains solid with a fifth consecutive quarter with strong cash flow and an increase in cash during the period with 69.3 million. Despite unfavorable current effects, with this report, with a strong adjusted operating result and a solid cash flow, we continue to confirm a strong operating leverage and a business scalability. During the period, the Swedish krona has continued to strengthen against the US dollar. Other operating income and expenses therefore contain foreign exchange gains and losses from the translation of the group's assets and liabilities in foreign currency, amounting to a negative 5.7 million. Simply put, the negative 5.7 million is mainly driven by the operating assets in the US, such as inventories and trade receivables. These are originally valued in US dollars and at quarter end translated into a much stronger Swedish currency versus last quarter. The graph on this slide shows with the 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 right y-axis. The blue dotted line read out to the left y-axis shows the reported adjusted operating results. The adjusted operating result excluding translation exchange effects is the orange line. To explain, in Q4 2024, the US dollar per sec was above 11 sec, which gave the positive effect of 20 million in the quarter. And therefore, the blue dotted line is above the orange line. In Q1 2025, the U.S. dollar-to-sec rate was 10.02, creating a negative impact of 30 million. In Q2, the U.S. dropped down to 9.49, creating a negative impact of 11 million. And in Q3, continuing down to 9.41 with a negative impact of 5.7 million, meaning that the blue dotted line dropped below the orange line for these three quarters. The orange line eliminates the translation exchange effects and gives a more comparable view of the underlying trend in operating profit. In the table below the graph, you can see the FX adjusted operating margin of close to 29% in the period compared with 23% in the same quarter last year. And with this, I hand back to you, Torbjörn.

speaker
Torbjörn Skrold
CEO

Thank you, Håkan. And if we take the last slide, so to summarize Q3 2025, we're going in constant currency, reflecting steady and consistent progress. Adjusted operating margin reached 27%, cash flow remains robust, underscoring the health of the business and its scalability. With the publication of the CERAHIP studies from endorsement from leading surgeons at Charité and detailed procedural guidance for using CERAMENT in revision arthroplasty, we're unlocking a new avenue for market expansion. This marks a significant step forward in our ongoing mission to transform the standard of care. We maintain our guidance on sales growth above 40% in constant exchange rates for full year 2025. And to conclude, my first period at Bonesport has been as rewarding as it has been intense. I'm convinced that the most exciting part of our journey still lies ahead. And as said, to provide a clearer view of what that journey will look like, We will host a capital market stay in the spring of 2026. Lastly, again, apologies for the technical issues that we've had during the call, but now we're happy to open the line for any questions that you might have. Thank you.

speaker
Operator
Operator

If you wish to ask a question, please dial pound key 5 on your telephone keypad. To enter the queue, if you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Eric Castle from Dansky Bank. Please go ahead.

speaker
Eric Castle
Analyst, Danske Bank

Hi, good morning. Yeah, so India has probably cut out 70% of what you said, so you have two excuses if we repeat some stuff. But first, I just want to confirm the sales level for 7G in the U.S. Was that 19.9 million in USD, 59% organic growth, or is it a completely different figure?

speaker
Håkan Johansson
CFO

Again, as commented, my ceremony reported a 59% growth.

speaker
Eric Castle
Analyst, Danske Bank

Okay, good. First, I then want to ask, what are you seeing for trauma now during the initial three weeks of MTAP for ceremony in the US?

speaker
Håkan Johansson
CFO

Again, somehow, as communicated previously, what we see is a slightly different market dynamics than what we experienced launching into when there is a bone infection. Somehow, when there is a bone infection, the surgeon was looking for treatment options, and CERAMON-D fitted very well. With trauma surgeons, it's a bit of a timing issue. We meet the trauma surgeon and the trauma surgeon haven't had a patient coming back with a bone infection during the latest weeks or months, etc. It's a harder call to convince the surgeon to try a new product. However, if the surgeon has had a bone infection lately, it's an easier call to convince the surgeon to start trying. So what we see is control of what's been previously communicated. So big market potential in trauma, but market penetration to start with will be somewhat slower than when there is a bone infection.

speaker
Eric Castle
Analyst, Danske Bank

Okay. But just specifically on the end type, you haven't seen that in and of itself accelerate uptake anything?

speaker
Håkan Johansson
CFO

Again, the NTAP, Erik, is valid from 1st of October, so it's too early to see whether this has any impact in the penetration of the trauma segment.

speaker
Eric Castle
Analyst, Danske Bank

Okay, thanks. And then UK down 5.5% year-over-year. Germany, you said, was worse. Is it possible to give any sort of more specific numbers on how bad Germany is doing and of how much that represents of the European sales.

speaker
Håkan Johansson
CFO

Again, we have always been precautious to disclose exact numbers on geographic level. But again, there are structural challenges.

speaker
Moderator
Moderator

The speakers have been disconnected again, but if you have to stay on the line, I hope they will.

speaker
Eric Castle
Analyst, Danske Bank

The speakers were not disconnected. We heard them. Okay.

speaker
Håkan Johansson
CFO

So do you hear us now, Erik? Okay.

speaker
Matthias Vadsten
Analyst, SEB

Yeah, I hear you loud and clear. Thank you.

speaker
Håkan Johansson
CFO

So, again, some of the challenges with... Okay, now I don't hear the speakers.

speaker
Moderator
Moderator

Yes, just a second. We're trying to fix the connection problems.

speaker
Håkan Johansson
CFO

Good job. So, dear moderator, where are we now in terms of technology? Because it feels like things went silent.

speaker
Moderator
Moderator

Yes, now you came back. So, maybe, Erik, can you repeat your last question so we can go back from there?

speaker
Eric Castle
Analyst, Danske Bank

Yeah, sure, sure. Yeah, sure. It was on Germany. UK down 5.5%. You said Germany was worse. And I asked for if we could add any more color on Germany. How much is it? down and how big is Germany in terms of Europe sales well Germany is our second biggest market so of course when we have a setting in the market that any market like Germany it impacts on the totals okay and then just lastly do you have any visibility on UK and Germany coming back you're seeing that you're seeing a gradual say recovering the UK but when can you be back to sort of normal levels or normal growth rates in those markets, you think?

speaker
Håkan Johansson
CFO

Again, what is impacting in the UK is that the UK is a market where a substantial healthcare backlog is impacting hospital priorities. Already before the pandemic, there were 5.5 million patients in queue. That has increased to 8 million patients. And the political priorities have started to reduce that queue, but still from a very high level. So, again, we will be fighting against hospital priorities from time to time. But in the environment, we start to see that patients that have been waiting for surgeries where sediment is a good fit are gradually coming back. As Torben said in the call, it will probably be a slow process for the market to return into a normal and steady situation.

speaker
Eric Castle
Analyst, Danske Bank

All right, thank you. I'll jump back in queue.

speaker
Operator
Operator

The next question comes from Victor Sundberg from Nordia. Please go ahead.

speaker
Victor Sundberg
Analyst, Nordea

Yes, thank you for taking my questions. I have two. So I guess it's not your main product in the U.S., but I just wanted to dig into the BVF product in the U.S. a bit. We've seen a negative trend in the U.S. for that product here for a couple of quarters, and I just wanted to understand a bit more what is driving it as to how to extrapolate that negative growth we see at the moment into the coming quarters and into 2026. And then I have other questions. Thanks.

speaker
Håkan Johansson
CFO

Again, I think that it's two sides. Again, as you said, we've seen that the BVF has been soft in the latest quarters, but also that showing volatility with a few quarters where we have good BVF sales. And we see that when we look at sales on hospital levels, that there is an underlying volatility in the volumes used. What we also see, and this is important for the longer term, is that with the extending customer base and with surgeons recruited thanks to CEREM and GE, we also see these surgeons starting to use DVF in such cases where there is a controlled infection risk, etc. So we remain with the belief that all the time, BVF will stabilize and BVF will, like we've seen in Europe, deliver a small organic growth. But the main driver will be our antibiotic and gluten products.

speaker
Eric Castle
Analyst, Danske Bank

Okay, thanks.

speaker
Victor Sundberg
Analyst, Nordea

And just looking into 2026, if we see substantial cuts to Medicaid as part of the one big beautiful bill act, Even if you're not particularly relying on Medicaid directly, I guess hospitals could see an increase in uncompensated care and maybe strained overall budgets due to this. What's your thinking around how hospitals will look at Cerament G as it carries a bigger upfront cost? Our feedback, just by speaking to some orthopedic surgeons, is that price is the main barrier for wider adoption of Cerament G in the U.S., and I'm just thinking that if major hospitals Cuts to Medicaid will materialize in 2026. Hospitals might focus even more on price next year. But I just wanted to understand how you plan to mitigate some of those budget headwinds, I guess, for next year.

speaker
Torbjörn Skrold
CEO

Yeah, no, I'll start and then Håkan can fill in. So I think the plan to mitigate that is just to follow the bone support strategy where we focus on evidence. And I think it was very interesting to listen in on what was discussed and presented at European Bone and Joint Infection Society. And it's very clear from those presentations and the discussions that are ongoing, and it's similar also at OTA that happened last week, which is a big trauma meeting in the US, is that it's very clear that there is a paradigm shift in the market in orthopedics going from long systemic antibiotic regimes in orthopedic surgeries to move to shorter, if any, systemic antibiotic regimes and combining that with local antibiotics with, for example, Cermet. So that paradigm shift is happening. There is clear evidence already now on the market. The topic is clearly highlighted and more evidence will come in the future Partly by bonus support and ceremony and partly because the market moves in this direction. So I think it's nothing new really. It's something that has been happening. It will continue. And our plan to address this is just to focus on the strategy, continue to be really, really strong. clinical and health economic evidence and make sure that that evidence is right and centered, not just in front of orthopedic surgeons, but also the other decision makers that play a role in those conversations. Anything to add, Hoka?

speaker
Håkan Johansson
CFO

I think that's quite well. And again, the pricing is something we meet in as part of the goals of dynamics that we have referred to. And we have hospitals that are becoming frequent users and hospital administration noticing that this drives a certain level of costs. But so far in those discussions, when we come with strong clinical evidence and health economic evidence, this is discussions that we're able to handle. So we're confident in the evidence around the technology and the difference to standard of care it represents.

speaker
Victor Sundberg
Analyst, Nordea

Thank you very much.

speaker
Operator
Operator

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

speaker
Matthias Vadsten
Analyst, SEB

Hello, Torbjörn Håkan. I have three questions. I think I'll take them one by one. First, I think quite confident wording around Q4, if I read it correctly. You want to reach the guidance of at least 40% sales growth. This requires a quite strong finish to the year. I guess very close to 40% organic sales growth at least. And an acceleration quarter over quarter. So Just what brings this confidence and, yeah, if you have any further color on sort of how the start of Q4 have looked for you. That's the first question.

speaker
Torbjörn Skrold
CEO

Sure. I'll start with more from a, let's say, tactical operational side, and then Håkan can hopefully back it up in the numbers. So as we've reviewed both the US business and as we've reviewed the Euro business in detail and the outlook for the quarter, the fundamentals look very strong from my view in terms of the number of accounts that we have, the penetration in the accounts, whether we are increasing penetration or losing penetration. So I feel very confident in the numbers. on an account level and regional level that we've gone through. I think also very high level, and Håkan will speak to this also, if you look at the comparables Q3 versus Q4, that also gives me more comfort in the numbers. So, yeah, I feel pretty confident in hitting that guidance that we've provided with 40% sales growth above prior year on a full year basis in constant currencies. Håkan?

speaker
Håkan Johansson
CFO

Again, I think you covered this quite well, Torbjörn. And again, to bear in mind that if we look at the US dollar, sales in US dollars, for instance, in the US Q3 to Q4 last year, Q4 was a bit soft after a strong Q3 and then followed by a strong Q1, etc. And with the momentum that we have, And again, we believe that Q3 somehow gives us a lot of confirmations in that underlying momentum.

speaker
Matthias Vadsten
Analyst, SEB

We are confident that we... No, I can't hear Torben Håkan anymore.

speaker
Moderator
Moderator

Yes, just a second. We're trying to fix the issue here. I hope they will be back at us soon.

speaker
Håkan Johansson
CFO

So moderator, do you hear us now over the mobile line instead of over the Internet?

speaker
Moderator
Moderator

Yes, now I can hear you.

speaker
Matthias Vadsten
Analyst, SEB

Now I can hear you, Håkan. I heard the full answer from Torbjörn, and I heard, I don't know, the first sentences from you, Håkan.

speaker
Håkan Johansson
CFO

Okay. So what I said is that when we look at, for instance, the U.S. in U.S. dollars, it Last year, Q3 was strong and Q4 was a bit soft. And with the underlying momentum we see in the U.S., we see good opportunities to be well in line with some of the targets we have set for the two years.

speaker
Matthias Vadsten
Analyst, SEB

Okay, that's perfectly clear. Thank you. Then I have two more. So the next one is? the revision are through plastic segments. I mean, as you said, quite supportive data, to say the least. Sort of what are the sales volumes for CEREMENT in this segment today? And could you talk about what you think is required to sort of achieve a meaningful update in this segment?

speaker
Torbjörn Skrold
CEO

Sure. So I think it's fair to say that currently this is a segment that where CEREMENT We've had, it's been on label. It's been on label in the U.S., and it's been on label in Europe. But at the same time, without clinical evidence, very few orthopedic surgeons will pick it up. That's just how orthopedics works. Now, over the last couple of years, the team has worked with Charité, which is, you know, I would argue top three, top five hospitals in the world when it comes to revision arthroplasty. They've done a study. And to be frank, the results could not have been better. So that's the first important step. But to answer your question, our sales in this segment, I would argue, is very, very limited. There is some, but very limited. And I think the potential, if we look at the number of procedures that are done in revision arthroplasty in general, and specifically in periprosthetic joint infection, is going to be our primary focus area. Those are pretty considerable volume numbers that we have at hand. And what is required is, of course, that we have a sales force that is in front of the customers that are in the ORs talking about this, and that we promote the evidence and the application techniques that we already have today. But also, let's be frank, we will continue to invest in education, we will continue to invest in further evidence in this space, and this is work that we've kicked off, and that's something that I foresee will continue for several years ahead, because this is such an interesting and important segment strategically for many years.

speaker
Matthias Vadsten
Analyst, SEB

Very clear. Then I have a final one. I think it will be quite quick. If you take away the effects of incentive program and sales commission costs, the OPEX look a bit low, I would say. I know quite substantial FX effects year on year, but I think down 5 million versus Q2. So, the question is, is this just usual seasonality, or is it anything you would mention here, Håkan?

speaker
Håkan Johansson
CFO

Primarily, that relates to normal seasonality in OPEX. Outside the U.S., people tend to have vacation, and during vacation period, there's a lower level of activities, et cetera. So you have to know those seasonality.

speaker
Matthias Vadsten
Analyst, SEB

Thank you very much.

speaker
Unknown

Thank you.

speaker
Operator
Operator

The next question comes from Christopher Liljeberg from Carnegie. Please go ahead.

speaker
Christopher Liljeberg
Analyst, Carnegie

Yeah, thank you. Three questions. First, just follow up on the previous one on implant revision. Is this something you think will start generate revenues for you already in 2026, or will that be later?

speaker
Torbjörn Skrold
CEO

On revision of the plastic? Yes. Yeah, I mean, it will generate revenue in Q4 this year. and it will for sure generate revenue in 2026. If it doesn't, then we do something fundamentally wrong.

speaker
Christopher Liljeberg
Analyst, Carnegie

Okay. So, but do you think you could see a faster uptake in this indication than for open fracture trauma, for example?

speaker
Torbjörn Skrold
CEO

So really good question, and I don't have any solid data points on that because of my somewhat limited history in bone support. But if you think about the segments and how surgeons generally work and how they take decisions, and you compare revision arthroplasty, which is an elective procedure, and trauma, and especially open trauma, which is acute trauma, so it's not an elective procedure. it's always easier to sell into a segment where you have elective procedures. So only looking at those sort of characteristics, you could argue that, well, it should be easier and faster to enter revision arthroplasty than it is trauma. So I think there's something in that that you're absolutely right on, but I have a hard time quantifying it, to be perfectly honest.

speaker
Christopher Liljeberg
Analyst, Carnegie

Okay, thanks. And then I don't know whether we missed that due to the technical problems, but did you say anything about expected launch timing for CEREMENT-V in the U.S.?

speaker
Torbjörn Skrold
CEO

So CEREMENT-V in the U.S., we follow the plan. So we deliver on the plans, and the plans that were previously communicated was that we submit additional data to the FDA in November. That is according to plan. And then we feel comfortable that we have the right data in place and expect a positive outcome of that review with the FDA. Exactly when FDA will come with an answer, it's hard for us to predict. But typically, historically, what we've seen is that there's a 90-day period following the submission of the supplemental data until an FDA decision is taken.

speaker
Unknown

So that's typically the guidance that we give on the CERAMENT-G for the U.S.

speaker
Christopher Liljeberg
Analyst, Carnegie

Great. And then finally, just on R&D cost, should we expect that to be more stable now quarter over quarter or year over year before you start the CERAMENT-G spine study?

speaker
Håkan Johansson
CFO

I think that's a fair comment. And again, you've seen quite a solid stable level over the last year, et cetera, and it's a fair estimate to assume that that level continues. The high activity level remains, but there is no true acceleration until we would start a clinical study preparing for getting 70 approved for spine.

speaker
Christopher Liljeberg
Analyst, Carnegie

Great. Thank you very much. That's all for me.

speaker
Operator
Operator

The next question comes from Stan Gustafson from ABG Sundal Collier. Please go ahead.

speaker
Stan Gustafson
Analyst, ABG Sundal Collier

Yes, thank you. Good morning. I think most of it has been covered already, even though there were some technical issues here. I just want to confirm that I heard it correctly. Did you say that you had CERM and GSALES in the U.S. of, was it $19.9 million in the quarter?

speaker
Håkan Johansson
CFO

We did not confirm the dollar amount, but we say that we confirmed that the growth is in context and rate is 59%.

speaker
Stan Gustafson
Analyst, ABG Sundal Collier

Okay. That's good. And then the number of procedures in the U.S. related to this hip joint infection, Did I hear it right, 70,000 or?

speaker
Torbjörn Skrold
CEO

So, what we say is that the number of primary hyponyme arthroplasty as per previously communicated data from bone support is estimated to one and a half million. So, that's the number of primary arthroplasty. is a smaller number, of course. But the initial focus that we have on revision arthroplasty is the subsegment that is called periprosthetic joint infection. The previous numbers from bone support that has been communicated related to the size of that segment is 70,000 for U.S. only. So those were the numbers that we referred to. So we're not communicating any new numbers on this call compared to what's been communicated earlier.

speaker
Stan Gustafson
Analyst, ABG Sundal Collier

And that was 17, 1-7? No, 17.

speaker
Torbjörn Skrold
CEO

And the 17,000, just for absolute clarity, those are revision arthroplasties with bone infection where a bone graft is needed. Okay.

speaker
Stan Gustafson
Analyst, ABG Sundal Collier

Excellent, thank you. And then on NTAP, finally, and I heard it, I think correctly, that you expect a bit of the trauma NTAP will be more challenging than when you got it initially on osteomyelitis, which makes perfect sense. But do you think that the net impact here short-term with the sort of will be then a negative driver or do you expect the underlying osmolytis procedures to carry on even though you don't have the NTAP on those particular procedures?

speaker
Håkan Johansson
CFO

Well, sorry, I think that to clarify, I think what we were talking about was the market dynamics and the differences between when there is a bone infection and in trauma. When we talk the value of the end tap specifically, I think that it shows to not have so much impact in when penetrating the market when there is a bone infection, et cetera. But when we are talking trauma, open trauma, There's always a consideration between risks and costs. And here, the NTAP is taking away the cost aspect. So, potentially, somehow the NTAP for open trauma has a bigger value, but again, it remains to be seen over time. It's been valid from 1st of October, so that after Q3, and we don't have the data to back that up, but we honestly believe that it has the potential of having a bigger impact than when it was a formal infection.

speaker
Matthias Vadsten
Analyst, SEB

Okay. Thank you very much.

speaker
Operator
Operator

The next question comes from Maria Vara from Stifel. Please go ahead.

speaker
Maria Vara
Analyst, Stifel

Good morning, and thank you for taking my questions, just a couple of them. I think, you know, we, of course, see extremities as the near-term opportunity, what's going to be driving growth for the company for many years. But, of course, I think we haven't dedicated much time to the opportunity in the spine during the Q&A session. So I just wanted to maybe get some thoughts on, how these recruitment of sales reps is going, and any kind of guidance on contribution we could see from the first quarter launch as well as from 2026. Thank you.

speaker
Torbjörn Skrold
CEO

Yeah, no, good question. And I think to put spine in perspective, spine is clearly a very interesting area for bone support for the long term, but we also want to be, realistic in the short term, we will likely see much bigger uptake from revision arthroplasty than we will see in spine. But spine is an important strategically and large opportunity for us. The approach that we take is that we first launch spine with CEREMENT BDS to build the market. So we are going to have a relatively focused launch So, we're not going to go fully and nationwide to all the accounts everywhere at the same time. We want to take a focused approach with certain distributors that we already work with, some new distributors that are specialized in spine, and we want to make sure that we build the right clinical evidence and the right validated surgical techniques over time. And then, of course, the big strategic play for us. is to go in into spine with sediment G. But that, of course, requires a market approval. But we see a couple of good scenarios ahead of us. So the question is not if, it's about how and when. And that's why we engage with a discussion with FDA in the near term to make sure that we feel comfortable on the right way to market.

speaker
Unknown

and that we are also able to execute on that.

speaker
Maria Vara
Analyst, Stifel

Okay, that's helpful. And then if we think about the profile of the sales commissions in the U.S., you know, we see a little bit of an increase with respect to the U.S. revenue for Q3, if I'm not wrong, 35% with respect to the U.S. sales. How should we think about this percentage changing over time, especially as of the U.S. launching is fine? I mean, there's not much of an investment there, but still with something. So if you can guide whether we could think about this same range with respect to revenue or any major changes here, we'll be appreciative.

speaker
Håkan Johansson
CFO

Well, thank you, Maria. And again, in the short-term, mid-term, you can expect the increase in Q3 is mainly related to short-term volatility. The commission level remains. There is no change in commission levels. There are a few performance-related aspects in the commission structure. That's why it can be some volatility between courses. But in general, it should keep itself some of the commissions plus other fees that is involved around, I mean, between 34% and 35% over time. And we don't see that the inroads into SpineWheeler BVF changing that structure.

speaker
Maria Vara
Analyst, Stifel

Okay. Thank you so much. That's from my side.

speaker
Christopher Liljeberg
Analyst, Carnegie

Thank you.

speaker
Operator
Operator

The next question comes from Oscar Bergman from Red Eye. Please go ahead.

speaker
Oscar Bergman
Analyst, Red Eye

Hello, Torbjörn and Håkan. I know you've answered a lot of questions, but I only have a few more to you guys. So, first off, on your current base of us simon g users is there any noteworthy crossover to spine surgery among these very limited i would say but one of the

speaker
Håkan Johansson
CFO

you have both surgeons on the extremity side and on the spine side. Yeah, but it's very different. And again, coming back to as we're communicating, our strategy in lowering into spine will be very focused. We have a list of hospitals and list of surgeons that we are addressing so that we reach the right surgeons to build additional clinical data and validation, et cetera, before we go wider. So with that, we also were very focused with what distributors and what sales reps were contracting.

speaker
Oscar Bergman
Analyst, Red Eye

Okay. And just wondering if you can elaborate a bit more on the situation on eventual pushback on price, both for customers in the bonus section segment and in trauma. Has this been sort of a driver of customers either not signing up or perhaps even signing off during this quarter?

speaker
Håkan Johansson
CFO

Well, Oscar, price is always a discussion. We're living in a commercial environment and so on. But so far, it has had no impact in terms of listing and continued growth of listed hospitals. Somehow, we meet that also, as I mentioned in the call, somehow as part of GoStopGo, we have hospitals where we have solutions becoming available. frequent and high users, and not seldom there is a reaction from hospital administration where we have them to involve with our med and health economic specialists to help explaining the data that is backing up the price level and the savings that is enabled by the clinical and health economic benefits by using CRMFG. So, of course, that's part of daily life, but so far we don't see a general pushback on price.

speaker
Oscar Bergman
Analyst, Red Eye

Okay, so those efforts in training and education on the health economic benefits, they are holding back customers from perhaps, well, signing off then, essentially.

speaker
Håkan Johansson
CFO

As for now, and again, that's also the reason why we're confident with the approach that we're using, and that's why we also will continue to invest in additional med ed and health economic resources.

speaker
Oscar Bergman
Analyst, Red Eye

All right, thanks. What do you say in terms of user rate at the existing customers? Are they at desirable levels in bone infection, or is there still plenty of room to grow the existing number of Sermon G surgeons?

speaker
Torbjörn Skrold
CEO

From my perspective, what I see is that there's plenty of room to grow in current markets, in current products, in current clinical indications. Now, you know, I might be wrong on that, but all the data that I've seen so far after a couple of weeks indicate that we're just scratching the surface on these three main segments that we prioritize short-term, which is foot and ankle, trauma, and revision arthroplasty. And then, of course, longer-term, we're entering spine. So I think there's plenty of room to grow going forward.

speaker
Oscar Bergman
Analyst, Red Eye

All right. Just two more quick questions. I suspect you're in a hurry. The geographical reach in the U.S., are you at a good capacity already in the different key regions, or are there any initiatives that you will accelerate on?

speaker
Torbjörn Skrold
CEO

I mean, the U.S., as you well know, that's our most important market, both from a growth and profitability point of view, so it has priority number one. I think we have good coverage, but that doesn't mean that we will not continue to invest. We're investing in Q3.

speaker
Unknown

We will continue to invest because if we're not investing, we're not taking advantage of the potential that we have. So I don't think it's a coverage issue. It's about making sure we invest to address the potential we have in terms of increasing the penetrations.

speaker
Oscar Bergman
Analyst, Red Eye

Okay, so there's no specific region in the U.S. where you feel like, okay, we should really focus on this specific region?

speaker
Torbjörn Skrold
CEO

I mean, when we look at the map, of course, we have certain regions where we think our penetration slash market share is lower, but that's not something that we disclose on this call. But on a high level, we will continue to invest to make sure that we increase the penetration in the U.S., and certain regions have higher priority than others.

speaker
Oscar Bergman
Analyst, Red Eye

Okay. Here's my final question. You are quickly accumulating a lot of cash, over 220 million since Q3 last year. Will you perhaps present some sort of plan on how you aim to deploy this growing mountain of cash in your CMD in the spring?

speaker
Håkan Johansson
CFO

Oscar, I think that as Tony mentioned during the call, and sorry for all the technical breakouts, is that That's an area where we own the market, some clearer communication, and the Capital Markets Day in the springtime is a good opportunity to do that. In the shorter term, again, this gives us the comfort of continuing to invest in the business. We believe in the business. We think we do the right things. We see strong confirmations also in the report on the work that we're doing, and the cash help helps us to continue investing in this.

speaker
Torbjörn Skrold
CEO

And it gives us the freedom to operate in a way to take advantage of all of the opportunities that we see in the three priority segments plus spine, as well as on more longer-term strategic initiatives and scenarios that we, of course, also work on. But more on that in the Capital Markets Day this spring. So, unfortunately, now we have to close this call. We're coming to an end. Again, thank you all for attending. And also, from our side, we apologize for the technical issues that you guys have experienced, and we thank you for your patience with us.

speaker
Unknown

Thank you.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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