BOEUF (BOEUF) Q3 2026 Earnings Report, Transcript and Summary

Welcome to BONESUPPORT Q3 2026. [Operator Instructions] Now I will hand the conference over to CEO, Torbjorn Skold; and CFO, Håkan Johansson. Please go ahead.

Thank you, operator. Welcome, everyone, to BONESUPPORT's Q3 2026 Results Call. My name is Torbjorn Skold, CEO of BONESUPPORT. With me here today is our Chief Financial Officer, Håkan Johansson; and our Chief Medical Officer, Dr. Diefenbeck. Together, we will use the next 30 minutes to guide you through the Q3 presentation and then open the line for questions. Slide 2. Before starting the presentation, I would like to draw your attention to the disclaimers covering any forward-looking statements we will make today. So let's look at the financial and operational highlights of the quarter. Q3 reflected solid execution across the business. Net sales came in at SEK 409 million, corresponding to a growth at constant exchange rates of 38% versus Q3 2025. Reported growth was 39%, showing that the currency impact on our figures for the quarter has decreased compared to previous quarters. Our adjusted operating result, excluding incentive program effects, was SEK 139 million, corresponding to an adjusted operating margin of 34%. Reported operating result was SEK 123 million. We saw another quarter of solid cash generation with operating cash flow reaching SEK 138 million. After the ongoing share buyback program, this resulted in a cash position of SEK 510 million at quarter end. After a period of significant commercial investments, it's encouraging to see the strong operating margin together with the continued strong cash flow as confirmation of the scalability of our business model. We continue to see strong traction for CERAMENT G in the U.S. with sales reaching SEK 288 million for the quarter compared with SEK 192 million in Q3 2025. In Europe and Rest of the World, we saw solid momentum across all markets and segments with a growth of 34% at constant exchange rates compared to Q3 2025. The most important event of the quarter was the publication of the SOLARIO study in the New England Journal of Medicine. The study shows that the duration of systemic antibiotic treatment can be reduced significantly without compromising treatment outcomes when local antibiotic therapy is used as part of the surgical treatment. Dr. Diefenbeck will give an overview of what this study shows and why we believe it is a very important milestone and a game changer for patients. During the quarter, important progress was made in the regulatory process for CERAMENT V within the framework of the de novo process. The supplemental data package requested by the FDA was submitted in September. 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(k) process. The dialogue with the agency is constructive, and we look forward to the continued review. In Q3, U.S. CMS confirmed improved reimbursement for the use of CERAMENT G in orthopedic infection surgery and more specific identification codes for CERAMENT G and CERAMENT V once approved by FDA. Progress on CERAMENT with antibiotics 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. Now let's move on to the sales development. The chart shows total last 12 months reported sales in Swedish krona 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 and EUROW has accelerated in the last 5 quarters. Given that we keep bringing new strong clinical studies and opening up new market segments and new indications, a product like CERAMENT G will remain in launch phase for many years to come. However, throughout 2025 and in the first half of 2026, we have 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 Q3 of 25% in the graph corresponds to an even stronger 31% at constant exchange rates. U.S. US CERAMENT BVF's last 12 month sales were flat year-over-year at constant exchange rates. In total, Antibiotic eluting CERAMENT grew 39% in last 12 months at constant exchange rates. In U.S., sales amounted to SEK 344 million, representing growth of 39% at constant exchange rates. We continue to experience strong growth of CERAMENT G, driven by both increased access to new accounts and new surgeons as well as wider adoption among existing users. We see growth from all 3 prioritized market segments; Foot & Ankle, Trauma, and Arthroplasty. In Q3, U.S. CMS, Centers for Medicare & Medicaid Services confirmed its proposed ruling in the full year '27 IPPS Inpatient Prospective Payment System, including changes that improve payments for the use of CERAMENT G in the treatment of orthopedic infections, such as periprosthetic joint infection, fracture-related infections and diabetes-related bone infection. More severe injuries result in higher reimbursement. Regardless of severity, the hospital can use the highest codes when claiming reimbursement. This means that moderately severe conditions receive the same high reimbursement as when accomplished injury is treated. Note that this uplift applies only when CERAMENT G is used. In parallel, CMS confirmed the introduction of more specific procedure and identification codes for CERAMENT G and CERAMENT V, consistent with the company's submission. 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. CMS ties the extra reimbursement specifically to on-label use of approved products in this category, where BONESUPPORT currently holds the only approval, strengthening our competitive moat. We have launched a rollout plan with supporting education and communication materials to fully capitalize on the ruling. The ruling came into effect on October 1, 2026. The initial and early feedback we have received from surgeons and administrators is very positive, and we expect it to substantially strengthen the case for broader and deeper use of CERAMENT G in existing and new accounts. 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, now moving into revision arthroplasty. 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 have built a solid foundation for our spine strategy over the past quarters by establishing distributor coverage and preparing the market. 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. Now let's turn to Europe and Rest of the World. Sales in EUROW came in at SEK 64 million, representing 34% growth at constant exchange rates. While part of this reflects a softer comparison base in Q3 2025 and also initial orders from distributor change in Australia and New Zealand, it was still a very, very strong quarter. We saw strong development across our 3 market structures; direct, hybrid and distributor markets. This model is well suited to the early stage the company is currently in. Our direct markets, including U.K. and Germany, delivered solid growth across the board. Our investments in hybrid markets developed well, underlying continued potential ahead. During the quarter, we entered into a distribution partnership with Stryker for Australia and New Zealand, which contributed SEK 3.8 million to sales through a couple of initial start-up quarters. The partnership strengthens our presence in the region and gives us a good basis to continue developing these markets. Our distributor markets show strong growth, and we see large potential to increase our footprint by increasing penetration in the countries in which we have presence as well as potential to entering more countries. The SOLARIO study was published the evening before the start of the joint Congress of the European Bone and Joint Infection Society, EBJIS, and the U.S. Musculoskeletal Infection Society, MSIS in Porto. It was featured in several presentations and scientific discussions. The response to SOLARIO reinforces our view that a paradigm shift is taking place and that local antibiotic therapy will play an increasingly important role in the treatment of orthopedic infections. SOLARIO has the potential to be an important catalyst for changing the standard of care and treatment protocols worldwide for the benefit of patients, health care providers and society, not least in antibiotic stewardship. Now for a deeper scientific and clinical perspective on SOLARIO, I will now hand over to our Chief Medical Officer, Dr. Diefenbeck.

Thank you, Torbjorn. My name is Michael Diefenbeck. I'm Chief Medical Officer at BONESUPPORT. After a bit of waiting, the SOLARIO trial has been published on the 16th of September. SOLARIO stands for Short or Long Antibiotic Regimens in Orthopedics. The study was published in the New England Journal of Medicine, one of the highest ranked journal in medicine. First author is Professor Martin McNally and senior author is Dr. Matt Scarborough, both from Oxford, England. You are probably familiar with the background. Orthopedic infection is usually managed with surgery, local antibiotics and a prolonged systemic antibiotic therapy. And exactly this prolonged systemic antibiotic therapy was the focus of the study. The research question was, "can the duration of systemic antibiotic therapy be limited to less than 7 days provided local antibiotics were used?" And the second objective is, if there is an advantage of local antibiotic therapy in terms of adverse events or side effects. This is a multicenter, open-label, noninferiority trial. Adults who had undergone surgery and implantation of a drug-device combination product, including antibiotics were randomly assigned to receive postoperative systemic antibiotic therapy over long, longer than 4 weeks; or short, less than 7 days duration. The primary outcome parameter is treatment failure by 12 months assessed according to protocol-defined criteria by a clinical endpoint committee whose members were unaware of the trial group assignments and who were not involved in the treatment of the patient. Next slide, please. Here are the results of the trial. 500 patients were randomized and 475 were assessed in the primary analysis. The primary outcome parameter is definite treatment failure and occurred in 14.1% in the long duration group and only in 11.1% in the short-duration group, which met the prespecified non-inferiority margin. This means that the short duration was non-inferior to the long duration. Next slide. And here are the results of the secondary outcome parameter. By week 6 after surgery, symptoms potentially related to the treatment had occurred in 45.2% of the patients in the long duration group and only in 17.2% in the short duration group. This was a significant difference. On the graph, you can see that there is a huge difference, especially in the severe and moderate adverse events. This means that the short duration of systemic antibiotic therapy is much more patient friendly than the long duration of treatment. Slide 10, please. The authors of the study came to the following conclusion. Among patients who had undergone orthopedic surgery and received local antibiotics, a short course of systemic antibiotics was non-inferior to a long course with respect to definite treatment failure by 12 months. So what do these results mean in a bigger picture? The World Health Organization declared at the end of 2019 that antimicrobial resistance is 1 of the 10 most urgent global health threats, along with, for example, HIV, climate change and Ebola. To reduce antimicrobial resistance, or maybe better, the development of antimicrobial resistance, the WHO defined 6 points. Number one, shorten the duration of therapy and SOLARIO has clearly shown that this is possible. Number two, improve compliance in patients. Well, the device-drug combination product, including antibiotics is implanted directly into the bone, so there is nothing to worry about compliance. The patient cannot remove the antibiotic. And on the other hand, they don't need to be constantly reminded to take their medication. Number three, narrow antimicrobial choice, indeed, mainly gentamicin and vancomycin was used. Number four, avoid underdosing. There is a high antibiotic concentration delivered by the local antibiotics. Number five, improved targeting. The antimicrobials are exactly at the right spot. They are implanted directly into the bone. And finally, number six, reduce the total antimicrobial burden. In a study, there was a saving of 6.4 kilogram not gram per 100 patients. And with this summary, I hand over to Håkan, BONESUPPORT's CFO for the financials. Håkan Johansson: Thank you, Michael. Net sales improved from SEK 294 million to SEK 409 million, equaling a growth of 39% in reported sales and a growth of 38% in constant exchange rates. Torbjorn has already spoken about the performance in both the EUROW and the U.S. and the major drivers behind the sales growth, but as large overtime movement in U.S. dollars hides the true trajectory in the U.S., I would like to share the U.S. sales performance for CERAMENT G in U.S. dollars. CERAMENT G is the growth driver in the U.S. And this slide shows the quarterly CERAMENT G sales in the U.S. in U.S. dollars with continued solid performance and a strong sequential growth in this quarter, both in net sales for the quarter and in net sales per workday. The contribution from the U.S. segment improved by SEK 60.2 million versus Q3 2025 and amounted to SEK 171.4 million. The improved contribution relates to the increased sales after the effect of increased costs. Selling and marketing expenses during the quarter amounted to SEK 152.3 million compared with [ SEK 123.6 million ] in previous year, of which sales commissions to distributors amounted to SEK 111.4 million compared with SEK 85.1 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 remained stable and strong at 94%. In Europe and Rest of World, a contribution of SEK 19.9 million was reported compared with SEK 12.5 million previous year. Selling and marketing expenses increased by SEK 6.4 million, mainly related to the previously communicated commercial investments in the EUROW booster. From the lower graph and the 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 12.7 million compared with previous year, following commercial investments in both U.S. and EUROW. Investments aimed at future sales growth driven both by market opportunities and by sustained high market activity. R&D expenses reflecting a continued high activity level focused on strategic initiatives such as the market authorization submission for CERAMENT V in the U.S., the research and studies in spine and future portfolio innovation. And finally, administrative expenses, excluding the effects from the long-term incentive programs, remaining stable with an increase of SEK 2.5 million compared with previous year. The adjusted operating result amounted to SEK 139.3 million with only minor currency effect impacting. This is something I will come back to also on the later slide. Gross margin levels returned after a temporary down in previous quarter following inventory write-downs in the second quarter. The difference between adjusted and operating result is costs related to our long-term incentive programs amounting to an expense of SEK 15.9 million in the quarter compared to an expense of SEK 13.7 million in previous year, as you could see on the previous slide. The increase in expense includes mainly a favorable share price development in the period. Operating cash flow was strong in the quarter and cash position closed at SEK 510.5 million despite the current share buyback program initiated in September and partially executed during the quarter and impacting the period with SEK 60 million. During the quarter, the Swedish krona has continued to weaken against the U.S. dollar 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 U.S. dollar closing rate and Swedish krona has varied over time. This is read out on the Y axis. The blue dotted line readout on the left Y axis showed adjusted operating results. The adjusted operating result, excluding translation exchange effect is the orange line and gives a more comparable view on the underlying trend. In the table below the graph, you can see the FX adjusted operating margin of 32.9% in the quarter compared with 28.6% in the same quarter last year. Through second half of '25 and early 2026, the operating margin has been impacted by the commercial investments made in both EUROW and U.S., and this quarter shows a return to gradually improved operating margins. A solid cash conversion has been reported continuously since Q3 2024 with an average cash conversion of 83%, visible at the dotted line in this graph. And Q3 reported a solid cash flow and cash conversion of close to 100%. And with this, I hand back over to Torbjorn.

Thank you, Håkan, and thank you, Dr. Diefenbeck. To summarize Q3 2026, sales grew by 38% at constant exchange rates, reflecting steady and consistent progress. U.S. growth was 39% and EUROW growth was 34%. The adjusted operating margin was 34% and the cash flow was solid, allowing us to buy back shares and still end the quarter with a cash position of north of SEK 0.5 billion. Important clinical and regulatory milestones in the quarter were the publication of the SOLARIO trial, the confirmation of CMS increased reimbursement for CERAMENT G and V and the submission of the complete data package to answer FDA's questions related to the CERAMENT V de novo submission. Following combined growth of 33% in constant currencies over the first 3 quarters, we confirm our previously communicated full-year outlook of sales growth between 33% and 36% in constant currency. The quarter confirms that the company's position has strengthened and continues to be characterized by low but rapidly increasing market penetration, creating significant room for expansion for many years to come. Now let's open the line for questions.

[Operator Instructions] The next question comes from Philip Ekengren from Nordea.

So U.S CERAMENT G increased substantially Q-on-Q, especially the incremental growth here from Q2. With new customer recruitment described as rather stable across the indications, could you split up how much of the acceleration come from increased usage among existing surgeons and perhaps also in which indications, please?

So we don't publicly disclose the numbers, but what we can say is that we see solid growth across all the 3 segments; Foot & Ankle, Trauma, Arthroplasty. We can also say that in all of the 3 segments, we see a good healthy balance between the 2 drivers, meaning new accounts as well as increased usage. Of course, taking into effect that Foot & Ankle, that's the segment where we have been in and actively worked on for several years. Trauma is somewhat newer and then Arthroplasty is the newest. But we're very pleased on the growth across the segments as well as by the growth type. That's how much we can say on it, Philip. And sorry, we don't disclose more numbers than that.

No, appreciate that, Torbjorn. On CERAMENT V, if and when approved, how much of the initial opportunity will come for patients or surgeons you cannot currently reach with CERAMENT G versus perhaps switching existing G procedures to V. Can you tell something about what your European experience suggests here going forward?

So our European experience and why is the European experience relevant? It is because we have had both products available in the market for several years. The European experience indicates that our product mix of all the G and V products that we sell, around 70% to 75% of that is G and the remaining is V. That's the product mix that we have. That is our starting point and starting assumption for the U.S. Now there are indications that we see in the U.S. market, and this is not anything new for this quarter. We've seen it for several quarters, and we've raised this publicly several times, is that there seems to be a tendency or a preference in the U.S. more weighted on V than G. Now how much of that is based on science versus tradition, history; that remains to be debated on. But our starting point is that we expect to see the U.S. come to a similar mix as we've had in EUROW. And then we'll see. But it's clear that U.S. surgeons want and need V. We expect the cannibalization to be limited, but there might be some. But clearly, CERAMENT V is expected to be a solid incremental driver of the growth case in the U.S. I hope that answers the questions, Philip.

It does. And then perhaps a final one for me, squeezing it in. With Q3 growth at 38% and is unchanged at 33% to 36%, what assumptions distinguish the lower end and upper end here? And do you expect the CMS changes to influence growth already in Q4? Or is that more of a '27 [ thing ]?

I'll leave that to Håkan. Håkan Johansson: Thank you. No. Again, I don't think that we should or should include a material impact from the CMS already in Q4. The guidance is more related on continued commercial execution on existing baselines. And again, we have seen volatility in sequential growth in the past. We'll continue to see that as well. So it more relates to -- the guidance more relates to continued and in mega terms, normalized commercial execution.

And on CMS, sorry, I missed that -- related to CMS. So on CMS, what we've seen is that -- and we saw it at EBJIS, we saw it at OTA, Orthopedic Trauma Association in Phoenix, is that U.S. surgeons and the ones that we've talked to are very, very positive towards this ruling. And also the initial conversations that we've had with administrators are also very positive. So it's definitely going to help us, and it's definitely a strong ammunition for us, especially in the conversations related to when hospitals and administrators simply think that, well, it's a very expensive product, and we get a lot of invoices on CERAMENT G and why do you need that? So then, of course, the CMS ruling is very, very helpful. Having said that, it is also very clear that it is not just something that we talk about to our surgeons and the administrators in the hospitals in 1 month. We expect this ruling to be an important topic for us in the coming quarters. But of course, it's very positive. We're well positioned for the growth journey ahead, not only with CERAMENT G, but also with CERAMENT V, which is actually also included in this ruling.

The next question comes from Mattias Vadsten from SEB.

So first one, just a follow-up. On your comment there, Håkan, on the incremental reimbursement for CERAMENT G in the U.S. And I think you said you do not rely on any help from that in Q4, but why would it not help really? Are you just being cautious on that end? Or sorry if it in the wrong way. Håkan Johansson: Thank you, Mattias, and good that you're asking the question. And what I said is I don't expect it to have a material impact on the revenue in Q4. Of course, it will be helpful, and it's helpful in terms of continuing to develop both adoption and access in the U.S. over time. So we are super happy to have CMS, but I don't think that anyone should exaggerate the impact in the very short term. we will make sure that this is something that -- this is a tool in our toolbox that we are using wisely in building the market.

And also maybe staying on the same note, in Q2, we talked about the go-stop-go dynamics for a bit. And you have touched on it before, but the communication was quite clear around that Q2. So just how has that developed since then? And also do you think this incremental reimbursement can change that picture? That's my next question.

Yes. Good. So go-stop-go that you referred to, Mattias, was something that we saw in Q2. But in all transparency, we have seen the dynamics of go-stop-go for many quarters previously. So it's a natural part of the business that we are in, and we see it on a clinician level, and we see it also on an administrative level. And what we mean by that is on a clinician level, when they are first exposed to CERAMENT and especially CERAMENT G and V, the surgeons typically want to try it on a relatively narrow indication and on a select group of patients. They try it and then they watch these patients. So they go, they use it in a couple of cases, and then they stop and evaluate whether it has the clinical impact and the clinical results that they want to see. If they're pleased with the results, they go again. So hence, this go-stop-go. That is on a clinician level. And it's relatively common. It's very common. We can also see it in -- on the administrative level in a hospital or in a hospital group, even on an IDN level in the U.S. And that's pretty much the same dynamics that we see on the clinician level, meaning that surgeons in the hospital start using the products. And then the more they use, they reach a certain level of value that the hospital purchase, then they typically are flagged to the buyers and the administrators. And if the surgeons and the hospital as well as us; if we haven't done the work to prepare the administrators and the buyers and the purchasers, what CERAMENT G and V is, then there could be these effects that we not only saw in Q2, but we've seen previously. So there you have this stop on a hospital level. And then the approach is simply that we go and talk to the administrators, the value approval committees around the value of CERAMENT G and V. So the go-stop-go, both on a clinician level as well as an administrator level has been there for years. We expect it to continue. We saw some of it in Q2. We continue to see it in Q3, and we expect to see it in Q4 as well as next year as well. So it's part of the business. But of course, Mattias, to your point, to have the ammunition with the CMS ruling, it's a fantastic tool. It's probably the ideal tool to use in that type of conversation, and it really helps strengthen our case in those conversations.

Very clear. Then my last question is, so based on the trajectory you see in trauma patients now, do you believe market share similar to diabetic foot ulcers is possible or with the long-term market share potentially in foot always be higher, you believe? I appreciate we cannot see into the future, you cannot either, but any insight sort of what you've seen in surgeon feedback, the uptick so far? Yes.

No, I mean great question. And what I can reference is simply the -- I think it was a couple of weeks ago, we were at the Orthopedic Trauma Association in Nashville, U.S. That was right after the SOLARIO publication that was right after the CMS ruling. And of course, it's only trauma docs there. There's not a lot of foot and ankle or diabetes doctors there. I don't see any reason why we wouldn't be able to reach the same type of penetration in trauma as we've done in foot and ankle, not at all. And having said that, in foot and ankle, we are still just scratching the surface. Yes, we've reached higher penetration, and we've been at many more years. But I don't see any reasons why we should be more or less bullish on trauma than we are on foot and ankle. The big question is, of course, how long will it take? But this is the beauty of BONESUPPORT that time is on our side. And the first principle that we always use is that you have to convert surgeon by surgeon, and you have to do it face-to-face. You don't do it with a study only. You don't do it with an e-mail because these products, they implant in patients. So yes, we remain very bullish on trauma as we've done previously as well. So no change on that, Mattias.

The next question comes from Sten Gustafsson from ABG Sundal Collier.

A number of questions, but I'll try to limit it to 2. Looking at the CMS ruling, I suppose it's for hospital only and not outpatient. Maybe that is sort of clarification. And secondly, if you could perhaps tell us your mix there between hospital versus outpatient. I guess I'm trying to figure out how much of your business will benefit from these improved reimbursements.

Yes. So thank you, Sten. The first question, yes, the ruling is only inpatient and that simply stands for how it's set up and how it's named. So it's called the full year '27 IPPS, so the inpatient prospective payment system. So this ruling relates to 100% inpatient. The majority of our sales is currently in inpatient. There is some in outpatient, but to the large extent, it's only inpatient. So it relates to that. Then, of course, how fast and how much of the hospital will use it. Time will tell, but we look very, very positively to this ruling and it will have positive impact for us in the quarters to come. And we have good reasons to believe that the ruling will stay in place a year from now. And then all the work that we do now in the coming years, it will, of course, help us in the long term as well. I hope that answers your questions, Sten.

Absolutely. And when it comes to -- I remember you had this NTAP and then you -- obviously, it's only temporary, but you gained it on another segment. Have you noticed a drop in usage among the doctors where the NTAP sort of disappeared after the 3-year period?

Not at all.

Very good. In terms of your organization in the U.S., I mean, it looks like given the improved reimbursement, you have a good opportunity here to capture a lot of growth. Will you invest in more salespeople? Or how are you going to sort of reach out to all these hospitals?

Very good and relevant question. So when we're growing in the U.S., 30%, 40%. And then, of course, we will need to continue to invest in our commercial organization, including sales. But you bring up a very, very relevant point, and it comes to the fact that we have, just as a company, started to step into this somewhat more mature phase where it's not only about the classical sales. That's still the core and that's still very important to be in front of orthopedic surgeons and to be in front of the infectious disease. So we're not going to sort of slow down on that. That's going to be continued. But the point that you bring up is that these kind of conversations when it comes to the CMS ruling. Of course, the surgeons are important, but even more important are the administrators, however they are defined and whichever titles they might have, that really depends. So in that area, we have invested and we are continuing to invest simply to make sure that we have the scale and the breadth and the depth in our organization. So that's an area that we have already invested. We have -- we're bringing on more people with a slightly different profile than the classical clinical sales. So that's an area that we have seen investments already done, and we're going to accelerate that in the coming quarter as well as in the next year.

The next question comes from Erik Cassel from Danske Bank.

I had a question on the guidance as well as a follow-up to Philip. As he said, the 33% to 36% basically implies anywhere between 32% to 44% growth in Q4. Do you view that full range as possible still? And if you do think that, I want to press a bit on what do you think are the factors that get you to either down towards 32% or up to 44%? And do you have any opinions on what is more likely in this sort of range?

Thank you, Erik. I mean we provide the guidance simply because we think that that's the guidance where we might end up, and that's why we provide it. So we think it's likely to end up anywhere in that. Otherwise, we wouldn't have provided it. So that's the first part. To your second question, what will it take? Well, it's very much the same that took us to deliver what we delivered in Q3, meaning that we continue to drive new accounts and to increase the penetration in existing accounts that we do it in U.S. as well as OUS, and we do it in all 3 segments: Foot & Ankle, Trauma, and Arthroplasty. And then we, of course, will not provide a sub-guidance to the guidance that we've already provided. The guidance is that we will end up in the year between 33% to 36%. And we focus more on the long term, and we're very pleased with the Q3. We look very positively to Q4, but we build this business for the long term, not just to hit one quarter or the next quarter.

Okay. Fair enough. And then it looks like the BVF have started to stabilize a bit more here in Q3. Would you say that you've sort of reached the stabilization point that you put back in Q1 that it now can start to grow again? Or is it -- expectation is a bit more muted still in the coming quarters?

Sorry, can you repeat the beginning of the question because I missed that one. Sorry.

Yes, of course. It looks like BVF in U.S. has started to stabilize, only down like 2% now, down 14% in Q2. So you talked about the stabilization in Q1 and then for it to sort of come back to growth, if I recall correctly. Would you say that we've reached that sort of stabilization point now and that we're looking towards growth again with the BVF product in the U.S.? Håkan Johansson: I think that's -- what we've seen and that is numbers also shared is that when we look at over the last 12 months, BVF has been relatively flat. And in a way, that is quite very much in line with our expectations. Are we reaching that inflection point where BVF will start to grow? Well, again, long-term, we don't expect a huge growth from the BVF. It will -- as we've seen in outside the U.S., in Europe Rest of the World, somewhat growing slowly with the market, but the main focus will be on CERAMENT G and hopefully around the corner on CERAMENT V. What we've said and that still stands is that with an extending customer base, we also see more surgeons using BVF. But again, not anything that will have material impact or, if I put it that way, accelerate BVF growth. The main focus for any investor should be to follow and see how CERAMENT G and eventually CERAMENT V performs in the U.S.

Okay. And then lastly for me for now, the SEK 3.8 million from Stryker, was that a one-off stocking order to sort of get them going? And what do you forecast for the sort of quarterly run rate from them in Q4? Is that likely going to be a much bigger account than the previous distributor that you have? And are the gross margin setup different compared to the previous hybrid model that you run there?

Excellent question. So yes, you are right. It's -- these were 2 start-up orders to get going. We have seen operations through this both in Australia and as well as in New Zealand. So really nice -- it's early days, but it's a really nice startup. We don't provide guidance on a country level, but we're very pleased with the fact that we get faster and better access to the total potential of Australia and New Zealand with a phenomenal player in this industry. So of course, we're doing it because we simply think we can do it faster than with the previous setup that we had. On your second question on the margins, for us, this is a very similar -- this is as close to a standard contract that you could have. So from a contractual level and a margin level, it's very similar to the contracts on the distributors and hybrid models that we already have.

The next question comes from Ed Hall from Stifel.

Most of them have been largely asked, but I think maybe just get back to the reimbursement side and maybe if we were to put ourselves in the foot of the hospital administrators, what is the time line and the aspects that they need to undergo before they could start to get sort of the updated billing sort of flowing through their P&L. So like what's the time line or lag that would need to happen? That would be my first question.

Yes. I mean the ruling is in effect as of 1st of October. So it's open now. So as long as they have been trained, they know what to do, they know how to code the surgeries, they know which surgeries to pay extra attention to. Everything else is set up. But it is also about making sure that we get access to the right people, inform them about what it means and how to do it. It's not very complicated. It's just they use the same software and the groupers that they're used to. It's just making sure that they are informed about it. Some hospitals will move very fast. Some hospitals will probably take a bit longer. But what is very interesting to see when we have done the analysis on a hospital basis. So we use the hospital's own patient volumes historically, then it's a no-brainer to use it. But to make someone understand that it's a no-brainer, there's a process to get there.

Absolutely. I guess what I'm trying to understand is when we had the NTAP payments, there was a certain number of hospitals that either didn't acknowledge that, understand the NTAP payments around. Would it be fair to assume that this obviously is a broader code, it's more widely used. So that issue that you've had historically may not be an issue going forward?

I think the way that you should see it is that some hospitals will jump very fast on this, especially the ones that are on top of their operations. They are on top of their case mix, they are on top of their P&L and what drives profit and what doesn't drive profit. I think those hospitals are easier to convince than ones that are not as call it, have that focus or are as operationally savvy, it will take time. It's hard for us to sort of compare it with the NTAP. NTAP from our perspective was much -- had a much smaller reach and much less importance than CMS ruling, arguably.

Okay. Perfect. And then maybe just -- I mean, I think maybe it's an obvious question, but I just wanted to clarify it from you. I mean, with these reimbursement changes, what do you see as the greater impact for your business? Is it new surgeon recruits? Or is it greater surgeon utilization? I'm sure it's probably a mix of both, but if there's any sort of leading indicator I'd find interesting.

Yes. It's both. And unfortunately, we wish we have the data to say that it's more of this than the other. But however we analyze this, it's both, and it's as positive on both.

The next question comes from Mattias Thärn from Brummer & Partners. Mattias Thärn: Congrats on the DRG decision [ effect ] and on the SOLARIO. I would be interested to hear, when you discuss SOLARIO with surgeons, how do you describe the findings across the carriers in the trial? And did the investigators look at the outcome by carrier type? That's my first question, if I may.

Okay. Very good. So if we start with the carrier types, do you want to start with that one, Dr. Diefenbeck, in terms of which carrier types that were included? And what can actually SOLARIO say related to the products? How was the study designed?

Yes, sure. Thanks for the question. It's a practical study. So there were no -- it was not focused on one single antibiotic eluting bone graft substitute. Even PMMA, so the bone cement was included into the study. This is a study focusing on, in total 17 different products. And this is what I meant in the beginning, it's practical for the class of local antibiotics. So far, there are no sub-analysis published, which show the differences. And this is not what the study was made for. It's not to identify the performance of one single antibiotic. It's on a group. So the task was to show that if local antibiotics are used, the systemic duration can be shortened.

Correct. So it's definitely not a CERAMENT study. You can -- clinically and scientifically, you cannot draw any conclusions on whether CERAMENT versus the other products did well or not. However, what you can say is that it clearly indicates that you can reduce the time of systemic antibiotics. And then you can also look at the number of patients that had CERAMENT G and/or V, and that was 70% of the total population in the study. Mattias Thärn: And then I'd like to bring up a topic. There was recently a peer-reviewed article in the Journal of Bone and Joint Surgery, where some researchers had effectively reanalyzed the foundational study, Stravinskas from 2016, foundational study in the sense from which BONESUPPORT has recently cited its sustained release antibiotic relief properties of CERAMENT G. And this was done by the researchers obtaining that data from this study and then this proved then by mathematically -- in quite a robust mathematical analysis, so not necessarily from any animal model that has been cited before. Now the reason I ask is this may or may not be correct. But on that basis, the product would effectively then function as a bone void filler with a short but potent pulse and presumably outcomes would be much more driven by debridement quality, soft tissue coverage and systemic therapy. Now -- so far, we have not heard the company publicly commenting on this nor have I seen any analysts written about this, which is a surprise in itself. So I would like to ask, I'm aware that one of your Board members wrote a letter to -- commenting on this, but it only touched the abstract and it did not, in any way, refute the principal conclusion of this very precise, mathematical argument that refuted the elution property of CERAMENT G. So I was wondering if the company could publicly just respond to how they stand against this. And I shall add that in discussions that we've had with U.S. surgeons and others, I mean, one of the principal qualities that's brought up of CERAMENT G is precisely the perception of a unique profile. And I should also add that it's very evident that the company, including the CEO, you commented on this on many occasions recently in the Capital Markets Day 2026, where the large package was devoted to the sustained elution properties of CERAMENT G. So if you don't mind, how important is this for the customer proposition of CERAMENT G and CERAMENT V, respectively? And to what extent is this conclusion valid that has been now brought up in the recent JBJS study?

Thank you for the question, Mattias, and that was a comprehensive background. So let's break it down. And first of all, for those of you who are not informed of which study this relates to, it is the so-called mouse study published by a group in Denmark, Aarhus, in the publication of Journal of Bone and Joint Surgery. The study was published in mid-August. And I think it's very relevant to bring up that the majority of the authors are not only part of the university there, they are also part of a company that is called Precision Antibiotics. And they have their own technology related to antibiotics and antibiotic elution. The technology is called CarboCell. We know of the company really well, and we've been made aware of this study early on. I'll start with the sort of the clinical relevance or how we see the clinical relevance of this and then Dr. Diefenbeck will comment on some of the -- our views on that study. So, first of all, from a commercial point of view, what we have seen is that we see very, very limited feedback or questions from the market on this; very, very few. That's number one. Number two, the reason why we believe it is commercially not really relevant is simply due to the fact that it is a preclinical study done on mice where they have used CERAMENT G off label, meaning not in a way that the product is intended to be used in soft tissue in mice and where they have used very, very small amounts of the product compared to the amounts that would be the typical case for when the product is used in patients. So that sort of summarizes why we simply don't think that this study has any meaningful clinical relevance to CERAMENT G. That's sort of fundamental. And then if we then go to the next steps, what is important when we sell our products is not so much preclinical. We stopped using preclinical data to sell our products. Actually, we haven't -- never used preclinical data to sell our products. What matters to customers is the clinical data in general and specifically by segment and by indication. So it's really the clinical data that is important. I think what is also good data points to have in mind is, for example, when this study was presented at EBJIS, what was the feedback from the audience, including Professor McNally from the SOLARIO trial, I think that's important feedback. So that's sort of the statement that we have from our side. Now from a more clinical and scientific point of view, Dr. Diefenbeck, would you happy to share your thoughts?

Sure. So, Torbjorn mentioned already very important points. So looking at -- the study has 2 parts, a bench testing and the animal study. And as mentioned already, in the animal study, the bone void filler was tested in soft tissue, which is not indicated for use. And of course, it should be obvious that the device needs to be tested according to the indication. Then a bit on a more general base, if we look at what testing you can do with bone void fillers, you would start in a lab with bench tests. So for example, you would look at the mechanical properties, the setting time and dilution. The next step would be the biocompatibility or now called biological evaluation where you test against cells or bacteria; then you come to small animal models. This is the area where the mouse study was done. The next step is large animal models. And then, of course, clinical studies, which reaches everything from case reports to randomized controlled trials. So here, this is a very, very early stage of research. Now if you want to start in a lab and compare this elution on the concentration of implants, you need to test, of course, the same volume with -- the same volume with the same volume of the test substance and of the liquid. And this has not been done. So the volumes were completely different, which were tested. Very, very small sizes were tested in the publication, so it's not comparable to what has been tested before. And then as you already right said, a mathematical model was provided without any measurements. So just according to what I told you before, the medical model is -- mathematical model is almost before the bench testing. So very, very early results. So as Torbjorn said, no impact for the clinical performance of the product.

The next question comes from Erik Cassel from Danske Bank. There are no more phone questions at this time. So I hand the conference back to the speakers for any written questions and closing comments.

Very good. Thank you, operator. Then let's go through some of the questions that we have online. And then the first question is, can you quantify how much of the U.S. growth is driven by increased utilization of existing hospitals versus new hospital customers and how much potential remains within your current hospital network? So again, we don't quantify it split, but what we say is that it's a healthy balance driven by both factors, and that is the same picture across the different segments in the U.S. Then the next question is U.S. gross margin declined from approximately 95.3% to 94% year-over-year. What explains this decline? And should we consider it temporary or structural? Håkan? Håkan Johansson: Thank you. It's a very good question. And the main reason why there is a decline in gross margin over time mainly relates to increased manufacturing costs. So the market price has been extremely solid and stable over time. So the main impact is coming from the increase in manufacturing costs. There's been some impact from the U.S. tariffs that impacted us now. And here, we expect returns to come in later part of this year, et cetera. But the gross margin as reported in this quarter and compared also in Q2 is a good indication of a sustained gross margin in the U.S.

Good. Very good. So let's see scroll down. Next one, U.S. market penetration on Level 1 trauma center. Can you provide an update on your penetration of Level 1 trauma centers and your estimate of how much of the addressable U.S. market you have reached so far? Okay. So we don't provide -- on a quarterly basis, we don't provide updates on the Level 1 trauma centers. But what we can say is the numbers and the growth that we have in the quarter gives a good indication of how we're doing. And in terms of how much of the addressable U.S. market we have reached so far, I still think the numbers that we provided on the Capital Markets Day is still relevant. So I would refer to that on that question. Then we have another question, operating leverage, long-term profitability. With adjusted EBIT margin now above 34% and sales commissions declining as a percentage of U.S. revenue, how do you assess the long-term EBIT margin potential while continuing to invest in market expansion? Okay, Håkan will take that. Håkan Johansson: Good question. And again, I think that the question is well phrased because it's all about the long-term EBIT margin potential because as we've seen also during the last year, we will have periods where we invest, especially in our commercial organizational structures that will slow down the EBIT improvement that we've seen also over time. We haven't given any guidance on the long-term potential, but I think that the gradual improvement in EBIT margin and the higher level of operating leverage gives a fair indication on a long-term potential.

Good. Then I think we have one more call -- one more question on the line. So operator, I get the message here that Kristofer Liljeberg from Carnegie is on the phone. Would you care to open the line for Kristofer?

The next question comes from Kristofer Liljeberg from Carnegie.

I really would like to go back to the accelerating U.S. growth this quarter. I think you had USD 4 million higher sales quarter-over-quarter. Previous record was $2.7 million. 12-month rolling trend has been $2 million after the second quarter. So would you describe this as more a temporary effect or are something more sustainable going on right now? Håkan Johansson: I think that, Kristofer, as with any month that is a difference to what you've seen previously, it's just 1 month. So I do not think that you should see this as a sustained acceleration. It's a period where we have seen less impact of the underlying mechanics that we saw in Q2 in go-stop-go, et cetera. It's a period where some of new assets and new distributors has performed well in the quarter. So I think that's -- I really recommend and I look forward to continue to have the discussion in the future quarter report and see what that can represent in future run rates. I think that here and now, it's a strong confirmation on the commercial structure that we have, the potential that we have, and we still have a lot of market opportunity to go after and how that will develop quarter-by-quarter. Let's come back to that and see.

Great. And then just a quick one. There was a question early on, on the call regarding the CERAMENT V potential if that is approved. So do you see this as an incremental opportunity? Or do you think a large part of the 20%, 25% of total sales will come from switching from current CERAMENT G used in the U.S.

It's incremental. Okay. Good. Thank you, Kristofer. Let's continue with the questions that we have on the chat. And then the next one is R&D in CERAMENT V. Given your strong cash flow and net cash position, do you see opportunities to accelerate R&D investments in CERAMENT V, spine applications and next-generation products without requiring additional shareholder capital? And can you provide an update on the remaining FDA regulatory steps for CERAMENT V? Okay. I'll start with the last part, and then we'll get into the other. So the last remaining steps on CERAMENT V is very much related to that. We have now submitted the package. FDA is reviewing it, and we stay in contact, we stay in dialogue, and we look forward to what they will say. So, we expect a formal reply from the FDA on this sometime in Q4 or in Q1. Those are the remaining steps. And then assuming that we get an approval, then the next step for us simply is to produce the product, ship them to the U.S., do the required trainings internally, externally and start selling the product. So we expect a couple of months between an FDA approval to actually when we start selling the product. Then if you go up a bit -- sorry, Håkan, you're too fast for me. I'm still not -- I'm still on the first part of that previous question. The question was given your [ platform ], do you see opportunities to accelerate R&D? I mean, R&D investments in CERAMENT V? No, we go as fast as we can. And if we could, we would go faster and we have the cash. So it's not cash constrained in any way. So we go as fast as we can. On spine applications, again, it comes back to that we need the clinical evidence to be able to, number one, get the required regulatory approvals; number two, to also go to market with evidence that make a meaningful difference. If the question relates to, well, could we accelerate the CERAMENT BVF? Strategically, we want to focus on the antibiotic products in spine. That's where we see the big potential. BVF is a great product, but it's a very, very competitive marketplace in that segment. So our play on spine is with antibiotics. Next-generation products, absolutely, that's an area that we are continuing to invest in and want to go as fast as possible. We don't need any more capital. We have more cash at hand to invest everything we need, both commercially as well as clinically, scientifically and from a research and development point of view. So we're in a very good place. More questions here. Regarding CERAMENT V, have you had any further communication or feedback from the FDA since submitting the complete response package on 21? And has anything changed regarding your expected time line? I mean we stay in contact, but nothing material or controversial with the FDA and the expected time line remains as previously communicated. And then another question here. As BONESUPPORT continues to grow and strengthen its market position, is your long-term ambition to remain an independent Swedish company? Or would you consider becoming part of a larger global medtech group? And have you received any strategic approaches or acquisition interest from larger industry players? So the second question, we, of course, cannot answer that. So we leave that. And our ambition whether to remain an independent Swedish company or consider becoming part of a larger global medtech group? We're a publicly listed company. So if a larger medtech group would be interested to buy us, they could do that. That's easy. We are running this company with a purpose to make sure that our unique and innovative technology with CERAMENT reaches as many patients as possible. We think it makes a very, very big difference to patients, to hospitals as well as to society when we think about the antimicrobial resistance. That's what we focus on. And -- I mean, our strategy is not including to become part of a bigger company if they want to acquire us. We're a public company. So I don't know what -- can that be explained in a better, smarter way. Håkan Johansson: No, I think you phrased it very well.

Okay. Thank you very much. I think we've gone through all the questions on the chat as well as on the line. Then thank you all for your interest, and have a great rest of the day.