Welcome to BONESUPPORT Q3 2026. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now I will hand the conference over to CEO Torbjörn Sköld and CFO Håkan Johansson. Please go ahead.
Thank you, operator. Welcome, everyone, to BONESUPPORT's Q3 2026 results call. My name is Torbjörn Sköld, 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 two, please. Before starting the presentation, I would like to draw your attention to the disclaimers covering any forward-looking statements we will make today. Let's look at the financial and operational highlights of the quarter. 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 SEK by quarter since 2019 in stacked bars per region and product category. As you can see, the launch momentum for CERAMENT G in the U.S. is strong, and EUROW has accelerated in the last five 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 SEK 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. CERAMENT BVF last 12 months sales were flat year-over-year at constant exchange rate. In total, antibiotic eluting CERAMENT grew with 39% last 12 months at constant exchange rates. In the 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 through new accounts and new surgeons, as well as wider adoption among existing users. We see growth from all three prioritized market segments, foot and ankle, trauma, and arthroplasty.
In Q3, U.S. CMS, Centers for Medicare & Medicaid Services, confirmed its proposed ruling, the FY 2027 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 reimbursements as when a complex 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 1st, 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 three 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 startup orders. The partnership strengthens our presence in the region and gives us a good basis to continue developing these markets.
Our distributor markets showed 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
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 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, healthcare 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, Torbjörn. My name is Michael Diefenbeck. I am Chief Medical Officer at BONESUPPORT. After a bit of waiting, the SOLARIO trial has been published on September 16th. 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. 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 seven days, provided local antibiotics are used?
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, non-inferiority 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 four weeks, or short, less than seven days duration. The primary outcome parameter is treatment failure by 12 months, assessed according to protocol-defined criteria by a clinical event 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 defined 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 pre-specified non-inferiority margin. This means that the short duration was non-inferior to the long duration. Next slide. Here are the results of the secondary outcome parameter. By week six 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 shorter duration of systemic antibiotics 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. What do these results mean in a bigger picture? The World Health Organization declared at the end of 2019 that antimicrobial resistance is one 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 six points. Number one, shorten the duration of therapy, and SOLARIO has clearly shown that this is possible. Number two, improve compliance in patients. The device drug combination product, including antibiotics, is implanted directly into the bone. 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 the 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, improve targeting. The antimicrobial is exactly at the right spot. They are implanted directly into the bone. And finally, number six, reduce the total antimicrobial burden. In the study, there was a saving of 6.4 kg, not gram, per 100 patients. With this summary, I hand over to Håkan, BONESUPPORT CFO, for the financials.
Thank you, Michael. Net sales improved from SEK 284 million- SEK 409 million, equaling a growth of 39% in reported sales and a growth of 38% in constant exchange rates.
Torbjörn has already spoken about the performance in both the EUROW and the U.S. and the major drivers behind the sales growth. As large over time movement in U.S. dollar hides a true trajectory in the U.S., I would like to share the U.S. sales performance for CERAMENT G in U.S. dollar. 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. dollar 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 $60.2 million versus Q3 2025 and amounted to $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 previous year. Of which sales commissions to distributors amounted to SEK 111.4 million compared with SEK 85.1 million the same quarter last year. From the graph at the bottom of the screen showing net sales as bars and gross margin as the orange marker, it can be noted that the gross margin remains stable and strong at 94%. In EUROW and rest of world, a contribution of SEK 9.9 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 Europe booster program. 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 the U.S. and Europe. 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. 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 effects impacting. This is something I will come back to on a 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 cost related to our long-term incentive programs, amounting to an expense of SEK 50.9 million in the quarter, compared with an expense of SEK 30.7 million 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 SEK has continued to weaken against the U.S. dollar, with only minor exchange gains and losses reported as under 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 read out on the left Y axis showed adjusted operating results. The adjusted operating result, excluding translation exchange effects, 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. From second half of 2025 and early 2026, the operating margin has been impacted by the commercial investments made in both Europe 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 as the dotted line in this graph. Q3 reported a solid cash flow and cash conversion of close to 100%.
And with this, I hand back over to Torbjörn.
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 500 million . 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 three quarters, we confirm our previously communicated full year outlook of sales growth between 33% and 36% in constant currencies.
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.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Philip Ekengren from Nordea. Please go ahead.
Thank you, operator, and good morning, all. CERAMENT G increased substantially Q-on-Q, especially looking 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?
We do not publicly disclose the numbers, but what we can say is that we see solid growth across all the three segments, foot and ankle, trauma, orthoplastic. We can also say that in all of the three segments, we see a good, healthy balance between the two drivers, meaning new accounts as well as increased usage. Of course, taking into the effect that foot and ankle, that is a segment where we have been in and actively worked on for several years. Trauma is somewhat newer, and then orthoplastic is the newest. But we are very pleased on the growth across the segments as well as by the growth type. That is how much we can say on it, Philip. And sorry, we do not disclose more numbers than that.
No, I appreciate that, Torbjörn Sköld. On CERAMENT V, if and when approved, how much of the initial opportunity will come from patients or surgeons it 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?
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, so of all the G and V products that we sell, around 70%-75% of that is G, and the remaining is V. That is 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 have seen it for several quarters, and we have 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.
Our starting point is that we expect to see the U.S. come to a similar mix as we've had in Europe. Then we'll see. It's clear that U.S. surgeons want and need V. We expect the cannibalization to be limited, but there might be some. 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. Thank you very much. Then perhaps a final one for me, squeezing it in. With Q3 growth at 38% and unchanged at 33%- 36%, what assumptions distinguish the lower and upper ends here? Do you expect the CMS changes to influence growth already in Q4, or is that more of a 2027 play?
I'll leave that to Håkan.
Thank you. No, again, I don't think that, [inaudible], we should or should include material impact from the CMS already in Q4. [inaudible], the guidance is more related on continued commercial executions on existing baselines. Again, [inaudible], we have seen volatility in sequential growth in the past. We'll continue to see that as well. The guidance more relates to continued and, in mega terms, normalized commercial execution.
On CMS, sorry, I missed that you related to CMS. On CMS, what we've seen is that, and we saw it at EBJIS, we saw it at OTA, Orthopaedic Trauma Association in Phoenix, is that U.S. surgeons and the ones that we've talked to are very positive towards this ruling. Also the initial conversations that we've had with administrators are also very positive. 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 while it's a very expensive product and we get a lot of invoices on CERAMENT G, and why do you need that? Then of course, the CMS ruling is 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 and the hospitals in one 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.
Perfect. Thank you very much. I'll get back into the queue.
The next question comes from Mattias Vadsten from SEB. Please go ahead.
Hi, thanks. [inaudible] . First one, just a follow-up on your comment there, Håkan, on the incremental reimbursement for CERAMENT G in the U.S. 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 I am sorry if I cast it in the wrong way.
Thank you, Mattias, and good that you are asking the question. What I said is, I do not expect this to have a material impact on the revenue in Q4. Of course, it will be helpful. It is helpful to some in terms of continuing to develop both adoption and access in the U.S. over time. We are super happy to have CMS, but I do not think that anyone should exaggerate the impact in the very short term. We will make sure that this is a tool in our toolbox that we are using wisely in building the market.
Thanks for that. Also maybe staying on the same note. In Q2, we talked about the go-stop-go dynamic for a bit, and you have touched on it before, but the communication was quite clear around that Q2. Just how has that developed since then, and also do you think this incremental reimbursement can change that picture. That is my next question.
Yeah. Good. 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. It is 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. What we mean by that is on a clinician level, when they are first exposed to CERAMENT, and especially CERAMENT G and CERAMENT 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. 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 wanted to see.
If they are pleased with the results, they go again. Hence this go, stop, go. That is on a clinician level, and it is relatively common, or it is very common. We can also see it on the administrative level in a hospital or in a hospital group, even on an IDN level in the U.S. That is pretty much the same dynamics that we see on the clinician level, meaning that surgeons in the hospital start using the product, 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.
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 CERAMENT V is, then there could be these effects that we not only saw in Q2, but we have seen it previously. There you have this stop on the hospital level. The approach is simply that we go and talk to the administrators, the value analysis committees around the value of CERAMENT G and CERAMENT V. 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. It is part of the business.
But of course, Mattias, to your point, to have the ammunition with The CMS ruling. It is a fantastic tool. It is probably the ideal tool to use in that type of conversation, and it really helps strengthen our case in those conversations.
Thanks. Very clear. My last question is, based on the trajectory you see in trauma patients now, do you believe a market share similar to diabetic foot ulcers is possible? Or will 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, what you have seen, surgeon feedback, the uptake so far? What you can share.
Yeah, no, great question. What I can reference is simply the, I think it was a couple of weeks ago, we were at the Orthopaedic Trauma Association in Nashville, U.S. That was right after the SOLARIO publication, that was right after the CMS ruling. 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. 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. 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? This is the beauty of BONESUPPORT, that time is on our side. 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 email, because these products, they implant in patients. Yeah, we remain very bullish on trauma as we've done previously as well. No change on that, Mattias.
Thank you so much.
The next question comes from Sten Gustafsson from ABG Sundal Collier. Please go ahead.
Good morning. A number of questions, but I will try to limit it to two. Looking at the CMS ruling, I suppose it is for hospital only and not outpatient. Maybe that first sort of clarification. Secondly, if you could perhaps tell us your mix there between hospital versus outpatient. I guess I am trying to figure out how much of your business will benefit from these improved reimbursements.
Yes. Thank you, Sten. First question. Yes, the ruling is only inpatient, and that simply stems for how it is set up and how it is named. It is called the FY 2027 IPPS, so the Inpatient Prospective Payment System. This ruling relates to 100% inpatient. The majority of our sales is currently inpatient. There is some in outpatient, but to the large extent, it is only inpatient. 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 positively to this ruling, and it will have positive impact for us in the quarters to come.
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.
No, absolutely. Thank you very much. When it comes to, I remember you had this NTAP, and then obviously it is 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 three-year period?
Not at all.
Very good. In terms of your organization in the U.S., 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 reach out to all these hospitals?
Very good and a relevant question. When we're growing in the U.S. 30%-40%, then of course we will need to continue to invest in our commercial organization, including sales. You bring up a 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. We're not going to slow down on that. That's going to be continued.
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. 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. That's an area that we have already invested. We're bringing on more people with a slightly different profile than the classical clinical sales. 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.
Perfect. Thank you very much. I'll get back to the queue.
The next question comes from Erik Cassel from Danske Bank. Please go ahead.
Hi, good morning. I had a question on the guidance as well as a follow-up to Philip. As he said, the 33%-36% basically implies anywhere between 32%-44% growth in Q4. Do you view that full range as possible still? If you do think that, I want to press you a bit on what do you think are the factors to get to either down towards 32% or up to 44%? Do you have any opinions on what is more likely in this sort of range?
Thank you, Erik. We provide the guidance simply because we think 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. 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 three segments, foot and ankle, trauma, and arthroplasty. 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%-36%.
We focus more on the long term, and we are very pleased with Q3. We look very positively to Q4. We build this business for the long term, not just to hit one quarter or the next quarter.
Okay. Fair enough. It looks like the BVF products have started to stabilize a bit more here in Q3. Would you say that we have reached the stabilization point that you put back in Q1, and that it now can start to grow again? Is it expectations a bit more muted still in the coming quarters?
Sorry, Erik Cassel, can you repeat the beginning of the question because I missed that one. Sorry.
Oh, yeah. Of course. It looks like BVF in the U.S. has started to stabilize, only down like 2% now, down 14% in Q2. You talked about the stabilization back in Q1, and then for it to sort of come back to growth, if I recall correctly. Would you say that we have reached that sort of stabilization point now, and that we are looking towards growth again with the BVF product in the U.S.?
I think that, [inaudible], what we've seen, and that is numbers also shared, [inaudible], is that when we look at over the last 12 months, BVF has been relatively flat. In a way that is very much in line with our expectations. Are we reaching that inflection point where BVF will start to grow? Well, again, [inaudible], long term, we don't expect a huge growth from the BVF. It will, as we've seen outside the U.S., in Europe, rest of 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, [inaudible], not anything that will have material impact or, if I put it that way, accelerates BVF growth.
[inaudible], 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. Thank you. Lastly from me for now, the $3.8 million from Stryker, was that now a one-off stocking order to sort of get them going? What are your forecasts 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? Are the gross margin set up different compared to the previous that you run there?
Excellent question. Yes, you are right. These were two stock-up orders to get going. We have seen operations through this, both in Australia and as well as in New Zealand. So it's really nice. It's early days. But it's a really nice stock-up. 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 as close to a standard contract that you could have.
From a contractual level and the margin level, it is very similar to the contracts on the distributors and the hybrid models that we already have.
Okay, great. Thank you so much.
The next question comes from Ed Hall from Stifel. Please go ahead.
Good morning, guys. Thanks for taking my questions. Most of them have been largely asked, but I think maybe just go back to the reimbursement side, and maybe if we were to put ourselves in the foot of the hospital administrators, what is the timeline and the aspects that they need to undergo before they could start to get this updated billing flowing through their P&L? What is the timeline or lag that would need to happen? That would be my first question.
Yeah. The ruling is in effect as of October 1st. It is open now. 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. It is also about making sure that you get access to the right people, inform them about what it means and how to do it. It is not very complicated.
It is just they use the same software and the groupers that they are used to. It is just making sure that they are informed about it. Some hospitals will move very fast. Some hospitals will probably take a bit longer. What is very interesting to see when we have done the analysis on hospital basis, so we use the hospital's own patient volumes historically. Then it is a no-brainer to use it.
I get it.
To make someone understand that it is a no-brainer, there is a process to get there.
Absolutely. I guess what I am trying to understand is when we had the NTAP payments, there was a certain number of hospitals that either did not acknowledge that, understand the NTAP payments around. Would it be fair to assume that this obviously is a broader code, it is more widely used, so that issue that you have 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. The 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 compare it with the NTAP. NTAP, from our perspective, had a much smaller reach and much less importance than the CMS ruling, arguably.
Okay, perfect. Maybe just I think maybe it's an obvious question, but I just wanted to clarify it from you. 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.
Yeah. It's both, Ed, unfortunately, we wish we had 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.
Okay, perfect. Very clear. Thank you very much.
The next question comes from Mattias Thärn from Brummer & Partners. Please go ahead.
Hi. Good morning. Thank you very much. My question. 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? Did the investigators look at the outcome by carrier type? That is my first question, if I may.
Okay. Very good. 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 SOLARIO actually say related to the products? How was the study designed?
Yes, sure. Thanks for the question. It is a practical study. 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. This is what I meant in the beginning. It is practical for the class of local antibiotics. So far, there are no sub-analyses published which show the differences, and this is not what the study was made for. It is not to identify the performance of one single antibiotic. It is on the group. The task was to show that if local antibiotics are used, the systemic duration can be shortened.
Correct. It's definitely not a CERAMENT study. 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 CERAMENT V, and that was 70% of the total population in the study.
Thank you very much. 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 repeatedly cited its sustained antibiotic release properties of CERAMENT G. This was done by the researchers obtaining the data from this study and then disproved by mathematically in quite a robust mathematical analysis. Not necessarily from any animal model as has been cited before. Now, the reason why 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 comment on this, nor have I seen any analyst written about this, which is a surprise in itself. 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 and mathematical argument that refuted the elution property of CERAMENT G. I was wondering if the company could publicly just respond to how they stand against this. I shall add that in discussions that we've had with U.S. surgeons and others, one of the principal qualities that's brought up of CERAMENT G is precisely the perception of a unique elution profile.
I should also add that it's very evident that the company, including the CEO, you've commented on this on many occasions. Recently in the Capital Markets Day 2026, where a large passage was devoted to the sustained elution properties of CERAMENT G. 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.
Thank you for the question, Mattias, and that was a comprehensive background. 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're 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 CarboCel. We know of the company really well, and we've been made aware of this study early on.
I'll start with the clinical relevance or how we see the clinical relevance of this, and then Dr. Diefenbeck will comment on some of our views on that study. First of all, from a commercial point of view, what we have seen is that we see very limited feedback or questions from the market on this. 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.
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. 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 have 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 Martin 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. Torbjörn mentioned already very important points. Looking at the study had two 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. Of course, it should be obvious that a device needs to be tested according to the indication. 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. For example, you would look at the mechanical properties, the setting time, and elution. 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. Then of course, clinical studies, which reaches everything from case reports to randomized controlled trials. Here, this is a 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 volumes, the same volume of the test substance and of the liquid. This has not been done. The volumes were completely different, which were tested. Very, very small sizes were tested in the publication, so it is not comparable to what has been tested before. As you already right said, a mathematical model was provided without any measurements. Just according to what I told you before, the mathematical model is almost before the bench testing, so very early results.
As Torbjörn said, no impact for the clinical performance of the product.
Thank you. Next question, please.
The next question comes from Erik Cassel from Danske Bank. Please go ahead. 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. Let's go through some of the questions that we have online. 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? We do not quantify it split, but what we say is that it is a healthy balance driven by both factors, and that is the same picture across the different segments in the U.S. The next question is: U.S. gross margin declined from approximately 95.3%- 94% year-over-year. What explains this decline, and should we consider it temporary or structural? Håkan?
Thank you. It is a very good question. The main reason why there is a decline in gross margin over time mainly relates to increased manufacturing costs. The market price has been extremely solid and stable over the time. The main impact is coming from the increase in manufacturing cost. There has been some impact from U.S. tariffs, and that impacted up to now, when here we expect some 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 gives a good indication of a sustained gross margin in the U.S.
Good. Very good. Let's see. Scroll down. Next one. U.S. market penetration in 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? On the quarterly basis, we do not 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 are doing. 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. I would refer to that on that question. We have another question. Operating leverage, long-term profitability.
With adjusted EBIT margin now above 34% and sales commissions declining as percentage of U.S. revenue, how do you assess the long-term EBIT margin potential while continuing to invest in market expansion? Okay, Håkan, you take that.
A good question. Again, I think that the question is well-phrased because it's all about a long-term EBIT margin potential. As we've seen also during the last year, we will have periods where we invest, especially in our commercial organization and 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 some of the gradual improvement in EBIT margin and the high level of operating leverage gives a fair indication on a long-term potential.
Good. I think we have one more question on the line. Operator, I get a 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. Please go ahead.
Thank you very much for those in the queue from the beginning. I really would like to go back to the accelerating U.S. growth this quarter. I think you had SEK 4 million higher sales quarter-over-quarter. Previous record was SEK 2.7 million. 12-month rolling trend has been SEK 2 million after the second quarter. Would you describe this as a temporary effect or something more sustainable going on right now?
I think that, Kristofer, as with any month, that is a difference to what you have seen previously. It is just one month. I do not think that you should see this as a sustained acceleration. It is a period where we have seen less impact of the underlying mechanics as we saw in Q2 in go-stop-go, et cetera. It is a period where some new access and new distributors has performed well in the quarter. I really recommend, I look forward to continue having the discussion in the future quarter reports and see what that can represent in future run rates. I think that here and now it is 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 us come back to that and see.
Great. Just a quick one. There was a question early on on the call regarding the CERAMENT V potential if that is approved. 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 use in the U.S.?
Incremental.
Okay, great. That's all. Thank you.
Okay, good. Thank you, Kristofer. Let's continue with the questions that we have on the chat. The next one is R&D and 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? 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. 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. We expect a formal reply from the FDA on this sometime in Q4 or in Q1. Those are the remaining steps.
Assuming that we get an approval, then the next step for us is simple, is to produce the products, ship them to the U.S., do the required trainings internally, externally, and start selling the product. 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 on the first part of that previous question. The question was, given your strong platform, do you see opportunities to accelerate R&D? R&D investments in CERAMENT V, no. We go as fast as we can and if we could, we would go faster. We have the cash, so it's not cash constrained in any way. 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 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 competitive marketplace in that segment. 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 that 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 timeline? We stay in contact, but nothing material or controversial with the FDA, and the expected timeline remains as previously communicated. 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? Have you received any strategic approaches or acquisition interest from larger industry players? The second question, we of course cannot answer that. We leave that. 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 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 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, Håkan, can that be explained in a better, smarter way?
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.