7/15/2025

speaker
Emil
Chief Executive Officer

sales for sediment G in the US has now reached 1 billion Swedish krona. Visually, it almost looks as if the last quarter is slowing down, which is, of course, not the case. It is an effect of the sharp drop in dollar to SEC. And if we look at the growth at constant rates for the last 12 months, the LPM in quarter two versus quarter two a year ago, the growth number is 47%. In total, antibiotic eluting serum grew with 49% in the last 12 months for the quarter for the global business. Let's push forward and go to the next slide, please. In North America, Quarter two sales reached 236 million SEC, which is a growth of 36% compared to quarter two last year, or 49% at constant exchange rates. As mentioned, we've seen large swings in the US dollar to Swedish krona rate, which is impacting both reported sales and sales growth. The uncertainty regarding the future of potential tariffs continues. Regardless of outcome in this volatile situation, the impact on bone support will be very small, as we have covered previously in the April press release. Some highlights in the quarter. We're seeing strong progress in the market penetration for Ceramide G, with sales reaching 18.3 million US dollars. The growth is coming from new users, but even more so from increased and expanded use in broader sets of indications by surgeons that have made their first experience with CEREMENT-G six to 12 months ago. We are making steady progress in getting CEREMENT-G approved with hospital systems, and we are quickly approaching 200 systems listings. It takes anywhere between three to nine months to get an approval for a listing with a hospital system. And usually the bigger the system, the longer time it takes. We will continuously see a lot of go, stop, go dynamics. But so far, there's only one or two of the hospital systems that have rejected to list Cerament G. The knowledge of the benefits of bone repair with local elution of antibiotics is increasing. To further nurture the growth driven by increased demand, we have signed up a few specific independent distributors specialized in trauma and specialized in prosthetic joint infection. We've done this for states and regions where we did not have coverage with our legacy distributors. The submission to FDA for market authorization of sediment V was made at the end of March. During quarter two, we received questions and requests for clarification on the data from FDA. The submission follows a 510K pathway where sediment G has been used as a predicate device. The package of questions received should be looked at in the perspective of the very rigid and very demanding requirements on clinical data, elution profiles, and special controls established when the category of antibiotic eluting bone grafts was established by FDA. There is, by the way, only one product in that whole category, and that is the sediment G. But by the end of this year, we hope to be able to add one more product to that category, namely Cerament V. The deadline to respond to FDA's question is in November this year. The expectation is that Cerament V will open up additional avenues for growth in the US market and increase the pace of market penetration for use of local antibiotics. The therapeutic ratio is totally different with local antibiotics versus systemic antibiotics, which has been shown in many clinical studies, among those the Solario study. With both gentamicin and vancomycin in the toolbox, we believe that we completely meet all the US surgeons need for treatment and prevention in relation to bone healing. Go to next slide, please. So finally, when it comes to the US, I would like to give an update on the plan for our spinal procedure market entry. At the capital markets day end of 2023, we announced that we will eventually enter the area of spinal procedures with both Cerament BVF and Cerament G in the US. Since then, supplementary regulatory approval has been accomplished for Cerament BVF and several preclinical application studies have been conducted and even more are ongoing. The launch into the spine segment with Cerament BVF will take place in December of this year. We are launching simultaneously in the US and in Canada. The launch will start with orthopedic departments where Cerament is already fairly established and used for extremities. Cerament is overall starting to become quite well known in the market, and there's a large amount of high quality public data on the bone remodeling capabilities of Cerament, including a level one randomized clinical trial showing equivalence to autograft. This is in extremities. So in spine, while there are some patient case series, there are no published clinical studies yet. This is something that we will address and generate over time with our partner hospitals. Recruitment of specialized independent distributors focused on spinal procedures is ongoing. Details on regulatory and clinical study strategy for Ceramide G in spine procedures will be presented in the autumn 2025 as earlier announced. The pictures on the slide just show a few snapshots of some of the details generated from the preclinical study data. These ones are from a fusion study using Cerament according to the Boden model. Strong fusion results were recorded across the study samples. Now let's turn to Europe. Next slide, please. Sales in Europe came in at 49 million Swedish krona, representing 4% year-over-year growth. which is 7% at constant exchange rate. Sales in Great Britain is in recovery from the NHS imposed surgery priority program. Every month has seen gradual increase in number of surgeries and growth rates versus previous year, leaving the quarter at a percentage growth in the mid teens. Sales growth in percent for the quarter was negatively impacted by fewer surgery days, a strong comparative quarter in 2024, and the ongoing hospital reform in Germany. A number of German federal states have launched cost reduction programs related to hospital consumables and surgical procedures. The programs have resulted in quite a disruption for us, with some hospitals reverting back to the use of autograft at the expense of synthetic bone grafts. What we have seen previously with similar historical cost-driven initiatives is that the dip is rather temporary in nature as it relates to innovative products capable of improving the standard of care and providing strong health economic data. To drive understanding of the benefits of CERAMENT, we intend to further intensify our efforts with decision makers on all levels. CERAMENT has very strong evidence supporting and confirming the benefits given to patients, caretakers and payers. In the quarters, two additional clinical studies were published in well-reputed medical journals. with impact factors of 1.8, respectively 2.8. Reduced amputation rate has previously been shown in clinical studies, both from the UK and from Australia. And the recent study was made at Herlev Hospital in Denmark, shows similar strong patient outcome following a dedicated protocol where Cerament G or Cerament V was used. The second study mentioned here follows a patient group that has been featured in previous publications by Henry and Al-Jawadi. The recent publication shows that the great results on deep infection avoidance and avoidance of amputation withheld and remained also over long-term period follow-up. The study had a 10-year follow-up of patients that previously had been reported on in a four and a half year follow-up. And with that, I will leave to Håkan to do and lead us a deep dive in the numbers.

speaker
Håkan
Chief Financial Officer

Thank you, Emil. So net sales improved from 219.8 to 284.4 million, equaling a reported sales growth of 29% or 40% in constant exchange rates. Emil has already spoken about the strong performance in especially the US and the major drivers behind the sales acceleration. But as the weak US dollar somewhat hides the continued strong trajectory in the US, I would like to share the US sales performance in US dollars. This slide shows the quarterly sales in the US in US dollars. Not only can we see a strong performance in this quarter, but also a strong performance over the years. with double sales in recent six quarters and triple sales over the recent nine quarters. The dollar growth in a quarter of 49% should be viewed in perspective of a record strong quarter Q2 last year. The contribution from the North America segment improved with 37.6 million and amounted to 104.4 million. The improved contribution relates to increased sales of the defect from increased costs. Sales and marketing expenses during the quarter amounted to 117.8 million compared with 98.3 million previous year, of which sales commission to distributors and fees amounted to 78.5 million compared with 61.6 million the same quarter last year. From the lower graph showing net sales as bars and gross margin as the orange marker, it can be noted that the gross margin remains stable and strong around 95%. In Europe and rest of the world, a contribution of 13.6 million was reported to be compared with 14.2 million previous year. Sales and marketing expenses increased with 2.2 million, including 2.1 million related to the previously communicated commercial investments in the euro booster program. From the lower graph and the orange marker, a minor drop in gross margin is noted, mainly impacted by market mix. The decrease in selling expenses is due to a depreciated US dollar, but also an effect of seasonality, depending on how the expense for large conferences play out. As mentioned previously, the quarter also included 2.1 million related to the euro booster program. R&D remained focused on the execution of strategic initiatives, such as the application studies in spine procedures and the market authorization submission for Sermon V in the US. These initiatives have been progressing well during the quarter and, among others, leading up to the launch of our product Sermon BVF in spine later this year. And administrative expenses, excluding the effects from the long-term incentive programs, remain on a stable level, involving 1 million in non-recurrent expenses in the quarter. The reported operating profit amounted to 54.9 million, despite unfavorable currency effects totaling 11.4 million. And I will come back to this in the following slide. There is no impact from tariffs in the quarter, and we are following the conversations between EU and the US with great interest. It should be said that regardless of the final outcome, the impact on bone support is expected to be non-material. As an example, a 10% tariff implemented in our business would have meant an EBIT reduction on the just reported quarter Q2 this year of 1.3 million SEC, or about 2% of reported adjusted EBITs. A worst-case scenario with 30% tariff would have meant a reduction of the reported EBIT of 4 million. The difference between adjusted EBIT and reported EBIT are costs related to the long-term incentive programs amounting to an expense of 7.6 million in the quarter compared with 7.3 million previous year, as you could see on the previous slide. Cash conversion remains solid with a fourth consecutive quarter with strong cash flow and an increase in cash during the period with 42.6 million. With this report, with a strong adjusted operating result, despite unfavorable currency effects and a solid cash flow, we continue to confirm a strong operating leverage and business scalability. During the period, the Swedish krona has continued to strengthen against the US dollar. Other operating income and expenses therefore contain foreign exchange gains and losses from the translation of the group's assets and liabilities in foreign currency amounting to a negative 11.4 million. Simply put, the negative 11.4 million is mainly driven by the operating assets in the US, such as inventories and trade receivables. These are originally valued in US dollars and at quarter end translated into a much stronger Swedish currency versus the last quarter. The graph on this slide shows with the gray bars how the relationship between the US dollar closing rate and the Swedish krona has varied over time. This is read out on the right eye axis. The blue dotted line read out to the left of the eye axis shows reported adjusted operating result. The adjusted operating result, excluding translational change effects, is the orange line. In Q4 2024, the US dollar to SEC rate was 11.03, which gave a positive effect of 20 million SEC. And therefore, the blue dotted line is above the orange line. In Q1 this year, the U.S. dollar rate was 10.02, creating a negative impact of 30 million. And in Q2, the U.S. dropped down to 9.49, creating a negative impact of 11 million, meaning that the blue dotted line drops below the orange line for these two quarters. The orange line eliminates the translation exchange rates and give a more comparable view of the underlying trend in operating profit. In the table below the graph, you can see the FX adjusted operating margin of 26% in the period compared with 16.8% in the same quarter last year and compared with 24.6% in Q1 this year. And with this, I hand back to Emil.

speaker
Emil
Chief Executive Officer

Thank you, Oka. So to summarize, we've seen a strong momentum in 2025 with 40% sales growth at constant exchange rate in the quarter and 44% in constant exchange rate for the first six months. The continued success for Cerament G in the US is one of the main drivers for this strong growth. And yet this product has just begun the journey towards its full potential. We have a strong underlying profit development and operational cash flow of 50 million SEC in the quarter. So all in all, we are confident in our guidance of sales growth above 40% in constant exchange rate for the full year. Bone support continues to perform steadily, converting an outdated standard practice into technically advanced patient centric care. And we remain committed to expanding into new geographies and indications as we're now starting the ramp up for the December spine launch. So let's open the line for questions.

speaker
Operator
Operator

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

speaker
Matthias Vadsten
Analyst, SEB

Hello, Emil and Håkan. Good morning. I have a few questions today. Take them one by one, I think. First one, you said something regarding expansion of the distributor network. I think it was trauma and prosthetic joint infection where the distributors, the legacy distributors for you is not covering those. So my question is really, you know, how many states or regions does this cover? And do you foresee an uplift of this to sales already from quarter three? I'm just trying to get a feel for the incremental upside from this move. That's the first one.

speaker
Emil
Chief Executive Officer

Yeah, thank you, Mattias. We have shown at a couple of places before how early we are on the journey with Cerament G in the US and that our market shares is less and in its infancy in both trauma, and in prosthetic joint infection. And there are a couple of reasons for this. We got the approval for trauma only a year ago, and we launched in October last year. On PGI, we have barely gotten started. We're still waiting for the clinical study from Charity in Berlin to support our case and to give valuable data points to drive penetration. But we're starting also already now to see more demand from the market. There are surgeons calling us that we have not been in contact with before within open trauma. There are surgeons calling us with infected joints and they ask if they could start using the product. So we have signed up specialist distributors to cover these target groups where our previous distributors couldn't cover. Now, the question you ask is, well, how to quantify this? What should we expect going forward? What you should expect going forward is many years of very strong growth. If we will succeed in trauma, if we will succeed in PJI, as we have done in other areas where we also have continuous and further opportunities to seize, then this company will be on a very long growth trajectory. But exactly how that will translate into distributors, regions, states, I think we cannot share that data from time to time. I think one important observation is surgeons are starting to call us. Distributors are coming to us. Cerament GE has a very strong reputation in the marketplace and those surgeons that have used it also speak with their colleagues in other indications, which is creating a strong demand. But the specific numbers, unfortunately, we will not be able to share that.

speaker
Matthias Vadsten
Analyst, SEB

I appreciate that and think that's a good answer. Second one relates a little bit to I think it's two questions in one really, but on the BDF and the preclinical application studies, so can you say anything about what results you're seeing? Can you talk anything about fusion rates based on what you're seeing and what you expect maybe? And if the results are overall in line with your expectations beforehand or if they are even better? And then on Sermon G there in spine procedures and So what makes you confident in an updated timeline for autumn 2025? Does this mean that the preparatory work is developing in line with expectations and that you can maybe start a study towards the end of this year? Or how should we look upon that? Thank you.

speaker
Emil
Chief Executive Officer

So we have done a lot of preclinical testing on CRM and BVF. We have also done some on Cerament G. Some results are ready since a while ago, and other results are pending to be finished with the report, and others are still to be completed later during this year. You asked specifically about fusion, so let me say that we're targeting spine procedures quite broadly. where we're looking at several different application areas and several different indications. But when you ask about the fusion specifically, yes, we have done fusion studies with the Bowden model, which you can say is a bit of standard at least today. when it comes to preferences expressed by FDA. This is a demanding model, which is a rabbit spine model intended to replicate human fusion. And yes, the results are very good. Now, we don't release results from preclinical studies. We feel that can be quite deceiving. I think we should wait until there are clinical studies, which we intend to start up sometimes next year when we have established the partner centers. But I wouldn't sit here today and tell you that the launch takes place in December this year, unless we had very encouraging results from the preclinical studies. When it comes to Cerament G, Well, the contrast here is Cerament BVF has gone to market or will go to market through a 510K. So there are products in the market and a lot of them are performing within a certain range so they can get the regulatory approval. When it comes to Cerament G or V for spine, there is nothing like it. There's nothing even close to it. which means we will have to again create a new category. We feel confident in doing that. We have done that before, and we're one of the few companies that have succeeded. We have the first ever combination product of medicinal substance and medical device registered through de novo in orthopedics. And de novo is the pathway most likely that we will have to go through with Cerament G for spine. And there's still some conversations that has to be had with our external partners, with FDA, with regulatory consultants, before we feel that we can give a clear answer. But you can be very sure that since we addressed the market from the capital markets day, we have been working very hard to get all the pieces of the puzzle in place. And it's not long more that people have to wait now for us to be able to share when and how that will look like going forward.

speaker
Matthias Vadsten
Analyst, SEB

Sorry for the long question. I think that's a good answer. Thank you very much.

speaker
Emil
Chief Executive Officer

Yeah, thank you, Mattias, and sorry for the long answer.

speaker
Operator
Operator

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

speaker
Christopher Liljeberg
Analyst, DNB Carnegie

Thank you. Two questions here. Three, actually, but the first one are related to it. On the selling expenses that were down here sequentially, how much of that is just a U.S. dollar effect, if that's possible to quantify? And related to this, I'm wondering, have you viewed the potential operational leverage going forward? How much are you planning to increase operating costs here for the remainder of the year, maybe into 2026? And that's, of course, excluding the royalty you pay to to distributors or the distributor commission so that's my first question uh and then how do you view the potential to accelerate this sequential growth you see in the us in in uh in u.s dollar thank you well thank you christopher and

speaker
Håkan
Chief Financial Officer

And again, Samaya, I can understand the questions more related to expenses, also giving some also that as with revenue, there is naturally also consequences in terms of translation of expenses in foreign currencies. The FX impact in the quarter is around 5 million SEC from currency. And the rest is coming back to, as we mentioned, somehow it's the seasonality. It's really also the timing when the last Congress is happening. That was the first part. And then on the operating costs going forward? Again, we have been giving guidance on revenue and revenue only. And we have communicated that we expect this year to grow with more than 40 percent in constant exchange rates. And the reason for not being more disclosed in terms of expenses or operating result is that somehow we continue to do investments. We continue to do commercial investments and we communicated late last year some of the euro booster program, etc. And we will seek all... opportunities to continue investing in continued sales growth. For that reason, we don't give any firm guidance on operating expenses. However, saying that, just by looking at the general trajectory, we can see that whether we talk selling expenses and general and administration, et cetera, we can see that it's coming down as a percentage sale despite those initiatives and cost increases.

speaker
Christopher Liljeberg
Analyst, DNB Carnegie

But you're not planning any larger programs, rest of the world, or adding a large number of sales reps in the U.S. or any big clinical trials that will significantly increase R&D cost or anything like that?

speaker
Håkan
Chief Financial Officer

No, that's right. We're not. I think it's fair to say that we have a tradition to communicate such initiatives in good time in advance.

speaker
Emil
Chief Executive Officer

Yeah, I mean, there's no hesitation to invest, but it's rather three, four people in different slots of the commercial or central organization that wouldn't have that kind of pivotal effect. So you also have the question on how confident are we on accelerating the sequential growth in U.S. dollars? And I assume you refer to Cerement GE. So such a breakthrough and pioneer product is going to be an intensive launch phase for the first 60 months. It takes about five years to really be actively launching the product. And then you have to nurture and continue to build the customers. What we see today is it's an everyday battle. Every day battle to get the attention from the surgeons, every day battle to convince them to go through the science, go through the clinical studies, use the product and then follow up on the product. And unfortunately, we're not alone in the marketplace. We are one of the smallest players, but we're one of the fastest growing players. There are some gigantic sales teams out there from big orthopedic companies, and it happens that just by force and total assortment, they convince customers to switch back to older kinds of orthobiologic products, even like bone cement, when it is given to them as part of a package deal when the customer buys robotics, hardware, metalware, knee implants, and all other things. The KPIs that we follow, with the exception of sales, of course, sales is one of our main KPIs, is how many doctors we convert, how many hospitals that put us on listing, and how many protocols we show up in. But over the first five years of launching a product, we will win accounts and we will lose accounts. But overall, it's like stopping a tidal wave. We are winning almost every head-to-head comparison with any of the other products out there. So by commercial muscles, sometimes we lose an account and sometimes we win an account. But in the long term, we are strongly convinced that Cerament will become a major part of standard of care. As we are opening up more indications, as we are increasing also loyalty with customers who have used Cerament, maybe being convinced by one of the big orthopedic companies to switch back to an older therapy and noticed they don't get the same results. So they're switching back to Ceramid. As all these dynamics will stabilize, I am sure that we will see also an acceleration in our growth from Ceramid G versus a rather linear trend that we have seen over some of the recent quarters. Again, a long answer again. Sorry, but hopefully it was clear.

speaker
Operator
Operator

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

speaker
Sten Gustafsson
Analyst, ABG Sundal Collier

Good morning. A few questions here. Firstly, on the hip and joint potential you talked about, just maybe a clarification, is that part, those patients, are they part of the sort of the addressable market that you have talked about in the past of around 50,000 infected and 90,000 for prevention use, or is this incremental new potential procedures that you will target going forward? And if that's the case, what does the timeline look like? When will you start to address those potential procedures?

speaker
Emil
Chief Executive Officer

Thank you, Stan. The procedures related to infected prosthetic joints is part of our total addressable market as we have identified it. However, we have not done so much efforts in this area. So it's a rather untapped area within the total addressable market. Why have we not? Well, When launching a breakthrough product like Cerament G, the surgeons will try the product in various different ways. And we are trying to take the lead to explain which protocols, which manuscripts we believe will work the best in different applications technique for the different surgical techniques. There are so many different surgical techniques that exist. Many of them have the last name of the person who invented them. And we have to adapt many times how to use the product to fit different techniques. In PJI or in joint infections, there are several doctors that are now starting to use the product very intensely. And what we can tell, they have also very strong results. But we don't have any published clinical study with a clear instruction on how have the study authors used the product which techniques have they used to arrive at the conclusions and the results they have so when that comes hopefully now after summer in a published way we will have the chance to further explore this group and we expect a strong market penetration then Local antibiotics is used preventively for joint surgeries. This is a huge market but we don't have that on label yet. So we have actually excluded that from our total addressable market. Of course there might be surgeons that decide that they have such good results with for their infected joints that they decide also to use it to prevent the infection from even establishing. But this is something that we have to pursue more long term to also broaden the label into prevention of joint infections. and then it will be a significant increase to the total addressable market. But this is something we will have to come back to because we don't have clear plans to communicate on these steps yet.

speaker
Sten Gustafsson
Analyst, ABG Sundal Collier

Thank you very much for that clarification. My second question would be on I think you mentioned in the text, and correct me if I'm wrong here, but you talk about reimbursement, positive reimbursement changes in the U.S. and whether or not you see a potential there for raising your prices. I think we talked about this in the Q1 as well, but maybe you know more today on that topic and also on the NTAP. if you could just remind me on the net effect of the MTAP for the two different parts. Thank you.

speaker
Emil
Chief Executive Officer

Yes, so we're positive to see that CMS has made a proposal, a proposal to basically themselves. They make the proposal and they also make the final decision in August. They made a proposal in general to increase the the diagnostic-related group codes, so the reimbursement codes for orthopaedic extremity surgeries with 6% effective 2026. This is an increase which is close to twice as much as they've had previous years. it shows that there's a broader understanding and recognition taking place that orthopedic surgeries actually do have a very positive impact on total health economics because the patient comes back to mobility and to a normal life. So we are looking constantly at raising prices and we do that in different ways. Whenever the market allows and would accept a raise price, we will take that opportunity. So not specifically related to higher reimbursements, but related to what we believe that the health care can carry in terms of cost related to the benefits that we provide. The end type that has been proposed is on open trauma. So before we've had an NTAP which was on infection, meaning if there was an infection present. And the NTAP that is now being proposed is for the use of Sermon-G preventively. We do believe that NTAPs on prevention is slightly more relevant than if you have an infection. Why? Because if there is an infection, you probably had also quite a severe injury. The codes, the DRG codes, the reimbursement codes will be high as they are. While prevention is... The codes does not reflect that you have an infection because the infection hasn't started yet. So an NTAP will, of course, function for some surgeons as a tipping point of making the choice to do effective infection prevention versus hoping for the best. The prevention NTAP in open trauma will be decided in August and be effective from October if the decision is positive.

speaker
Sten Gustafsson
Analyst, ABG Sundal Collier

Just a follow up. So on the on the ANTAP for already infected patient, which is in place today, do you see a chance that that ANTAP will remain? Because I think that's about to disappear. Is that correct?

speaker
Emil
Chief Executive Officer

Yes, there is a discussion with FDA. So there's a discussion with CMS. I'm mixing them up. There's a discussion with CMS, of course, to, I use the word to permanent the codes, but what it basically means that those specific codes where NTAP has been used, because the DRG codes in themselves was rather low in the past, we are pledging and pushing for those to get a permanent increase. And CMS has been a bit overwhelmed with administrative work recently, so we have not received answers. And that's fine because the final decision will be taken also in August, which is next month. Which codes and if there will be a permanent increase to accommodate an innovative product like Cerament G? Historically, we have seen both rejections of when the NTAP has disappeared. There have been rejections of raising the codes. And we have seen acceptance when it comes to other innovative medical devices. So we couldn't give any forecast or read out on the observations we have so far from the conversations, but have to wait probably another one and a half month before we will have a final decision from CMS.

speaker
Sten Gustafsson
Analyst, ABG Sundal Collier

Okay, thank you very much for that. I'll get back into the queue.

speaker
Emil
Chief Executive Officer

Thank you, Stan.

speaker
Operator
Operator

The next question comes from Eric Castle from Danske Bank. Please go ahead.

speaker
Eric Castle
Analyst, Danske Bank

Hello, good morning, everyone. First question on ServantV. Now, given that the FDA has returned with some questions on that, how do you see the likely timeline for getting that to market?

speaker
Emil
Chief Executive Officer

Oh, that's a million-dollar question, or even more, I would say. It all depends on FDA, actually. They have undergone quite some disruptions with the entry of the new U.S. administration. Now, Sermon V is a breakthrough device, and I must say that the contacts we have had on FDA have worked diligently through the extensive material. So once we get the approval or final notification from FDA, we will need a couple of months for production. So we are not producing these products in advance. The reason is that even though it's a 510K using Sermon G as a predicate device, it is a breakthrough therapy. It is one of its kind. And it will come with very strict quality controls, batch controls like we have today. I think I've shared with the market that every batch we produce on Cerament G, we have to do specific measures and control parameters related to, among other things, the elution of antibiotics. And if we have similar demands for Cerament V, it will be difficult if those products are already pre-produced. So let's say best of case, we answer the questions in November and there's a fast process. I couldn't speculate on that, but theoretically, then we would launch somewhere in the first six months of 2026. Okay, good.

speaker
Eric Castle
Analyst, Danske Bank

Thank you. Then I wanted to understand the setup for sales and distribution a bit more on spine and sort of what commissions we are to expect and really just anything you can share on the likely setup you're going to go with for selling in Spine. Absolutely.

speaker
Emil
Chief Executive Officer

So very few of our existing distributors cover both extremity and spine there are a few and we will work with them but mainly what we have is calls incoming calls from distributors completely specialized in spine and spine instrumentation and they have heard about a sediment they've seen sermon they have surgeons that have requested it In top of that, we are reaching out through our networks to a few of these very specialized spine distributors. They are independent distributors. So we're not signing up a partnership at this stage with any large sales team. It will be independent distributors that have between three sales reps, maybe up to 30, 40 sales reps. and the commission will be on the same, the price of the product will be the same as an extremity and the commission will be the same as we have an extremity. We have validated this and we've already had discussions with distributors and given that CEREMENT has such strong documentation in extremities and such strong and evolving and growing reputation, the commission will be the same between the two indications. So around 30% plus minus 5%.

speaker
Eric Castle
Analyst, Danske Bank

Perfect. Thank you. And then just the last question, a housekeeping one, we can call it. There seems to be a lot of confusion on the FX effects now as well. You know, seeing FX negative 18% on sermon G in the U.S., where isn't really how the USD SEC has developed year over year, but I understand there's some special effects there. Can you just get it? Can you sort of explain it so I have it on the books, how that sort of FX effects work?

speaker
Håkan
Chief Financial Officer

So again, somehow doing this very technical, Eric, is that somehow all the financials, somehow we take the translation of revenue and cost is down by using the the yearly average fx rates and then the reported quarter is the year-to-date less previous reported quarter and that somehow gives us an impact somehow more or less or equal to the average fx rate in the the reported quarter so it becomes a bit technical and somehow you have to work the numbers when you compare the the various years to to uh uh uh understand the movements in between. And that's why also, again, somehow we took the opportunity today to show the revenue graph in US dollars as well when it comes to the US.

speaker
Eric Castle
Analyst, Danske Bank

All right, great. Yeah, I appreciate the USD graph that you showed. I'll jump back in the queue. Thank you.

speaker
Emil
Chief Executive Officer

Yeah, thank you, Eric. So it is indeed a bit confusing also because the dollar is swinging pretty rapidly, but you can rest assured that the numbers we share with you are all audited. Okay, so I think possibly we have room for one more question before we break this up. Are there any more questions online?

speaker
Operator
Operator

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

speaker
Maria Vara
Analyst, Stifel

Hi, good morning. Thank you for taking my question. Maybe a very last one question could be, what is the price in that respect for Ceramen BVF when we launch it in Pine in the US? Could we think about a similar range to what you're charging for extremities and if this is under any kind of reimbursement code?

speaker
Emil
Chief Executive Officer

Yes. Thank you, Maria. What a lovely way to finish this session. So the price, the weighted price for Cerament BVF is around 2,600, 2,650 US dollars. And that is a blend of the three different sizes that exist. It's the five millilitre, it's the 10 millilitre and it's the 18 millilitre. Before we announced that we would go into spine procedures, we did extensive market research, and we have continued with that market research after the announcement that we did at the end of 2023, where we have had big focus groups and also advisory boards, and we've done general surveys and market research to see What is the price that would be accepted for this kind of product? And it has landed that the price between spine and as we charge an extremity would be the same, namely an awaited average around 2600, 2650. When you look at the reimbursement codes, they're quite generous in spine. but it also depends on the severity of the injury or the intervention. So let's say there's a spinal fusion, an interbody fusion, or it's a posterolateral fusion. They both come with codes that have no problems to accommodate cerament BVF. If we look at scoliosis, for example, big codes, big reimbursements. So we don't expect any pushback. We've also done on price. We have also compared our intended pricing point with what is common in the market. And we have got also that confirmed that we are on the right level. And then. in the future, well, something we will have to come back to when all that material is in place.

speaker
Maria Vara
Analyst, Stifel

Thank you. Very clear.

speaker
Emil
Chief Executive Officer

Thank you, Maria. And with that, I think we wrap up this session and thank everyone for taking the time to call in and listen to our presentation on quarter two. And also would like to wish everyone a nice summer and thank you for the great work that we've had together during my seven and a half year as CEO for Bone Support. Thank you and goodbye.

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