Welcome to BONESUPPORT Q1 2025. For the first part of the conference call, the participants will be in listen-only mode. During the Q&A 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 Emil Billbäck and CFO Håkan Johansson. Please go ahead.
Yes, thank you, Operator. Good morning and welcome everyone to the BONESUPPORT Q1 2025 result call. My name is Emil Billbäck, and I'm making this broadcast, as always, together with Håkan Johansson, our CFO. We will use the next 25 minutes to go through the presentation of the first quarter results, and then we will open up the line for questions and answers. Let's go first to slide two. Before we start the presentation, may I just draw everyone's attention to covering any forward-looking statements that we might do today? Now, let's get into it. Slide three. Let me begin with some of the highlights from the quarter. Quarter one 2025 was another strong quarter for BONESUPPORT, with solid execution across the business. Net sales came in at SEK 284 million, corresponding to a growth of 54% versus quarter one last year.
This is 50% growth at a constant exchange rate. The quarter saw some quite dramatic swings in the U.S. dollar to Swedish krona ratio, which had an impact on the reporting operating profit. Later in the presentation, Håkan will show the details on this and the very strong normalized underlying profit development. The operating cash flow was SEK 40 million in the quarter as a result of the solid performance in the business. Moving to the highlights of the quarter operationally, we continue to see strong traction with CERAMENT G in the U.S., with an emerging base of trauma surgeon customers. Sales reached a record SEK 178 million for the quarter. Another key highlight was the submission of our CERAMENT V application to the FDA. Shortly after the quarter, CMS published their proposals for revised reimbursement codes to come into effect in October this year.
We are pleased to see CERAMENT G is proposed to receive incremental NTAP reimbursement of $5,688 for use in open trauma. We will cover all of these topics in greater detail during the presentation. Let's now move to the sales development. Next slide, please. This chart shows total last 12 months' sales in Swedish currency every quarter since early 2018 in stacked bars per region and product category. As you can see, the launch momentum for CERAMENT G in the U.S. continues to accelerate, despite the long conversion cycles inherent in changing the standard of care for a sophisticated orthopedic product, where each surgeon must undergo training before being allowed to use the product.
We are seeing a powerful trend, meaning a high level of repeat usage and expansion into additional indications among existing customers, at the same time as there is a steady flow of new users. Now, since we're working with a product that saves not only arms and legs, but also lives, it is, of course, gratifying to see that Professor Lars Lidgren's unique invention, intended to transform an outdated standard of care, has now almost reached SEK 1 billion in the last 12 months and still only scratched the surface of its full potential. In total, with U.S. and Europe combined, the antibiotic-eluting sediment was growing with 72%. Let's go to the regional specific slide, starting on the next page. In North America, in quarter one, sales reached SEK 231 million, which corresponds to a growth of 63% compared to quarter one 2024.
In constant exchange rate, that would be 59%. CERAMENT G sales amounted to SEK 178 million, which is a year-over-year growth of 92%, basically driven by continued adoption and a clear pickup in trauma. If we look at some of the highlights in the quarter, at the AAOS meeting, the American Academy of Orthopaedic Surgeons, that meeting was held earlier this year, and BONESUPPORT hosted a well-attended satellite symposium focused on bone infection, featuring a European professor with deep expertise in trauma-induced bone infections. In addition, there were several trauma patient cases presentations from prominent U.S. trauma surgeons. Their real-world cases showed excellent results, mirroring the positive patient outcome seen in large-scale published clinical studies from, among others, Manchester University Hospital. We're seeing a strong growing interest among trauma surgeons, especially those dealing with severe injuries from, in example, traffic accidents, where infection risk is high.
Many of these surgeons have not previously used any local antibiotics, mainly due to the lack of FDA-approved options. CERAMENT G is now filling that gap and expanding their infection prevention toolkit for a large part of the market. As mentioned earlier, CERAMENT V market authorization request was submitted to the FDA at the end of the quarter. This is an important step in providing surgeons with a broader range of local antibiotic solutions, especially in the face of rising antimicrobial resistance and the awareness of proper antibiotic stewardship. The submission is based on a very comprehensive data package, including CERAMENT's mechanism of action, bone remodeling data, biocompatibility, and elution data, supplemented with specific CERAMENT V patient data.
The submission is tailored to meet the very strict and unique special controls that FDA has defined for the product category antibiotic-eluting bone void fillers, which was created in May 2022 with the approval of CERAMENT G. These special controls create high demands on clinical effectiveness evidence for entry into such category. I mentioned that CMS is promoting NTAP for CERAMENT G of $5,688 in open trauma. In the April publication, it was also encouraging to see that CMS is proposing a general uplift of the DRG code, which means the reimbursement codes for orthopedic surgery in extremities. This proposed reimbursement increase for 2026 is 6%, which stands out versus the historical average of between 3% and 4%. Both topics are pending final decision in August. Let's go just shortly to the next slide.
To wrap up the U.S. section, we wanted to share the sales development of CERAMENT G with sales in U.S. dollars since the product was launched. Naturally, the official reporting is done in SEK, so this slide graphically displays the increasing trend in the original currency without any distortion of currency swings. The trend seen here is very strong and is representative of the number of procedures done with CERAMENT G in the U.S.. Let's now turn to Europe and the rest of the world. Sales in Europe, which is Europe and the rest of the world, came in at SEK 52 million, representing a growth of 22%. This would be 21% at constant exchange rates. We continue to see some short-term structural disruptions in certain healthcare systems, mainly in Germany and in the U.K.
The strains on staffing lead to regional limitations in market access. In the U.K., we saw a lingering effect in quarter one 2025 from the late 2024 programs, where political priorities had the NHS direct surgical capacity away from areas relevant to our current indications. Despite the regional swings in surgical volumes, we note that CERAMENT is growing five to six times the market growth and is steadily gaining market shares on both synthetic bone grafts as well as on autograft. In several of the markets where CERAMENT has been introduced over the last couple of years, we are seeing a rapid adoption once surgeons see the clinical impact and the improvement in patient outcome by themselves, so first-hand experience.
Now, to support the transition to a standard of care which includes CERAMENT, we have launched a Euro booster program modeled on the successful hybrid approach used in Spain and Italy. We plan to add about 10 full-time equivalents to drive penetration in underpenetrated markets with large potential. Several of the key recruitments in this program took place in quarter one. We have been granted market authorization for CERAMENT V in Canada, and we expect to launch CERAMENT V in Canada during quarter two. This achievement demonstrates our ambition to offer the complete portfolio in all markets where we are present. With that brief overview, I will hand over to Håkan to bring us through a more deep dive into the financial data.
Thank you, Emil. Net sales improved from SEK 184.4 million to SEK 283.5 million, equaling a growth of 54% in reported sales or 50% in constant exchange rates.
Emil has already spoken about the strong performance in, especially the U.S., and the major drivers behind the sales acceleration. Let's move to the next slide. The contribution from the North America segment improved with SEK 41.3 million and amounted to SEK 97.1 million. The improved contribution relates to increased sales after the effect from increased costs. Sales and marketing expenses during the quarter amounted to SEK 121.6 million compared with SEK 78.4 million previous year, of which sales commissions to distributors and fees amounted to SEK 78.8 million compared with SEK 47.8 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 and amounts to 95%. In Europe and the rest of the world, a contribution of SEK 15.4 million was reported to be compared with SEK 10.7 million previous year.
Sales and marketing expenses increased with SEK 2.5 million, including SEK 1.8 million related to the previously communicated commercial investments in the Euro booster program. From the lower graph and orange marker, a minor drop in gross margin is noted following a higher share of indirect sales in the period. The increase in selling expenses reflects the investments made in both the U.S. and Europe and also the investments in organizations as well as in systems to improve customer handling and inventory management to stay ahead of the increasing demand. R&D remained focused on the execution of strategic initiatives such as Spine and the planned market authorization submission for CERAMENT V in the U.S.. These initiatives have been progressing well during the quarter, which explains the increasing spend compared to previous year. Administration expenses, excluding the effects from the long-term incentive programs, remain on a stable level.
The reported operating profit amounted to SEK 29.6 million and was substantially impacted by unfavorable currency effects, totaling SEK 30.4 million, of which SEK 27.6 million are unrealized. I will come back to this in the following slide. The difference between adjusted EBIT and reported EBIT operating results are costs regarding the long-term incentive programs amounting to an expense of SEK 10 million in the quarter compared with SEK 9.3 million previous year. Following the mandate from the AGM in May 2024, a share swap agreement was entered into during the end of last year to secure the commitments within this incentive program. The difference between fair value and value of the equity swap agreement is reported as a financial liability and included in net financial items with a negative effect of SEK 15 million.
Cash conversion remains solid with a third consecutive quarter with strong cash flow and an increase in cash position during the period of SEK 40 million. During the period, the Swedish krona has strengthened against the U.S. dollar, euro, and pounds, with the largest strengthening effects related to the U.S. 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 SEK 30.4 million, of which SEK 27.6 million is unrealized. Simply put, the negative SEK 28 million is mainly driven by the operating assets in the U.S., such as inventories and trade receivables. These are originally valued in U.S. dollars at the end of the quarter and translated into a much stronger Swedish currency versus the last quarter. The term unrealized means that it's just an effect from updating the valuation of our assets.
The graph on this slide shows, with the gray bars, how the relationship between the U.S. dollar closing rate and the Swedish krona has varied over time. This is read out on the right Y axis. The dotted line read out to the left Y axis shows reported adjusted operating result. The adjusted operating result, excluding translation exchange effects, is the orange line. In Q4 2024, the U.S. dollar to SEK rate was just above SEK 11, which gave a positive effect of SEK 20 million, and therefore the blue dotted line is above the orange line. In Q1 2025, the U.S. dollar to Swedish SEK rate was SEK 10, creating a negative impact of SEK 30 million, meaning that the blue dotted line drops below the orange line. The orange line eliminates the translation exchange rates and gives a more comparable view of the underlying trend in operating profit.
In the table below the graph, you can see the FX adjusted operating margin of 24.6% in the period compared with 22.6% in Q4 of last year. To round off the financials, a few words on the tariffs. As communicated in a separate press release, tariffs are not estimated to have a large financial impact. The cost of sales in the segment North America well reflects the import value to the U.S.. With the assumption of the current 10% tariffs, gross margin would hypothetically drop from 92.6% to 91.8%, with a total estimated financial impact of SEK 2.2 million in Q1 2025. With this, I hand over back to Emil.
Thank you very much, Håkan. Let me then wrap up this presentation and summarize a bit.
BONESUPPORT had a very strong start into 2025, well above our guidance, with 54% reported sales growth in the quarter, which then was 50% at constant currency. The continued success of CERAMENT G in the U.S., with emerging momentum in trauma, the FDA submission of CERAMENT V, market share gains in Europe, and strong cash conversion all speak to the strength of our business model and our execution. In a rather tumultuous world, BONESUPPORT continues to perform solidly and steadily, gaining ground hospital by hospital and surgeon by surgeon, converting an outdated practice into a technically advanced and unique bone healing concept. We remain financially strong and committed to expanding into new geographies and indications, and it is with high confidence we view our guidance of sales above 40% this year and with equally high confidence that we view the journey ahead.
With that, I would like to end this presentation and 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 Matthias Vatsten from SEB. Please go ahead.
Good morning, Matthias Vatsten from SEB. I have a few questions today. Take them one by one, I think. First one, just to touch base as usual, a little bit on the penetration. I wonder how many hospitals out of the total that you address with CERAMENT G right now. Also to this, I think we touched on it in previous calls, but regarding the extent to which CERAMENT G is expanding the actual market.
If you could say anything around what share of surgeons today using CERAMENT G that previously had not been using local antibiotics at all in the past. This is the first question.
Yeah, thank you, Matthias. When it comes to exactly how many hospitals we have met and introduced CERAMENT G to, we are not sharing that data. The reason is that in certain quarters, that number could be quite high, which means that the following weeks, the sales reps are working diligently with the staff at those hospitals to implement the concept. That means that the next quarter could then be very low in terms of new hospitals. The third quarter, possibly it takes off again. It is at this still early stage of the launch. I know it can be puzzling to hear that it is still early stage. It really is.
I can share we have trained a bit more than 1,000 orthopedic surgeons on the concept, on CERAMENT G, out of a total of around 20,000. This launch will continue for a long time. Possibly when these parameters start to even out a little bit and become a bit more straight lined, we will share the data. We still think it's too early now because it creates a volatility. What I can share with you is that of the surgeons that have come on board starting to use CERAMENT G since January last year, so from January 2024 up until now, approximately 15%, one five, 15% of those that we have interviewed and enrolled in service have not used local antibiotics before.
That number is slightly higher than we anticipated, which shows that when there is a product approved by the regulatory authorities, in this case FDA, it opens up for broader and more extensive use by surgeons that either by themselves or by the protocol of the hospitals previously have not been able to use such therapy. I think for you, Matthias, of course, very competent together with your colleague, if you look back at pharmaceuticals or medical devices in history, whenever there's a regulatory approval, usually the market that these products play in also gradually is actually increasing because there is a more easily accessed and well-documented therapy options for those patients.
Thank you. I think that's very interesting. The second one on NTAP on open fractures. Any assessment on how long this will last if it is approved?
If you could also remind us on for how long the NTAP on osteomyelitis will last. Also, when you expect the approval for CERAMENT V in the U.S..
Wow, three great questions. Let's start from top to bottom. The NTAP that we have been proposed for will have a final ruling in August. I think we know that it is very, very seldom that what is proposed by CMS will not get through in a final decision. I actually have not seen any cases so far. Passing that milestone in August, the NTAP will start to be valid from 1st of October this year, and it will last for two years forward.
Before going to the next question, I just would like to point out that it's quite an exceptional level of NTAP that we have received because we're talking about open trauma, meaning where the antibiotic is used preventively. If you have a patient in front of you with a severe infection, then you usually have quite high DRG codes and you have a strong incentive to use it. We actually think this is quite exceptional. Get proposed an NTAP for preventative use of such a new breakthrough therapy. The osteomyelitis NTAP is expiring in October this year, or sorry, in September because the new codes are valid from October. That means that after September this year, there will be no more NTAP for CERAMENT G in bone infections.
We are in a process right now in discussion with CMS to make sure that the existing codes, the existing DRG codes, are at the level where an NTAP does not have to be needed for bone infection. That means that we have filed proposals to see permanent increase in certain DRG codes specifically related to where CERAMENT G is used. As you know, when an NTAP expires, either it disappears completely or if you have good data, you can get the permanent increase of code. Sorry, I actually lost your finding. Sorry, no, you asked about CERAMENT V. That is the most difficult one, is it not right now? Because normally, even under stable circumstances, I would not dare to speculate on the timing of FDA. Given the turmoil right now between FDA and the rather new U.S. administration, I think it is almost impossible.
If I say that a normal review process of something like this would be anywhere between 90 and 180 days, if it's a breakthrough therapy, possibly a little bit on the longer. Of course, given on how functional FDA is in receiving new applications, we don't know actually. We just have to hope and it goes through an effective and diligent process. I can tell you that I have a great organization who has really put strong efforts into this submission, which I believe is of very high quality.
Thank you, Emil. That's probably where more than three questions, but thanks for all the answers.
The next question comes from Sten Gustafsson from ABG Sundal Collier. Please go ahead.
Thank you. Good morning, everyone. My first question is regarding CERAMENT G in the U.S. and what type of traction you received among trauma surgeons.
If you can somehow break it out, how much of the growth is coming from that segment would be very helpful, or if you have any other comments on it, how the launch into trauma surgery is developing. That would be my first question. Thank you.
Okay. A piece of the last part of the question there, we could not hear it, but let me start anyhow to address your question, and then I think you can follow up with what you would look for. We cannot tell you how much of the business is on trauma. We have decent visibility on that when we get the reimbursement codes and the case sheets. What I can tell you is that it is quite an interesting dynamic.
When we promoted CERAMENT G to doctors that constantly treat infected bone, they have a very obvious need in front of them and a patient that might run the risk of an amputation. When we come to a trauma surgeon, it's a big difference if this trauma surgeon has experienced a recent infection, which they see as a failure, then they are very open to trying new things, to sit down and to discuss CERAMENT G with us. If it's a surgeon that has not experienced a bone infection in quite a while, there is likely less interest. It shows that we have to be on our toes and we have to meet as many trauma surgeons as possible in a short period of time because we need to catch them when they are open to discuss new therapies.
Of course, with the NTAP that we received, we will have a very strong argument now also to work with the surgeon as well as administration and the billing specialist at the hospitals. First reactions I can tell you about the market dynamics is that we have to meet more trauma surgeons before we find the ones that are really interested. The ones that are interested show a massive interest and very quick adaptation of the product. It seems as if we have really brought a product here that fulfills a need that had stood open as a white sheet of paper, an unmet need for many years, and it slots perfectly into the concerns of those surgeons that have patients with rather big trauma where the infection rate is high.
I know you wanted to know more also how big of the current sales is specific to trauma. It's still quite a small part since this is a group of surgeons that we have had very little interactions with in the past. Many of them have never even heard about CERAMENT, but we'll have to come back at a later stage if we want to share also how the CERAMENT G sales split into different indications. It's still very early in the launch, and hence it could be some volatility there that could be misinterpreted. Let us come back to that. Let's see, there were more in your question there where the line broke up maybe. Did I miss something?
No, I think I can't even remember my own question then, but I think that's good. Thank you for the comments you gave there.
Another question is regarding potential pre-buying during Q1 due to the tariffs. Do you think that could be one explanation for the strong growth that hospitals pre-ordered ahead of tariffs?
Yeah, thank you. Yeah. Maybe if you forgot the previous question, it's because I talked too much, so I apologize. There hasn't been any pre-orders. I can say that 100%. We send products to hospitals when the product is to be used. The hospitals don't have the system when it comes to CERAMENT or the space or the finances to buy products. We have also not announced any price increases that would trigger such behavior. Quarter one has very normal trading.
As I alluded to a bit in the presentation, the very solid and strong growth rate, which is actually the percentage growth rate is up versus quarter four last year, is due to hospital by hospital, surgeon by surgeon, patient by patient, and use of the product.
Excellent. Thank you very much. May I squeeze in a follow-up question maybe on Matthias' NTAP question there? It is regarding the expiration on the osteomyelitis. Do you see a risk that your sales development will be negatively impacted by the expiration of NTAP unless you get a permanent reimbursement in place?
That is difficult to say. I'll try to answer short if I'm capable. I don't know. I seem to. We should remember that the Medicare, CMS Medicare NTAP relates to about 17% of the population.
Let's say half of that is in hospital and half of that is outside hospital. That leaves the NTAP that is disappearing now in October, about 8.5% of the population. If we then just assume that 50-60% of those patients are actually in quite bad shape, so there is a high DRG code to start with, the NTAP becomes a tipping point only for a few percentage points. I think if you are a doctor and you have worked with a product and you have seen the results, I think you are in complete disregard if there is an NTAP or not. The NTAP can maybe help you to get the first try. If you have used the product and seen the results, the strong ethical care that a doctor has for their patients will let them continue to use the product.
If we do not get any permanent codes and it is completely vanished, yeah, maybe a few percentage points maybe on sales could be influenced over time or let's say slightly slower in those specific segments, but the recruitment of customers and the ramp-up of trauma and other areas is so strong. I actually do not know if any of us will even notice it. I think in open trauma, it is slightly different with the NTAP because here we are talking about preventative use, meaning to add just to ensure that you do not get an infection, which has a slightly higher meaning.
Okay. Excellent. Thank you very much for the comments there. Excellent. I will get back into the queue.
The next question comes from Oscar Bergman from Redeye. Please go ahead.
Morning, guys. I have three, four questions that I will ask you one by one, and you can answer them.
The first one, I know we're all very interested in the dynamics between bone infection and trauma sales in Q1, but I'm not going to get anything out of you if I ask the question you upfront. Instead, I wonder if you can elaborate more on the main differences between your opportunities and challenges in these two indications.
Yeah. You're right. We're not going to share the information, but we'd be happy to speak a little bit about the market dynamics, which is fascinating. When we speak about an existing infection, it's many times induced from a trauma. There's been a trauma, and the patient comes back, and the patient is in bad shape. The infection is maybe spreading and is in an acute stage.
The doctor will, in some cases, feel a bit hopeless in terms of tools to use for eliminating the infection, repairing the bone, and restoring the patient's health. There is a very high motivation to address the bone infection. There is a high motivation to try new products because when the infection occurs, sometimes the doctor has already tried other options, and they are running out of therapies. The potential in preventing an infection, let's say it like this, the traditional what we see in medtech and pharmaceutical is that the prevention market is usually five to six times bigger than the treatment market. If we look at the current circumstances in the U.S., I think it is only a ratio of one to three. We believe the prevention market could grow significantly.
For that to take place, there has to be a product, and now eventually there is with the regulatory approval that we have received. You have to catch the doctor when they have the. If they do not have a concern about infection, then they are not willing to listen to the product that we offer. Every surgeon almost that does trauma will have patients where there is a medium risk or a high risk for infection. It means that when we look at our structure, we would like to possibly work with even more distributors, more sales reps to have even broader coverage because we have to pop in more often. We have to counter those surgeons more often. As you know, with our model, that does not come with extra cost because the cost only shows up as commission when the product has sold.
Here are some dynamics that we have reflected upon. The opportunity is very large, and it raises some demands also on us to have these very frequent visits with trauma surgeons to make sure we catch them at the point where they have patients with concerns. The trick really is to have a surgeon try the product for the first time. We know when we get to that point that they will have most likely a positive experience on the patient outcome.
Okay. Thanks. To what degree would you say orthopedic surgeons are conducting both bone infection treatment and trauma infection? Is this mostly the same surgeons, or are they typically focused on one of the two? Can you elaborate more on the dynamic or customer base if there is a scenario in which the surgeons are focusing on both?
They're focusing on both, but what we should just separate here. There are specific surgeons taking care of foot and ankle. If they then have a big population of patients with diabetes, they have infection rates between 20-30%. They see frequently a lot of infections. If you're a trauma surgeon and you have a trauma-induced infection, you are the person then to take care of that patient because the patient should stay with the doctor. If you only take care of maybe closed fractures, less trauma, maybe the infection rate with those patients is 2%-3%, 4%, maybe 2%-5%, which means you don't see a lot of those infections and it's not the biggest concern.
If you're on a level one trauma center, a big trauma center at one of the larger hospitals, you will see a lot of open traumas and you will see a lot of infections. You are also the same surgeon that will take care of those specific infections. Within trauma, it's the same doctors. In foot and ankle, it's the same doctors, but there's no crosslink in between those.
Do you see a difference in success rate if you are targeting a customer base with CERAMENT for trauma for customers who already use it for bone infection? Are you more likely to succeed with those surgeons?
Yes, without any doubt.
When we have a trauma surgeon that has used CERAMENT G to treat infections that that surgeon has experienced with patients that they treated maybe a couple of weeks earlier for trauma, the adaptation rate is very high. They immediately start using the product. Most trauma surgeons that we know that have infections see it as a very frustrating consequence of not having treated the patient correctly. That's emotional. Of course, they can do the best they can for the patient, but all the surgeons we know, they will anyhow see an infection as a bit of a failure. If there is a chance to avoid those failures, they are very willing to go ahead and do so.
Okay. I understand that trauma sales is a bit more tricky than bone infection sales.
Just wondering if there's a risk of a pushback on price for trauma in higher risk than it is for bone infection. We haven't seen that.
No. I wouldn't say it's trickier either, actually. It's just a slightly different dynamic. It is a dynamic that we embrace and that we feel very comfortable with. There's not much pushback on price, I would say, with trauma. We're talking not about just, say, a broken finger. We're talking about some quite bad accidents, and the DRG code by themselves are quite elevated and high. Of course, the trauma surgeons are usually quite independent and work with high discretionary authority. They have the life of a patient in their hands. When they say, "I will use CERAMENT G," they will use CERAMENT G.
Okay.
You mentioned also that maybe you would have to look into broadening the number of sales reps and distributors. Do you think there is a scenario in which you increase your commission rates or your distributors increase their commission rates? No. The product CERAMENT G fulfills such an obvious need in the market. We do not have to scout the market for distributors. They come to us. This is a product that salespeople see that it has a clear place in the market, and it is unique, and it is the only approved product. No, nothing like that. Very good to hear it, Emil. I just have a final question before I head back into the line. Is there anything you can share with us regarding the launch of CERAMENT BVF into spinal fusion?
How are you looking into early-stage activities for getting CERAMENT G and V potentially approved also for spinal fusion?
Yeah. On spine procedures in general, where fusion is one out of a few, we are doing preclinical application studies. Several of those have been completed. They were completed during spring and are now sent to laboratory for detailed examinations. In early April, we started even more preclinical trials. We want to be very thorough when we go to market. It is all in movement, one could say. A lot of very interesting findings. I think we'll stick to the timing there that early autumn, we will come back and also share details. There will be a more detailed plan in early autumn, both on CERAMENT BVF and also on CERAMENT G and potentially V.
We will provide you with an update that will articulate both timings and cost and potential to a bit more granularity than what we have done so far. We need to wait for these preclinical studies to give the full results before we feel confident to commit to those plans in the public market.
Okay. You mentioned that your distributors, they seek you. Is this something that you have experienced also for spinal fusion?
Yes, indeed. Yes. Yes, indeed. Here we're actually holding off because we have a very specialized, we have a special protocol on how we want to do these things. We do not want to go to market without having a toolkit of those variants and applications that the doctor will use, and also a complete set of manual on how to use the product.
Because we have a responsibility that when our product goes into the body of a patient, that the surgeon does it in a way that it is successful both for the surgeon and the patient.
Okay. All right. Thanks. Sounds very good. Talk to you later.
Thank you.
The next question comes from Kristofer Liljeberg from Carnegie. Please go ahead.
Thank you. Hi. Four questions, trying to be quick here. First, I want to hear your view about the potential to accelerate the sequential sales increase in the U.S.. If we look at the trend there in the last three quarters, that seems maybe to be about to happen, but we'd like to hear your view on that. Then, given the uptick here in reimbursement, do you see a potential to increase price, maybe to compensate a bit gross volume for the lower U.S. dollar?
I was just interested to hear about the U.K. and the issues there. Do you still grow in the U.K. business, or is sales there down or flat? Finally, if you could say something about R&D costs here coming quarters. Was up a bit sequentially. Will it continue to be sequentially higher coming quarters, or is this a new more level where you will be this year? Thank you.
Thank you. Yeah. How do we step up sequential growth of CERAMENT G? We're a little bit here at the, how do you say, the influence of the healthcare system. I actually think that as we are growing, growth will also be our biggest friend on the trend.
The more surgeons that start to use CERAMENT G and have positive experience will also be an ambassador to speak to his or her colleague in the same hospital or nearby hospital. We're also looking at how can we meet the market. Many of the surgeons that we are promoting the product to are quite stressed, high workload. We try to find ways how could we get their attention in the very strong noise of information that they're flooded with every day. We are increasing also distributors. We are increasing sales reps. We are also looking at different ways of training the distributor reps in the U.S. to make sure that we are creating ways of seeking out the attention of these trauma surgeons. Let me give you an example. I was in the U.S. already a couple of times this year.
When our sales rep comes to visit some of these high-level users, there could already be two, three reps waiting outside the office or waiting outside the operating theater. There is a noise that we constantly have to break through. There has not been a lot of innovation in this area. We had to really catch their interest and explain and make them understand that this is a breakthrough technology. Once we get the surgeon to try the product on a patient, we know that we are on a path to something good. It is really to break through that first contact that is the dynamic. You asked about the U.K. The U.K. indeed is growing.
The volumes of surgeries have been moved away from indications where CERAMENT is used, and it has been very focused on hips and knees in the orthopedic space, but also a lot of other surgeries that have a long backlog since the COVID years. The U.K. grew in the quarter, but not at the level it did before the political prioritization program. Your question was also on prices. Is there ability to increase prices due to the currency effects? There's always the chance for us to raise prices. We raise prices when we believe the market can endure it. We never give an explanation to the customer with tariffs or currency or any other reasons. We raise prices usually when we can then push our argumentation of a unique product that has results that no one else can show and strong health economic effects.
Right now, we have not announced to the public market any price increases, but this is something that we constantly consider when it is the right time and the right message.
My question was, given the higher than normal reimbursement increase this year, I guess that should make it easier to have customers accept a higher price.
Yes. Sorry, I missed that part. Yes. The reimbursement changes are kicking in from 1st of October. Right now, you are right, that could provide a nice incentive also to look over pricing. Right now, we are analyzing which codes and which of those codes would be most relevant to CERAMENT G and how that could play out. We have not come to a conclusion that we can share yet. Okay.
The final one on R&D cost.
Again, thank you, Kristofer.
Yes, as explained somehow, there is a high activity level and has been in the quarter, mainly related to the preparation for spine and the market authorization submission on CERAMENT V. This is the thing somehow with these kind of investments that they will always be somewhat volatile because somehow if we take the application studies, etc., they do involve certain milestone payments, etc. Activity levels will, for the nearest quarters, remain high. I think it's fair to expect that the run rate should be somewhere between what we reported in Q4 and what we reported in Q1.
Yeah. Yeah.
Perfect. Thank you very much.
The next question comes from Maria Vara from Bryan, Garnier & Co. Please go ahead.
Good morning. I'll just be super quick given that we don't have much time left. Just two questions to kind of wrap up the call maybe.
Rate of the success in CERAMENT G, I believe, is given your positive sales traction, sales rep training, etc., but also the robust clinical data you're generating, and among those, the SOLARIO study. Could you maybe elaborate how this is being utilized and if we could expect any other clinical trials that are ongoing that could benefit maybe reimbursement? I believe you were running the Conviction Study in France. If you comment on that. The last question related to guidance. Of course, you're providing this sales growth, and as you mentioned, you're probably going to beat it. Could you comment on whether you aim to provide any other kind of guidance in terms of profitability in the mid or long term? Thank you.
Thank you, Maria. Thank you so much also for joining this call. I know you have a lot of companies to cover as everyone else.
The SOLARIO study is having impact already. More than 75% of the patients in the SOLARIO study had their infection because of a trauma. The SOLARIO study is almost a trauma study, one could say. What we encounter right now is the following dynamic. The surgeons, they see the top-line results from the SOLARIO, and they get very excited. They see the ability here to reduce the systemic antibiotics and see that with local antibiotics with CERAMENT, they can have great results. We get attention also from the hospital administration, but they ask us, "Where's the full-length publication? Where are all the details?" which we don't have yet. Surgeons, very positive. Administrative staff, a little bit in a waiting pattern. The full-length publication this year is going to be a big event. We are constantly doing health economic studies. There are a couple ongoing.
They are much smaller than the SOLARIO trial. The SOLARIO trial will be the biggest inflection point when it comes to health economics. The smaller one we're doing is more modeling as doing health economic studies is very expensive. You should expect also in the midterm that there will be more data coming from us. The Conviction Study in France is done to specifically get French reimbursement. The French authorities only accept to give reimbursement on those products that have been done on French patients at French centers. I think we will have to wait further. The recruitment is ongoing, and I cannot report on any deviation from previous plans on Conviction. It's a bit tedious, but when it comes, it will come. Finally, you're right. There's so much going on now.
There's so much happening that we only felt that we could give guidance on sales growing with more than 40%. In the midterm, we will also have opportunities to give more thorough guidance that will include both top and bottom line. Not this year, but in the near future after that.
Thank you. That's very helpful.
Thank you, Maria.
The next question comes from Matthias Tharn from Bremer and Partners. Please go ahead.
Hi. Thank you very much. Questioning a trauma in the U.S., just a general observation. We look at open payments data in the U.S.. The doctors that are listed there, it should be said, is from 2023. Very few of the doctors that are linked to you that specialize in trauma.
What I also noticed is that your competitor, Biocomposites, has almost three times more, at that point had three times more doctors specializing in trauma listed as, well, consultants working with them. I mean, how important is that? How has that changed since then is the first question. The second question I need to ask, because this is now the third time I think you referenced to mortality and survival ratios, and you referenced this to the study from Manchester. I think, I mean, first of all, since then, there's been another study that has not been printed. It's an article, but it's from the same center over the same time period. It's one year prior to the article you referred to. Bottom line is that shows a mortality ratio of over 25%, a five-year mortality ratio.
I think when you deduct the data, it appears as if the trial or the article you referred to excludes the one-year mortality ratio. Obviously, this is not sort of a randomized and serious clinical trial by any means. I think it's quite difficult to sort of extrapolate causality claims between CERAMENT and mortality or healing based on the data and the methods presented. I mean, observations are questioned if it's scientifically sound. With that being said, however, I think I'm wondering why you insist on sort of commenting on these ratios given the relatively simple study. Second of all, how do you balance the risk of, for instance, false claim and sort of misleading information advertising by the FDA, which I presume requires conclusions to be scientifically sound?
Then the last question, I think, is if you can disclose what accrued income was or sort of unbilled revenue accounted for in Q1, please. Thank you very much.
Absolutely. Thank you, Matthias, for your questions. The first question was on open trauma. How many of the trauma surgeons that we work with as consultants? We've only had open trauma approved for a year. There are very few of the trauma surgeons that agree to be on a speaker's list for us before they've had thorough examination of the product. Usually what happens is that the trauma surgeon would like to try the product and collect at least 10-20 trauma cases with full X-rays before they agree to stand on a podium and talk about the product.
If you would compare the number of speakers that we work with, engaged with on trauma compared to indications where we have had longer approval, you will see a clear correlation there. Now, when we had the big convention, AAOS, almost the whole theme of our satellite symposium was on trauma. And you're right. I mean, there are other products out there where several companies engage doctors to speak for them. I don't know which one exactly you mentioned, but I think it was a technology that actually doesn't have FDA approval. Maybe that's a slightly older technology that is being replaced. You had also questions regarding us mentioning survival rate. I disagree with you that it is a simple study. I don't think there's anything you could find in this study that would categorize it as simple. I think it's a very well-done study indeed.
The fact that we mention it is simply that we're incredibly proud that for the first time, a study with such strong statistical significance has shown what many surgeons have testified about. Of course, when you work with surgeons, you hear them praise different therapies and anecdotally share certain results that they will notice. It's very rewarding to have a well-done and published clinical study. I think we have to separate between studies that are interim reports or case reports or when they really are published and have undergone the scrutiny of peer review. Our claim is not CERAMENT G the lifesaver, but clearly CERAMENT G has appeared in a study where those patients that were treated had a better five-year survival rate. It just gives a very strong meaning to all of us that work with this product that we can make such a difference.
You had also a question on the income statement. Do you want to respond to that?
Your question was on the accrued revenue. What I think you referred to is that in the U.S., we have products that have been used in surgery, but we have not received the surgery data to do the invoice to the hospitals. These accrued revenues have been reduced compared to the end of last year and reported to around $3.5 million, so roughly SEK 35 million end of this quarter.
Thank you. Sorry, just a comment on the study without debating the overall quality of the study. I think what is interesting is that there has been a second, even though it is not printed, study.
There's been an article done with two of the same authors from Manchester University over the same period that shows a five-year mortality rate of 25% for CERAMENT treated patients. It is the difference in that mortality rate versus the mortality rate that you referred to, which is a small population, but it seems to be there's a crossover in patients. There is a selection bias. I think that's another observation that I think is important to consider.
Okay. I mean, we're not going to be able to clear that today possibly, but I'm sure there was also a control group. When you look at these studies, the performance is always versus a control group. Probably something we have to refer to off this call because I don't have that data here. This was rather on the quarterly results.
Thank you very much.
As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more phone questions at this time. I hand the conference back to the speakers for any written questions or closing comments.
Yeah, thank you, everyone. Thank you for today. It took a long time, a lot of questions, impressive results. We know that all of you are attending to several different companies releasing the report. Thank you for taking the time to visit our call. We look forward to keep you posted. Happy spring to everyone. Thank you.