OssDsign Aktie

Hello, and welcome to OssDsign Q2 presentation. My name is Elvin Rolder. I work here at DNB Carnegie, and I will be moderating today's presentation. I'm joined here by Mark Waugh, the CEO of OssDsign; and Anders Svensson, the CFO.

I will now leave the word to OssDsign's team for their presentation.

Thank you. Good morning, everyone. This is Mark Waugh, and I'm the CEO of OssDsign. And if you're new to our quarterly calls, I'll mention again that I joined the company January of this year. I also have our CFO, Anders Svensson, with me today, and we're going to walk you through our second quarter 2026 results. As always, when we do these presentations, the normal disclaimer. Moving into our Q2 2026 highlights. For the quarter, OssDsign sales of SEK 37.8 million or approximately USD 4 million were essentially flat versus Q1 sales performance, and that was in line with my prior guidance.

On a year-over-year comparables basis, Q2 translated to a 16% decline in constant currency terms, although that was on a very challenging comparable driven by some large bulk orders occurring in the last day of that same 2025 period. Gross margin and EBIT both improved for the quarter versus Q1. I'll let Anders cover the details on those after I finish with these highlights. And the science behind Catalyst and the results we continue to publish remain strong. I've mentioned before that our preclinical and our clinical data were 2 of the biggest reasons I joined the company. We continue to share that data with our customers during the Southernmost Spine and the International Society for the Advancement of Spine Surgery meetings recently.

Additionally, on June 3, OssDsign shared the publication of a new scientific article in the Journal of Bone and Mineral Research, or JBMR. This was a preclinical study that evaluated OssDsign Catalyst as a stand-alone bone graft in trauma versus an earlier generation bone graft. And I'm pleased to tell you that the results showed significantly more bone formation with OssDsign Catalyst at earlier time points as well as clear evidence that the graft is remodeled over time or in other words, broken down and replaced by bone growth in the body.

This study and others continue to support the outstanding performance of fourth-generation nanosynthetic bone grafts like Catalyst. Next, some additional significant organization updates. On June 25, we announced Adam [ McAllister ] as OssDsign's new VP of Sales. Adam is an experienced medical devices sales leader with a great track record of leading teams to achieve above-market performance in his previous roles. He's quickly getting up to speed, working closely with our regional sales teams. And regarding those teams, our new area sales Director for the East also started on August 10. That role had been vacant since May, and we screened and interviewed a number of candidates, and I'm very pleased with who we were able to hire for this important position, and I know she's going to be a great asset for our sales team.

Overall, since January, when I joined the company, we've replaced more than 50% of OssDsign's commercial team. I've mentioned before that our path to doubling the size of our team, which was a goal set forth by my predecessor, would not be a linear progression, and we'd see some turnover alongside the additions we're making.

The changes we made have better positioned us for commercial execution going forward. We'll continue to add members to this team, and I don't see an immediate ceiling on that as long as our hiring both supports and delivers on our commitments to growth. I also want to let you know that I'm personally involved in our hiring process for the commercial team members because it's important to me that we're hiring the right people, both professionally and from a cultural fit perspective.

Finally, regarding organization, I mentioned in our release that since February, our entire team's incentive structures are aligned to growth. That's another important dynamic that ensures our reward structure is tied to our shareholders' expectations. And before I hand things over to Anders, I'll reiterate that I still believe we can achieve the goals put forth last year as part of OssDsign's scale to profit strategy. The market is highly competitive, but OssDsign catalyst is as well.

And as you can see, we're making aggressive changes to return our sales trajectory to strong growth. I'm also pleased with the progress we've made on our next product release, MIS Catalyst. I'll have more to communicate next quarter on this launch, but things are moving forward quite nicely since our last release call.

I'll now hand you over to Anders who's going to walk you through the financial results this quarter in more detail. Anders?

Thank you, Mark. Now as Mark mentioned, in Q2, we saw a decrease in sales compared to the second quarter of '25. In SEK, we reported SEK 37.8 million in sales. That's compared to SEK 46.5 million last year, which translates to an 18.7% decrease. As you can see here in the growth chart, we still experienced some U.S. dollar headwind on sales, but considerably less than we did in previous quarters. So the actual underlying decrease, as Mark mentioned, is 16% for the quarter. You may also remember that our Q2 '25 sales were inflated by some last day orders, which would explain roughly half of that organic decrease. Still, we acknowledge that there's room for improvement, and we're working hard to achieve that.

Now when we presented our Q1 results, we guided that Q2 sales were expected to come in around the same level as Q1. And as you can see in the growth chart here, we actually grew by 2.4% quarter-over-quarter. But as you can also see, the growth was entirely exchange rate driven. So in fact, Q2 sales did come in at the same level as Q1 as per our guidance. Moving to the LTM chart. You've heard us say so many times now that growth is not going to be linear over time, more likely take the form of a staircase. And I guess the current LTM slide is case in point with the decreasing last 12-month run rate presenting as our current sales plateau. The latest 12-month period sales are 7% higher than the 12-month period leading up to Q2 2025, which, of course, is an increase, but much less of an increase than we've seen in previous observations.

As stated earlier, our sales reorganization, which is still ongoing, has been quite extensive, and we expect those efforts to start delivering improved commercial momentum later in the year. On the gross margin, 92.1% was an improvement over the 91.6% in the first quarter, but clearly below the 96.8%, very high margin reported in Q2 last year. Now there are so many factors that impact gross margin. I can't go into detail on all of those. But suffice to say that the main drivers behind our current gross margin development is product and customer mix, as was the case in Q1, but with very different mix effects. There are still some exchange rate-related production cost effects from when the dollar peaked in early '25, but the main current driver is mix.

And with that, I'll hand you back to Mark.

Thanks, Anders. Although Catalyst has only been in this space for about 4 years, we've built a strong body of evidence. I'm pleased to tell you that we now have 19 preclinical and clinical publications and white papers and a world-class registry that contains an always growing number of patients. OssDsign has consistently been reporting both high fusion rates and fast bone formation with Catalyst. This demonstrates rapid progression to fusion. The Boden model, a highly regarded preclinical model showed 100% fusion for Catalyst and our TOP FUSION study also showed 100% fusion again at 2 years. Speaking of the world-class registry I mentioned, our PROPEL registry showed Catalyst with an 88.4% fusion in a highly complex real-world patient population.

When we see other products marketing their product fusion rates, those rates are often among patients with multiple exclusion criteria. And in this industry, this is basically filtering out the risky, less likely to fuse patients for a clinical study, comorbidities such as high BMI, smoking, osteoporosis or other issues such as failed prior surgeries and more. This means that some of the competing data out there is not showing what the real-world performance of a product is. We include all kinds of challenging patients in OssDsign's Catalyst registry and our reported results. This is why you and our customers will continue to hear us say real-world data, real-world results.

These ongoing investments in clinical data are a key part of our strategy. And before we wrap things up and take questions, I will quickly reiterate our scale to profit strategy, which OssDsign shared in Q3 of 2025. Again, there's 4 pillars in this strategy. First, accelerating access and coverage within the U.S. market. We are still working to double our U.S. sales force. We are very close. But as I discussed, we've made some changes in our organization. We are absolutely stepping up on our marketing efforts, especially from an awareness perspective, and I look forward to seeing some of the things we have planned continue to roll out this year.

As I've mentioned previously, we are starting to see uptake in the foot and ankle segment of the market as well. Second, expanding our product portfolio and indications. I mentioned the MIS solution for Catalyst and our hydrophilic strip product is also progressing. We said this before, but we will be seeking another indication for Catalyst this year. Third, to continue investing in and building a leading repository of clinical evidence. I already covered our PROPEL registry. Our Level 1 randomized controlled trial is moving forward according to plan, and we will continue to strengthen OssDsign's reputation as a differentiated top-tier biologics company with very compelling clinical evidence to support Catalyst.

And finally, the fourth pillar is to scale production and to add a U.S. production footprint. We are working to implement a more scalable, more cost-efficient production process and to bolster our existing production. The good news is we believe we've identified a way to do this in a very cost-efficient manner. I want to close our call today by reiterating what I said during our Q1 release regarding transparency. I've committed to transparency with this team and to our shareholders, and I'm not in any way communicating to you today with some sort of a mission accomplished attitude or victory lap kind of messaging.

However, I am pleased so far with the transformation we're undergoing. We delivered a Q2 sales result that was in line with our guidance, slightly improved our gross margin and did a large amount of fundamental commercial restructuring while delivering improvements to our adjusted EBIT. We have not usually provided specific guidance but did so last quarter. As we communicated within our release for this quarter, we do expect some headwinds in Q3 solely based on what we historically experienced given U.S. vacations or holiday seasonality during both July and August. However, I still have confidence that the changes we've made and the foundation we've laid will translate into tangible results later this year, and I still look forward to reporting on that.

I want to thank you for joining our call today, and I will now hand it back to the operator who will handle questions.

[Operator Instructions] But maybe we can begin a little bit on these contract renegotiations. You mentioned in the report that you're seeing progress there on that matter. Can you give us some more kind of indications on how one should think on how far you resolved these matters and if they will continue to affect your business here in H2?

Sure. I think the takeaways on that are given the size and scale of our company, there were a couple of larger IDN sort of customers that we were in renegotiations with. And I'm pleased to say that one of those has resolved, and we're now on a 3-year contract with them going forward. And the other one, unfortunately, is not yet resolved. We're still working through the details on that. We continue to do cases in many of their facilities, but these things often take quite a amount of time. And so hopefully, I'll have an update on that on a future call.

Great. You mentioned the MIS option for Catalyst, and you will give an update here in the next quarters. But can you also comment a little bit on the hydrophilic strip? How has the development been going for that release? And what are your internal kind of expectations on what that will be able to unlock versus what you're currently able to offer?

Yes. Thanks. So we view Catalyst's underlying technology as sort of a platform. And so anything we do is within the frame of reference of that being a line extension and sort of taking that technology and putting it into other uses. And that's really what that strip is all about. That project is also progressing quite nicely. We are -- we have completed some initial preclinical animal studies. We are in the process right now of basically investigating that data with great rigor and looking at the pros and cons and the outcomes in each of those animal studies. That will move forward much more quickly once we get past the preclinical phase, but I can't really commit to timing on that until I see what the results of all that is.

But in terms of kind of positioning the company against IDNs and hospitals and surgeons alike, what are your kind of internal expectations on how much more of a market can you kind of unlock with this product? Will it be like 1/3 of the market? Or what should one's expectations be on what it enables you to do?

Yes. I think I would temper that just a bit, not because it's not a great product or project in both cases for both the strip and MIS, but Catalyst itself has such a huge opportunity ahead of it in the market in the U.S. But I will say this, when it comes to these kinds of line extensions that are not fundamental brand-new products, but again, leveraging that Catalyst core technology and people having the expectation that it will deliver on the clinical performance. What it does is allows us to use a U.S. saying to kind of keep the Fox out of the henhouse. I don't know if that translates well to things in Sweden.

But it's always good to have those kinds of ancillary line extension type products so that if a surgeon does prefer to use a strip in those kinds of cases, they don't have to call on one of our competitors, and we're giving them an opportunity to speak to one of our customers. But on the other side of that coin, it does allow us to penetrate accounts where maybe somebody prefers to use a strip for many of their cases, but we don't have that technology yet. So we have the putty right now, but we could go in and say, "Hey, we have the strip now, can we have that conversation again. So that's what it really means for us.

Great. And in terms of kind of sales hiring activity for the sales force, how far along have you like gone now? Or do you feel that you've kind of hit a plateau that you're satisfied with for the coming foreseeable future? Or are you continuously kind of adding more? And how much more should we kind of think that you would like to add to the organization?

I'm not satisfied just yet. We've done a great job transforming the sales team. And as I mentioned in our comments in our release, we've now changed or turned over 50% of the commercial team as it existed on an org chart as of Jan 1. We have multiple open positions still open right now that we're recruiting for and hiring for. But I do think we'll see some more stability in that team now that we've made the changes in terms of what that org chart looks like right now, and I'm very pleased with how the team has responded to some of the changes we've made.

But there's no real ceiling on the hiring. So yes, we've had this stated goal to sort of double where we were from Jan 1 of 2025, which is still our goal, but I wouldn't be surprised to see us exceed that goal in rapid fashion, too. I mean as long as we can support the business case for a hire in a new geographic area that helps us to accelerate growth, we're going to explore that.

Perhaps staying a bit on your last comment there. Has these hires been mostly kind of filling in these kind of geographical white spots that you've had previously? Or has it also been doubling down on existing geographies to kind of help penetrate markets that are perhaps too big for 1 or 2 people to kind of target?

I'll answer the second half of that first. I would say that our scale and presence in the U.S. markets, we don't have an issue yet where we need to sort of double up in specific markets to enable us to tap additional opportunities. So most of the hires have been in that white space or to replace people who are no longer with the organization.

Perfect. We'll move on to perhaps the U.S. manufacturing footprint. I think it has been kind of not been discussed as much recently in favor of other topics, but can you perhaps give a more detailed kind of explanation on what you're able to do there? I think it will be interesting on how one should think on when you're perhaps able to move more of the footprint towards the U.S., both time line-wise and what that maybe can unlock in terms of gross margins and inventory levels as well as.

Yes. I think it will make us more efficient. I don't see it moving the gross margin side of the equation as far as that second source, what it's going to do for us, though. is take out a lot of geopolitical risk. I mean, I think I commented on this after the Q4 call.

There's always some level of risk when you're sole site, especially when you're a sole site with a production facility elsewhere. I mean we're in great shape from an inventory perspective at all times. So it's a pretty low risk for us. But it will be good to have that second site. I mean, I don't know if the U.S. will enter any new tariff programs or other things like that, that could actually impact gross margins at some point if we don't have that second site.

But I mentioned the cost-effective way we've identified to do this. I mean, fortunately, for us, from a partner perspective, we've -- we believe we've identified a way to add that second production facility without sort of spinning up our own higher level of CapEx to accomplish it. So I'm very pleased with the progress that our team is making on that right now. I can't give you specific timing on it just yet because it's still too early, but the solution that presented itself only happened within the last quarter or so, and we're very -- we think not only will we be able to do that faster than anticipated, but at a much lower sort of cost to organizational resources as well.

Great. And then perhaps finally, on the randomized controlled trial, you're mentioning that enrollment can begin perhaps quite soon, at least. Is it possible to give some comments more on the study design? How many centers are included in the study? How big is it? And any further kind of additional details on what the kind of readout will be able to tell the market and tell surgeons and so on.

Yes. I'm going to paint in broad brush strokes here because we are -- I would categorize it as sort of 99% baked on the protocol design. We had a great meeting with our Clinical Advisory Board approximately 4 weeks ago, if I recall correctly. Ongoing discussions with our Chief Clinical lead on this to get the protocol completely signed off, moved forward. My clinical management team member is in the U.S. right now, traveling around, meeting with a bunch of the sites that we've been vetting for this. That's going exceptionally well. And so I think what we're going to see as we move into the latter part of Q3 and into Q4 is more of a deliberate tactical contracting with these sites that we've identified.

I think timing-wise, it's difficult on these kinds of things in terms of how much time it's going to take. And I'll probably be in a better position in the next quarterly call to actually share like specific end numbers based on where we are with the statistical analysis on that as well as a little bit more of a timing. The timing itself is always sort of TBD depending on how fast each site enrolls. But I think the key takeaway on this is I'm very pleased that this was something that was started to sort of be moved into place before I joined, and we've been able to sort of accelerate it and move it to fruition.

Because if you really look at the U.S. landscape on products in this space, there's only a handful that have actually taken the strategic tack and actually made the investment to go after getting Level 1 data. I think it's also important to note that although that is a sort of check box or a watermark that some systems want to see on Level 1 data, I'll continue to be bullish on the data that we are mining from PROPEL in the registry. And I frequently, even on my own and certainly, our team members do even more frequently than I do, have discussions with both clinicians and with value analysis committees and others that show the strength of that PROPEL registry because we're not filtering out all those patients that have comorbidities and other things, we're not excluding them.

You can actually see how this product performs in a real-world U.S. population that is frequently full of high BMI, other comorbidities. So as great as I think it is that we're doing a Level 1 study, I equally think it's fantastic that we have PROPEL, and we are one of the few companies that has an ongoing registry like this in the space. And soon, we will be joining a very, very small list of companies that actually have either a Level 1 study in progress or the ability to report out on that.

Great. Thank you. There are no more questions at this time. So I think we'll conclude the presentation there. Thank you so much to both Mark and Anders for the presentation and Q&A session, and thank you for everyone for listening in. Have a good day.

Thank you.

Thank you.

Hello, and welcome to OssDsign's Q1 presentation. My name is Elvin Rolder. I work here at DNB Carnegie, and I will be moderating the presentation and questions-and-answer session. I'm joined here by Mark Waugh, the CEO of OssDsign; and Anders Svensson, the CFO, who will give the presentation now.

Thank you. Welcome, everyone. Again, my name is Mark Waugh, and I'm the CEO of OssDsign. And if you're new to our quarterly calls, I'll just mention briefly that I joined the company in January this year. As Elvin mentioned, I have our CFO, Anders Svensson, with me. And today, we want to walk you through our first quarter 2026 results. As usual, when we do these presentations, the normal disclaimer.

Before I go into the details, I do want to make one comment about our Q4 results call, and then I'm going to give you my view of the highlights in the quarter. It's important for me to communicate that we had a significant technical challenge during the Q4 call. And unfortunately, when the call began, Anders and I could hear multiple other earnings calls on the conference line. So imagine trying to deliver our company results while being interrupted continuously. Thankfully, we don't believe those listening to that call could hear the same cross talk.

I will say that our conference operator also informed us that there were no questions, but we learned later that there were indeed a queue of individuals who wish to ask a question. And I just want to apologize for that technical issue. It was so unacceptable to us that we actually switched our call hosting provider going forward. So I have confidence that today's call will be delivered much more smoothly.

Now on to the highlights. I believe I said this during our Q4 release, but I just want to reiterate that I joined OssDsign because I was drawn really into Catalyst's strong clinical performance, the robust underlying science that the company has generated and a significant market opportunity in the U.S. Those reasons remain very valid, and I'm confident that the factors contributing to our first quarter sales challenges are identifiable and addressable.

I want to say that this was really not the start of the year that I would have wished for, and I don't believe it's acceptable. As communicated, revenue for the period, January through March 2026, totaled approximately USD 4 million or SEK 36.9 million, a decrease of 3.6% in U.S. dollar terms compared to the same quarter of 2025. That significant difference that you note between the USD and SEK results, a 3.6% decline in U.S. dollar terms versus a 17.1% decline in SEK terms, is due entirely to the depreciation of the dollar against the SEK during the comparable periods. Adjusted EBIT for the quarter was SEK minus 13.4 million, with marginal exchange rate impact due to the nature of the cost base. This sales outcome really fell short of our expectations. And as I communicated prior to this report, is also below market expectations.

Since joining as the CEO, I have continued to get up to speed in our history. And I now understand that due to the volatile capital market in Q1 2025, OssDsign's proposed share issue was delayed until June of last year. The result of that delay was some of the activities were executed in the plan a bit more slowly or even paused.

Second, we had a slowdown in recruitment and hiring within the sales team during the latter part of 2025 that weighed on sales growth into the fourth quarter of last year, and its effects carried into Q1 2026. I've stated previously that my goal is to build a high-performing commercial organization, and that's a very deliberate activity. When the hiring slows, the impact to our forward revenue growth is definitely impacted in the following period, and that really materialized this quarter as well.

I also spent some time in the recent released annual report talking about shifting our culture. As we made some deliberate changes, some less highly performing sales employees did leave the company. We also experienced temporary slowdowns in certain accounts due to extended contract renegotiations. And none of what I just covered were isolated events. They really converged in the same quarter, which amplified the pressure on the top line.

I want to stress, however, that the recent sales results should not reflect badly on the product, the core science or its market potential. In my opinion, OssDsign Catalyst should be the #1 synthetic bone graft option in the spinal fusion market. Our real-world clinical data and results continue to be collected in complex patient groups, and that reinforces our truly great performance.

As I mentioned in our formal release comments, Catalyst strengths are naturally attracting attention from our competitors. And I expected this when I took the role. I am confident we're making the right investments in clinical, marketing and sales to ensure that OssDsign is a fierce and respected competitor in this market. And I'm pleased to tell you that we had strong surgeon to surgeon clinical presentations at the Selby Spine, ISASS and NASS Evidence & Technology Spine Summit meetings during Q1.

I think I'm most pleased today to tell you that we have implemented concrete measures to energize and focus our hiring process and consistently expand our sales team with more high-quality driven individuals. As a CEO, we now have leadership base in the U.S., and that allows us to accelerate and address issues promptly. In addition to managing and working with our leadership team to develop and expand the U.S. organization, I'm able to more directly support our sales endeavors by interacting in person with our key opinion leaders, our distributors and hospital systems. In other words, there are benefits to being in market with the commercial team, especially when it's a market I've worked in for many years.

Now regarding that commercial expansion. We continue to strengthen our sales foundation. And over the past 90 days, there's been excellent progress in identifying and hiring new commercial team members. I would say that the groundwork has been laid this quarter, and I'm excited to see early progress among some of our new hired team members. Additionally, discussions have been ongoing with several key accounts that faced slowdowns due to contract renegotiations, and I anticipate that purchasing patterns will return to normal once the agreements are finalized.

I've committed to transparency with the organization as our shareholders, and we're working to transform into a more open, bold and dynamic culture. I mentioned this during our last call. When I joined, I really believed in the product, and I still do. I believe there are very tremendously huge opportunities ahead of the company, and I'm confident in our potential to deliver increased sales, and I also remain confident in our potential to create value for shareholders.

The other part of working to lead OssDsign is I get to be part of this great team that supports surgeons by providing a product that benefits their patients. The market we participate in for spinal fusion is large, growing and very receptive to products that actually show differentiated evidence-based results and unique properties, which is what Catalyst offers.

I believe we're building the right team. We're investing in additional clinical data, and the existing clinical data continues to speak for itself. We have the right product to win in our market, and I remain confident of hitting our SEK 400 million revenue target as set out in the ScaleToProfit strategy we communicated in 2025. I think the first step in delivering improved commercial momentum is in the second half of 2026, and I look forward to reporting on that in the coming quarters.

I'll now hand it over to Anders to walk you through the financial results for the quarter in more detail. Anders?

Yes. Thank you, Mark. So as Mark mentioned, in Q1, we saw a decrease in sales compared to the first quarter of '25. Now in SEK, we did SEK 36.9 million, as you can see in this chart, compared to SEK 44.5 million last year, which translates to a 17.1% decrease. Although a decrease is obviously neither good nor anything we're happy with, the underlying development is not quite as severe as the second numbers suggest due to the U.S. dollar headwind. As you can see in the growth chart to the right, the bulk of the SEK decrease is actually not organic, but rather exchange rate related, with an actual underlying decrease in U.S. dollars of 3.6%.

Now as we've also said many times before, growth for us is not likely to be linear over time, rather more likely to take the form of a staircase with higher and lower quarterly increases and even some where the staircase step is flat. Now granted, we did not expect any step to be negative, but that is unfortunately what happened in the first quarter for a number of reasons, as outlined earlier by Mark. And this is also evident from the LTM chart for the latest 12-month period, as you can see in this slide.

But what is also evident here is that the latest 12-month period, sales are about 28% higher than they were in the 12-month period leading up to Q1 2025. Be that as it may, as stated earlier, we've had to make a few changes in terms of corrective measures, and we expect those measures to deliver improved commercial momentum in the second half of '26.

Moving over to the gross margin. Now as you can see, the gross margin followed suit on the lower sales in the quarter. Those 2 are quite interconnected. And so it came in at 91.6% versus the 96.4% in the comparison quarter.

Now in addition to the sales related or sales level related effect, we also experienced some negative mix effects, both on product and customer mix in the quarter. And of course, on top of that, we also have the U.S. dollar headwind, which continued to weigh on COGS. And that's -- especially on raw materials because as I'm sure you know, we've talked about before, the products that we sell in the quarter were produced quite some time ago, more expensively at a much higher U.S. dollar-SEK exchange rate.

So all in all, a lot of negative effects converging in a single quarter, which makes it all the better to note that all those effects that we've now mentioned are variable and therefore, temporary.

And I will now hand you back to Mark.

Thanks, Anders. I just want to cover this briefly. We covered it on the Q4 call. But although OssDsign has only been active in the market for 4 years, we built a very solid body of evidence with 17 preclinical and clinical publications and white papers.

And I think -- I know many of you have seen this slide before, too, if you've been following the call for some time, but this is a summary of clinical studies OssDsign has published. The big takeaway on this is that Catalyst has consistently been reporting both high fusion rates and fast bone formation. This means rapid progression to fusion.

Our Boden model, a well-established preclinical model, showed 100% fusion, and we saw 100% fusion at 2 years within our TOP FUSION study. Most importantly, OssDsign has reported 88.4% fusion in a highly complex real-world population within our ongoing registry.

I mentioned before that the 88.4% result is probably the most impressive. When competitors often showcase their products fusion rates, those rates are, at many times, among patients that have been selectively filtered out. In the industry, this is known as exclusion criteria for a clinical study. So for example, comorbidities like high BMI, smoking or other issues such as failed prior fusion surgeries, et cetera. As such, in the most challenging patients, you often don't see what the real-world performance of a product is.

OssDsign does not exclude those challenging patients within our registry, and these results are real-world scenarios. Catalyst continues to show this real-world performance for a synthetic bone graft rarely seen in the market before, and we've communicated ongoing investments in this clinical data being a part of our strategy.

Before we conclude and take questions, I do want to reiterate that ScaleToProfit strategy, which we originally communicated in Q3 of 2025. Again, the strategy consists of 4 pillars: First, accelerating access and coverage within the U.S. market. We are doubling our U.S. sales force, increasing our marketing efforts. And I want to be clear again that this doubling is not a ceiling. We will go beyond that as we continue to scale our presence in new geographic areas in the U.S. And additionally, we've begun to enter adjacent market segments, as I mentioned last quarter with foot and ankle.

Second, expanding our product portfolio and indications. We are currently working to launch 2 new products, an MIS solution for Catalyst and then a hydrophilic strip product as well as obtaining a new indication for Catalyst.

Third, to continue building a complete repository of clinical evidence. I covered this on the prior slide, but we continue to build and publish data from our PROPEL registry. We're making great progress on initiating a large Level 1 randomized controlled trial, and we plan to further strengthen our reputation as a differentiated top-tier orthobiologics company with compelling clinical evidence supporting Catalyst.

And finally, fourth, to scale production and to add a U.S. production footprint. We will implement a more scalable, more cost-efficient production process and to bolster our existing production as we expand and grow.

Before we get to Q&A, I just want to make a quick 2 comments. I want to close out today by reiterating that I've committed to transparency with this organization and our shareholders. We're really working hard to transform into a more open, bold and dynamic culture, and I mentioned the shift within our annual report. Again, I joined the company because I believe in the product and the large opportunities ahead of the company, and I'm confident in the company's potential to deliver increased sales. I also remain confident in OssDsign's potential to create value for shareholders. The other part of working to lead OssDsign is I get to be part of a team that supports surgeons by providing a product that benefits their patients, which I've said before.

The orthobiologics market for spine fusion is large, it's growing, it's increasingly receptive to products that actually show differentiated evidence-based results and the unique properties, which is what Catalyst offers. We are building the right team. We are investing in additional clinical data, and the existing clinical data continues to speak for itself. We have the right product to win our market.

We remain confident of hitting the SEK 400 million revenue target set out in the ScaleToProfit strategy communicated in 2025. The first step is delivering improved commercial momentum in the second half of '26, and I look forward to reporting that in the coming quarters.

I want to thank everybody for joining the call today. And now I'm going to hand it back to Elvin, who will handle the Q&A.

Great. Thank you so much, Mark and Anders. Let's begin with the first question here. Last year, the company talked about putting new products on the markets, a bone graft strip, for example. Is that still your plans? Can you give us an update on that?

Yes, the 2 new products, which I covered in the comments today, are an MIS product for Catalyst, which is still on track, and we hope to get that out by the end of the year, if not the beginning of 2027. And we are making good progress on the hydrophilic strip product. We are in preclinical right now with a variety of solutions, and that continues to move forward with great progress.

Great. And how many sales managers do you have today? And how many distributors are they managing?

So we started 2025 when the goal was announced, I think, mid-'25 to double the sales force. If you go back and look at what that number was predicated on, I believe, at the beginning of '25, we had 10 direct people in the commercial organization. We will achieve that doubling within Q2. We've had some losses. We've had quite a bit of gains. I'm very impressed by our pace of hiring over the last 90 days.

And as far as distributors, I'm not going to comment on exactly how many we manage or how many each person manages just because of the competitive nature of that information.

Great. And regarding the randomized controlled trial, can you give us an update on that? Is it going to start this year? Have you come to any finalization on how you want to set up the trial?

Yes. We haven't finalized the protocols yet, but we made good progress. We just had an excellent meeting with our Clinical Advisory Board approximately 1 week, 1.5 weeks ago, where we walked through some of the final sort of decision points around patient selection, the type of comparison that we're going to do, the number of sites, the sort of end that would be needed to generate sort of statistical results that would show equivalency. So I feel really good about where we are.

In terms of an actual start date, I'm not quite ready to communicate that yet, but I feel like the progress has been accelerating, and I hope to have more material updates on subsequent calls relative to what that timing looks like for patient 1 enrollment.

Yes. Thank you. Continuing here. You mentioned that some activities were slowed or paused because of a later-than-planned capital injection last year. Can you comment on what those activities were?

Sure. I mean I've commented previously that we did see some hiring slowdown as we got into the back half of the year. And I think the results on the pace of hiring in the back half of the year stemmed from some of those slowdowns associated with the funding. And then we did see some delays in executing on some of the related marketing activities as well as clinical related activities. I mean we've continued to enroll patients in our registry. And despite some of the slowdowns that I mentioned, we've managed to continue producing a great repository of clinical evidence. But my comment there is really indicative of being able to do even more, had some things not paused or been slowed down.

Perfect. Regarding the contract negotiations, why are they coming into a negotiation stage? And what do you see as a likely outcome?

Yes. So I think it's important to comment that within the med tech space in the U.S., this is not atypical or irregular or a one-off type of event that's targeted at us. It's rather just a natural process that happens among both small and large systems, IDNs and GPOs. They regularly go through RFP processes or seek to streamline formularies or to come up with how clinicians are going to operate within their systems. And so the 2 that we commented on for our Q1 results were just part of that process.

Those are long drawn-out processes. One individual system that we're dealing with right now, I believe, started their process mid-last year, expected to finish it in early Q1, but they're still involved, and this covers their entire spine service line. So it's not just OssDsign Catalyst that's dealing with this particular RFP. It's every single vendor within that system far and wide. I couldn't even guess at how many individual vendors they are currently dealing with that are going through that process.

But I will say that the conscious decision that Morten and the Board made last year to move to a U.S.-based CEO has been very beneficial in those discussions. I've been able to directly participate probably much more easily than somebody in a different time zone. And I view those discussions as favorable and things that will resolve sooner rather than later.

Perfect. What has been the reason for the difficulties in the hiring process? And are you confident that this has been addressed now?

I don't think there's been difficulties per se. I just think that we did not accelerate the way we needed to the back half of last year. And since that time, we've had some turnover. We did take some deliberate steps early in the year to sort of realign our incentive comp structure for sellers to more closely align with growth. And we've had some people choose to depart. At the same time, we've been aggressively hiring new talent.

And I would also say that within that process, we've deliberately identified sort of the behavioral traits within our top sellers, and we have some tools now that we employ in recruiting where we try to model those behaviors as we screen candidates. And I've personally injected myself into every single commercial interview, which I think is important for our culture going forward.

Reasonable to expect that some of the gross margin decline will last the coming quarters or years? Or will these customers reach the prior levels again?

Anders, do you want to cover that?

Yes. We have no reason to believe it's going to stay at the level it was in Q1. This is -- the customer mix, especially then it swings every quarter. It was just unfortunate that there was a big swing in Q1 and it was a swing of both customer mix and product mix in the same direction. [indiscernible] [ negative ]. That will change.

Very clear. Can you describe what the sales process looks like? How much of it is recurring? And how much of the sales requires a salesperson to kind of actively work and engage the customer?

Yes. So I think -- to answer the question technically, a lot of the sales themselves are recurring, but the process itself involves a couple of different things. Our direct sales managers are responsible for engaging with independent representatives that are around the country, and supporting those representatives as well as selling directly to surgeons and basically explaining the value proposition that Catalyst provides for their own practice as well as dealing with decision-makers within those facilities that make buying decisions.

I think on a recurring basis, it's important to note within that process that our direct sellers do stay engaged with both the independent representatives and the surgeons, making sure that they're pleased with service levels, with performance of the product, with any other issues that arise. But I'm not sure what the caller was interested in, in terms of what mix of it was new versus recurring. Obviously, more of the sales themselves are recurring, but we stay engaged throughout the process through the lifetime of a customer.

Great. And considering the strong study results, what is the biggest objection to choosing Catalyst and continuing with the product that they are using today?

That's a great question. I mean I believe in the product so fully, and I wouldn't have joined without that belief. So I think -- I mentioned this that we've drawn attention from competitors, and there's, I think, an effort on our side to be a little bit more aggressive and pointed in doing more comparative types of selling and marketing within the space.

So I really -- I don't think I can comment on like objections so much as it's a competitive space, and we're trying to carve out the fact that we do have real-world results based on real-world data. And when we do comparative types of pieces, which I think some of the people that are in the investment community that e-mail me regularly, I mean, I've seen some favorable responses on some of the competitive pieces we've done on LinkedIn recently, which really were in response to what we witnessed our competitors doing to us, and we had to have a sit down as a team and say, "Let's not just take that on the chin. Let's go head-to-head and be a little more pointed and aggressive in our marketing and our sales tactics," and I'm pleased to see that happening now.

When is the likely timing on further data with more patients on fusion rates from PROPEL? And what is the time line on other clinical milestones ahead?

Yes. So we're always actively mining additional clinical data, and there are some studies that we're kicking off and teeing up both preclinical and clinical right now, but I won't comment on, but I hope to have additional comments for you probably Q1 of next year just given the timing to complete those things.

As far as PROPEL registry data, the mining of that data for the next sort of cohort is already underway. I'll probably have a better answer timing for everybody when we do the next quarter call and when that press release will come out and what that data looks like. But we've been working on that. It's a pretty big statistical process that our clinical manager is dealing with right now as far as juggling that and juggling a lot of other things. But the data is there. It's just the mining at all and kind of doing the statistical analysis and making sure that we have something we can release that is as clear as what we released the last time when we did the first patient cohort.

Great. And would it be an option to license out the sales of catalyst in Europe as well as in Asia?

Yes. I mean right now, we're 100% focused on the U.S., but I wouldn't rule out other markets. We have -- and I know the company has discussed in the past, going after a CE mark and looking at various partnerships in other countries. But I would say in the short term, our focus is 100% U.S. just because of the growth opportunity there and our share position right now. But I would not rule out us considering to expand in the future.

Great. Thank you. That actually concludes the questions-and-answer session. I will leave the word back to you guys for any closing remarks.

Great. I've made my closing remarks. I just want to thank everybody again for joining on the call today, and I look forward to reporting out our results again next quarter. Thank you.

Thanks.

Thank you.

Hello, and welcome to today's Finwire broadcast presentation with OssDsign. After presentation, there will be a question-and-answer session. So if you have any questions, you can submit them using the form on the right. With that said, I'll hand the floor to you CEO, Mark Waugh, and CFO, Anders Svensson. Please go ahead.

Thank you. Welcome, everyone. My name is Mark Waugh, and I'm the new CEO of OssDsign effective January 1 of this year. I have with me our CFO, Anders Svensson. Today, we want to walk you through our fourth quarter and full year 2025 results. As always, when we do these presentations, the normal disclaimer.

Before we go into the details, let me give you my view of the highlights in the quarter. First, we continue to see strong growth. Constant currency growth in U.S. dollar sales for Q4 was 24% and reported 9%. Although this predates my tenure with OssDsign, I'm very proud of the team's achievement of full year constant currency growth of 45% or reported 35% due to the U.S. dollar to SEK exchange rate fluctuations. Two, it's worth noting that the optics quarter-over-quarter are still skewed by further deterioration in the U.S. dollar to SEK exchange rate. We've seen further erosion in the U.S. dollar, which impacts our reported figures in SEK given our sales are generated in U.S. dollars. Three, we continue to generate strong gross margins and we saw further improvement in adjusted EBIT levels net of some transition costs we incurred with our CEO change.

During the quarter, we saw an additional publication of OssDsign Catalyst and a challenging revision foot and ankle case, showing rapid bone in growth. This confirms again the potential for wider application in adjacent orthopedic segments. We also gained access in 2 new Western region IDNs, allowing us to pursue new business within their numerous facilities. Finally, our ScaleToProfit strategy is on track. The full year performance at 45% constant currency is outstanding, but frankly, the 24% growth in Q4, while solid, is slightly disappointing. A slowdown in the pace of recruiting and hiring sales team members impacted our fourth quarter growth rate. Our commercial team are already addressing that and recruiting and hiring with a greater cadence. I'm pleased to communicate to you that the entire team is fully aligned and refocused on delivering our strategic imperatives as we begin 2026. I will now hand you over to Anders to walk you through the financial results for the quarter in more detail.

Thank you, Mark. So as Mark mentioned, looking at sales in Q4 first, we continue to see pretty good growth in the company during the quarter, we believe. So the reported growth of 24%. Of course, on a constant currency basis, that is the reported basis is so punished by the U.S. dollar headwind. It's a bit extreme right now, and it has continued to decline in Q4, but as you also may remember, it took a really big jump up in Q4 last year. So the discrepancy is just extra large right now. Hopefully, there won't be much more further down the dollar can go.

If we look at the full year, we did SEK 180.2 million. Now 45%, regardless of the Q4 number regardless of the dollar, 45% growth is to us a fantastic growth number for the full year. So very pleased with that one. And as we've also said before, over and over again that growth will not necessarily be linear in our business and for our company. It will more take the form of the staircase, with some higher quarters and some lower quarterly increases. And this was particularly evident as you may remember, between the second and the third quarter, we had some business shifting between the quarters. It's also the case in Q4. Now added to this, as Mark mentioned earlier, we have also experienced a slowdown in the recruiting and hiring of sales team members in the second half of the year, and that's just contributing to the reduced growth rate for that period. What's important, however, is the underlying momentum that you see on this slide in the company that we see as the best indicator at the 12-month run rate, which we call LTM, which, of course, after December is exactly the same as the full year.

And as you can see, for the fourth quarter, it continues here on a pretty strong trajectory and 45% up for the year. Shifting to the gross margin. It continues to be very strong in OssDsign catalyst for the fourth quarter, 96.3% for the quarter, which is also what it was for the full year. That's a step-up from the previous quarter in '25. And to remember as well, this is despite the adverse exchange rate effects on sales and COGS, and especially on the raw materials because a lot of the products that we're selling now, they were produced at a more costly time with a much higher U.S. dollar SEK rate. Our gross margin continues to perform very well and along way above the 93% that we've guided. So very happy about that. And now I'll hand you back to Mark.

Thanks, Andres. As I mentioned during the highlights, in Q4, we had a case study on the performance of Catalyst in a patient with revision sub tailor arthrodesis that was showcased in the Journal of Orthopedic Experience and innovation. This particular case highlighted the use of Catalyst as part of a revision surgery to address a failed fusion in a 72-year-old patient. Both x-ray and CT scan showed evidence of early and complete fusion at 3 months in this challenging revision case.

Although our strategy focuses on Catalyst in the spine market, we also have long-term plans for commercial expansion into adjacent indications where Catalyst is already cleared for use. The foot and ankle market is one of those areas. We again welcome the publication of this second positive case report, which also happens to be in a challenging case. This confirmed the same rapid bone-in growth we've shown and come to expect with Catalyst, and also the potential for broader applications of our nanosynthetic Bone Graft. Although OssDsign has only been active in the orthobiologics space for 4 years, we built a solid body of evidence with a total of 17 preclinical and clinical publications, and white papers. Some of you have seen a similar slide before, but one of the reasons I joined the company was the strength of our clinical evidence surrounding Catalyst, our next-generation nano synthetic bone graft. What you see here is a summary of those clinical studies we have published.

Across all these studies, we have consistently been reporting high fusion rates and fast bone formation with rapid progression to Fusion. Catalyst Boden model showed 100% Fusion, and we saw 100% Fusion again at 2 years in our top Fusion and perhaps most importantly, 88.4% Fusion in a highly complex real-world population of patients. That result is perhaps the most impressive given when competitive companies highlight their products fusion rates, those rates are often patients that have been selectively filtered out for things like high BMI, smoking or other comorbidities. In clinical studies, these are known as exclusion criteria. This means that in the most challenging patients, you often don't see what the actual real-world performance of the product is. Our ongoing registry data collection and its associated results do not exclude these challenging patients.

The bottom line is the Catalyst shows the degree of performance for a synthetic bone graft rarely seen in the market before. We will continue to add to the strong and growing body of demonstrated clinical excellence and ongoing investments in clinical data collection are a key part of our strategy. And speaking of that strategy, I also want to reiterate the strategy and our priorities going forward. My predecessor communicated our ScaleToProfit strategy in Q3 of 2025, and it has 4 clear focus areas. The first is accelerating access and coverage within the U.S. market. We are doubling our U.S. sales force. We're increasing our marketing efforts. And additionally, we've begun to enter adjacent orthopedic segments, as I mentioned earlier, with Foot and Ankle as an example.

The second is to expand our product portfolio and indications. We plan to launch 2 new products, a MIS solution for Catalyst in 2026 and then a hydrophilic strip product as well as obtaining at least one new indication expansion. Our third priority, which I covered related information on this call is to continue building a complete repository of clinical evidence. We will continue to build and publish data from our PROPEL registry. We are also planning a large Level 1 randomized controlled trial. Through these investments, OssDsign will further strengthen its reputation as a differentiated, top-tier orthobiologics company with some of the most compelling clinical evidence available supporting Catalyst use.

Our final priority is to scale production and to add a U.S. production footprint. This means we'll implement a scalable, more cost-efficient production process and to bolster our existing production capacity as we continue our growth curve. To reiterate our financial ambition, these initiatives support our plan to increase OssDsign sales to over SEK 400 million by 2028 and to achieve a profitable operating results and positive cash flow in the latter part of that strategy period. I'll close by saying I joined OssDsign for 2 main reasons after doing my own due diligence. First, the clinical evidence and performance of Catalysts are quite frankly, excellent. I had the pleasure of addressing and meeting our entire commercial team recently. We talked a bit about what separates high-performing companies from others. One of the things we discussed was belief. I and everyone on the team believe strongly in Catalyst performance and what it can do to help our customers and most importantly, their patients. I mentioned this because it's so important for me and for our team members to be working every day promoting and selling a product, we truly believe in based on its strong level of clinical evidence.

Second, when I looked at the company's impressive growth strategy, it only told part of the story. As I share our results today, our share in the U.S. market is less than 1%. We also have a large concentration of existing sales in the eastern half of the U.S. with lots of metropolitan areas across the country we have yet to sell into. This is why we are expanding our sales team, expanding our marketing efforts, continuing to expand our portfolio, investing in ongoing clinical evidence and expanding our production footprint. I view the opportunity to go after this huge opportunity with a great product and dedicated team, as exciting and exactly the kind of scenario I would like to be in, given my experience and what I believe OssDsign is capable of. I want to thank you all for joining our call today, and I will now hand back to the operator who will handle questions.

There are no more questions at this time. So I hand over to you for some closing remarks.

Well, I just want to thank you again for participating on today's call, and we look forward to updating you again next quarter. Thank you very much.

Hello, and welcome to today's webcast with OssDsign where CEO, Morten Henneveld and CFO, Anders Svensson, will present the report for the third quarter of 2025. [Operator Instructions] And with that said, I hand over the word to you guys.

Thank you very much, and welcome, everyone. My name is Morten Henneveld. I'm the CEO of OssDsign. And as always, I have our CFO, Anders Svensson, with me today. And today, we want to walk you through our third quarter results and the results for the first 9 months. As always, when we do these things, we have the normal disclaimer. Before we go into the details, I want to give you my view of the highlights in the quarter.

Firstly, we continue to see good growth. In the first half of the quarter, we witnessed a general dip in procedures due to seasonality. But very importantly, the quarter finished exceptionally strong with September being the highest sales month ever recorded. And I can also disclose that we have seen that trajectory continue into the month of October. It's also worth noting that the upticks quarter-over-quarter is significantly skewed by the changed order pattern from a few larger customers, resulting in SEK 1.5 million in sales that shifted from Q3 into the last day of Q2, which we also communicated with the second quarter report. And then we also saw further deterioration in the USD exchange rate.

And adjusted for this, the underlying growth quarter-over-quarter came in at 5%, which is very much within where we wanted to see. Despite this shift in sales, we saw very impressive operating leverage in the company, resulting in the best EBIT result in the history of the company. During the quarter, we also saw the very first publication of OssDsign Catalyst used in an extremity case showing rapid bone ingrowth at 3 months, and that confirms the potential for wider application in adjacent orthopedic segments.

And then finally, we entered the quarter fully capitalized to launch our new growth strategy, scale to profit to further accelerate the company in the quarters and years to come. And we have already started executing this strategy with specific focus, of course, on doubling the U.S. sales force. So with that, I'll now hand you over to Anders to walk you through the financial results for the quarter in more detail.

Thank you, Morten. So as Morten mentioned, we continue to see good growth in the company during the quarter. We reported organic growth of 35% compared to the same period last year on a constant currency basis and 23% on a reported basis. Now that is due to the U.S. dollar headwind, as you mentioned.

Now the result was, of course, also adversely impacted by the SEK 1.5 million shift in order pattern that Morten just talked to. Looking at the sales for the first 9 months, sales came in at SEK 135 million. That's an organic growth of 54% and 45% on a reported basis. As we've also said before, time and time again, growth will not necessarily be linear, but will more take the form of a staircase. So there will be some higher and some lower growth quarters. This quarter is actually an example of that where we jumped a lot in Q2 and came in a bit lower on growth in Q3.

To us, what's important is that the underlying momentum in the company is the best indicator being the 12-month run rate, which we call LTM. And as you can see in this slide, for the third quarter as well, it continues on a very strong trajectory and the LTM momentum is up 48% year-over-year, which is an excellent performance in our view that we're really satisfied with.

Moving to the gross margin. It also continues to be very strong in the quarter, 95.6%. This is a little bit down compared to previous quarters, but this is driven by perfectly normal mix effects, customer mix and product mix, which vary from quarter-to-quarter. And then you also have a smaller adverse currency effect in there on raw materials since we don't sell what we produce in the same month. So what we've started to sell now is what we produced maybe 6 months ago or 8 months ago when the dollar rate was really, really high. Gross margin, however, it continues to perform well above the guided level of 93%, and we are very pleased with that performance.

I'll now hand you back to Morten.

Thank you very much, Anders. I want to get back to the case we published on the extremities because as we've said from the very beginning of starting the journey on orthobiologics, we are actually clear broader than spine, even though we have a strategic focus on spine. We have an existing clearance for use outside spine in extremities and in some pelvis cases and even in trauma cases.

And during the quarter, we published a case study on the performance of OssDsign Catalyst in a patient with post-traumatic ankle arthritis, and that was published in the peer-reviewed journal Biomedical Journal of Scientific and Technical Research. And although our new strategy focused on maximizing the potential of OssDsign catalyst in the spine segment, which, as you know, we have just hit the 10% access mark. So we have 90% of untapped potential in that segment. It also involves long-term efforts for commercial expansion into adjacent indications where we are cleared for use. We, therefore, welcome the publication of this positive case report in an extremity case, which confirms not only that we can also demonstrate the same rapid bone ingrowth in a foot and ankle case, it also confirms the potential for broad application of our nanosynthetic bone graft.

And as you know, we have consistently showed very high fusion rates and very fast bone formation throughout every single study we've done from the very first preclinical study where we showed 100% fusion after 26 weeks in our first TOP FUSION study, first inpatient study called TOP FUSION, we demonstrated 93% fusion at 12 months and 100% at 24 months. And then, of course, the biggest study was the PROPEL that was published earlier this year in a very challenging patient cohort where we demonstrated a fusion rate of 88.4%, significantly above market average. And we're also seeing that those results being agnostic to all the known patient and surgical risk factors that exist. And we demonstrated very high fusion rate throughout all of these different patient groups. So we are in a very good place relative to our performance of OssDsign Catalyst relative to the market. We are demonstrating results that have not really been seen in the market, and it does resonate incredibly well with surgeons.

So to sum up, even though we've only been active in the orthobiologics space for a little under 4 years, we have now already built a very solid body of evidence and with a total of now 16 preclinical and clinical publications and white papers. And again, I just want to draw your attention to the fact that when we enter '24, we did not have a single piece of clinical evidence, but had up until that point, only commercialized on preclinical. So it's quite a stunning progress we've seen in the company within the last 18 months and something which is materially important for the company in the coming quarters and years.

I also just want to take the opportunity to reiterate our growth strategy and priorities going forward. In June, we launched our new growth strategy. And as part of that, we also significantly strengthened the balance sheet, which means that we have a fully funded growth strategy, which we call scale to profit. And we have already started to execute on that. The strategy has 4 very clear focus areas. The first is to accelerate access and coverage in the U.S. market. In order to do this, we will double the sales force by 2026 and accelerate our marketing effort.

In addition, we will, at some point during the next strategy period, more aggressively also enter adjacent orthopedic segments. The second one is to expand our product portfolio and indication. And here, we expect to launch 2 new products and MIS solution already next year and a hydrophilic strip product between '27 and '28 as well as obtaining minimum one new indication expansion.

The third priority is to continue to build a complete repository of clinical evidence, that means that we will continue to build and publish data from our PROPEL registry, which have consistently shown very strong results. But equally important, we will initiate a large Level 1 randomized controlled trial, which is expected to start during the second half of '26. And by investing in this, OssDsign will become a top-tier orthobiologics company and one in only very few companies that can demonstrate such clinical evidence.

And the final and fourth priority is to scale production and increasingly build a U.S. production footprint. That means we'll be implementing a scalable, more cost-efficient production process and over time, move production focus to the U.S. And that also means that despite the fact, as Anders mentioned, that we are operating with a very high gross margin, we actually have line of sight to reduce our costs even further and thereby be able to boost that gross margin in the quarters and years to come.

Now finally, since this will also be my last quarterly report and earnings call for OssDsign as we build an even stronger leadership presence and focus on the U.S. market, I want to thank all OssDsign team members, our partners, all of you investors in the company and all of you who have listened to me during the last 21 quarterly report. Thank you for your trust and continued support of the company over the years.

Since joining in 2020, the company has been transformed from an EU-centric patient-specific cranial implant company to a high-growth U.S.-focused orthobiologics company. In just a few years, we've multiplied revenue, significantly lifted gross margin, strengthened the shareholder base with new Swedish and international institutional investors and created substantial shareholder value.

Commercially, we are now approved in many hospitals in the U.S., have secured contracts with the U.S. military as well as a GPO contract with Premier. We've built a large distribution network and simultaneously, as I talked about, generated a very solid robust body of excellent clinical evidence. In other words, OssDsign is now stronger and more focused than ever, and I'm confident that the company will have a very prosperous future. And with those final words, I want to thank you all for listening to the presentation and hand back to the operator for questions.

[Operator Instructions] And the first question here, sales were a bit more flat -- sales was a bit more flat, but there also seem to be some very positive developments in the quarter. What is your overall take on the report?

Yes. No, I think you're right. And as we've also -- as Anders mentioned, we've said this over and over again, there will be some stronger quarters and there will be some more flatter quarters. This was, of course, one of the more flat quarters.

Now I want to highlight the fact that the quarter started fairly low, as I mentioned, because of the seasonality. And -- but we are seeing a momentum in September that means that this was the highest sales month that we've ever recorded. And as I also mentioned, we saw that continue into the month of October as well. So we're seeing a very strong underlying momentum.

Secondly, we continue to operate with an exceptional strong gross margin above 95%. And then despite the more flattish sales quarter, we saw significant better operating leverage again this quarter in the company, which means that we were able to report the best EBIT result in the history of the company. So I think this is a very decent report. I think it shows that there is a strong underlying momentum. And then, of course, we are right now in the process of doubling the sales force, which inevitably will have a very positive impact on sales and growth rates going forward.

The next question here is, how have catalyst selling prices developed increased, flat or decreased?

It's -- selling prices have actually increased for quite a number of quarters now.

Moving on to the next question here. How much do you expect the upcoming randomized controlled trial to cost? And when should we expect patients to be recruited?

Well, I think I don't think we can talk about the actual cost. That will depend on the final protocol, which is what we are in dialogue right now with some very noteworthy centers across the U.S. We expect this to get off the ground in the second half of next year when we have everything lined up relative to sites selected and so on.

Here's a pretty long question. Considering you so far have no particular strong clinical evidence, hence, the RCT, is there a risk that you have already met your potential on the customer base that is willing to try out new products? Could sales growth from here on be struggling considering you have much stronger data for further market penetration?

Yes. That is a long question. Let me try to answer it. So let me be very clear. There is an enormous potential for the companies, and we are still just scrapping the surface. As I mentioned, we've only gained access right now to 10% of the spine market. And in addition, we can go into extremities, pelvis and even trauma if we wanted to in the years to come. So the potential is enormous. Then I'll also dispute that we don't have strong clinical data. What we published with PROPEL is some of the strongest data that exists on the market, 88.4% fusion rate in a very complex cohort is not something anyone else has published. It is in line with what you normally see in ECDF trial, so in the cervical space in the neck, which are much, much smaller procedures. So this data is very strong. It resonates incredibly well.

What we are saying and the reason we want to do a larger RCT trial is because we want to have a complete repository whereby we can both demonstrate very strong real-world market data which we already have and will continue to do so with PROPEL, but then we want to combine that with a larger randomized controlled trial to cover all the bases. So we have exceptionally strong data, and we have data that really no one else has published in the market today.

When are you going to release a new product in 2026?

Well, that's going to come in 2026. I don't think we want to go into more detail about the exact timing of that. There are still a few things we need to go through that can move the exact time line. But we are very, very confident it's going to come next year.

Have you seen or experienced any issue or effect regarding sales communication and so on with -- have you seen or experienced any issues or effect regarding sales, communication and so on with hospitals in general due to the governmental shutdown in U.S.?

No, I think what we saw during the summer here, we believe it's more seasonality, which is not something that we've really seen to the same level before. But directly as related to the shutdown, no. From what we can see, hospitals continue to go strong. Also bear in mind that there is a very large part of the U.S. health care market, which is for profit, which means that it's owned by private companies who are not affected by this.

What time will tell is, of course, what is the impact on FDA and new clearances and other things, but I think it's premature right now. From what we can see, there's still processing applications.

What do you view as the greatest risk for continued growth for OssDsign in the coming 12 months?

Well, I think as we also said when we announced the strategy, we need to double the sales force. We came into Q3 here with a sales force of about 10. And we want to see that doubling. We're hoping to finish by 15 by year-end and with an additional 5 people recruited in the next 3 to 4 months coming into '26.

So our aim is by Q2 of next year to have a doubling of the sales force. And I think you have to bear in mind that even if all these new people deliver mediocre, say, [ $0.5 million or about $5 million ] in the first year, when you have 10 more people, that actually will create a huge boost to sales and growth going forward. So that, by far, is the most important thing for us to do in the next 6 months or so.

Do you plan some price increase going forward to compensate a bit for the dollar devaluation?

Well, I think it's not really as easy as that, right? Because our U.S. subsidiary are actually the ones selling it. We are always trying to get the highest prices, of course, as you can also see on the gross margin. As we've also said, there are big price differences in the U.S. between states. And we have a multi-tier pricing strategy in the U.S. And of course, we are always trying to maximize on that. As Anders said, we've been successful. We have continuously been able to increase ASP over the years steady. And that's also something we continue to do going forward.

We have received a lot of questions here. Could you update us on the hiring progress in the U.S. and the difficulties to find great people?

Yes. I mean I think we -- things are going per plan. We are hiring people. Of course, we launched the strategy and did the fundraise in June, which means that we've really started executing on this strategy when we came into August. So that is going to plan. As I said, we hope to have an increase from 10 to 15 in our sales force by year-end with an additional 5 in the next 3 to 4 months into next year. So I think we have a really, really good story. We have a good track record as a company. We are coming to market with what is clearly a very, very innovative product and a product that seems to generate results that hasn't been seen in the market before. And of course, that helps us tremendously in our ability to recruit salespeople.

And a follow-up question there regarding the hiring in the U.S. How long does it take for new salespeople to be productive?

Well, I think honestly, it varies a lot depending on who you get in. It also varies whether you hire people into what we call a virgin territory where you have very little or where you have existing users and business. We have seen some sales reps going very high within 12 to 18 months. But normally, I would say it takes a couple of years for them to get into what we would consider the strong average sales of around $2 million, which is what we're seeing right now per head on average.

Why was PROPEL not peer reviewed?

Well, it was. So I think that's -- I don't know who asked the question. It is published. It is peer reviewed and the journal was published.

And moving on to the last question here. You say you have started to execute the new growth strategy. Can you explain that more in detail?

Yes. As I said, there are 4 important priorities in that. Right now, where we are going all in is on the doubling of the sales force, which we want to get done as fast as we possibly can. So that is in full motion. We also work on the products, as I said, feel very confident that we will launch the next product already next year. We are mobilizing fully on the larger randomized controlled trial. There is a lot of milestones to achieve before you can get that study off the ground. That's going to plan. We are getting very good feedback from, I would say, some very big surgeons and very noteworthy centers to work with us on this.

And then as I said, we are also now starting to take the next step on creating a scalable and more cost-efficient production. So we are executing on all of that. We've done that fairly swiftly. But of course, some of these are also longer-term projects that we will continue to work on for the next year and years after that.

Thank you so much for the presentation here today, and thank you all for sending in questions and watching. And thank you, Morten, for these 21 quarters.

Thank you very much. It's been a pleasure. Take care, everyone.