OssDsign AB (publ) (OSSD) Earnings Call Transcript & Summary

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.