OssDsign AB (publ)

Hello and welcome to today's FineWire broadcast presentation with Host Design. 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 Volk or CFO Anders Svensson. Please go ahead.

Thank you. Thank you. Welcome, everyone. My name is Mark Waugh, and I'm the new CEO of AusDesign, effective January 1st of this year. I have with me our CFO, Anders Vinson. 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 AustDesign, 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 SEC 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 SEC exchange rate. We've seen further erosion in the U.S. dollar, which impacts our reported figures in SEC, 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 Ostazine Catalyst and a challenging revision foot and ankle case showing rapid bone ingrowth. This confirms, again, the potential for wider application in adjacent orthopedic segments. We also gained access in two new Western Region IDNs, allowing us to pursue new business within their numerous facilities. Finally, our scale-to-profit 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 a 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 significant punished by the US 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... 180 million, 0.2. 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 we're 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 a 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've 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 a 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 quarters 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 our design 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 period. with a much higher US dollar sec rate. But gross margin continues to perform very well and a long way above the 93% that we've guided. So very happy about that. And now I'll hand it back to Mark.

Thanks, Anders. As I mentioned during the highlights, in Q4, we had a case study on the performance of Catalyst in a patient with revision subtalar 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 scans showed evidence of early and complete fusion at three months in this challenging revision case. Although our strategy focuses on Catalyst and the spine market, we also have long-term plans for commercial expansion and to 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 ingrowth we've shown and come to expect with Catalyst and also the potential for broader applications of our nanosynthetic bone graft. Although Ost Design has only been active in the orthobiologic space for four years, we've 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's nanosynthetic bone grafts. 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 Bowden model showed 100% fusion, and we saw 100% fusion again at two 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 product's 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 a product is. Our ongoing registry data collection and its associated results do not exclude these challenging patients. The bottom line is the catalyst shows a degree of performance for a synthetic bone graft rarely seen in the market before. We will continue to add to this 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 scale to profit strategy in Q3 of 2025, and it has four clear focus areas. The first is accelerating access and coverage within the US market. We are doubling our US 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 two 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 one randomized controlled trial. Through these investments, Ost Design 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 OS design sales to over SEC 400 million by 2028 and to achieve a profitable operating result and positive cash flow in the latter part of that strategy period. I'll close by saying I joined Ostesign for two main reasons after doing my own due diligence. First, the clinical evidence and performance of Catalyst 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's performance and what it can do to help our customers and most importantly, their patients. I mention 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 Oss Design 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.

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.