Bioretec gave a business update today, and we have with us Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec. Good to see you, Sarah. Would you start by telling us a little bit about Q3 in a nutshell?

Yeah. Likewise. Good to see you as well. Thanks for having me back. Sure. So Q3 in a nutshell, strong commercial momentum continued. We had net sales growing by 85.5% to EUR 1.33 million. With the U.S. and Europe continuing to deliver that growth, the U.S. more than doubled, and the quality of our sales continued to improve, with adjusted sales margin also up to 68.7% from 59.4 in the comparison period. We delivered our first near-term pipeline approval, the FDA 510(k) for the ActivaScrew cannulated compression screw. And we strengthened the team with a new CFO and Head of R&D. And costs basically stayed close to the same level as last year while our sales nearly doubled.

If we talk geographies, in Europe you showed strong year-over-year growth of 69%. If we look at the quarterly development, it's been relatively flat during this year. So how would you describe the developments behind the numbers in different countries in Europe and overall?

So when we've been on previous webcasts, I continue to talk about our where-to-play strategy and our high-priority countries. And we saw in Q3 that we had revenue delivery from all regions of the globe, actually. From Latin America, from Europe, from Asia-Pacific, leadership coming in most recently from countries like the UK, Israel, Taiwan, Colombia. Colombia, China, where I happen to be today. All of those countries contributed to our Q3 performance in our top line. And it's in line with what we're expecting in terms of just gradual, steady improvement in the quality of the revenue coming from our U.S. markets.

In the U.S.A., you are showing clear sequential growth. Can you talk a little bit about the developments there?

Yeah. So Q3 was our strongest performance yet. With U.S. top line for the year. And that's exactly what we would expect. We're continuing to expect to see quarter-over-quarter growth, which is what we're trying to drive. That's what we aim for.

And I think as surgeons in the market become, first of all, more familiar with Bioretec and our products, we went from a relatively unknown business to a business now that many U.S. surgeons are aware of and understand what products we sell, we also have very high repeat surgeon utilization rates, which is something we track. And that really shows that once surgeons are using our products, they're continuing to use them, they're not an experiment and this is interesting. And then one bad experience and they stop or something, but we have actually strong repeat surgeon utilization rates coming out of the U.S. And that also helps to drive and build on a foundation of quarter-over-quarter growth when you add new surgeon utilization on top of that.

As you mentioned, you've got the FDA approval for the new ActivaScrew product. Can you provide a little bit of context? How important is this product and how does it fill or supplement your current portfolio?

Sure. So ActivaScrew has been a longstanding product for Bioretec, particularly in markets outside the United States, but it's relatively new to the United States market. And I'd say we really started pushing sales on ActivaScrew. And seeing really strong momentum with Activa in the back half of last year and into this year. And as surgeons become more familiar with our Activa line and gain more experience with the different product portfolios in the ActivaScrew portfolio, we heard a lot of surgeon feedback that they wanted this cannulated headless compression screw design. And so that was the preferred design used by many surgeons in the U.S. market.

So it's one of the top designs used in this type of category. And we just at that time didn't have it. It wasn't necessarily as popular outside of the United States, where we had been previously selling Activa or had the majority of our sales. So this headless compression design now is in addition to our existing U.S. product range that's already commercially available. The clearance came in September. And it was part of our planned near-term pipeline approval priorities. And we expect it to help deliver momentum in the U.S. market and continue to help drive sales.

What's the sales model for this particular product? Are you using stocking distribution or direct sales? And also, when would you expect this product to materially contribute to sales numbers?

Sure. So we have no intention of using a stocking distribution model outside of pediatrics in the United States. So with every new product addition, or product approval we receive for the adult market, we will continue to use the direct sales distribution model that we have, or in many cases in orthopedic companies, we call it a hybrid sales model where you have some of your own executive sales talent in the country that's overseeing a large number of direct sales agents. And so that is the same model and distribution model we're going to be using to deploy and commercialize ActivaScrew.

How about your product development pipeline? I guess this is one of the key products in there. So can you update us a little bit on the developments in the pipeline?

So with the onboarding of the new Head of R&D in the Q3 financial period, we conducted another full pipeline review and a deep dive from both commercial, regulatory and clinical perspectives, bringing in external expert guidance as well to help us reground ourselves and do a review. And this has obviously resulted in even clearer priorities, as well as some opportunities to support the company's market-leading position in the coming 12 to 24 months. Our near-term product portfolio and priorities remain the same. And our product development team is really laser-focused on their objectives and those deliverables in line with those priorities.

You recently announced a new round of change negotiations, which aim for some cost reductions. And also in Q3 already your costs were relatively well in control. So are there any updates for the cash runway?

Not at this time. I mean, we're heading into the end of the year at this moment. And so we will be looking at our budget and our plans for 2027 in particular. So relooking at what we expect to do in the coming 12 months and how we're going to remain competitive and continue to position ourselves as a category leader and a first mover in the U.S. market in particular, but also a category leader globally. So at the moment, there is no update to our previous statements on cash burn and runway.

Okay. To wrap up, what are the milestones and upcoming things for the next 12 months that investors should be looking for?

Continued U.S. sales growth, including the first contributions coming from the ActivaScrew cannulated compression screw approval and further adoption supported by the pass-through payment confirmation we received again just this month. I would also say progress on the short-term pipeline. So really looking to progress our position from a regulatory perspective in the U.S. with the Ramirez trauma screw U.S. expansion. And first milestones for our Ramirez drill pin, likely within that 12-month period. And I would expect us to be focused on driving disciplined growth, advancing our position as a category leader. And of course, this all starts with the right people on board and the right team and the right amount of capital behind us to support us in achieving those objectives.

Thanks very much for the interview, Sarah.

Oh, you're welcome. It's great to talk to you again. Thank you.