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

Quite a cold, sure thing. We have, in a nutshell, strong commercial momentum continued. We had net sales growing by 95.8% to EUR 1.33 million, with the US and Europe continuing to deliver the growth. The US more than doubled, and the quality of our sales continued to improve with just ad sales. Margin also up to 60.7% from 59.4% in the comparison period.

We delivered our first near-term pipeline approval, the FDA marketing approval for the ActivaScrew. We strengthened the team with a new CFO and Head of R&D, and cash 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?

In previous webcasts, we talked about our where-to-play strategy and our high-priority countries. We saw in Q3 that we had revenue delivery from all regions of the globe, actually from Latin America, from Europe, from Asia Pacific, with leadership coming in most recently from countries like the UK, Israel, Taiwan, Colombia, China, where I happen to be today. All of these countries contributed to Q3 performance and our top line, and it's in line with what we are expecting in terms of just gradual, steady improvement in the quality of the revenue coming from our markets.

In the USA, you are showing clear sequential growth. Can you tell a little bit about the developments there?

There was a strong Q3 performance, yet with US top line growth there, and that's exactly what we would expect and continue to expect to see quarter-over-quarter growth as what we're trying to drive, what we are aiming for. 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 US surgeons are aware of, understand what products we sell. We also have very high repeat surgeon utilization rates, which is something we track that really shows that once surgeons are using our product, they are continuing to use them. They are not experimenting and then having one bad experience and they stop or something. We have actually strong repeat surgeon utilization rates coming out of the US, 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 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. 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 real strong momentum back in H2 and into this year, 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 screw compression scale design, and so that was the preferred design used by many surgeons in the US market. So it is one of the top designs used in this type of category. We just at that time didn't have this, and this has been as equally as popular outside the United States, where we have been previously selling ActivaScrew and had maturity in our sales. This headless compression design now is in addition to our existing US product range that is already commercially available.

The clearance came in September as part of our planned near-term pipeline approval priorities, and we expect it to help deliver momentum in the US market and continue to help drive sales.

What is 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 pediatrics in the United States, so with every new product addition, product approval we receive for the adult market, we 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 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 the ActivaScrew.

How about your product development pipeline? Remedy 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 quarter and 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 pressure around ourselves and do a re-review. This has resulted in even clearer priorities as well as some opportunities to support the company's market-leading position in the coming years. For now, our near-term product portfolio priorities remain the same, and our product development team is really laser-focused on their objectives and the deliverables in line with these priorities.

You recently announced a new round of change negotiations which aim at 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. We're heading into the year-end moment, and so we will be looking at our budget and our plans for 2027 in particular, so really looking at what we expect to do in the coming 12 months and how we're going to remain competitive, continue to position ourselves as a category leader and a first mover in the US 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.

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

Continued US sales growth, including the first contributions coming from the ActivaScrew cannulated compression screw. Approval, further reimbursement assumptions supported by the past year payment confirmation. We received again just this month outside progress in the short-term pipeline, so really looking to progress our position from a regulatory perspective in the US with a Remedy trauma screw use expansion and first milestones for our Remedy trial likely within the 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 capital behind us to support us in achieving these objectives.

Thank you very much for the interview, Sarah.

You're welcome. Thank you.