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Summary
Transcript
  • Bioretec reported Q2 net sales growth of 62% YoY, with the company stating >100% YoY growth in the US and >60% in Europe, and said revenue diversification and an improved adjusted sales margin reduced concentration risk.
  • The company announced leadership transitions in H1, including CTO and CFO changes and the hiring of a new Head of R&D and a new CFO (the CFO hire occurred after the reporting period).
  • Bioretec said US growth is being driven predominantly by ActivaPin sales and noted a limited RemeOs portfolio in the US; the company plans to expand US headcount, product approvals and portfolio to support further growth.
  • R&D updates: Bioretec is investing in preclinical spine development after receiving a breakthrough device designation for an interbody cage and expects to continue development into 2027; an investigator‑initiated trial with Mass General is being finalized but not yet initiated.

This content is generated by AI based on a video transcript. You can give feedback on it in the Inderes forum.

Disclaimer: This is a machine-generated transcript and may contain inaccuracies.

AS
Antti Siltanen
00:00 - 00:08

Bioretec released today their half-year numbers. And we have with us the CEO, Sarah van Hellenberg Hubar-Fisher. Sarah, good to have you on the interview.

SvHH
Sarah van Hellenberg Hubar-Fisher
00:09 - 00:11

Thanks. Likewise. Good to see you again.

AS
Antti Siltanen
00:11 - 00:16

How would you summarize your H1 in a nutshell?

SvHH
Sarah van Hellenberg Hubar-Fisher
00:17 - 01:31

So H1, let's start with commercial momentum. I mean, I think we saw continued growth in Q2. In Q2, with net sales year over year growing by 62%. We achieved over 100% year-over-year growth in the US and over 60% in Europe, which is really demonstrating consistent volume growth and representation across different targeted geographies. Our revenue base also continues to reflect that deliberate diversification through a broader mix of customers, distribution partners, and across key markets. And this is really reducing concentration risk and strengthening the quality of the revenue that we report. This is also reflected. These improvements are actually also reflected in the adjusted sales margin.

H1 was also a period of additional leadership transition. So we had announcements of a CTO and CFO transition, as well as the hiring of a new Head of R&D and a new CFO, which occurred after the reporting period. But these transitions reflect our laser focus on repositioning for growth, and the first two quarters of 2026 have really provided clear signals. We believe that our strategy and our commercial investments are really translating into measurable results. So we plan to carry this momentum and increase confidence into the rest of 2026.

AS
Antti Siltanen
01:33 - 01:50

As you mentioned, in Europe, you grew over 60%. So can you add a little bit of detail on what were the drivers and how that growth materialized? And specifically, how did RemeOs commercialization develop during the period?

SvHH
Sarah van Hellenberg Hubar-Fisher
01:50 - 02:35

So the growth in Europe is a direct reflection of our where-to-play strategy, which we conducted in the back half of 2025 and communicated through previous updates. In those updates, we stated that our strategy was set to focus on high-priority markets, where our 2025 revenue representation was lower than expected and desired, and where we knew that market demand was absolutely palpable. So this has resulted in delivering higher revenue numbers from those prioritized markets in Europe, including the U.K. and Germany, in the same comparison period. But this was also a direct result of the distribution changes we made in select markets, where our previous distribution partners were underperforming, and we were looking for some higher-performing partnerships.

AS
Antti Siltanen
02:35 - 02:50

In the US, you saw triple-digit growth year over year. So kind of the same questions for the US market. What were the drivers of growth in the US, and how did revenues develop? Sure. So we've communicated.

SvHH
Sarah van Hellenberg Hubar-Fisher
02:50 - 03:37

And we state consistently. We all know that the majority of the market for medtech sits within the United States. And so the US will continue to be a massive area of focus for us in terms of geographies. The US does, though, continue to deliver and to drive growth quarter over quarter. And our ActivaPin, again, will remain that predominant source of sales volume, as I just mentioned, because in the US we have an even more limited RemeOs portfolio than we have in Europe right now, with the one-leg solid screw design. So our focus is to increase our presence in the United States with people and increase our product offering in the United States through broader product approvals and product portfolio. And that will continue to help support driving growth.

AS
Antti Siltanen
03:38 - 03:52

Finally, the rest-of-the-world segment, is there anything specific you'd like to highlight there? And also, I wanted to ask about the Chinese market. How has that developed in terms of your business and the operating environment?

SvHH
Sarah van Hellenberg Hubar-Fisher
03:53 - 04:21

Right. So rest of the world is performing exactly as we had expected and planned. The comparison period, due to stocking orders from last year, gives, we believe, a real artificial impression of actual progress and expectations. Based on our where-to-play focus. So China is in line. Rest of world is still progressing, and we are also registering the products in new countries every single quarter. So rest of world is in line with our expectations.

AS
Antti Siltanen
04:22 - 04:32

I noticed there's another investigator-initiated trial from the famous Mass General Hospital from Boston. So can you talk a little bit about that trial?

SvHH
Sarah van Hellenberg Hubar-Fisher
04:32 - 05:36

Sure. So the majority of our clinical data collection has been in Europe. Historically for Bioretec, and I would still say predominantly that is our focus, especially for pre-market approval data. But also to meet post-market approval data collection requirements related to our CE mark. However, we do recognize that there are instances where US data is important. And in some cases there are procedures that are done within the United States that are not done in other parts of the world. And so it's the only location where data can be collected.

Mass General has been an institution that's highly respected. The Foot and Ankle Research Institute is called FAIR. It is also known globally and respected worldwide. And so we have been in conversation with them about a clinical trial, as you've mentioned, and we have plans to finalize those details related to that trial, which has not yet been initiated. But we're finalizing those details in the coming months.

AS
Antti Siltanen
05:37 - 05:47

In your own R&D efforts, you highlight the preclinical development in spine products. So can you share more details on that? Yes.

SvHH
Sarah van Hellenberg Hubar-Fisher
05:47 - 06:20

Spine is an area within orthopedics that has had a massive interest in biomaterials. And we're seeing that with interest in conversations that we have with industry players within our space. So in addition to our strong focus on foot and ankle procedures, we've made some early investments in preclinical data into spine on the back of our breakthrough device designation for the interbody cage. And we're going to continue this early development into 2027 and look to discuss the progress of this early development with strategic partners at that time.

AS
Antti Siltanen
06:21 - 06:24

Thank you very much for the interview, and best of luck for H2.

SvHH
Sarah van Hellenberg Hubar-Fisher
06:25 - 06:26

Thank you so much. It was a pleasure.

Bioretec H1'26: Expansion of the product portfolio into spinal applications progresses

BRETEC2026-08-13 13:16
Antti SiltanenAnalyst
Discuss

Bioretec sees opportunities to expand its product portfolio into spinal applications, with preclinical studies already underway. Bioretec CEO Sarah van Hellenberg Hubar-Fisher discusses the latest developments with analyst Antti Siltanen.
Topics:
00:00 Introduction
00:12 H1 highlights
01:33 Drivers behind growth in Europe
02:37 Drivers behind growth in the United States
03:39 Developments in China and other markets
04:22 Clinical trials
05:37 Preclinical studies for the spinal product portfolio

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