Welcome, and thank you all for joining us at Bioretec for this 2025 financial bulletin review webcast. Without further ado, I'd like to just get right into it. I'm Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec. 2025 was a year of rebuilding our foundation to enable real commercial growth. A number of key transitions took place during the course of the year, starting with two major C-suite adjustments, five new management team members now in place, a change in our distribution model in the United States, and an upgrade to our global go-to-market strategy. We also invested in improving organizational performance through increased data and analytics. Finally, we ended the year with a comprehensive review of the top-line targets, leveraging industry veterans in medtech, finance, and operations to support our newly communicated strategy.
These decisive actions were a required reset in order to pave the path forward for future success. As a result of these necessary adjustments, we exited 2025 with a more agile commercial organization, a strengthened strategic focus, and greater readiness to execute our next phase of growth. Yet, while we were rebuilding, we naturally continued to progress the business, and we achieved a number of major milestones in 2025. In the U.S. alone, from a regulatory and reimbursement perspective, we garnered our third Breakthrough Device Designation for the RemeOs platform for our Drill Pin. This makes us the first and only absorbable implant company in the world to obtain three Breakthrough Device Designations. In addition, in the fourth quarter, the largest payer in the United States, CMS, or the Centers for Medicare and Medicaid Services, granted our RemeOs Trauma Screw Transitional Pass-Through Payment.
This recognizes the economic value of our breakthrough technology on top of the clinical value. These key achievements are momentum drivers in support of our overall commercial strategy. In terms of commercial progress, the year also reported U.S. direct sales quarter-over-quarter growth of over 60% consistently since mid-Q2. These signals, coupled with the establishment of our surgeon Key Opinion Leader program in the United States and the expansion of our direct distribution footprint in key states across the country, were all strong signals of our renewed strategy and position us to accelerate. The focus of our progress, however, was obviously not limited to just the United States. Outside the U.S., we activated new distribution partners in high-priority markets, we conducted full contracting reviews and margin analysis in high-volume geographies, and we set clear and fully aligned three-year sales targets with each distribution partner we engage with.
We call this our where-to-play analysis, and as a result of this activity, we are now poised to not only deliver better in the key markets where our products are already commercially available, but also in the activation of new markets over the strategic period. 2025's financial results reflect the absorption and significant changes in our leadership and talent, as well as in our distribution models, our ordering cycles, and they include the one-time corrections associated with those changes. While the financial results reflect the impact of these strategic resets, they also reinforce the value of decisive action. To close the year, we released our updated strategic priorities and financial targets. The updated financial targets reflect a deliberate message. We're focused on building a company that our shareholders can trust and a company that delivers.
The associated strategic priorities clearly demonstrate that our ambition levels have not subsided, and we're focused on commercial market leadership, industry-leading innovation, and world-class clinical and economic evidence generation to ensure that our breakthrough portfolio reaches patients and delivers on its promise. The market's ready for us. Up until now, previously, we had communicated the roughly $14 billion total addressable market within which we play as Bioretec, but it's equally important to note the double-digit growth and pull for absorbable technologies within that addressable market. Furthermore, Bioretec is now being recognized by independent third-party research as a leading player, driving that shift in absorbable technology amongst many leading industry names, and we intend to do just that. Next slide, please. What do we need to accelerate? From a product portfolio perspective, we need to deliver on the near-term product line.
This not only provides an active product design support to support the U.S. market preferences more specifically, but it also includes a slight expansion of our current RemeOs portfolio, which is currently relying on the power of just one trauma screw in today's commercial markets. Near-term RemeOs products are required to begin to realize the full value of the trauma product line in market and to be able to compete properly in procurement bids and against earlier generation competitors. What's truly exciting about this near-term portfolio is that it not only includes products that are differentiated in the performance of the materials, but also in the efficiency of surgical technique, as demonstrated with our breakthrough DrillPin. Our overall pipeline also represents three distinct IP portfolios associated with three distinct product families: Activa, RemeOs Trauma, and RemeOs Spine.
The foundation of our proprietary products, coupled with decades of industry know-how, means we can actively pursue various business development pathways, creating shareholder value per product, per product family. Finally, after listening to and working with surgeons over my last nine months as the CEO of Bioretec, the message is clear: leading surgeons are ready for the shift to absorbable implant technology, and they're excited about Bioretec's future in that market, and so are we. Now, I'd like to close the presentation portion and shift over to our Q&A. In the Q&A, I'll be joined by my CFO, Tuukka Paavola. Tuukka, over to you.
Thank you very much, Sarah. Great to be here, presenting at the webcast. So, if anybody has any questions you would like to ask, you can post them online. So, we have time to go through at least a few questions here. So, let's start with last year. So, you took the helm last year, Sarah, as the CEO. So, how would you describe the business during the fourth quarter last year, and also the whole 2025? What are maybe the aspects that you're most proud of, and what still kind of maybe needs to be developed?
Thanks for the question. So, you know, as I mentioned, the quarter-over-quarter development in U.S. direct sales of 60% consistently is something we're extremely proud of in terms of the development of a rebuilding year. We now have an enhanced management team with five new members added in 2025, and the resilience of that team was demonstrated through this year of change. We also achieved those significant regulatory and reimbursement milestones. That third Breakthrough Device Designation puts us in a class of our own amongst other companies in absorbable technology to date. It's a real first for any company to have that sign of recognition from a regulatory perspective.
The pass-through payment associated with that, which was narrowed again with our release in January, around metallic implants, specifically, of which at the moment we are the first and only one in the market, so we make up the category ourselves, is real recognition of the leadership in innovation and the first-mover advantage we have right now that we need to fully execute against. In terms of how we need to execute then and what we still need to develop, I would say that the commercial resourcing in the U.S., including market access, contracting, pricing strategies, and partnerships to help us get more feet on the ground to accelerate that first-mover advantage that I mentioned, is critical.
Equally important is bolstering our clinical affairs capabilities so we can accelerate on our clinical trials and our U.S. regulatory capabilities so we can advance that near-term pipeline.
Hmm. Great. Thank you. And there's, yeah, now plenty of questions coming in. So this question regarding, regarding the revenue, of course, maybe I can start by saying a few words about revenue development. So of course, the 2025 revenue was slightly below the comparison year, 2024. Which, of course, kind of reflects this kind of transition that we are currently having. Transition in many ways in the strategy, in management team, and also in the distribution model. However, it's. I think it's worth noticing that the comparison period, 2024, includes this EUR 0.9 million of revenue from this old distribution model, so they're not fully kind of comparable.
And I would say that the kind of underlying business is actually strong, and we are confident that we have a strong foundation behind the numbers. There's a strong underlying demand, and the fact that we are just kind of getting started now after this strong reset. So I think that's kind of the overall on the revenue side, but maybe then, Sarah, for you, more about the RemeOs. So there's a question with regards to the kind of RemeOs revenue portion of the total revenue. How is it going? How is the introduction going, both, I guess, in the U.S. and also outside the U.S. when it comes to RemeOs?
Yeah, sure. So thanks for taking the note on the revenue, and I think just to come back to that for one second, I think it's important to remember that we transitioned away in the United States from those stocking distributors, and that's reflected in those unrepurchased inventory, which we reported earlier in 2025 as well, which resulted in that EUR 1.1 million one-off and the EUR 0.9 million of revenue recognized, as you mentioned, Tuukka. So when you take a look at those numbers, you can still see that, you know, behind that the demand for the product is still strong. I would say, you know, regarding RemeOs, clearly, this is our future platform leader, and we all know it, right?
There are other metal absorbable companies that will be coming down the pike in the years to come, and right now we are front and center in leading that charge. If you look at some of the quotations on the market momentum on this, the last slide that showed regarding surgeon sentiment, you can see that there's a ton of interest in RemeOs and metal absorbable technology. So the question becomes, you know, what is the actual commercialization process for that technology? And there, I think we've touched on two elements. The first of which is that we're talking about one screw at the moment, and even in the U.S., we're we have a bit, I think of a more narrow, a very narrower offering, which is we have one screw with one design on that screw.
So really, to realize the potential of the RemeOs product line and to see the value play out in market, we just slightly need to broaden that offering. We don't need to have a massive trauma portfolio offering, but we need to broaden the offering beyond one screw, and in particular, in the U.S., beyond one screw and one design. Despite that, we're still seeing demand for the RemeOs product line in market and so that's great signal. In addition, I think in Europe, the communication may have underestimated in 2025 the need for the additional steps that come after CE mark. So although CE mark was achieved in 2025 in January, in Q1, country registration and of both, not just the implant, but also the associated instruments. So with our implants, they require instruments to be able to be used.
So think about it in standard carpentry. You have a screw or a nail, but you need a drill, or you need a hammer, you need something else to actually use that screw or nail. And so that's what we define as instruments within Bioretec or within our orthopedic business. For RemeOs, there are no existing off-the-shelf instruments that can be procured by other parties or that are registered in countries to date. So those instruments and the related and the implants both need to be registered now in countries in order for them to even be commercially available on the back of the CE mark. So our team has been working extremely hard with the number of countries that we would like to be commercializing RemeOs with globally, that recognize the CE mark, to register both those implants and those instruments into those respective countries.
Which, of course, means that that took some time in 2025 to do, but we are now seeing the benefit of that and the momentum building into the current year.
Great. Thank you, Sarah, for a great answer here. Going back to the U.S., there's a question regarding these value analysis committee clearings that we have, we have 17 in total. So there's a question: Could we discuss what you expect and what is the timeline, and what kind of institutions are we talking about here?
So I spent a lot of time diving into go-to-market in 2025 and all the way into the beginning of 2026. The U.S. healthcare market is extremely complex from a commercial perspective, and the value analysis committees that happen at a hospital level are just one of the many steps that need clearance in order for you to be able to sell a product. So what we'll be investing in, and what we intend to invest in in 2026 and continue to work on, which we've already begun, is real expertise in contracting. Contracting and pricing strategy that enables us to, what we call market access, really open up the market for us to sell those products.
Some of that contracting needs to be done in the private setting, in the ambulatory surgery center setting, and some of that contract is more of a contract across major hospitals and healthcare systems. But a real capability in strategic contracting and a pricing strategy across the board will set up the infrastructure for us within the United States to be able to scale cost-effectively and really drive near-term volume. So that's a major focus for us in 2026.
Hmm. Thank you very much. Then there's a question about our financing situation and plan. If I take that one, yeah, so of course, the situation was at the end of the year that we had roughly a little bit more than EUR 4 million cash at hand. And naturally, for us to be able to execute on our new strategy, we need to improve our financial situation and our capital structure. For that reason, we have also today published, or announced, that we are investigating a potential rights issue. And of course, that financing needs come from this new strategy. We need to, we need to have, have, you know, financial backing to be able to execute on the strategy.
Because, like I said before, there's a great demand we are seeing in the market. We have a really fantastic plan for the strategy period 2026-2028. So of course, with financing side, we also need to have a solid foundation on which to build. While, you know, growing the top line, we, of course, need to make sure that we keep close focus on the costs and spend wisely, and on the matters that actually create most value. Is there anything you want to add to that, Sarah? No.
No. Thank you, Tuukka.
Fantastic. Then I think we have time for one final question here, which is about our guidance. So the question is or basically saying that we are not giving any 2026 guidance, which is true. But question is that looking at our 2028 targets, we should be growing clearly over this year, or have we missed something?
No, you haven't missed anything. We don't give annual guidance. As we say, we're at this moment, we don't give annual guidance, and our focus is 100% on commercial growth, period. That's what we're focused on doing, and, you know, depending on how well capitalized we enter and are able to execute in the strategic period, will also determine how fast we can accelerate to possibly even exceed the targets that we've set. Yeah, as a reminder, it's worth noting that the targets that we set are ones that do not include any additional acceleration from business development or partnership opportunities, and we made sure to make that statement explicitly.
It's hard when you're a company that doesn't actually have full visibility to your cash, or your capital allocation for the whole entire strategic period, to give high, highly accelerated numbers during that period with any level of trust and confidence. And as I mentioned, you know, I and the leadership team, from the board of directors down to the management team, all believe that it is the objective of Bioretec to be a company that shareholders can trust in and who delivers on its promise, and that's what we intend to do.
Good. And I think that was the final question for which we had time. So thank you very much for all the questions posted.
Thank you, all. Thanks for joining the webcast.
Thank you.