Bioretec - Will the US market open?

Following Bioretec’s results, the CEO’s thoughts are now available for viewing and listening in Antti’s interview :eyes:

Sales of the RemeOs™ trauma screw were at the comparison period’s level, while higher-than-expected revenue growth surprisingly came from the Activa product family. Key to the investment story’s progress is the commercialization development of the trauma screw following the CE mark received early in the year.

Topics:
00:00 Introduction
00:13 Summary of the past year
03:00 Strong development of Activa products
04:39 CE mark and next steps
06:33 Additional processes related to the CE mark
07:48 Actions needed for commercialization of the trauma screw
09:19 Insurance reimbursements in the USA
10:22 Role of single-use instruments
12:47 Status of the DrillPin product
14:57 Potential effects of tariffs
16:23 Financing situation
17:22 Expectations for 2025

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Good interview, and I’m eagerly waiting to see what 2025 brings.

As Alan mentioned: “we did more cases in January than any single month in 2024…”

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Here is the post-market closing release.

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I particularly appreciate the company for releasing a rather pleasant (and at the same time moderately expectation-raising) announcement at the close of after-hours trading, despite the share price dip.

Many more impulsive “sausage stands” (nakkikopit) we all know would have, in panic mode, shoved any kind of nonsense down the market’s throat just to calm down the slightly trembling share price curve (i.e., their own already frayed nerves).

Now, all of us (whales, small investors, analysts, followers from the sidelines…) have time to calmly chew on the matter and life over the weekend. It’s rare that we are all so well-behaved and in harmony in the same boat.

Have a wonderful and peaceful weekend everyone!

Edit.

Some of my own thoughts or expectations weren’t even that moderate.

I then remembered that a funding round is still coming in some form. Which, in this situation, I exceptionally see as a positive thing in this context.

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“”“The CE marking also increases the global potential of RemeOs products, as the CE marking is also recognized as a basis for local registration in almost all other countries except the United States, China, and Japan.”“”

Above is a copy from the press release that came in the evening. The CE approval indeed enables significant sales potential. :+1:

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I definitely recommend everyone watch this video. It thoroughly explores key topics and provides a more practical view of the commercialization plan and operating environment than official announcements.

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This had indeed gone unnoticed by me, but only from that financial statement release and Alan’s interview did I understand that the CE mark is truly groundbreaking and covers more indications than the FDA approval. For some reason, I was under the impression that the approval covered the same indications. So, the FDA approval seems to cover only medial malleolus fractures, but the CE mark covers all possible bones where that screw can be inserted. Thus, the range of indications is absolutely vast compared to that FDA approval.

Here is an excerpt from the CEO’s review:

The obtained CE mark covers all RemeOs models and a large number of
indications. The approval accelerates the collection of clinical evidence, which enables the expansion of indications
in the United States, where the current approval is more limited.

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Antti Siltanen has updated the company report after H2. :slight_smile:

Bioretec’s report exceeded our expectations regarding revenue. Sales of the RemeOs™ trauma screw (350 TEUR), which is key for the future, were at the same level as the comparison period (336 TEUR), which was in line with our expectations. Growth came somewhat surprisingly from the Activa product family in Europe and the Rest of the World region. Guidance was not typically provided by the company, and thus the outlook for 2025 includes significant uncertainty. However, obtaining the CE mark increases confidence in the realization of growth, which is reflected in our model as a decreasing cost of capital. Valuation multiples are somewhat high in the short term, but the realization of Europe’s potential this year brings significant opportunities. We reiterate our Add recommendation and raise the target price to 2.8 euros (previously 2.4), supported by Europe’s potential.

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The thread is quiet even though news is coming out. New Quality Director Mirva Ekman has joined the team. The merger-era options converted, and at the same time, W&M GmbH became a significant owner with over a 5% stake. So, back when the Remeos material was acquired by the company by merging Bri.Tech into Bioretec, it was done partly with options, and now, according to my understanding, they have been subscribed.

Annual Report 2024 also published:
https://mb.cision.com/Public/20509/4119340/b1ce9d39439047b5.pdf

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@Haminan_Mursu You forgot Mursu’s updated website :wink:
Just last week I was wondering when the website would be updated to reflect modern standards and this brand we admire! :wink:

Here you go: https://investors.bioretec.com/fi/

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From the annual report:

Most of Bioretec’s revenue comes from outside Finland. In 2024, the share of exports\nin revenue was 99%

This has been puzzling as it has felt that Bioretec’s products haven’t really gained a foothold domestically for some reason. 1% of 2024 revenue amounts to €45,400.

Finland is a small market, but surely the goal should be strong domestic demand and use for the products. Will this change with RemeOS or not?

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The short answer is that basic biodegradable implants (similar to Activa) are supplied in the domestic market by some international giant. It is probably not expedient to start expending energy on tenders, etc., if winning them can be challenging against Johnson & Johnsons and Medtronics.

RemeOs will, of course, change the situation. There is no other implant in this category, so if one wants to use such an implant in Finland, it is automatically only Retec’s business. But I, at least in management, would not invest in the domestic market at all. Why pursue revenue and customer relationships in a country of 5 million people when you can make broad agreements in Germany, France, or the United States?

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Today there seemed to be a general meeting, was anyone from the forum present?

It seems that at least new option programs were decided upon, there are already quite a few of these open.

The stock price has really taken a nosedive. Do tariffs affect Retec particularly much, or what’s the issue? CE approval is now in hand, and the path is open in the US as well. I don’t get why we’re sliding day after day.

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It seems the next share issue is expected for Q3, which should keep the price lower. The previous share issue was probably around €2, if I remember correctly, so there might be some support there. On the other hand, when the orange man in the white house talks nonsense, everything drops at the same time. Who knows about these things :man_shrugging:

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However, thinking positively, cash flow will start a substantial growth thanks to both European and USA sales, and on top of that, a partner will join the back implant project.
That back implant animal trial started late last year…and what might be the schedule for that? But it has been previously stated that a partner is intended to be brought in for this.

This partner thing might also turn into another kind of thing …:grin:

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I’ve also been puzzled by the same stock price decline, but it seems to be falling with the others right now :thinking: Or perhaps there aren’t long-term investors among them, and quick profits couldn’t be made, so the money has been put elsewhere - who knows. But since no negative news has come out, generally these are buying opportunities if/when one believes in the company and its products.

Below is Grok’s summary of the spinal implant. In my opinion, this company has a lot of potential, if only all the pieces fall into place. And of course, not forgetting the move by a larger player in the form of a possible acquisition, which is quite typical in the industry.

Summary

“Bioretec’s RemeOs spinal fusion implant is a promising innovation that combines biodegradability and high performance in spinal surgery. As of April 2025, it has progressed from the development phase towards commercialization, received FDA Breakthrough status and patent protection, and is supported by a strengthening sales and logistics network. Although sales permits are still in progress, the current status of the implant suggests that Bioretec is close to a significant breakthrough in the field of orthopedics.”

https://x.com/i/grok/share/KF1DYR8e3wLbFx7IHOUucNr2s

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In such a macroeconomic storm, loss-making small companies are tossed about like chips on the waves and go down with the bathwater. Now, that CE mark certainly appears very important, considering that economic relations between the EU and the USA have deteriorated quite a lot. If Biorec manages to show sales for RemeOs already in Q1 in Europe, which I consider quite possible due to established sales channels, the stock price could well correct upwards. However, that sales growth has been expected for some time now; primarily, permits have been secured, the company is still cash flow negative, and new offerings are still coming, so in that sense, I’m not surprised that the stock price is falling along with others.

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Interesting. Too bad, because I really liked the US CEO :thinking:
Did he then get a better and more lucrative position somewhere else?
Well, Donze didn’t really have time to show any amazing results, at least in terms of growth, but I would have gladly listened to the guy longer.
Let’s hope we find a long-term CEO for our small company.

To edit, just to add, this cannot be considered positive news in any way.
However, I’ll put on my Retec-glasses and repeat Donze’s words to myself after Q4: “More cuts were made in January than in any other month in 2024”

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