Bioretec - Will the US market open?

And here’s a link to the interview where Antti interviewed CEO Sarah Hubar-Fisher regarding Q3. :slight_smile:

Topics:

00:00 Introduction
00:12 H1 figures revisions
01:20 Summary of the third quarter
02:34 Gross profit
03:51 Status of the RemeOs launch in Europe
04:48 Reasons for the distribution model revision
07:23 Increased headcount
09:05 Change negotiations
10:30 Targets and strategy update
11:39 Timeline for clinical trial
12:32 Screw model approvals and indication expansions in the US
13:23 Cash runway
14:08 Turning the cash flow positive
14:45 Outlook for the rest of the year and 2026

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Here is a new company report on Bioretec from Antti. :slight_smile:

Bioretec’s Q3 business review shed light on the company’s situation and the commercial challenges of the RemeOs product family. Growth for the new product family is expected to be delayed until 2026. The company is seeking new commercial momentum through recruitments, changes in its distribution model, and a strategy update at the end of the year. In addition to business improvements, investor confidence, which has taken a hit, needs to be rebuilt over time. We are revising our forecasts downwards due to the weak outlook, based on which we lower our target price to 1.05 euros (previously 1.2 euros) and reiterate our add recommendation. The risk of capital loss in the investment remains high, which is balanced by a rather low absolute valuation.

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If Alan Donze slipped into hiding, it could also be because he simply realized he had messed everything up, burned out… such cases have been seen… It’s just a shame that it fell on Bioretec’s shoulders.

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It would be nice to hear an update from the company so that we don’t completely lose hope. One could assume that the restructuring also includes a very intensive search for channels through which sales could pick up. The stock price is at least quite low, but I already bought some more when it felt good. I didn’t buy quite this low, though. It’s affordable to get involved now if you don’t own any yet or to add to your holdings. I personally find it more likely that the wait will eventually pay off than that such a complete and good product would ultimately flop.

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Certainly, if relevant information has been provided, we must now patiently await new steps!

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Here are Mr. Siltanen’s comments on how Bioretec’s change negotiations have been concluded. :slight_smile:

Bioretec announced on Thursday that it had concluded the change negotiations initiated in November. As a result of the negotiations, the company will lay off two employees and furlough five production employees. The targeted savings are moderate in size, and they do not change the company’s big picture. The announcement does not cause immediate changes to our forecasts.

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I have been considering adding to my investment while the valuation is at rock bottom. But… this is quite a rollercoaster when looking at the numbers. What has gone wrong? Is the product not being marketed understandably? Or is it being marketed to the wrong audiences? Are the efforts on the wrong track? By all accounts, the product is ready and functional, patented and protected?

My investment horizon is already set for 5 years, but what can really be expected?

Money is certainly needed. A potential dilution itself won’t be a disaster, but this is a very ambivalent whole, and that’s why I would appreciate opinions.

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Investors have certainly had to wait, and are still waiting quite patiently, for this to break through. In my opinion, the product itself, its purpose, and the benefits it brings are quite a no-brainer deal from the consumer’s perspective. However, commercialization and sales haven’t really taken off much after obtaining the permits, even though the product itself seems excellent.

The forum has probably discussed the market’s readiness to “receive” the product before, and there has been talk, among other things, about whether business takes precedence with the idea of more surgeries = more money for hospitals, or if the still scarce indications could be a limiting factor for adoption? Or is the reason why the product isn’t selling simply that there are shortcomings in sales expertise in one way or another?

By the end of the year, we will hear about the future directions as the company publishes its strategy update and new financial targets. This is likely the next clear catalyst that might sway the stock price in one direction or another. This year’s performance has also been quite brisk, so many will probably find it easy to make tax-loss sales from this, and perhaps that also weighs on the stock price this December. Next year, a financing round is probably expected again, and with it, some dilution of ownership. It will be interesting to see at what valuation they manage to raise funds in the next offering, and if there will be another offering after that, and then…

Perhaps the possibility of an acquisition also lives somewhere in the background? The market capitalization at today’s price seems to be less than 22M€, so it would probably be a bite-sized acquisition for some major player in the field (who?), if they see the product and the R&D pipeline with its permits, etc., as an attractive part of their current operations. The finished product, with its long permit processes, was still more than double the price in the summer. If a takeover bid were made for this, a small premium wouldn’t be enough to get out of this unscathed.

All in all, first the slowness of the permit processes and then the launch of sales have certainly managed to surprise me, at least. I made my first purchases from Springvest’s last financing round, topped up a few times after the listing, and used the summer’s warrants. The position is, of course, quite firmly in the red. At the moment, I don’t feel like adding more; instead, I’d gladly wait for some good news with my current position. This probably avoids buying “at the bottom,” but keeps the risks in check.

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Thanks for this. It makes you think…we are comfortably in the red, but nothing is (yet) lost.

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Something positive for a change. Bioretec has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation status. Time will tell if that turns into money at some point.

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Here are Antti’s comments regarding this latest release. :slight_smile:
Bioretec announced on Sunday that the U.S. Food and Drug Administration (FDA) has granted its RemeOs-DrillPin Breakthrough Device Designation status. The news is a positive indication of the company’s technology potential and supports the product’s future marketing authorization process, but it does not solve the company’s short-term commercial challenges. The announcement has no immediate impact on our forecasts.

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Financial Goals:

In line with the strategy and the priorities for the 2026-2028 period, Bioretec’s new financial goals are:

  • Achieve a turnover of over 10 million euros by the end of 2028

  • Maintain an average sales margin of over 70% throughout the strategy period

A new three-year target and over 10 million in turnover :smiley: Now hundreds of millions have been forgotten, and the management team is pulling expectations straight into a pit and then pulling the rug out from under our feet.

Well, if there’s anything good, that target is already possible to exceed if things go well, and the ‘Reset’ button has now been pressed for Bioretec’s story. From here, we start building from scratch. In the short term, the new guidance is a disaster.

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If revenue reaches 10 million in three years, then the company has succeeded in something, meaning the growth slope would have increased.

2025 is roughly flat, so if we reach that 10 million, it’s good. Of course, the old targets were on a completely different scale, but so was the share price. I personally expect the new CEO to actually achieve something, otherwise, the patents will expire. If it drops to 50c, then the risk of someone buying it out increases, so I’ll buy then at the latest, otherwise I’ll just watch.

By the way, that unfortunately shows what the CEOs (whom I already declared terrible at the time) achieved. What a waste. The new CEO does seem better, but I’m waiting for proof.

Growth 21-22 40% 22-23 30% 23-24 10% 24-25 0%

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Bioretec’s products are very good, and there seems to be a continuous active approach to their development work. Marketing is understandably quite different from that of a weight loss drug or a cancer drug, which, if successful, are quickly absorbed into the market. On the other hand, once these products gain a foothold in surgery, I believe the market will be stable and grow sustainably. In my opinion, the strategy and goals are now realistic, and what could be better than if they can be exceeded. I believe that a new foundation is now being built, and they don’t want to cause new disappointments for investors. Some larger cooperation or acquisition is also reasonably likely. The obvious need for financing understandably creates uncertainty. I will definitely keep my position.

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Antti has written a new company report on Bioretec, following these companies’ new “updates”. :slight_smile:

Bioretec updated its strategy and financial targets for 2026–28. The company cut its 2028 revenue target to 10 MEUR (prev. 65 MEUR). The turnaround in earnings has also moved further away, and the company does not expect profitability during the strategy period. We are lowering our forecasts, especially regarding earnings for the coming years. Our target price is lowered to EUR 0.65 (prev. 1.05) and our recommendation is lowered to Reduce (prev. Accumulate) following the forecast changes.

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Antti discussed Bioretec’s new strategy and financial goals with Bioretec CEO Sarah Hubar-Fisher. :slight_smile:

Topics:

00:00 Introduction
00:08 New strategy
03:03 What has changed?
05:52 US development
08:12 Distribution channels outside the US
10:55 Revenue targets
12:56 Gross margin
14:51 Profitability development
18:03 Potential partners
20:28 New product launches
23:08 Year 2026

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Now during the tax-loss selling season, the share price has been driven into the ground and I’ve just been loading up on more… My own position is also heavily in the red, but I believe the products are so superior compared to competing products that a positive turnaround is bound to happen, one way or another. At its current valuation, the company and its patents are in the “free” category, meaning even a takeover bid is possible.

I personally keep wondering about the constant focus on the US market when the greatest need for these products is currently in Ukraine and the regions near Israel.

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I think tax-loss selling is a rather poor explanation for the recent decline, as the reasons lie more in the company’s performance. The final push for the drop was the updated strategy, and any remaining faith for some shareholders vanished following Siltanen’s recommendation change.

The company’s market value has fallen so low that, from the current shareholders’ perspective, it doesn’t have many good options left to remain independent. Additionally, the level of execution/results in terms of sales also suggests that these inherently promising products require stronger shoulders behind them to succeed.

Personally, I believe the main owners finally understand the realities and that corporate restructuring/strong partnerships are the way forward, rather than the owners’ wallets. On this basis, I bought a small amount of shares for my Christmas “Ace” scratch card portfolio.

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Bioretec: CMS has updated the HCPCS code description C1741 related to temporary TPT reimbursement | Kauppalehti

Someone has been selling like crazy for 8 consecutive days. Finally, some good news.

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David Gill is proposed as a new member of Bioretec’s Board of Directors. The Annual General Meeting is scheduled to be held on May 8, 2026.

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