I haven’t been involved in this for a long time, and I certainly don’t intend to get involved again, so I’m mostly just voicing my thoughts here. Don’t get me wrong.
But to me, this already seemed like a cash cow when it was listed, and now, looking at the lack of activity, the possibility that the company hasn’t had any real business purpose for a long time is emerging even more strongly.
Of course, it’s extremely unlikely, but that’s how it looks to me. The money has been moved out of reach of the bailiff and the taxman; now it’s time to exit the stage.
What money? So little money has come in from these share issues that there hasn’t been much to transfer or distribute. That money has surely been wasted in other ways anyway.
I exited a long time ago, as the CE marking never came in 2020 despite promises, and I’m shouting from the sidelines.
The future is indeed bankruptcy or a business acquisition, and in my opinion, this has been the situation for years, and calling for help from Business Finland or TES is not realistic. Facts on the table:
Let’s start with the fact that it’s impossible for the company to attract skilled personnel. Or does anyone admit to being a world-class expert in the pharmaceutical industry who would leave AstraZeneca behind and go build a career based on speculative reindeer bone paste in Reisjärvi? The whole thing was partly doomed from the start by locating the company’s critical operations in the spirit of local patriotism in a declining rural area where such business is not viable.
In reality, no one has any idea about the product’s true profitability or the competitive situation at the time if it actually makes it to the market. With these results, the per-kilogram price of reindeer bone paste is quite high, and there are other products already.
The company has no realistic chances of commercializing the product. Even if the CE marking came tomorrow, before cash flow would be positive, there would be years of painful journey ahead. The company has no prerequisites for real production or international sales, neither in terms of financing nor anything else. See point 1.
Credibility and reliability. Hello, Montreal hospital. We have this reindeer bone paste from few man company from Reisjärvi, Finland. You know, we are much trustworthy than Pfizer or Orion. Would you buy it? I wouldn’t. Even if the product were excellent, the requirements for public procurement in healthcare could prevent sales.
Bankruptcy or a business acquisition. The latter is possible if the reindeer bone paste cooking machines and laboratory equipment have some fair value and usability in other businesses as well.
Antti has written comments on BBS’s change negotiations.
BBS announced on Friday that the company will begin change negotiations on November 28, affecting the entire organization. The negotiations are due to a suspended CE marking process, in connection with which there is a need to reduce fixed costs. Visibility into the company’s future is currently very low and the situation is uncertain. However, further clarification from the company should come during the current week. We will update our view on the stock when the company provides more detailed information about its plans.
People are loudly shouting about bankruptcy here, and of course, freedom of speech. But let’s see all the cards first. IF the product is really good (I can’t evaluate it, because I know no more about orthopedics than a pig does about a silver spoon) but I mean IF, then money can surely be found for something like this. After all, hundreds of millions are not ultimately needed for this continuation, as is often needed for drug development!
One could briefly comment on this by saying that if the old MDD (Medical Device Directive) regulation were in use, BBS would have already received CE approval, and Artebone Paste would have been on sale for quite some time. And probably the next product versions would already be coming.
Artebone is truly a quality product. The results of clinical trials on humans prove this.
One risk is that the number of patients was a pretext and the real reason was a reversal in the previously given product classification.
There is no longer a need for the production director who led the ramp-up of serial production:
“Production Director and Management Team member Kimmo Tyni has resigned from the company’s service and will move to new duties outside the company. Tyni will continue in his position until December 31, 2024.”
One option is probably to lay off almost everyone and put the company into deep freeze until the number of patients has been increased. That is, if a possible appeal does not yield results.
"BBS is updating its action plans in a situation where the processing of the company’s Artebone® Paste product’s European marketing authorization application ended in rejection by the supervisory authority. The reason for the rejection was that the clinical trial conducted by BBS, which was intended to be supplemented by a “Post Market Clinical Follow-up” study after CE mark approval, was conducted in accordance with MDD rules. The supervisory authority demanded compliance with the new MDR regulation, which came into force after the completion of the clinical trial and requires a larger number of patients to demonstrate statistical evidence. The company can submit a new CE mark application after increasing the number of patients to meet MDR requirements. The company has made a plan and started preparations for conducting a supplementary patient trial.
In the current situation, the company’s board of directors has also decided to initiate investigations to secure the company’s financial situation and operations. The company has entered into a cooperation agreement with ConAlliance GmbH (https://www.conalliance.com/), which covers all possible alternative measures related to the company’s additional financing and strategic industrial cooperation options."
So, an appeal was not possible/realistic; the number of patients needs to be increased.
That seems to be the best option with the current information. How strongly is the exit option on the table?
The first study had 34 patients… does that need to be doubled or what is the number? What is the timeline for being able to submit the CE application again? Application processing time? It’s unlikely to start from scratch, they’ve already had 2.5 years to process it.
Is that really sufficient disclosure from a listed company? It certainly leaves room for speculation
ConAlliance’s business includes, among other things, arranging company mergers and acquisitions. My own interpretation is that BBS is trying to sell its patents and business. In a bad scenario, a suitable shell company would remain for another company’s reverse listing. In a good scenario, the patents would be licensed to a larger player who would also put them into use.
Yes, there would be a need for further clarification of the situation. Let’s see if we can arrange an interview. At least an update to the analysis is expected by Monday..
BBS’s CE marking process was recently rejected. The company’s clinical study conducted in 2013-2017 complies with the old MDD regulation, but does not meet the requirements of the MDR (Medical Device Regulation) which came into force in 2021. Starting the sale of the Artebone® Paste product therefore requires treating new patients and resubmitting the CE marking application, which we estimate to be at least a two-year process. We reiterate our reduce recommendation and lower the target price to 0.08 euros (previously 0.30) as the projected cash flows have once again shifted further into the future. Uncertainty and risks are at a very high level.
In my opinion, this is somewhat of an understatement. Haven’t some of the most significant risks even materialized? If a company has had so-called “pressure to demonstrate its expertise” for so long, and the CE mark application process has taken years, then given this outcome, can’t one already draw conclusions, depending on the perspective, about the company’s ability or willingness to complete the said process? Starting the entire business is, at this point, dependent on that one thing.
Well, this is Inderes’s “playing it safe comment”; no one can give a so-called ‘real price’ for something like this. It could just as well be 50c or 5c. Or something else!
Quite a nice observation about that old MDD suitability. However, it has nothing to do with the current situation.
In CE approvals, the responsibility always lies with the manufacturer, also regarding MDR. The manufacturer must assess, for example, the sufficiency of evidence. In this case, the company shifts responsibility and the origins of problems to other parties.
Regarding the quality of the company’s operations concerning the CE mark, one can conclude that the CE approval will not even come within a couple of years if the administration is not changed and people who truly understand the directives are not hired.
From the following, you can read information about clinical tests from BSI, the notified body chosen by BBS.
I am looking forward with interest to the outcome of the co-determination negotiations, as they conclude this week. From their results, one can perhaps then deduce which direction will be taken.
The co-determination negotiations are thus estimated to end tomorrow. We’ll see what happens.
Greater interest is focused on future plans. Most likely, strategic cooperation with an industrial partner in the field is on the table, and secondly, an exit.
This CE process has dragged on for too long. Broader shoulders are needed to bring Artebone to the finish line. Reisjärvi’s own financial situation is also in the red.
It certainly leaves room for speculation 