Polarean Imaging Share Discussion Threads

[yasrub] 13/1/2020 11:32

Hi Log

Not seen you so enthusiastic on a company for a while, not meant as a slight. I will start some research and hope it works out, but not too quickly if I want to take the plunge! ATB

[loglorry1] 13/1/2020 11:16

Encouraging to see funds buying in, after large CEO buy. Tyndall only small but may put the stock on other institutional watch lists.

Read out results due any time now should drive this higher. Stock tightly held and the underlying story and IP has fantastic potential.

[mcfly79] 13/1/2020 07:17

Tyndall Investment Management have increased their holding by around a million shares from the last notification on 30 July 2019.The last timeline we were given for readout was approximately 10 weeks from the 7 Nov enrolment completion. That takes us to this week.

[aimsurfer] 06/1/2020 08:27

Good posts here over the weekend. Bracco is a private company with €1.3B in revenue and paid $450m for Blue Earth Diagnostics. I personally see us getting bought out at some point before we get the opportunity to fully commersialise this. This is a perfect diversification and future growth protection opportunity for established imagining companies. Question is would the interest come after success phase three or after FDA approval.

[mcfly79] 05/1/2020 20:26

Thanks very much ESWR, extremely useful post.
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The Oxford study sounds very exciting and I can see how it could lead to Xenon being used much more broadly. (I assume an FDA approval for general use in pulmonary imaging would also help accelerate the breadth of clinical use in the US).
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What are your thoughts on the clinical unit sales forecasts from share price Angel. Do you think it is likely that Polarean will partner with a major medical device manufacturer and distribute through their network?

[mcfly79] 05/1/2020 19:00

Yes, and the numbers start to look good very quickly. I really like the razor/razor blade model with the recurring sale of the Xenon gas..The company already has 25 units installed or on order for research purposes, but it can't charge commercial rates for the Xenon on these..The company only needs to sell 10-20 units for clinical use and the recurring profit from Xenon sales will make the company break even..There are 11,000 installed MRI machines in the US alone. Polarean will initially target the top 100 pulmonary clinics (they know people in these clinics and have been working with a number of them on collaborations) ..The numbers are potentially vast..In 2021 (the first full commercial year) share price Angel's latest full note had a forecast of 17 clinical units sold, with $12.6m of revenue, $3.0m PBT and $3.3m free cash flow. By 2023 revenue is forecast as $41m and free cash flow is $15.6m. At that point the recurring Xenon sales will be over $20m a year. This forecasts are also all based just on the US market. I'm sure Polarean will look at the European market. Blue Earth gained EU approval a year after FDA approval.

[loglorry1] 05/1/2020 12:14

Fantastic post and I 100% agree. Very exciting growth opportunity.

[mcfly79] 05/1/2020 12:08

Sorry - the text in my last post gets all bunched together on the Advfn app.

[mcfly79] 05/1/2020 12:04

I think a successful phase 3 trial will be a huge value inflection point for the company. Once this happens I think the likelihood of FDA approval is high (given this represents a switch to a safer, more effective imaging technology). It's just a matter of the prescribed timelines with the FDA.
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Over $50m has been spent on the development of the product, much by GE before Polarean acquired it.
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To see where the company could go it's worth looking at a company called Blue Earth Diagnostics.
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Very similar business to Polarean. They are a UK imaging device company that developed a novel imaging agent for PET scans to help with prostate cancer imaging (whereas Polarean has developed a novel imaging agent for MR scans for Pulmonary imaging).
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Like Polarean the technology was pulled out of GE.
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From being formed in 2014 the company was sold in June 2019 for $450m to an Italian imaging business. Polarean is valued at $35m.
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As if there weren't enough similarities, the founder and CEO of Blue Earth Diagnostics is Jonathan Allis, who is a non-executive director of Polarean and very active in the business. Jonathan Allis bought 1,540,000 shares in Polarean in October as part of the Amphion buy out.
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It may take a year before we receive FDA approval but I think there is the potential for corporate action in that time, such as a partnership with a very large MR device manufacturer.
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Interestingly the Blue Earth Diagnostics FDA approval only took 6 months under a priority review:
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It would appear that the FDA decide if the application is going to get a standard review (up to 10 months) or priority review (up to 6 months) once it is submitted. The applicant can request a priority review.
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Reading the link it would seem we might qualify for a priority review.

[loglorry1] 03/1/2020 15:53

FDA approval is not for a while. Q1 or Q2 of 2021 I think. Although probably plenty of news flow between now and then.

[richardjohn10] 03/1/2020 09:53

When will FDA approval be announced if successful?

[mcfly79] 03/1/2020 08:34

Shares seem tightly held (including 51% not in public hands).

Price up 9% on fairly small amounts of buying (although there will be buys reported later - including small top ups from me).

Enrolment completed on 7th Nov and in the RNS it stated that readout would take approximately 10 weeks. That takes us to mid Jan.

I appreciate that people are expecting the trial to be successful and it may be somewhat baked into the price, but having a successful Phase III result is still huge news in the Pharma world. It will be noticed by those not currently familiar with the company.

Given the tightly held shares I think we could see a strong rise if the readout is a success.

[slicethepie] 02/1/2020 19:02

Just checked he has 2.1m options at 15p as well

[slicethepie] 02/1/2020 18:30

Massive vote of confidence. The ceo already owned a cool 2.6m shares ( plus options? Presumambly) so to invest a further £70k of after tax money is v positive.

[wooster4] 02/1/2020 18:20

ianb - as far as i understand the results of the trial are being interpreted by a third party, so when he knows we will know (although who knows he may have given a subtle nod and a wink).

[adorling] 02/1/2020 17:51

It cannot be deemed insider trading if he does not know the results. I presume that the results will be “unblindedR21; in the usual clinical trial protocol standards.

[ianb114] 02/1/2020 17:17

Definitely good news.
However, does this purchase indicate that news is in fact NOT imminent, otherwise it could be deemed to be insider trading?
I'm not a financial expert, so happy to be corrected on this point.
In any case, I will be taking the opportunity to top up if I can.

[adorling] 02/1/2020 17:02

Nice RNS showing CEO has bought 347,000 shares just before their clinical phase III data is about to be revealed. Me thinks some great news is coming any day now......

[loglorry1] 17/12/2019 15:31

@rHatton less of an upside on approval because the chance of non-approval is much lower in the first place.

They should be able to start cracking out large sales once they have approval though which should trigger a bit re-rate but more likely I suppose they'll just sell the firm to a much bigger player with good distribution.

[rhatton] 10/12/2019 15:25

Thanks for your response, I was thinking about it in terms of comparing this to what kind of share price reaction they might be on positive phase 3 results. That as it differs from a drug in terms of an actual cure or maybe a far better treatment option, it might be less of a rise than some expect

[loglorry1] 10/12/2019 14:06

@rHatton the risk of non-approval is very small because it is a non-inferiority test and the device it is up against is radioactive and lower resolution.

To some extent they will have to create a market but it can replace the current method and there is already an insurance code available for these tests that doctors can charge against insurance so its not that difficult.

In relative terms it's not an expensive purchase for a hospital.

[rhatton] 10/12/2019 13:55

What’s people’s thoughts on this phase 3?

Obviously different to a tradition phase 3 as this is a device not a drug?

If a phase 3 is being carried out for an unmet need in terms of a drug then it has a guaranteed market post FDA approval?
Where as Polx will hVe to convince people to buy this product?

[cooltools] 28/11/2019 16:49

Buy The F'g Dip - i.e. when you're feeling bullish about a stock, and it goes down instead of up.

POLX charts show plenty of dips - in hindsight, buying under 20p is ideal - looks like going there again soon. As the spread is wide (>10%), best to hold on - suspect PIs are selling as soon as able to make a small profit, hence the cyclic nature. Needs more conviction that these ships will come home.