PEB - Pacific Edge Ltd

[Minerbarejet]

Didnt we use to have a stock called XRO or something for a number of years selling at phenomenal prices?
I heard they only made a profit last year.
I suppose shares on offer might have been smaller than PEB but I do remember a lot of hype involved at 24.00
What is it now?
As far as PEB is concerned looking at the HY with 3.2 million in the kitty and comparing it with the 4.5 FY 2020 I think with all the additional revenue streams coming on board they might be looking at 8 million or so this year.


Wonder what this latest Govt development in DHBs will do for PEB.
Hopefully bring all the rest of NZ (30 -40%) into the cxBladder fold.

[artemis]

Didnt we use to have a stock called XRO or something for a number of years selling at phenomenal prices?
I heard they only made a profit last year.
I suppose shares on offer might have been smaller than PEB but I do remember a lot of hype involved at 24.00
What is it now? ......

Well XRO is slightly but not completely off topic for this thread. XRO was very clear year after year after year - it's all about growth so don't look for profit, look for revenue.

And so it came to pass. SP currently AUD141.

[Leftfield]

Given their past record of 'over promise and under deliver' this made me smile.

Pacific Edge is delighted to have been named as a finalist in the INFINZ Awards for Emerging Leaders Best Investor Relations.

The award is open to all companies outside the NZX20 and is judged by an expert panel of investor relations and investment professionals.

CEO of Pacific Edge, David Darling, said: “As a high growth NZX-listed company, providing our shareholders and the market with informative, consistent and transparent communications has always been an essential part of our investor relations programme. Clearly communicating our growth strategy and financial performance is key to achieving a fair value in the market. We are delighted to have been recognised as a finalist for this award alongside other well regarded companies.”

[forest]

Clearly communicating???
How many times did they clearly communicate that a capital raising was the last time???

[winner69]

Clearly communicating???
How many times did they clearly communicate that a capital raising was the last time???

You are only as good as your last announcement

[850man]

Clearly communicating???
How many times did they clearly communicate that a capital raising was the last time???

Over time, I've sent 2 emails to PEB investor centre asking for clarity in some of their comms where these differ from other published information - not a peep in reply.

[850man]

I thought I'd put Psychic's questions anonymously to the PEB investor centre (hope ya don't mind Psychic) here's what I just got back, thought I'd share with this forum. Their answers in red font below:


Newsletter quietly offers a few corrections to past embellishments I think, before a disappointing result is published next month.

The big news items taking the SP from about .10 to $1.30 over the past 10 months have been as follows:

Inclusion in NCCN guidelines
PE made much of Cxbladder being included in the clinical pathway but this was an exaggeration in the extreme.
It wasn’t.
There is no mention of Cxbladder in there at all, surveillance is still Cystoscopy and cytology. The guidelines simply, with the weakest of recommendations (2B), now say that the additional use of Biomarkers (in general) may be considered in surveillance but that it was unclear whether the additional information was useful.

Guidelines current March 2021
https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf
The newsletter now confirms that they have more work to do before inclusion.

NCCN Guidelines: The inclusion of urine molecular tests for UC markers into the NCCN
guidelines in 2019 is specifically for follow up of high-risk NMIBC with level 2B evidence,
as indicated. This inclusion language is a departure (improvement) from previous
versions which explicitly excluded the use of urinary UC markers for all follow up
patients. The use of urinary UC markers is specifically referenced in the NCCN review
language and collectively refers to those biomarker tests assessed in the 2015 Review
paper by Chou et al. which includes Cxbladder.

Deal with Kaiser June 2020

PE finally announced completion of Triage trial with KP in Nov 2016.
We still know nothing of the Commercial deal or number of tests being paid for.
But todays newsletter confirms that they are “using” Monitor only, Triage has not been adopted by KP

Kaiser Permanente (KP): The commercial arrangements of the relationship with KP are
confidential however as stated, the agreement covers all of the available Cxbladder
products. You are correct that the initial clinical evaluation of Cxbladder by KP was in a
hematuria evaluation setting and we would have expected this to translate to KP
adopting Cxbladder Triage, however KP indicated that they wished to introduce
Cxbladder into their organisation in the follow up surveillance setting to start with. This
is their decision and entirely understandable since it allows KP clinicians to maintain
contact with their bladder cancer patients as they socialise the Cxbladder technology
within the organisation (clinicians and patients alike). We have every expectation that
KP will at some point publish their hematuria study data and in time will also extend their
adoption of Cxbladder into the hematuria evaluation setting, but ultimately that is their
decision.


July 2020 LCD by CMS

Medicare now cover Cxbladder Monitor and Detect where medically necessary
Yet the Local Coverage Decision says Cxbladder is NOT considered medically necessary

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=38388&ver=13

The American Urological Assn directive last reviewed Jan 2021
https://www.auanet.org/guidelines/bladder-cancer-non-muscle-invasive-guideline
It says:
9. In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

So the “medically necessary” tests PEB is saying are now being reimbursed by CMS I suggest are only a small portion of those being completed. As for reimbursement of all those past tests, again, I think very few will have been “medically necessary” so good luck with that.

July LCD by CMS: The link you have provided is an earlier version of the ‘proposed
LCD’ which was in circulation for consultation. The final published LCD is L35396 and
the exclusion language relating to Cxbladder you refer to was removed following
submissions from Pacific Edge and other parties such that now the only requirement for
reimbursement by CMS is the use of valid CPT codes and the statement of medical
necessity. Medical necessity is determined by the referring physician and does not
require that Cxbladder is used instead of cystoscopy, since in most cases Cxbladder is
used in addition to cystoscopy in the US. Provided these criteria are met (which they are
for all CMS patients) Pacific Edge is receiving 100% (full) reimbursement for claims
within 40 days of claim submission. As we noted in the newsletter and at the half year,
CMS related tests accounted for a significant proportion (~67%) of our commercial test
throughput in the US for the first half of FY21 – this is quite different from the ‘very few’
you suggest.

April 2021 United Healthcare covers Cxbladder

Well, they don’t, really. More exaggeration.

United has a Medicare Policy which is effectively back to back /underwritten by CMS as primary payer. Todays newsletter confirms that United doesn’t cover Cxbladder under its own Healthcare Plans. Neither do Aetna, Blue Cross or any others as far as I can see.
United has simply added the CPT codes so as to match Medicare for consistency

United Healthcare: As stated in the newsletter and as announced to the NZX United
Healthcare have commenced coverage of Cxbladder in the Medicare Advantage
policies. We have provided you with a link to their policy. View Full Policy - PDF (page
2 of 52).

[Leftfield]

Very helpful 850man. Thank you.

[Brain]

Thanks 850 and also thanks to Psychic. We need people to be critical on sharetrader. We need contrary views.

[Cyclical]

For also having experienced a single cystoscopy in order to remove a ureteral stent while being fully awake, I'd also do anything to avoid experiencing this ever again.

I had this procedure done 8 years ago but you bet that my screams are still echoing in that hospital—I'm still traumatized to this day.

Go PEB!
Yep, been there, done that. In my 20s off the back of a small kidney stone. Glad I wasn't the only one that screamed! Not sure if it was actually necessary or if it was a case of lining a urologist's pockets.

[trader_jackson]

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/371394/345061.pdf

... DD building another deck?

[Greekwatchdog]

Retirement Village

[Maxtrade]

The rubber hits the road end of May.

https://www.pacificedgedx.com/investors/key-dates/

Thank you very much for posting this jridler.

From reading recent forum posts, is the general consensus still looking overall positive for another pump up in share price once we get this update end March??

Don't know why the SP has been grinding lower over the past month. It seems PEB investors are rather impatient these days. It hit 1.29 recently, then for no reason people have been gradually selling, forcing the SP down bit by bit. It would make more sense for shareholders to just sit tight and not get antsy. It seems there is a sell off right after every SP jump with each bit of positive news. Shaky hands traders I guess?

[Maxtrade]

Retirement Village

Well earnt :) He's got tonnes more, sitting pretty and will probably only cash in bit by bit as his family needs. Until the true potential SP hits where it may. Imagine once PEB starts getting recognised by US traders and institutional investors. I'm hoping maybe in time might be able to be on par with AFT share price. Here's hoping :)

[zs_cecil]

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/371394/345061.pdf

... DD building another deck?

Perhaps his family are doing 'deck consolidation' :-)

[jridler]

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/371394/345061.pdf

... DD building another deck?
Look at the detail of the registered holders before/after.

[jridler]

Thank you very much for posting this jridler.

From reading recent forum posts, is the general consensus still looking overall positive for another pump up in share price once we get this update end March??

Don't know why the SP has been grinding lower over the past month. It seems PEB investors are rather impatient these days. It hit 1.29 recently, then for no reason people have been gradually selling, forcing the SP down bit by bit. It would make more sense for shareholders to just sit tight and not get antsy. It seems there is a sell off right after every SP jump with each bit of positive news. Shaky hands traders I guess?
Market will be watching movements in revenue, net loss, and cash position. If it's above expectation, the SP will be buoyed. PEB has not given too many clues around this since the interim result.

You must understand your own risk appetite and timescale, else unexpected short-term movements may cause you to take action contrary to your investment thesis.

Benjamin Graham: "In the short run, the market is a voting machine but in the long run, it is a weighing machine."

[psychic]

I thought I'd put Psychic's questions anonymously to the PEB investor centre (hope ya don't mind Psychic) here's what I just got back, thought I'd share with this forum. Their answers in red font below:

Hell no, I don't mind 850man. Great that you received a reply!

Soooo, what did you guys read into the responses?

[Leftfield]

Hell no, I don't mind 850man. Great that you received a reply!

Soooo, what did you guys read into the responses?

How about..... steady progress and "Rome wasn't built in a day" ......."good things take time..." etc etc....happy to hold and wait patiently for the end May update (as gridler posts above... then it's all about revenue, cash and profit/loss figs.)

[winner69]

Price Sensitive announcement this morning

Earnings upgrade or something ...can’t access

[silu]

Price Sensitive announcement this morning

Earnings upgrade or something ...can’t access

this one? FLLYR: PEB: PEB Full Year Result to be Announced 27 May 2021

[calledone]

I think a mistake by NZX!? Why is an announcement of an announcement which was well known before hand be price sensitive?! Am I missing something here!

[850man]

Price Sensitive announcement this morning

Earnings upgrade or something ...can’t access

An announcement of an announcement it would appear. PEB taking lessons from Cindy on this one, now that's not boding well:confused:

[Brain]

An announcement of an announcement it would appear. PEB taking lessons from Cindy on this one, now that's not boding well:confused:

The NZX decide on what is price sensitive so they must have made a misteak.

[steveb]

The NZX decide on what is price sensitive so they must have made a misteak.
did you misspell mistake on purpose,or did you miss out on lunch!

[Brain]

did you misspell mistake on purpose,or did you miss out on lunch!

I like to spell it that way - it gives the word more meaning.

[tim23]

An announcement of an announcement it would appear. PEB taking lessons from Cindy on this one, now that's not boding well:confused:

Who is Cindy?

[barney]

Who is Cindy?

The best Prime Minister we've had since Lange.

[LEMON]

Mark is an experienced corporate finance professional, with approximately 25 years of experience in the
Australasian capital, corporate and financial markets. He was an Executive Director for Investment Banking at
Goldman Sachs where he worked for nearly 20 years and has been involved in many large prominent New Zealand
transactions including the IPOs of Meridian, Mighty River Power and Vector. Mark is a Director of a number of
entities including being Chair of Astrolab VC Investment Committee and a Director of Mariposa Holdings (a large
charitable organisation).

Could this be a signal for a take over, big financial pro to help the sale of pacific Edge to some big pharma company?

DD retires in a years time

[winner69]

Mark is an experienced corporate finance professional, with approximately 25 years of experience in the
Australasian capital, corporate and financial markets. He was an Executive Director for Investment Banking at
Goldman Sachs where he worked for nearly 20 years and has been involved in many large prominent New Zealand
transactions including the IPOs of Meridian, Mighty River Power and Vector. Mark is a Director of a number of
entities including being Chair of Astrolab VC Investment Committee and a Director of Mariposa Holdings (a large
charitable organisation).

Could this be a signal for a take over, big financial advisor to help the sale of pacific Edge to some big pharma company?

DD retires in a years time

At least talk and thinking like that will keep the share price up

[LEMON]

Just curious, I was speaking with a friend whose partner was a financial buff and was hired into the company to help the sale of a huge wine company in Europe, that of which we would all be familiar with the name.

[LEMON]

Demi has held senior leadership roles since 2004. Her most recent role was as Head of Operations of the Children
Medical Research Institute in Australia. Previous to this, her roles included Program Director – Executive Strategy
Delivery for Firmenich SA in Switzerland; and Program Manager - APAC Network Transformation for Caterpillar in
Australia.

More senior roles being filled for future growth.

[Snow Leopard]

... Transformation for Caterpillar. ....
https://upload.wikimedia.org/wikipedia/commons/thumb/3/3d/Fesoj_-_Papilio_machaon_%28by%29.jpg/480px-Fesoj_-_Papilio_machaon_%28by%29.jpg
Impressive.

[850man]

Demi has held senior leadership roles since 2004. Her most recent role was as Head of Operations of the Children
Medical Research Institute in Australia. Previous to this, her roles included Program Director – Executive Strategy
Delivery for Firmenich SA in Switzerland; and Program Manager - APAC Network Transformation for Caterpillar in
Australia.

More senior roles being filled for future growth.

Addition of a number of senior roles, let's hope this is all funded and more by increased revenue. Guess we'll have to wait until 27th to find that out

[Greekwatchdog]

This is all about setting up for the future. 27th is just a date where we will get a loss. How big anyones guess. $10/12m?? This role will be paid out in FY22 figures on wards

[LEMON]

Agree, personally don't mind a fall of the SP on the 27th to have a chance to pick up a few more cheap shares.
It all about the future.

The research and work is done.
Now it's all about building the team for future growth potential and getting established in the markets.

[silu]

Everyone here is talking about a loss which would indicate that the price wouldn't move much downwards when they eventually announce it right?

[Greekwatchdog]

It will do what the buyers/sellers do.

[Minerbarejet]

The SP at the end of the month will reflect the markets attitude to the extent that the cashflow has improved.

I dont think there is much doubt that it has improved but if the hiring of additional management at the current rate is anything to go by it could be an indication of a considerable improvement.

[psychic]

Hey 850 man, did you think about PE's replies to what I had posted?
To me, they agree with 3 of 4.
And I'm not convinced about the 4th (CMS)

My observations in italics, Pacific Edge comments in red
I know it is boring to wade through some of this stuff but worth thinking about as a shareholder, just sayin.

Newsletter quietly offers a few corrections to past embellishments I think, before a disappointing result is published next month.

The big news items taking the SP from about .10 to $1.30 over the past 10 months have been as follows:

Inclusion in NCCN guidelines
PE made much of Cxbladder being included in the clinical pathway but this was an exaggeration in the extreme.
It wasn’t.
There is no mention of Cxbladder in there at all, surveillance is still Cystoscopy and cytology. The guidelines simply, with the weakest of recommendations (2B), now say that the additional use of Biomarkers (in general) may be considered in surveillance but that it was unclear whether the additional information was useful.

Guidelines current March 2021
https://www.nccn.org/professionals/p...df/bladder.pdf
The newsletter now confirms that they have more work to do before inclusion.

NCCN Guidelines: The inclusion of urine molecular tests for UC markers into the NCCN
guidelines in 2019 is specifically for follow up of high-risk NMIBC with level 2B evidence,
as indicated. This inclusion language is a departure (improvement) from previous
versions which explicitly excluded the use of urinary UC markers for all follow up
patients. The use of urinary UC markers is specifically referenced in the NCCN review
language and collectively refers to those biomarker tests assessed in the 2015 Review
paper by Chou et al. which includes Cxbladder.

Deal with Kaiser June 2020

PE finally announced completion of Triage trial with KP in Nov 2016.
We still know nothing of the Commercial deal or number of tests being paid for.
But todays newsletter confirms that they are “using” Monitor only, Triage has not been adopted by KP

Kaiser Permanente (KP): The commercial arrangements of the relationship with KP are
confidential however as stated, the agreement covers all of the available Cxbladder
products. You are correct that the initial clinical evaluation of Cxbladder by KP was in a
hematuria evaluation setting and we would have expected this to translate to KP
adopting Cxbladder Triage, however KP indicated that they wished to introduce
Cxbladder into their organisation in the follow up surveillance setting to start with. This
is their decision and entirely understandable since it allows KP clinicians to maintain
contact with their bladder cancer patients as they socialise the Cxbladder technology
within the organisation (clinicians and patients alike). We have every expectation that
KP will at some point publish their hematuria study data and in time will also extend their
adoption of Cxbladder into the hematuria evaluation setting, but ultimately that is their
decision.


July 2020 LCD by CMS

Medicare now cover Cxbladder Monitor and Detect where medically necessary
Yet the Local Coverage Decision says Cxbladder is NOT considered medically necessary

https://www.cms.gov/medicare-coverag...d=38388&ver=13

The American Urological Assn directive last reviewed Jan 2021
https://www.auanet.org/guidelines/bl...sive-guideline
It says:
9. In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

So the “medically necessary” tests PEB is saying are now being reimbursed by CMS I suggest are only a small portion of those being completed. As for reimbursement of all those past tests, again, I think very few will have been “medically necessary” so good luck with that.

July LCD by CMS: The link you have provided is an earlier version of the ‘proposed
LCD’ which was in circulation for consultation. The final published LCD is L35396 and
the exclusion language relating to Cxbladder you refer to was removed following
submissions from Pacific Edge and other parties such that now the only requirement for
reimbursement by CMS is the use of valid CPT codes and the statement of medical
necessity. Medical necessity is determined by the referring physician and does not
require that Cxbladder is used instead of cystoscopy, since in most cases Cxbladder is
used in addition to cystoscopy in the US. Provided these criteria are met (which they are
for all CMS patients) Pacific Edge is receiving 100% (full) reimbursement for claims
within 40 days of claim submission. As we noted in the newsletter and at the half year,
CMS related tests accounted for a significant proportion (~67%) of our commercial test
throughput in the US for the first half of FY21 – this is quite different from the ‘very few’
you suggest.

April 2021 United Healthcare covers Cxbladder

Well, they don’t, really. More exaggeration.

United has a Medicare Policy which is effectively back to back /underwritten by CMS as primary payer. Todays newsletter confirms that United doesn’t cover Cxbladder under its own Healthcare Plans. Neither do Aetna, Blue Cross or any others as far as I can see.
United has simply added the CPT codes so as to match Medicare for consistency

United Healthcare: As stated in the newsletter and as announced to the NZX United
Healthcare have commenced coverage of Cxbladder in the Medicare Advantage
policies. We have provided you with a link to their policy. View Full Policy - PDF (page
2 of 52).

[psychic]

My question is, given these announcements have driven the SP, and you have no other proof od adoption, is the current SP warranted?

[calledone]

My question is, given these announcements have driven the SP, and you have no other proof od adoption, is the current SP warranted?

I guess we will know with a bit more clarity in couple of weeks. Either way I don't see them delivering the dough in a substantial way from these announcement till starting FY2022.

[Brain]

My question is, given these announcements have driven the SP, and you have no other proof od adoption, is the current SP warranted?

Who knows?

I remain a shareholder and I am positive about the future because.

A. The test costs about $100 and sells for $ 1000 approx
B CX way less invasive than cystoscopy
C Insurers will save money.
D very large market potential

PEB is speculative but in my view has huge potential but we will have to wait 2 years at least before we see substantial growth and some profitability.

[psychic]

Can I unpack and comment on these responses for you then.

NCCN Guidelines: The inclusion of urine molecular tests for UC markers into the NCCN
guidelines in 2019 is specifically for follow up of high-risk NMIBC with level 2B evidence,
as indicated. This inclusion language is a departure (improvement) from previous
versions which explicitly excluded the use of urinary UC markers for all follow up
patients. The use of urinary UC markers is specifically referenced in the NCCN review
language and collectively refers to those biomarker tests assessed in the 2015 Review
paper by Chou et al. which includes Cxbladder.

Use of urinary biomarkers went from explicity excluded to "may use" as an adjunct in high risk nmibc surveillance only, with the weakest 2b recommendation. Yes, Cxbladder was one of the tests mentioned by Chou et al who came up with conclusion that Urinary biomarkers should not be used. You will find no support there, from memory the study was critical of both results and bias of available studies.
(ie studies funded by Pacific Edge). At best it is mentioned in passing.

Implying to the market that Cxbladder was now part of the clinical pathway seems downright misleading to me.

Kaiser Permanente (KP): The commercial arrangements of the relationship with KP are
confidential however as stated, the agreement covers all of the available Cxbladder
products. You are correct that the initial clinical evaluation of Cxbladder by KP was in a
hematuria evaluation setting and we would have expected this to translate to KP
adopting Cxbladder Triage, however KP indicated that they wished to introduce
Cxbladder into their organisation in the follow up surveillance setting to start with. This
is their decision and entirely understandable since it allows KP clinicians to maintain
contact with their bladder cancer patients as they socialise the Cxbladder technology
within the organisation (clinicians and patients alike). We have every expectation that
KP will at some point publish their hematuria study data and in time will also extend their
adoption of Cxbladder into the hematuria evaluation setting, but ultimately that is their
decision.

So they don't argue. The much ramped Triage review was a flop, no acknowledgement about this to market. Odd for a Company on the podium for Investor relations. Maybe KP are concerned about imaging being the adjunct as Minerbarejet is, I don't know.
But okay, hopefully they will adopt in time. KP have been looking into ways they can reduce unnecessary cytoscopies for many years.
We have no evidence of uptake of Monitor at this stage, sure is taking a long time to bed into the KP system or however it was PE explained the lag

July LCD by CMS: The link you have provided is an earlier version of the ‘proposed
LCDÂ’ which was in circulation for consultation. The final published LCD is L35396 and
the exclusion language relating to Cxbladder you refer to was removed following
submissions from Pacific Edge and other parties such that now the only requirement for
reimbursement by CMS is the use of valid CPT codes and the statement of medical
necessity. Medical necessity is determined by the referring physician and does not
require that Cxbladder is used instead of cystoscopy, since in most cases Cxbladder is
used in addition to cystoscopy in the US. Provided these criteria are met (which they are
for all CMS patients) Pacific Edge is receiving 100% (full) reimbursement for claims
within 40 days of claim submission. As we noted in the newsletter and at the half year,
CMS related tests accounted for a significant proportion (~67%) of our commercial test
throughput in the US for the first half of FY21 – this is quite different from the ‘very few’
you suggest.

L35396 does not seem to mention Cxbladder at all but will take PE’s word for it that the Monitor and Detect tests are included in the approved Novitas schedule which I cannot access but the LCD references. But the draft we have is certainly not supportive and so that must have been a very convincing argument by PE to have the final policy contradict this. Some proof would be nice.

For me it comes back to this“medically necessary” requirement then, the part I struggle to have confidence in most. Cxbladder is largely being used as an adjunct to cystoscopy. The physician must be able to certify that the test is necessary when the AUA say they should not and the NCCN guidelines offer the weakest “may use” as an adjunct (and for monitoring high risk NMIBC only)

If they are able to demonstrate in the financial results 100% reimbursement of all CMS tests as this reply suggests then I will be happy that they are making the progress they claim – regardless of my wild interpretation of the guidelines. I will try work out an estimate of what that should mean later…

"Medically necessary" implies
(a) it is in accordance with nationally accepted standards (ie The AUA / NCCN guidelines)
(b) It is clinically appropriate and effective
(c) Not primarilly for personal comfort or convenienceof patient or physician

United Healthcare: As stated in the newsletter and as announced to the NZX United
Healthcare have commenced coverage of Cxbladder in the Medicare Advantage
policies. We have provided you with a link to their policy. View Full Policy - PDF (page
2 of 52).

They agree. CxBladder is only covered by United under its Medicare Policy, not those it underwrites itself.
Aside from the tricky notion they present that United are aboard and all their customers have access to Cxbladder, then seemingly it is only for those under Medicare, only as an adjunct in surveillance of high risk NMIBC, only when considered medically necessary.

We will see.

[Minerbarejet]

Given that the Medicare covers most of the population over 65 and Bladder Cancer as a disease falls mainly in that group I would suggest they (United) may find it "medically unnecessary" to include all the others.

[psychic]

Given that the Medicare covers most of the population over 65 and Bladder Cancer as a disease falls mainly in that group I would suggest they (United) may find it "medically unnecessary" to include all the others.

Then why exclude those outside this group, why hasn't United covered Cxbladder under its own policies?

United cover only those in that group under Medicare. Medicare say tests are covered if medically necessary. Medically necessary means must be recommended under clincal guidelines. Clinical guidelines say maybe(?) use tumour markers as an adjunct in surveillance of high risk non muscle invasive bladder cancer only (otherwise do not use).

How many tests do you reckon?

[Minerbarejet]

Then why exclude those outside this group, why hasn't United covered Cxbladder under its own policies?

United cover only those in that group under Medicare. Medicare say tests are covered if medically necessary. Medically necessary means must be recommended under clincal guidelines. Clinical guidelines say maybe(?) use tumour markers as an adjunct in surveillance of high risk non muscle invasive bladder cancer only (otherwise do not use).

How many tests do you reckon?

"Tens of thousands":)



You did ask.

With all the shenanigans over Covid how do you follow clinical guidelines if you cant get into the clinic to follow them?

[psychic]

"Tens of thousands":)



You did ask.

With all the shenanigans over Covid how do you follow clinical guidelines if you cant get into the clinic to follow them?

Haha, yes, several tens of thousands perhaps.

And a fair question that, I have no idea but I'm going to guess that Covid or no Covid, Urologists are still turning a coin through cysto's.

[Brain]

Haha, yes, several tens of thousands perhaps.

And a fair question that, I have no idea but I'm going to guess that Covid or no Covid, Urologists are still turning a coin through cysto's.

I would expect the insurance companies will get pissed off with the Urologists taking the more expensive option. Both the insurance companies and the patients will be in PEB’s corner.

[psychic]

I would expect the insurance companies will get pissed off with the Urologists taking the more expensive option. Both the insurance companies and the patients will be in PEB’s corner.

Can't agree, the US Insurers are not in PEB's corner yet, Cxbladder is investigational only and not covered. They will always need to follow gold standard. It is simply not a Cystoscopy vs Cxbladder test thing in the US yet, Cxbladder is only an adjunct in Surveillance, and an expensive one at that.

I've never really understood the price point around the tests tbh. Perhaps if the tests were a tenth of the price and on high volume they might have become mainstream as an excellent adjunct to both Cytology and cystoscopy years ago? So many promising tests being developed these days, price will become an issue sooner or later.

I'd question if a cystoscopic exam is more expensive than Cxbladder atm. Not my understanding.

[Minerbarejet]

The whole point of the cxBladder test is it covers the entire urinary tract with one test right up to the kidneys as I understand it.

Cant see a camera being shoved into your kidneys as a desirable method of analysis.

Although rare, upper tract problems can occur and if the cystoscopy reveals nothing then there could still be a problem.

cxBladder will keep telling you there is a problem that needs attention.

This is what put me onto Pacific Edge in the first place was the finding by cxbladder indicating that further investigation was needed in 4 cases that cystoscopy could not find anything

and it was later established with further procedures that cxbladder was right with one tumor right in the kidneys

Expense doesnt enter into it.

Do you want to know what is wrong and where or not?

This is where the adjunct part of it comes in.

[psychic]

The whole point of the cxBladder test is it covers the entire urinary tract with one test right up to the kidneys as I understand it.

Cant see a camera being shoved into your kidneys as a desirable method of analysis.

Although rare, upper tract problems can occur and if the cystoscopy reveals nothing then there could still be a problem.

cxBladder will keep telling you there is a problem that needs attention.

This is what put me onto Pacific Edge in the first place was the finding by cxbladder indicating that further investigation was needed in 4 cases that cystoscopy could not find anything

and it was later established with further procedures that cxbladder was right with one tumor right in the kidneys

Do you want to know what is wrong and where or not?

This is where the adjunct part of it comes in.


We'll see but I think expense is and will continue to be a factor. I also think it unlikely that the US Healthcare system will fund the additional cost just to screen for rare upper tract tumours. And If the study that produced these results was funded by Pacific Edge as most are then I doubt it even less - even though the science is clearly very good.

So many needs for that Healthcare budget.

[winner69]

PEB won that ‘prestigious’ Investor Relations thing at the IFINZ awards last night

David beside himself ...being in the limelight again

[Minerbarejet]

This came to light today for a bit of perspective on what urologists think and the way that cxbladder is used.

https://grandroundsinurology.com/industry-perspective-panel-discussion-on-cxbladder-genomic-urine-test-for-bladder-cancer/?utm_campaign=Cxbladder&utm_content=167018410&utm_medium=social&utm_source=facebook&hss_channel=fbp-446253858904655

[Leftfield]

This came to light today for a bit of perspective on what urologists think and the way that cxbladder is used.
https://grandroundsinurology.com/industry-perspective-panel-discussion-on-cxbladder-genomic-urine-test-for-bladder-cancer/?utm_campaign=Cxbladder&utm_content=167018410&utm_medium=social&utm_source=facebook&hss_channel=fbp-446253858904655

Well spotted and thanks for posting Miner. Impressive test results on quite a large sample.

(...much more beneficial than today's other news of the 'investor relations' award IMO.)

[Minerbarejet]

Well spotted and thanks for posting Miner. Impressive test results on quite a large sample.

(...much more beneficial than today's other news of the 'investor relations' award IMO.)
Just passing it around from others to others but as you say impressive.

Exciting isnt it, Winner.

[Greekwatchdog]

Thanks Miner for sharing.

[jridler]

This came to light today for a bit of perspective on what urologists think and the way that cxbladder is used.

https://grandroundsinurology.com/industry-perspective-panel-discussion-on-cxbladder-genomic-urine-test-for-bladder-cancer/?utm_campaign=Cxbladder&utm_content=167018410&utm_medium=social&utm_source=facebook&hss_channel=fbp-446253858904655

Great to hear from those in the thick of it, thanks for sharing.

[Mel]

This came to light today for a bit of perspective on what urologists think and the way that cxbladder is used.

https://grandroundsinurology.com/industry-perspective-panel-discussion-on-cxbladder-genomic-urine-test-for-bladder-cancer/?utm_campaign=Cxbladder&utm_content=167018410&utm_medium=social&utm_source=facebook&hss_channel=fbp-446253858904655
Whilst it was sponsored by PEB, there are some telling observations (that we know) they make about the ease of administration (incl. in home), the need to avoid biopsies, invasive cystoscopies and the very high '-ve predictive value'. Now, just need the rest of the urology fraternity to come onboard......I'm in it for the long haul, so will have to show patience and keep waiting! Thanks for sharing Minerbarejet

[artemis]

The recent deal with Facey in the US was initiated by their urologists. That is a good sign.

[Retired Doc]

This came to light today for a bit of perspective on what urologists think and the way that cxbladder is used.

https://grandroundsinurology.com/industry-perspective-panel-discussion-on-cxbladder-genomic-urine-test-for-bladder-cancer/?utm_campaign=Cxbladder&utm_content=167018410&utm_medium=social&utm_source=facebook&hss_channel=fbp-446253858904655
Thanks Miner. The video is PEB sponsored but the figures are convincing. This has the emphasis on Cx Monitor which is probably the easiest one to get over the line into regular use. Note these urologists are at the younger range of the spectrum. I feel positive.......

[silu]

Is it normal for PEB to have a run-up in SP before a result announcement?
discl. small recent shareholder taking a punt

[calledone]

Is it normal for PEB to have a run-up in SP before a result announcement?
discl. small recent shareholder taking a punt

Not in this range as what's happening in the last 3 trading days. Also note that another research firm has started coverage of PEB this week so perhaps that might be the uplift today. The expectation for this results are not very high and probably will disappoint some but could there be a surprise!? Will know this Thursday. I for one is hoping to add more if the SP drops on results provided the numbers are looking in the range of my expectation.

[silu]

Not in this range as what's happening in the last 3 trading days. Also note that another research firm has started coverage of PEB this week so perhaps that might be the uplift today. The expectation for this results are not very high and probably will disappoint some but could there be a surprise!? Will know this Thursday. I for one is hoping to add more if the SP drops on results provided the numbers are looking in the range of my expectation.

Thank you. Which broker has initiated coverage? To be honest I bought after reading the United Healthcare announcement without knowing much about the company or the product. Only recently have I started to take more interest in what Cxbladder can do so I'm quite an ignorant and non-conviction holder and appreciate any posters here willing to educate.

[calledone]

Thank you. Which broker has initiated coverage? To be honest I bought after reading the United Healthcare announcement without knowing much about the company or the product. Only recently have I started to take more interest in what Cxbladder can do so I'm quite an ignorant and non-conviction holder and appreciate any posters here willing to educate.

A firm called ATM stock research. Not sure who or how relevant these guys are though.

[Maxtrade]

Not in this range as what's happening in the last 3 trading days. Also note that another research firm has started coverage of PEB this week so perhaps that might be the uplift today. The expectation for this results are not very high and probably will disappoint some but could there be a surprise!? Will know this Thursday. I for one is hoping to add more if the SP drops on results provided the numbers are looking in the range of my expectation.

Are the results due out today, or Thursday?

[Greekwatchdog]

Thursday 27th.

[Balance]

Thursday 27th.

PEB has been very much event driven stock - results announcements in the past not having much impact, except when PEB announced its regular capital raising with the results.

Market will be watching very closely with these results what kind of traction PEB has made with KP commercial agreement & the LCD inclusion, as these will be the first results with the first full six months impact from the two milestone developments.

There could be an update on how things are progressing in Asia.

[silu]

PEB has been very much event driven stock - results announcements in the past not having much impact, except when PEB announced its regular capital raising with the results.

Market will be watching very closely with these results what kind of traction PEB has made with KP commercial agreement & the LCD inclusion, as these will be the first results with the first full six months impact from the two milestone developments.

There could be an update on how things are progressing in Asia.

At some stage the traction should get the wheels spinning. Like the dung beetle it is starting slow and small until it has this big piece of dung worth fighting over.

I'm bored and out of platitudes.

[Balance]

At some stage the traction should get the wheels spinning. Like the dung beetle it is starting slow and small until it has this big piece of dung worth fighting over.

I'm bored and out of platitudes.

Patience and more patience are required when you invest in PEB!

[silu]

Patience and more patience are required when you invest in PEB!

I've got patience. I spent a whole 8 years on the sideline with this one. And back in 2013 I was a shareholder for less than a week when my stop-loss hit.

[pierre]

Patience and more patience are required when you invest in PEB!

Very true!

That issue will be overcome when we have patients and more patients using PEB products.

Let's hope Thursday's report gives investors positive news on progress from those KP and LCD developments. If there's been no significant traction then the SP will plummet (again) and any future announcements will be treated with a high degree of skepticism.

On the other hand...

[Maxtrade]

Very true!

That issue will be overcome when we have patients and more patients using PEB products.

Let's hope Thursday's report gives investors positive news on progress from those KP and LCD developments. If there's been no significant traction then the SP will plummet (again) and any future announcements will be treated with a high degree of skepticism.

On the other hand...

Whats the general consensus here, expecting SP to push up to the analysts previous 1.40+ target. Or a pull back in SP again??

[tango]

A firm called ATM stock research. Not sure who or how relevant these guys are though.

I remember that company. A guy from the company private messaged me after seeing me in a facebook investors group and offered me a free trial. I can't say it was any better than any other research company.

[tango]

Whats the general consensus here, expecting SP to push up to the analysts previous 1.40+ target. Or a pull back in SP again??

It feels as if there might be some inside knowledge filtering out ahead of the results pushing it up but it could just be a business as usual update and then the price will go south

[Leftfield]

Whats the general consensus here, expecting SP to push up to the analysts previous 1.40+ target. Or a pull back in SP again??

Hardly worth speculating...... one more sleep and all will be revealed.

[Balance]

Whats the general consensus here, expecting SP to push up to the analysts previous 1.40+ target. Or a pull back in SP again??

If the results show PEB gaining real traction in terms of test throughput and revenue collection, I would say the sp will also gain traction and it will push past $1.40 within a week as analysts update & upgrade their numbers.

[thegreatestben]

Glad we've had our housing project as a distraction, haven't had time to think about a result either way.
Fingers crossed for all holding tomorrow :)

[zs_cecil]

I hope the number of CMS tests will be at least the same as last year. I also hope there will be some revenue recovery from US (non-CMS and non-KP test) and some more revenue increases from New Zealand. I guess the number of KP tests won't be large according to the latest investor newsletter. And the weaken US dollar would have a substantial impact to the overall revenue.

I bet the revenue will be 8m+

[Guild]

I know of three tests referrals for the CX triage test amongst my social circle within the last month in Christchurch. One was told the test was $200NZ so make sure you get it right ie midstream urine sample. So even if it is not US$900 at least it seems to be getting used.

[LEMON]

6 executive team members hired in the past 6 months, all focused on growth. Even if this Ann today isn't great they are hiring by meeting demand at this time or PEB is preparing for what's going to be an accelerated reach in growth this coming months. Either way, the direction of the SP goes today I will hold and if it drops I will be topping up. Good luck all

[calledone]

6 executive team members hired in the past 6 months, all focused on growth. Even if this Ann today isn't great they are hiring by meeting demand at this time or PEB is preparing for what's going to be an accelerated reach in growth this coming months. Either way, the direction of the SP goes today I will hold and if it drops I will be topping up. Good luck all

Agree with you. I’m topping up both ways up or down(provide numbers from KP shows some traction) but will top up much more if SP goes up.

[silu]

Highlights:
FLLYR: PEB: PEB Financial Results for the 12 months to 31 March 2021

PACIFIC EDGE FINANCIAL RESULTS FOR THE 12 MONTHS TO 31 MARCH 2021
Pacific Edge reports strong growth momentum despite COVID-19

Summary of performance for the period (% changes compared to prior
comparative period (pcp)):

o Total revenue increased 101% to $10.4m, with operating revenue from test
sales up 76% to $7.7m, despite the negative impact from COVID-19 on test
volumes
o Cash receipts from customers increased 52% on pcp to $6.7m
o Total operating expenses increased 2% on pcp to $24.7m
o Net Loss After Tax improved 25% to $(14.2)m
o Net cash, cash equivalents and short-term deposits increased 56% to $23.1m
as at 31 March 2021
o Operating revenue and cash receipts benefited from reimbursement coverage
by Centers for Medicare and Medicaid Services (CMS) for Cxbladder Detect and
Cxbladder Monitor from 1 July 2020
o Strong performance in 2H21 driven by CMS reimbursement coverage from 1 July
2020 and growing commercial adoption of Cxbladder following a significant
negative impact on test volumes from COVID-19 pandemic in 1H21
o Commercial test use by Kaiser Permanente commenced in late 2020 at a slower
rate than initially expected due to COVID-19 challenges and demands on
physicians; demand is now starting to lift as restrictions ease
o Positive results from the scale-up of US commercial operations starting to
be seen in late Q4 FY21 with record test volumes and U.S. cash receipts
recorded in March 2021
o Positive growth outlook with opportunities being deployed in all target
markets, particularly the U.S.
o Increasing test volumes expected to underpin strong revenue and operating
cashflow growth in FY22 and beyond

[850man]

Summary of performance for the period (% changes compared to prior comparative period (pcp)):
• Total revenue increased 101% to $10.4m, with operating revenue from test sales up 76% to $7.7m, despite the negative impact from COVID-19 on test volumes
• Cash receipts from customers increased 52% on pcp to $6.7m
• Total operating expenses increased 2% on pcp to $24.7m
• Net Loss After Tax improved 25% to $(14.2)m
• Net cash, cash equivalents and short-term deposits increased 56% to $23.1m as at 31 March 2021
• Operating revenue and cash receipts benefited from reimbursement coverage by Centers for Medicare and Medicaid Services (CMS) for Cxbladder Detect and Cxbladder Monitor from 1 July 2020
• Strong performance in 2H21 driven by CMS reimbursement coverage from 1 July 2020 and growing commercial adoption of Cxbladder following a significant negative impact on test volumes from COVID-19 pandemic in 1H21
• Commercial test use by Kaiser Permanente commenced in late 2020 at a slower rate than initially expected due to COVID-19 challenges and demands on physicians; demand is now starting to lift as restrictions ease
• Positive results from the scale-up of US commercial operations starting to be seen in late Q4 FY21 with record test volumes and U.S. cash receipts recorded in March 2021
• Positive growth outlook with opportunities being deployed in all target markets, particularly the U.S.
• Increasing test volumes expected to underpin strong revenue and operating cashflow growth in FY22 and beyond

[Roskat]

Is todays report available to view live today? Cheers

[t.rexjr]

Test throughput is the same so revenue uplift is literally because they are now being paid for the tests... Though no doubt there is definitely a rather large momentum shift in play

[winner69]

Some 25% of the 10m revenue from grants and covid support ....that’s good

Cash burn pretty hefty


But things going to plan ....great future.

[zs_cecil]

Pay attention to Note 5 from the financial statements. It provides very useful insight of the revenue regonition and source. It also provide some info about 'medically necessary' and 'Medicare Adcantage'.

[tomm]

Dub dubs.....

[tomm]

The potentials of this business are so high, all the gears are in places, now just.. VROOM...VROOM...VROOM...
This business is a gold mine to invest for the future.

[calledone]

Not a bad result I think but can anyone actually find the test numbers from KP in any of the reports? Though test through put was down it is picking up quite significantly lately(+37% for March 2021) which if it's to follow through with rest of the year and with 50%+ US population vaccinated 2022 might be a bumper year.

[psychic]

I was right. The tests are not as "medically necessary" as Pacific Edge make out. Test throughput is down despite claims of adoption by CMS and KP.
(i just love the way they say "medically neccessary tests" instead of "tests if considered medically necessary"

Gawd, they have even created a provision now for possible refunds where CMS or Insurers find claimed tests were not medically necessary.

Market still duped.

[jridler]

Not a bad result I think but can anyone actually find the test numbers from KP in any of the reports? Though test through put was down it is picking up quite significantly lately(+37% for March 2021) which if it's to follow through with rest of the year and with 50%+ US population vaccinated 2022 might be a bumper year.

As per the investor call, the KP split will be included in financial reports going forward. It is too early to split this out, as per DD.

[calledone]

As per the investor call, the KP split will be included in financial reports going forward. It is too early to split this out, as per DD.

Thanks, I could not attend the call as I was in a meeting. How was the general feel from management?

[jridler]

Thanks, I could not attend the call as I was in a meeting. How was the general feel from management?

Positive, as you would expect. Questions were largely forward-looking and focused on opportunities (and conversion of these) rather than concentrated on cash position, revenue, etc. Here is what I can recall from the session.



Growth is continuing. TLT for March 2021 was 69% higher than previous 11-month avg according to results presentation. A question was raised regarding April throughput, and it was mentioned that this was higher than March. So growth has accelerated of recent, which is line with the overall narrative.
COVID has had an impact to sales efforts in the US, with virtual sales being the current standard practice. The expectation is that once the US opens up more, sales efforts will be improved.
Negotiations still in progress for CMS reimbursement. DD initially said "we expect" to see a positive outcome, but quickly changed this to "hope". This may be for some or all of the tests.
Singapore does not feel like a strong opportunity, as the premise for this was based on medical tourists. With COVID, there is not much of this at all. It felt like this was intentionally downplayed during the session but I could be misreading this. A white paper on the completed user programs is expected in the near future.
Commercial negotiations with remaining NZ DHBs are in progress, and the centralised model is expected to be beneficial.


All going accordingly, it will be a strong first half to FY22, even with COVID impact continuing.

[Leftfield]

Thanks for posting. Very helpful.

[tim23]

I was right. The tests are not as "medically necessary" as Pacific Edge make out. Test throughput is down despite claims of adoption by CMS and KP.
(i just love the way they say "medically neccessary tests" instead of "tests if considered medically necessary"

Gawd, they have even created a provision now for possible refunds where CMS or Insurers find claimed tests were not medically necessary.

Market still duped.

You would always be right with a name like psychic!

[calledone]

Positive, as you would expect. Questions were largely forward-looking and focused on opportunities (and conversion of these) rather than concentrated on cash position, revenue, etc. Here is what I can recall from the session.



Growth is continuing. TLT for March 2021 was 69% higher than previous 11-month avg according to results presentation. A question was raised regarding April throughput, and it was mentioned that this was higher than March. So growth has accelerated of recent, which is line with the overall narrative.
COVID has had an impact to sales efforts in the US, with virtual sales being the current standard practice. The expectation is that once the US opens up more, sales efforts will be improved.
Negotiations still in progress for CMS reimbursement. DD initially said "we expect" to see a positive outcome, but quickly changed this to "hope". This may be for some or all of the tests.
Singapore does not feel like a strong opportunity, as the premise for this was based on medical tourists. With COVID, there is not much of this at all. It felt like this was intentionally downplayed during the session but I could be misreading this. A white paper on the completed user programs is expected in the near future.
Commercial negotiations with remaining NZ DHBs are in progress, and the centralised model is expected to be beneficial.


All going accordingly, it will be a strong first half to FY22, even with COVID impact continuing.

Thanks for the input. I’ve listened to the recording and was pleased with their calm confidence in responses.

I’ll add that medical tourism is big business in Singapore (~1million every year) but the real opportunity is the larger southeast asian market which will be similar or bigger than US. DD was certain we will hear about Singapore outcome this financial year so that is something big to look forward to.

The slower uptake from KP was attributed to logistical issues rather than clinicians not using the tests. User experience from urologist is good so we’ll have to wait and see.

Overall the momentum looks stable and plenty of growth opportunities ahead.

[Snow Leopard]

I was a little disappointed with todays result :(
But not disappointed enough to sell any :)
Going to continue you believe that it is onwards and upwards now :mellow:

[Greekwatchdog]

For Bar update
OUTPERFORM
Pacific Edge (PEB) reported strong FY21 revenue growth and an improved NPAT loss, however, COVID-19 was a much
larger handbrake to revenue growth momentum than we had forecast. The March exit-run rate was encouraging, which
bodes well for a step-change in revenue from FY22. There was nothing in the result to change our view of the opportunity
or PEB’s ability to capitalise on this. COVID-19 has clouded the short-term upside, however, the prize is substantial and
headwinds are showing some signs of easing. With the range of justifiable long-term outcomes wide, we expect the share
price to continue to be driven by newsflow — which is likely to be positively skewed. OUTPERFORM.
What's changed?
COVID-19 a significant handbrake through FY21
PEB reported FY21 product sales of NZ$7.7m, up +76% on the prior year albeit materially below our expectations (-NZ$2.1m) — with
larger than anticipated COVID-19 headwinds weighing on overall test volumes. Recent data points to a meaningful recovery, with
indications March 2021 volumes were ~2,100 (+69% on the 11-month average through FY21). Extrapolating this, we estimate a baselevel exit run-rate for revenue of ~NZ$18m. Consistent with recent results, costs were well controlled, and cash receipts have
materially improved since coverage was secured from key US public health insurer, CMS (Centre for Medicare & Medicaid Services).
Cash position remains healthy
PEB reported net cash of NZ$23m at FY21, enough for c. 23 months operations using 2H21 cash burn rates and significantly longer
using our forecast burn rates. There is also upside risk given it excludes tests for CMS patients prior to commercial coverage (22,634
tests; or ~US$17m at US$760/test) where partial reimbursement is feasible, albeit the quantum and timing unknown. This is not
included in our forecasts.
Where to from here? We forecast a strong near-term revenue growth profile & operating leverage; quantum the key unknown
The FY21 result includes c. 8 months of contribution from CMS, albeit very little contribution from large US healthcare provider,
Kaiser Permanente with COVID-19 delaying progress. Both of these should be more material contributors from FY22E. Commentary
suggests FY22 has started well, albeit we expect COVID-19 disruption will linger at least into 1H22E. The range of reasonable and
justifiable outcomes remain very wide, particularly for revenue. We expect strong operating leverage as revenue grows even with a
step-up in SG&A costs, aided by highly attractive gross margins (>~85%). Potential near-term newsflow includes: new commercial
agreement(s), stronger mention/inclusion in clinical guidelines, back payment from CMS, additional clinical evidence.

[Brain]

Thanks for posting that Mr Watchdog. Greatly appreciated

[Merc]

Saw this article today. Nothing we didn't know, more a PR article in the public arena.
https://www.odt.co.nz/features/sponsored-content/good-news-mission-gospel-john-01

[ecuttel]

Think it was this article you were after Merc ...
https://www.odt.co.nz/business/pacific-edge-increases-revenue-101-reduces-loss

[Merc]

Oops. How did that happen? Opened it in Google, sent it to Chrome and copied and pasted the link. Very odd.

[850man]

Market seems not all that impressed with PEB's result based on the 4% SP drop since announced. Kinda odd really, it was not a "look at all the pots of gold we have" result but did anyone expect that? To me it was all about moving in the right direction which they have been along with a plausible future forecast of further growth.

[pierre]

Market seems not all that impressed with PEB's result based on the 4% SP drop since announced. Kinda odd really, it was not a "look at all the pots of gold we have" result but did anyone expect that? To me it was all about moving in the right direction which they have been along with a plausible future forecast of further growth.

The PEB SP only moves up when there's a good news announcement.

The FY report was far from bad news but it wasn't good enough to move the price upward - hence the mild wobble over the past two days. Astute investors will be taking this opportunity to buy in or top up.

PEB has crept up to 23% of my portfolio so I'm sitting on my current holding and waiting for the wave of good news that will come over the next 6-12 months.

[Greekwatchdog]

Nice article in the Herald. Paywalled. https://www.nzherald.co.nz/business/rags-to-riches-start-up-pacific-edge-ceo-david-darling-has-the-last-word/QX4THZCYGGF53RGOLAGQNHDTAU/

[Balance]

Nice article in the Herald. Paywalled. https://www.nzherald.co.nz/business/rags-to-riches-start-up-pacific-edge-ceo-david-darling-has-the-last-word/QX4THZCYGGF53RGOLAGQNHDTAU/

Being a shareholder, I am allowed to quote DD from the article :

"Keep standing up when people keep knocking you down.

"Get out there, find some support.

"And keep going."

And add this :

“…. & keep spinning even when you are caught lying.”

[Brain]

Being a shareholder, I am allowed to quote DD from the article :

"Keep standing up when people keep knocking you down.

"Get out there, find some support.

"And keep going."

And add this :

“…. & keep spinning even when you are caught lying.”

Does the end justify the means? I see this as one of the great problems. Board and management need to be positive to attract investment to sustain a business until it gets traction and is profitable. If they do not succeed they are crooks who have been bleeding shareholders dry to pay the salaries and directors fees. If they are successful all is good. If Darling had said 10 years ago this will take at least 10 years and maybe more to show positive results and is going to be very tricky nobody would have invested.

[Balance]

Does the end justify the means? I see this as one of the great problems. Board and management need to be positive to attract investment to sustain a business until it gets traction and is profitable. If they do not succeed they are crooks who have been bleeding shareholders dry to pay the salaries and directors fees. If they are successful all is good. If Darling had said 10 years ago this will take at least 10 years and maybe more to show positive results and is going to be very tricky nobody would have invested.

You under-estimate the capacity of seed investors & capital markets to support companies with great ideas & products.

But all credit to DD for his perseverance & ability to spin his way to get to where PEB is today.

As W69 pointed out in a previous post, that is unquestionably his greatest strength. So probably the right time for him to move on to another position which could use his greatest strength - fund raising & spinning.

Personally, I admire & respect what companies like Serko & Xero do - set out their plans, strategies & execute with 100% commitment of time & $$$$ by directors & management.

[psychic]

Fake it till you make it right?

Spin may seem morally okay while shareholders hang onto those (unjustifiable) gains, for now. Not so for those that have lost money believing in annoucements and investing accordingly. A lot here have held throughout, and those dark days of hanging onto awful losses are mostly forgotten for now. But will they be dealt to again? I fear so. There is nothing holding this thing up but falsehood, hope and likely -manipulation.

Four announcements got the Sp to where it is today. All misleading. And the observant will have seen tiny acknowledgemnets of this creep out, to now cover. Had they presented proof in these results that traction was indeed a thing, I'd have been delighted. They didn't. We have still have zero evidence of significant adoption. KP, Medicare, Vets. Test throughput down, all blamed on Covid. Do me a favour!. If, as we are told, CxBladder is included in the clinical pathway, covered by Medicare, United, KP, if the tests filled the needs and gaps suggested by Pacific Edge, then you will have seen test throughput sky rocket. Don't give me this wimpy crap about Covid. If the tests were reliable, Covid should have sent useage to the moon!

Even in NZ where we know the tests are in use, and in the DHB clinical pathway, the growth is simply uninspiring. No good example set there. Australia? Asia? What about the Spain thing? Don't get be started on gastric or melanoma tests, all forgotten.


Be careful.

[barney]

Why don't some of you guys just admit you got it wrong and move on.

[psychic]

Why don't some of you guys just admit you got it wrong and move on.

Got what wrong Barney?

[Biscuit]

Why don't some of you guys just admit you got it wrong and move on.

I bought into the last lot of hype, made a decent profit and moved on. Too risky to hold in my view, they never deliver on their hype.

[Biscuit]

PEB is a share that is almost always in a down trend with sudden bursts of good news propelling the sp up. Over the last 2 years its had 3 hyper-jumps. The first was about 700%, the second about 100% and the last about 10%. Law of diminishing returns?

[Baa_Baa]

I bought into the last lot of hype, made a decent profit and moved on. Too risky to hold in my view, they never deliver on their hype.

This time is different (https://invst.ly/uzhmx)?

[winner69]

This time is different (https://invst.ly/uzhmx)?

Nice chart baa_baa

Of course this time is different

I'm allowed to comment on PEB any way I like because I have donated real cash to their coffers a couple of times

Thanks for reminding how good things were in 2013 ..... i think they announced a cap raise at 50 odd cents and then our mate Swann talked about hundreds of thousands of things and the share price was over 120 when you had to front up with the donation ....remember selling those at 150 something

[Leftfield]

This time is different (https://invst.ly/uzhmx)?

Its been different for over a year some time now and in that time some of us have done v well.

Your chart says it well. Both MACD and RSI still bullish.

The trend is your friend (until the bend in the end.)

[jridler]

This time is different (https://invst.ly/uzhmx)?

Volume is the real story in this chart.

[Balance]

Volume is the real story in this chart.

Actually, relative to the number of shares issued, the period Sept 2012 to Feb 2014 when PEB shares spiked on the back of 'positive' announcements saw greater volume of shares traded.

PEB has issued humongous number of shares via its capital raising in the last 8 years.

Real difference, I believe, is the institutions now on the register.

[HITMAN]

I moved away from this share today. Made a tidy profit. I may get back in when share price drops a bit. As Phychic said there is a lot of hype, numbers don't yet support the high value.
All the best for those still in for the ride, I hope PEB can live up to the expectations. I'm waiting in the background to see how far it may drop.

[jridler]

Actually, relative to the number of shares issued, the period Sept 2012 to Feb 2014 when PEB shares spiked on the back of 'positive' announcements saw greater volume of shares traded.

PEB has issued humongous number of shares via its capital raising in the last 8 years.

Real difference, I believe, is the institutions now on the register.

I agree - and that is all part of the story. Tempted to backsolve the % shares outstanding traded in 2014 vs the recent run but haven't quite found the motivation...

[pierre]

I moved away from this share today. Made a tidy profit. I may get back in when share price drops a bit. As Phychic said there is a lot of hype, numbers don't yet support the high value.
All the best for those still in for the ride, I hope PEB can live up to the expectations. I'm waiting in the background to see how far it may drop.

Up 4 cents (3.4%) as I write - not to say it wont drop again though. However, picking the low point for any share is always a tricky game and if you stay out you may miss the next rise when it occurs. Who knows when the next bit of news will be announced, but I'm pretty sure it will be positive, rather than negative.

Brokers have targets of $1.40-$1.60 on PEB - just saying.

[tim23]

I moved away from this share today. Made a tidy profit. I may get back in when share price drops a bit. As Phychic said there is a lot of hype, numbers don't yet support the high value.
All the best for those still in for the ride, I hope PEB can live up to the expectations. I'm waiting in the background to see how far it may drop.

If it drops - no one I know can predict the bottom.

[psychic]

If it drops - no one I know can predict the bottom.

I can :)
Gap at .30

[Minerbarejet]

I was right. The tests are not as "medically necessary" as Pacific Edge make out. Test throughput is down despite claims of adoption by CMS and KP.
(i just love the way they say "medically neccessary tests" instead of "tests if considered medically necessary"

Gawd, they have even created a provision now for possible refunds where CMS or Insurers find claimed tests were not medically necessary.

Market still duped.
At this point I find it necessary to make a few necessary remarks about necessity medical or otherwise.

1. The whole object of the cxBladder test is to prove that in the cases of Haematuria presentation requiring Triage and in some cases of Monitoring for recurrence it is not necessary to have a cystoscopy.

2. Every single test that is done that returns a negative result proves the point that a cystoscopy was unnecessary in that case.

[psychic]

I don't think anybody would argue that this is the object.

The problem as I see it is that there is still insufficient clinical evidence to be able to rely upon it. And so, the Clinical guidelines still insist on cystoscopy.

It is not medically necessary. The use is not recommended. It has not been adopted, it is considered investigative only.

And this is reflected in Lab throughput numbers.

[pierre]

I don't think anybody would argue that this is the object.

The problem as I see it is that there is still insufficient clinical evidence to be able to rely upon it. And so, the Clinical guidelines still insist on cystoscopy.

It is not medically necessary. The use is not recommended. It has not been adopted, it is considered investigative only.

And this is reflected in Lab throughput numbers.

I wouldn't buy any shares in PEB if I were you.

[Minerbarejet]

I don't think anybody would argue that this is the object.

The problem as I see it is that there is still insufficient clinical evidence to be able to rely upon it. And so, the Clinical guidelines still insist on cystoscopy.

It is not medically necessary. The use is not recommended. It has not been adopted, it is considered investigative only.

And this is reflected in Lab throughput numbers.

So it is necessary to go on with unnecessary invasive procedures at great cost.

I tell you what once they, AUA and all manage to get their collective heads around it there will be a massive uptake.

How much evidence do they need or is there political stonewalling and lobbying going on?

[tim23]

I wouldn't buy any shares in PEB if I were you.

As long as you take your own advice?

[pierre]

As long as you take your own advice?
I've been a shareholder since 2012 and still am, having substantially increased my holding at opportune times since then.

My suggestion was targeted at Psychic who clearly is not a believer in the company or its products.

There have been other tiresome naysayers on this thread over the years - I expect the current iteration to be proved wrong sooner than later.

[jridler]

I've been a shareholder since 2012 and still am, having substantially increased my holding at opportune times since then.

My suggestion was targeted at Psychic who clearly is not a believer in the company or its products.

There have been other tiresome naysayers on this thread over the years - I expect the current iteration to be proved wrong sooner than later.

Perhaps he will make an about turn, like other forum posters have done...

[Brain]

We need people with opposing views, for me other views is what sharetrader is all about. I treat posts as opinions, not advice. I do not take offence if people are critical of companies I have invested in.

[tim23]

I've been a shareholder since 2012 and still am, having substantially increased my holding at opportune times since then.

My suggestion was targeted at Psychic who clearly is not a believer in the company or its products.

There have been other tiresome naysayers on this thread over the years - I expect the current iteration to be proved wrong sooner than later.

Nice one - I'm a holder as well

[pierre]

We need people with opposing views, for me other views is what sharetrader is all about. I treat posts as opinions, not advice. I do not take offence if people are critical of companies I have invested in.
I have no problem whatsoever with anyone holding or expressing their views about any company.

What gets tiresome though is the constant repetition of the same message.

I'll stop now - I might be running a risk of doing the same thing. :D

[tim23]

I've been a shareholder since 2012 and still am, having substantially increased my holding at opportune times since then.

My suggestion was targeted at Psychic who clearly is not a believer in the company or its products.

There have been other tiresome naysayers on this thread over the years - I expect the current iteration to be proved wrong sooner than later.

In a recent post Psychic can tell us when to buy more as Psychic can pick the bottom...

[pierre]

In a recent post Psychic can tell us when to buy more as Psychic can pick the bottom...

Hmmm. Not so sure about that. I may be wrong but I don't recall receiving any advice from Psychic when the SP plummeted to 12 cents about a year ago. Anyone who bought then is sitting on a 10 bagger!

[psychic]

I have no problem whatsoever with anyone holding or expressing their views about any company.

What gets tiresome though is the constant repetition of the same message.

I'll stop now - I might be running a risk of doing the same thing. :D

How about less waffle and more discussion? Counter my findings, that is why I post. It is healthy to research and discuss these things, it is what the site is all about.

I have argued that the four announcements giving rise to the SP are all misleading and that the market has been duped. Tell us all why I am wrong.

[psychic]

So it is necessary to go on with unnecessary invasive procedures at great cost.

I tell you what once they, AUA and all manage to get their collective heads around it there will be a massive uptake.

How much evidence do they need or is there political stonewalling and lobbying going on?

We've been waiting for them to "get their heads around it" for many years now, does it worry you that they have not? I imagine that studies not funded or written by Pacific Edge will help their cause, perhaps the potential for bias regardless of peer review is a bigger issue than we imagine?

The cost of the Cxbladder test is also significant, perhaps needlessly so.

As for US uptake being massive, why has it not been so in NZ (proportionally) given that the tests are in the DHB's clinical pathway and supported by it's study?

[Ggcc]

We've been waiting for them to "get their heads around it" for many years now, does it worry you that they have not? I imagine that studies not funded or written by Pacific Edge will help their cause, perhaps the potential for bias regardless of peer review is a bigger issue than we imagine?

The cost of the Cxbladder test is also significant, perhaps needlessly so.

As for US uptake being massive, why has it not been so in NZ (proportionally) given that the tests are in the DHB's clinical pathway and supported by it's study?
From memory NZ gets the tests at a substantial discount to the US hence the financial is very small.

There was a clinical advisor of Hawkes Bay DHB I spoke with about bladder cancer and he said in Hawkes bay there would be very few customers suffering from bladder cancer. Maybe similar in other DHBs

[850man]

How about less waffle and more discussion? Counter my findings, that is why I post. It is healthy to research and discuss these things, it is what the site is all about.

I have argued that the four announcements giving rise to the SP are all misleading and that the market has been duped. Tell us all why I am wrong.

Well said Psychic! Exactly why we should be welcoming opposing views to ensure we have a balance. Sometimes the gloss is too good on the outside to see the rust underneath

[Balance]

PEB needs to get cracking on getting the test numbers in the US up in a big and meaningful way.

Pays to keep an eye on what's happening out there with competitors and potential competitors :

1. Veracyte

https://www.genomeweb.com/reimbursement-news/veracyte-bladder-cancer-test-receives-medicare-coverage#.YMJ0Dy0Ro6o

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?lcdid=38576&ver=5&contractorName=all&updatePeriod=940&sortBy=id&bc=AAAABAAAAAAAAA

Veracyte announced on Friday that its Decipher Bladder test for cancer will be covered under a future local coverage determination from Medicare. (LCD to apply from 18 July 2021.)

2. KDx Diagnostics

https://www.360dx.com/cancer/kdx-diagnostics-launch-clinical-study-bladder-cancer-test-hematuria-patients#.YMJ3SC0Ro6o

URO17 is a urine-based test that uses the oncoprotein keratin 17 as a biomarker to detect new and recurrent bladder cancer. It received CE marking and a breakthrough device designation from the US Food and Drug Administration in 2020.

https://news.yale.edu/2021/06/04/study-shows-novel-test-can-detect-new-and-recurrent-bladder-cancer

A revolutionary new urine screening test that utilizes a novel Keratin 17 (K17) cancer biomarker can detect the presence of new bladder cancer in patients with hematuria, or blood in the urine, according to a study led by researchers at Yale Cancer Center, Stony Brook University, and KDx Diagnostics, Inc. The findings also show the test can detect recurrent bladder cancer in patients under surveillance for relapse.

[psychic]

Very interesting , thanks for posting Balance.
I have yet to see any of the Cxbladder tests being specifically approved by CMS as the Decipher test is in this proposed LCD and in what circumstances it should be used.

I know Cxbladder Monitor and Detect have CPT codes, but this is an administrative thing only and does not mean the tests are approved. Admit I don't fully understand this LCD review, but it almost now seems to approve the use of biomarkers when considered medically necessary and if the test has passed the MOiDx Technical approval process. I don't recall Pacific Edge have ever trumpeted this achievement and wonder if any of the tests have it?

[psychic]

From memory NZ gets the tests at a substantial discount to the US hence the financial is very small.

There was a clinical advisor of Hawkes Bay DHB I spoke with about bladder cancer and he said in Hawkes bay there would be very few customers suffering from bladder cancer. Maybe similar in other DHBs

Yes, using ROW (ie NZ) commercial test lab throughput and revenue I get around NZ$245 per test. Do the Americans feel a bit prickly at the US $760 price point when it costs so little to complete?

[850man]

PEB needs to get cracking on getting the test numbers in the US up in a big and meaningful way.

Pays to keep an eye on what's happening out there with competitors and potential competitors :

1. Veracyte

https://www.genomeweb.com/reimbursement-news/veracyte-bladder-cancer-test-receives-medicare-coverage#.YMJ0Dy0Ro6o

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?lcdid=38576&ver=5&contractorName=all&updatePeriod=940&sortBy=id&bc=AAAABAAAAAAAAA

Veracyte announced on Friday that its Decipher Bladder test for cancer will be covered under a future local coverage determination from Medicare. (LCD to apply from 18 July 2021.)

2. KDx Diagnostics

https://www.360dx.com/cancer/kdx-diagnostics-launch-clinical-study-bladder-cancer-test-hematuria-patients#.YMJ3SC0Ro6o

URO17 is a urine-based test that uses the oncoprotein keratin 17 as a biomarker to detect new and recurrent bladder cancer. It received CE marking and a breakthrough device designation from the US Food and Drug Administration in 2020.

https://news.yale.edu/2021/06/04/study-shows-novel-test-can-detect-new-and-recurrent-bladder-cancer

A revolutionary new urine screening test that utilizes a novel Keratin 17 (K17) cancer biomarker can detect the presence of new bladder cancer in patients with hematuria, or blood in the urine, according to a study led by researchers at Yale Cancer Center, Stony Brook University, and KDx Diagnostics, Inc. The findings also show the test can detect recurrent bladder cancer in patients under surveillance for relapse.

I put this to PEB's investor Centre and received the following responses:

Decipher Bladder, which is manufactured and sold by Veracyte in the US, is not a diagnostic test in that it does not indicate the presence or absence of disease. Instead it is a prognostic test to identify the likely patient survival benefit from neo-adjuvant chemotherapy prior to surgery for selected bladder cancer patients.

Pacific Edge does not consider Decipher Bladder to be a competitor to Cxbladder, rather completely complimentary. The target customer for ‘Decipher’ is a small subset of bladder cancer patients - those with Muscle Invasive Bladder Cancer (MIBC) and for those that are post-treatment (TURBT) but prior to possible cystectomy. These patients would typically not be candidates for testing with Cxbladder.

The URO17 test (KDx) is still in development and is an immunocytochemistry test that claims a high level of performance (sensitivity), superior to cytology. The mode of operation is to be used in conjunction with cytology. However the development and validation of URO17 has been performed on a small cohort of 179 patients in total (development: n=81, validation n=98) where the incidence of disease is abnormally high (nearly 33%) and does not reflect a real life population. This ‘enrichment’ of the study cohort will invariably overstate the performance of the test and will require further large-scale clinical studies, with prospectively recruited cohorts from real-world patient populations to validate these results. Equally the number of high grade / late stage vs low grade tumours, and the ratio of males to females in this study is inconsistent with what would be expected from a prospectively recruited patient cohort. The overall conclusion is that this single biomarker test has performance that is inferior to Cxbladder.

We don’t consider this level of performance competitive as it is based on a very small study and accordingly the URO17 test does not currently represent a threat to Cxbladder. There may well be other new tests developed over time, however all will have to complete many years and many 10’s of millions of dollars of evidence development to achieve adoption and reimbursement recognition.

Over time, however Pacific Edge continues to observe and evaluate these products on their merits while maintaining our marketing, and R&D efforts on expanding clinical adoption and product improvement (respectively).

[Leftfield]

I put this to PEB's investor Centre and received the following responses:

Decipher Bladder, which is manufactured and sold by Veracyte in the US, is not a diagnostic test in that it does not indicate the presence or absence of disease. Instead it is a prognostic test to identify the likely patient survival benefit from neo-adjuvant chemotherapy prior to surgery for selected bladder cancer patients.

Pacific Edge does not consider Decipher Bladder to be a competitor to Cxbladder, rather completely complimentary. The target customer for ‘Decipher’ is a small subset of bladder cancer patients - those with Muscle Invasive Bladder Cancer (MIBC) and for those that are post-treatment (TURBT) but prior to possible cystectomy. These patients would typically not be candidates for testing with Cxbladder.

The URO17 test (KDx) is still in development and is an immunocytochemistry test that claims a high level of performance (sensitivity), superior to cytology. The mode of operation is to be used in conjunction with cytology. However the development and validation of URO17 has been performed on a small cohort of 179 patients in total (development: n=81, validation n=98) where the incidence of disease is abnormally high (nearly 33%) and does not reflect a real life population. This ‘enrichment’ of the study cohort will invariably overstate the performance of the test and will require further large-scale clinical studies, with prospectively recruited cohorts from real-world patient populations to validate these results. Equally the number of high grade / late stage vs low grade tumours, and the ratio of males to females in this study is inconsistent with what would be expected from a prospectively recruited patient cohort. The overall conclusion is that this single biomarker test has performance that is inferior to Cxbladder.

We don’t consider this level of performance competitive as it is based on a very small study and accordingly the URO17 test does not currently represent a threat to Cxbladder. There may well be other new tests developed over time, however all will have to complete many years and many 10’s of millions of dollars of evidence development to achieve adoption and reimbursement recognition.

Over time, however Pacific Edge continues to observe and evaluate these products on their merits while maintaining our marketing, and R&D efforts on expanding clinical adoption and product improvement (respectively).

Thanks 850 - good to have more info' on this.

[Retired Doc]

I put this to PEB's investor Centre and received the following responses:

Decipher Bladder, which is manufactured and sold by Veracyte in the US, is not a diagnostic test in that it does not indicate the presence or absence of disease. Instead it is a prognostic test to identify the likely patient survival benefit from neo-adjuvant chemotherapy prior to surgery for selected bladder cancer patients.

Pacific Edge does not consider Decipher Bladder to be a competitor to Cxbladder, rather completely complimentary. The target customer for ‘Decipher’ is a small subset of bladder cancer patients - those with Muscle Invasive Bladder Cancer (MIBC) and for those that are post-treatment (TURBT) but prior to possible cystectomy. These patients would typically not be candidates for testing with Cxbladder.

The URO17 test (KDx) is still in development and is an immunocytochemistry test that claims a high level of performance (sensitivity), superior to cytology. The mode of operation is to be used in conjunction with cytology. However the development and validation of URO17 has been performed on a small cohort of 179 patients in total (development: n=81, validation n=98) where the incidence of disease is abnormally high (nearly 33%) and does not reflect a real life population. This ‘enrichment’ of the study cohort will invariably overstate the performance of the test and will require further large-scale clinical studies, with prospectively recruited cohorts from real-world patient populations to validate these results. Equally the number of high grade / late stage vs low grade tumours, and the ratio of males to females in this study is inconsistent with what would be expected from a prospectively recruited patient cohort. The overall conclusion is that this single biomarker test has performance that is inferior to Cxbladder.

We don’t consider this level of performance competitive as it is based on a very small study and accordingly the URO17 test does not currently represent a threat to Cxbladder. There may well be other new tests developed over time, however all will have to complete many years and many 10’s of millions of dollars of evidence development to achieve adoption and reimbursement recognition.

Over time, however Pacific Edge continues to observe and evaluate these products on their merits while maintaining our marketing, and R&D efforts on expanding clinical adoption and product improvement (respectively).

Thanks for doing the mahi on that. That is reassuring re CxBladder’s leading position over the competition.

[thegreatestben]

PEB
21/06/2021 09:33
GENERAL
PRICE SENSITIVE
REL: 0933 HRS Pacific Edge Limited

GENERAL: PEB: Kaiser Permanente to Commence Use of Second Cxbladder Test

KAISER PERMANENTE TO COMMENCE COMMERCIAL USE OF SECOND CXBLADDER TEST

Cancer diagnostics company, Pacific Edge Limited (NZX: PEB) is pleased to
announce that it has been informed by Kaiser Permanente that it intends to
commence the commercial use of a second Cxbladder product, Cxbladder Triage,
from the beginning of July 2021.

In June 2020, Kaiser Permanente approved the commercial use of Cxbladder
products by its urologists for patients being evaluated and managed for
bladder cancer. Kaiser Permanente commenced its commercial use with Cxbladder
Monitor for patients being monitored for the recurrence of bladder and
urothelial cancer.

Kaiser Permanente has now informed Pacific Edge that it intends to commence
the commercial use of a second Cxbladder product, Cxbladder Triage for
patients presenting with haematuria (blood in the urine and a key indicator
of bladder cancer).

Kaiser Permanente will start its commercial use of Cxbladder Triage in a
single clinic comprising six urologists. This initial clinic is also using
Cxbladder Monitor. Kaiser Permanente plans to progressively roll out
Cxbladder Triage, alongside Cxbladder Monitor, across their network. Kaiser
Permanente will use Pacific Edge's Patient In-Home Sample System for
Cxbladder Triage, as is currently being done with Cxbladder Monitor,
providing a simple and convenient way for both the patient and the physician
to manage urine sample collection.

CEO of Pacific Edge, David Darling, said: "We are delighted to continue the
growth of our commercial partnership with Kaiser Permanente. Since reaching
commercial agreement with Kaiser Permanente we have focused on working with
them to provide their urologists with a great user experience. This requires
successfully integrating Cxbladder into their internal electronic medical
records systems to ensure that our products and services are easily
accessible to their urologists and patients. While Covid-19 continues to
impact the speed of the Cxbladder rollout across the Kaiser Permanente
network, going forward we expect that their demand for Cxbladder will
continue to increase as Covid-19 related restrictions ease and they expand
the use of the use of two Cxbladder products."

ENDS

[Alpha]

https://www.nzx.com/announcements/374228

[tango]

Woohoo
Just saw this on my email. I have no idea the profit margin on this product but I am seeing lots of $$$

Disc: holding

[thegreatestben]

Bit of SP action would be great but if nothing else it makes me a bit more comfortable on holding :)

[Minerbarejet]

Its just Kaiser doing what they deem necessary for their patients. :)

[psychic]

June a year ago. KP approve use of ALL Cxbladder tests, 39 Hospitals, 23000 Physicians.

A year later, KP "intend" to start using Triage, at one clinic, six urologists. Meantime very little evidence of use of Monitor.

Time will tell

[Greekwatchdog]

Go recheck what was said. I don't recall ALL CXBLADDER SUITES in original agreement.

[calledone]

June a year ago. KP approve use of ALL Cxbladder tests, 39 Hospitals, 23000 Physicians.

A year later, KP "intend" to start using Triage, at one clinic, six urologists. Meantime very little evidence of use of Monitor.

Time will tell


I think this is good progress and shows KP's growing confidence in PEB. Also the announcement mentioned this in the next paragraph, "Kaiser Permanente will start its commercial use of Cxbladder Triage..." so It seems to me it's guaranteed.

[psychic]

Go recheck what was said. I don't recall ALL CXBLADDER SUITES in original agreement.

You are correct, thank you. The original announcements I think said "tests" not "all". Plural, not singular. What should investors have thought given the long awaited research by KP was on Triage?

The Oct 2020 update says

"Firstly, we reached agreement with Kaiser Permanente, one of the
US’s largest and best regarded healthcare providers, to
commercially use our all of our Cxbladder products in the US"

What does this suggest to you?


I agree this is positive, but how positive is very hard to say with PE given the smoke and mirrors over years

[zs_cecil]

I think this is good progress and shows KP's growing confidence in PEB. Also, the announcement mentioned this in the next paragraph, "Kaiser Permanente will start its commercial use of Cxbladder Triage..." so It seems to me it's guaranteed.

I think this update could imply that the back-office integration in KP was done. The in-home sampling programme is/has been ready to roll out to their patients.

[Leftfield]

I think this is good progress and shows KP's growing confidence in PEB. Also the announcement mentioned this in the next paragraph, "Kaiser Permanente will start its commercial use of Cxbladder Triage..." so It seems to me it's guaranteed.

Good news for holders..... well done all.

[Minerbarejet]

I think this update could imply that the back-office integration in KP was done. The in-home sampling programme is/has been ready to roll out to their patients.

And we can look forward to another announcement when Kaiser will start using Detect in the process.
And of course the 4th one Resolve which hasn't been released in the USA yet AFAIK.

[Retired Doc]

DD said “This requires successfully integrating Cxbladder into their internal electronic medical
records systems to ensure that our products and services are easily accessible to their urologists and patients.”

I fervently hope PEB has done/ does all it can to facilitate the inclusion of the testing process into KP’S Electronic Health Records (EHR) system to make it easy for clinicians to initiate and then follow the process. My experience is that a “clunky” EHR process is very inhibiting to the adoption of new procedures by busy clinicians and more so with older clinicians 🤔.

A most encouraging announcement.

[Minerbarejet]

This may provoke some action out of Johns Hopkins who were doing a commercial assessment of cxBladder but have been very quiet about it all.

They will be taking note of the Kaiser Permanente developments, no doubt.

https://www.cxbladder.com/nz/news/2018/cxbladder-commercial-evaluation-by-johns-hopkins-medicine/

[Balance]

Lighten up some of my shares into the spike this morning.

Happy.

[Greekwatchdog]

I am sure they have learned along the way in regards to how they deliver the "message". Mistakes were made and caused over reaction to share price. I am happy with what I have read. Progress is being made. Boosters are warming..

[zs_cecil]

And we can look forward to another announcement when Kaiser will start using Detect in the process.
And of course the 4th one Resolve which hasn't been released in the USA yet AFAIK.

Good to see the progress here indeed. It is encouraging I think that KP will start using Triage. I remembered DD in one of his interview last year mentioned that CX Monitor and Detect are used primarily in the US market. This is because these two products are fitting their clinical setting the most. I hope KP's adoption of Triage will become a showcase of clinical application that other clinical players would follow.

[psychic]

I am sure they have learned along the way in regards to how they deliver the "message". Mistakes were made and caused over reaction to share price. I am happy with what I have read. Progress is being made. Boosters are warming..

The four anouncements in the past 12 months that took the SP to where it is today were misleading so I'd question your certainty that they have learnt from past mistakes. Boosters may be warming but there is little evidence of this outside what Pacific Edge ask us to believe.

[Greekwatchdog]

I guess Psychic its upto the individual to decipher/interpret the info provided by PEB. Until we see dollars there will be those that remain skeptical.

[blu3]

Great news for the world but maybe not as much for PEB investors?

Blood test that finds 50 types of cancer is accurate enough to be rolled out (https://www.theguardian.com/society/2021/jun/25/blood-test-that-finds-50-types-of-cancer-is-accurate-enough-to-be-rolled-out)

[Panda-NZ-]

Long time coming, hopefully the trails go well.

[Leftfield]

Great news for the world but maybe not as much for PEB investors?
Blood test that finds 50 types of cancer is accurate enough to be rolled out (https://www.theguardian.com/society/2021/jun/25/blood-test-that-finds-50-types-of-cancer-is-accurate-enough-to-be-rolled-out)

Thanks for posting. Remains to be seen whether this good/bad for PEB.

Could expand the total market for blood/cancer tests? PEB could adapt and become part of this expanding new treatment industry?

Interesting times.

[tim23]

The four anouncements in the past 12 months that took the SP to where it is today were misleading so I'd question your certainty that they have learnt from past mistakes. Boosters may be warming but there is little evidence of this outside what Pacific Edge ask us to believe.

Have you bought back in or waiting for price to come back?

[tim23]

The four anouncements in the past 12 months that took the SP to where it is today were misleading so I'd question your certainty that they have learnt from past mistakes. Boosters may be warming but there is little evidence of this outside what Pacific Edge ask us to believe.

Have you bought back in or waiting for price to come back?

[artemis]

Dunedin's tech 'gold rush' - includes a big segment on PEB.

https://pointofordernz.wordpress.com/2021/06/28/dunedins-modern-day-gold-rush-and-business-resurgence-has-been-triggered-by-a-swathe-of-high-tech-developments/#more-11048

[kiora]

POD the other tech's have far greater income & better cash flow?

[artemis]

Duplicated.

[thegreatestben]

Small scale but highlights the product benefit of being able to help remote communities, great to see it being useful to the north. Some people there have it pretty tough!

https://announcements.nzx.com/detail/375215

[Sideshow Bob]

I see David is on Sharsies "Lunch Money" tomorrow.

[psychic]

Small scale but highlights the product benefit of being able to help remote communities, great to see it being useful to the north. Some people there have it pretty tough!

https://announcements.nzx.com/detail/375215

I'm not sure how this works really. Cxbladder Triage must be supported by imaging to be relied upon?

[850man]

Small scale but highlights the product benefit of being able to help remote communities, great to see it being useful to the north. Some people there have it pretty tough!

https://announcements.nzx.com/detail/375215

This is positive but a drop in the bucket. What we really need to see is significant revenue flow from the USA and a mandate for CXBladder by their insurers

[Leftfield]

Step by step folks, Rome wasn't built in a day.

This is good news and when the NZ Govt finally amalgamates all the DHB's PEB will be in the box seat.

[Greekwatchdog]

Maybe you will get an update at ASM in 3 weeks....

[pierre]

Softly, softly, catchee monkey!

[Greekwatchdog]

More good news...
Outperformance confirmed from combined use of Cxbladder8/7/2021, 9:48 am GENERALCOMBINED USE OF CXBLADDER PRODUCTS SHOWS SIGNIFICANT OUTPERFORMANCE
• A pivotal, peer-reviewed paper, accepted for publication in the Journal of Urology, demonstrates the significant clinical and patient benefits from the use of a combination of Cxbladder products to correctly identify haematuria patients, who have urothelial cancer (UC) and also, further segregate those patients with high-impact tumours (HIT) requiring priority investigation.
• Of significant importance, the study concluded that the sequential use of the Cxbladder products achieved 4.8 times greater efficiency in accurately assigning patients to the physician’s prioritisation of investigation than the latest American Urology Association (AUA) 2020 guidelines.
Cancer diagnostics company, Pacific Edge Limited, is pleased to advise that a new scientific and clinical paper validating the diagnostic performance of its fourth Cxbladder test, Cxbladder Resolve (CxbR), has been accepted for publication in the Journal of Urology. The Journal of Urology is the official Journal of the AUA and the most widely read and highly cited journal in the field of Urology.
Cxbladder Resolve was designed for use by a physician following a patient’s initial evaluation using both Cxbladder Triage (CxbT) and Detect (CxbD). Those patients that test positive to CxbT and then also test positive to CxbD, will receive the Cxbladder Resolve (CxbR) test. CxbR accurately identifies those patients with a high-impact tumour (HIT), who require high priority intervention by their urologist. High-impact tumours are those that have the highest probability of invasion and progression and where early detection is critical for a successful outcome.
The paper titled ‘Cxbladder for prioritising high-risk urothelial cancer patients’ evaluates the use of Cxbladder Resolve, alone and in combination with other Cxbladder tests, to identify and prioritise patients at high risk for urothelial carcinoma/cancer’ (UC) . Cxbladder Resolve was developed on 863 haematuria patients recruited in the US, New Zealand and Australia; and then tested, both separately and in combination with other Cxbladder tests, on a further 548 Kaiser Permanente patients, with outstanding results.
Of note, Cxbladder Resolve correctly identified all patients with high-impact tumours, allowing those patients to be prioritised for further investigation.
The paper concluded that Cxbladder Resolve has high sensitivity (92.4%) and specificity (93.8%) and correctly identified all high-impact tumours. In addition, sequential use of Cxbladder tests accurately segregated patients with a low vs high probability of high-impact tumours, enabling the prioritisation of physician resources for these patients.
With the sequential use of Cxbladder tests for each patient (Triage, followed by Detect, followed by Resolve):
• 87.6% of patients were correctly ruled out from requiring further workup (negative predictive value 99.4%)
• 100% of high-impact tumours were accurately identified for prioritised investigation in both study cohorts
CEO of Pacific Edge, David Darling, said: “Our long-standing strategy has been to develop a suite of Cxbladder products that can be used alone or in combination to address unmet needs across the entire clinical pathway for urothelial cancer. This is a pivotal paper for urologists, outlining the significant increase in clinical resolution that can be achieved from using the multiple Cxbladder products in this fashion. This is the first time that the clinical benefits of this novel approach have been validated.
“The paper confirmed that the combined use of three of our Cxbladder products for each patient, using just one urine sample, can firstly rule out those who do not have cancer, then accurately identify those with cancer and finally, segregate out those with high-impact tumours for priority investigation. This approach provides significant benefit to both physicians and patients, substantially reducing the number of patients requiring further work up while prioritising those patients with high impact tumours.
“A significant outcome confirmed by this paper is the outperformance of Cxbladder used in this format where the sequential use of the three Cxbladder tests achieved 4.8 times greater efficiency in accurately assigning patients to the physician’s prioritisation of investigation, than the latest AUA guidelines. We expect this outcome to support additional AUA guideline inclusion and greater adoption of Cxbladder.”
“A testament to the quality of this study (where the primary author is one of the key Kaiser Permanente’s urologists), is that it shows the successful use of Cxbladder on Kaiser Permanente patients, supporting our now established relationship with one of the US’s largest healthcare provider and payers.”
Feedback from the Journal’s independent peer reviewers during the publication process was very positive, highlighting the potential for the study to “change the diagnostic paradigm for patients presenting with hematuria, better identifying high-risk patients and decreasing the time to tumor diagnosis.”
Additionally, “This series of urine based tests appears to represent an exciting pathway for hematuria workups better stratifying risk of malignancy, and perhaps obviating the need for cystoscopy in workup of many patients with hematuria.”
Reviewers noted that “The study is novel, as results of CxbR have not been reported before (vs CxbT and CxbD). Based on the high-negative predictive value achieved in the cohort, the purported clinical value of the study is to allow clinicians to triage patients with high risk for expedited workup by sending them straight to transurethral resection and avoiding cystoscopy and CT scans in those that are low priority.”

[Greekwatchdog]

More good news...
Outperformance confirmed from combined use of Cxbladder8/7/2021, 9:48 am GENERALCOMBINED USE OF CXBLADDER PRODUCTS SHOWS SIGNIFICANT OUTPERFORMANCE
• A pivotal, peer-reviewed paper, accepted for publication in the Journal of Urology, demonstrates the significant clinical and patient benefits from the use of a combination of Cxbladder products to correctly identify haematuria patients, who have urothelial cancer (UC) and also, further segregate those patients with high-impact tumours (HIT) requiring priority investigation.
• Of significant importance, the study concluded that the sequential use of the Cxbladder products achieved 4.8 times greater efficiency in accurately assigning patients to the physician’s prioritisation of investigation than the latest American Urology Association (AUA) 2020 guidelines.
Cancer diagnostics company, Pacific Edge Limited, is pleased to advise that a new scientific and clinical paper validating the diagnostic performance of its fourth Cxbladder test, Cxbladder Resolve (CxbR), has been accepted for publication in the Journal of Urology. The Journal of Urology is the official Journal of the AUA and the most widely read and highly cited journal in the field of Urology.
Cxbladder Resolve was designed for use by a physician following a patient’s initial evaluation using both Cxbladder Triage (CxbT) and Detect (CxbD). Those patients that test positive to CxbT and then also test positive to CxbD, will receive the Cxbladder Resolve (CxbR) test. CxbR accurately identifies those patients with a high-impact tumour (HIT), who require high priority intervention by their urologist. High-impact tumours are those that have the highest probability of invasion and progression and where early detection is critical for a successful outcome.
The paper titled ‘Cxbladder for prioritising high-risk urothelial cancer patients’ evaluates the use of Cxbladder Resolve, alone and in combination with other Cxbladder tests, to identify and prioritise patients at high risk for urothelial carcinoma/cancer’ (UC) . Cxbladder Resolve was developed on 863 haematuria patients recruited in the US, New Zealand and Australia; and then tested, both separately and in combination with other Cxbladder tests, on a further 548 Kaiser Permanente patients, with outstanding results.
Of note, Cxbladder Resolve correctly identified all patients with high-impact tumours, allowing those patients to be prioritised for further investigation.
The paper concluded that Cxbladder Resolve has high sensitivity (92.4%) and specificity (93.8%) and correctly identified all high-impact tumours. In addition, sequential use of Cxbladder tests accurately segregated patients with a low vs high probability of high-impact tumours, enabling the prioritisation of physician resources for these patients.
With the sequential use of Cxbladder tests for each patient (Triage, followed by Detect, followed by Resolve):
• 87.6% of patients were correctly ruled out from requiring further workup (negative predictive value 99.4%)
• 100% of high-impact tumours were accurately identified for prioritised investigation in both study cohorts
CEO of Pacific Edge, David Darling, said: “Our long-standing strategy has been to develop a suite of Cxbladder products that can be used alone or in combination to address unmet needs across the entire clinical pathway for urothelial cancer. This is a pivotal paper for urologists, outlining the significant increase in clinical resolution that can be achieved from using the multiple Cxbladder products in this fashion. This is the first time that the clinical benefits of this novel approach have been validated.
“The paper confirmed that the combined use of three of our Cxbladder products for each patient, using just one urine sample, can firstly rule out those who do not have cancer, then accurately identify those with cancer and finally, segregate out those with high-impact tumours for priority investigation. This approach provides significant benefit to both physicians and patients, substantially reducing the number of patients requiring further work up while prioritising those patients with high impact tumours.
“A significant outcome confirmed by this paper is the outperformance of Cxbladder used in this format where the sequential use of the three Cxbladder tests achieved 4.8 times greater efficiency in accurately assigning patients to the physician’s prioritisation of investigation, than the latest AUA guidelines. We expect this outcome to support additional AUA guideline inclusion and greater adoption of Cxbladder.”
“A testament to the quality of this study (where the primary author is one of the key Kaiser Permanente’s urologists), is that it shows the successful use of Cxbladder on Kaiser Permanente patients, supporting our now established relationship with one of the US’s largest healthcare provider and payers.”
Feedback from the Journal’s independent peer reviewers during the publication process was very positive, highlighting the potential for the study to “change the diagnostic paradigm for patients presenting with hematuria, better identifying high-risk patients and decreasing the time to tumor diagnosis.”
Additionally, “This series of urine based tests appears to represent an exciting pathway for hematuria workups better stratifying risk of malignancy, and perhaps obviating the need for cystoscopy in workup of many patients with hematuria.”
Reviewers noted that “The study is novel, as results of CxbR have not been reported before (vs CxbT and CxbD). Based on the high-negative predictive value achieved in the cohort, the purported clinical value of the study is to allow clinicians to triage patients with high risk for expedited workup by sending them straight to transurethral resection and avoiding cystoscopy and CT scans in those that are low priority.”

[pierre]

More good news...
Outperformance confirmed from combined use of Cxbladder

Oh dear - more bad news for Psychic. :scared:

[Retired Doc]

I think today’s announcement answers this Psychic. Onwards and upwards!

[psychic]

More good news...
Outperformance confirmed from combined use of Cxbladder

Oh dear - more bad news for Psychic. :scared:

Not at all! I think this is very encouraging but will wait till I can read the study before becoming too excited.

You didn't answer my last post Pierre in which I invited you to challenge what I had said. Kinda went to ground on that.
If you have nothing to constructively add then stay quiet man, don't make this a personal thing. The thread is for debate, if you don't like me questioning things put me on ignore.

[psychic]

I think today’s announcement answers this Psychic. Onwards and upwards!

Thank you, I'm not sure and had hoped you might comment. I was questioning PE's suggestion that people in the far North could take the Triage Test without travelling to main centres when Triage needs the support of imaging anyway. (this was the DHB's finding in the orig study)
What were your thoughts on this?

[davflaws]

If the protocols call for cystoscopy then it's Whangarei or a travelling clinic, but the resulting imagery is then available to a GP anywhere. My own BT was diagnosed by ulltrasound after acute haematuria and clotting obstruction, but I have no idea whether ultrasound of that quality is available further north.

But the important bit to me as a patient, is that if the CXBladder suite can avoid even one cystoscopy (leave aside any driving time) I'm for it and I believe that everyone else from the minister downward will be too - if not for the same reasons!.

[Minerbarejet]

“A significant outcome confirmed by this paper is the outperformance of Cxbladder used in this format where the sequential use of the three Cxbladder tests achieved 4.8 times greater efficiency in accurately assigning patients to the physician’s prioritisation of investigation, than the latest AUA guidelines. We expect this outcome to support additional AUA guideline inclusion and greater adoption of Cxbladder.”

Might get some reaction from the woebegone, behind the times AUA.

[Roskat]

https://www.sharetrader.co.nz/blob:https://www.sharetrader.co.nz/455a703d-8359-4ebc-ac75-2607f98fafc5

[Roskat]

CxBladder test kits available on line in NZ at $368

[thegreatestben]

DD speaking to sharesies today
https://www.youtube.com/watch?v=PDvlEGHr9BQ

[kiora]

CxBladder test kits available on line in NZ at $368

I thought they where charging around $900/test a few years ago?

[Greekwatchdog]

Not in NZ. The US Market is where they get that and then some..

[Lescy]

I'm a hospital clinical staff member & hope this answers part of your question.
I just checked our DHB guidelines and CxBladderTriage is firmly entrenched in the workup procedure for both patients currently in hospital, and those who are at home. I see patients referred for CxBladder during my routine work.

At my DHB, the CxBladder test is used as a screening test for patients with haematuria (blood in the urine) that isn't explained by a bladder infection. Some higher risk patients also have an ultrasound at this point. Our guidelines highlight that it picks up 97% of urological cancers, and will 'rule out' 99% of patients who don't have bladder cancer. If a positive result is reported, the patient is then referred to the urologist. This is when further specialist investigations such as imaging may be undertaken, to both finalise a diagnosis and decide upon a treatment plan.

(replying to psychic from 7/8/21)

[Retired Doc]

Thank you, I'm not sure and had hoped you might comment. I was questioning PE's suggestion that people in the far North could take the Triage Test without travelling to main centres when Triage needs the support of imaging anyway. (this was the DHB's finding in the orig study)
What were your thoughts on this?
Thanks Psychic.
The excellent negative predictive value and it’s apparent 100% ( though I am always wary of any thing said to be 100% in medicine) detection of nasty tumours will hugely reduce the uncertainty in managing haematuria in the primary care setting at least. If you receive a negative result then you can watch and repeat later knowing in the very small chance of a tumour being missed at least it won’t be at the nasty end of the spectrum. This will take pressure ( probably quite a lot ) off imaging and, Hallelujah for the patients, cut down cystoscopy numbers significantly with an attendant saving in resources. Win win win all around. Haematuria ( particularly microscopic) was often the source of significant clinical management anxiety for me in primary care and I believe my colleagues and this testing process will leave a clearer path in many cases which would otherwise have carried a significant burden of uncertainty for the clinician and patients as will as inconvenience and discomfort for the latter

[psychic]

Lescy and Retired Doc, thank you both for these excellent posts.

[Retired Doc]

Thank you Psychic.You are welcome. I think it is important to refresh views as new information becomes available even if it only confirms previous positions. This most recent study is another plank in a very sound base. IMHO CxBladder will be a fundamental part of any haematuria work up algorithm.

[Arthur]

Thank you Psychic.You are welcome. I think it is important to refresh views as new information becomes available even if it only confirms previous positions. This most recent study is another plank in a very sound base. IMHO CxBladder will be a fundamental part of any haematuria work up algorithm.

Any idea why the take-up rate is so slow in USA? I would off thought even the most mercenary urologist in USA would have seen the merit of clipping the ticket during lock-down by getting "clients" to take the test, they must have had a database of suitable candidates to draw on.
Ethical urologists would have sent them to do the best by their patients.
What am I missing?

[Retired Doc]

Any idea why the take-up rate is so slow in USA? I would off thought even the most mercenary urologist in USA would have seen the merit of clipping the ticket during lock-down by getting "clients" to take the test, they must have had a database of suitable candidates to draw on.
Ethical urologists would have sent them to do the best by their patients.
What am I missing?

My 2c take is that CxBladder is a major disruptor and the AUA is likely a very conservative organisation. Also as you are likely aware the US health system bears a heavy litigation burden and there will be some anxiety re omitting an erstwhile gold standard procedure (cystoscopy) where you actually “have a look” and using a molecular test. What will likely weigh against persisting with cystoscopy is patient preference and the fact that there is a complication rate and morbidity with cystoscopy which although very low does raise the spectre of a lawyer asking in the situation of a cystoscopy gone wrong, why cystoscopy was done when a simple urine test would have sufficed.
I am not sure how the money flows in the US but cutting down on cystoscopies is going to decrease revenue for some urologists and hospitals/ clinics. Insurance companies should love CxB but again I donÂ’t know the details of the system.
I believe CxB is now popular in NZ urology practice and it wonÂ’t be far off penetrating primary care here albeit with some restrictions.
I feel confident that my modest PEB holding will grow but being largely ignorant of the economics of this I have no idea of by what factor the increasing numbers of tests will translate into profits. There will be others out there who may be able to comment on thatÂ…Â…Â…

[Arthur]

Thank you Retired Doctor.

[Carpenterjoe]

My 2c take is that CxBladder is a major disruptor and the AUA is likely a very conservative organisation. Also as you are likely aware the US health system bears a heavy litigation burden and there will be some anxiety re omitting an erstwhile gold standard procedure (cystoscopy) where you actually “have a look” and using a molecular test. What will likely weigh against persisting with cystoscopy is patient preference and the fact that there is a complication rate and morbidity with cystoscopy which although very low does raise the spectre of a lawyer asking in the situation of a cystoscopy gone wrong, why cystoscopy was done when a simple urine test would have sufficed.
I am not sure how the money flows in the US but cutting down on cystoscopies is going to decrease revenue for some urologists and hospitals/ clinics. Insurance companies should love CxB but again I donÂ’t know the details of the system.
I believe CxB is now popular in NZ urology practice and it wonÂ’t be far off penetrating primary care here albeit with some restrictions.
I feel confident that my modest PEB holding will grow but being largely ignorant of the economics of this I have no idea of by what factor the increasing numbers of tests will translate into profits. There will be others out there who may be able to comment on thatÂ…Â…Â…

Yip, guidelines move soooooo slow, when I first looked at this guideline, cxbladder had half a page on information. 5 years on we have 7 pages of information. At least it allows coverage in certain cases.

https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.evicore.com/-/media/Files/eviCore/Clinical-Guidelines/Highmark_Lab_Manamement_Guidelines_V212021_Eff0801 2021_Pub051421.pdf&ved=2ahUKEwiQhMvWueLxAhVXHnAKHRjkAmUQFnoECAgQAQ&usg=AOvVaw2pe_O9SiUKgyehz5aAvlae

[thegreatestben]

PACIFIC EDGE REPORTS CONTINUED GROWTH MOMENTUM INTO Q1 FY22
PACIFIC EDGE’S Q1 FY22 Update
Cancer diagnostics company, Pacific Edge Limited (NZX: PEB) has reported a continuation of the positive growth momentum seen in the second half of the prior financial year, with sales of its Cxbladder tests continuing their strong growth.
The company, which is holding its Annual Meeting in Dunedin today, has delivered a record quarter in both test throughput and cash receipts for the three months from 1 April to 30 June 2021.
Laboratory throughput has risen consistently over the last five quarters
 179% on the same time last year
 109% increase on the preceding quarter (Q4 FY21)
Cash Receipts from Customers also continue to grow as reimbursement success and volumes grow.
 242% on the same time last year
 121% increase on the preceding quarter (Q4 FY21)
Growth Outlook
Pacific Edge has a positive growth outlook, with opportunities being addressed in each of its key markets. The priorities going forward are to firstly encourage commercial use of Cxbladder by large scale institutional healthcare organisations in each market; and secondly, to encourage customers to include multiple products from the Cxbladder suite of tests in their standard of care and mainstream commercial use.
The US remains the primary focus, with an annual addressable market of US$3.5 billion . With the Company’s recent commercial milestones achieved in reimbursement for tests, Pacific Edge has scaled up its sales team and resources in the US. An increasing number of commercial tests from the CMS, Kaiser Permanente and other scale payers such as United Healthcare are expected to underpin revenue and operating cashflow growth in FY22 and beyond. The company notes that the impact of the Covid-19 pandemic is still being felt, particularly restricted access to clinics and urologists for Pacific Edge’s sales team.
The focus in New Zealand is expanding the coverage by New Zealand’s public healthcare providers and continuing the evolution towards mainstream commercial use of more than one Cxbladder product. Australia and South East Asia are at an earlier stage in their commercial journey, with the goal being to transition the large scale public healthcare providers from clinical trials to a commercial customer model.
CEO David Darling said: “Our recent progress and commercial achievements over FY21 underpin our future growth. We are now seeing the commercial benefits of our efforts and the resources that have gone into the development and commercialisation of our Cxbladder technology, rolling into the company’s performance in the first quarter of FY22.”
ENDS

[Leftfield]

Great news for holders.

Laboratory throughput has risen consistently over the last five quarters
§ 179% on the same time last year
§ 109% increase on the preceding quarter (Q4 FY21)
Cash Receipts from Customers also continue to grow as reimbursement success and volumes grow.
§ 242% on the same time last year
§ 121% increase on the preceding quarter (Q4 FY21)

[Snow Leopard]

Easier to read the ann via the NZX website (https://www.nzx.com/announcements/376408).

Specially good that cash receipts are well-up.

[pierre]

The good news journey continues.

We're not on a bullet train, but I think we're no longer on a roller coaster with PEB.

[winner69]

Great news for holders.

Laboratory throughput has risen consistently over the last five quarters
§ 179% on the same time last year
§ 109% increase on the preceding quarter (Q4 FY21)
Cash Receipts from Customers also continue to grow as reimbursement success and volumes grow.
§ 242% on the same time last year
§ 121% increase on the preceding quarter (Q4 FY21)




$100m sales before we know it ;)

[Maxtrade]

Wonder why there is still a relatively large sell volume sitting around 1.25. If only those sellers would just remove or increase their sell price then the share price could continue on its merry way. Seems this block there is prevent the natural progression of the SP rallying. Let the good news take course.

Take a break sellers and let the bull run :)

[Leftfield]

$100m sales before we know it ;)

Passed the 'point of inflection' maybe?

[Snow Leopard]

Easier to read the ann via the NZX website (https://www.nzx.com/announcements/376408).

Specially good that cash receipts are well-up.

Amended notice (https://www.nzx.com/announcements/376409)

Not so well-up then ;). Cancel that reversing truck.

[Leftfield]

Wonder why there is still a relatively large sell volume sitting around 1.25. If only those sellers would just remove or increase their sell price then the share price could continue on its merry way. Seems this block there is prevent the natural progression of the SP rallying. Let the good news take course.
Take a break sellers and let the bull run :)

Some big blocks being removed, only a matter of time before it gets to 1.30. Many will be watching/attending the ASM later today before they commit, so tomorrow will be interesting.

[Leftfield]

Attended online meeting today. Some points in the Q & A's not covered in released info.

- No NASDAQ listing anticipated currently though constantly under review
- Recovery of old invoice payments not anticipated in budgets and any recovery will be 'cream'. More impt to concentrate on developing ongoing supply relationship.
- No Dividend likelihood in short term.
- Singapore study of 400 patients complete. Likely to be published in next 6 months.
- How strong is IP? Extensive patent portfolio and expenditure on IP is biggest area of expense after wages and patient studies. In addition they claim to have numerous trade secrets "which we don't dare to put into patents."
- USA Lab's current test availability is 260,000 tests pa this at $US760 per test = potential revenue of $US 197 mill.
- Australia hospitals progress is slow. Studies underway.

Above my interpretation only. DYOR.

[Greekwatchdog]

Thanks Left Field for passing on what you picked up from ASM. Nice start to financial year.

[pierre]

Thanks LF

I like the comment about recovery of old invoices. In my experience, chasing the past is generally an expensive and often fruitless exercise that takes one's eye off present and future opportunities.

As I mentioned earlier we are not on a bullet train with PEB but the track ahead looks pretty clear and there is no reason not to expect most, if not all future announcements to be in the good or great category.

When that USA lab is operating at full capacity the news will be better than great - sensational comes to mind.

[Arthur]

The new study soon to be published soon looks interesting. If they get in the guidelines all bets are off. Who wants to be the urologist not using the test if it's in the guidelines?

[Retired Doc]

The new study soon to be published soon looks interesting. If they get in the guidelines all bets are off. Who wants to be the urologist not using the test if it's in the guidelines?
.. or their patients..

[Minerbarejet]

Would I be wrong in assuming that we are to get quarterly updates from here on?

Would be nice after the paucity of information over the years relative to tests and uptake.

Now it seems to be getting some traction it will make for much more in depth projections.

5300 tests in the 1/4 just gone bodes well for a possible 2 "tens of thousands" of tests.

Couple of years late but never mind.:rolleyes:

[Leftfield]

Certainly a lot for the new CEO to get his/her teeth into. Paucity of reporting just one.

IMO the change of a CEO is the biggest short term risk ahead for us holders. The ASM was told that a Melbourne head hunting firm are busy looking. I guess that's better than a Dunedin head hunting firm?

Another take from the ASM I forgot to mention was quiet confidence that NZ's proposed changes to a 'national' DHB with 'national standards' will be good for PEB. Seems some DHB's like Otago/Southland just too busy with new buildings, delivering Covid inoculations and stopping babies being born in cars while enroute to distant hospitals, to have time to think about PEB.

Anyways.... onwards and upwards. North of 1.30 next week?

[Balance]

Following the instos, lightened my overweight position and sold a few into the spike, thanks to the 'good' news.

[Brain]

I will not be following the instos and sell any of my overweight position. With a $US 3.5 billion addressable market and a low COGS I will sit tight. I find it hard to be pessimistic with this share and I really do not care if my 25% overweight position turns into a 80% overweight position due to share price appreciation in fact I will be very pleased.

[thegreatestben]

PEB is worth being overweight on for me, could be life changing. At worst it looks like a good long term hold, I think it was exactly a year today since I bought in.

[calledone]

PEB is worth being overweight on for me, could be life changing. At worst it looks like a good long term hold, I think it was exactly a year today since I bought in.

Maybe more people will get on this rocket if it slows down to the value range between 1.06 and 1.15

[Leftfield]

I will not be following the instos and sell any of my overweight position. With a $US 3.5 billion addressable market and a low COGS I will sit tight. I find it hard to be pessimistic with this share and I really do not care if my 25% overweight position turns into a 80% overweight position due to share price appreciation in fact I will be very pleased.


PEB is worth being overweight on for me, could be life changing. At worst it looks like a good long term hold, I think it was exactly a year today since I bought in.

For years I was overweight in ATM at 70% (and yes Ben it was life changing.) Now a heap of those realised ATM profits have found their way into PEB making it 26% of my much expanded portfolio and up over 120% on my PEB DCA. Early days. Well done holders. Onwards and upwards. Love these 'small cap' wins.

[davflaws]

For years I was overweight in ATM at 70% (and yes Ben it was life changing.) Now a heap of those realised ATM profits have found their way into PEB making it 26% of my much expanded portfolio and up over 120% on my PEB DCA. Early days. Well done holders. Onwards and upwards. Love these 'small cap' wins.

I haven't either the time or the energy to follow a lot of shares, and I don't trade because I have proved to myself (and my wife) that I am not very good at it.

So my best chance of doing well with small caps is to pick and follow a few "conviction stocks" in their early stages and climb aboard (if I have the $s at the time) as the train pulls out. So far that has worked for me with BLT, PEB, and PLX. It didn't with PRC.

But I haven't got the exit sussed (as ATM proved) - fortunately, for reasons totally unrelated to my judgment about the SP, I halved my ATM at around $12 so bought my DCA down to $7.12, and when those $s were available again, I put them into OCA at 135.

[Leftfield]

So far that has worked for me with BLT, PEB, and PLX. It didn't with PRC.
But I haven't got the exit sussed (as ATM proved) -

FWIW, my take is that it is all about preserving and growing your capital, not so much about picking tops or bottoms.

As ATM climbed I promised myself to sell 2k if/when it reached $20. This more than preserved my original capital by freeloading my original investment.

When a rare death cross occurred in Aug 2020 at around $18.00 I slowly sold most of my holding down to 10% of my portfolio which I still hold.

I find the 30/90 day MA cross for either a death cross (ATM) or golden cross (TLL and PEB) as very useful indicators to buy/sell. (Especially when backed my the MACD indicator.) Look at TLL recently, and PEB back in June 2020 as really useful guides.

12796

12797

12798

[Leftfield]

Another DHB signs up. See it here. (https://www.nzx.com/announcements/376607)

Brent Pownall, VP Commercial and Franchise at Pacific Edge, said: “This agreement furthers the reach of Cxbladder into regional New Zealand, helping physicians with their evaluation of patients who present with haematuria (blood in the urine) at our busy public hospitals. Pacific Edge’s suite of Cxbladder products are now well-placed to extend their coverage under a national clinical pathway as New Zealand’s health system consolidates towards the Maori Health Authority and Health NZ next year.”

Onwards and upwards.

[zs_cecil]

Very good progression. The potential national coverage in NZ will provide more valuable evidence and validation of the product effectiveness.

[850man]

https://www.nzx.com/announcements/376607 Good news and the SP dips 2c... no pleasing some people :confused:

[Minerbarejet]

This was published 2 days ago on docwire news and confirms PEBs announcement.

https://www.docwirenews.com/gu-oncology-now/the-diagnostic-performance-of-cxbladder-resolve-alone-and-in-combination-with-other-cxbladder-tests-in-the-identification-and-priority-evaluation-of-patients-at-risk-for-urothelial-carcinoma/

The confirmation of a 4 fold better outcome than the AUA guidelines has surely swung the door wide open.

[850man]

This was published 2 days ago on docwire news and confirms PEBs announcement.

https://www.docwirenews.com/gu-oncology-now/the-diagnostic-performance-of-cxbladder-resolve-alone-and-in-combination-with-other-cxbladder-tests-in-the-identification-and-priority-evaluation-of-patients-at-risk-for-urothelial-carcinoma/

The confirmation of a 4 fold better outcome than the AUA guidelines has surely swung the door wide open.

That's very good news. Further evidence of the accuracy of CXbladder. PEB moving ahead in leaps and bounds.

[Minerbarejet]

Now we await better definition to be included in the AUA guidelines as one of the options available instead of cystoscopy under certain conditions

If and when that happens there will be an upsurge.

As more and more tests are done by more and more medical entities in various countries then ATM looks like a Sunday school picnic to me.

[Brain]

Now we await better definition to be included in the AUA guidelines as one of the options available instead of cystoscopy under certain conditions

If and when that happens there will be an upsurge.

As more and more tests are done by more and more medical entities in various countries then ATM looks like a Sunday school picnic to me.

Yes I agree with the comparison to ATM. A2 milk probably is not really required by the general population and it’s success will be primarily as a result of effective marketing. I drink the stuff and really wouldn’t know if it is much better for me personally than A1 because it is almost impossible to rule out the Placebo effect.

PEB is a totally different story. Huge market ,low test cost and a genuine need for the tests along with clinical evaluation which continually backs up the accuracy of the tests. A Snowball rolling down a hill comes to mind.

[Getty]

Bulk of trades going through as Special Placements.

Anyone read anything into that?

[Harrie]

I understand that there has been no formal approval for CXbladder by the FDA, despite many years of data and recent AUA findings. Despite this its just a matter of time before two important outcomes come about:

1. Anyone diagnosed with blood in the urine will be going online and reading up on all investigative procedures available. Whats the chances when they read that cxbladder can offer a NPV of around 98% that they will want to discuss that with their urologist wanting to do an invasive cystoscopy?

2. Why would any insurance company be happy to front up with paying out on expensive claims for a cystoscopy when a simple CXbladder urine test would indicate the necessity for it (if any)

When this happens, and it will, watch the SP explode upwards

[Minerbarejet]

https://www.pacificedgedx.com/company/quality-assurance/

Pacific Edge has CLIA approved laboratories.

I dont think the FDA has been involved as PEBs test is neither a food or a drug.
I think the more than adequate approval came through last year from the CMS which is US Govt controlled.

[baaantom]

I Spoke to Dave Darling about FDA last year. They decided early on not to go down that route because 1) FDA approval is for drugs/treatments that are marketed direct to the patient - think what a patient would see in a pharmacy. 2) They market CxBladder at the Uroligist / Clinician level who then recommend the test to the patient, rather than directly to the patient. 3) It is a very expensive process.

[Greekwatchdog]

Another large chunk just brought.

[Leftfield]

Another large chunk just brought.

Crikey..... 2 mill! and very encouraging that it's at prices well north of me.

[Harrie]

I think what I was saying was that while the urologist is generally the one giving advice on investigative procedures, there is a lot more money to be made out of a cystoscopy than a urine test, hence a vested interest in that procedure.
If it were me I would be wanting to find out what is involved in a cystoscopy and whether there were any other procedures that would work just as well. A simple google search would or should bring you to CXbladder where it is relatively easy to see where a genomic test is different to cytology and a cystoscopy. Thats the discussion point with the urologist.
I admit its a longer road to getting urologists to open up other options but word does get around with forums on this topic and its just a matter of time before patients will be demanding it.

[Leftfield]

Another large chunk just brought.

Westpac been selling. See it here. (http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/377179/352088.pdf)

mmm

[850man]

Westpac been selling. See it here. (http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/377179/352088.pdf)

mmm

Might account for the dip in SP despite more postivie news from PEB

[zs_cecil]

I think It is good for the liquidity if these big holders release some shares on the market. Westpac has accumulated a hug amount of shares in the past ten years. ANZ has been accumulating on the market since their first initial investment last year.

[Harrie]

It’s just normal risk adjusted management strategies adopted by most fund managers. Westpac May have felt that their exposure to PEB was above the mandate that they had set themselves proportional to an index they follow eg NZX 50 or managing volatility
Either way I don’t think it’s a lack of faith in PEB’s trajectory. They still hold a significant exposure

[Yottie]

Greetings all and sundry ...
As a long term holder in this corporate, with its fluctuating fortunes over the years, I thought that on the reading of Michael Lewis's latest; "The Premonition" would give a fundamental insight as to the reasons for the various delays / obfuscations etc in obtaining the 'permissions' that are required to succeed in the American health system.
Chapter six - The Red Phone - Page 157 et seq - gives one a good understanding of the tribulations of dealing with the internecine "snakes and ladders" of the health bureaucracy in the USA.
Enjoy.



Disc: Holding 10k @ 26c [ after many ups and downs ]

[850man]

3.2% SP drop today with reasonable volume, wonder why?

[psychic]

Encouraging stuff, use of Monitor during Covid

https://www.auajournals.org/doi/abs/10.1097/JU.0000000000002107.12

[850man]

Encouraging stuff, use of Monitor during Covid

https://www.auajournals.org/doi/abs/10.1097/JU.0000000000002107.12

Non-funded research as well. Very good to see independant promotion of CxB and a highly relevant use case within the AUA

[thegreatestben]

Additional study of patient ease and acceptability is ongoing.

This part of the conclusion touches on earlier discussion, I'd expect to see similar positive sentiments in future publications.

[Minerbarejet]

Encouraging stuff, use of Monitor during Covid

https://www.auajournals.org/doi/abs/10.1097/JU.0000000000002107.12

Thanks very much for finding something useful at last.

Well done.
Cheers
Sundry :)

[psychic]

Thanks very much for finding something useful at last.

Well done.
Cheers
Sundry :)

Ouch
So it's just the good news you want. Got it. :)