PEB - Pacific Edge Ltd

[psychic]

https://scholar.google.co.nz/scholar_url?url=https://www.auajournals.org/doi/abs/10.1097/JU.0000000000003126&hl=en&sa=X&d=13919462877916927177&ei=K4ezY9fkLtKxywSLm5agCA&scisig=AAGBfm2iIcMghxuh10PRcxtISGRYehRlBA&oi=scholaralrt&hist=UBDHjzYAAAAJ:6841515572808951338:AAGBfm2xhyiK CfbrFvwMGSQyqSAiz8G5tQ&html=&pos=0&folt=kw

Singapore study

[whatsup]

Harbour asset Mgt buying more shares , must be a sign of confidence unless they are averaging down !!

[Mel]

Quarterly investment updated has been issued:
https://www.nzx.com/announcements/405516

[850man]

Quarterly investment updated has been issued:
https://www.nzx.com/announcements/405516

Movement in the right direction with test volumes being up 36% on PCP. Substantial improvement in CXB sensitivity with the "enhanced" version appears to be received very well by the urology community and a deadline for the KP EMR system integration of March. Only nasty hanging around is the Novitas LCD.

[Retired Doc]

Harbour asset Mgt buying more shares , must be a sign of confidence unless they are averaging down !!
2.1 m shares traded yesterday. The largest volume of any company that I could see. Any insights/comments?

[pierre]

2.1 m shares traded yesterday. The largest volume of any company that I could see. Any insights/comments?

No insights. Just continuing to hold and wait for the Novitas announcement and the results of the KP system integration.
Success on both counts will have immediate positive impacts on the SP.
Onwards and upwards.

[winner69]

This day 20 years ago PEB listed on the NZX

Jeez 20 years

Well done Pacific Edge

[Sideshow Bob]

This day 20 years ago PEB listed on the NZX

Jeez 20 years

Well done Pacific Edge

https://www.rnz.co.nz/news/business/483945/bladder-cancer-firm-pacific-edge-celebrates-20-years-of-growth-despite-no-profit?utm_source=ST&utm_medium=email&utm_campaign=ShareTrader+AM+Update+for+Friday+10+F ebruary+2023

The bladder cancer diagnostic firm Pacific Edge is celebrating 20 years since it listed on the NZX, growing significantly over that time without ever making a bottom-line net profit.

[winner69]

https://www.rnz.co.nz/news/business/483945/bladder-cancer-firm-pacific-edge-celebrates-20-years-of-growth-despite-no-profit?utm_source=ST&utm_medium=email&utm_campaign=ShareTrader+AM+Update+for+Friday+10+F ebruary+2023

The bladder cancer diagnostic firm Pacific Edge is celebrating 20 years since it listed on the NZX, growing significantly over that time without ever making a bottom-line net profit.

and the important bit -

Chief executive Peter Meintjes said the NZX listing had helped the company raise growth capital over the past couple of decades, which has been key to its success.

[Balance]

and the important bit -

Chief executive Peter Meintjes said the NZX listing had helped the company raise growth capital over the past couple of decades, which has been key to its success.

But not so successful for the shareholders who eagerly jumped on the bandwagon and parted with ever more money in PEB's upsized CR ($1.35 price) in 202.

Never mind, all in a good cause.

Has DD sold out of his shareholding yet?

[winner69]

From the announcement and media reports you get the impression that PEB never intend to ‘make a profit’ …just grow.

Not surprising really as David Darling’s definition of ‘commercialisation’ was just getting somebody to pay a test and profit was never part of his vocabulary

Things ain’t changed

Maybe one day some greater fool will acquire them for 2 billion plus

[psychic]

This study on CxBladder Monitor just published seems very encouraging. Surprised PE hasn't mentioned it.
https://scholar.google.co.nz/scholar_url?url=https://www.sciencedirect.com/science/article/pii/S1078143923000091&hl=en&sa=X&d=17559916666977190339&ei=_t4CZLb3B5n0yAT_xK_ADg&scisig=AAGBfm1vH5G8khV2tS3CcP9pbFaeeprfVQ&oi=scholaralrt&hist=UBDHjzYAAAAJ:6841515572808951338:AAGBfm2xhyiK CfbrFvwMGSQyqSAiz8G5tQ&html=&pos=0&folt=kw

[whatsup]

Ann out today PEB to showcase Biomarkers in the U S march 18 , but as yet this notice is not released to the market , why ?

[850man]

Ann out today PEB to showcase Biomarkers in the U S march 18 , but as yet this notice is not released to the market , why ?

In their comms they say "PEB has not released the information contained in this release to the NZX or ASX as it does not regard it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act."

I would have thought it market worthy news myself

[winner69]

In their comms they say "PEB has not released the information contained in this release to the NZX or ASX as it does not regard it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act."

I would have thought it market worthy news myself

Market worthy maybe but not material, ie not going to do much for PEB underlying performance.

David might have a spun a story around it ….like next week he would have começou saying -

Taking the podium, Pacific Edge hosted a symposium on the current and future use of molecular biomarkers in the dectection and surveillance of non-muscle invasive bladder cancer (NMIBC) blah blah. This was one of the biggest gatherings of oncologists held in the USA blah blah. Attendees were impressed with what they saw and heard and many promising leads were obtained blah blah.

[winner69]

Pumping out good news after good news these days

Study Adds Support for Cxbladder Monitor Use in Cancer Surveillanceg

The independent study2 is to be published in the prestigious journal Urologic Oncology and was undertaken at the University of California San Francisco (UCSF) and the University of Michigan. It examined whether a negative Cxbladder Monitor test could safely postpone a patient’s next scheduled cystoscopy, the current ‘gold standard’ for bladder cancer surveillance.

[850man]

Pumping out good news after good news these days

Study Adds Support for Cxbladder Monitor Use in Cancer Surveillanceg

The independent study2 is to be published in the prestigious journal Urologic Oncology and was undertaken at the University of California San Francisco (UCSF) and the University of Michigan. It examined whether a negative Cxbladder Monitor test could safely postpone a patient’s next scheduled cystoscopy, the current ‘gold standard’ for bladder cancer surveillance.

Yeah odd that they don't publicise to the market, reinforces the improving efficacy of CXB

[zs_cecil]

Pumping out good news after good news these days

Study Adds Support for Cxbladder Monitor Use in Cancer Surveillanceg

The independent study2 is to be published in the prestigious journal Urologic Oncology and was undertaken at the University of California San Francisco (UCSF) and the University of Michigan. It examined whether a negative Cxbladder Monitor test could safely postpone a patient’s next scheduled cystoscopy, the current ‘gold standard’ for bladder cancer surveillance.

This was the same one mentioned by psychic last week. Every piece of good news is a solid step closer to massive adoption. :t_up:

[Mel]

Update on Kaiser EMR integration - any +ve news is welcome in this market!!
https://www.nzx.com/announcements/409266

[850man]

Update on Kaiser EMR integration - any +ve news is welcome in this market!!
https://www.nzx.com/announcements/409266

Good to see this update from PEB following up their earlier update that the integration was on track to be completed by end of March. Delivering what they said they would do.

[winner69]

Good to see this update from PEB following up their earlier update that the integration was on track to be completed by end of March. Delivering what they said they would do.

Depends on what you define 'delivery' as .... seems a bit more work to be done yet

[Balance]

Depends on what you define 'delivery' as .... seems a bit more work to be done yet

Totally irrelevant to the future of PEB - what's happening with the LCD coverage?

[Greekwatchdog]

Totally irrelevant to the future of PEB - what's happening with the LCD coverage?

For Bar put an Analysis on this today. The longer it takes is better for PEB. Short version.

It has been 206 days since Pacific Edge's (PEB) Local Coverage Determination (LCD) comment period ended. We have undertaken thorough analysis of every proposed LCD since 1 January 2010. In this time there have been 2,013 unique proposed LCDs. Of these 84% have been finalised (unfavourable for PEB). Despite this evidence, our analysis shows that as time passes the odds tilt in PEB's favour. Of LCD decisions over 200 days, the odds of finalisation reduce dramatically with only 55% finalised (versus 92% for those under 200 days). We retain our NEUTRAL rating. Our analysis shows (1) the odds are evenly split at this point in the process, and (2) the stock price broadly reflects the current balance of probabilities. It is a binary outcome and we expect the stock price to remain range bound until we get increased clarity.

Most LCDs are finalised but as time passes the odds tilt in PEB's favour
On 1 August 2022, PEB confirmed notification of Cxbladder codes in a proposal for a different approach to determine which cancer biomarker tests are eligible for reimbursement. If finalised, PEB will no longer receive reimbursement payments for its CMS tests (~80% of FY23 sales). Novitas must finalise or reject the draft LCD within a year of the announcement date (28 July 2022).
In the 206 days since PEB's comment period ended we have learnt very little about whether the proposal will go ahead or not. We have undertaken a thorough exercise by analysing all 2,013 unique LCDs that have occurred since 2010 to understand (1) the finalisation rate of proposed LCDs, and (2) the decision timeframes. We acknowledge this analysis isn't perfect given the nuanced nature of each LCD, and PEB is of the view the proposal won't go ahead, but history is ultimately our most useful indicator.


Decision outcome — the majority of LCDs are finalised: 84% of LCDs have been finalised, 13% rejected and 3% are still pending.
​​​​​​​Decision timeframes — finalised LCDs are much shorter than rejected LCDs: Of all finalised LCDs, the median time to decision is 69 days. Of all rejected LCDs, the median time to decision is 182 days. By Bayesian inference, the probability reduces dramatically for those decisions that occur after 200 days — 55% finalisation rate for those over 200 days versus 92% for those under 200 days.


Breaking it down — Novitas, molecular diagnostics and National Comprehensive Cancer Network (NCCN)
To further add to our analysis we have specifically filtered for LCDs related to Novitas, molecular diagnostics, and NCCN references.


Novitas appears more stringent relative to other contractors: 93% of its LCDs have been finalised.
​​​​​​​Molecular diagnostics: 74% have been finalised. Median finalisation time of 119 days and median rejection time of 221 days.
NCCN: 296 LCDs had some reference to NCCN, only PEB's current proposal specifically uses guidelines as a coverage criteria.

[t.rexjr]

For Bar put an Analysis on this today. The longer it takes is better for PEB. Short version.

It has been 206 days since Pacific Edge's (PEB) Local Coverage Determination (LCD) comment period ended. We have undertaken thorough analysis of every proposed LCD since 1 January 2010. In this time there have been 2,013 unique proposed LCDs. Of these 84% have been finalised (unfavourable for PEB). Despite this evidence, our analysis shows that as time passes the odds tilt in PEB's favour. Of LCD decisions over 200 days, the odds of finalisation reduce dramatically with only 55% finalised (versus 92% for those under 200 days). We retain our NEUTRAL rating. Our analysis shows (1) the odds are evenly split at this point in the process, and (2) the stock price broadly reflects the current balance of probabilities. It is a binary outcome and we expect the stock price to remain range bound until we get increased clarity.

Most LCDs are finalised but as time passes the odds tilt in PEB's favour
On 1 August 2022, PEB confirmed notification of Cxbladder codes in a proposal for a different approach to determine which cancer biomarker tests are eligible for reimbursement. If finalised, PEB will no longer receive reimbursement payments for its CMS tests (~80% of FY23 sales). Novitas must finalise or reject the draft LCD within a year of the announcement date (28 July 2022).
In the 206 days since PEB's comment period ended we have learnt very little about whether the proposal will go ahead or not. We have undertaken a thorough exercise by analysing all 2,013 unique LCDs that have occurred since 2010 to understand (1) the finalisation rate of proposed LCDs, and (2) the decision timeframes. We acknowledge this analysis isn't perfect given the nuanced nature of each LCD, and PEB is of the view the proposal won't go ahead, but history is ultimately our most useful indicator.


Decision outcome — the majority of LCDs are finalised: 84% of LCDs have been finalised, 13% rejected and 3% are still pending.
​​​​​​​Decision timeframes — finalised LCDs are much shorter than rejected LCDs: Of all finalised LCDs, the median time to decision is 69 days. Of all rejected LCDs, the median time to decision is 182 days. By Bayesian inference, the probability reduces dramatically for those decisions that occur after 200 days — 55% finalisation rate for those over 200 days versus 92% for those under 200 days.


Breaking it down — Novitas, molecular diagnostics and National Comprehensive Cancer Network (NCCN)
To further add to our analysis we have specifically filtered for LCDs related to Novitas, molecular diagnostics, and NCCN references.


Novitas appears more stringent relative to other contractors: 93% of its LCDs have been finalised.
​​​​​​​Molecular diagnostics: 74% have been finalised. Median finalisation time of 119 days and median rejection time of 221 days.
NCCN: 296 LCDs had some reference to NCCN, only PEB's current proposal specifically uses guidelines as a coverage criteria.






If I'm understanding: Rejection refers to rejecting the inclusion in the draft of non inclusions. So rejection means inclusion of coverage and is a positive rather than the more oft negative inferance of the term 'rejection'.

45% positive rejection still feels like gambling with ods favouring the bookie

[Balance]

If I'm understanding: Rejection refers to rejecting the inclusion in the draft of non inclusions. So rejection means inclusion of coverage and is a positive rather than the more oft negative inferance of the term 'rejection'.

45% positive rejection still feels like gambling with ods favouring the bookie

Of these 84% have been finalised (unfavourable for PEB).

RUN!

[t.rexjr]

Of these 84% have been finalised (unfavourable for PEB).

RUN!

With only 3% of decisions to be made it seems a little mad (bonkers even) to even apply an 'odds' formula to their annalysis. Throwing darts at flies

[t.rexjr]

With only 3% of decisions to be made it seems a little mad (bonkers even) to even apply an 'odds' formula to their annalysis. Throwing darts at flies

In fact given Novatis has a 93% finalisation record you'd have to assume odds on that they're gone

[Ggcc]

Of these 84% have been finalised (unfavourable for PEB).

RUN!
I agree. I was lucky to get out sooner at and average of roughly 80 cents

[winner69]

You can’t beat Bayesian influences to give a likely result

[whatsup]

Interesting close today up .02, are we expecting anything special ?

[Cabinet]

Interesting close today up .02, are we expecting anything special ?

I have been expecting something special for ages. I live in hope.

[jonu]

I have been expecting something special for ages. I live in hope.

It's the hope that kills yer. (Overheard from a Wallabies supporter)

[Greekwatchdog]

Interesting close today up .02, are we expecting anything special ?

Nothing announced, however we are due for a 4th Quarter Update or Update on confirmation Novitas announcement in regards to payment. Or any more news on adoption would also be welcome. So we wait.....

[whatsup]

Off the bottom ( for now ) after a 18 month slide @ .47 > +17% in a week, not too shabby imo.

[Mel]

ANZ have increased their stake in PEB from 6.2% to 7.2% - hoping this an optimistic signal and they're not simply averaging down:
https://www.nzx.com/announcements/410011

[whatsup]

ANZ have increased their stake in PEB from 6.2% to 7.2% - hoping this an optimistic signal and they're not simply averaging down:
https://www.nzx.com/announcements/410011

Actually the ANZ entity now has a 14.5 % shareholding .

[Mel]

Actually the ANZ entity now has a 14.5 % shareholding .
Re-reading the notice, I have to say I'm confused as it appears be a 9.43% aggregate holding on a second read. Having said this, you might be correct whatsup as it's not clear to me!

[winner69]

Last time theyhad a SSH the share price was in the 120's

Even so I suppose they still ahead or is just a trading thing for them and hoping they don't lose in the process

[winner69]

New record

That's good

[Balance]

New record

That's good

And stillno news on the single most important determinant of PEB's future - LCD coverage.

`

[whatsup]

This continued growth is great news but how is it reported on the balance sheet ?

[Greekwatchdog]

This continued growth is great news but how is it reported on the balance sheet ?


You will have to wait until next month to get those details at FY results.

[Sideshow Bob]

Hardly anything to get too excited by. Obviously different strategy to old DD. To me, PEB has to "show me the money".

But I do like how they have the headline "Standing Room only at CXBladder Symposium" and then the photo shows everyone sitting.....:laugh:

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/410042/392733.pdf

[winner69]

Good piece by Tim hunter in NBR today

Paywalled so won’t post a link but if not a subscriber worth the effort going to the library or somewhere to access.

Market view of Pacific Edge still rose-tinted

Part I found interesting is that he reckons revenues in 2030 could be $200m ….but could still be losing money

[Sideshow Bob]

Results 25th of May.

https://www.nzx.com/announcements/410674

Will this year be 21 or 22 years without making a profit?? :mellow:

[winner69]

Results 25th of May.

https://www.nzx.com/announcements/410674

Will this year be 21 or 22 years without making a profit?? :mellow:


You mean how much they will add to the $200m of accumulated losses

I was a bit worried about Forbar saying they’ll still be losing money in 2025 even if revenues grow at 40% pa

No worries, it’ll all fall into place one day

[Retired Doc]

No worries, it’ll all fall into place one day[/QUOTE]

Hmmmmm …. as an Aussie might say “It’s a bit like leaving the porch light on for Harold Holt”.

[Sideshow Bob]

https://www.nzx.com/announcements/412015

PACIFIC EDGE DELIVERS ON GROWTH STRATEGY IN FY 2023

FINANCIAL AND PERFORMANCE HIGHLIGHTS:

• Annual operating revenue increases 71% to $19.6 million; total revenue increases 88% to $26.1 million lifted by a 39% rise in commercial test volumes and favorable currency movements.

• Total laboratory throughput (TLT) of Cxbladder tests increases 37% to 31,565 tests, commercial tests increase 39% to 26,691 tests; US ordering clinicians grow 46% to 1,150 at the end of Q4 23

• Net loss after tax increases to $27.0 million from $19.8 million, reflecting a 58% increase in operating expenses to $53.1 million as the company invested to drive growth.

• Pacific Edge is well funded; cash and cash equivalents and short-term deposits at $77.8 million from $93.5 million at the end of September 2022 and $105.4 million at the end of March 2022

STRATEGIC HIGHLIGHTS:

• Diversified commercial roles, creating specialized sales roles and increasing headcount across commercial teams; updated sales process to meet the needs of different customer types; scaling largely complete for announced strategic initiatives

• Established medical education program; scientific and medical communications to support sales and marketing efforts; reconfigured the clinical evidence generation program within the analytical validity (AV), clinical validity (CV) and clinical utility (CU) framework to focus on retaining coverage and inclusion in guidelines

• New product enhanced with DNA biomarkers, Cxbladder Detect+, developed as a single product for hematuria evaluation

• FY 24 focus on execution – growth catalysts include clarity on Medicare coverage, the ‘go-live’ of the Kaiser Permanente Electronic Medical Records (EMR) integration and the maturation of the new sales force

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today announces financial and operational results for the year to 31 March 2023 and reports a year of delivery on its strategic goals.

Through FY 23 Pacific Edge has advanced initiatives to drive the adoption and more frequent use by clinicians of Cxbladder, the company’s suite of advanced genomic tests, and generate clinical evidence to support Cxbladder coverage and the inclusion of the tests in global standards of care.

Operating revenue, the income generated from Cxbladder test sales, increased 71% to $19.6 million from $11.4 million in the prior financial year. Revenue growth followed a 39% increase in commercial tests to 26,691 from 19,196 tests in the prior year, with US commercial test numbers growing 46% to 23,072 from 15,752 for FY 22. Favorable exchange rate movements also positively impacted FY 23 operating revenue. Without this favorable movement, operating revenue increased 55% on FY 22.

As reported in Pacific Edge’s Q4 shareholder update in April, total test volumes for FY 23 rose to 31,565, a 37% increase on the 23,086 tests processed in FY 22. Total revenue, which includes government grants and other income, increased 88% to $26.1 million from $13.9 million in the prior financial year assisted by higher interest income, up $2.2 million to $2.8 million and foreign exchange gains, up $2.1 million to $2.3 million.

The net loss after tax increased to $27.0 million, from $19.7 million in the prior year. This result followed a 58% increase in net operating expenses to $53.1 million from $33.7 million in the prior year as the company invested in growth, particularly in the US market. While exchange rate movements have increased reported revenue from the US, expenses in the US were also increased due to these movements. Removing the impact of the exchange rate movements, underlying operating expenses increased 47%.

These increased expenses reflected the expansion of the company’s global team including direct sales, marketing and sales support teams and the introduction of new Medical Affairs and Market access capabilities to the business. Investment in people accounted for 52% of operating expense growth. The company has now largely completed scaling for its next phase of growth.

Pacific Edge retains a strong balance sheet with cash, cash equivalents and short-term deposits at 31 March 2023 of $77.8 million, compared to $93.5 million at the end of September 2022 and $105.4 million at the end of March 2022.

Chairman Chris Gallaher said: “Pacific Edge has successfully executed on the strategic priorities we outlined to investors a year ago to drive the adoption of Cxbladder and to work towards the entrenchment of our tests as a global standard of care for bladder cancer.

“Our efforts have been rewarded with a strong increase in commercial test volumes in the US, our most important market; increased Cxbladder adoption by US clinicians and a significant improvement in operating revenues. Following the introduction of new capabilities and the building of the team to the point that we are able to deliver on the next phase of growth, Pacific Edge is well positioned to accelerate this momentum in the current financial year.

“Our successes have been tempered by the ongoing lack of clarity over Cxbladder’s continued coverage by Medicare. While unlikely, an unfavorable final version of the LCD has the potential to significantly reduce revenue from patients with Medicare and Medicare Advantage insurance plans. Still, with cash reserves of $77.8 million we are well positioned to execute on the significant opportunities we see, whatever the Medicare outcome,” Mr Gallaher said.

Chief Executive Dr Peter Meintjes said the 2023 financial year had been one of enormous change and achievement for the company.

“I am immensely proud of what we have achieved over my first full financial year leading Pacific Edge. The team has embraced change and the new approaches we are taking to drive the commercial success of the company in the US, our most significant market, and around the world.

“We have scaled the global team to execute on the immediate opportunities with new hires in direct sales, marketing, and sales support. We have brought in new capabilities, including the recruitment of a Medical Affairs team, which is tasked with engaging the urological opinion leaders that exert significant influence over the adoption of Cxbladder tests by healthcare providers and payors. The team is also at the heart of our strategy to embed Cxbladder in global standards of care, notably playing a key role in the design and execution of the clinical evidence program that is foundational to that goal.

“We have enhanced our Market Access capability to drive coverage and reimbursement by national healthcare providers and build resilience into our business in the face of complex healthcare regulatory and funding systems in all the markets where we operate. We have also stepped up our business development capabilities in APAC and introduced a variety of roles in digital technologies and innovation to support the company’s strategic growth plans.

“We have gained coding and coverage for Cxbladder Triage. We have developed Cxbladder Detect+, a new test enhanced with DNA biomarkers that we are now advancing as a single product for hematuria evaluation. Cxbladder Detect+ delivers performance superior to our existing Triage and Detect tests and is well positioned to change the standard of care.

“Pacific Edge is geared for growth. While the draft LCD from Novitas has created some uncertainty, Cxbladder remains a covered test by Medicare, and we have observed little impact on demand for Cxbladder from customers.

“Supported, however, by the advice and feedback we have received from our legal advisors, industry, academics and clinicians and following numerous representations to Novitas, we remain optimistic that Cxbladder will retain coverage,” Dr Meintjes said.
“We are looking forward to the deadline on July 28 when Novitas must either finalize or withdraw the proposed Local Coverage Determination (DL 39365) and the associated Local Coverage Article (DA 59125) that cast Cxbladder’s continued Medicare coverage into doubt.”

ADOPTION RETENTION AND REVENUE GENERATION

Our US business is making steady progress. US Total Lab Throughput (TLT) for the year was up 44% to 27,217 from 18,864 tests in FY 22. Commercial tests increased 46% to 23,072 from 15,752 in the prior year.

We are already seeing the benefits of expanding the direct sales force and creating differentiated commercial roles to meet the needs of different customer types. We now have dedicated teams for national accounts, regional sales, virtual sales and market access.

The Medical Affairs team has changed the narrative on biomarker utility in bladder cancer detection and patient surveillance, driving increased engagement with key opinion leaders, department heads and the chairs at leading institutions, or owners and partners at private practices.

The team is also driving clinical behavior change. This is most evident at Kaiser Permanente, our largest US customer with an estimated 12.5 million members covered by its health plan. Pacific Edge is a valued innovation partner for Kaiser Permanente, underpinned by our shared desire to reduce unnecessary cystoscopies during hematuria evaluation and surveillance.

Adoption within Kaiser is growing steadily. Two of its clinics were in the top 20 Pacific Edge accounts by volume in the last quarter. A catalyst of further acceleration in growth will be the ‘go-live’ of Cxbladder’s integration with Kaiser’s EMR system. We have completed the software development and integration testing on the project and are now focussed on completing the required administrative and review processes.

Our New Zealand business has delivered a steady performance. Our tests are available to more than 75% of New Zealand’s population, but there remains an opportunity to drive the utility to primary care, to increase adoption for hematuria evaluation among surveillance users and increase adoption for surveillance among hematuria evaluation users.

Over the last year we added contracts with Te Whatu Ora Health New Zealand Southern District and expanded coverage in Tairawhiti on the East Coast of New Zealand. The most significant catalyst in the New Zealand market is an opportunity to expand access through a national contract with Te Whatu Ora.

The rest of the APAC market is in the early stages of development. We recently appointed a President APAC charged with building on the company’s presence in Australasia in the broader APAC region. APAC TLT for the year rose 3% to 4,348 from 4,222 tests in FY 22. Commercial tests increased 5% to 3,619 from 3,444 in the prior year.

Our strategic focus across both regions for the year ahead remains the same, although we are embarking on a new range of digitalization and performance excellence initiatives to improve the effectiveness and efficiency of our operations.

EVIDENCE COVERAGE AND GUIDELINES

We reviewed and reconfigured our evidence generation program. Our aim is to ensure it achieves our goals of assisting the clinical adoption of Cxbladder and the inclusion of the tests in global standards of care. Clinical evidence is also at the heart of our goals to foster trusted relationships with key urologic opinion leaders and enhance the scientific credibility of the Cxbladder brand.

Our focus is on generating data to demonstrate the analytical and clinical validity and ultimately the clinical utility of Cxbladder, including the new product Cxbladder Detect+. We have six key studies underway directed towards these goals and have accelerated enrolment and site monitoring to drive the studies more rapidly towards completion.

In the closing months of the financial year, we were pleased to gain Medicare coverage for Cxbladder Triage. This followed the test’s inclusion in the Local Coverage Article (LCA 58917) that Pacific Edge currently relies upon for Medicare coverage of all our tests in the US.

As signalled in April, we expect the development to lead to modest increases in rates of payment from Medicare and Medicare Advantage payors for Triage. We also see coding and listing in LCA 58917 as a faster tangible path for Cxbladder Detect+ to gain coverage, should the current approach to reimbursement of our tests in the US continue.

Finally, we are now working to supplement our evidence generation program with investigator-initiated trials and the establishment of a Cxbladder registry, where clinicians can record a wide range of patient data, including follow up and outcomes. The registry, as it grows, becomes a multi-site, real-world evidence clinical trial. While clinical utility trials are the gold standard for guidelines inclusion, and we expect many private payors to cover Cxbladder after inclusion in guidelines, real-world evidence is frequently required by many private payors to drive medical policy and subsequent contracting.

RESEARCH AND INNOVATION

The key success of our innovation team in FY 23 was the publication of evidence supporting the analytical validity of Cxbladder Detect+ in the prestigious Journal of Urology, which demonstrated significant improvements in test performance. A key focus in the coming year will be to investigate the potential for a Monitor+ product for surveillance based on similar DNA SNPs. Our R&D team continue to evaluate product concepts to address unmet clinical needs in urology diagnostics, for example, our MONSTER study is aimed at identifying additional markers of residual disease in surveillance patients.

OUTLOOK

Pacific Edge is building on the steady growth we have achieved in FY 23. We continue to invest prudently to improve the effectiveness and efficiency of the team we now have in place, Dr Meintjes said. “The lack of clarity over continued Medicare coverage continues to represent a headwind for the company, but we remain confident and optimistic about our outlook. We have world-leading technology, a strong balance sheet and we are building momentum in the US and establishing footholds in new markets.

“We also see the potential for several catalysts to drive our success in the coming year, including a positive Medicare determination, the ‘go live’ of the Kaiser EMR integration, the growing maturity of our sales force and, locally, a national contract with Te Whatu Ora. Longer-term we are looking to the publication of clinical utility evidence from our studies and those conducted independently of Pacific Edge,” Dr Meintjes said.

“The entire Pacific Edge team is working hard to bring all of these catalysts to fruition, and we look forward to providing an update to our shareholders at our annual meeting in Auckland at the end of July.”


Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.

[winner69]

Good to see PEB ‘delivering on growth strategy’

They’ve grown their accumulated losses to $217m

Is this years $27m loss a record year ….must be or close to it

[Sideshow Bob]

Good to see PEB ‘delivering on growth strategy’

They’ve grown their accumulated losses to $217m

Is this years $27m loss a record year ….must be or close to it

Nothing financial in the outlook - just that they've got plenty of cash to burn for the next few years!! :scared:

[winner69]

Does this mean we’ll know one way or the other re Novitas

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/412459/395789.pdf

[Greekwatchdog]

Does this mean we’ll know one way or the other re Novitas

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/412459/395789.pdf

Looks like it. Could be a nervous week, I wonder if the TAB will open the books. My money is on there will be no change.

[Mel]

Does this mean we’ll know one way or the other re Novitas

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/412459/395789.pdf
Good to know the definitive date, no news will be excellent news in this instance - nervous week ahead for shareholders!

[winner69]

Rereading these announcements I get the impression that PEB don’t have a handle on this at all ..maybe no even knowing what they are doing

But then I just might be thick as

[Retired Doc]

Yes ambiguous “clarification “. June 9 deadline but the statement says Novitas not required to make an announcement. Jungle drums…….?

[Mel]

Rereading these announcements I get the impression that PEB don’t have a handle on this at all ..maybe no even knowing what they are doing

But then I just might be thick as
No I agree, given the materiality of this announcement - if I was in their shoes, I would have sought absolute clarity on the communication framework (including the deadline) well ahead of this junction.

[psychic]

Yup, don't know where they get this 1 year limit thing but to be sure, this "draft article" has significant implications for many and so it's not like Novitas are sitting there thinking about cxbladder at all. It is more about how such tests will be approved in future, and the increased reliance of the likes of NCCN etc for evidence.

Remembering that Cxbladder does not have the endorsement of the AUA or NCCN it's hard to understand how this holding pattern won't be a thing for Pacific Edge for some time yet while the can gets kicked down the road. Probably not a bad thing for now..

[winner69]

So I was rather thick not understanding what announcement meant

Share price up 14% …must have been good news

[Habits]

So I was rather thick not understanding what announcement meant

Share price up 14% …must have been good news

Volumes up a lot, Vote of confidence
Price be back down on Monday, but then I'm often wrong.

[clip]

Volumes up a lot, Vote of confidence
Price be back down on Monday, but then I'm often wrong.


I'll bet you $1000 the price at the end of monday, will be the same as the price at the end of today

[Habits]

I'll bet you $1000 the price at the end of monday, will be the same as the price at the end of today

Not sure its allowed, but it would be worth it just to see a price that keeps me out of the red

[clip]

Not sure its allowed, but it would be worth it just to see a price that keeps me out of the red

Monday is a public holiday so market will be closed ;)

[Habits]

Monday is a public holiday so market will be closed ;)

Didn't know that.... self employed. Kings Bday

[psychic]

Well we know you are not thick W69, the market however, has been duped many times on PE announcements and yep, I say totally misunderstood the situation here again

[Harrie]

Well we know you are not thick W69, the market however, has been duped many times on PE announcements and yep, I say totally misunderstood the situation here again

I suppose we should have expected that management should have least known when the finalization process needed to be made.
By the same token I don't think that we could expect that they insistently rattle Novitas into providing updates about their decision making process.
Management provide as much info as they can to ensure that they get a favourable outcome. Thats all you can expect them to do, so I am not that phased that they did not get the dates correct. Its a bit of a mute point anyway because it does not appear that Novitas is obliged to meet that deadline.

I'm assuming that the 15% rise today is predicated on the fact that a late finalisation improves the odds of a positive outcome. If PEB is removed from the non reimbursement list, I doubt it will drive the SP much more than around 20c although it could go 50c on a speculative short term spike. The main issue is where I agree with Psychic and that is there is still no endorsement from the AUA nor the NCCN. Until that happens the SP will settle below $1.00 for quite some time based on the expected growth rate with or without reimbursement.

[Santiago]

In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test’s parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.

[Santiago]

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39365&ver=80

[winner69]

In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test’s parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.

What’s that all about

[Santiago]

What’s that all about

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39365&ver=80

It appears it’s what SHs have been waiting for, but click the link and DYOR.

[Jhunt]

well that's that then, terrible news for shareholders. Just as revenue started to really pick up

[psychic]

That CMS conclusion pretty much sums up all that we have worried about over the years but refused to accept. . Will they need to now refund Cms for past tests that they claimed as medically neccessary but were not? Not insignificant.

[winner69]

That CMS conclusion pretty much sums up all that we have worried about over the years but refused to accept. . Will they need to nowrefund Cms for past tests that they claimed as medically neccessary but were not? Not insignificant.

Refund …..that sounds like really bad news

[BigBob]

What exactly is the rationale for refunds? The tests are currently funded.

Stirring again are we..?

[Greekwatchdog]

Expected..https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02672815-2A1452985?access_token=83ff96335c2d45a094df02a206a 39ff4

[Balance]

So I was rather thick not understanding what announcement meant

Share price up 14% …must have been good news

Looks like the thick ones are the reef fishes herded into the shark’s mouth?

[JSwan]

Nice long weekend for all holders 😢

[Greekwatchdog]

Nice long weekend for all holders 

Actually nice long weekend for Management and the board not.

[Rokko]

14624 not what was hoped for

[Balance]

14624 not what was hoped for

30c on opening (could be Wednesday morning at this stage as it’s Sunday in US & lawyers there charge triple if you spoil their weekends)?

[RTM]

30c on opening (could be Wednesday morning at this stage as it’s Sunday in US & lawyers there charge triple if you spoil their weekends)?

Out of curiosity Balance…what is your rationale for 30c ?
I was thinking much lower.

[kiora]

Tax losses???

[winner69]

What exactly is the rationale for refunds? The tests are currently funded.

Stirring again are we..?

Was asking what psychic what he may have meant when he mentioned refunds

[winner69]

It was about 10 years ago that our David Darling was super excited when he talked about their entry in Spain which has the highest rate of bladder cancer in the world.

Spain and the EU was at their mercy …….Dave used the word transformational a lot back then.

Was enough for me to give PEB some actual cash (like through a capital raise and not buying somebody else’s shares). Was good as I think the new ones were at 55 cents but market was selling well over a buck at the time. Because I’ve actually out real cash in their bank once I still feel I own a bit (even though sold out) of the company and that gives me license to say what I want about them

[psychic]

Was asking what psychic what he may have meant when he mentioned refunds

I'll have to dig back to evidence this, but there were refunds made at around the time I was having this grand debate on here with Miner (RIP Sandy mate) over the meaning and implication of the term "medically necessary". DD the magician was implying the CxBladder tests were "medically necessary" when I argued that the CMS "coverage" (unintended I believed) applied only when and if the tests were medically necessary. I argued they were not, as the AUA and NCCN had pretty much said they were not and and I thought it pretty unlikely that a Urologist in the US might stick his head out beyond the recommendation of his governing body and the guidelines and say one was. . Anyway, it was one of a number of DD's play on words, all smoke and mirrors really.

But Winner, you are an accounts buff. Have a read of the notes. Scary really. If you read through revenue recognition etc you may agree that this determination by CMS / Novitas creates a few problems, one of which might be further refunds (or in the very least , significant write-offs.)

See, when a Urologist orders a test, PE are obliged to run and report results back. Its sales contract is still actually with the poor sod with blood in the Urine, not CMS or Kaiser or sundy Insurer (of which there are practically none covering anyway imo). If the individual is covered by Medicare, then an invoice is raised to CMS - no doubt on the basis that the test was medically necessary. So PE have this tortuous process for revenue recognition using their experience and judgement as to the likelihhod of payment being received. But they acknowledge all this wizardry and the revenue assumptions are subject to (imagined, ongoing) cms approval.


edit The notes in the 2023 accounts (receivables) record refunds in the US for the past 2 years. I assumed these relate to sales recorded but then declined by CMS but don't know this. $271000 2023, $171000 2022. I'd suggest both these will be reviewed....

[psychic]

Out of curiosity Balance…what is your rationale for 30c ?
I was thinking much lower.

30 cents was the gap. Sadly agree, I don't tghink it will find much support there right now.
Its such a frikkin shame. The science seemed to be so good and offer so much promise. Likely still does. Why tf didn't they do the right thing, get full validation first in the US before going down this hard sell route. Gutted tbh, always hoped they'd get there.

[psychic]

The purpose of the LCD is not to limit beneficiary access to care but to ensure that Medicare is paying for services/tests that are deemed medically reasonable and necessary as supported by evidence.

At this time, the Contractor does not have an LCD with a positive coverage statement for any of the Pacific Edge Diagnostics tests which include the Cxbladder Detect (CPT code 0012M) and Cxbladder Monitor (CPT code 0013M). These CPT codes are only located in the article Billing and Coding: Molecular Pathology and Genetic Testing A58917 which includes the statement “This instruction focuses on coding and billing for molecular pathology diagnostics and genetic testing. Nothing stated in this instruction implies or infers coverage.”

This copied from cms responses to submissions regarding cxbladder
It seems to confirm that they never had Cms coverage. Class action anyone?

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59417&ver=17

[psychic]

The response also leaves the door open for PE to reapply. A long process I would imagine?

[Balance]

30 cents was the gap. Sadly agree, I don't tghink it will find much support there right now.
Its such a frikkin shame. The science seemed to be so good and offer so much promise. Likely still does. Why tf didn't they do the right thing, get full validation first in the US before going down this hard sell route. Gutted tbh, always hoped they'd get there.

It is very sad for PEB shareholders, management and staff indeed.

It is also extremely disappointing for NZ as a country as we desperately need companies like PEB to blaze a path for other biomed NZ companies to follow (just like FPH did before). Think of the inspiration that our young scientists and graduates in the universities can obtain if PEB is a huge success.

Agree that PEB should have obtained full validation and FDA approval first before jumping into the US with both feet.

$200m+ and 20 years - so very sad.

[850man]

The market and shareholders were misled by prior announcements from PEB, this is more than sad, it's criminal

[RTM]

Completely agree. NZ Inc would have really benefited from this company being successful.
Really disappointing in so many ways, not the least of which is the pain born by shareholders over the years.
I was one of those at one stage.



30 cents was the gap. Sadly agree, I don't tghink it will find much support there right now.
Its such a frikkin shame. The science seemed to be so good and offer so much promise. Likely still does. Why tf didn't they do the right thing, get full validation first in the US before going down this hard sell route. Gutted tbh, always hoped they'd get there.


It is very sad for PEB shareholders, management and staff indeed.

It is also extremely disappointing for NZ as a country as we desperately need companies like PEB to blaze a path for other biomed NZ companies to follow (just like FPH did before). Think of the inspiration that our young scientists and graduates in the universities can obtain if PEB is a huge success.

Agree that PEB should have obtained full validation and FDA approval first before jumping into the US with both feet.

$200m+ and 20 years - so very sad.

[winner69]

Surely not the end of Pacific Edge is it?

[RTM]

Surely not the end of Pacific Edge is it?

“Net loss after tax increases to $27.0 million from $19.8 million, reflecting a 58% increase in operating expenses to $53.1 million as the company invested to drive growth. “

What is their road to making a $ Winner ?

[Balance]

Surely not the end of Pacific Edge is it?

Will not be the end but what is the game plan now to become a U.S. player, and from there, the world?

Maybe they should just downscale, make the company profitable by downsizing and be a small niche player?

[psychic]

Nah, not the end. Pacific Edge will flog off Cxbladder, get Dave back (having probably sold his shares now and owning the biggest deck in Dunnie?) to start all over again with Colorectal cancer and drum up some more enthusiasm and cash...The Scientists will happilly carry on with what they love doing. When that fails, they'll get onto the Melanoma thing and finally wrap up the deal in Spain.

[850man]

So essentially this was a lie? https://www.directbroking.co.nz/DirectTrade/dynamic/announcement.aspx?id=5400495

[Balance]

So essentially this was a lie? https://www.directbroking.co.nz/DirectTrade/dynamic/announcement.aspx?id=5400495

Logic says that PEB will have to refund all payments made by CMS as CxBladder is NOT medically necessary.

Lawyers are going to be busy and wealthy.

[psychic]

So essentially this was a lie? https://www.directbroking.co.nz/DirectTrade/dynamic/announcement.aspx?id=5400495

A lie? No just misleading as were most of their announcements.
It says, coverage for tests that are medically necessary. None were.

[850man]

A lie? No just misleading as were most of their announcements.
It says, coverage for tests that are medically necessary. None were.

So I asked PEB back in 2021 what "medically necessary" meant. This is their reply

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.

[Balance]

Out of curiosity Balance…what is your rationale for 30c ?
I was thinking much lower.

Just a number (40% lower than last closing price) for the price on opening.

Then, I agree with you that the sp will drift lower as even the die-hard believers finally bail out.

[psychic]

So I asked PEB back in 2021 what "medically necessary" meant. This is their reply

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.


My interpretation of that response is that they'd leave it to you to find out how, why and when the referring physician determines medical necessity. My argument at the time was that it would be unlikely a physician could comfortably make a determination outside the governing AUA or NCCN guidelines and so there would not be many situations where the tests were so.

This is why I suspected the refunds made in 2022 and 2023 were likely as a result of later audit by CMS.

[Balance]

My interpretation of that response is that they'd leave it to you to find out how, why and when the referring physician determines medical necessity. My argument at the time was that it would be unlikely a physician could comfortably make a determination outside the governing AUA or NCCN guidelines and so there would not be many situations where the tests were so.

This is why I suspected the refunds made in 2022 and 2023 were likely as a result of later audit by CMS.

Who can forget the infamous 'Several tens of thousands of tests" in 2014 after which shares were sold by directors and management?

[psychic]

Agree, been so much crap over the years. Remember the mad excitement when PE signed up its first US "payor", giving access to cxbladder to squillions of Insurance customers, what a load of bollocks. Heres some more I posted this April 2021...


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.

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

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.

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

[thegreatestben]

Has to be said Psychic, I know you've had a tough gig being objective in your views on PEB. For me I started to feel like you were making more sense than the positives and I made it out with my original "contribution" in part thanks to your contributions. Obviously feeling for anyone on here who remained holders but credit to you mate.

[RTM]

EBOS managed to get its trading halt, announcement, and trading resumption completed in an impressive time frame.
Wonder what is going on at PEB ?

[Balance]

EBOS managed to get its trading halt, announcement, and trading resumption completed in an impressive time frame.
Wonder what is going on at PEB ?

Spin takes a longer time to come around?

This is damning of PEB's handling of the LCD issue : How can the company not know the timeline for the LCD? And did the company really have no inkling of the withdrawal when it made the announcement on Friday last week?

Then there are the punters who jumped in on the announcement that earlier news is good news!

https://www.nzx.com/announcements/412459

"As noted most recently in its FY 23 results announcement, released on 25 May 2023, Pacific Edge stated that it’s understanding was that Novitas, the Medicare Administrative Contractor with responsibility for its US laboratory, must either finalize or withdraw the proposed LCD (DL 39365) and the associated LCA (DA 59125) that cast Cxbladder’s continued Medicare coverage into doubt, by 28 July 2023 (NZT).

Following further review, and discussions with its advisors and other industry participants, Pacific Edge now understands that Novitas must either finalize or withdraw the proposed LCD and LCA by 9 June 2023 (NZT), 12 months after the original date of posting, not 12 months after date of last revision as previously communicated. We understand that there is no required announcement from Novitas upon passing the expiration date."

[RTM]

Exactly. And so what credibility do they have left ? No amount of spin will (should ?) work this time.


Spin takes a longer time to come around?

This is damning of PEB's handling of the LCD issue : How can the company not know the timeline for the LCD? And did the company really have no inkling of the withdrawal when it made the announcement on Friday last week?
"

[Greekwatchdog]

Announcement attached. https://www.nzx.com/announcements/412611

[DavidB]

I'm not a shareholder, but does this mean the company might go out of business? I mean who is it going to sell its tests to?

[Balance]

Announcement attached. https://www.nzx.com/announcements/412611

Note the wording “proposed ceasing”?

This is not a proposal to cease …. the reimbursement is going to cease from July?

[Santiago]

Unless they have something up their sleeves, and I’m no expert in this process so there may be avenues and approaches they can take, but if this is a final determination then this could be a company killer. Will KP progress with them if there’s both doubt about coverage as well as the underlying science? Anyone else? I doubt it, but watch this space.

[Santiago]

Having said that, surely they were planning for this possibility. Gross negligence if they weren’t. Tomorrow’s announcement will be very interesting.

[Balance]

They definitely have the right to appeal which they will do. That will probably be the best expenditure they are going to make in the company’s history.

For the diehards, there is still hope?

[850man]

Note the wording “proposed ceasing”?

This is not a proposal to cease …. the reimbursement is going to cease from July?

Although the latest from Novitas says there never was coverage for CXB, just the creation of billing codes. This is at odds with PEB's statement to the market on 3 July 2020 the first paragraph of which follows:
"PACIFIC EDGE NOTIFIED OF POSITIVE LCD DECISION IN USA

Transformational reimbursement milestone for Pacific Edge with notification
of LCD coverage for CMS patients in the USA. The LCD coverage facilitates
reimbursement for CMS patients using Cxbladder Detect and Cxbladder Monitor."

If this is not misleading then what is?

[jonu]

Trading halt lifted without further announcement. Very odd!

[Balance]

Trading halt lifted without further announcement. Very odd!

No, it hasn’t?

Looks like NZX has cleaned out market depth however.

[Greekwatchdog]

This is what For Barr have to say for what its worth.


Proposed LCD has been finalised — not good news for PEB


The final LCD retains the reliance on evidence based guidelines for a test to be considered medically reasonable and necessary, and therefore tests to be covered. The requirement for a test to be within Category 1 or 2A of the National Comprehensive Cancer Network (NCCN) guidelines has been retained. Cxbladder is currently in Category 2B which by virtue of the reimbursement criteria rules it out of coverage. Our analysis suggests this is the only finalised LCD since 2010 to explicitly rely on NCCN guidelines as a coverage criteria. The final LCD effective date (when it appears reimbursement for PEB’s Cxbladder tests will cease) is 17 July 2023.
​​​​​​​The key question from here is what the future coverage path within CMS looks like. A key change in the finalised LCD is that Novitas "will accept LCD reconsideration requests" as to whether tests meet CMS' reasonable and necessary criteria. The complex legalities means forming a strong view on the future coverage path right now is very difficult but US industry feedback suggests that a revision request can be lodged at any time, though the probability of a change in the near-term is “low”.

Rating and target price UNDER REVIEW until more information is provided


We have not yet had the opportunity to speak to the company and we acknowledge the coverage path from here is highly uncertain. There is a wide range of outcomes depending on the success of LCD reconsideration requests based off PEB's (and potentially others) likely objections to the finalised LCD. Until we get confirmation on the forward coverage path based off potential reconsiderations, and as new information comes to light, our rating and target price are UNDER REVIEW.

[Santiago]

I imagine there are some very worried directors (law suits incoming) and some very excited lawyers (appeal the decision, defend the class action…). What a hot mess

[Lego_Man]

Trading halt lifted without further announcement. Very odd!

It's halted again but appears to have briefly traded at 28c according to my screen. Announcement tomorrow?

[Crisis]

Talked to the ASB Securities. NZX has lifted trading halt by.mistake. They might reverse today's transactions.

[trader_jackson]

I thought EBOS had the worst announcement of the day/week/month/(maybe year?) but wow this is much worse... after being a holder way back I fully understood the whole basis for PEB's existence was to commercialize this very thing that has now been determined as 'not considered medically reasonable and necessary'... it took a bit longer than I expected to gain signoff and I cut my losses at the time accordingly, however, I was pleased to see in mid 2020 it was signed off and things looked alot brighter... for the signoff to effectively be canned just 3 years after is embarrassing at best, and at worst, looks like PEB has been deceitful and possibly fraudulent with their previous statements... will be most interesting to see how they navigate this one

[Lego_Man]

This is what For Barr have to say for what its worth.


Proposed LCD has been finalised — not good news for PEB


The final LCD retains the reliance on evidence based guidelines for a test to be considered medically reasonable and necessary, and therefore tests to be covered. The requirement for a test to be within Category 1 or 2A of the National Comprehensive Cancer Network (NCCN) guidelines has been retained. Cxbladder is currently in Category 2B which by virtue of the reimbursement criteria rules it out of coverage. Our analysis suggests this is the only finalised LCD since 2010 to explicitly rely on NCCN guidelines as a coverage criteria. The final LCD effective date (when it appears reimbursement for PEB’s Cxbladder tests will cease) is 17 July 2023.
​​​​​​​The key question from here is what the future coverage path within CMS looks like. A key change in the finalised LCD is that Novitas "will accept LCD reconsideration requests" as to whether tests meet CMS' reasonable and necessary criteria. The complex legalities means forming a strong view on the future coverage path right now is very difficult but US industry feedback suggests that a revision request can be lodged at any time, though the probability of a change in the near-term is “low”.

Rating and target price UNDER REVIEW until more information is provided


We have not yet had the opportunity to speak to the company and we acknowledge the coverage path from here is highly uncertain. There is a wide range of outcomes depending on the success of LCD reconsideration requests based off PEB's (and potentially others) likely objections to the finalised LCD. Until we get confirmation on the forward coverage path based off potential reconsiderations, and as new information comes to light, our rating and target price are UNDER REVIEW.




Another brokerage house estimates a 60% hit to revenue for FY25.

[RRR]

400 million market cap at the current price - their only product is CX bladder...just wow..market got it so wrong for years...
but they have 90 million cash (?) - will survive at least the short to medium term...

[Ggcc]

400 million market cap at the current price - their only product is CX bladder...just wow..market got it so wrong for years...
but they have 90 million cash (?) - will survive at least the short to medium term...
If lucky they might get a takeover happening. I am so happy I sold out when I did and buy SPy

[bull....]

400 million market cap at the current price - their only product is CX bladder...just wow..market got it so wrong for years...
but they have 90 million cash (?) - will survive at least the short to medium term...

so its worth 9c eh + goodwill for there remaining product

[Balance]

I thought EBOS had the worst announcement of the day/week/month/(maybe year?) but wow this is much worse... after being a holder way back I fully understood the whole basis for PEB's existence was to commercialize this very thing that has now been determined as 'not considered medically reasonable and necessary'... it took a bit longer than I expected to gain signoff and I cut my losses at the time accordingly, however, I was pleased to see in mid 2020 it was signed off and things looked alot brighter... for the signoff to effectively be canned just 3 years after is embarrassing at best, and at worst, looks like PEB has been deceitful and possibly fraudulent with their previous statements... will be most interesting to see how they navigate this one

Just wondering aloud about why KMS has taken so very very long to roll out CxBladder - could it be because they have been waiting for confirmation (or otherwise) of LCD reimbursement to be properly determined?

Something smells bad and it’s not the urine in the test kit.

[winner69]

I suppose funds like Harbour/Jarden and ANZ and Salt will hang in there to the bitter end

[whatsup]

Wernt there payments in the financials a year or so ago that had to be wound back because they actually had not been received but were credited all the same as income ?

[whatsup]

If one reads the second page of todays NZX T H ann one could get the impression that PEB has a wonderful/exciting future !!!!

[Balance]

I suppose funds like Harbour/Jarden and ANZ and Salt will hang in there to the bitter end

Just out of interest :

Harbour 109,302,528 shares

ANZ 58,714,600 shares

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/410011/392697.pdf

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/405498/387175.pdf

[Balance]

Jarden’s view is pretty grim :

https://www.nzherald.co.nz/business/pacific-edge-shares-in-trading-halt-as-jarden-ponders-novitas-notice/RIHHKKVHCJE33KLEEMOLHU7V7E/


Analyst Christian Bell said in a note that the decision is a “demonstrable change in circumstances” removing Medicare coverage in the US and calling into question “the foundational evidence that supports the clinical validity of all Cxbladder tests”.

“The decision comes as a surprise, and analysis of evidence appears left-field.

“Pacific Edge is yet to make an announcement but given what feels like a change in scope, we are not sure if there is potential grounds or the ability for Pacific Edge to make an appeal.”

[psychic]

Seriously, I would be stunned by the the ineptness of these collective muppets if they really had no grasp on what was really happening here. This is a bs response surely to save face. The games go on.

[Balance]

Seriously, I would be stunned by the the ineptness of these collective muppets if they really had no grasp on what was really happening here. This is a bs response surely to save face. The games go on.

But of course. They have put their in-house funds into PEB and they underwrote the capital raisings of PEB.

Next, they will drop coverage of PEB just as they dropped coverage of MFB. Not their money and they have milked plenty of fees from PEB.

[steve06]

Kaiser and other payers not affected by the Novitas decision.......? Watch the second half of the video


https://www.nzherald.co.nz/business/markets-with-madison-construction-slowdown-hits-suppliers/I55OT6PTYFC3NJKBM5FEQYTVVQ/

[Carpenterjoe]

Why not get more independent validation of the Cxbladder product and re apply/appeal the desion of CMS. Continue to grow at investors expense, Continue to apply pressure to the stupid medical boomer generation. It seems the demand for the product is growing.

[Balance]

Why not get more independent validation of the Cxbladder product and re apply/appeal the desion of CMS. Continue to grow at investors expense, Continue to apply pressure to the stupid medical boomer generation. It seems the demand for the product is growing.

So what has PEB been doing for the last 20 years? Busy wasting and burning the $200m+ of funds ‘donated’ by believers?

[winner69]

So what has PEB been doing for the last 20 years? Busy wasting and burning the $200m+ of funds ‘donated’ by believers?

There will always be believers eh Balance

Our David did achieve his ‘commercialisation’ dream / target …..in his words commercialisation was selling a few tests and getting paid for them. Profit wasn’t a word in his vocabulary

Better off using ‘transformational’ and ‘exciting’ and ‘global’ ….racked in more cash

[Balance]

Unbelievable that there’s no announcement from PEB first thing this morning.

Says a lot imo about how inept & out of touch the management of this company really really are.

Un-investable.

[winner69]

Unbelievable that there’s no announcement from PEB first thing this morning.

Says a lot imo about how inept & out of touch the management of this company really really are.

Un-investable.

Maybe 9.04am

[psychic]

Kaiser and other payers not affected by the Novitas decision.......? Watch the second half of the video


https://www.nzherald.co.nz/business/markets-with-madison-construction-slowdown-hits-suppliers/I55OT6PTYFC3NJKBM5FEQYTVVQ/

Well Pete might be correct on that score. Income from Kaiser non evidential to date. As for other Payors, CxBladder is still not covered by any major US Insurer and the NZ sales, where it is in the guideline are - flat.

Yes we need external validation, more to the point, we need it to agree with our in-house studies which have always been wanting.

[psychic]

Dave has really given Pete the hospital pass here right. Can't help but feel for the guy but there is still an outstanding amount of BS going on. They KNEW they did not have cover.

[850man]

CMS LCA59417 dated 2 June 2023 states “At this time, the Contractor does not have an LCD with a positive coverage statement for any of the Pacific Edge Diagnostics tests which include the Cxbladder Detect (CPT code 0012M) and Cxbladder Monitor (CPT code 0013M). These CPT codes are only located in the article Billing and Coding: Molecular Pathology and Genetic Testing A58917 which includes the statement “This instruction focuses on coding and billing for molecular pathology diagnostics and genetic testing. Nothing stated in this instruction implies or infers coverage.”


PEB made an announcement on 3 July 2020 - “PACIFIC EDGE NOTIFIED OF POSITIVE LCD DECISION IN USA. Transformational reimbursement milestone for Pacific Edge with notification of LCD coverage for CMS patients in the USA. The LCD coverage facilitates reimbursement for CMS patients using Cxbladder Detect and Cxbladder Monitor. New Zealand bladder cancer diagnostics provider, Pacific Edge Limited (NZX:PEB), has been notified by Novitas that the LCD: Biomarkers for Oncology (L35396) provides coverage for Cxbladder, CPT codes 0012M (Cxbladder Detect) and 0013M (Cxbladder Monitor), for tests performed on or after July 1, 2020 that are medically necessary.


On 2/6/2023 CMS advises that there has never been any coverage for CXB yet PEB advised the market on 3/7/2020 that there was. Misleading??

[Balance]

Dave has really given Pete the hospital pass here right. Can't help but feel for the guy but there is still an outstanding amount of BS going on. They KNEW they did not have cover.

And the fund managers who underwrote the CRs and have large shareholdings obviously did not do enough due diligence and understand how tenuous PEB’s LCD coverage was.

Oh well, not going to worry them as it’s not their money.

[RTM]

A lot of very careful wordsmithing going on. That is being critically reviewed before publication.
Yes Balance, simply unbelievable.



Unbelievable that there’s no announcement from PEB first thing this morning.

Says a lot imo about how inept & out of touch the management of this company really really are.

Un-investable.


Dave has really given Pete the hospital pass here right. Can't help but feel for the guy but there is still an outstanding amount of BS going on. They KNEW they did not have cover.

[psychic]

CMS LCA59417 dated 2 June 2023 states “At this time, the Contractor does not have an LCD with a positive coverage statement for any of the Pacific Edge Diagnostics tests which include the Cxbladder Detect (CPT code 0012M) and Cxbladder Monitor (CPT code 0013M). These CPT codes are only located in the article Billing and Coding: Molecular Pathology and Genetic Testing A58917 which includes the statement “This instruction focuses on coding and billing for molecular pathology diagnostics and genetic testing. Nothing stated in this instruction implies or infers coverage.”


PEB made an announcement on 3 July 2020 - “PACIFIC EDGE NOTIFIED OF POSITIVE LCD DECISION IN USA. Transformational reimbursement milestone for Pacific Edge with notification of LCD coverage for CMS patients in the USA. The LCD coverage facilitates reimbursement for CMS patients using Cxbladder Detect and Cxbladder Monitor. New Zealand bladder cancer diagnostics provider, Pacific Edge Limited (NZX:PEB), has been notified by Novitas that the LCD: Biomarkers for Oncology (L35396) provides coverage for Cxbladder, CPT codes 0012M (Cxbladder Detect) and 0013M (Cxbladder Monitor), for tests performed on or after July 1, 2020 that are medically necessary.


On 2/6/2023 CMS advises that there has never been any coverage for CXB yet PEB advised the market on 3/7/2020 that there was. Misleading??



The trick here is in the last few words, tests covered "that are medically necessary". They have cover when they are, but they are not.

Dave the magician. Called them "medically necessary tests" lol

[percy]

https://www.nzx.com/announcements/412643

[winner69]

Remember when PEB won a prestigious investor relations award in 2021

Judges said: “Pacific Edge clearly demonstrated alignment between its Investor Relations strategy and outcomes delivered, such as increased sell side coverage and conversion of interest to investment. During 2020, Pacific Edge kept the market informed as headlines came thick and fast taking advantage of the acceleration of Covid-19 trends - both for the company (telehealth) and in its engagement with shareholders/potential shareholders via increased virtual engagement. The combination of improved investor engagement and positive milestones for Pacific Edge has seen the company deliver excellent investor outcomes through 2020 with its share price re-rating strongly, liquidity improving and the number and diversity of shareholders increasing.”

[Balance]

10c by the end of next week if one of the big holders like ANZ or Harbour decides to get rid of this embarrassment in their portfolios?

[winner69]

No worries … just a hiccup on our journey to greatness …….we will push on with that journey

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/412643/396025.pdf

[bull....]

so its worth 9c eh + goodwill for there remaining product

even worse than i thought

[bull....]

who loaded up 9c cash on balance sheet ?

[Sideshow Bob]

6 cents.

Ewooooaaaaaaawwwww!!! :ohmy::(:blink::blink:

What a blood bath!

[clip]

Wowwwww :| blood bath is 100% correct

[bull....]

6 cents.

Ewooooaaaaaaawwwww!!! :ohmy::(:blink::blink:

What a blood bath!

yep only good for a very short trade , there cash will run down super fast with no revenue coming in so that 9c will end up like an option expiry date senario

nearly 100% gain in 30 mins for early birds

[hey_homes]

Damn. This was my first big investing mistake. Signed up to this forum, read the PEB thread, got excited having never heard of the company before, thought I’d better get in before it kicks off, and spent my meagre available funds of $1500 on x amount of shares at 1.45. I’ll write it off as a hard lesson.

[sunnysleeper11]

Damn. This was my first big investing mistake. Signed up to this forum, read the PEB thread, got excited having never heard of the company before, thought I’d better get in before it kicks off, and spent my meagre available funds of $1500 on x amount of shares at 1.45. I’ll write it off as a hard lesson.
Hey heyhomes
ive done that a number times - buying at the the top and selling at a lot less
trying to find the lesson to learn in every trade is the secret - why it went well/why it didn't go well - use that knowledge to influence your next trade
cutting losses early is a great thing to be able to do - tricky thing to learn tho
personally I'm very slowly getting better this whole share market thing but it ain't that easy - persistence is the key
all the best!

[hogie]

Personally I'd never sell at a loss ... for the next 10+ years I'll be patiently hoping that PEB turns around somehow ... if they last 10 years =P

[hey_homes]

Well there’s certainly not much point selling now!

[strikereureka]

Acquisition target for a well-established medical/pharma company based in the US?

[bull....]

multi bagger stuff , anyway there's your 9c + goodwill at current prices i reckon ...

[ddrone]

A few people did very well buying at 5c, 3x in an hour a'int a bad day!

[850man]

I was late to the party and missed out. 5c purchase now worth 3x that. Well done those who were on the ball

[DavidB]

When matters like these arise, I like to think about: - What are the investing lessons to be learned here? What are some of the red flags to look out for that can guide whether or not to allocate capital to an investment? Do I fully understand the business?


Starting with the last question first, and going back to first principles, the question is what problem is PEB trying to solve and who are its customers? As I understand it, PEB’s test is trying to solve the problem of expensive, uncomfortable, time-consuming, and frankly embarrassing cystoscopy examinations in those who have had, or who are suspected to have bladder cancer. Sounds good. So, the customer must be the bladder cancer patient then? Ah, no. The customer is the doctor who performs/ orders the test.


So, what problem for the doctor does PEB’s test solve? Is it expensive, uncomfortable, time-consuming, and frankly embarrassing for the doctor to perform a cystoscopy? Answer no, it’s not for them. In fact, they get paid good money to do one, but more importantly, by their own professional association, e.g., the British Association of Urological Surgeons, it is treated as the gold standard in the diagnosis and management of bladder cancers and is, therefore, the recommended method in the bladder cancer treatment guidelines.


In fact, here are the NICE guidelines (National Institute for Health and Care Excellence) from the UK for the diagnosing and staging of bladder cancer. I’m sure it is much the same standards and guidelines for most of the other Urological Associations around the world.


1.2 Diagnosing and staging bladder cancer

Diagnosis

1.2.1 Do not substitute urinary biomarkers for cystoscopy to investigate suspected bladder cancer or for follow‑up after treatment for bladder cancer, except in the context of a clinical research study.

https://www.nice.org.uk/guidance/ng2/chapter/1-recommendations#diagnosing-and-staging-bladder-cancer-2


So, on this analysis, it would seem that not only does PEB’s test not solve a problem for its actual customer, its customer is largely prevented from using it as it falls outside of the existing guidelines for the diagnosis and management of bladder cancer patients that clinicians are expected to follow.

Referring back to the first question, what red flags are present that I need to be mindful of before I decide to invest in the company? Well, the obvious one of course is that this company only has one commercial product. One of anything is never a good thing. One product, one customer. If anything happens to the product, what then does the company do?



So based on my analysis, PEB would not be a company that I would invest in as it appears not to have a product that solves a problem for its customer, and in addition, it only has one product that leaves it in a very vulnerable position.

Good luck to investors who take a different view from me. And for traders maybe they will make some coin from time to time trading the stock. But my view is that until such time that the company is able to win over both urologists and their associations to get the bladder cancer treatment guidelines changed to include biomarkers in diagnosis and surveillance I really don't see how the company can do well if it is going to stick to just the one product.

[whatsup]

When matters like these arise, I like to think about: - What are the investing lessons to be learned here? What are some of the red flags to look out for that can guide whether or not to allocate capital to an investment? Do I fully understand the business?


Starting with the last question first, and going back to first principles, the question is what problem is PEB trying to solve and who are its customers? As I understand it, PEB’s test is trying to solve the problem of expensive, uncomfortable, time-consuming, and frankly embarrassing cystoscopy examinations in those who have had, or who are suspected to have bladder cancer. Sounds good. So, the customer must be the bladder cancer patient then? Ah, no. The customer is the doctor who performs/ orders the test.


So, what problem for the doctor does PEB’s test solve? Is it expensive, uncomfortable, time-consuming, and frankly embarrassing for the doctor to perform a cystoscopy? Answer no, it’s not for them. In fact, they get paid good money to do one, but more importantly, by their own professional association, e.g., the British Association of Urological Surgeons, it is treated as the gold standard in the diagnosis and management of bladder cancers and is, therefore, the recommended method in the bladder cancer treatment guidelines.


In fact, here are the NICE guidelines (National Institute for Health and Care Excellence) from the UK for the diagnosing and staging of bladder cancer. I’m sure it is much the same standards and guidelines for most of the other Urological Associations around the world.


1.2 Diagnosing and staging bladder cancer

Diagnosis

1.2.1 Do not substitute urinary biomarkers for cystoscopy to investigate suspected bladder cancer or for follow‑up after treatment for bladder cancer, except in the context of a clinical research study.

https://www.nice.org.uk/guidance/ng2/chapter/1-recommendations#diagnosing-and-staging-bladder-cancer-2


So, on this analysis, it would seem that not only does PEB’s test not solve a problem for its actual customer, its customer is largely prevented from using it as it falls outside of the existing guidelines for the diagnosis and management of bladder cancer patients that clinicians are expected to follow.

Referring back to the first question, what red flags are present that I need to be mindful of before I decide to invest in the company? Well, the obvious one of course is that this company only has one commercial product. One of anything is never a good thing. One product, one customer. If anything happens to the product, what then does the company do?



So based on my analysis, PEB would not be a company that I would invest in as it appears not to have a product that solves a problem for its customer, and in addition, it only has one product that leaves it in a very vulnerable position.

Good luck to investors who take a different view from me. And for traders maybe they will make some coin from time to time trading the stock. But my view is that until such time that the company is able to win over both urologists and their associations to get the bladder cancer treatment guidelines changed to include biomarkers in diagnosis and surveillance I really don't see how the company can do well if it is going to stick to just the one product.

So where does it leave the N Z hospitals that have signed up for this blood cancer tests ?

[DavidB]

So where does it leave the N Z hospitals that have signed up for this blood cancer tests ?

I don't know, I'm assuming they are doing both? Although signing up and actually using them are two different things. Are the test numbers in NZ hospitals increasing, decreasing or staying the same? The problem though is that New Zealand is a very small market, and it is unlikely to have much influence on the clinical guidelines that are adopted around the world. By the way, I thought it was a pee test??

[bottomfeeder]

Where it was mentioned that you should be wary of companies with one product. I had misgivings about investing in PEB for a similar reason. Development of a test product is very expensive. Also doctors who are a driving force behind PEB just cant help themselves. They are naturally on a mission for new treatments, tests and vaccines. I saw profits ( if any) from CX bladder as well as capital raises being reinvested in new development, which means the poor shareholder will never get a return on investment and particularly so if the future development costs never bear fruit. So in the case of PEB one product is the only way this would succeed as an investment.

[Balance]

All over for PEB imo. It’s a train wreck in slow motion from here as management has been caught with no coherent Plan B even after 11 months’ notice that the LCD coverage was in jeopardy.

Having cash in the bank will buy the company some time but watch that cash now dissipate rapidly as cash burn ratchets up with the dramatically reduced revenues and increased costs, especially legal. CR can be forgotten as an option as the cash runs out.

Management need to urgently tell the market what its strategy is to address the cash burn and provide PEB with a new pathway to full commercialisation. The alternative is liquidation when the cash is down to just enough to shut the company down.

[whatsup]

All over for PEB imo. It’s a train wreck in slow motion from here as management has been caught with no coherent Plan B even after 11 months’ notice that the LCD coverage was in jeopardy.

Having cash in the bank will buy the company some time but watch that cash now dissipate rapidly as cash burn ratchets up with the dramatically reduced revenues and increased costs, especially legal. CR can be forgotten as an option as the cash runs out.

Management need to urgently tell the market what its strategy is to address the cash burn and provide PEB with a new pathway to full commercialisation. The alternative is liquidation when the cash is down to just enough to shut the company down.

Whats the employee head count and overhead costs ?

[mr optimistic]

I dont agree with any of the "game over" sentiment. They have a viable diagnostic. Kaiser wouldnt back it otherwise. Unfortunately, they've been hiring based on an old fashioned diagnostic commercial roll out by hiring has beens in the industry (tick the box ****). Time to up there game, reduce BS costs like sales reps on 250K USD plus bonuses. Get smart, support their VA and Kaiser opportunity, keep pushing in NZ. Get some traction in the Aussie. Focus on other markets. Europe etc. Just an FYI, the VA hospital system in the US is the largest public healthcare system in the OECD. They'll be raising funds and they'll be plenty to invest in it. I reckon this is the come to jesus moment for this outfit. Nothing wrong with a little cost focus to keep everyone honest. Dave Darling was a complete idiot, living the high life, while paying himself exorbitant fees from cash raise after cash raise. That culture has got to go. And now, it finally will.

[stoploss]

Just out of interest :

Harbour 109,302,528 shares

ANZ 58,714,600 shares


http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/410011/392697.pdf

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/405498/387175.pdf


Harbour have a truck load of MFB, is that a Kiwisaver fund ? Some serious losses here .....

[Balance]

Harbour have a truck load of MFB, is that a Kiwisaver fund ? Some serious losses here .....

It’s ok as Jarden makes lots of money from doing the IPOs and capital raisings?

[Balance]

Looks like 10c close? Big boys coming out to sell. :scared:

[blackcap]

Harbour have a truck load of MFB, is that a Kiwisaver fund ? Some serious losses here .....

Don't worry, its other peoples money. Harbour will be fine....

[Balance]

Whats the employee head count and overhead costs ?

52 employees at end of March 2022 (Annual Report) with salaries over $100,000 - company has been furiously adding on more sales and marketing staff so expect that number to be a lot more by now.

Latest financials show Sales & Marketing and General & Admin expenses at $35.2m (up 60% on 2022).

To survive, PEB is going to have to cut expenses to the bone and get rid of all the extra sales & marketing personnel taken on in the last 3 years.

Biggest question facing the company now is whether Peter Meintjes the right CEO to lead the restructuring as he was brought in to accelerate the growth of PEB!

[RRR]

CX bladder is an overhyped test..PEB have been promoting for more than a decade. If CX bladder was really that a good test for bladder cancer doctors would have started using by now..doctor blaming should stop..They really need to look beyond CX bladder but do they any product that is close to commercialisation?? I am not sure

[whatsup]

52 employees at end of March 2022 (Annual Report) with salaries over $100,000 - company has been furiously adding on more sales and marketing staff so expect that number to be a lot more by now.

Latest financials show Sales & Marketing and General & Admin expenses at $35.2m (up 60% on 2022).

To survive, PEB is going to have to cut expenses to the bone and get rid of all the extra sales & marketing personnel taken on in the last 3 years.

Biggest question facing the company now is whether Peter Meintjes the right CEO to lead the restructuring as he was brought in to accelerate the growth of PEB!

and this is the crox of the problem now, do they slash and burn in order to try and survive or keep on spending until the money runs out ?

[Balance]

and this is the crox of the problem now, do they slash and burn in order to try and survive or keep on spending until the money runs out ?

Let’s hope they go back to basics and use the $87m left wisely to get proper validation before embarking on another wild goose chase in the States.

Sometimes one has to go backwards and go on another path to move forwards again if there’s an insurmountable barrier in the way.

[Harrie]

The biggest problem is that the AUA and the NCCN have never bought into Cxbladder. The association that urologists belong to is there specifically to protect and enhance earnings of their members, and maybe they saw that a simple urine test would upset the fee income earning capacity coming from other more traditional methodologies being used. Navitas obviously drew a lot of the material used to decline LCD for Cxbladder in entirety from these sources and who knows who may have been corrupted inside Navitas to decline it.
I have never really been crystal clear on just how much more reliable Cxbladder detect is c/f current methodologies. I have seen a NPV of 97% quoted, but how far does this go. Are there variables that are not included that the AUA are sceptible about? etc.
Have managment ever sat down with the AUA to discuss their findings or peer reviewed AUA's findings?
PEB need to have a more honest conversation with its shareholders.

[silverblizzard888]

I remember when they first had their breakthrough with the FDA and they considered selling the whole thing to other companies, but got offered peanuts. In their minds it was worth much more, even to the point of saying they could generate $100 million in sales in 5 years. Fast froward to the current point you can definitely see why they were offered peanuts because getting this thing off the ground has not only been a grind without success, but also a massive loss making exercise in hope. Truth is the companies they offered to sell out to all those years ago saw the challenges and it turns out they were right.

Now they have to recognize what all those years of work has amounted to and reset the strategy. Start cutting cost to the point that they can reach break-even on a minimum amount of test. To an extent it might even be worth withdrawing from the US as a main focus and start pursuing countries who might offer a smaller market, but at least one they could breakeven in and build a base for the future. No more big dreams of hyper sales and success, just build a sustainable operation first. Maybe its even in the name like 'peb' standing for pebble, you can chuck all those all day without effect; should have called it 'roc' for better effect ;)

[Balance]

I remember when they first had their breakthrough with the FDA and they considered selling the whole thing to other companies, but got offered peanuts. In their minds it was worth much more, even to the point of saying they could generate $100 million in sales in 5 years. Fast froward to the current point you can definitely see why they were offered peanuts because getting this thing off the ground has not only been a grind without success, but also a massive loss making exercise in hope. Truth is the companies they offered to sell out to all those years ago saw the challenges and it turns out they were right.

Now they have to recognize what all those years of work has amounted to and reset the strategy. Start cutting cost to the point that they can reach break-even on a minimum amount of test. To an extent it might even be worth withdrawing from the US as a main focus and start pursuing countries who might offer a smaller market, but at least one they could breakeven in and build a base for the future. No more big dreams of hyper sales and success, just build a sustainable operation first. Maybe its even in the name like 'peb' standing for pebble, you can chuck all those all day without effect; should have called it 'roc' for better effect ;)

They actually never had a FDA breakthrough as they wanted to ‘fast track’ the rollout of CxBladder in the States - so they did not bother with the FDA accreditation & approval process. Big big mistake and now shareholders are paying a horrendous price for that short sighted decision 10+ years later.

Meanwhile, it does look like they will try to conserve cash by signalling a freeze on hiring, discretionary spend and capex. What they have to do is scale back ruthlessly as you suggest and start again but with some revenues coming in.

https://www.odt.co.nz/business/pacific-edge-shares-plunge-after-setback

Will be the big boys keep selling while the minnows snap up the shares at a ‘bargain’ price?

[winner69]

Wasn’t that long ago (mid 2020) ANZ fronted up with $22m new growth capital …..paid a premium at the time for the 33 million new shares PEB issued

Exciting times ahead for PEB after the break through with Medicare the ANZ man said. Even Dave was excited

[Balance]

Wasn’t that long ago (mid 2020) ANZ fronted up with $22m new growth capital …..paid a premium at the time for the 33 million new shares PEB issued

Exciting times ahead for PEB after the break through with Medicare the ANZ man said. Even Dave was excited

And such was their confidence they increased their shareholding to 58m shares.

Maybe they are buying more at current bargain basement prices?

DD may be able to offer them some or has he sold & moved on?

[mr optimistic]

Interesting

[Balance]

https://www.odt.co.nz/business/pacific-edge-shares-plunge-after-setback

Will be the big boys keep selling while the minnows snap up the shares at a ‘bargain’ price?

Notice how the big boys are taking turns selling down their shareholdings?

They let the bids build up and then, sell down.

Only 400m shares more to go?

[Sideshow Bob]

The Novitas decision is not all doom and gloom for Pacific Edge (https://businessdesk.us20.list-manage.com/track/click?u=786ac0b2dc4f2240875208882&id=130f8c66a4&e=3b6f9185d3)



News Pacific Edge's Cxbladder tests will no longer be covered by US national health insurance provider Medicare is a “game-changing announcement” but “not all doom and gloom” says Forsyth Barr analysts.
On Wednesday, the company confirmed a so-called “local coverage determination” from Novitas (https://businessdesk.us20.list-manage.com/track/click?u=786ac0b2dc4f2240875208882&id=1b41b950e5&e=3b6f9185d3) – the Medicare administrative contractor – that meant its suite of products does not meet the threshold required for coverage under the US Social Security Act.

https://businessdesk.co.nz/article/markets/the-novitas-decision-is-not-all-doom-and-gloom-for-pacific-edge?utm_source=7am+Headlines+from+BusinessDesk&utm_campaign=e612e935c2-7am+Headlines&utm_medium=email&utm_term=0_617c2ef34a-e612e935c2-402467359 (Paywalled)

[Balance]

The Novitas decision is not all doom and gloom for Pacific Edge (https://businessdesk.us20.list-manage.com/track/click?u=786ac0b2dc4f2240875208882&id=130f8c66a4&e=3b6f9185d3)



News Pacific Edge's Cxbladder tests will no longer be covered by US national health insurance provider Medicare is a “game-changing announcement” but “not all doom and gloom” says Forsyth Barr analysts.
On Wednesday, the company confirmed a so-called “local coverage determination” from Novitas (https://businessdesk.us20.list-manage.com/track/click?u=786ac0b2dc4f2240875208882&id=1b41b950e5&e=3b6f9185d3) – the Medicare administrative contractor – that meant its suite of products does not meet the threshold required for coverage under the US Social Security Act.

https://businessdesk.co.nz/article/markets/the-novitas-decision-is-not-all-doom-and-gloom-for-pacific-edge?utm_source=7am+Headlines+from+BusinessDesk&utm_campaign=e612e935c2-7am+Headlines&utm_medium=email&utm_term=0_617c2ef34a-e612e935c2-402467359 (Paywalled)



Soothing words from Forbar, one of the brokers involved in the capital raisings for PEB. Could they possibly write anything else?

The other two brokers are Jardens (ouch for Harbour!) and Bell Porter (clients will be livid).

But let’s hope Forbar is right. PEB has a future but some very very hard decisions need to be made and executed immediately for the company to survive.

[850man]

The Novitas decision is not all doom and gloom for Pacific Edge (https://businessdesk.us20.list-manage.com/track/click?u=786ac0b2dc4f2240875208882&id=130f8c66a4&e=3b6f9185d3)


News Pacific Edge's Cxbladder tests will no longer be covered by US national health insurance provider Medicare is a “game-changing announcement” but “not all doom and gloom” says Forsyth Barr analysts.
On Wednesday, the company confirmed a so-called “local coverage determination” from Novitas (https://businessdesk.us20.list-manage.com/track/click?u=786ac0b2dc4f2240875208882&id=1b41b950e5&e=3b6f9185d3) – the Medicare administrative contractor – that meant its suite of products does not meet the threshold required for coverage under the US Social Security Act.

https://businessdesk.co.nz/article/markets/the-novitas-decision-is-not-all-doom-and-gloom-for-pacific-edge?utm_source=7am+Headlines+from+BusinessDesk&utm_campaign=e612e935c2-7am+Headlines&utm_medium=email&utm_term=0_617c2ef34a-e612e935c2-402467359 (Paywalled)



So where does this then leave the KP integration and continued use of CXB or are KP not governed by the US Social Security act?

[Getty]

But let’s hope Forbar is right. PEB has a future but some very very hard decisions need to be made and executed immediately for the company to survive.

Yep, PEB need to stop pissing around .

[Balance]

Soothing words from Forbar, one of the brokers involved in the capital raisings for PEB. Could they possibly write anything else?

The other two brokers are Jardens (ouch for Harbour!) and Bell Porter (clients will be livid).

But let’s hope Forbar is right. PEB has a future but some very very hard decisions need to be made and executed immediately for the company to survive.

PEB a takeover target*, according to Bell Porter.

https://www.odt.co.nz/business/pacific-edge-potential-takeover-target-report

"An Australian investment firm is reportedly suggesting Pacific Edge could be in line for a takeover bid."

"Craigs Investment Partners investment adviser Peter McIntyre, of Dunedin, said it was "very possible" a company was looking at Pacific Edge."











* Report issued a year ago so takeover must be any day now.

[HITMAN]

Nice little fine print, I was trying to figure why you'd post something from April 2022. Glad I jumped when I did.


PEB a takeover target*, according to Bell Porter.

https://www.odt.co.nz/business/pacific-edge-potential-takeover-target-report

"An Australian investment firm is reportedly suggesting Pacific Edge could be in line for a takeover bid."

"Craigs Investment Partners investment adviser Peter McIntyre, of Dunedin, said it was "very possible" a company was looking at Pacific Edge."



* Report issued a year ago so takeover must be any day now.

[Balance]

Nice little fine print, I was trying to figure why you'd post something from April 2022. Glad I jumped when I did.

There are going to be a lot of really pxssed off Bell Porter clients who participated in the CR at the time - $1.35 and they have lost over 90%.

Remember how the CR was upsized due to the overwhelming demand from the Australians?

https://www.nzx.com/announcements/379737

Takeover talk come out often enough by brokers to give their clients hope that not all is lost.

Big lesson there to be learnt.

[whatsup]

PEB a takeover target*, according to Bell Porter.

https://www.odt.co.nz/business/pacific-edge-potential-takeover-target-report

"An Australian investment firm is reportedly suggesting Pacific Edge could be in line for a takeover bid."

"Craigs Investment Partners investment adviser Peter McIntyre, of Dunedin, said it was "very possible" a company was looking at Pacific Edge."











* Report issued a year ago so takeover must be any day now.

I thought that AFT could possible be interested , a real long shot but the sharks will come sniffing sometime .

[winner69]

Maybe an Otago merger ……..PEB and BLT merge

[Sideshow Bob]

Maybe an Otago merger ……..PEB and BLT merge

Two dogs merge.....to get a bigger dog!! :huh:

[nztx]

Two dogs merge.....to get a bigger dog!! :huh:

the number of fleas might grow too :)

Perhaps EBO might be able to come up with a plan to fix that ? :)

[whatsup]

IMO a floor is in at .10.

[Balance]

IMO a floor is in at .10.

Looks more like a ceiling to me - sellers happy to cut their losses and exit at 10c in volume.

[stoploss]

IMO a floor is in at .10.
It’s already been to 5 , so 10 isn’t the floor ….

[whatsup]

Looks more like a ceiling to me - sellers happy to cut their losses and exit at 10c in volume.

we will see.

[Retired Doc]

Retrospectoscopy is an exact science ( unlike flexible cystoscopy which although being a “gold standard” also has false positive and negative results 😊!). IMHO ,and I alluded to this some time ago and I think some here agree, PEB has come off badly by taking on the AUA and a medical system which has huge flaws and is dominated by an insurance industry mentality. The phrase “medically necessary” is a crucial issue here and the interpretation leaves out personal considerations of the patients and seems to override primary care considerations. CxBladder in its various forms is a very good test and it would be very unfortunate if it falls through the cracks ( admittedly very large ones) of the US system. I have long thought a UK/Europe approach would have encountered far less resistance and had a far greater uptake. I also suspect CxBladder may have been significantly overpriced? Sadly this 20 year saga may end in the “How not to” section of business education textbooks or their equivalents.

[barney]

It's been an interesting twenty years all right. I sold my last remaining shares after the trading halt came off last year when they announced Novitas potentially withdrawing coverage. Despite the optimism from the company that it was an unlikely event, I couldn't reconcile this with the fact that Novitas would not advise such a move if they weren't serious. I had hoped to look at buying back in if the outcome was positive but that's not on the cards.

Over the years I have attended a few of the company annual meetings in Dunedin and talked with some of the PEB staff. They are a very talented group of people, and it is them I feel most sorry for in this situation as many may well lose their jobs. It would be a sad loss.

[Balance]

The damning thing about the negative development this week to me was the shock & surprise expressed by management and delay by the company to make an announcement on what plan B they have and how they are going to execute plan B.

Staff would have seen the sp tanked and know the writing is on the wall.

The company’s management have basically sat on their hands for the last 11 months since the proposed LCD withdrawal announcement in July 2022! In fact they have added on more staff in the US.

Clueless and now running out of options, and soon $$$.

Devastating outcome for staff and for shareholders.

Feeling very very angry at the management.

[winner69]

So I was rather thick not understanding what announcement meant

Share price up 14% …must have been good news

To me that (confusing) announcement on June 2nd Clarification of Timeline was bad news but share price went up 14% on above average volume.

Must be many true believers in PEB ….maybe slightly disappointed but probablybremain believers

[kiora]

To me that (confusing) announcement on June 2nd Clarification of Timeline was bad news but share price went up 14% on above average volume.

Must be many true believers in PEB ….maybe slightly disappointed but probablybremain believers

Or "investors" being "manipulated"?

[barney]

The damning thing about the negative development this week to me was the shock & surprise expressed by management and delay by the company to make an announcement on what plan B they have and how they are going to execute plan B.

Staff would have seen the sp tanked and know the writing is on the wall.

The company’s management have basically sat on their hands for the last 11 months since the proposed LCD withdrawal announcement in July 2022! In fact they have added on more staff in the US.

Clueless and now running out of options, and soon $$$.

Devastating outcome for staff and for shareholders.

Feeling very very angry at the management.

Yes, I would have thought plan B would be waiting in the wings in the event of an adverse outcome and would have been rolled out to shareholders in the announcement prior to the trading halt being lifted this week.
They will now have to do some major restructuring to keep the company going but that in itself can be expensive. Possibly the best outcome is that another company comes in and takes a majority stake or buys it out right.
At the end last year's annual meeting one of the directors mentioned that the board was going to spend the following day together brushing up on risk and audit skills, which just happened to be the day of the trading halt. Irony knows no bounds.

[Balance]

To me that (confusing) announcement on June 2nd Clarification of Timeline was bad news but share price went up 14% on above average volume.

Must be many true believers in PEB ….maybe slightly disappointed but probablybremain believers

Shows just how well the company has primed shareholders to expect a positive outcome? Looking back on the company’s results announcements, never a hint that there was ever going to be a negative outcome.

So the market fully expected that an ‘earlier’ decision will be a positive one.

Could not be more wrong.

[snigmac]

Does anyone have any information on the appeal process for the recent negative LCD decision? Normally the appeal process(that is built into the system) is set out clearly in a decision letter, but I can't seem to find this. When PEB refers to an appeal, does anyone know if they are referring to a appeal process that is built into the assessment system or a informal through the courts thing?

[zs_cecil]

Does anyone have any information on the appeal process for the recent negative LCD decision? Normally the appeal process(that is built into the system) is set out clearly in a decision letter, but I can't seem to find this. When PEB refers to an appeal, does anyone know if they are referring to a appeal process that is built into the assessment system or a informal through the courts thing?


Are you looking for this document (section 13.3)?

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c13.pdf

If this is the right document, it seems PEB had gone through the process mentioned in section 13.2.4 before LCD was finalized.
Now perhaps they would need to go with the process mentioned in section 13.3 for reconsideration or maybe section 13.4 for an appeal.

[Balance]

Sobering note from Craig’s :

So far we think the best approach is to re-apply for Medicare coverage using data from the Strata study, due to be published in 2025, which we expect will be sufficient for Cxbladder to be included in the key NCCN guidelines (one of the two conditions for Cxbladder to recover Medicare coverage), with potential for Medicare coverage to be re-instated from late FY26. However it may take longer for PEB to provide evidence to satisfy Novitas' other concerns (p.4). On p.6-7 we model a base and bear scenario based on reinstatement in FY26 and FY28 respectively. While PEB has $78m of cash, even in our base case scenario we estimate PEB will need an additional $44m of equity by FY27.

[Balance]

IMO a floor is in at .10.

Looks like the floor is actually a ceiling?

[snigmac]

Sobering note from Craig’s :

So far we think the best approach is to re-apply for Medicare coverage using data from the Strata study, due to be published in 2025, which we expect will be sufficient for Cxbladder to be included in the key NCCN guidelines (one of the two conditions for Cxbladder to recover Medicare coverage), with potential for Medicare coverage to be re-instated from late FY26. However it may take longer for PEB to provide evidence to satisfy Novitas' other concerns (p.4). On p.6-7 we model a base and bear scenario based on reinstatement in FY26 and FY28 respectively. While PEB has $78m of cash, even in our base case scenario we estimate PEB will need an additional $44m of equity by FY27.

I thought there was a 10cent cash only valuation somewhere?

[Balance]

I thought there was a 10cent cash only valuation somewhere?

10c per share is what they have in cash but they need every cent to survive in the next 3 years. PEB is not going to pay back the cash - in fact, Craig’s believe PEB needs to raise new capital by 2026.

DD has to be commended for raising all that capital when he did. Otherwise, it’s all over for PEB.

[850man]

10c per share is what they have in cash but they need every cent to survive in the next 3 years. PEB is not going to pay back the cash - in fact, Craig’s believe PEB needs to raise new capital by 2026.

DD has to be commended for raising all that capital when he did. Otherwise, it’s all over for PEB.

Next step for PEB is to show a path to increased revenue and profitability but with all their eggs falling out of the CMS basket that's now a huge challenge. One can only hope for upside in other areas. KP integration going live would help restore some faith but that has also gone uncomfortably quiet.

[winner69]

Will never be profitable now ….that’s how I see things

[Balance]

Next step for PEB is to show a path to increased revenue and profitability but with all their eggs falling out of the CMS basket that's now a huge challenge. One can only hope for upside in other areas. KP integration going live would help restore some faith but that has also gone uncomfortably quiet.

KP?

Go back to the initial announcement and subsequent announcements - I for one will not expect much given how clueless management has been with the LCD coverage and the ‘misinformation’ we have all been subjected to.

[snigmac]

Feel bad for anyone holding that paid more than 13cents per share. Going to be hard to break even now.

[HITMAN]

With the risk factor I'm surprised people are even buying at 10cents...

[snigmac]

The appeal process seems built into the system. Will just need new, cogent and/or compelling information to turn the decision around :)

[Balance]

The appeal process seems built into the system. Will just need new, cogent and/or compelling information to turn the decision around :)

4 more years? Or 20 more years?

[snigmac]

4 more years? Or 20 more years?

The document didn't say how long the appeal process will take. Will need someone that I'd a specialist in the area to comment.

[Habits]

The appeal process seems built into the system. Will just need new, cogent and/or compelling information to turn the decision around :)

Hopium or more than that

[Airw0lf]

Oh well, this company isn't a total lost cause. David Darling did get a new deck out of it.

[Balance]

IMO a floor is in at .10.

The floor has collapsed?

Got to admire the many attempts by punters to create a floor at 10c though but note how competing sellers are allowing the bids to build up and then, taking out the bidders in one go like wave after wave?

400m shares to go?

[snigmac]

The floor has collapsed?

Got to admire the many attempts by punters to create a floor at 10c though but note how competing sellers are allowing the bids to build up and then, taking out the bidders in one go like wave after wave?

400m shares to go?

I think that's abit of a overreaction until further information is released. The market has priced PEB as it has. I dont think we will see too much movement below 10c until a few months have passed or further negative information has been released. Currently, no news is bad news.

[Greekwatchdog]

Harbour Asset keeping the faith! https://www.nzx.com/announcements/413064

[mr optimistic]

Harbour Asset keeping the faith! https://www.nzx.com/announcements/413064

Arent they just. Bloody good stuff.

[RTM]

Arent they just. Bloody good stuff.

Pleased they aren't playing with my $'s.

[Balance]

Pleased they aren't playing with my $'s.

Yup - between MFB & PEB, they have burnt a lot of $$$$!

[Balance]

The floor has collapsed?

Got to admire the many attempts by punters to create a floor at 10c though but note how competing sellers are allowing the bids to build up and then, taking out the bidders in one go like wave after wave?

400m shares to go?

Volume sellers now moving a notch down to 9.8c?

[Habits]

Volume sellers now moving a notch down to 9.8c?

What price will you buy at. Down ramping well

[Balance]

What price will you buy at. Down ramping well

PEB is un-investable imo until it comes out with a properly costed coherent achievable plan to become profitable/cash flow positive.

Several tens of thousands of tests in 2014, remember?

US$100m in revenues within 5 years?

The market has been extremely patient and forgiving - I cannot see that happening again.

You think this company has any credibility left with investors (especially new ones) after the mis-information about the LCD’s coverage regarding medically necessary tests?

[Davexl]

From Yesterdays 'Good Returns'

https://www.goodreturns.co.nz/article/976521859/auckland-international-airport-shares-stumble-all-eyes-on-fed.html?utm_source=ST&utm_medium=email&utm_campaign=ShareTrader+AM+Update+for+Thursday+15 +June+2023

"Harbour Asset Management picked up another 1% stake in cancer diagnostic firm Pacific Edge. The investment company already had a 13.5% stake but now has a total shareholding of 14.5%.

Pacific Edge’s shares slumped 89.9% last week on the news that the firm was likely to lose Medicare coverage of its Cxbladder tests in the US from mid-July.

“In for a penny,” Davies commented on Harbour’s move.
Pacific Edge’s stock was flat at 9.8 cents per share by early Wednesday evening"

They clearly see some value in PEB, perhaps from a buyout, IP already accumulated - anyway bought a lot yesterday - we'll see what happens...

[Sideshow Bob]

Circa $800,000 for the further 1%.

Not sure what the original 13.5% would have cost them.

Averaging down always a winning strategy isn't it?? ;)

[Davexl]

Circa $800,000 for the further 1%.

Not sure what the original 13.5% would have cost them.

Averaging down always a winning strategy isn't it?? ;)

Not usually - but Harbour Asset Management seem to think their 14.5% is useful for something...

[Habits]

PEB is un-investable imo until it comes out with a properly costed coherent achievable plan to become profitable/cash flow positive.

Several tens of thousands of tests in 2014, remember?

US$100m in revenues within 5 years?

The market has been extremely patient and forgiving - I cannot see that happening again.

You think this company has any credibility left with investors (especially new ones) after the mis-information about the LCD’s coverage regarding medically necessary tests?

Just why are you so interested in a dead duck. It may be dead of course and the directors and mgmt not have anything new to add. Though there's every reason to think otherwise.

In which case its a good trade for you?

[Balance]

Just why are you so interested in a dead duck. It may be dead of course and the directors and mgmt not have anything new to add. Though there's every reason to think otherwise.

In which case its a good trade for you?

You are asking the wrong question - you should be asking why you or some other posters here only want to read one sided view of PEB which has resulted in such massive destruction of wealth.

I have been following PEB since 2013 and find the company an excellent study of investors’ behaviour. And if you are on your toes, potentially a good stock to make gains but equally, a terrible stock if you are not on your toes.

As for a good trade, let’s see if the management are capable of coming out with a coherent & executable strategy to make the company profitable & cashflow positive after blowing over $250m of capital.

Until then, PEB imo is un-investable. Now tell me, Habits, what is your issue with what I wrote?

You do not want to end up like the losers in DGL ASX, trust me.

[snigmac]

Its good to have all perspectives when discussing PEB XD. I for one think PEB is a prime target for take over currently.

[Balance]

Its good to have all perspectives when discussing PEB XD. I for one think PEB is a prime target for take over currently.

If PEB is going to be taken over, it would have happened already.

Like patriotism is the last refuge of traitors, takeover is the last refuge of a company going broke.

PEB must come out with a revised credible and coherent strategy asap - credibility is already pretty much out the window.

Looking like stock is heading towards 9c with buyers now getting filled fast by the big boys bailing out.

400m shares to go? :eek2:

[bottomfeeder]

I knew a guy who was coerced into paying for a stud service by loan funds on the basis that when the foal was put into auction it would make cost plus: the guy had to pay for all the costs, training, vet fees, living expenses, until the foal got to two year old. Then pressure was put on him to repay the $100k stud service loan. Those in the know of course knew the financial pressures he was under, so when it went to auction "one of the club" put in a relatively low ball bid. He bought the horse ready to run all trained up as a two year old for the cost of the stud fee.

You may wonder where I am going with this.

PEB is like that. All the research, groundwork, financing has been carried out to get to this stage. The company is now at a stage where new financing is going to be difficult. Now whether engineered to some extent the low blow by those in the US and resultant current SP makes it a prime takeover target for someone who is capable of resurrecting the US market and expansion to other markets will soon be active. Buying now may be rewarding if you want to take the risk.

[RRR]

PEB takeover target - not really! The only product which was bringing some revenue is gone - they have lots of scientists staff..last year they paid 33 million to staff and suppliers! PEB will be bleeding money..77 million cash they have right now will be depleted in the next few years.

[RTM]

Think of smart-phones, tablets etc and how much they have changed over the last 10-15 years.
Science in this area is the same. I would bet it’s moved on significantly.
Pretty risky to be buying PEB IMO.
Not for me.


I knew a guy who was coerced into paying for a stud service by loan funds on the basis that when the foal was put into auction it would make cost plus: the guy had to pay for all the costs, training, vet fees, living expenses, until the foal got to two year old. Then pressure was put on him to repay the $100k stud service loan. Those in the know of course knew the financial pressures he was under, so when it went to auction "one of the club" put in a relatively low ball bid. He bought the horse ready to run all trained up as a two year old for the cost of the stud fee.

You may wonder where I am going with this.

PEB is like that. All the research, groundwork, financing has been carried out to get to this stage. The company is now at a stage where new financing is going to be difficult. Now whether engineered to some extent the low blow by those in the US and resultant current SP makes it a prime takeover target for someone who is capable of resurrecting the US market and expansion to other markets will soon be active. Buying now may be rewarding if you want to take the risk.

[bottomfeeder]

Think of smart-phones, tablets etc and how much they have changed over the last 10-15 years.
Science in this area is the same. I would bet it’s moved on significantly.
Pretty risky to be buying PEB IMO.
Not for me.

Worth a peek at under 10 cents. Will put an order in for 40k shares. Not too much to lose. All tax deductible for me.

[Moneyman]

With no external debt I can’t see PE fail in the next 4-5 years. The shareholder base has been very loyal and arguably the company is in a better position today than it was during COVID when it traded at 7 cents. Significant upside remains but it’s not without risk. If somehow they get coverage reinstated the SP is likely worth 50 cents (probably more). A takeover form a US business is also a real possibility with the low market cap and current exchange rate!

[Snoopy]

Worth a peek at under 10 cents. Will put an order in for 40k shares. Not too much to lose. All tax deductible for me.


Don't forget that 'tax deductible' means that for for every 28c in the dollar of loss shouldered by the tax man, you lose 72c in the dollar of your own money.

SNOOPY

[Balance]

Don't forget that 'tax deductible' means that for for every 28c in the dollar of loss shouldered by the tax man, you lose 72c in the dollar of your own money.

SNOOPY

Indeed, tax deductibility is from the same school of thought that no loss is made until shares are sold?

[winner69]

I see PEB Chair Gallagher has put some of his play money into an ownership group of the Highlanders

Seems to like being involved with losers ……shouldn’t say that because that’s cruel

[Balance]

Harbour Asset keeping the faith! https://www.nzx.com/announcements/413064

This was Harbour back in Jan 2023 :

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/405498/387175.pdf

6.562m shares bought at average price of 70c

And in March 2022 :

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/388600/366381.pdf

14.585m shares bought @$1.35

:eek2::scared::eek2:

[haewai]

With no external debt I can’t see PE fail in the next 4-5 years. The shareholder base has been very loyal and arguably the company is in a better position today than it was during COVID when it traded at 7 cents. Significant upside remains but it’s not without risk. If somehow they get coverage reinstated the SP is likely worth 50 cents (probably more). A takeover form a US business is also a real possibility with the low market cap and current exchange rate!

Everyone should weigh that sort of optimism against the text in the LCD decision (linked from the PEB announcement on 7 June):

In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test’s parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.

[winner69]

With no external debt I can’t see PE fail in the next 4-5 years. The shareholder base has been very loyal and arguably the company is in a better position today than it was during COVID when it traded at 7 cents. Significant upside remains but it’s not without risk. If somehow they get coverage reinstated the SP is likely worth 50 cents (probably more). A takeover form a US business is also a real possibility with the low market cap and current exchange rate!

Perfectly reasonable ‘investment case’ as of today

But it’s sad that it’s had to come to this for you ……seems more of a reason to keep holding

You’ve been so bullish in the past - like this post from a while ago -


The upside in PEL from here is unrivalled on the NZX and the downside risk is reducing with each announcement. PEL has significantly more upside than PPH yet it’s market cap is c 1/3 of PPH.

Largest holding and continuing to accumulate with each announcement


And to think you were touting shares will $2 once.

You must feel terribly disappointed with how PEB have stuffed all this up.

[Habits]

Worth a peek at under 10 cents. Will put an order in for 40k shares. Not too much to lose. All tax deductible for me.

Buy 40k at 10c sell at 50c or buy at 10c and lose all. Potentially 16k gain vs 4k loss. The loss scenario is less likely for a few years as market value is backed with cash in hand

[winner69]

Buy 40k at 10c sell at 50c or buy at 10c and lose all. Potentially 16k gain vs 4k loss. The loss scenario is less likely for a few years as market value is backed with cash in hand

That seems a reasonable sort of punt habits ……..and if you think things not going to plan and lose patience you could even 20 cents

Think I’ll give up punting PEB after being lucky going from 5.5 to about 15 the other day.