PEB-Pacific Edge

[Left Field]

Mmm not sure about  smoke and mirrors.

If there is a trend it is that Qtr 3 sales are traditionally weaker than Qtr 2. Such a trend is normally called 'seasonality.'

Here's what PEB said, "Volumes were flat on the Q2 23's 7,864 tests reflecting the traditional
slowdown the company sees from Thanksgiving through to the New Year and the
start of the fourth quarter. As the company has seen in prior years, it
expects a return to quarter-on-quarter growth in Q4 23."

In addition PEB are talking 'volumes' not revenue.   I'll make my judgement when I see Qtr 4 figs.

[Left Field]

Another brick in the wall.......

https://www.pacificedgedx.com/news-and-events/news/2023/pacific-edge-to-showcase-leading-biomarker-strategies-for-the-evaluation-and-management-of-bladder-cancer-at-sesaua/

[winner (n)]

Another brick in the wall.......

https://www.pacificedgedx.com/news-and-events/news/2023/pacific-edge-to-showcase-leading-biomarker-strategies-for-the-evaluation-and-management-of-bladder-cancer-at-sesaua/

Not a good analogy that another brick in the wall

Sounds like they building this Great Wall ...a barrier to stop users using their products

[Left Field]

Not a good analogy that another brick in the wall
Sounds like they building this Great Wall ...a barrier to stop users using their products

Building an IP Moat or Wall a cool strategy these days...

However many punters still blinded by former CEO's glossy claims and not appreciating the odds for a favourable resolution of the Novitas funding proposal.



   

[winner (n)]

Another brick in the wall  Leftie ...hope the wall don't tumble down

Got an email telling me this

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.

[winner (n)]

Suppose this is good news

Must have been worried about the share price falling into the 30's so came out with something

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/409266/391796.pdf

[Teitei]

Suppose this is good news

Must have been worried about the share price falling into the 30's so came out with something

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/409266/391796.pdf

Totally irrelevant to what is most critical to PEB's future - what is happening with the LCD coverage?

[Shareguy]

Totally irrelevant to what is most critical to PEB's future - what is happening with the LCD coverage?

Exactly.  And another president appointed last week draining the trough even further.

[Greekwatchdog]

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.

[Shareguy]

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.

Thanks for posting.  I hope so.  Cant say I like this.

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

[Left Field]

SP of PEB all over the place lately...... no reason other than pure speculation on the outcome of the Novitas LCD.

Seems today the optimists are back in charge.

[Left Field]

Interesting....... ANZ has been busy recently.

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

Optimists still in charge?

[Left Field]

Crikey, more optimism.....

https://www.nzx.com/announcements/410042

https://www.pacificedgedx.com/assets/Investor-Files/PEB-Quarterly-Investor-Update-Q4-FY23.pdf

In addition it seems we will know the fate to the Novitas proposal by end July 2023....

"Novitas put forward DL39365 (their proposal not to fund,)  in July 2022, and must either finalize or withdraw it within 12 months of the date of the proposal."

All in all, it's likely the new CEO and team are making good progress..... however we need more info on mere things like income, profitability, cash drain etc., to really judge this.

[Shareguy]

Level of growth disappointing. Q4 23 increased to 8,878 tests, a 14% rise on the 7,768 tests in the prior quarter (Q3 23).

Unless they increase the number of tests significantly or increase the price dramatically then the huge cash burn will continue. And no doubt another cap raise as soon as 2025 is suggested by some. 14 percent is nothing when you consider the opportunity that they say is their .   We no the market is huge so can only conclude that the market thinks the product is simply not that good. It all hinges on Novitas in my opinion.

FB seem to think longer is better for a positive Novitas decision. I think it's 50/50 and believe the share price will be decimated if the decision does not go our way.

[Left Field]

More key appointments according to my inbox.......cynics will point to increased payroll costs.

Optimists will like this as a vote of confidence by management.

1.) Pacific Edge has promoted its VP of Medical Affairs Dr Tamer Aboushwareb into a new role as Chief Medical Officer. The appointment, which will see Dr Aboushwareb join Pacific Edge's senior leadership team, is a recognition of the early impact the Medical Affairs Team has had on Pacific Edge's market engagement in the USA.

The appointment elevates medical and clinical influence into the core of strategic decision making and recognizes the value that a strong clinical focus has on coverage, guidelines and long-term shareholder value.

Pacific Edge Chief Executive Dr Peter Meintjes said: "The Medical Affairs team, established under Tamer's leadership in June 2022, has taken the opportunity to change the narrative for biomarker utility in bladder cancer detection and patient surveillance.

"The increasing engagement with KOLs, department heads and chairs at leading institutions, or owners and partners at private practices is gaining more mindshare of physicians and clinicians than ever before. This is leading to a perception change of Pacific Edge and Cxbladder, and subsequent behavior change in the management of bladder cancer patients to increasing rely on Cxbladder."

2.) Pacific Edge today announces the appointment of Danielle Gutter as its new Vice President of Sales.

Ms Gutter joined Pacific Edge Diagnostic USA (PEDUSA) on April 10th, 2023 and will head up Pacific Edge's sales efforts for Cxbladder in the USA, leading the three regional sales teams, the virtual sales team, the national accounts team, and sales operations.

Ms Gutter brings a track record in driving growth in senior sales leadership positions across the biotechnology sector. Most recently she was Vice President of Global Sales at digital healthcare company Igentify, where she was charged with building global sales strategy, marketing, and promoting the company's first-to-market digital genetic counselling platform.

Prior to that Ms Gutter held sales leadership roles in the oncology diagnostics division at Natera, diagnostics company Centogene, and scientific equipment and services provider Thermo Fisher Scientific. At Natera she built, launched, and led Oncology Division sales teams focused on the Signatera test for circulating tumor DNA (ctDNA) and immunotherapy products and testing. At Centogene she re-built and launched the company's US sales team and grew its market share.