PEB-Pacific Edge

[Shareguy]

Craigs say "Drafts" of this type are often rescinded.

Medicare coverage of Detect & Monitor could be lost
On Friday PEB went into a trading halt, citing proposed changes to a key
document which enables Detect and Monitor to be reimbursed by Medicare,
the US government insurer which provides healthcare coverage to c.65% of
PEB's target population and the majority of PEB's revenue. The key change is
that Cxbladder will now need to be included in NCCN (a key US oncology
industry body) clinical guidelines for Medicare to reimburse the product (vs
current need to be for a valid medical purpose). These changes were
proposed by Novitas, a company to which Medicare outsources decisions to
cover diagnostic tests. The proposals are open for feedback from industry
participants and clinicians until Sep 6th, a process during which it will be
critical for PEB to gather support to push back against the draft proposal.
Best case scenario could see "business as usual" by September
The best case scenario would involve the proposed draft being rescinded
following a period of public comment, or the draft being published but with
all mention of Cxbladder removed. We see this scenario as more likely given
1) Detect and Monitor had demonstrated enough clinical utility data to
warrant Medicare coverage in 2020 - since then test utility data has only
improved 2) drafts of this type are frequently rescinded

[Left Field]

Shareholders update....tracking along nicely.

https://www.nzx.com/announcements/400636

"In the three months to the end of September (Q2 FY23) total test volumes processed in the company's laboratories were 7,861 up 36% on the 5,780 tests processed in the same quarter of the prior year and up 11% on the 7,055 tests processed in the three months to the end of June 2022 (Q1 FY23). Volumes for the quarter are 36% more than the average volumes recorded in the 2022 financial year.

For the six months to the end of September 2022, Pacific Edge processed 14,916 tests in its laboratories, a figure that represents a 34% increase on the 11,136 tests processed in the same period in the prior financial year. "

Plus this update re Novitas:

Pacific Edge maintains that in the absence of any adverse reporting event about the performance
of Cxbladder, it would be unprecedented to lose coverage. To this end, we have offered comments on the proposal (see page 4).

We maintain our position that the proposed LCD is unlikely to survive in its current form and continue to responsibly plan for all eventualities.
We look forward to providing a further update when we release our half year financial results on 24 November 2022.

More info here; https://www.pacificedgedx.com/assets/Investor-Files/Investor-Updates/PEB-Investor-Update-Oct22.pdf

[Left Field]

Based on today's news there was a tempting opportunity to re-purchase shares sold at 1.30 back in Dec 2021.

Plenty of upside from today's VWAP of .47c provided the 24 Nov update continues today's positive theme.

What could possibly go wrong?

[Left Field]

This posted by Defater on the other forum;

"Minerbarejet (Miner) Died on Friday. He had a Brain Bleed at his home in Hawera and died later that day of a stroke at the New Plymouth Base Hospital. I played golf with Sandy for years and worked beside him for 17 Years at Silver Fern Farms Beef Processing Plant where he was the Stock Grader. He was very intelligent, witty and loved a glass of red wine. I'm sure his comments will be missed by all here. If there are any messages for his wife (Julie) and family I will print them and pass them on as Julie does not use the computer. Sandy's funeral is this Thursday 10th November. RIP Miner."

I will miss his informed posts. A very intelligent observer and friend of PEB.

[Hectorplains]

Miner had unshakeable faith in CDY/ AN1 on the ASX too.  It's sad that they never came close to repaying this. He was very well read on both CDY and PEB. Moenga roa. 

[Shareguy]

$51 cents. Has been slowly going up. Apart from investor update on the 24th and other news?

[Left Field]

$51 cents. Has been slowly going up. Apart from investor update on the 24th and other news?

Speculation on the outcome of the Novitas coverage review that PEB is hoping to give alongside the 1H FY23 update next week (See post #76 above.)

Good chance it will be favourable.

Up about 17% on recent lows.

[Left Field]

There's an old saying...... something about 'following the trend till the bend in the end.'

And there's another old TA saying about 'gaps have to be filled.'

There's a lot of old sayings.....

[Left Field]

1H FY23 Results out.... not bad IMHO..... but no Novitas update.....yet.

https://www.nzx.com/announcements/402943

HIGHLIGHTS
• Operating revenue from test sales increases 62% to $8.7 million when compared to the same period of the prior year (1H22); total revenue increases 102% to $13.6 million when compared with 1H22, with increases from commercial test volume growth boosted by foreign exchange gains
• Total laboratory throughput rises 34% to 14,917 in line with analyst expectations, lifted by a 35% increase in commercial test volumes to 12,422, with growth led by the US market
• Investments driving Cxbladder adoption and lifting US clinician engagement; staff numbers increase from 86 at the end of March 2022 to 100 full-time-equivalents (FTE) at 30 September 2022
• Kaiser Permanente using Cxbladder Triage at 11 sites, two of which are in the Top 20 sites by volume during 1H23
• Net losses after tax increased to $10.6 million, from $9.0 million in 1H22 as Pacific Edge continues to invest for growth
• Cash, cash equivalents and short-term deposits of $93.5 million as at 30 September 2022, down from $105.4 million at 31 March 2022, provides strong foundation for continued investment
• Optimistic outlook tempered by proposed LCD from Novitas and the potential to affect Medicare reimbursement.

[winner (n)]

Out of a morbid fascination of this company I looked at the Balance Sheet

Accumulated Losses rolled over the $200m mark

Another milestone met?

[BlackPeter]

Out of a morbid fascination of this company I looked at the Balance Sheet

Accumulated Losses rolled over the $200m mark

Another milestone met?

Don't you remember the millions of tests they promised 15 or so years ago? Was probably just a typo, they meant millions of losses ...

Clearly, they not just kept their promise, but overdelivered ...

[Left Field]

The market not too fussed by the results so far today.

Clearly the uncertainty surrounding the unresolved Novitas proposal is hurting.

"As we look towards the long-term, the proposed LCD from Novitas has been
factored into the phasing of our investment program. At present, we continue
to be reimbursed by Medicare for our tests and have not seen any reduction in
demand for Cxbladder since the release of the proposed LCD. Pacific Edge
maintains that in the absence of any adverse reporting event on the
performance of Cxbladder, it would be unprecedented to lose CMS coverage.

[winner (n)]

BIG news

All falling into place

Marked Price Sensitive so must be BIG news

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/403937/385487.pdf

[Left Field]

All that matters is that the market likes today's announcement....

up 7% today to approx 49.5c

no doubt a few more valuable patents to store in the cupboard too..

Next news should be a satisfactory conclusion to the draft Novitas reimbursement proposal.

Onwards and upwards.

[850man]

Lot of end of trading action today - 1.2M shares traded up 7.4% to 51c