PEB - Pacific Edge Ltd

[MAC]

Well what some may know others may not, and what some may not others may well, and something’s may never make this thread too.

Generally though Pacific Edge are ticking the boxes along the commercialisation timeline nicely as they go I reckon, are they not, and pretty much within a multiyear plan perspective, around about on time also.

Next in the immediate sequence, Cxbladder(triage) launch in the US, CMS policy inclusion, Kaiser Permanente user programme results to be publicised, and later in the year the launch of Cxbladder(prognosis).

And the company do confidently continue to affirm they are on track against their five year goal of achieving $100M in revenues. There are some whom may be cautious about long term goals as I am, hence the need for research and a close following of the company, though some with area 51 post codes may doubt anything.

And, in the background, lots of validation too presently underway with three clinical studies in the US soon to come to a close, adding ever more to the library of bed time reading for urologists and insurance managers everywhere.

Agree about value, 69% upside to Forbar's price target from 74c for those that want it.

Personally, having read the Forbar analysis and report, I think they are overly conservative actually, but I have some reasons for thinking that.

[Snow Leopard]

...Cxbladder clinically outperforms all other tests within this first market, and because it has high sensitivity, 100% for most early stage tumors, it is a much lower litigation risk, and will demand a price point in commensuration of those two reasons....

I was of the impression that most early stage tumors were Ta tumors and the clinical trial results state that CxBladder has a sensitivity of 68% for these. [The numbers imply that in the tests about 57% of all the tumors were Ta].

For the remaining 43% (which includes Tis early stage) then the study does state a sensitivity of 100%.

The flip side of this is the low overall specificity of 85%.

Best Wishes
Paper Tiger

[MAC]

I was of the impression that most early stage tumors were Ta tumors and the clinical trial results state that CxBladder has a sensitivity of 68% for these. [The numbers imply that in the tests about 57% of all the tumors were Ta].

For the remaining 43% (which includes Tis early stage) then the study does state a sensitivity of 100%.

The flip side of this is the low overall specificity of 85%.

Best Wishes
Paper Tiger

Hancock's can talk to that better than I ever could, Ta tumors are important, agree with that, and with Cxbladder(detect) having a 68% Ta sensitivity, it is twice as sensitive as Cytology.

But one important thing that we must note is that what we commonly refer to, on this thread anyway, is the Cxbladder(detect) specification only.

The Cxbladder(prognosis) and Cxbladder(health) specs are likely to target other tumor groups, and will have different sensitivities.

And, it is the Cxbladder(triage) test that is the important one for specificity having an NPV spec of 98%, that's pretty much what it's dedicated for.

Overall sensitivity is also a function of how each test product appears to be tuned to specific tumor groups also.

Attachment 7052

[skid]

Well what some may know others may not, and what some may not others may well, and something’s may never make this thread too.

Generally though Pacific Edge are ticking the boxes along the commercialisation timeline nicely as they go I reckon, are they not, and pretty much within a multiyear plan perspective, around about on time also.

Next in the immediate sequence, Cxbladder(triage) launch in the US, CMS policy inclusion, Kaiser Permanente user programme results to be publicised, and later in the year the launch of Cxbladder(prognosis).

And the company do confidently continue to affirm they are on track against their five year goal of achieving $100M in revenues. There are some whom may be cautious about long term goals as I am, hence the need for research and a close following of the company, though some with area 51 post codes may doubt anything.

And, in the background, lots of validation too presently underway with three clinical studies in the US soon to come to a close, adding ever more to the library of bed time reading for urologists and insurance managers everywhere.

Agree about value, 69% upside to Forbar's price target from 74c for those that want it.

Personally, having read the Forbar analysis and report, I think they are overly conservative actually, but I have some reasons for thinking that.

I think most will agree,that although the management may claim thay are on track with their 5 year plan, In terms of sales, the growth curve that is necessary depends on exponential growth and there is nothing to point towards that yet--It really depends on something really lighting a fire under sales to catapult them.(my idea of commercialization is not only bringing a product to market--but selling it as well)

The Forbar report really doesnt mean much to me--Seriously-do you think they would have predicted a SP of 74c at this stage?(those that fell for that ''those that want it''last time will most likely not be so quick this time around)
There has been some talk of conflict of interest,but that is another issue.

So anyway,we are back to ''The product will sell itself'' vs The product needs an aggressive marketing campaign as well.debate

I believe that some are more or less pushing all of their chips in on the clinical trails not only being CLEARLY successful but the medical world going head over heals in its reaction to it---Others are thinking that is an overeaction (and the market is not so sure atm)

I believe your assumption that since management has invested alot of money (your money)that they must know what they are doing.
That imo is not a given. Investing alot of money does not validate your plan--that is yet to be proven,so we will watch this space.

[skid]

I guess we will just have to wait and see if all those accounts executives are successful in lighting a fire under sales-
It would be interesting to know if they were on salary or commission(or both)
So you are saying that their marketing campaign is through their accounts executives(Who I assume are looking for new accounts)--ok,fair enough
-wouldnt it be great if they just kept us all up to speed.

They ,of course, are not the only co. that make us wait for reports.

[skid]

Hancock's can talk to that better than I ever could, Ta tumors are important, agree with that, and with Cxbladder(detect) having a 68% Ta sensitivity, it is twice as sensitive as Cytology.

But one important thing that we must note is that what we commonly refer to, on this thread anyway, is the Cxbladder(detect) specification only.

The Cxbladder(prognosis) and Cxbladder(health) specs are likely to target other tumor groups, and will have different sensitivities.

And, it is the Cxbladder(triage) test that is the important one for specificity having an NPV spec of 98%, that's pretty much what it's dedicated for.

Overall sensitivity is also a function of how each test product appears to be tuned to specific tumor groups also.

Attachment 7052

Wouldnt it have been better to have developed a test that was more specific in early stage tumors(57%)than late stage(43%)? Detecting early stage would of course prevent late stage tumors ,if caught and treated. (Im assuming that when a patient goes to the doctor with the first signs of trouble they are most likely in the first stage)?

[MAC]

First and foremost it takes a sales force to actually be hired, and that’s the key thing that some on this thread haven’t recognised in the past. That there are dozens of steps required to commercialise any product, but the sales curve doesn’t start on that timeline until sales staff are actually on board and active.

There are steps before staff are hired like clinical trials, regulatory approvals, and commercial agreements with the network providers. And steps after they are hired, trained and up to speed, like establishing regional bases, initiating contact with LUGs and insurance company management.

And, that’s exactly where Pacific Edge are at this point in time, staff on board and just now active.

One can read their Linkedin profiles to see they are quite experienced in biotech sector sales and marketing actually, and most have prior sales experience with former pharma and biotech companies.

To answer your question, yes the sales staff are hired on a sales based scheme. Pacific Edge had this to say before they were hired within the 2013 capital raising presentation;

“The remuneration structure of Pacific edge’s individual sales force personnel in the US is geared significantly towards performance (sales) based targets”

Couldn’t ask for a better team IMO having read up on them.

[skid]

But the point is,you can have heaps of salesmen if they are not costing you much(in answer to Hancocks about account executives)

In researching on the American Urological Ass. website under urine biomarkers -the last sentence is

Despite their present and future potential, the critical evaluation and comparison of urine-based markers is beyond the scope of the current guideline involving the management of nonmuscle invasive bladder cancer.

Doesnt it just make you livid!

[MAC]

I’m a long term investor and don’t really care too much what happens with the share price unless I’m planning an entry or an exit, I’m content holding to see through the five year plan, and it would not surprise one bit if they were a $5 before then.

But, for those looking to enter it’s a pretty good time whilst the SP is in a dip and is undervalued against analyst valuations and price targets.

Invested capital is just that, it’s what is required as an input, it’s not the amount of cash invested that determines potential, it’s market analysis and the competitiveness of a product that determines potential.

One can read the Edison report’s for a gauge of the potential market, although I think they are conservative also in places.

But, certainly having a disruptive technology, a first mover advantage with it, the best clinically performing product, no serious competition within two years, the first product ever to outperform Cytology, an operational lab, twelve strategic sales staff just hired, and a very capable and successful CEO to drive it along is a recipe for success.

$100M in revenues in five years can sound like a big goal to us Kiwi’s in our little corner of the world, in the context of a US market of 319M people it’s not really. Biotech sector companies at that level of turnover are generally considered as new entrants to the market.

Now that the sales force is on board, analyst consensus is for revenue growth of 278% to FY15, and for revenue growth of 309% to FY16. And, sure that’s off a low base, but it all starts from here.

And, as you say let’s see, FY15 reporting is in just three months.

[MAC]

And yet there is healthy profitable market that has been in place for 10 years !

Until this new Cxbladder test came along all bladder cancer diagnostic tests were inferior to Cytology, what Pacific Edge have done is to break through that barrier with a new technology.

And that now offers the prospect of much much greater policy adoption from LUGs, HMOs and yes also by the Urological Association over time.

It’s a five year plan, and the first step is to partner and work with one of the large HMOs, which is exactly what Pacific Edge are doing with Kaiser Permanente, they have clinical studies underway with them and also a 2,000 test user programme.

It’s takes an insitu clinical demonstration to drive policy change, and doing so with a large well recognised company like Kaiser Permanente with 109 of their own in-house urologists is a very good move by Pacific Edge.

That change is not required for Pacific Edge to meet their goal, but the shear potential over time if they do is just simply enormous, and they are positioned to take advantage if or when it occurs.

Personally, I think we may very well possibly look back on that five year goal as having been really quite understated.