Pacific Edge Limited ($PEB)

Earnings Call Transcript · May 24, 2026

NZSE NZ Health Care Biotechnology Earnings Calls 56 min

Earnings Call Speaker Segments

Peter Meintjes

Executives
#1

Good morning, everybody, and welcome to Pacific Edge's FY '26 Financial Results. I'm Dr. Peter Matas, Chief Executive Officer; and with me is Grant Gibson, Chief Financial Officer. And available later for questions will be Simon Flood, the Chair of Pacific Edge. So I just want to remind everybody, there is an important notice disclaimer about the information that we are presenting today. But to move quickly through to our financial results. And what we expect that you will notice is that these fully audited financial results are not particularly different from the results that we published early on May 11. So I will take the opportunity to move relatively quickly through this. We have 24,190 global tests 1,783 commercial tests, $1 million -- $11.5 million in operating revenue, which is down substantially as a consequence of the prior Medicare coverage and a net loss after tax of $35.8 million. But importantly, we worked pretty hard on our cash burn in the second half and had that at $2.4 million per month for the second half compared to $3.3 million in the first half. So as a reminder, our Cxbladder Triage, Detect, Triage Plus are used to risk stratify patients in the hematuria evaluation setting and our other products, Cxbladder Monitor and Surveillance Plus are used a therapeutic intervention on patients who have non-muscle invasive bladder cancer for the surveillance of those patients for recurrence. -- use appropriately on the right patient populations, Cxbladder tests drive economic value for patients, hospitals and payers. This is a key part of our message. On the left, you can see that the incidence of cancer in patients is low. And consequently, the current standard of care using cystoscopies only means that 100 patients will have to have 100 cystoscopies to find 5 cancers. But we have a better alternative that shows that 85% of those patients when using Triage based on its performance characteristics. 85% of those patients can safely avoid a cystoscopy, 15% will still need one. And of those, we will find the same 5 cancers. Cxbladder avoid invasive unnecessary procedures for patients, driving down costs for health systems and payers. And at scale, Cxbladder can spend more than 1.5 million patients in the U.S. with cystoscopy and save greater than $500 per patient, the information for our budget impact model. But importantly, there are 3 high-level trends across the market. The population in the U.S. is aging and with an increasing number of patients requiring urology care as they age. Importantly, the number of urologists is falling. We're not training enough in the United States. And this -- the combination of those 2 things is quite likely to lead to delay in diagnosis for patients as waitlist get longer and longer. Importantly also, Medicare reimbursement for cystoscopy has been declining for a number of years and is likely to continue to decline. That creates additional drivers for urologists to spend their time on other procedures and to have fewer patients incurring a cystoscopy. So our product development approach is to drive strategic value through innovation. And our next-generation tests do exactly this. So we are at an important inflection point, particularly since Triage Plus has also been covered recently in the draft coverage policy established by Novitas, which is a fantastic result. But we've been in the process of moving from Triage to Triage Plus. Triage Plus has been successfully analytically validated and clinically validated. That information was available to Novitas. And so they have made a decision to cover the test on that basis. And the price has already been established by Medicare's pricing system at $1,328 per test. And that dramatically changes the economics of operating our sales force and account executive and that underpins the future profitability of the company. We've made Triage Plus available as an option to all physicians and clinicians who currently order our test. Our prior position has been that Triage Plus is available under early access. Early access really with a limited number of customers. So our change since receiving coverage has been that we will now allow any customer to order it but we have many systems we need to build for handling Triage Plus volume both in our lab and in our operations that are outside our lab before we can fully launch that product and encourage and scale Triagelus. So at the moment it's an opt-in for our customer base. So we're seeing to have Triage added to the microhial guideline alongside Triage in FY '27. That may no longer be possible. We have received information that the next update will only commence midway through 2027 at the earliest. And so the guideline may not be updated until closer to 2028. We also have a second product, and we will -- as we reach various developmental milestones for Surveillance Plus, we will be -- we will slightly be removing monitor, but those steps are only in calendar '27 and a long way ahead. Surveillance Plus is focused on multiple types of DNA market, which is the innovation. It uses a combination of Ss and fragment lengths and other polymorphisms and to create an interesting signal. But those publications are not expected until late FY '27 or FY '28. Surveillance Plus has completed the freedom to operate and provisional patent is progress. And our commercial target for is to have a CPT code, a submission for a CPT code by December 9 in 2026. And then if that date is achieved, it rolls forward. And in about 6 months' time, we'll be able to be reimbursed on a claim-by-caim basis for that tetmurveanceus. And if that date is not achieved, we will then have the opportunity to achieve it again in March as the submission dates are quarterly. So moving on -- the draft Medicare policy that Novitas has now developed was sparked by -- triggered by an excellent contractor advisory committee that we had on February 19. During that cap, they noted strong clinical evidence supporting CSR Triage and Triage Plus. And the panel supported the validated use or the use of validated biomarkers for a range of different hematuria risk groups, initial evaluation, reflex, adjunctive repeat use and as a noninvasive option to anyone declining it. So there were a number of use cases that not all that are covered by the guidelines today that urologists made very clear are of interest to them. There were also a number of logistical and economic benefits that were communicated from primary care use through to rural use using in-home sampling and the prioritization of high-risk referrals, early detection to avoid more invasive disease and improved care for women, many women having their UTI diagnosis completed with the possibility of bladder cancer. Strong alignment that CSO tests have robust evidence and clinical utility with several experts explicitly appealing for Medicare reimbursement and broad access to improved standards of care and a pathway to recoverage, which is what we are talking about, which is one of the things we'll talk about a bit more today. So Novitas has now proposed a draft that includes coverage for Triage and Triage Plus. They have also confirmed in follow-up that hematuria test claims that are outside of the scope of genetic testing in oncology can be paid on a claim-by-claim basis. So Pacific Edge has already begun submitting intermediate risk patients that with data service after May 15 to Novitas to see if we will get paid. Novitas has issued the draft -- no other urine-based biomarkers are included in the draft coding article, creating a moat around our microhematuria business. This is a very important development. So there are legacy tests and generic codes that are noncovered for the purpose of ruling out cystoscopy and intermediate risk patients. There are also competing codes that are -- that have been given noncoverage is not after reviewing their evidence in the local coverage article as well. The inclusion of Triolus gives us an opportunity to shift our U.S. customers over to the higher performing and higher-margin test. The higher clinical utility -- it does have a higher clinical utility and works on a broader range of patient types. that even though it is more expensive, the performance characteristics means they can reliably rule out a greater percentage of patients, particularly higher-risk micro hematuria and potentially even gross hematuria, but we're not yet after that in chasing that indication. But by ruling out a greater percentage of patients and a greater percentage of higher-risk patients, we are able to provide even more value to the system in a model in a budget impact model. And that work is in process as well, and we'll be publishing that soon. So shift -- another thing that Trius does is it shifts the economics of Pacific Edge towards operating profitably given that the price is higher. And so a 70% improvement and a substantial improvement in margin and margin percentage over our legacy products is what we can now look forward to as we migrate customers over to the 1328 test, Triage Plus. The clear language in the LCD is another major highlight for us. The language is not ambiguous, and that's very, very important. We've never had this before. This is a huge achievement. The language makes it easy for Medicare Advantage payers to pay us. They can look at the language themselves and they can go that patient is clearly eligible and we're going to pay for the test. It removes objections that we have historically got for Medicare Advantage patients. And similarly, commercial payers who can read the guidelines, they can read the Medicare policy, they then have -- even though they make independent decisions of which tests to cover and which tests not to cover, they have fewer reasons to deny coverage at this point. And they also have clear language that they can copy. So we see that as a major benefit of having this published policy. And so Pacific Edge is seeking claim by claim reimbursement for Triage and have been advised by Novitas that products covered in the draft are eligible for that claim-by-claim reimbursement. And I think the recent events on to a time line 4th of May in the U.S. was when we were advised of the coverage policies very early in the morning. I happen to be in the U.S. at that time attending the AUA meeting in the following days. The notice and comment period starts on June 6, and the Novitas is going to hold an open meeting on June 18. Pacific Edge intends to attend that open meeting. Pacific Edge will also speak with a number of key opinion leaders in the industry to attend that meeting and give their views. The notice and comment period is open until the 18th of July. And then we enter another period of waiting where it is a black box. Novitas controls the time line. But we -- based on our prior estimates of when we would expect to get the policy finalized, approved by Medicare and published, and we expect that to happen before January 2027. It is important to acknowledge that Novitas could still retire the LCD. But what we want to make clear for everyone is that, that no longer appears likely. They have very -- they have definitive policy supported by the evidence supported by the experts and it's available for everyone to see. So talking a little bit more about the impact that Medicare coverage can have on U.S. commercial payers. Specifically, U.S. commercial payers are the largest group as a group, but there are hundreds of thousands or hundreds and thousands of commercial insurance plans that we would have to get coverage. So while it's the largest group, it is a complex landscape to try to navigate. The Medicare policy plays an important role in how those individual payers and plans will pay for tests. The Medicare policy essentially establishes that for a large number of these plans, it's no longer experimental and investigational. So this large opportunity is even more important for the patient type that we are currently pursuing. The patient type is intermediate risk microhematuria policy and all of the men that are in the intermediate risk category will have commercial insurance rather than Medicare insurance because they are under 60. So microhematuria patients skew younger with commercial health insurance and thus represent most of the total serviceable market for hematuria evaluation in the current Medicare policy and in the current guidelines. Final coverage policy for Medicare is expected to unlock revenue from commercial payers by removing a key reason that they could deny us as experimental investigational, so they can no longer do that. providing additional evidence to overturn denials on appeal. So some might still try, but then as we appeal through their market access teams, we can still get paid and providing language that commercial payers can adopt in their own policies, I mentioned that earlier and leveraging state biomarker laws to mandate payments from commercial payers. We can also remind them in the states where these laws have been passed that they are expected to pay by law for tests that are also covered by Medicare. So we focus on establishing medical policy directly with payers or through third parties like Avalon,iore, Carl, Concgenics and E. And we already have positive reviews from Avalon and -- so trying to summarize some of that in the next slide here. So back in 2020, we actually had our first payer coverage of sort. It was a letter of agreement between us and Kaiser Permanente where they approved commercial payment for Cxbladder tests. Subsequently, we started -- we published on our preferred -- sorry, our improved test, TROlus in December 2022. We've had an EMR integration go live in Kaiser Permanente. We then in May 2024, we had STRATA on the podium at AUA. And from there, we -- because STRATA was a randomized controlled trial, what we've been highlighting for investors for some years is that this starts the march forward for commercial payers to adopt all payers to adopt policy and aided by having a Medicare local coverage determination as well. So in April 2025, we had ECR giving us a 4 out of 5. I'm not sure that I've elaborated on this previously, but 4 out of 5 is a very, very high rating on the ECRI website. And many other comparable diagnostic testing services in the U.S. only have 3. Those that have a 4 include Oncotype DX Breast and Cologuard and a couple of others, but that's to highlight that, that ECRI 4 out of 5 is very significant for us to have for Triage. And it has also helped us to -- the randomized controlled trial has helped us to get policy with Avalon Healthcare -- and then the 2 punch from the randomized controlled trial is developing guidelines. And so with the guidelines with the -- with ECRI, with Avylon and with the CA of February 2026 and with Medicare coverage as of 2 weeks ago now or 10 days ago now, we are in a position where the dominoes are starting to fall. It is very challenging specific to predict how quickly. But what we want to highlight for investors is that we did the work on making sure that we have very good quality evidence because this is how you underpin your future commercial success. And these are the policies we know about. Sometimes it's not public information that we can easily determine, but we do our best to show how many lives are now covered for triage and how many are covered for monitoring. All right. Moving forward, our largest customer and largest payer Permanente. And we want to highlight the importance of that partnership. I did get to celebrate in -- at the AUA meeting with some of the members of KP that we work closely with. Of course, some of them also have senior roles in the American Urological Association and the AUA were instrumental in submitting their own reconsideration request and working with Novitas to help raise the profile and importance of hem valuation as a policy. So there's a lot to celebrate. But what we want to highlight here is the importance of not just the commercial side of the business, but also how we have an enduring collaboration with Kent, particularly the group in Southern California, where we have performed the largest ever clinical trial of Europe-based biomarker hematuria evaluation with 3,353 mismatched patients. That's over 6,700 patients total in the study. That kind of evidence is things that is very difficult for payers to refute. And so not only we've got the full house of clinical evidence, the AV, CV, the CU from a randomized controlled trial and the CU from a real-world evidence study. While we have achieved a very important milestone, and we do expect ourselves to focus on commercial metrics as we chart a path towards profitability, it is important to know that our evidence generation is not finished. We have a number of publications that are coming up in the coming quarters through FY '27. And we expect the STRATA second publication to deliver the Aussie clinical validation study to deliver. Those are clinical utility of Triage Plus and the clinical validation of Triage Plus. The other studies won't result in the next financial year, but pretty soon thereafter, we have a number of studies that we also expect to result. Our independent studies are also very important to us, and they provide us with the opportunity to explore new indications in a very low-cost way. The partner that the independent study does work, do all the science. We provide free testing. And it's a way for us to work closely with the key opinion leaders in a way that's meaningful for them and for us and stay in the headlines of conferences to make sure that we can become Done standard of care through our -- being front and center in the activities that they hold important. So we do have 2 that we are expecting in the upcoming quarters. One that is has been submitted and we're just waiting on that to publish, and that is our patient preference and satisfaction of biomarkers versus cystoscopy. While this is obvious to almost anyone who's given a leading consideration that a biomarker might be preferred as a noninvasive option over having a cystoscope urethra, no one has actually documented that while also taking into account the performance of the test because if your test doesn't perform well, you may -- your patient may have ongoing anxiety about did that test actually find or find the cancer or could miss the cancer. So a very important study done entirely independently coming up. All right. FY '26 volumes have fallen, but this is a trend that we will be looking to start to reverse with all of the tailwinds that we now have across our business. It's important to remember that actually in APAC, the volumes were steadily increasing the entire time, and it is really only the consequence of the Medicare noncoverage and the smaller sales team that we've had over there. These have been the drivers behind our reduction. And as we are able to act on the tailwinds that we have, putting more resource behind commercial scaling, we expect to be able to grow our volumes. So our U.S. operations have faced a number of challenges. This has been a common theme. The disruption of transitioning U.S. customers for CX to Triage after noncoverage was a big effect on our financial results. The post results, notwithstanding last year was a challenging year, and we have a reduced -- a smaller sales force that's been trying to deliver for us as a business. All right. Highlighting where we have some strategic wins in the -- across the entire Asia Pacific region, we are charting a path towards profitability. And this is the key message we want you to take away. The APAC commercial and clinical operations when you exclude the R&D cost is trending towards profitability on a direct cost basis. with an FY '26 cash burn of $0.6 million. And we are aiming to close that as much as possible over the next 12 months. And we'll report on that in our half year results to see how well we're doing. That was at least in part fueled by repricing efforts to bring our tests in line with market expectations. And going forward, it will be fueled by a wider adoption of 300 Plus over the legacy products, which we'll be promoting throughout the Asia Pacific region. In New Zealand, we know that we're in the closing stages of a national pathway. We expect to hear from them prior to July. But at this stage, we don't know whether we've been accepted or not, but we continue to push for that, working closely with the Urology Council. In Australia, we are focused on hospital contracting. And until we have a simplified IVD that we can run in Australia, that will be our main go-to-market option. But when we have an IVD that can be run in Australia, we can attempt exact reimbursement. And in Asia, no new milestones in the last couple of weeks, but we're continuing to grow that area. We are processing samples, commercial samples from 7 markets selling either directly or through a distributor lab partner. and continuing to try to get as much as we can from the pathways that we have already implemented specifically in Singapore General Hospital. So I'm going to move to Grant, who's going to talk about the financial performance.

Grant Gibson

Executives
#2

Thanks, Peter. So as Peter mentioned, our operating revenue fell 47.4% on FY '25, and that was predominantly due to the loss of media coverage, which impact both volumes and price received per test. We also reverted to cash accounting for Medicare revenue in the current financial year, which impacted current year. We have focused strongly on reducing operating expenses and down 9.5% on FY '25. And in the second half of '26, we're down 11.9% on the first half of the current financial year. So we focus on cash preservation while we made sure that we maintained a market presence that positions us for the company regaining coverage. We've also seen focus with the net cash flows in operating activities down 32.1% for the second half of the financial year compared to the first half. So cash at the end of the financial year was $7.8 million, but that has been increased with the successful completion of the $25.4 million placement, which settled on the 15th of May. It is also worth noting that we do have a share purchase plan that's currently open for shareholders with the New Zealand address and hold shares on 8th of May 26. This closes on Friday, the 28th of May. So I will point you to the release we made this morning on the NZX and ASX platforms and that provides an update on the -- we were targeting $6 million in the placement. But as of this morning, we've had confirmed interest of $14 million in applications. While we still haven't made any decision as to the acceptance of subscriptions, and we will make that the retail offer is closed, based on the level of acceptances received today, the Board considers it is likely that scaling applications will be required. So any scaling will be made by reference to the number of shares by eligible investors at the record date, which was of May. As we look at operating expenses -- this has been a focus for the year with a reduction of 9.5% year-on-year. And if we look at the individual categories, lab operation expenses are down, as you would expect with reduced volume for our U.S. lab in particular. Research is down 8.2% on FY '25, and that has been largely impacted by reduced clinical study costs. So the cost for clinical studies are largely forward weighted. And as studies have come to completion or nearing completion, we've seen some expense savings in that category. Sales and marketing has been the largest impact as we reduced our frontline sales staff. We have reduced expenses in sales and marketing area by 20% second half versus first half and down 13.2% year-on- general admin costs are also down as we focus on cash preservation. Thank...

Peter Meintjes

Executives
#3

Thank you, Grant. Just moving ahead to the outlook slides. So the recent events have been very important. We are positioned to unlock the value through upcoming commercial clinical and innovation milestones. We've been waiting for this for a long time. We have an opportunity that we can get claim revenue coming in now. The grant LCD has proposed coverage for Triage and Triage plus for intermediate risk mrahematuria patients. So that's where we will be focusing. Claimlaim reimbursement for Triage and Triage Plus for intermediate risk mhematiament is in alignment with the draft LCD is something that Novitas has advised us, we can submit for payment. Progressively phasing in Triage Plus at 13 28 U.S. customers accelerates our path to profitability while saving costs for health care systems. This is very important. Advancing medical policy for Triage with commercial payers, leveraging the draft LCD, the AUA guideline, in review and Avolon policy, all of those things are the dominoes we already have that have fallen, and we expect more to come in the coming months and quarters. C is under consideration by Health New Zealand for National Pathway in FY '27. We expect news relatively soon. In the medium term, we drive value for the business using clinical evidence development. The DV publication supported Triage plus validity, and we are awaiting an updated literature review by the AUA for subsequent guideline inclusion. As mentioned, that's not proposed to start until June 2027 as we understand it. Kmanentage study shows real-world evidence for triage in the largest based biomarker study of hematuria patients. Our evidence generation program continues because to make something the standard of care, you kind of never need to stop generating evidence and Triage Plus still needs this randomized controlled trial to be able to change the game all over again. The draft LCD have created the precedent and a number of other events have created the precedent for turning CXlayer evidence into robust medical policy, and we are already seeing the evidence of Blue Cross Blue Shield in North Carolina, South Carolina, Kansas City and Centara already adopting that medical policy. And innovation drives our long-term value creation. The next-generation products have -- are positioning ourselves very well. They have superior performance and that underpins their application in a broader range of clinical indications, improved patient experience and great cost savings for health care systems. For Pacific Edge, we, of course, have the benefit of improved unit economics. With Surveillance Plus, we are targeting a CPT PLA coding submission for December, where we can then expect revenue on a claim-by-claim basis after July 1, 2027. And we are seeking an $1,800 price for Surveillance Plus with provisional local pricing for Novitas with final pricing to be determined by a crosswalk during FY '28. Ongoing investment in product simplification and IVD products to enable decentralized international development is another area for long-term value creation through innovation. So with that, I'm going to pause for questions. And I believe we have some people, but I'll turn over to the MUFG folks to guide us through that.

Operator

Operator
#4

[Operator Instructions] And your first question comes from the line of Rob Morrison of Craigs Investment Partners.

Rob Morrison

Analysts
#5

It's a great outcome and really good on you and the wider team for sticking with it during what must have been some pretty challenging times. So first question on the monthly cash burn. So you have this target for FY '27 of $2.5 million per month. And I see you basically kept that in place following gaining Medicare coverage or draft coverage. Is the way to look at that, that you have this $2.5 million target and the revenue will be higher, but offsetting that pretty much exactly the OpEx will be higher to support the ramp.

Peter Meintjes

Executives
#6

Look, that's what you can conclude at this stage. We do expect ourselves as a Board and the management team to have a strategy session at some point to evaluate whether that is is what we want to do. But there's more evidence that we have to gather before we can commit to a forward-looking scaling. So what we need to do is we need to make sure that we can successfully run Triage plus tests at scale by opening it up to a broader number of customers as we have done. So we need to show that those elements are working. We need to then determine an official launch date by which we would start to move everybody over sort of put more force behind it from triage to Triage Plus. And we also need to show that we are getting the right kind of profitability and the right kind of volume with the restrictions that we have of accepting only at risk patients. That's going to be very important part of our operating environment. So as we can demonstrate those to ourselves, we would then look to reevaluate how quickly we can scale and whether or not changes in burn rate are justified. But at this stage, your conclusion is accurate.

Rob Morrison

Analysts
#7

That's great. And I appreciate it's early days, but are there any thoughts on when you'll hit free cash flow breakeven? Is that kind of a very near-term thing or a bit further out?

Peter Meintjes

Executives
#8

Look, we know what that can look like based on volume. What we have to do is prove to ourselves that we are bringing in that volume and at an acceptable level of unit economics for the sales reps. So that will be -- so we've modeled scenarios that there but we need to see execution. So we to be managing the business that way.

Rob Morrison

Analysts
#9

Okay. That's fair enough. Final question for me, if I may. It's a pretty big market opportunity, $7 billion in the U.S. Can you give me a rough sense on what a successful terminal penetration would look like?

Peter Meintjes

Executives
#10

Sorry, Rob, the sound a little clear. Tim penetration -- at this stage, look, we don't want to give any definitive time lines, we've got to prove some of the fundamentals to ourselves that, yes, it is a very large market, but we're also changing the behavior of physicians. And we are going to be selling our tests in a way that we haven't been selling it before, right? So historically, we have been selling triage and detect for any hematuria patient. Right now, we will be selling very strictly in accordance with the guidelines. So we'll be selling intermediate risk only, and we have to make sure that we are effective at that. And so as and when we are effective at that. And that is still a very, very large market, right? So it's a narrow indication, but it's a narrow indication of a large market, but it is a sudly different way that we have to sell. And so as and when we do that successfully, and we know that we've got that commercial model working, we can probably give you more insight into how quickly we can penetrate things. But one other thing I'll add to that is -- and because we're probably going to get a question from someone about it is we believe our tests do work in low-risk hematuria patients, intermediate risk hematuria patients and high-risk microhematuria patients. We believe they work in all 3 of -- and so as a consequence, while we deeply appreciate what Novitas has developed policy and in the context of LCDs, this has been policy that has been drafted very, very quickly, and we appreciate all of that. It is important for us to also push back on Novitas and say, hey, the guidelines might say intermediate risk patients, but the guidelines were actually -- they stopped reviewing evidence in May 2024, and the world has moved on from there. Most importantly, it has moved on from there with an analytical validation and clinical validation of Trius and a real-world evidence study for Triage that shows using it in low intermediate and high-risk patients. So -- but that's the way to change the indication. Using the test outside of the indication is not smart when you have a very, very clear indication. And so we won't be doing that. But we will be -- on the basis of any new piece of evidence, we will be asking Novitas to consider the evidence as a reason to change the patients that are indicated for.

Rob Morrison

Analysts
#11

[indiscernible].

Operator

Operator
#12

And your next question comes from the line of Ben Crozier with Forsyth Barr.

Ben Crozier

Analysts
#13

Just wondering if you can touch a little bit on the growth in either revenue or test volumes from the sort of non-CMS part of the U.S. business, so Kaiser and the remainder of those private payers. What sort of growth did you achieve in FY '26?

Peter Meintjes

Executives
#14

It is a very good question. We don't want to single out any one customer like Kaiser commenting on them on their own. We try to avoid doing. But it is -- we do want everybody to know that the Kaiser opportunity is performing in line with expectations for the current indication that they are using it for, which is actually slightly different from the AUA guidelines. It's on slightly lower risk patients, et cetera, et cetera. But that is -- they are using it optimally in their system and they are growing accordingly. I don't have numbers to hand on what the growth in the commercial overall is. But it is worth noting another couple of points. The volume is one thing to grow. You also have to get paid on all the tests. With the commercial payers, our -- the paid amount that we get is actually higher than the $760. So we don't get paid on every test. and that's often difficult for folks to understand. We do expect that to change now that we are in guidelines and have Medicare coverage, and we've got -- and they've essentially got fewer reasons to not pay for our tests. But commercial payers will do everything they can to not pay for the test. That's why things like state biomarker laws have been brought in. But we have more aggressive ways of chasing them now than we ever have had. And so we expect what's called our success percentage for those initial claims and for the subsequent appeals to increase. As an anecdote, there is something that we've told the market about before, you can take a commercial insurance company to what's called external review, which is where they get a panel of experts and they get paid $2,000 to be there to provide their opinion on whether or not a test is reasonable and necessary and should be paid. And we have had one of one actually happen because there's a long lag between when we run the test and when we can get through to -- through the appeal process through an external review. We have been paid on that test. So we expect as part of our revenue cycle management and billing processes to be because we have the evidence behind us and we want to go after those payments. But it is a long time to change that market. And I hope I haven't been too off scattering in answering your question. I don't intend to be, but it is a complicated thing...

Ben Crozier

Analysts
#15

Yes. some good color. And then maybe just on what proportion of your test volumes actually fall into this intermediate risk category today?

Peter Meintjes

Executives
#16

So we have not disclosed that figure, and I would elect not to disclose the figure just as a question and answer here. But you can use some basic prevalence for bladder cancer to give yourself an estimate of it. Bladder cancer -- sorry, yes, bladder cancer is disproportionately something for older people, Medicare age. Hematuria is younger. But we have predominantly been targeting a population of patients that are higher risk, gross hematuria. And so our population has been more biased towards Medicare and therefore, not intermediate risk patients previously. So we have some work to do to make sure that we are targeting the right patient types with this very clear indication from Novas and very clear indication from the guidelines.

Operator

Operator
#17

And that concludes our Q&A session on the phone. I'd like to hand back to management.

Grant Gibson

Executives
#18

Great. Thank you. We have online Okay. The first one, I think you probably answered just you want to add anything else. So it comes from Andrew and it focuses on the commercial team now focusing on commercial payers instead of focusing solely on CMS. Am I correct in understanding? And what impact will that have on revenue?

Peter Meintjes

Executives
#19

Yes. So when we -- the way we structure our commercial team is that there is sales, marketing and market access and reimbursement is a third discipline. It is also true that -- so sales and marketing have been able to focus on Medicare, Medicare Advantage that they actually don't think about the insurance nature of the patients that they're going after. They should be thinking about the patient based on their clinical criteria. So is that patient intermediate risk yes, go after them. Whereas our market access team has absolutely been heavily focused on Medicare. But again, I don't mean to be too candid with my answer, but if that was the only thing we were focused on, that's not a full-time job, right? So they have been focused on the Medicare as #1 priority, but they have been focused on a number of other things as second, third, fourth priorities. And that is why we have had Blue Cross Blue Shield GPO wins. That's why we have had policy with Avalon and Embry. That team is very busy. We have also been in the background trying to appeal the Medicare Medicare denials on the basis of -- through the Medicare process on the basis that they are reasonable and necessary. And that is another activity for that team. So the sales and marketing team, they will have to refine the strategy to sell to intermediate risk patients, the market access teams who deal with the insurance companies, they are -- they will have to put less work behind Medicare now on the front end, but we will have to adapt our billing processes to make sure that we can handle the new environment. And there's a lot of work to be done there, too.

Grant Gibson

Executives
#20

Great. meeting open for discussion LD on Thursday, the 8th of June. Is it possible for Pacific Edge shareholders to listen into this meeting?

Peter Meintjes

Executives
#21

The short answer to the question is yes. These are very dull meetings though, and I don't think that, that is good use of investors' time. It's up to you to disagree with me though. They typically run from around 1 in the morning until about 7 in the morning, so they are not in a suitable time zone. And to find the dial-in details, you have to use the VPN to access them on the Novitas website. We will have people on the calls. I have attended 1 or 2 of these meetings. We will -- we may try to make those details available if it is of interest to investors, but they are 95% of the call will be not Pacific Edge related.

Grant Gibson

Executives
#22

Have there been any approaches by acquirers to be the perfect bol.ara?

Peter Meintjes

Executives
#23

I mean no comment. I would be found by confidentiality on that. So -- but the -- I maintain as a program of work relationships with people in business development, large companies and CEOs of similarly sized but more commercially advanced companies within the diagnostics and therapeutics space and as part of my conference activities throughout the year. And so that's probably about the only color I think I can meaningfully give to that.

Grant Gibson

Executives
#24

Another question from Andrew. Why is the price for cystoscopy...

Peter Meintjes

Executives
#25

I guess I actually don't -- I don't know a concrete answer for that, but they -- I guess they are viewed as not adding sufficient clinical value by Medicare when Medicare reviews it. And as a consequence, they lower the rate. They want you to be doing something else with your time. So they incentivize you appropriately. But it's not unusual for the prices within the Medicare system to come down. And it's actually one of the reasons why there are lobbying groups, for example, like is that they're predominantly a lobbying association for large urology group practices and they try to keeposopy rates high so that physicians can generate more revenue from them. But Medicare overall, if they can lower the price on something, they will. And they see a huge pushback from an agency that can be justified or sorry, by an advocacy group that's justified, you should expect the price of things to go down.

Grant Gibson

Executives
#26

Great. This one I might direct to Simon Flood, who's company Chair. So with the retail offer scaling, would you consider scaling based on time the shares have been held?

Simon Flood

Executives
#27

Okay. Thank you, Grant. I think the person who put that in said that they were a long-suffering shareholder of Pacific Edge. So look, I just -- first and foremost, I just want to thank the person who put that question forward for a, asking a question, but b, for sticking with Pacific Edge for as long as they have. To answer your question directly, look, we in making allocations are guided by New Zealand Stock Exchange rules. And the rules insist and understandably so that you create a level playing field where all shareholders are treated consistently and fairly and the Board will be guided by that. And I think the rule that we are following, and we've said this in the retail offer documents is that what we will be guided by is the number of shares that people held at the record date, which I think Grant was 8th of May, yes.

Grant Gibson

Executives
#28

Correct. Okay. This question from Adrian. Is the end of the notice and comment period for the draft LCD, the logical milestone to reconsider ramping up the U.S. sales force, you have taken over on I think you've actually covered that. Is there anything else you want to talk about what you need to see before we start scaling?

Peter Meintjes

Executives
#29

Before we start scaling. Yes, look, a fairly extended painted a picture there earlier in the presentation. But look, it's not tied to the end of the notice and comment period at all. It's tied to the evidence that the things that we need to prove to ourselves internally that we are ready to scale. And that revolves around making sure that we've got robust processes around processing intermediate risk patients, robust processes around processing Triage tests and the ability to migrate every hematuria test over to Triage. And it is about demonstrating to our satisfaction that we have the unit economics that we have talked about since trying to get that price for Trio Plus. When we can demonstrate those things satisfactory through ourselves, that will be the signal that we can be more aggressive. But I hope that answers your question.

Grant Gibson

Executives
#30

And there was only one other question, AJ, but I think that was answered in the presentation as well. So that brings to a close the questions.

Peter Meintjes

Executives
#31

Awesome. Thank you everyone.

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