Pacific Edge Limited (PEB) Earnings Call Transcript & Summary

Good morning, everybody, and welcome to Pacific Edge's 1H '25 Financial Results Presentation. I'm Dr. Peter Manches, Chief Executive. With me here in the room is Grant Gibson, our CFO; and online and available for questions are the Chairman of the Board, Chris Gallagher; and Chairperson of the Audit and Risk Committee, Sarah Park. So please note that by listening to today's presentation, we have this important notes and disclaimer, and we abide by all the conditions listed here. Brief agenda for what we'll cover today. We're going to look at the highlights. We're going to look at the strategic delivery. We're going to look at our financial performance and outlook, and then we are happy to take your questions. So starting with the financial performance. And guess I would position this as there are sort of two areas of focus. One is the financial performance and the other, of course, is the strategic milestones that the business has been hard at work on -- in tandem. So global tests are down 1.1%. Commercial test volumes up 3.2%, operating revenue up 1.4% for a net loss of $14.5 million, leaving us with $35.9 million cash. The headline from a financial perspective is that we are largely flat over prior half, which is not unanticipated given our priorities and our focus. We are, of course, awaiting the outcome on various potential catalysts for our business. Medicare coverage certainty, AUA guidelines review and the outcome from that committee. We are also awaiting Triage plus pricing. And -- we are -- so those three key milestones. Operating revenue, net losses and cash rate are steady, and that's the key financial message. And our commercial operations remain focused on profitable territories, non-Medicare revenue streams and some of the economic value of Cxbladder. And our business has been focused on the clinical development of Triage Plus and Monitor Plus and the various digital systems that make sure that we're able to deliver that to the best of our ability. As a reminder, Pacific Edge creates value through three pillars. The short-term focus is on adoption, retention and revenue generation. Our medium-term focus is on dividend coverage and guidelines and our long-term focus is on research development and innovation. And we do this all with foundations on a values-driven diverse results-focused culture, scalable processes, training and quality systems and continuous improvement with a digitalized architecture, automated operations and real-time analysis for business insights. So our first half test performance are steady against prior half, the Medicare uncertainty, and this was largely predictable based on the throughput numbers that we published at the quarter. And you can see here a summary of our global test volumes being very consistent with prior half, but off a lower cost base than the first half of FY '24, and consequently, a lower volume than first half '24. We've also got global test volumes that, again, are slightly higher than last half, and but again down over FY '24 first half. Our products continue to be broken down. The mix is largely margin consistent that we have seen an increase in Triage usage. And this you can attribute to the adoption within the Kaiser system because that is the primary products that they use for hematuria valuation of the Kaiser system where the hematuria evaluation outside the Kaiser system. The dominant product has been Cxbladder Detect. Monitor has remained roughly consistent. So our foundation for growth. U.S. test volumes are steady. Kaiser Permanente has gained partially offset by some of the Medicare uncertainty that we see in the kind of general market. The -- so the throughput has been relatively stable. But there has been strong performance in Kaiser. The throughput, overall, has reduced from -- by 34% from its peak in Q1 '24, but this has largely been driven by the reduction in sales force that we had back when we reduced the size of our team. And what you can see here is that as the team has stabilized, the performance has roughly stabilized. This includes some of the challenges that we do have, which is that the sales territories are larger for the sales reps. But these -- that is offset to a degree by focusing on larger and more reliable accounts through that process as well. Importantly, we have focused on messaging on the clinical value of Cxbladder for risk stratification to reduce the cystoscopy. So what that means is that regardless of whether the product being sold as Triage or the product being sold is Detect when it is for hematuria valuation. We've been focused on the risk stratification messaging in preparation for the launch of Triage Plus, which will focus more on that messaging. So the foundations for growth, our performance improvements are sustained. So we've highlighted for investors, two key metrics for a while now. We are guiding you to focus on the sales force efficiency as we have lost members of the team. And so the size of the team as indicated in the top graph, looking at the bars in the bar graph. While the sales force efficiency, you can see has improved, but now plateaued as we have plateaued the -- as we have plateaued -- reached the stable number of sales people in our team. The clinical commitment as measured by the number of unique ordering clinicians is largely unchanged. So we think we're largely seeing variance, but we have, of course, had a reduction in the number of clinicians using our tests over a period driven by having fewer sales reps in the market and those are the key messages here. So we continue to point investors at the quality -- the changes that we have made behind the seats to improve the reimbursement and cash collections. This has been a focus since I've joined the business. And for me, it's a very meaningful improvement that we have been able to make despite the headwinds that we faced by increasing our ASP from $472 in this quarter at $618. And what we want to highlight for investors is essentially that this is baked in, which is what we presented half a year ago when we noted that it had gone up to [ $630 ]. The drivers that underpin this rise are things that we expect to maintain as we eventually hit the strategic milestones coming up for the business and revert to growth. So we are -- we look forward to reaching those strategic milestones and demonstrating to the market that these are indeed baked in. While the U.S. is easily our largest market and should rightly take the majority of our focus. And we often follow the mantra that where we have a single point of failure, we also have a single point of focus. We do also recognize that it is prudent to look at other markets -- and we're generally very happy with the progress that we have been making within New Zealand, which continues to grow -- within Australia becoming a slightly bigger contributor and also the work across Southeast Asia, we're starting to see some low volume of tests trickle in from those activities. We do just advise investors that these are -- Southeast Asia is in the early stage. And so is Australia really. We spent a long time doing clinical studies in Australia working with the KOLs. We do know that well. But from a commercial standpoint, we are still in the early stage there. So there's a lot of potential upside, but it's early days, and the hard work is still ahead of us. One of the major things we've been working on within the research development and innovation is to simplify Cxbladder as we create Triage and creating Triage Plus. So the portfolio suite of offerings that we will have going forward will differ from what we have today. And we have been talking for a while about Triage Plus, we talk about Monitor Plus. But currently, we have Detect and Triage for hematuria valuation and Monitor for surveillance. But as we reach our R&D milestones and as we reached our clinical evidence generation milestones, we will be commercializing two tests Triage Plus, which will have two value propositions that will focus both on the risk stratification at the top of the funnel, but also due to its high positive predictive value be able to be useful for adjudicating diagnostic dilemmas as well. And also and seek that Monitor, will be superseded by Monitor Plus, the timelines for that are less established. It's at an earlier stage while we focus the majority of our resources on the larger market, which is, of course, Triage Plusfor microhematuria. So as we continue to prepare for the commercialization of Triage Plus, we are focused on getting a price that reflects the clinical value and economic benefit of the test. We did learn -- I just learned by e-mail before joining this call, that it has confirmed that we will go for a gap fill next year. We were waiting for that decision. That is -- there are two parts, Crosswalk and Gapfill. Pacific Edge have been advocating strongly for a crosswalk. But a Gap ill is not a bad result. Gapfill emphasizes the novelty of the test and the novelty of the technology underlying the test. And consequently, it recognizes that there are no existing tests with similar technology in the CMS database. So we are also -- [ Gapfill ] does not, in any way, undermine our ability to launch Cxbladder Triage Plus on its existing time frames because we are able to work with Novitas to get a provisional price. That is not a process that is essentially the absence of process, it's ad hoc, but we will be following that process to the extent it exists to create -- to launch our product in line with our existing clients. So we will be focused on reliable Medicare reimbursement for existing coverage of our tests and new arrangements following Novitas policy decision on the draft genetic testing for oncology, which is yet to be determined. The work that we are doing in the meantime, though, is driving the coverage of reimbursement of Triage Plus, adding capabilities and capacity to the PEDUSA laboratory, a whole new DNA workflow needs to be added in the lab, simplifying laboratory workflow for improved efficiency that reflects our need to scale as we revert to growth. We're optimizing our sales team structure and expanded product adoption. We are going to have to run legacy products for Triage and Detect for some period of time, because it takes some time to migrate New York state licenses over to a new product longer than it takes for the rest of the population, and we will continue to support that Kaiser with their Triage tests while we migrate to Triage Plus. Those things will be done on different time scales. We are preparing sales and marketing training materials to ensure that our existing team and any future expansion of that team will have the appropriate training materials to get up and running quickly. But a large portion of this work has already been done. While the product name has been changed from Triage or Detect to Triage Plus, selling the value proposition that we have for risk stratification we've been doing for a year now. And that is one of the reasons why we have, we will at launch call our product, Triage Plus in the marketplace, because we're selling it for that value proposition. We're going to continue to work through our medical affairs team, enhancing medical education with the speakers bureau of podium presentations and evidence development. So a reminder of where we stand today. So Triage Plus pricing stands to bolster Pacific Edge's economics. And as I mentioned on the prior slide, we have learned on the Pacific Edge will go to a Gapfill. So that information is in real time. And -- and so that extends the process for -- regarding how long it will take for us to get a final price but we are able to have -- to approach Novitas for a local provisional price in the meantime. So it does not disrupt our launch plans for Triage Plus in 2025. And as I've emphasized through the presentation so far, we are focused on selling Cxbladder clinical economic and patient value and the budget impact model also supports this. So it is the best clinical value. It's also the best economic value when you're able to remove a very large number of patients from the guideline -- sorry, from the workup that is recommended by the guidelines. So we remain optimistic that through the AUA's consideration of that process, even though they don't consider the economic value. The combination of the economic value and the information presented in the randomized controlled trial which is STRATA, are evidence that the AUA guidelines groups cannot really ignore when determining what the new guidelines should be. We're also strengthening our customer experience. We're driving to get a long-term market share. We have developed a digital connection to [ Lumea ]. We announced this at the shareholder meeting. And so this is kind of a follow-up to that. We have a number of integrations already. We are integrated with Kaiser Permanente, as you know, for the Southern California region. We have integrations with our Awanui New Zealand that serves the local population here. And you can think of Lumea as they are a commercial company with -- that behave similarly to Awanui, they are a digital pathology lab. They have their own lab where they run tissue samples and other diagnostic tests. But their focus is on integrating diagnostic tests and pathways. And so this provides us with an opportunity -- I'm sorry, they are very focused on the urology sector and the partnerships that Lumea is developing, they expect it to be roughly 25% of the tissue typing market in prostate cancer, making them a meaningful partner for us going forward in bladder cancer because many of those customers will be the same. So what are we trying to achieve here? We're trying to achieve these one-to-many integrations, and improve the end-to-end experience to drive stickiness within our customers. And so while we've worked with partners, we're also developing our own customer portal, and that is expected to be launched before the end of the year. And we will advise in our next quarterly update how that launch has gone. Importantly, Kaiser EMR is supporting adoption. EMR integration went live a year ago, all 15 sites are using. We have great visibility within which sites are using at capacity and which sites are still to really get underway. There's plenty of room for growth within the Southern California region, but there are some sites that have more or less fully adopted for the value proposition that they intended to use it for. So we are delighted, 1 year on, with how this has gone. It is something I'd point to internally within the company as a marker of our future success. While Kaiser is a closed system where we've been able to create this kind of value, we should be able to do exactly the same kind of thing when we have digital integrations directly with EMRs at customer sites and guidelines that support users being able to use the test easily. So all of -- a number of tracks that we've been working on for a while are coming together here. Moving on to the AUA hematuria guidelines. The AUA commenced to review in September time frame, and they opened it up for public comment. We have no -- we have no information on how this is moving forward, but -- and there is no time frame provided. But we do -- based on the timing that they have that -- they have launched in September. We expect that they are reviewing as part of that STRATA clinical study. And what you should take from this is that we've long maintained that the model is make sure you've got good analytical validation and good clinical validation and good clinical utility. And clinical utility is what drives medical policy and guidelines committees are a form of medical policy, just the ones owned by the association. And so we expect that they will use this information in determining a change to the guidelines, whatever the update is we have -- and we hope that sometime in the new year that we will be advised of what the AUA are thinking in terms of their changes to the hematuria guidelines. And we stand ready to adapt to that when it comes out. What would a positive -- positive editorial was already published and highlighting the utility of clinical non-invasive biomarkers like Cxbladder. It specifically mentioned Cxbladder. And this is for me a reflection of how community are responding to the messages we've been pushing for a while, but there is momentum building within the community and increased recognition that biomarkers or biomarkers backed by randomized clinical trials are ones that should be considered by urologists and endorsed by guideline groups. The topic that we have that has dominated in Pacific Edge has existed over the last 2 years is generic testing for oncology DL-39365. But it's our view that the longer that the drags on, the more challenging it is for CMS to accept that this has been a process that holds true to the 1-year time line required for these kinds of things by law. So while extensions are reasonable, CMS have advised us that the extension is not indefinite. But for every day that it increases, we believe that it increases the likelihood of a favorable outcome, either by removing noncoverage determination or retirement. And so we continue to work in the background through C21 through directly approaching CMS through the Office of the General Counsel of the Health and Human Services. And we -- and through the force of those efforts, we remain optimistic that we are continuing to improve our position in this outcome. Regardless, if we do have a noncoverage determination, it is the work that we've done on clinical evidence generation and the time lines to those publications that would then become the most important strategic elements in our in our time line. And so these are the clinical evidence publications that we have been working on. One of them, of course, is already out, and -- two of them are already out. And STRATA, as I mentioned, clinical utility of Triage something that can drive medical policy and appears to be being considered by AUA has been provided to Novitas, and it is the basis for Kaiser Permanente using Triage in their system as well. So we have -- and then we have the analytical validation of Triage, Detect and Monitor that's also been published, and Novitas has also been notified about that. We are working on the Triage Plus analytical validation. We are working on the DRIVE study. And the DRIVE study, just as a note, is now fully enrolled. The -- we have also created -- reached a milestone called database lock, which means we are making no more changes, and we are in the stages of analyzing the data in preparation for publication. There's still a tremendous amount of work still to be done. But to my teams that are working on this very aggressive set of priorities. There is -- there's a huge thank you to my team for the work that goes into getting these publications over line. And it's not just the clinical evidence generation team that's involved in making these catalysts to become a reality. It is members of the digital team, it is members of the R&D team, it is members of the clinical operations teams. This is pretty much a whole company effort that is behind getting the data that's needed for these studies -- and to hit time lines that I'm sure every investor watching can see that this is an aggressive time and that we are very hard at work on what is the most important focus of our business. And while we're very hard at work on that, our customers and partners at Kaiser Permanente are developing independent real-world evidence of Cxbladder clinical utility. We gave a little prelude to this at the Annual Shareholder Meeting. The Kaiser Permanente presented an abstract now at the Western section of the AUA conference regarding the ongoing experience with Cxbladder, Triage. They are processing large numbers of tests very, very quickly. And the partnership with Kaiser is definitely expected through their comprehensive use of our products to drive very high number -- patient numbers in our States. So over [ 200] patients avoided invasive cystoscopy, improving patient satisfaction, urology access and lowering the overall cost of care and a peer-reviewed publication that will supersede the conference abstract on the complete data set targeting the AUA conference in 2025. This is another publication that has the potential to be used with Medicare as part of a reconsideration request in a noncoverage determination or even if we have coverage as well. So the strategic responses that we've been considering for more than 2 years here to an appending Medicare determination. So in the event that we have an affirmation of coverage, we would have a strategic review from management with our Board of Directors about the adoption of Cxbladder among patients, clinicians and health care payers to see what changes we might need to make to potentially accelerate. In our response to a loss of coverage, and we would continue to explore all legal options. So I would note that legal options would be targeted and low cost if we were to initiate them, because large sums of money would be better directed at our clinical evidence generation program. So we're not tilting at windmills with our legal options. Further review the structure of our operations to see whether there are anything that we can do to reduce our cash flow in line with our goals to retain -- regain Medicare coverage -- within our existing cash reserves and then continue to explore other strategic alternatives with Pacific Edge that could support the company through to regain Medicare coverage and advancing the commercialization of Cxbladder globally. And so all of those things are already mapped out in our response plan. Long-term value creation strategies continue. So we continue to advance our clinical evidence generation program for inclusion in AUA and NCCN guidelines noting, of course, that NCCN guidelines are not applicable to hematuria evaluation only AUA ones are. And we continue to invest in medical affairs, the digitalization efforts that will enable clinicians to continue to order Cxbladder to follow clinical pathways on all appropriate patient types and lock them into today. Research and innovation and focused on DNA enhanced products. As I mentioned this at the top of the presentation, here are the details. We are readying for the launch of Triage Plus and in later years Monitor Plus. We're focused on ensuring that R&D, digital lab operations have the resources necessary for commercial scaling of Triage Plus and Monitor Plus. So at least some of the increase in costs are preparing our labs for that, Grant can comment on the specifics in his section. We are simplifying Cxbladder. We do this for a number of different reasons. We aim to reduce technician time, lower cost of goods, turnaround time, increased throughput, just general efficiencies, but we also aim to create an IVD-ready kittable Cxbladder for marketing in our international markets. So right now, we ask customers to send your in samples to our lab in Dunedin. This makes sense when the labs don't want to make the investment or even a lab partner doesn't want ot make the investment when volumes are low. But at some point, volumes will increase to the point that we will start to get requests saying, "Hi, I run your test in my country. And then we're looking to create that optionality with an IND-ready Cxbladder kit." Analytical Validation of automated end-to-end laboratory operations for our NDA workflows that is -- that is completed for our current product products, but we do have to continue that as we update our products. And it's just worth a small side bar that we regularly update our products with minor improvements in one of the other things that our R&D team have done a great job of recently is creating an alternative buffer with a longer shelf life. But all of our processes, everything that we automate will have to be recalibrated through that, but the automated -- sorry, for that alternative buffer as we make that incorporate that into our laboratory routine. And there is continued engagement with industry and economic research and development collaborations to address unmet needs in a cancer diagnosis and management. We're constantly looking at a very low level -- or at a very surface level, should I say, for opportunities beyond bladder cancer. Moving to financial performance. Grant?

Great. Thank you, Peter. Operating revenue of $11 million was up half-on-half by 1.4% and down 16.3% in the same period last year. So as Peter mentioned, the restructuring that we only took late in the first half of FY '24, which was focused on resuming capital will navigate Medicare coverage uncertainty, resulting in a reduced sales force producing both revenue and more importantly the cost base when compared to first half financial year '24. This will also impacted our sales mix with APAC contributions to increase from 5% to 8%. As U.S. revenue fell slightly offset by higher revenue in the APAC region. We continue to maintain a strong balance sheet with cash and short-term deposits of $35.9 million at the end of 30th of September 2024. Cash bearing of $14.3 million was higher than the [ $12 ] million in the second half of last financial year, with the first half taking the seasonal impact of higher weighted costs compared to the expectation for the second half of the financial year. Positively, capital participation initiatives continue to deliver. As we mentioned, operating income was up 1.4% on the second half of financial year '24, driven by a higher average sales price, lifting from $613 in the second half of last financial year to $618 per test in this current half. It's positive to see this is maintained, and it is a 25% increase on the average sales price that we obtained 2 years ago. Operating expenses post restructure have been maintained in the second half financial year '24 levels. Cash receipts were up 5.3% from last half, while the seasonal impact of the higher weighting of cash outflow in this first half of the financial year foreseen operating cash flow increased 16% in the second half of financial year '24. But on the same half of last financial year, down 16.8%. A net loss of $14.5 million is largely the same as the prior half and a 5% improvement on the first half of last financial year. So we'll drop quickly into the operating expenses. As we've mentioned, the operations are up slightly on the second half of last financial year, and that's largely driven by preparations for the commercial launch of Triage Plus. Research and development reflects the continued investment in clinical evidence. It's up 9% on the second half of last financial year and up 31% to [ 31.8 ]% from the first half of the last financial year. Sales and marketing expense reductions are seen predominantly in the first half of this financial year versus the last financial year, where they are down 42%, and it reflects the focus of our investments in profitable territories. Our general and admin expenses are up to $5.2 million from $3.5 million in the second half of financial year '24 as a result of receiving a high proportion of [indiscernible]. Great. I'll pass you back on to Peter.

Thanks very much, Grant. As a summary, we just want to highlight for all investors that we continue to manage cash prudently while we seek to maintain reliable reimbursement for existing products and establish reimbursement for our future products. We will continue to engage directly and through industry partners with CMS Novitas to preserve reimbursement for our existing portfolio of tests and anything that has -- that can be affected by DL-39365. In addition to that, we are focused on the clinical development of Triage Plusand Monitor Plus for guidelines inclusion and increased coverage certainty. We're going to focus on commercial operations in profitable territories, non-Medicare revenue streams and cash collections and emphasize the clinical and economic value of Cxbladder in our sales messaging. There remains some possible headwinds. We've acknowledged this for some time and that there is a possible noncoverage determination from Novitas on a new proposed LCD after they have followed the appropriate notice and common procedure and given the extension that they've been granted by CMS. But there's also a possible negative physician or patient response to enhanced patient responsibility on commercial insurance. We have already reacted to some of that and have updated our program while still seeking to -- seeking payment from patients whose insurance companies deny the claim, but there are more catalysts than there are headwinds. And so we -- the possible inclusion of Cxbladder Triage in the AUA microhematuria guidelines amendment would really recognize the fantastic work that has gone into the STRATA study and recognize Cxbladder as the first randomized controlled trial of a noninvasive urine-based biomarker anywhere in the world. It is another potential catalyst for our business that there's the possible requirement of the Novitas LCD there and alongside the possible recoverage determination from Novitas on the new proposed LCD after following the cost of the appropriate procedure. And the last one, I guess, we have to strike this cross that will grow -- cross out the [ Crosswalk ]. but we expect to determine provisional pricing now with Novitas for Cxbladder, Triage at a greater margin than current generation of products. And we will work on a gap fill price through 2025, which will give us a final national Medicare price. So with that, we are ready to take your questions. And open it up to those. And as a reminder, the Chairman of our Board and the Chairperson of the Audit and Risk Committee at Serra Park and [ Chris Gallagher ] are available to take questions that come through as well.

Your first question from the phone line is from Robert Morrison of Craigs.

Can you hear me?

Yes, we can.

Really good job to you and the team for making some good progress on these strategic objectives during what's a really difficult time. So first question is that it sounds like the key reason for the extension from Novitas was so that I can respond to comments. And so first thing is you didn't mention a time line, I'm guessing you weren't given a time line. And then if that is the case, do you know what the longest period an extension has lasted for historically is?

We are in unchartered territory. Since the 21st Century Cures Act has come into place only 1 past the 365 days and it was automatically retired. So this is the first extension under the rules of the 21st Century Cures Act. So these are unusual circumstances. In terms of what they're doing, and again, we have to take them at their word. And yes, what they have said is that there was unprecedented feedback to which they need to respond, but they failed to acknowledge that there were unusual circumstances to justify the extension. So it is very difficult to know anything else would be [indiscernible] feeding. So hopefully, that clarifies.

Yes. Helpful. And then I think you guys reiterated that if coverage was lost, you reckon you could get it back with the current cash reserves. Could you give me a little bit of color on the assumptions underlying this maybe not the dollar values, but just for that assumption, like when does that assume losing it? When does that assume getting it back?

So again, we probably wouldn't want to make any assumptions about the specific date of losing it. But I mean even if you used tomorrow as the date of losing it, we think that, that statement is accurate. Maybe because of changes we can potentially make to the business if we need to, but also because of the time line, and I believe it is -- let me just quickly look through my deck to give you the slide reference number. Slide 18. So Slide 18 outlines where we believe we can be recovered and for what. So focusing -- and again, typically, for coverage, clinical validation is sufficient. For guidelines inclusion, clinical utility is typically required. And that's why coverage usually actually happens before guidelines inclusion, again, another inconsistently about the proposal from Novitas of DL 39365. But we would point you to DRIVE data being published as clinical validation of Triage Plus in Q2 2025 as to when they would be reconsidered. So that information is -- governs our thinking.

Okay. Okay helpful. And then -- so correct me if I'm wrong, for -- to get coverage for a new test, you need three things, you need the CPT code or at least the part that you've gone down, you need a price and you need a LCD or NCD. So it seems like things are on track for the first two. What gives you confidence that Novitas would grant your new Triage Plus test coverage in 2025?

So there is quite a long answer to that question. And it's also just worth mentioning. So -- you can actually be paid by Medicare for tests without codes and without coverage and without a price. And many, many, many tests are -- what you do is you use generic billing codes like 84179. And -- and then you described the test, you provide supporting documentation and you make up a price and then Medicare will pay for the test. This is extremely common and is actually what Pacific Edge used before it had codes for its earlier products. So -- but your general framing is spot on for reliable reimbursement, you need the three things that you talked about. You need a code, but it does not actually have to be a code that is specific to your test, but that is the path that we have chosen -- just specifically get a PLA code, a proprietary laboratory Association code. Laboratory analysis code, which means that it is specific to our products and that makes them highly identifiable. Some companies desire to have it a bit more obfuscated, and there are many of those, but the general trend is toward PLA codes, particularly of what you're targeting is higher prices. And so our earlier -- it's -- our codes are PLA codes, they're uniquely identified and then you need a price. And -- but you can also -- you can build Medicare without establishing a price you will just get a -- you'll be locally priced by the contractor when you do so. But you can have a conversation with them about it. They will take into account many of the same effects, and it will not be binding until you have gone through a gap fill process. And then coverage, as we've discussed previously, that is dependent on clinical evidence. It is still the same contractor that does the work. It's different -- with different individuals involved, but they review clinical evidence. They go through a reconsideration request process, and then they either add it to the LCD or the coverage termination or a noncoverage determination. What is unique to molecular diagnostics is the 21st Century Cures Act, which essentially says that you should be covered on a case-by-case basis, unless there is a noncoverage determination. And so that allows companies to launch and have a reasonable degree of or a high degree of reliability than other companies might have based purely on a billing article like 858917. So that billing article is currently the guiding for coverage, even though building articles strictly speaking, are not guides for coverage that they are guiding our code to be paid in the absence of a noncoverage determination. So apologies, that's a very technical answer to those who are listening, but hopefully, that helps you, Rob.

Super, I'll just clarify one thing before I jump off. So yes, because I understand the collection rates -- sorry. So as you say, if you don't have a coverage determination place, you can build Medicare and MA, but I understand the amount that they pay you would be, say, less than 50% whatever you charge or I think that's what it was. Looking at your historical. But what you're saying that with this new Triage Plus test, you can pretty much just start charging because of the 21st Century Cures Act, the recoverable amount should be pretty decent.

So 21st Century Cures Act doesn't govern pricing. It just governs coverage and whether or not they will pay. And so we expect to -- it's also important to note that Triage Plus when it was still called DEDUCT Plus, but it's code [ 0420U ], has been on the 858917 since January 2023 -- January 2024. So it has already been put on the list of codes that we use to guide our existing products for coverage -- now that. And so -- and as a reminder, we've previously disclosed, I'm sure our Medicare payment percentage is very, very close to 100%. So when you think about that and what reliability really means, Yes, the fact that Triage Plus code is already on [ 58917], absent a decision from Novitas that noncovers our test is highly likely to lead to reliable coverage. We will test it to though -- we will test that reliability before making claims about how reliable it is, and we have ways to do that.

Your next question comes from Matt Montgomery with Forsyth Barr.

Non-CMS U.S. revenue grew around 20% in the first half versus the second half of last year with minimal price growth in the period. Is it fair assume that this growth rate is broadly consistent with Kaiser growth, the first half versus second half of last year?

There hasn't been a significant change in mix on our other traditional products or traditional markets that we've been distributing into. So -- the only significant change is addition of KP. Yes. Sorry, I don't know whether you are looking at U.S. specific data or whether you were looking at global data. Are you looking at U.S. specific data?

Yes. That's U.S. specific. So you've disclosed your CMS revenue in the last three halves and you've just -- and we obviously get your U.S. revenue. So yes, I'm just looking within the U.S. specifically.

Then yes, the increase will be largely attributable to KP, yes.

And just a follow-up, in the U.S. business, if we were to strip out Kaiser and CMS, the pricing performance in the first half versus second half of last year would be largely flat. Then like you sort of baked in the gains. But yes, this is non-Kaiser and non-CMS.

So non-CMS, are you wanting us to take out Medicare Advantage as well? Or are you talking about Medicare Advantage and...

Yes. Yes-- everything ex Medicare [indiscernible] Kaiser.

Yes, I would say payment success is marginally increasing. So it is the dollar -- the allowable on our commercial insurance is roughly the same that's been more or less consistent for years. But the percentage of claims in which we get paid has increased and how we manage denials has also improved. So again, we're able to use the STRATA publication as part of our appeals process. That's one thing we do is part of our clinical dossier in the appeals process. But also, we have asked patients to pay a brighter share. So that is a driver of improved performance in the commercial in the ASP from the commercial segment.

Yes. Then you made a comment earlier that sort of from here onwards, we should more or less expect these current levels to hold rather than, say, materially improve. Is that right?

Correct. Like the gains that we've -- great question. So the gains that we've made are the kind of gains you can make without guidelines. The next major step that we can make in improving our ASP will come as a consequence of clinical evidence in the form of guidelines and in the form of very, very clear local coverage determinations when we have those, we expect to be able to be more aggressive with the private payers, you should expect to see more contracting with payers from us. We will not announce when we've contracted with X, Y, Z plan, there's [ 6,600 ] of them, that's not relevant will be part of BAU for us. but what you will see the evidence for there will be an increase in paid percentage and an increase in ASP, but it will all be off the back of the clinical evidence that we're generating.

Yes, yes. And then you made an interesting comment, Peter, around how you've got quite good transparency within Kaiser. I guess to that point, how far through Southern California, do you think you are in terms of penetration? Because I think you made a comment that some were sort of up there already and then others weren't sort of about a weighted average.

So there are just quite a few land lines here and caveats and other things that you just have to think about. But for the stated intended use and for what they have implemented in their clinical protocol, things are going very, very well. But the clinical protocol that they've implemented today isn't giving Cxbladder to every eligible patient yet. So there are -- this is what's known as type expansion. So the type that they're using it on today is patients presenting with microhematuria in the general practice setting and at the decision to refer but they are rolling out UTIs and kidney stones and various other things at this point before referring to urology and other things like that. But they could use it for other uses. And they are using in the monitoring setting, but the monitoring setting is being much less frequent -- don't actually -- they are not using it as consistently aligned with the protocol that they stated to us yet. So that, again, provides us with how we should support them. I mean we -- to my comment about the transparency of information that we have is sort of a two-way thing. We can see exactly which physician is ordered and from which facility they come in. We can actually correlate the data and show up to Kaiser and say, "Hey, we have noticed these patterns is that what you're seeing, when you think we should help you by putting resources here, here and here." And then we go through that kind of account management process with them. And then once we have learned how to do that really effectively with Kaiser, we expect to do that for other accounts as well.

Yes, yes. Makes sense. And then there's a comment around outlook in terms of cost base into the second half to decline, assuming, I guess, the current status quo and coverage holds -- or sorry, maybe there's no decision. Are you able to give us a sense of, I guess, the quantum and where it comes from, given it appears as if the sales force has stabilized for now?

Yes. If you look at the second half versus the first half last year, revenue is largely the same, the expense base is largely the same. So the first half or second half last year sort of has that same sort of split between the weighting on the first half being higher than the second half. So you'd expect the second half to be the fundamental base line for our second half next year, all things assuming being all set. We're a margin holding pattern per say.

Yes. Okay. So no further cuts, if you were more just consistent with last year, second half?

Yes, that would be the starting point.

There are no further questions at this time.

Great. Thank you. We do have one that has come in online. So thanks, Adrian. The question is with $35 million of cash, if the Novitas decision is not favorable and you're not picked up in the AUA guidelines which appeared to the $35 million in roughly 12 months and would you need to raise cash by issuing shares? So there's no comment on the need to raise capital. Again, what we would focus here -- we think this has actually been answered through the presentation that even if we -- even if we lose coverage and the evidence that we are generating today that will be published by Q2, and submitted for reconsideration in Q2 next year will be sufficient to regain coverage. So there are rules that we have to play by. There are also rules that Novitas and Medicare have to play by. And we are doing in the way that we generate our clinical evidence and the way that we publish and communicate our clinical evidence, there's a step change different from the way that we used to do this. And consequently, I have very high confidence that the quality of the underlying research, the quality of the clinical evidence and the quality of the publications that we will put out -- they are what Novitas is asking us to do. They are what CMS is asking us to do in all of the other private payers. So we shouldn't see as much uncertainty as we have had to navigate this the last couple of years because we have played by the rules of how to generate best quality clinical evidence. And I understand that some people may maintain some healthy skepticism around that. But this is something we will prove to our investors given the passenger type. So any other questions that came through online, Grant?

No, that is it.

Thank you very much, everybody. We look forward to hearing your feedback. You can always e-mail us at investors at pacificedge.com, and we'll get that, look forward to it as well. So thank you.