Good morning, everybody, and welcome to the Financial Year 2025 Results Presentation for Pacific Edge. My name is Dr. Peter Meintjes, Chief Executive. With me here is Grant Gibson, and online and available for questions is our Chairman, Chris Gallagher. Please pay attention to the important notice and the disclaimer for all the information that relates to this presentation. A quick agenda: we are going to look at our highlights. We're going to look at strategic delivery, financial performance, and then end with some outlook. All right, so recapping our financial position here, we have had a reduction in the number of global tests that we operated this year, 11% down to 28,894 tests. We have had a reduction, but not quite as dramatic, with our commercial tests down to 24,642. Our operating revenue, as a consequence, has also come down.
Our net loss has remained roughly the same, and our cash-on-cash equivalence for the end of the March 31, 2025 reporting period is NZD 22.6 million. Importantly, though, we consider this to be a resilient operating performance amid the Medicare uncertainty that we had navigated through the entirety of the last financial year. While we have had an adverse Medicare local coverage determination after the end of the financial year, which I'm also happy to talk about, that has impacted us as well. The operating revenue, net losses, and cash burn are steady. Our tests per sales FTE has actually risen, so efficiency metrics that we care deeply about have improved. Our ASP, when looking year- over- year, has improved, although we did see a reduction due to some accounting accrual artifacts in the second half, and we can discuss those later.
Non-Medicare revenues are actually up and represent now 57% of US volumes and are continuing to grow. That has been a focus for us as a business since we had the reduction in our sales force back in 2023. This has been supported largely by the inclusion of Triage in the AUA Microhematuria Guideline. The longer-term economics we believe are reinforced by the draft CMS pricing of Triage Plus, which has been established at $1,018 per test, an improvement over the $760 per test for the current generation tests. A reminder, particularly since today's financial announcement comes at the same time as an announcement about a capital raise, is a reminder of what we're all chasing here.
We're chasing an $8.5 billion global total addressable market that focuses on two products or two areas of value: the hematuria evaluation, in which we have Triage, Detect, and Triage Plus, and the non-muscle invasive bladder cancer area, where we have Cxbladder Monitor and, in the future, Monitor Plus. The total addressable markets are substantial, and that is one of the great opportunities that we have here. Our goal is to capture as much of that as we possibly can. How do we do that? We create value for shareholders through three pillars. The first of those, adoption, retention, and revenue generation. We'll speak quite a lot about that in the context of our financial results today.
Evidence coverage and guidelines, something that has increasingly become a strength of ours at Pacific Edge and has been the driving force behind our inclusion in the AUA guidelines and will be the driving force behind the reconsideration requests for coverage. Of course, Pacific Edge has a proud history of research, development, and innovation, our third pillar of value creation. Since the last time I spoke with our investors in a financial results call, the major achievement that we have knocked off as a company is inclusion in the AUA's microhematuria guideline. This is a company-defining strategic milestone and allows us to think differently about our path forward. Importantly, while the guideline focuses on intermediate risk patients who want to avoid cystoscopy, clinicians can actually order this on microhematuria patients of any risk.
The primary driver for the change in the guidelines was the clinical utility in the Strata paper. The AUA would not have updated their guidelines to include multiple different urine-based biomarkers had it not been for the strength of the Strata study that demonstrated how they should update the guidelines. The Strata study is excellent, but it is also imperfect. The guidelines language that you see today is the strongest language that we think was achievable on the basis of the evidence in the Strata study. Our ongoing studies will only improve the quality of that language. Importantly, Triage was mentioned as the only urine-based biomarker to have grade A evidence. Again, grade A evidence is something that is only available to tests that have performed a randomized controlled trial.
Since we are the only one to have done so and the only company continuing to do so, this has created not only a first-mover advantage for us, but also allows us to build a moat around our business vis-à-vis any competitors. The change was actually quite significant. Prior guidelines actually advised against the use of urine-based biomarker, and that's one of the reasons that the AUA took us through a protracted process through 2024, where it had to go out for peer review in September. The 2025 guideline brings bladder cancer or hematuria evaluation for bladder cancer more closely aligned with other established disease states within oncology for prostate, sorry, prostate, breast, colon, and other cancers. Although, so intermediate risk patients, we have estimated at being around 70%.
This is actually something that's kind of unknown at this point because during the update to the guideline, the AUA also changed their definition of low, intermediate, and high-risk patients. That is something that we estimate at being around 70% of the patients, but that will be something that pans out over the course of the next couple of years. Importantly, this is about patients, and there are significant benefits to patients by reducing the burden of cystoscopies. At the same time, there are benefits to payers where we reduce the costs associated with treating patients. We also, for the physicians, reduce any legal liability of providing this option to those patients. We had the opportunity very shortly after Triage was included in the guidelines to be physically present at the AUA's annual meeting.
We have updated our investors about our presence at that meeting. It was really fantastic to see independent urologists talking about the changes to the guidelines and using Cxbladder as the example for how they should treat patients going forward when cystoscopy is not appropriate. Of course, around the same time as we spent time at the AUA, there was a Medicare non-coverage determination that came out in April. We note, of course, that this is inconsistent with the AUA guideline, and the company believes very strongly that over time, it is a matter of time before the coverage by Novitas is brought into line with the recommendation from an entire association of urologists based in the United States.
However, in the meantime, as we look at Medicare, it has been historically, we were paid at greater than 98%, and it has been the bulk of our revenue to date. As mentioned already in this presentation, and I will mention it again, the percentage of tests, though, and the percentage of revenue that comes from non-Medicare sources has increased since it has been a focus for us as a business. We have challenged this determination, but ultimately we lost. We believe that this can't really stand when contrasted with the AUA guideline recommended recommendation for testing. While 47% of US volumes are from other contracted payers like Kaiser, the Veterans Administration, Blue Cross, Blue Shield, and non-contracted private payers, we expect these volumes to continue to grow without interruption.
For our Medicare volume, we are continuing to seek reimbursement for all Triage tests ordered on Medicare patients through the Medicare appeals process. We are also, for commercial patients, seeking to create client billing relationships, and we will have more on that information as we go through our early access program for that. Long term, the definitive path forward for Pacific Edge is to be recovered on an LCD, and that LCD will be L39365. We have reconsideration requests that have already been lodged with Novitas. We lodged the one for Triage on the 20th of March, US time, and we lodged the other one in mid-May for Monitor. The one for Triage, of course, includes Strata, the evidence that Novitas did not review as part of establishing the LCD, and it also includes the guideline recommended language and references to that guideline. It is now under review.
For Cxbladder Monitor, we've included two new real-world studies from Australia that were published in March, and those are of a clinical utility and clinical validation of Monitor in that setting. For Cxbladder Detect, we haven't generated new clinical evidence for some time. One of the requirements for a reconsideration request with Novitas is to have new evidence submitted. Given that there is no new evidence, we have accelerated a plan that we had proposed to coincide with the migration to Triage Plus. We've now done a commensurate with this decision and are moving users from Detect to Triage. One of the sort of post-results points I will mention is that this is, by and large, going very well. It is operationally very difficult to do for our customer service team and our commercial team.
They have responded very, very well to this, and I'm pleased at the % of volume of Detect that has moved to Triage since we have deprecated the availability of Detect in the US. The bigger picture, industry experts typically estimate that it would take six to nine months from the time that a reconsideration request is deemed valid for a single product with only a small number of publications supporting it to be reviewed by Novitas. Novitas does control that timeline entirely. Also noting, as I mentioned before, we will attempt to get reimbursed on all Triage tests, and that includes an approach of appealing all of those tests through the stages of Medicare appeals, using the guidelines as the primary reason for that, as justification for them being medically reasonable and necessary despite a non-coverage determination.
As we look ahead to Triage Plus, which is very much how we think about the future of our business, Triage Plus incorporates DNA to be a multimodal RNA plus DNA test. And the analytical validation and the clinical validation of Triage Plus has already been internally complete. The analytical validation we have put into a fast track journal to get that turned around and published really quickly. The clinical validation, we go for journals with an impact factor that is commensurate with the quality of the study that is in it, and so we're chasing a higher impact factor journal. And because that includes the results from the DRIVE study, which have been published as interim results as part of the AUA meeting as well, showing the performance characteristics for Triage Plus. So we will submit a reconsideration request for Triage Plus as soon as it is available.
We need, or sorry, as soon as the AV and the CV for Triage Plus has been published. We are currently expecting that those will be before the end of the quarter, though when you go for a higher impact journal, as we are for our clinical validation, the timelines can sometimes get pushed out. In the meantime, we are running Triage Plus under early access, and we are leveraging Triage's inclusion in the AUA guideline as a de facto medical policy for Triage Plus. We are going to appeal those claims for Triage Plus during the early access program as well. Further evidence for Triage, and this is actually, this is far more than a single bullet point on a single slide.
The evidence published by Kaiser Permanente at the AUA was phenomenal, and we have put this out to our investors in a prior update highlighting the importance of this. It is 3,353 patients, which puts to bed any notion that we might have poor statistical power in our clinical studies. The results of the study are in very, very tight alignment with what has already been published for Strata. Again, solidly endorse the position of the AUA guidelines in recommending Cxbladder with grade A evidence. An additional bonus, once this has been peer reviewed and published, which we are anticipating will be in Q3 of FY2026, we expect that it will also demonstrate clinical utility and health economics in tandem within the Kaiser system. One final point, several months ago, we told investors that we were chasing three things.
We were chasing coverage for all our products in Triage Plus, which at the present time, we are not successful. But we were chasing two other things, and that was guidelines inclusion, and we have that. We were also chasing a higher price for Triage Plus, and we also have that. That price becomes effective in January 2026. Importantly, how should we be thinking about Medicare recoverage and the estimated timelines? I already mentioned the six to nine months. How are we mapping this out as we think about it internally? What we're really looking at is a decision somewhere between late Q3 and Q4 on Triage, if all things go as we expect. We note that it may take longer than that. That is, of course, possible.
On the strength of the evidence of the Strata study and of the strength of the AUA microhematuria guidelines, we expect a very high probability of success for the reconsideration request for Triage. There is also a reconsideration request for Monitor based on the analytical validation publication that we put out last year and two real-world studies. As mentioned on the previous slide, the reconsideration request for Triage Plus will only begin once we have the analytical validation and the clinical validation complete. At the bottom of this slide, you can also see the future catalysts for guidelines inclusion of Medicare coverage because our evidence generation program is ongoing. The Strata concordance publication is very important because that will allow us to establish equivalence between the performance of Triage and the performance of Triage Plus.
When we try to make the arguments that if Triage is medically reasonable and necessary, Triage Plus should also be medically reasonable and necessary, this will be a foundational paper for that. The Kaiser Permanente publications, I've already mentioned the first one, the one on Triage. There will be a second one on Monitor to come out, and that one is also currently under construction, but there is no interim abstract that's been submitted to a conference yet for that. Our other critical clinical validation studies for Triage Plus include Aussie and Microdrive, and they will be combined together in a pooled analysis. We are already thinking about the analytical validation of Monitor Plus, the Lobster interim analysis, and Credible, which is the clinical utility study to change the standard of care again with Triage Plus.
During the last year, our volumes did fall amid the sales force being able to reach not as many customers as we would have liked because there just were not as many people in the team and the uncertainty of Medicare coverage. Nonetheless, global throughput was not particularly different between the first half and the second half, but just a little bit down on all of last year. Our payer mix has changed a little bit. As we look at FY2025, we can see a greater percentage of Triage tests. This is mostly driven by Kaiser, but going forward, this will be substantially driven by our decision to stop offering Detect, and you should see a significant change in that product mix. Our contracted US payers underpin the growth that we have observed, and our relationship with Kaiser Permanente is very strong.
We've seen an increase in US commercial volumes of 2.7% against the prior half. Our non-Medicare volumes overall represented 47% of our commercial volumes versus only 40% in FY2025. And qualitatively, there's been strong performance from Kaiser in the Southern California region with all 15 sites ordering, again, dominated by Triage, but sorry, dominated by Triage, but with Monitor also increasing. The real-world evidence from Kaiser and the partnership that we enjoy there is already returning dividends for us as they look to grow internally. When they start to publish outside their system, that will attract even more urologists to the value proposition of Triage. We have begun to see the impact of the Medicare LCD after it's become effective on some of the volumes, but we expect to continue to use Triage, sorry, to use the guidelines to drive volume for Triage across all payer types.
The sales team has been focused on a couple of key performance indicators here, and both of them are trending upwards, which is good. What we've observed towards the end of the fourth quarter for the year is that we have 405.6 tests per sales FTE and actually our highest ever tests per ordering clinician, and also with ordering clinicians not actually reducing. Both those two graphs are showing positive trends within the context of the headwinds that we've been asked to navigate. We continue to focus on the most profitable territories, and overall, we are seeing a change in the mix of clinicians that understand the value proposition of Triage and that understand that they should be using Cxbladder tests more generally as part of the decision to defer a cystoscopy.
Our cash collections continue to improve year- over- year, but we do note that the 571 for the second half of the year is down on the 618. The overall increase has been generally driven by the enhanced patient responsibility program, the increased % of Kaiser Permanente in our payer mix, the Medicare reimbursement for Triage, which historically kept that low, and improved payment on initial claims and on appeals because we have the right medical necessity documentation. We generally expect that these improvements are maintained, and barring the variances related to accruals and the increased provisions against revenue, we expect this to continue to maintain or increase. As previously mentioned, we have established a higher draft price of $1,018 per test, and this improves the margin and margin % for any test ordered going forward.
This will not be effective until January 2026, and it will not be effective until we have coverage for Triage Plus. When thinking about the future prospects and the future profitability of the company, this is the number that you should have in mind for Triage for all hematuria volume. As noted earlier, a reconsideration request will be made as soon as we have the AV and the CV, and those are estimated to be published in June, though the CV may take longer through peer review. We are also accelerating our path to profitability by adding digital capabilities. Specifically, we have launched versions of a digital customer portal and a digital portal that reaches multiple users through the Lumaya system. Of course, those announcements were made through the course of the year.
We continue to work on optimizing our laboratory information management system for improved workflow and efficiency of the technicians operating in the lab, and that's going to continue to be a point of focus going forward. Optimizing our sales team structure and for expanded product adoption, sales and marketing materials now reflect the AUA guideline messaging. We continue to enhance the way we educate our customers through medical education, speakers' bureaus, podium presentations, talking about our evidence development. Of course, it's not just what's happening in the United States. As we look to the Asia-Pacific region and consolidating in New Zealand, we did have a slightly down half for the second half over the first half. Sorry, when you consider the entire year, we are up over any prior year and doing well in the Asia-Pacific region.
The Strata paper and the AUA microhematuria guideline are also well understood within the New Zealand operating environment, though they do not, strictly speaking, follow the AUA guidelines. Southeast Asia is still in business development, and we continue to extend into that market through a distributor network. One of the things that we are working on from an R&D perspective is that we will continue to seed this market until we have an IVD-kitted product that can serve the markets with a laboratory in their local market. Our customer experience initiatives are delivering value. As mentioned on a previous slide, we give customers a number of different ways to connect with Pacific Edge. The best example that we have is our one-to-one EMR integration, of which Kaiser is the most notable.
We also develop one-to-many integrations with digital pathology of, for example, Lumaya and also Awa Nuhi in New Zealand. We have a customer portal that is available to any customer account in the United States for the current release. We actually had to use, as we transitioned customers away from Detect and to Triage, we had to modify the digital tools, but it provided us with a great incentive to get people into those platforms as well. This improves the end-to-end experience for the ordering clinicians, and it makes it easier, whether it's in clinic or the in-home sampling. Future features include the optimization of test kit management, where each clinic will have a better understanding of their own inventory because it can track the inventory within the customer portal.
The primary features are having enhanced visibility and tracking over the orders as well, where once they have placed an order, they also know where it is in our system. Pacific Edge is, there are obviously a number of operating benefits for us, and that includes fewer errors on manually provided paper TRFs that are faxed or emailed to us, faster accessioning in our lab and delivering results, and thus reducing the demand on our sales force and our customer service teams to be more efficient and effective. One of the extensions of an initiative we have talked to investors about for quite some time, we have largely talked about simplifying CXbladder. One goal of, there are a couple of different goals associated with simplifying CXbladder.
One of the goals, of course, is to make our current laboratory-developed test, our testing service, simpler for the technicians to operate. Another goal that has now been segmented from that goal more completely within our R&D team is to focus on making Cxbladder so simple that the reagents necessary to run it can be put in a single kit and that that kit can be provided to other partner labs as an IVD. This will take some time to fully develop, but we intend to make that a focus of our R&D going forward. What it means is that Pacific Edge will operate in an IVD environment, will operate in an IVD superset environment that encompasses the regulations of Europe, the U.S., and the rest of the world through ISO 13485.
When we achieve these status in the different markets, it also increases the moat around our product versus any other competitors. I'll turn now to Grant for financial performance.
Great. Thank you, Peter. Top line operating revenue for the financial year 2025 was NZD 21.8 million. That was flat half on half, but it was down 8.6% on the prior year. As Peter mentioned, the reduction in revenue was largely attributed to the drop in our U.S. sales force in the second half of the financial year 2024. The key point on this slide is the increasing contribution that the Asia-Pacific region is making to our overall contribution, our overall revenue, which has reduced our reliance on a single market, and that is one area of focus for us. If we look at the cash, we had NZD 22.6 million as at 31st of March 2025, and the cash burn was largely flat, half on half.
The cash on hand will be assisted by the capital raise that we announced this morning on the ASX and NZX platforms of NZD 20 million. When we look a bit deeper into the numbers, as we said, revenue was steady half on half, but we do note that there was an increase in the average sales price to $594 versus $584 in the last financial year. Our operating expenses increased slightly second half versus the first half, but they were down 7.3% on the prior year. That is largely in line with the revenue reduction as we focused on cost efficiencies and cost saving to make sure that our cash burn was retained at a level similar to prior years. Digging slightly further into our expenses, there are two key points here, and they really show in the year-on-year comparison of our research costs, which were up 21%.
That increased investment, particularly in our clinical studies, aligns heavily with our third pillar of evidence, coverage, and guidelines. The other key point is the reduction in our sales and marketing costs of 31% year-on-year, and that was driven by a significant reduction in our US sales force in the second half of last financial year. Thank you, Peter.
Thanks very much, Grant. As we look forward, the AUA microhematuria guideline inclusion was a company-defining milestone because it enables us to drive sales, improve our marketing messages, but importantly, on the back end, handle reimbursement activities in a way that we did not have opportunity to do so before. We are determined to maximize this milestone through existing and new initiatives. The Triage Plus draft pricing gives us essentially a larger total addressable market based on the price of the test, supports stronger unit economics margins and sales force efficiency for a faster path to cash flow break-even and profitability if successful in reestablishing Medicare coverage. Our growth strategy that we are looking to accelerate with the new capital is, number one, entrench our first mover advantage and the moat for Triage given the AUA guidelines inclusion.
Two, continue clinical evidence generation for our future products, Triage Plus and Monitor Plus. Three, increase Triage throughput, throughput per sales headcount, and throughput per clinician to demonstrate the unit economics and profitability of our sales team. We will continue to seek reimbursement through the Medicare appeals process, again, relying on the AUA guidelines ahead of the resolution of the multiple reconsideration requests. We will increase the percentage of electronically ordered tests in our business, and we will also be focused more on patients with commercial insurance. We will continue to emphasize the clinical and economic value of Cxbladder as a value-based care solution in our messaging to selling to institutional integrated hospital systems and payers. We will initiate a client billing program to allow LUGPS and hospitals to pay Pacific Edge for a test and then take over the billing for the commercial insurers themselves.
We will continue to invest in innovation and product development for IVD kits to support entry into international markets in a decentralized deployment model. Further catalysts, Cxbladder is under consideration by Te Whatu Ora for a national pathway in New Zealand. With all of that, I'll thank everyone for listening, and now I will take questions.
Thanks.
Have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Again, that is star one to join the queue. Your first question comes from the line of Rob Morrison of Craig's Investment Partners. Please go ahead.
Hi, Rob.
Hey, good morning, guys. You mentioned that post-coverage loss had been an impact on US commercial test volumes. Could you quantify that, please? Was it down, say, 20%, or is it more like 30% plus?
We have not obviously published that figure to the market as part of these results, but just to give you some context, we think the number is less than 20%.
Great. Thank you. Then looking at the other, so what is revenue per number of tests? On the revenue per test, about 40% that, or if your revenue was coming from Medicare, there would be a decline of about 40% there, but there would be some gains from private pay and mix shift. Is that the right way to look at it?
Yes. We do expect a greater percentage of commercially insured or private payers in our mix going forward, although it will vary quite a bit by product. Again, our appeal strategy for Triage means that we will continue to expect physicians to order Triage tests on their patients, and that applies to Medicare, Medicare Advantage, and commercially insured patients. The high-level market trend, as it were, is that Triage is used a lot on microhematuria patients. Microhematuria patients, and that's what the guideline was for, right? Microhematuria, they skew slightly younger than the Medicare population. The average age of someone with microhematuria is 52. We expect on average that for Triage, the average age will be down, and the payer mix will be a greater percentage of commercial patients going forward.
Okay. Okay. Wonderful. And then so putting those two data points together, I guess it would be reasonable to expect FY2026 revenue to fall maybe 30%?
We obviously don't give forward-looking guidance on that, but there will be some reduction in revenue anticipated, and we have modeled those scenarios as part of the capital raise.
Oh, very good. Could you give me a point on the cost space then, please? Just directionally, because I look at that NZD 21 billion in the second half and wonder if I should annualize it. I think the sales force had contracted a fair amount in the fourth quarter. How should I be thinking about that?
I think as a first pass, noting that there's quite a lot still to come for the year as a first pass, it would be about the same in terms of cost base. We will continue to look for any avenues that we reasonably have to reduce unnecessary costs. That's just part of our MO in a cash-burning company. You can model it at this stage as being about the same.
Great. Great. Thank you. Final question, if I may. Could I please just get an update on Kaiser? Specifically in Southern California, is there still a decent runway to growth so we could triple where we are from here and then just progress on Northern California?
Yeah. I maintain the view that the Kaiser implementation in Southern California has gone about as well as it could have gone. We saw an immediate step up. Again, we do not quantify this for investors, and we do not want to pull out Kaiser-specific revenue or data. We would not do that for any customer. Sort of qualitatively, we did see a significant step up immediately after the EMR was integrated. We have seen steady growth. I think there was only one month where we did not grow. Is there room to grow? Absolutely, in our view. There are still plenty of doctors that are not using it on all of their patients. Maybe as a kind of an anecdote, the team at Kaiser were recently, they went through an internal process where their finance department came and chatted to them about how the program is going.
Their finance department came out feeling pretty happy about the whole thing. When your finance department's on your team, you're in pretty good shape. They are recognizing the savings in their system. They're recognizing the improvements in patient care, and the physicians that we speak to at conferences are loving it. I believe there is room to grow, and there are always going to be some laggards who will take some time to adopt despite a protocol.
Okay. And then on Northern California?
Look, we continue to try to press into other parts of California, sorry, of the Kaiser system. Northern California is obviously the largest single system within that, but those conversations remain in their infancy. The publication of the data there was published as interim results at the AUA and is in preparation. We see that as the major trigger point to getting the rest of the Kaiser system on board, as does that financial meeting, right? If the folks in Northern California understand how much they'll be able to save by adopting something that already exists in Southern California, we may be able to build momentum through that as well. There is not yet any clarity around a timeline that I could give you for that.
No worries. Hey, thank you guys so much, and best of luck.
Thank you, Rob.
Thanks, Rob.
Before we continue on to the next question, a reminder to join the queue, please press star one. Your next question comes from the line of Matt Montgomery of Foresight Partners. Please go ahead.
Hi guys, just checking you can hear me okay?
Hey, Matt. Yes, we can.
Are you?
Yep. Perfect. Just firstly, on sort of triage in the context of guidelines, I'd be interested if you could talk to, I guess, urologist view/feedback and maybe even sort of ordering patterns in the non-CMS bucket post the announcement a few months ago around guideline inclusion.
Yeah. The feedback, admittedly, when we go to conferences like the AUA, we interact a lot with our key opinion leaders, people who have been involved in our studies, people who are in the Kaiser system. We also do spend a lot of time meeting new doctors and new physicians, and many of them actively came to seek us out during the AUA because of the prominence given to the change in the microhematuria guidelines and Cxbladder's prominent role within that. Now it's up to our commercial team to capitalize on all of that momentum. I would say there are a number of users who are new to Pacific Edge, and there are a number of users, a significant number of existing Detect users that are now new to Triage as we're migrating them across.
The reaction when they understand that it's in guidelines and this is the test they should be using is overwhelmingly positive. We view the kind of impact that we have observed to the number of resulted tests to be largely an artifact of the logistics of trying to migrate customers over from one test to another, and then actually we'll be growing volume pretty soon.
Okay. Then just going back to Rob's question on the cost base, just confirming, are you suggesting that the first half OpEx will be similar to last year, or is it just clarifying?
It'll be slightly down, but I think as a first pass, you can model similar, but slightly down is probably the way we're thinking about it.
Yeah. Okay. And then just cognizant you've got reconsideration requests out there, it'd be useful just to understand the scenarios, well, the ranges in light of the different scenarios in terms of OpEx. If you get an unfavorable reconsideration request or outcome, where do you think how aggressive and where do you think OpEx goes to? And then equally on the other side, how should we be thinking about it?
I mean, I think the OpEx is going to stay roughly the same. Again, we are expecting our sales force have an objective to sell every Triage test that they possibly can, and we are going to be working very hard on the billing and reimbursement side to make sure that we get paid on every one of those tests. We expect the OpEx cost base to be about the same. Maybe it will be dependent on volume. Going forward, of course, that will be determined by the per rep unit economics.
If the economics of operating a sales rep can be improved to the point that they are bringing in two to three times their cost when contrasted with what they do today, which is roughly break even, then that is how we are thinking about how we would add further cost to the cost base. Grant, do you want to add anything else to that answer?
No, I think you've covered it. Yeah. A lot of the investments we're doing are about making it easy to order. We've got the guidelines at our back, so we're expecting that sales force efficiency to increase, and that'll really be the determinant. We continue to monitor that really closely as to how many tests each account exec is putting through and then their economics.
Yeah. And just specifically on research costs, like $14.6 million a year just being, yeah, that's sort of the area where presumably you've got a very good line of sight almost irrespective of the RCD. How should we be thinking about that in FY2026 and then maybe a few years thereafter?
I mean, we do not foresee that increasing. I mean, we have a series of trials that as one rolls off, another will roll on, but we are not expecting to increase the cost on a monthly basis associated with any of the R&D work that we do.
Okay. That's useful. Just sort of in the non-CMS US business, revenue per test has been flat for sort of a couple of halves. With guideline inclusion now, are you sort of expecting any growth there, or do you think you're sort of from a patient pay point of view, you've exhausted the lower-hanging fruit and just the billable percentage as well?
That's a really great question. Look, as commercial becomes a greater part of our payer mix and as we become successful with our commercial payer-focused initiatives, we would expect that the ASP increases. However, these things take quite a long time, particularly if they have to go through appeals. I mean, you're looking at 90-180 days often to get paid by third-party commercial insurers in the U.S. That will delay our ability to answer that question with any level of accuracy, but that is a long-term expectation that I think you can have. Yes.
Yeah. Okay. Then just sort of if we get a positive outcome around the RCD reconsideration shortly, would you look to raise capital again at that point? Cognizant that with revenue falling, NZD 20 million raise is obviously helpful in the context where the business is.
Look, we.
We just didn't see any sorts on just the quantum of the raise today, and then.
Yeah. The most uncertain variable regarding coverage, again, if we restrict ourselves to just thinking about Triage, the biggest variance is uncertainty comes from when we will be covered. That's not really, I mean, look, nobody can guarantee anything in life, but we have talked to no expert anywhere that believes that when you are in guidelines, that your test is not covered. That kind of inconsistency, it can exist, but it has to resolve. It has to resolve in favor of guidelines. That's a very, very firm view. It would be, we contemplate the scenario theoretically, but the view overwhelmingly that we have and that we're operating towards is that Triage will be successful. Monitor is a different story because Monitor is not in guidelines. Monitor has new evidence that supports its inclusion as a coverage test.
Again, we expect a fair hearing from Novitas on that, but I would put a lower probability than that on that, but a very, very high probability on success for Triage.
Yeah. I suppose what I'm getting at is if you include your net cash today or 31 March, we're sort of looking at NZD 42 million-NZD 43 million, I guess on a pro forma basis, if you will. OpEx is still relatively high, which is obviously understandable given the investment for growth over the long term, but it still feels like there's a decent gap potentially.
If in the event that Triage is non-covered, let's entertain something that, to be perfectly honest, I think is ridiculous. If it becomes non-covered after our reconsideration request, if it remains non-covered after our reconsideration request, then we have Triage Plus coming, which is all new development in our AVCVCU framework that, at least from my perspective, is also essentially unimpeachable. NovaTest has to play by a set of rules too, right? If you are medically reasonable and necessary, they are supposed to pay for your tests. They do that. They assess whether it is medically reasonable and necessary by reviewing a reconsideration request. We have that in. It is a very powerful one. We have to let that process play out rather than dance around things that are extraordinarily unlikely.
Maybe another way of asking, assuming CMS, if we just assume CMS coverage for the sake of the argument, do you think what you've raised today is sufficient? You can get to break even within a certain time period. Let's put sort of timelines aside. Do you think, call it the NZD 40 million-odd in cash is sufficient if you get coverage?
Okay. That is a different question and one that is very difficult to answer, again, because of the high, but it depends on a couple of things, right? It depends on how quickly we get recovered. If recoverage is quick, then obviously the chances of us having sufficient capital to reach profitability or break even increases. If it is delayed over the estimates we have provided, then it would jeopardize that, and there may need to be more capital. If it happens the way we anticipate, there are other variables. At least one of those other variables, so there are really two, whether or not we can increase the price of Triage Plus even further, which, again, we have flagged that as unlikely, but we do have some initiatives around that.
How successful our client billing process is, how successful our commercial payer strategy in general is, like whether we're getting paid on 30%, 40%, 50%, 60%, 80% of tests, right? We don't know that yet, and it will depend on that. It will also depend on how efficient we can make our sales force as a consequence of better messaging, guidelines, all the medical education that we do, and whether they can genuinely deliver two to three times their cost. Because when your sales reps can deliver two to three times their costs, then the answer is, how quickly can we get them to that point? Sorry, I can't give you a date, but those are the variables that we are focused on as a business that will determine our future capital strategy.
Thanks, Matt.
No, that's useful. Thank you.
Cheers. All right. I do have some questions that have come in.
There are no further questions.
Oh, great. Thank you. I do have some questions that have been put in online. Thank you, Andrew. The first one is, I've read that the DOGE team with Trump and Musk are working on cutting costs in veteran affairs and also Medicare. Will this impact your clinical trials, and are there any other impacts expected for Pacific Edge?
That's probably a bigger question than you really know, but I'll just give you some examples. Short answer is yes. Number one, in the veterans, we have had one or two partners on our clinical studies lose some of their research capabilities. We've been fortunate enough that it hasn't affected us in any kind of serious way. We've been insulated from it, but that is something that could theoretically happen, is other sites could be affected, and our partners may not have the resources to be able to do that. Another thing that could be affected is if we were looking for a national coverage determination or working with the FDA, these government agencies, they might be affected. We work with Novitas, which is actually a private company. Novitas is owned by GuideWell.
GuideWell is owned by Blue Cross Blue Shield of Florida, I think, or South Carolina, I forget. They're a commercial entity, so they're going to be insulated from that. You could imagine that some processes for either government reimbursement or regulatory approval might be delayed as a consequence of those investments. A counterpoint to that is also that we save the Veterans Administration money, and we save the Medicare system money. We know this, and we continue to implore them to adopt this at scale so that they can recognize those savings. It is difficult to get them to think of this at a system level because they see it as a cost for genetic testing as increasing, and they do not necessarily see the reduction in procedures in the same budget.
That's our challenge as a business to solve, but those that do get it will start to adopt the test more quickly because we can save the Veterans Administration money, we can save the Medicare program money, and we can make politicians and CMS political appointees aware of that, and we have.
Great. Thanks, Pete. Next question is from Steve. Thank you. We could have managed a few more months with the cash that we have at NZD 22.6 million. This capital raise, a vulnerable time in the share price, indicates that we're obviously not expecting any good news in the next few months. Is that a reasonable assumption?
I do not think it is a reasonable assumption, and I would also note that we raised at a premium to the current share price, obviously $0.10 being a premium over, I think, $0.082 at the close of play yesterday. We encourage shareholders to take advantage of this capital raise because we think that the commercial and clinical milestones that this business has achieved are shortly to be translated into the commercial success we have all desired for a number of years. Maybe I will leave it at that.
Great. Thank you. There is a further question. In 2018, it was announced that Johns Hopkins Medicine has commenced their commercial evaluation. Has this progressed or died?
I would have to answer that it died, and I would assume it died before I joined the company in 2022. At the same time, sorry, I would also say that we actually have a new engagement with Johns Hopkins unrelated to that, as we do with all major institutions in the United States that are interested in using. While I do not think there is continuity between that statement and any sales activity that we have today, Johns Hopkins is a major center for urology and urologic oncology. We do know the key opinion leaders in Johns Hopkins. I believe they currently order commercial volume for our test, though I could not tell you the volume without looking it up. They do not make systematic hospital-wide decisions like you might imagine DHBs do in New Zealand, right? That is the challenge.
There will be individual physicians within Johns Hopkins that are advocates, and we need to foster that for greater penetration within that account.
Thank you. I'm going to have to summarize the next one. There's quite a bit of colorful language, but in summary, this calls out Novitas's flawed review of the LCD and the evidence of Pacific Edge. The question is, is it now realistic for them to, in this environment, quickly review the latest submitted documentation, and do CMS have any sway to bring some common sense to the coverage issue?
Look, we'll continue to do everything we can here. The short answer, though, is yes. Novitas have the capacity and the capability and the legal requirement to review our reconsideration requests. It's important to note that what we were trying to do prior to losing coverage, the procedural process was kind of against us. Here, the process is what we are following, and there are two of them. One is the appeals process that I spoke about through the presentation. We will appeal denied Triage claims with guidelines inclusion all the way through the Medicare appeals process.
In a meeting with Novitas, they told us, "You're perfectly entitled to do that and tell us we're wrong for denying your claims that way." Similarly, if you disagree with our evidence assessment, the process you need to follow for a definitive change in your local coverage determination is to provide us with new evidence in the form of a reconsideration request, send us your strongest possible evidence, which is why we waited until we had the guidelines as well to independently validate the Strata publication before sending. We sent it within three weeks, right? In March, we sent it to them, and they now have it in their pipeline to review. I have personally emailed the director of the coverage and analysis group at CMS to ask them if they can accelerate the review.
I do not know whether they will do that, but they have said they will take it to their meeting and try and do that. We will try everything that we can to get Novitas to pay attention to the importance of this issue, including asking urologists to send letters where we just provide the bullet-pointed talking points, and then they put it on their letterheads to remind them that this is guideline-recommended testing that is not being made available to the Medicare population and that it is on them to fix it. Those points have been made in multiple forums. To those who might think Novitas is just one big block, there are people on the inside there who genuinely respect the role that evidence plays in these decisions.
It is worth noting anecdotally, though, that the medical director for the Novitas program left in March, and a new medical director for Novitas joined in May. That medical director who has joined is from MaldiX and is experienced in molecular technologies. We view this as a positive development, though it is definitive of nothing. We do not believe that we are bashing our heads against a wall. We are following the process that Novitas and CMS have given us to get coverage on the basis of our new evidence.
Great. Cheers. Final couple. Do the clinical guidelines impact the legal liability for a user of Cxbladder?
Look, this is one of those things that may be a little bit hard to explain to a New Zealand audience, how litigious the United States can be. It's also hard for us to understand these risks. Some of them may be red herrings. When a guideline explicitly, like it did in 2020, said biomarkers are not considered appropriate for use in lieu of a cystoscopy, right? That's fairly clear language that if you go against the recommendation of that association and you use it for that purpose, and let's say a patient does have bladder cancer and you told them they didn't have it, that physician is the one taking the risk. That physician can be sued. Being agnostic of the language for biomarkers, this applies to anything. If a physician deviates from guidelines, a physician has some level of legal exposure.
Now, that might make one say, "Oh, Cxbladder is included in guidelines. Now they're going to get sued if they don't use it." That's not the correct conclusion to come to because of the specific language that is being used and that it is about appropriately counseled intermediate risk patients may receive a urine-based biomarker in lieu of a cystoscopy. Could we get stronger language at some point in the future? We could. It'll be on the basis of evidence, and that is the kind of thing that we are looking to create with the credible study. That won't be available for another couple of years, though.
Great. Cheers. Matthew, I think we've answered your question on how long to reach break-even after coverage. We'll just go to John's question. Is Pacific Edge considering a share consolidation, for example, one share for every two existing? I can answer that one. We've had a number of issues we've been dealing with that the share structure hasn't reached the top of tasks to do, but we will look at that. The current structure seems to be working, but we will consider it. That's the end of the questions.
All right. Thank you, everybody, for listening, and thank you for your questions. We appreciate your time today. Please also have a look at the capital raise presentation that has been published today. We look forward to having more investors come and join us on this journey. This is a really fantastic opportunity to be part of the future of Pacific Edge as we conquer the various milestones that are in front of us towards a profitable future. Thank you.
Thank you.