Pacific Edge Limited (PEB) Earnings Call Transcript & Summary
August 6, 2025
Earnings Call Speaker Segments
Chris Gallaher
executiveThank you. Well, welcome, everybody, to Pacific Edge's Annual Shareholder Meeting today. My name is Chris Gallaher and I'm the Chairman of Pacific Edge. And hopefully, the slides are following me, but there should be a slide now that says here is very important. So we have a notice of disclaimer that we'll leave up there for a second. Our directors are here mostly. So we have Bryan Williams online from Melbourne. Tony Barclay is an apology today. His dad passed away on Monday, so Tony is down in Dunedin. On my left, we have Anatole Masfen. Next to Anatole, we have Anna Stove. We have Dr. Pete Meintjes, our CEO. And on my right, we have Sarah Park. And online is Bryan Williams. As it's now 3 p.m., and we have reached a quorum, I declare the meeting open. Today's meeting has been conducted both in person and online. We're very pleased to welcome you today on behalf of the Board as well as those of you participating online through the virtual meeting platform provided by our share registrar, MUFG Corporate Markets. I'll provide you with further instructions as we progress through the meeting, but if you do encounter any issues, please refer to the virtual meeting online portal guide or you can phone the helpline. For those of you in attendance here physically, personally, can I ask that you please put your mobile phones to silent? Restroom facilities are located near to the door where you came in. And if a fire alarm does go off, follow the directions from staff. We also -- as well as directors, we have neglected to welcome Grant Gibson, our Chief Financial Officer, who's down on the back. Our auditors, PricewaterhouseCoopers, are here and represented by audit partner, John Dixon; and our lawyers, Harmos Horton and Lusk, represented by Nathanael Starrenburg. Welcome. The agenda will follow the Notice of Meeting that was sent out to shareholders on the 17th of July. Peter and I will both give short presentations, and then we'll take your questions as a panel before moving on to the formal resolutions of the meeting. After that, I hope you'll join us for some refreshments out in the foyer. The minutes of previous meetings held in this very room last year are available for inspection on request, and I believe now we're at Slide 6. So the financial year ended -- just ended has seen some significant strategic gains, one in particular that I will speak about that have been overshadowed by the notification of our noncoverage by Medicare. The year -- F '25 year was a year in which we achieved one of our most strategically important milestones, with far-reaching implications for both the clinical adoption of our tests and long-term shareholder value creation. First of the milestones was the inclusion of Cxbladder Triage in the American Urological Association's microhematuria guidelines with the highest possible Grade A evidence rating. This is has come at the end of a very long journey, and it's been on our to-do list now for the 10 years that I've been involved in the company. So it's a fantastic milestone to have achieved. It's not only a major clinical endorsement. It's also a powerful validation of Pacific Edge's evidence generation, which has long been a core pillar of our approach to market development. The AUA's decision to assign the Grade A evidence rating reflects the depth and rigor of the data that we have provided particularly the STRATA randomized controlled trial, which demonstrated compelling real-world utility for Cxbladder. This milestone serves as a reminder that our commitment to robust scientific validation of our intellectual property is a critical enabler of test adoption, payer recognition and ultimately sustainable commercial growth. This guideline also reinforces our position as a leading provider of noninvasive bladder cancer diagnostics, establishes Cxbladder as a clinically preferred urine biomarker test for evaluating hematuria in the U.S. and strengthens the commercial moat around our business. Now second and also a very important milestone was the receipt of draft pricing from the centers for Medicare and Medicaid for Triage Plus of USD 1,018 per test, which is up from the $760 of our current pricing for our current test. This pricing reflects the enhanced performance of the test, the novel benefit for patients that arises from genomic risk stratification without the use of clinical risk factors and stands to strengthen the commercial foundation for growth once coverage is secured. Of course, the year also saw a major, setback. After a 3-year process, the loss of Medicare coverage in April 2025 arrived at our doorstep. This ended reimbursement that accounted for around 56% of our F '25 revenues. We were a bitterly disappointed by this decision, particularly because Novitas did not evaluate the most current clinical evidence, including both the STRATA trial and the newly updated AUA guideline. I'm very proud of the way that the Pacific Edge team navigated the uncertainty that preceded this decision, which hung over us for approximately 3 years, then the decision itself. We delivered a residual financial performance, demonstrating the strength of our business model and the commitment of our team. Operating revenue of $21.8 million was down 8.6% year-on-year. Total laboratory throughput was 28,894 tests, down 11.5% on the year before but stable in the second half. Our average U.S. sales price increased to USD 594 from USD 584 the year before and improved cash collections. Throughput per sales full-time equivalent and test per ordering clinician both increased over the year, reflecting greater focus and productivity in the field. This resilience has continued into the first 3 months of the new financial year, our first quarter without Medicare coverage since 2020. After taking into account the loss of one salesperson and the disruption of the strategic decision to discontinue Cxbladder Detect in the U.S., volumes were relatively stable. We believe that the ease with which clinicians have accepted the transition to Triage in the place of Detect demonstrates the shift in the sentiment among the early adopters of our tests and an understanding of the AUA guidelines. In summary, in F '25 and into the financial year, we have continued to demonstrate the strength of our business model and our ability to adapt to changing conditions. And now with the tailwind of AUA guidelines inclusion, we see significant opportunities to accelerate test adoption and deepen engagement with clinicians. Slide 7, raising $21 million in new capital to continue our momentum. Our success with guidelines inclusion has allowed us now to look upon the Medicare noncoverage determination that came into effect in April '25 a little differently and build on the momentum already established rather than cutting costs sharply while we pursued re-coverage for our tests. That's why we launched the capital raise alongside the announcement of our F '25 results. The option of cutting costs harshly and dramatically was always an option that we had in front of us. But the Board considered that to be a counterproductive action at this point and could have also put our continuing inclusion in the AUA guidelines at risk if there were no sales of Cxbladder in the U.S. So we have secured $16.1 million via placement to our institutional shareholders and a further $4.7 million through the share purchase plan, which closed at the end of July. Both of those tranches are subject to shareholder approval, which will be put to the meeting today. This capital will extend our cash runway for more than 12 months even without Medicare coverage, advance the commercialization of Triage and Triage Plus and maintain the critical investment in clinical research and evidence development that underpins our go-forward strategy. Your support for today's resolutions will give Pacific Edge the financial flexibility and strategic stability needed to deliver on our strategy and assist the return to sustain growth. Before I close, I do want to speak briefly about my continued leadership of the company. In March 2024, which seems like a long time ago, I informed the Board of my intention to retire, and the last AGM was a little bit of a valedictory session. However, we have faced significant challenges in recruiting my successor. In particular, the uncertainty over Medicare coverage and the challenges this has presented, the commitments of our existing Board, which have prevented any of them being able to commit to taking over the Chair role and considering these challenges and the importance of continued stability, I accepted the Board's invitation to carry on and remain as Chair for the time being. I will therefore be standing for reelection later in today's meeting. It does remain my intention to step down once we have greater clarity on the company's outlook, and we are able to recruit a director who is also willing to take the Chair. That said, I continue to lead the company with complete confidence in our science, our people and our prospects. I believe 2 of the barriers that were in the road of recruiting last time around, firstly, no inclusion in guidelines; and secondly, diminishing cash runway, have now been overcome. So we will go back to the market and see if we can identify another suitable Chairman. Peter will speak to you shortly about the year ahead and provide detail on our strategy to achieve the broad aims of the capital raise. But before he does, let me finish with a simple thank you. Your continued support has enabled us to navigate an exceptionally challenging year, and your belief in our mission has kept us focused, motivated and optimistic for what lies ahead. And with that, now I'd like to hand over to Dr. Peter Meintjes, our Chief Executive Officer.
Peter Meintjes
executiveThank you very much, Chris. So Chris mentioned that we've been able to stick to our mission, and for the last 3.5 years, we've been deeply focused on that mission and building value for investors through 3 pillars of adoption, retention, revenue generation, evidence, coverage and guidelines, and research, development and innovation. And we continue to create value for investors through this framework. So Chris highlighted the importance of AUA guideline inclusion. It is a company-defining moment and was achieved earlier in this calendar year at the tail end, of course, of the last financial year in February 2025. Importantly, the guideline -- so the guideline supports the use of urine-based biomarkers for intermediate risk patients as an alternative to cystoscopy. And this is a significant change from the prior guideline inclusion language. And the primary driver for that change was the STRATA randomized controlled trial that we developed. So Cxbladder Triage was then specifically mentioned as the only urine-based biomarker that has Grade A evidence. And as Chris mentioned, this cements our first-mover advantage and builds a moat versus our competitors. The change was significant. The 2020 guidelines prohibited the use of urine-based biomarkers in lieu of a cystoscopy in hematuria patients. However, in 2025 and off the back of the evidence that we developed and some others, they established a policy that brings in line genomic testing to the same levels as in hematuria evaluation as there are 4 other forms of cancer, for example, prostate, breast, colon and others. The intermediate risk cohort is a large cohort within the context of microhematuria patients, and this is a significant market opportunity. But it should also not be thought of as limiting on our market opportunity. Our tests work in all -- in patients of all risk, all hematuria patients of all risk. But it's just that the guidelines expressly recommend them in intermediate risk patients. And so this offers significant benefits to patients, reduces the burden of unnecessary cystoscopies and improves access to care at a lower cost and reduces legal liability for using biomarker alternatives, a common pushback from various physicians. So we have already noticed a shift in the mindset of the physicians that we speak to, and we continue to build on that. So our evidence generation program specifically seeks to change clinical practice. And that's one of the reasons why what we do is difficult. We get paid to do challenging things. But where there is a defined way in which we do it and when you follow this formula, we believe we will be successful. So we start with clinical evidence generated in analytical validation, clinical validation and clinical utility framework, but there are multiple audiences who ultimately need to review that clinical evidence. Importantly, health care payers, the insurance landscape, for example, Medicare, Kaiser, Veterans Administration and the myriad of 6,600-odd commercial health insurers in the United States all review these evidence in 1 way, shape or form. We provide that same evidence to the professional societies and the professional societies make guidelines, AUA; European Association of Urology, EUA -- sorry, EAU; and NCCN, the National Comprehensive Cancer Network. And of course, we provide that evidence directly to our customers, the urologists that we serve. And what do they use that evidence for? Each of them use it slightly differently. So the health care payers, they use it to change medical policy. You'll notice an emphasis here, my repeated use of the word change, right? They then need to change not just the medical policy, but also they need to change the reimbursement policies or the -- and the contracts with which they pay for our services. The professional societies change the standard of care guidelines. And urologists, they are the ones who actually have to change the way that they behave and the way that they treat patients, changing clinical practice. So all of that requires extraordinary quality of evidence, and that is what our evidence generation program is all about. We have seen some guidelines change. Our process is working. We have seen health care payers adopt. Our process is working. Regarding the Medicare noncoverage, it is unfortunately inconsistent with the AUA guideline, and we are in a unique situation that we have to navigate as a consequence of this. But as in Chris' note, we have had the opportunity to lean into this challenge with AUA guidelines at our back. Medicare accounted for a significant volume of our test and was reimbursed very reliably for very many years. And even though there was a negative proposal in 2022, we spent a while challenging it, and we are now in a non-covered position. Our response, though, is what's really important here. and roughly 47% of our U.S. volumes are from other contracted payers, predominantly Kaiser, but also an increasing volume from the U.S. Veterans Administration and from patients who have Blue Cross Blue Shield, BCBS, as their insurer, and other non-contracted private payers. And so we monitor this as a shift in payer mix towards more commercial use. Our commercial team will continue to promote and supply tests to existing U.S. users and drive demand to maintain the momentum building from this guideline. And through this process, we continue to seek reimbursement through the Medicare appeals process and external review. One of the challenges we did face is that with the noncoverage of Cxbladder Detect and with Cxbladder Detect not having new evidence published for it over the last several years, we're unable to take Cxbladder Detect through the reconsideration request process. However, this was anticipated in the longer term. Our goal was always to move both Triage and Detect users over to Triage Plus in the long term. So we've taken the intermediate step of moving all of our hematuria valuation over to Triage in the United States because we can get -- we believe we can be paid on those tests through the appeals process. So what else are we doing? And it's on our mind every day that we are seeking re-coverage via LCD reconsideration in Medicare appeals. So we have had 2 meetings with Novitas, 1 in June and 1 in July. I wrote about it in the recent quarterly update. We've seen a very different engagement in 2025 with Novitas, positive engagement and one where we believe they are better understanding of the issues, asking the questions where they don't understand, either the urology practice or the science behind our tests, and giving us the opportunity to explain that more clearly to them. So a reconsideration request for Triage has been -- was submitted in March. We had a public meeting, sorry, we had a private meeting, a formal meeting with them in June. Cxbladder Monitor was submitted in May, and we had a private formal meeting with them in July. We are also attempting -- so we're attempting to get reimbursed on all of the Triage tests that have been submitted since the AUA guideline through the Medicare appeals process on the grounds that the tests are medically reasonable and necessary. That is a process that requires more effort on our part, but it is also something that applies pressure on Novitas to act quickly to open an LCD for the reconsideration requests that we have already put out there. Looking further towards the future, and not just our current products, but towards Triage Plus, the analytical validation for Triage Plus is complete, and it is published. We wrote about that also in the quarterly update. The clinical validation has been submitted and is in peer review, and we should hopefully see that soon. Pacific Edge expects to submit a reconsideration request for Triage Plus when the CV is published, but we could also choose to -- if the LCD has already opened, we could choose to submit it as part of the comments for that. And then inclusion of Triage in the AUA guideline establishes medical policy to which Triage Plus can be added, meaning that if we already have a medical policy that demonstrates the utility of one test, just showing performance equivalence or performance superiority with analytical validation and clinical validation may be sufficient to have coverage for that same indication. So we don't always have to wait for clinical utility. You get coverage when the benefit has already been established in policy. So further evidence for Triage Plus by -- sorry, for Triage published by Kaiser Permanente has already been presented as -- at the AUA. And what is fantastic about this evidence is that there were 3,353 patients that were risk matched to another 3,353 patients in the study, which blows out of the water any concerns that 1 might have over the size of our studies being small. Some of our other studies, the internally one -- run ones are small. But that study is very large and shows that Triage works as we expect it should in clinical practice. So we hope that, that -- or that publication has now been submitted for review as well. And we are tracking that closely. We don't control the time lines for that. That is -- that rests with Kaiser Permanente. So one of the things that, of course, on everyone's mind is when will we be re-covered. And so everything we have on these slides are our best estimates, but they also include some worst-case scenarios. So importantly, we have made 2 of the reconsideration requests already, the ones for Triage and the one for Monitor and have listed here the catalyst or the evidence that is behind those requests. What we expect Novitas to do, though they have not directly indicated that this is the case, it makes sense from a workload management perspective for them and it is something that is available in the Program Integrity Manual, is to open the LCD once for all of the products. We also know that Castle Biosciences have submitted a reconsideration request for their test that has been similarly affected by the LCD, increasing the probability that this LCD becomes open. So as per the first bullet there on my slide, Novitas has the discretion to combine reconsideration requests. And from a workflow management standpoint, that makes sense for them to do. And so that's why we expect this is the most likely approach. We have the discretion to submit Triage Plus as part of the comments. So if it is already open, we can submit it as part of the comments and -- but importantly, Novitas controls the timing of the LCD opening. But once opened, it's -- the LCD must finalize within 12 months of opening. And they're -- yes. So looking more broadly to our -- across our evidence generation portfolio. There are a number that have been now published and some that have been submitted. We are now working towards a second publication from STRATA. And importantly, what this establishes is the concordance between Triage and Triage Plus showing that Triage Plus has the same utility as Triage in exactly the same patients. We run the same test on the same patients. And it shows non-inferiority. In fact, it will show superiority. We're confident of that. The -- as mentioned, the Kaiser Permanente one has been submitted, and so we're anticipating a publishing date in Q3 calendar 2025. And then the AUSSIE and microDRIVE speak to the Triage Plus validation as do the pooled analysis for microhematuria and gross hematuria, while the Monitor Plus analytical validation comes from a separate study and shows, while we've prioritized hematuria evaluation in the Triage Plus products, we have not forgotten our Monitor Plus product, and there will be more information coming on that as and when available. And actually, the LOBSTER clinical validation, which includes multiple years of follow-up is progressing very, very well from a clinical study standpoint. U.S. contracted payer demand supports the volume growth in the second half of last year. So the U.S. commercial volumes increased 2.7% against the first half, supported by contracted payer volumes. Our non-Medicare volumes represented 47% of U.S. commercial volumes in financial '25 versus 40% in the prior half. So the trend that we are outlining for you is that there is a trend in the direction of an increasing percentage of our tests as part of that -- for patients who have commercial insurance. So that is a decreasing reliability or reliance on Medicare. Q1 '26 volumes are resilient in the face of the Medicare non-coverage determination and the transition from Detect to Triage. Chris already mentioned this as well. We are -- it is a very difficult thing to -- when customers have been used to, for multiple years, ordering 1 test, the Detect test to say, "Hey, next week, you won't be able to order this test. We'll process it for you for a week. But if you order it 2 weeks from now, we're going to ask you to change your order to Triage Plus." And that's the process we asked our field force to navigate through. And by and large, we were able to retain the majority of those orders even though it is quite a challenging exercise. The volumes were aided by strong performance through the Southern California Permanente Medical Group, and the sustained sales force efficiency gains have been mitigated the impact of the Medicare uncertainty. The volume drop that we've observed is primarily due to the physician switch from Triage to Detect. As I mentioned, that is a challenging process, and it could have been more impactful. And I'm very grateful to how hard the team have worked to make sure that it was not more impacted. And -- but we are still yet to see the real benefit of the AUA guidelines as a tailwind to our organization and something that our sales team continue to be hard at work on. So I wanted to highlight another element here of progress that we're making in the commercial insurance landscape. So the AUA guideline recommends Triage for intermediate risk hematuria patients, and male patients that are intermediate risk are actually defined by the clinical factor criteria as being between 40 and 59, while females in this -- in the intermediate risk category can be greater than 60. So what you'll notice is that the vast majority of Medicare-insured patients are over 65. So the AUA have essentially recommended this test for non-Medicare patients when they are male. And so what is this expected to do? It is expected to drive a shift in payer mix away from Medicare and towards commercial insurance. So what do we need to be good at as a business? We need to be good at selling to patients who have commercial insurance, which is subtly different because sometimes they may have a patient obligation when the insurance company doesn't pay. Sometimes we need to appeal that multiple times before we get there. So where have we had some recent successes? So we've recently -- we already have established pricing. We've talked about it probably for over a year now in our investor updates with the Blue Cross Blue Shield GPO, the group purchasing organization, which helps drive contracting and policy and adoption in the Blue Cross Blue Shield network. We've got individual contracts off the back of that GPO contract with Texas, Illinois and Wellmark, which represents 2 states. Separately, we've gained a favorable 4 out of 5 score from ECRI. And again, this has featured in some of my CEO letters and other correspondence. ECRI are a data curator to which multiple commercial payers subscribe so that they don't have to go and do evidence reviews all themselves. So this is a big deal. It's one that we are yet to see flow through fully into the way that we bill and get paid for our tests, but it is progress in the right direction. Avalon Healthcare Solutions is a similar type of entity. And while we don't have a formal policy at this time, we have received acknowledgment from them that they expect to follow the guidelines, which we see as positive. We've secured in-network status with the Optum Veterans' Affairs Community Care Network. And overall, commercial payers have increased 5% since the pre-May -- since before May 2025 to 37% of the payer mix, and this is when you exclude Kaiser Permanente. So again, I'm highlighting that our payer mix is shifting more towards commercial, shifting to have less reliance on Medicare despite the continued importance of Medicare. We're also expanding access to Triage Plus. So Triage Plus has been available by early access. And even under early access, we're able to bill those patients. We're just not able to chase those -- chase patients for payment if the insurance company doesn't pay. But at the VA, we don't have the same limitations, and so we actually meet all our criteria for providing Triage Plus in that environment, in that system. So we have offered a few VAs to join the pilot program and check that everything is working because the VA does have slightly different operations -- operational details. Sales performance improvements that we have seen embedded throughout financial year '25. The sales force efficiency speaks for itself. Again, this has largely been driven, we know, by the denominator rather than the numerator, but we have noticed our sales force being able to maintain a larger relative number of tests over the course of the last 2 to 3 years. And the sales FTE have dropped, but we've managed to continue to demonstrate a stable clinical commitment from our customers, which we demonstrate through our U.S. -- the number of tests, unique tests per ordering clinician, which has remained roughly stable between 6 and 7 most of the year -- most of the last 2 years. Our foundations for growth as U.S. cash collections improve. So despite a dip in 2H, the -- in our average sales price, which is largely due to timing variances related to accruals and increased provisions against revenue, our ASP actually has increased substantially between the first half and the second half. Our enhanced patient responsibility that is patients with non-contracted private insurance, i.e., non-Kaiser pay a fixed dollar amount, which we term or U.S. terms a maximum out of pocket, which allows sales teams a very clear message for what the patient responsibility will be when they are discussing it with the physician. We've got increased utilization of appropriate patient types from Kaiser Permanente after the EMR integration and showing nice growth there. We have a historical milestone of having reimbursement of Triage since January 2023 and improved medical necessity documentation to improve our ability to appeal and collect cash from Medicare Advantage claims as well. So the AUA guideline offers new opportunities for client billing. We have attempted the client billing approach under early access. We're yet to make sufficient progress here, and -- but we are considering that as a potential option as we go forward. It can, when it works, provide a revenue incentive to hospitals and LUGPAs that have the -- and that therefore have an incentive as well. So this slide contains a little more detail than some of you might be prepared for. So hopefully, you can follow along. And so pricing for Triage Plus is very, very important. Every extra dollar that we are actually able to get in the final determined price for Triage Plus is something that adds to our margin and margin percentage. And so in April, we got a draft Gapfill price of $1,018, which is a meaningful improvement over where we currently stand with $760 per test after adding the DNA markers into our assay and after redoing all the bioinformatics, all the extra work that we're going to have to do to validate the test. But we regard this as a floor in our current negotiations with Medicare, and we -- but it does materially lift the floor -- or the prior floor of $760. So why does this matter? It improves the overall unit economics. It improves our ability to operate sales resources profitably and gives us, as a business, a faster path to profitability. And so one of the things that we're doing since the draft pricing, is that we have challenged that Gapfill price by reaching out to MolDX and asking them -- and they don't tell us, right? But we've asked them, "How did you calculate this price," and said, "Well, have you considered X? Have you considered Y? Have you considered Z?" They are experts at what they do, but they are not experts in our product. So the opportunity for dialogue there has allowed us to show them a couple of things that are unique to the way that we run our Triage Plus test. And we're optimistic that they may -- well, they have agreed to take that under advisement. They've obviously not agreed to anything beyond that. But if they are amenable to our arguments, a new final Gapfill price would be published in September and recommended to CMS. If they're not, we expect that the $1,018 would continue to remain as a Gapfill. But secondly, last year, when they sent us to Gapfill in the first place, we had proposed a cross-walking strategy, and we have asked for a reconsideration request based on the fact that they sent us to Gapfill in the first place. And so we have proposed also a new cross-walking strategy that is at a lower amount than what we were previously targeting with logic that is supported by the coding descriptors. It's a little bit technical. I won't bore you with the details. But that -- the process from here is that the subcommittee who have -- sorry, the panel who have reviewed the codes are expected to make a recommendation to CMS in September. And if they are amenable to any of our arguments, our cross-walking price would be $1,390, which we consider, if it happens, to be quite an important event for the company. And -- but a final decision from CMS would only be due in November 2025. And it's important that CMS, as a general rule, maintains some level of skepticism over crosswalks that involve adding codes and fractional multipliers. Ours has both. But we are -- this is -- but if a crosswalk price is agreed, the Gapfill price becomes irrelevant. Under the Social Securities Act, the crosswalk price would become our price. Driving growth in Asia Pacific and consolidating our presence in New Zealand. So we continue to seek a national hematuria evaluation pathway in New Zealand. Conversations are ongoing with that group, and -- but we do not have progress to report at this time. STRATA and the AUA guidelines do help in all of these situations, although the New Zealand market as a general rule has a lot of experience with our products to date and have kind of made up their own mind, which is obviously quite good. But there's still plenty of health inequity. You can't get a Cxbladder test everywhere. This is largely due to funding, and there are some Te Whatu Ora regions that no longer have funding for Cxbladder, all of which we intend to manage as part of normal business operations. Southeast Asia continues to be in business development, and we're extending our reach into the market through our distributor network. And so while our primary near-term focus remains on the U.S., Southeast Asia does have large population centers that if we can establish a base in those markets through private health care systems and wealthy individuals that are often interested in preventative care, and with favorable cultural and demographic considerations, this could also be something where we ultimately bring an IVD product to market when that is available at larger volumes. Importantly, we think about ourselves as much more than a diagnostic test manufacturer. We think about the end-to-end customer experience. And digital technologies are -- they're commonplace in every part of our lives, and we have invested in making sure that it is easy to order a Cxbladder test. If we're perfectly honest, it's not easy enough yet, and this is an area where we need to continue to invest. What are we doing about it? So we give customers a range of different options as to how they can integrate with us that are better than fax or e-mail, and these digital channels are either a one-to-one direct EMR interface that we have with Kaiser or a one-to-many integration that we actually have with Lumea Digital Pathology, and we've got a partial interface with Awanui in New Zealand. And we have created our own customer portal. In case it is difficult to either work with partners or if there are other types of restrictions, the portal is really just a website that they can log into that is secure, PHI compliant. They can send test orders and receive test results and even load in historical test results so that they can view them that way. And then that portal itself can be linked to an EMR separately. This improves the end-to-end experience for physicians, creating easier ordering in the clinic. It can also be directly linked to our in-home sampling capabilities. We've got optimized test kit management, ordering visibility, and tracking is easier for our customers and for ourselves, and there is a streamlined access to the results. So our -- there are obviously operational benefits for us where there are fewer errors when we receive test orders in the digital form and allows us to more quickly turn around samples and improve our customer service. So one of the next phases of the company involves continuing to improve our existing products, and we have proposed, as part of the capital raise, to put more effort into developing an IVD for the international markets. So -- and the -- well, for our existing products, it's all about readying for the launch of Triage Plus. And our product development investments in digital systems ensure that the lab is scalable for any volume that we -- can come in. So simplifying Cxbladder means to reduce turnaround time, lower cost of goods, lower turnaround time, increase the throughput and increase the level of automation in our labs. And similarly, we also aim to automate lab operations from end to end from both the DNA and the RNA component as part of our lab testing services. We have continued engagement with industry and academic research development collaborations to address the unmet needs in bladder cancer and diagnosis and management. So advancing the IVD development and talking about that for international markets, so we intend to use some of the capital towards accelerating the development of a kitted IVD, which is an in vitro diagnostic product from our existing lab service called Triage Plus IVD. So this is essentially a little box that will take everything that we do in the lab to, distill it down into the key components, and we can sell a box of reagents to another lab so that they can reproduce. We've got to put a lot of work into the simplification of the assay before it's easy to do that because this is a highly complex assay. But when we can, we can partner with labs overseas, and they will be able to deploy it in a decentralized way. So importantly, we need to establish a quality management system and a regulatory framework within Pacific Edge that meets those objectives and -- which is IVD-R for Europe, FDA for U.S.A. and ISO-13485 for the rest of the world. This has been one of the barriers -- in the context of Pacific Edge historically, this has been one of the barriers for our ability to sell in Australia because we need to be able to sell -- the test itself needs to be run in Australia for us to be able to get federal reimbursement. So this is the -- the same kind of thing applies in other countries. And so by simplifying down to an IVD product in a box that can be sold to any other lab, we can enable more markets. Achieving an IVD-approved status may make it more difficult for competitors as well to develop a parity with our level of evidence. And because we are starting from a product that -- or testing service that already has a large body of evidence behind it, when we have a kitted version of that product, we can leverage the entire body of evidence that we've already developed in support of seeking that product's regulatory approval. So my last slide. So the -- I want you to take away from this that the AUA guidelines is a really big deal, and it's allowed us to operate differently as a company and to lean into the challenges that we face because there are many of them. The AUA microhematuria guidelines enable sales, marketing and reimbursement activities, and we're determined to maximize this milestone through existing and new initiatives. Triage Plus draft pricing at $1,018 supports stronger unit economics, margins, margin percentage for a faster path to cash flow breakeven, if successful, in establishing Medicare coverage. And as noted on an earlier slide, we're continuing to try to increase the price of that test as well. So our growth strategy that is to be assisted with new capital: entrench our first-mover advantage and moat for Triage given the AUA guidelines inclusion; continue our evidence generation in an analytical validation, clinical validation and clinical utility framework for coverage, guidelines and medical policy for Triage Plus and Monitor Plus; to increase the Triage throughput and throughput per sales head count and throughput per clinician. These are the key metrics we report to you on every quarter; seek reimbursement through the Medicare appeals process, relying on the AUA guidelines ahead of the resolution of multiple consideration requests; to advance medical policy with commercial payers at the -- as the market for Triage or microhematuria patient shifts the payer mix towards commercial payers; to increase the percentage of electronically ordered tests in patients with commercial insurance; and to focus on the clinical value of Cxbladder; and to invest in continued innovation as our capital allows. And we continue to work with Te Whatu Ora, as we are being considered for a national pathway in New Zealand. Thank you very much for your time. Happy to take questions as part of the panel. Next section is yours, Chris.
Chris Gallaher
executiveThanks, Pete. And we now move to the business end of the meeting, where we have matters that are requiring resolution, which were outlined in the Notice of Meeting. I'll take the Notice of Meeting as read, and I'll provide a short summary of the reason for each of the resolutions as we progress through them. For the sake of good order, shareholder questions raised should relate directly to the resolution in front of us. When I call for questions, can shareholders present in the room please raise your hand and wait for a microphone to be provided to you before clearly stating your name and whether or not you are a shareholder or a proxy holder? Online voting and question instructions. [Operator Instructions] Now moving to the resolutions. A poll will be held on each of these resolutions. Shareholders joining us here today will have already received your shareholder voting card. If you are a shareholder and have not registered on arrival and wish to vote, please make your way to the registration desk outside the room, and staff from MUFG will assist you. Please mark your voting intention for each resolution on your voting card, which will be collected at the conclusion of the meeting. Shareholders joining online will be able to cast their vote using the electronic voting card received when online registration is validated. To vote, you will need to click Get Voting Card within the online meeting platform, and you'll be asked to enter your shareholder or proxy number to validate. Please then mark your voting card in the way you wish by clicking for, against or abstain on the voting card. Once you have made your selection, please click submit vote on the bottom of the card to lodge your vote. Please refer to the virtual meeting online guide portal or use the helpline specified if you require assistance. Voting will remain open until 5 minutes after the conclusion of the meeting. Results of the votes will be announced via the NZX later today. Each resolution set out in the Notice of Meeting is to be considered as an ordinary resolution, and as such, must be approved by a simple majority of the votes cast by shareholders who are entitled to vote and voting on the resolution. The outcome of proxy votes will be displayed for your information after voting on all of the resolutions is completed. That was quite a mouthful. The first of the resolutions is the reappointment of our auditors, PricewaterhouseCoopers. I now propose that shareholders record the reappointment of PricewaterhouseCoopers as auditor of the company and to authorize directors to fix the auditor's remuneration for the ensuing year. Are there any questions from shareholders about this resolution? Anything online? No.
Grant Gibson
executive[ This person has a question ].
Chris Gallaher
executiveThere's a question?
Grant Gibson
executiveYes.
Chris Gallaher
executiveSorry. Right in front of me. I'm looking for online. Yes.
Unknown Shareholder
shareholderSorry. Yes. So like I went through the annual report and I found...
Chris Gallaher
executiveSorry, your name?
Unknown Shareholder
shareholderMy name is [ Jagat Doey ]. I bought Pacific Edge shares through Sharesies.
Chris Gallaher
executiveYou're a shareholder?
Unknown Shareholder
shareholderYes. So I myself is an accountant and I'm a finance guy also. So this is the first company that -- science-based company -- scientific company that I've attended as the AGM. So I'm very surprised how auditors would come to know whether the management -- whatever the management is talking is possible or like how the audit is different like -- because sometimes the worry is that these science companies, what do they do? We don't know as an account, as an investor. So how are auditors making sure?
Chris Gallaher
executiveSo if I think -- without putting words in your mouth, I think how do our auditors enable themselves to audit the financial materials in front of them when they're not scientists. Is that essentially what I think you're saying?
Unknown Shareholder
shareholderSpeaking [indiscernible] how they make sure there's something [indiscernible]
Chris Gallaher
executiveOkay. So whether it's a science company or a manufacturer of widgets, the audit and financial reporting procedures are pretty much the same. They have their audit procedures that they follow, inventories, validation, revenues, costs. And I could ask -- perhaps ask -- John might want to speak to this. But I -- the fact that we're a scientific company I don't think changes what the auditors do to validate the financial statements of the company. But John, you might want to add being a non-scientist. Microphone for John -- this is John Dixon from PricewaterhouseCoopers, our audit partner.
John Dixon
attendeeSo I actually think you covered that pretty well, Chris. You might get another job as an auditor once you step down. But we do a number of procedures to obviously understand the company, and we don't just talk to the finance people. We go out into the business. I've visited the site in the states and I've also visited a number of other things that impact and are used by the company. So Chris is right. We don't try and get into the science in a lot of detail because in a lot of cases, we're talking about is a test performed, is it being paid for and how does that ultimately end up in the financial statements. So hopefully, that answers your question.
Chris Gallaher
executiveAre you happy with that answer? A little bit. Okay. Thank you. Are there any other questions on the reappointment of our auditors? No. Thank you. So please mark your voting cards and the way you wish to vote by ticking or clicking for, against or abstain in the appropriate place on the voting card. [Voting]
Chris Gallaher
executiveThe next resolution concerns my reelection to the Board. And I'd now like to hand over the meeting to Sarah given I can't talk about myself.
Sarah Park
executiveThank you, Chris. So in accordance with NZX Listing Rules, Chris Gallaher retires by rotation and being eligible, has offered himself for reelection. Chris' biography was listed in the Notice of Meeting, which I hope you've all had time to review. In summary, Chris was elected to the Pacific Edge Board in 2016, and he brings to this company extensive financial and governance experience and in-depth understanding of Pacific Edge, its strategy and the market in which we operate both in New Zealand and in overseas. As previously discussed this afternoon, in March 2024, Chris notified the Board of his intention to step down. However, directors extended an invitation to Chris for him to remain in this role because they believe shareholders' best interests are served with the continuity and stability of his leadership while this company continues to navigate the loss of Medicare coverage for our products. Chris was delighted -- sorry, we were delighted when Chris accepted this invitation. The Board has determined that Chris Gallaher is an independent director for the purposes of the listing rules, and the Board unanimously supports his reelection. On that basis, I now propose that Chris Gallaher, who retires by rotation and is eligible for reelection, be reelected as Director of the company. And I now invite him to address the meeting.
Chris Gallaher
executiveThank you, Sarah. Thank you for those nice words. I have the same commitment and beliefs that I had when I joined Pacific Edge 10 years ago. We have a world-leading product in a market that will afford us great financial opportunity as we go forward. We've got a terrific team, committed management and Board and very supportive shareholders who have supported this company for a very long time as it's been a very long journey. Despite wanting to retire, I'm very happy to continue until we can find the right person to lead this company into the next stage of its life cycle. I remain energetic and committed and I'm very grateful for the team, both management and Board, that I have around me. So with that, can I please ask you to mark your voting cards for -- questions, any questions? Yes.
Unknown Shareholder
shareholder[ Richard Solomon ]. As a shareholder from almost the beginning and as a shareholder from the public sector, I would just like to say thank you, Chris, for your decision to stay with the company through the final stretch of this difficulty. I'm quite sure your decision to retire reflected your personal wish to have some time to yourself, and I really appreciate that you're seeing it through.
Chris Gallaher
executiveThank you very much. And look, my decision, as I said last year when we had a little bit of a valedictory was when I turned 70, it was time to wind it back. Well, I'm 71 next week and still going, so that's all good. Thank you very much for your kind comments. Anyone else have a comment? So with that, can you mark your voting cards for, against or abstain? [Voting]
Chris Gallaher
executiveNext, we have the reelection of Sarah Park to the Board. In accordance with NZ Listing Rule 2.7.1, Sarah Park retires by rotation and being eligible, has offered herself for reelection. Sarah's biography was included in the Notice of Meeting, and she was first appointed to the Board in 2018. Her financial, capital markets, audit and risk and governance experience across a range of sectors combined with a strong focus on diversity is a strong value to Pacific Edge as the company continues its growth strategy while remaining always conscious of risks that we encounter. The Board has determined that Sarah Park as an independent Director for the purposes of the listing rules, and the Board unanimously supports her reelection. I will now ask Sarah to say a few words.
Sarah Park
executiveThank you, Chris. So good afternoon, fellow shareholders and other stakeholders in Pacific Edge. As outlined in your meeting materials, I bring over 25 years of international corporate finance and capital markets experience and more recently, tenures of professional governance experience. My background includes investing in personally and on behalf of a venture capital fund and supporting high-growth companies, particularly in health care. And I believe that experience continues to serve me well on this Board. More specifically, in terms of what I've contributed to the Board is since 2019, I've chaired the Audit and Risk Committee, and I focused during that time on strengthening our governance framework, our financial reporting and our oversight of risk. Under my leadership, we introduced a structured approach to enterprise risk governance. We've established a clear linkage between risk appetite and strategic objectives. We've clearly defined our risk appetite and tolerance levels, albeit they have been challenged somewhat at times in recent times. And we've implemented a more robust risk assessment process and established a regular cadence of risk review assessment and importantly, action. I've worked collaboratively across the board and with our management team, in particular, our COO, CFO and most recently with Sustainability Committee, to modernize our risk framework further. We've integrated emerging risk scanning in areas like cyber, climate and supply chain resilience. Together, I believe we fostered a risk-aware culture that's rooted in proactivity, open dialogue and competence. These improvements have become especially evident -- or the benefit of these improvements have become especially evident over the last -- what I realized is nearly 36 months since the first proposal of our Medicare reimbursement being withdrawn. But during that time, our strategy remained firmly anchored in clinical evidence generation and pursuit of AUA guidelines inclusion, and that has allowed us to remain focused and resilient amidst significant disruption. Another area of contribution, which I continue to make and will continue, if I'm reelected as a member of the Capital Committee and I've also -- during that time, I've been a voice at the table requesting and ensuring that we have a disciplined capital management plan, and we've also been able to, hopefully with results today, have had 2 successful capital raises. Looking ahead, I'm all about value creation, and I see 3 critical challenges that Pacific Edge must address. First has been said many times today. We need to secure Medicare reimbursement. We need to navigate that journey successful over the next period while managing our cash runway. We need to really fully unlock our market potential. The recent AUA guidelines inclusion is a really great step, but we mustn't forget we have a very large addressable market, and we must strengthen our foundations and work smarter to maximize the effectiveness of our clinical data generation, our market access and our commercial sales strategies so that we not only deliver financial returns to you, our shareholders, but we also improved -- deliver improved health care that comes to those patients, patient populations and who we serve. Finally, I think one of our challenges as well is we need to leverage our advantages more. Our Cxbladder suite of tests offer high sensitivity, high specificity and noninvasive collection. These advantages position us very well in the next generation of innovation and diagnostics, for example, the IVD test kits that Pete has talked about today as well as more point-of-care testing on precision medication. So with my experience governing Pacific Edge, chairing the Audit and Risk Committee and personally investing in med tech and diagnostics across Australasia and the U.S., I believe I'm well equipped to help us navigate these challenges while maintaining commercial agility and managing cash reserves. So overall, my commitment to you is based on my values, which center on intellectual integrity, accountability and transparency. I ask the tough questions. Some grant -- got scars to prove it. I request data and recent analysis to support major decisions. I have an independent mind, and I'm not constrained by how things have been done in the past. But most importantly, I believe, we're to support and challenge management to ensure value creation while protecting stakeholder interest. So as we move forward, we all agree that we must execute on our commitments, and I will continue to advocate for focused discipline and the highest standards of execution of our strategic plan. By doing those 3 things well, I believe we will firmly deliver on our commitments and maximize return on your investment. Thank you for your trust and support. I respectfully ask for your vote and look forward to continuing to serve you with, I guess, authenticity and independence. Thank you.
Chris Gallaher
executiveThank you, Sarah. Any questions from the room on Sarah's reelection? Any questions online? No. That being so, could people please cast their votes for, against or abstain? [Voting]
Chris Gallaher
executiveThe next resolution is the reelection of Tony Barclay to the Board. In accordance with NZX Listing Rule 2.7.1 Tony Barclay retires by rotation and being eligible, has offered himself for reelection. Tony's biography is listed in the Notice of Meeting, and he was first appointed to the Board in 2022. He brings to the company significant leadership experience in the health care sector, including nearly 18 years as the Chief Financial Officer for Fisher & Paykel Healthcare. The Board has determined that Tony as an independent director for the purposes of the listing rules and unanimously supports his reelection. Tony is in Dunedin, as I mentioned earlier, dealing with the death of his dad, so on his behalf, Anna will now say a few words.
Anna Stove
executiveThank you, Chris. It's a pleasure to present this on behalf of Tony, and our thoughts are with him and his family at this sad time. Tony's background is set out in the Notice of Meeting, so I will not repeat it here, except to say that he spent most of his career at Fisher & Paykel Healthcare from its demerger in 2001 through to his retirement from the company in 2018. He is now a professional director sitting on the boards of a variety of medtech companies. Tony has seen firsthand what it takes to guide a medtech business through complexity, international expansion and the specific challenges faced in the public company environment. That experience has helped shape how Tony contributes to the Pacific Edge Board, particularly around financial oversight, governance and setting a clear strategy through periods of uncertainty. You've heard today and you know well, it's been a challenging time for the company, but we now have something that we have not had for some time, and that's clarity. The inclusion of Cxbladder Triage in the AUA clinical guidelines is a pivotal moment. It provides a foundation of confidence for clinicians, investors and our team. This positions us well to accelerate uptake in the U.S. market and beyond. Tony is looking forward to working with the team to make the most of this opportunity. A key change for Tony this year has been to step up into the role of Chair of Audit and Risk Committee following on from Sarah Park's very capable leadership. Like Sarah, Tony takes very seriously the responsibility to ensure that we maintain the trust of our shareholders and meet the high standards expected of a company at this stage of its growth. But beyond governance and financials, Tony is here because he's excited by what this business stands for, increasing access to care, reducing unnecessary costs and procedures, and delivering better outcomes for patients and health systems. Pacific Edge has the science, the products, the team and the market position, and he's looking forward to assisting the company to fulfill its potential. Tony thanks you for your continuing support.
Chris Gallaher
executiveThank you, Anna on behalf of Tony. Are there any questions from anybody in the room on the resolution? No. Anything online, Grant? If there are no questions, could shareholders please vote for, against or abstain? [Voting]
Chris Gallaher
executiveThe next resolution, resolution 5, concerns the $16.1 million share placement made last month to our institutional shareholders. The reasons for this resolution now on the screen are set out in detail in the Notice of Meeting. But broadly, shareholder approval is required because the number of new shares issued in the placement exceeds the 15% limit allowed without shareholder approval under the listing rules. The issue of shares in the placement is a material transaction as defined in the listing rules, and some of the placement participants are related parties of Pacific Edge. Because of the related party involvement in the transaction, the listing rules require the preparation of an independent appraisal report prepared for the benefit of shareholders not associated with the related parties. Simmons Corporate Finance was appointed to prepare the report for this resolution. And this, we will discuss shortly. The report was included in the Notice of Meeting, and it concluded the placement -- it concluded that the placement was fair to nonassociated shareholders because the benefits of the increased capital secured through the placement outweighed the disadvantages of any potential dilution of nonassociated parties. Finally, it is important to note that -- the consequences should resolution 5 not be passed. The placement is conditional on shareholder approval, and the retail offer is conditional on the placement proceeding. If resolution 5 is not approved, neither the placement nor the retail offer will take place. In that case, Pacific Edge will not receive the additional funding to fund the initiatives that Peter and I have set out in our addresses at the start of the meeting. Additionally, a no vote in this resolution would precipitate a significant restructuring of the company to substantially reduce its costs. The Board, excluding Anatole Masfen, supports this resolution. Anatole has abstained from the recommendation as he is a related party to Masfen Securities, which is a placement participant. Are there any questions from shareholders about this resolution? Yes, sir.
Unknown Shareholder
shareholder[ Jeremy Thomas ], I'm a shareholder. Just reading the resolution here, it seems to me there's 1 number and 2 expressions of units. So you've got NZD 0.1 and then the cents after the number. That seems, to me, inconsistent. Is there any view on that?
Chris Gallaher
executiveWhereabouts are you referring to?
Unknown Shareholder
shareholderSo resolution 5 says participants at an issue price of NZD 0.1 [ cents ]. Do you see it?
Chris Gallaher
executive$0.10 [ cents ], yes.
Unknown Shareholder
shareholderJust from a scientific point of view, I'd only put 1 set of units for 1 number but...
Chris Gallaher
executiveYou're heading into -- you're taking me into territory that I'm -- so the alternative is to write 10 cents instead of writing $0.10. We take that as a comment or a question?
Unknown Shareholder
shareholderPerhaps, it would be a clarification, but [indiscernible].
Chris Gallaher
executiveIt is $0.10 per share. Okay. And I think that was well...
Unknown Shareholder
shareholder[indiscernible]
Chris Gallaher
executiveThank you. Any further questions on the resolution? That being so, anything online, Grant?
Grant Gibson
executiveNo.
Chris Gallaher
executiveNo. Can I ask then shareholders vote for, against or abstain? [Voting]
Chris Gallaher
executiveAnd we move to resolution 6, which is the directors' remuneration pool. This resolution, as set out on the screen, is to approve an increase in the total remuneration pool to -- a director's remuneration pool to $628,000 per annum, effective from the start of the F '26 financial year. Pacific Edge is committed to attracting and retaining directors of the highest caliber, individuals with the skills, the experience and the judgment required to guide the company through its current challenges and future opportunities. However, the current director fee structure has not been reviewed since 2021. In late 2024, we undertook a comprehensive remuneration review, and this confirmed that our fees have fallen significantly behind market benchmarks. The review found that average base fees for NZ-listed companies are approximately 33% higher than those currently offered by Pacific Edge. For Chair roles, the gap widens to around 40%. Additionally, committee chairs and members are not currently compensated appropriately for the additional time and responsibilities that those roles entail. The directors believe that this represents a material risk to the company's ability to recruit and retain suitably qualified directors with the skills to assist the company as it seeks Medicare re-coverage and pursues its numerous global commercial opportunities that it has identified. Accordingly, the Board is recommending an increase in the total pool available for non-executive director fees to $628,000 per annum. This will bring remuneration in line with market expectations, ensure a fair and reasonable compensation and will strengthen our ability to attract and retain directors with the capabilities that we require. The allocation of the pool will be conducted in a fair and transparent manner as outlined in the Notice of Meeting. The proposed increase will be from the 1st of April 2025, which was the beginning of our F '26 financial year. However, the Board is acutely aware of our current financial position and the rationale for our recent cap raise. For that reason, the Board has resolved that any increase in directors' fees for the financial year 2026 will be paid in shares rather than cash at the same price as the placement and retail offer. This ensures alignment with shareholder interest and conserves cash during this important phase in the company's development. Are there any questions on this resolution? Anything online, Grant?
Grant Gibson
executiveNo.
Chris Gallaher
executiveThank you. So can I then ask that we -- that shareholders vote yes, no or abstain? [Voting]
Chris Gallaher
executiveThe next resolution covers the issuance of shares to directors in lieu of the increase in directors' fees. Shareholder approval is required under the listing rules for the issue of shares related to the fee increase as the resolution on the screen states. The details in terms of the share issue are covered in the Notice of Meeting. Meanwhile, Simmons Corporate Finance independent appraisal of the issue of shares to the directors has been -- has concluded that the proposal is fair to nonassociated shareholders. This resolution follows on from resolution 6. If that resolution is passed, shareholders will approve an increase in directors' fees. If resolution 6 is not passed, this resolution will not take effect. Are there any questions from shareholders on this resolution? No, nothing in the room. Grant, nothing online?
Grant Gibson
executiveNo.
Chris Gallaher
executiveSo that having been said, please -- shareholders, please vote yes, no or abstain. [Voting]
Chris Gallaher
executiveThat completes the voting on resolutions. At this time, I'd like to advise the meeting of the outcome of proxy votes that were lodged in respect of each of the resolutions. I will not read the proxy results for each resolution, but they are shown on the screen now. As I mentioned earlier, these resolutions were ordinary resolutions that required 50.001% shareholding approval to pass, and there's an overwhelming for vote for each of the resolutions. Final votes will go up on the NZX when the votes cast today, both online and in the room, are accounted for. We're now into the general business section of the meeting, and very happy to open the meeting up to questions of the Board or management, Pete and Grant who are here. And I intend not to answer all these but to spread them around to willing directors. Any questions? Yes.
Unknown Shareholder
shareholderThank you Mr. Chairman. I have a couple of questions, if that's right with you but firstly, a very quick compliment. I'd like to pay a compliment to the Board and also to Cameron Partners, who I thought ran quite an effective and efficient capital raise process. So the shareholder placement that was done via the web portal, I thought was very easy to use, efficient, and I thought that it went very well. So it's just a very quick compliment on that.
Chris Gallaher
executiveThank you. Ross Christie's here.
Unknown Shareholder
shareholderRight. Well done. You worked well. The second thing that I would -- the first question I have is I don't want to be a cherry picker of just one line, but there was a line, I think, in the -- one of the earlier presentations that we have already noticed clinician interest on the basis of the AUA guidelines. Could you perhaps just provide a little bit more color about how that clinician interest is taking place?
Chris Gallaher
executivePete, this one's for you.
Peter Meintjes
executiveYes, yes, sure. So there's a very particular example in mind when we wrote that particular bullet. There was a story, and it's actually been mirrored in our social media, LinkedIn feeds. Dr. Zachary Klaassen was someone who, about 18 months ago, was unaware of any Cxbladder products. And through the -- but he sits within like the broader AUA sphere and became aware of Cxbladder as we were trying to work it through into the guidelines. And he started using it, and he has become a speaker for us in a very short amount of time. And so it was part of some of the videos that were produced and posted on our social media channels and was also one of the people who spoke about the update to the guidelines at the AUA. And that bullet point was really channeling the enthusiasm that we felt at the AUA being -- because the most significant change to the microhematuria guidelines was the change around biomarkers. And so that was the enthusiasm that we felt from physicians learning about this for the first time that now, wow, biomarkers are no longer prohibited in appropriately counseled intermediate risk patients. We've felt very positively about that. Does that answer the question there?
Unknown Shareholder
shareholderIt does. And the second question I had was, as you migrate people from Detect to Triage Plus, am I correct in understanding that the economics are that Detect would have been charged at an average sale price of approximately USD 580 something and you're now migrating them over to something which is on a Gapfill, I think, of $1,018 but potentially could be higher if you're successful with your negotiations with CMS?
Peter Meintjes
executiveYes. So maybe I'll walk through. So our original intent was to move all Triage users and all Detect users over to Triage Plus at the same time as we launched Triage Plus. And Triage Plus is currently in early access and is not commercially launched outside of early access. However, with the AUA guidelines coming into effect at the end of February and then with Medicare making a non-coverage determination, we were able to leverage that. Sorry, I've forgotten the thrust of your question there.
Unknown Shareholder
shareholder[indiscernible]
Peter Meintjes
executiveAt a higher price.
Unknown Shareholder
shareholder[indiscernible] am I right in understanding that we're getting approximately $580 a test averaged out across all the tests that you do?
Peter Meintjes
executiveYes. So the...
Unknown Shareholder
shareholder[indiscernible] going to change by migrating the old Detect to the Triage Plus, it's a step-up.
Peter Meintjes
executiveYes. So we've had to do a 2-step migration. That was where I lost myself. So we're going from Detect to Triage first because of the non-coverage determination and the inability to get paid on Detect tests. And we still believe we can be paid on Triage tests but through an appeals process, and so we wanted everybody to be using Triage. So we've basically done it in 2 steps. Instead of taking all Triage and all the Detect users at a later stage with -- commensurate with Triage Plus launch and moving them to Triage Plus, we're now moving Detect to Triage, and then we're going to move all of those users to Triage Plus when launched. And Triage Plus is not yet launched.
Chris Gallaher
executiveAt the higher price and better economics.
Peter Meintjes
executiveCorrect. Yes. So we won't enjoy the higher price and the higher economics until it's Triage Plus.
Chris Gallaher
executiveYes?
Unknown Shareholder
shareholderAn informational question on Kaiser Permanente. There must have been a comfort to have Kaiser Permanente there while working through all of this with Medicare and Novitas. Of course, it's only Southern California Kaiser Permanente. I'm interested, in the past, it's been information that the rest of Kaiser Permanente Group is moving towards, I think, largely on technical things. But where has that got to? And is the AUA guideline having an impact on the speed with which they might come forward?
Chris Gallaher
executiveI'll have first crack. Pete, if you like, then you can follow on. Northern California was always the next major target. Our champions were in Southern California, Ron Loo and Eugene Rhee. The publication of the Kaiser paper, which is due sometime this year, later this year?
Peter Meintjes
executiveWas ideally this quarter.
Chris Gallaher
executiveThis quarter will be a significant flag in the ground for the whole of Kaiser when they see this paper published in the leading urology journal. We know where Kaiser operates. We know their geographies. We know they've just taken over Geisinger. So Kaiser continues to get bigger and more substantial and more important for us. But Northern -- and Pete can elaborate on this. Northern California has been slow to -- despite the urgings of their colleagues in Southern California. They -- we would have liked to have engaged them -- we've certainly engaged them. We would like to have them contracted a lot faster, but it's slow, Pete, but you might want to add.
Peter Meintjes
executiveYes. At a high level, it is really just the fact that the individual hospital systems within Kaiser, so they have 1 health plan, but I think it is 9 different Permanente medical groups that make up the different hospital systems. The largest of which is Northern California. The second largest of which is Southern California. And combined, those 2 are about 70% of all of Kaiser. So as Chris said, the logical place to go from Southern California is Northern California, and we have identified clinical champions who are interested in moving it through. But Kaiser is a very large organization, and what I think is important to understand, that operationalizing the implementation is something that's extremely challenging. And there are -- within the Southern California group, the people we were working with were very closely linked to the implementation group. And so there's just a lot of connections inside Kaiser that we need to bring together on a particular project. And it would now appear that Northern California is unlikely to be next because we have a greater level of interest from one of the others, but we prefer to sort of keep that to ourselves until we've actually made the milestones rather than getting everybody's hopes up about it. But it is -- it continues to be a priority for us to expand within the Kaiser network. And as Chris mentioned, the Kaiser network itself is expanding.
Chris Gallaher
executiveYes?
Unknown Shareholder
shareholderJust wondering, given that we're a New Zealand company and we have American lab and a lot of American customers, so we pondered any danger of tariffs impacting the business?
Chris Gallaher
executiveTariffs are impacting us already on some of the reagents that we bring in from Europe. I think we're paying, Grant, 10% on those?
Grant Gibson
executiveYes.
Peter Meintjes
executiveIt will move to 15%.
Chris Gallaher
executiveSo it will move to 15% just on the reagent piece. So there is a financial impact, around $100,000 to $200,000 a year, Grant?
Grant Gibson
executiveOn 10%, it was calculated around $100,000 a year. So it is a nuisance factor but not overly material to our financial results.
Unknown Shareholder
shareholderSo in case that we go and charge for, they won't be considered American produced by virtue being the American lab or sort of danger that the sales could be impacted as well?
Chris Gallaher
executiveWell, the -- we're paying tariffs on the materials that we import to the U.S. to do the test. So if they go wider, and we do argue that this is a New Zealand test, and what's the tariff here now, Grant, 25%?
Grant Gibson
executiveThat's moving to 15%.
Chris Gallaher
executive15%. Well. Yes. So we ride the horse that we have. We are paying tariffs at the moment on reagents in particular. I won't make any political comment. I'll leave it for others.
Grant Gibson
executiveWe are trying to work with suppliers to generate the reagents, et cetera, within the U.S. So a number of our suppliers have factories in various locations around the world. So we are looking to try and limit the impact of tariffs.
Chris Gallaher
executiveSo we're not kind of treaty shopping, but we are country shopping to find the lowest tariff [ in way ] of the U.S. Really productive use of our time. Any other questions?
Grant Gibson
executiveWe have a number online, so let's start moving through those. I'll try and summarize them. We've got an investor that invested at $0.90. The share offer at $0.10 will dilute our investment. Did the directors consider alternative financing?
Chris Gallaher
executiveWe did. And I've got shares that I paid $1.24. So we've all been in that boat. The other principal source of funding would be debt. And the Board have no interest in raising debt at this point in time until we're showing signs of being cash flow neutral. To lay a debt on to a company like ours at the moment, it would just be another -- just too difficult to manage.
Grant Gibson
executiveGreat. Thanks, Chris. Another question is the U.S. no longer appears to be accepting scientific facts. Will Pacific Edge rapidly move away from the U.S. market and expand into Europe and Asia? And I think that was covered in part with the IVD. But do you want to stress?
Chris Gallaher
executiveYes. Look, it was. It remains the biggest, most lucrative market for health care in the world. And to move away from it, we know what we generate in Australasia per test. We know what we could generate in other parts of the world per test. So without getting political, the U.S. market remains the single biggest opportunity for Pacific Edge. Now that doesn't mean that we are not looking elsewhere and we are. And I think Pete outlined some of the green shoots we're now seeing coming out of some of the Asian markets. As we move to develop our IVD capability, other markets will open up to us. So we're not sitting back complacently with all our eggs in one basket. We are looking at other baskets, and this cap raise will help to fund some of that, in particular, the IVD capability development.
Grant Gibson
executiveThank you.
Chris Gallaher
executiveWell, I'm answering all these by the way. We're about to spread a few around.
Grant Gibson
executive[ Andrew ] has decided to put Anatole on the spot. He's asked, Anatole has been a director of Pacific Edge for 17 years. He's a related party of Masfen Securities, had invested $5 million in the placement. I'd be interested to hear Anatole address the meeting and talk about his involvement with the Pacific Edge to date and how he views the company now and how he sees the outlook.
Chris Gallaher
executiveWhat a great question. Anatole, for you.
Anatole G. Masfen
executiveYes. Thank you. Look, I have been involved for a very long time. And I know that's not -- you don't mean to be a director for more than about 10 years. And look, I've enjoyed and still really enjoy working with all the directors and with a lot of the staff, Pete and Grant and some other of the Kiwi staff and some other staff that I don't know so well in the U.S. And people are everything. And the great thing about this business is everyone in this room associated with the business has still got full confidence in where we're going and that we're going to get there. I mean the key thing for me -- and I've invested over time where we invest in quite a few sort of aged care, health care things, including Mabel and some aged care businesses and Pure Foods, which is some food, health stuff for elderly people. And as populations get older, we're getting to a situation where living to 100 is not going to be unusual and living to 120 is not going to be unusual if you can get through your 50s and 60s, and you can get diagnosed with things that are actually going to kill you earlier. And better cancer and prostate care and some of these sort of not super -- well, cancers that you usually die with rather than die of, early detection is going to be everything. And if economies and governments are going to be able to afford to have people living into their old age, then they're going to have to do a hell of a lot better job at spending their dollars widely. And this is -- it's a disruptive technology, which changes the whole economics of it, but it's a bit like disintermediation in the financial business, is there's only going to be a few winners, and there's going to be a lot of losers. And if you can detect 95% of people early with bladder cancer, then they're not going to die of bladder cancer. So you're not going to need nearly as many urologists and you're not going to need nearly as many surgeries and the rest of it. We went into the U.S. very early on, which I've very quickly learned was a health care industry, not a health care system. And the Americans -- United States of America, Americans pay dearly for that, and they have very poor coverage. They have very expensive health care. They have a lot of squabbling parties from all different directions fighting against each other. But the one thing that was very clear to me is, pretty early on, is if you can get to a situation where you're sort of getting pulled through the system rather than pushing your way into the system, which is getting into guidelines, in my mind, then you really -- that is the key, the absolute gold standard for developing -- for continuing to sell a product. So Pete, to my right, denies the significance of this, but with a litigious society like that, using a test that's not in guidelines puts the urologist at risk of getting sued for not doing something else. Now that we're in guidelines and certain things, not using the test, they get their risk of getting sued for not using the test. And it's a massive swing. So how do I think the prospects are going forward? I think we're in a far better place than we've ever been as far as box ticking. I think when we were -- the share price was $1.30 or whatever, that was probably a bit of a disadvantage because a lot of the future earnings have been baked into the share price already. But I think where we are now is we're one step away from really getting some real traction, and that is getting back into the reimbursement in the U.S. and getting our sales team really supercharged to be selling things. The other thing you've got to remember is that it's very hard with a territory like the U.S. to cover it all off with 10 or 15 or 20 or even 100 salespeople selling 1 product. And that's -- we've always known that no one's going to want to swallow you up, none of the big pharma, and incorporate you into their product suite until you've proven that you can survive on your own. Surviving on your own with your own sales team is near impossible from a pure economics point of view. So yes, I mean, someone else said before, do you think -- with the way the U.S. is going, do you think that's the future? Personally, absolutely not. When people say Americans, I sort of say Canadians, Mexicans, Puerto Ricans Argentinians, all that sliver of dictatorship that lies in the middle there that's run by that nasty orange person. But it's -- look, if we can make it in the U.S., we've been able to do testing in other labs, the real market is at a lower price like it is in New Zealand, where we deal with one client, which is the New Zealand government or we're in one of the -- or in the U.K. or we're in some of those Nordic countries or Canada or -- there's a lot of very good, very well-run democracies around the world that have Medicare -- health care systems that will absolutely adopt this product if it's proven out in the U.S. So it's -- and maybe the future is that we sell off the U.S. and we run the rest of the world because they're not very interested in the rest of the world over there. So -- but look, in answer to the question, I think we're in a better position than we've ever been. We're very happy to put more money in, although I have to stand aside on that decision. And the key thing is it's -- end of the day, it's all about the people, and you've got a whole lot of dedicated people that are 100% behind making this work.
Chris Gallaher
executiveThanks very much, Anatole. That was terrific.
Grant Gibson
executiveThanks, Anatole. Another question, which I can probably answer, speed it along. Annual report disclosed that Singapore entity has been dissolved in the last year. Is this a reflection on the Singapore market? No, that is not. The Singapore entity was actually expensive to maintain, and we received little benefit out of maintaining that company, particularly as we expand into other countries in Southeast Asia. So for structural purposes and cost saving, we dissolved the Singapore entity, and we're selling to all Southeast Asian countries out of the New Zealand entity. So it's not a reflection on the Singapore market.
Chris Gallaher
executiveThanks, Grant.
Grant Gibson
executive[ Ken's ] asked a question around the business model. He says you've had knockback after knockback with little financial progress in the U.S. Do we see a different model, for example, licensing IP to one of the big pharma companies who can take it global?
Chris Gallaher
executiveWho wants to -- Pete, do you want a crack at that?
Peter Meintjes
executiveSo probably not saying anything terribly different from things in Anatole's and Chris' prior answers. Yes, we faced some knockbacks, but the framework within which we generate evidence is what will ultimately get us over the line. It's analytical validation, clinical validation and clinical utility of our tests that is going to make us successful. And I don't believe that having a pharmaceutical company that we -- either with a -- we partner with them so that they can -- so we can leverage their sales force or we sell to them in some capacity is a meaningful way to drive success in the U.S.
Grant Gibson
executiveGreat. Thank you. This might have been answered. I think this question came in before one of the slides. What proportion of patients are subject to Medicare coverage decision that were sort of in the recommended intermediate risk group in the AUA guidelines? And I think we said that we are pivoting and moving more towards commercial testing. Is there anything else anyone wanted to add on that?
Chris Gallaher
executiveMedicare is 65 and over. We're now pivoting. Is there anything further to add, Pete?
Peter Meintjes
executiveThere's nothing further to add from the slides that we talked through. I mean, intermediate risk as defined by the AUA for men is 40 to 59 and for women, it is over 60. And so we expect that as Triage becomes the dominant product and as more people follow the AUA guidelines -- and remember, some will follow AUA guidelines strictly, and some will follow AUA guidelines loosely. And it is hard to identify the perfect eligible patient. The AUA -- that's why the AUA guidelines change as more information comes along. So we view that at a high level as something that will shift the payer mix in favor of more commercial testing, but they will continue -- Medicare will continue to be a very important part of our payer mix.
Chris Gallaher
executiveThanks, Pete.
Grant Gibson
executiveThank you. We're getting through them. So the number of countries that Pacific Edge -- where Cxbladder is being sold and is still low, what is the main barrier to that? Is it regulatory? Or is it a bureaucratic, which could be addressed through lobbying? And are we doing anything around the lobbying?
Chris Gallaher
executiveYes. Pete?
Peter Meintjes
executiveYes. So look, it's largely in regulatory/market access. So -- and also finding the right partners. So you could -- before you can really do business in a meaningful way, you have to go and find who the right distributor for your products are, and we've got ways of doing that. We qualify them in certain ways. We look for ones who have experience with send out testing, for example, and to run their own labs so that in the future, they could actually run an IVD version and they get -- so we don't have to establish a partnership and then go, hey, actually, they can't run the test in their own lab, so now that we've got an IVD, we need a new partner, right? So there's a partner selection process. And then we also have to do urologist education. And I would just point out that, historically, when we had -- when we ran a Singaporean study, nobody -- no physician in that study actually saw a Cxbladder result because it was a clinical validation study that didn't -- where the physicians didn't interpret a result of the test. We were just really collecting samples and running a validation to show that it worked on Asian populations. So up until we launched our activities in -- I think it was March 2023, we really weren't actually attempting to sell in any of those countries prior to that. We just were collecting some samples through a couple of clinical study sites. So this is a very new initiative for us. And there is a -- like I said, a partner selection process to find the right partners. Then there is a market access and regulatory process. There's import, export. And the vast majority of these countries do require some form of IVD and would prefer that IVD to be run locally. So that's why it's a future catalyst to have an IVD kit that is available for sale in those markets.
Chris Gallaher
executiveGreat. Thank you, Pete.
Grant Gibson
executiveOkay. The NCCN is currently reviewing updates to the bladder cancer guidelines. They've previously shown strong interest with 2B recommendation. With another meeting on the horizon, do you think there's a strong chance Cxbladder could receive even more encouraging news?
Chris Gallaher
executivePete?
Peter Meintjes
executiveSo August is the month -- so the questioner is right that August is the month where bladder cancer submissions are made to the NCCN, and we are submitting the latest evidence for Cxbladder Monitor, which consists of 3 publications, 2 out of Australia relating to clinical validation and clinical utility of Monitor and 1, which is our own internal publication from last year, which relates to the analytical validation of Cxbladder Monitor. And so we have presented them with that information for consideration, specifically requesting that we be a named test. And we do know that there is some level of interest from talking to KOLs who are involved in the bladder cancer part of the NCCN in updating the monitoring guidelines, but we have not generated as much evidence for Monitor as we have for Triage. And so as a consequence, we've still got -- the more evidence we generate, the more likely we're to see change there. And similarly, from our competitors, no one has generated sufficient evidence to drive change there yet.
Chris Gallaher
executiveJust for the sake of simplicity, the NCCN guidelines are for those people who have had cancer or who have cancer. So that's where our Monitor product plays. And Monitor as a percentage of our business is a fraction of Detect, isn't it?
Grant Gibson
executiveYes, very small. 10% to 15%.
Chris Gallaher
executive10%. So the Detect, about to be Triage, is the main game from a product profitability point of view.
Grant Gibson
executiveOkay. Changing tact. If the price for Triage Plus gets too high, does the risk of Cxbladder becoming more expensive than a cystoscopy and therefore, making it less compelling?
Peter Meintjes
executiveSo the short answer to that one is no. And you got to remember that this is a Medicare price and this is a third-party insurance price. So it doesn't affect the way that hospital systems or physicians think about the care for the patient. So that's basically the headline. However, when we commercially contract with organizations like Kaiser or like Geisinger, Intermountain or anybody else that has insurance plan, they do value-based contracting. And as a consequence, we -- there might be a reason to offer a lower price that's value-based to those hospitals. And I won't bore you with the details, but then there is a subsequent process that kicks in called PAMA, Protecting Access to Medicare Act, which is specifically designed to reduce Medicare pricing over time to become value-based. Medicare pricing initially is technology and resources-based. That's why they have the latest and greatest of everything because you get paid for how much it costs to build and operate. But over time, you get benchmarked to the average of the value-based insurers and your price comes down.
Chris Gallaher
executiveThanks, Pete.
Grant Gibson
executiveFive questions left. Peter mentioned the European Association of Urology in the presentation. Does Cxbladder feature in the guidelines? And is this another market opportunity?
Peter Meintjes
executiveThe short answer is -- so there has been mention of Triage and mention of Monitor at different times in the guidelines in Europe. I don't keep the current status of that in my head, and they are updated every year around March. And because they're only tangentially relevant, I don't sort of store it away. But they definitely review all Cxbladder evidence, and we can and have been included by name in some of the guideline language from the EAU. But in terms of what opportunity that represents, again, the critical thing is, is you can't see in clinical samples from most European countries outside of the country. So that's why we need a decentralized IVD model to provide that clinical testing in that country, and that involves simplifying our product to the point that it can be put in a little box and then sold to another lab so that, that lab can run the test in the market. And at least in theory, we could own that lab and run it in that market, but what's more likely is that we will find appropriate partners to run that test for us with lab infrastructure.
Grant Gibson
executiveThank you. Next question from [ Richard ]. Despite the highly compelling evidence of the value of Cxbladder, could Novitas still say no? And if that happens, what's the plan?
Chris Gallaher
executiveYes, they can say no. Of course, they can always say no. That would lead us to some pretty major decisions about how we're structured and how our cost base is organized. Pete and the U.S. team are a lot closer to it than I. But if I've heard it once, I've heard it a number of times from key U.S. people that to be in guidelines and not covered by Medicare is very unusual. But again, it's a decision that's outside of our hands. We deal with the cards as they're dealt to us. And Pete, do you want to add anything further?
Peter Meintjes
executiveIt would also depend on the reason that they said no if they said no. And so my immediate reaction is to mirror what Chris has said, so -- but also to recognize that, yes, it would -- depending on the reason, it may be the case that Triage Plus still has a path to coverage, and it is incredibly unusual that you can be in the guidelines and also non-covered. And the only reason that has eventuated was because of the tortured process that the LCD followed, so -- and creating a timing issue. So the latest evidence hasn't been considered, and that's why we're here. When they consider the latest evidence, we believe very strongly that they will -- the evidence doesn't lie. So they'll interpret it the same way that everybody else has.
Grant Gibson
executiveThank you. What other competitors have come to the market the time Pacific Edge has been trying to get U.S. coverage?
Chris Gallaher
executiveIn the U.S. or globally?
Grant Gibson
executiveLet's just focus on the U.S.
Chris Gallaher
executiveOkay. Sure.
Peter Meintjes
executiveSo look, I get this question a lot. And I think it's important that the word competitor can be quite misleading. There are products that make competing claims to Cxbladder Triage. There are ones that make completing claims to see Cxbladder Monitor. The reason we talk about ourselves as having, firstly, a first-mover advantage and secondly, a moat around our product is the clinical evidence that we have developed in favor of our products. It's not just enough to say, "Hey, I've got a new product. It can detect bladder cancer and microhematuria patients, believe me because I said so," versus, "Hey, I've done a randomized clinical trial in hundreds of patients, and I've had that trial reviewed by the AUA guidelines committee, and they've come up with favorable language in support of it," right? That is the reason that we are confident in our evidence portfolio, and that is why evidence is the biggest moat around our business going forward.
Chris Gallaher
executiveI would just add to that, Grant. The other moat around our business is time. If we look at the amount of time it's taken us to get Kaiser from 0 to where they are now, the amount of time it's taken to get into guidelines with our evidence generation, the time for a new competitor, it's a 10-year journey for anyone else coming in and competing against us.
Grant Gibson
executiveGood point. [ Jonathan ] probably gets the question that he's paid the most attention. What's the motivation for FDA approval of an IVD, noting that IVD wasn't highlighted for use in the U.S.? And in particular, will the FDA approval of an IVD help regain Medicare coverage?
Peter Meintjes
executiveSo that is a great question and picks up on an element of nuance. So the reality is we don't need to have an FDA-approved product in the U.S. market. But by making FDA requirements, which are very, very, very similar to IVD-R requirements and very, very similar to ISO-13485, part of our quality management system would kind of get the -- we prepare ourselves, and I call this the defensive strategy because it means we are prepared for a future situation in which the FDA say, "Hey, we're going to regulate you now," or in the case of an IVD, which does require FDA approval, that is our defensive strategy for being able to sell a kit to a lab so that they can run it instead of the current model, which is a testing services. There's another element to that, though, and that is that there are these things called state biomarker laws. And state biomarker laws are favorable for FDA-approved products, and they are favorable for products that are covered by Medicare and New York State, among other things. And so you can improve the percentage of tests you get paid on by commercial insurers using state biomarker laws if you have FDA approval.
Grant Gibson
executiveGreat. Thank you. And last question. Are Pacific Edge and Castle Biosciences collaborating to build a strong case for reopening the LCD?
Chris Gallaher
executiveThat's certainly for you, Pete.
Peter Meintjes
executiveYes. So look, collaborating is not the -- not my preferred word choice, but I maintain a professional contact with the CEO of Castle Biosciences and that -- and so I am aware of the -- what they are doing regarding their resubmission. Yes.
Chris Gallaher
executiveThank you, Grant. Anything further from the room before we bring -- yes.
Unknown Shareholder
shareholderAfter listening to everything, I see as a stock -- as someone who -- so after hearing -- listening everything, I have -- like I think that is everything about pessimistic side, if the company is losing $30 million per year, 2024 and 2025, and if we are raising $20 million, that means whatever the loss was, we are just raising the money. Simply, can we say like that? So I suppose if the loss is again $25 million, then would we raise the capital again?
Chris Gallaher
executiveWell, we'll deal with that when we come to it. It's going to depend on the speed of re-coverage by Medicare. And that could happen. There could be a draft LCD, [ Pete ], anytime. We just don't know, but it could drop in August or September. And that then would change the dynamics for us. But -- so we're conscious of our spending. And with that, I think I've said in my remarks, we completely -- getting the place is doable that it would destroy everything that we've built. And not being able to sell the product to clinicians for a period would lead those clinicians to look elsewhere. So keeping a presence in that market is something we think is important.
Unknown Shareholder
shareholderSo now let's -- if you think about positively and everything goes right, so I think if it's a disruptive product, it's like a disruptive technique to help the patients, then can we say that the revenue can increase by 10x if the product is very successful and everybody likes the product in U.S.? Can we say that the sales can go to 10x? Because if somebody...
Anatole G. Masfen
executive20 or 30x.
Chris Gallaher
executiveYes. Anatole, please jump in.
Anatole G. Masfen
executive10x would be a failure. 20 or 30x, yes. 50x.
Unknown Shareholder
shareholder50x.
Chris Gallaher
executiveIt's a very big opportunity, very big financial opportunity.
Peter Meintjes
executiveYes. While we didn't put anything in the slide deck today on this, the market opportunity is estimated between 3.5 million and 4.5 million testing opportunities per year. And so when you put the average sales price of $1,018 on a Triage Plus test, you can see how big the potential market actually is. So are there a few things that we have to get right between now and then? Absolutely. But that's the price that we're paying for and that's why it matters.
Chris Gallaher
executiveAnd that's just the U.S. market without thinking about other markets. Last call, anything further? So with that, I'd like to close the meeting with a special thanks to our shareholders, in particular, who have been very patient as we've been on this journey. Thanks to the Board for their commitment in what has been a challenging and trying period, to Pete and his management team for keeping the faith, keeping the endgame in sight and to you all. I may not be here next year with a bit of luck, so thank you very much for your support and onwards to refreshments outside, and we'll go well. Thank you.
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