Okay. Ladies and gentlemen, good afternoon. I am Simon Flood, and I would like to welcome you all to Pacific Edge's 2026 Annual Shareholders' Meeting. I am a recent member of the board and also assumed the position of Chair in December last year. For those of you who are regular attendees at this meeting, my predecessor, Chris Gallaher, who had chaired the business for, I think, nine years, Tony? If he is, just want to thank him for his service to the company and to the contribution that he made to it during his time here. Before getting underway, I need to draw your attention to an important notice, which is apparently right. Do you need time to read that or can we just. We will take it as read. Given that it is now 2:00 P.M., and we have a quorum, I can declare the meeting open.
I will provide further instructions as we go through the meeting. If you are joining us online, there is a virtual meeting guide, or you can use the helpline provided by our friends at MUFG. For those of you who are here in person, there are a couple of housekeeping points that we need to cover off. First is if you have a mobile phone, could you please put it on silent?
The restroom facilities are down the hall and to the left. If a fire alarm goes off, the staff will tell you how to get out of here safely. I would like to introduce our directors, Anatole Masfen, who is here to my right, who chairs our Capital Committee, Anna Stove, who is to Anatole's left, who is chair of our People and Culture Committee. Bryan Williams, who is up there on the far left, is there.
There is Bryan there. That is a surprise. Anyway, lovely to see you, Bryan. Bryan has got a new beard since I saw him last. He is currently in the outback of Australia, so he is beaming into us. Bryan is Deputy Chair of the business. Sarah Park to my right, and Sarah sits on a number of our committees. Tony Barclay, who you will be hearing more of later, chairs our Audit & Financial Risk Committee. We also have members of our senior management team. I am sure all of you will know Peter Meintjes and Grant Gibson, our CFO, is sitting down the back there. Our auditors, I think Nathan Wylie is online. Is that right?
Yep. We have two representatives from Harmos Horton Lusk, Nathanael and Tim. Nice to see you guys. Thank you for being here. The meeting agenda. This is the meeting's agenda. We have got the chairman's address, which is me. I am going to start with some comments, then Peter will give his chief executive's address, and then we will take questions before moving on to the resolutions of the day, where we have six resolutions. After that, for those of you who can give us some more time, there will be an opportunity for us to mingle and enjoy some refreshments out the back. I have received two apologies. The first is from Rosemary Stephen, and the second is from Richard Solomon. Are there any other apologies that should be recorded in the minutes? No? Okay.
Now, the minutes of the previous annual shareholders' meeting are available for inspection on request. They are also on the company's website. Let's go to the first slide because I wanted to spend a few moments putting Pacific Edge's current position in context, where we have been, the opportunity we have in front of us, and why we are positive about the future. I want to clearly set out what we need to do to realize what we believe to be a significant opportunity ahead of us. When I joined Pacific Edge late last year, I did so because what I saw, in very simple terms, was a company that had assembled something that is actually quite rare and exciting in a sector that I have strong affinity with.
Patented, non-invasive tests with proven clinical utility, a substantial and expanding evidence base, a recognized patient and healthcare system need, and a meaningful global opportunity. I also believe that, and there has been a lot talked about the Medicare process, that while challenging, would ultimately recognize the value that Pacific Edge's Cxbladder products offer, and that is also recognized by the urologists' community both here and in the U.S. The draft local coverage determination, and we will refer to that as an LCD, was published by the Medicare Administrative Contractor, Novitas, in May. That proposes that Medicare coverage for both Cxbladder Triage and the successor product Triage Plus, o ur test for the evaluation of patients presenting with hematuria, or blood in the urine. Importantly, those are the only biomarkers proposed to be reimbursable under this policy, and that gives us a tremendous opportunity relative to our competition.
This is a company-defining milestone and a significant validation of our evidence-led strategy, and it is a major step forward to an opportunity worth, in revenue terms, and you will see it up there in the top left of that chart, $10.2 billion. The draft LCD is good to have. It is a huge step forward, and it is a hard-won recognition for the years of work put in by our team, led by Peter. But it is a draft, and disciplined execution remains essential as we wait for the confirmation of a final LCD, which we hope to receive before the end of this year. The difference that the draft LCD makes is that it gives Pacific Edge a clearer reimbursement pathway and a legitimacy that confirms Cxbladder as the leader in its field. That is a great place for us to start rebuilding our sales momentum.
Bladder cancer diagnosis often begins with the evaluation of the causes of hematuria, and there are millions of hematuria evaluations carried out each year in the U.S. Cxbladder is designed to help identify hematuria patients at a low risk of cancer. Properly used, it will ensure that patients are able to receive an accurate diagnosis that was previously only available if the patient underwent a cystoscopy. That is a procedure that many have chosen to avoid because it is invasive, it is uncomfortable, and at times, quite painful. The risk stratification of patients by clinicians also ensures that the higher-risk patients continue through the appropriate pathway, which has then been freed up by the redirection of those low-risk and intermediate-risk patients, which is where Triage and Triage Plus come in.
That delineation of care is valuable for patients, it is valuable for clinicians, and it saves money for the healthcare system as a whole. As a company, Pacific Edge is now better positioned to pursue that opportunity than it was 12 months ago when you may have been meeting here with the board and management. The draft LCD deepens the commercial and scientific moat around the business, and the inclusion of the successor product, Triage Plus, also introduces the potential for improved economics. Growing the commercial payer support in the U.S. from what effectively amounts to a validation of our products by the draft LCD will in turn support growth in other markets, such as the Asia Pacific, which often look to the U.S. for direction. We continue to see good progress in the Asia Pacific.
We just jump to the next slide, and I am not, you will be pleased to know, going to go through all of it for you, but bring you up to date with the far right. Pacific Edge's progress has been the result of a long and deliberate journey; b uilding evidence, establishing diagnostic operations in New Zealand and the U.S., launching the Cxbladder products, securing early commercial use, and working over many years to embed our tests into clinical practice. For a diagnostics company, adoption is earned through evidence, demonstrated clinical utility, better patient pathways, and the confidence of clinicians and payers. That hard work has been done.
The achievements of the last two years have been significant markers on that journey, and they include the groundbreaking STRATA study that established the clinical utility of Cxbladder Triage, the inclusion of that test in the American Urological Association guideline in 2025, the resounding support for the test expressed by the Contractor Advisory Committee, which was convened by Novitas in February of this year, and now the draft LCD. Together, they have endorsed our strategy of placing thoroughly researched and validated clinical evidence at the heart of value creation. Those elements also give us a highly credible pathway to convert market access into growth and, over time, profitability. As shareholders will be well aware, the journey has not been linear. The Medicare non-coverage period was a serious challenge for the business. I want to thank our shareholders for sticking with us through those challenging times.
The long-term direction of travel is clear. The company has continued to build evidence, protect its intellectual property, and develop products with the potential to improve the standard of care in bladder cancer diagnostics. That was also the basis for my own conviction. I am aligned with shareholders, not only as chair, but as someone who chose to invest in the company. I have done so alongside my fellow directors and the management and the broader team because we believe that the opportunity is real, the evidence is increasingly recognized, and the company now has a pathway to create shareholder and stakeholder value. Let us move to the next slide. The financial results reflect the impact of the Medicare non-coverage. Commercial test volumes and operating revenue were down, and the company recorded a large net loss. Still, as I have highlighted, FY 2026 was a year of strategic delivery.
Pacific Edge preserved its core assets, it managed its costs carefully, it reduced cash burn in the second half, and completed a capital raise to support the next phase of strategy, which is all about delivery and growth. Most importantly, FY 2026 delivered the draft LCD. The company also built the commercial payer momentum in the States, while Asia Pacific has continued to advance through clinical pathway adoption and commercial progress. These developments broaden the opportunity beyond Medicare alone. Triage Plus also improves the outlook, and it was gratifying to see Triage Plus included alongside Triage in the draft LCD. It has higher performance and the Medicare price create the potential to improve revenue per reimbursed tests, improve margins, and the company's path to profitability. Surveillance Plus remains an important future opportunity with further clinical validation and reimbursement steps ahead.
We are in a materially different and stronger position than we were a year ago. Look, the message I wanted to leave shareholders with is this. Pacific Edge has been through a difficult period. But while it has been navigating those choppy waters, it has not stood still. It has protected and strengthened the foundations of the business. As chair and as a member of the board, I am and we are excited about the future of the business. I am also realistic about the execution required. We will continue to be measured, disciplined, and transparent. I believe that the company can now convert its first mover position, clinical evidence, and product innovation into meaningful value for patients, the healthcare system, and shareholders. As I said before, look, I want to thank you. I am an investor by training.
I know what it is like being in companies where the share price is volatile. I want to thank you for your ongoing patience and support. I also want to thank the Pacific Edge team, led by Peter, for their commitment. Our professional advisors, HHL, who are here today, and the clinical community whose engagement has helped us bring the company to this important point. I am now going to hand over to Peter, who is going to speak in more detail about the company's operational progress, commercial priorities, and outlook. Thank you, Pete.
Thank you, Simon, and thank you to all of you for coming this afternoon. I am Dr. Peter Meintjes, and I will be talking about all those priorities Simon just mentioned. Next slide. I wanted to start, though, by reminding everybody about how we create value for shareholders. We create value in three pillars. Our top pillar is adoption, retention, and revenue generation, which are the activities that we are focused on in the near term to drive shareholder value. A core discipline of Pacific Edge is our evidence coverage and guidelines. This is our second pillar. We generate fantastic clinical evidence through a rigorous evidence generation program as part of pillar two so that we can develop coverage, medical policy, and guidelines off the back of the strength of that evidence. Our third pillar is research, development, and innovation.
These are the activities that we undertake to drive shareholder value over the long term. Next slide. How have we advanced various priorities against those three pillars of value over the last year? In our view, strong execution on evidence pillar has underpinned our future commercial success. We have a draft LCD, as Simon has talked about, supporting Medicare coverage of Triage and Triage Plus that we are expecting will be final and effective before the end of this year. Our clinical evidence generation program is something that is ongoing, and the focus of that evidence generation program right now is to extend the thresholds between intermediate- risk and high-risk patients, so that we can have more inclusion of more patients eligible for Cxbladder testing to deliver our tests to a larger serviceable market.
As we think about the near term with adoption, retention, and revenue generation, our U.S. commercial testing has stabilized, and you will see some data on that in a coming slide. But we are expecting that off the back of the work that we have already done with the draft coverage in place and with the final coming towards the end of the year, that our expectations are set to rise. In the meantime, though, we have pushed ahead on multiple fronts, including medical policy wins with U.S. commercial payers, which have been increasing through this year. We now have over 10.5 million lives covered with commercial medical policy for Cxbladder Triage.
In the APAC region, we have been focusing towards operating profitably on a direct cost basis, and it has been really pleasing to see test throughput increase, the proportion of commercial tests of total tests increasing, the average sales price increasing, and most recently, since the launch of Triage Plus, the product mix shifting towards increasing levels of Triage Plus, which creates a greater margin and margin percentage for our business. In the long term, we are driving long-term enterprise value with product improvements and new products through our research, development, and innovation. The most recent milestone for that came last year with $1,328 price established for Triage Plus. As we look towards the future, we are targeting a $1,800 price for Surveillance Plus.
When we achieve these milestones, the value delivered by research development and innovation will improve the unit economics that we can focus on in our first pillar as we drive revenue. Next slide. A little bit more detail on what Novitas has actually proposed. Again, I am more than happy to take a range of questions on this at the end of the session. But the finalized LCD is expected to accelerate our path to profitability because we did not have one before. Importantly, Triage and Triage Plus have both been proposed for Medicare coverage. As Simon also highlighted, there are no other urine-based biomarker tests that have been proposed for Medicare coverage. Final and effective coverage is expected before the end of the year. Move forward, I think. Final LCD expected to catalyze reimbursement and testing volume. If you can complete the slide. Thank you.
Our immediate focus as a business is to improve the unit economics of operating a frontline sales team. What does that mean? That means making sure that the number of tests that one sales rep is able to reliably generate for our business increases from where it is today in ways that start to pay back the costs to the business, giving us operating leverage for the future. We want to shift our customer base from Triage to Triage Plus because we get paid more per test, because it is at a higher margin with a higher margin percentage, but also because this is the most accurate test, and it is what is best for physicians, and it is what is best for patients.
Importantly, we are seeking to ensure payment success on more than 80% on commercial tests by operating only in the areas where we have a reliable history of commercial success or existing medical policy, and in the future, contracting. Next slide. A reminder of the total market that we are chasing here. The market opportunity is substantial. $ 10.2 billion at full global TAM. We have currently focused on the U.S. market, and of course that total global TAM figure is driven by the $ 6.4 billion in the U.S. market, where we have a higher test price and a substantial testing volume.
Specifically, we are targeting the low, the intermediate, the high risk, and the gross hematuria, with our Triage Plus product. In the surveillance setting for non-muscle invasive bladder cancer patients with an $1,800 price for Surveillance Plus, we will be targeting the 750,000 patients that are annually on a surveillance protocol.
We expect that those patients will be surveilled one to two times per year using a tool like Surveillance Plus to drive that TAM. What we also know is that our current indication is only for intermediate risk. Right now, our serviceable market is smaller than our TAM, but we expect to expand that over time, and that is one of the near-term focuses of the business. Next slide. How are we doing that? We are driving the expansion of the indications that we have through our clinical evidence generation program. The studies in yellow that you can see here, these are the studies that have already been published. The studies in green are the important upcoming studies that will drive the expansion of the market from intermediate risk to low, intermediate, and high risk.
The way we will do that is through a series of sub-analyses on the different populations within the microhematuria patients and include gross hematuria patients. With that, we will be able to publish convincing clinical evidence that the serviceable market should be expanded to include all risk microhematuria patients. To summarize there, collectively, these studies are expected to redefine the AUA risk categories for a greater serviceable market. Next slide. Other parts of our evidence generation system, but not part of our core evidence generation program are the independent studies that supplement our evidence portfolio. These are a great way to keep ourselves in the headlines. These are high-impact research at low cost, driven by the customers that we work most closely with.
While only one of these studies has been published, and there's been a few delays behind the second one, we are optimistic that the first ever patient preference and patient satisfaction study of biomarkers versus cystoscopy will be published within the next quarter. It has been submitted. This is in partnership with excellent researchers at the Mayo Clinic in the United States. Investigator-initiated trials across the spectrum here are targeted at extending the evidence portfolio and keeping Pacific Edge in the news at conferences. They are an important part of our key opinion leader engagement program and how and why our key opinion leaders support Pacific Edge in return. Next slide. Having a quick look at our commercial performance over the last year. It is simply a fact our performance in terms of test throughput has declined over the year.
However, over the last three quarters, we have observed that it has stabilized, and we are delighted with that achievement. As our sales force has declined, this means that we have been able to improve the sales force efficiency as the number of FTEs in our sales force has lowered while maintaining the same level of throughput. The next steps from here are focused on the lower graph. What you can already see is that we were able to successfully change the ordering behavior of our physicians from using Detect to using Triage. That transition is no small feat. But we have another one, and a more important one coming up. That one was done under duress. The next one is planned, and we are planning to shift all of our customers from using Triage to using Triage Plus, and that won't be immediate.
Some of our customers are contracted to use Triage and will be using it for some period of time. Some states, like New York State, we do not yet have approval for Triage Plus. It requires a separate approval. But overall, we are transitioning our customers from Triage to Triage Plus, and you will see it manifest here in the product mix. This is how you will know we will have an increasing ASP. We'll be driving up our margins, and we'll be driving up our margin percentage for greater commercial success. Next slide. Just to talk through what is our near-term commercial strategy with draft Medicare coverage. We do believe that draft Medicare coverage is a fantastic milestone, final obviously being more important, but what are we doing while we have draft and before we have final?
Importantly, we have to look at the words of the draft, and we have to focus on Triage Plus, and we have to focus on intermediate-risk microhematuria patients. We are configuring our sales operations around the intermediate-risk patients. What does this mean? As we look to try to reduce our cash burn, we've got to be able to identify the core points with high numbers of intermediate-risk patients and migrate customers to Triage Plus. If you could just go forward all through the slide. Thank you. We're going to be targeting the intermediate-risk microhematuria patients because many of those patients are female. In the bottom right corner, you can see that the vast majority of low-risk patients are female. The vast majority of the intermediate-risk patients are female.
As a consequence, we need to find those female-specific core points, and many of those are women's health providers. Examples of those women's health providers are URPS, urogyns, OB-GYNs, and FPMRS. We have helpfully included expansions of all those acronyms down the bottom in the footnote. But those are all important subspecialties of urology that see more women. Other important targets are the systems that are integrated between primary care and secondary care, something that here in New Zealand we may take for granted. Nearly all of our care is integrated, but not so in the United States. But there are a number of what are called integrated delivery networks where primary care and secondary care are integrated, and that is a defining feature of IDNs. Another important element to this is that urologists frequently triage the intermediate-risk microhematuria patients using people that are not the treating physician.
Support teams in the office, the advanced practice providers, the nurse practitioners, and the physician's assistants, these are all people who might see the patient when they are lower risk before a physician would actually see them, and consequently, they need to know about our test, and we need to be actively targeting them. Our commercial team, the sales teams, are focused on concentrations of demand in integrated delivery networks, which are hospital systems, academic institutions, and the Veterans Association. Pacific Edge is making selective investments, as Simon also highlighted, aimed at growing Triage Plus volume ordered on intermediate-risk microhematuria patients that have the highest chance of reimbursement success and delivering consistent revenue. Next slide. What does the breakdown of the market look like when you think about these IDNs and these private practice, t hey're private practice urology groups.
Private practice, if we actually start at the bottom here, those basically come in large and small. Large urology group practices, also called LUGPAs, often are private equity backed. They're very cost-driven, and they're very procedure revenue driven. Similarly for community urology, but community urology is practiced on a much smaller scale. That's typically one and two doctor practices, and those make up around 40% of the market of private practice. Our account executives are the ones that are going to continue to be responsible for calling on these private practice accounts and converting them from ordering on all microhematuria patients to ordering on the intermediate risk microhematuria patients.
However, the larger share of the 1.14 million intermediate- risk patients are seen in an integrated environment in one of the types of IDNs, which as I mentioned, are hospital networks, academic centers, Veterans Administration, and one particular example of an IDN is where we are already operating, which is Kaiser Permanente. Around the country, there are around 1,000 of these strategic accounts, including 130 academic centers, 170 VA medical centers, nested within 18 VISNs, which is how the Veterans Administration is broken up. These are typically characterized by, one, the integration between primary care and secondary care, two, a capitated system of managing patients, and three, the adoption of clinical pathways. It is this opportunity of clinical pathways and pathway-based medicine that allows us to pivot our sales process from selling tests to physicians to selling pathways to institutions.
While this is a longer sales cycle, the upside is clear. When you have implemented a protocol at an institution, your revenue is stickier, and patients and physicians are able to more clearly adhere to that pathway than with individual decision-making on its own. Next slide. Another important component is not where the ordering happens, but who is going to pay for it. We have multiple customers, which is often difficult to explain. Multiple customers for a given test. There is the person who orders the test, which is the physician, there is the patient who receives the test, or the person who receives the test, which is the patient, and then there is the person who pays for the test, which is the insurance company. These are called commercial payers.
With Medicare policy, we are expecting that there are fewer barriers to adoption by the commercial payers, and commercial payers are actually the larger market opportunity because there are 223 million lives insured by commercial payers, contrasted with only 66 million lives insured by Medicare across the system. Commercial payers cover almost 4x more lives than Medicare. Intermediate risk microhematuria patients skew younger, female, and importantly, commercially insured. Final coverage from Medicare is expected to unlock revenue from commercial payers by removing a key reason to deny reimbursement. Currently, commercial payers might look at a test and say, "It is not covered by Medicare. I do not have to cover you either." That is changing, and that is powerful. Providing additional evidence to overturn denials on appeal is another thing that we can do.
If a commercial payer does choose to deny us, we can provide additional evidence in the form of Medicare draft policy to improve our appeals success. Because these are written documents published online, private payers can go and read those policies. Their medical policy teams can, if they are efficient, cut and paste the existing policy, modify it to suit their specific needs, but they are able to leverage that existing language in their own policies. Then finally, there has been an initiative through the American Cancer Society for many years to create what are called state biomarker laws. Although state biomarker laws are in their infancy, state biomarker laws do say that if Medicare covers your test, commercial payers are expected to pay for that test. That provides us with extra legal avenues to pursue commercial payers in certain states that are respecting those state biomarker laws.
Next slide, please. A little bit on APAC. We are quite buoyed by our progress in APAC. It is small, but it is significant. We have not faced the same level of headwinds, and we are showing that we can chart a path to profitability. If we look, the volumes are smaller than they are in the U.S., but we have been able to see quarter-on-quarter growth for the last five quarters, which is really fantastic. The thing that I am actually most excited about in APAC is the same thing that I was talking about on the U.S. slides. It is about the transition to new products where the test price is higher, the margin is higher, the margin percentage is higher.
What we can already see is that where we haven't faced market headwinds, we have shifted from 0% to 1% adoption for Triage Plus. We have shifted to 7.6% over a quarter, and that is just the immediate impact since launch. Around 60% of that 7.6% is ex New Zealand, showing that that is an increasingly important segment of our market from a geographic standpoint as well. APAC proves the rest of the world concept, and we can replicate this in other markets where we do not currently operate, but we're proving the model. We can replicate it in the Middle East, the U.K., Europe, but we do need to continue our path for RUO and IVD development. Next slide. All right.
I wanted to talk a little bit about our third pillar, and how we generate value with research, development, and innovation over the long term. Our next-generation products, we've been working on them for a long time, but they are already delivering strategic value. I've talked a bit about the headline here. Of course, it's about revenue, margin, margin percentage. Triage Plus is the future of our hematuria evaluation. For Triage Plus, we have analytical validation complete, clinical validation complete, a price of $1,328 per test for Medicare, draft coverage proposed by Novitas, and we are seeking over the next several months, more likely timeframe is mid-2027. We are seeking to have Triage Plus added to the AUA guidelines and to expand the definition of AUA guidelines themselves. This builds a substantial moat around our hematuria evaluation business.
Surveillance Plus is in a slightly earlier stage of development. The markers have been validated, and we are working simultaneously on publishing our analytical validation and our clinical validation, which we expect to publish early in FY 2028. Surveillance Plus has completed its freedom to operate, and provisional patenting is in process. We are targeting to make submissions for Surveillance Plus mid next year, with a view of being paid and generating early revenue from 2028. That is a six-month delay over what we previously announced to the market. This does allow us to have additional revenue coming into the business during FY 2028 while seeking the crosswalk price and while seeking coverage on an LCD from Novitas. In parallel to those activities for our U.S. testing services, we are also advancing IVD development for international markets.
While these programs are in a prototype phase and a plan is in place to be ready to implement, subject to budget approval, the opportunity is real. Our international markets, we can build one kit that by differentiating the labeling and working with different suppliers or different partners in each of those market, we can access all of those markets simultaneously. Of course, we choose to do them one by one and on a prioritized basis, but the opportunity that we have to enter those markets is based on a single product line differentiated by labels. Pacific Edge is simplifying its test to create a Triage Plus IVD product, and that will allow us to go into these international markets with a decentralized lab deployment approach for international market expansion.
It is worth noting that this is when contrasted with the United States, that is lower margin, and lower revenue per test, but it is also a substantial untapped and nascent market for us as a global diagnostics company, where it is important for us to establish a footprint. Our key objectives are establishing an IVD regulatory framework. This is deeper than the CAP/CLIA LDT framework that we currently operate in the United States, and involves IVDR, FDA, and ISO 13485 requirements. We have already dipped our toes into that quality system by making sure our urine sampling system, the jar that our patients pee in, that has already gone through the approval process to be an IVD. Next slide, please. Next one. Thank you very much. I just want to talk a little bit about the outlook.
We are at an important point, and as Simon has already thanked you, I would like to do so myself. You as investors have kept the company going through many challenging years. Your support is deeply appreciated. We are positioned to unlock the value of that investment through upcoming commercial, clinical, and innovation milestones. In the near term, we are still pushing for case-by-case reimbursement for Triage and Triage Plus under the draft LCD. We are awaiting the final LCD published by the end of 2026. Our U.S. customers adopting Triage at $1,328 per test and building commercial payer medical policy momentum as we speak. We are still waiting for explicit news from Te Whatu Ora/ Health New Zealand about a national pathway, but we continue to answer their questions and respond in a formal capacity there.
In the medium term, we are going to continue with our evidence generation program for the sustained strategic value that underpins our ability to commercialize. Our U.S. commercial payer policy for Triage and Triage Plus will fundamentally drive test adoption. We are focused on the opening of the AUA guidelines some time after the middle of 2027, and it might stay open till as late as 2028, and that is expected to expand our serviceable market. We continue to use investigator-initiated trials to generate novel evidence for new indications. In the long term, Triage and Triage Plus deliver better patient outcomes at higher margin, and improved unit economics for Pacific Edge. Surveillance Plus, targeting June next year for launch, and claim- by- claim revenue.
Sorry, June next year for coding submission and claim- by- claim revenue from the 1st of January, seeking a higher price than we have now, and then focused on the IVD kitted products for international markets. Thank you very much for your time. I look forward to taking your questions.
Thanks, Pete. Okay. How are we doing? It is kind of warm in here, isn't it? Folks, before we move to the formal resolutions, just wanted to give you, and the people who are watching online, the opportunity to ask questions. These are questions, as they relate to the business, that you have heard about from me and from Peter. They are not questions related to the resolutions. When we get to the resolutions, then you will have an opportunity to ask questions about the resolutions. The only people apparently entitled to ask questions are shareholders and their proxies or representatives of the shareholders. For anyone here in the room, if you have a question, please just raise your hand. My friend at the back here will bring you a microphone.
If you could then state your name, whether you are a shareholder, a proxy holder or a corporate representative, and then we will answer your question. For the shareholders attending online, you can submit questions through Ask a Question function on the virtual meeting platform. Does anyone start in the room? Does anyone have any questions of the board, of Peter, of Grant, who is sitting down the back, but he can still answer questions. Sir.
Thank you. Before I ask my question, I would just like to record my thanks to the board for the fantastic work that has been done over the last year. It would appear that the company has never been better positioned in terms of its commercial opportunities. I recognize the incredible work that has been done by the board and by the staff, by the senior leadership team to deliver a company that is vastly better positioned than it has been, that I can recall in the last few years. My first question relates to something that I read by a prominent American commentator called Dr. Bruce Quinn, who made a point that commercial payers and Medicare contractors are more interested in clinical utility than clinical validity as a tool for unlocking coverage and payment pathways.
I guess I would just like to ask, do you think that Pacific Edge has been able to unlock clinical utility as the key part of the equation for commercial success? Then I have a second question after that.
Pete, do you want to answer that? For everybody listening, do you want to explain the difference between clinical utility?
Yeah, sure. This one is working. Thank you, Aaron, for your question. Bruce Quinn is spot on, and there is a long and a short answer to this. To acknowledge Simon's question, we generate multiple different kinds of clinical evidence. The first is analytical validation, which essentially just shows is your test repeatable, reproducible in a laboratory? Those are the classical measures of clinical performance. Clinical validation answers a slightly different question. You use the test in a population of patients that were not part of the development test to prove that the performance characteristics you have seen are not just an artifact of the patients you developed it on or the samples you developed it on, and that it works for other patients.
Clinical utility involves, typically, in its gold standard form, a randomized controlled trial, which is comparing the test arm, which includes your new product, to a control arm, which is the standard of care, to show that there is a difference in outcomes between the control arm and the test arm, and that shows that your test has clinical utility. That clinical utility, the pathway, the protocol that you follow, then provides a way for saying how and when a physician should use the test. Not just that the test works. How and when does the test work, and what can you do with the outcome? Bruce Quinn is 100% correct, that that is what drives payer policy, long-term value, but you have to do all of the steps to get to clinical utility.
Even then, another form of clinical utility is called real-world evidence, and we also have this in the form of the Kaiser study. Just relating it back to Pacific Edge. For Triage, we have the whole portfolio. For Triage Plus, we are building that whole portfolio. For Triage, we have a real-world evidence study from Kaiser Permanente. We have the clinical utility trial, which was STRATA, and we have all the AV and CV work necessary for maximizing that market. For Triage Plus, we have the AV and the CV. We do not yet have the clinical utility study t hat is credible, but the policy for urine-based biomarkers has already been established by the clinical utility study done by STRATA.
Now, maybe I will stop there, but there is nuance to it that relates to what is called the 21st Century Cures Act, which also mandates that if you have a valid test that is medically reasonable and necessary, and medically reasonable and necessary is not a direct one-to-one translation from AV/CV/CU, Medicare is expected to cover that test. But if you do not have clinical utility, how can you prove medical necessity? So there are ways that you can, and there are situations which you can get paid. The gold standard way to make sure you get paid is a clinical utility study, is a randomized controlled trial.
Thank you. If I may ask my second question, Mr. Chairman, it would appear that Pacific Edge has something of an 18 to 24-month moat over competing products and demonstrating clinical utility for that to draft LCD. I was just wondering whether there is any color that you might add about the competitive landscape and the moat that you believe that Pacific Edge has them.
Yeah, look, happy to answer that one as well. So there are a number of different companies, and always have been, that have made competing claims that they are urine-based biomarkers for the evaluation of microhematuria or for use in non-muscle invasive bladder cancer patients. So there are some legacy technologies like NMP22, like cytology, like FISH, and there are companies like Vesica Health that has AssureMDx product that was recently acquired by Photocure. There is another one called Oncuria, and there is another one called, I think, bladder detect, and another one out of Israel. I am blanking on the name right now. Beg your pardon?
Cepheid?
Oh, no. Well, I am not sure much about the Cepheid test if that is really much of a competitor. But yes, there was one on that platform as well at one point. But what is important to recognize here is that while they might have a product that can be used in those patients, the medical policy that Medicare has established or that Novitas has established makes absolutely clear for the utility of use in a hematuria patient, when the goal is to omit a cystoscopy, there are only two technologies that can be used, and they are Triage and Triage Plus. So there are a number of different technologies that can then work in these patients, but the ones for that utility, that are validated for that utility, are only Cxbladder products.
Whether there is an 18 to 24-month time horizon for somebody else to produce equivalent evidence is something that is up to them. We will see whether they can hit their deadlines. I am aware that one of those companies has made announcements and expects to have a last patient in in their study in mid-2027, which is roughly 12 months from now. If they are able to quickly write that up and publish it could be 6 to 12 months from that point. Competition is possible, but competition is also a validation that what we are doing is important and valued by our customers. If they think there is a spot for somebody second in the market, you can be damn certain there is a spot for us at first, and we should look to dominate.
I think the other bit you might want to comment on that is the perspective of the American Urological Association and the product that they recommend.
Yes, thank you, Simon. The AUA have a, i t always helps me to remember the specifics. It is table five in section 13 of the microhematuria AUA guidelines, and it has eight entries in it. Of those, two are Pacific Edge entries, Triage and Resolve, which is surprising that Resolve was included. While there were a couple of other tests included, only Triage had grade A clinical evidence supporting it. Again, the clinical utility is what drives the A recommendation versus the C, which is what was recommended for all the competing tests and legacy tests.
Okay, cool. Done. Any other questions? Grant, do we have some questions for online?
We do. Thank you. Right. We will start at the top. The first one is from Andrew Ott. Thanks, Andrew. The 2026 capital raise, you raised an additional NZD 12.1 million, over what the amount that you targeted. Will this now enable you to continue with the development of your kit-based IVD tests, which you had previously said were being temporarily put on hold? Are you able to provide any color on how your plans are now being altered given the additional capital?
Why do I start off with that, and I will get Pete to sort of follow up with the specifics on the IVD. The capital raise was probably more successful than we had thought going into it, obviously spurred by the issuing of the draft LCD right in the middle of the raise. That was sort of both good news and bad news because we had sort of a story of two halves. What we had was we had a successful raise of circa NZD 36 million. That is great.
We are still in cash burn as a business, and one of the things that the board and I, particularly Tony with his audit and risk hat on, work very closely with Pete and Grant on is the level of our cash burn and the length of our runway. What we are doing as a business is we are making selective investments to support management in growing our sales, both in the U.S. and in Asia. Because we recognize, from the question from Aaron before, in terms of competition never sleeps. We have been afforded an advantage by the draft LCD, and we need to capitalize on that. So we need to invest to get ourselves in a position to build sales momentum when that draft LCD is confirmed, and that is something that we have no control over.
One thing, my dad had an expression that he would rather be mean than poor. Basically, that meant he had short arms and deep pockets. I have inherited similar genes. So we want to make sure that the money that we are spending has a direct connection to sales. We recognize that cash is finite. Shareholder cash is very, very important to us, and how we spend it is something that we spend a lot of time thinking about. What I would like to believe is that shareholders have invested in us and entrusted the board and management to make this company grow. Last year was a strategically very significant year in the history of this business, and it sets us up well, competitively and scientifically, to actually drive sales once the LCD goes from a draft to a confirmed LCD.
We are looking at that. Product strategy is something that will figure in that, but also is sort of geographic representation, how we work with the commercial payers, Medicare, the Veterans Association, how we roll out in Asia. It's a complicated jigsaw. IVD is one of the things that we talk about. Pete, you might want to put a little bit more color on that.
Yeah, sure. Happy to do so. Look, what I think is just important to also characterize for investors is, even though we took over subscriptions from the original intent, there is not a one-to-one mapping between that and turning on some of the programs that we turned off. As Simon has articulated, and I have also articulated, we are going through a process of selective investments and reevaluating which of those things turn on. Just because we raise more capital, doesn't mean we turn on all the things we turned off. That we want to make clear. But in terms of the priorities of IVDs, they are a topic of active discussion. Per the slides that I had, we have a prototype, and we have a developmental plan that we are ready to execute.
We also have a forum agreed between board and management about how we will bring proposals from management to board, discuss them, and approve them. We are scheduled to discuss things in more detail, IVD being among the highest priorities, at a strategy session that we will have during October. I probably wouldn't elaborate beyond that. Yeah.
Thanks. Grant?
I'll actually just do a follow-up question to that from Kaushik Patel. They have asked what the current cash burn rate, and we cannot confirm what that is. We cannot state what that is at the moment for disclosure reasons. They wanted to know whether we are going to come back to the market for additional capital.
I'm not sure how you answer that. There's certainly no plans at the moment to come back to the market for additional capital. We had a successful cash raise. We have enough money in the bank to sustain operations and make selective opportunities. As you sort of build sales momentum, you build more cash in the business. At the moment, we're all equity-financed. Equity, speaking as an investor, is an expensive way of thinking about running a business. As we become more mature, as we get a bigger top line, we can review the way that we finance the business. I would not rule out a capital raise at some point in time in the future. But at the moment, it is not under active discussion.
Great. Thank you. This question comes from Stephen Mayne . It's a bit of a change of focus. Could the new Chair, Simon Flood, please comment on the biggest changes in board process, delegations, reporting lines, or governance that he's implemented since taking over as chair in December? Following that, could CEO Peter Meintjes also comment as to whether Simon is more or less hands-on than his predecessor? So putting you both on the spot.
You better be careful how you answer that, yeah? I'm not sure what the right answer is. Look, I inherited, and as I said at the beginning, Chris, as I was being recruited, I got to know Chris a little bit. I was obviously thrilled to be appointed to the board. But I suppose one of my disappointments in that was that as I stepped on, Chris stepped off. He had made a great contribution to the business. In the moment that I had to get to know him, I thoroughly enjoyed his company and his professionalism. We all have different approaches. I am reasonably hands-on. I'm trained as an investor and an analyst, so I like to open doors, pull out drawers, and I'm not sure I can extend that analogy. I like to ask a lot of questions. Yeah.
Which Chris obviously didn't need to do because he knew the business much better than I did after nine years as chair. I ask a lot of questions. I have been very focused on cash burn, how we invest our cash, how we spend our money. I also am a strong believer in communications, and Pete and the team have been doing a good job. I hope you think they're doing a good job in terms of communicating with our shareholders. I have a very, very good and experienced board who have provided me with guidance. I would say in answer to the question, that it's been a process of just gentle evolution. What I inherited was very good, and that's why we are in the position that we are in today, because of the work that has gone before.
Pete, am I more or less hands-on than the previous chair?
Perhaps before I answer that, when Simon took over in December, it was less than 30 days, I think, before Simon joined me in Dunedin for a three-day director induction program. This is something that management had been preparing for Chris to retire from Pacific Edge and for a new chair or a new director to come in for some time. We were quite well prepared with various documents. Much like an onboarding of someone who comes onto my executive team, we had a different style of onboarding that we had put together for Simon, in which he met all of my C-suite and some of the team in the middle management.
He had the opportunity to address the company, and he had the opportunity to observe me giving my I do four town hall presentations to the company per year, talking about things on the inside, and he had the opportunity to observe that. I think he was given a thorough introduction, induction, sorry, to the company's operations quite early on in his tenure, putting him in a good position to be successful as chair. That's part of the responsibility that myself on behalf of management and the directors all share whenever a new director comes on board. I'll decline to answer the specifics of that question, but of course, there are differences in styles between chairs. Thank you.
Just to give you an insight into that, I speak to Pete probably a couple of times a week. We have scheduled meetings where we go through what's going on in the business and any priorities that the board has, then we catch up on an ad lib basis as we need to. Nik, you had a question. Gentleman's just going to bring you a microphone.
My name is Nik Kasabov. I am a Professor of Knowledge Engineering and AI at AUT previously with University of Otago. I just have a comment. I just want to congratulate the leadership of the company for taking the company through very difficult period last two years and to showing a very promising plan for the future. Thank you. One small comment. I saw on the diagram of the history of Pacific Edge that the first year that is shown is 2011. Of course, that was the starting commercial. Let me say that as one of the co-founders of Pacific Edge, we founded that in 2001, and I would like to see this year as well, along with the dotted lines. I am sure professors Parry Guilford, Tony Reeve, and Mike Sullivan, who are also co-founders, will be happy to see that. Thank you.
Okay. Thank you.
Nik, it is nice to see you again. I think we met when I first took the job. I am 100% to blame for that. We do have a variant of the slide that does go all the way back to the founding of 2001 and has the photo of yourselves in the stairwell of the innovation center. For the purposes of focusing on commercialization, that is the variant that we have used today. But yeah.
We'll use the other one next time. S Ir.
We talk a lot about America and how it's funded in America. How is the rest of the world going, and how is the rest of the world funding? Like in New Zealand, are we as insurance companies funding it all? Southeast Asia, how is it funded over there?
I think what we'll do, it's a good question. Pete had a slide. Can we just go back? There was a slide that showed Medicare commercial payers, and that will give you an insight. I'm going to get Pete to talk down. Sorry, you've gone too far. Keep going. Keep going. That one. Pete, why don't we talk to that in terms of the model? That's what you're asking about, the model? Yeah.
The non-U.S. model.
This is the U.S. model, then we will come to Asia.
Yeah. Look, so I think I understand the question, and this probably is not the right slide to look at while I am answering. But you are essentially asking about commercial payer coverage in countries that are not the United States. Let us look at New Zealand, Southern Cross. Do they pay for the test? No, they do not. I believe one of the other smaller ones, and you will have to forgive me because I do not know the smaller insurance companies by name, but I believe one of the other ones does. But from the business's perspective, it is not really an incredibly relevant path for us to go down.
The relevant path is for us to have these contracts with the DHBs historically, which then became the Te Whatu Ora regions, which are now all under the pathway. That allows us to get all of the New Zealand patients covered for that indication. But let us expand that to Australia. Let us say, what are we doing in Australia?
Well, we already know, and it is on some slides that I do have in other decks. We omitted it for simplicity today. But in Australia, we know that we cannot get federal reimbursement unless we run the test in Australia. So how do we run the test in Australia? Well, that is our RUO/IVD path. We need to complete that work. We need to have that test run by Sonic or some other testing service in Australia and set that up. It is a totally different business model, but we can absolutely do that, and then we would be eligible for federal reimbursement. There is an enormous amount of work to show concordance between the test we have and the box we make with the other test that gets run in Australia.
But assuming we do all that, we should be able to have a reimbursement path in Australia, and that is the point at which you can get it in every other country. Right now, we operate what is called a send-out testing model, and we can contract directly with hospitals, we can contract with governments, we can contract with individuals for just cash pay kind of thing. So the business development that we are doing through the Asia Pacific is limited and is largely not going to be covered by reimbursement. Singapore might be an exception to that, just because of the way that it works. People have health savings accounts that are owned by the individual. So from their perspective, it is cash pay, but it is coming out of something that they were taxed into a health savings account for.
They are probably fine to just pay for the test that way. Every market is different. Those are the ones I know something about. There is plenty that I do not, and I will need expertise to help us go into those markets. It comes at a time for the business when we go in with the IVDs, and we do that on a targeted and prioritized basis. We can, in theory, go to any country at that point, differentiated by labeling and the various approval processes that we go through.
Okay. Yep. Okay, cool. Sir.
I arrived a little late, so you might have covered this already, but if the Medicare decision is as favorable as you expect, do you have a calculated amount that the company will receive retroactively from Medicare for the period of time that it was not covered? If you know that figure, how will that affect the cash burn rate?
Yeah. Unfortunately, it does not work that way. That is why one of the other things that I did talk about is so important. Novitas has offered us an opportunity to get paid on claim- by- claim coverage with a draft, but we will only get paid when the LCD is finalized from 45 days after the policy is finalized. If it finalizes 1st of November, we will get paid from 15th of December kind of thing because it is based on data service, and that is just how that works. However, what they have given us is the opportunity to appeal with documentation using the draft coverage as evidence that these patients are eligible, and that is something that we can do for Novitas.
That's the thing that I mentioned we are yet to be successful because the process involves us getting denied then going back for what's called a redetermination. Different parts of the organization don't talk to each other as well as they should. We have no reason to believe that there is a problem with that process. We're just yet to actually make it complete. Can I put a number on that? Unfortunately, that would be irresponsible of me at this time. But internally, we're doing everything we can to make that number as big as possible.
Okay, Grant.
Great. Yep, another couple of questions from online. This is from Ming gang Chen . The draft LCD sets out a list of patient eligibility criteria that must be met before the test qualifies for coverage. For example, the patient has not undergone the same or a similar test within the previous six months. Do these criteria align with how Cxbladder products are actually or should be used in clinical practice? Would that restrict the use cases comparing to the previous LCD?
The short answer is, while we have some comments into Novitas about some of those specific eligibility criteria, by and large, Triage, which is what this affects, is a single-use diagnostic test at a point in time. For a clinically separate bout of hematuria, we expect to be able to use the test again. We could not use it repeatedly, but actually, that's not the intended use of our test. So for us, we meet that requirement and have no major issue with it.
The gentleman here had a question.
Hi, my name is [Sija]. It's probably easy to call me Kevin. I'm a shareholder. My question is to Peter. With the AUA guideline change in 2025 and this new Novitas LCD that's setting new policy, could you please give an indication as to the dynamics with which the practicing clinicians would align themselves to that guideline? Would you expect they'd do that quickly, or was that something that they will slowly or eventually converge to? Thank you.
That is a great question, and this is where there's a little bit of devil in the details, a little bit of nuance. It is important to remember that even though we have established for the first time biomarker policy for use in microhematuria patients, and it is for intermediate-risk patients. That is a huge milestone, and we don't want to take anything away from that. It is also important to know that front line, they basically say for appropriately counseled intermediate-risk patients. The recommendation from the AUA is still to use a cystoscopy, but this makes it medically reasonable and necessary if they choose an alternative. That's the power of the guideline. Many urologists may still say, "I'm just going to keep doing what I was doing." We are at the early stages of changing clinician practice.
Those that are most familiar with the test and familiar with the value and recognize actually that it's in their own interests economically to not waste time on the patients who are unlikely to have disease. Until they've really been educated on all of the points, they may continue with the old standard of care. But it is our job to change that. There's a whole lot ahead of us to do so. But at the moment, it is not a hard requirement to change as dictated by guidelines, so you would expect adoption to be more based on our effort than on guidelines being directive.
Great. Thank you. We have another question from Stephen Mayne . There are two parts to this. Thank you for offering the best practice hybrid AGM today, and could you please publish a full copy of the AGM webcast on your website, not just the presentation slides as has occurred in the past? I can answer that one. The previous AGMs are actually on the Pacific Edge YouTube site. You can find the 2025 copy of the AGM there, and you will see the 2026. We will put that up there as well.
Next part of the question is, are we getting good value from being dual listed, paying listing fees to both ASX and NZX? What is the split between Australia and New Zealand and the rest of the world in terms of the share registered by both shares and shareholders? I will answer the shares and shareholders. We have 5% of our shareholders based overseas. Most of those are within Australia, and that represents 2% of our share base, so predominantly New Zealand based.
Are we getting good value? Look, I think this is one of the things that we look at. The decision to have a dual listing obviously predates me, but it makes sense to me to have a listing outside of the country where you are going to be growing. We are going to be growing a global company from New Zealand. The pools of capital that are available are bigger outside of the country. There is logic to having a second listing. In terms of value, that is a hard thing to define. At the moment, we have got the vast majority, as Grant just said, of our shareholders here in New Zealand. But as the company has removed the regulatory overhang, I think we are going to get on the radar of more people.
Pete has been in conversation and communication as recently two weeks ago with contingents of investors from Australia. One of the things that we are going to be looking at as we go forward and as we can focus on growing the business is to get the story out there. One of the first places that we will go and visit to get our story out there is Australia, where we already have a listing and an opportunity for people to be able to invest in the company from the Australian market. The question on value is something that we will review as time goes by, but it makes sense to have exposure to another capital market with deep resources.
Sorry, Mr. Chairman. Is it also true that by being ASX listed, international fund managers would be able to invest in Pacific Edge, whereas they may not have a mandate to invest in NZX companies because our market is too small?
Yeah, look, when I ran portfolios, we did not invest a lot of money in New Zealand simply because the liquidity issue. Australia was a market that we did spend a bit of time looking at. You find that people are more concerned about the opportunity than they are about the destination of the money. New Zealand is a well-respected, well-regulated capital market. Yeah. Very transparent, very well-regulated, very fair in terms of overseas ownership rights. But it is a market that it would probably be the top four or five companies by market capitalization that would attract most foreign investment. The way that companies can get the exposure to additional capital is to take their listing and put it in another market.
You have seen that happen a number of times with New Zealand companies looking for additional capital and additional exposure. They move to a bigger pool. We have kept a dual listing.
Great, thank you. We only have one other question, and that was from Andrew Ott, and that was around AssureMDx. But Pete, I think you covered that pretty well in your competitor analysis.
Yeah.
I think we can move on.
We are done? Okay, cool. Thank you, Grant, and thank you, ladies and gentlemen, for your questions. Right. Look, now we come to the formal part of the meeting in terms of the shareholder resolutions, which have been outlined in the notice of meeting. There will be an opportunity for you to ask questions on each matter being put to the shareholders. For the sake of good order, questions raised at that point should relate directly to the specific resolution being considered. When I call for questions, if you shareholders in the room could raise your hand, we will give you a microphone. If you could state your name, whether you are a shareholder, a proxy holder, or a corporate representative. Only shareholders, proxies, or corporate representatives are entitled to ask questions. Online attendees can submit questions by clicking the Ask a Question button, in the virtual meeting platform.
As part of today's formal business, as you know, I am standing for election by shareholders, and when we reach that item, I am going to hand to my board colleague and friend, Tony Barclay, who is the Chair of our Audit & Risk Committee, to conduct that part of the business. Let's go to the resolutions. A poll is going to be held on each of the six resolutions. Shareholders joining us today should have received a shareholder voting card when you registered. If you are a shareholder and have not registered and you wish to vote, you can go to the registration desk outside, and the MUFG staff will assist you.
If you mark your voting intention for each resolution on the voting card, and then I imagine, Grant, and I am looking at you, is there a box or something that people can post their cards in on the way out? Yep, there is. Okay. You have, I think, three choices. You can vote for, against, or abstain. It is the same for the people voting online. People voting online, you can use the virtual meeting guide or use the helpline if you require specific assistance. Voting is going to remain open until five minutes after the conclusion of the meeting, and the results of the vote will be published on the NZX and the ASX, and on the company's website following the meeting.
Each resolution is an ordinary resolution, which means it must be approved by a simple majority of the votes cast by shareholders entitled to vote and voting on that resolution. There are no shareholder voting restrictions on resolutions 1 to 3 or on resolution 6. There are voting restrictions on resolutions 4 and 5 as outlined in the notice of meeting. I will remind you of those restrictions, or Tony will, including how they apply to directors appointed as proxies when we reach the relevant resolutions. The outcome of valid proxy votes received before the start of this meeting will be displayed for your information after the voting on all six resolutions. Next. Right. Okay, this is a very standard resolution, and it concerns the remuneration of our auditor, PricewaterhouseCoopers. Under the Companies Act, PricewaterhouseCoopers is automatically reappointed as auditor at this meeting.
The resolution before shareholders authorizes the board to fix PricewaterhouseCoopers' remuneration for the coming year. The board unanimously recommends that shareholders vote in favor of resolution 1, and I now propose that shareholders authorize the directors to fix the auditor's remuneration for the coming year. Are there any questions on auditors' remuneration? You have one?
We have one online.
Yeah, sure.
that comes from Stephen Mayne . PwC has been your auditor for more than a decade. Whilst a five-yearly partner rotation is required under Australian and New Zealand law.
Yeah.
There is no mandatory tendering after 10 years as now occurs in the U.K. When did we last tender the external audit, and when are we most likely to run a competitive tender for the job?
Okay. Grant, can you answer when we last tendered for the auditor, please?
I cannot actually recall. It hasn't been in the last six years since I've been here. We did discuss it, but at the time, the business was going through a lot of uncertainty, and we felt that continuity of an auditor was probably the best course of action.
Yeah. Okay. My view, I am happy to put it on an agenda for the board to discuss, and we would take advice on that. We look at auditors as an important contributor to the numbers that we make public. Obviously, the integrity of those numbers is essential for any business, and it is really important that shareholders have confidence, which is why we go with a well-established firm who has served us very well for more than a decade.
We do ensure fresh eyes are brought to the audit through the rotation, which is required by law, but it is good practice anyway of the partner in charge of the audit. We are very much an open book and very transparent. I am happy to put the matter on an agenda, maybe at the AFRC, Tony, for discussion. We can take advice, and we will see where we end up. Next question.
That is it.
That is it? Okey-dokey. I sort of feel like there might be a countdown clock or something to let people vote. There's no countdown.
Okay. Let's move on to resolution 2. Resolution 2 is the re-election of our Deputy Chair, Bryan Williams, as a director. In accordance with NZX Listing Rule 2.7.1, Bryan retires by rotation, and being eligible, has offered himself for re-election. Bryan was first appointed to the board in June 2013. He is an internationally recognized cancer researcher and research administrator with significant business and governance experience. He provides the board with extensive knowledge of Pacific Edge and the healthcare sector. The board carefully considered the application of the independence factors in the NZX Corporate Governance Code to Bryan during his 13-year tenure as a director. The notice of meeting sets out the board's assessment of that tenure.
Amongst other things, the board is satisfied that the length of Bryan's service as a director has not compromised his ability to apply independent judgment to matters before the board in the interests of all shareholders. Accordingly, the board has determined that he remains an independent director for the purpose of the listing rules. The board, other than Bryan, who abstains, unanimously supports his re-election. I now propose that Bryan Williams, who retires by rotation at the conclusion of this meeting and is eligible for re-election, be re-elected as a director of the company. I invite Bryan, granted we have him online, to address the meeting.
Yes, I'm here. Thank you, Simon. I'd just like to begin by reiterating some of the thanks that we've had from our shareholders for their support over the past three years. It's been a really difficult process that we've gone through, and we really appreciate how much they've continued to support us, as exemplified by the latest cap raise. So thank you very much for this. I would be very excited to be able to continue my appointment as a director of the company and as Vice Chair. We've got an exciting journey ahead of us, and I look forward to working with my fellow board members and Pete and his executive team on this journey. So thank you very much.
Thank you, Bryan. Are there any questions on this resolution? No? Okay, great. You can now mark your voting cards in the way that you wish to vote. I am going to step away from the lectern and hand to my friend, Tony Barclay.
Try and do a little dance here and not get in each other's way.
I'll just get out of the way.
Right. Thank you, Simon. Resolution 3, thank you, concerns the election of Simon Flood as a director of Pacific Edge. Simon was appointed by the board on 4 December 2025 and assumed the role of chair on 19 December 2025. Under NZX Listing Rule 2.7.1, a director appointed by the board must retire at the next annual meeting and may then offer themself for election. Accordingly, Simon retires, and being eligible, has offered himself for election. Simon has more than 25 years of experience in the global investment management industry, including senior investment and business leadership roles in London, Hong Kong, and Singapore. His experience spans listed equities, fixed income, commercialization of intellectual property, early-stage investment, and governance. He also has a long-standing interest in the global healthcare industry, hence Simon being here today.
The board has determined that Simon is an independent director for the purposes of listing rules, and the board, other than Simon, who abstains, unanimously supports his election. I now propose that Simon Flood, who retires at the conclusion of this meeting in accordance with NZX Listing Rule 2.7.1 and is eligible for election, be elected as a director of the company, and I invite Simon to address the meeting again. He's back.
Thank you, Tony. Ladies and gentlemen, just a couple of brief words from me. This is my first annual shareholders' meeting. I became a director and then was elected chair in December of last year. I'm an investor by training. I've lived and worked most of my professional life overseas. I spent 15 years in London and then spent 10 years in Asia. In that time, I was trained as an analyst, then an investment manager. I ran portfolios. I then ran teams of people who ran portfolios. Then ran divisions, and then countries, regions, and then came back to New Zealand.
I love the markets, and we're a listed company. I love the healthcare sector because it's actually a sector that does stuff to improve people's lives. The work that is being done by Pacific Edge, started by Nik, continued by a number of others that have followed him, and carried by Pete, Grant and our board, is important, and it makes a difference to people's lives. The reason that bladder cancer is an important cancer is that there are a lot of people who don't seek treatment until it's too late. There are a lot of people who don't like cystoscopies because they're uncomfortable, they're invasive, and they're sometimes painful. Pacific Edge's product, backed by scientific evidence that has been built over many, many years, offers a cost-effective solution to that market.
When I was offered the opportunity, I saw some key building blocks, the scientific evidence which confirms the validity of the products. We have a listing, which gives us access to shareholders and capital markets. We have a good management team. We have a very good board, and I was very excited by what I saw in front of me. I am a very numerate numbers person. I love business, and I love the healthcare sector, probably above all else. My discipline is around money, and how you spend it, and how you drive returns. Something that I have learned all the way through my career in terms of identifying businesses that can create and deliver shareholder value. I hope that the skills that I have learned, and the experiences that I have had, will be of use to Pacific Edge as it writes the next chapter.
I hope that you will be able to give me your vote today. I am very happy to take any questions, but that is me, Mr. Chairman.
Mr. Chairman. Simon has already asked whether there is any questions, but I guess, just while he is stood away from the chair, just one last opportunity. Nothing online? Okay. Thank you. Please mark your cards in the way you wish to vote. Okay, Simon, I will just give two or three seconds. Right. Resolution 4. The next resolution concerns the payment of director remuneration to Simon Flood. At the 2025 Annual Shareholders' Meeting, shareholders approved an increase in the non-executive director remuneration pool for FY 2026.
The increased component of FY 2026 director remuneration was to be satisfied in shares rather than cash, and shares were issued to the then directors in August 2025. When former chair Chris Gallaher retired on 18 December 2025, he repaid NZD 12,699 to the company under the agreed repayment mechanism. Simon had been appointed to the board on 4 December and became chair on 19 December.
The 2025 shareholder approval did not contemplate the payment of the increased remuneration component to a replacement director, either in cash or by way of the issue of shares. Simon's total entitlement to director remuneration for FY 2026 is NZD 47,616. Of that amount, NZD 34,918 has been paid in cash, and NZD 12,699 has been accrued but remains unpaid. Resolution 4 therefore seeks shareholder approval for the company to pay Simon the outstanding NZD 12,699 in cash. If approved, the company intends to make the payment within a week of this meeting.
The payment of this amount, if approved by shareholders, will not result in any increased accounting cost to the company, as the accrual was included in the company's most recent audited financial statements, nor will it result in any net cash outflow as the proposed payment to Simon is equal to the repayment received from the former chair.
The board, other than Simon, who abstains, unanimously recommends that shareholders vote in favor of resolution 4. There is a voting restriction on this resolution, as detailed in the notice of meeting, which provides that Simon and his associated parties cannot vote in favor of this resolution. As a result of that restriction, where Simon has been appointed by a shareholder as a discretionary proxy on resolution 4, including in his role as chair of the meeting, he will not vote the shareholder's shares on the resolution. Well, I now propose that the payment in cash of NZD 12,699 to Simon Flood, being unpaid director remuneration accrued in respect of the period from 19 December 2025 to 31 March 2026, be approved for all purposes, including NZX Listing Rule 2.11.1. Are there any questions on the resolution?
Yep, we do have one online. This is from Stephen Mayne . If we're having a special resolution just to approve a small payment to the new chair, will the chair undertake to lead a board discussion on whether Pacific Edge should voluntarily follow the law in Australia where we're dual listed a nd put the remuneration report up for a non-binding vote at next year's AGM? The likes of Fletcher Building and Xero already voluntarily do this, and it's standard practice in an English-speaking world, making New Zealand look like a governance backwater by not adopting this measure.
I think I'll hand that to the real chair.
Thank you. Grant, did you say it was Stephen?
Yes.
Stephen, thank you, Stephen, for the question. We want to follow best practice. We do in everything that we do. I would be very happy to table that for consideration, take appropriate advice, and just do what we think is the right thing. That is the way we run the business.
Any further questions online, Grant? Okay. Thank you. Again, please mark your voting cards in the way you wish to vote, remembering to take into account the voting restrictions discussed which apply to this resolution. Resolution 5. Resolution 5 concerns ratification of shares issued in connection with Pacific Edge's recent capital raising in reliance of the 15% placement provisions of the NZX Listing Rules. In May 2026, Pacific Edge announced a capital raising comprising a placement and a retail offer at an issue price of NZD 0.17 per share.
The placement was completed on 15 May and the retail offer on 4 June. In total, 152,561,001 shares were issued in reliance on the company's 15% placement capacity under NZX Listing Rule 4.5.1, comprising shares issued under the placement, certain shares issued under the retail offer, and shares issued in consideration for professional services provided in connection with the placement and retail offer. I feel I need to take a breath there. The purpose of resolution 5 is to ratify those share issues. If the resolution is passed, it will effectively replenish Pacific Edge's 15% placement capacity, giving the company its full capacity under Listing Rule 4.5.1 to issue shares without prior shareholder approval, where the board considers it appropriate and the requirements of the listing rules are satisfied.
If resolution 5 is not passed, Pacific Edge's ability to raise equity quickly will remain constrained until its placement capacity refreshes within 12 months after the relevant component of the capital raising. For example, to the extent that the company's 15% capacity was used to issue shares under the placement, that capacity will refresh on 16 May 2027. The board, other than Simon Flood, Anatole Masfen, and Bryan Williams, who each abstained because they or their associated persons were issued shares under Listing Rule 4.5.1 in the placement, unanimously recommends that shareholders vote in favor of resolution 5. Again, there are voting restrictions on resolution 5 as set out in the notice of meeting, which provide that recipients of shares issued in reliance under Listing Rule 4.5.1 and their associated persons cannot vote in favor of the resolution.
The voting restrictions apply to Simon, Anatole, and Bryan as recipients of shares under the placement. This means that where any of them has been appointed by a shareholder as a discretionary proxy on resolution 5, they will not vote the shareholder shares on the resolution. I now propose that the issue of 152,561,001 shares, under NZX Listing Rule 4.5.1, as described in the notice of meeting, be approved and ratified for all purposes, including NZX Listing Rule 4.5.1(c). Are there any questions in the room on the resolution? Aaron.
Thank you, Mr. Chairman. Hypothetically, does this mean if it is approved that the company has greater freedom to pursue a strategic relationship with a larger U.S. investor, for example?
Absolutely. It basically gives the company flexibility to look at its capital requirements without needing to come to shareholders.
Fantastic. Thank you.
Yes. We have another question online from Stephen Mayne . Our shares have almost tripled since July 2025 when we did a NZD 16 million placement at NZD 0.10, which was followed by a NZD 5 million SPP, which brought in NZD 4.7 million. The pricing at the time was a 22% premium on the previous close of NZD 0.082, and the stock is now at AUD 0.23. With the benefit of hindsight, shouldn't this have been a pro rata offer to minimize dilution of existing holders? If we raise capital again, will the chair undertake to do as a pro rata raising, which treats all shareholders equally and doesn't need shareholder approval like this resolution?
I am happy to give this a crack, by the way. Look, thank you for the question, Stephen. Look, when we undertook that capital raise the previous time to this latest one, there was reasonable uncertainty in terms of where the business was at. There was no CAC scheduled. We did not have the draft LCD. Whenever we look at raising capital, we look at what is best for the business at the time. And both that raise and the raise we have recently done, we have attempted through the SPP to make it fair to everybody and try and make shareholders have the ability to be whole in terms of their percentage ownership of the business.
If we were, which we have not committed to clearly, raise capital in the future, we would look at all options in terms of how we might raise that capital and at all ways try and be fair to all shareholders. I do not know whether you have got anything to add to that as chair of the cap com at all, Anatole?
Yeah. I know I am not voting in this, but I think it is important to lay out that as a board and as a cap committee, we absolutely, hand on heart, try to make any issue as fair as possible on a pro rata basis, and our first preference was absolutely to have a rights issue. Unfortunately, in the New Zealand market, it is very hard to get that underwritten, and especially when you have got some uncertainty. And with reasonable confidence that we have got a draft LCD coming, we had pushed out that capital raise as far as we possibly could, probably too far, for the comfort of directors and the requirements of us for having runway for six and 12 months as per the listing requirements.
We went down that road as much as we possibly could, and that when we did, i t is a bit of a bugbear of mine in the New Zealand market, is that most issues currently are done by this placement and then SPP mechanism, which gets to a quasi sort of rights issue, pro-r ata solution in most instances. And we spent an inordinate amount of time trying to get to that fairness situation, which is why the institutions and the large shareholders really bore the brunt of trying to put their hand up for the pro rata-ish, large chunk of that last issue. Then, blow me down, we get the good news, and then everyone wants to get involved in the SPP.
We did increase the SPP to an amount which would have been far more than we would have naturally raised if we hadn't had that information. But we were very careful to allocate those shares as close as we could on a pro- rata basis so that everyone right down the shareholding was able to get their pro- rata allocation. However, we did bump into a real problem in that we weren't able to do the SPP, I'm pretty sure I'm saying in Australia. It did disadvantage Australian small shareholders who weren't able to participate in that. And that is something, it doesn't affect a lot of people, but it definitely affects the person who answered the question, I think. And we did spend a lot of time trying to rectify that but weren't able to come up with a solution.
100%, we would much rather have done it as a rights issue. I think the key to this is, don't expect any more capital raising coming from the current shareholders. That's not our number one source of future capital. But I really do believe resetting the cap to the 15% and giving the company the ability to raise capital through a strategic partner or through a different avenue or through a placement or something else creates a lot more value and certainty to the business. I hope that sort of answers the question.
Thank you very much for that additional color, Anatole. Any other question online? Thank you, Grant. Okay. There being no further questions online, thank you again, everyone. Please mark your voting cards in the, n o, I'm in the wrong place here. Thank you. Please mark your voting cards the way you wish to vote, taking into account the voting restrictions applying to this resolution. And that completes the resolutions concerning Simon. I will now hand the chair back to him for the remainder of the meeting. Thank you.
Actually, I'll let you get out before I try and get in.
Okay. Thank you, Tony. Our final resolution, resolution 6, ratification of share purchase plan, share issue. Resolution 6 concerns the ratification of the shares issued under the retail offer in reliance on the share purchase plan provisions of the NZX Listing Rules. Pacific Edge issued 59,998,716 shares under the retail offer on the 4th of June 2026 in reliance on Listing Rule 4.3.1(c). Resolution 6 seeks shareholder ratification of that issue. If the resolution is passed, it will effectively replenish the dollar value of shares that may be issued to each shareholder under the share purchase plan rule before the 5th of June 2027, so that Pacific Edge would again be able to issue up to NZD 50,000 of shares to each shareholder under that rule, subject to the listing rules.
If resolution 6 is not passed, any further offer structured as a share purchase plan before the 5th of June 2027 may be constrained, limiting shareholder participation and potentially the amount of capital that could be raised. The board, other than Anna, Sarah, and Tony, who each abstained because they or their associated persons were issued shares under the retail offer in reliance on Listing Rule 4.3.1(c), unanimously recommends that shareholders vote in favor of resolution 6. There are no shareholder voting restrictions on resolution 6. I now propose that the issue of 59,998,716 shares under NZX Listing Rule 4.3.1(c), as described in the notice of meeting, be approved and ratified for all purposes, including paragraph A of the definition of the share purchase plan in the NZX Listing Rules. Are there any questions from shareholders about this resolution?
Yes, there is one online.
Yeah.
For Andrew Ott. It is a shame that the New Zealand rules, NZX rules, meant that many shareholders were limited in participating in the 2026 share purchase plan. Could directors do their best to avoid this problem in the future? I think Anatole's discussed this during the last answer, so hopefully that answers your question, Andrew.
Cool. Thank you, Grant. I agree. I think Anatole's comments did, that we did our absolute level best to make sure our shareholders were able to be kept whole. Yeah. So if there are no further questions, please mark your voting cards in the way that you wish to vote. Okay. That completes the consideration of the six resolutions. As mentioned earlier, the online voting platform will remain open for five minutes after the close of this meeting. At this time, I would like to advise the outcome of proxy votes that were lodged in respect of each of the resolutions before the meeting commenced. I will not read the proxy results for each resolution, which you will be relieved about, but they are shown on the screen now. The share registrar will now move through the room to collect voting cards.
For shareholders online, please ensure your electronic voting card is submitted within the voting period. Good practice for the 7th of November. Get those votes in. Okay. Next slide, general business. I would like to give shareholders the opportunity to ask questions or raise any other general business that may properly be brought before this meeting. Shareholders online can continue to provide questions through the portal, and we will also address questions from the room. Are there any further questions from shareholders? Grant, do we have any online? No, we do not. Right. So if that is the end of the questions, I would like to thank everyone who has attended today, both virtually and in person, and to thank our shareholders for your ongoing support of Pacific Edge.
I now declare the 2026 Annual Shareholders Meeting closed, and for those of you here in this room, I hope that you will join the board and management for some refreshments, which I think is just outside. Is that where we are going? Okay. Thank you very much, ladies and gentlemen. Thank you.
Thank you.