Pacific Edge Limited (PEB) Earnings Call Transcript & Summary

July 28, 2022

New Zealand Exchange NZ Health Care Biotechnology shareholder_meeting 100 min

Earnings Call Speaker Segments

Chris Gallaher

executive
#1

Is this mic on? Yes. I was giving a few minutes' grace, but I think we'll make a start. It's a bit wet and miserable out there, so people might be a little bit late, but the appointed hour has come, so we'll make a start. Welcome to the Pacific Edge 2022 Annual Shareholder Meeting. My name is Chris Gallaher, for those who don't know me, and I'm the Chairman of Pacific Edge. As we have a quorum present, I declare the meeting open. On behalf of the Board, many thanks for attending this meeting on such a miserable day in Dunedin. And also a special welcome to those who are attending virtually. Over the last 2 years, for me anyway, the Annual Shareholder Meeting has been a video event. And it's really great to be here in person, both reconnecting with the Board again other than by Zoom and also getting a chance to get in front of our shareholders in person. COVID and the weather has interrupted or knocked us around a little bit. We have a director down with COVID but still fit enough to be on the screen. And I'm sure, with the, yes, combination of weather and influenza and COVID, our numbers are down a bit this year, but welcome to those who have been able to make it. Before we start with the formal business of the meeting, I have a couple of housekeeping points. And I've left them in my briefcase, which I'll just go and grab. Now firstly, masks are up to you. If you feel more comfortable wearing a mask, then it's your choice, but there's no mass mandate here in this building. In the event of an emergency or a fire evacuation and the alarm system sounds, please evacuate the building using your nearest fire exit; and you'll see those here well illuminated. The meeting point is the DCC -- council car park located on Harrop Street. And do not reenter the building until the head warden has given you the all clear. In the event of an earthquake, please remain in the building. Move away from any equipment, windows and furniture; and take immediate shelter under solid furniture and then follow instructions from your wardens. Toilets are located down the foyer hallway adjacent to the side of the room. Please follow the signage. Smoking is prohibited inside the venue, and there is a designated smoking area outside the main entrance on Harrop Street. So with that, we've disposed of the housekeeping. A few welcomes. And I'd first like to introduce to you my fellow directors, and we'll go to the ones on the screen, first: on the right-hand side, Bryan Williams. Bryan is coming to us today from Cleveland in Ohio, where he's working at the Cleveland Clinic for the time being. Then we have Anatole Masfen and -- on the bottom right, who is joining us from England. And on the bottom left, we have Sarah Park, Chairman of our Audit and Risk Committee, who's down with COVID and Zooming in from the Hawke's Bay. Then in person, starting from my far right, we have Tony Barclay from Auckland; Mark Green from Auckland; Anna Stove from the Hawke's Bay; and Peter Meintjes from Dunedin, our CEO. So that's our Board. We also have on screen David Levison. Hi, Dave, coming in from San Francisco, close to, in the States. And David heads up our U.S. business. There are a number of our senior management team present. And when I call your names, I'm just going to ask you perhaps just to put your hand up. We have Justin Harvey, Chief Technical Officer. There's Justin; Andy McIntosh, Chief Digital Officer; VP, Clinical Science, Tony Lough. There he is; and VP, Commercial, Brent Pownall. So that's the team, the senior team, of the business that will be around afterwards and are available for chat. I'd also like to welcome our auditors, PricewaterhouseCoopers, represented here today by our audit partner, John Dixon; and Senior Manager Morgan Wong. Last but not least, welcome to our legal counsel, Anne McLeod from Anderson Lloyd here in Dunedin. With that, I'm relying now on Grant, my technical manager, to get me through these slides. Grant, thank you. The meeting will follow the agenda that we set out in the notice of meeting to shareholders on the 22nd of June. Peter and I will give you a short presentation and then take your questions before moving on to the formal resolutions for your consideration today. We'll then move on to general business before the meeting closes. And after that, I hope you are able to join us, being directors and management, for some refreshments in the foyer. Firstly, to apologies. We haven't received any. Are there any apologies from the floor? No, no apologies to record. The minutes of the previous meeting held here on the 26th of July 2021 are available for viewing on the NZX website. Now I'd like to make a few remarks and observations on the past financial year, that one ended 31 March 2022, and how we are positioned for the future. The focus of our efforts, both Board and management, is of course Cxbladder, which is a suite of tests used in the detection and management of bladder cancer. It's a unique, advanced set of -- suite of genomic biomarker diagnostic tests that can help clinicians to safely de-intensify or intensify the clinical workup of patients presenting with hematuria. And those of you who know this well, it means blood in the urine. It also helps physicians to resolve diagnostic dilemmas during evaluation. And finally, it helps physicians to monitor for the recurrence of bladder cancer in those patients which are post treatment. Cxbladder can safely and reliably rule out the need for referral to a urologist for further workup. This provides an opportunity for the health system to free up limited health care funding and resources for those patients most in need. Additionally, the tests can spare patients from the potential risks and discomfort of an invasive cystoscopy examination. And they represent a new standard of patient care that can facilitate improved compliance with cancer surveillance and management. Cxbladder is a well-proven and peer-reviewed technology that works. There is no questions remaining on the technical efficacy of our tests. The challenge before us now is to drive its adoption worldwide. I'm pleased to report, in the 2022 financial year, we have continued to make significant progress -- Grant, you got that one? Thank you. The company ended the year posting a strong growth in test volumes and operating revenues. Cxbladder tests through our laboratories in Hershey, Pennsylvania and here in Dunedin for the year ended 31 March 2022 increased by 46%. We also saw a 48% growth in commercial tests to 19,196 tests for the year, and this drove a 49% increase in operating revenue to $11.4 million. Together, these results reflect significant positive momentum in the business and a tangible demonstration of the company's potential. Still it's fair to say that, whilst these results were demonstrative of strong growth, we believe the results represent below that which we would have had expected had the working in -- or normal environment pertained. COVID, as you can see from the chart on the left, put the brakes on growth in test volumes in 2021. Although the 2022 financial year does show a strong rebound, selling conditions remained challenging. COVID has imposed severe restrictions on the face-to-face engagement that our salespeople were able to have with clinicians, payers and health care providers. And that is the key to driving adoption of our tests. We're still recovering from this pandemic, but as Peter will set out shortly, the momentum in test volumes that we began to see at the end of last financial year, year ended March 31, 2022, has continued into the first quarter of this financial year. And this has given us confidence in the prospects for the year ahead. Pacific Edge still falls well short of achieving the critical mass sufficient for the company to produce positive cash flows and profits, and consequently, we continue to invest to achieve that goal. The upshot was, not unsurprisingly, a net loss for the year. At this stage in our life cycle, our focus is driving increases in test volumes and revenues. That having been said, we're also very conscious of not falling into the profitless growth trap and therefore carefully manage our costs according to a clear and well-developed plan. We're well positioned to continue to invest to deliver on the strong potential we see for the business, thanks to the successful $103.5 million equity raise we completed in October last year. As a result, we ended the financial year with a fortress balance sheet. Our reserves of $105.4 million at the end of March allow us to look through the current market uncertainty and continue to drive sales. That very successful capital raise also enabled us to get out of the cycle of annual capital raises that many of you will be very familiar with, which were hugely distracting for management and the Board. And it gives Peter a terrific financial platform on which now to drive sales and growth. Thanks, Grant. New leadership. So during the year, we welcomed new leadership to the company. Peter Meintjes, who joined the company in January this year after a lengthy executive search, has brought to the company new energy and thinking; and is rapidly building on the strong legacy left by his predecessor, Dave Darling, who had 20 years leading Pacific Edge. And I see David has just come in. Welcome, Dave. We're delighted to have attracted a Chief Executive of Peter Meintjes' caliber and experience and particularly pleased that we've been able to welcome him back to New Zealand and back to Dunedin. I may have said this before, but when we embarked on the search for our new Chief Executive Officer, we had as one of our top criteria that person being a New Zealander and a person who was prepared and willing to live in Dunedin. And well into the process, I can tell you that the list provided to us by our recruitment agencies were all American; and not too many, if any, were prepared to move to Dunedin. However, Peter arrived midway through the process onto the radar screen. And the Board is delighted to welcome him to the team, welcome him to Dunedin. And I'm sure those of you who stick around for a cup of coffee afterwards will be able to have a chat to Peter. As I mentioned in this year's annual report, he has a deep understanding of the diagnostics market. He's brought to the business a track record of commercializing novel and complex molecular diagnostics with the potential to improve the standard of care through the -- changing the behavior of health care professionals. Along with the executive team and Board, Peter has established a clear set of priorities to drive growth in test volumes, revenues and long-term shareholder value. He will provide more detail on this shortly, but I do want to reinforce the fact that we have not changed direction or strategy. That's been well set and well developed and well ingrained in the broader management of the company. Rather, we've been able now with the strength of the balance sheet we have to change the way we execute that strategy to achieve our goals of driving commercial success. More importantly, we believe that this refined focus on innovation, clinical evidence and people will deliver on our goals and potential. Peter has very quickly established himself within the business and is bringing the team along with him. He's also investing for growth in line with this new approach and doing so in a way -- a disciplined way, with the program linked to carefully planned commercial milestones. The last few months has seen a bolstering of the U.S. executive team, and this has delivered capabilities to the company that are fundamental to our commercialization efforts. We have continued to evolve the governance of Pacific Edge. This year, we rounded out the Board with the appointment of Tony Barclay in March. Many of you will know Tony as the former Fisher & Paykel Healthcare Chief Financial Officer and a respected business leader. I'll have some more to say about Tony later on. He brings to the company 2 decades of international health care experience [ and a company in a New Zealand context ] as a world leader. He also brings a deep understanding of the challenges of fast-growing health technology companies [ phased in taking ] their products to the world. I'm now confident that we have the Board composition to take the company through to its next phase of growth. This evolution will continue in the current year. We will be, for instance, preparing to report against the new financial sector, climate-related disclosures and other matters, act in the 2024 financial year. We'll also continue to look at how we can meet the increasing demands from investors for information on how we are best managing the other environmental, social and governance factors that are material to our business. Thanks, Grant. Moving to the outlook. There has, as I'm sure you will all have noticed, been a sharp downward shift in market sentiment towards growth companies since the start of the year. This reflects a reduction in the risk appetite of investors as they face up to the effect of fast-rising interest rates that global economies have introduced to head off inflation. Pacific Edge has fared relatively well to our peer companies. We raised capital early and at a good price. We've -- and thereby, we've insulated ourselves from the change in risk appetite of investors. We now have the reserves to fund our growth aspirations and continue to look carefully at the expenditure to ensure that we're making every dollar count. We understand the share price fall is disappointing for investors, particularly those who participated in the capital raising. And I'm one of those. However, we continue to focus on the things that we can control. And that is building long-term sustainable value through the execution of our strategy and prudent management of the capital that you have entrusted us with. Nothing has changed in terms of our fundamentals. We have a technology that works. We have an addressable market around the globe for bladder cancer that is, if anything, increasing. The fundamentals for our business work. It's now a task for the Board and management to get on and drive the growth. Before closing, I do want to acknowledge the support of my fellow directors. It's not been easy meeting remotely. And while the recruitment of Tony Barclay to the Board and Peter as our new Chief Executive was by video and very challenging by definition -- I generally like to look people in the eye when hiring them. I did meet Peter for the first time in March this year and it was great to see that he had 2 legs. Up until then, I'd only seen him from the waist up on a Zoom call. The transition of leadership from Dave to Peter, the capital raising, the recruitment of new directors and the refinement of our investment program is a significant workload. That we have achieved all of this against the backdrop of the pandemic is a testament to the depth, capability and commitment of our Board. On behalf of shareholders, I thank you for your contribution and ongoing commitment to the company. Before closing. We've just had a Board meeting this morning. And it was the last Board meeting that Jackie Walker, our Chief Executive in the U.S., attended. Jackie has been in that role now for 10 years and has seen the business in the U.S. rise from not a lot to a point now where it's poised to do some extraordinary things, so I do want to acknowledge Jackie's contribution over 10 years as she heads off to a very well-deserved retirement. Finally, I want to thank Peter and the senior management team and all of Pacific Edge's people around the world for their commitment to the company and the successes of last year. I will now hand you over to Dr. Peter Meintjes for his presentation.

Peter Meintjes

executive
#2

All right, good afternoon, everybody. Thank you all for coming. I'm delighted to be here. As Chris pointed out, I'm a new resident of Dunedin since January and actually a homeowner in Dunedin since around a month ago and delighted to be so. One of the first things I wanted to talk about in helping everyone understand what Pacific Edge is today and where it's going in the future is to outline our place in the molecular diagnostics value chain. And the way that we look at this is everything from genetic screening through early detection, through to how we manage patients and on to a surveillance paradigm. And so when you look at the start of the patient journey, disease actually starts prior to the point at which a patient might engage in their physician. And so I'd point you to maybe this -- I don't have any kind of -- I do have some kind of cursor. So looking at the asymptomatic screening. And there are tests out there in molecular diagnostics that are actually able to find disease before symptoms even begin. This is actually not currently where Cxbladder plays, but that's something that we can all agree is potentially an opportunity. However, for most people, when symptoms onset, they go and see a physician. And at this point, we have the Cxbladder test that helps the physician understand and manage the patient with some -- with their clinical decision-making. We have a couple of different tests in the hematuria evaluation pathway, and I'll elaborate on those in the next slide. If you're unfortunate enough to have been positively diagnosed with the disease though, hopefully, your physician or your surgeon will recommend something -- some kind of therapeutic or surgical intervention. And at that point, one might want to know the answer to the question was it successful. Did we get it all? And in that situation, you might look for residual disease; or response to therapy; or in the case of Cxbladder, recurrence of bladder cancer, which is a major challenge. So looking at the specifics of the products that we offer in this space. A -- our 3 major products are triage, detect and monitor. And triage is for use in the primary care and specialist components of the pathway with the value proposition that it assists clinicians to safely de-intensify hematuria evaluation; or send healthy patients home, particularly those from low-incidence populations and those that are at low risk of disease. Cxbladder Detect is for use by specialists, where the primary value that it delivers is to adjudicate diagnostic dilemmas, for example, equivocal cystoscopies and atypical cytologies, and -- but importantly this is -- the test itself is actually run prior to these cystoscopies and cytologies so that the result is available at the time physicians run the other tests. And then delivering value in the surveillance setting is Cxbladder Monitor, for use by specialists who are looking after patients who have already had a transurethral resection of a bladder tumor, TURBT, and monitoring for recurrence of the disease. And this is important because more than 70% and probably closer to 80% of patients who have urothelial cancer may have a recurrent event. How big of a challenge is urothelial cancer? Well, it's pretty significant. There's -- there are a large number of cases annually. And our internal estimates are that there are $7.7 billion worth of total addressable market globally across all of the markets represented in the map here and, as highlighted before, a 70% chance that a patient who's had the disease will have it again. So I'm going to talk a little bit about our operational and financial performance that Chris, of course, did give you all of the high notes already. I'm going to mention the strong growth in the U.S. but also note for you guys that we will have David Levison dialing in by Zoom. I think Chris already pointed him out. And so he will talk specifically about some activities that we have underway in the U.S., but the important thing to understand on this slide is that we -- within the United States, we are in use in basically every state. We have sales reps running around covering almost the entirety of the United States but also importantly clustered in the areas where there are the most people. That's where we can add the most value, although one of the new initiatives that we do have underway is one where we have a virtual team. And one of the remits of the virtual team is to address some of the big, expansive areas that are underserved populations where there aren't as many physicians available to patients because they -- and they may have to travel a long way. So what has actually been the performance in the United States? Well, if we look here quarter-on-quarter growth over the last little while here, FY '23, FY '22 -- and these are throughput statistics that are included for Q1 of FY '23, so the data is really current. This is up until June 31 (sic) [ June 30 ] and was published last week in our shareholder update. We are seeing fantastic growth in the throughput on a quarterly basis, acknowledging of course somewhat of a setback, as Chris talked about, predominantly due to the effects of COVID and access during COVID. We continue to build on the existing adoption that we have with an approach that is focused not just on the physicians, not just on the patients but also on the payers. Importantly, we have a market, this little bullet point here, that is very heavily biased towards patients who have Medicare as their primary insurance. And so as a consequence, the most foundational achievement that we had was getting CMS coverage in 2020. That allowed us to get paid on roughly 2/3 of all patients that come into our business. Another milestone achievement from 2020 was the Kaiser health plan. This is -- Kaiser is the world's largest payer and provider with over 12.5 million members. And then the second largest payer provider is the veterans administration , and they have about 9 million or 9.5 million patients that are covered under that system. And all of that underpins what we can then observe from our -- from a performance standpoint, which is a continuous growth. And one of the soft metrics that we are bringing to the market rather than hard metrics like revenue is the growth in the number of unique ordering clinicians. And so what we're seeing is that this is growing every month. We have efforts across the Asia Pacific. And the main focus in New Zealand, because we already have a large percentage of the population covered with the test, in -- is that we are trying to move the point of utility of the test from being used by urologists to being used at primary care. Our results over the last year have not been as good as we would have liked here. Some of this is due to the effects of COVID often stressing out hospitals so that tests like ours don't necessarily get ordered, but this is something we intend to obviously address and will become less of an issue over time as COVID recedes. But it's also something that we can actively address in the -- by the process of driving Cxbladder usage further towards primary care. One of the major health initiatives in New Zealand is Te Whatu Ora, Health New Zealand. And we are actively engaged in making sure that this is a positive step for Cxbladder and that we go from having 75% of patients in New Zealand covered to covering the entirety of New Zealand. And we are working actively with the appropriate contacts inside Health New Zealand and to make sure that that's the case. Just looking purely at the financials here. The throughput increase of 46% led to a 49% increase in operating revenue. And it also reflected an increase in cash receipts from customers, up 62% to $10.9 million, but what I'd really like to focus on with you all today is the look to the future. So these are our results as they currently stand, but where are we going to from here? And how will we get there? So we've identified 3 pillars of investment. The longest term is research and innovation. The medium term is evidence, coverage and guidelines. And the short term is adoption, retention and revenue generation; execution, in the moment. When we think about research and innovation, we have to understand the commercialization pathway all the way from the concept, the idea; right the way through to a completed product, to a commercially available product and one that is paid for in our industry by third-party payers like Medicare, like Kaiser, like VA in the United States. So we spend our time, when we're focused on research and innovation, in evaluating product concepts that address an unmet clinical need. It's very important to identify these unmet clinical needs so that there is high utility in hindsight for the products that we develop, so we evaluate cutting-edge technologies that meet these market requirements. We are actively engaged in growing our patent portfolio with novel clinical applications of the cutting-edge tools that we are developing. And we turn patented technology into validated products that address an unmet clinical need. One way that we -- well, once we have a product and we start to figure out that it's worked, we've got to generate increasing bodies of evidence in support of the claims that we want to make for it. And to do that, we run a series of clinical studies. We're very much with a focus initially on analytical validity, clinical validity but increasingly on clinical utility. We use clinical utility evidence to drive the adoption of Cxbladder by clinicians to tell them when and where in the patient care pathway they should be using our test. Sometimes this is easy. Other times, this requires a significant amount of behavior change, education, becoming trusted advisers to physicians; and so we have a number of initiatives that are related to building a depth of relationship between ourselves at Pacific Edge and our customers. We also have to look to include Cxbladder in globally relevant standards and guidelines. The major ones are NCCN and the AUA. And as we continue to build trusted relationships with our customers in general, we're going to build speakers' bureaus and scientific and clinical advisory boards so that many of them can speak on our behalf, that they're trained speakers to -- in slides that we have put together on our products and that they can evangelize on our behalf in the appropriate settings at conferences and so forth. I wanted to quickly highlight how we -- how the guidelines process works and how that is coupled with the active engagements that we have on clinical studies. So one of the most important things -- and we've been asked quite frequently, "When are you going to get in guidelines?" When we're getting guidelines -- well, we're already in guidelines, [ NCCN to be ], but the language of inclusion is something that really matters, so the strength of that language is actually what's going to drive the utility -- of whether physicians will adopt our test or not. So it's important not to think of this as binary, meaning included or not yet included. And so that's the purpose of this diagram that highlights, once we are accepted by the AUA, the EAU or the NCCN, in one of the guideline standard, we will continue with these studies and further studies that we have not yet named to drive additional patient types to be included in the guidelines; and stronger language that -- for example, instead of saying we suggest you use this test, saying we recommend that you use this test. And the third pillar of our value creation is adoption, retention and revenue generation. And this really -- in a single word, this is about execution. This is about a go-to-market strategy, the things that will in the soonest possible sense translate to revenue. And so we have already begun to diversify our sales process and making sure that we have a focus on strategic accounts and direct selling and recognizing that they are different, building out the key opinion leaders that I mentioned before and engaging them through a newly created medical affairs team. We want to drive protocolized adoption of Cxbladder that, instead of a physician just being convinced and saying, "Hey. Look. I like this test. I'm going to order it," we have to work with institutions to create their own guidelines that say every patient that meets certain eligibility criteria will be treated with this test. We've allocated some of the funds raised last year towards increased event marketing; sponsorship; being an integral component of conference activity in the scientific program, in the vendor-based program; and embedding ourselves in that community. We're going to be working on creating in-network or contracted relationships with private payers. And we did recently hire a VP of market access and reimbursement, and that is among the focuses that he will have. And importantly, another thing we can be doing today is empowering patients through patient awareness and patient advocacy initiatives. I mean the -- May was bladder cancer month -- bladder cancer awareness month. And we engage actively with the Cancer Society in New Zealand; and with BCAN, which is the world's largest bladder cancer advocacy network. So other investment initiatives that are linked to the kind of value creation initiatives. I'm not going to go into much detail here. I just included these for completion here. David Levison will give a little update on the initiatives in the Americas, but our focus for APAC will be on adding remaining DHBs, positioning ourselves really well with Te Whatu Ora to make sure that our tests are available to all New Zealanders as Health New Zealand adopts a countrywide approach, to move the utility of Cxbladder to primary care. It's used in primary care and in secondary care right now, so it's our goal to move it more towards primary care. To engage in market development activities through clinical studies in Australia and Singapore, clinical studies being the kind of leading indicator and driver of subsequent growth; and ultimately we do -- the commencement of commercial revenue in Australia, where we have had a presence for a significant number of years. Speaking a bit more to our patient strategy that I was mentioning before through -- with BCAN, the activities that we were engaged in earlier this year. I think they've now completed, but there will be more similar initiatives to come this year and next year. Is -- we sponsored a series of national walks to end bladder cancer across the country; and a lot of people wearing orange shirts, which is the color of bladder cancer awareness month. Another important thing, a bit more on the kind of academic and medical affairs side, is we've actually been given the opportunity through our sponsorship of BCAN to codevelop materials with them. And this is the site that people will go to when they are diagnosed with bladder cancer. The very first pamphlet, brochure that they will receive is a resource that we will have co-written in terms of the section on biomarkers and their options in that space. I don't actually have any content yet about what we've co-written, but I'll make that a to do for some of my team that we can actually show you what this content looks like. And we also have partnership activity with the Cancer Society of New Zealand. And we -- independently at Pacific Edge, under the Cxbladder brand, we have a resource hub at that website for patients to go to, to build a growing library of clinical and care-focused articles for them to go and read about because many patients are engaged in the science behind their own condition. Internally, we're making what changes we can. And we are a growing company, so it is very, very important that we have a focus on attracting and retaining talent. And it's our view that we build a performance culture through a shared mission and vision, a shared purpose. Driving engagement across all departments and management levels for tenured and new staff, although it's not just about the people who've been here for 15 years. We've got plenty of those. It's also about the new people. They -- to help them immediately add value. We have a strong sense of celebrating diversity. Being on a university campus, I think it's hard not to be part of a diverse culture. And of course, hiring in, I think, 30 different states in the United States. It's not a homogeneous place and it's fantastic to have the diversity of people across the board there too. We have a focus on ESG. And we have an inherently social mission with a view to providing early detection tools for the better management and treatment of cancer. And these -- but extending our inherently social mission to other elements of ESG is the foundation from which we intend to do that. And all -- I think, as Chris alluded to earlier in his speech, we're going to be improving our disclosure over the next little while as we begin charting our progress on various other ESG activities, including carbon footprint. So with that, David, we're going to try to have technology support, what happens next. And you will be talking by Zoom, and I'll just hang here until you're done. We can't hear you yet, but...

Chris Gallaher

executive
#3

[ We can't hear you, David ]...

David Levison

executive
#4

Now you can because now I've unmuted. Can you hear me now?

Chris Gallaher

executive
#5

Yes.

Peter Meintjes

executive
#6

We can.

David Levison

executive
#7

Great. Well, thank you very much, Pete, for the introduction. And I will -- just going to go through a couple of slides. Grant, if you would just go down to the -- my first slide, that would be great, super. So one of the things that Pete mentioned was a key pillar of ours, and that's really execution. We have developed around the world but specifically in the U.S. a very nice platform for growth. And you've seen some of the recent results of that growth, but what I wanted to focus on here in the next few minutes is digging down into some of the details of what makes up the tactics that drive that growth and the tactics that are really execution. And we very much are in execution mode right now. We've been doing things many ways very well for the last several years, but given the new focus on execution and some of the new resources that we're able to put to place, we can not only do more of what we've been doing, but we can do it smarter and better. And that's really what I want to focus on here. On this first slide. One of the key initiatives in the Americas is obviously our sales force. Our sales force is the biggest group within the entire global organization. It total with about 35 people today. We are adding up to 9 additional account executives and another regional sales director somewhere over the course of the year, depending on how quickly we're able to grow, which will take the team to about 40. That's probably not the ultimate place that we'll end up with the sales team, but it's a really good, solid place to get extensive coverage throughout the U.S. in terms of where our footprint is. And our team is made up of both tenured and seasoned account executives that have been here for 5, sometimes more, years, but also we've had some success recently bringing in some really strong new talent. And sometimes that talent is folks that have been in the urology space for quite a while. In other times, we found just really strong, good salespeople, good athletes I call them. And we've been teaching them [ in ] oncology space. And we're monitoring and [ metric-ing ] how well they do so we can continue sort of those programs in the future. Pete already mentioned a new initiative that we started in this fiscal year, the virtual sales team. This was an idea that we've been thinking about for a while, but now we have the opportunity to execute on it. It was really an opportunity to see how do we leverage the resources we already had on staff with a team that's virtual. And this is a virtual team in the fact that they are not only using the telephone and the computer to be their vehicles and get around the country, but also actually they're not our employees. We have outsourced this to a group that is expert at this, and so far, the early returns are very positive. As Pete mentioned earlier, we've had success in leveraging our existing sales reps. We had success in getting tests from accounts that we had not had success before. We've had success with leveraging our customer service team. So basically what we did with the virtual team is we've tried a number of things; and we're going to see what sticks, what works the best. So far, everything is working pretty well. And then we will leverage and we will grow the parts that are the most successful. The other big piece and the one that I think has had the -- an impact immediately is the medical affairs team. Historically, the medical affairs and the clinical evidence development have been driven successfully from New Zealand. And that will continue, but to really be successful in the U.S., we need a fully functional organization here where we can deliver to the customers everything they expect. And our customers expect great products, state-of-the-art service and the ability to generate data within their practices and institutions. And that's really what the medical science team will do. We were fortunate to hire a very seasoned individual in Tamer Aboushwareb. He comes to us from not only Exact Sciences and Genomic Health but Allergan before that. He's a physician by training and a urologist, so he knows -- he not only knows the individual, but he knows the challenges they face. We're in the process of hiring several medical science liaisons or MSLs. They will be the "day in, day out" contact with the customers not only supporting the sales team but also driving our clinical initiatives. And one of their key objectives is management of the key opinion leaders, KOL. We have developed strong relationships with KOLs over the past 10 or 15 years. We've not been able to leverage that in the way that I hope we can going forward by providing them more access to more of our resources. And as Pete said, one of the key initiatives for this year and going forward is a bigger, stronger presence at both national and regional meetings. And that means many more clinical and scientific presentations at podiums and sponsored conferences. And that's another focus that is a combination of both what we're doing on the medical affairs team but on the marketing side. So these are -- each one of them individually can have an impact, but the real value is when we bring them all together. And as you can see, there's lots of things on this list. And it has created a challenge for the organization, but I'm pleased to say that the organization has really stepped up to the plate and we are executing very nicely on each and every one of these. Next slide, please, to sort of finish out the discussion of where our execution initiatives are coming from. I talked a little bit about the marketing. What I think people probably don't understand historically: We have had a single individual in marketing. That is unusual for an organization of this size and this breadth. And he has done a phenomenal job, but it's we're now able to leverage Gerhard with some additional people. And one of the things that Pete mentioned so important to our culture is making sure we give our individuals within the organization new opportunities, so the first person we hired in marketing is somebody who's been a very successful sales representative for us. So she knows the sales side. She's coming to marketing. She already has the credibility with the sales team, and she's been extraordinarily effective in her first several months. Customer experience is another thing that we are investing in not only because we have more customers to service. We've got more tests that need servicing, but we need to do it in a better way than we have in the past. We have typically had a pretty manual process and that stood us in good stead for the size of the organization we are. That will start to break and fall apart as we move forward, so not only are we managing and automating to some extent the customer service function, but one of our key initiatives is electronic medical record integration. Right now, the almost 20,000 tests we did last year, everyone had to be initiated with a piece of paper that got filled out and sent to us. And the results coming back were either a fax or an e-mail. That whole process will continue, but we're going to give our customers opportunities to automate and electronify that. We're already doing that with a number of small customers and some large ones. Pete already mentioned the extensive integration with Kaiser. I can't emphasize enough the complexity of working with a Kaiser on this kind of thing. I was telling the Board earlier today I sit on the weekly calls the Kaiser folks have on integration, and there are over 15 people from the Kaiser side on these weekly calls. So it's a long-term project that will take multiple months, but it will have a huge impact on us when we're done. Market access and reimbursement. We are dominated by the Medicare age population, and so CMS is our most important payer, but we need to expand and extend that to the other commercial payers as we grow the business. And David Sosa, who we brought in as our VP of market access and reimbursement, has an extraordinarily depth of knowledge in this and experience. And he has already been effective just in his first several weeks. We need additional data that Tony and the team and Tamer and the team are generating to really move all the way through the market access and reimbursement, but we are well on our way to doing that. And then lastly, it's great that we've now got the resources to invest in these areas, but we are very conscious that we have precious resources here regardless of the amount of money we have in the bank account. And so we are really focused on making sure we are measuring and [ metric-ing ] what's working and what's not working and aren't afraid to change directions and change our plans. I'm very pleased with the dialogue we have at the Board level, where they're not afraid to ask, "Hey. If that's not working, why are you still doing it?" and those kinds of things. So I think we are -- we need some more tools like a better CRM and some other automation, but we are well down the road to start to develop the extra tools we'll need to help performance management be a key infrastructure to our growth. I think -- I'm sure we'll take questions later on, but that just gives you a little -- insights into some of the tactics that we're using to execute on the U.S. business opportunity.

Peter Meintjes

executive
#8

Thanks very much, David. And I think, just one more slide for me, to cap it off. So yes. And hopefully, that paints you a pretty nice picture of how we are executing in real time in the moment and also a disciplined approach to spending the capital that was raised last year. So I'll just end my section by saying we spend a lot of time trying to figure out what the -- and well, trying to architect processes and build from a foundation that develops strong throughput as a leading indicator of revenue over the coming years. There will be some rise in operational costs associated with trying to drive revenue, but our disciplined approach is linked to growth milestones. And we are focused on long-term shareholder value. So for all the reasons that Chris mentioned earlier in terms of some market forces having a negative impact on share price, we have a long-term view of how to address that when it comes from our value creation engine. And that's where we'll be spending our time. So thank you very much for your time. I look forward to sharing a drink with you afterwards. Chris, the floor is yours.

Chris Gallaher

executive
#9

Before opening the floor and the screen to questions. I trust that the last little while from Peter and Dave has given you a sense of the ability of the company now has to focus on driving sales. Previous -- or prior to the capital raise last year, every year, one of the first items on the Board agenda was how we're going for cash. How much cash have we got left? [ And off we'd go ] on another cap raise which would consume 2 or 3 months of Board and management time. That's now a thing of the past with the bank balance and the cash that we have in place. And that's enabled Peter and David and the U.S. and the rest of the team the freedom to get on and drive test volumes and drive sales. That -- as I said earlier on, that's what we're all about. [ Righto ], I'm happy to take questions, first, from the floor, of Peter or myself; and secondly, if there are any questions in relation to the audit. And if you [ could confine ] those to the audit, then I'm sure our good friends from PricewaterhouseCoopers will be pleased to answer. And then I believe we have some questions virtually, [ and Grant has got them ]. So we'll deal with those at the conclusion of this in-person piece. So questions from the floor? No. Everybody is happy. [ Righto ], grant, from virtual?

Grant Gibson

executive
#10

All right, we get the first question is, "Can you talk to whom are your major competitors, particularly in the U.S.? And why is the Pacific Edge suite of products [indiscernible] better, superior?

Chris Gallaher

executive
#11

Well, one of the benefits of chairmanship is that I can delegate these questions around the group, both the Board and management. David Levison, that seems a pretty good one for you to start with.

David Levison

executive
#12

I would be happy to. So our direct competitors are technologies that have been around for decades, basically cytology and cystoscopy. That is our competitor in terms of the way the physician thinks about it. They can get information from those procedures or they can get information from our test, and often they use both. And so in many ways, those two are competitive but also collaborative because the -- one of the marketing and selling positions that we take is we can provide additional information, orthogonal information, to what you're getting. And as Pete mentioned earlier about diagnostic dilemmas, many times, those tests actually don't give you an answer. So you spent money. You have put the patient through pain and effort, but you don't get an answer. And so our tests are very useful in that. If you look at it from another perspective, does anybody else have the suite of products in the molecular diagnostics space that we have? The answer is no, so we don't have any direct competitors. We're always on the lookout for who's coming up and doing some things. Just as one example: There is a test that is being tested right now called [ URO17 ]. It is closer to our triage product. It also is sort of targeted at early stage, before you're diagnosed; and has a ability to sort of rule out low-risk patients. They've taken a different approach. Their approach is this is not a test that is run in a central lab like we have, a lab-developed test. Theirs is a test that is distributed and the physician can make a little bit of money potentially on running these tests. It's still in the early phase and we've seen very little data. We've heard some physicians that like it, some that don't, but for any of these products, this is not a winner take all. There will be multiple products in these marketplaces. Right now we have a very strong first-mover advantage. And with the data we're developing, we expect to extend that first-mover advantage.

Chris Gallaher

executive
#13

Thanks, David. The next question is an annual [indiscernible]. What are the internal projections for the year [ in which ] Pacific Edge will reach profitability? And look. I'm happy to take that one and save you guys. Our entire focus is driving sales. Profits will take care of themselves when we break through the sales thresholds that we've set and when we get into guidelines. I did talk about profitless growth and we're very conscious of that, but the sole focus of the Board and the team at the moment is to drive revenues. Peter, in his slide, suggested the total global addressable market for a product like ours was around $7 billion. Well, you can take any percentage of that you like. It's a very big number. And getting after a percentage of that total addressable market at the revenue line is where we're focused. Once we have broken through that barrier, the profits will come. Okay, what proportion of tests processed are being reimbursed? Is this increasing or decreasing? Where is the pricing headed? How many tests are required annually to achieve breakeven? Which was a bit similar to the question I just had. Where am I going to put this one? Peter. He's been volunteering.

Unknown Attendee

attendee
#14

[indiscernible]...

Peter Meintjes

executive
#15

Yes. Hopefully, my mic is still working. So in terms of the proportion of tests that are being reimbursed, again, specifically that is around 65% by Medicare. That's a published number that we put out there. We do attempt to get paid on all our tests. That's actually a legal obligation. And of course, in New Zealand we actually do get paid on 100% of our tests, but the price point is different. But in the United States market we get paid on -- by CMS, by our Medicare-approved contractor Novitas on about 65% of claims. We get paid for every test that is run at Kaiser. And we bill private payers for all of the other tests. The next part of that question is a little bit complicated because there is an element to which there is diminishing returns. There are 5,000 other payers to get you that last 32%, 33%, all right, so if you just went after -- even if you just went after the big ones, that may not necessarily even get you what you want. You'll spend more resources to try to capture [ a dollar ] than you'll get, so you have to think about this in a clever way. And we do. And that is why we have hired David Sosa as VP of reimbursement and market Access, but one of the things that we can do is we can look at the claims. And we can look to see [ whether there ] is a particular area of the country where we might have one payer that is just the dominant player in that region and we're getting lots of tests from that payer. And then we can make an in-network contract, which is one of the things that David will be doing with that payer. And it's important that, in that context, what we should be doing is making sure that we influence the medical policy of that payer and then actually try to get the contract. How do you influence medical policy? Well, most of that is through the guidelines. And so that's typically your first question from when you approach a private payer is, "We would like to influence your medical policy. We'd like to [ get a network ]." They will say, "Well, are you in guidelines?" So all of the things that we are doing from a clinical studies perspective, generating clinical utility evidence in particular is something that sets us closer and closer to getting a greater percentage of overall tests reimbursed. It is also worth noting I don't think it is foundational to the investors' understanding of how you should think about us as a business, but when we do build private payers, even as an out-of-network provider, we do sometimes get paid on those tests. Sometimes we get paid the full amount. Sometimes we even get paid more than Medicare will pay us, but I don't want to get anyone's hopes up that this is like a significant thing, all right? That is somewhat irregular, but all of the initiatives in market access and reimbursement will aim to address how much we get paid, how frequently get -- we get paid and how quickly we get paid in terms of [ like net 30 terms ] and things like that.

Chris Gallaher

executive
#16

Thanks, Peter. Next question: In 2018, Pacific Edge signed a commercial agreement in Singapore. When can we expect significant revenue from Southeast Asia? Unfortunately, Pete, that's probably going to come to you as well to tell us about what's happening in Singapore.

Peter Meintjes

executive
#17

It is, [ so I would have to follow my thoughts ] slightly. I don't know what specific agreement is being referred to as being signed in 2018. It may have been the hiring of someone to do some business development work and help with clinical studies there...

Chris Gallaher

executive
#18

[ It was the Raffles ] agreement, I think, Peter.

Peter Meintjes

executive
#19

Okay. So that agreement specifically doesn't generate us any revenue and we're looking at it from a different approach. At the moment, we -- the key elements that we -- that are already underway are that we've already run a Singapore -- a study, a clinical study, in Singapore. That data is soon to be published. So the clinical study element is always the first [ part of it ]. One challenge associated with this is that, that particular study was a blinded study, so they actually do not yet have familiarity with our product, but once we have -- but we have recently hired someone in a business development role to start in September who will reinvigorate our efforts in Singapore. And their task will be to go to not only those 4 hospitals who have previously done clinical studies work with us but to any hospital in Singapore and Southeast Asia that's all within their remit and approach them to do user experience studies. We want them to be engaged with us, develop familiarity with the product so that we can subsequently put a contract in front of the hospital administration and get those folks to say, "Yes, this is a test that we want." So at the moment, we are in the stage of analyzing the clinical data that we already had, trying to get that published as a leading component to commercialization. And we are simultaneously working on user evaluations in that market. And yes, that will kick off in earnest when that new person is hired in September.

Chris Gallaher

executive
#20

It's probably fair to add, Peter, also that we were recruiting patients into the study during COVID, which hasn't been the easiest thing in the world to do. Are you still -- next question. Are you still -- Bryan, I can see your name next to this one. "Are you still making improvements to your Cxbladder product? If yes, when is there a new version? Will it be required to start the clinical trials and evidence generation all over again?" Bryan, are you able to take that?

Bryan Raymond Williams

executive
#21

I think it's probably best for Pete to take that. He's come in and had a look at where we are in terms of our research program...

Chris Gallaher

executive
#22

Okay. I was doing my little best to spread some of these around, but it looks like I'm found. Peter?

Peter Meintjes

executive
#23

That's all right. So absolutely. We do continue to make improvements to our Cxbladder products, but we have not advised the market of any impending time line as to when that will -- when those improvements will be available. The second question -- the second part of that question is a really good one. Will we need and -- I'm sorry. It's just disappeared off my screen. It's helpful having it up there while I'm answering...

Chris Gallaher

executive
#24

[ Would we ] start again with clinical trials?

Peter Meintjes

executive
#25

Yes. So I mean, simply put, no and yes. The evidence -- once you've gathered evidence for your product, that evidence is evidence and can continue to be used, but will we need to run additional studies to validate and demonstrate the clinical utility of the new products? Absolutely, but not all studies are the same. And one of the things that you can do, if you've already got a product commercially available in the market, you -- there are 2 kinds of studies -- there are more than 2, but I'll just single 2 out here. You can run what's called a registry study, which is when you're using a product as standard of care in the market and you analyze in real time. Another is a look-back study. And we could analyze a whole bunch of samples that have already been run with the new [ markets ] where we've managed to keep samples available and that would still have been a prospectively recruited study to analyze new products. And we take all of those things into account when designing our studies, to begin with, so we believe that we are in a good position as we're developing future products. To minimize repeat work essentially is the way to think about it.

Chris Gallaher

executive
#26

Thanks, Peter. Is that it, Grant? No, okay. In terms of current cash flow and net cash balance, how long can it sustain the company going forward? And is there any further planned capital raising in the pipeline, e.g. placements or rights issues? Well, I can deal with this one. We have no plans for any further capital raisings or rights issues. The money we raised last year, we are very hopeful, will be sufficient to see us through to cash flow positivity and profit. Grant? Is Cxbladder Resolve no longer a core product? Pete.

Peter Meintjes

executive
#27

[ Okay ]. So we did highlight this for investors at the financial results presentation in May, that -- so resolve performs very well as a product for what it was designed to do. It was designed to discriminate identified tumors into those of high impact and those of low impact. Our market feedback from the United States, which is our largest market, was that, that wouldn't actually change clinical practice because, if you've got a tumor, we're going to go do something about that. It doesn't matter whether it's high impact or low impact. However, in other systems like New Zealand where there are long waiting lists, it would -- it does provide some value. And so we're looking at the opportunity in capitated systems as to where and how we launch resolve, but we are -- we've also put it back into R&D to say is there a way in which we can adapt the resolve product to provide additional value that would be clinically meaningful in the U.S. context. And so those are the 2 questions that I've put to our team, and we'll advise the market systematically as and when we make progress on either of those.

Chris Gallaher

executive
#28

Thanks, Pete. Another question. It's becoming a Pete and Chris show. Is there any intention in the near to mid term to list on the NASDAQ? I'm happy to take this one. We listed on the ASX last year to open ourselves up to a wider pool of investors. It is fair to say that trading, liquidity levels on the ASX are thin. There's not a lot of available stock on the Australian Stock Exchange to be really meaningful. The NASDAQ option has been around for as long as I've been on the Board and it tends to get promoted every once in a while. Given my answer to the previous question and we're not looking to -- we have no plans to raise any additional capital in the near term or near to medium term, going to the NASDAQ wouldn't serve any purpose. You need a purpose to go to the NASDAQ, and that is to raise money. So it's a little bit academic. "Have you considered marketing via the public? For example, approaching retirement villages and educating residents on the benefits and ease of Pacific Edge testing and encouraging them to ask their doctor to implement a Pacific Edge no-intrusive test. [ Martin McLean ]. I want to give you guys something. Pete?

Peter Meintjes

executive
#29

So that specific idea is not one that we've actually considered, but patients in general is a strategy that is very important to us. We do believe that there are ways to reach large numbers of patients with marketing efforts and that we should be doing that. I will just caution that there are some regulations around marketing medical devices and diagnostic tests directly to patients, particularly in the United States where obviously we have the bigger market, but in New Zealand I believe that it is entirely possible for us to execute more deeply on that strategy and we can do it. I do -- patients are a very important component of this. And patient pull to kind of get maybe some of the laggard clinicians and physicians over the line might be necessary, but I think in a system like New Zealand it does make more -- we'll gain more market share more quickly with the approach that we currently have of working with DHBs; working -- getting the urologists onboard; getting those urologists to say, hey, the best place for this test is primary care, so that -- best for patients, best for everything; and working through that education process. But we absolutely do have parallel patient education efforts and we will continue to do so.

Chris Gallaher

executive
#30

It's certainly worthy of all of our shareholders when -- visiting their GP to -- and being suggested they go down the [ scope or cytology route ] to us for Cxbladder tests. All right, did the [indiscernible] issues have any impact on PEB?

Peter Meintjes

executive
#31

You can probably punt that to David. So -- and I think it's a misspelling and I think they're meaning Theranos...

Unknown Executive

executive
#32

Yes.

Unknown Executive

executive
#33

Yes.

Unknown Executive

executive
#34

Yes.

Chris Gallaher

executive
#35

David...

David Levison

executive
#36

Thank you. I was struggling with my New Zealand translation [ there ].

Chris Gallaher

executive
#37

No, that's okay. I was struggling with how to pronounce it. Over to you, David.

David Levison

executive
#38

Certainly. So for those of you that don't know: Theranos was a highly touted diagnostic company not doing anything close to what we do that got a lot of press and flamed out miserably. And there have been plenty of series and movies about it. It hasn't really impacted us at all. The Theranos business model was completely different than what we were doing. It gave a little bit of a black eye for a while to sort of diagnostics in general. Diagnostics have tended to be the less sexy and glamorous than either therapeutics or devices and so it played into that a little bit, but I think, with some of the interesting things that are going on in the U.S. on the diagnostics side, particularly the growth of things like Exact Sciences; and this whole new movement into next-gen sequencing, NGS; and this company GRAIL that's doing some really fascinating things -- I think that was -- whatever negative impact it was, was short lived. And we don't hear about it in the marketplace at all.

Chris Gallaher

executive
#39

Thanks, David.

Bryan Raymond Williams

executive
#40

David, perhaps I can make a comment. Chris, could I make a comment on that?

Chris Gallaher

executive
#41

You -- certainly, Bryan.

Bryan Raymond Williams

executive
#42

Yes. So the other thing to note about Theranos was that they had a Board who was not paying attention to detail. And it really behooves a Board to very carefully monitor CEO performance, and we certainly do that. And in this case of Theranos, that just did not happen. They had a high-profile Board and they also had a high-profile scientific advisory board, neither of whom really [ reacted ] appropriately.

David Levison

executive
#43

And Bryan, let me add one more thing to that, that differentiates. Theranos was here in the backyard of where I live in the San Francisco Bay Area, and I know many of the players involved. They also had no investment dollars from anyone that had ever made an investment in a medical device or a diagnostic company before, so they had no expertise.

Chris Gallaher

executive
#44

Thanks, David and Bryan. Next question. "Are you concerned that analysts may not undertake research on PEB, Pacific Edge, due to its current share market performance and lowered capitalization, particularly in Australia? I'll be kind, yes. The answer is no. Analyst coverage has gone from really 2, we had Jarden's and Forsyth Barr in New Zealand, to now including Macquarie; Bell Potter; and one other...

Unknown Executive

executive
#45

[ Craigs ].

Chris Gallaher

executive
#46

[ Craigs ] in New Zealand, who had never covered us. And we now sit about 30 on the NZX 50, so those index buyers and -- are now compelled to buy or compelled to hold a proportion of Pacific Edge in their portfolio as befits our position on the NZX 50, but it also has meant that they have been -- not forced, but they are now covering us. And that's a significant increase in coverage, yes. So Bell Potter in Australia, Macquarie across both countries, [ Craigs ] here in New Zealand, Jarden's and For Barr (sic) [ Forsyth Barr ] now cover us, so we do get plenty of coverage. Pete, it would be fair to say that some of the analytical work done on us require some love and attention from us, but I think now we're at a much -- we're much more widely covered. And as a result of that, the onus on us is to make sure that the analysts that are covering us are making comments and reports and recommendations that are based on fact and not supposition. Grant?

Grant Gibson

executive
#47

Just one last one that sort of covers about two or three I've got sitting here. So it's really just a question on the current business model and the confidence we've got that we can actually get enough traction to make a profit.

Chris Gallaher

executive
#48

So are we confident the business model we have can take us through to profit? Yes.

Grant Gibson

executive
#49

Yes.

Chris Gallaher

executive
#50

If that's all the questions and -- I'm sorry, directors. I have, as has been my past practice, managed to delegate off a bunch, but I just -- [ I'm just not ] going to be cruel. With that, if that's the end of questions, and our friends at PwC have got off lightly again, we can now move to the formal part of the meeting. This will cover the resolutions that were included in your notice of meeting. And there will be an opportunity to ask questions on each matter being put to shareholders. As is now required by the NZX listing rules, a poll will be conducted on each of the resolutions. The polls will be conducted all together at the end of formal business. Your Board supports each of the resolutions being put to the meeting. And as stated in the notice of meeting, each director intends to vote all shares and undirected proxies held by them in favor of these resolutions. Proxies have been appointed for the purposes of the meeting in respect of -- and I'll turn to Grant -- [ latest ].

Grant Gibson

executive
#51

Yes, we've got proxies that will come up on the slides for each of the individual resolutions.

Chris Gallaher

executive
#52

Okay. Representing roughly 40% of the shares on issue, close to. Resolution #1. Since the first resolution is concerning my reelection to the Board, it's particularly improper for me to say too much more, so I would like to hand over to our Deputy Chairman, Bryan Williams, who will conduct this section of the meeting.

Bryan Raymond Williams

executive
#53

Thank you, Chris. So resolution #1. The first resolution is that Chris Gallaher, who retires by rotation and is eligible for reelection, be reelected as a director of the company. As most of you know, Chris has held senior positions in both CEO and CFO roles with a number of large international companies; and was a partner in Arthur Young, chartered accountants. Prior to retiring from full-time corporate life, Chris was the CFO of Fulton Hogan, a large New Zealand resources-based civil contractor. Chris holds a Bachelor of Commerce degree from Otago university; is a chartered accountant, a member of the Australian Institute of Company Directors and is Chairman of VinLink Marlborough and Mariposa holdings. Chris has extensive financial and governance experience; and in-depth understanding of Pacific Edge, its strategy and the market it operates in. His diligence, attention to detail and constant availability during the difficult COVID lockdown period ensured PEL's success in the recruitment of our new CEO, Peter Meintjes; the cap raise you've heard about; the ASX listing; and recruitment of new director Tony Barclay. He is a valuable member of the Board. The Board has determined that Chris Gallaher is an independent director, for the purposes of listing rules. The Board unanimously supports his reelection. I would now like Chris -- to invite Chris to address the meeting.

Chris Gallaher

executive
#54

Thank you, Bryan, and thanks for that support. We're at a stage in our life cycle now where the next 3 years are really exciting and going to be exciting to be part of. We have a new CEO who has picked up a platform that was well established by his predecessor. We have a strong balance sheet that will enable us to fund the activities that we are looking to fund to drive sales. And at the end of the day, we have an amazing opportunity to be a serious global player in cancer detection that maximizes the value of our technology for our shareholders, so for me the next few years look really exciting. And with that, any questions on the resolution? No. You've got the proxy votes up, Grant?

Grant Gibson

executive
#55

Yes, I have just put them up.

Chris Gallaher

executive
#56

Thank you. And there'll be -- the results of all resolutions will be notified to the NZX tomorrow. Resolution 2 is one that I'll take. And it's for Sarah Park, who also retires by rotation and is eligible for reelection, to be reelected as director of the company. Sarah has more than 20 years of international corporate finance and capital markets experience after a professional career with PricewaterhouseCoopers in New Zealand and HSBC investment bank in London. During her executive career, Sarah has held a wide variety of roles, including being involved in numerous M&A and capital market transactions, managing family office investments and as an equity research analyst. Sarah is the co-founder of Even Capital, a venture capital fund focused 100% on investing in female entrepreneurs. She's also a director of the National Provident Fund, Hawke's Bay Airport and Orbis Diagnostics. Sarah has a MA honors in economics from The University of Edinburgh. Her financial capital markets and governance experience across a range of sectors, combined with a strong focus on diversity and risk, is of great value to Pacific Edge as we continue our growth strategy. The Board has determined that Sarah Park is an independent director, for the purposes of the listing rules, and the Board unanimously supports her reelection. Can I add that, in the 3 years that Sarah has been on the Board as Chairman of the Audit and Risk Committee, she has made a big impact as we look to improve our processes around the financial management and risk management of the company. And she's taken our processes to a new level in their effectiveness. Thank you, Sarah. Any -- Sarah, I'll invite you now to add any comments.

Sarah Park

executive
#57

Okay, thank you, Chair. Good afternoon to you all, and I'm sorry I can't be with you today. I'm going to keep this relatively brief because I am probably going to lose my voice quite soon, unfortunately. I joined Pacific Edge Board in the late 2018 and this is the first time I've stood for reelection. And as Chris said, I'm Chair of the Audit and Risk Committee and also on the Board -- sorry, on Capital Committee. Rather -- I think Chris has covered my experience, so I won't dwell on that there. What I did want to delve a little bit deeper into is my role as chair of audit and risk. As chair of audit and risk, I lead by guiding the Board in this area to ensure that both our financial statements and -- are fair and accurate representation of our performance. And we also have a robust risk management framework in place that is owned both by the Board and by in particular senior leadership team both in New Zealand and in the U.S. Tomorrow, we're going to be spending several hours doing a risk management workshop, which I am really looking forward to and I'm sure my fellow Board members are as well, in terms of really taking a step back from our existing risk management framework and saying is this still fit for purpose and appropriate. And we've done some prework on this and I think we're going to have a really good day tomorrow and look forward to managing this. We're also looking forward to having a discussion around the emerging risks that some of us may see in the horizon. And also, more importantly, sometimes is -- what people forget is also with risk and challenge comes opportunity. And I look forward tomorrow to discussing those too. I think that's all from me. And I welcome your support in my reelection.

Chris Gallaher

executive
#58

Thank you, Sarah. Any questions in relation to the resolution? No questions. Thanks. Grant, can you put the proxies up? Overwhelmingly carried. And I think, Sarah, I'll be buying you a bottle of wine. You've got more votes than me again. The next resolution is for Tony Barclay, resolution #3, who was appointed as a director by the Board during the year, to be a director of the company. Tony brings over 30 years experience in business and 22 years health care experience. He was the Chief Financial Officer at medical device company Fisher & Paykel Healthcare from the time of its separation to -- from Fisher & Paykel appliances in 2001 until retiring from full-time employment in 2018. Prior to Fisher & Paykel Healthcare, Tony worked for Pricewaterhouse and Arnott's Biscuits in finance roles. Tony was a key part in the Fisher & Paykel Healthcare leadership team that oversaw a global expansion from 1 country to 30 countries over the period that he was with the company. And that's what he brings to our Board, the experience knowing the pitfalls, knowing the right things to do when driving global expansion. Another [indiscernible], and that seems to be a bit of a pattern in the appointment of directors to Pacific Edge, Tony holds a BCom from the University of Otago is a chartered accountant and a member of the New Zealand Institute of Directors and INFINZ. Tony's significant leadership experience in the health care sector fills a skill identified by the Board, and he's already proven himself to be a strong contributor. The Board has determined that Tony Barclay is an independent director, for the purposes of the listing rules, and unanimously supports his election. I would now like to invite Tony to address the meeting.

Antony Barclay

executive
#59

Thank you very much, Chris. Hopefully, the microphone is working now. Look. It's a pleasure, as a former [indiscernible], as Chris said, to be with everybody here today. I guess, a little bit of repetition, but yes, the most of my working career was with Fisher & Paykel Healthcare, which given its size on the market and profile today, most of you will have some knowledge of the business. And when I joined that business, it was relatively small. And as Chris said, we expanded around the globe with a very singular focus in terms of what we could bring to the market in terms of helping people improve care and outcomes. And a large part of why I've joined the Board is that I think that Pacific Edge is at a position that F&P was a number of years ago. It has that opportunity, that global opportunity, to take something to the world and improve care and outcomes for many, many people. That impressive technology is, as Peter has talked to earlier, I view, as being new, really starting to see some leverage in the marketplace, which is really, really exciting; and as Chris says, being well capitalized at the moment. [ And the businesses ever being capitalized ] gives us some really good options in terms of what we can do to try and take the business forward. So to keep it brief. I'm really excited about the opportunity to work with the business; my fellow Board members, management, who many are here today. And I look forward to being in Dunedin more regularly than I have been of late. So I thank you for your ongoing support. Thank you, Chris.

Chris Gallaher

executive
#60

Thank you, Tony. Proxy votes are up. Well done, Tony. It looks like you've been elected. The next resolution is that the meeting records the reappointment of PricewaterhouseCoopers as auditor of the company and authorizes directors to fix their annual remuneration for the ensuing year. Are there any comments or questions on the resolution from the floor? Any virtually, Grant? On that basis, Grant, can I ask you to put the voting up on the screen? Voting. We'll now move to vote, other than proxies, on the resolutions. With those here in Dunedin who have not yet cast your votes, please now fill in your voting cards. And the team from our share registrar, Link's market services, will now collect your vote. There are forms around and here, so if anyone wants to exercise their democratic right, you're most welcome to. [Voting]

Chris Gallaher

executive
#61

Thank you, everybody. And Grant, I believe the result -- the full results, proxies and actuals, will be up on the NZX tomorrow, yes. So they'll be there for everybody to see. Good. We'll now move to general business. Are there any items of general business to put before the meeting? Happy to take questions from the floor, first, except from you, [ Paul ]. Any question from the floor? Excellent, no more questions. Virtually, Grant?

Grant Gibson

executive
#62

I've just put one up.

Chris Gallaher

executive
#63

Here we go. What efforts are being put into further diversification of our products? i.e., other cancer markets -- market, detection, for example, prostate, ovarian or lung. Pete?

Peter Meintjes

executive
#64

Yes, sure. All right, yes. So at this time, our -- so our technology can be applied to numerous other disease states and cancers, but we do -- and we do have some intellectual property in some of those, but in terms of what we're actively working on, we're looking at evaluating the market landscape and building a framework behind how we decide. where is the market opportunity. What is the level of competition? What kinds of technologies are needed to enter? And is there a genuine unmet clinical need? And so we're going to use that kind of framework to evaluate where the opportunities really are, and that work is in its infancy. So while we do have some arrows in our quiver, we are kind of reverting to first principles and business casing to make sure that we have a clear direction to chart. And we'll advise the market systematically when we do.

Chris Gallaher

executive
#65

To be very clear on that: We -- our big focus, major focus, our entire focus is on bladder cancer at the moment and exploiting the IP and the technology that we have while Pete and his team have a look at some of these other opportunities in which we have IP. All right, any other -- oh my. It's a large one.

Peter Meintjes

executive
#66

I'm happy to take that one, Chris.

Chris Gallaher

executive
#67

Don't read it out, Pete.

Peter Meintjes

executive
#68

So the question relates to our DRIVE study, which is a study that we're running in Veterans Affairs population. And actually we did receive this via e-mail earlier today as well, so that's one of the reasons why I'm happy to answer the question here. And so we are -- so the specific question relates to where's -- our claim is that full data will be collected mid-2025. And then the question becomes kind of like what can we do at the Veterans Affairs prior to the completion of the DRIVE study in 2025, and so I'd point out a couple of things. Number one, we are contracted with the veterans administration. We have a price set. We are on the fee schedule. That's an important milestone. So that means, tests that are ordered by physicians, we can get paid for. However, there are some barriers and -- but they are the same kind of traditional selling barriers that we run into with every customer. It's like can we convince this physician to use our test on their patients. And one component of demonstrating utility to them is the DRIVE study and specifically validating in a veterans cohort. The veterans cohort validation is actually very important because veterans have served in the military, which is actually a risk factor for getting -- developing bladder cancer. They are also a very high-smoking population, which is a significant risk factor for developing bladder cancer. And so consequently it does actually make sense to specifically validate in a veterans cohort when looking to demonstrate the validity of your test and the utility of your test for veterans and to be paid by veterans. But the most important thing that we can be doing more of and subject to the higher level of resourcing that we now have is focusing on which are the clinicians and physicians inside the VA that are early adopters of genomic tests; and say, "Oh, yes, I've seen one in prostate cancer. I use that already. I'd like to use yours for bladder cancer." So we've got to make sure that we're targeting the right physicians that are early adopters of the test to drive adoption inside the VA, but from an administrative perspective, we've got a lot of things in the right place. And it's also just worth mentioning as an aside again because we're doing all of the right things. And that is that we have congressional lobbying efforts to specifically appropriate budget for the use of biomarker tests for bladder cancer. And I was actually briefed on this for the first time 3 weeks ago. And so I'm very impressed by the things we've already done and by the road map that we have to drive further into the VA, but it is very early days. And we do not have to wait for the veterans -- for the DRIVE study to complete before we can be successful, but that will definitely add to our ability to sell over time.

Chris Gallaher

executive
#69

Thanks, Peter. And that -- and thanks, [ Andrew ], for that question. It was a very long question, but I think, Pete, you've got the nub of it. Grant? We're done. Then it remains for me to thank all of you who have taken the time to come along today. I -- both in person and virtually. I hope you have -- you found it informative and getting a very clear signal as to the direction that the company is going and its prospects. I now declare the meeting closed. And for those of you here in Dunedin, I hope you will stay and join us for some refreshments. And with that, I declare the meeting closed. Thank you.

Unknown Executive

executive
#70

Thank you.

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