Good morning, everybody, and welcome to the Pacific Edge 1H Financial Results Presentation. I'm Pacific Edge's CEO, Dr.

Peter Meintjes. And with me today is Grant Gibson, our CFO, and available online for questions is our Chairman, Chris Gallaher.

But just an important notice to take notice of when considering the information in today's presentation. So, our financial results for this half are below our expectations.

We ran fewer tests than we had desired. We have ran fewer commercial tests than desired and our operating revenue is down.

However, we maintain that we are in the strongest strategic position yet. And despite a net loss of $19.1 million and cash of $22.1 million in the bank, we want to highlight for investors the importance of the strategic milestones that we have managed to achieve through this half.

And we managed to do this maintaining a U.S. market presence to position ourselves to successfully appeal Medicare tests and commercial tests.

And so while there have been some challenges associated with non-coverage determination being the predominant feature of operating the market and we have had to migrate our customers from Triage to Detect. Our U.S.

sales per FTE has maintained its -- our sales force efficiency has been maintained, and we are operating as well as we can under the circumstances. Most importantly, though, we have an expert Contractor Advisory Committee, a C-A-C or CAC that has been convened by Novitas for February 19 in 2026.

And this acknowledges the weight of the evidence behind urine-based biomarkers for hematuria evaluation in general, of course, driven by the evidence portfolio of Cxbladder. We also, in the half, achieved an absolutely critical milestone with longer-term economics for Triage Plus being locked in at USD 1,328 per test, a significant uplift from our previous $760 per test for the prior generation.

Given this market position, though, we are considering capital alternatives to meet longer-than-expected Medicare re-coverage time line. We wanted to remind all our investors of how Pacific Edge creates value and specifically with adoption, retention and revenue generation, evidence coverage and guidelines and research and development because while our revenue -- adoption revenue and retention and revenue generation is somewhat down, we continue to be market-leading in the performance of our evidence coverage and guidelines, and we maintain our strength in development of new products within our research, development and innovation.

In fact, we have the strongest position we have ever had. We are in the strongest position we have ever been in to drive Medicare policy change.

The importance of the Contractor Advisory Committee cannot be understated. We currently -- since 2020 or between 2020 and April 2025, Pacific Edge had reliable reimbursement from Medicare, but no coverage policy with coverage policy language explicitly documented at Novitas.

And while that was good for revenue growth in our business and the subsequent non-coverage determination has obviously been a challenging headwind for us to navigate, it will become a defining change for Pacific Edge to have positive coverage language and actual positive Medicare policy change as a consequence of the Contractor Advisory Committee. And so these Contractor Advisory Committees are generally convened ahead of developing new or substantially revised Medicare medical policy of an LCD and it's worth noting given that our current status is non-covered, we expect that a substantially revised medical policy would lead to a coverage policy after considering all of the evidence.

Of course, this has been precipitated by 2 things. One, the strength of our evidence from our STRATA Study, but two, that the STRATA Study has already been recognized as something sufficient to drive policy change with the AUA Guidelines.

And that allowed the biomarkers for the first time to be used for microhematuria evaluation. The purpose of a CAC is to discuss -- evidence of this CAC is to discuss evidence for the use of urine-based biomarkers in patients with microhematuria.

And given the recent published evidence for Triage Plus, we expect that Triage Plus will also be considered as part of that Contractor Advisory Committee in February. The people who make up a Contractor Advisory Committee, and I look forward to questions on this later, are health care professionals, beneficiary representatives and representatives of medical organizations.

And Pacific Edge has been given the opportunity by engaging with Novitas to nominate urologists that we believe are familiar with the latest evidence for urine-based biomarker testing for patients with hematuria. And among those are many of our clinical advisers who are familiar with Cxbladder specifically.

The meeting date is set for the 19th of February at 6:00 p.m. East Coast Time, which will be noon on Friday, February 20 in New Zealand.

So as we look to our evidence road map, the evidence generation road map, the top 4 studies have been highlighted. That highlight represents that these are all new publications that have not previously been considered by Novitas, and we expect that all of these can be considered firstly by the CAC and in the creation of the integration draft policy, but ultimately, in the final policy as it is developed.

One thing that has changed is we've historically reported in this view, the study from Kaiser Permanente, but we have separated out the publication time lines for our core evidence that's internally developed and independent studies like the Kaiser study. And so you'll see that on a later slide in this presentation.

Looking at the following slide. This is one of key significance to many investors.

This is management's best understanding of the time lines that Novitas is operating under given the information that we have. Of course, acknowledging first that we have had a Medicare non-coverage determination for Triage, Monitor, Detect and Triage Plus since April 24 this year, but that was on an evidence review that was limited to evidence published prior to the 9th of September 2023, which at this stage is very stale evidence on which to have based the decision.

Pacific Edge has submitted reconsideration requests of the -- what's known as genetic testing for oncology specific tests, L39365 for Triage and for Monitor. Pacific Edge has submitted a new LCD request for hematuria evaluation for Triage and Triage Plus.

This is important regardless of whether Novitas elects to make a change to 39365 or establish a new LCD, the critical distinction between prior reliable reimbursement with the absence of any positive policy and what we are trying to achieve through a CAC and draft LCD language is the establishment of clearly articulated language that supports the appropriate use of non-invasive urine-based biomarkers, for example, Triage and Triage Plus in the evaluation of hematuria patients. No prior policy exists for that, and that is one of the reasons that Novitas is following this robust approach in using a Contractor Advisory Committee.

So, Novitas controls all the timings of these events. And while from our perspective, announcing a CAC to convene on the 19th of February is a delay from our prior expectations, given the robustness of the process, this is something that we see as tremendously positive because of the increased certainty in medical policy change that we expect to come from convening a CAC.

Furthermore, evidence published after the Contractor Advisory Committee, they can also be submitted during the comment period. So, those studies highlighted in yellow, that's not the limit of what can be considered for the coverage policy.

That's just the limit of what can be considered during the Contractor Advisory Committee. Our independent studies also supplement our primary evidence generation portfolio, the most important of which is the real-world utility study of Triage in microhematuria patients at Kaiser Permanente, but we also wanted to highlight that some of our investigator-initiated trials that have been part of a program of work for the last 2 or 3 years, the first one of those is reaching maturity.

It's going through peer review at the moment, and we are optimistic that it will publish in Q1 2026. This is evidence that is not necessarily -- well, I'll retract that.

In the first of these, the one from Kaiser Permanente is extremely relevant in the changing of medical policy for an organization like Novitas. The patient preference, for example, is less likely to sway organizations like Novitas that are extremely influential in helping physicians adopt our test for our sales force because we are able to make very, very clear that patients actually prefer to use our test when offered the alternative.

And that is somewhat of a no-brainer. The difference between an invasive procedure and a non-invasive procedure, patients typically prefer non-invasive to actually show that with data will be a first-of-kind study and that has been developed under the banner of our investigator-initiated trials.

And what you can see in the bullet points below, 74.2% preferred Monitor versus cystoscopy and comparable diagnostic performance is shown. And we expect this research to be published as an abstract for AUA 2026 and possibly before that will even come out in print.

Importantly, our budget impact models continue to demonstrate the economic value for Cxbladder. We've updated this slide to highlight the value proposition when performing this -- when running a budget impact model using Triage Plus.

And so where with Triage, you were able to rule out, I believe, 78% of microhematuria patients, with Triage Plus, we're able to rule out 85% of hematuria patients. And the greater number of patients that you can rule out, the greater value you are creating for hospital systems that deploy this kind of testing across the patient population that they serve.

Again importantly, this is not the end of the road for Pacific Edge in terms of developing budget impact models. And we are targeting a publication for Triage Plus in FY '27.

And we are targeting a publication -- or sorry, we are targeting commencing work for a budget impact model for Surveillance Plus in FY '28. And also along the general theme of health economics and sustainability, there is also a publication that we are working on with collaborators at the Canterbury Health System in New Zealand about the carbon footprint impact of implementing Cxbladder at primary care and draft presentations at conferences have already been communicated.

So talking about some of the numbers explicitly here. Global commercial test volumes of 13,191 for 1H '26 were down 10% on the 2H figures amid the challenges of selling a test that is not covered by Medicare.

The reduced reach of our sales force as our sales force continues to shrink, but that has been partially offset by a 5.4% uplift in APAC. Our response to the Medicare non-coverage has been a very important focus for us in this half.

Cxbladder Detect is something that has not had new evidence generated for some time and is not included in the guidelines. Consequently, all the tech customers were migrated over to Triage, accelerating a plan we had hoped to implement at the time of launching Triage Plus with coverage, and that has created some operational challenges as we do that.

But nonetheless, that allows us to collect revenue on the Triage tests through the appeals process. The sales force continues to be focused on patients that are suitable for Cxbladder Triage, which are younger patients with commercial insurance and typically with microhematuria presentations.

Our sales performance has been sustained from an efficiency standpoint in 1H '26. The clinical commitment that we measure as tests per ordering clinician has fallen, reflecting the disruption of transition from Triage -- sorry, a disruption to Triage from Detect and challenges of selling a test not covered by Medicare.

But we are well ahead of the low point we had in Q3 2022 of 160, and we've largely been able to maintain our sales force efficiency at 403 for this quarter. Our sales FTE are down to an average of 12 in Q2 '26 from greater than 30 as we continue to focus on cash conservation where prudent.

Importantly, foundations for growth, we have U.S. cash collections processes continue to improve, although a loss of Medicare coverage has impacted our testing volumes.

Denied Triage tests will be appealed to an Administrative Law Judge, ALJ. And given the guideline inclusion, we expect we can successfully make the case that Triage has been used in a medically reasonable and necessary fashion.

Unfortunately, appealing takes time, but we are appealing over 2,000 tests to Medicare and commercial providers through external review. And for Medicare, it takes 6 to 9 months.

For commercial payers, it can take longer than that in excess of a year. So, Medicare tests completed in 1H that have been denied for payment have had no revenue recognized in this half, but we expect to recognize some revenue again in the second half when we have successfully appealed.

There are measures in place to mitigate the loss of Medicare coverage and including enhanced patient responsibility, increased utilization of appropriate patient types through EMR integration and improving the medical necessity documentation to improve the payment success that we have during billing and appeals processes. And improved cash collections are typically permanent improvements, although we are in a situation with a non-coverage determination.

So some of those things are challenging for the current half, but we expect a resumption of those improvements after we establish -- reestablish coverage. So, consolidating New Zealand and developing Australia and APAC, we continue to seek a national hematuria evaluation pathway in New Zealand.

And we're working with local urologists and with Te Whatu Ora to affect that. In Australia and South -- and the Asia Pacific regions, Southeast Asia is still in business development.

We're planting early green shoots there. But we are also working on a number of contracting arrangements with Australian hospitals, and we hope to have some non-material announcements about progress in that area in the coming months.

We also continue to drive value through product innovation. And our next generation of tests is our major focus of the Research Development & Innovation pillar and specifically the development part of that.

We've been working very hard on Triage Plus and Surveillance Plus. Triage Plus has been analytically validated and clinically validated for all hematuria patients, micro and gross hematuria patients.

That's a broader indication than for Triage and a broader indication than what the guidelines currently support. And this bodes well for an expanded patient population as and when Triage Plus complete -- as and when we complete our credible study for the utility of Triage Plus.

It also has a higher price. That price is still in draft, but is expected to become final within the next few days and effective on -- sorry, January 1 next year.

It is currently being run in early access with a select few customers as we -- and we are leveraging the AUA Guideline for Triage in appealing Triage Plus tests as well. With Surveillance Plus, we are looking at recurrent disease in non-muscle invasive bladder cancer patients.

The product is still in development and is the improvement over the Monitor product that we currently have. And Surveillance Plus has deviated from Triage Plus through the development process.

And this is, of course, expected that they serve a different patient population and different markers are informative and the work that we've done internally has demonstrated to us that the DNA markers from the ddPCR are more informative than the RNA markers that we historically used in Cxbladder Monitor to the point that we can actually exclude the RNA markers from the final product. And we have taken that product through a freedom to operate, which has been completed satisfactorily and gives us the freedom to operate.

And we are taking it through a provisional patenting process. We are also seeking a technology crosswalk for Surveillance Plus to a test that has an $1,800 price point in the Medicare fee schedule and are hopeful for a claim-by-claim reimbursement because there is no coverage -- there's no non-coverage determination for Surveillance Plus.

And so our expected path is to get it coded, get it priced by crosswalk to the candidate mentioned here and then to initiate claim-by-claim reimbursement until the local coverage determination incorporating Surveillance Plus is developed. That we expect to take a number of years.

We have not put specific timings on that, but that is the future state that we imagine for our business with Triage Plus for the risk stratification of hematuria patients and Surveillance Plus for the surveillance of non-muscle invasive bladder cancer patients for recurrence. I wanted to also highlight the importance of the DRIVE Study.

So the DRIVE Study has been referred to for a number of years. It was started as far back as 2019.

It began enrolling and enrolled largely entirely for veterans population. And the study confirmed the superior performance characteristics in both gross hematuria and microhematuria for Triage Plus over our existing tests.

And it also works on a broader range of hematuria patients as established in the clinical validity. So hopefully, we made clear in the diagram on the left that while the AUA Guidelines recommends Triage for a narrow patient population, and that's based on the STRATA evidence.

The STRATA evidence itself actually covers patients that were in the low-risk group, intermediate risk group and the high-risk group and the STRATA study can be used to justify using Triage in any of those risk categories for microhematuria. But the DRIVE Study has validated Cxbladder Triage Plus for all of the risk categories of microhematuria and the gross hematuria patients, so the broadest range of patients in hematuria evaluation.

We remind our investors of the opportunity that we are chasing here. So with the increase of our test price to $1,328, we've increased our estimate of the TAM in the U.S.

while maintaining the TAMs for APAC and Europe constant. And it is a substantial TAM at full volume of $10.8 billion.

And specifically, we are targeting the patients that are referred for clinical work. That's how we determine our TAM that using Triage Plus for the intended use at the point of being referred for clinical workup gets us the largest possible TAM and the evidence we are generating is for that.

We're also looking to expand our market opportunities with innovation at the product level. And for this, we have made clear for investors that we are pursuing an IVD product that is a simplified version of the assay that we currently run as a service.

And over time, we will be able to simplify the product -- simplify the service to the point of being able to put it in a kit and allow labs other than Pacific Edge in appropriate jurisdictions where we have sought. We've completed all the product registration and market access initiatives to be able to run that test in clinical routine.

So the benefits of this approach are that IVDs can be run by any accredited lab partner in any geography. The customer-side logistics are easier, faster and customer service is local.

Lab partners make a margin by running the IVD test, which increases their enthusiasm and motivation for sales and marketing efforts in their territory. It is a decentralized deployment, which allows faster scalability, and we need to focus on scaling our logistics, but the clinical operations can be scaled very dramatically by working with established partners in the region and as they focus on customer acquisition.

So the work that we're doing, Pacific Edge is simplifying the test and accelerating the development of an IVD called Triage Plus IVD for decentralized lab deployment and international market expansion with the key objectives of: one, establishing an IVD regulatory framework for our next-generation tests that include Europe, FDA and ISO-13485 for the rest of the world. And then we're targeting prototypes by the end of FY '26, manufacture and commencement of clinical and analytical validation commencing in FY '27.

I'll now turn to Grant for our financial performance for the half.

Great. Thanks, Peter.

So in the first half, our operating revenue was down to $5.9 million from $10.9 million in the second half of '25. So, all that reduction is actually from the U.S.

market. As Peter mentioned, the loss of Medicare coverage has meant that total tests post 24th of April have not been accrued or included revenue and will only recognize revenues if we are successful at the ALJ appeal level, which, as Peter noted, it's going to take 6 to 9 months for us to be able to refresh those tests if they're successful.

Volumes have also been impacted by the disruption caused by the loss of coverage and transitioning clinicians from the previously dominant tests in the U.S. market to Triage.

We've also have reduced sales FTE as we've looked to manage our costs through this time. So with the drop in the U.S.

revenue, APAC contributed 15% of the revenue for the half, up from 8% in the second half of FY '25. So, we continue to maintain a U.S.

presence that positions us for an affirmation of Medicare coverage. We're reducing operating expenses where possible.

So in the second half of '25, we actually dropped our cost base by 5.9% in the first half of this year. As we continue to focus on expenses, we can reduce them where possible.

Our operating cash flows of $19 million were higher than the $12.3 million in the second half of '25. But we do note that cash outflow in the first half of the year is generally higher in the second half, with payments that cover a 12-month period weighted towards the first half.

As noted, we've also been impacted by the loss of Medicare coverage and we expect to receive revenue for tests that we performed in the first half, 6 to 9 months after as we take them through the ALJ appeal level. Cash at the end of the half was $22.1 million and we did a capital raise of $20.7 million in August 2025.

As Peter has noted though, with the delay of the re-coverage, we expect that we will need to complete capital initiatives and/or reduce cash burn and we're in the process of considering options. Our operating expenses were down 5.9% in the second half.

So of those, the lab costs were down approximately 10% based on lower test volumes. Our research costs were also down 4.5%, and some of the clinical studies come to an end and the cost base -- and the costs related to those start to reduce.

Our sales and marketing were down 9% as we managed our FTE in the U.S. market to ensure that we were prudent with our operating expenses.

General and admin costs were up 3.4%. We had some late legal fees relating to our efforts to overturn the Medicare loss of coverage in late FY '25 that come into this first half.

And I'll pass you back to Peter.

Thanks very much, Grant. As we look forward, from my perspective, it's extremely important for investors to understand that this is -- Pacific Edge is in the strongest strategic position than we ever have been.

And my conviction is underpinned by a number of long-term value creation notes here, medium-term value creation and near term. And so in the long term, the price increase that we have for Triage Plus provides us with extraordinarily improved economics.

And so as that test becomes our dominant test, when it has successfully achieved coverage, we are in a vastly different operating position than we are today and then we were when we had a $760 price with increased margin and margin percentage. Surveillance Plus, while in development, is also seeking a direct technology crosswalk to an $1,800 price point based on its final product configuration.

And that, we think, is a very important long-term consideration for generating value for investors. So, our continued investment in innovation and product development for IVD kits supports our ambitions to enter international markets and to adopt a decentralized deployment model and that remains a focus of us in a smaller capacity, but is something we continue to try to activate.

In the medium term, the DRIVE publication provides a clinical validation of Triage Plus that we believe is sufficient for inclusion alongside other tests in the AUA Guidelines and is sufficient for Novitas to make a positive coverage determination. So, we are delighted that, that has been published in time to be considered firstly by the CAC and secondly, when Novitas begin to draft policy.

Our clinical evidence generation program is scheduled out for over 4 years to deliver strategic milestones that will deliver sustained value creation for shareholders with multiple catalyzing events. And AUA Guideline inclusion demonstrates that the success of this strategy that can be repeated to expand the indications for existing products and establish new indications for new products.

In short, we know what it takes to get a product included in guidelines, and we expect of ourselves to be able to do it again. Commercial headwinds, acknowledging that there remain some, commercial headwinds is important.

There remains a non-coverage determination for Triage, Detect, Monitor and Triage Plus, and it creates challenges for our sales and marketing teams in that operating environment. and additional challenges for reimbursement.

But we are doing everything that we can from an appeals standpoint and doing everything that we can to convince customers of the value of the test despite the Medicare non-coverage determination given the AUA Guideline inclusion. The convening of the Contractor Advisory Committee is a major catalyst for forward-looking policy.

And specifically, as I mentioned before, it will be the first time that there will be coverage policy language that would be proposed by Novitas not just paying for our tests on a claim-by-claim basis. And that provides us with the greatest certainty of enduring coverage from Novitas, but also the greatest ability to improve the success percentage of being paid on Medicare Advantage tests and for commercial payers.

So the commercial catalysts for near-term value creation, the AUA microhematuria guidelines are an enabler of sales, marketing and reimbursement activities. But because of the language associated with Triage and the language associated with intermediate risk patients, we have to reeducate our customer base and that has proved to be challenging at least initially, and we're continuing to work on that.

We are continuing to seek payment from Medicare for all Triage tests performed on Medicare patients through the Medicare Appeals process relying on the AUA Guideline, and we are doing the same through the external review process for commercial insurers. We also expect through the efforts that we've made in digital development to increase the percentage of electronically ordered tests.

And that, of course, is expected to lead to stickier customers and more reliable payment over time. And we are -- as mentioned earlier, Cxbladder is under consideration by Te Whatu Ora for a national pathway in New Zealand and we're optimistic that, that will be -- that we will learn something in FY '27 about the status of implementing Cxbladder in that national pathway.

We thank you for your time, and we look forward to taking your questions.

Congratulations on getting Novitas to open that committee, looking forward to a positive result from that. So on the call and in the documentation, you speak about the options available to you include raising capital and/or burn reduction.

Have you reduced your burn so far in the second half?

We have made modest reductions to our burn. And I think as Grant highlighted, we actually do expect -- there are a number of expenses that are front loaded for the year and we expect the second half to have a lower burn rate than the first half, yes.

Okay. But it won't be something like -- so the cost base in the first half was $26 million.

You wouldn't expect that to half. It might be down, I don't know, like low tens of percentages.

We would not expect it to half, yes.

Cool. So, you've given best and worst-case scenarios for re-coverage, which look to be between June and September quarter 2027.

Could you give us a bit of a flavor for the assumptions behind that?

Yes. Absolutely.

So from our perspective, it always feels like Novitas is acting very slowly. But the reality is, in March 2025, they had a change in personnel, a new person joined in May, which was a month after we lost coverage.

And so since being newly appointed in the role and with the -- it's been less than 6 months of non-coverage and less than 6 months of a new Medical Director at Novitas to actually get Novitas to initiate a CAC. What it would have been great if they could have scheduled that CAC for November, but they didn't.

They scheduled it for February. And so while that is a prima facie delay in time lines, that's the greatest level of confidence that we have ever had in forward-looking policy.

So, I think from Novitas' perspective, they would consider how quickly they're acting to be very quick, whereas from our perspective, it feels very slow, particularly since we have a high burn rate. Past the CAC, there is no commitment to the time line.

And so we're clear that these are management estimates, but the assumptions in why we think it might be on the shorter side are that they have restricted the Contractor Advisory Committee to the microhematuria guideline and tests that fit into that, which is very narrow. And so consequently, the policy that they could develop would also be narrow and the number of products that they would have to consider would be relatively narrow.

And the AUA research team have already done the research and created the guidelines. So, they have a step up.

So from the 20th of February, we estimate it would be around 3 months for them to develop draft policy and publish it because of the narrow scope. If it was a broader scope, we think they would take longer.

So, that's one of the main assumptions. We also believe that they have -- that there is a lot of pressure from the AUA.

And that pressure from the AUA will also encourage Novitas to act quickly, but within the bounds of the process they are obligated to follow as outlined by the program integrity manual. But once draft policy is published, it would then be at 60 days of notice and comment.

And any time after they have successfully considered all of the comments, they could then publish with 45 days of becoming effective. And we think that they are motivated because of the aforementioned factors, the narrow scope of pressure from the AUA and ongoing dialogue that we have with them in formal situations that we think that they could act quickly.

Nonetheless, we paint the worst-case scenario for our investors out of an abundance of caution and acknowledge also that even after the CAC, there is a non-zero chance that they don't develop policy at all. We consider that to be extremely unlikely, but Novitas does control it.

Okay. And just to read that back to you, so the committee will happen in Feb, 3 months to draft the policy and publish it, but then there's kind of a year in there for various other processes that need to occur based on your conversations with Novitas.

Yes. So, I would point you to Slide 7 of our deck, the Medicare re-coverage and estimated time lines.

And so we are estimating Q3 to Q4 of 2026. But we are highlighting that the -- and that's based on those assumptions that Novitas is under pressure to act quickly and has the information they need to act quickly given the CAC formation and the narrow scope.

But we also note for investors that it could be between Q2 and Q3 that they have given that is 12 months after when they open.

Just on your language, Pete, in terms of the CAC meeting, it's coming across extremely positive in terms of the likelihood that you think there will be a re-coverage decision. I'm keen to double-click on that a little bit around, is that extreme positivity coming from precedent around CAC meetings?

Or is it coming from direct conversations that are being had between you and others in the industry?

It's coming from multiple sources. But probably the most relevant one is just the facts that are specific to this situation.

So the facts in this situation are that there is a guideline that recommends the use of our products and others for hematuria evaluation and there is no policy at Novitas for hematuria evaluation. This has practicing urologists and the entirety of the AUA quite frustrated, confused, annoyed in your preference there that they are unable to use guideline recommended testing on their Medicare patients without having to go through extra administrative procedures, et cetera.

They basically believe that Medicare should fall in line with what urologists have recommended. So when we think about -- and so that's one set of facts is that there is a guideline.

There's also the evidence for Triage Plus as well. And then there is the non-coverage determination.

So if you've got a non-coverage determination and the purpose of a Contractor Advisory Committee is to make changes to policy, we're going to be changing it from a non-coverage determination to something else. And while we cannot rule out that it will change -- that it will just change the language and still be a non-coverage determination, the overwhelming odds are that when you have clinical utility data, guidelines and physician opinion in a Contractor Advisory Committee saying, we want this test, we need this test.

This is how we want to practice medicine. That's what the result needs to be from Novitas.

Now, what is Novitas' job in the situation? It's not to tell urologists know.

Novitas' job is to figure out the appropriate policy so that only the appropriate patients are getting the testing and getting and they are only paying for when appropriate patients are getting the test. So that's -- it moves from an if to a how.

Does that make sense? And does that answer your question for you?

Yes, no, that's a good response. And then secondly, going back to one of Rob's question.

I was wondering, Grant, if you could give us guidance for second half OpEx. Presumably, you've got pretty good foresight on it given that the CMS changes won't be coming through in the second half.

And clearly, the rope for cash is relatively limited at the present time. So, I assume you've got quite structured plans in place for the second half.

Yes, we do. We've got to continually balance that though with the expectation of reaffirmation of Medicare coverage.

So if we do cut too deep, that will take a long time to get us back and we don't believe that that's in the benefit of the long term value of the shareholders. So it is a continuing balance.

You will see though that if you look at our FTE numbers in the U.S., we have reduced our sales presence in the U.S. We are looking at other areas where we can continue to reduce costs, but I won't actually put a figure on that.

But it would be fair to assume -- it'd be fair to assume like the decline will be relatively small then on that basis in the second half?

Yes. As Peter mentioned before, we won't be halving or anything of that space.

We need to maintain a strong presence in the U.S. really for re-coverage.

Yes. A lot of the support that we get from the AUA is essentially contingent on maintaining a presence in the market commercially and fighting the fight together.

Yes. And then one more on sort of the non-CMS U.S.

price. Looks like it collapsed or fell quite meaningfully in the half.

Could you just sort of talk through this and then what the CMS contribution was in the half in the very short period in April that you had coverage?

I wouldn't -- I don't think your classification is actually correct. Medicare dropped to basically 0 from 24th of April.

So it was like the tap got turned off when the non-coverage came through. Other reimbursement has been reasonably strong and continuing to increase.

As Peter mentioned, we are focusing more on commercial payers as that patient mix moves more towards the Triage intermediate risk. And we are working on growing the revenue from those commercial payers as well.

So, Medicare is the big story in our reimbursement mix that has dropped to basically 0 until we go through these ALJ appeals.

That's right. The last thing that Grant said there, it's like it has dropped to 0.

We cannot confidently accrue until we have developed a pattern with the ALJ, and we are yet to have an ALJ scheduled. The government shutdown, we do believe has delayed some of the scheduling here, but we have probably half a dozen or a dozen tests that are ready for scheduling.

We don't have that yet. So, we anticipate to have at least some success that we can point at.

And while we have modeled for ourselves 0 success at the ALJ because we believe it is responsible to do so, we actually expect on the basis of the fact pattern that evidence up until 2023 was the only thing that was considered in policy that went into effect in 2025 when in 2024, there was a randomized controlled trial that was ignored. There was an additional analytical validation that was ignored.

And then earlier in 2025, there was a guideline that was created on the basis of those pieces of evidence. We think that an Administrative Law Judge is going to understand that fact pattern and find in our favor.

Now, is that more work for us? Yes, it is.

But we are up for that challenge because we think we should have that revenue. Notwithstanding, even if we are successful at that, that does not ameliorate the operating challenges that we have in driving volume when physicians have to go through extra administrative lengths to manage patients when there is a non-coverage determination.

It's just more admin basically.

Just on the CMS mix, like I appreciate, it's gone to 0 since late April. But if we sort of pro rata the revenue from the first half of last year within CMS on the 24 days that you had coverage, it implies and then do the same for volumes.

It implies that non-CMS U.S. revenue was sort of flat on the second half of last year, strong volume growth.

But like I suppose the math is the math, the missing piece that I don't have is what the CMS revenue contribution was in 1H '26 to then sort of work it out? Like my estimate here is sort of a shade under $1 million.

I don't think there's anything additional we can really give you on that, Matt. We don't break down costs.

We'll see if we can come with something.

We can take it offline. That's fine.

Okay. Andrew, your first question was about the Kaiser study.

I believe that's been covered on Slide 8. So, that is going through the final stages prior publication.

So, that should be available for the CAC meeting. Okay.

Next question from [ Andrew ]. The Novitas CAC, while it's very disappointing with the meeting pushes out the potential time line for reinstatement of Medicare, is it reasonable to actually feel optimistic that Medicare coverage will be obtained?

I believe we've answered that one. And given the clinical evidence, will the CAC meeting review the Kaiser study?

So again, we answered that. Okay.

Andrew, so Triage Plus pricing in the U.S., at its 2025 AGM, Pete discussed that under the Protecting Access to Medicare Act, the price of Triage Plus will over time decline from the original technology resources based pricing down to the value-based pricing. Are you able to give any indication as to how long this initial technology and resource-based pricing will be in place and when the change to value-based pricing will occur?

And has this changed some or fixed in over a period of time?

So great question. Triage Plus is what's called a CDLT, a clinical diagnostic lab test, which means it is subject to PAMA review every 3 years.

It's only subject to that review after it reaches a certain threshold. And so it will be -- it will be a number of years before it crosses that threshold.

But when it crosses that threshold, the math on this is something that I can sort of describe in general terms, but it will be imprecise. It is available for people to go and do their own research on.

But you can roughly -- it roughly approximates the average of the private payers. It is also worth noting though -- so it doesn't include zeros.

So if a private payer gives you -- declines your test, that doesn't count towards your average. If a private payer pays for your test but pays you 0, it also doesn't count.

But you take the average of what private payers pay you and it becomes that. Now, there is a theoretical situation in which it actually doesn't come down at all, particularly since our Medicare price is $1,328 and our commercial price is $3,995 a test.

And what are colloquially termed Cadillac plans, they actually pay the full amount for that kind of test. So, $1,328 in the context of genomic test is not high.

It is, we believe, a good price for the value that it delivers to the system based on how much -- based on the budget impact modeling that we have done. When we publish the budget impact model, we can be more precise -- sorry, when we publish the budget impact model for Triage Plus, we can be more precise about what value we deliver to the health system.

But we actually expect that it could rise as a consequence of value-based practices as well. And that is totally possible and within the rules of PAMA, but it only happens if private payers are paying more on average than less.

But given the low technology resources pricing we have today, compared to other genomic tests, it is also possible that, that number goes up. It's a long way away.

And I don't think that this should be a significant part of anybody's model at this time.

Okay. [ Adrian ], I'm going to combine both your questions.

So, you did ask on the second half cash burn, and we provided answers that we can on that. Any capital initiative, is it likely to follow the tone of that CAC meeting in the 16th of February?

And how much would you be looking to raise? Is $50 million reasonable for additional equity through re-coverage?

So, I don't think we can comment on any of the specifics that are noted in that question. But we do believe that the Contractor Advisory Committee, that will be open to the public to dial in.

The details will be on Novitas' website. When we have the details, we will likely make those available to our New Zealand audience because it's actually geo-blocked their website and you might not be able to access it, but we will figure out a way to get those details through to our shareholders who would like to dial in.

And we're anticipating an overwhelmingly positive Contractor Advisory Committee, but we will leave that to shareholders in the market to decide what they think from that language. Noting the timing, we will try to coalesce and condense everything that happens on that call and distill it down for our investors and our shareholders and provide a market update after the Contractor Advisory Committee summarizing our view of that.

But the other elements of your question, I can't comment on.

Great. And that's the end of the online questions.

Well, thank you very much, everybody. That's everything for me today.

I appreciate your time, and thank you, Grant. Thank you, Chris.

Thank you.