everybody, and welcome to the first half results for financial year 2024. I'm Dr. Peter Meintjes, and with me is CFO Grant Gibson.
Good morning.
So, just an important reminder, we agreed to abide by all the rules on the slide, but particularly in regards to forward-looking statements. We're gonna go through a brief summary of the first half highlights. We're gonna have a little reminder around the delivery of our strategy. We'll look at our financial performance, we'll discuss our outlook, and then we'll take questions from the audience. So in terms of the highlights for the first half, importantly, the global testing volumes are up 22% over the first half of 2023. Our commercial test volumes are up 24% over the first half of 2023, which corresponds to a growth in operating revenue of an increase of 50%.
We have continued to make a loss to generate that growth of NZD 15.1 million, and that leaves us with a cash balance of NZD 62.2 million of cash and cash equivalents. So importantly, throughout this half, you know, we have—While we have seen volume growth, it has been tempered by the reorganization late in the second quarter in response to the Novitas draft. But the immediate focus of our business has been on the profitable sales territories, alternative revenue streams, and cash preservation rather than top-line revenue alone. We have a longer-term focus on, you know, an uncompromising focus on the generation of high-quality clinical evidence for guidelines inclusion to give the Cxbladder product coverage certainty.
We have also undertaken a sales messaging emphasis shift to focus more clearly on the clinical value proposition to support the enhanced patient responsibility and the patient assistance program. As well as including messaging around the health economics through the publishing of our Budget Impact Model, and a focus on strategic accounts. Pacific Edge's strategy is unchanged. We continue to generate value for shareholders through three pillars, adoption, retention, and revenue generation as the top pillar, evidence, coverage, and guidelines as the second pillar, and research and innovation as the third pillar. Our results for this half, you know, we have continued to grow despite the headwinds that we see here. Again, restating that the total lab throughput is up 22%.
A similar increase in commercial testing volumes and the breakdowns of the various products are shown here for the triage, detect, and monitor. We do, of course, acknowledge that there is uncertainty facing the business, as you know, for the last several months, we have been aware of Novitas's evidentiary review, which was published as final. And then the final was retired, but then republished a few weeks later, on the twenty-seventh of July, New Zealand time. So we then undertook a tremendous ground operation to get physicians who order our tests to submit opinions during the comment period to Novitas. We had key opinion leaders publish an article with their views on Novitas.
We had clinical advisory council members from one of the MACs present on behalf of the AUA, LUGPA, and AACU to Novitas and First Coast Service Options, the sister MAC to Novitas. And both the open public meetings, where oral comments are provided, and the written comments, which Novitas is required to respond to, have demonstrated an extraordinary level of support from the urology community, something for which we are very grateful. And we believe can be beneficial to securing a positive outcome. However, it will again, this is a largely closed process from here.
We are unaware of any progress Novitas is making in terms of finalizing, and so the timelines that we outline here, that they must finalize or withdraw the LCD by July twenty-sixth, 2024. But if they elect to finalize this either in its current form or in any altered form, they can do so at any time during the next few months, but they... It takes at least 45 days before it can become effective. So, while the U.S. market remains, you know, our number one priority, and we are continuing to grow in that market, we have devoted some resources to de-risking our business by looking in for opportunities in other markets.
That was actually something that was ongoing prior to the June news from Novitas. But we have, you know, modest levels of activity in Israel, the LATAM countries, through our PEDUSA operations, and we are also looking internationally, through or in the APAC region, where we have signed distribution agreements in Vietnam, the Philippines, and Malaysia. So we will look to activate those over the coming months. We have undergone a restructuring and redimensioning event in the last quarter that we advised the market that we would undertake, where the sales territories have reduced from 29 to 17.
We've also, you know, to ensure the success of our enhanced patient responsibility and patient assistance programs, we've focused in a more detailed way on the clinical value, the economic value, and the patient value in the messaging. We've increased the expectations of our sales force, which is not without its challenge. Sales territories are larger as a consequence of this change. But we are expecting an increase in throughput per salesperson and also an increase in throughput per physician, two of the metrics we've historically reported to the market.
We, wherever possible, and in an uncompromising fashion, we are accelerating our clinical evidence generation program, and focusing on the monitoring of existing studies, which is what we do to ensure, you know, that every patient that is enrolled in the studies can have their data used in our final analysis. Is ongoing, is emphasized, and is driving us to a rapid completion. That was most notable with STRATA, but continues to be a focus for DRIVE. We have observed, in the most recent quarter, a decrease in an impact to our business in terms of the ordering clinicians. Many of those are clinicians who ordered only a few tests.
Some were clinicians that ordered multiple tests. But in all cases, as we've gone out and visited the customers who may have reacted to some of the news, we've been able to ensure that those customers remain loyal to Pacific Edge. So, one other milestone that has been, you know, long talked about at Pacific Edge, was that we have economic value to systems who would adopt Cxbladder at a protocolized level within their institution. And so we've developed a budget impact model, and we first talked about this at the annual shareholder meeting back in July.
And this has become an increasing focus of our messaging as we look to sell to capitated systems, integrated delivery networks, and other large customers that you know that would look to establish a defined clinical pathway for Cxbladder across their networks. And it is also very important that the way that we constructed this budget impact model was to compare directly to the AUA guidelines, and then to introduce Cxbladder for just one crucial component, and that is the risk stratification into high, intermediate, and low risk patients at risk for microhematuria. And you know this messaging for the health economics component is exactly in line with the protocol that we have proposed for the CREDIBLE clinical utility study.
So we are intending to demonstrate that the pathway that has the optimal clinical utility also has the optimal health economic utility, for systems and payers. We have continued to grow in New Zealand, and while the APAC region makes up a minority of our revenue, it is pleasing that we have had our largest quarter, and that's off the back of growth in New Zealand. A number of small successes here, where the Nelson Marlborough region advised us that they were going to move triage from being ordered at secondary care to primary care.
And we, you know, we are continuing to work with key opinion leaders in New Zealand, with a protocol, to utilize Cxbladder nationally, and we'll advise everyone when we make progress on that. You know, as mentioned earlier, Australia and the Asia Pacific continue to be resourced as areas of future growth, but they are still in business development with modest volumes coming in there. But we are optimistic that they will move out of evaluation through the distributors and into commercial routine. So as we have, you know, looked to focus as a business, you know, one of the other things that we can do is ensure that we are operating as efficiently and effectively as possible. We have...
While we have had, you know, very recent success with the Kaiser EMR implementation, we understand that this can serve as a model for any organization, hopefully with lower complexity, because Kaiser is a very, very large system. But smaller practices can benefit in the same way as Kaiser can from the introduction of EMR. And having, you know, got our number one EMR focus out of the way, we are looking to deploy a customer portal and to standardize EMR integrations with customers, which can dramatically reduce, you know, well, it can improve the efficiency of ordering and the customer experience. Just a note on the Kaiser EMR rollout.
So Kaiser's EMR is called HealthConnect, and we are now live in that interface as of the fourteenth of November. Initial volume is being sent through that interface to our lab, so it is working. There are 15 facilities in the Southern California region that are eligible to order, and we are working with the folks at Kaiser who have the most experience from the former ordering pathway, which was in-home sampling only, to ensure that all of those physicians continue to order those tests for their patients as they migrate to a new model, and then look to expand further across Southern California. And then consider using the evidence in Southern California, how we can expand beyond that.
We will continue to update the market, you know, as and when appropriate, about progress with Kaiser. So underpinning our future prospects are a migration away from two hematuria evaluation products to a single hematuria evaluation product. So we are focusing very heavily on the clinical evidence generation for Cxbladder Detect Plus. It has improved performance characteristics, and we are continuing in the development stage and analytical validation stage with Monitor Plus, for improved performance in a surveillance setting as well. Crucial to our long-term success is guidelines inclusion. Our evidence generation program is focused on that. So just as a reminder, our most relevant guidelines group is the American Urological Association.
However, NCCN is also important, and internationally, the European Association of Urology is also important. The list of our clinical studies is below there in the boxes, but probably more relevant is to move to the next slide, and just talk you through our roadmap. So, the STRATA Study is now in the data cleaning, sorry, is now in the records review and follow-up phase. And as soon as that is complete, we will go into data cleaning, and look to close out that study with a publication. Hopefully, that's clear from the roadmap that you're looking at. DRIVE is also enrolling as fast as possible so that we can move that study to completion as well.
One of the key things about those two studies is these are legacy studies that were all paper-based, and we, rather than at the last moment, convert them to digital studies, we are having to complete them on a paper basis. So they are taking a significant amount of effort to wrap up. However, when completed, we'll be able to divert resources that are currently on those studies to the other studies, and ensure that those go according to plan. The MicroDrive Study is another one that I would never want to miss the opportunity to highlight. The MicroDrive Study is pretty special.
What you'll notice is that the timeframe for execution is very short, and the number of patients that we're expecting to enroll is quite high. It's 1,000 patients for that study. And the reason we're able to achieve that kind of rate of enrollment is because we have contracted with a single VA site, that's Veterans Administration site. And that site has access to patients within the entirety of the VA system and acts kind of like a contract research organization. This allows us to enroll patients literally at a rate that is faster than we can monitor them. And we rely quite heavily on that contracted partner for our ability to execute there. But they are very experienced at it.
And so we're delighted, you know, to have the first patient in and to already be underway with that study. So the timelines for that are very aggressive. As we look at the other future studies, we've got a pooled analysis for the clinical validation of Detect Plus. We will elect to validate it in two populations, which is why you see two publications submitted, one on the microhematuria population, which is our primary, and one on the gross hematuria, which is secondary.... The CREDIBLE Study is a clinical utility study that compares the current standard of care by the AUA guidelines, risk stratified using clinical factors to the standard of care with Cxbladder implemented to do the risk stratification for you.
And that site, sorry, that study, is now ready to begin pre-activation, with all of the various contracting, et cetera. And we hope to get the first patient in by around this time next year. And the surveillance setting, you know, that we consider Lobster has was actually our first fully digital study, and first study with the appropriate monitoring resources from the get-go, and is enrolling very steadily, and so we're well on track according to these timelines here with the LOBSTER study. And the U.S. clinical utility surveillance study is a proposed study, and we are not yet working on the protocol for that.
That's in early discussions, but we expect to have to perform a clinical utility study for surveillance as well, according to a defined protocol, for you know, optimal guidelines inclusion. So a couple of topics that we have, you know, we've raised on several prior occasions, is the importance of the clinical dossier. And we continue to add every new publication on Cxbladder to that clinical dossier, and we use that for submission to NCCN or to AUA, and we also use it to help establish ourselves in new markets. We are expanding or we are amplifying the messages through podiums, presentations, and posters on a regular basis at conferences. Although the level of activity has been scaled back to ensure appropriate cash conservation.
But we continue to work on the publications associated with all of the work that we do and to appropriately communicate our medical data. We have an active KOL relationship building program, and this helps us with all of the different professional associations, and it helps us with finding appropriate clinical trial sites, and it also helps drive revenue in a commercial sense as well. There was news a couple of months ago, and we made an announcement to the market just to highlight for investors that the FDA is interested in regulating the LDT space. But we also really want to make sure we've appropriately contextualized this for the investment community. You know, since that time, there's been a number of experts weigh in publicly.
And so, you know, we provide this slide as a kind of consensus view of the status quo. Yes, the FDA is interested in regulating LDTs, but they face an enormous number of challenges to do so. Essentially, because the framework in which they would like to regulate it, known as the Medical Device Amendments of 1976, is not a very good framework for the regulation of LDT. Primarily due to the fact that laboratories are not manufacturers, and laboratories vary their tests on a regular basis. Now, this has long been recognized, and indeed, the VALID Act was proposed to kind of address both the FDA's concerns and the concerns of the laboratory community. And, unfortunately, in the United States, the Congress failed to pass that.
Pacific Edge, consequently, does not support regulation under the Medical Device Amendments of 1976, but Pacific Edge welcomes, and will respond appropriately, to FDA regulation through an act of Congress. But we will continue to prepare for both eventualities. Our third pillar, research and innovation, is, as described earlier, focused on enhancing our existing product line with, DNA markers. And so, you know, we're, we're working with R&D, digital and lab operations to ensure that we can launch Detect+ in both clinical labs, in PEDNZ and, PUSA. We are looking to simplify, the, the Cxbladder product, which there's, there's no better time to do that with than when you're essentially making it more complicated by adding DNA and RNA in a single workflow.
That creates a really important opportunity to ensure that we're also looking to simplify it in terms of the amount of technician time it uses, how we can lower cost of goods, improve the turnaround time, and ultimately increase the number of, well, the throughput, and reduce handle time through increased automation. We're gonna continue to focus on meeting all of the compliance hurdles that an IVD company would need. And we are continuing to engage with industry and academic researchers on collaborations to identify any unmet clinical needs in bladder cancer diagnosis and management, for which we can provide a solution. I will now turn over to CFO, Grant Gibson, to talk about the financial performance slides.
Great. Thanks, Peter. So some of these figures have been mentioned before, but, it's worth highlighting again, the strong operating revenue performance, up 50% on the prior year to NZD 13.1 million. And it's also an increase on the second half of last financial year, up 20% on that period. So the driver of that is higher volumes and high average payment on the tests that we're performing and getting paid for. The composition of our revenue is still largely based out of the Americas, with 95% of our revenue derived from that region, with APAC delivering another 5%. But as Peter has mentioned, there is a focus to increase the revenue from outside the Americas. We take a bit of a look deeper into some of the numbers.
So in addition to the operating revenue growth, total revenue is also up 22% on the prior year to NZD 16.6 million. It's worth noting that in the first half of 2023, there was an additional NZD 3 million of foreign exchange gain, and that compares to NZD 700 thousand in this half, sorry. Operating expenses are up 32% on the first half of 2023, and 10% on the second half of 2023. So the driver of that is largely headcount. We invested in headcount and additional expertise when we were seeking revenue growth. As we've discussed, we have restructured the sales area in particular, and we expect to see a reduction in that expense for the second half of this financial year.
The other component that has had an impact on our expenses has been the legal expenses that we've incurred in combating the Novitas decision, and we will see how that progresses. Loss for the year is NZD 15.1 million, and that compares to NZD 10.2 million for the first half, and it's a reduction of NZD 16.9 million in the second half of last financial year. Cash receipts have continued to grow strongly, up to NZD 13.6 million, which is an 86% increase on the prior financial year. We've got a very strong balance sheet with NZD 62.2 million in cash and short-term deposits. That's a reduction of NZD 15.1 million on the second half of last financial year.
That cash burn is at the same level as the second half of last financial year. We have a bit more of a look at the expenses, the operating expenses. Our lab costs increased 37% period on period. That's driven largely by volume increases and also increasing freight costs. Research, as Peter has mentioned, is up 48%, and that focuses, that is, the driver is one of those pillars that we have discussed, and in particular, the commencement of the MicroDrive Study. Sales and marketing is up 26% on the prior period, and that's focused on the additional headcount that we have recruited. As we mentioned, with the restructuring, we're expecting that cost to decrease into the next half of the financial year.
Our general and admin cost is up 27% on the prior half, and that is, it's up 6% on the second half of the 2023 financial year. Thank you, Peter.
Thanks, Grant. And so, as we look to have our first year of ESG reporting, you know, we've put the slide together to remind everyone, of course, firstly, on Pacific Edge is that it's a very strongly socially focused business. You know, our mission is to improve the lives of patients with the diagnostic tools that we develop, and this in many cases, some of the things that we develop are able to improve healthcare equity outcomes, particularly with things like the in-home sampling system that we've developed, and to actually reduce the costs in, you know, to healthcare payers.
You know, we have, from a governance perspective, we've integrated oversight of the ESG matters, including carbon reporting into the Audit and Risk Committee charter. Then regarding New Zealand climate standards, we've measured carbon emissions, Scope 1, 2, 3, in FY 2023, and positioned to provide base year data, in FY 2024. We're working closely with advisors to do to do all of this, and developing strategies and policies, and evolving our risk management framework to meet those reporting requirements.
Within the context of New Zealand, and again, just highlighting, you know, how we how Cxbladder can reach, you know, not just the urban centers, but it can also reach all the rural communities, we focus on promoting healthcare equity through our in-home sampling and direct-to-patient activities. So finally, as we look forward, you know, Pacific Edge expects to manage the available cash, and that it is sufficient to support the company, even in the event of an adverse Medicare coverage decision, through to regaining coverage. A process that may take up to four years. But with interim coverage attempts with every piece of new evidence.
It's important in parallel to remind everyone that we remain a covered test, and it remains possible that we can continue to have coverage with a positive Novitas decision. So we've refocused the business to appropriately handle that uncertainty. We are focused on clinical development for guidelines inclusion and increased coverage certainty for Detect+ and Monitor+. And we have initiated a selling focus on clinical value as the driver of higher throughput per headcount and higher throughput per clinician. Of course, the headwinds remain. There is the possibility of non-coverage determination from Novitas on a new proposed LCD after following the appropriate procedure.
There's also a possible negative physician or patient response to the enhanced patient responsibility for commercially insured patients, which has been active for a couple of months now. But there are also catalysts for our business, and it remains strictly possible that we retain our coverage after Novitas have reviewed our responses to their comments, and after they have followed the appropriate procedure. It is, you know, as mentioned earlier, we have New Zealand KOLs that have submitted Cxbladder as a proposed clinical pathway for a national implementation of Cxbladder.
And there is always the possibility that clinicians that we have been working with for some time will be generating clinical utility evidence that we are not currently aware of. And they may elect to publish that on their own, independently of us, and that, of course, could be a catalyst supporting the adoption of Cxbladder. In summary, we have, we have world-leading technology, we have a strong balance sheet, and we are effectively navigating the headwinds that we have come our way, and we are establishing a foothold in new markets, as well. So, thank you everyone for listening in. We are now happy to take questions.
Thank you. At this time, I would like to remind everyone on the phones, in order to ask a question, press star, then the number one on your telephone keypad. And in the interest of time and to ensure we answer as many of you joining us as possible, we do request that you please limit to two questions and a follow-up. And your first question comes from the line of Matt Montgomery from Forsyth Barr. Your line is open.
Hi, Pete and Grant. Thanks for taking my questions. Good morning. I might just start on the cost base. I know it's a sensitive topic, but I was just wondering if you could provide a little more detail around, you know, the exit run rate in the cost base. Because as you pointed out in your release, you know, restructuring changes were only made late in the quarter. So I'm just wondering if you'd just give us a feel for where sort of the true base is now in the cost base, and if you think there's further scope for more?
So, Matt, I mean, the slide I would guide you to is where we have, you know, reduced from 29 sales territories to 17. That's the primary area where there's been the reduction. It is also important to remember, even though it was, there was a reduction in force there, there was also a reallocation of resources to focus on the generation of clinical evidence. And so where it was appropriate, that we had someone who could help the clinical evidence generation side in terms of site monitoring and so forth, we elected to shift headcount from one area of the business to another.
And in some cases, we have continued to add headcount in a small capacity to ensure that we can stick to those aggressive timelines for clinical evidence development. But that's definitely the best slide to guide you. And that's probably all we can say at this point, until the-
I mean, I, I appreciate all that, but I guess the crux of my question is, on the basis of the LCD not proceeding, which is, I guess, in essence, how you've orientated the business, not necessarily that it's gonna take place. But, you know, where, where do you think, you know, the cost base on an annualized basis would, would bottom out? Would something like NZD 40 million feel appropriate in terms of, you know, building up the, you know, the cash burn trajectories from there? Because I know you've, you've got guidance essentially out there for, your cash burn in.
Yeah, so we're looking, Matt, we're thinking about this in terms of the four-year time horizon. And we are, of course, modeling two scenarios. So right now, we are modeled for coverage uncertainty. We are not modeled for loss of coverage. And I think we've established that with the market. So in the event of a loss of coverage, there are additional steps that we would need to take to ensure the four-year runway is maintained. But so we essentially keep two plans for everything. So that we get coverage certainty positively, and we get coverage certainty negatively.
In both of those scenarios, we expect to be able to manage our cash over the four years until we have regained coverage for Detect Plus and Monitor Plus.
Okay, that's good. Thank you. I was just wondering, you know, as part of the, the EMR renegotiation or the EMR integration with Kaiser, you know, the, the sense I've, I've got is that there's potentially, you know, renegotiations with, with Kaiser, with res- potentially with respect to, to pricing, you know, alongside maybe more volume commitment. Are you able just to comment on sort of the implications of potential renegotiations that have taken place?
No. So obviously those negotiations are confidential, and we hope that our colleagues at Kaiser will maintain the same levels of confidentiality that we will. What we are comfortable with, having the market understand, because this is just a normal business practice, to help drive the rollout, we will incorporate into the contract the concept of discounting associated with volume, but we would not comment beyond that. But you know, for your models, Matt, I think it's important that right now you should stick to, you know, what you understand today about the Kaiser model. You know, the volume increase hasn't occurred yet. That is something that we will work on over the coming months.
And, you know, we've done our best to negotiate an outcome that is good for both Kaiser and us. But importantly, recognizing some of the other comments that you may be aware of from the folks at Kaiser, is that our product, even at its current price, already saves their system money. That's their words, not mine. And as a consequence, even though we are, you know, in discussions around the level of discounting associated with volume, we already know that we save them money. So I think you can use that, you know, as you think about how steep those discounts might be.
Great. That's good color. Thanks, Pete. Maybe just one more in terms of pricing per billable test was quite a robust number in the half. Are you able just to comment on, you know, where specifically you're seeing the uptake? I'm assuming it's sort of in the other U.S. bucket, and you're able to sort of drive more billable test throughput.
Yep, I can, I can touch on that, Matt. So one of the changes that we've seen in the last year, of course, is the addition of triage into the payment by Medicare. So we're now getting paid on that, where previously we weren't. We have seen a general uptick in the amount we're getting paid and the frequency, the success that we are getting paid, as an increase in our clinical data comes out and more awareness amongst all the payers. The other component we have started to see are the changes that we talked about in that July-August period, where we are starting to see an impact from our patient pay. So that is beginning to be seen.
It's still late in the half that we actually began to see that, but that is beginning to have an impact on our average revenue per test. So those are the three things that are really driving that increase.
Great. As usual, I'll leave it there.
The-
Thank you very much.
Yeah.
Sorry.
No worries. The other thing to note really is that the effects has had very little impact on the revenue half on half on half. So, you know, it, it, it is a, it's a real driver, is the average increased price per test.
Your next question comes from the line of Rob Morrison from Craigs Investment Partners. Your line is open.
Cool. Hey, Peter and Grant. Congratulations on some good revenue growth, especially given what must have been a pretty tough final quarter. So kicking off with Kaiser. So from what Matt said as well, so now that there's an EMR, your EMR's in place, will volumes just start to run naturally on their own, or do we like... Sorry, ramp well on their own, or do we have to wait for the implementation of a contract to expect that?
We are not waiting on any other, any other elements of this process to ramp. The limiting factor for the ramp was the EMR. So that is now available to us, but, as you can imagine, it is not a light switch. It requires education. But we can also say that, you know, education of Kaiser physicians has been ongoing prior to this. As you may remember, we were, you know, we've been forecasting that this is in the works for quite some time, and Kaiser have known the exact same thing internally, and so they are preparing for this. But, yeah, it's not a light switch. And Kaiser tends to drive the education of their own physicians on this.
And, you know, but as with any project of this nature, I think it is important to sort of proceed with caution. So right now, everything is working from a technical standpoint. We need to start to drive adoption, but very, very soon after we've seen adoption in this new framework, we need to revisit. And we just do this as part of standard account management. We go in, and we set a clinical review with them and say: firstly, are you actually implementing it the way you said you would? And if you are implementing it the way you said you would, are you seeing the changes that you expected to see?
So you know, that we're gonna set a review point for roughly a year, but obviously, we're not going to be disclosing that. But we will have a review with Kaiser to see how they're tracking against their own expectations and against our expectations, and that's just good account management. But also, I just want to make it clear, we're not going to be reporting on Kaiser progress separately in any kind of quantitative fashion. The Kaiser throughput will be something that we expect to report in our total throughput numbers.
Okay, okay, got it. Yeah, so the rate limiting step has been eliminated. Now we can focus on ramping things up.
Great.
Speaking of that, actually, so Novitas understand that, you're in the part of the process where Novitas won't really speak to anyone. But I think it was previously mentioned that an important bottleneck for them is that they have to reply to all comments submitted over the, comment period, and therefore, you know, they can't make a decision before that. So first of all, do you know if they've finished replying to all those comments? And then secondly, you know, I believe Kaiser presented some data to them. Do you know if that changed their thinking at all?
So maybe I'll answer the second one first. No, we don't know if it changed their thinking at all. They haven't corresponded with us. But the way that they respond to the comments, and this is important, is they write another type of LCA, Local Coverage Article. It is a type of Local Coverage Article that is called a Response to Comments Article, and in that, they basically have a table, and they say something like... You can actually see the one from that that was co-published on June second, U.S. time, from the last version that went final. They responded to the comments that they had received.
And so we received 14 comments about the Cxbladder product, and we agree that it or we disagree that it should be covered, and that kind of thing. So they can be very general in how they respond to the comment, or they can be very specific in how they respond to the comment. And there is no hard requirement on whether they are specific or generic. There just is a requirement that they respond to every comment. So they may collate and say, we received 17 letters outlining to us that the male bias in Pacific Edge's studies is not appropriate, and we agree that male bias in the study is actually not appropriate.
Sorry, not inappropriate criticism, because, of course, the study is a male bias because the incidence of bladder cancer is male biased. So that's how the response to comments would come, and so everyone would become aware of it at exactly the same time. It will be published through the CMS reporter coverage database.
Okay. Sorry, so have they made their way through all those comments yet so that they can make a decision soon or?
There's absolutely no way for us to tell.
Oh.
Yeah.
Okay, sweet. I'll just slip a final one in. Test volumes, because I understand second quarter was pretty tough, right? Because, you know, from what I see, it seems like you had a month there where you thought you would have lost coverage, right? So I imagine, you know, there was some confusion with customers, and perhaps more importantly, you're reorganizing the sales force. Can you talk about how 3Q volumes are looking to date? Or, you know, if you can't, if you don't want to, then perhaps you could comment on what exit rates were doing at the end of 2Q in terms of volumes.
So, yeah, we're not gonna make any comment on Q3 volumes. That will come in January. But maybe I'll just try to give a reasonable degree of color here. You know, the sales force are at the front line of these kinds of things. You know, they have had to combat messaging with customers, where customers tell them, "Oh, so we've heard you've lost Medicare coverage." And we say: No, that was proposed, and we are still a Medicare-approved test. They have to deal with that stuff at the front line, but we've equipped them to do so. But that is an addition that...
You know, when we talk about the headwinds that we're facing with, you know, our team on the ground, those are the kinds of things that they have to address. Similarly, if there is a, you know, you know, if there are other vendors out there, selling cystoscopy products or single biomarker, you know, urinary biomarkers for bladder cancer, you know, they may also want to promote their test, and are happy to spread rumors. So these are just, in my view, these are very ordinary things for us to combat, but they do manifest in depressed numbers, and we just have to combat it with time.
It's also fair to say that the pivot that we have undertaken, from a messaging standpoint, to really stress the value of Cxbladder in terms of risk stratification, is something that, and I think you've published extensively on this, in your work, Rob, is that our customers are often using it adjunctively. So to convince them that adjunctively is not the appropriate way to use our test and that they should be using it for risk stratification purposes, and that that works outside the Kaiser system... That is going to potentially have some short-term consequences, but it is one of the most important things that we can do as a business.
Because if we are driving genuine behavior change in our physicians, that's when we'll see sticky customers, that's when we'll see growth in throughput per per ordering physician. But those navigating that kind of messaging pivot in the United States while facing all these other headwinds, that's a it's a 12-month you know project, 12-month campaign.
Okay. Okay. No, makes sense. So thanks, guys, very much, and have a good day.
Thank you, Grant.
As-
Thanks, Grant.
As a reminder for those joining us by phone, if you would like to join the queue to ask a question, please press star one on your telephone keypad. Your next question comes from the line of Christian Bell from Jarden. Your line is open.
Yes, good morning, guys. First question from me. When you talk about the two scenarios, coverage, CCP and loss of coverage, and then combined with the fact that you think you have sufficient cash reserves in both scenarios, are you able to just please talk to, like, what kind of volumes are underpinning that? Like, after the dip in the second quarter, you obviously think that was one-off, and so are expecting to see a U- or V-shaped recovery. Then how does that sort of change in the case where you actually lose Medicare coverage?
So I might actually just use your metaphor there, Christian. So, you know, we're obviously doing everything that we can to make it a V-shaped recovery rather than a U-shaped recovery. Of course, those, you know, that's only gonna happen through active leadership and active management. So that, that's our focus. But at this stage, you know, either of them are possible. But we are doing everything that we can to have our sales reps out there, meeting the physicians that they don't know in their larger territories. You know, getting underway with that, you know, calling on the IDNs and other strategic accounts as a matter of practice through our national accounts team.
So all of those things are in flight, but we can't, I don't think we can guarantee a V-shaped rebound, but that is what we are working towards.
So how does that change, though, like in the case you actually lose Medicare coverage, and the patient becomes more responsible for making the payment themselves? Like, how does your thinking change there?
There's a sense in which our thinking doesn't change at all, and that is that our priorities don't change because our priorities don't change. Our priorities are that we will restructure as necessary to ensure that we have profitable territory. There are obviously a different set of underlying assumptions in the event that we have to provide ABNs to customers to be able to bill for Medicare patients who would get denied on the basis that it's not a Medicare-covered test. I think some of that information we put into the market back in June when we were first confronted with this situation.
So to try to answer the question a little better, you know, we are prepared for both of those eventualities with a different set of underlying assumptions regarding revenue, throughput, and ASP. The hardest one to predict is actually, you know, the impact that it will have on throughput. Again, we've acknowledged that in our outlook slide.
Okay. And are you able to just give some color as to how dependent your sort of recovery protocol is on Kaiser? Like, I know you're not gonna give numbers, but is it a majority, a minority of your sort of throughput in that recovery path?
Oh, look, it's too early to say. But you know, Kaiser remains an important component of Pacific Edge's future, and how we drive that. So how we drive adoption through the hospitals of Southern California and then extend that through to Northern California and all of the Kaiser system, those are all priorities for us as a business. And while there would need to be additional business cases and additional EMR development, you know, having an actual example of a system within Kaiser that is already executing is the best possible business case. So we put our best foot forward with the folks in SoCal, and if this demonstrates to Kaiser what we expect it to, we will...
You know, leveraging that is how we move into the other areas of the Kaiser system. So we're laser focused on the Southern California opportunity.
Okay, cool. Thank you. And then just, sales, on your sales reps, you've gone from 29 to 17 territories. What is it actually in terms of sales reps numbers? You were 37 in March, I think. So what is that now? And in the event of loss of coverage, where do you expect that to go to, again?
Yeah. So, we have historically reported on what that means in terms of direct headcount. And right now, we are talking about the 17 territories, which each of which would have an account executive. We are talking about 2 regional sales directors, who would, we are talking about 3 national account managers, one of which is focused exclusively on the Veterans Administration. And, of course, leading that organization, is a VP, and we also have 4 people in the virtual team.
So, that's 22 in the direct and 4 in the sort of support team, if we use like for like, compared to what you guys then—
That sounds right.
That's about right. Yep.
Where would that get to? What do you expect it to sort of go down to in the loss of coverage scenario? Like, how much more would you cut?
Sorry, Christian, it's a bit hard to hear you on this line, but you're saying how much more would we cut in the event of a loss of coverage?
Yes, that's right.
Obviously, we're not—we would not disclose that information. And again, our priorities remain unchanged. Our priorities are that we have to be able to establish profitable territories.
Okay, great. Thank you. That's it for me.
That does conclude our phone Q&A session. I'd like to hand back to the team for any online questions.
Great. Thank you. There's no further questions coming through online, so the phone callers have done a good job there. That wraps up the conversation. That, yeah, thank you very much, everyone, for listening in. We'll have more results in January.
Great. Thank you, everyone.