Renalytix Plc (NASDAQ:RNLX) Q3 2023 Earnings Call Transcript

So, that gives you a better understanding of the parameters or the scope of this first phase. And we hope that it proves to be very successful and it is a first phase with EVERSANA, so that we know working with them we can accelerate rapidly in other markets, as we have the evidence that KidneyIntelX will be successful in that primary care practice area.

Mark Massaro: Okay, great. Thanks for all the color. That’s it for me.

James McCullough: Thanks, Mark.

Operator: [Operator Instructions] The next question will come from Randy Baron of Pinnacle. Your line is open.

Randy Baron: Hi, guys. Good morning. I have two questions. The first is for O.J. I totally get that we’re not giving guidance on test, but I’m really curious about the glide path for the billable percentage? And how should we model that out? Do you think by the end of this calendar year, we’re 80% billable? Like, just directionally, when do we get towards kind of 100% billable on the tests?

James Sterling: As long as we’re doing studies on future products and so forth, there will always be some portion of the tests that are not billable. But at the moment, study tests are relatively constant. And as we grow the business and develop commercially, we should see billable tests increasing as a percentage of the total, certainly. So, let’s see how the new sales initiatives are taking hold in the months and quarters ahead as well as, hopefully, messaging around positive FDA approval. And I would expect that to continue to build the commercial side of things.

Randy Baron: All right. Let me ask the question this way. Is the current rate of study tests, is that kind of a constant number — is studies ever going to be thousands of tests, or is it always kind of be in that 100 range? So, as you model those out, kind of a year or two, I get that there’s always — I just don’t know enough about studies, does it ever become, I don’t know, 10,000 tests?

James Sterling: It depends. That wouldn’t necessarily be a set. If study tests go up, it means we have future iterations or products that we’re working with and developing. So, there’s no concrete forecast or plan at the moment for what those study test volumes will look like in the future. It all depends on how things build. The R&D team is active in assessing additional biomarkers, indications and so forth. So, the work continues there. So, that should have an impact in many years ahead on.

Randy Baron: And would study — will it generate cash upfront? Is that kind of the trade-off?

James Sterling: It varies. It’s really not a case where there’s an awful lot of cash upfront. It’s just the test as they’re run. They’re just not billable. So, we absorb the cost of these tests.

Randy Baron: Okay. And James, I mean, obviously, the tone today very positive, which is great. And I know you’re cautiously optimistic on FDA and who knows what comes out of Washington. But assuming you get that positive regulatory outlook in the next couple of weeks, which is what it sounds like from your press release. Can you just give us high level what you think the milestones you’re looking for later this year? I mean, it seems like there’s a thunder cloud on the horizon. You’ve got the sales force ramp and you’ve got insurance approval, like just looking out for the rest of this calendar year, assuming you get FDA, how should we think about how the business could really evolve and evolve at an exponential rate?