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

James McCullough: Yes. Thanks, Mark. I have to be very careful. This is a sensitive time. And let me just say that we’re very pleased with our communication with FDA. It has been iterative and we think it is a very productive process. At the moment, we disclosed to the market, we expect a decision by the end of June. That’s where we are at the moment. I will remind the market that until you have FDA, you don’t have it. And we’re just going to let the process continue to run. But at the moment, we’re very optimistic.

Mark Massaro: Okay, great. Hopefully, that comes in, in the next few weeks or months. Maybe moving on to another question, maybe for O.J. I might have missed it. I didn’t see the volumes reported in the quarter. I know in the prior quarter, you indicated they would be down sequentially due to the transition at Mount Sinai. But can you just give us a sense for what the volumes were in the quarter? And then, as we think about — as we think about the next quarter, would it be reasonable to assume that volumes can tick back up sequentially?

James Sterling: So, volumes were [Technical Difficulty] for the quarter, of which roughly two-thirds are billable. So, there’s still a set of tests in there, Atrium Wake Forest, for example, that are part of study tests, are not billable. So volumes are improving a bit in this quarter, but offset by something we indicated in the call. Tests that used to be billable or reimbursed from Mount Sinai are not now, under the traditional commercial pay model, and it represents about a third of the tests at Mount Sinai currently. So at the moment, we have that headwind against growth for the current quarter. We do expect that percentage to go down as a total of the Mount Sinai tests going forward as commercial tests ramp up, but also seeing continued growth and diversification away from Mount Sinai, primary care doctor, the independent PCP tests are increasing, et cetera. So, encouraged overall, but we do have that short-term impact from the Mount Sinai transition.

Mark Massaro: Okay. Sorry. I think you might have gone out. What were the volumes in the quarter?

James Sterling: Just over 1,200, about 1,240, and about two-thirds of that is billable.

Mark Massaro: Okay. I appreciate that. I think you indicated that the transition to commercial payment at Mount Sinai was completed. Is that right? So, I know that testing at Mount Sinai was paused in March. Given the transition at Mount Sinai, is it right that we should expect more of a normal cadence of volume growth going forward, or is there still a little bit of work to do to get that sort of squared away?

James Sterling: No. Total volumes are back, but the ongoing impact is that a third of those — currently a third, hopefully, less going forward, are no longer billable, whereas we were — when we were under the $6 million contract at Mount Sinai, we were getting paid for those. Those are study tests that are not commercially billable at the moment. So, while volumes are back, a third of them are not revenue generating.

Mark Massaro: Okay. That makes sense. And I would be curious to just get an update on the EVERSANA partnership. Maybe how many — it seems like it’s a contract sales organization if that’s a fair way to characterize them. How many folks do you think you have access to boots on the ground, sales reps? And I know you indicated that they could become employees of Renalytix going forward. Maybe just walk me through how you expect that type of transition to play out.