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

So another power of that study is that we have amassed data on outcome benefits for hundreds of members of the major health plans in the New York City metro area. And we can sit down and talk to them in specifics about their members. And so, as we look to expand into large practice groups and other health systems, having that ability to bring the recommendations from payers who are confident about the benefits of incorporating KidneyIntelX testing into care for their members is also going to be a lot of wind in our sails as we begin to build off those Mount Sinai successes as we go forward. And that is an outcome of the work with Mount Sinai that has broad implications across that whole metro area.

Dan Arias: Okay. So if I could just ask a follow-up and sort of combine those two thoughts there. Where is the confidence that in 2024, you will at least at Mount Sinai see quarterly progression of volumes that barring some sort of shock to the system or unique circumstance, will have people thinking about a natural path upward on KidneyIntelX? And then, associated with that, if I could, for O.J., presumably, the next time we’re on the phone here will be the end of the calendar year. It sounds like you should have FDA approval. Do you think you’ll be able to give an outlook on revenues or if not revenues, volumes for fiscal ’24, just to sort of — people are trying to inform their models here and think about it, but I’m just wondering what ability we have to do that at this point.

James McCullough: Yes. Let’s see when we get there. We’re obviously especially after this market environment, cautious. That doesn’t mean that we’re cautious operationally. We’re moving assertively operationally. But we want to make sure that going forward, we are under-promising and over-delivering and that we remain in that continuum. And I think, again, as we emerge, hopefully, in the summer with this trifecta of regulatory reimbursement and data we should be able to grow consistently. And I think what you’re going to see is the emergence of growth diversity. And that’s important. So, we’re going to start to see testing volume develop in different categories, direct to physician, for example, other health care systems. That’s really the metric for success as opposed to just relying exclusively on Mount Sinai. But, O.J.?

James Sterling: That’s correct. No, I’d like to see — we need a bit more time to see some consistent volume development and build to have a basis on which to provide guidance with full confidence. And so, we all recognize that — the desire and the need to provide some guidance in quarters ahead. I just want to make sure that when we do so, we do so on a strong basis of confidence, and we can see the trends that we’ll be consistently building.

Operator: [Operator Instructions] Our next question will come from Titania Galia Kota of H.C. Wainwright. Your line is open.

Chait G.: Hey. This is Chait on behalf of Yi Chan. And just following up from the previous question, and I know you’ve addressed this in your prepared remarks. But, could you summarize the key factors required to drive volume growth moving forward and subsequently, testing volume as well — test volume as well? Thank you.

James Sterling: So, the trifecta is a great — it’s three legs of the stool. It’s outcomes data, diverse reimbursement and regulatory approval. In this particular market, which is so large, the diabetic kidney disease, patients with diabetes and kidney disease in the United States runs well into the 8 figures. And we felt from the beginning we needed to have an FDA process in order to set a baseline standard for early-stage prognosis. And that was new. So, this is a de novo marketing authorization that we are seeking. It is unique. And so to really drive scaled growth, you need to have all three legs of the stool, regulatory, reimbursement and data. The data looks great. That’s the foundation for everything. We’re obviously validating reimbursement quite rapidly.