Renalytix PLC Q3 2023 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Dan Arias - Stifel Financial Corp. - Analyst : Good morning, guys. Thanks for the questions here. Tom or James, to Tom's point on the importance of the New York metro area, can you just maybe talk about the ramp path forward for usage at this point and the headwinds that may or may not exist? And, obviously, it's been a long and winding road here, at least as it relates to the New York City area. So, to what extent do you feel like you're past the various issues you've encountered when it comes to just the way that things work at institutions like Mount Sinai? And how do we think about heading into 2024, the successive volume increases that we could expect perhaps?

Question: Dan Arias - Stifel Financial Corp. - Analyst : 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 the ramp. But I'm just wondering what ability we have to do that at this point.

Question: Dan Arias - Stifel Financial Corp. - Analyst : Okay. Thanks, James.

Question: Chaitanya Gollakota - H. C. Wainwright & Co., LLC - Analyst : Hey. This is Chait on behalf of Yi Chen. 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, test volume as well? Thank you.

Question: Mark Massaro - BTIG, LLC. - Analyst : Hey, guys. Good morning. Thanks for the questions. The first one is, James, can you perhaps provide an update on communications you've received from the FDA? I know you've indicated that you're hopeful to obtain approval by the end of June, end of this month. But I'd be curious to hear, like, are you still having some back-and-forth dialogue between you and the agency? And then, I know you've talked about how the agency plans to prepare reclassification order to complete its review. Just any update you could provide there, I think, would be helpful.

Question: Mark Massaro - BTIG, LLC. - Analyst : 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 the next quarter, would it be reasonable to assume that volumes can tick back up sequentially?

Question: Mark Massaro - BTIG, LLC. - Analyst : Okay. Sorry. I think you might have gone out. What were the volumes in the quarter?

Question: Mark Massaro - BTIG, LLC. - Analyst : Okay.

Question: Mark Massaro - BTIG, LLC. - Analyst : 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?

Question: Mark Massaro - BTIG, LLC. - Analyst : Okay. That makes sense. And I would be curious to just get an update on the EVERSANA partnership. 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. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 09, 2023 / 12:30PM, RENX.L - Q3 2023 Renalytix PLC Earnings Call

Question: Mark Massaro - BTIG, LLC. - Analyst : Okay, great. Thanks for all the color. That's it for me. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 09, 2023 / 12:30PM, RENX.L - Q3 2023 Renalytix PLC Earnings Call

Question: Randy Baron - Pinnacle Associates, Ltd. - Analyst : 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?

Question: Randy Baron - Pinnacle Associates, Ltd. - Analyst : Let me ask the question this way. Is the current rate of study tests, is that kind of a constant number. Are 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 10,000 tests?

Question: Randy Baron - Pinnacle Associates, Ltd. - Analyst : And will study -- will it generate cash upfront? Is that kind of the trade-off?

Question: Randy Baron - Pinnacle Associates, Ltd. - Analyst : 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. 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?

Question: Randy Baron - Pinnacle Associates, Ltd. - Analyst : Good luck