Renalytix PLC Q4 2021 Earnings Call Transcript

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

Question: Unidentified Participant - Stifel - Analyst : Hi, guys, this is [Dan Mayseck] on for Dan Arias this morning, thanks for the question. So I guess, first of all, is there an overall volume number or range that we should think about for fiscal 2022? And I assume it's probably safe to say that Mount Sinai's 6,000 tests is maybe a starting point but realizing that there is ramping opportunities in the VA and also Wake Forest in Utah. I was just wondering if there's some sort of volume number that we should be thinking about.

Question: Unidentified Participant - Stifel - Analyst : Yes, that's helpful, thanks. And you mentioned you expect initial testing for Wake Forest in Utah. First, I just want to make sure I heard that right. Was it in this fiscal or fiscal 2Q or was it in the fiscal year. I just want to make sure I heard that right. And then -- and where are you in terms of those ramps -- in terms of implementation and integration, physician education? You mentioned how different every health system is. So I'm just trying to get a -- get a feel for the both of those.

Question: Unidentified Participant - Stifel - Analyst : Okay, appreciate that. And then lastly, maybe just give similar thoughts in terms of the VA ramp. It's obviously early but if you could just speak to the -- to the path toward ramping there. And then I'm wondering too if there's a -- you have -- I think you said you plan on hiring, I forget the exact number, but I just -- I'm wondering if hiring maybe a risk? And if you just hired a person in-charge there and I'm just wondering if there's -- how's that going and if there's risk to other hires potentially as well? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 21, 2021 / 12:30PM, RENX.L - Q4 2021 Renalytix PLC Earnings Call

Question: David Westenberg - Guggenheim Securities - Analyst : Hi, thanks for taking the question. Just a quick clarification on the FDA. If there's -- I -- you know, I was reading through the press release, and just want a clarification in terms of like the missing the 150 days, that's nothing new right? I mean when you're commenting there, that was just on the August date, am I correct? There's no new delay or anything like that, and that's just a quick clarification.

Question: David Westenberg - Guggenheim Securities - Analyst : Appreciate it. And then just on reimbursement and private payers. How many private payers should we expect prior to the LCD, and, you know, do you -- is there any kind of snowball effect from, you know, signing the first blue to maybe some of the other blues? It seems like sometimes there is and sometimes there isn't, so I'd love to get your thoughts on that?

Question: Unidentified Participant - Stifel - Analyst : Got you. And then just my last question in terms of new hospital system integration goals or -- and I do apologize, you know, we are tracking different companies that are reporting this morning, so if -- sorry if I missed it. How do you feel you're tracking in terms of your new hospital system adoption goal and what's kind of the puts and takes in terms of hitting hit, missing it, going over, going under, et cetera? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 21, 2021 / 12:30PM, RENX.L - Q4 2021 Renalytix PLC Earnings Call

Question: Unidentified Participant - Stifel - Analyst : Hi, this is [Julia] on for Tycho, thanks for taking the question. Just want to follow-up on the Mount Sinai ramp, I know you expect 6,000 total testing next year with a run rate of 300 tests per week, which equates to 15,000 tests per year versus the 258,000 total patients that you mentioned earlier. So I was just curious how did you get to that run rate number and what can drive that ramp faster or slower versus your expectations? What key factors are at play? Is it, you know, this pace of your sales and service reps hiring, you know, is it timing of publications or, you know, LCD coverage? So just talk through kind of, you know, the moving pieces and upside and downside versus that run rate number. And then I know it's a -- still a little early, but how should we think about the long-term ramp beyond that -- that 600 -- that 6,000 number you gave? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 21, 2021 / 12:30PM, RENX.L - Q4 2021 Renalytix PLC Earnings Call

Question: Unidentified Participant - Stifel - Analyst : Got it, thanks for that color. And then I'm sorry as I missed it, as you mentioned earlier, did you say how many new systems are you looking to add in 2022 and as we think about your broader commercialization effort, like how would you say the relative focus is between adding new systems versus ramping the existing partners you have?

Question: Anita Dushyanth - Berenberg Capital - Analyst : Hi, good morning, thanks for taking my question. So, just want a little bit -- talk about the approval timeline from the FDA. I know you mentioned earlier that it's -- they're busy with the emergency use applications related to COVID. But as much as this year and the past has been very unusual in terms of keeping up timelines from the agency. How do you feel about whether the approval is more -- coming before end of this year or it's likely to get pushed out to next year?

Question: Anita Dushyanth - Berenberg Capital - Analyst : Yes, that's understandable. But thanks for the -- explaining the process, that's helpful. And then I just have one more question about the revenue ramp again. I'm sorry if I missed the earlier -- if you had addressed it earlier. Getting to that 300 tests per week with Mount Sinai something that they had come up with, how do we think about the ramp from VA and Wake Forest on a comparative basis? I know as much as that -- the systems are different but is that something higher than 300 or less than that? And how quickly can you get that? By maybe mid-year next year?