Full Year 2023 Renalytix PLC Earnings Call Transcript

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

Question: Daniel Arias - Stifel - Analyst : Thanks for taking the questions. It's Paul on for Dan here. Just wondering about the sequential cadence looking forward into 2024 fiscal. So could you give some color on what you're looking for in Q1 out of Q4 and and from there, you know, how does that play out through the year?

Question: Daniel Arias - Stifel - Analyst : Sure, sure -- and then just for the follow-up, in terms of the Wake Forest EHR integration that you're working on, do you see a big inflection point in terms of how that cadence will roll out over the year? Or is that more of a -- you can start scaling some volumes before that's fully integrated and it will be a little smoother?

Question: Daniel Arias - Stifel - Analyst : Great. That's helpful. Thank you. And congrats on all the progress.

Question: Chris Glasper - Singer Capital Markets - Analyst : Yeah, morning, guys. Just a couple of questions, please. Firstly, can you just give us a little bit more color on the target penetration that you've outlined? I'm assuming that's cumulative over three years? And then second question, really, just again, quantifying a little bit of detail around the further cost savings that you're expecting to make? Thanks.

Question: Chris Glasper - Singer Capital Markets - Analyst : Just around the 1% target penetration rate within three years?

Question: Chris Glasper - Singer Capital Markets - Analyst : Understood. Thanks very much.

Question: Mark Massaro - BTIG - Analyst : Hey, guys. Thanks for taking the questions and congrats on the milestones achieved in the in the calendar year. The first question I have -- so obviously you obtained FDA approval for KidneyIntelX.dkd. In the press release, you noted that the DKD, or the FDA-approved version has not yet been launched. Can you maybe clarify when you expect to launch the FDA-cleared version? And mechanically, like, what needs to happen? Is it the label? Is it messaging -- marketing? It would be helpful to learn what's needed to go ahead and commercially launch the FDA-cleared version.

Question: Mark Massaro - BTIG - Analyst : Excellent. That's great color. So you were also included in the draft KDIGO guidelines. Is it your expectation that you'll be in the final guidelines? Can we expect that roughly by the end of the calendar year 2023?

Question: Mark Massaro - BTIG - Analyst : Excellent. And then last question is a two-pronged one. You know, you had your CAC meeting -- I believe it was with NGS in New York. Can you just give us a procedural update of where we are in your quest to obtain an LCD from either NGS or, you know, one of the other local contracting MACs? And also, you know, there have been other blockbuster diagnostics that have had FDA approval that have obtained national coverage determinations. Can you just give us maybe an update on -- just maybe reiterate -- do you still think that you're qualified to obtain an NCD? Is that a pathway you guys are pursuing? And also procedurally, what needs to happen there to get a sense of how achievable an NCD or LCD might be?

Question: Mark Massaro - BTIG - Analyst : That's super helpful. There are quite a few avenues ahead of you, but thanks -- thanks so much for all the color.

Question: Jens Lindqvist - Investec - Analyst : Yeah, hi, guys. Just coming back to the KDIGO guidelines for a moment -- I assume you have seen at least part of the draft report. Now, can you share any color -- unless you've been sworn to silence by the KDIGO committee -- on the recommended positioning and use of KidneyIntelX in the revised guidelines? I mean, in terms of eligible patient groups, or potential repeat use, et cetera? And is this consistent with your own view on how to best deploy the test? And second, on the question raised earlier by Chris Glasper, can you be just a bit more specific on the out of the possible, please, with regards to cost reductions? You know, broadly, what proportion of OpEx would you say is realistically variable without jeopardizing the medium term performance of the business? Are we talking about single-digit, or potentially double-digit million over the current year? And then finally, for OJ, what's the reason for the unexpected increase in payables, please? How can we see that unwind over the coming couple of quarters? Thank you.

Question: Jens Lindqvist - Investec - Analyst : Okay. Thanks guys -- very helpful. Thank you.

Question: Yi Chen - H.C. Wainwright - Analyst : Thank you for taking my questions. My first question is, could you comment on the test volume in the health system versus Mount Sinai? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 28, 2023 / 12:30PM, RENX.L - Full Year 2023 Renalytix PLC Earnings Call

Question: Yi Chen - H.C. Wainwright - Analyst : I mean, is there a specific reason, the VA health system is not generating high test volume?

Question: Yi Chen - H.C. Wainwright - Analyst : Okay. So going forward, do you expect a steady growth in test volume from quarter to quarter, or do you think there will be variations and fluctuations?

Question: Yi Chen - H.C. Wainwright - Analyst : Okay. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 28, 2023 / 12:30PM, RENX.L - Full Year 2023 Renalytix PLC Earnings Call