Renalytix PLC Q1 2022 Earnings Call Transcript

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

Question: Tycho Peterson - JP Morgan - Analyst : Good morning. First question, just on the sales ramp, so I know you hired Jed Fulk and I think his plan to hire 43 people to support him. Is that all dedicated to the VA? Can you talk a little bit about scaling up there and then just broader plans for the sales force?

Question: Tycho Peterson - JP Morgan - Analyst : And then LCD timing, I know you've previously said summer 2022. Any chance that the approval could accelerate that or any risks of push out? (Inaudible).

Question: Tycho Peterson - JP Morgan - Analyst : Okay. On the -- on the development roadmap, I know you've also talked about repeat testing for treatment response monitoring. How far out is that in your view?

Question: Tycho Peterson - JP Morgan - Analyst : Great. Last one from me. I know AstraZeneca revenues are still small, when does that start to become more material? And I guess similar question for DaVita, and I think you're launching in three markets this year. So, when do you start to recognize revenues from that?

Question: Tycho Peterson - JP Morgan - Analyst : Okay, thank you.

Question: Anita Dushyanth - Berenberg Capital - Analyst : Hi, good morning. Thanks for taking my questions. James, could you please share some of the trends that you're seeing in the (inaudible) KidneyIntelX from the (inaudible) up until now? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 07, 2021 / 1:30PM, RENX.L - Q1 2022 Renalytix PLC Earnings Call

Question: Anita Dushyanth - Berenberg Capital - Analyst : That was very helpful. And as a follow-up to that, I know you mentioned that you might have some publications coming maybe end of Q1 [or through] the calendar year next year. So would one of the topics be around what the outcome is with the support for population health versus from those without?

Question: Anita Dushyanth - Berenberg Capital - Analyst : Okay. Okay, great. Thanks for answering that. And then just one last thing about the number of patients that will be screened by second half next year, it's about 6,000 at Mount Sinai. So the run rate of about 300 patients per week, is that kind of a low end of what can be achieved?

Question: Anita Dushyanth - Berenberg Capital - Analyst : [Right].

Question: Anita Dushyanth - Berenberg Capital - Analyst : Great, thank you for that, James, very helpful.

Question: Dan Arias - Stifel Financial Corp. - Analyst : Yes, good morning. Thanks for taking the questions. James, on the 20 institutions that you're targeting for 2022, just a couple of clarifying points there. Number one, is that -- is that a goal for fiscal or calendar '22? And number two, by my tally that's 14 new partners that you think you can sign up in that period, is that right? And then what -- if it is right, what do you envision the makeup of that group being, just in terms of hospital systems, payers, pharmas, 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. DECEMBER 07, 2021 / 1:30PM, RENX.L - Q1 2022 Renalytix PLC Earnings Call

Question: Dan Arias - Stifel Financial Corp. - Analyst : Okay, just maybe one more clarification on top of that. Is the -- is the VA [counting] as one underneath that 20 institutions or are you considering multiple [VISNs] under the VA as part of the 20?

Question: Dan Arias - Stifel Financial Corp. - Analyst : Okay, so if you were to sign up for [VISNs] in 2022, then that would be four counting towards the [20 institution] goal that you're having -- that you have? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 07, 2021 / 1:30PM, RENX.L - Q1 2022 Renalytix PLC Earnings Call

Question: Dan Arias - Stifel Financial Corp. - Analyst : Okay, I'm sorry guys, I'm not trying to belabor a point, but what should the... Unidentified Company Representative (Inaudible).

Question: Dan Arias - Stifel Financial Corp. - Analyst : Okay, thanks very much. Unidentified Company Representative It's a good question. Unidentified Company Representative Thanks, Dan.

Question: Mark Massaro - BTIG - Analyst : Hey guys, thanks for the questions. I guess obviously the FDA has been busy reviewing COVID submissions. I do think one value-creating milestone for you would be to secure FDA approval. I guess can you just give us a sense for how that review process is going, whether or not the dialog is moving, iterative conversations going back and forth or has there been months' worth of not hearing anything? I'm just trying to better understand how that conversation is going and just try to handicap when you think comfortably do you think you can get FDA approval by the end of Fiscal Year '22? Unidentified Company Representative So [I am loathe to be] pinned down to FDA timing. Thank you, Mark, it's good to hear you on the call. This has been -- let me answer the question first, and then I'll give you my -- I'll give you some color. I won't give FDA timing as I've said from the beginning that's a fool's game and I've been that fool before, I don't want to be that fool again. The process is moving well. We believe we have a good application, we have a very good understanding, we have a significant amount of third-party expertise, which is at the table. Many of these folks don't take prisoners, they're very data-oriented, statistical-oriented. We've mentioned some of the -- some of the folks that have been involved, so I think we have one of the highest iterations and solid basis for an FDA-regulatory process that I've experienced in my career. That being said, I'm not going to comment on timing because I will inevitably be wrong. The agency, as you know more than anybody, has been under a considerable amount of stress and there's been consequence across the board for that. I talked to many other CEOs, all of whom are having similar experiences. But I -- I'm confident that we're on the right track and the communication with FDA has been very good and very comprehensive. So FDA will come when FDA will come. In the meantime, obviously we intend to build a very significant business, and obviously FDA is important. But if you ask me what the number one reimbursed -- number one risk factor associated with growth, it's reimbursement. And I've said this from the beginning when we started the company, we talked to the management team and I said, look, we got three things we have to worry about. We know how to -- we ultimately know how to do FDA, we know how to build a sales force, we know how to build a product, we know how to build a business; we've got to focus on reimbursement, reimbursement, and reimbursement, because if you don't get paid for your product, then you don't have a revenue stream, you can't access the capital markets to fund all of the other things that you need. So reimbursement has very much been a focus and we're succeeding there. FDA will help that. Do I expect and FDA [donoble] marketing authorization in this fiscal year? I do. That is my expectation. We are building for that component. But again, nobody can guarantee this, especially in the COVID era. How's that? Did I answer that question [well enough]?