Renalytix Plc (NASDAQ:RNLX) Q2 2023 Earnings Call Transcript

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Thomas McLain: Thanks, James. On the reimbursement side, we’ve achieved payment with Medicare under the individual claim review process, which is a nationwide coverage. We also have a contract with the Federal Government under the General Services Administration. Beyond that we’ve executed 37 private payer contracts, we provide that information on our website. You will see that we’ve concentrated those efforts in markets that are significant for near-term growth of KidneyIntelX revenues, markets like what we’ve discussed today, New York City and New York State, Illinois and in the Carolinas. In addition to that we’ve established payment with 26 other payers that are important to those regions and we’re at a point now where we are positioned for that type of super majority payment, where we’re looking to drive revenues for KidneyIntelX at a large scale.

Unidentified Analyst : Awesome, thanks for taking the questions.

James McCullough: Thank you.

Operator: . The next question comes from Jens Lindqvist with Investec. Your line is now open.

Jens Lindqvist: Hi guys, couple of questions for me. First of all, there’s a growing body of evidence relating to predictive genetics and CKD. I mean, including but not exclusively, Apple 1 . How are you looking at that, is that is that a potential threat to KidneyIntelX, would you like to at some point incorporate that or combine it with a test in its current form? That’s my first question. The second question is on the prime CKD initiative in Europe, what you’re expecting from that in terms of a commercial outcome, and also how you look at the opportunity in Europe more generally, because it would seem to me like KidneyIntelX will be quite well positioned for uptake in the sort of more integrated European healthcare systems? Thank you.

James McCullough: Yes, thank you. Jens we’ll bring Fergus in on this discussion. Just quickly, KidneyIntelX is an expandable platform, it was designed that way. So we can add biomarkers, we can add genetic components, we can add patient record features, all of which ultimately move into this precision medicine equation, which was subtyping disease to specific groups. So it is a powerful design. And with a regulatory platform and a reimbursement platform, what we’re establishing now is the ability to roll additional versions or additional enhancements of KidneyIntelX into an established reimbursement regulatory pathway. So again there’s a lot of intrinsic value associated with moving KidneyIntelX forward in the regulatory and reimbursement framework, which I think is absolutely necessary if you’re going to get standardized, broad scale adoption, so that any physician can use it.

There are a lot of folks who are creating homebrew tests or algorithms. The challenge for all of them is how do you get somebody else to use it outside of the immediate purview of the person who’s creating it? Well, you have to regulate it and you got to get paid for it, which is a very expensive, time consuming process, which puts KidneyIntelX in a class of its own. And we expect to move forward with different versions of KidneyIntelX as we move along. So no, I don’t see any competitive threat at the moment. And I don’t see one in the foreseeable future, because it does take so much time and money to generate the evidence, the validation to get through the regulatory, and the very complex reimbursement pathway that we’re now validating. So those are significant competitive barriers to entry.

And we continue to have expansive relationships with different groups to be able to examine other features that we can add to improve KidneyIntelX or create new versions. But Fergus, please, please step in.

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