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

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Thomas McLain: If I could reiterate on the Medicare price, our Medicare price for our test code is set on CMS clinical lab fee schedule, that’s a public process national process. And there is a period that CMS has specified for reconsideration of that price. And we are in a cycle where the earliest that the $950 price would be reconsidered, would be for the year beginning January 1, 2026. So that price is locked in until then, for our reimbursement code. And certain contracts that we execute are set at a premium to Medicare price. So that is what leads to pricing above the $950 price for certain contracts.

Unidentified Analyst : Okay, perfect, thank you. And then could you just provide an update on the number of private payers that you’re in contract with and if you could potentially share the number of covered lives as well? And then just a follow up to that, I think you’ve also talked about peer review or real world evidence moving the needle for payers. So can you just update us on any timing we should expect there on real world evidence publication? Thanks.

O. James Sterling: Sure and I’ll answer the one on real world evidence. This has an enormous intrinsic value for Renalytix and when we started the company again, we took a look at what would it take to get national comprehensive reimbursement and at the top of the list was data generation. And there are no shortcuts here in terms of costs and in terms of time. So from the very beginning of the company we started to invest heavily in generating the type of real world evidence that would be convincing to clinicians, payers, regulators, everybody that’s required that KidneyIntelX was in fact validated and it works in the wild, particularly at the primary care level, which is our focus market. So it became critical for us to demonstrate that KidneyIntelX in the hands of primary care physicians, generalist physicians made a difference.

And we are now demonstrating that and we’re demonstrating that at scale. That real world evidence program is just getting started in terms of pumping out results. As we move along in 2023, we are adding large institutions, academic medical institutions that are looking at KidneyIntelX, we’re also expanding the breadth of that real world evidence to look at specific issues like health equity and diverse populations. So this is a substantial body of work that we will keep giving. We’ve just started to publish the results and again, what I mentioned in my prepared remarks is we’ve been very pleasantly surprised by the observational impacts on HBA1C and UACR, the two critical measurements for diabetes and kidney health that we didn’t expect to see so soon.

The fact that we’re observing these changes inside of a 12-month period, is quite remarkable. I don’t think that that’s ever been demonstrated before. And so KidneyIntelX is working, it’s working very well, that has direct impacts on health economics, meaning, how much money does it save if you deploy KidneyIntelX across primary care, which is a critical equation for insurance reimbursement. So all of this is interconnected and we are now demonstrating that that real world evidence data is having an impact on our ability to get coverage. So the real world evidence is very important. We have just processed a 12-month time period in our Mount Sinai Health System real world evidence program. We will be releasing those results and putting them into circulation through conference publications and peer reviewed publications, starting as early as this summer.

And that, again, is an ongoing program we expect to release results every six months off of the real world evidence. So that investment has been very worthwhile. And Tom, I’ll turn it over to you on the reimbursement question.

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