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

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James McCullough: I think there are quite a few variables. So it becomes impossible to answer. We can get a long way with the cash that we have. The question is, do we end up for example, with a strategic partnership. What does the landscape look like after FDA assuming we get a positive decision? Are we now and investors should hold our feet to the fire, showing evidence that with comprehensive coverage we start to scale testing adoption. Do we have additional systems in the pipeline that are going to come online. And obviously, all of this comes in the context of controlling the cost basis. So there are a number of different levers, I think the most important thing is we are reaching a point where we’ve got three legs of the diagnostic stool, which are necessary to grow a significant revenue base, reimbursement, data, and regulation.

Once you mitigate those three, it becomes a sales and marketing exercise. And the sales and marketing exercise is either difficult, easy, or easier dependent upon the efficacy of your data, and the diversity and depth of your insurance coverage. And things I can point to which gives a lot of optimism for this model, going forward in terms of ultimately generating revenue, which reduces cash burn on a quarterly basis and frees up the capital markets to give us access to capital at lower cost is we have fabulous data. And we have clearly demonstrated that the original mission, before we spend a nickel when we started the company was reimbursement, reimbursement, reimbursement. And we’re validating that now in a way that I think is incredibly important.

It’s not just one coverage contract with one Medicare contractor. We are now demonstrating Blue Cross Blue Shield coverage, large for profit, large nonprofit, Medicare, Medicare Advantage. I’m trying to think of another diagnostic company example that has been able to generate the diversity of coverage and maintain hold the price that Medicare set back to an earlier question. So the answer to your question is, I am actually quite optimistic that in 2023 we cross the Rubicon. So we check off start to completely check off the box of data, real world evidence, which is now being published, diversity of insurance reimbursement and concentration in specific regions with high populations of diabetes and kidney disease like Chicago, Illinois, like New York, the Carolinas, where the vast majority of people will have some form of insurance coverage to KidneyIntelX.

And then of course, let’s see what goes on with FDA, it’d be nice to get it here in the short term, so now we check off the regulatory box. Now, it’s strictly a function of what type of sales force do we hire into those regions. And we prove in those specific regions that we can generate significant testing adoption against our established reimbursement coverage, then we can turn to Wall Street and say look, without spending gobs of cash to roll out nationally, we can say, here are three or four major markets, we have shown that we can get comprehensive reimbursement and we have shown that we can get testing adoption. We now want to go back to the capital markets at some point in the future, hopefully, when interest rates have leveled off, hopefully when the market has come out of its malaise.

And people can say, yeah, this is something that’s worth financing to grow out nationally, and then subsequently internationally, because it’s wide open. I don’t see us having any direct competition today. Because everybody wants to compete with us, it’s going to have to invest in a multi-year multicenter, very expensive program to generate real world evidence to show the thing works. And they’re going to have to go through a regulatory process and the reimbursement process, there are no shortcuts. So the answer your question is we’ve got the cash to be able to prove that model in specific, large population, key major markets like Chicago, New York, and the Carolinas, and we’re probably going to add one other. And that doesn’t have to break the bank to do that.

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