Renalytix Plc

Good morning and welcome to the Renalytics conference call to review fourth quarter and full year fiscal 2022 financial results. At this time, all participants are in listen-only mode. We will be facilitating a question and answer session toward the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Peter DiNardo of Capcom Partners for a few introductory comments.

Thank you, Michelle, and thank you all for participating in today's call. Joining me today from Rinalytics are James McCullough, Chief Executive Officer, Tom McClain, President, Michael Donovan, Chief Medical Officer, and James Sterling, Chief Financial Officer. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. Examples of these statements include, without limitation, the potential benefits, including economic savings, of kidney intellects, the potential for kidney intellects to receive regulatory approval from the FDA, the commercial prospects of kidney intellect if approved, including whether kidney intellects will be successfully adopted by physicians and distributed and marketed, our expectations regarding reimbursement decisions, and the ability of kidney intellects to curtail costs of chronic and end-stage kidney disease, optimize care delivery, and improve patient outcomes. Trends in our market and potential benefits of government policy change, the impact of COVID-19, and other world events on our business, our expectations for hiring, product development, strategic partnerships and collaborations, reimbursement decisions, clinical studies, and regulatory submissions, our business strategies and future growth, including plans, expectations, and opportunities for financing operations and revenue projections and guidance. These statements involve material risks and uncertainties that could cause actual results or events to material differently from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a description of the risks and uncertainties associated with our business, please refer to the risk factors section of our annual report on Form 20F that was filed on October 21, 2021, with the Securities and Exchange Commission. All forward-looking statements made on this call are based on management's current estimates and various assumptions. Renalytics disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, October 31, 2022. And with that, I'll turn the call over to James McCullough. James? Thank you, Peter.

Good morning and good afternoon. From our first funding in November of 2018, Renalytics was built to generate extensive data evidence and comprehensive reimbursement for early risk assessment in kidney disease with our advanced prognostic tool, Kidney IntellX. In both of these categories, we have had significant wins, which are widening the opportunity to grow market share and drive real change in patient care. We have now expanded Blue Cross Blue Shield coverage to our third state, And as was in our SDC filing last week, kidney and telex billings are now being paid by the Medicare system. Medicare in the United States covers approximately 64 million beneficiaries. Tom McClain will speak in detail about payment and insurance shortly. We are reaching a tipping point where in certain population centers with a large prevalence of diabetes and kidney disease, a super majority or greater than 70% of individuals will have some form of insurance payment for kidney and telex testing. Supermajority coverage is a critical feature for kidney and telex implementation at the front end, primary care level of medicine. To put the sheer size of this health problem in opportunity and perspective, some 40 million Americans are estimated to have existing kidney disease today. Over half of the adults with diabetes will develop kidney disease. Costs here pile up quickly. An October report in the Journal of American Medical Association citing Medicare dialysis costs at over 80,000 in their first year alone on dialysis, while privately insured patients are costing close to $200,000 in their first year alone. This is simply unsustainable. And unfortunately, a large portion of individuals suffering from this preventable course of kidney failure are from economically disadvantaged groups. kidney disease has become a raging center of health inequity in the United States with disastrous consequences for communities. Our chief medical officer, Michael Donovan, will summarize data now being published, which shows doctors using Kidney IntellX are much more likely to prescribe new medicines early, conduct timely referrals to specialists, and initiate important blood pressure controls to prevent their patients from suffering the consequences of progressive kidney disease and dialysis. In this quarter alone, Four new presentations are being given next week at the American Society of Nephrology Kidney Event Week, and one of our real-world evidence programs on 1,658 patients has just been accepted for publication, showing positive changes in patient management and outcomes. In the period ended to September 30th, we posted our first million-dollar quarter. For the month of September alone, we recorded a record 527 kidney and telex patient reports issued. And while month to month results will continue to vary, we are encouraged to see testing volume beginning to emerge from disparate sources, including individual physician groups located in different states where insurance payment has now been established. We continue to have productive discussions with FDA under our breakthrough device review. We have been fortunate to use this past year to recently submit additional data on over 1,000 patients that further confirms the performance of kidney Intellix and risk discrimination for patients with diabetic kidney disease. We now believe we are approaching the completion of the de novo regulatory process. And while there is no guarantee of success until FDA has made its final determination, we are optimistic based on both the quality of the analytical and the clinical evidence provided, and the high level of engagement we have had with FDA. Our current expectations are for a decision to be made in the first quarter of calendar 2023, ending March, but there can be no guarantee on this timeframe. Also, as clarity builds for kidney and telex insurance, we have been able to reduce our cash burn by focusing on regional markets with developing supermajority payments. We have also reduced third-party vendor contracts, made selective headcount reductions, and slowed our rate of hospital integrations. If our business progress continues as expected, we could very well be in a position in the coming quarter or two where we have mitigated risks for insurance payment, regulatory approvals, and utility validation of kidney and telex. And while it's been nothing short of a roller coaster getting here with market conditions, we cannot forget that Renalytics is achieving its major milestones and objectives in a very short period of time, four years from our founding financing round in November of 2018, and just over a year from our commercial product launch. I will now turn the call over to our president, Tom McLean, who will detail progress with insurance and commercial rollout. Tom? Thank you, James.