Renalytix Plc

Good morning and welcome to the Rinalytics conference call to review third quarter fiscal year 2023 financial results. At this time, all participants are now listen-only mode. We will be facilitating a question and answer session toward the end of today's call. And 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. Sir, please go ahead.

Thank you, Chris. Thank you all for participating in today's call. Joining me today from Reno Linux to provide formal remarks are James McCullough, Chief Executive Officer, Tom McLean, President, and Jane 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 clearance from the FDA, the commercial prospects of kidney intellects, including whether kidney intellects will be successfully adopted by physicians and distributed and marketed, our expectations regarding reimbursement decisions, and the ability of kidney intellect to curtail costs of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes, spends in our market, 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, are business strategies and future growth, including plans, expectations, and opportunities for financing or operations, and revenue projections and guidance. These statements involve material risks and uncertainties that could cause actual results or events materially different 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 sections of our annual report of Form 20F that was filed on October 31, 2022, 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. It's accurate only as of the live broadcast today, June 9th, 2023. I'll now turn the call over to James McCullough. James?

Thank you, Peter, and good morning. As we close our fiscal year 2023, we are approaching what will be a simple and powerful message to primary care providers across the country for our lead product, Kidney IntellX. One, we accept all insurance. Two, patient outcomes improve when you use it, and three, as anticipated, kidney IntellX is FDA approved. Completing these three pillars would assure kidney IntellX will be accessible across all of primary care and will have achieved a distinct product proposition in a largely untapped market that could benefit millions of Americans with diabetes and kidney disease. And in anticipation of securing this diagnostic trifecta, We are moving to advance the Kidney Intellex commercial footprint to win adoption across large groups of primary care providers who are helping patients with diabetes and kidney disease. Our expanding real-world evidence proves these patients can get better and more equal access to the care they need through the healthcare systems, in independent practice offices, and through government institutions. Kidney Intellex is a unique medical device that combines blood-based biomarkers with key features in the patient's electronic medical record all processed by an artificial intelligence-enabled multimodal algorithm. Our goal has been to create a safe and clinically validated artificial intelligence-enabled prognostic test result that can be easily used by a primary care provider to better understand a patient's risk of developing kidney failure at a very early stage. This is important because it is at the early stages when therapy specialist involvement and behavior modifications can have the greatest effect to keep people healthy and productive. We believe Kidney IntellX is exhibit A as to how artificial intelligence using clinical and biological data can be harnessed in a clinical product capable of being regulated by FDA, reimbursed by insurance, including Medicare, and subject to rigorous real-world evidence validation. Kidney IntellX also provides us with a blueprint for future product development that uses important biomarkers, electronic data features, and powerful algorithms to create the best performing, safest, and ethically responsible medical devices. With broad insurance reimbursement, definitive outcomes data, and an FDA regulatory pathway in sight, our commercial strategy is clear. We are focusing on regions of the United States where there are large populations of individuals with diabetes and kidney disease, and where insurance reimbursement for kidney and telex is fast approaching a super majority status. Our regional focus for the remainder of calendar 2023 is in Illinois, Illinois, New York, North Carolina and South Carolina, Texas and Florida. As of this quarter in Chicago, Illinois and the New York Metro area, our estimated insurance payment for kidney and telex from a combination of groups like Medicare, Medicaid, and private payers have already exceeded 90% of the Kidney IntellX eligible testing population. During the third quarter, we secured insurance coverage with Emblem Health, covering over 3 million lives in New York and Connecticut, and more recently with CareFirst Blue Cross Blue Shield, which is the largest healthcare plan in the U.S. Mid-Atlantic region. In total, CareFirst serves 3.4 million members in Maryland, Washington, D. C. and Northern Virginia, as well as the federal employee program administered by care. 1st. This agreement compliments Blue Cross Blue Shield contracts already secured with Wellmark Blue Cross Blue Shield in Iowa, South Dakota. With an estimated 2Million covered lives and Blue Cross Blue Shield of Illinois with an estimated 8Million covered lives. Our recent coverage contract wins with leading insurance groups are reinforcing our approach to developing strong data evidence. defining the health economics consequences of uncontrolled kidney disease, and validating kidney IntellX in real-world use. We expect this momentum with insurance contracts to accelerate with an anticipated successful conclusion with FDA. To expand our commercial footprint, we announced in May the selection of Eversano, a global leader in life science commercialization services. Eversana will launch its field deployment and training solutions with renalytics to cost-effectively build awareness across key parts of the United States beginning this summer. This Eversana renalytics model is expected to accelerate the adoption of kidney Intellix. Our president, Tom McLean, will discuss this in more detail shortly. As we signaled last quarter, we completed the milestone of transitioning to long-term commercial insurance payments for patients tested at the Mount Sinai Health Systems. During this transition, there was a short-term adverse impact on testing volumes. Importantly, Mount Sinai has this month issued a population health update to all physicians to include the kidney IntellX testing in the diabetes kidney disease care pathway based on their newly published kidney IntellX utility evidence. We expect additional health systems will likely do the same given the important positive results from the growing body of positive real-world evidence. Two recent studies presented at the National Kidney Foundation Spring Clinical Conference illustrate the following. First, Atrium Health System demonstrated kidney IntellX testing accurately assesses the higher risk for progression of chronic kidney disease in black patients versus other races. This is an important precursor in addressing healthcare access inequalities within this patient population. Notably, with an atrium, a kidney and telex test result led to increased prescription of SGLT2 inhibitor drug therapy to provide improved care for black patients. Second, researchers from the University of Illinois Chicago and the University of Utah presented a contemporary analysis of type 2 diabetes and kidney disease in the Veterans Health Administration population. The higher incidences and poor outcomes in the veteran population versus the U.S. population at large demonstrated the need for risk assessment in early-stage kidney disease as recommended by the VA's care directive titled Chronic Kidney Disease Prevention, Early Recognition, and Management. Please look for significant new real-world evidence data to be released at the American Diabetes Association 83rd scientific sessions from June 23rd to June 26th this month. I will now turn over to Tom McClain, our president, to discuss additional aspects of our commercial progress. Tom?