Renalytix Plc

Good morning and welcome to the Renalytics conference call to review fourth quarter results for fiscal year 2021. At this time, all participants are in a listen-only mode. We will be facilitating a question and answer session towards 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, Mary, and thank you all for participating in today's call. Joining me today from Rentalytics are James McCullough, Chief Executive Officer, Tom McClain, President, and James Sterling, Chief Financial Officer. Before we begin, I'd like to remind you that management will make remarks 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, statements related to Kidney Intellect's ability to lower healthcare costs, improve patient quality of life, and set long-term standard of care, trends in our market and potential benefits of government policy change, the impact of COVID-19 on our business, our expectations for hiring, product development, strategic partnerships, and collaborations, reimbursement decisions, clinical studies, and regulatory submissions, and our business strategies and future growth. These statements involve material risks and uncertainties that could cause actual results or events that materially differ 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 today, October 21, 2021, with the Securities Exchange Commission. All forward-looking statements made on this call are based on management's current estimates and various assumptions. RENEL X 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 21, 2021. And with that, I'll turn the call over to James McCullough.

Thank you, Peter. Good morning and good afternoon, everyone. Over the past year, we have continued a methodical execution of the fundamentals for the Renalytics Care Model, which was designed to change outcomes, costs, and patient quality of life in chronic kidney disease. We believe the next six to 12 months will be event-filled with new hospital system partnerships, broad real-world evidence development and publications, expanded private and public reimbursement coverage, an FDA de novo marketing authorization for Kidney IntellX, growing pharmaceutical partnership activities, and the build-out of our direct sales, marketing, and customer service capability. We expect revenue growth this fiscal year from three main areas. Our announced scale up of Kidney IntellX testing in the Mount Sinai Health System, initiation of the Kidney IntellX program across the Veterans Administration Health System, and expanding pharmaceutical partnership related activity. Our Kidney IntellX EHR integration with Atrium Wake Forest is expected to go live this current quarter. The universe of Kidney IntellX insurance coverage has increased to 20 private commercial contracts and we are pleased to announce today now includes our first Blue Cross Blue Shield coverage contract and a coverage contract from a major New York State insurance provider. We have also continued to build on our Medicaid strategy with 27 approved state provider contracts. For the kidney space, the stakes have never been higher. With close to 40 million Americans who have existing kidney disease, Most, fortunately, are in the early stages where advanced risk assessment and active treatment can have the greatest impact on maintaining health and limiting social costs. Globally, the number of people living with kidney disease is estimated to exceed 850 million. This is a massive challenge that needs to be addressed assertively with education, early detection, prognosis, proactive treatment, all beginning right at the primary care physician level. The unsustainable health economics here are readily apparent. Kidney disease-related illness consumes more than 20% or $120 billion annually of the U.S. Medicare budget. For our U.S. veterans, the Veterans Administration Health System spends an estimated $19 billion annually for non-dialysis kidney disease alone. Rapid growth in diabetes and obesity continue to fuel kidney function impairment across the global population. One in five Americans with kidney disease will suffer life-threatening complications in their lifetimes. with many progressing unchecked until an emergency room visit. The very good news here is the cost of preventable suffering has ignited a new era of accelerated drug and medical device innovation across the kidney spectrum. Recent government policy shifts have underscored the importance of early prevention to maintain kidney health and have started the migration from late-stage disease management. These policy changes and the growing awareness in the clinical and patient community have provided significant tailwinds for our Kidney and Telex Early Risk Assessment and Care Management Program. These converging economic regulatory reimbursement and clinical dynamics have created the most opportunistic environment we have experienced in our collective diagnostic careers. And we believe that will provide lasting benefits for patients, doctors, and investors alike. We believe the solution to kidney disease epidemic ultimately lies in the accurate risk assessment of large populations with early-stage kidney disease, closely matched with corrective clinical actions that can be implemented by the estimated 210,000 practicing primary care physicians in the United States. To be effective, this clinical action must be guided by a patient's current biology, as measured by active blood biomarkers. Kidney Intellex currently uses three well-established blood biomarkers for kidney status predictions. The preventable solution also needs to be deployed with physician education, advanced population health strategies, and a dedication to continuous real-world evidence development. This, in a nutshell, is our Kidney and Pelex care model. In this current half year, 2021, Renalytics is building on a national commercial launch strategy for Kidney and Pelex. In less than 36 months from our first funding, The Kidney IntellX program is now scaling system-wide in the Mount Sinai Health System, which is currently caring for an estimated 250,000 patients with chronic kidney disease. We have been granted a 10-year U.S. General Services Administration agreement, allowing us to initiate a comprehensive sales program into the VA Health System, which is currently caring for a chronic kidney disease population that could exceed 2 million individuals. Additional program implementations are underway at the University of Utah in the southwest region and Atrium Wake Forest in the southeast that we expect to begin live testing this quarter. We expect Kidney Intellex will achieve payment by Medicare at the set national Medicare rate of $950 per reportable result by the summer of 2022. With GSA, Medicare, and other private and government reimbursement, we expect Kidney Intellex insured covered lives will exceed 10 million people with diabetic kidney disease in the United States. We are working on expanding the Kidney Intellex product capabilities to support a breadth of precision medicine diagnostic, therapeutic, and monitoring strategies, further expanding the potential eligible and insured market size for testing. On now to two key operational areas, our Mount Sinai health system implementation and the VA health system launch that we've just announced. Both market categories will drive revenue for this fiscal year and growing in the fiscal 2022. One of the remarkable value points to our hospital system implementations is engagement with population health, which brings the capability to coordinate care services across broad groups of treating physicians. With Mount Sinai, early success has triggered a system-wide scale-up with a target testing run rate of 300 patients per week in the near term. Mount Sinai expects to complete approximately 6,000 patients tested around the second calendar quarter of 2022, which will result in an important large real-world evidence demonstration. All testing conducted is set at the National Medicare and General Services Administration price of $950 per reportable result. To support this scale-up, we are deploying newly hired renalytic sales, customer service, and medical science liaison personnel around Mount Sinai, and other healthcare institutions we expect will bring the Kidney Intellect Solution Program online in coming months. We believe the real world evidence emerging from Mt. Sinai is validating our business model that integrating with Kidney IntellX within a population health management system can drive meaningful change in care for early stage kidney disease patients. This Kidney IntellX Pop Health care model is also demonstrating a capital efficient means to drive revenue growth by reaching regional bases of primary care physicians and at-risk patients quickly with a consistent, actionable message. I'd like to turn the conversation now to our president, Tom McClain, who will detail our launch into the Veterans Administration health system currently underway. Tom? Thank you, James.