Renalytix Plc

Good morning, and welcome to Renalik's conference call to review second quarter and first half fiscal year 2022 results conference call. At this time, all participants are in a listen-only mode. We'll be facilitating the question and answer session towards the end of the 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 moments.

Thank you, Norma, and thank you all for participating in today's call. Joining me today for Renalytics are James McCullough, Chief Executive Officer, Tom McLean, President, Fergus Fleming, Chief Technology 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, Predictions of future events, results, or performance are forward-looking statements. Examples of these statements include, without limitation, statements related to Kidney Intel X's ability to lower healthcare costs, improve patient quality of life, and set a 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 to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For description of the risks and uncertainties associated with our business, please refer to the risk factors section of our annual report on Form 20F, and 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 is accurate only as of the live broadcast today, March 31st, 2022. And with that, I'll turn the call over to James Okola.

James? Thank you, Peter. Good morning and good afternoon. We are pleased to report quarter-over-quarter growth with Kidney Intellect's testing volume within a backdrop of increasing insurance coverage and new health systems coming online. In our New York launch market, Kidney Intellect's utilization has continued to accelerate through the end of March. I am pleased to report we have now provided integrated advanced risk assessment testing for more than 2,600 patients with kidney disease and diabetes. Physician response has been overwhelmingly positive. Over the past six months, Kidney IntellX clinical testing has now been brought online with the Veterans Health Administration through our Albany, New York physician-led payer partnership and at Atrium Health and Wake Forest Baptist Health in the Southeast region of the United States. We now estimate our current Kidney Intel X serviceable insured population at greater than 1 million patients. There are now currently an estimated 180 primary care physician outside of the Veterans Administration health system using Kidney Intel X today, a number we plan to grow significantly through the remainder of the calendar year. The combination of partnered hospital distribution, the Veterans Health Administration launch, and increasing visibility on Broad insurance payment provides the fundamentals necessary to drive kidney and telex volume growth in 2022, 2023, and 2024. Our focus remains delivering on major milestone catalysts, including quarterly revenue growth, expanded insurance payment, including Medicare and Medicare Advantage, strategic partnerships to expand distribution capability, and regulatory approvals. Demand for our recently closed financing was strong, particularly from investors who have known the company for several years. We were fortunate to have multiple terms from several parties from which to choose, and we believe this illustrates investor views on the strengths of the intrinsic value proposition for Renalytics in solving such a large unmet medical need. We expect Ellucian Impact will be limited to high single digits against creating a two-year runway on which to execute our objectives. Particularly if one or more of our ongoing advanced strategic partnerships discussions comes to fruition in calendar 2022, we are increasingly comfortable with the potential for driving fiscal 2023 expectations for top line revenue. We will continue to manage costs diligently and conduct periodic strategic reviews of resource allocation to optimize our growth. As discussed on previous calls, we believe insurance payment remains the single biggest factor for driving kidney and telex adoption. Over the past year, we have consistently demonstrated that we can secure payment for kidney and telex from a diverse set of insurance programs. To date, we have received 22 private insurance coverage contracts and contracted with 31 state Medicaid programs. We have secured a 10-year federal government contract covering among others, a $950 payment for patient testing in the Veterans Health Administration system. Medicare and CMS has also established a national pricing of $950 per reportable result for Kidney IntellX. This successful pace of securing insurance payment and pricing for Kidney IntellX has exceeded what is typical for the first year of launch for a laboratory-developed test. We expect this aggressive pace to continue with our stated goal of achieving greater than 10 million patients under various forms of insurance payment for Kidney IntellX in calendar 2022. Our primary distribution model was founded on partnering with health systems to reach large physician practice groups, particularly primary care physicians. With the addition of the Veterans Health Administration, we expect to meet or exceed our previously stated goal of 20 health centers running Kidney IntellX by the end of calendar 2022. We also expect additional health systems to be brought up online in the June quarter, including recently announced St. Joseph Health in Central New York State. To discuss our commercial progress further, I will now turn over to Tom McLean. Tom. Thank you, James.