Renalytix Plc

Good day and thank you for standing by. Welcome to the Rinalytics AI third quarter fiscal 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Carrie Mendeville. Please go ahead.

Thank you. Joining me today from Renalytics are James McCullough, Co-Founder and Chief Executive Officer, Tom McLean, President, 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 in the meaning of 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 italics' ability to lower health care costs, improve patient quality of life, and set a long-term standard of care. Trends in our market and potential benefits as 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 a description of the risks and uncertainties associated with our business, please refer to the risk factors section for our annual report on Form 20-F filed with the Securities and Exchange Commission on October 28, 2020. All forward-looking statements made on this call are based on management's current estimates and various assumptions. Reanalytics AI disclaims any intention or obligation, except as required by law, to update or revise any 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, June 16th, 2021. And with that, I'll turn the call over to James.

Thank you, Carrie. Good morning and good afternoon, and thank you all for joining for the third quarter fiscal 2021 results and our update on business progress. The opportunity for Renalytics and our shareholders continues to materialize as we cross additional key milestones in reimbursement, regulation, real-world evidence, and major distribution for our lead program, Kidney Intellects. In the past few months, we have announced a partnership with the University of Utah Health System to enable more than 1,700 clinicians to get EHR integrated kidney and telex access in the Southwest. We've announced a partnership with Atrium Health, Wake Forest Baptist Health that can provide kidney and telex access for care teams in 37 hospitals in more than 1,350 care locations in the Southeast. We've also received a 10-year contract from the U.S. General Services Administration for kidney and telex testing services, which applies to more than 140 U.S. government departments, including the important U.S. Veterans Administration. We published peer-reviewed data demonstrating performance in kidney and telex in a cohort of 1,146 type 2 diabetes patients with early-stage kidney disease risk. We've crossed the 40% threshold for contracted state Medicaid programs with 21 states now completed. And we've continued progress with private insurance coverage, including a June coverage determination for Kidney Intellex by one of New York State's largest not-for-profit insurance companies with over 1.5 million members. We expect the pace of milestone events to continue into the first half of fiscal 2022, beginning in this July, including a potential FDA clearance, additional major health system partnership announcements, beginning operations in the VA medical system, increasing our portfolio of real-world evidence data, particularly at the all-important primary care level, a potential national Medicare coverage determination, and an acceleration in kidney and telex testing volumes. With the recent Atrium-Wake Forest partnership and the new potential to onboard from 1,293 healthcare facilities in the Veterans Administration Medical System, we remain confident in our previous guidance of five to seven announced major health system partnerships in calendar 2021. Shortly, Tom McLean will detail our progress with reimbursement and plans for scaling operations on a region by region basis with our cornerstone health system partnerships and now the complementary opportunity provided by the General Services Administration contract. On to our regulatory partnership and operations progress. The Food and Drug Administration has reinitiated review of the Kidney Intellect's final submission under breakthrough device ahead of their previously targeted April 15th deadline following a sector-wide COVID delay. Our regulatory review team and outside advisors will continue to diligently respond to any remaining FDA questions until the conclusion of the breakthrough review. While we can make no guarantees on timing or outcome, we are gearing our internal plans based on an assumption that the FDA process will be complete in the second half of this 2021 calendar year. As we have discussed previously, clearance from FDA breakthrough device designation will set Kidney Intellex up for an immediate national Medicare coverage determination at $950 per reportable result under the Medicare coverage for innovative technology rule, also known as MSIT. MSIT is now scheduled for final implementation on December 15th of this year. As Medicare and Medicare Advantage cover a majority of the diabetic kidney disease patients in the United States, FDA clearance and Medicare coverage would have a material positive impact on our business. To the potential for a covered Medicare population this year, we can now add a significant and wholly accretive population of diabetic kidney disease patients covered under the recently announced General Services Administration 10-year government-wide contract for kidney and telex testing. This payment contract was stated pricing of $950 per reportable result. It covers kidney and telex testing in the U.S. Veterans Administration, Department of Defense branches, including Army, Navy, Air Force, and Marines, and the Indian Health Services. Notably, our GSA contract is structured as an indefinite delivery, indefinite quantity, or IDIQ contract, providing for an unlimited quantity of services over the contract term. The GSA contract is a major win for renalytics and for patients with diabetic kidney disease under government physician care. and carries important strategic implications this year that Tom will discuss shortly. As we have stated since inception, we view insurance reimbursement as one of the biggest hurdles to our long-term growth. Achieving a government-wide payment contract, which mirrors our national Medicare pricing, represents a significant de-risking of our business model and will require us to accelerate build out of sales, customer service, education, and other supporting components for initiation of a 2020 rollout in select VA hospital systems. From a strategic view, the VA hospital provides kidney intellects with a perfect complement distribution channel to our three cornerstone integrated disease network partnerships, Mount Sinai University of Utah and Atrium Lake Forest. All of the health systems have significant diabetic kidney disease populations and share treating physicians with their nearby VA hospital facilities. At Mount Sinai, we now have approximately 120 physicians from primary care to specialist nephrology who have been onboarded to EHR integrated kidney and tele-X score ordering and reporting. By the end of this calendar year 2021, we expect to have onboarded an additional 500 physicians and will continue to expand customer service sales and medical science liaison personnel to support system-wide care. We are now recognizing revenue from testing at Mount Sinai and expect this revenue will grow in the second half of this calendar year, 2021, as more physicians are onboarded and COVID-related restrictions recede. Most importantly, as the real-world evidence continues to mount, our Kidney Intellex integrated care model approach with Mount Sinai is providing us with invaluable insights. The Mount Sinai Partnership is doing exactly what we thought it would when we designed the launch back in 2018. As a result, we are now able to move into a national launch phase with solid evidence as to what works and what doesn't to maintain kidney health on both an individual and a population health basis. Our announcement last month with Atrium Wake Forest for advancement of kidney disease, excuse me, kidney health, creates an anchor partnership in the Southeast region of the United States, also referred to as the Diabetes Belt. Atrium Wake Forest presents us with a major opportunity to integrate the Kidney IntellX care model with a fully developed population health program, supporting primary care, endocrinology, nephrology, and care teams serving patients in 1,350 care locations. At the core of the partnership is the ability to generate data that will be critical to optimizing care and improving outcomes using kidney protective medications, specialist referrals, and lifestyle changes. Mount Sinai, University of Utah, Atrium, Wake Forest, and soon to be the VA Health System will provide a powerful and deep real-world evidence generation program that crosses demographics, treatment regimes, and racial barriers. This evidence will build upon a growing body of recently published peer-reviewed evidence that supports the Kidney Intellect's care model's role in maintaining kidney health and slowing the advancement of kidney disease beginning at the primary care physician's office. As we have stated previously, our goal for the remainder of this year is to establish as broad a distribution channel as possible for the Kidney Intellect solution through both EHR integrated implementations and through our independent online secure ordering portal for those physician practices where Kidney Intel X is unavailable on an EHR integrated basis. Ultimately, we are building towards a footprint where any primary care or specialty physician in the United States is able to access easily the Kidney Intel X risk assessment and care support. We just signed an agreement with Quest Diagnostics Exam 1 which will now allow any patient to receive an at-home blood draw for their Kidney IntellX assessment in all 50 states. We believe firmly that broad, open access to Kidney IntellX early-stage risk assessment is key to stemming the kidney disease epidemic and maintaining population kidney health. Finally, we are now processing billable Kidney IntellX patient samples in both our Salt Lake City and New York City laboratory facilities. Our Salt Lake City laboratory should receive full CLIA certification in July of this year, at which time we believe we will have processing capacity in excess of any forecasted need through fiscal 2022. With that, I would like to turn the call over to our President, Tom McLean, to provide additional detail on reimbursement and commercial strategy. Tom?