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Renalytix Reports Full Year Fiscal 2022 Results

November 1, 2022

LONDON and SALT LAKE CITY, Oct. 31, 2022 (GLOBE NEWSWIRE) — Renalytix plc (NASDAQ: RNLX), (LSE: RENX) an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, announces its full year results for the twelve months ended 30 June 2022. Download PDF

Highlights (includes post-period events):

Regulatory & Reimbursement

  • New commercial coverage in fiscal year 2022; 28 private insurance and network provider contracts now executed to date including:
    • Largest private payer in Illinois with 8.1 million members
    • Largest independent provider network in the tristate North Carolina, South Carolina and Virginia area, with over 100,000 health care providers in-network
  • Achieved Medicare payment for KidneyIntelX through the individual claims review (ICR) process based on our Medicare clinical lab fee schedule (CLFS) pricing of $950 per test
  • 33 state Medicaid programs contracted to date
  • Continued data generation and analysis reinforcing the benefits of KidneyIntelX as part of collaborative De Novo process with the FDA, with anticipation that the agency’s review is nearing completion. Data supports significant breakthrough in risk stratification for patients with diabetic kidney disease

Commercial & Partnerships

  • Sales and medical affairs support buildout across core, strategically-focused market channels:
    • Deployed sales directors and representatives targeting large hospital systems, provider networks and independent primary care physicians, and veterans’ hospitals
    • Added VP of Medical Affairs to support KidneyIntelX physician onboarding, education, and test ordering
    • Deployed market access and health systems partnership personnel to drive expansion
    • Developed comprehensive physician and patient marketing and education material
  • Launch of myIntelX provider access portal for simplified, decentralized on-line ordering of KidneyIntelX
  • Partnered with Singing River Health System to deploy KidneyIntelX informed care management to improve kidney health in individuals across the Mississippi Gulf Coast with type 2 diabetes and early-stage chronic kidney disease
  • Partnered with St. Joseph’s Health, based in Syracuse, NY and part of the Trinity Health System, for KidneyIntelX deployment and to advance value-based care
  • Progressed through layers of vendor approval at several VA hospitals as part of nationwide 10-year payment contract from the U.S. General Services Administration (GSA), with initial test orders and pre-payments received
  • Joint program with American Diabetes Association® to improve overall kidney health in patients with type 2 diabetes in the United States
  • Kidney disease education programs in partnership with the National Kidney Foundation
  • Continued KidneyIntelX testing volume growth
  • Growth in number of active physicians ordering KidneyIntelX

Clinical & Validation

  • Published data in the American Journal of Nephrology in which KidneyIntelX successfully monitored patient response to new drug therapy in 1,325 multinational clinical trial cohort patients
  • KidneyIntelX showed ability to assess risk of heart failure hospitalization and death in large international diabetic kidney disease patient cohort (published in Kidney360)
  • Peer-reviewed publication in Journal of Medical Economics supporting payer coverage for early-stage risk assessment and care management in the primary care office; projecting significant five-year savings from KidneyIntelX testing at primary care level
  • Data results published in American Journal of Managed Care supporting adoption and clinical utility of KidneyIntelX; 98% of 401 primary care physicians surveyed confirmed KidneyIntelX has value as a risk decision tool
  • Multiple data presentations at the American Diabetes Association (ADA) 82nd Scientific Sessions® meeting, including one showing KidneyIntelX testing in 1,112 adult diabetic kidney disease (DKD) patients at Mount Sinai Health System showed utility in driving guideline appropriate use of therapies, including SGLT-2 inhibitors and RAAS inhibitor use, and timely consultation to specialists in high-risk patients
  • World Congress of Nephrology data showing KidneyIntelX predicted the future rate of decline in kidney function compared with current standard diagnostics in patients with early-stage chronic kidney disease and type 2 diabetes
  • Ongoing clinical studies at Wake Forest / Atrium Health and Mount Sinai Health System substantiating clinical utility of KidneyIntelX

Finance & Operations

  • Commercial development progress with annual revenue growth
  • Completion of $30.0 million equity and convertible note financing package ($26.8 million gross proceeds)
  • Cost rationalization enacted at end of period reducing annualized spend by over $12 million with review of other cost-savings opportunities ongoing
  • Salt Lake and New York laboratories operating to most rigorous audited standards; CLIA, CAP, ISO, and U.S. Food and Drug Administration audit compliant
  • The Group had cash on hand of $41.3m (FY21: $65.2m).

Read the Full Report Here »