Renalytix plc(US:RNLX)2023-09-30 00:43Financial Data and Key Metrics - Total revenue for fiscal year 2023 was $3.4 million, up 15% from fiscal 2022 [35] - Fourth quarter revenue was $520,000, compared to $830,000 in the prior year's fourth quarter [35] - Operating expenses for the fourth quarter were $9.8 million, down from $13.2 million in the prior year period [37] - Net loss for the fourth quarter was $11.1 million or $0.11 per share, compared to a net loss of $5.2 million or $0.07 per share in the prior year's fourth quarter [38] - Net cash used in operating activities for the year ended June 30 was $33.4 million, down 27% from $45.9 million in the prior fiscal year [39] - The company ended the fourth quarter with approximately $24.7 million in cash [39] Business Line Data and Key Metrics - KidneyIntelX achieved FDA de novo marketing authorization and was included in the draft KDIGO guidelines for 2023 [10] - The company aims for 1% US market penetration over the next three years, targeting 14 million adults with diabetes and kidney disease [11] - KidneyIntelX is priced at $950 or greater, with contracts in place with major insurance providers including Blue Cross Blue Shield, Medicare, and Medicaid [12][19] - The company is expanding its direct-to-physician sales force in key US regions with high rates of diabetes and kidney disease [29] Market Data and Key Metrics - The company has secured insurance coverage agreements with Blue Cross Blue Shield of Texas and Parkland Community Health Plan, covering millions of lives [19][32] - International opportunities are promising, particularly given the global growth in diabetes [12] - The company is focusing on regions with high rates of diabetes, kidney disease, and insurance coverage for KidneyIntelX [25] Company Strategy and Industry Competition - The company is reducing its quarterly cash burn rate, with reductions expected to become apparent in the second half of fiscal 2024 [13] - KidneyIntelX is positioned as the only FDA-authorized, machine learning-enabled prognostic tool for chronic kidney disease [14][15] - The company is exploring non-dilutive funding sources, including strategic partnerships and international licensing opportunities [13] - KidneyIntelX has demonstrated improved outcomes in diabetes and kidney disease, with real-world evidence showing clinical benefits [30] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the commercial prospects of KidneyIntelX, citing FDA authorization, reimbursement milestones, and inclusion in clinical guidelines [10][11] - The company is focused on expanding hospital system partnerships and insurance coverage to drive adoption [11][19] - Management expects to see increased testing volumes and revenue growth in fiscal 2024, particularly with the launch of the FDA-cleared version of KidneyIntelX [36][62] Other Important Information - The company filed an S-3 shelf registration statement to provide flexibility in sourcing capital [17] - KidneyIntelX has been integrated into major health systems like Mount Sinai and is being deployed in Wake Forest Atrium through Epic [43][47] - The company is pursuing Medicare coverage determination for KidneyIntelX, with expectations of achieving local or national coverage by early 2024 [53][65] Q&A Session Summary Question: When will the FDA-cleared version of KidneyIntelX be launched? - The FDA-cleared version is expected to launch in the March quarter of 2024, pending Medicare payment establishment and regulatory language updates [62][65] Question: What is the target market penetration for KidneyIntelX? - The company targets 1% penetration of the 14 million FDA-authorized use population over the next three years [51] Question: What are the expected cost reductions? - The company has already reduced operating expenses by $11 million year-over-year and is targeting further single-digit million reductions [88] Question: What is the status of the KDIGO guidelines inclusion? - The company expects KidneyIntelX to be included in the final KDIGO guidelines by the end of 2023 [66] Question: What is the outlook for test volume growth? - Test volumes are expected to grow, particularly with the FDA-cleared version launch and expansion in key regions [96]