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Renalytix Reports Financial Results for First Quarter of Fiscal Year 2023

December 1, 2022

LONDON and SALT LAKE CITY, Nov. 30, 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, today reported financial results for the fiscal first quarter ended September 30, 2022.

Recent Highlights (including post period events)

  • New commercial coverage for KidneyIntelX; now 30 private insurance and network provider contracts 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, with over 100,000 health care providers in-network
  • Over 1,200 KidneyIntelX tests performed in the first quarter of fiscal 2023, a record, of which over 80% were billable, yielding approximately $1.0 million revenue
  • 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
  • Publication of new real-world evidence in Primary Care and Community Health in which KidneyIntelX resulted in a 4.5-fold increase in new drug prescriptions (for SGLT2 inhibitors) for high-risk compared to low-risk patients, observed reduction of HbA1c levels in highest risk patients who were prescribed SGLT2 inhibitors, and more than a 20% increase in antihypertensive therapeutic prescriptions in high-risk patients
  • 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
  • KidneyIntelX clinical utility and health economics validated in multiple data releases at American Society of Nephrology
  • 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

First Quarter 2023 Financial Results

During the three months ended September 30, 2022, the Company recognized $1.0 million of revenue (Q1 FY22: $0.5 million). Cost of revenue for the three months ended September 30, 2022 was $0.7 million (Q1 FY22: $0.2 million).

Operating expense for the three months ended September 30, 2022 was $12.0 million compared with $12.1 million during the prior year period. As stated in August, we have taken action to lower annual expenditures by over $12 million through program, vendor and employee reductions, with additional opportunities to reduce expenditures under review.

Within operating expenses, research and development expenses were $3.8 million for the three months ended September 30, 2022, a decrease of $0.2 million, from $4.0 million for the three months ended September 30, 2021. The decrease was primarily due to a $0.2 million decrease in employee related expenses.

General and administrative expenses were $8.2 million for the three months ended September 30, 2022, increasing by $0.1 million from $8.1 million for the three months ended September 30, 2021. The increase was primarily due to a $0.6 million increase in employee related expenses, which included $0.3 million of severance expense offset by a $0.5 million decrease in insurance expense.

Net loss was $12.0 million for the three months ended September 30, 2022 compared with $10.1 million for the prior year period.

Cash and cash equivalents totaled $31.0 million as of September 30, 2022.

The Company will host a corresponding conference call and live webcast today to discuss the financial results and key topics including business strategy, partnerships and regulatory and reimbursement processes, at 8:30 a.m. (ET) / 1:30 p.m. (GMT).

Conference Call Details:

To participate in the live conference call via telephone, please register here. Upon registering, a dial-in number and unique PIN will be provided in order for interested parties to join the conference call.

Webcast Registration link: https://edge.media-server.com/mmc/p/88vepbze