Renalytix Reports Financial Results for Q1 FY2024
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LONDON and SALT LAKE CITY, November 14, 2023 - 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, 2023.
Recent Highlights (including post period events)
- Financing discussions in process with goal to provide operating runway through at least early calendar 2026, enabled by cost reductions and sales growth from adoptions by new hospital systems and independent physicians
- Cost cutting initiative projected to reduce payroll expense by over 35% and total SG&A by over 30% year-over-year. Now with FDA authorization of kidneyintelX.dkd, real-world outcomes data published, and anticipation of inclusion in final medical guidelines, personnel have been realigned to focus on sales
- KidneyIntelX EPIC-integrated commercial roll-out progressing at Atrium Health with expected integration completion in December 2023
- Additional Illinois hospital system launch expected December 2023 to highlight health equity benefits of KidneyIntelX guided care pathway in diabetes
- Long-term Medicare reimbursement process advanced with August independent Clinical Advisory Committee meeting for Local Coverage Determination (LCD), and submission of application for National Coverage Determination (NCD)
- Second Medicare contractor, First Coast Options, now paying for billed KidneyIntelX tests
- Additional key commercial payer coverage achieved, including contracts with:
o BlueCross and BlueShield of Texas, the largest statewide health care plan serving 7,000,000 members
o Parkland Community Health Plan (PCHP), a Dallas-based insurance plan with over 300,000 covered lives
o Provider Network of America (PNOA) a PPO plan contracted with 525,000 physicians, 27,500 hospitals and membership of over 8 million patients across all 50 states
- Evidence from 12 months of care following KidneyIntelX prognostic testing released at American Diabetes Association demonstrated clinical actions that led to improvement in both diabetes (A1C reductions) and kidney health (eGFR slope improvement) in patients with type 2 diabetes and chronic kidney disease; detailed results paper submitted for publication
- Senior executive Howard Doran appointed as chief business officer, leading global sales effort with full direct-to-physician sales force expected to be in field by January 2024
- Testing volumes in fiscal first quarter:
o Total tests of 1,297 of which 56% were billable, compared to 1,232 (57% billable) in the prior quarter and 1,252 (82% billable) in the prior-year fiscal first quarter. Certain study-related tests at Mount Sinai are no longer billable following transition from Mount Sinai as payor to traditional commercial insurance billing, as previously communicated
o 699 tests conducted at Mount Sinai (529 were billable)
o 396 tests conducted at Atrium Health Wake Forest (to date, all non-billable study tests);
o Remainder mainly direct-to-physician billable commercial testing
- Clinical advisory board featuring multi-disciplinary experts formed to advise on adoption of FDA authorized kidneyintelX.dkd within the 14 million patient addressable market in the U.S.
- Distribution agreement executed to expand availability of kidneyintelX.dkd to an estimated four million diabetic kidney disease (DKD) patients in the Middle East
- Intellectual property:
o U.S. Patent Office allows patent claims for intellectual property exclusively licensed to Renalytix, specifically biomarkers sTNFR1 and sTNFR2 used in KidneyIntelX technology
o IP relating to protein biomarker pipeline continues to expand with data presented at American Society of Nephrology Kidney Week from collaborators at Joslin showing potential for expanded indications and utility
- KidneyintelX.dkd recommended for pricing by Centers for Medicare & Medicaid Services (CMS) at $950 per test, matching the pricing of the pre-FDA authorized version of the prognostic; final decision to be made by the end of December 2023.
First Quarter 2024 Financial Results
During the three months ended September 30, 2023, the Company recognized $0.5 million of revenue, compared to $1.0 million for the three months ended September 30, 2022. Cost of revenue for the three months ended September 30, 2023 was $0.5 million, compared to $0.7 million for the three months ended September 30, 2022.
Operating expenses for the three months ended September 30, 2023 was $8.8 million, compared to $12.0 million for the three months ended September 30, 2022. As previously stated in FY23, we have taken action to lower annual expenditures by over $11 million with additional cost reduction initiatives underway to extend cash runway while preserving revenue generating activity.
Within operating expenses, research and development expenses were $2.8 million for the three months ended September 30, 2023, decreasing by $1.0 million from $3.8 million for the three months ended September 30, 2022. The decrease was attributable to a $0.7 million decrease in compensation and related benefits and a $0.7 million decrease related to external R&D projects and studies with Mount Sinai, Wake Forest and Joslin Diabetes, offset by a $0.3 million increase related to consulting and professional fees and $0.1 million increase in other miscellaneous expenses.
General and administrative expenses were $6.1 million for the three months ended September 30, 2023, decreasing by $2.2 million from $8.3 million for the three months ended September 30, 2022. The decrease was driven by our ongoing cost cutting measures, which resulted in a $1.0 million decrease in compensation and related benefits, including share-based payments, due to decreased headcount, $0.4 million decrease in consulting and professional fees, $0.3 million decrease in insurance costs, $0.2 million decrease in marketing, and $0.3 million decrease in other operating expenses.
Net loss was $10.2 million for the three months ended September 30, 2023, compared to a net loss of $12.0 million for the three months ended September 30, 2022.
Cash and cash equivalents totaled $13.9 million as of September 30, 2023.
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:
Webcast Registration link: https://edge.media-server.com/mmc/p/mdyeh2j3
RENALYTIX PLC
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)
For the Three Months Ended September 30,
| (in thousands, except share data) | 2023 | 2022 | ||||
|---|---|---|---|---|---|---|
| Revenue | $ | 459 | $ | 969 | ||
| Cost of revenue | 502 | 696 | ||||
| Gross (loss) profit | (43 | ) | 273 | |||
| Operating expenses: | ||||||
| Research and development | 2,787 | 3,757 | ||||
| General and administrative | 6,059 | 8,250 | ||||
| Performance of contract liability to affiliate | - | (12 | ) | |||
| Total operating expenses | 8,846 | 11,995 | ||||
| Loss from operations | (8,889 | ) | (11,722 | ) | ||
| Equity in net (losses) earnings of affiliate | - | (9 | ) | |||
| Foreign currency gain, net | 289 | 1,730 | ||||
| Fair value adjustment to VericiDx investment | (447 | ) | (854 | ) | ||
| Fair value adjustment to convertible notes | (1,207 | ) | (1,213 | ) | ||
| Other income, net | 100 | 114 | ||||
| Net loss before income taxes | (10,154 | ) | (11,954 | ) | ||
| Income tax benefit | - | 1 | ||||
| Net loss | (10,154 | ) | (11,953 | ) | ||
| Net loss per ordinary share-basic | $ | (0.11 | ) | $ | (0.16 | ) |
| Net loss per ordinary share-diluted | $ | (0.11 | ) | $ | (0.16 | ) |
| Weighted average ordinary shares-basic | 94,767,841 | 74,804,712 | ||||
| Weighted average ordinary shares-diluted | 94,767,841 | 74,804,712 | ||||
| Other comprehensive income (loss): | ||||||
| Changes in the fair value of the convertible notes | 75 | 397 | ||||
| Foreign exchange translation adjustment | 42 | (1,087 | ) | |||
| Comprehensive loss | (10,037 | ) | (12,643 | ) | ||
| RENALYTIX PLC | ||||||
| CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||
| (in thousands, except share and per share data) | September 30, 2023 | June 30, 2023 | ||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 13,891 | $ | 24,682 | ||
| Accounts receivable | 1,014 | 776 | ||||
| Prepaid expenses and other current assets | 1,566 | 1,424 | ||||
| Total current assets | 16,471 | 26,882 | ||||
| Property and equipment, net | 944 | 1,027 | ||||
| Right of Use Asset | 131 | 159 | ||||
| Investment in VericiDx | 978 | 1,460 | ||||
| Other Assets | 1,016 | 1,101 | ||||
| Total assets | $ | 19,540 | $ | 30,629 | ||
| Liabilities and Shareholders' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,715 | $ | 1,485 | ||
| Accounts payable - related party | 1,653 | 1,451 | ||||
| Accrued expenses and other current liabilities | 4,566 | 6,644 | ||||
| Accrued expenses - related party | 2,539 | 1,963 | ||||
| Current lease liability | 131 | 130 | ||||
| Convertible notes-current | 4,569 | 4,463 | ||||
| Total current liabilities | 15,173 | 16,136 | ||||
| Convertible notes-noncurrent | 5,848 | 7,485 | ||||
| Noncurrent lease liability | 10 | 41 | ||||
| Total liabilities | 21,031 | 23,662 | ||||
| Commitments and contingencies (Note 10) | ||||||
| Shareholders' equity: | ||||||
| Ordinary shares, £0.0025 par value per share: 102,537,697 shares authorized; 95,019,440 and 93,781,478 shares issued and outstanding at September 30, 2023 and June 30, 2023, respectively | 290 | 286 | ||||
| Additional paid-in capital | 188,031 | 186,456 | ||||
| Accumulated other comprehensive loss | (1,333 | ) | (1,450 | ) | ||
| Accumulated deficit | (188,479 | ) | (178,325 | ) | ||
| Total shareholders' (deficit) equity | (1,491 | ) | 6,967 | |||
| Total liabilities and shareholders' (deficit) equity | $ | 19,540 | $ | 30,629 | ||
| RENALYTIX PLC | ||||||
| CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) | ||||||
| For the Three Months Ended September 30, | ||||||
| (in thousands) | 2023 | 2022 | ||||
| Cash flows from operating activities: | ||||||
| Net loss | $ | (10,154 | ) | $ | (11,953 | ) |
Adjustments to reconcile net loss to net cash used in operating activities
| (in thousands, except share data) | 2023 | 2022 | ||
|---|---|---|---|---|
| Depreciation and amortization | 127 | 130 | ||
| Stock-based compensation | 523 | 767 | ||
| Equity in losses of affiliate | - | 9 | ||
| Reduction of Kantaro liability | - | (12 | ) | |
| Fair value adjustment to VericiDx investment | 447 | 854 | ||
| Unrealized foreign exchange loss | - | 456 | ||
| Fair value adjustment to convertible debt, net interest paid | 945 | 921 | ||
| Non cash lease expense | 28 | - | ||
| Changes in operating assets and liabilities: | ||||
| Accounts receivable | (238 | ) | (322 | ) |
| Prepaid expenses and other current assets | (153 | ) | 312 | |
| Receivable from affiliates | - | (13 | ) | |
| Accounts payable | 250 | 555 | ||
| Accounts payable - related party | 202 | 1,287 | ||
| Accrued expenses and other current liabilities | (2,060 | ) | (125 | ) |
| Accrued expenses - related party | 579 | 22 | ||
| Deferred revenue | - | (7 | ) | |
| Net cash used in operating activities | (9,504 | ) | (7,119 | ) |
| Cash flows from investing activities: | ||||
| Net cash used in investing activities | - | - | ||
| Cash flows from financing activities: | ||||
| Payment of convertible notes principal | (1,060 | ) | (1,060 | ) |
| Payment of issuance costs | (5 | ) | - | |
| Proceeds from the issuance of ordinary shares under employee share purchase plan | - | 116 | ||
| Net cash used in financing activities | (1,065 | ) | (944 | ) |
| Effect of exchange rate changes on cash | (222 | ) | (2,230 | ) |
| Net decrease in cash and cash equivalents | (10,791 | ) | (10,293 | ) |
| Cash and cash equivalents, beginning of period | 24,682 | 41,333 | ||
| Cash and cash equivalents, end of period | $ | 13,891 | $ | 31,040 |
| Supplemental noncash investing and financing activities: | ||||
| Noncash lease liabilities arising from obtaining right-of-use assets | $ | 4 | $ | - |
| Cash Paid for interest on convertible debt | $ | 249 | $ | 292 |
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