CDI(CODX) - 2025 Q2 - Quarterly Results

Executive Summary & Business Highlights Second Quarter 2025 Financial Overview Co-Diagnostics, Inc. reported a significant decline in revenue for Q2 2025 to $0.2 million, primarily due to the absence of grant revenue, recording an operating loss of $8.1 million and a net loss of $7.7 million, or $0.23 per diluted share, while decreasing operating expenses by 19.1% year-over-year Financial Performance Summary | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change (%) | | :----------------------- | :----------------- | :----------------- | :--------- | | Revenue | $0.2 | $2.7 | -92.6% | | Operating Expenses | $8.2 | $10.1 | -19.1% | | Operating Loss | $(8.1) | $(7.7) | +5.2% | | Net Loss | $(7.7) | $(7.6) | +1.3% | | Diluted EPS | $(0.23) | $(0.25) | -8.0% | | Adjusted EBITDA Loss | $(7.2) | $(5.9) | +22.0% | - Revenue decline primarily attributed to no grant revenue recognized in Q2 2025, compared to $2.5 million in Q2 2024[7][15] - Cash, cash equivalents, and marketable securities stood at $13.4 million as of June 30, 2025[7] Recent Business Highlights The company is on track to initiate clinical evaluations for all tests in its Co-Dx PCR platform pipeline before year-end, with training for enhanced COVID-19 test participants beginning imminently, and the CEO emphasized the robust framework developed for market entry and confidence in regulatory submissions - Company remains on track to initiate clinical evaluations for all tests in Co-Dx PCR platform pipeline before year-end[4] - Currently training clinical evaluation sites for enhanced COVID-19 test and expect to begin accepting trial participants imminently[4] - The Co-Dx PCR platform (including PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to FDA and/or other regulatory bodies' review and is not yet available for sale[6] Company Information & Disclosures About Co-Diagnostics, Inc. Co-Diagnostics, Inc. is a Utah-based molecular diagnostics company specializing in developing, manufacturing, and marketing advanced diagnostic technologies that utilize nucleic acid detection and analysis, with proprietary technology also used for its Co-Dx PCR at-home and point-of-care platform and identifying genetic markers beyond infectious diseases - Develops, manufactures, and markets state-of-the-art molecular diagnostics technologies[8] - Technologies are utilized for tests designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA)[8] - Uses proprietary technology for Co-Dx PCR at-home and point-of-care platform and to identify genetic markers for non-infectious disease applications[8] Non-GAAP Financial Measures This section defines Adjusted EBITDA as a non-GAAP measure, explaining its exclusion of items like depreciation, stock-based compensation, and interest, highlighting its utility for management in trend analysis and budgeting, and for investors in evaluating ongoing operations and comparing performance, while also cautioning against its use in isolation from GAAP results - Adjusted EBITDA is a non-GAAP measure defined as net income excluding depreciation, amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, and realized gain (loss) on investments[9] - Management uses Adjusted EBITDA for trend analyses, budgeting, and planning, believing it provides useful information to investors for evaluating ongoing operating results and comparisons[9] - Non-GAAP measures should not be considered in isolation or as an alternative/substitute to GAAP results due to the exclusion of significant expenses[10] Forward-Looking Statements The company includes a standard disclaimer regarding forward-looking statements, which are based on current facts and predictions, and are subject to inherent uncertainties, risks, and changes in circumstances, specifically mentioning statements about the Co-Dx PCR platform's clinical evaluations, development, regulatory submissions, and its potential role in diagnostic testing accessibility, cautioning investors against undue reliance, and disclaiming any obligation to update these statements unless required by law - Forward-looking statements are identified by words like 'believes,' 'expects,' 'estimates,' and are based on existing facts and future predictions[11] - Statements include advancement into clinical evaluations, continued development, regulatory submissions for the Co-Dx PCR platform, and its role in transforming global diagnostic testing accessibility[11] - Actual results may differ materially due to inherent uncertainties and risks, as detailed in SEC filings; investors are cautioned not to place undue reliance on these statements[11] Investor Relations Contact Contact information for investor relations is provided for inquiries - Investor Relations Contact: Andrew Benson, Head of Investor Relations, +1 801-438-1036, investors@codiagnostics.com[12] Consolidated Financial Statements Consolidated Balance Sheets As of June 30, 2025, Co-Diagnostics, Inc. reported total assets of $46.5 million, a decrease from $64.0 million at December 31, 2024, primarily driven by a significant reduction in marketable investment securities, with total liabilities also decreasing from $9.7 million to $5.3 million, while total stockholders' equity declined from $54.3 million to $41.1 million Consolidated Balance Sheet Summary | Balance Sheet Item | June 30, 2025 (USD) | December 31, 2024 (USD) | Change | | :----------------- | :------------------ | :---------------------- | :----- | | Total Assets | $46,465,833 | $63,999,919 | -27.4% | | Total Liabilities | $5,327,439 | $9,688,001 | -45.0% | | Total Stockholders' Equity | $41,138,394 | $54,311,918 | -24.3% | - Cash and cash equivalents increased significantly from $2.9 million to $11.1 million, while marketable investment securities decreased from $26.8 million to $2.2 million[14] - Current liabilities decreased by 49.3% from $7.3 million to $3.7 million, driven by reductions in accounts payable, accrued expenses, and contingent consideration liabilities[14] Consolidated Statements of Operations and Comprehensive Loss For the three months ended June 30, 2025, total revenue plummeted to $0.16 million from $2.66 million in Q2 2024, primarily due to the absence of grant revenue, with gross profit consequently falling from $2.44 million to $0.13 million, and despite a reduction in total operating expenses by 19.1% to $8.19 million, the company reported an increased loss from operations of $8.06 million and a net loss of $7.73 million Consolidated Statements of Operations Summary | Income Statement Item | Q2 2025 (USD) | Q2 2024 (USD) | Change (%) | | :-------------------- | :------------ | :------------ | :--------- | | Product Revenue | $162,910 | $161,102 | +1.1% | | Grant Revenue | $0 | $2,495,738 | -100.0% | | Total Revenue | $162,910 | $2,656,840 | -93.9% | | Gross Profit | $130,804 | $2,444,692 | -94.6% | | Total Operating Expenses | $8,188,568 | $10,124,654 | -19.1% | | Loss from Operations | $(8,057,764) | $(7,679,962) | +4.9% | | Net Loss | $(7,730,117) | $(7,599,318) | +1.7% | | Basic and Diluted EPS | $(0.23) | $(0.25) | -8.0% | - Research and development expenses decreased by 16.5% from $5.6 million in Q2 2024 to $4.7 million in Q2 2025[15] - Sales and marketing expenses decreased by 41.4% from $1.04 million to $0.61 million[15] GAAP and Non-GAAP Measures Reconciliation The reconciliation of net loss to Adjusted EBITDA shows an Adjusted EBITDA loss of $7.20 million for Q2 2025, an increase from the $5.92 million loss in Q2 2024, with key adjustments including adding back depreciation and amortization, stock-based compensation, and income tax provision, while subtracting interest income and realized gains on investments Reconciliation of Net Loss to Adjusted EBITDA | Reconciliation Item | Q2 2025 (USD) | Q2 2024 (USD) | | :------------------ | :------------ | :------------ | | Net loss | $(7,730,117) | $(7,599,318) | | Interest income, net | $(12,158) | $(342,188) | | Realized gain on investments | $(340,358) | $(74,165) | | Depreciation and amortization | $291,414 | $338,335 | | Stock-based compensation expense | $580,265 | $1,499,658 | | Income tax provision | $12,327 | $20,590 | | Adjusted EBITDA | $(7,199,845) | $(5,916,472) | - Stock-based compensation expense significantly decreased from $1.50 million in Q2 2024 to $0.58 million in Q2 2025[17]