Core Insights - Co-Diagnostics, Inc. reported financial results for Q2 2025, highlighting a significant decline in revenue primarily due to the timing of grant revenue recognition [2][8] - The company remains on track to initiate clinical evaluations for its Co-Dx PCR platform tests by year-end, with an enhanced COVID-19 test expected to be the first submitted for regulatory clearance [3][5] Financial Performance - Revenue for Q2 2025 was $0.2 million, down from $2.7 million in Q2 2024, with no grant revenue recognized during the quarter [8] - Operating expenses were approximately $8.2 million, a decrease of 19.1% from the prior year [8] - The operating loss was $8.1 million compared to a loss of $7.7 million in Q2 2024 [8] - The net loss for the quarter was $7.7 million, or $0.23 per fully diluted share, compared to a net loss of $7.6 million, or $0.25 per fully diluted share in Q2 2024 [8][14] - Adjusted EBITDA loss was $7.2 million for Q2 2025 [8][16] Balance Sheet Highlights - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $13.4 million [8] - Total assets decreased to $46.5 million from $64.0 million at the end of 2024 [12] - Total liabilities were $5.3 million, down from $9.7 million at the end of 2024 [13] Business Developments - The company is training clinical evaluation sites for the enhanced COVID-19 test and expects to begin accepting trial participants imminently [3] - The CEO emphasized the importance of investments made in developing the Co-Dx PCR platform, which are expected to support successful market entry and regulatory submissions [3]

Core Insights - Co-Diagnostics, Inc. will release its second quarter 2025 financial results on August 14, 2025, after market close [1] - A conference call and webcast will be held on the same day at 4:30 p.m. ET to discuss the financial results with analysts [1] - Key management participating in the call includes CEO Dwight Egan, CFO Brian Brown, and Head of Investor Relations Andrew Benson [1] Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah, specializing in the development, manufacturing, and marketing of advanced diagnostic technologies [3] - The company's technologies focus on tests that detect and analyze nucleic acid molecules (DNA or RNA) [3] - Co-Diagnostics utilizes proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform, as well as to identify genetic markers for various applications beyond infectious diseases [3]

Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah that develops, manufactures, and markets advanced diagnostic technologies [4] - The company's technologies focus on tests designed for the detection and analysis of nucleic acid molecules (DNA or RNA) [4] - Co-Diagnostics utilizes proprietary technology to create specific tests for its Co-Dx PCR platform, which includes at-home and point-of-care testing [4] Conference Participation - Co-Diagnostics will participate in the D. Boral Capital Inaugural Global Conference on May 14, 2025, in New York City [1] - The conference aims to connect emerging growth issuers across various sectors with institutional investors [2] - Company representatives will engage in one-on-one meetings to present the company's value proposition and the upcoming Co-Dx PCR testing platform [2] Product Information - The Co-Dx PCR platform includes the PCR Home™, PCR Pro™, a mobile app, and associated tests [3] - The platform is currently under review by the FDA and other regulatory bodies and is not yet available for sale [3]

Core Insights - Co-Diagnostics, Inc. reported a quarterly loss of $0.24 per share, better than the Zacks Consensus Estimate of a loss of $0.33, and an improvement from a loss of $0.31 per share a year ago, resulting in an earnings surprise of 27.27% [1] - The company posted revenues of $0.05 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 86.84%, and down from $0.47 million in the same quarter last year [2] - Co-Diagnostics shares have declined approximately 53.3% year-to-date, contrasting with the S&P 500's decline of 4.3% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.33 on revenues of $0.38 million, and for the current fiscal year, it is -$0.91 on revenues of $1.5 million [7] - The estimate revisions trend for CoDiagnostics is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical Services industry, to which Co-Diagnostics belongs, is currently ranked in the top 22% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8] - Another company in the same industry, Surgery Partners, is expected to report quarterly earnings of $0.08 per share, reflecting a year-over-year decline of 20%, with revenues projected at $796.68 million, an increase of 11.1% from the previous year [9][10]

Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2025 decreased to $100,000 from $500,000 in the same period of the prior year [17][59] - Total operating expenses decreased to $8,600,000 from $10,500,000 year-over-year [18][59] - Research and development expenses were $4,900,000 compared to $5,700,000 in the prior year [18][59] - Net loss for the first quarter was $7,500,000 or a loss of $0.24 per fully diluted share, compared to a net loss of $9,300,000 or a loss of $0.31 per fully diluted share in the prior year [18][60] - Adjusted EBITDA loss improved to $7,400,000 from $8,400,000 in the prior year [18][60] - Cash, cash equivalents, and marketable investment securities at the end of the quarter totaled $21,500,000 [19][60] Business Line Data and Key Metrics Changes - The company is advancing its CoDiEX PCR platform and associated test pipeline, focusing on tests for tuberculosis, COVID-19, a four-plex respiratory panel, and an eight-plex HPV panel [6][48] - The design for the updated COVID-19 test has been completed, and extensive verification testing has been conducted [9][49] - Progress has been made on the TB test, with preliminary analytical studies completed and instruments identified for sample preparation [10][51] - The four-plex respiratory panel is designed to deliver simultaneous PCR test results for flu A and B, COVID-19, and RSV, with significant market interest identified [11][52] - The HPV panel is being prepared for clinical evaluations, supported by a grant from the Bill and Melinda Gates Foundation [12][54] Market Data and Key Metrics Changes - The company expects to begin clinical evaluations for its TB test in India and South Africa in the latter half of 2025 [10][51] - India is identified as a top priority market for TB testing, with significant experience in regulatory, commercial, and manufacturing infrastructure through a joint venture [10][51] - The company plans to pursue regulatory clearance in India for the HPV test before expanding to South Africa and other regions [14][55] Company Strategy and Development Direction - The mission is to increase accessibility to affordable, high-quality diagnostics in the U.S., India, and globally [6][48] - The company aims to bring its Kodiak's PCR platform to market, focusing on operational and manufacturing efficiencies [8][57] - Engagement with local health officials and potential customers is ongoing to evaluate commercialization strategies [10][52] - The company is committed to achieving regulatory objectives and successfully launching the Kodiak's PCR Pro instrument and test kits [15][57] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued progress and future developments within the test pipeline for 2025 [19][61] - The company is focused on managing its spend to maintain a healthy balance sheet for future commercial launches [19][60] - The timeline for clinical trials is influenced by the prevalence of COVID-19, with a focus on effective testing conditions [26][68] - The company anticipates that the HPV and tuberculosis tests may enter clinical trials sooner due to the availability of samples in India [30][73] Other Important Information - The company has hosted events to build awareness of the Kodiak's PCR platform, including a symposium in India and participation in local life sciences events [14][56] - The manufacturing facility build-out in India is on track to be completed by the end of the year, enhancing regional capabilities [16][57] Q&A Session Summary Question: Timeline for COVID test resubmission - Management confirmed that the new design for the COVID test is complete, and they are preparing for clinical evaluations, with a revised submission expected to increase the probability of successful clearance [24][66] Question: Specific submission date for COVID test - The timing for submission is dependent on the prevalence of COVID-19, with management indicating it is a waiting game for effective testing conditions [26][68] Question: Timeline for other products in India and South Africa - All tests, including the multiplex ABCR test, HPV test, and TB test, are expected to enter clinical trials during the remainder of 2025 [28][70] Question: Pricing and gross margins for devices and test cups - The expected cost of the instrument is in the $300 to $500 range, with test cartridges priced at $15 to $20 in developed markets, and lower pricing for low and middle-income countries [36][79]

Financial Performance - For the three months ended March 31, 2025, the company generated revenues of $0.1 million, a decrease of 80% compared to $0.5 million for the same period in 2024[86] - The cost of revenues for the three months ended March 31, 2025, was approximately $22,000, down from $0.2 million in the same period in 2024[87] - Total operating expenses decreased to $8.6 million for the three months ended March 31, 2025, from $10.5 million in the same period in 2024, primarily due to reduced stock-based compensation and personnel-related expenses[88] - Research and development expenses were $4.9 million for the three months ended March 31, 2025, compared to $5.7 million for the same period in 2024, reflecting a decrease of approximately 14%[91] - The net loss for the three months ended March 31, 2025, was $7.5 million, an improvement from a net loss of $9.3 million for the same period in 2024[93] - Net cash used in operating activities was $8.7 million for the three months ended March 31, 2025, compared to $8.5 million for the same period in 2024[95] Assets and Liabilities - As of March 31, 2025, the company had cash and cash equivalents of $1.9 million and marketable investment securities of $19.6 million, totaling current assets of $23.8 million against current liabilities of $5.4 million[94] - The company is seeking additional equity and/or debt financing, but such funding is not assured and may not be available on favorable terms, creating substantial doubt about its ability to continue as a going concern[99] Equity and Financing - The company has entered into an Amended and Restated Equity Distribution Agreement allowing for the sale of common stock with an aggregate offering price of up to $17,111,650[98] - The company has sold 833,806 shares of common stock under the ATM Agreement, resulting in net proceeds of $0.6 million as of March 31, 2025[98] Internal Controls and Procedures - The company maintains effective disclosure controls and procedures as of March 31, 2025, ensuring timely decisions regarding required disclosures[101] - There have been no changes in internal control over financial reporting that materially affected or are likely to materially affect the company's internal control during the three months ended March 31, 2025[102] - There are no off-balance sheet arrangements reported by the company[100] Product Development - The company plans to submit a new version of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance after collecting clinical evaluation data to support the new test's performance[79]

Revenue Performance - Revenue for Q1 2025 was $0.1 million, a decline from $0.5 million in Q1 2024, primarily due to the timing of grant revenue recognition[6] - Total revenue for Q1 2025 was $50,277, significantly down from $467,854 in Q1 2024[16] - The company reported a gross profit of $28,687 for Q1 2025, down from $233,349 in Q1 2024[16] Operating Expenses - Operating expenses decreased by 18.2% to $8.6 million compared to $10.5 million in Q1 2024[6] - Adjusted EBITDA loss for Q1 2025 was $7.4 million, compared to a loss of $8.4 million in Q1 2024[18] Net Loss - Net loss for Q1 2025 was $7.5 million, an improvement from a net loss of $9.3 million in Q1 2024, resulting in a loss of $0.24 per fully diluted share compared to $0.31 in Q1 2024[6] Cash Position - Cash, cash equivalents, and marketable securities totaled $21.5 million as of March 31, 2025[6] Development and Initiatives - The company is on track to initiate clinical evaluations for four tests in its product pipeline and complete its manufacturing facility in India by year-end 2025[6] - The company hosted a symposium in India for International HPV Awareness Day 2025, preparing for pre-clinical studies for its HPV test[6] - The company continues to focus on operational efficiency while advancing towards several development milestones[5]

Core Viewpoint - Co-Diagnostics, Inc. reported its financial results for Q1 2025, highlighting a decline in revenue but a reduction in operating losses, while continuing to advance its product pipeline and operational efficiency [1][4][3]. Financial Results - Revenue for Q1 2025 was $0.1 million, down from $0.5 million in Q1 2024, primarily due to the timing of grant revenue recognition [4][13]. - Operating expenses decreased by 18.2% to $8.6 million compared to $10.5 million in Q1 2024 [4][13]. - The operating loss for Q1 2025 was $8.6 million, an improvement from the $10.3 million loss in Q1 2024 [4][13]. - The net loss was $7.5 million, compared to a net loss of $9.3 million in Q1 2024, resulting in a loss of $0.24 per fully diluted share, improved from a loss of $0.31 per share in Q1 2024 [4][13]. - Adjusted EBITDA loss was $7.4 million for Q1 2025 [4][15]. Business Highlights - The company is on track to initiate clinical evaluations for four tests in its product pipeline and complete its manufacturing facility in India by the end of 2025 [3]. - Co-Diagnostics hosted a symposium in India to honor International HPV Awareness Day 2025 [3]. - The CEO emphasized the importance of the Co-Dx PCR platform in enhancing global accessibility to diagnostic testing solutions [3]. Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $21.5 million [4]. Operational Developments - The company is preparing for pre-clinical and pre-analytical studies for its HPV test to be utilized on the Co-Dx PCR Pro instrument [5]. - Co-Diagnostics showcased its upcoming at-home and point-of-care Co-Dx PCR platform at BioUtah's Life Sciences Day [5]. Balance Sheet Overview - Total assets as of March 31, 2025, were $55.1 million, down from $64.0 million at the end of 2024 [12]. - Total liabilities decreased to $7.2 million from $9.7 million at the end of 2024 [12]. Summary of Operations - The company reported a gross profit of $28,687 for Q1 2025, significantly lower than $233,349 in Q1 2024 [13]. - Total operating expenses for Q1 2025 were $8.6 million, down from $10.5 million in the same period last year [13].

Core Viewpoint - Co-Diagnostics, Inc. is set to release its first quarter 2025 financial results on May 8, 2025, and will host a conference call to discuss these results with analysts [1]. Group 1: Financial Results Announcement - The financial results will be released after market close on May 8, 2025 [1]. - A conference call and webcast will take place on the same day at 4:30 p.m. ET [1]. - Key management participating in the call includes the CEO, CFO, and Head of Investor Relations [1]. Group 2: Conference Call Details - The conference call can be accessed via a toll-free number or a toll number, with a participant passcode provided [2]. - A recording of the call will be made available on the company's website for those unable to attend the live session [2]. Group 3: Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah, specializing in the development and marketing of advanced diagnostic technologies [3]. - The company's technologies focus on the detection and analysis of nucleic acid molecules, including DNA and RNA [3]. - Co-Diagnostics also utilizes proprietary technology for specific tests related to its Co-Dx PCR at-home and point-of-care platform, as well as for identifying genetic markers for various applications [3].

Core Viewpoint - Co-Diagnostics, Inc. (CODX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, suggesting that upward revisions in earnings estimates can lead to higher stock valuations [4][6]. - CoDiagnostics is expected to earn -$0.91 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 26.6% [8]. Analyst Sentiment and Market Position - Analysts have increased their earnings estimates for CoDiagnostics, with the Zacks Consensus Estimate rising by 22.2% over the past three months [8]. - The upgrade to Zacks Rank 2 places CoDiagnostics in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [10].