Co-Diagnostics (CODX 0.91%), a diagnostics technology company focused on infectious disease testing, announced its Q2 2025 results on August 14, 2025. GAAP EPS loss of $0.23 was better than analysts' estimate of a $0.25 loss. However, GAAP revenue fell short at $0.2 million, compared to the $0.3 million analysts anticipated, and marking a sharp drop from $2.7 million in Q2 2024. While the loss shrank, revenue relied heavily on grant timing, accentuating the company’s ongoing pre-commercial phase. The quarter reflected both progress in product development and the financial pressures of a business not yet generating steady sales.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | ($0.23) | ($0.25) | ($0.25) | 8.0 % |
| Revenue (GAAP) | $0.2 million | $0.3 million | $2.7 million | (92.6 %) |
| Operating Loss | ($8.1 million) | ($7.7 million) | (5.2 %) | |
| Adjusted EBITDA | ($7.2 million) | ($5.9 million) | 22.0 % | |
| Cash, Cash Equivalents, and Marketable Securities | $13.4 million(as of June 30, 2025) | N/A |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Strategic Focus
Co-Diagnostics specializes in molecular diagnostics, with a focus on infectious disease detection using polymerase chain reaction (PCR) technology. At its core is the proprietary Co-Primers technology, which is designed to enhance the accuracy and specificity of PCR tests by reducing common errors like false positives caused by primer-dimers. Its business centers on developing tests and platforms that can be used both at point-of-care settings and at home, aiming to offer affordable, accurate diagnostic solutions globally.
In recent years, the company’s efforts have shifted toward advancing the Co-Dx PCR platform, which is a set of point-of-care and home-based PCR diagnostic systems. Continuous technology innovation, gaining regulatory approvals, and building partnerships, such as its joint venture with CoSara Diagnostics in India, are critical for its long-term progress. Success will depend on regulatory clearances, effective commercialization, and its ability to transition from dependence on grants to recurring product sales.
Quarter Highlights and Financial Developments
During Q2 2025, the company reported that GAAP revenue dropped sharply, mainly due to the absence of grant funding. Grant revenues can be unpredictable and typically fluctuate based on the timing of awards and recognition. With just $0.2 million in GAAP revenue recognized—and no grant revenue—the company’s results showed how exposed it is without commercial product sales. Product revenue (GAAP) held flat at roughly $0.16 million, highlighting negligible organic growth in its commercial business.
Operating loss widened slightly year over year, reaching $8.1 million, up from $7.7 million in Q2 2024. The company reduced its operating expenses by 19% to $8.2 million, compared to the prior year second quarter, with research and development expenditures at $4.7 million and sales and marketing at $0.6 million (GAAP). While cost controls were effective, lower revenue contributed to a larger operating loss. Adjusted EBITDA (non-GAAP) loss also increased compared to Q2 2024, reflecting ongoing investment in product development and regulatory readiness.
Progress continued on the Co-Dx PCR platform, which bundles a set of infectious disease tests designed for point-of-care and home markets. These include enhanced COVID-19 PCR tests, as well as panels for tuberculosis (TB), a four-plex respiratory panel (simultaneously detecting flu A and B, RSV, and COVID-19), and an eight-plex HPV (human papillomavirus) panel. All pipeline products remained in the pre-commercial, pre-approval stage. During the quarter, preparations advanced for clinical trials of all assays; management stated it expects to begin clinical evaluations before the end of the year. The company is currently training clinical evaluation sites for the COVID-19 test and expects to enroll trial participants soon. No new U.S. Food and Drug Administration (FDA) submissions or clearances were made in the period.
The absence of new grant revenue was a key drawback for the quarter. Strategic partnerships with organizations such as the Bill & Melinda Gates Foundation and National Institutes of Health remain an important resource. However, as of June 30, 2025, cash, cash equivalents, and marketable securities had fallen to $13.4 million, down from $21.5 million at the previous quarter-end and from a combined $29.7 million (cash and cash equivalents of $2.9 million and marketable investment securities of $26.8 million) at year-end 2024. Company statements again referenced the possibility of raising capital or securing new grants to supplement its financial position. CODX does not currently pay a dividend.
Regulatory, Market, and Product Pipeline Progress
The company’s core technology, Co-Primers, continues to underpin its strategic work. This technology, which enhances PCR test accuracy, is being integrated into all upcoming platform products. Management’s focus is on bringing the Co-Dx PCR platform through clinical trial phases and securing the necessary regulatory approvals. The enhanced COVID-19 PCR test is set to be the first of four infectious disease panels submitted for regulatory review after trial completion. In past calls, the company stated it has resolved feedback received from earlier regulatory submissions by improving the stability of test components—it plans to use new clinical data for resubmission to regulators.
The tuberculosis test and multi-pathogen respiratory panel remain important strategic priorities. For the TB PCR test, the company aims to launch initial clinical evaluations in India and South Africa, leaning on its joint venture manufacturing and regulatory infrastructure within India. Market research, cited by management, suggests significant demand for the 4-plex respiratory PCR panel covering flu A and B, COVID-19, and RSV. An eight-plex HPV PCR panel is also in line for clinical trials, developed in collaboration with grant funding to address persistent global healthcare needs.
From a market expansion angle, the company continued to leverage partnerships and attend industry events. During the quarter, it hosted a symposium for International HPV Awareness Day in India in collaboration with CoSara, and participated in industry forums to increase awareness of its new platform. However, the period confirmed that new product launches and material revenue generation remain contingent on progress in clinical trials and regulatory reviews.
The company’s reliance on grant revenue continued to show as a risk factor during the period. With no grant income recognized, and only minimal commercial sales, the quarter’s results underscored the challenge the company faces in funding its operations until commercial launch. There were no reported one-time financial events or new partnership funding secured.
Outlook and What to Watch
Leadership provided no explicit financial revenue or earnings guidance for future quarters. This is typical for companies still in the pre-commercialization phase, particularly where timing of clinical and regulatory milestones is uncertain. Management reiterated its goal of starting clinical studies for all diagnostic tests in its pipeline by the end of the year, including enhanced COVID-19, TB, respiratory, and HPV panels.
Given declining cash reserves and the continued absence of commercial product sales or new grant revenue, investors and observers should monitor the company’s clinical and regulatory progress, funding developments, and expense trends in coming quarters. The timing and success of FDA or international approvals for platform products will likely have a significant impact on the company’s future prospects. CODX does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
