Co-Diagnostics, Inc. (Nasdaq: CODX) Q2 2025 Earnings Call | 08/15/2025

Co-Diagnostics, Inc. held its Q2 2025 earnings call, led by CEO Dwight Egan and CFO Brian Brown, with Andrew Benson, Head of Investor Relations, hosting. The company reported progress on its CoDx PCR point-of-care platform, which is on track to initiate clinical evaluations for all tests in its pipeline in 2025. Key updates include:

1. CoDx PCR Platform Development:
   • The platform is advancing toward market launch, with clinical evaluations for the CoDx PCR COVID-19 test set to begin imminently, followed by a 510(k) FDA submission.
   • The pipeline includes a four-plex respiratory panel (Flu A/B, COVID-19, RSV), supported by an NIH grant, and tests for tuberculosis (TB) and an HPV 8-type multiplex panel, both backed by the Bill & Melinda Gates Foundation.
   • TB testing is a priority, especially in India (27% of global TB cases) and Africa, with clinical evaluations planned in India and South Africa by year-end for regulatory submissions to CDSCO and SAHPRA.
   • The HPV test targets high-risk subtypes linked to cervical cancer, aiming to improve testing accessibility in India and Africa.
   • The respiratory panel is designed for the 2025 North American flu season, with data to support an FDA 510(k) application.
2. Commercialization Strategy:
   • In the U.S., the company targets physician offices, clinics, skilled nursing facilities, pharmacies, and potentially home use for COVID-19 and respiratory panel tests.
   • In India, the focus is on primary healthcare centers, leveraging the joint venture with CoSara Diagnostics for manufacturing and distribution.
   • The platform’s cloud-based analysis enables real-time epidemiological data sharing, enhancing global health monitoring.
3. Financial Results:
   • Q2 2025 revenue was $0.2 million (all from product sales), down from $2.7 million in Q2 2024 (which included $2.5 million in grants).
   • Operating expenses decreased to $8.2 million from $10.1 million, reflecting improved efficiency.
   • R&D expenses were $4.7 million, down from $5.6 million in Q2 2024.
   • Net loss was $7.7 million ($0.23 per share) vs. $7.6 million ($0.25 per share) in Q2 2024.
   • Adjusted EBITDA loss was $7.2 million, compared to $5.9 million in Q2 2024.
   • Cash and equivalents stood at $13.4 million, with plans for equity/debt financing, grants, and operational efficiencies to fund commercialization.
4. Future Outlook:
   • Clinical trials for all four tests (COVID-19, respiratory panel, TB, HPV) are expected to start in 2025, with COVID-19 leading, followed by the respiratory panel, TB, and HPV.
   • Commercial launches are anticipated in 2026, potentially earlier for the COVID-19 test, pending FDA clearance (expected within ~100 days post-submission).
   • The company aims to expand manufacturing in the U.S. and India to meet demand and is engaging with local health officials and trade organizations to support commercialization.