CODX — Co-Diagnostics, Inc.

Summary of Co-Diagnostics, Inc. Q4 2025 Earnings Call

1. Key Financial Results and Metrics

• Total Revenue: $0.6 million for 2025, down from $3.9 million in 2024, primarily due to reduced grant revenue.
• Product Revenue: $0.4 million, compared to $0.8 million in 2024, reflecting limited commercial activity.
• Operating Expenses: $50.6 million, up from $43.0 million in 2024, largely due to an $18.9 million noncash impairment charge related to R&D intangible assets.
• Net Loss: $46.9 million ($35.25 per share), compared to a net loss of $37.6 million ($37.22 per share) in 2024. Excluding the impairment, the adjusted net loss would be $28.0 million.
• Adjusted EBITDA: Loss of $28.0 million, improved from a loss of $33.5 million in 2024.
• Cash Position: Ended the year with $11.9 million in cash, down from $29.7 million in 2024.

2. Strategic Updates and Business Highlights

• Regulatory Progress: Successfully relisted on NASDAQ, enhancing shareholder confidence.
• CoSara Joint Venture: Expanded operations in India, receiving CDSCO license for local manufacturing of the PCR Pro instrument and increasing market reach to include Bangladesh, Pakistan, Nepal, and Sri Lanka.
• Clinical Pipeline: Advancing TB and HPV tests, with TB representing a significant opportunity in India, supported by WHO guidelines favoring near point-of-care molecular tests.
• CoMira Joint Venture: Focused on establishing local manufacturing in Saudi Arabia, aiming to be the first domestic manufacturer of molecular diagnostics in the region.
• Intellectual Property: Secured international patents for key components of the Co-Dx PCR platform, bolstering competitive positioning.

3. Forward Guidance and Outlook

• Clinical Trials: Expect to initiate TB clinical performance studies in India, with commercialization anticipated by Q3 2026.
• Regulatory Submissions: Planning to submit for FDA approval for the upper respiratory multiplex test, focusing on flu A, flu B, and RSV, while keeping the option to add COVID-19 later.
• Financial Management: Continuing to evaluate financing alternatives, including equity and strategic partnerships, while managing liquidity and cost structure.

4. Bad News, Challenges, or Points of Concern

• Revenue Decline: Significant drop in total and product revenue compared to the previous year, raising concerns about commercial viability.
• Operating Losses: Continued operating losses expected in the near term as the company invests in development and regulatory milestones.
• Impairment Charge: The substantial noncash impairment charge indicates challenges in asset valuation and may signal underlying issues in R&D effectiveness.
• Market Conditions: The limited availability of COVID-19 samples affected the clinical trial timelines and may impact future product offerings.

5. Notable Q&A Insights

• COVID-19 Testing Flexibility: Management clarified that the decision to exclude COVID-19 from the multiplex test was based on sample availability, not platform limitations. They expressed confidence in reintroducing COVID-19 testing when conditions allow.
• Expansion Strategy: The expansion into South Asia is seen as a strategic move to leverage existing capabilities and address similar disease burdens in the region.
• Sample Requirements for FDA Studies: Management indicated that they are nearing completion of patient enrollment for FDA studies, with expectations of needing over 1,200 samples for the upper respiratory multiplex test.

This earnings call reflects a period of strategic repositioning for Co-Diagnostics, with a focus on regulatory advancements and international expansion, despite facing significant financial challenges and operational losses.