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Co-Diagnostics Inc (CODX) (Q2 2026) Earnings Call Highlights: FDA Submission Milestone and ...

This article first appeared on GuruFocus .

  • Revenue:Total revenue was $166,000 for Q2 2026, compared to $163,000 in the same period last year.

  • Gross Profit:Gross profit was approximately $121,000, compared to $131,000 in the prior year period.

  • Operating Expenses:Total operating expenses were $6.3 million, down from $8.2 million in the prior year period.

  • Research and Development Expenses:R&D expenses were $4.2 million, compared to $4.7 million in the prior year period.

  • Sales and Marketing Expenses:Sales and marketing expenses were $467,000, compared to $610,000 in the prior year.

  • General and Administrative Expenses:G&A expenses were $1.5 million, compared to $2.6 million in the prior year.

  • Net Loss:Net loss was $6.3 million, or $1.46 per basic and diluted share, compared to a net loss of $7.7 million, or $7 per share, in the same period last year.

  • Adjusted EBITDA:Adjusted EBITDA loss was $5.8 million, compared to a loss of $7.2 million in the prior year period.

  • Cash and Cash Equivalents:Ended the quarter with $3.6 million, compared to $11.9 million at the end of 2025.

  • Total Assets:Total assets were $16.6 million, compared to $24.7 million at year-end.

  • Total Liabilities:Total liabilities were $3.9 million, compared to $4.1 million at year-end.

Release Date: August 13, 2026

For the complete transcript of the earnings call, please refer to the full earnings call transcript .

Positive Points

  • Co-Diagnostics Inc ( NASDAQ:CODX ) submitted its dual 510(k) and CLIA waiver application to the FDA for its flu A, B and RSV assay on the Co-Dx PCR platform, a major regulatory milestone.

  • The company completed extensive analytical and clinical validation studies, including over 10,000 test runs and a clinical study with more than 1,400 patients across 9 U.S. sites.

  • Co-Diagnostics Inc ( NASDAQ:CODX ) is advancing its tuberculosis program in India, targeting CDSCO and WHO ERPD submissions later this year, with costs partially supported by NGO partners.

  • The company demonstrated platform versatility by completing a proof-of-concept study for an Ebola assay using direct plasma samples, expanding beyond traditional swab-based testing.

  • Co-Diagnostics Inc ( NASDAQ:CODX ) reduced total operating expenses to $6.3 million in Q2 2026 from $8.2 million in the prior year, reflecting disciplined cost management.

  • The company is expanding its digital infrastructure and AI-enabled capabilities, aiming to create a connected ecosystem for decentralized testing and population-level health insights.

Negative Points

  • Co-Diagnostics Inc ( NASDAQ:CODX ) reported minimal revenue of $166,000 in Q2 2026, with limited current revenue levels and variability in gross margin performance.

  • The company's net loss for Q2 2026 was $6.3 million, or $1.46 per share, reflecting continued operating losses.

  • Cash and cash equivalents decreased significantly to $3.6 million at the end of Q2 2026 from $11.9 million at the end of 2025, indicating a tight liquidity position.

  • Co-Diagnostics Inc ( NASDAQ:CODX ) anticipates continued operating losses in the near term and may need to seek additional capital through equity or debt financings, which could lead to dilution.

  • The company's regulatory submissions, including the FDA application and TB-related filings, are subject to review and approval, with no guarantee of clearance or commercialization timelines.

  • The Ebola assay development is still in early stages, with no clear timeline for regulatory approval or commercial availability, and the company's strategy is to be 'ready when needed' rather than immediate revenue generation.

Q & A Highlights

Q: Did I understand correctly that you plan to submit the tuberculosis test for ERPD assessment later this year? A: Yes, that is correct. Dwight Egan, CEO, confirmed the planned submission to the WHO's Expert Review Panel for Diagnostics (ERPD) later this year, following the advancement of clinical studies in India.

Q: Could you expand upon the Ebola strategy, including timelines for development and how early the test could be used in infection? A: Dwight Egan, CEO, explained that the Ebola strategy is designed to be ready when needed. The company rapidly responded to the development need, completing a proof-of-concept study for a blood-based assay on the Co-Dx PCR Pro. They have already fulfilled a request from India's C-CAMP for 200 Bundibugyo tests to be evaluated by a third-party laboratory, positioning the company to respond as the disease evolves.

Q: What were the key financial results for the second quarter of 2026? A: Brian Brown, CFO, reported total revenue of $166,000, a net loss of $6.3 million ($1.46 per share), and an adjusted EBITDA loss of $5.8 million. Operating expenses decreased to $6.3 million from $8.2 million in the prior year, driven by lower R&D, G&A, and stock-based compensation expenses. The company ended the quarter with $3.6 million in cash.

Q: What is the status of the U.S. regulatory submission for the upper respiratory panel? A: Dwight Egan, CEO, highlighted the submission of the dual 510(k) and CLIA waiver application to the FDA for the Flu A, B and RSV assay on the Co-Dx PCR platform. This was supported by 27 analytical studies, over 10,000 test runs, and a clinical study enrolling more than 1,400 symptomatic patients across 9 U.S. sites.

Q: How is the company progressing with its tuberculosis program in India? A: Dwight Egan, CEO, noted meaningful progress with clinical studies advancing on the CoSara PCR Pro instrument and MTB test. The company is targeting regulatory milestones later this year, including submissions to India's CDSCO and the WHO's ERPD, leveraging its CoSara joint venture's manufacturing and commercial infrastructure.

Q: What is the strategic significance of the recent WHO guidance on near point-of-care TB testing? A: Dwight Egan, CEO, stated that the WHO guidance recommending near point-of-care molecular testing, including tongue swab sampling, aligns closely with the design of the Co-Dx platform and MTB assay. This convergence, combined with CoSara's infrastructure and domestic manufacturing, creates a compelling path to market in high-need regions.

Q: How is the company expanding its digital infrastructure and data capabilities? A: Dwight Egan, CEO, discussed the investment in a connected ecosystem combining molecular diagnostics, a mobile app, and secure cloud-based infrastructure. This platform is designed to support decentralized testing, secure reporting, and real-time data access, with plans to expand to all regulatory regions, including India and Saudi Arabia. The data generated is viewed as a valuable long-term strategic asset.

Q: What progress is being made with the CoMira joint venture in Saudi Arabia? A: Dwight Egan, CEO, reported hosting the CoMira executive team at headquarters to prepare for technology transfer activities. The company unveiled its future automated manufacturing line to support increased production capacity, aiming to complete localized manufacturing in Saudi Arabia to support expansion into the Middle East and North Africa.

Q: How is the Vector Smart business performing? A: Dwight Egan, CEO, noted that commercial momentum for Vector Smart continues to build, expanding the customer footprint across mosquito abatement districts nationwide. The business demonstrates the versatility of the technology beyond clinical diagnostics, enabling in-house molecular testing to reduce turnaround times for public health applications.

Q: How is the company managing its capital resources given the continued operating losses? A: Brian Brown, CFO, stated that the company is managing capital with discipline, prioritizing investments for key clinical and regulatory milestones. They expect to evaluate available sources of capital, including equity or debt financings and strategic transactions, while staying mindful of dilution and pursuing non-dilutive funding such as grants.

For the complete transcript of the earnings call, please refer to the full earnings call transcript .

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