Co-Diagnostics (CODX) Q1 2026 earnings summary

Executive summary

• Revenue for Q1 2026 was $146,000, up from $50,000 year-over-year, with most sales from the U.S. and a significant portion from a few customers.

• Net loss widened to $9.1 million ($4.06 per share) from $7.5 million ($7.05 per share) year-over-year, driven by higher R&D and legal expenses and lower other income.

• Advanced clinical and commercialization pipeline, focusing on upper respiratory multiplex and TB tests, and expanded international presence in India and Saudi Arabia.

• Achieved key regulatory milestones, including CDSCO license and ISO 13485 certification for manufacturing in India, and initiated shipments of PCR Pro instruments and TB test materials.

• Strengthened global presence through partnerships, distributor relationships, and participation in major industry events.

Financial highlights

• Q1 2026 revenue was $146,000, up from $50,000 year-over-year; cost of revenue was $194,000, resulting in a gross loss of $48,000 versus a gross profit of $29,000 last year.

• Operating expenses rose to $9.2 million from $8.6 million, mainly due to increased R&D and legal costs.

• Net loss was $9.1 million ($4.06 per share) compared to $7.5 million ($7.05 per share) in Q1 2025.

• Adjusted EBITDA loss was $8.7 million, up from $7.4 million year-over-year.

• Cash and equivalents at quarter-end were $8.2 million, down from $11.9 million at 2025 year-end.

Outlook and guidance

• Anticipates continued operating losses and cash use in the near term as investments in clinical pipeline and regulatory submissions persist.

• Additional capital likely required to execute commercialization and development plans; evaluating equity, debt, and strategic partnerships.

• Focus remains on disciplined capital allocation and securing non-dilutive funding, including grants.

• FDA 510(k) submission for upper respiratory test expected in Q3 2026; TB clinical studies in India to begin imminently.

• Substantial doubt exists about the ability to continue as a going concern for the next 12 months without new capital.