Revenue Growth Year-over-Year
Total revenue for Q1 2026 was $146,000, up from $50,000 in Q1 2025, an increase of approximately 192% YoY, demonstrating early commercial traction despite low absolute dollar levels.
Co-Diagnostics
· CODX
May 14th, 2026
Summary
- Earnings Call Date:
- 2026-05-14
- Change Since:
- +119.02%
- Next Earnings Date:
- 2026-08-06
Earnings Call Sentiment
NeutralThe call communicated meaningful operational and regulatory progress across multiple strategic fronts — completed upper respiratory enrollment (>1,400 patients), India manufacturing license and expanded TAM (~$13B), TB clinical start timing, land allocation in Saudi Arabia, and manufacturing automation plans (~4x efficiency). However, the company still reports very limited absolute revenue, a negative gross margin, widening net loss and adjusted EBITDA losses, and a substantial cash decline to $8.2M with an anticipated need for additional capital. Program-level uncertainties (COVID prevalence affecting submission scope), unfinished manufacturing rollouts and no assurance on strategic transactions temper the positive operational milestones. Overall, operational momentum is clear, but financial constraints and execution risks balance the outlook.
Company Guidance
Management provided near‑term regulatory and commercial guidance highlighting that the upper‑respiratory clinical study is fully enrolled with more than 1,400 patients and management believes the data support an initial 510(k) submission for Flu A/Flu B/RSV (COVID to be added later if needed), with analytical work and documentation being finalized and a targeted filing in Q3 2026 for CLIA‑waived point‑of‑care clearance; TB clinical performance studies are scheduled to begin before month‑end with potential commercialization in India as early as the end of Q3; CoSara (9 years in market) has a CDSCO license to manufacture the PCR Pro, 15 CDSCO‑cleared PCR tests, a nationwide presence serving hundreds of lab customers, an expanded South Asia addressable market of roughly $13 billion, and an oligo facility inaugurated end‑2024, while Utah has produced hundreds of thousands of test cups and is developing an automated cup line expected to improve efficiency by ~4x; CoMira secured industrial land allocation in Sudair and has completed initial funding contributions; financials and capital guidance included Q1 revenue of $146k (vs. $50k), cost of revenue $194k (gross loss ≈$48k vs. prior gross profit $29k), operating expenses $9.2M (R&D $5.9M, S&M $0.5M, G&A $2.5M), net loss $9.1M or $4.06 per diluted share (vs. $7.5M or $7.05), adjusted EBITDA loss $8.7M (vs. $7.4M), cash of $8.2M (vs. $11.9M year‑end 2025), and the company expects additional capital will likely be required and is evaluating equity, debt, strategic partnerships and nondilutive funding.
Upper Respiratory Clinical Enrollment Completed (>1,400 Patients)
Clinical study enrollment for the upper respiratory multiplex test exceeded 1,400 patients. Management believes the data supports an initial 510(k) submission focused on Flu A, Flu B and RSV and is preparing to file for CLIA-waived point-of-care clearance, targeted for Q3 2026 (subject to validations).
India (CoSara) Regulatory and Manufacturing Progress
CoSara has a nationwide commercial presence, has served hundreds of laboratory customers, holds 15 clinical PCR test clearances from CDSCO, received a CDSCO license to manufacture the PCR Pro instrument, and has expanded distribution across South Asia increasing the total addressable market to about $13 billion.
TB Program Advancement and Alignment with WHO Guidance
Clinical performance studies for the MTB (TB) test are scheduled to begin before month-end; management expects potential commercialization in India as early as end of Q3 2026. The test design aligns with recent WHO recommendations for near point-of-care molecular TB testing and tongue swab samples.
Saudi Arabia (CoMira) Expansion Milestone
CoMira secured industrial land allocation in Sudair Industrial City, progressed facility lease and site development, and completed initial required funding contributions, positioning the JV for localized manufacturing and potential procurement advantages in the MENA region.
Manufacturing Capacity and Automation Improvements
Utah facility has produced hundreds of thousands of test cups for studies and R&D and is developing an automated test cup manufacturing line expected to improve efficiency by ~4x in time and overhead, reducing manual steps and potential errors.
Platform and Pipeline Diversification
Continued advancement of non-TB programs (HPV in preclinical/qualification, expanding Vector placements), cloud-connected architecture with ML/algorithmic capabilities, and ongoing automation in consumable production, supporting broader use cases and scalability.
Operator
Thank you for standing by. At this time, I would like to welcome everyone to the Co-Diagnostics, Inc. First Quarter 2026 Earnings Webcast. [Operator Instructions] I would now like to turn the conference over to Andrew Benson, Head of Investor Relations. The floor is yours.
Andrew Benson
Good afternoon, everyone. Thank you all for participating in today's conference call. On the line today from Co-Diagnostics, we have Dwight Egan, Chief Executive Officer; and Brian Brown, Chief Financial Officer. Earlier today, Co-Diagnostics released financial results from the first quarter ended March 31, 2026. A copy of the press release is available on the company's website. We will begin with management's prepared remarks and then open up the call to analysts for Q&A. Before we begin, we would like to inform listeners that certain statements made by Co-Diagnostics during this call, which are not historical facts, are forward-looking statements. In addition to diagnostic test developments and timing for commencement of clinical evaluations, this includes statements concerning the company's Co-Dx PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale.
Actual outcomes and results may differ materially from what is expressed or implied in any statement. Important factors which could cause actual results to differ materially from those in these forward-looking statements are detailed in Co-Diagnostics' filings with the SEC. Co-Diagnostics assumes no obligation and expressly disclaims any duty to update any forward-looking state...
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