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Co-Diagnostics, Inc. (CODX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 revenue was $0.145M, down 77% year over year as grant revenue recognized last year did not recur; diluted EPS improved to $(0.16) vs $(0.32) in Q3 2024, with operating expenses reduced 32.6% YoY .
  • Versus S&P Global consensus, revenue missed ($0.145M vs $0.300M*) while EPS beat (−$0.16 vs −$0.19*); the miss was driven by lower grant revenue, and the EPS beat reflected cost discipline and lower OpEx .
  • Strategic catalysts: formation of Saudi JV CoMira (KSA + 18 MENA), new AI business unit (Primer Ai™), and engagement of Maxim for a potential SPAC transaction for India JV CoSara; these actions seek to expand commercialization, unlock JV value, and accelerate R&D/AI execution .
  • Liquidity: “cash, cash equivalents, and marketable securities” were $11.4M at quarter-end; subsequent registered offerings totaled $10.8M gross proceeds, adding flexibility ahead of clinical evaluations and potential FDA 510(k) submissions .

What Went Well and What Went Wrong

What Went Well

  • Cost discipline: OpEx fell to ~$7.1M (−32.6% YoY) and adjusted EBITDA loss improved to $(6.3)M, materially narrowing the net loss to $(5.9)M (from $(9.7)M) .
  • Strategic progress and narrative clarity: “We are entering one of the most active and strategically important periods,” linking the CoMira JV, potential CoSara SPAC, and AI unit as pillars for growth and value creation .
  • Clinical momentum: Company prepared upper-respiratory multiplex clinical evaluations and announced initiation on Nov 18 to support FDA 510(k) submission for the test and Co-Dx PCR Pro™ instrument .

What Went Wrong

  • Top-line pressure: Revenue fell to $0.145M (vs $0.641M in Q3 2024), missing consensus; management cited lower grant revenue recognition as the primary driver .
  • Continued losses and dependency on external capital: Net loss $(5.9)M and continued negative adjusted EBITDA necessitated capital raises ($3.8M in Sept; $7.0M in Oct) to fund operations and development .
  • Execution risk remains: Management reiterated platform not yet cleared for sale; regulatory timelines and clinical enrollment dynamics (e.g., positive/negative case mix) could shift commercialization timing .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$0.641 $0.050 $0.163 $0.145
Gross Profit ($USD Millions)$0.344 $0.029 $0.131 $0.119
Gross Margin %53.6% 57.1% 80.3% 81.9%
Total Operating Expenses ($USD Millions)$10.579 $8.581 $8.189 $7.133
Operating Loss ($USD Millions)$(10.235) $(8.552) $(8.058) $(7.014)
Net Loss ($USD Millions)$(9.696) $(7.533) $(7.730) $(5.887)
Diluted EPS ($)$(0.32) $(0.24) $(0.23) $(0.16)
Adjusted EBITDA ($USD Millions)$(8.825) $(7.398) $(7.200) $(6.302)

Revenue mix (Product vs Grant):

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Product Revenue ($USD Millions)$0.207 $0.050 $0.163 $0.145
Grant Revenue ($USD Millions)$0.434 $0.000 $2.496 $0.000

Operating expense components:

Opex Component ($USD Millions)Q3 2024Q1 2025Q2 2025Q3 2025
Sales & Marketing$1.060 $0.657 $0.610 $0.569
General & Administrative$4.287 $2.773 $2.600 $1.816
Research & Development$4.880 $4.870 $4.687 $4.481
Depreciation & Amortization$0.351 $0.280 $0.291 $0.267

Liquidity snapshot:

MetricMar 31, 2025Jun 30, 2025Sep 30, 2025
Cash & Cash Equivalents ($USD Millions)$1.903 $11.115 $11.444
Marketable Investment Securities ($USD Millions)$19.576 $2.248 $0.000
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$21.5 $13.4 $11.4

Vs estimates (Q3 2025):

MetricActualS&P Global ConsensusSurprise
Revenue ($USD Millions)$0.145 $0.300*MISS
Primary EPS ($)$(0.16) $(0.19)*BEAT

*Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FDA 510(k) COVID test submission/commercialization2025–2026Q2 call indicated clinical evals imminent; potential mid-2026 commercialization depending on FDA timing Q3 reiterated imminent clinical evaluations; focus on pipeline; home/POC, physician offices, SNFs, pharmacies targeted; timeline dependent on clinical enrollment and FDA 120-day review norm Maintained qualitative timeline; clarified target channels
Upper respiratory multiplex (Flu A/B, COVID, RSV)2025–2026Expected evaluations concurrent with North American flu season Clinical evaluations initiated Nov 18, 2025 to support FDA 510(k) for test and Co-Dx PCR Pro™ Progressed from planned to active evaluations
MTB and HPV multiplex2025On track to initiate clinical evaluations before year-end; supported by Gates Foundation Reaffirmed timelines; AI/Primer Ai integration to support development Maintained
Financial metrics (Revenue, Margins, OpEx, OI&E, Tax rate, Dividends)Q3 2025 onwardNo quantitative guidance providedNo quantitative guidance providedMaintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Clinical evaluations & FDA pathQ2: COVID clinical sites trained; respiratory panel planned during flu season; MTB/HPV targeted to India/Africa; FDA 510(k) submissions contemplated CEO/CFO reiterated imminent clinical starts; Nov 18 PR confirms respiratory multiplex evaluations initiated for FDA submission Accelerating; moved from planning to execution
AI/Primer Ai™ initiativesLimited explicit detail in Q1/Q2; cloud-based analytics discussed Formed AI business unit led by Chief Technology & AI Officer to unify and accelerate AI tools across design, interpretation, and predictive epidemiology Intensifying; formalized org and platform vision
Saudi JV (CoMira)Not present in Q1; JV vision in planning [—]Definitive agreement signed to localize Co-Dx PCR platform across KSA and 18 MENA nations; SFDA path anticipated New strategic footprint; clear regional roadmap
India JV (CoSara) & strategic alternativesOngoing manufacturing footprint; India a priority market Engaged Maxim to pursue SPAC or similar transaction to unlock JV value and support funding strategy Corporate action underway; potential value unlock
Financing & liquidityATM usage and financing structures under evaluation Closed $3.8M (Sept) and $7.0M (Oct) registered direct offerings to fund working capital Proactive capital raising to bridge to commercialization

Management Commentary

  • “We are entering one of the most active and strategically important periods in our Company’s history,” highlighting CoMira JV, CoSara SPAC exploration, and the AI business unit as an aligned strategy for financial strength, innovation, and long-term value creation .
  • On pipeline execution: “We are preparing to initiate clinical evaluations for our upper-respiratory multiplex test supported by a grant from the NIH’s RADx Tech program” and to leverage Primer Ai™ to drive development and operational efficiency .
  • CFO: “Total operating expenses… decreased to $7.1 million… Net loss… was $5.9 million… We ended the quarter with $11.4 million in cash, cash equivalents, and marketable investment securities,” reinforcing cost optimization and liquidity posture .

Q&A Highlights

  • JV performance and market focus: Management emphasized strong performance at CoSara and the strategic rationale for establishing CoMira in KSA where Saudi Arabia has historically been CODX’s largest international customer; the JV aims to localize production and distribution for the Co-Dx PCR Pro .
  • Affordability and competitive positioning: CODX designed PCR Pro to reach a materially lower price point by engineering from a “clean slate” and leveraging Co-Primers® multiplexing (e.g., HPV 8-plex + human control), enabling relevant affordability at scale .
  • Deployment priorities: For U.S. commercialization, targets include physician offices/clinics, skilled nursing facilities, home-use, and pharmacies; in India, primary care centers are key, with intent to replace smear microscopy with molecular diagnostics .
  • Timeline clarification: COVID test clinical evaluations expected to conclude near year-end with a reasonable possibility of mid-2026 FDA clearance; timing depends on achieving adequate positive/negative enrollment mix .

Estimates Context

  • Q3 2025 comparison: Revenue $0.145M vs $0.300M consensus* (MISS); EPS −$0.16 vs −$0.19 consensus* (BEAT). The revenue miss was largely due to lower grant revenue recognition; the EPS beat was supported by lower OpEx and improved operating leverage .
  • Forward estimates: Consensus revenue for the next three quarters is ~$0.300M* each; EPS consensus trends from −$0.16* in Q4 2025 to −$0.10* by Q2 2026, reflecting an expected gradual improvement as clinical and regulatory milestones advance.
  • Potential estimate revisions: Sell-side may lower near-term revenue assumptions if grant revenue remains limited, but maintain/improve EPS trajectory assumptions if cost reductions persist and capital raises de-risk near-term funding .

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalysts include active clinical evaluations for the upper respiratory multiplex (initiated Nov 18) and anticipated submissions for FDA 510(k); regulatory progress is the primary stock narrative driver .
  • Strategic optionality from CoSara SPAC exploration could unlock JV value and augment funding capacity ahead of 2026 commercialization objectives .
  • The CoMira JV establishes a localized KSA/MENA manufacturing and distribution pathway, potentially accelerating regional adoption once SFDA clearance is achieved .
  • AI platform formalization (Primer Ai™) is designed to enhance assay design, automated interpretation, and predictive epidemiology—differentiating CODX’s point-of-care PCR offering .
  • Operational execution remains disciplined: materially lower OpEx and improved adjusted EBITDA loss underpin an EPS beat despite revenue headwinds from reduced grant recognition .
  • Funding runway is supported by $11.4M in cash/marketable securities at quarter-end and $10.8M of subsequent gross proceeds from registered offerings, reducing near-term financing risk .
  • Risk/reward hinges on clinical enrollment cadence, regulatory timing, and successful commercial channel development (physician offices, SNFs, pharmacies, home-use) in the U.S. and primary care deployment in India and KSA .