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Co-Diagnostics, Inc. (CODX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 revenue was $0.16M, down sharply year over year due to zero grant revenue recognition, while net loss was $7.73M and diluted EPS was -$0.23; operating expenses fell 19.1% YoY as cost efficiencies took hold .
  • Versus S&P Global consensus, CODX posted a modest EPS beat (actual -$0.2335 vs -$0.25 estimate) but a meaningful revenue miss ($0.163M vs $0.300M estimate) in Q2 2025; revenue was up sequentially from Q1’s $0.05M on product sales only [*].
  • Management reiterated imminent start of clinical evaluations for COVID-19, multiplex respiratory (Flu A/B, COVID-19, RSV), tuberculosis (TB), and HPV tests, targeting 510(k) submission after trials and suggesting a potential mid-2026 commercialization for COVID-19, contingent on FDA timing and trial enrollment dynamics .
  • Liquidity ended Q2 at $13.4M (cash, equivalents, and marketable securities), with CFO highlighting continued use of ATM and exploring financing; subsequent to quarter-end, CODX raised ~$3.8M in a registered direct offering, modestly improving runway .

What Went Well and What Went Wrong

What Went Well

  • Operating expenses decreased ~19.1% YoY to ~$8.2M, reflecting ongoing efficiency efforts; R&D dropped to ~$4.69M from ~$5.61M YoY .
  • Execution milestones: clinical evaluation sites trained for enhanced COVID-19 test with enrollment expected imminently; management “remain[s] on track to reach our 2025 development and regulatory milestones” .
  • Strategic positioning and pipeline support: NIH RADx Tech-backed multiplex respiratory panel and Gates Foundation-supported TB and HPV assays; CEO emphasized confidence in platform quality and regulatory prospects .

What Went Wrong

  • Revenue fell to $0.16M from $2.66M in Q2 2024, driven by the absence of grant revenue recognition; gross profit declined accordingly despite high gross margin on limited product sales .
  • Adjusted EBITDA loss widened YoY to -$7.20M (vs -$5.92M), and operating loss increased to -$8.06M from -$7.68M, underscoring ongoing pre-commercialization cash burn .
  • Cash plus marketable securities declined vs year-end as CODX self-funds pipeline progression ahead of regulatory clearance; CFO signaled reliance on ATM, additional debt/equity, and grants to meet capital needs .

Financial Results

GAAP Results (comparisons vs prior quarter and prior year)

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD)$2,656,840 $50,277 $162,910
Gross Profit ($USD)$2,444,692 $28,687 $130,804
Operating Expenses ($USD)$10,124,654 $8,580,643 $8,188,568
Operating Loss ($USD)$(7,679,962) $(8,551,956) $(8,057,764)
Net Loss ($USD)$(7,599,318) $(7,533,271) $(7,730,117)
Diluted EPS ($)$(0.25) $(0.24) $(0.23)

Revenue Breakdown

Revenue TypeQ2 2024Q1 2025Q2 2025
Product Revenue ($USD)$161,102 $50,277 $162,910
Grant Revenue ($USD)$2,495,738 $215,109 $0

Margins (%)

MarginQ1 2025Q2 2025
Gross Profit Margin %57.06%*80.29%*

Values retrieved from S&P Global.*

Estimates vs Actuals (Wall Street Consensus – S&P Global)

MetricQ1 2025 ActualQ1 2025 ConsensusQ2 2025 ActualQ2 2025 ConsensusResult
Revenue ($USD)$50,277 $187,500*$162,910 $300,000*Q1: Miss; Q2: Miss
Primary EPS ($)$(0.2574)*$(0.27)*$(0.2335)*$(0.25)*Q1: Beat; Q2: Beat

Values retrieved from S&P Global.*

KPIs

KPIQ1 2025Q2 2025
Adjusted EBITDA ($USD)$(7,397,727) $(7,199,845)
Cash & Equivalents ($USD)$1,903,034 $11,115,181
Marketable Securities ($USD)$19,575,902 $2,247,638
Cash + Securities ($USD)$21,478,936 $13,362,819
Weighted Avg Shares (Basic & Diluted)32,048,953 33,108,399

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Clinical evaluations start (COVID-19)2025“Remain on track for initiation of clinical evaluations… by year-end 2025” Sites trained; trial participant enrollment “imminent” Firmed timing (near-term start)
Clinical evaluations start (Resp. multiplex, TB, HPV)2025“Remain on track for initiation… by year-end 2025” “Expect all… into clinical trials during the remainder of this calendar year” Affirmed and specified
510(k) pathway (COVID-19 test & PCR Pro)Post-trialsPrior: withdrew initial 510(k); plan enhanced submission with new clinical data Submit after clinical evaluations; FDA ~120-day review typical; potential mid-2026 commercialization (not guaranteed) Clarified timeline/expectations
Capital strategy2025Manage spend; pursue equity/grants “Using our ATM… evaluating debt and equity financing… seeking grant support” Maintained; reiterated tools
Post-quarter capital raiseN/AN/AClosed ~$3.8M registered direct at $0.40/share (9.619M shares) New funding completed

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24 & Q1’25)Current Period (Q2’25)Trend
Regulatory strategy (510(k))Withdrew initial 510(k); plan enhanced submission with updated chemistry & clinical data Submit after clinical evaluations; FDA ~120-day review typical; aiming for mid-2026 commercialization Advancing; timeline clearer
Clinical evaluations (COVID-19)Preparation underway; verification testing complete Sites trained; enrollment “imminent” Accelerating
Multiplex respiratory (Flu A/B, COVID, RSV)FDA pre-submission assigned reviewer; evaluations expected H2’25 “Nearly prepared for clinical evaluations” concurrent with fall/winter season On schedule
TB test (India/Africa)Identified sample prep & pathway; plan evaluations H2’25; CDSCO/SAHPRA submissions Remaining on track to begin evaluations in India & South Africa before year-end On schedule
HPV multiplex (Gates-funded)Chemistry optimization done; path toward India clearance Clinical evaluations to initiate before year-end Advancing
Funding & liquidityBalance sheet management; plan equity/grants Using ATM; evaluating debt/equity; seeking grants Active financing posture

Management Commentary

  • CEO: “We remain on track to reach our 2025 development and regulatory milestones… [and] believe that the results of our clinical evaluations will position us for strong regulatory submissions” .
  • CEO on respiratory panel: designed to deliver simultaneous PCR results for flu A/B, COVID-19, RSV; “nearly prepared for clinical evaluations” as flu season approaches .
  • CFO: “We plan to provide for the company’s capital requirements through equity and or debt financing, additional grant funding, and operational efficiencies. More specifically, we’re using our ATM to generate capital when appropriate” .

Q&A Highlights

  • Clinical cadence: COVID-19 trials first, followed by respiratory multiplex, TB, then HPV; all indications expected to enter clinical trials in 2025 .
  • Commercialization timeline: CEO hopes for commercialization before end-2026, with a “reasonable possibility” by mid-2026 for COVID-19 pending trial completion and FDA review (~120 days typical, not guaranteed) .
  • Go-to-market: U.S. focus on physician offices/clinics, skilled nursing facilities, home use (seeking clearance), and pharmacies; India focus on primary healthcare centers in place of microscopy .

Estimates Context

  • Q2 2025: EPS modest beat (actual -$0.2335 vs -$0.25 estimate); revenue miss (actual $162,910 vs $300,000 estimate) [*].
  • Q1 2025: EPS beat (actual -$0.2574 vs -$0.27 estimate); revenue miss (actual $50,277 vs $187,500 estimate) [*].
  • No consensus target price or recommendation available from S&P Global for CODX at this time [].
    Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalysts: formal start of COVID-19 clinical evaluations and progress updates across respiratory multiplex, TB, and HPV; each step reduces regulatory risk and can drive sentiment and liquidity .
  • Regulatory path clarity: expect 510(k) submissions post-trials; average FDA review ~120 days suggests potential mid-2026 commercialization for COVID-19 contingent on enrollment and positivity rate dynamics; monitor trial enrollment pace .
  • Funding watch: continued ATM usage and subsequent ~$3.8M raise post-quarter indicate reliance on external capital ahead of commercialization; dilution risk persists until revenue scale-up .
  • Revenue composition: product-only sales with no grant recognition drove YoY revenue decline; sequential product revenue improved, but grant timing remains a swing factor for reported top line .
  • Execution priorities: maintaining OpEx discipline while accelerating R&D milestones; sustained cost control is supportive, but EBITDA losses will likely continue pre-clearance .
  • Geographic strategy: India/Africa for TB/HPV and U.S. for COVID-19/respiratory multiplex align with funding support and market need, potentially smoothing initial adoption curves .
  • Stock drivers: concrete trial start announcements, FDA interactions/submissions, financing updates, and any early data readouts are the most likely near-term share price catalysts .