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Co-Diagnostics, Inc. (CODX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 topline and EPS missed a very low-coverage Street bar: revenue was ~$0.15M vs ~$0.38M consensus and EPS was -$0.38 vs -$0.34; the quarter remained pre-commercial and grant-light, with negative gross margin on minimal revenue (1 estimate) [Values retrieved from S&P Global]*.
  • Management withdrew its FDA 510(k) for the Co-Dx PCR COVID-19 test/Pro instrument based on FDA feedback around shelf-life stability monitoring, and plans to resubmit an enhanced version with updated clinical data; this reset the regulatory timeline but management emphasized clearer path and manufacturability gains .
  • FY24 revenue fell to $3.9M (product $0.8M, grant $3.1M), operating loss $40.1M, net loss $37.6M; cash, cash equivalents and marketable securities were $29.7M at 12/31/24 (down from $37.7M at 9/30/24 and $44.9M at 6/30/24) .
  • Pipeline cadence: target clinical evaluations in 2H 2025 for TB, HPV multiplex, and upper-respiratory multiplex (FDA pre-sub completed and reviewer assigned), while India “Make in India” manufacturing footprint was expanded via CoSara’s oligo facility and test manufacturing license to support evaluations .

What Went Well and What Went Wrong

  • What Went Well

    • Clearer FDA path and platform enhancements after withdrawing the 510(k): “we believe we have a clear path forward based on their feedback” and “submit an enhanced COVID-19 test” .
    • Pipeline traction and timelines: TB, HPV multiplex, and upper respiratory multiplex evaluations targeted for 2H 2025; FDA pre-sub for respiratory multiplex already assigned a reviewer .
    • Manufacturing and regional strategy strengthened: new Utah facility for instruments/test cups and CoSara’s India oligonucleotide facility inaugurated to support cost-efficient, in-country production and “Make in India” benefits .

  • What Went Wrong

    • Regulatory delay: withdrawal of the COVID-19 510(k) submission due to shelf-life stability monitoring issue for a test component resets commercialization timing .
    • Minimal quarterly revenue and negative gross margin on low volume: Q4 revenue of ~$0.15M, gross profit negative on S&P data, highlighting grant timing and pre-commercial profile [Values retrieved from S&P Global]*.
    • Elevated legal spend pressured OpEx: 2024 legal expenses rose to ~$7.0M from ~$1.7M (securities class action defense), contributing to net loss; case was later dismissed in March 2025 .

Financial Results

Quarterly results vs prior periods and consensus (oldest → newest)

  • Income statement highlights (actuals vs consensus):
MetricQ4 2023Q2 2024Q3 2024Q4 2024
Revenue (Actual, $)$3,555,177*$2,656,840 $641,141 $149,325*
Revenue (Consensus, $)$3,625,000*$375,000*$375,000*$375,000*
EPS (Actual)-$0.50*-$0.25 -$0.32 -$0.38*
EPS (Consensus)-$0.20*-$0.34*-$0.33*-$0.34*
  • Margins and costs (actuals):
MetricQ4 2023Q2 2024Q3 2024Q4 2024
Gross Profit ($)N/A$2,444,692 $343,738 -$105,743*
Gross Margin (%)N/A92.02%*53.61%*-70.81%*
Net Income ($)N/A-$7,599,318 -$9,696,455 -$11,031,192*
Net Income Margin (%)N/A-286.03%*N/A*N/A*
Total Operating Expenses ($)N/A$10,124,654 $10,578,675 $12,056,349*
  • Liquidity KPIs:
MetricJun 30, 2024Sep 30, 2024Dec 31, 2024
Cash, Cash Equivalents + Marketable Securities ($)$44.9M $37.7M $29.7M
  • Revenue mix (where disclosed):
MetricQ2 2024Q3 2024FY 2024
Product Revenue ($)$161,102 $206,876 $770,048
Grant Revenue ($)$2,495,738 $434,265 $3,145,112

Notes: All cells marked with an asterisk (*) are Values retrieved from S&P Global.

Guidance Changes

Metric/ItemPeriodPrevious (Q3 2024)Current (Q4 2024)Change
FDA 510(k) – Co-Dx PCR COVID-19 test/Pro instrument2024-2025Under active FDA review; progressing submission Withdrew 510(k) based on FDA feedback re shelf-life stability monitoring; will resubmit enhanced test with updated clinical data Revised pathway/timeline reset
Respiratory Multiplex (Flu A/B, COVID-19, RSV)2025Development progressing; no timeline prior FDA pre-sub completed; reviewer assigned; preparing full evaluations (H2 2025) More concrete regulatory steps
TB test2025Development progressing Clinical evaluations targeted H2 2025 (South Africa, India) Timeline specified
HPV multiplex2025Development progressing Clinical evaluations targeted H2 2025; chemistry optimization complete Timeline specified
Quantitative revenue/margin guidance2024-2025Not providedNot providedMaintained (no financial guidance)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024)Trend
FDA path for COVID-19 OTC test/Pro instrumentSubmitted first 510(k) (Q2) ; active FDA review (Q3) Withdrew 510(k) to address shelf-life stability monitoring; resubmission planned with enhanced test and updated clinical data Regulatory re-route; clearer plan
Respiratory multiplex (Flu/COVID/RSV)Development ongoing; grant support (NIH RADx) (Q3) FDA pre-sub completed, reviewer assigned; evaluations expected H2 2025 Advancing toward evaluations
TB testR&D progress (Q3) H2 2025 clinical evaluations planned in South Africa and India; sample prep approach identified; CDSCO pathway in India outlined Operationalizing clinical plan
HPV multiplexDevelopment ongoing (Q3) Chemistry optimization complete; H2 2025 clinical evaluations targeted; India-first path Moving to clinical readiness
Manufacturing footprintNew Utah facility for instruments/test cups (Q2) CoSara India oligo facility inaugurated (Dec 2024) ; CDSCO test manufacturing license to support evaluations Capacity/cost base strengthened
Legal/regulatory overhangNot highlighted previouslyLegal expenses rose materially in 2024 due to litigation; subsequent lawsuit dismissal Mar 2025 Overhang improving post-dismissal

Management Commentary

  • “We received feedback from the FDA regarding the ability to monitor the shelf life stability of [a] test component… management made the decision to withdraw our 510(k) [and] submit… with updated clinical data… We believe we have a clear path forward based on their feedback.” — CEO Dwight Egan .
  • “We are on track to commence clinical evaluations in both South Africa and India in the second half of 2025 [for TB]… [and] FDA pre-sub… assigned a reviewer [for respiratory multiplex].” — CEO Dwight Egan .
  • “We inaugurated a new manufacturing facility in South Salt Lake… and a second facility in India to support cost-effective manufacturing of our Co-Primers oligonucleotides.” — CEO Dwight Egan .
  • “Legal expenses for 2024 increased to $7.0M from $1.7M in 2023 due to securities class action defense… We ended the quarter with $29.7M in cash, cash equivalents and marketable securities.” — CFO Brian Brown .
  • FY24 release: “Revenue of $3.9M (grant $3.1M; product $0.8M)… Adjusted EBITDA loss of $33.5M… Cash and securities of $29.7M.” .

Q&A Highlights

  • Avian flu readiness: On H5N1, “We have developed a H5N1 test… prepared to make additions… for humans and/or livestock and birds” if needed — CEO Dwight Egan .
  • No other material Q&A disclosures; call focused on regulatory plan, pipeline timelines, and operating posture –.

Estimates Context

  • Coverage is extremely thin (1 estimate each), limiting the signal from “beats/misses.” Q4 2024: revenue ~$0.15M vs ~$0.38M (miss ~$0.23M); EPS -$0.38 vs -$0.34 (miss ~$0.04). Q3 2024: revenue ~$0.64M vs ~$0.38M (beat), EPS -$0.32 vs -$0.33 (slight beat). Q2 2024: revenue ~$2.66M vs ~$0.38M (beat), EPS -$0.25 vs -$0.34 (beat) [Values retrieved from S&P Global]*.
  • Given the regulatory reset and H2’25 clinical timelines, Street models may trim near-term revenue and push out commercialization, while OpEx/cash-burn cadence remains a key variable for path-to-launch .

Key Takeaways for Investors

  • Regulatory reroute but clearer plan: Withdrew COVID-19 510(k) to address shelf-life stability monitoring; resubmission of enhanced test planned with updated clinical data—expect timeline push but potentially higher likelihood of clearance .
  • Pipeline execution framing 2025: TB, HPV multiplex, and respiratory multiplex clinical evaluations targeted for 2H 2025; respiratory multiplex already through pre-sub and reviewer assignment .
  • Liquidity runway tightening: Cash + securities declined to $29.7M at 12/31/24 from $37.7M at 9/30/24 and $44.9M at 6/30/24; management plans to fund via equity, grants, and efficiencies—monitor capital needs and timing vs clinical/regulatory milestones .
  • Revenue remains grant-driven and lumpy; product revenue minimal pre-clearance—near-term P&L remains predominantly expense-side while manufacturing and regulatory readiness progress .
  • Legal overhang improved post-quarter with March 2025 class action dismissal, potentially easing 2025 legal spend vs 2024 spike .
  • Stock reaction catalysts ahead: COVID-19 enhanced 510(k) resubmission timing/acceptance, initiation of H2’25 clinical evaluations, and any India regulatory steps (CDSCO) or partnership announcements .

Additional detail and sources

  • FY24 press release and 8-K financials (including product vs grant mix, Adjusted EBITDA, cash and securities): – –.
  • Q3 2024 and Q2 2024 press releases: operational and financial detail (revenue, adjusted EBITDA, cash balances): – –.
  • Regulatory update (510(k) withdrawal and resubmission plan): .
  • Q4 2024 earnings call transcript (prepared remarks and timelines): –.
  • India manufacturing footprint (CoSara oligo facility inauguration): .
  • Legal update (March 2025 dismissal): .

Note: All table values marked with an asterisk (*) are Values retrieved from S&P Global.