Executive Summary

Q1 2025 revenue fell sharply to $0.05M as no grant revenue was recognized; OpEx fell 18% YoY, narrowing GAAP net loss to $7.5M and GAAP EPS to -$0.24 . Versus S&P Global consensus, EPS modestly beat (actual -$0.24 vs -$0.27*), while revenue missed (actual $0.05M vs $0.19M*) [functions.GetEstimates].
Cash, cash equivalents, and marketable securities declined to $21.5M from $29.7M at 12/31/24 and $37.7M at 9/30/24; the 10‑Q includes a going‑concern warning and notes reliance on the ATM, grants, and cost controls to fund operations .
Management reaffirmed platform progress: COVID-19 test redesign is complete and verified; clinical evaluations targeted for 2H25 for TB, HPV, and respiratory multiplex; India manufacturing build‑out targeted by YE25 .
Call commentary highlighted resubmission timing depends on COVID prevalence; initial pricing framework remains low-cost (device ~$300–$500; test cups ~$15–$20 in developed markets) with margins expected to mirror historical lab-based tests and equipment .

What Went Well and What Went Wrong

What Went Well
- OpEx discipline: operating expenses down 18.2% YoY to $8.6M; adjusted EBITDA loss improved to $(7.4)M from $(8.4)M YoY .
- Platform progress: “The design for the augmented Co‑Dx PCR COVID‑19 test has been completed and undergone extensive verification testing” and clinical studies will precede a new 510(k) submission .
- Regulatory and clinical momentum: respiratory multiplex pre‑submission completed in March with FDA reviewer assigned; clinical evaluations for respiratory multiplex expected in 2H25 .
What Went Wrong
- Revenue air pocket: total revenue fell to $0.05M (from $0.47M YoY) as no grant revenue was recognized in the quarter; gross profit fell to $0.03M .
- Liquidity pressure and going concern: cash and securities fell to $21.5M with negative operating cash flow; management disclosed substantial doubt about going concern absent external financing and cost actions .
- Timeline slippage vs earlier ambitions: TB clinical trials shifted from “early 2025” (Q3’24) to 2H25 (Q4’24 and reiterated Q1’25); COVID resubmission gating factor (real‑world prevalence) adds timing uncertainty .

Financial Results

Actuals across periods

Metric	Q1 2024	Q3 2024	Q1 2025
Revenue ($USD)	$467,854	$641,141	$50,277
Gross Profit ($USD)	$233,349	$343,738	$28,687
Gross Margin (%)	49.9% (calc from $233,349/$467,854)	53.6% (calc from $343,738/$641,141)	57.1% (calc from $28,687/$50,277)
Total Operating Expenses ($USD)	$10,492,736	$10,578,675	$8,580,643
Net Loss ($USD)	$(9,312,043)	$(9,696,455)	$(7,533,271)
GAAP Diluted EPS ($)	$(0.31)	$(0.32)	$(0.24)
Adjusted EBITDA ($USD)	$(8,428,535)	$(8,825,436)	$(7,397,727)

Estimate vs actual (Q1 2025)

Metric	Consensus Q1 2025	Actual Q1 2025	Surprise
Revenue ($USD)	$187,500*	$50,277	$(137,223) (calc)
EPS ($)	$(0.27)*	$(0.24)	+$0.03 (calc)

Values marked with an asterisk (*) were retrieved from S&P Global.
Management also disclosed: “Operating expenses of $8.6M decreased by 18.2% YoY,” and “Cash, cash equivalents, and marketable securities of $21.5M as of March 31, 2025” .

Liquidity KPIs

KPI	Q3 2024	Q4 2024	Q1 2025
Cash, cash equivalents, and marketable securities ($USD)	$37.7M	$29.7M	$21.5M
Cash and cash equivalents ($USD)	$10.8M	$2.94M	$1.90M
Marketable investment securities ($USD)	$26.86M	$26.81M	$19.58M

Operating expense mix (Q1 2025 vs Q1 2024)

OpEx Line ($USD)	Q1 2024	Q1 2025
Sales & Marketing	$1,563,682	$657,030
General & Administrative	$2,918,803	$2,773,149
Research & Development	$5,679,678	$4,870,019
Depreciation & Amortization	$330,573	$280,445

Notes

Company reports a single operating segment .
No quarterly segment revenue breakdown provided.

Guidance Changes

Metric/Topic	Period	Previous Guidance	Current Guidance	Change
TB clinical evaluations	2025	“Initiate clinical trials in early 2025” (Q3’24 call)	Clinical evaluations expected in 2H25 in India and South Africa	Pushed later (early 2025 → 2H25)
Respiratory multiplex (Flu A/B, COVID, RSV) clinical evaluations	2025	In development; pre‑submission pending (Q4’24 set‑up)	FDA pre‑submission completed in March; reviewer assigned; evaluations targeted for 2H25	Clarified and scheduled for 2H25
HPV multiplex clinical evaluations	2025	Optimization completed; planning clinical pathway (Q4’24)	Preparing for clinical evaluations; initial India focus, then Africa	Maintained; nearing evaluations
COVID-19 test 510(k)	2025	2024 510(k) withdrawn; resubmit with updated clinical data in 2025	Redesign complete and verified; resubmission after clinical data; timing depends on COVID prevalence	Maintained resubmission plan; timing contingent on prevalence
India manufacturing build‑out	YE 2025	India oligo facility inaugurated Dec’24 (and U.S. facility inaugurated Apr’24)	Remain on track to complete India manufacturing facility by YE25	New explicit YE25 target for expanded facility

No formal numerical financial guidance (revenue, margins, OpEx, tax, dividends) was provided in Q1 2025 materials .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3’24, Q4’24)	Current Period (Q1’25)	Trend
Regulatory path (COVID-19 510(k))	510(k) submitted mid‑2024; later withdrawn to enhance stability and resubmit with new data in 2025	Redesign verified; resubmission timing gated by COVID prevalence; clinical evaluations ahead of 510(k)	Path clearer; timing still uncertain
TB clinical evaluations	“Early 2025” start (Q3’24)	Shifted to 2H25; India and South Africa focus	Timing pushed; plan more concrete
Respiratory multiplex	Development progress; RADx support; high interest (Q3’24)	FDA pre‑submission done (Mar); reviewer assigned; 2H25 clinical evaluations	Advancing toward trials
HPV multiplex	Chemistry optimization complete (Q3’24/Q4’24)	Preparing for clinical evaluations; India first; Gates Foundation support	Execution next step
Manufacturing footprint	US facility inaugurated (Apr’24); India oligo plant inaugurated (Dec’24)	India manufacturing facility completion targeted YE25	Incremental capacity milestone
Pricing/margins	Not previously framed on a call	Device ~$300–$500; cups ~$15–$20 in developed markets; margins to resemble historical equipment/tests	First explicit pricing context
Liquidity/capital	Cash/securities $37.7M (Q3’24); $29.7M (YE’24)	$21.5M at 3/31/25; going‑concern disclosure; ATM capacity $16.5M remaining	Tightening; reliant on financing

Management Commentary

“The design for the augmented Co‑Dx PCR COVID‑19 test has been completed, and the test has undergone extensive verification testing… We plan to submit this updated version… after updated clinical data has been collected.” — CEO Dwight Egan .
“We expect to begin clinical evaluations in India and South Africa in the back half of 2025… for TB.” — CEO Dwight Egan .
“We have been assigned a reviewer [for the respiratory multiplex] and plan to initiate clinical evaluations… in the second half of this year.” — CEO Dwight Egan .
“We ended the quarter with $21.5 million in cash, cash equivalents and marketable investment securities… we plan to provide for the company’s capital requirements through equity financing… additional grant funding and operational efficiencies.” — CFO Brian Brown .

Q&A Highlights

COVID-19 510(k) resubmission: New design validated; prior stability issue solved; entering clinical evaluations; timing depends on infection prevalence at trial sites .
Clinical evaluations: TB, HPV, and respiratory multiplex are all expected to enter clinical trials during the remainder of 2025; sample availability is not a constraint for TB/HPV in India/South Africa .
Pricing/margins: Device targeted at ~$300–$500 (scaling toward the low end); test cup pricing ~$15–$20 in developed markets with lower pricing in LMICs; product margins expected to resemble historical lab-based tests and equipment .

Estimates Context

Q1 2025 vs S&P Global consensus: EPS beat by ~$0.03 (actual -$0.24 vs -$0.27*), revenue missed by ~$0.14M (actual $0.05M vs $0.19M*) [functions.GetEstimates].
Estimate breadth was limited (2 estimates on EPS and revenue for Q1 2025*), and there is no target price/consensus rating shown by SPGI for this period in our query results* [functions.GetEstimates].
Primary driver of revenue miss was grant revenue timing (no grants recognized in Q1), partially offset by lower OpEx supporting the EPS beat .
Values marked with an asterisk (*) were retrieved from S&P Global.

Key Takeaways for Investors

Liquidity runway shortened to $21.5M cash and securities; 10‑Q flags substantial doubt about going concern, elevating financing risk despite $16.5M of remaining ATM capacity .
Execution milestones in 2H25 (clinical evaluations for TB/HPV/respiratory multiplex and COVID clinical data collection) are the principal catalysts to watch .
Revenue visibility remains limited until platform commercialization; quarterly swings tied to grant timing are likely to persist near term .
Pricing statements (low-cost device and cups) suggest a volume-driven model; eventual gross margin structure is expected to resemble historical tests/equipment, but scale and geography mix will be key .
Regulatory pathway is clearer but dependent on exogenous factors (COVID prevalence) and regional clearances (CDSCO/SAHPRA); investors should anchor timelines to 2H25 trials before regulatory filings .
OpEx cuts are working (OpEx -18% YoY), improving adjusted EBITDA loss; sustaining discipline is critical given cash burn and financing overhang .
Stock setup: near-term trading likely catalyst-driven (trial starts, regulatory filings); financing headlines (ATM usage or other raises) may be an overhang until milestones reduce execution risk .

Appendix: Additional Data

Non‑GAAP reconciliation (Q1 2025)

Adjusted EBITDA reconciles from GAAP net loss of $(7,533,271) by adding back D&A ($280,445), income taxes ($12,004), stock‑based comp ($875,228) and reversing interest income and realized gains, and change in contingent consideration, to $(7,397,727) .

Press releases in period

Q1 2025 results press release (May 8): financials and business updates consistent with 8‑K exhibit .
Earnings date announcement (Apr 29) and participation in D. Boral Capital conference (May 14) .

Regulatory and manufacturing notes

India oligo synthesis facility inaugurated Dec 2024; India manufacturing facility completion on track by YE25 .
Company operates one segment; no segment financial disclosure .
No dividend program; focus on funding development and commercialization .

Co-Diagnostics, Inc. (CODX)·Q1 2025 Earnings Summary