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APPLIED DNA SCIENCES INC (APDN)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 FY2024 revenue was $0.813M, up 4% YoY, with operating loss improving to $(3.3)M from $(4.2)M YoY; EPS was $(0.32) vs $(5.29) YoY as share count increased following corporate actions .
  • Applied DNA announced a strategic restructuring to prioritize manufacturing critical starting materials for genetic medicines (Linea DNA and Linea IVT), target ~15% OpEx reductions vs FY2024 by FQ2’25, and pursue divestiture of the CertainT platform; leadership roles were realigned with Judith Murrah promoted to President .
  • GMP facility buildout is slated for completion by January 9, 2025, with annual revenue capacity modeled at $4–$16M depending on product mix; GMP production runs are expected to begin in H1 CY2025 for mRNA clinical trial materials .
  • Liquidity improved post quarter: cash was $6.4M at 9/30/24, rising to ~$10.1M after the Oct 31 registered direct offering; the quarter also included a $500K follow-on order for Linea DNA in IVD cancer diagnostics .
  • Wall Street consensus estimates via S&P Global were unavailable for Q4 FY2024 in this instance; no formal beat/miss determination can be made (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well

  • Restructuring sharpened strategic focus on Linea DNA/IVT; management expects this to “return the Company to revenue growth and expand shareholder value” and enable “long-term, high-margin GMP supply agreements” upon GMP completion .
  • Q4 operating loss improved to $(3.3)M vs $(4.2)M YoY on lower SG&A (notably stock-based comp), partially offset by higher professional fees .
  • Commercial traction: $500K follow-on Linea DNA order for a global IVD manufacturer; investor update confirmed GMP capacity and near-term timelines .

What Went Wrong

  • Full-year revenue declined to $3.4M from $13.4M on the winding down of COVID-19 testing (CUNY contract terminated in June 2023); clinical lab revenues remained pressured .
  • Adjusted EBITDA remained meaningfully negative in Q4 at $(3.15)M and net loss was $(3.31)M, underscoring the small revenue base vs operating structure .
  • Sequential product revenue decreased vs Q3; the mix relies on service/clinical lab revenues that are in secular decline post-COVID .

Financial Results

Income Statement Snapshot (Quarterly)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD)$929,631 $797,519 $813,106
EPS (Primary, $USD)$(5.31) $0.47 $(0.32)
Gross Profit ($USD)$295,651 $245,232 $244,899 (calc from revenue − total cost of revenues)
Gross Margin (%)31.8% (295,651 ÷ 929,631) 30.8% (245,232 ÷ 797,519) 30.1% (244,899 ÷ 813,106)
Operating Loss ($USD)$(3,617,751) $(3,346,693) $(3,271,256)
Adjusted EBITDA ($USD)$(3,255,840) $(3,182,295) $(3,152,804)
Net Income Margin (%)−483.4% (−4,493,783 ÷ 929,631) 231.8% (1,849,501 ÷ 797,519) −408.0% (−3,313,744 ÷ 813,106)
EBITDA Margin (%)−350.5% (−3,255,840 ÷ 929,631) −399.0% (−3,182,295 ÷ 797,519) −387.9% (−3,152,804 ÷ 813,106)

YoY Comparison (Q4)

MetricQ4 2023Q4 2024
Revenue ($USD)$779,736 $813,106
EPS (Primary, $USD)$(5.29) $(0.32)
Operating Loss ($USD)$(4,170,821) $(3,271,256)
Adjusted EBITDA ($USD)$(3,488,589) $(3,152,804)

Revenue Mix (Quarterly)

Revenue Component ($USD)Q2 2024Q3 2024Q4 2024
Product Revenues$393,125 $246,644 $127,727
Service Revenues$205,486 $226,145 $359,899
Clinical Lab Service Revenues$331,020 $324,730 $325,480
Total Revenues$929,631 $797,519 $813,106

Operating Profile and Cash

KPI ($USD)Q2 2024Q3 2024Q4 2024
SG&A Expense$3,000,208 $2,678,894 $2,684,444
R&D Expense$913,194 $913,031 $831,711
Total Operating Expenses$3,913,402 $3,591,925 $3,516,155
Total Cost of Revenues$633,980 $552,287 $568,207
Cash & Cash Equivalents (Quarter-end)$3,149,640 $10,442,131 $6,431,095
Cash & Cash Equivalents (Nov 3, 2024)~$10,100,000 (post Oct 31 offering)

Results vs Estimates

MetricQ4 2024 ActualQ4 2024 S&P Global Consensus
Revenue ($USD)$813,106 N/A (unavailable)
EPS ($USD)$(0.32) N/A (unavailable)

Note: S&P Global consensus data was unavailable for APDN Q4 2024 in this instance; therefore, no beat/miss determination can be made.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating ExpensesFY2025 vs FY2024Not specifiedTarget ~15% reduction vs FY2024, to be completed by FQ2’25New
GMP Facility CompletionTimingOn track for FY24 year-end completion Buildout completion by Jan 9, 2025Updated date
GMP Annual Revenue CapacityOngoingCapacity described in grams and dose equivalents $4–$16M per year depending on product mixNew quantified range
GMP Production RunsStartEarly CY2025 for clinical trial materials H1 CY2025Maintained/refined
CertainT PlatformStrategic PathCommercialization agreement (Indus) Pursuing divestiture (negotiations ongoing)Strategic shift
ADCL TR8 PGxStrategyLaunch and capacity up to $25M/year Retained; pursuing profitable growth via PGx servicesMaintained with focus

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
GMP Facility TimelineOn schedule for FY24 year-end GMP launch; vendor approvals progressing Buildout completion Jan 9, 2025; GMP runs H1 CY2025 Progressing; timing refined slightly
Linea IVT CommercializationTwo customers validated/onboarding; third pending; platform evaluations with large pharma/CDMOs Expect several long-term GMP supply agreements post-completion Moving from evaluation to supply agreements
TR8 PGx TestingLaunched; capacity >$25M; targeting concierge then enterprise Exploring reference lab opportunities; refining GTM Early commercialization; building volume
CertainT PlatformIndus multi-year commercialization agreement; initial PO anticipated Pursuing divestiture; negotiations ongoing (no assurance of completion) Monetization/strategic deemphasis
Capital/ListingRegained Nasdaq minimum bid compliance as of May 10; later received deficiency notice in July, exploring reverse split Not discussed in Q4 releaseMixed; monitoring listing compliance
Leadership ChangesPresident roles updated (Murrah at APDN; Shorrock at LineaRx); CEO remains Realignment to support strategy

Management Commentary

  • “Our actions today will sharpen our focus on commercialization initiatives for our Linea DNA and Linea IVT platforms to return the Company to revenue growth and expand shareholder value.” — Dr. James A. Hayward, CEO .
  • “We believe the completion of our GMP manufacturing facility will allow us to win several long-term, high-margin GMP supply agreements for IVT templates, resulting in the significant utilization of our GMP manufacturing capacity in FY2025.” — Dr. James A. Hayward .

Q&A Highlights

Note: No Q4 earnings call transcript was available; the company scheduled an investor update webcast for January 9, 2025 . Highlights below reflect Q3 call Q&A, which informed expectations entering Q4:

  • GMP customers/timeline: “Verbal commitments…about half of our GMP capacity in early calendar year 2025” with onboarding processes beginning late FY2024/early FY2025 .
  • PGx state expansion: “Completing registration…to sell in…47 additional states…no validation required” due to rigorous NY approval; initial focus on concierge practices to optimize workflows before enterprise rollout .
  • Commercial model emphasis: Not a “number of customers game” but the size/modality of mRNA orders to fill GMP capacity .

Estimates Context

  • S&P Global consensus estimates for APDN’s Q4 FY2024 revenue and EPS were unavailable in this instance; therefore, no beat/miss assessment can be provided. When available, we default to S&P Global for consensus comparisons.

Key Takeaways for Investors

  • Near-term catalyst: GMP facility completion (Jan 9, 2025) and H1 CY2025 GMP runs could unlock $4–$16M annual capacity, supporting potential long-term, higher-margin supply agreements in mRNA workflows .
  • Strategic focus: Divestiture of CertainT and leadership realignment concentrate resources on genetic medicines starting materials; OpEx targeted ~15% lower by FQ2’25, improving path to operating leverage .
  • Revenue mix shift: Post-COVID clinical lab revenues have structurally declined; growth hinges on Linea DNA/IVT commercialization and PGx services; watch product vs service mix and the ramp of platform evaluations to GMP contracts .
  • Liquidity: Cash was $6.4M at 9/30/24 and ~$10.1M on 11/3/24 post offering; monitor cash burn vs commercialization timing; FY2025 execution will be key to sustaining runway .
  • Valuation drivers: Evidence of GMP supply conversions, magnitude of initial orders (IVT templates and polymerase), and PGx enterprise wins could re-rate the equity; conversely, delays in GMP onboarding or divestiture proceeds would weigh on sentiment .
  • Risk factors: Persistent net losses and small revenue base; warrant-related fair value swings influence reported EPS; execution risk in scaling new platforms and achieving vendor approvals remains heightened .