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INTELLIGENT BIO SOLUTIONS INC. (INBS)·Q3 2025 Earnings Summary

Executive Summary

  • INBS delivered solid sequential improvement: revenue rose 20% q/q to $0.73M while gross profit grew 91% YoY; net loss narrowed by ~$0.43M YoY as mix shifted toward higher‑margin cartridges and production efficiencies improved .
  • Mix and scale levers strengthened durability: cartridges reached 58% of YTD revenue (nine months) vs 49% a year ago, supporting margin expansion and recurring revenue resilience .
  • U.S. FDA clearance for the opiate (codeine) test remains on track for a 2025 U.S. launch; FDA issued an Additional Information request, which pauses the 90‑day clock, but the pathway is proceeding as expected (typical total timeline 3–6+ months) .
  • International pipeline continues to build: 35 new accounts in Q3 and >450 active accounts across 19 countries; multilingual upgrades and expanded EMEA distribution underpin broader access ahead of U.S. entry .
  • No formal financial guidance or Street consensus was available; near‑term stock catalysts include FDA clearance timing, sustained cartridge mix gains, and additional enterprise/government adoption .

What Went Well and What Went Wrong

What Went Well

  • Margin and profitability drivers: gross profit +91% YoY on improved mix and cost efficiencies; management cited “notable reduction in losses” with recurring cartridge sales strengthening fundamentals .
    • CEO: “Our focus on growing cartridge adoption, our highest‑margin revenue stream, is strengthening the business fundamentals… We’ve also seen a notable reduction in losses this quarter” .
  • Commercial momentum: 35 net new accounts in Q3; active accounts surpassed 450; expansion in Spain/Andorra via Detecto and broader EMEA via IVY Diagnostics .
  • Strategic readiness: multilingual upgrades for the reader/system (Arabic and Latin American Spanish) to support global distribution; additional U.S. patent granted (sixth) fortifies IP position ahead of U.S. entry .

What Went Wrong

  • Revenue down YoY: Q3 revenue of $0.73M vs $0.82M in Q3 2024 (–11.6% YoY), despite q/q growth; the company is leaning on mix/margins rather than top‑line growth YoY .
  • OpEx intensity persists: Q3 selling, general and administrative expense was $2.41M with total operating expenses at $3.07M, sustaining operating losses despite gross profit improvement .
  • Regulatory timing risk: FDA AI request pauses the 90‑day clock; while still “on track,” clearance can take 3–6+ months or longer if further data is requested, pushing revenue inflection later if timelines extend .

Financial Results

Income Statement Summary

Metric (USD)Q3 2024Q1 2025Q2 2025Q3 2025
Revenue$823,800 $872,287 $607,494 $728,867
Cost of Revenue (ex‑amort.)$(645,311) $(525,486) $(384,381) $(387,499)
Gross Profit$178,489 $346,801 $223,113 $341,368
Selling, General & Administrative$(2,425,830) $(1,949,016) $(1,809,114) $(2,407,558)
Development & Regulatory Expenses$(471,313) $(948,752) $(506,944) $(358,351)
Depreciation & Amortization$(318,923) $(300,422) $(305,177) $(301,978)
Loss from Operations$(2,953,735) $(2,725,261) $(2,264,482) $(2,553,248)
Government Support Income$83,842 $126,128 $133,640 $173,271
Net Loss$(2,986,765) $(2,694,799) $(2,256,797) $(2,550,674)
Net Loss per Share (basic/diluted)$(1.43) $(0.70) $(0.50) $(0.44)

Notes:

  • Sequential revenue growth: +20% q/q (Q3 vs Q2) as cited by the company and reflected above .
  • YoY: Revenue declined vs Q3 2024, but gross profit nearly doubled on mix/efficiency .

Balance Sheet Highlights (Quarter‑End)

Metric (USD)Q3 2025
Cash and Cash Equivalents (Mar 31, 2025)$2,807,112
Shareholders’ Equity (Mar 31, 2025)$4,943,766

Revenue Mix KPI (Nine Months YTD)

KPI9M FY20249M FY2025
Cartridges as % of Revenue49% 58%

Operating KPIs (Q3 2025)

KPIQ3 2025
New Accounts Added (Quarter)35
Active Accounts (Cumulative)>450
Government Support Income (Quarter)$173,271

Guidance Changes

MetricPeriodPrevious GuidanceCurrent Guidance/UpdateChange
U.S. FDA 510(k) Clearance (Opiate test)2025 Launch510(k) submitted Dec 18, 2024; launch planned 2025 FDA issued AI request; process remains on track for 2025 launch; total clearance timeline commonly 3–6+ months Maintained timeline; added process detail
Financial Guidance (Revenue, EPS, Margins, OpEx)FY/QtrNone disclosed None disclosed Maintained (no formal guidance)
Product/Localization2025Planned multilingual upgrade Arabic and LATAM Spanish integrated; broader multi‑language rollout in plan Progressing

Earnings Call Themes & Trends

Note: No Q3 2025 earnings call transcript was available; the analysis below tracks themes across Q1–Q3 press materials.

TopicPrevious Mentions (Q1 2025, Q2 2025)Current Period (Q3 2025)Trend
U.S. FDA 510(k) PathQ1: In‑clinic PK/biocompatibility completed; on track to submit by YE 2024 FDA AI request received; remains on track for 2025 U.S. launch Steady progress; timeline clarified
Sales Mix (Cartridges)Q2: Mix shift drove 11‑pt margin expansion on 6M basis Cartridges 58% YTD vs 49% PY; margin tailwind sustained Positive mix trend
International ExpansionQ1: KSA distributor; 22 new accounts 35 new accounts; >450 total; Spain/Andorra via Detecto; IVY Diagnostics for EU/ME Broadening reach
Product/LocalizationQ2: Planned multilingual reader upgrade Arabic/LATAM Spanish integrated; broader multi‑language rollout planned Executing upgrades
IP/DefensibilityQ2: Expected patent U.S. patent granted (6th) on cartridge lateral flow tech Stronger IP moat
Cost DisciplineQ2: Higher R&D for FDA studies; SG&A supporting expansion Loss narrowed YoY; reiterates cost control focus Incremental improvement

Management Commentary

  • CEO (Q3 PR): “As we expand further into new markets, our focus on growing cartridge adoption, our highest‑margin revenue stream, is strengthening the business fundamentals… We’ve also seen a notable reduction in losses this quarter… [and] introduced multilingual functionality… ready for broader distribution across international markets” .
  • CFO (Q2 PR): “Gross profit grew to 32.6% while gross profit margins increased to 38.5% for the six months ended December 31, 2024… We expect cartridge sales to continue outpacing reader sales… maximizing our recurring revenue” .
  • CEO (FDA update): “We appreciate the thoroughness of the FDA’s process… we remain confident in the strength of our data… preparing for our planned U.S. launch in 2025” .

Q&A Highlights

  • No Q3 2025 earnings call transcript was available; no Q&A disclosures to report [ListDocuments search returned none for the period].

Estimates Context

  • Consensus comparison: S&P Global consensus estimates for Q3 2025 EPS and revenue were unavailable; therefore, no vs‑consensus comparison is provided. Values retrieved from S&P Global.
  • Actuals: Revenue $0.73M; EPS $(0.44) (basic/diluted) .
MetricQ3 2025 ConsensusQ3 2025 Actual
RevenueN/A (S&P Global, unavailable)$728,867
EPS (Primary)N/A (S&P Global, unavailable)$(0.44)

Key Takeaways for Investors

  • Mix/margin story is working: cartridges at 58% YTD (vs 49% PY) and production efficiencies lifted gross profit +91% YoY despite YoY revenue decline—underscoring recurring revenue and unit economics improvements .
  • Regulatory catalyst remains “live”: FDA AI request is a normal part of the 510(k) process; a 2025 U.S. launch remains the base case, with clearance timelines commonly extending beyond 90 days (3–6+ months) .
  • Commercial pipeline strengthening: 35 new Q3 accounts, >450 active accounts across 19 countries; localization and distributor build‑out should support adoption and velocity ahead of U.S. entry .
  • OpEx overhang persists: SG&A and development costs keep operating losses elevated; continued cost control and operating leverage post‑clearance will be key to the path toward breakeven .
  • Balance sheet adequate near‑term: $2.81M cash and $4.94M equity at Q3 end; watch cash burn into FDA clearance and U.S. commercialization ramp .
  • Near‑term trading setup: headline sensitivity to FDA milestones (AI response acceptance, clearance decision) plus additional patent/IP wins and enterprise/government wins could drive volatility and upside/downsides skews .

Appendix: Additional Q3‑Relevant Disclosures

  • Spain/Andorra distribution via Detecto and EMEA expansion via IVY Diagnostics .
  • Multilingual rollout plan and initial integrations (Arabic, LATAM Spanish) to expand global usability .
  • U.S. IP strengthened: 6th U.S. patent (lateral flow test strip) granted, protecting current and future cartridge products .