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KNOW LABS, INC. (KNW)·Q3 2023 Earnings Summary

Executive Summary

  • Pre-revenue quarter; net loss was $3.60M and GAAP EPS to common was a loss of $0.18, widened by recognition of $4.96M in preferred stock dividends (cash settlement plus deemed accretion). Management also cited EPS loss of $0.07 before preferred dividends, unchanged YoY, creating a key GAAP vs “before dividends” discrepancy .
  • R&D intensity remained elevated to accelerate Bio‑RFID validation: MARD improved to 11.3% in July from 12.9% in May (20.6% in early May), supported by >300 three‑hour datasets and ~2B data points collected over six months .
  • Liquidity tightened: cash fell to $3.93M with updated runway “at least” through December 2023 (vs prior guidance to February 2024); burn rate reduced from ~$1.2M/month to ~$0.8M/month; management expects 2023 capital raises via preferred stock, convertible debentures, and equity .
  • Strategic progress: Gen1 portable prototype completed (enables scaled data collection); Gen2 design underway (target at least 50% smaller); patent portfolio expanded to >169 issued/pending, with intent to maintain #1 non‑invasive glucose IP position .
  • Stock catalysts: further peer‑reviewed accuracy improvements, FDA engagement milestones, Gen2/device characterization, and financing actions; listing risk addressed—NYSE American focuses on market cap, not sub‑$1 share price (market‑cap threshold context discussed) .

What Went Well and What Went Wrong

What Went Well

  • “We reduced our burn rate from $1.2 million per month to roughly $800,000 per month,” improving cash efficiency while continuing R&D and algorithm work .
  • Accuracy momentum: MARD improved from 20.6% (technical feasibility, May) to 12.9% (algorithm refinement, late May) to 11.3% (expanded dataset, July), moving closer to sub‑10% target .
  • Scale and IP: “Our research and development team has collected more than 300, 3‑hour glucose data sets… almost 2 billion data points” and patent portfolio grew to >169 issued/pending, reinforcing IP leadership in non‑invasive glucose monitoring .

What Went Wrong

  • GAAP EPS to common shareholders deteriorated due to $4.96M preferred dividend impacts; Q3 GAAP EPS was a loss of $0.18 vs $0.07 YoY, highlighting capital structure dilution to common holders despite operational EPS commentary excluding dividends .
  • Liquidity compressed: cash fell to $3.93M and runway shortened to “at least” December 2023, increasing reliance on external financing this year .
  • Regulatory readiness needs: management emphasized more work on generalizability—wider glycemic ranges, diverse physiologies, and real‑world environmental conditions—before seeking FDA trials, implying timing uncertainty .

Financial Results

MetricQ1 2023 (Dec 31, 2022)Q2 2023 (Mar 31, 2023)Q3 2023 (Jun 30, 2023)
Revenue ($USD)$0 $0 $0
Net Loss ($USD)$(3,822,859) $(4,930,202) $(3,599,927)
GAAP EPS (Basic & Diluted) ($)$(0.08) $(0.10) $(0.18)
R&D Expense ($USD)$1,743,051 $2,563,469 $1,879,519
SG&A Expense ($USD)$1,905,071 $2,242,658 $1,359,782
Operating Loss ($USD)$(3,648,122) $(4,806,127) $(3,239,301)
Cash & Equivalents ($USD)$9,680,272 $6,226,029 $3,928,865

YoY (Q3 2023 vs Q3 2022):

MetricQ3 2022Q3 2023
Net Loss ($USD)$(3,003,286) $(3,599,927)
GAAP EPS (Basic & Diluted) ($)$(0.07) $(0.18)
R&D Expense ($USD)$1,272,537 $1,879,519
SG&A Expense ($USD)$1,588,823 $1,359,782

Segment (Q3 2023):

SegmentRevenue ($USD)Segment Operating Loss ($USD)Segment Assets ($USD)
Development of Bio‑RFID™ and ChromaID™$0 $(3,239,000) $4,436,000

KPIs and Program Metrics:

KPIValue
MARD (Tech Feasibility, NN model)20.6% (Dec 2022–Feb 2023 testing)
MARD (Algorithm Refinement, lightGBM)12.9% (May 30, 2023)
MARD (Expanded Dataset, lightGBM)11.3% (July 26, 2023)
Datasets/Observations>300 three‑hour datasets; ~2B data points (last six months)
Gen1 Prototype StatusCompleted; portable research‑grade device
Gen1 Units Built / Planned~12 units built; inventory to build ~100
Gen2 TargetAt least 50% smaller; designed for manufacturing
Patents>169 issued & pending; expanded >70% in six months
Monthly Burn RateReduced to ~$0.8M/month (from ~$1.2M)
Cash Runway“At least” through Dec 2023

Estimate comparison: Wall Street consensus (S&P Global/Capital IQ) was unavailable for KNW; therefore, no estimate beat/miss analysis for Q3 2023 is provided.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayOperating horizonThrough Feb 2024 (Q2 filings) At least through Dec 2023 (Q3 filings) Lowered
Monthly Burn RateNear term~$1.2M/month ~$0.8M/month Reduced
Accuracy Target (MARD)Program goalAim for <10% Aim for <10% (reiterated) Maintained
Device Roadmap2023Gen1 prototype completed Gen2 targeting ≥50% smaller; designed for manufacturing New specific sizing target
Financing Plan2023Expect raises via convertible debentures/equity Expect raises via preferred stock, convertible debentures, and equity Expanded instruments
FDA Timeline2023Pursuing clearance; submission targeted in 2023 (Q1 call context) “Difficult to set exact dates”; continued FDA socialization More caution on timing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Algorithm/MARD progression>90% correlation; <10% mean absolute error cited in internal testing (Q1) ; 12.9% MARD (May) 11.3% MARD on expanded dataset; continued ML refinement Improving accuracy
Device developmentWorking toward KnowU/UBand; Gen1 planned (Q1) Gen1 completed; Gen2 design targeting ≥50% smaller; scalable data collection Hardware maturation
Regulatory preparationPursuing FDA; targeted 2023 submission (Q1) ; initiated internal FDA processes (Q2) More work needed: diverse populations, wider glycemic ranges, real‑world conditions; ongoing FDA socialization More explicit diligence
Data collection scaleTens of millions observations (Q1) >300 three‑hour datasets; ~2B data points; multiple IRB protocols Significant scale-up
Liquidity & burnCash $9.68M; runway to Feb 2024 (Q1) ; cash $6.23M; runway to Feb 2024 (Q2) Cash $3.93M; runway “at least” to Dec 2023; burn cut to ~$0.8M/month; financing planned Tightening liquidity; efficiency gains
Listing/market contextNYSE American focuses on market cap, not sub‑$1 price; monitoring compliance Addressed investor concerns

Management Commentary

  • “We reduced our burn rate from $1.2 million per month to roughly $800,000 per month.” — Ron Erickson .
  • “We have… collected more than 300, 3‑hour glucose data sets in the last six months… almost 2 billion data points.” — Ron Erickson .
  • “We learned there is more work to do… data accuracy across all glycemic ranges… patient physiological characteristics… real‑world environmental conditions.” — Ron Erickson .
  • “Our core goals for the balance of 2023 are… algorithm refinement with the goal to deliver an under 10% MARD… Generation 2 design… regulatory strategy and technology socialization with the FDA.” — Ron Erickson .
  • “Know Labs reported a net loss of $3.59 million… EPS of a loss of $0.07, unchanged from the year‑ago period… before preferred stock dividends.” — Pete Conley .

Q&A Highlights

  • FDA accuracy threshold: Management targets MARD under 10% with broad, diverse clinical populations as necessary for FDA readiness .
  • NYSE listing concern: NYSE American does not specify a minimum share price; market cap criteria and multi‑day evaluation emphasized; company monitors compliance .
  • Investor confidence: Focus on transparency via published clinical studies and manuscripts; belief that informed investors gain confidence as differences become apparent .
  • Gen1 deployment: ~12 units built; component inventory to build ~100; external testing anticipated around end of 2023/early 2024 .
  • Cash runway change: From prior “February 2024” commentary to “December 2023” tied to accelerated development spend; financing plan underway for 2023 .

Estimates Context

  • S&P Global/Capital IQ consensus estimates were unavailable for KNW in Q3 2023; the company has limited analyst coverage, so no beat/miss analysis vs Wall Street consensus can be provided. Future estimate anchoring should be revisited as coverage evolves.

Key Takeaways for Investors

  • KNW remains a pre‑revenue, R&D‑stage med‑tech focused on non‑invasive glucose monitoring; near‑term stock moves likely hinge on scientific validation (MARD trends), device characterization, and FDA engagement milestones rather than financial metrics .
  • Liquidity tightened: cash $3.93M and runway “at least” through Dec 2023; watch for financing (preferred, convertibles, equity) and dilution risk to common holders—especially given recent preferred dividend impacts on GAAP EPS .
  • Accuracy trajectory is favorable (20.6% → 12.9% → 11.3% MARD); further improvements toward sub‑10% will be key catalysts and de‑risk regulatory narrative .
  • Device roadmap progressing: Gen1 enables scaled data collection; Gen2 targeting ≥50% smaller and designed for manufacturing—milestones around Gen2 design/characterization can be incremental positives .
  • Regulatory path requires broader datasets (glycemic ranges, diverse physiologies, real‑world conditions); investors should expect continued publication cadence and FDA “socialization” rather than hard submission dates in the immediate term .
  • IP remains a strategic asset (169+ patents); continued portfolio expansion supports defensibility in non‑invasive glucose monitoring, aiding potential partnerships/licensing optionality .
  • Trading implications: near‑term—monitor press releases/manuscripts on accuracy and Gen2 progress; mid‑term—track financing structure/terms, FDA engagement markers, and listing compliance disclosures .

Appendix: Press Releases in Q2–Q3 2023

  • May 5, 2023: Technical feasibility study (MARD 20.6%) .
  • May 30, 2023: Algorithm refinement (MARD 12.9%) .
  • June 7, 2023: Gen1 prototype completion .
  • July 26, 2023: Expanded dataset with novel preprocessing (MARD 11.3%) .

Notes on EPS: The press release and call highlighted EPS loss of $0.07 before preferred dividends for Q3 2023, while GAAP EPS to common shareholders was a loss of $0.18 due to $1.63M Series D cash dividend settlement and $3.34M deemed dividends accretion on Series C/D recognized in the quarter .