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KL

KNOW LABS, INC. (KNW)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 FY2024 (quarter ended December 31, 2023) delivered reduced net loss ($3.45M) and improved EPS (-$0.04 vs -$0.08 YoY), reflecting lower R&D and controlled OpEx even as SG&A rose modestly for key hires .
  • Cash balance fell to $4.82M from $8.02M at September 30, 2023; management reiterated runway “until at least June 30, 2024” and highlighted an $18M shelf registration effective January 11, 2024 as part of capital plans .
  • Strategic execution advanced across four work streams: hardware (Gen 2 miniaturization), clinical trials (up to 100 participants; focus on hypo/hyper ranges), algorithm development (targeting ≤10% MARD), and IP growth (264 patents issued/pending/in process as of Dec 31, 2023) .
  • Potential catalysts: presentation at ATTD (Florence, Mar 6–9) including Mayo Clinic-led ePosters; active exploration of rest-of-world revenue paths that may not require FDA clearance; ongoing JDA discussions with large partners under NDAs .
  • No Wall Street consensus estimates available from S&P Global for KNW; therefore no “beat/miss” framing this quarter (S&P Global consensus unavailable) [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • EPS improved 50% YoY (-$0.04 vs -$0.08) on lower R&D and disciplined OpEx; net loss contracted 9.8% YoY to $3.45M .
  • Advancing toward <10% MARD: management reaffirmed the algorithm development goal and described steps to broaden data diversity for generalizability; “Our goal is to achieve an algorithm with a mean absolute relative difference or MARD of 10% or less” .
  • IP leadership expanded: 264 patents issued/pending/in process as of Dec 31, 2023, supporting a defensible technology moat in noninvasive glucose monitoring .

What Went Wrong

  • Liquidity tightened: cash declined to $4.82M (from $8.02M at Sep 30) with net cash used in operations of $3.39M; equity fell to $1.23M (from $3.74M) .
  • Burn dynamics: core burn steady at $700–$800K/month, with incremental Gen 2 development spend ($200–$300K/month); Q1 included a ~$1M one-time financing-related expense to auditors/counsel .
  • No revenue reported and continued going concern disclosure (previously noted by NYSE requirement) underscores reliance on external financing and strategic milestones to sustain operations .

Financial Results

Income Statement and Operating Metrics

MetricQ3 2023Q4 2023Q1 2024
Net Loss ($USD Millions)$3.59 N/A (not disclosed in available documents)$3.45
EPS ($USD)-$0.07 N/A (not disclosed)-$0.04
R&D Expense ($USD Millions)$1.87 N/A (not disclosed)$1.49
SG&A Expense ($USD Millions)$1.35 N/A (not disclosed)$2.01
Operating Loss ($USD Millions)N/A (not disclosed)N/A (not disclosed)$3.50
Non-cash Charge ($USD)$4.96M (preferred dividends, Q3) N/A$0.79M (incl. $0.70M SBC)

Notes:

  • Q1 FY2024 “Net loss attributable to common shareholders” reflects deemed preferred dividends of $63,629 .
  • Company did not report revenue figures in the materials reviewed.

Balance Sheet and Liquidity

Metric6/30/20239/30/202312/31/2023
Cash & Equivalents ($USD Millions)$3.93 $8.02 $4.82
Shareholders’ Equity ($USD Millions)$0.72 $3.74 $1.23
Total Assets ($USD Millions)N/A$8.27 $5.01
Convertible Notes Payable, net ($USD Millions)N/AN/A$2.76
Net Cash Used in Operations (Quarter) ($USD Millions)N/AN/A$3.39

Estimates vs Actuals (S&P Global Consensus)

S&P Global consensus for KNW was unavailable; thus, no beat/miss comparisons this quarter (S&P Global consensus unavailable) [GetEstimates error].

MetricQ1 2024 ActualQ1 2024 ConsensusDelta
EPS ($USD)-$0.04 N/AN/A
Revenue ($USD)N/A (not reported)N/AN/A

KPIs and Operating Progress

KPIQ3 2023Q4 2023Q1 2024Trend
Algorithm Accuracy (MARD) TargetWorking toward <10% Reiterated <10% target Goal ≤10%; generalizability focus Improving
Patents (Issued/Pending/In Process)169 >250 264 Increasing
Clinical Trial ScalePlanning broader cohorts; venous blood protocol Up to 100 participants Trial with up to 100 participants ongoing; aiming broader diversity and glycemic ranges Expanding
Core Burn Rate~$800K/month ~$700K/month ~$700–$800K core + $200–$300K incremental Gen 2; ~$1M one-time in Q1 Controlled core; investment in Gen 2
Hardware ProgressGen 1 portable data collection device Gen 2 prototype in development; >50% smaller Gen 2 miniaturization continues Advancing

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating RunwayThrough at least 6/30/2024Indicated in FY2023 filing/Dec call remarks Reaffirmed runway “until at least June 30, 2024” Maintained
Capital PlanN/AExpect to raise funds via equity/preferred/convertible debentures $18M shelf filed 12/22/2023; effective 1/11/2024 Formalized
Revenue Outlook2024N/AExploring rest-of-world revenue path not requiring FDA; uncertain timing New exploration (non-U.S.)
Product MilestonesEarly 2024Reveal Gen 2 “next few months” ATTD presence; potential device updates shown in Italy Event-timed updates

No explicit quantitative guidance on revenue, margins, OpEx, OI&E, tax rate, or dividends was provided in the documents reviewed.

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023)Previous Mentions (Q4 2023)Current Period (Q1 2024)Trend
AI/Algorithm AccuracyProgress to 11.3% MARD; target <10% Goal <10%; data scale needed for generalizability Target ≤10%; broadening data diversity; considering calibration Improving accuracy
Hardware/Gen 2Gen 1 revealed; Gen 2 planned Gen 2 wearable CGM; >50% smaller; reveal in “next few months” Gen 1 characterization; miniaturizing to next iteration; updates at ATTD Approaching reveal
Clinical TrialsVenous blood protocol; diversify cohorts Up to 100 participants; scale data; broader ranges Ongoing internal trial with up to 100 participants; focus on hypo/hyper ranges Scaling
Regulatory PathEarly engagement; need generalizable accuracy Must achieve repeatable standard before FDA trials Highlights FDA accuracy requirements; algorithm generalizability Prereq work continues
IP Portfolio169 patents issued/pending >250 portfolio; leadership documented 264 issued/pending/in process; defensible moat Expanding
Funding/RunwayBurn reduced to ~$800K/month; financing plans ~$700K/month; runway to at least 6/30/24; plan to raise funds Reaffirmed runway; shelf effective; burn breakdown and one-time legal/audit cost Stable runway; capital optionality
Market/Revenue PathN/AN/AExploring rest-of-world revenue without FDA; potential non-medical field-of-use licensing New avenues

Management Commentary

  • “Our goal is to achieve an algorithm with a mean absolute relative difference or MARD of 10% or less. We'll also need to meet FDA's requirements for accuracy in varying glycemic ranges” — Ron Erickson .
  • “Core burn rate has remained relatively flat at between $700,000 and $800,000 a month… incremental spend on top of the core burn has been running about $200 to $300K a month… Q1 [had] a one-time expense… close to $1 million to auditors and counsel” — Pete Conley .
  • “We are actively and aggressively exploring [a rest-of-world] path to see if… we can generate revenue without having to go through the FDA” — Pete Conley .
  • “As of December 31, 2023, we had cash and cash equivalents of $4.82 million… we filed an $18 million S‑3 shelf… declared effective on January 11, 2024” — Press Release .
  • “As of December 31, 2023, we have 264 patents issued, pending and in process… [building] a defensible intellectual property moat” — Ron Erickson .

Q&A Highlights

  • Burn and spending mix: Core OpEx ~$700–$800K/month; Gen 2 acceleration adds ~$200–$300K/month; Q1 included ~$1M one-time legal/audit costs tied to financing .
  • JDA status: Multiple joint development agreements in progress under NDAs with large potential partners; scope and timing undisclosed .
  • 2024 revenue possibilities: Actively exploring non-U.S. markets for spot-check use cases and field-of-use licensing outside medical diagnostics; timing uncertain, not counted upon .
  • ATTD rationale: Global KOL engagement and showcasing clinical updates; Mayo Clinic collaborator presenting ePosters; potential material announcements .

Estimates Context

  • Wall Street consensus (S&P Global) for KNW EPS and revenue was unavailable; as a result, there is no beat/miss assessment this quarter. Estimates comparisons are omitted (S&P Global consensus unavailable) [GetEstimates error].
  • Given pre-revenue status and limited coverage, future estimates may remain sparse; investors should anchor near-term narrative to product milestones and financing updates rather than headline “beats/misses” .

Key Takeaways for Investors

  • Liquidity is the near-term focus: runway “until at least June 30, 2024” and a now-effective $18M shelf add financing optionality; monitor potential raises and dilution .
  • Execution milestones: anticipate Gen 2 device updates and clinical data presentations at ATTD in March; these are key sentiment catalysts .
  • Technical progress: algorithm targeting ≤10% MARD with broader hypoglycemic/hyperglycemic data collection to satisfy FDA accuracy requirements; generalizability remains the gating factor .
  • Strategic optionality: exploration of rest-of-world revenue paths (spot-check use, screening) and non-medical field-of-use licensing could provide interim monetization ahead of U.S. FDA clearance .
  • IP moat strengthening: 264 patents as of Dec 31 underscores defensibility in noninvasive glucose monitoring versus incumbents and new entrants .
  • Burn discipline vs. acceleration: core burn stable; incremental spend directed to Gen 2; one-time Q1 costs related to financing; watch cash cadence into mid-2024 .
  • Risk lens: no revenue reported; prior going concern disclosure noted by NYSE rule; outcomes hinge on clinical validity, regulatory trajectory, partnership execution, and capital access .