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MI

Movano Inc. (MOVE)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 revenue was $0 as previously deferred revenue was offset by customer refunds; shipments totaled 1,837 Evie Rings and operating loss improved year over year to $6.4M from $7.4M in Q2 2023 .
  • Management focused on three catalysts: Sept. 17 “back in stock” Evie Ring relaunch, FDA 510(k) clearance path for EvieMED (mid‑August agency meeting), and initial B2B opportunities with pharma and payor partners; later, on Sept. 3, the company reported a positive FDA meeting outcome and moving to the final review phase (post-quarter) .
  • Product and operations were meaningfully strengthened: deep-learning heart-rate-in-motion accuracy, expanded AI insights, improved production yields/logistics, and Android app targeted by Black Friday; management expects these to enhance D2C relaunch conversion and customer experience .
  • Liquidity improved with cash of $16.9M at quarter end following the $24.1M April private placement; cash burn ~$4.4M excluding payables catch-up; turnkey manufacturing agreement expected to improve working capital alignment .
  • Near-term stock reaction catalysts: back-in-stock relaunch execution, FDA clearance timeline for EvieMED, and concrete B2B agreement announcements with pharma/payers .

What Went Well and What Went Wrong

What Went Well

  • Management advanced B2B pipeline: agreement phase with a global pharma (late‑2024 start), Tier 1 pharma evaluation in Fall for 2025 trial, and engagement with a large payor for high‑risk population RPM (late‑2024/early‑2025 start) .
  • Operational improvements across production yields, cycle times, logistics/warehouse systems, and upgraded algorithms; expanded AI insights engine and customer support readiness for relaunch .
  • Clinical/R&D progress: completed an arterial‑line cuffless blood pressure study in June; planning next study in Q4 2024; continued focus on multi‑analyte sensing and proprietary RF SoC roadmap .

Quote: “We are excited to be back in stock on the Evie Ring… improving the consumer experience across product, delivery and customer service in order to maximize our sales potential.” — CEO John Mastrototaro .

What Went Wrong

  • Revenue was $0 in Q2 (refunds offset deferred revenue) and D2C orders were paused since mid‑February given capital constraints, impacting near-term top line .
  • FDA 510(k) clearance timeline extended as the agency requested additional information regarding wellness aspects; meeting scheduled for mid‑August (later resolved positively post-quarter) .
  • Shipments fell sequentially to 1,837 rings from ~5,305 in Q1, reflecting halted order intake and initial launch learnings that led to cancellations; management intends to avoid this with ample prebuilt inventory in Q3 relaunch .

Financial Results

MetricQ2 2023Q1 2024Q2 2024
Revenue ($USD Millions)$0.000 $0.852 $0.000
Operating Loss ($USD Millions)$(7.384) $(5.754) $(6.397)
Net Loss ($USD Millions)$(7.267) $(5.720) $(6.190)
EPS (Basic & Diluted, $USD)$(0.17) $(0.10) $(0.06)
R&D Expense ($USD Millions)$4.171 $2.887 $2.907
SG&A Expense ($USD Millions)$3.213 $2.504 $3.110

KPIs and Balance Sheet

KPI/MetricQ2 2023Q1 2024Q2 2024
Evie Ring Shipments (Units)N/A5,305 1,837
Cash & Cash Equivalents ($USD Millions)N/A$2.145 $16.868
Deferred Revenue ($USD Millions)N/A$0.251 $0.000
Cash Burn (Approx., $USD Millions)N/A~$4.1 ~$4.4 (excl. payables catch‑up)

Notes:

  • No revenue recognized in Q2 2024 due to refunds offsetting previously deferred revenue .
  • Balance sheet reflects April private placement proceeds and payables catch‑up .

Estimates vs. Actuals

MetricQ2 2024 ConsensusActual
Revenue ($USD Millions)N/A (consensus unavailable via S&P Global)$0.000
EPS ($USD)N/A (consensus unavailable via S&P Global)$(0.06)

Consensus note: Wall Street consensus via S&P Global was unavailable at time of retrieval due to source limitations.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Evie Ring D2C RelaunchSept 2024“Will announce ship start date once inventory built” (Q1) Back in stock Sept 17, 2024 Raised specificity; date confirmed
FDA 510(k) for EvieMED (Pulse Oximetry)Summer 2024Expected July 2024 decision (Q1) FDA requested wellness info; meeting mid‑Aug (then positive outcome Sept 3, post‑quarter) Timeline extended; wellness issue resolved post‑quarter
Android App AvailabilityHoliday 2024Initiating Android development (Q1) Targeted by Black Friday 2024 Timeline set
Cuffless Blood Pressure Clinical Study2024June arterial‑line study planned (Q1) June study completed; next study planned Q4 2024 Progressed; next milestone scheduled

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023 & Q1 2024)Current Period (Q2 2024)Trend
FDA 510(k) for EvieMEDHypoxia trial RMSE 2.46% vs 3.5% guidance; expected July decision FDA wellness questions; mid‑Aug meeting planned; management confident Slight delay; constructive engagement
B2B Pipeline (Pharma/Payor/RPM)Beta partners across channels; RPM/payer engagement; TAMs highlighted Agreement phase with global pharma; Tier 1 pharma evaluation; large payor engagement Building momentum
D2C Execution & OpsInitial launch learnings; halt orders; plan for inventory buffer Back in stock date set; improved yields/logistics; expanded customer service Operational readiness improved
AI/Tech/AlgorithmsInsight Engine launch; sleep tracking improvements Deep-learning HR-in-motion; expanded AI insights; auto activity detect Feature quality rising
R&D: Blood Pressure & GlucoseBP study MAD 5.9 mmHg; June arterial-line study planned; RF SoC focus June arterial-line study completed; next study Q4; RF chip hardware iterations Continued execution
Regulatory/LegalCollaborative FDA interactions; addressing questions Mid‑Aug FDA meeting; confidence reiterated Progressing

Management Commentary

  • “We are committed to working collaboratively with the FDA to obtain a 510(k) clearance for EvieMED, the cornerstone of our enterprise initiative.” — CEO John Mastrototaro .
  • “We shipped 1,837 Evie Rings in the second quarter… The company did not report any revenue for the second quarter as previously deferred revenues [were] offset by refunds.” — CFO Jeremy Cogan .
  • “We improved production yields and cycle times… updated our Ring algorithms… expanded our proprietary AI generated insights engine… [and] expect to have an Android version of the app ready… by Black Friday.” — CMO Tyla Bucher .
  • “We are in the agreement phase with a global pharmaceutical company… EvieMED is expected to be evaluated this Fall by a Tier 1 global pharmaceutical company… engaged with a large payor…” — CEO John Mastrototaro .

Q&A Highlights

  • Algorithms and features: Deep-learning HR‑in‑motion and auto activity detect will improve workout accuracy and user experience (Leabman/Bucher) .
  • B2B engagements: Partners in provider/payer/RPM channels are in beta/initial agreements pending FDA clearance (Soule) .
  • FDA timing/tone: No change to mid‑Aug meeting; seasoned regulatory advisors; strong clinical foundation; optimistic tone (Mastrototaro) .
  • R&D learnings: June arterial‑line BP study yielded hardware/antenna and form factor updates; next arterial-line study targeted around November (Leabman) .
  • Burn rate and manufacturing: Cash burn trending lower; turnkey manufacturing agreement to better align COGS with sales, improving cash flow profile (Cogan) .

Estimates Context

  • S&P Global consensus for Q2 2024 revenue and EPS was unavailable at time of retrieval due to source limitations. As a result, estimate comparisons are not provided (see “Financial Results” table).
  • Given zero revenue recognition in Q2 and pending D2C relaunch/FDA developments, we expect sell‑side models (where available) to pivot around Q3/Q4 volumes, gross margin trajectory post turnkey manufacturing, and B2B monetization milestones .

Key Takeaways for Investors

  • Near-term binary catalysts: Sept. 17 back‑in‑stock D2C relaunch and progress toward EvieMED FDA clearance; watch for conversion, refund rates, and customer service efficacy as indicators of sustainable D2C scale .
  • B2B optionality is growing: Pharma agreement phase and payer evaluations can diversify revenue away from D2C cyclicality; any signed contracts would be material sentiment drivers .
  • Improved liquidity and operations: Post‑raise cash of $16.9M and turnkey manufacturing should smooth working capital and cost alignment; monitor quarterly burn trajectory and gross margin as D2C resumes .
  • Product differentiation via AI and clinical evidence: Deep-learning algorithms and superior hypoxia trial accuracy underpin brand and regulatory narrative; quality improvements may aid retention and pricing power .
  • Risk management: FDA process timing remains the primary execution risk; while the post‑quarter update was positive, clearance is not assured—position sizing should reflect regulatory path uncertainty .
  • Trading lens: In the near term, stock likely reacts to D2C relaunch KPIs (orders, shipments, refunds, CSAT) and any FDA/partner newsflow; medium-term thesis hinges on converting clinical/RPM use cases into scalable B2B revenue .
  • Watch Android app timing and feature rollout cadence through holiday season; these can amplify TAM and improve conversion during peak demand periods .