Movano Inc. (MOVE)·Q1 2024 Earnings Summary

Executive Summary

• Q1 marked first revenue with $0.85M as Movano began shipments (5,305 Evie Rings) but paused orders to fix delivery and service bottlenecks; operating loss narrowed to $5.8M from $7.2M YoY as R&D and SG&A stepped down .
• Management reiterated July 2024 timing for FDA 510(k) decision on the Evie Med Ring pulse oximeter after submitting new “exemplary” SpO2 trial results (RMSE 2.46%) on April 22; engagement with the FDA reviewer is ongoing .
• Balance sheet was bolstered by a $24.1M private placement in early April (including a strategic investment from a tier-1 medtech company), lifting pro forma cash to ~$24.8M versus $2.1M at 3/31/24, enabling D2C relaunch prep, B2B buildout, and RF pipeline studies .
• Key near-term catalysts: 510(k) decision (July 2024), relaunch of Evie D2C with improved inventory and CX, and arterial line blood pressure study in June (precursor to pivotal study); management framed these as potential stock drivers .

What Went Well and What Went Wrong

• What Went Well

  • Initial commercialization: first shipments on Jan 22 drove $0.85M revenue with 5,305 units shipped; operating loss improved YoY as expenses declined .
  • Regulatory momentum: April 22 resubmission included SpO2 RMSE 2.46% (below 3.5% FDA threshold) and accuracy exceeding two hospital-grade references; “continue to expect” July decision; CEO: “We…submitted exemplary clinical trial results… bode very well for us” .
  • Strategic funding: $24.1M raise (incl. tier-1 medtech investor) and move toward turnkey manufacturing to free working capital; pro forma cash ~$24.8M supports D2C and B2B execution .

• What Went Wrong

  • Execution growing pains: high demand but manufacturing delays led to cancellations, pressuring Q1 revenue conversion; management paused orders until inventory buffers and CX are strengthened .
  • Negative gross margin at launch scale: COGS ($1.215M) exceeded revenue ($0.852M) given early inefficiencies; focus is on automation, tooling, and process to raise yields before relaunch .
  • Liquidity tight pre-raise: cash at 3/31/24 was $2.1M (before April financing), highlighting reliance on fresh capital to fund relaunch and regulatory roadmap .

Financial Results

Sequential and YoY comparisons (oldest → newest):

YoY for the current quarter:

KPIs and operating metrics:

Notes:

• Segment breakdown: not applicable; the company reports as a single operating focus at this stage .
• Negative gross margin reflects early-stage scale, launch inefficiencies, and paused order flow as operations are retooled .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We…submitted exemplary clinical trial results… The Rings not only exceeded…FDA benchmarks, but…provided more accurate results than 2 FDA-approved hospital-grade control devices” — CEO John Mastrototaro on FDA resubmission and performance .
• “We shipped 5,305 Evie Rings… $852,000 in revenue… operating loss of $5.8 million… We intend to avoid [delivery delay] issues… by ensuring ample inventory prior to taking orders again” — CFO Jeremy (Jay) Cogan on Q1 metrics and relaunch approach .
• “We…expect that our next blood pressure study will take place this June and will be the first…with an arterial line… precursor to an FDA pivotal study” — CEO on BP program milestones .
• “Following…$24 million…private placement… we believe we have the resources to…drive our D2C business, launch Evie Med, target B2B and accelerate clinical trials” — CFO on capital and priorities .
• “We are…engaged with…pharmaceutical, medical device and payer channels… see our solution as an integral part of their future initiatives” — CEO on B2B interest contingent on clearance .

Q&A Highlights

• FDA process and data quality: Management emphasized strong SpO2 accuracy vs FDA benchmark and hospital devices; back-and-forth with the reviewer is “going pretty well” en route to a July decision .
• D2C relaunch discipline: After cancellations from manufacturing delays, the company will hold order intake until it can sustain 1–2 months of SKU-level inventory; delivery target 5–7 business days post-relaunch .
• B2B demand: Beta partners across pharma/medtech/payers “looking forward” to clearance; backend data systems being built to “hit the ground running” .
• Strategic investor: New medtech investor providing collaboration and expertise; alignment on roadmap including RF-based BP/glucose .
• BP roadmap: Arterial line study in June mirrors pivotal design; algorithmic work and productization steps underway to fast-track BP .

Estimates Context

• Wall Street consensus (S&P Global) for Q1 2024 revenue/EPS was not available at the time of request due to data access limits; the company also appears to have limited formal sell-side coverage. As a result, no estimate comparisons are provided for this quarter [Values retrieved from S&P Global unavailable due to API limit].

Where updates emerge, estimates are most likely to adjust around: (1) D2C relaunch timing and scale; (2) 510(k) decision in July; and (3) visibility into B2B contract ramp following clearance .

Key Takeaways for Investors

• Commercialization has begun but is being carefully reset: expect a measured D2C relaunch once inventory and CX are demonstrably fixed; near-term revenue cadence depends on this execution window .
• Regulatory is the primary catalyst: a July 2024 510(k) decision for Evie Med could unlock B2B trials/RPM opportunities; management’s tone suggests rising confidence post-April resubmission and reviewer interaction .
• Balance sheet de-risked: April financing (incl. strategic investor) lifts liquidity to pursue D2C relaunch, B2B infra, and RF studies, reducing near-term funding overhang .
• Margin structure should improve with scale: negative Q1 gross margin reflects launch-stage inefficiencies; automation/tooling, higher yields, and turnkey manufacturing should help as volumes normalize .
• RF pipeline adds optionality: June arterial line BP study is a step toward pivotal; success could expand TAM and partnership leverage beyond SpO2 .
• Watch deferred revenue and shipment cadence: the drop in deferred revenue Q4→Q1 and 5,305 shipments provide an early read on fulfillment; sustained order intake and delivery SLAs will be key KPIs post-relaunch .
• Stock setup: binary-ish regulatory catalyst (July), followed by execution catalyst (relaunch) and strategic optionality (B2B deals, BP results) — all likely to drive multiple re-rating if delivered .