Sign in

You're signed outSign in or to get full access.

II

InspireMD, Inc. (NSPR)·Q3 2025 Earnings Summary

Executive Summary

  • Record revenue of $2.523M (+39% YoY) on initial U.S. launch; sequential growth “over 40%” QoQ. Revenue beat Wall Street consensus ($1.760M*) and EPS was slightly better than expected (-$0.17 vs -$0.195*) .
  • U.S. commercial launch contributed $0.497M with more than 100 U.S. procedures completed and favorable mix driving gross margin expansion to 34.2% (vs 22.9% YoY), a key profitability lever as U.S. scales .
  • Initiated Q4 2025 revenue guidance of $2.5–$3.0M; international sales expected stable with sequential growth in U.S.; consensus sits at $2.6215M* .
  • Cash and marketable securities rose to $63.4M (from $19.4M at 6/30) via a $40.1M PIPE and $17.9M milestone warrant exercise, providing runway to expand U.S. field force and commercialization .
  • Near-term catalysts: ongoing U.S. account activation; TCAR milestones (CGUARDIANS II enrollment completion by year-end; potential approval mid-2026; integrated SwitchGuard/CGuard Prime TCAR solution targeted mid-2027); CREST-2 data presentations raising carotid intervention visibility .

What Went Well and What Went Wrong

What Went Well

  • Strong U.S. launch traction: “completed more than 100 cases in the U.S.”; management positioning CGuard Prime as a “workhorse” stent with a modest premium to CAS/TCAR pricing (hundreds of dollars, not thousands) .
  • Mix-led gross margin expansion: GM rose to 34.2% (vs 22.9% YoY) as U.S. sales carry higher margins; management expects continued expansion as U.S. mix grows .
  • Global demand intact: International revenue of $2.0M (+12% YoY) with >30 markets and accumulated real-world traction (approaching 70,000 implants sold to date) supporting global scale .

What Went Wrong

  • Operating expenses rose 57% YoY to $13.9M on U.S. personnel expansion and headquarters costs; net loss widened to $12.7M (-$0.17/share) from $7.9M (-$0.16/share) YoY .
  • Financial income decreased to $343k (from $572k) due to lower investment income and FX-related expenses, partly offsetting gross profit gains .
  • Coverage remains thin: only two Street estimates for revenue and EPS, which can amplify estimate dispersion and post-print volatility* [GetEstimates].

Financial Results

Quarterly Performance (GAAP)

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD)$1,529,000 $1,778,000 $2,523,000
Gross Profit ($USD)$292,000 $313,000 $864,000
Gross Margin %—17.6% 34.2%
Total Operating Expenses ($USD)$11,752,000 $13,332,000 $13,915,000
Net Loss ($USD)$(11,166,000) $(13,151,000) $(12,708,000)
EPS (Basic & Diluted, $USD)$(0.22) $(0.26) $(0.17)

YoY Comparison (Q3 2025 vs Q3 2024)

MetricQ3 2024Q3 2025
Revenue ($USD)$1,810,000 $2,523,000
Gross Margin %22.9% 34.2%
Total Operating Expenses ($USD)$8,876,000 $13,915,000
Net Loss ($USD)$(7,890,000) $(12,708,000)
EPS (Basic & Diluted, $USD)$(0.16) $(0.17)

Segment Breakdown (Q3 2025)

SegmentRevenue ($USD)YoY Change
United States$497,000 First commercial quarter
International$2,000,000 +12% YoY (vs $1.8M)

KPIs and Operating Metrics

KPIQ3 2025
U.S. procedures completed since launch100+
Gross Margin %34.2%
Cash & Marketable Securities (9/30/25)$63.4M
Q4 2025 Revenue Guidance$2.5–$3.0M
U.S. Field Organization“More than 30” exiting year (mostly field)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueQ4 2025None provided$2.5–$3.0M Initiated
U.S. Sales TrajectoryQ4 2025None providedSequential growth expected Initiated
International SalesQ4 2025None providedStable vs Q3 Initiated
Gross MarginForwardNone providedExpect continued expansion as U.S. mix grows Narrative raised

Earnings Call Themes & Trends

TopicQ1 2025 (Prior-2)Q2 2025 (Prior-1)Q3 2025 (Current)Trend
U.S. Launch ProgressBuilding commercial infrastructure; awaiting PMA approval in Q3 2025 PMA approval received; early account activations; double-digit physicians; shelf stocking begins >100 U.S. cases; $0.497M U.S. revenue; scaling field org >30 Accelerating
TCAR Strategy (CGUARDIANS II/III, SwitchGuard)Enrollment “excellent pace” (CGUARDIANS II) Timelines updated; integrated SwitchGuard clearance targeted 2027 CGUARDIANS II enrollment completion by year-end; mid-2026 approval; integrated solution mid-2027 On track; clarity improved
Reimbursement/Macro—CMS stenting shift enabling endovascular-first Continues to support demand and mix Supportive
International DemandSteady adoption in served markets OUS adoption continued; distributors managed inventory OUS revenue $2.0M (+12% YoY); >30 markets Stable-to-growing
Gross Margin/Profitability—GM 17.6% GM 34.2%; expansion expected with U.S. mix Improving
Regulatory/Clinical VisibilityOptimistic for PMA approval Q3 2025 PMA achieved; claims data emphasize opportunity CREST-2 data forthcoming; tandem lesion FES >50% enrolled Building awareness

Management Commentary

  • “In the third quarter, we reached $2.5 million in total revenue, representing year-over-year growth of 39% and sequential growth of over 40%... driven by strong early momentum in the U.S.” — CEO, Marvin Slosman .
  • “Gross margin increased to 34.2%... driven primarily by favorable revenue mix from our commercial launch in the U.S.... We expect continued expansion of gross margins in future quarters.” — CFO, Mike Lawless .
  • “Our communication is that we're requesting a modest premium... in the hundreds of dollars, not thousands... we want it to be a workhorse stent.” — CCO, Shane Gleason .
  • “For the fourth quarter, we expect sequential growth in U.S. sales... resulting in revenue of approximately $2.5–$3.0 million.” — CFO .
  • “We are on track to complete [CGUARDIANS II] enrollment by the end of the year and potential approval anticipated in mid-2026... integrated TCAR solution... expected FDA clearance and launch in mid-2027.” — CEO .

Q&A Highlights

  • Pricing and positioning: Modest premium to CAS/TCAR (hundreds of dollars) to enable “workhorse” usage, not limited to extreme cases .
  • Account activation: Several accounts opened per rep in initial quarter; approvals occurring in “months, not quarters,” with reps present during early cases .
  • Mix and margins: As U.S. becomes a larger share, margins expected to approach typical medtech levels over time (no formal numeric guidance) .
  • Q4 guide parsing: Stable international with U.S. sequential growth underpinning $2.5–$3.0M total revenue .
  • Field force: Scaling toward “more than 30” people exiting the year, mostly customer-facing roles; further expansion planned through 2026 .

Estimates Context

  • Q3 2025: Revenue $2.523M vs consensus $1.760M*; EPS -$0.17 vs -$0.195*. Clear revenue beat; EPS slightly better than expected [GetEstimates].
  • Q2 2025: Revenue $1.778M vs $1.518M*; EPS -$0.26 in line with -$0.26* [GetEstimates].
  • Q1 2025: Revenue $1.529M vs $1.452M*; EPS -$0.22 vs -$0.20* (worse than expected) [GetEstimates].
  • Q4 2025: Company guided $2.5–$3.0M; consensus $2.6215M* — guidance range brackets Street expectations [GetEstimates].

Actual vs SPGI Consensus (Quarterly)

MetricQ1 2025Q2 2025Q3 2025Q4 2025
Revenue (Actual, $USD)$1,529,000 $1,778,000 $2,523,000 —
Revenue Consensus Mean ($USD)*1,452,000*1,518,000*1,759,500*2,621,500*
EPS (Actual, $USD)-0.22 -0.26 -0.17 —
Primary EPS Consensus Mean ($USD)*-0.20*-0.26*-0.195*-0.20*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Mix-led operating leverage: U.S. revenue carries higher margins; early traction and guided sequential growth point to further GM expansion near term .
  • Revenue inflection: Q3 print demonstrates demand elasticity and activation pace; guidance suggests a constructive Q4 setup with U.S. growth on top of stable OUS .
  • Capitalized to execute: $63.4M cash/marketable securities supports field expansion, training, and clinical programs, reducing financing overhang risk near term .
  • Clinical catalysts: TCAR pathway clarity (mid-2026, mid-2027) and tandem lesion feasibility progress expand TAM and narrative support into 2026–2027 .
  • Watch OpEx discipline: Elevated spend is necessary for launch but scrutiny will shift to productivity per rep and OpEx scaling vs revenue ramp .
  • Estimate resets likely: With a strong beat and guided Q4 range bracketing consensus, sell-side numbers for revenue and margin trajectory may move higher; coverage remains thin (2 estimates*), increasing sensitivity to new data [GetEstimates].
  • Trading setup: Near-term catalysts include additional account wins, Q4 print vs guidance, and CREST-2 visibility; stock reaction likely driven by U.S. ramp pace, margin expansion, and clinical/regulatory milestones .