InspireMD, Inc. (NSPR)·Q4 2024 Earnings Summary

Executive Summary

• Q4 revenue hit a record $1.95M, up 10.7% YoY, and above S&P Global consensus of $1.82M*; GAAP EPS was ($0.19), modestly better than ($0.20)*; gross margin was 24.1% vs 28.7% YoY as OpEx ramped ahead of a U.S. launch .
• Management reiterated an anticipated H1 2025 U.S. PMA approval and launch for CGuard Prime; global Q4 stent units were 3,512, and management framed this as a sizable U.S. revenue opportunity at prevailing ASPs .
• U.S. commercialization build is underway: HQ established in Miami, >12 sales professionals onboarded (including four regional directors), and VAC readiness work progressing pending approval .
• TCAR pipeline advancing: CGUARDIANS II is enrolling; management targets early 2026 for the TCAR supplement approval and 2H 2026 for SwitchGuard NPS clearance; next IDE (C‑GUARDIANS III) expected to initiate in Q2 2025 .
• Liquidity of $34.6M at year-end; PMA approval would trigger a $17.9M milestone tranche, providing additional funding for the U.S. launch and pipeline execution .

What Went Well and What Went Wrong

• What Went Well

  • Record quarterly revenue ($1.95M) and units (3.5K) on sustained OUS growth; CEO: “2024 was a year of tremendous progress… toward potential U.S. approval” .
  • Regulatory momentum: interactive PMA review with FDA and on-track H1 2025 approval/launch; “We remain on track for an anticipated U.S. approval and launch… in the first half of 2025” .
  • Commercial readiness: new U.S. HQ and field buildout; “We are not just prepared but ready to aggressively execute a robust… launch plan” .

• What Went Wrong

  • Gross margin compression: Q4 GM 24.1% vs 28.7% YoY; full-year GM 21.5% vs 29.1% in 2023, driven by higher materials/labor and scaling costs .
  • OpEx surged 56% YoY in Q4 to $9.8M on hiring and U.S. launch prep; full-year OpEx +52.5% to $35.0M, increasing losses .
  • No formal revenue guidance, limiting near-term visibility; CFO highlighted continued OpEx growth in 2025 due to sales/R&D investment .

Financial Results

Quarterly progression (oldest → newest)

Q4 year-over-year

KPIs

Vs S&P Global consensus (Actual vs Consensus*)

Note: Values marked with * are from S&P Global consensus (GetEstimates).

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We remain on track for an anticipated U.S. approval and launch of CGuard Prime in the first half of 2025… We are not just prepared but ready to aggressively execute a robust commercial and operational launch plan.” – CEO, prepared remarks .
• “C-GUARDIANS’ results demonstrated… major adverse events rates of just 0.95% through 30 days and 1.95% through 12 months… the lowest event rate ever reported in a pivotal study of a carotid stent or embolic protection device.” – CEO .
• “Gross margin decreased to 24.1%… Total operating expenses… increased… primarily due to salaries and share-based compensation associated with our expected launch into the U.S. market.” – CFO (prepared remarks) .
• “Most hospitals will not consider a product until it’s approved… we’re able to hold the place in line so that upon approval, we won’t then be queuing up at the back of the line for consideration.” – CCO on VAC process .

Q&A Highlights

• Approval timing: Management “optimistic” on H1 2025 approval; no material macro/FDA changes expected to alter timing; interactive review ongoing .
• TCAR timelines: CGUARDIANS II supplement approval targeted for early 2026; SwitchGuard NPS clearance targeted for 2H 2026; C‑GUARDIANS III anticipated to initiate in Q2 2025 .
• U.S./OUS split and launch pacing: 2H 2025 is a foundational build period post-approval with VAC cycles and onboarding; more level-set growth into 2026 .
• Field buildout: 13 initial commercial hires including four regional sales directors; ongoing additions of territory managers and clinical specialists in 2025 .
• OpEx outlook: Expect continued growth in 2025 across Sales and R&D as CGUARDIANS II/III progress and PMA activities complete .

Estimates Context

• Q4 revenue beat: $1.95M actual vs $1.82M* consensus; EPS ($0.19) vs ($0.20); FY 2024 revenue $7.01M vs $6.90M; FY 2024 EPS ($0.76) vs ($0.78)* .
• Coverage depth remains thin (two estimates for EPS and revenue); consensus target price $4.50* (two estimates) suggests upside contingent on regulatory and launch execution. Values marked with * are from S&P Global (GetEstimates).
• Potential estimate revisions: modest upward adjustments to revenue on demonstrated OUS momentum and Q4 beat; OpEx/margin trajectory likely to temper near-term EBITDA paths until scale is realized post-approval .

Key Takeaways for Investors

• Near-term catalyst path is intact: PMA decision/launch in H1 2025, followed by TCAR milestones into 2026; stock should be highly sensitive to FDA timing and early launch traction .
• Q4 print was clean on top-line and units, with a revenue beat versus consensus*, but margin compression and OpEx ramp continue as they invest ahead of U.S. entry .
• Commercial readiness appears advanced (HQ, sales leadership, initial field hires, VAC timing work), de-risking initial access bottlenecks post-approval .
• Liquidity is adequate into the catalyst window with $34.6M at year-end and a PMA-triggered $17.9M tranche to extend runway .
• TCAR is a meaningful second leg; CGUARDIANS II (enrolling) and SwitchGuard NPS (2H 2026 clearance target) expand TAM and physician relevance .
• Watch operating leverage: sequential GM improved vs Q2/Q3, but remains below prior-year; scaling, mix, and manufacturing learnings will be key to drive margin recovery through 2025–2026 .
• No formal revenue guidance; track OUS momentum, U.S. VAC conversions, hiring pace, and first 6–12 months’ utilization post-approval for signs of sustainable acceleration .

Footnote: Values marked with * are retrieved from S&P Global consensus via GetEstimates.