InspireMD, Inc. (NSPR)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 revenue was $1.529M, up 1.2% year over year, and beat Wall Street consensus by ~$0.077M (5.3%); EPS was -$0.22, missing consensus by $0.02 as operating expenses surged with U.S. launch buildout .*
• Gross margin compressed to 19.1% (vs 24.1% in Q4 and 22.9% in Q3), reflecting elevated costs and mix, while net loss widened to $11.166M on higher R&D and SG&A tied to commercialization .
• Management shifted expected FDA PMA approval for CGuard Prime to Q3 2025 (from H1), citing agency timing and February facility audit follow-up; SwitchGuard TCAR neuroprotection clearance now targeted for late 2026 .
• Units fell sequentially to 2,611 (from 3,512 in Q4), partly due to distributor inventory adjustments ahead of European CGuard Prime approval; cash and marketable securities declined to $26.086M (from $34.637M in Q4) .
• Near-term stock reaction catalyst: PMA approval in Q3 2025 and progress on TCAR programs (CGUARDIANS II enrollment, CGUARDIANS III IDE), with management emphasizing U.S. ASPs could translate current volumes into materially higher revenue post-approval .

What Went Well and What Went Wrong

What Went Well

• Revenue beat vs consensus (+~$0.077M, 5.3%) on continued adoption in served markets; management highlighted robust commercial preparation and a “world-class” team for U.S. launch .*
• Strong clinical and pipeline execution: CGUARDIANS II enrollment proceeding “remarkably well” with 8 active sites; tandem lesion early feasibility enrolled first four patients, expanding neurovascular opportunity .
• Clear commercialization roadmap and U.S. demand narrative: Q1 international unit volume (2,611 stents) would imply ~$12M revenue at U.S. ASPs, framing sizable step-up upon approval .

What Went Wrong

• Margin and loss deterioration: gross margin fell to 19.1% and net loss widened to $11.166M as operating expenses (+52.5% YoY) grew with U.S. sales force expansion, launch prep, and facility costs .
• Sequential volume/revenue decline vs record Q4: units dropped to 2,611 (from 3,512) and revenue to $1.529M (from $1.949M), impacted by FX and distributors managing inventory ahead of EU Prime approval .
• Regulatory timing pushed: PMA approval expectation moved to Q3 2025 due to audit follow-up and FDA resource dynamics; SwitchGuard clearance target shifted to late 2026, extending TCAR catalyst timeline .

Financial Results

S&P Global disclaimer: Values marked with * retrieved from S&P Global.

Estimates vs Actual (Q1 2025)

S&P Global disclaimer: Consensus values marked with * retrieved from S&P Global.

KPIs

Segment breakdown: Not applicable (single-product carotid stent portfolio focus).

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We’ve built and trained a world-class commercial team—ready to execute at scale upon potential FDA PMA approval.” — Marvin Slosman, CEO
• “Based on our latest communication with FDA, we are optimistic for approval in the third quarter of 2025.” — Marvin Slosman
• “Had this volume [2,611 stents] been realized in the U.S. at current market ASPs, it would have generated approximately $12 million in revenue.” — Marvin Slosman
• “Gross margin during the 3 months ended March 31, 2025, was 19.1%… Total operating expenses… increased… primarily due to higher salaries and share-based compensation tied to U.S. sales force expansion ahead of FDA approval.” — Jeremy Feffer (for CFO)

Q&A Highlights

• Regulatory timing: PMA moved to Q3 2025 due to the February site audit and subsequent FDA feedback; team remains “very confident” in approval despite agency resource dynamics .
• CGUARDIANS II enrollment: “Remarkably well” with 8 active sites; timeline consistent with early 2026 approval for the TCAR stent supplement .
• SwitchGuard: IDE resubmitted; clearance now targeted for late 2026, reflecting enrollment and review considerations .
• Hiring cadence and OpEx: Foundational team built; scaling to accelerate upon approval; OpEx will continue to grow through 2025 given R&D and commercialization needs .
• CREST-2 expectations: Management/CCO imply limited practice change depending on patient mix; subset analyses expected; overall tone is steady state .

Estimates Context

• Revenue beat and EPS miss vs consensus: Actual revenue $1.529M vs $1.452M estimate; EPS -$0.22 vs -$0.20 estimate, reflecting heavier operating expenses ahead of launch. Two estimates in each category suggest a thin sell-side base, increasing potential for post-approval model adjustments .*
• Estimate revisions likely: Post-call, models should reflect delayed PMA (Q3), lower near-term margins due to hiring, and potential step-up in revenue post-approval given the ASP translation framing .*

S&P Global disclaimer: Consensus values marked with * retrieved from S&P Global.

Key Takeaways for Investors

• PMA timing shift to Q3 2025 is the key gating item; regulatory approval remains the primary stock catalyst .
• Revenue outperformed consensus despite FX and inventory headwinds; sequential softness vs record Q4 is manageable given pending U.S. launch .
• Margin compression and wider losses underscore investment phase; expect continued OpEx elevation through 2025 as the U.S. field and infrastructure scale .
• Liquidity is adequate near term ($26.086M cash/securities) with potential milestone financing ($17.9M upon PMA) to extend runway into commercialization .
• U.S. ASP translation of current volumes points to significant revenue uplift post-approval; launch readiness and hospital VAC positioning should accelerate early adoption .
• TCAR strategy progressing (CGUARDIANS II/III), but SwitchGuard clearance now late 2026; near-term focus remains CAS launch with TCAR following .
• Trading implications: watch FDA interactions and milestones; upside skew on PMA approval and early adoption; near-term downside from any further regulatory delays or higher-than-expected burn.