InspireMD, Inc. (NSPR)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 revenue was $1.78M (+2.3% YoY), gross margin fell to 17.6%, and net loss widened to $13.15M ($0.26/share) as U.S. commercial build-out lifted OpEx; no formal guidance was provided, but management expects sequential revenue growth beginning in Q3 as U.S. sales commence .
• Transformational catalysts in the quarter: FDA PMA approval for CGuard Prime (6/24), official U.S. commercial launch (7/9), CE Mark under EU MDR (6/13), and combined gross proceeds of ~$58M via PIPE and warrant exercises, strengthening liquidity for commercialization .
• Operating expenses rose 55% YoY to $13.33M on U.S. sales-force expansion, launch preparation, HQ occupancy, and CFO severance, driving operating loss to $13.02M; cash and marketable securities ended Q2 at $19.37M (pre-PIPE), improving further with July/August financings .
• Pipeline updates: CGuardIANS II (TCAR catheter with existing NPS) pacing toward 2026 clearance; SwitchGuard NPS + CGuard Prime 80 (integrated TCAR solution) timeline reset to 2027 to reflect enrollment/regulatory variability; management emphasized methodical launch and U.S. account openings with early stocking orders .
• Stock reaction catalysts near term: U.S. launch ramp and account conversions, TCAR clinical progress, reimbursement tailwind (CMS NCD), and incremental financings unlocking milestones; watch for execution vs hiring/OpEx discipline and gross margin trajectory as manufacturing scales .

What Went Well and What Went Wrong

What Went Well

• FDA PMA approval and U.S. launch: “the most significant milestone in our company’s history”—commercial rollout begun with trained, “world-class” team and early stocking orders in multiple accounts .
• Balance sheet strengthened: ~$58M raised ($40.1M PIPE + $17.9M warrants) to fund U.S. commercialization and pipeline, deepening commitment of key shareholders and adding new investors .
• Regulatory momentum OUS: CE Mark approval under EU MDR for CGuard Prime EPS, enabling unified platform and broader scale across served markets .

What Went Wrong

• Profitability deterioration: Gross margin declined to 17.6% (vs 19.0% LY) and net loss widened to $13.15M as OpEx rose 55% YoY on U.S. expansion ahead of revenue recognition, and FX headwinds reduced financial income .
• Geographic headwinds: European distributors managed inventory ahead of EU launch; Russia revenues decreased, weighing on quarterly revenue mix .
• TCAR integrated solution timeline extended: SwitchGuard NPS + CGuard Prime 80 clearance now anticipated in 2027 (vs late 2026) to accommodate clinical enrollment and FDA review variability .

Financial Results

P&L and Key Metrics (oldest → newest)

Balance Sheet Liquidity

Geographic Revenue Mix (Quarter)

Notes:

• Q2 2025 YoY revenue growth driven by adoption and FX tailwinds, offset by Russia decline and European distributor inventory management ahead of Prime launch .
• Gross margin compressed due to production variances and write-offs, partially offset by lower material/labor costs .

Guidance Changes

Management reiterated no formal revenue or margin guidance; commentary indicates methodical launch and foundation-building before robust scale .

Earnings Call Themes & Trends

Management Commentary

• CEO on PMA and launch: “We are now focused on scaling with discipline and precision to unlock the full potential of our platform” and entering “a new era of growth” with breakthrough technology aimed to become standard of care .
• CEO on launch progress: “As of today, we've successfully completed approvals, orders and commercial procedures…demand” observed across U.S. centers; team assembled with deep vascular experience .
• CFO on Q2 dynamics and outlook: U.S. revenue recognition begins in Q3; expects sequential revenue growth as launch progresses; OpEx elevated due to U.S. personnel and HQ occupancy .

Q&A Highlights

• U.S. account openings: approvals progressing; “procedures with double-digit physicians” and early stocking orders; headcount ~20 in field with ~10 additions planned by YE .
• Market mix shift: surgery now <60% with stenting >40%; lines converging toward 50/50 in ~12 months, supporting endovascular-first narrative .
• TCAR timelines: CGII still pacing to 2026; integrated SwitchGuard solution reset to 2027 to accommodate enrollment/FDA review variability .
• Launch pacing: Emphasis on methodical ramp, VAC processes, and disciplined scale rather than overnight adoption .

Estimates Context

• Q2 2025: Wall Street consensus for revenue/EPS was not available or too sparse to be reliable; management provided no formal guidance .
• Forward estimates snapshot:

*Values retrieved from S&P Global.

Implication: With only two estimates and an early-stage U.S. launch, models likely need to incorporate higher near-term OpEx and gradual account conversions; directional sequential revenue growth is reasonable, but formal ranges are lacking .

Key Takeaways for Investors

• Near-term revenue inflection hinges on U.S. launch execution: watch cadence of account approvals, stocking orders, and procedure volumes through Q3–Q4; management targets sequential growth starting Q3 .
• Liquidity improved post-quarter to fund scale: ~$58M raised via PIPE and PMA-triggered warrants strengthens runway for commercialization and pipeline milestones .
• Margin trajectory is a key monitor: gross margin compressed to 17.6% on production variances/write-offs; scalability and U.S. manufacturing transfer to Aptyx should be tracked for COGS improvements over time .
• TCAR strategy intact but integrated system delayed: CGII supports entry via existing NPS (2026 target), while SwitchGuard integrated solution reset to 2027; this phases the TCAR opportunity .
• Reimbursement tailwind supportive: CMS NCD broadened coverage for CAS/TCAR, favoring stent-first care amid market shift toward endovascular intervention .
• Execution vs OpEx discipline: OpEx up 55% YoY reflecting hiring and HQ expenses; investors should monitor hiring cadence, productivity, and cash burn vs launch ramp .
• Clinical differentiation underpins adoption: C-GUARDIANS trial delivered lowest 30-day and 1-year event rates ever reported in carotid stenting pivotal studies, a credible adoption catalyst in U.S. market .

Citations:

• Press release Q2 2025 results and tables .
• 8-K Item 2.02 with Exhibit 99.1 .
• 10-Q details (financials, revenue disaggregation, risks, manufacturing, reimbursement) .
• Earnings call transcript Q2 2025 (prepared and Q&A) .
• Prior quarter press release and transcript for trend .
• Q4 2024 press release and transcript .
• FDA PMA approval, CE Mark, U.S. launch, and financing press releases .