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    NSPR
    Earnings call· Jun 2026(Q2 FY26)

    InspireMD Q2 FY26 earnings call NSPR

    Aug 17, 2026 Source

    Executive summary

    InspireMD Q2 FY26 — Strategic Realignment Amidst Recall, Focus on Regulatory Milestones

    InspireMD navigated a challenging quarter marked by a voluntary recall of its CGuard Prime 135 system, which significantly impacted reported financials. Despite this, the company demonstrated resilience with strong international growth and made meaningful progress on multiple regulatory fronts, including advancing its TCAR and CAS platforms towards anticipated Q4 FDA approvals. Management has also taken decisive actions to streamline its cost structure and organization, positioning the company for a strategic U.S. market re-entry and long-term growth.

    Highlights

    3

    • International revenue grew 21% year-over-year to $2.1 million, reflecting strong demand for CGuard.

    • CGuard Prime 80 platform for TCAR showed outstanding 30-day results from CGUARDIANS II trial, strengthening pending FDA submission.

    • Workforce reduction of almost 20% is expected to save approximately $9 million annually, improving financial flexibility.

    Concerns

    4

    • Total revenue was flat year-over-year at $1.8 million, impacted by a voluntary recall.

    • Gross profit was a loss of $0.8 million or negative 43.7% of revenue, down from 17.6% in Q2 FY25, due to recall-related credits and inventory impairment.

    • Net loss increased to $14.3 million or $0.17 per share, compared to $13.2 million or $0.26 per share in Q2 FY25.

    • Cash and cash equivalents and marketable securities decreased to $30.4 million as of June 30, 2026, from $54.2 million at the end of 2025.

    Guidance & targets

    5
    CategoryTargetConfidence
    CGuard Prime 80 platform for TCAR approval
    Q4 2026
    high materiality
    High
    Original CGuard platform for CAS approval
    Q4 2026
    high materiality
    High
    Redesigned CGuard Prime 135 CAS delivery system market reentry/approval
    H1 2027
    high materiality
    Medium
    SwitchGuard neuroprotection system U.S. approval and launch
    H2 2027
    high materiality
    Medium
    Restructuring charge
    $0.9M-$1.2M
    medium materiality
    High

    Segment performance

    1
    SegmentRevenueYoYQoQMargin
    International
    Growth driven by continued demand for the CGuard stent platform; foreign exchange rates were immaterial.
    		$2.1M21%——

    Operational metrics

    9
    Adjusted gross profit
    $0.6M
    Q2 FY26

    Excludes the impact of recall-related customer credits and inventory impairment charge.

    Gross profit margin (GAAP)
    -43.7%down from 17.6%
    Q2 FY26

    Decline primarily resulted from $734,000 customer credits and a $612,000 inventory impairment charge.

    Gross profit margin (GAAP)
    17.6%
    Q2 FY25

    Comparison point for current quarter's gross profit margin.

    Operating expenses increase
    $0.4MYoY
    Q2 FY26

    Increase compared to $13.3 million in Q2 FY25, primarily due to greater headcount-related expenses for U.S. commercial team and higher development, clinical, and regulatory expenses.

    Cash and cash equivalents and marketable securities
    $30.4Mdown from $54.2M
    as of Jun 30, 2026

    Compared to the balance at the end of 2025.

    Workforce reduction
    almost 20%
    Q3 FY26

    Initiated in the third quarter to reduce the number of positions in the organization.

    Annual savings from workforce reduction
    $9M
    annual

    Expected savings from the workforce reduction initiated in Q3.

    Annual U.S. stenting procedures
    approximately 75,000
    annual

    The total addressable market for stenting procedures in the U.S.

    Addressable market increase (TCAR)
    double
    future

    The CGuard Prime 80 platform for TCAR would essentially double the addressable market by offering the implant for TCAR in addition to CAS procedures.

    Industry KPIs

    3
    MetricValueDetails
    Segment franchise organic growth21%%
    Indicated addressable patient population75,000procedures
    Pivotal trial clinical evidence milestonesOutstanding 30-day results

    Risks & headwinds

    5
    Voluntary recall of CGuard Prime 135 carotid stent systemQ2 FY26

    $734,000 customer credits; $612,000 inventory impairment charge

    Mitigation: Identified design modifications, initiated validation and performance testing, submitted pre-sub dossier to FDA for H1 2027 re-entry (potential for earlier).

    Increased net lossQ2 FY26

    Net loss of $14.3 million ($0.17 per share) in Q2 FY26, compared to $13.2 million ($0.26 per share) in Q2 FY25

    Mitigation: Workforce reduction initiated in Q3 FY26 to save approximately $9 million annually and align cost structure.

    Cash burnH1 FY26

    Cash and cash equivalents and marketable securities decreased to $30.4 million as of June 30, 2026, from $54.2 million at the end of 2025

    Mitigation: Proactive actions to reduce cost structure and improve financial flexibility and operational efficiency, including workforce reduction.

    Restructuring chargeQ3 FY26

    $900,000 to $1.2 million

    Mitigation: This charge is a one-time cost associated with the workforce reduction, expected to lead to annual savings.

    Regulatory timeline delaysQ3-Q4 FY26

    Original CGuard platform for CAS approval shifted from Q3 to Q4 2026

    Mitigation: Management is being realistic about regulatory timeframes, including required testing and FDA's workload. They are working closely with the FDA and have submitted pre-sub requests to potentially accelerate timelines for the redesigned CGuard Prime 135.

    What to watch in Q3 FY26

    5

    CGuard Prime 80 for TCAR FDA approval

    Q4 FY26
    CurrentPending Q4 2026 decision
    TargetApproval decision

    Why it matters

    This approval would significantly expand the addressable market for TCAR procedures and is a key catalyst for U.S. re-entry.

    all signals point to potential approval in the fourth quarter, as we previously indicated.

    Q&A highlights

    5

    Why has the U.S. approval timing for the original CGuard system shifted from Q3 to Q4, and what are the interactions with the FDA like?

    The shift to Q4 is due to being realistic about regulatory timeframes, including required testing and FDA's workload. Interactions remain constructive, and the company is on top of all necessary details.

    “I think the wiggle, as you mentioned it, is we're just trying to be realistic about the regulatory time frames as always, request from FDA and just general time frames.”

    asked by Adam Maeder · answered by Marvin Slosman

    2 min read5 chapters

    Detailed Narrative

    01

    Voluntary Recall and Remediation Progress

    The second quarter was significantly impacted by the voluntary recall of the CGuard Prime 135 carotid stent system. This led to a $734,000 customer credit and a $612,000 inventory impairment charge. Management has identified required design modifications for the delivery system, initiated validation and performance testing, and submitted a pre-sub dossier to the FDA. The company is optimistic about a market re-entry in the first half of 2027, with potential for an earlier approval if the FDA agrees to an accelerated review.

    02

    Regulatory Advancement for U.S. Market Re-entry

    InspireMD is actively pursuing multiple regulatory catalysts to re-establish its U.S. market presence. The CGuard Prime 80 platform for TCAR is anticipated to receive FDA approval in Q4 2026, following outstanding 30-day results from the CGUARDIANS II trial. A decision for the original CGuard platform for CAS is also expected in Q4 2026. These approvals would allow the company to address the approximately 75,000 annual U.S. stenting procedures.

    03

    International Business Strength

    Despite U.S. market challenges🌐, the international business demonstrated robust performance, growing approximately 21% year-over-year to $2.1 million. This growth reflects continued physician adoption and strong demand for the CGuard stent platform in international markets. The company plans to fine-tune pricing and margin assumptions in these markets to improve bottom-line contribution, leveraging its experience with over 75,000 OUS implants.

    04

    Cost Structure Alignment and Workforce Reduction

    The company undertook decisive actions to align its organization and cost structure with near-term priorities. A workforce reduction initiated in Q3 2026 will reduce the number of positions by almost 20%, leading to approximately $9 million in annual savings. A restructuring charge of $900,000 to $1.2 million is expected in Q3. These measures aim to create a leaner, more efficient organization while maintaining commercial readiness for U.S. relaunch.

    05

    SwitchGuard Neuroprotection System Progress

    Enrollment has begun for CGUARDIANS III, the pivotal study evaluating the next-generation SwitchGuard neuroprotection system. This system is considered fundamental to the company's overall TCAR strategy, as it aims to provide both the implant and a neuroprotection device. The company is tracking towards a U.S. approval and launch in the second half of 2027, with investigators reportedly pleased with the device's performance in human applications.

    AI-generated summary of the company’s earnings call. Not investment advice.