InspireMD — Second Quarter 2026 Earnings Summary

Financial Performance

• Total revenue for the quarter ended June 30, 2026, was $1,771,000, a 0.4% decrease from $1,778,000 in the same period of 2025.
• U.S. revenue for the quarter was negative $351,000, compared to $27,000 in 2025, driven by $734,000 in customer credits related to a voluntary recall that exceeded gross U.S. sales.
• International revenue was $2,122,000, a 21% increase from $1,751,000 in 2025.
• Gross loss for the quarter was $774,000, compared to a gross profit of $313,000 (17.6% margin) in 2025.
• The gross loss included a $612,000 inventory impairment charge and $734,000 in revenue credits associated with the recall.
• Adjusted gross profit for the quarter was $572,000 on a non-GAAP basis.
• Total operating expenses were $13,671,000, an increase of 2.5% from $13,332,000 in 2025, primarily due to higher headcount-related expenses for the U.S. commercial team and increased clinical/regulatory expenses.
• Net loss for the quarter was $14,324,000 ($0.17 per share), compared to $13,151,000 ($0.26 per share) in 2025.
• For the six months ended June 30, 2026, total revenue increased 56.3% to $5,169,000 from $3,307,000 in 2025.
• Gross loss for the six-month period was $87,000, compared to a gross profit of $605,000 (18.3% margin) in 2025.
• Adjusted gross profit for the six-month period was $1,732,000 on a non-GAAP basis.
• Net loss for the six months was $28,013,000 ($0.33 per share), compared to $24,317,000 ($0.48 per share) in 2025.
• Cash and cash equivalents plus marketable securities totaled $30,421,000 as of June 30, 2026, down from $54,211,000 as of December 31, 2025.

Guidance and Future Outlook

• Management anticipates FDA decisions on the CGuard Prime 80 cm implant for TCAR procedures and the original CGuard platform for traditional carotid stenting later in 2026.
• An FDA submission for the design-modified CGuard Prime 135 cm delivery system is anticipated before year-end.
• The company expects to return to the U.S. market with both TCAR and CAS delivery systems subject to regulatory approvals.
• Savings actions initiated after the second quarter are expected to generate approximately $9 million in annual savings.

Business Segments and Product Lines

• The CGuard Prime carotid stent system is the company's primary product, with a voluntary recall of the 135 cm delivery system impacting U.S. sales.
• Patient enrollment has commenced in the CGUARDIANS III pivotal trial for the SwitchGuard neuroprotection system (NPS) used with the CGuard Prime 80 cm stent platform.
• 30-day outcomes from the CGUARDIANS II clinical trial for the CGuard Prime 80 cm implant showed 100% acute device success, no deaths, strokes, or myocardial infarctions, no stent thrombosis, and complete stent patency in evaluable subjects.
• Kathleen Kennedy was appointed Senior Vice President of Global Sales and Marketing to support the anticipated U.S. re-launch.
• Design changes to the CGuard Prime 135 cm delivery system are undergoing validation and performance testing ahead of FDA submission.

Market and Competitive Landscape

• International markets saw broad-based demand increases, offsetting the impact of the U.S. recall.
• Management believes the CGuard platform is a best-in-class implant in the carotid stenting space.
• The company aims to strengthen its competitive position and increase market penetration upon U.S. re-entry.

Risks and Challenges

• The voluntary recall of the CGuard Prime 135 cm delivery system resulted in negative U.S. revenue, inventory impairments, and revenue credits.
• The company faces risks related to the adequacy of liquidity to pursue business objectives and substantial doubt regarding its ability to continue as a going concern.
• Potential risks include product liability lawsuits, regulatory actions, and the need to raise additional capital which could be costly or dilutive.
• The company relies on a single manufacturing facility and faces risks regarding compliance with quality standards and production scaling.
• Intense competition exists with competitors possessing greater financial and operational resources.

Management Commentary and Tone

• CEO Marvin Slosman stated the company executed steps to consolidate resources and streamline the commercial organization to support the U.S. re-launch.
• Management expressed confidence in the design improvements to the 135 cm delivery system and the potential for the CGuard platform to drive future revenue growth.
• The tone indicates a focus on aligning resources with near-term commercial and regulatory priorities while maintaining dialogue with the FDA.

Other Key Points

• Savings actions initiated after the second quarter aim to reduce the cost structure and improve operational efficiency.
• The company reported a net loss per share of $0.17 for the quarter and $0.33 for the six-month period.
• The company holds 46,921,061 shares of common stock issued and outstanding as of June 30, 2026.
• A conference call and webcast were scheduled for August 17, 2026, at 8:30 am EDT to discuss results.