Loading...
01/09 20:08
Loading...
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call highlights several concerns: increased net loss, rising operating expenses, and lack of revenue guidance. While there is optimism for FDA approval of CGuard Prime, delays and regulatory risks pose significant challenges. The financial health is strained with decreasing cash reserves. The Q&A session revealed vague responses about FDA interactions, raising uncertainty. Despite the potential for future growth and a shareholder return plan, immediate financial pressures and uncertainties weigh heavily, suggesting a negative stock price movement in the short term.
CGuard Revenue $1.53 million, reflecting a 1.2% growth year-over-year.
Gross Profit $292,000, flat compared to the first quarter of 2024, with a gross margin of 19.1%.
Total Operating Expenses $11,752,000, an increase of $4 million or 52.5% compared to $7,706,000 for the first quarter of 2024, primarily due to higher salaries and share-based compensation tied to U.S. sales force expansion, CGuard Prime launch preparation, U.S. facility rent, and CFO recruitment fees.
Total Financial Income $294,000, a decrease of $88,000 or 23% compared to $382,000 for the first quarter of 2024, primarily due to less interest income from investments in marketable securities and money market funds.
Net Loss $11,166,000 or $0.22 per basic and diluted share, compared to a net loss of $7,032,000 or $0.21 per basic and diluted share for the same period in 2024.
Cash and Cash Equivalents and Marketable Securities $26,086,000 compared to $34,637,000 as of December 31, 2024.
CGuard Revenue: CGuard revenue reached $1.53 million, reflecting a 1.2% growth year-over-year.
CGuard Prime Approval Status: Anticipated U.S. approval for CGuard Prime in Q3 2025, with preparations for commercial launch underway.
CGuard Prime Market Potential: If Q1 sales were realized in the U.S., it could generate approximately $12 million in revenue.
SwitchGuard Neuroprotection System: Potential introduction of SwitchGuard Neuroprotection System for TCAR as a catalyst for revenue expansion.
Market Growth: Significant market growth for CAS and TCAR procedures, with a shift from surgery to stenting expected.
TCAR Procedures: Over 30,000 TCAR procedures performed annually in the U.S., representing a growing opportunity.
Sales Team Expansion: Onboarded and trained roughly 20 sales and marketing professionals to support U.S. launch.
Operational Readiness: Building a world-class commercial and operational engine to support the U.S. launch.
Miami Facility: State-of-the-art facility in Miami to meet market demand efficiently and diversify supply chain.
Clinical Pipeline Progress: Strong enrollment in C-GUARDIANS II pivotal study for CGuard Prime stent system.
Funding Milestones: Receipt of premarket approval would trigger a $17.9 million financing tranche.
Regulatory Risks: InspireMD is awaiting FDA approval for CGuard Prime, with optimism for approval in Q3 2025. However, any delays or negative feedback from the FDA could impact the launch and revenue projections.
Supply Chain Challenges: The company is establishing a domestic production facility in Miami to mitigate supply chain risks and ensure efficient market demand fulfillment amid macroeconomic uncertainties.
Financial Risks: Increased operating expenses of $11.75 million in Q1 2025, a 52.5% rise from the previous year, primarily due to U.S. sales force expansion and launch preparations, could strain financial resources.
Market Competition: The introduction of CGuard Prime is positioned against significant competition in the carotid stent market, and the success of the product will depend on its ability to capture market share from existing solutions.
Economic Factors: Foreign exchange impacts and distributor inventory management in anticipation of CGuard Prime approval in Europe may affect revenue stability and growth.
Clinical Trial Risks: The success of ongoing clinical trials, including the C-GUARDIANS II and III studies, is critical for future product approvals and market acceptance, with potential delays or failures posing risks to growth.
CGuard Revenue: CGuard revenue reached $1.53 million, reflecting a 1.2% growth year-over-year.
CGuard Prime Approval Status: Anticipated FDA approval in Q3 2025, with preparations for commercial launch underway.
Sales Team Expansion: Onboarded and trained roughly 20 sales and marketing professionals to support U.S. launch.
Production Facility: State-of-the-art facility in Miami, Florida to support U.S. operations and meet market demand.
Clinical Pipeline Progress: Strong enrollment in C-GUARDIANS II pivotal study, on track for clinical milestones.
Tandem Lesion Study: First four patients enrolled in the Tandem Lesion Early Feasibility Study.
Financing Tranches: Receipt of premarket approval will trigger the second of four milestone-based financing tranches.
Revenue Expectations: If U.S. sales matched international volume, it could generate approximately $12 million in revenue.
Market Growth: Significant growth anticipated in CAS and TCAR procedures, with a shift towards endovascular solutions.
Long-term Growth Strategy: Focus on both CAS and TCAR technology to serve a broad physician base and lead in endovascular care.
Net Loss: Net loss for Q1 2025 totaled $11.17 million, compared to $7.03 million in Q1 2024.
Cash Position: Cash and cash equivalents were $26.09 million as of March 31, 2025.
Shareholder Return Plan: InspireMD announced a transformational private placement of up to $113.6 million, with milestone-based financing tranches. The second tranche, triggered by premarket approval, would raise an additional $17.9 million in gross proceeds.
The company reported strong financial metrics with 39% YoY revenue growth and improved gross margins. Despite a net loss, the cash position is strong due to recent financing. The U.S. launch of CGuard Prime shows positive momentum with strong physician feedback. The Q&A highlighted positive sentiment and growth expectations, although management avoided specific margin guidance. Overall, the earnings call suggests a positive short-term outlook, with expected growth in the U.S. market and improved margins.
The earnings call indicates a challenging financial position with increased net losses and operating expenses, alongside decreased gross margins. While there is positive momentum with the U.S. launch of CGuard Prime, adoption is gradual, and management's lack of specific guidance raises concerns. The Q&A section highlighted uncertainties in timelines and market strategies. Despite some positive developments, the overall sentiment is negative due to financial strain and unclear future prospects.
The earnings call reveals several concerns: missed earnings expectations, increased operating expenses, and a significant net loss. The lack of forward-looking revenue guidance and the delay in FDA approval for CGuard Prime add to uncertainties. Despite positive clinical trial data and a strong sales force expansion, these factors, combined with competitive pressures and supply chain challenges, create a negative outlook. The absence of share repurchase or dividend programs further limits investor appeal. Overall, the sentiment is negative, with potential for a stock price decline in the range of -2% to -8%.
The earnings call highlights several concerns: increased net loss, rising operating expenses, and lack of revenue guidance. While there is optimism for FDA approval of CGuard Prime, delays and regulatory risks pose significant challenges. The financial health is strained with decreasing cash reserves. The Q&A session revealed vague responses about FDA interactions, raising uncertainty. Despite the potential for future growth and a shareholder return plan, immediate financial pressures and uncertainties weigh heavily, suggesting a negative stock price movement in the short term.
All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.
Full verbatim transcripts are typically published within 4–12 hours after the call ends. Same-day availability is guaranteed for all S&P 500 and most mid-cap companies.
No material content is ever changed or summarized in the “Full Transcript” section. We only correct obvious spoken typos (e.g., “um”, “ah”, repeated 10 times”, or clear misspoken ticker symbols) and add speaker names/titles for readability. Every substantive sentence remains 100% as spoken.
When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.
They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.
