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01/09 20:07
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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%.
CGuard Revenue $1.53 million, reflecting a 1.2% growth year-over-year. This increase was driven by growth in existing markets, offset by the impact of foreign exchange and distributors managing CGuard inventory levels in anticipation of CGuard Prime approval in Europe.
Gross Profit $292,000, flat compared to the first quarter of 2024. Gross margin during the three months ended March 31, 2025, was 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. This increase was primarily due to higher salaries and share-based compensation tied to U.S. sales force expansion ahead of FDA approval, along with 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. This decrease was 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.
CGuard Prime Launch Preparation: Preparing for commercial launch with a growing sales team and significant demand expected.
SwitchGuard Neuroprotection System: Potential introduction of SwitchGuard for TCAR as a catalyst for revenue expansion.
Market Opportunity: Current international sales suggest potential U.S. revenue of approximately $12 million based on current market ASPs.
Endovascular Procedures Growth: Significant market growth with a shift from surgery to stenting expected.
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 for the U.S. launch.
Miami Facility: State-of-the-art facility in Miami to support domestic production and meet market demand.
Clinical Pipeline Progress: Strong enrollment in C-GUARDIANS II pivotal study for CGuard Prime.
TCAR Strategy Advancement: Engaged with FDA for C-GUARDIANS III IDE submission, anticipating approval in Q3.
Long-term Growth Strategy: Focus on both CAS and TCAR technologies to reshape the market.
Earnings Expectations: InspireMD missed earnings expectations with a reported EPS of $-0.22, compared to the expected $-0.17.
Regulatory Approval Risks: The company is awaiting FDA approval for CGuard Prime, with potential delays impacting market entry and revenue generation.
Supply Chain Challenges: The company is addressing supply chain uncertainties, particularly in light of macroeconomic factors, to ensure efficient domestic production.
Financial Performance: Total operating expenses increased by 52.5% due to higher salaries and launch preparations, which may strain financial resources.
Market Competition: The introduction of CGuard Prime is positioned against competitive pressures in the carotid stent market, necessitating effective marketing and sales strategies.
Foreign Exchange Impact: Revenue growth was offset by foreign exchange impacts and inventory management by distributors, indicating potential volatility in international markets.
Investment Risks: The company’s financial income decreased by 23%, reflecting risks associated with investments in marketable securities and interest income.
CGuard Revenue: CGuard revenue reached $1.53 million, reflecting a 1.2% growth year-over-year.
CGuard Prime Approval: Anticipated U.S. approval for CGuard Prime in Q3 2025.
Sales Team Expansion: Onboarded and trained roughly 20 high-powered sales and marketing professionals.
Commercial Launch Preparation: Preparing for a comprehensive commercial launch of CGuard Prime.
Clinical Pipeline Progress: Strong enrollment in C-GUARDIANS II pivotal study and TCAR strategy advancement.
Tandem Lesion Study: Successfully enrolled first four patients in the Tandem Lesion Early Feasibility Study.
Milestone Financing: Receipt of premarket approval would trigger the second of four milestone-based financing tranches.
Revenue Expectations: If U.S. sales matched international sales, it could generate approximately $12 million in revenue.
Future Financial Projections: Anticipate significant revenue expansion following regulatory approval of CGuard Prime.
Operating Expenses: Total operating expenses increased by 52.5% to $11.75 million due to sales force expansion.
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 has a transformational private placement of up to $113.6 million announced in May 2023, which includes milestone-based financing tranches. The second tranche, triggered by FDA premarket approval, would raise an additional $17.9 million in gross proceeds.
Share Repurchase Program: None
Dividend Program: None
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.
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