InspireMD(US:NSPR)2025-05-08 20:05Financial Performance - For the three months ended March 31, 2025, revenue increased by $18,000, or 1.2%, to $1,529,000, compared to $1,511,000 for the same period in 2024[84] - Gross profit for the same period was $292,000, with a gross margin decrease to 19.1% from 19.3% year-over-year[86] - Net loss for the three months ended March 31, 2025, increased by $4,134,000, or 58.8%, to $11,166,000, primarily due to increased operating expenses[91] - As of March 31, 2025, the company had an accumulated deficit of $265 million and a net loss of $11.166 million, indicating ongoing financial challenges[92] Expenses - Research and development expenses rose by $1,434,000, or 54.6%, to $4,059,000, primarily due to increased costs associated with the SwitchGuard NPS development and regulatory approval[87] - Selling and marketing expenses increased by $1,513,000, or 122.3%, to $2,750,000, driven by compensation and travel expenses related to building U.S. commercial infrastructure[88] - General and administrative expenses increased by $1,099,000, or 28.6%, to $4,943,000, mainly due to higher compensation expenses and new hires for the Miami headquarters[89] Cash Flow and Financing - Cash and cash equivalents decreased to $12.383 million as of March 31, 2025, down from $18.916 million as of December 31, 2024[97] - Net cash used in operating activities increased by $3.728 million, or 73.6%, to $8.792 million for the three months ended March 31, 2025, compared to $5.064 million for the same period in 2024[98] - Cash provided by financing activities was $506,000 for the three months ended March 31, 2025, sourced from share issuance under the ATM Program[100] - Under the ATM Program, the company sold 920,898 shares for total gross proceeds of approximately $2.396 million as of the report issuance date[95] - The company raised approximately $42.2 million from a private placement offering in May 2023, with potential additional gross proceeds of $71.4 million if warrants are fully exercised[94] - Cash provided by investing activities decreased to $1.702 million for the three months ended March 31, 2025, down from $4.817 million for the same period in 2024[99] Market and Regulatory Developments - The addressable market for the CGuard Carotid Stent System and SwitchGuard NPS is estimated at approximately $1.3 billion, with a total available market of about $9.3 billion assuming full penetration[80] - The CGuard EPS received CE mark recertification in January 2024 under the EU's Medical Device Regulation[72] - The C-GUARDIANS pivotal study completed enrollment in June 2023 with 316 patients, evaluating the safety and efficacy of the CGuard Carotid Stent System[73] - In October 2023, CMS expanded coverage for carotid artery stenting to include asymptomatic and standard risk patients, supporting future growth in the U.S. market[78] Future Outlook - The company expects to continue incurring losses and negative cash flows until its product, CGuard EPS, achieves commercial profitability[92] - Future operating results may be affected by various factors, including regulatory approvals and economic conditions impacting customer demand[102] - The company has no off-balance sheet transactions or material changes to contractual obligations as of March 31, 2025[101]