InspireMD(NSPR) - 2024 Q4 - Annual Report

Revenue and Profitability - For the twelve months ended December 31, 2024, revenue increased by $804,000, or 13.0%, to $7,009,000 from $6,205,000 in 2023, driven by growth in existing and new markets[323]. - Gross profit decreased by 16.7%, or $301,000, to $1,506,000, with gross margin dropping to 21.5% from 29.1% in 2023, primarily due to a $1,105,000 increase in cost of goods sold[325]. - Net loss rose by $12,089,000, or 60.7%, to $32,005,000 for the twelve months ended December 31, 2024, driven mainly by a $12,059,000 increase in operating expenses[332]. Expenses - Research and development expenses increased by 70.8%, or $5,653,000, to $13,634,000, mainly due to increased compensation and costs associated with the development of SwitchGuard NPS and clinical trials[326]. - Selling and marketing expenses rose by 57.0%, or $2,204,000, to $6,069,000, driven by increased compensation expenses as the company builds its commercial sales force in anticipation of FDA approval[328]. - General and administrative expenses increased by 37.8%, or $4,202,000, to $15,306,000, primarily due to a rise in share-based compensation and salary expenses[329]. Market and Product Development - The addressable market for the CGuard Carotid Stent System and SwitchGuard NPS is estimated to be approximately $1.3 billion, with a total available market of approximately $9.3 billion assuming full penetration[314]. - The C-GUARDIANS trial enrolled 316 patients across 24 trial sites, with a 30-day DSMI rate of 0.95% and a one-year follow-up rate of 1.95%[311]. - The company received FDA approval for the IDE to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System in October 2024[312]. - The company is seeking strategic partners for the potential launch of CGuard EPS in Japan and other Asian countries following its CE mark recertification in January 2024[308]. Financial Position - Cash and cash equivalents were $18,916,000 and marketable securities were $15,721,000 as of December 31, 2024, compared to $9,640,000 and $29,383,000 respectively in 2023[338]. - Net cash used in operating activities increased by $5,492,000 to $21,868,000 for the twelve months ended December 31, 2024, from $16,376,000 in 2023[339]. - Cash provided by financing activities was $18,452,000 for the twelve months ended December 31, 2024, down from $37,534,000 in 2023, with the primary source being proceeds from warrant exercises[341]. - The company had an accumulated deficit of $254 million as of December 31, 2024, and expects to continue incurring losses and negative cash flows until the product CGuard EPS reaches commercial profitability[333]. - The company raised approximately $42.2 million from a Private Placement Offering in May 2023, with potential additional proceeds of $71.4 million if warrants are fully exercised[335]. - The company entered into an Equity Distribution Agreement allowing for the sale of up to $17 million in common stock, with $2,199,395 raised as of the report date[337]. Future Outlook - Future operating results may be affected by various factors, including regulatory approvals, clinical trial phases, and economic conditions impacting customer demand[344]. - The total future payments for operating lease obligations were approximately $2,939,000 as of December 31, 2024[342].