InspireMD Inc
For the period ended Dec 31, 2024. Filed Mar 12, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 12, 2025
NSPR$0.70+8.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-05.
0001493152-24-008850
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-12.
0001493152-25-009909
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 67 previous paragraphs and 50 current paragraphs.
24 unchanged; 18 reworded; 7 added; 25 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
In October 2024, the FDA approved the Company’s IDE to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures.
Current report
Following the announcement of the one year follow up study results from the Company’s C-GUARDIANS trial, Series H Warrants to purchase 12,914,086 shares of common stock were exercised in full into 292,996 of shares of common stock and pre-funded warrants to purchase 12,621,090 shares of common stock. The net proceeds to the Company from the exercise of the Series H Warrants were $16.9 million, after deducting placement agent fees. The Series H warrants, each exercisable at $1.3827 per common share and $1.3826 per pre-funded warrant, were issued as part of the private placement financing that the Company consummated on May 15, 2023. In connection with the exercise of the Series H Warrants, we also paid LifeSci Capital LLC, a placement fee equal to 5.6% of the aggregate gross proceeds from such exercise, or approximately $1.0 million.
Current report
Research and Development Expenses. For the twelve months ended December 31, 2024, research and development expenses increased by 70.8%, or $5,653,000, to $13,634,000, from $7,981,000 during the twelve months ended December 31, 2023. This increase resulted primarily from an increase in compensation expenses of $2,705,000, mainly due to an increase of share-based compensation-related expenses and due to hiring personnel in connection with our expansion plans in the United States, an increase of $1,379,000 of SwitchGuard NPS development and regulatory cost, $961,000 related to clinical trials for CGuardians II and CGuardians III, an increase of $914,000 related to CGuard Prime product preparation expenses for the anticipated U.S. commercial launch of CGuard Prime, an increase of $448,000 related to an early feasibility study of CGuard Prime for the treatment of acute stroke patients with tandem lesions, an increase of $239,000 related to the establishment of operations in the United States and an increase of $71,000 in miscellaneous expenses. These increases were offset by a decrease of $1,064,000 in expenses associated with the C-Guardians FDA Study as the one-year follow-up finalized in the second quarter of 2024 and the submission this quarter of the PMA application to the U.S. FDA.
Current report
General and Administrative Expenses. For the twelve months ended December 31, 2024, general and administrative expenses increased by 37.8%, or $4,202,000, to $15,306,000, from $11,104,000 during the twelve months ended December 31, 2023. The increase was primarily driven by a $3,113,000 increase in share-based compensation expenses, a $877,000 increase in salary expenses and related accruals (mainly due to expected severance payments accrued for following the CFO’s announced retirement, new hires for our Miami headquarters, and salary increases), and a $284,000 increase in employee headhunting fees. These increases were offset by a $72,000 decrease in miscellaneous expenses.
Current report
We had an accumulated deficit as of December 31, 2024, of $254 million, as well as a net loss of $32.0 million and negative operating cash flows. We expect to continue incurring losses and negative cash flows from operations until our product, CGuard EPS, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with our current cash position, we believe we do not have sufficient resources to fund operations for at least the next 12 months. Therefore, there is substantial doubt about our ability to continue as a going concern.
Current report
Following the announcement of the one year follow up study results from the Company’s C-GUARDIANS trial, Series H Warrants to purchase 12,914,086 shares of common stock were exercised in full into 292,996 of shares of common stock and pre-funded warrants to purchase 12,621,090 shares of common stock. The net proceeds to the Company from the exercise of the Series H Warrants were $16.9 million after deducting placement agent fees. The Series H warrants, each exercisable at $1.3827 per common share and $1.3826 per pre-funded warrant, were issued as part of the private placement financing that the Company consummated on May 15, 2023.
Current report
In May 2024, we entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Piper Sandler & Co., as sales agent (“Piper Sandler”), pursuant to which we may offer and sell from time to time, at our option, through or to Piper Sandler shares of our common stock having an aggregate offering price of up to $17 million (the “ATM Facility”). Wewill pay Piper Sandler a commission at a fixed rate of 3.0% of the aggregate gross proceeds from each sale of the shares under the Distribution Agreement. As of the date hereof, we sold 845,399 shares pursuant to the Distribution Agreement for aggregate gross proceeds of approximately $2,199,395.
Removed paragraphs (25)
Previous report
In connection with the Purchase Agreement, we entered into a registration rights agreement (the “Registration Rights Agreement”). Pursuant to the Registration Rights Agreement, we were required to file a resale registration statement (the “Registration Statement”) with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the “Signing Date”), and to have such Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC. We were obligated to pay certain liquidated damages if we fail to file the Registration Statement when required, fails to cause the Registration Statement to be declared effective by the SEC when required, of if we fail to maintain the effectiveness of the Registration Statement. The Registration Statement was subsequently filed on May 23, 2023 and declared effective on June 1, 2023. We paid LifeSci Capital LLC, a placement fee equal to 5.6% of the aggregate gross proceeds from the closing of the Private Placement Offering, or approximately $2.4 million, and legal expenses of $41,600. In addition, we paid Piper Sandler & Co. a financial advisory fee of $1.5 million, AGP/Alliance Global Partners a financial advisory fee of $250,000 and lead investor counsel expenses of $125,000.
Previous report
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates using assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of sales and expenses during the reporting periods. Actual results could differ from those estimates.
Previous report
Marketable securities
Previous report
Marketable securities consist of debt securities. We elected the fair value option to measure and recognize our investments in debt securities in accordance with ASC 825, Financial Instruments as we manage our portfolio and evaluates the performance on a fair value basis. Changes in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements of operation as finance expense (income), net.
Previous report
Concentration of credit risk and allowance for doubtful accounts
Previous report
Financial instruments that may potentially subject us to a concentration of credit risk consist of cash and cash equivalents and short-term bank deposits, which are deposited in major financially sound institutions in the U.S, Israel and Germany, and trade accounts receivable and other receivables. Our trade accounts receivable is derived from revenues earned from customers from various countries. We perform ongoing credit evaluations of our customers’ financial condition and, requires no collateral from our customers. We also have a credit insurance policy for some of our customers. We maintain the allowance for estimated losses resulting from the inability of our customers to make required payments. The allowance represents the current estimate of lifetime expected credit losses over the remaining duration of existing accounts receivable considering current market conditions and supportable forecasts when appropriate. The estimate is a result of our ongoing evaluation of collectability, customer creditworthiness, historical levels of credit losses, and future expectations. The allowance for expected credit losses was immaterial during the periods presented.
Previous report
Inventory
Previous report
Inventories are stated at the lower of cost (cost is determined on a “first-in, first-out” basis) or net realizable value. Our inventories generally have a limited shelf life and are subject to impairment as they approach their expiration dates. We regularly evaluate the carrying value of our inventories and when, based on such evaluation, factors indicate that impairment has occurred, we impair the inventories’ carrying value. In addition, we write-off fails in production based on actual and estimated.
Previous report
Revenue recognition
Previous report
A contract with a customer exists only when: 1) the parties to the contract have approved it and are committed to perform their respective obligations, 2) we can identify each party’s rights regarding the distinct goods or services to be transferred (“Performance Obligations”), 3) we can determine the transaction price for the goods or services to be transferred, 4) the contract has commercial substance and 5) it is probable that we will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer. Revenues are recorded in the amount of consideration to which we expect to be entitled in exchange for Performance Obligations upon transfer of control to the customer, excluding sales taxes.
Previous report
Revenue from sales of goods, including sales to distributors, is recognized when the customer obtains control of the product, once we have a present right to payment, legal title, and risk and rewards of ownership are obtained by the customer. This occurs when products are shipped.
Previous report
We recognize the incremental costs of obtaining contracts as an expense since the amortization period of the assets that we otherwise would have recognized is one year or less. The costs are recorded under selling and marketing expenses.
Previous report
We recognize revenue net of value added tax (VAT).
Previous report
Share-based compensation
Previous report
Employee option awards are classified as equity awards and accounted for using the grant-date fair value method. The fair value of share-based awards is estimated using the Black-Scholes valuation model and expensed over the requisite service period, net of estimated forfeitures. We elected to account for forfeitures as they occur.
Previous report
We elected to recognize compensation expenses for awards with only service conditions that have graded vesting schedules using the accelerated multiple option approach.
Previous report
The attribution for nonemployee awards is in the same manner as if we had paid cash for the goods or services.
Previous report
In addition, certain of our share-based awards to service providers are performance based, i.e., the vesting of these awards depends upon achieving certain goals. We recognize compensation expenses for awards with performance conditions when we conclude that it is probable that the performance condition will be achieved.
Previous report
Research and Development Expenses. For the twelve months ended December 31, 2023, research and development expenses increased by 2.2%, or $171,000, to $7,981,000, from $7,810,000 during the twelve months ended December 31, 2022. This increase resulted primarily from an increase of compensation expenses to employees and consultants of $638,000 mainly due to an increase of approximately $341,000 of share-based compensation-related expenses due to the expense recognition of grants made during the second quarter of 2023, an increase of $165,000 in expenses related to the SwitchGuard regulatory and approval process, and an increase of $513,000 in miscellaneous expenses offset, in part, by a decrease of $1,145,000 in expenses related to the C-GUARDIANS FDA study as we completed enrollment in June 2023.
Previous report
General and Administrative Expenses. For the twelve months ended December 31, 2023, general and administrative expenses increased by 32.9%, or $2,748,000, to $11,104,000, from $8,356,000 during the twelve months ended December 31, 2022. This increase resulted primarily from an increase in compensation expenses of $2,177,000, mainly due to an increase of approximately $1,585,000 of share-based compensation-related expenses due to the expense recognition of grants made during the second quarter of 2023 and an increase in salary expenses and related accruals of $592,000 mainly due to hiring of a General Manager of North America and VP of Global Marketing (who was subsequently promoted to the Company’s Chief Commercial Officer in the third quarter of 2023), an increase in legal expenses of $292,000 and an increase of $279,000 in miscellaneous expenses.
Previous report
As of the date of issuance of the consolidated financial statements, we have the ability to fund our planned operations for at least the next 12 months. However, we expect to continue incurring losses and negative cash flows from operations until our products (primarily CGuard reaches commercial profitability. Therefore, in order to fund our operations until such time that we can generate substantial revenues, we may need to raise additional funds.
Previous report
As of December 31, 2023, our current assets exceeded our current liabilities by a multiple of 7.3. Current assets increased by $22,833,000 during the period and current liabilities increased by $950,000 during the period. As a result, our working capital increased by $21,883,000 to $38,139,000 as of December 31, 2023.
Previous report
Recent Accounting Pronouncements
Previous report
In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments. This guidance replaces the current incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates (“ASU 2019-10”). The purpose of this amendment is to create a two tier rollout of major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU 2016-13. Larger public companies had an effective date of December 15, 2019, including interim periods within those fiscal years. +All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022. Under the current SEC definitions, we meet the definition of an SRC and are adopting the deferral period for ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption. We adopted the provisions of this update as of January 1, 2023 with no material impact on our consolidated financial statements.
Previous report
In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities ‘segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. We are currently evaluating this guidance to determine the impact it may have on our consolidated financial statements related disclosures. In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. We are currently evaluating this guidance to determine the impact it may have on our consolidated financial statements related disclosures.
Reworded paragraphs (18)
Previous wording
We are a medical device company focusing on the development and commercialization of our proprietary MicroNet™ stent platform for the treatment of carotid artery disease and other vascular disease. A stent is an expandable “scaffold-like” device, usually constructed of a metallic material, that is inserted into the lumen of the artery to create patency and revascularization of blood flow. MicroNet, a micron mesh sleeve, is attached over a stent to provide embolic protection both during and after stenting procedures.
Current wording
We are a medical device company focusing on the development and commercialization of products for the treatment of carotid artery disease and other vascular disease, including our proprietary CGuard™ stent platform. A stent is an expandable scaffold-like device, usually constructed of a metallic material, that is inserted into the lumen of an artery to create patency and improved blood flow. A sleeve of MicroNet™ mesh is attached over a stent to provide embolic protection both during and after stenting procedures.
Previous wording
The primary endpoint is a composite of: (1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. All events are adjudicated by an independent clinical events committee. The composite index will be compared to a performance goal based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard. The performance goal will be considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.
Current wording
The primary endpoint was a composite of: (1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. All events were adjudicated by an independent clinical events committee. The composite index was compared to a performance goal based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard. The performance goal was considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.
Previous wording
In November 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the C-Guard Carotid Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured from the date of the procedure through 30 days follow-up post-procedure. We anticipate reporting primary endpoint results from the C-GUARDIANS trial in mid 2024 that may support the submission of a PMA application in the third quarter of 2024 with a view to potential FDA approval of the CGuard Prime stent system in the first half of 2025.
Current wording
In November 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the C-Guard Carotid Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured from the date of the procedure through 30 days follow-up post-procedure. In May 2024, we announced positive one-year follow up results from the C-GUARDIANS trial, with a rate of 30-day DSMI and ipsilateral stroke between 31 and 365 days of 1.95%
Previous wording
On May 12, 2023, we entered into a securities purchase agreement (the “Purchase Agreement pursuant to which we agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 shares (the “Private Placement Shares”) of our common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,078 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,078 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants.
Current wording
On May 12, 2023, we entered into a securities purchase agreement (the “Purchase Agreement pursuant to which we agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 shares (the “Private Placement Shares”) of our common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,078 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants.
Previous wording
As applicable to these consolidated financial statements, the most significant estimates and assumptions relate to inventory valuations and assessing the likelihood of exercise of options to extend the lease term.
Current wording
As applicable to these consolidated financial statements, the most significant estimates and assumptions relate to the determination of the lease terms in operating leases.
Previous wording
Revenues. For the twelve months ended December 31, 2023, revenue increased by $1,034,000, or 20.0%, to $6,205,000, from $5,171,000 during the twelve months ended December 31, 2022. This increase was predominantly driven by a 21.1% increase in sales volume of CGuard EPS, from $5,123,000 during the twelve months ended December 31, 2022, to $6,205,000 during the twelve months ended December 31, 2023. This sales increase was mainly due to growth in existing and new markets.
Current wording
Revenues. For the twelve months ended December 31, 2024, revenue increased by $804,000, or 13.0%, to $7,009,000, from $6,205,000 during the twelve months ended December 31, 2023. This increase was predominantly driven by growth in existing and new markets.
Previous wording
With respect to regions, the increase in revenue was primarily attributable to a $1,036,000 increase in Europe, a $76,000 increase in Asia and $24,000 increase in Latin America. This growth was mainly due to growth in existing and new markets. This increase was offset by a $92,000 decline in revenue in the U.S. as less stents were used in our C-GUARDIANS FDA study as trial enrollment ended in June 2023 as well as a $10,000 decline in other markets.
Current wording
With respect to regions, the increase in revenue was primarily attributable to a $772,000 increase in Europe, a $141,000 increase in Asia and a $14,000 increase in the Middle East. This growth was mainly due to growth in existing and new markets. This increase was offset by a $103,000 decline in clinical revenue in the U.S . mainly driven by the completion in June 2023 of the enrollment of patients in our CGuardians IDE clinical trial as well as a $20,000 decline in other markets.
Previous wording
Gross Profit. For the twelve months ended December 31, 2023, gross profit (revenue less cost of revenues) increased by 61.8%, or $690,000, to $1,807,000, compared to a gross profit of $1,117,000 for the same period in 2022. This increase in gross profit resulted from a $484,000 increase in revenues less the associated related material and labor costs, a decrease in write-offs of $179,000 and a decrease of $27,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 29.1% during the twelve months ended December 31, 2023, from 21.6% during the twelve months ended December 31, 2022, driven by the reasons mentioned above.
Current wording
Gross Profit. For the twelve months ended December 31, 2024, gross profit (revenue less cost of revenues) decreased by 16.7%, or $301,000, to $1,506,000, compared to a gross profit of $1,807,000 for the same period in 2023. This decrease in gross profit resulted from an increase in cost of goods sold of $1,105,000. This increase was primarily due to an $891,000 increase in material and labor costs, driven mainly from higher sales volume, and increased compensation expense for new and current employees. In addition, there were an additional $214,000 other cost of goods sold related expenses. The increase of cost of goods sold was offset by the increase in revenues of $804,000 as described above. Gross margin (gross profits as a percentage of revenue) decreased to 21.5% during the year ended December 31, 2024, from 29.1% during the year ended December 31, 2023, driven by the factors mentioned above.
Previous wording
Selling and Marketing Expenses. For the twelve months ended December 31, 2023, selling and marketing expenses increased by 5.5%, or $201,000, to $3,865,000, from $3,664,000 during the twelve months ended December 31, 2022. This increase resulted primarily from an increase of compensation expenses of $151,000 mainly due to an increase of share-based compensation-related expenses due to the expense recognition of grants made during the second quarter of 2023 and an increase of $50,000 in miscellaneous expenses.
Current wording
Selling and Marketing Expenses. For the twelve months ended December 31, 2024, selling and marketing expenses increased by 57.0%, or $2,204,000 to $6,069,000, from $3,865,000 during the twelve months ended December 31, 2023. This increase resulted primarily from an increase in compensation expenses of $1,870,000 as we build our commercial sales force in the United States in anticipation for FDA approval, an increase of $254,000 of promotional activities and an increase of $80,000 in miscellaneous expenses.
Previous wording
Financial Income (Expenses). For the twelve months ended December 31, 2023, financial income increased by $1,042,000, to $1,292,000 from $250,000 during the twelve months ended December 31, 2022. The increase in financial income primarily resulted from a $1,152,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.
Current wording
Financial Income, net. For the twelve months ended December 31, 2024, financial income increased by $265,000, to $1,557,000 from $1,292,000 during the twelve months ended December 31, 2023. The increase in financial income primarily resulted from a $293,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.
Previous wording
Tax Expenses. For the twelve months ended December 31, 2023, tax increased by $37,000 compared to the twelve months ended December 31, 2022. Our expenses for income taxes reflect primarily the tax liability due to potential tax exposure.
Current wording
Tax Expenses. For the twelve months ended December 31, 2024, tax decreased by $6,000 compared to the twelve months ended December 31, 2023. Our expenses for income taxes reflect primarily the tax liability due to potential tax exposure.
Previous wording
Net Loss. Our net loss increased by $1,425,000, or 7.7%, to $19,916,000 for the twelve months ended December 31, 2022, from $18,491,000 during the twelve months ended December 31, 2022. The increase in net loss resulted primarily from an increase of $3,120,000 in operating expenses, offset by an increase of $1,042,000 in financial income and increase of $690,000 in gross profit.
Current wording
Net Loss. Our net loss increased by $12,089,000, or 60.7%, to $32,005,000 for the twelve months ended December 31, 2023, from $19,916,000 during the twelve months ended December 31, 2023. The increase in net loss resulted primarily from an increase of $12,059,000 in operating expenses.
Previous wording
Our plans include continued commercialization of our products and raising capital through sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances, however, that we will be successful in obtaining the level of financing needed for our operations. If we are unsuccessful in commercializing our products or raising capital, we may need to reduce activities, curtail or cease operations.
Current wording
Our plans include continued commercialization of our products and raising capital through sale of additional equity securities, debt or capital inflows from strategic partnerships and exercise of warrants. There are no assurances, however, that we will be successful in obtaining the level of financing needed for our operations. If we are unsuccessful in commercializing our products or raising capital, we may need to reduce activities, curtail or cease operations.
Previous wording
General. At December 31, 2023, we had cash and cash equivalents of $9,640,000 and marketable securities of $29,383,000 as compared to $4,632,000 of cash and cash equivalents and $13,171,000 Short-term bank deposits as of December 31, 2022. We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research and development, marketing and sales activities, finance and administrative cost, capital expenditures and general working capital.
Current wording
General. At December 31, 2024, we had cash and cash equivalents of $18,916,000 and marketable securities of $15,721,000 as compared to $9,640,000 of cash and cash equivalents and $29,383,000 marketable securities as of December 31, 2023. We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research and development, marketing and sales activities, finance and administrative cost, capital expenditures and general working capital.
Previous wording
For the twelve months ended December 31, 2023, net cash used in our operating activities increased by $834,000 to $16,376,000, from $15,542,000 during the same period in 2022. The primary reason for the increase in cash used in our operating activities was an increase of $731,000 in payments for third party related expenses and for professional services, an increase of $937,000 in salary and bonus payments from $8,558,000 in the twelve months ended December 31, 2022 to $9,495,000 during the same period in 2022, offset, in part, by an increase of $137,000 in payments received from customers to $5,470,000 during the twelve months ended December 31, 2023, from $5,333,000 during the same period in 2022 and an increase of $697,000 in interest income received from marketable securities, money market funds and short-term bank deposits
Current wording
For the twelve months ended December 31, 2024, net cash used in our operating activities increased by $5,492,000 to $21,868,000, from $16,376,000 during the same period in 2023. The primary reason for the increase in cash used in our operating activities was an increase of $4,409,000 in payments for third party related expenses and for professional services, an increase of $2,518,000 in salary and bonus payments from $9,495,000 in the twelve months ended December 31, 2023 to $12,013,000 during the same period in 2024, offset, in part, by an increase of $1,746,000 in payments received from customers to $7,216,000 during the twelve months ended December 31, 2024, from $5,470,000 during the same period in 2023 and an decrease of $311,000 in interest income received from marketable securities and money market funds.
Previous wording
Cash used by our investing activities was $16,092,000 during the twelve months ended December 31, 2023, compared to cash provided by our investing activities of $8,441,000 during the twelve months ended December 31, 2022. The primary reason for the increase in cash used by our investing activities is an investment in marketable securities, net of withdrawal of $28,644,000, offset by an increase in withdrawal from short-term bank deposits, net of investment in short-term deposits, of $4,000,000, and a decrease of $92,000 in payments made for purchase of property, plant and equipment during the twelve months ended December 31, 2023.
Current wording
Cash provided by our investing activities was $12,641,000 during the twelve months ended December 31, 2024, compared to cash used by our investing activities of $16,092,000 during the twelve months ended December 31, 2023. The primary reason for the increase in cash provided by our investing activities is proceeds from matured marketable securities, net of withdrawal of $43,200,000, offset by a decrease in withdrawal from short-term bank deposits, net of investment in short-term deposits, of $13,000,000, an increase in an investment in long- term lease deposits of $426,000 and an increase of $1,021,000 in payments made for purchase of property, plant and equipment during the twelve months ended December 31, 2024.
Previous wording
Cash provided by financing activities for the twelve months December 31, 2023, was $37,534,000. The principal source of the cash provided by financing activities during the twelve months ended December 31, 2023 were the proceeds from the Private Placement Offering in May 2023 that resulted in approximately $37,534,000 of aggregate net proceeds. Cash used by financing activities for the twelve months ended December, 2022 was $140,000, the cash used by financing activities during the twelve months ended December, 2022 were due to issuance costs associated with a shelf registration statement on Form S-3 filed with the SEC on June 3, 2022.
Current wording
Cash provided by financing activities for the twelve months December 31, 2024, was $18,452,000. The principal source of the cash provided by financing activities during the twelve months ended December 31, 2024 were the proceeds from exercise of warrants of $16,854,000 net of issuance costs and funds received from our ATM Facility that resulted in approximately $1,598,000 of aggregate net proceeds. Cash provided by financing activities for the twelve months ended December 31, 2023, was $37,534,000. The principal source of the cash provided by financing activities during the twelve months ended December 31, 2023, were the proceeds from the Private Placement Offering in May 2023.
Previous wording
Operating lease payments represent our commitment for future rent made under non-cancelable lease for our offices in Israel. The total future payments for our operating lease obligation at December 31, 2023 were approximately $1,815,000 and are due in the next twelve months. For additional details regarding our lease, see Note 7_ to our consolidated financial statements included in this Annual Report on Form 10-K.
Current wording
Operating lease payments represent our commitment for future rent made under non-cancelable lease for our offices in the U.S. and Israel. The total future payments for our operating lease obligation at December 31, 2024 were approximately $2,939,000. For additional details regarding our lease, see Note 7 to our consolidated financial statements included in this Annual Report on Form 10-K.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
These data were used tothat may support the PMA submission in September 2024 with a view to potential FDA approval of the CGuard Prime carotid stent system in the first half of 2025.