InspireMD, Inc. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. Unless the context requires otherwise, references in this Form 10-Q to the “Company,” “InspireMD,” “we,” “our” and “us” refer to InspireMD, Inc., a Delaware corporation, and its subsidiaries. Forward-Looking Statements This Quarterly Report on Form 10-Q contains “forward-looking statements,” which include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation, including revenue growth. Words such as “may,” “will,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to: ● our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; ● our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; ● market acceptance of our products; ● an inability to secure and maintain regulatory approvals for the sale of our products; ● negative clinical trial results or lengthy product delays in key markets; ● our ability to maintain compliance with the Nasdaq listing standards; ● our ability to generate significant revenues from our products; ● our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; ● the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; ● intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; ● entry of new competitors and products and potential technological obsolescence of our products; ● inability to carry out research, development and commercialization plans; ● loss of a key customer or supplier; ● technical problems with our research and products and potential product liability claims; 3 ● product malfunctions; ● price increases for supplies and components; ● insufficient or inadequate reimbursement by governmental and other third-party payers for our products; ● our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; ● adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; ● the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; ● security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel; ● current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and ● changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements and the impact of such policies on us, our customers and suppliers, and the global economic environment. The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements. For a discussion of these and other risks that relate to our business and investing in our common stock, you should carefully review the risks and uncertainties described in this Quarterly Report on Form 10-Q, and those described from time to time in our future reports filed with the Securities and Exchange Commission. The forward-looking statements contained in this Quarterly Report on Form 10-Q are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. Overview 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. Our CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a unique self-expandable nitinol stent in a single device for use in carotid artery revascularization. Our CGuard EPS originally received CE mark approval under Medical Device Directive 93/42/EEC (“MDD”) in the European Union (“EU”) in March 2013 and was fully launched in Europe in September 2015. Subsequently, we launched CGuard EPS in over 30 countries and on February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in the Asian markets. In January 2024, we received CE mark recertification under the EU’s Medical Device Regulation regulatory framework. On September 8, 2020, we received approval from the U.S. Food and Drug Administration (“FDA”) of our Investigation Device Exemption (“IDE”), thereby allowing us to proceed with a pivotal study of our CGuard™ Carotid Stent System, C-GUARDIANS, for prevention of stroke in patients in the United States. C-GUARDIANS is a prospective, multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting (“CAS”). The study, which completed enrollment in June 2023, enrolled 316 patients across 24 trial sites in the U.S. and Europe and from April 2023 included deployment of the CGuard stent using CGuard Prime, our next generation CAS stent platform. 4 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. In May 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the CGuard 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%. These data were used to support the premarket approval (“PMA”) submission in September 2024 with a view to potential FDA approval of the CGuard Prime carotid stent system, currently expected in the third quarter of 2025. 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. In October 2023, the Centers for Medicare and Medicaid Service (“CMS”) issued its final National Coverage Determination (“NCD”), expanding coverage for both CAS and TCAR to include both asymptomatic and standard risk patients, significantly expanding and supporting the future growth of the U.S. CAS addressable market. We continue to invest in current and future potential new indications, products and manufacturing enhancements for CGuard that are expected to reduce cost of goods and/or provide the best-in-class performing delivery systems, such as CGuard Prime. In furtherance of our strategy that focuses on establishing the CGuard Carotid Stent System as a viable alternative to vascular surgery, we are developing a new transcarotid artery revascularization (TCAR) system, SwitchGuard™ neuroprotection system (“SwitchGuard NPS”), for transcarotid access and neuro protection. In addition, we intend to explore new indications for CGuard to leverage the advantages of stent design and mesh protection, well suited in labels such as acute stroke with tandem lesions. We consider our current addressable market for our CGuard Carotid Stent System and SwitchGuard NPS to be both symptomatic and asymptomatic individuals with diagnosed high-grade carotid artery stenosis for whom intervention is preferable to medical (drug) therapy. This group includes not only carotid artery stenting patients but also individuals undergoing carotid endarterectomy, as the two approaches compete for the same patient population. Assuming full penetration of the intervention caseload by CGuard, we estimate that the addressable market for CGuard Carotid Stent System and SwitchGuard NPS is approximately $1.3 billion (source: Health Research International Personal Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography and Addressable Markets and internal estimates). According to this same report and internal estimates, assuming full penetration of treatment for all individuals diagnosed with high-grade carotid artery stenosis, we estimate the total available market for CGuard Carotid Stent System and SwitchGuard NPS to be approximately $9.3 billion, which may grow over time if expanded treatment options such as CGuard Carotid Stent System and SwitchGuard NPS lead to increased patient screening for carotid artery disease. We were organized in the State of Delaware on February 29, 2008. In October 2024, we established our global headquarters in Miami, Florida to support the anticipated U.S. launch and commercialization of the CGuard Prime carotid stent system. 5 Critical Accounting Policies A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting policies are more fully described in both (i) “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and (ii) Note 2 of the Notes to the Consolidated Financial Statements included in the Annual Report on Form 10-K for the year ended December 31, 2024. There have not been any material changes to such critical accounting policies since December 31, 2024. The currency of the primary economic environment in which our operations are conducted is the U.S. dollar (“$” or “dollar”). Results of Operations Three months ended March 31, 2025, compared to the three months ended March 31, 2024 Revenues . For the three months ended March 31, 2025, revenue increased by $18,000, or 1.2%, to $1,529,000, from $1,511,000 during the three months ended March 31, 2024. Growth in the quarter was driven by continued adoption of our CGuard technology, offset by the impact of foreign exchange and distributors managing CGuard inventory levels in anticipation of the potential CGuard Prime approval in Europe. With respect to geographical regions, the increase in revenue was primarily attributable to a $50,000 increase in Latin America, a $21,000 increase in Asia due to continued adoption of our CGuard technology, and a $22,000 increase in North America due to sales in the United States related to stents used in our CGUARDIANS II pivotal study. This increase was offset by a $71,000 decrease in Europe driven by the impact of foreign exchange and distributors managing CGuard inventory levels in anticipation of the potential CGuard Prime approval in Europe and a $3,000 decrease in other territories. Gross Profit . For the three months ended March 31, 2025, our gross profit was $292,000, no change in our gross profit compared to the three months ended March 31, 2024. Gross margin (gross profits as a percentage of revenue) decreased to 19.1% during the three months ended March 31, 2025, from 19.3% during the three months ended March 31, 2024. Research and Development Expenses . For the three months ended March 31, 2025, research and development expenses increased by 1,434,000, or 54.6%, to $4,059,000, from $2,625,000 during the three months ended March 31, 2024. This increase resulted primarily due to an increase of $670,000 of SwitchGuard NPS development and regulatory approval process including expenses related to the IDE application for the CGUARDIANS II pivotal study of the CGuard Prime 80cm Carotid Stent System, an increase in compensation expenses of $373,000, due to an increase of share-based compensation-related expenses and due to hiring of new employees in connection with our expansion in the United States, an increase of $282,000 related to CGuard Prime product preparation expenses for the anticipated U.S. commercial launch of CGuard Prime, and an increase of $109,000 in miscellaneous expenses. Selling and Marketing Expenses . For the three months ended March 31, 2025, selling and marketing expenses increased by $1,513,000, or 122.3%, to $2,750,000 from $1,237,000 during the three months ended March 31, 2024. This increase resulted primarily from an increase in compensation expenses of $1,123,000 and related travel expenses of $129,000 as the Company build its U.S. commercial infrastructure to enter the U.S. market in anticipation of the potential FDA approval for CGuard Prime. In addition, there was an increase of $236,000 in promotional activities and an increase of $25,000 in miscellaneous expenses. General and Administrative Expenses . For the three months ended March 31, 2025, general and administrative expenses increased by $1,099,000, or 28.6%, to $4,943,000, from $3,844,000 during the three months ended March 31, 2024. The increase was primarily driven by a $757,000 increase in compensation expenses and related accruals, mainly due to new hires for our Miami headquarters, salary increases and expected severance payments accrued for as a result of our chief financial officer’s announced retirement, a $223,000 increase in employee headhunting fees, $98,000 for rent expenses, mainly related to our Miami headquarters, and an increase of $21,000 in miscellaneous expenses. 6 Financial Income . For the three months ended March 31, 2025, financial income decreased by $88,000 or 23.0%, to $294,000, from $382,000 during the three months ended March 31, 2024. The decrease in financial income primarily resulted from a $90,000 decrease in interest income from investment in marketable securities, money market funds and short-term bank deposits. Tax Expenses. For the three months ended March 31, 2025, there was no material change in our tax expenses as compared to the three months ended March 31, 2024. Net Loss . Our net loss increased by $4,134,000, or 58.8%, to $11,166,000, for the three months ended March 31, 2025, from $7,032,000 during the three months ended March 31, 2024. The increase in net loss resulted primarily from an increase of $4,046,000 in operating expenses. Liquidity and Capital Resources We had an accumulated deficit as of March 31, 2025, of $265 million, as well as a net loss of $11,166,000 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. 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. In May 2023, we closed a private placement offering 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 12,914,086 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 that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by us. If the Warrants issued in the private placement offering are exercised in cash in full this would result in an additional $71.4 million of gross proceeds. In May 2024, we entered into an Equity 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 up to $75,000,000 of our common stock (the “ATM Program”). As of the issuance date of this report, we have sold 920,898 shares of our common stock for total gross proceeds of approximately $2,396 thousands under the ATM Program. During June 2024, 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. Three months ended March 31, 2025, compared to the Three months ended March 31, 2024 General . At March 31, 2025, we had cash and cash equivalents of $12,383,000 and marketable securities of $13,703,000, as compared to cash and cash equivalents of $18,916,000 and marketable securities of $15,721,000 as of December 31, 2024. 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 costs, capital expenditures and general working capital. 7 For the three months ended March 31, 2025, net cash used in our operating activities increased by $3,728,000, or 73.6%, to $8,792,000, from $5,064,000 during the same period in 2024. The primary reason for the increase in cash used in our operating activities was an increase of $986,000 in payments for third party related expenses and for professional services, an increase of $2,151,000 in compensation costs paid during the three months ended March 31, 2025 (from $3,675,000 in the three months ended March 31, 2024 to $5,826,000 in the three months ended March 31, 2025), a decrease of $555,000 in payments received from customers during the three months ended March 31, 2025 (from $2,110,000 in the three months ended March 31, 2024 to $1,555,000 during the three months ended March 31, 2025) and a decrease of $36,000 in interest income received from money market funds and marketable securities. Cash provided by our investing activities was $1,702,000 during the three months ended March 31, 2025, compared to $4,817,000 during the three months ended March 31, 2024. The primary reason for the decrease in cash provided by our investing activities is withdrawal of $2,949,000, net of investment in marketable securities and an increase of $164,000 in payments made for purchase of property, plant and equipment during the three months ended March 31, 2025. Cash provided by financing activities for the three months ended March 31, 2025, was $506,000. The source of the cash provided by financing activities during the three months ended March 31, 2025, were the proceeds from issuance of shares of $506,000, net of issuance costs, received from our ATM Program. There was no cash provided by financing activities for the three months ended March 31, 2024. Off Balance Sheet Arrangements We have no off-balance sheet transactions, arrangements, obligations (including contingent obligations) or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. Factors That May Affect Future Operations We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the cyclical nature of the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment. Our operating results could also be impacted by a weakening of the Euro and strengthening of the NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products. Contractual Obligations and Commitments During the three months ended March 31, 2025, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2024. Recently Adopted and Issued Accounting Pronouncements See Note 3 to our condensed financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for new accounting pronouncements adopted. Item 3. Quantitative and Qualitative Disclosures About Market Risk. Not applicable. 8