InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update
- Record fourth-quarter 2023 CGuard EPS revenue of $1.76 million, up 71.6% over fourth quarter 2022.
- Positive 30-day data from the ongoing U.S. IDE clinical trial, C-GUARDIANS.
- Appointment of lead principal investigators for the C-GUARDIANS II clinical trial.
- Strategic agreement with the Jacobs Institute and support for CMS's expanded coverage for CAS.
- Total revenue for the fourth quarter increased by 71.6% to $1,761,000.
- Gross profit increased by 155.1% to $505,000.
- Cash, cash equivalents, short-term bank deposits, and marketable securities were $39.0 million as of December 31, 2023.
- Net loss for the fourth quarter was $5,405,000.
- Total operating expenses for the fourth quarter increased by 23.0%.
- Increase in total financial income was primarily due to interest income from investments.
- Net loss for the full year ended December 31, 2023, was $19,916,000.
Insights
The substantial 71.6% increase in Q4 revenue for InspireMD, primarily driven by the recertification of the CE Mark under the EU's new MDR regulatory framework, indicates a robust demand for the company's CGuard EPS product. The financial results suggest that the company has effectively capitalized on the regulatory approval to expand its market share in the approved CE Mark territories. Furthermore, the 74.5% increase in units sold year-over-year reflects a growing acceptance of the technology among healthcare providers and patients, potentially translating into sustained revenue growth.
However, despite the revenue growth, the company reported a net loss for both the quarter and the full year, which investors should carefully consider. While increased gross margins, up to 28.7% for the quarter, show improved efficiency, the net loss indicates ongoing significant investment in research, development and market expansion. This strategy may be aimed at long-term market positioning but does entail risks related to cash flow sustainability.
Looking at the cash reserves, the company appears to be adequately capitalized in the short term, with $39.0 million in cash and equivalents. This financial cushion is critical as the company navigates the path to profitability and continues to invest in clinical trials and product development.
InspireMD's strategic focus on expanding its product pipeline and conducting clinical trials, such as the C-GUARDIANS and the Early Feasibility Study with the Jacobs Institute, is indicative of the company's commitment to innovation and clinical validation. The positive 30-day data from the C-GUARDIANS trial, showing a DSMI rate of 0.95%, positions the CGuard EPS as a potentially superior alternative to existing carotid artery stenting options. This could significantly impact the company's market share and value proposition in a competitive landscape.
The CMS's final National Coverage Determination, which expands coverage for CAS procedures, is another pivotal development that could substantially increase the addressable market in the U.S. This policy change aligns well with InspireMD's clinical trial advancements and could accelerate market penetration upon U.S. approval of CGuard Prime.
Furthermore, the appointment of experienced medical professionals and advisors like Dr. Patrick Geraghty, Dr. Patrick Muck and Dr. William Gray signals a strong clinical leadership that might enhance the credibility and clinical adoption of InspireMD's products within the medical community.
From a healthcare economics perspective, the advancements in InspireMD's product offerings, particularly the CGuard EPS, are poised to impact both the quality and cost-effectiveness of care for patients with carotid artery disease. By potentially reducing the incidence of adverse events associated with carotid artery stenting, healthcare systems could see a decrease in long-term costs related to stroke management and associated complications.
The expansion of Medicare and Medicaid coverage for carotid artery stenting (CAS) procedures represents a significant policy shift that may lead to increased procedural volumes and, by extension, demand for InspireMD's products. This could result in a more favorable reimbursement environment, which is a critical factor in the adoption of new medical technologies.
However, one must also consider the broader economic implications of the high R&D and operational costs reflected in the company's net loss. The balance between innovation and cost control remains a critical challenge for medical device companies like InspireMD, with potential implications for pricing strategies and healthcare affordability.
- Record fourth quarter 2023 CGuard EPS revenue of
- Announced positive 30-day data from the Company’s ongoing U.S. Investigational Device Exemption (IDE) clinical trial, C-GUARDIANS, designed to support U.S. approval of CGuard Prime -
- Named Patrick Geraghty, M.D. and Patrick Muck, M.D. as lead principal investigators for the Company’s C-GUARDIANS II clinical trial of its SwitchGuard™ NPS for Transcarotid Artery Revascularization (TCAR), as well as Dr. William Gray, as advisor to the company -
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Management to host investor conference call today, March 6, at 8:30am ET
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TEL AVIV, Israel and MIAMI, March 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the fourth quarter and full-year ended December 31, 2023.
Fourth Quarter 2023 and Recent Developments:
- Generated record CGuard revenue in the fourth quarter 2023 of
$1.76 million , a71.6% increase over the fourth quarter of 2022. - Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of
74.5% . - Announced presentation of positive 30-day results from the C-GUARDIANS U.S. clinical trial of CGuard EPS at the Vascular InterVentional Advances Annual Meeting (VIVA23) and the VEITH Symposium. The results demonstrated that patients with carotid artery stenosis and at high risk for carotid endarterectomy (CEA) had an overall major adverse event rate (death, stroke or myocardial infarction, or DSMI) of
0.95% from procedure through 30 day follow up when treated with carotid artery stenting (CAS) using the CGuard EPS. - Announced re-certification of the Company’s CE Mark under the European Union’s new Medical Device Regulation (MDR) regulatory framework.
- Named Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, as lead principal investigators for the Company’s C-GUARDIANS II clinical trial of its SwitchGuard™ neuroprotection system for use with CGuard Prime in TCAR procedures.
- Appointed William Gray, M.D., system chief of the cardiovascular division at Main Line Health in Wynnewood, PA and professor of medicine at Thomas Jefferson University in Philadelphia, PA, as an advisor to the Company.
- Announced a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo, and Dr. Adnan Siddiqui, Vice-Chairman and Professor of Neurosurgery, to execute an Early Feasibility Study (EFS) evaluating the CGuard EPS carotid stent to treat severe carotid stenosis or occlusion, in conjunction with thrombectomy, in patients presenting with acute ischemic stroke and tandem lesions.
- Announced support for the Centers for Medicare and Medicaid Services’ (CMS) final National Coverage Determination expanding coverage for CAS to include both asymptomatic and standard risk patients, significantly expanding the U.S. CAS addressable market.
- Announced the appointment of medical technology executive Pete Ligotti as Executive Vice President and General Manager of North America.
Marvin Slosman, CEO of InspireMD, commented: “We delivered another strong quarter of sales growth in our approved CE Mark territories while at the same time advancing our U.S. clinical trial and product development pipeline. Our total revenue of
“Also during the quarter, we were extremely pleased to report 30-day follow-up data from our C-GUARDIANS clinical trial at VIVA23 and the VEITH Symposium, which are among the most important annual gatherings of specialists who treat vascular disease. The data showed that stenting with CGuard in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of
“Finally, we made progress advancing our new product pipeline by announcing the lead PIs for our upcoming C-GUARDIANS II clinical trial of our SwitchGuard NPS for use with CGuard Prime in TCAR procedures. We also announced an agreement with Jacobs Institute to conduct an early feasibility study of CGuard Prime to treat patients with acute ischemic stroke and tandem lesions.
“We believe InspireMD is uniquely positioned with a best-in-class implant and solutions to support both CAS and TCAR procedures, with line-of-sight to significant clinical and regulatory catalysts this year and next,” Mr. Slosman concluded.
Financial Results for the Fourth Quarter Ended December 31, 2023
For the fourth quarter of 2023, total revenue increased
Gross profit for the fourth quarter of 2023 increased by
Total operating expenses for the fourth quarter of 2023 were
Total financial income for the fourth quarter of 2023 was
Net loss for the fourth quarter of 2023 totaled
As of December 31, 2023, cash, cash equivalents, short-term bank deposits and marketable securities were
Financial Results for the full year ended Dec 31, 2023
For the twelve months ended December 31, 2023, total revenue increased by
Gross profit for the twelve months ended December 31, 2023, increased by
Total operating expenses for the twelve months ended December 31, 2023 were
Total financial income for the twelve months ended December 2023, was
Net loss for the twelve months ended December 31, 2023 totaled
Conference Call and Webcast Details
Management will host a conference call at 8:30AM ET today, March 6th, to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.
Wednesday, March 6th at 8:30 a.m. ET
| Domestic: | 1-877-407-4018 |
| International: | 1-201-689-8471 |
| Conference ID: | 13744173 |
| Webcast: | Webcast Link – Click Here |
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.
We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
Forward-looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with 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; 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 revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; 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; 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; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com
| CONSOLIDATED STATEMENTS OF OPERATIONS (1) | ||||||||||||||||
| (U.S. dollars in thousands, except per share data) | ||||||||||||||||
| Three months ended | Twelve months ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenues | ||||||||||||||||
| Cost of revenues | 1,256 | 828 | 4,398 | 4,054 | ||||||||||||
| Gross Profit | 505 | 198 | 1,807 | 1,117 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 2,035 | 2,013 | 7,981 | 7,810 | ||||||||||||
| Selling and marketing | 1,309 | 1,087 | 3,865 | 3,664 | ||||||||||||
| General and administrative | 2,969 | 2,034 | 11,104 | 8,356 | ||||||||||||
| Total operating expenses | 6,313 | 5,134 | 22,950 | 19,830 | ||||||||||||
| Loss from operations | (5,808 | ) | (4,936 | ) | (21,143 | ) | (18,713 | ) | ||||||||
| Financial expenses (income) | (468 | ) | (119 | ) | (1,292 | ) | (250 | ) | ||||||||
| Loss before tax expenses | (5,340 | ) | (4,817 | ) | (19,851 | ) | (18,463 | ) | ||||||||
| Tax expenses | 65 | 28 | 65 | 28 | ||||||||||||
| Net Loss | ) | ) | ) | ) | ||||||||||||
| Net loss per share – basic and diluted | ) | ) | ) | ) | ||||||||||||
| Weighted average number of shares of common stock used in computing net loss per share – basic and diluted | 33,937,425 | 8,034,547 | 24,268,181 | 7,871,814 | ||||||||||||
| CONSOLIDATED BALANCE SHEETS (2) | |||||
| (U.S. dollars in thousands) | |||||
| ASSETS | December 31, | December 31, | |||
| 2023 | 2022 | ||||
| Current Assets: | |||||
| Cash and cash equivalents | |||||
| Short-term bank deposits | - | 13,171 | |||
| Marketable securities | 29,383 | - | |||
| Accounts receivable: | |||||
| Trade, net | 1,804 | 1,034 | |||
| Other | 648 | 213 | |||
| Prepaid expenses | 578 | 655 | |||
| Inventory | 2,106 | 1,621 | |||
| Total current assets | 44,159 | 21,326 | |||
| Non-current assets: | |||||
| Property, plant and equipment, net | 1,060 | 917 | |||
| Operating lease right of use assets | 1,473 | 1,554 | |||
| Funds in respect of employee rights upon retirement | 951 | 856 | |||
| Total non-current assets | 3,484 | 3,327 | |||
| Total assets | |||||
| LIABILITIES AND EQUITY | December 31, | December 31, | |||||
| 2023 | 2022 | ||||||
| Current liabilities: | |||||||
| Accounts payable and accruals: | |||||||
| Trade | |||||||
| Other | 5,081 | 4,411 | |||||
| Total current liabilities | 6,020 | 5,070 | |||||
| Long-term liabilities: | |||||||
| Operating lease liabilities | 1,038 | 1,195 | |||||
| Liability for employee rights upon retirement | 1,084 | 995 | |||||
| Total long-term liabilities | 2,122 | 2,190 | |||||
| Total liabilities | 8,142 | 7,260 | |||||
| Equity: | |||||||
| Common stock, par value | 2 | 1 | |||||
| Preferred C shares, par value 1,172,000 shares authorized at December 31, 2023 and 2022; 1,718 shares issued and outstanding at December 31, 2023 and 2022, respectively | * | * | |||||
| Additional paid-in capital | 261,000 | 218,977 | |||||
| Accumulated deficit | (221,501 | ) | (201,585 | ) | |||
| Total equity | 39,501 | 17,393 | |||||
| Total liabilities and equity | |||||||
(1) All financial information for the twelve months ended December 31, 2023 is derived from the Company's 2023 audited financial statements and all financial information for the twelve months ended December 31, 2022 is derived from the Company's 2022 audited financial statements, included in the Company's Annual Report on Form 10-K, for the twelve months ended December 31, 2023 filed with the Securities and Exchange Commission. All financial information for the three months ended December 31, 2023 and 2022 is derived from the Company’s unaudited, financial statements.
(2) All December 31, 2023 financial information is derived from the Company's 2023 audited financial statements and all December 31, 2022 financial information is derived from the Company’s 2022 audited financial statements, as disclosed in the Company's Annual Report on Form 10-K, for the twelve months ended December 31, 2023 filed with the Securities and Exchange Commission.
FAQ
What was the percentage increase in CGuard EPS revenue for the fourth quarter of 2023 compared to the same period in 2022?
Who were named as lead principal investigators for the C-GUARDIANS II clinical trial?
What strategic agreement did InspireMD announce?
What was the total revenue for the fourth quarter of 2023?
What was the net loss reported by InspireMD for the fourth quarter of 2023?
How much cash and marketable securities did InspireMD have as of December 31, 2023?
