InspireMD Reports Third Quarter 2024 Financial Results and Provides Business Update
InspireMD (NSPR) reported Q3 2024 financial results, highlighting record quarterly revenue of $1.81 million, a 16.3% increase year-over-year, with 3,129 CGuard stents sold. The company submitted a Premarket Approval application to FDA for CGuard Prime carotid stent system and received IDE approval for CGUARDIANS II pivotal study. Net loss widened to $7.89 million ($0.16 per share) from $5.18 million in Q3 2023. Cash position stood at $40.4 million as of September 30, 2024. The company established new headquarters in Miami, Florida, anticipating U.S. commercial launch in H1 2025, pending approval.
InspireMD (NSPR) ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando un fatturato trimestrale record di 1,81 milioni di dollari, con un aumento del 16,3% rispetto all'anno precedente, con 3.129 stent CGuard venduti. L'azienda ha presentato una domanda di approvazione pre-commercializzazione all'FDA per il sistema di stent carotideo CGuard Prime e ha ricevuto l'approvazione IDE per lo studio fondamentale CGUARDIANS II. La perdita netta è aumentata a 7,89 milioni di dollari (0,16 dollari per azione) rispetto ai 5,18 milioni di dollari nel terzo trimestre 2023. La posizione di cassa era di 40,4 milioni di dollari al 30 settembre 2024. L'azienda ha stabilito una nuova sede a Miami, Florida, anticipando il lancio commerciale negli Stati Uniti nel primo semestre del 2025, in attesa di approvazione.
InspireMD (NSPR) informó los resultados financieros del tercer trimestre de 2024, destacando un ingreso trimestral récord de 1.81 millones de dólares, un aumento del 16.3% año tras año, con 3,129 stents CGuard vendidos. La empresa presentó una solicitud de aprobación previa al mercado a la FDA para el sistema de stent carotídeo CGuard Prime y recibió la aprobación IDE para el estudio pivotal CGUARDIANS II. La pérdida neta se amplió a 7.89 millones de dólares (0.16 dólares por acción) desde 5.18 millones de dólares en el tercer trimestre de 2023. La posición de efectivo se situó en 40.4 millones de dólares al 30 de septiembre de 2024. La empresa estableció nuevas oficinas centrales en Miami, Florida, anticipando el lanzamiento comercial en EE. UU. en el primer semestre de 2025, sujeto a aprobación.
InspireMD (NSPR)는 2024년 3분기 재무 결과를 보고하며, 181만 달러의 분기별 매출 기록을 강조했습니다. 이는 전년 대비 16.3% 증가한 수치이며, CGuard 스텐트 3,129개가 판매되었습니다. 회사는 CGuard Prime 경동맥 스텐트 시스템에 대한 FDA에 사전 시장 승인 신청을 제출했으며, CGUARDIANS II 주요 연구에 대한 IDE 승인을 받았습니다. 순손실은 789만 달러 (주당 0.16달러)로 확대되었으며, 이는 2023년 3분기의 518만 달러에서 증가한 수치입니다. 2024년 9월 30일 기준 현금 보유고는 4040만 달러였습니다. 회사는 플로리다주 마이애미에 새로운 본사를 설립하였으며, 2025년 상반기에 미국 상용 출시를 예정하고 있습니다. 승인 대기 중입니다.
InspireMD (NSPR) a annoncé ses résultats financiers pour le troisième trimestre 2024, mettant en avant un chiffre d'affaires trimestriel record de 1,81 million de dollars, soit une augmentation de 16,3 % par rapport à l'année précédente, avec 3 129 stents CGuard vendus. L'entreprise a soumis une demande d'approbation préalable au marché à la FDA pour le système de stent carotidien CGuard Prime et a reçu l'approbation IDE pour l'étude pivot CGUARDIANS II. La perte nette s'est creusée à 7,89 millions de dollars (0,16 dollar par action) contre 5,18 millions de dollars au troisième trimestre 2023. La position de trésorerie s'élevait à 40,4 millions de dollars au 30 septembre 2024. L'entreprise a établi un nouveau siège à Miami, en Floride, en prévoyant un lancement commercial aux États-Unis au premier semestre 2025, en attente d'approbation.
InspireMD (NSPR) hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht und ein rekordverdächtiges Quartalsergebnis von 1,81 Millionen Dollar hervorgehoben, was einem Anstieg von 16,3 % im Vergleich zum Vorjahr entspricht, mit 3.129 verkauften CGuard-Stents. Das Unternehmen hat einen Antrag auf Marktzulassung für das CGuard Prime Karotis-Stentsystem bei der FDA eingereicht und die IDE-Zulassung für die wegweisende Studie CGUARDIANS II erhalten. Der Nettoverlust weitete sich auf 7,89 Millionen Dollar (0,16 Dollar pro Aktie) aus, verglichen mit 5,18 Millionen Dollar im dritten Quartal 2023. Die Liquiditätsposition belief sich zum 30. September 2024 auf 40,4 Millionen Dollar. Das Unternehmen hat eine neue Zentrale in Miami, Florida, gegründet und erwartet eine kommerzielle Einführung in den USA im ersten Halbjahr 2025, vorbehaltlich der Genehmigung.
- Record quarterly revenue of $1.81M, up 16.3% YoY
- Strong cash position of $40.4M
- FDA PMA submission completed for CGuard Prime
- IDE approval received for CGUARDIANS II study
- Unit sales increased 14.4% YoY to 3,129 stents
- Net loss increased to $7.89M from $5.18M YoY
- Operating expenses rose 46.1% to $8.88M
- Gross margin decreased to 22.9% from 28.1% YoY
- Gross profit declined 5.6% to $414,000
Insights
InspireMD's Q3 results reveal mixed signals. While achieving
The PMA submission and IDE approval for TCAR procedures are important regulatory milestones. The potential H1 2025 U.S. market entry could be transformative, considering the larger addressable market. However, investors should note the
The FDA submissions represent significant strategic positioning in the carotid stent market. The dual approach targeting both traditional CAS and TCAR procedures demonstrates market awareness, as TCAR is gaining popularity among vascular surgeons. The inclusion in CREST-2 trial with 23 patients adds clinical credibility.
The Miami headquarters establishment is strategically sound, placing operations in a medical device hub with access to talent and logistics infrastructure. The
– Submitted a Premarket Approval (PMA) application to the FDA seeking marketing approval of the CGuard Prime carotid stent system in the U.S. –
– Announced approval of an IDE application to initiate the CGUARDIANS II pivotal study of the CGuard Prime carotid stent system for use during TCAR procedures –
– Established its Headquarters in Miami, Florida, to optimally support the anticipated U.S. commercial launch of CGuard Prime in H1 2025, if approved –
Achieved another record high revenue and unit quarter of
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Management to host investor conference call today, November 12th, at 8:30am ET
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MIAMI, Nov. 12, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the third quarter ended September 30, 2024.
Third Quarter 2024 and Recent Developments:
- Announced that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the CGuard Prime carotid stent system in the U.S.
- Announced approval of its Investigational Device Exemption (IDE) application to initiate the CGUARDIANS II pivotal study of the CGuard Prime carotid stent system for use during TCAR procedures.
- Established its Headquarters in Miami, Florida, to optimally support the anticipated U.S. commercial launch of CGuard Prime in the first half of 2025, if approved.
- Announced completion of enrollment in the groundbreaking CREST-2 clinical trial, with 23 patients in the stenting arm treated with CGuard, the only investigational device allowed by FDA for inclusion in the trial.
- Generated record quarterly revenue of
$1.81 million , an increase of16.3% over the third quarter of 2023, on 3,129 CGuard stents sold, up nearly14.4% over the third quarter of 2023.
Marvin Slosman, CEO of InspireMD, commented: “Since our last quarterly update, we have made significant progress advancing our best-in-class carotid implant, CGuard Prime, towards potential U.S. approval while also moving toward the initiation of a pivotal study of CGuard Prime for a TCAR indication, which represents a key component of our commercial strategy.”
“The submission of our PMA application to FDA seeking U.S. approval of CGuard Prime is the result of years of tireless work by the entire InspireMD team and gives us line of sight to entry into the U.S. market in the first half of 2025, if approved. To support a robust launch, we’ve announced the opening of our new headquarters in Miami, Florida, that ideally positions us to support the world class commercial and operational infrastructure that we are assembling. South Florida has a rich history of medical device innovation, and we are pleased to be able to continue in that tradition.”
“We also announced that the FDA has approved our IDE application allowing us to move forward with the initiation of a pivotal trial of CGuard Prime for use in TCAR procedures. This represents an important step in the advancement of our development pipeline and demonstrates our commitment to addressing the broadest set of physician and patient needs with tools for both CAS and TCAR procedures. I look forward to additional clinical and regulatory milestones in the months ahead, highlighted by the potential U.S. approval and commercial launch of CGuard Prime in the first half of next year,” Mr. Slosman concluded.
Financial Results for the Third Quarter Ended September 30, 2024
For the three months ended September 30, 2024, revenue increased by
For the three months ended September 30, 2024, gross profit (revenue less cost of revenues) decreased by
Total operating expenses for the third quarter of 2024 were
Financial Income for the third quarter of 2024 was
Net loss for the third quarter of 2024 totaled
As of September 30, 2024, cash, cash equivalents and marketable securities were
Financial Results for the Nine Months Ended September 30, 2024
For the nine months ended September 30, 2024, revenue increased by
For the nine months ended September 30, 2024, gross profit (revenue less cost of revenues) decreased by
Total operating expenses for the nine months ended September 30, 2024, were
Financial Income for the nine months ended September 30, 2024 was
Net loss for the nine months ended September 30, 2024 totaled
Conference Call and Webcast Details
Management will host a conference call at 8:30 am ET today, November 12th, to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.
Tuesday, November 12th at 8:30 a.m. ET
Domestic: 1-800-225-9448
International: 1-203-518-9708
Conference ID: IMD3Q24
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 future events, future financial performance, strategies, expectations, competitive environment and regulation, including potential U.S. commercial launch. 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; substantial doubt about our ability to continue as a going concern; 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 BALANCE SHEETS (2) | |||||
| (U.S. dollars in thousands) | |||||
| ASSETS | September 30, | December 31, | |||
| 2024 | 2023 | ||||
| Current Assets: | |||||
| Cash and cash equivalents | |||||
| Marketable securities | 24,584 | 29,383 | |||
| Accounts receivable: | |||||
| Trade, net | 1,530 | 1,804 | |||
| Other | 741 | 648 | |||
| Prepaid expenses | 1,276 | 578 | |||
| Inventory | 2,445 | 2,106 | |||
| Total current assets | 46,394 | 44,159 | |||
| Non-current assets: | |||||
| Property, plant and equipment, net | 1,946 | 1,060 | |||
| Operating lease right of use assets | 1,145 | 1,473 | |||
| Funds in respect of employee rights upon retirement | 996 | 951 | |||
| Total non-current assets | 4,087 | 3,484 | |||
| Total assets | |||||
| LIABILITIES AND EQUITY | September 30, | December 31, | |||||
| 2024 | 2023 | ||||||
| Current liabilities: | |||||||
| Accounts payable and accruals: | |||||||
| Trade | 1,305 | 939 | |||||
| Other | 5,960 | 5,081 | |||||
| Total current liabilities | 7,265 | 6,020 | |||||
| Long-term liabilities: | |||||||
| Operating lease liabilities | 682 | 1,038 | |||||
| Liability for employees rights upon retirement | 1,183 | 1,084 | |||||
| Total long-term liabilities | 1,865 | 2,122 | |||||
| Total liabilities | 9,130 | 8,142 | |||||
| Equity: | |||||||
| Common stock, par value | 3 | 2 | |||||
| Preferred C shares, par value 1,172,000 shares authorized at September 30, 2024 and December 31, 2023; 1,718 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively | * | * | |||||
| Additional paid-in capital | 285,680 | 261,000 | |||||
| Accumulated deficit | (244,332 | ) | (221,501 | ) | |||
| Total equity | 41,351 | 39,501 | |||||
| Total liabilities and equity | |||||||
(1) All 2024 financial information is derived from the Company’s 2024 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2023 financial information is derived from the Company’s 2023 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.
(2) All September 30, 2024, financial information is derived from the Company’s 2024 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2023 financial information is derived from the Company’s 2023 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
| CONSOLIDATED STATEMENTS OF OPERATIONS (1) | |||||||||||||||||
| (U.S. dollars in thousands, except per share data) | |||||||||||||||||
| Nine months ended | |||||||||||||||||
| Three months ended | |||||||||||||||||
| September 30, | September 30, | ||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Revenues | |||||||||||||||||
| Cost of revenues | 1,396 | 1,118 | 4,023 | 3,142 | |||||||||||||
| Gross Profit | 414 | 438 | 1,037 | 1,302 | |||||||||||||
| Operating Expenses: | |||||||||||||||||
| Research and development | 3,915 | 2,110 | 9,941 | 5,946 | |||||||||||||
| Selling and marketing | 1,472 | 876 | 4,154 | 2,556 | |||||||||||||
| General and administrative | 3,489 | 3,091 | 11,078 | 8,135 | |||||||||||||
| Total operating expenses | 8,876 | 6,077 | 25,173 | 16,637 | |||||||||||||
| Loss from operations | (8,462 | ) | (5,639 | ) | (24,136 | ) | (15,335 | ) | |||||||||
| Financial income | 572 | 461 | 1,305 | 824 | |||||||||||||
| 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 | 48,369,412 | 33,984,953 | 39,413,004 | 21,148,538 | |||||||||||||
FAQ
What was InspireMD's (NSPR) revenue in Q3 2024?
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