InspireMD Reports Fourth Quarter and Year-End 2021 Financial Results
- CGuard™ Revenue Generated 87.5% growth over Q4’20 and 55.9% Year-over-Year –-
- Published CGuard Clinical trial results in Journals of the American College of Cardiology -
- Established Reimbursement Approval for CGuard from the French National Authority -
- CGuard Included as Carotid Stent Treatment Option in National Institute of Neurological Disorders and Stroke NINDS Sponsored CREST-2 Trial Following
FDA Approval of IDE Supplement Application -
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Management to Host Investor Conference Call Today,
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- CGuard revenues for the fourth quarter 2021 were
$1,291,000 an 87.5% increase over the same period in 2020 and for the 12-month period endedDecember 31, 2021 , CGuard revenues totaled$4,309,000 representing a year over year increase of 55.9%. - Appointed
Katherine Arnold , to the Board of Directors and Dr.Adnan Siddiqui to the Scientific Advisory Board; each provide leadership and guidance to their respective boards with vast industry specific experience in the medical device market. - Accelerated enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial despite surging Omicron infection rates, staffing limitations and resource constraints at hospitals and healthcare systems across
the United States . Under the leadership ofChris Metzger , M.D., system chair of clinical research at Ballad Health System inEastern Tennessee the trial has 12 sites actively enrolling or recruiting patients. - Gained approval and reimbursement coverage for CGuard EPS in
France from the French National Authority for Health (HAS) and instituted a direct sales structure for commercial expansion, building on European market growth. - Published a randomized study (
SIBERIA ) in Journals of the American College of Cardiology (JACC), comparing InspireMD CGuard EPS to the Abbott Acculink™, demonstrating CGuards’s 4.5-fold superiority in clinical outcomes versus this first-generation open cell Abbott stent.
“In 2021, we initiated and accelerated enrollment in our ongoing C-Guardians IDE pivotal study of CGuard™ EPS (C-Guardian) in
“In terms of our global strategy, in 2021 we continued to expand our market presence, obtaining registration and reimbursement in
“Our cash position remains sound, having raised an aggregate of approximately
“We enter 2022 with tremendous momentum, anticipating growth of CGuard, continuing pipeline development and advancing the growing body of evidence demonstrating CGuards’s superiority in clinical performance amongst all other stent options and surgery,” said
Financial Results for the
For the fourth quarter of 2021, revenue increased by
For the fourth quarter of 2021, gross profit increased
For the fourth quarter of 2021, total operating expenses were
For the fourth quarter of 2021, financial expenses decreased by 7.6%, or
Financial Results for the full year ended
Total revenue for the year ended
Gross profit for the year ended
Total operating expenses for the year ended
Net loss for the year ended
As of
Conference Call and Webcast Details
Management will host a conference call at
Domestic: International: Conference ID: Webcast: | 877-407-4018 201-689-8471 13727214 Webcast Link |
About InspireMD, Inc. (NSPR)
InspireMD (NSPR) 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, and certain warrants are quoted on the Nasdaq under the symbol NSPRZ.
For more information, please visit www.inspiremd.com.
Forward-looking Statements
This press release contains “forward-looking statements.” 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. For example, the company is using forward looking statements when it discusses its plans to apply for regulatory and reimbursement approvals in new jurisdictions, its belief that it has sufficient capital to continue its growth initiatives and business development plans and that it anticipates momentum in 2022, the belief that expanding its leadership in transfemoral delivery of CGuard into its rapid advancing TCAR accessory device platform, will enable broader adoption of trans carotid procedural preference, thus enabling greater conversion of surgeries to stenting and its anticipation for continuing pipeline development and advancing the growing body of evidence demonstrating CGuards’s superiority in clinical performance amongst all other stent options and surgery. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) 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. 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:
Chief Financial Officer
InspireMD, Inc. (NSPR)
888-776-6804
craigs@inspiremd.com
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 | ||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||
Revenues | $ | 1,380 | $ | 158 | $ | 4,495 | $ | 2,485 | |||||||||
Cost of revenues | 1,086 | 548 | 3,741 | 2,402 | |||||||||||||
Gross Profit | 294 | (390 | ) | 754 | 83 | ||||||||||||
Operating Expenses: | |||||||||||||||||
Research and development | 1,534 | 720 | 5,158 | 2,233 | |||||||||||||
Selling and marketing | 761 | 617 | 2,907 | 2,103 | |||||||||||||
General and administrative | 1,930 | 1,991 | 7,405 | 6,127 | |||||||||||||
Total operating expenses | 4,225 | 3,328 | 15,470 | 10,463 | |||||||||||||
Loss from operations | (3,931 | ) | (3,718 | ) | (14,716 | ) | (10,380 | ) | |||||||||
Financial expenses (income) | 121 | 131 | 157 | 160 | |||||||||||||
Loss before tax expenses | (4,052 | ) | (3,849 | ) | (14,873 | ) | (10,540 | ) | |||||||||
Tax expenses | 45 | 4 | 45 | 4 | |||||||||||||
Net Loss | $ | (4,097 | ) | $ | (3,853 | ) | $ | (14,918 | ) | $ | (10,544 | ) | |||||
Net loss per share – basic and diluted | $ | (0.53 | ) | $ | (1.52 | ) | $ | (2.03 | ) | $ | (6.97 | ) | |||||
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted | 7,796,027 | 2,533,936 | 7,346,022 | 1,512,439 |
CONSOLIDATED BALANCE SHEETS (2) | |||||
(U.S. dollars in thousands) | |||||
ASSETS | |||||
2021 | 2020 | ||||
Current Assets: | |||||
Cash and cash equivalents | $ | 12,004 | $ | 12,645 | |
Short-term bank deposits | 22,036 | - | |||
Accounts receivable: | |||||
Trade, net | 1,224 | 476 | |||
Other | 165 | 146 | |||
Prepaid expenses | 522 | 334 | |||
Inventory | 1,143 | 1,415 | |||
Receivable for sale of Shares | - | 323 | |||
Total current assets | 37,094 | 15,339 | |||
Non-current assets: | |||||
Property, plant and equipment, net | 632 | 448 | |||
Operating lease right of use assets | 1,081 | 1,265 | |||
Funds in respect of employee rights upon retirement | 905 | 725 | |||
Total non-current assets | 2,618 | 2,438 | |||
Total assets | $ | 39,712 | $ | 17,777 |
LIABILITIES AND EQUITY | |||||||
2021 | 2020 | ||||||
Current liabilities: | |||||||
Accounts payable and accruals: | |||||||
Trade | $ | 893 | $ | 236 | |||
Other | 3,454 | 3,469 | |||||
Total current liabilities | 4,347 | 3,705 | |||||
Long-term liabilities: | |||||||
Operating lease liabilities | 781 | 999 | |||||
Liability for employee rights upon retirement | 1,052 | 910 | |||||
Total long-term liabilities | 1,833 | 1,909 | |||||
Total liabilities | 6,180 | 5,614 | |||||
Equity: | |||||||
Common stock, par value | 1 | * | |||||
Preferred B shares, par value 500,000 shares authorized at | - | * | |||||
Preferred C shares, par value 1,172,000 shares authorized at | * | * | |||||
Additional paid-in capital | 216,625 | 180,339 | |||||
Accumulated deficit | (183,094 | ) | (168,176 | ) | |||
Total equity | 33,532 | 12,163 | |||||
Total liabilities and equity | $ | 39,712 | $ | 17,777 |
(1) All financial information for the twelve months ended
(2) All
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Source: InspireMD Inc. (NSPR)