8-K
InspireMD, Inc. (NSPR)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): March 30, 2023
InspireMD,Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
| 001-35731 | 26-2123838 |
|---|---|
| (Commission<br><br> <br>File<br> Number) | (IRS<br> Employer<br><br> <br>Identification<br> No.) |
| 4 Menorat Hamaor St.<br><br> <br>Tel Aviv, Israel | 6744832 |
| --- | --- |
| (Address<br> of Principal Executive Offices) | (Zip<br> Code) |
(888)776-6804
(Registrant’s Telephone Number, Including Area Code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $0.0001 per share | NSPR | The<br> Nasdaq Capital Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item2.02 Results of Operations and Financial Condition.
On March 30, 2023, InspireMD, Inc. issued a press release announcing its financial and operating results and recent highlights for the fourth quarter and year ended December 31, 2022. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K that is furnished pursuant to this Item 2.02 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press release, dated March 30, 2023 |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| **** | INSPIREMD, INC. | |
|---|---|---|
| Date:<br> March 30, 2023 | By: | /s/ Craig Shore |
| Name: | Craig<br> Shore | |
| Title: | Chief<br> Financial Officer |
Exhibit99.1
InspireMDReports Fourth Quarter and Year-End 2022 Financial Results and Provides Business Update
-2022 CGuard EPS revenue of $5.1 million increased 18.9% over 2021 –
-Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical Device Directive (MDD) regulatory framework; Companyanticipates re-certification under new Medical Device Regulation (MRD) framework in coming weeks –
-Continued enrollment in the C-Guardian US IDE trial, with 20 sites currently enrolling patients; on track to complete enrollment by approximatelyend of Q2 2023 -
—
Managementto host investor conference call today, March 30, at 8:30am ET—
TelAviv, Israel— March 30, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for treatment of carotid artery disease (CAD) and prevention of stroke today announced financial and operating results for the fourth quarter ended December 31, 2022.
FourthQuarter 2022 and Recent Developments:
| ● | Generated<br> CGuard revenues for the fourth quarter 2022 of $1,026,000, a 20.6% decrease from $1,291,000 for the fourth quarter of 2021. The decrease<br> was caused by reduced shipments due to the temporary expiration of the Company’s CE Mark for the second half of the fourth<br> quarter, due to delays in the European regulatory bodies in the Medical Device Regulation (MDR) recertification process. |
|---|---|
| ● | In<br> mid-March 2023, resumed shipments of CGuard EPS to CE Mark territories on a temporary basis under the pre-existing Medical Device<br> Directive (MDD) regulatory framework while awaiting final re-certification under MDR. |
| ● | Hired<br> medical device commercial veteran Shane Gleason as General Manager of North America and Vice President of Global Marketing to position<br> InspireMD to capitalize on the US market upon expected FDA approval. |
| ● | Promoted<br> the Company’s Vice President of Global Sales and Marketing, Andrea Tommasoli, to Chief Operating Officer to meet the Company’s<br> increasing demand for CGuard. |
| ● | Delivered<br> multiple presentations highlighting the superior safety of CGuard, and resulting positive patient outcomes, at the 2022 VEITH Symposium<br> in November. |
| ● | Continued<br> enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial. The Company currently has 20 trial sites enrolling<br> patients. The Company anticipates completing enrollment by approximately the end of Q2 2023. |
MarvinSlosman, CEO of InspireMD, commented: “We are very pleased to have resumed shipments of CGuard to our major European markets under the existing MDD framework as we await final approval and CE Mark recertification under MDR. While revenues in Q4 of 2022 and Q1 of 2023 were impacted by the temporary lapse of our CE Mark, our team did an outstanding job converting backlog to revenue, and we anticipate that the remaining backlog will be shipped over the next two quarters.”
“Our U.S. IDE trial continues to progress, and now has 20 sites enrolling patients. We anticipate having the trial fully enrolled by approximately the end of the second quarter, a critical step forward in our goal to gain eventual marketing approval of CGuard EPS in the U.S.”
“With the expectation of potentially obtaining CE Mark recertification under MDR in the next few weeks, we plan to work tirelessly to continue to gain share in our key European territories, further driven by conversion of existing endovascular carotid procedures to CGuard from other stent systems, and the potential introduction of two new delivery systems, our SwitchGuard Trans Carotid (TCAR) and CGuard Prime Transfemoral (TFEM) platforms, later this year, subject to regulatory approval. I believe we are well positioned for continued success as we progress through 2023,” Mr. Slosman concluded.
FinancialResults for the Fourth Quarter ended December 31, 2022
For the fourth quarter of 2022, total revenue decreased 25.7%, to $1,026,000, from $1,380,000 during the fourth quarter of 2021. This decrease was predominantly driven by a 20.6% decrease in sales of CGuard EPS, to $1,026,000 in the fourth quarter of 2022 from $1,291,000 in the same period one year ago. This sales decrease was due to the temporary expiration of the CE Mark and resulting inability to ship to EU countries for the second half of the quarter, due to delays in the European regulatory bodies in the MDR recertification process, offset by an increase in US sales related to stents used in the C-Guardian U.S. Food and Drug Administration (FDA) clinical trial.
Gross profit for the fourth quarter of 2022 decreased by $96,000, or 32.7%, to $198,000, compared to a gross profit of $294,000 for the fourth quarter of 2021. This decrease resulted from lower revenue offset by a decrease in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) decreased to 19.3% during the three months ended December 31, 2022, from 21.3% during the three months ended December 31, 2021.
Total operating expenses for the fourth quarter of 2022, were $5,134,000, an increase of $909,000, or 21.5% compared to $4,225,000 for the fourth quarter of 2021. This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study, sales and marketing expenses, and regulatory expenses.
Net loss for the fourth quarter of 2022 totaled $4,845,000, or $0.60 per basic and diluted share, compared to a net loss of $4,097,000, or $0.53 per basic and diluted share, for the same period in 2021.
As of December 31, 2022, cash, cash equivalents and short-term bank deposits were $17.8 million compared to $34.0 million as of December 31, 2021.
FinancialResults for the full year ended Dec 31, 2022
For the twelve months ended December 31, 2022, total revenue increased by $676,000, or 15.0%, to $5,171,000, from $4,495,000 during the twelve months ended December 31, 2021. This increase was predominantly driven by a 18.9% increase in sales of CGuard EPS, to $5,123,000 during the twelve months ended December 31, 2022 from $4,309,000 during the twelve months ended December 31, 2021. This sales increase was mainly due to growth in existing and new markets and sales in the United States related to stents used in our C-Guardians FDA study as enrollment accelerated.
Gross profit for the twelve months ended December 31, 2022 increased by $363,000, or 48.1%, to $1,117,000, compared to a gross profit of $754,000 for the twelve months ended December 31, 2021. This increase in gross profit resulted from higher revenue, and a decrease of $177,000 in miscellaneous expenses. Gross margin increased to 21.6% during the twelve months ended December 31, 2022 from 16.8% during the twelve months ended December 31, 2021.
Total operating expenses for the twelve months ended December 31, 2022, were $19,830,000, an increase of $4,360,000, or 28.2% compared to $15,470 for the twelve months ended December 31, 2021. This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study, share-based compensation, resumed activities in tradeshows and travel, regulatory expenses, and miscellaneous expenses.
Net loss for the twelve months ended December 31, 2022 totaled $18,491,000, or $2.35 per basic and diluted share, compared to a net loss of $14,918,000, or $2.03 per basic and diluted share, for the twelve months ended December 31, 2021.
ConferenceCall and Webcast Details
Management will host a conference call at 8:30AM ET today, March 30^th^, to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.
Thursday,March 30^th^ at 8:30 a.m. ET
| Domestic: | 1-877-407-4018 |
|---|---|
| International: | 1-201-689-8471 |
| Conference<br> ID: | 13735869 |
| Webcast: | Webcast<br> Link – Click Here |
AboutInspireMD, 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-lookingStatements
Thispress release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statementsregarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Suchstatements 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 guaranteesof future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many ofwhich are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materiallyfrom those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks anduncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitmentsand the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regardingour ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future andsuch capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptanceof our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial resultsor lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generaterevenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectualproperty; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standardsand to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficientto 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 technologicalobsolescence 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 suppliesand components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts tosuccessfully 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 conductbusiness in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communicationschallenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalationof hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic andmarket conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed informationabout the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’sfilings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its QuarterlyReports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site athttp://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of newinformation, future events or otherwise.
InvestorContacts:
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
CONSOLIDATEDSTATEMENTS OF OPERATIONS ^(1)^
(U.S. dollars in thousands, except per share data)
| Three months ended | Twelve months ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| December 31, | December 31, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenues | $ | 1,026 | $ | 1,380 | $ | 5,171 | $ | 4,495 | ||||
| Cost of revenues | 828 | 1,086 | 4,054 | 3,741 | ||||||||
| Gross Profit | 198 | 294 | 1,117 | 754 | ||||||||
| Operating Expenses: | ||||||||||||
| Research and development | 2,013 | 1,534 | 7,810 | 5,158 | ||||||||
| Selling and marketing | 1,087 | 761 | 3,664 | 2,907 | ||||||||
| General and administrative | 2,034 | 1,930 | 8,356 | 7,405 | ||||||||
| Total operating expenses | 5,134 | 4,225 | 19,830 | 15,470 | ||||||||
| Loss from operations | (4,936 | ) | (3,931 | ) | (18,713 | ) | (14,716 | ) | ||||
| Financial expenses (income) | (119 | ) | 121 | (250 | ) | 157 | ||||||
| Loss before tax expenses | (4,817 | ) | (4,052 | ) | (18,463 | ) | (14,873 | ) | ||||
| Tax expenses | 28 | 45 | 28 | 45 | ||||||||
| Net Loss | $ | (4,845 | ) | $ | (4,097 | ) | $ | (18,491 | ) | $ | (14,918 | ) |
| Net loss per share – basic and diluted | $ | (0.60 | ) | $ | (0.53 | ) | $ | (2.35 | ) | $ | (2.03 | ) |
| Weighted average number of shares of common stock used in computing net loss per share – basic and diluted | 8,034,547 | 7,796,027 | 7,871,814 | 7,346,022 |
CONSOLIDATEDBALANCE SHEETS ^(2)^
(U.S. dollars in thousands)
| December 31, | December 31, | |||
|---|---|---|---|---|
| 2022 | 2021 | |||
| ASSETS | ||||
| Current Assets: | ||||
| Cash and cash equivalents | $ | 4,632 | $ | 12,004 |
| Short-term bank deposits | 13,171 | 22,036 | ||
| Accounts receivable: | ||||
| Trade, net | 1,034 | 1,224 | ||
| Other | 213 | 165 | ||
| Prepaid expenses | 655 | 522 | ||
| Inventory | 1,621 | 1,143 | ||
| Total current assets | 21,326 | 37,094 | ||
| Non-current assets: | ||||
| Property, plant and equipment, net | 917 | 632 | ||
| Operating lease right of use assets | 1,554 | 1,081 | ||
| Funds in respect of employee rights upon retirement | 856 | 905 | ||
| Total non-current assets | 3,327 | 2,618 | ||
| Total assets | $ | 24,653 | $ | 39,712 |
| December 31, | |||||
|---|---|---|---|---|---|
| 2021 | |||||
| LIABILITIES AND EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable and accruals: | |||||
| Trade | 659 | $ | 893 | ||
| Other | 4,411 | 3,454 | |||
| Total current liabilities | 5,070 | 4,347 | |||
| Long-term liabilities: | |||||
| Operating lease liabilities | 1,195 | 781 | |||
| Liability for employee rights upon retirement | 995 | 1,052 | |||
| Total long-term liabilities | 2,190 | 1,833 | |||
| Total liabilities | 7,260 | 6,180 | |||
| Equity: | |||||
| Common stock, par value 0.0001 per share; 150,000,000 shares authorized at December 31, 2022 and 2021; 8,330,918 and 8,296,256 shares issued and outstanding at December 31, 2022 and 2021, respectively | 1 | 1 | |||
| Preferred C shares, par value 0.0001 per share; 1,172,000 shares authorized at December 31, 2022 and 2021; 1,718 shares issued and outstanding at December 31, 2022 and 2021, respectively | * | * | |||
| Additional paid-in capital | 218,977 | 216,625 | |||
| Accumulated deficit | (201,585 | ) | (183,094 | ) | |
| Total equity | 17,393 | 33,532 | |||
| Total liabilities and equity | 24,653 | $ | 39,712 |
All values are in US Dollars.
(1) All financial information for the twelve months ended December 31, 2022 is derived from the Company’s 2022 audited financial statements and all financial information for the twelve months ended December 31, 2021 is derived from the Company’s 2021 audited financial statements, included in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2022 filed with the Securities and Exchange Commission. All financial information for the three months ended December 31, 2022 and 2021 is derived from the Company’s unaudited, financial statements.
(2) All December 31, 2022 financial information is derived from the Company’s 2022 audited financial statements and all December 31, 2021 financial information is derived from the Company’s 2021 audited financial statements, as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2022 filed with the Securities and Exchange Commission.