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): November 8, 2022
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 November 8, 2022, InspireMD, Inc. issued a press release announcing its financial and operating results and recent highlights for the three and nine months ended September 30, 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 November 8, 2022 (furnished herewith pursuant to Item 2.02) |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
| 2 |
| --- |
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> November 8, 2022 | By: | /s/ Craig Shore |
| Name: | Craig<br> Shore | |
| Title: | Chief<br> Financial Officer |
| 3 |
| --- |
Exhibit99.1
InspireMDReports Third Quarter 2022 Financial Results and Provides
BusinessUpdate
-Generated 38.8% growth in CGuard™ revenue year-over-year -
-Continued enrollment in the C-Guardian US IDE trial, with 24 sites currently enrolling patients; on track to complete enrollment by approximatelyend of Q1 2023 -
-Announced strategic partnership with NAMSA, a med tech contract research organization (CRO), to accelerate new medical device developmentand commercialization -
—
Managementto Host Investor Conference Call Today, November 8^th^, at 8:30am ET—
TelAviv, Israel— November 8, 2022 – 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 third quarter ended September 30, 2022.
ThirdQuarter 2022 and Recent Highlights:
| ● | CGuard<br> revenues for the third quarter 2022 were $1,430,836, a 38.8 % increase over the same period in 2021, on 2,624 stent systems sold,<br> as compared to 1,709 stents sold in the same period in 2021. |
|---|---|
| ● | Continued<br> enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial. The company currently has 24 trial sites enrolling<br> patients (19 US, 5 EU) and anticipates adding two more US sites by the end of the year. The company anticipates completing enrollment<br> by approximately end of Q1 2023, consistent with prior guidance. |
| ● | Professor<br> Piotr Musialek presented at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) Conference long term patient results from the<br> ongoing CGuard Optima study establishing a new baseline of carotid stent performance. |
| ● | Announced<br> strategic outsourcing partnership with NAMSA, a med tech contract research organization (CRO), to accelerate new medical device development<br> and commercialization. |
MarvinSlosman, CEO of InspireMD, commented: “During the third quarter, we continued to gain share in our key European markets, contributing to nearly 40% CGuard revenue growth over the prior year period. We continue to work with our Notified Body to secure our CE Mark certification under the MDR, which currently expires November 12, while preparing our customers and distributors with sufficient inventory to mitigate as best as possible any potential delay in the recertification process.
“At the same time, our U.S. IDE trial now has 24 sites enrolling patients. We continue to anticipate having the trial fully enrolled by approximately end of Q1 of next year, a critical step forward in our goal to gain eventual marketing approval in the U.S.”
“We believe we have set the stage for a catalyst-rich 2023, driven by continued share gains in our established markets, ongoing progress with our U.S. IDE trial, conversion of existing endovascular CAD procedures to CGuard from other stent systems, and the introduction of two new delivery systems, our SwitchGuard Trans Carotid (TCAR) , and CGuard Prime Transfemoral (TFEM) platforms which will allow us to continue to address the comprehensive needs for all vascular specialist treating Carotid disease and stroke, including vascular surgeons who continue to treat a significant percentage of Carotid patients,” Mr. Slosman concluded.
FinancialResults for the Third Quarter ended September 30, 2022
For the third quarter of 2022, total revenue increased 33.6%, to $1,431,000, from $1,071,000 during the third quarter of 2021. This increase was predominantly driven by a 38.8% increase in sales of CGuard EPS, to $1,431,000 in the third quarter of 2022 from $1,031,000 in the same period one year ago. This sales increase was due to growth in existing markets as well as US sales related to stents used in the C-Guardian U.S. Food and Drug Administration (FDA) clinical trial.
Gross profit for the third quarter of 2022 increased by $274,000, or 297.8%, to $366,000, compared to a gross profit of $92,000 for the third quarter of 2021. This increase resulted from higher revenue and a reduction in write offs of $64,000, training expenses of $64,000 and miscellaneous expenses of $51,000. Gross margin (gross profits as a percentage of revenue) increased to 25.6% during the three months ended September 30, 2022, from 8.6% during the three months ended September 30, 2021.
Total operating expenses for the third quarter of 2022, were $4,976,000, an increase of $853,000, or 20.7% compared to $4,123,000 for the third quarter of 2021. This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study and share-based compensation expenses.
Net loss for the third quarter of 2022 totaled $4,529,000, or $0.58 per basic and diluted share, compared to a net loss of $4,071,000, or $0.53 per basic and diluted share, for the same period in 2021.
As of September 30, 2022, cash, cash equivalents and short-term bank deposits were $21.0 million compared to $34.0 million as of December 31, 2021.
FinancialResults for the Nine Months ended September 30, 2022
For the nine months ended September 30, 2022, total revenue increased by $1,030,000, or 33.1%, to $4,145,000, from $3,115,000 during the nine months ended September 30, 2021. This increase was predominantly driven by a 35.7% increase in sales of CGuard EPS, to $4,097,000 during the nine months ended September 30, 2022 from $3,018,000 during the nine months ended September 30, 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 nine months ended September 30, 2022 increased by $459,000, or 99.8%, to $919,000, compared to a gross profit of $460,000 for the nine months ended September 30, 2021. This increase in gross profit resulted from higher revenue, partially offset by a decrease of $141,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 22.2% during the nine months ended September 30, 2022 from 14.8% during the nine months ended September 30, 2021.
Total operating expenses for the nine months ended September 30, 2022, were $14,696,000, an increase of $3,451,000, or 30.7% compared to $11,245,000 for the nine months ended September 30, 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, directors’ and officers’ liability insurance and miscellaneous expenses.
Net loss for the nine months ended September 30, 2022 totaled $13,646,000, or $1.75 per basic and diluted share, compared to a net loss of $10,821,000, or $1.50 per basic and diluted share, for the nine months ended September 30, 2021.
ConferenceCall and Webcast Details
Management will host a conference call at 8:30AM ET today, November 8^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.
Tuesday,November 8^th^ at 8:30 a.m. ET
| Domestic: | 1-877-407-4018 |
|---|---|
| International: | 1-201-689-8471 |
| Conference<br> ID: | 13733319 |
| 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.
For more information, please visit www.inspiremd.com.
Forward-lookingStatements
Thispress 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 assumptionsand are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannotbe predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-lookingstatements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance ofour existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secureregulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinationalcompanies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractorsfor assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) ourefforts 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, including the changing regulatoryenvironment in Europe and the timing of the renewal of certificate to continue to sell CGuard under the new MDR rule structure, (xi)our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meetour business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the factthat we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical andcommunications 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 setforth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report onForm 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge onthe SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statementsas a result of new information, 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 | Nine months ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| September 30, | September 30, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenues | $ | 1,431 | $ | 1,071 | $ | 4,145 | $ | 3,115 | ||||
| Cost of revenues | 1,065 | 979 | 3,226 | 2,655 | ||||||||
| Gross Profit | 366 | 92 | 919 | 460 | ||||||||
| Operating Expenses: | ||||||||||||
| Research and development | 2,061 | 1,495 | 5,797 | 3,624 | ||||||||
| Selling and marketing | 845 | 802 | 2,577 | 2,146 | ||||||||
| General and administrative | 2,070 | 1,826 | 6,322 | 5,475 | ||||||||
| Total operating expenses | 4,976 | 4,123 | 14,696 | 11,245 | ||||||||
| Loss from operations | (4,610 | ) | (4,031 | ) | (13,777 | ) | (10,785 | ) | ||||
| Financial income (expenses) | 81 | (40 | ) | 131 | (36 | ) | ||||||
| Net Loss | $ | (4,529 | ) | $ | (4,071 | ) | $ | (13,646 | ) | $ | (10,821 | ) |
| Net loss per share – basic and diluted | $ | (0.58 | ) | $ | (0.53 | ) | $ | (1.75 | ) | $ | (1.50 | ) |
| Weighted average number of shares of common stock used in computing net loss per share – basic and diluted | 7,838,506 | 7,739,463 | 7,816,974 | 7,194,379 |
CONSOLIDATEDBALANCE SHEETS ^(2)^
(U.S. dollars in thousands)
| September 30, | December 31, | |||
|---|---|---|---|---|
| 2022 | 2021 | |||
| ASSETS | ||||
| Current Assets: | ||||
| Cash and cash equivalents | $ | 3,934 | $ | 12,004 |
| Short-term bank deposits | 17,111 | 22,036 | ||
| Accounts receivable: | ||||
| Trade, net | 1,166 | 1,224 | ||
| Other | 207 | 165 | ||
| Prepaid expenses | 860 | 522 | ||
| Inventory | 1,414 | 1,143 | ||
| Total current assets | 24,692 | 37,094 | ||
| Non-current assets: | ||||
| Property, plant and equipment, net | 876 | 632 | ||
| Operating lease right of use assets | 1,635 | 1,081 | ||
| Funds in respect of employee rights upon retirement | 858 | 905 | ||
| Total non-current assets | 3,369 | 2,618 | ||
| Total assets | $ | 28,061 | $ | 39,712 |
| December 31, | |||||
|---|---|---|---|---|---|
| 2021 | |||||
| LIABILITIES AND EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable and accruals: | |||||
| Trade | 404 | $ | 893 | ||
| Other | 3,557 | 3,454 | |||
| Total current liabilities | 3,961 | 4,347 | |||
| Long-term liabilities: | |||||
| Operating lease liabilities | 1,261 | 781 | |||
| Liability for employees rights upon retirement | 969 | 1,052 | |||
| Total long-term liabilities | 2,230 | 1,833 | |||
| Total liabilities | 6,191 | $ | 6,180 | ||
| Equity: | |||||
| Common stock, par value 0.0001 per share; 150,000,000 shares authorized at June 30, 2022 and December 31, 2021; 8,335,606 and 8,296,256 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 1 | 1 | |||
| Preferred C shares, par value 0.0001 per share; 1,172,000 shares authorized at June 30, 2022 and December 31, 2021; 1,718 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | * | * | |||
| Additional paid-in capital | 218,609 | 216,625 | |||
| Accumulated deficit | (196,740 | ) | (183,094 | ) | |
| Total equity | 21,870 | 33,532 | |||
| Total liabilities and equity | 28,061 | $ | 39,712 |
All values are in US Dollars.
(1) All 2022 financial information is derived from the Company’s 2022 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2021 financial information is derived from the Company’s 2021 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, 2022 financial information is derived from the Company’s 2022 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, 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, 2021 filed with the Securities and Exchange Commission.