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): August 8, 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 August 8, 2023, InspireMD, Inc. issued a press release announcing its financial and operating results and recent highlights for the three and six months ended June 30, 2023. 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 August 8, 2023 (furnished herewith pursuant to Item 2.02) |
| 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> August 8, 2023 | By: | /s/ Amir Kohen |
| Name: | Amir<br> Kohen | |
| Title: | Interim<br> Chief Financial Officer |
Exhibit99.1
InspireMDReports Second Quarter 2023 Financial Results and Provides
BusinessUpdate
-Completed transformational private placement for up to $113.6 million, including $42.2 million upfront –
-Completed enrollment in the C-Guardians US IDE trial; on track to announce primary and secondary endpoints and, if successful, submitPMA application in H2 2024 –
-Generated Q2 2023 CGuard EPS revenue of $1.6 million, an increase of nearly 10% over Q2 2022 –
—
Managementto host investor conference call today, August 8, at 8:30am ET
—
TelAviv, Israel, and Miami, FL — August 8, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for treatment of carotid artery disease and prevention of stroke today announced financial and operating results for the second quarter ended June 30, 2023.
SecondQuarter 2023 and Recent Developments:
| ● | Successfully<br> completed a transformational private placement of common shares, prepaid warrants and warrants<br> for up to $113.6 million in gross proceeds, including $42.2 million upfront and additional<br> proceeds of up to $71.4 million upon exercise of milestone-driven warrants. |
|---|---|
| ● | Completed<br> enrollment in the C-Guardians Investigational Device Exemption (IDE) Clinical Trial. The<br> Company anticipates announcing primary and secondary endpoints and, if successful, submitting<br> a Premarket Approval (PMA) application to FDA in the second half of 2024. |
| --- | --- |
| ● | Announced<br> the first-in-human cases successfully performed with its CGuard Prime CAS stent delivery<br> platform as part of C-Guardians trial enrollment. |
| --- | --- |
| ● | Generated<br> record CGuard revenue for the second quarter 2023 of $1,649,000, a 9.6 % increase over the<br> same period in 2022 and a 33% increase over the first quarter of 2023. |
| --- | --- |
| ● | Sold<br> 2,804 CGuard EPS stent systems in the second quarter of 2023, as compared to 2,602 in the<br> second quarter of 2022, an increase of 7.8%, and compared to 2,033 in the first quarter of<br> 2023, an increase of 38%. |
| --- | --- |
MarvinSlosman, CEO of InspireMD, commented: “Our second quarter was marked by several transformational milestones for our business, including the financing of up to $113.6 million that we announced in May. This capital allows us to advance our business towards multiple value-creating milestones, including obtaining potential regulatory approval of and launching our CGuard stent system in the U.S., initiating regulatory pathways for new advanced indications for CGuard, and developing new products, while at the same time continuing to grow our business in approved markets outside of the United States.
“We also announced completion of enrollment in our C-Guardians IDE trial, which includes the first ever cases performed with our CGuard Prime CAS stent delivery platform that we also plan to include in our regulatory submissions. Importantly, enrollment was completed efficiently in under 24 months and gives us line of sight to results and, if successful, a PMA submission in the second half of next year. In parallel, we continue to advance critical pre-commercial activities in the U.S. with the goal of launching CGuard Prime in the first half of 2025, if approved.
“The ongoing shift toward an endovascular standard of care with both CAS and TCAR, highlighted by the current CMS proposed decision memo to expand reimbursement for CAS, further validates our strategic direction. We are striving to serve all physician specialties that treat carotid disease, both CAS and TCAR, with our best-in-class CGuard EPS implant. We believe we are optimally positioned to make the CGuard EPS stent system the standard of care, not only in the U.S. but globally,” Mr. Slosman concluded.
FinancialResults for the Second Quarter ended June 30, 2023
For the three months ended June 30, 2023, revenue increased by $118,000, or 7.7%, to $1,649,000, from $1,531,000 during the three months ended June 30, 2022. This increase was predominantly driven by a 9.6% increase in sales of CGuard EPS from $1,505,000 during the three months ended June 30, 2022, to $1,649,000 during the three months ended June 30, 2023.
For the three months ended June 30, 2023, gross profit (revenue less cost of revenues) increased by $60,000, or 14.0%, to $491,000, from $431,000 during the three months ended June 30, 2022. This increase in gross profit resulted from a $90,000 increase in revenues (as mentioned above), less the associated related material and labor offset by $30,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 29.8% during the three months ended June 30, 2023, from 28.1% during the three months ended June 30, 2022, driven by the factors mentioned above.
Total operating expenses for the second quarter of 2023, were $5,806,000, an increase of $694,000 or 13.6% compared to $5,122,000 for the second quarter of 2022. This increase was primarily due to an increase in compensation expenses.
Net loss for the second quarter of 2023 totaled $5,077,000 or $0.24 per basic and diluted share, compared to a net loss of $4,636,000, or $0.59 per basic and diluted share, for the same period in 2022.
As of June 30, 2023, cash, cash equivalents and short-term investments and bank deposits were $47.0 million compared to $17.8 million as of December 31, 2022. This includes the initial net funding of $37.5 million received upon closing of the transformational private placement that was announced in May, after deducting transaction expenses.
FinancialResults for the Six Months ended June 30, 2023
For the six months ended June 30, 2023, revenue increased by $174,000, or 6.4%, to $2,888,000, from $2,714,000 during the six months ended June 30, 2022. This increase was predominantly driven by a 8.3% increase in sales volume of CGuard EPS from $2,666,000 during the six months ended June 30, 2022, to $2,888,000 during the six months ended June 30, 2023.
For the six months ended June 30, 2023, gross profit (revenue less cost of revenues) increased by 56.2%, or $311,000, to $864,000, compared to a $553,000 for the same period in 2022. This increase in gross profit resulted from a decrease in write-offs of $181,000 and a $161,000 increase in revenues (as mentioned above) less the associated related material and labor costs. This increase was partially offset by an increase of $31,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 29.9% during the six months ended June 30, 2023, from 20.4% during the six months ended June 30, 2022, driven by the reasons mentioned above.
Total operating expenses for the six months ended June 30, 2023, were $10,560,000, an increase of $840,000, or 8.6% compared to $9,720,000 for the six months ended June 30, 2022. This increase was primarily due to an increase in compensation and other general and administrative expenses.
Net loss for the six months ended June 30, 2023 totaled $9,333,000, or $0.64 per basic and diluted share, compared to a net loss of $9,117,000, or $1.17 per basic and diluted share, for the six months ended June 30, 2022.
ConferenceCall and Webcast Details
Management will host a conference call today, Tuesday, August 8, at 8:30 AM ET, 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,August 8^th^, at 8:30 a.m. ET
| Domestic: | 1-844-826-3035 |
|---|---|
| International: | 1-412-317-5195 |
| Conference<br> ID: | 10180798 |
| Call<br> me™ | Link<br> here |
| Webcast: | Link<br> 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; our need to raise additionalcapital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could diluteout stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvalsfor the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliancewith the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals forour products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and ourability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collectedfrom our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative toother 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, developmentand commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential productliability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmentaland other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection coveringour products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israeland other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currencyexchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and politicaland economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufactureour products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutionsand associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-lookingstatements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’sAnnual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents freeof charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-lookingstatements as 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
| CONSOLIDATED STATEMENTS OF OPERATIONS ^(1)^ | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (U.S. dollars in thousands, except per share data) | ||||||||||||
| Three months ended | Six months ended | |||||||||||
| June 30, | June 30, | |||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||
| Revenues | $ | 1,649 | $ | 1,531 | $ | 2,888 | $ | 2,714 | ||||
| Cost of revenues | 1,158 | 1,100 | 2,024 | 2,161 | ||||||||
| Gross Profit | 491 | 431 | 864 | 553 | ||||||||
| Operating Expenses: | ||||||||||||
| Research and development | 1,993 | 2,056 | 3,836 | 3,736 | ||||||||
| Selling and marketing | 892 | 986 | 1,680 | 1,732 | ||||||||
| General and administrative | 2,921 | 2,070 | 5,044 | 4,252 | ||||||||
| Total operating expenses | 5,806 | 5,112 | 10,560 | 9,720 | ||||||||
| Loss from operations | (5,315 | ) | (4,681 | ) | (9,696 | ) | (9,167 | ) | ||||
| Financial income | 238 | 45 | 363 | 50 | ||||||||
| Net Loss | $ | (5,077 | ) | $ | (4,636 | ) | $ | (9,333 | ) | $ | (9,117 | ) |
| Net loss per share – basic and diluted | $ | (0.24 | ) | $ | (0.59 | ) | $ | (0.64 | ) | $ | (1.17 | ) |
| Weighted average number of shares of common stock used in computing net loss per share – basic and diluted | 21,074,187 | 7,807,795 | 14,619,622 | 7,806,030 |
| CONSOLIDATED BALANCE SHEETS ^(2)^ | ||||
|---|---|---|---|---|
| (U.S. dollars in thousands) | ||||
| June 30, | December 31, | |||
| 2023 | 2022 | |||
| ASSETS | ||||
| Current Assets: | ||||
| Cash and cash equivalents | $ | 11,545 | $ | 4,632 |
| Short-term bank deposits | 6,631 | 13,171 | ||
| Marketable securities | 28,817 | - | ||
| Accounts receivable: | ||||
| Trade, net | 1,470 | 1,034 | ||
| Other | 312 | 213 | ||
| Prepaid expenses | 56 | 655 | ||
| Inventory | 1,689 | 1,621 | ||
| Total current assets | 50,520 | 21,326 | ||
| Non-current assets: | ||||
| Property, plant and equipment, net | 873 | 917 | ||
| Operating lease right of use assets | 1,388 | 1,554 | ||
| Funds in respect of employee rights upon retirement | 857 | 856 | ||
| Total non-current assets | 3,118 | 3,327 | ||
| Total assets | $ | 53,638 | $ | 24,653 |
| December 31, | |||||
|---|---|---|---|---|---|
| 2022 | |||||
| LIABILITIES AND EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable and accruals: | |||||
| Trade | 768 | $ | 659 | ||
| Other | 4,061 | 4,411 | |||
| Total current liabilities | 4,829 | 5,070 | |||
| Long-term liabilities: | |||||
| Operating lease liabilities | 970 | 1,195 | |||
| Liability for employees rights upon retirement | 1,026 | 995 | |||
| Total long-term liabilities | 1,996 | 2,190 | |||
| Total liabilities | 6,825 | $ | 7,260 | ||
| Equity: | |||||
| Common stock, par value 0.0001 per share; 150,000,000 shares authorized at June 30, 2023 and December 31, 2022; 21,192,204 and 8,330,918 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 2 | 1 | |||
| Preferred C shares, par value 0.0001 per share; 1,172,000 shares authorized at June 30, 2023 and December 31, 2022; 1,718 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | * | * | |||
| Additional paid-in capital | 257,729 | 218,977 | |||
| Accumulated deficit | (210,918 | ) | (201,585 | ) | |
| Total equity | 46,813 | 17,393 | |||
| Total liabilities and equity | 53,638 | $ | 24,653 |
All values are in US Dollars.
(1) 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; 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.
(2) All June 30, 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. 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, 2022 filed with the Securities