NSPR InspireMD Inc New

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q.

Unless the context requires otherwise, references in this Form 10-Q to the “Company,” “InspireMD,” “we,” “our” and “us” refer to InspireMD, Inc., a Delaware corporation, and its subsidiaries.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements,” which include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation. Words such as “may,” “will,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to:

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements. For a discussion of these and other risks that relate to our business and investing in our common stock, you should carefully review the risks and uncertainties described in this Quarterly Report on Form 10-Q, and those described from time to time in our future reports filed with the Securities and Exchange Commission. The forward-looking statements contained in this Quarterly Report on Form 10-Q are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.

Overview

We are a medical device company focusing on the development and commercialization of our proprietary MicroNet™ stent platform technology for the treatment of complex vascular and coronary disease. A stent is an expandable “scaffold-like” device, usually constructed of a metallic material, that is inserted into an artery to expand the inside passage and improve blood flow. Our MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.

Our CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a self-expandable nitinol stent in a single device for use in carotid artery applications. Our CGuard EPS received CE mark approval in the European Union in March 2013, and we launched its release on a limited basis in October 2014. In January 2015, a new version of CGuard, with a rapid exchange delivery system, received CE mark approval in Europe and in September 2015, we announced the full market launch of CGuard EPS in Europe. Subsequently, we launched CGuard EPS in Russia and certain countries in Latin America and Asia, including India. We expect to receive approval to launch CGuard EPS in Brazil, and we are seeking strategic partners for potential launch of CGuard EPS in Japan and China.

In April 2017, we had a pre-investigational device exemption (“IDE”) submission meeting with the U.S. Food and Drug Administration (“FDA”) regarding CGuard EPS where we presented materials that we believed would support a formal IDE submission seeking approval to conduct a human clinical trial in the United States which included our draft synopsis for the clinical trial design. The FDA agreed to our pre-clinical test plan and clinical trial design. On July 26, 2019, we submitted an IDE application for CGuard EPS. In connection with such application, on August 23, 2019, we received a request for additional information from the FDA in support of our application. We continue to work closely with the FDA to address FDA’s information and testing requests in support of our pending IDE application, as the initiation of clinical testing in the U.S. is one of our top priorities. Following resolution of all comments from the FDA, we plan to re-submit the IDE application in May 2020, as IDE approval by the FDA would be a critical step toward the commencement of a human clinical trial using CGuard EPS in the United States.

Additionally, we intend to continue to evaluate potential product enhancements and manufacturing enhancements for CGuard EPS that are expected to reduce cost of goods and/or provide the best-in-class performing delivery system. In furtherance of our strategy focusing on establishing CGuard EPS as a viable alternative to vascular surgery, we are exploring adding a procedural protection device to our portfolio incorporating the principal of reverse flow of the carotid artery as an adjunctive alternative to femoral access. We cannot give any assurance that we will receive sufficient (or any) proceeds from future financings or the timing of such financings, if ever for potential product enhancements and manufacturing enhancements. In addition, such additional financings may be costly or difficult to complete. Even if we receive sufficient proceeds from future financings, there is no assurance that we will be able to timely apply for CE mark approval following our receipt of such proceeds. We believe these improvements may allow us to reduce cost of goods and increase penetration in our existing geographies and better position us for entry into new markets.

We consider the addressable market for our CGuard EPS consists of individuals with diagnosed, symptomatic high-grade carotid artery stenosis (HGCS, ≥70% occlusion) for whom an intervention is preferable to medical (drug) therapy. This group includes not only carotid artery stenting patients but also individuals undergoing carotid endarterectomy, as the two approaches compete for the same patient population. Assuming full penetration of the intervention caseload by CGuard EPS, we estimate that the addressable market for CGuard EPS was approximately $1.0 billion in 2017. (source: Health Research International 2017 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography and Addressable Markets).

Our MGuard™ Prime™ Embolic Protection System (“MGuard Prime EPS”) is marketed for use in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions (bypass surgery). MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent. MGuard Prime EPS received CE mark approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection. However, as a result of a shift in industry preferences away from bare-metal stents in favor of drug-eluting (drug-coated) stents, in 2014 we decided to curtail further development of this product in order to focus on the development of a drug-eluting stent product, MGuard DES™. Due to limited resources, though, our efforts have been limited to testing drug-eluting stents manufactured by potential partners for compatibility with MicroNet and seeking to incorporate MicroNet onto a drug-eluting stent manufactured by a potential partner. The FDA has clarified that the primary mode of action for drug-eluting cardiovascular stents, which are regulated as combination products, is that of the device component and has assigned the FDA Center for Devices and Radiological Health (CDRH) primary responsibility for premarket review and regulation, providing some clarity about what to expect regarding the regulatory framework related to the development of MGuard DES™.

We also intend to develop a pipeline of other products and additional applications by leveraging our MicroNet technology to new applications to improve peripheral vascular and neurovascular procedures, such as the treatment of the superficial femoral artery disease, vascular disease below the knee and neurovascular stenting to seal aneurysms in the brain.

Presently, none of our products may be sold or marketed in the United States.

Recent Developments

COVID-19 Developments

In December 2019, a strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China, and has reached multiple other countries, and, on March 12, 2020, the World Health Organization (the “WHO”) declared COVID-19 to be a pandemic. In an effort to contain and mitigate the spread of COVID-19, many countries have imposed unprecedented restrictions on travel, quarantines and other public health safety measures. We have not experienced significant COVID-19 related impact on our financial condition and results of operations in the first quarter 2019. However, procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, have mostly been postponed as hospitals shift resources to patients affected by COVID-19. To our knowledge, most European countries in which we operate are slowly reinstating elective procedures, but we do not know when the hospitals will resume to normal pre-pandemic levels with such procedures. In addition, most of our sales have historically come from Europe, where the pandemic has had a severe impact. We anticipate that the continuation of the pandemic and related restrictions and safety measures may result in a significant decline in sales of our products for the upcoming periods. For more discussion on our risks related to COVID-19, please see risk factors included under “Item 1A. Risk Factors” herein.

In response to significant market volatility and uncertainties relating to COVID-19, our board of directors (the “Board”) and management have taken the following voluntary reductions of compensation as a measure of fiscal responsibility.

Effective April 1, 2020, the Board approved a 50% decrease in the annual cash compensation for non-employee directors from an aggregate amount of $154,000 to $77,000.

On April 21, 2020, Marvin Slosman, our President, Chief Executive Officer and Director, signed a waiver reducing his annual base salary from $400,000 to $200,000 for the period beginning April 1, 2020 and ending on such date as Mr. Slosman shall determine, and Craig Shore, our Chief Financial Officer, Chief Administrative Officer, Secretary and Treasurer, signed a waiver reducing his monthly base salary from NIS 80,125 to NIS 40,063 for the period beginning April 1, 2020 and ending on such date as Mr. Shore shall determine. In addition, effective April 1, 2020, we reduced the annual salaries of most of our employees by 20% to 30% until further notice. We expect that such reductions of the base salaries of our employees, including Mr. Slosman and Mr. Shores, will result in a decrease of approximately $300,000 in operating expenses in the second quarter of 2020.

NYSE American Deficiency

On August 7, 2019, we received notification from the NYSE American that we do not meet continued listing standards of the NYSE American as set forth in Part 10 of the NYSE American Company Guide (the “Company Guide”). Specifically, we are not in compliance with Section 1003(a)(iii) of the Company Guide because we reported stockholders’ equity of less than $6 million as of June 30, 2019, and net losses in our five most recent fiscal years ended December 31, 2018. As a result, we became subject to the procedures and requirements of Section 1009 of the Company Guide.

On October 11, 2019, NYSE American accepted our plan to regain compliance with Section 1003(a)(iii) of the Company Guide by August 7, 2020. We are subject to periodic review during the period covered by the compliance plan. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the plan period could result in our common stock being delisted from the NYSE American.

Critical Accounting Policies

A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting policies are more fully described in both (i) “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and (ii) Note 2 of the Notes to the Consolidated Financial Statements included in the Annual Report on Form 10-K for the year ended December 31, 2019. There have not been any material changes to such critical accounting policies since December 31, 2019.

The currency of the primary economic environment in which our operations are conducted is the U.S. dollar (“$” or “dollar”).

Contingencies

We and our subsidiaries are involved in legal proceedings that arise from time to time in the ordinary course of business. We record accruals for these types of contingencies to the extent that we conclude the occurrence of such contingencies is probable and that the related liabilities are estimable. When accruing these costs, we recognize an accrual in the amount within a range of loss that is the best estimate within the range. When no amount within the range is a better estimate than any other amount, we accrue for the minimum amount within the range. Legal costs are expensed as incurred.

Results of Operations

Three months ended March 31, 2020 compared to the three months ended March 31, 2019

Revenues. For the three months ended March 31, 2020, revenue increased by $619,000, or 149.2%, to $1,034,000, from $415,000 during the three months ended March 31, 2019. This increase was predominantly driven by a 158.2% increase in sales volume of CGuard EPS from $376,000 during the three months ended March 31, 2019, to $971,000 during the three months ended March 31, 2020, mainly due to our previous third-party sterilizer equipment failures, which caused a significant interruption in sterilized product supply for the majority of the first quarter 2019 as well as our continued focus in expanding revenue base in our major markets. In addition, MGuard Prime EPS sales increased from $39,000 during the three months ended March 31, 2019, to $63,000 during the three months ended March 31, 2020, due to the delayed shipments of sterilized products during the three months ended March 31, 2019, as mentioned above.

With respect to geographical regions, the increase in revenue was primarily attributable to a $567,000 increase in revenue from sales made in Europe (driven by a $559,000 increase of CGuard EPS sales for reasons discussed in the paragraph above), as well as an increase of $35,000 in revenue from sales made in Asia and Middle East (driven by a $33,000 increase of CGuard EPS sales for reasons discussed in the paragraph above), as well as an increase of $17,000 in revenue from sales of CGuard EPS made in Australia and South Africa.

Gross Profit (Loss). For the three months ended March 31, 2020, gross profit (revenue less cost of revenues) increased by $368,000, to a gross profit of $295,000, compared to a gross loss of $73,000 during the same period in 2019. This increase in gross profit resulted from a $223,000 increase in revenues (as mentioned above), less the related material and labor costs, resulting from delays related to product sterilization interruption during the three months ended March 31, 2019 as discussed above, which did not occur during the three months ended in March 31, 2020, a decrease of $118,000 in write-offs of inventory during the three months ended March 31, 2020 due to the same sterilization issue mentioned above and a decrease of $27,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 28.5% during the three months ended March 31, 2020 from (17.6)% during the three months ended March 31, 2019, driven mainly by delays in product sterilization and write-offs of CGuard EPS inventory during the three months ended in March 31, 2019.

Research and Development Expenses. For the three months ended March 31, 2020, research and development expenses decreased by 53.5%, or $602,000, to $523,000, from $1,125,000 during the three months ended March 31, 2019. This decrease resulted primarily from a decrease of $328,000 in clinical expenses associated with CGuard EPS, mainly related to IDE approval process, a decrease of $354,000 due to a settlement expenses made to a former service provider pursuant to settlement agreement during the three months ended March 31, 2019, which did not occur during the three months ended on March 31, 2020 (see Part II, Item 1. “Legal Proceedings” below) and a decrease of $25,000 in miscellaneous expenses. These decreases were partially offset by an increase of $105,000 in development expenses related to CGuard EPS.

Selling and Marketing Expenses. For the three months ended March 31, 2020, selling and marketing expenses decreased by 1.6%, or $10,000, to $624,000, from $634,000 during the three months ended March 31, 2019.

General and Administrative Expenses. For the three months ended March 31, 2020, general and administrative expenses decreased by 9.9%, or $129,000, to $1,169,000, from $1,298,000 during the three months ended March 31, 2019. This decrease resulted primarily from a decrease of $175,000 in legal expenses due to the reduced need for legal services partially offset by an increase of $46,000 in miscellaneous expenses.

Financial Expenses (Income). For the three months ended March 31, 2020, financial income increased by 155.8%, or $120,000, to $43,000 of financial income, from $77,000 of financial expenses during the three months ended March 31, 2019. The increase in financial income primarily resulted from an increase of $122,000 in financial income related to changes in exchange rates and a decrease of $2,000 in miscellaneous expenses.

Tax Expenses (Income). For the three months ended March 31, 2020, there was no material change in our tax expenses as compared to the three months ended March 31, 2019.

Net Loss. Our net loss decreased by $1,229,000, or 38.3%, to $1,978,000, for the three months ended March 31, 2020, from $3,207,000 during the three months ended March 31, 2019. The decrease in net loss resulted primarily from a decrease of $741,000 in operating expenses, an increase of $368,000 in gross profit and an increase of $120,000 in financial income.

Liquidity and Capital Resources

We had an accumulated deficit as of March 31, 2020, of approximately $160 million, as well as a net loss of $1,978,000 and negative operating cash flows for the three months ended March 31, 2020. We expect to continue incurring losses and negative cash flows from operations until our products (primarily CGuard EPS) reach commercial profitability. As a result of these expected losses and negative cash flows from operations, along with our current cash position, we only have sufficient resources to fund operations through the end of August 2020. Therefore, there is substantial doubt about our ability to continue as a going concern.

Our plans include continued commercialization of our products and raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances, however, that we will be successful in obtaining the level of financing needed for our operations. The COVID-19 pandemic has resulted in significant financial market volatility and uncertainty in recent weeks. A continuation or worsening of the levels of market disruption and volatility seen in the recent past could have an adverse effect on our ability to access capital and on the market price of our common stock, and we may not be able to successfully raise capital through the sale of our securities. If we are unsuccessful in commercializing our products or raising capital, we may need to reduce activities, curtail or cease operations.

Anti-Dilution Provisions

Our outstanding shares of Series B Preferred Stock and Series C Preferred Stock contain anti-dilution provisions that may result in the reduction of the conversion price thereof in the future. This feature may result in an indeterminate number of shares of common stock being issued upon conversion of the Series B Preferred Stock or the Series C Preferred Stock. Sales of additional shares of common stock issuable upon conversion of the Series B Preferred Stock or Series C Preferred Stock as a result of anti-dilution adjustments will dilute the interests of other security holders and may depress the price of our common stock. Accordingly, we may find it more difficult to raise additional equity capital while any of our Series B Preferred Stock or Series C Preferred Stock is outstanding. As of May 10, 2020, 17,303 shares of Series B Preferred Stock and 26,558 shares of Series C Preferred Stock were outstanding.

Three months ended March 31, 2020 compared to the three months ended March 31, 2019

General. At March 31, 2020, we had cash and cash equivalents of $3,141,000, as compared to $5,514,000 as of December 31, 2019. We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research and development, marketing and sales activities, finance and administrative cost, capital expenditures and general working capital.

For the three months ended March 31, 2020, net cash used in our operating activities decreased by $1,131,000 to $2,354,000, from $3,485,000 during the same period in 2019. The primary reason for the decrease in cash used in our operating activities was a decrease of payments for third party related expenses and for professional services of $975,000 (primarily due to production related payments) and an increase of $323,000 in payments received from customers to $989,000 during the three months ended March 31, 2020, from $666,000 during the same period in 2019. These changes that decreased the cash used in our operating activities were partially offset by an increase of $167,000 paid during the three months ended March 31, 2020 in compensation costs from $1,737,000 in the three months ended March 31, 2019 to $1,904,000 during the same period in 2020 (mainly driven by an increase of $280,000 in termination payments to James Barry, Ph. D., our former chief executive officer, president and director, in connection with his resignation effective December 31, 2019 offset by other payroll and bonus payouts change of $113,000).

Cash used by our investing activities was $3,000 during the three months ended March 31, 2020 compared to $105,000 during the three months ended March 31, 2019. The primary reasons for the decrease in cash used by our investing activities were a decrease of $66,000 in payments made for purchase of property, plant and equipment to $0 during the three months ended March 31, 2020, from $66,000 during the same period in 2019 and a decrease of $36,000 deposited to employee funds to $3,000 during the three months ended March 31, 2020, from $39,000 during the same period in 2019.

Cash provided by financing activities for the three months March 31, 2020 was $3,000, compared to $16,000 during the same period in 2019. The principal source of the cash provided by financing activities during the three months ended March 31, 2020 and March 31, 2019 was the funds received from the exercise of pre-funded warrants that resulted in approximately $3,000 and $16,000, respectively.

As of March 31, 2020, our current assets exceeded our current liabilities by a multiple of 2.1. Current assets decreased by $2,374,000 during the period and current liabilities decreased by $512,000 during the period. As a result, our working capital decreased by $1,862,000 to $2,833,000 as of March 31, 2020.

Off Balance Sheet Arrangements

We have no off-balance sheet transactions, arrangements, obligations (including contingent obligations) or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

Factors That May Affect Future Operations

We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the impact of the COVID-19 pandemic, cyclical nature of the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment. Our operating results could also be impacted by a weakening of the Euro and strengthening of the New Israeli Shekel, or NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products. For a discussion of these and other risks that relate to our business, you should carefully review the risks and uncertainties described under the heading “Part II – Item 1A. Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2019, and those described from time to time in our future reports filed with the Securities and Exchange Commission.

The ultimate impact of the COVID-19 pandemic on the Company’s operations is unknown and will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the COVID-19 outbreak, new information which may emerge concerning the severity of the COVID-19 pandemic, and any additional preventative and protective actions that regulators, or the board or management of the Company, may determine are needed.

Contractual Obligations and Commitments

During the three months ended March 31, 2020, there were no material changes to our contractual obligations and commitments.