UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2123838 (State or other jurisdiction of incorporation or organization) 4 M ...

InspireMD, Inc. (NASDAQ:NSPR) Q3 2019 Earnings Conference Call November 12, 2019 8:30 AM ET Company Participants Jim Barry - President and Chief Executive Officer Craig Shore - Chief Financial Officer. Conference Call Participants Vernon Bernardino - H.C. Wainwright & Co Operator Greetings, and welcome to the InspireMD Third Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instruction ...

Market Opportunity & Impact - Stroke is a major global health issue, causing 62 million deaths annually[10] and costing $34 billion annually in the US alone[10] - Carotid artery disease (CAD) is responsible for approximately 20% of ischemic strokes, affecting 22 to 24 million people[10] - The addressable market for stroke prevention devices is estimated to be over $1 billion[7, 31, 69] CGuard™ EPS Technology & Clinical Data - InspireMD's CGuard™ EPS, with its MicroNet™ technology, aims to shift the paradigm in carotid artery stenting (CAS) for stroke prevention[5, 7] - Clinical trials demonstrate the benefits of CGuard™ EPS, showing no device-related major adverse events and sustainable long-term results[7] - The MicroNet™ technology in CGuard™ EPS permanently covers plaque, preventing debris from passing through and acting as a "safety net"[5, 34, 38] - In the CARENET clinical trial, CGuard™ EPS showed zero major adverse cardiac or cerebral events (MACCE) at 30 days, compared to a comparative data of 572%[42] - PARADIGM 101 trial showed 991% device success, with 0% major stroke at 30 days[43] Commercial Growth & Strategy - CGuard™ EPS sales increased 55% year-over-year in 2018[7] - The company is evaluating opportunities to go direct in key markets and expanding into OUS markets like Brazil, Japan, and China[7] - The company submitted an IDE FDA submission for CGuard™ EPS in July 2019[7, 65] - The company's strategy includes transitioning current carotid stent users to CGuard™ EPS and vascular surgeons to CGuard™[61] Financials - As of October 31, 2019, the stock price was $113, with an average daily trading volume of 242K shares[75] - As of September 30, 2019, the company had $72 million in cash[75]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2019 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. E ...

InspireMD, Inc. (NASDAQ:NSPR) Q2 2019 Results Conference Call August 6, 2019 8:00 AM ET Company Participants Jeremy Feffer - IR Jim Barry - CEO Craig Shore - CFO Conference Call Participants Vernon Bernardino - H.C. Wainwright Operator Greetings, and welcome to the InspireMD Second Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being r ...

Part I [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) InspireMD, Inc.'s June 30, 2019, unaudited financials show decreased assets, widened net loss, and growing deficit, raising going concern doubts - The company has an accumulated deficit of **$153 million** as of June 30, 2019, and its current cash position is only sufficient to fund operations until the end of **Q4 2019**, which raises substantial doubt about its ability to continue as a going concern[31](index=31&type=chunk) [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2019, total assets decreased to $9.28 million, primarily due to lower cash, while total equity declined to $5.57 million Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2019 | December 31, 2018 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $4,823 | $9,384 | -$4,561 | | Total Current Assets | $7,222 | $11,419 | -$4,197 | | Total Assets | $9,284 | $12,288 | -$3,004 | | Total Current Liabilities | $1,945 | $2,920 | -$975 | | Total Liabilities | $3,710 | $3,525 | +$185 | | Total Equity | $5,574 | $8,763 | -$3,189 | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) Q2 2019 revenues increased to $1.35 million, but net loss widened to $2.21 million; six-month revenues decreased to $1.77 million, with net loss growing to $5.41 million Quarterly and Six-Month Operating Results (in thousands, except per share data) | Metric | Q2 2019 | Q2 2018 | Six Months 2019 | Six Months 2018 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $1,354 | $1,003 | $1,769 | $2,010 | | Gross Profit | $442 | $277 | $369 | $570 | | Loss from Operations | $(2,183) | $(1,473) | $(5,313) | $(3,426) | | Net Loss | $(2,206) | $(627) | $(5,413) | $(3,016) | | Net Loss Per Share | $(1.59) | $(7.66) | $(4.86) | $(38.48) | [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $6.38 million for H1 2019, while financing cash decreased, resulting in a $4.56 million net cash decrease Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,382) | $(3,974) | | Net cash used in investing activities | $(224) | $(41) | | Net cash provided by financing activities | $2,046 | $6,780 | | **Decrease in Cash and Cash Equivalents** | **$(4,561)** | **$2,732** | | **Cash at End of Period** | **$4,823** | **$6,442** | [Notes to the Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) Notes detail business, liquidity, new accounting standards, equity changes including a reverse stock split, disaggregated revenue, and a new $2.0 million lawsuit - The company effected a **one-for-fifty reverse stock split** of its common stock, effective **March 29, 2019**. All share and per-share data have been retroactively adjusted[44](index=44&type=chunk) - In April 2019, the company closed a public offering of common stock, receiving net proceeds of approximately **$2.0 million**[43](index=43&type=chunk) - In July 2019, a former distributor filed a suit seeking damages up to **€1,830,000 (approx. $2.0 million)** related to a 2014 voluntary field action[59](index=59&type=chunk) Revenue by Product for Six Months Ended June 30 (in thousands) | Product | 2019 | 2018 | | :--- | :--- | :--- | | CGuard | $1,492 | $1,664 | | MGuard | $277 | $346 | | **Total** | **$1,769** | **$2,010** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses MicroNet stent focus, Q2 revenue growth, six-month revenue decline, increased R&D for CGuard IDE, and critical need for additional financing due to limited liquidity - The company is focusing on the development and commercialization of its proprietary **MicroNet stent platform technology**, with the **CGuard EPS** product being a key priority[67](index=67&type=chunk) - On **July 26, 2019**, the company submitted an **Investigational Device Exemption (IDE) application** to the FDA to commence a human clinical trial of **CGuard EPS** in the United States[70](index=70&type=chunk) - The company has sufficient resources to fund operations only until the end of the **fourth quarter of 2019**, creating substantial doubt about its ability to continue as a going concern[103](index=103&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q2 2019 revenue grew 35% to $1.35 million, but net loss widened significantly due to R&D surge; six-month revenue fell 12% to $1.77 million, with net loss increasing 79.5% Q2 2019 vs Q2 2018 Performance (in thousands) | Metric | Q2 2019 | Q2 2018 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | $1,354 | $1,003 | +35.0% | | Gross Profit | $442 | $277 | +59.6% | | R&D Expenses | $865 | $230 | +276.1% | | Net Loss | $(2,206) | $(627) | +251.8% | Six Months 2019 vs 2018 Performance (in thousands) | Metric | H1 2019 | H1 2018 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | $1,769 | $2,010 | -12.0% | | Gross Profit | $369 | $570 | -35.3% | | R&D Expenses | $1,990 | $482 | +312.9% | | Net Loss | $(5,413) | $(3,016) | +79.5% | [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and equivalents fell to $4.8 million by June 30, 2019, with $6.4 million used in operations; existing cash is only sufficient through Q4 2019, making additional capital critical - Cash and cash equivalents decreased from **$9,384,000** at Dec 31, 2018, to **$4,823,000** at June 30, 2019[112](index=112&type=chunk) - Net cash used in operating activities for H1 2019 increased to **$6,382,000** from **$3,974,000** in H1 2018, driven by higher payments for R&D, professional services, and salaries[113](index=113&type=chunk) - Cash from financing activities in H1 2019 was **$2,046,000** from a public offering, compared to **$6,780,000** in H1 2018 which came from two separate offerings[115](index=115&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that this item is not applicable - The company states that Quantitative and Qualitative Disclosures About Market Risk are not applicable[121](index=121&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2019, with no material changes to internal control over financial reporting identified - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** at a reasonable assurance level as of **June 30, 2019**[122](index=122&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[123](index=123&type=chunk) Part II [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company settled a lawsuit with Medpace Inc. in April 2019 and faces a new $2.0 million suit from a former distributor regarding a 2014 product recall - The lawsuit with Medpace Inc. was settled **confidentially**, and the case was dismissed with prejudice in **April 2019**[126](index=126&type=chunk) - On **July 10, 2019**, former distributor Bosti Trading Ltd. filed a suit against the company's subsidiary seeking damages of approximately **$1.1 million to $2.0 million** related to a voluntary field corrective action from 2014[127](index=127&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The primary risk is potential delisting from NYSE American due to low stock price, despite resolving a prior non-compliance notice, with immediate suspension possible if price falls below $0.06 - Although the company resolved its low selling price deficiency with NYSE American on **July 8, 2019**, it remains at risk of delisting[132](index=132&type=chunk) - If the company is found to be non-compliant again within **12 months** of **July 8, 2019**, it may face truncated compliance procedures or immediate delisting proceedings[132](index=132&type=chunk) - The NYSE American policy is to immediately suspend trading and begin delisting if a stock's market price falls below **$0.06 per share** at any time[133](index=133&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) The company states that this item is not applicable - The company states that this item is not applicable[134](index=134&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed with the Form 10-Q, including corporate governance documents and Sarbanes-Oxley certifications - The report includes an index of all exhibits filed, such as certificates of incorporation, bylaws, and **Sarbanes-Oxley certifications**[135](index=135&type=chunk)[137](index=137&type=chunk)

Financial Data and Key Metrics Changes - For Q1 2019, revenue was $415,000, a decrease of 59% from the same period in 2018, primarily due to a 55% decrease in CGuard EPS sales and a 78% decrease in MGuard EPS sales [32][34] - The company's gross loss for Q1 2019 was $73,000, compared to a gross profit of $293,000 in Q1 2018, with gross margin decreasing to negative 17.6% from 29.1% [35] - Total operating expenses increased by 36% to $3.1 million in Q1 2019, up from $2.2 million in Q1 2018 [37] - Net loss for Q1 2019 totaled $3.2 million or $3.82 per share, compared to a net loss of $2.4 million or $0.54 per share in Q1 2018 [38] Business Line Data and Key Metrics Changes - CGuard EPS sales decreased from $831,000 in Q1 2018 to $376,000 in Q1 2019, while MGuard EPS sales fell from $176,000 to $39,000 during the same period [32][34] - The sterilization issue led to a backlog of approximately $600,000, which has since been resolved, and the majority of the backlog has been shipped [34][36] Market Data and Key Metrics Changes - Bookings for CGuard increased by 63% in India, 74% in Poland, close to 30% in Spain, and 288% in Switzerland compared to the same period last year [7] - The company is targeting a minimum $1 billion addressable market for CGuard, with an estimated 13 million people worldwide suffering from high-grade carotid artery stenosis [27][28] Company Strategy and Development Direction - The company is focused on expanding its sales efforts in key European markets while preparing for a US IDE filing expected mid-year [12] - Discussions are ongoing to introduce CGuard into higher regulatory territories, including China and Japan, and a regulatory dossier has been submitted to Brazil's ANVISA [13][14] - The establishment of Centers of Excellence (COEs) aims to educate clinicians on CGuard's benefits and generate new clinical data [18][22] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the sterilization issue as a timing problem rather than a loss of revenue, expressing confidence that the deferred revenue will be recognized within the year [10][30] - The company completed an equity financing raising approximately $2.5 million, providing resources to execute growth and development plans [30] Other Important Information - The company has transitioned to a direct sales model in the Czech Republic and is building its direct sales model in the UK, with early successes reported [25] - The company is expanding its local sales and marketing focus by adding clinical specialist teams in key European markets [23] Q&A Session Summary - No specific questions or answers were recorded in the provided content, as the call concluded without a detailed Q&A segment [40]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2019 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Emplo ...

InspireMD, Inc. (NASDAQ:NSPR) Q4 2018 Earnings Conference Call February 19, 2019 8:00 AM ET Company Participants Jeremy Feffer - IR, LifeSci Advisors, LLC Jim Barry - CEO Craig Shore - CFO Conference Call Participants Operator Greetings and welcome to the InspireMD Fourth Quarter and Fiscal Year 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conferen ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2123838 (State or other jurisdiction of incorporation or organization) 4 M ...