InspireMD(NSPR)

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InspireMD(NSPR) - 2020 Q3 - Earnings Call Transcript
2020-11-09 17:40
Financial Data and Key Metrics Changes - Total revenues for Q3 2020 were $980,000, a 4.4% increase from $939,000 in Q3 2019, and a 213% increase from $313,000 in Q2 2020 [18][26] - Gross profit for Q3 2020 was $298,000, a 133% increase from $128,000 in Q3 2019, with gross margin rising to 30.4% from 13.6% [28] - Net loss for Q3 2020 was $2,233,000 or $0.06 per share, compared to a net loss of $2,070,000 or $1.26 per share in Q3 2019 [31] Business Line Data and Key Metrics Changes - Sales volume of MGuard EPS increased by 69% from $87,000 in Q3 2019 to $147,000 in Q3 2020, driven by a recent tender win [26] - Sales volume of CGuard Prime EPS decreased by 2.2% from $852,000 in Q3 2019 to $833,000 in Q3 2020, attributed to the return of non-emergency procedures [27] Market Data and Key Metrics Changes - The resurgence of elective procedures in key markets led to a 213% increase in total sales compared to Q2 2020, with nearly 50% of sales occurring in the last month of the quarter [9][18] - New restrictions due to COVID-19 create uncertainty in market impact moving forward [19] Company Strategy and Development Direction - The company aims to broaden market share in endovascular carotid artery stenting (CAS) procedures and position CGuard EPS as a first-line stent solution [22] - Global expansion efforts are focused on high-priority markets like China and Japan, with ongoing discussions for distribution partnerships [24][25] - The company is investing in new leadership to drive growth objectives and enhance commercial focus [8][12][13] Management's Comments on Operating Environment and Future Outlook - Management expresses cautious optimism about market recovery despite ongoing uncertainties due to COVID-19 [7][19] - The company remains committed to improving clinical outcomes and maintaining a focus on stroke prevention and carotid artery disease management [52] Other Important Information - The FDA granted conditional approval for the pivotal study of CGuard EPS, with preparations underway for the trial [10][11] - Key hires include a new Vice President of Business Development and a Senior Vice President of Global Sales and Marketing to enhance strategic initiatives [12][13] Q&A Session Summary Question: How did the company secure Dr. Roubin as a board member? - The connection was made through Dr. Christina Brennan, leading to discussions that highlighted Dr. Roubin's valuable insights and experience [34][35] Question: How will the company strategically move the business during COVID? - The company is focusing on being commercially driven and ensuring that CGuard EPS is prioritized among distribution partners [37][38] Question: What is the timeline for advanced delivery options? - The company aims to have new products to market in a meaningful timeframe within 2021, with progress being made on a new transfemoral delivery system [42][43] Question: When will the CGuard trial begin enrolling patients? - The company is finalizing decisions on trial partners and site selection, with a clearer schedule expected soon [44][45]
InspireMD(NSPR) - 2020 Q3 - Quarterly Report
2020-11-09 13:22
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, 2020 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) Delaware 26-2123838 (State or other juris ...
InspireMD(NSPR) - 2020 Q2 - Earnings Call Transcript
2020-08-05 17:19
Financial Data and Key Metrics Changes - For Q2 2020, total revenue was $313,000, a decrease from $1.354 million in Q2 2019, representing a 77% decline [18][26] - For the first half of 2020, total revenue was $1.347 million compared to $1.769 million for the same period in 2019, indicating a 24% decrease [18] - The net loss for Q2 2020 was $2.48 million or $0.20 per share, compared to a net loss of $2.206 million or $1.59 per share in Q2 2019 [30] Business Line Data and Key Metrics Changes - Sales volume of CGuard EPS decreased by 76% from $1.1 million in Q2 2019 to $300,000 in Q2 2020 [26][27] - Sales volume of MGuard EPS fell by 82% from $238,000 in Q2 2019 to $42,000 in Q2 2020 [28] - Gross margin decreased to -38.3% in Q2 2020 from 32.6% in Q2 2019 [29] Market Data and Key Metrics Changes - The company is seeing a resurgence of elective procedures in key markets, particularly in Italy, Spain, and Germany [18] - Brazil's healthcare market is expected to reach $1.8 billion with a CAGR of 9% through 2023, representing a significant opportunity for expansion [10] Company Strategy and Development Direction - The company aims to convert vascular surgeons to adopt carotid artery stenting as a standard of care, similar to other vascular conditions [21] - Plans to expand into growth markets in South America and the Asia-Pacific region are ongoing, with Brazil being a key focus [18][24] - The company is pursuing both standard and special reimbursement pathways in France to expedite market entry [38] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the adverse impact of COVID-19 on elective procedures but remains optimistic about recovery as healthcare systems adapt [7][19] - The company is focused on operational efficiency and cost reduction to navigate the challenges posed by the pandemic [8][20] - Management believes that the technology represents a significant advancement in treating carotid artery disease and is optimistic about future growth [19] Other Important Information - The company completed an equity financing raise of $11.5 million to support its operations during challenging times [9] - The FDA granted conditional approval for the Investigational Device Exemption (IDE) application to initiate a pivotal study of CGuard EPS [15][16] Q&A Session Summary Question: What is the plan regarding launching in Brazil and the timeline? - The groundwork is in place for launching CGuard in Brazil, with contracts established and preparations made for market entry [33][36] Question: Can you explain the dual pathway for reimbursement in France? - The company is pursuing both standard and special reimbursement pathways, with the standard expected to be quicker, while the special may take 9-12 months [37][39] Question: What has historically held back carotid stenting from becoming more prevalent? - Early generation carotid stents did not perform as expected compared to open surgical procedures, which has affected adoption rates [44] Question: What advancements are being made in peri-procedural devices? - The company is exploring various options for peri-procedural devices to enhance the CGuard offering and broaden its portfolio [51]
InspireMD(NSPR) - 2020 Q2 - Quarterly Report
2020-08-05 11:38
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission file number: 001-35731 InspireMD, Inc. 4 Menorat Hamaor St. [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2020 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Delaware 26-2123838 (State or other jurisdiction of (I.R.S. ...
InspireMD(NSPR) - 2020 Q1 - Earnings Call Transcript
2020-05-12 16:42
InspireMD, Inc. (NASDAQ:NSPR) Q1 2020 Earnings Conference Call May 12, 2020 8:30 AM ET Company Participants Jeremy Feffer - Investor Relations Marvin Slosman - Chief Executive Officer Craig Shore - Chief Financial Officer Conference Call Participants Operator Greetings and welcome to the InspireMD First Quarter 2020 Earnings Conference Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this c ...
InspireMD(NSPR) - 2020 Q1 - Quarterly Report
2020-05-11 20:16
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, 2020 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) Delaware 26-2123838 (State or other jurisdict ...
InspireMD(NSPR) - 2019 Q4 - Earnings Call Transcript
2020-03-10 16:59
InspireMD, Inc. (NASDAQ:NSPR) Q4 2019 Earnings Conference Call March 10, 2020 8:30 AM ET Company Participants Jeremy Feffer ??? Investor Relations Marvin Slosman ??? Chief Executive Officer Craig Shore ??? Chief Financial Officer Conference Call Participants Vernon Bernardino ??? H.C. Wainright Operator Greetings, and welcome to the InspireMD Fourth Quarter 2019 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operat ...
InspireMD(NSPR) - 2019 Q4 - Annual Report
2020-03-09 22:32
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(NSPR) - 2019 Q3 - Earnings Call Transcript
2019-11-12 19:56
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 ...
InspireMD (NSPR) Investor Presentation - Slideshow
2019-11-12 19:03
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]