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InspireMD(NSPR) - 2022 Q4 - Earnings Call Transcript
2023-03-30 14:34
InspireMD, Inc. (NASDAQ:NSPR) Q4 2022 Earnings Conference Call March 30, 2023 8:30 AM ET Company Participants Chuck Padala - IR, LifeSci Advisors Marvin Slosman - CEO Craig Shore - CFO Conference Call Participants Benjamin Haynor - Alliance Global Partners Operator Good morning, and welcome to the InspireMD Fourth Quarter and Full Year 2022 Earnings Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to Chuck Padala with LifeSci Advisors. Thank ...
InspireMD(NSPR) - 2022 Q4 - Annual Report
2023-03-30 12:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 Menor ...
InspireMD(NSPR) - 2022 Q3 - Earnings Call Transcript
2022-11-08 17:56
Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was $1.431 million, an increase of 33.6% compared to $1.071 million in Q3 2021 [22] - CGuard revenue grew by nearly 39% year-over-year, reaching over $1.4 million [7] - Gross profit increased to $366,000 in Q3 2022 from $92,000 in Q3 2021, representing an increase of almost 300% [23] - Gross margin improved to 25.6% in Q3 2022 from 8.6% in Q3 2021 [23] - Net loss for Q3 2022 was $4.529 million, or $0.58 per share, compared to a net loss of $4.071 million, or $0.53 per share, in the same period in 2021 [25] Business Line Data and Key Metrics Changes - The company sold 2,624 CGuard stent systems in Q3 2022, a growth of 54% year-over-year compared to 1,709 units sold in Q3 2021 [7] - The increase in sales was driven by growth in existing markets and U.S. sales related to the C-Guardians FDA clinical trial [22] Market Data and Key Metrics Changes - The company enjoys greater than 20% market share in approximately half of its markets, with some territories exceeding 80% [8] - The regulatory landscape in Europe is undergoing significant changes with new compliance regulations under the MDR certification for CE Mark [11] Company Strategy and Development Direction - The company is focused on dominating the carotid revascularization space with the CGuard stent system and plans to launch new delivery systems to enhance market share [9][19] - A strategic partnership with NAMSA has been established to accelerate new product development and commercialization [16] - The company aims to change the paradigm of carotid stenosis management with its CGuard EPS stent platform [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the enrollment progress for the C-Guardians trial, expecting completion by Q1 2023 [28] - The company is closely monitoring the regulatory compliance process in Europe and is prioritizing inventory management to mitigate potential delays [31][33] - Management remains optimistic about the growth potential in Asia, particularly Japan, where discussions with potential distributor partners are ongoing [18] Other Important Information - The CGuard Optima study was presented at the 2022 TCT conference, highlighting the device's performance in preventing carotid artery-related complications [13][14] - The company is developing two new delivery systems to enhance the utilization of CGuard across the vascular specialist community [19] Q&A Session Summary Question: Status of enrollment for C-Guardians trial - Management confirmed that enrollment is progressing well, with expectations to complete by the end of Q1 2023 [28] Question: Update on CREST-2 trial - Management noted that the process of finalizing contracts with sites has been slower than anticipated, but they expect progress as more sites are added [30] Question: CE Mark certification timeline - Management indicated that estimating the timeline for CE Mark certification is challenging due to regulatory complexities, but they are working closely with their notified body [31][32] Question: Impact of currency fluctuations on ASPs and market share - Management acknowledged the impact of currency fluctuations but confirmed that local currency ASPs have increased mid-single digits, with market share gains in several regions [34][36] Question: Terms of potential partnership in Japan - Management discussed considerations for distributor partnerships in Japan, including regulatory paths, distributor capabilities, and potential investment structures [38]
InspireMD(NSPR) - 2022 Q3 - Quarterly Report
2022-11-07 21:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2022 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(NSPR) - 2022 Q2 - Earnings Call Transcript
2022-08-09 18:50
Financial Data and Key Metrics Changes - Revenue for Q2 2022 totaled $1.5 million, representing a growth of nearly 48% compared to Q2 2021 [7] - Gross profit increased to $431,000 in Q2 2022 from $262,000 in Q2 2021, with gross margin rising to 28.1% from 25.2% [28][30] - Net loss for Q2 2022 was $4.636 million or $0.59 per share, compared to a net loss of $3.507 million or $0.46 per share in Q2 2021 [31] Business Line Data and Key Metrics Changes - Sales volume of CGuard EPS increased by 47.8% to $1.505 million in Q2 2022 from $1.019 million in Q2 2021, driven by growth in existing and new markets [27][28] - The volume of units sold increased by 60%, with 2,602 units sold in Q2 2022 compared to 1,623 in Q2 2021 [8] Market Data and Key Metrics Changes - Market share growth is now greater than 20% in over half of the markets, with some territories reaching up to 60% [10][39] - The company is focusing on converting open surgeries to endovascular treatments, as less than 35% of carotid artery disease cases are currently treated through endovascular stenting procedures [12][13] Company Strategy and Development Direction - The strategy focuses on converting open surgery to endovascular procedures and promoting CGuard as a first-line endovascular device [14] - The company is expanding its direct sales model, currently active in the UK and France, with plans to extend to additional territories [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing transition from open surgery to endovascular standard of care, highlighting the significant potential for market penetration [12][19] - The company is optimistic about the enrollment completion for the U.S. IDE trial, C-Guardians, expected by Q1 2023 [20] Other Important Information - The company has a significant presence at medical conferences, which aids in demonstrating CGuard and influencing market demand [15] - Discussions with potential distribution partners in Japan are ongoing, indicating a high level of interest in the CGuard product [21] Q&A Session Summary Question: Comments on Q2 numbers and ASP decline - Management noted that the ASP decline was predominantly due to currency exchange impacts, with a 12% effect, while unit sales grew by 60% [34][35] Question: Market share growth statistics - Market share is calculated based on carotid artery stenting (CAS) procedures, with over 20% share in more than 50% of markets and up to 60% in some [37][38] Question: Competitor's regulatory clearance and market opportunity - Management acknowledged the ongoing need for TCAR as an alternative delivery option in Europe and expressed excitement about serving that market [40][41] Question: Update on CGuard Prime and Switchguard development - Development efforts for CGuard Prime and Switchguard are on track, currently in the regulatory approval phase [43] Question: Enrollment status for CREST-2 trial - Management indicated that they do not have a firm number on patient enrollment but are optimistic about making CGuard available to the 20 sites involved [44][45]
InspireMD(NSPR) - 2022 Q2 - Quarterly Report
2022-08-08 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 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) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2022 (State or other jurisdiction of (I.R.S. Employer i ...
InspireMD(NSPR) - 2022 Q1 - Earnings Call Transcript
2022-05-10 17:36
InspireMD, Inc. (NASDAQ:NSPR) Q1 2022 Earnings Conference Call May 10, 2022 8:30 AM ET Company Participants Chuck Padala - Investor Relations Marvin Slosman - Chief Executive Officer Craig Shore - Chief Financial Officer Conference Call Participants Ben Haynor - Alliance Global Partners Operator Greetings and welcome to InspireMD First Quarter 2022 Earnings Call. [Operator Instructions] At this time, I???d like to turn the call over to your host, Chuck Padala, LifeSci Advisors. Thank you. You may begin. Chu ...
InspireMD(NSPR) - 2022 Q1 - Quarterly Report
2022-05-09 20:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission file number: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) Delaware 26-2123838 4 Menorat Hamaor St. ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO S ...
InspireMD(NSPR) - 2021 Q4 - Earnings Call Transcript
2022-03-08 19:33
InspireMD, Inc. (NASDAQ:NSPR) Q4 2021 Earnings Conference Call March 8, 2022 8:30 AM ET Company Participants Chuck Padala - Managing Director, LifeSci Advisors Marvin Slosman - Chief Executive Officer Craig Shore - Chief Financial Officer Conference Call Participants Ben Haynor - Alliance Global Operator Greetings, and welcome to InspireMD Fourth Quarter and Full-Year 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentati ...
InspireMD(NSPR) - 2021 Q4 - Annual Report
2022-03-07 21:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 Menor ...