Q4 2024 InspireMD Inc Earnings Call
Unknown Executive: Please stand by. Your program is about to begin.
Please stand by your program is about to begin if you need audio assistance during todays program. Please press star zero.
Unknown Executive: If you need audio assistance during today's program, please press star zero.
Unknown Executive: Hello and welcome to InspireMD's fourth quarter 2024 earnings conference call. Currently, all participants are in a listen-only mode.
Speaker Change: Hello, and welcome to inspire MTS fourth quarter 2024 earnings Conference call. Currently all participants are in a listen only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes I would now like to turn the call over to web Campbell from Gilmartin group for introductory disclosures.
Unknown Executive: We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes.
Webb Campbell: I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory disclosures. Please go ahead.
Please go ahead.
Webb Campbell: Thank you for joining us for the InspireMD fourth quarter 2024 conference call.
Web Campbell: Thank you for joining us for the inspire M D fourth quarter 2024 conference call joining us today from inspire M. D are Marvin <unk>, Chief Executive Officer, and Craig Shore, Chief Financial Officer during the call management will be making forward looking statements not historical facts.
Webb Campbell: Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer, and Craig Shore, Chief Financial Officer. During the call, management will be making forward-looking statements, not historical facts, which are based upon management's current expectations, beliefs, and projections, many of which, by their nature, are inherently uncertain. These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed in such forward-looking statements. For more information about these risks, please refer to the risk factors described in InspireMD's most recently filed periodic reports on Form 10-K and Form 10-Q, or any updates in our current reports on Form 8-K, filed with the U.S.
Web Campbell: Which are based upon management's current expectations beliefs, and projections many of which by their nature are inherently uncertain.
Web Campbell: These forward looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed in such forward looking statements for more information about these risks. Please refer to the risk factors described in inspire and <unk>. Most recently filed periodically reports on Form 10-K.
Web Campbell: K and Form 10-Q or any updates in our current reports on form 8-K filed with the U S Securities and Exchange Commission and inspire them DS press release that accompanies this call, particularly the cautionary statements made in it.
Webb Campbell: Securities and Exchange Commission and InspireMD. Please also refer to InspireMD's press release that accompanies this call, particularly the cautionary statements made in it.
Webb Campbell: This call contains time-sensitive information that is accurate only as of today, March 12, 2025. except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.
Web Campbell: This call contains time sensitive information that is accurate only as of today March 12 2025.
Web Campbell: Except as required by law inspire indeed disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur. After this call.
Marvin Slosman: It is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead. Thank you and good morning. We're pleased to welcome everyone to the call today.
Web Campbell: It is now my pleasure to turn the call over to Marvin Sullivan, Chief Executive Officer Marvin. Please go ahead.
Web Campbell: Thank you and good morning, we're pleased to welcome everyone to the call today.
Marvin Slosman: I'd like to start by highlighting our strong fourth quarter and full year performance. Seaguard revenue reached a new quarterly high of $1.95 million in the fourth quarter, reflecting a 10.6% growth year-over-year, with $7 million in revenue for the full year 2024. Translating our momentum in unit sales of 3,512 C-guard stents sold for the quarter in 12,100 units for the full year, thus benefiting thousands of patients in our end market suffering from carotid artery disease. These results contribute to more than 60,000 implants sold to date as a testament to our strong global commercial foundation and real world experience as we build toward anticipated approval and launch of C-Guard Prime in the United States.
Web Campbell: I'd like to start by highlighting our strong fourth quarter and full year performance. She guard revenue reached a new quarterly high of $1 $95 billion in the fourth quarter, reflecting a 10, 6% growth year over year with $7 million in revenue for the full year 2024.
Web Campbell: Translating our momentum in unit sales of 30, 512, <unk> sold for the quarter and 12100 units for the full year, thus benefiting thousands of patients in our end markets suffering from crowded artery disease.
Web Campbell: These results contributed to more than 60000 implants sold to date is a testament to our strong global commercial foundation and real world experience as we build toward anticipated approval and launch of CCAR right in the United States.
Marvin Slosman: I'm pleased to share that we remain on track for an anticipated U.S. approval and launch of SeaGuard Prime in the first half of 2025. With the potential approval, I'd like to illustrate how our global Q4 sales would translate in U.S. market revenue. to help frame the potential opportunity. With 3,512 stents sold internationally during the fourth quarter, had this number of stents sold in the U.S., they would have generated over $16 million in revenue, assuming a balanced mix between TAS and TCAR sales at current U.S. market ASX. To put this in perspective, we estimate that more than 7,000 U.S.
Web Campbell: I'm pleased to share that we remain on track for and it gets paid U S approval and launch of <unk> Prime in the first half of 2025.
Web Campbell: With the potential approval I'd like to illustrate how our global Q4 sales would translate in U S market revenue.
Web Campbell: To help frame the potential opportunity with 30 512 stent sold internationally during the fourth quarter at this number of stents sold in the U S. It would've generated over $16 million in revenue, assuming a balanced mix between cash and T car sales at current U S market a S P.
Web Campbell: To put this in perspective, we estimate that more than 7000 U S. T car procedures were performed in the fourth quarter, making our global unit sales close to 50% of the U S. Only T car market before we've even entered the market with both cats and T car solutions.
Marvin Slosman: TCAR procedures were performed in the fourth quarter, making our global unit sales close to 50% of the U.S. only TCAR market before we've even entered the market with both CAF and TCAR solutions. Therefore, with the U.S. market entry of both CATS and TCAR platforms, we are confident in the significant revenue expansion upon regulatory approval.
Web Campbell: Therefore, with the U S market entry of both Katherine T car platforms. We are confident in the significant revenue expansion upon regulatory approval.
Marvin Slosman: To recap our regulatory status in the U.S., in September 2024, we submitted the final module of our premarket approval, our PMA application to FDA. and have since engaged in an interactive review process. We are optimistic for a timely and positive decision, which would enable our U.S. market launch of Seaguar Prime, triggering the commercialization of our best-in-class STEM platforms in the U.S. While our review continues with FDA, we've been diligently building a world-class commercial and operational engine to support our highly anticipated U.S. line. We're not just prepared, but ready to aggressively execute a robust commercial and operational launch plan.
Web Campbell: To recap our regulatory status in the U S. In September 2024, we submitted the final module of our pre market approval or PMA application to FDA.
Web Campbell: It had fence engaging and interactive review process.
Web Campbell: We are optimistic for a timely and positive decision.
Web Campbell: Which would enable our U S market launch of CCAR Prime triggering the commercialization of our best in class stent platforms in the U S.
Web Campbell: While our review continues with FDA, we've been diligently building a world class commercial and operational engine to support our highly anticipated U S launch.
Web Campbell: We're not just prepared but ready to aggressively execute our robust commercial and operational launch plan.
Marvin Slosman: We believe C-GaR Crime is poised to redefine carotid artery disease treatment and stroke prevention and plan to fully capitalize on the shift toward an endovascular first approach. Our new headquarters in Miami, Florida, is strategically positioned to support the anticipated U.S. launch and commercialization of Seaguard Prime upon approval. This state-of-the-art facility represents our commitment to scaling operations in the U.S. and further strengthens our ability to execute on a national level. Contingent upon U.S. approval, we also believe we are well-positioned to meet robust demand for Seaguard Prime as our infrastructure and operations will support significant growth and success in the U.S.
Web Campbell: We believe CCAR crime, it's poised to redefine carotid artery disease treatment and stroke prevention.
Web Campbell: And plan to fully capitalize on the shift toward an endovascular first approach.
Our new headquarters in Miami, Florida is strategically positioned to support the anticipated U S launch and commercialization of CCAR Prime upon approval.
Web Campbell: State of the art facility represents our commitment to scaling operations in the U S and further strengthens our ability to execute on a national level.
Web Campbell: Contingent upon U S approval. We also believe we are well positioned to meet robust demand for CCAR tried as our infrastructure and operations will support significant growth and success in the U S market.
Marvin Slosman: market. In addition to building the support functions of marketing and commercial operations, we have onboarded more than a dozen world-class field sales professionals and will continue to build our field sales presence with intention over the next 24 months. There is overwhelming interest from highly talented seasoned professionals interested in joining our organization at this pivotal time, reflecting the potential of Sea Guard Prime and the shifting change in the landscape of carotid revascularization.
Web Campbell: In addition to building the support functions of marketing and commercial operations, we have on boarded more than it does in world class field sales professionals and will continue to build our field sales presence with intention over the next 24 months.
There is overwhelming interest from highly talented seasoned professionals interested in joining our organization at this pivotal time, reflecting the potential of CCAR prime and the shifting change in the landscape of carotid revascularization.
Marvin Slosman: Given us confidence in our submission and the pending approval of C-Guard Prime is the overwhelmingly positive one-year data from the C-Guardians Pivotal Clinical Trial, first presented at the Leipzig Interventional Course in 2024. This trial evaluates the safety and efficacy of C-Guard and C-Guard Prime in treating carotid artery stenosis, enrolling 316 patients across 24 trial sites in the U.S. and Europe. The C-Guardians results demonstrated an unprecedented primary endpoint with major adverse events rates of just 0.95% through 30 days and 1.95% through 12 months post-procedure, making this the lowest event rate ever reported in a pivotal study of carotid stent or embolic protection device.
Web Campbell: Given us confidence in our submission and the pending approval of CCAR crime is the overwhelmingly positive one year data from the C. Guardians pivotal clinical trial first presented at the Leipzig Interventional course in 2024.
Web Campbell: This trial evaluated the safety and efficacy of CCAR to CCAR prime in treating carotid artery stenosis enrolling 316 patients across 24 trial sites in the U S and Europe.
Regarding <unk> results demonstrated an unprecedented primary endpoint with major adverse event rates of just point, 95% through 30 days and 195% through 12 months post procedure, making this the lowest event rate ever reported in a pivotal study of carotid stent or.
Web Campbell: Or embolic protection device.
Marvin Slosman: As a reminder, receipt of pre-market approval from the FDA would also trigger the second of four milestone-based financing tranches pursuant to the transformational private placement of up to $113.6 million that we originally announced in May of 2023. If fully exercised, the second tranche would raise an additional $17.9 million in gross proceeds for the company, like the first tranche, which was triggered this past July upon the presentation of positive one-year Sea Guardian's pivotal data. After pre-market approval, the remaining two milestones would each trigger additional charge financings, including receipt of FDA clearance for the SwitchGuard TCAR neuroprotection system, along with our TCAR-indicated C-Guard Prime stent, and the completion of four quarters of commercial sales of C-Guard Prime in the United States, which we anticipate in the back half of 2026, pending the approvals I mentioned earlier and based on our current plan.
Web Campbell: As a reminder, receipt of pre market approval from the FDA, but also triggered the second of four milestone based financing tranches pursuant to the transformational private placement of up to $113 $6 million that we originally announced in May of 2023.
Web Campbell: If fully exercised the second tranche would raise an additional $17 $9 billion in gross proceeds for the company like the first tranche, which was triggered this past July upon the presentation of positive one year see guardians pivotal data.
Web Campbell: And for pre market approval, the remaining two milestones would each trigger additional tranche financings, including receipt of FDA clearance for the switch switch guard Teacart neuro protection system, along with our T car indicated <unk> stent and the completion of four quarters of commercial sales of CCAR Prime in the United States, which.
Web Campbell: We anticipate in the back half of 2026 pending the approval as I mentioned earlier and based on our current plans.
Marvin Slosman: Shifting gears to our clinical pipeline. As a reminder, in October, we received the FDA approval for an Investigational Device Exemption, or IDE, application to begin the C-Guardians 2 pivotal study of our C-Guard Prime carotid stent system in TCAR procedures. This study is intended to evaluate the safety and effectiveness of our novel C-Guard PrimeStent platform in a short TCAR-indicated version compatible with commercially available neuroprotection systems for TCAR procedures. I'm pleased to share that we are enrolling very well in this study as we progress into 2025. We've also engaged with FDA in the filing of our C-Guardians 3 IDE for the investigation of our complete TCAR solution, including the C-Guard Prime 80 stent and switch guard neuroprotection system, and anticipate approval to initiate the study in the second quarter of this year.
Web Campbell: Shifting gears to our clinical pipeline as a reminder, in October we received the FDA approval for an investigational device exemption or IDE application to begin to see Guardians two pivotal study of our CCAR Prime carotid stent system and Teacart procedures.
Web Campbell: <unk> is intended to evaluate the safety and effectiveness of our novel <unk> Prime stent platform and a short T car indicated version compatible with commercially available neuro protection systems for T car procedures I.
Web Campbell: I am pleased to share that we are enrolling very well in this study as we progress into 2025.
Web Campbell: We've also engaged with FDA and the filing of our C. Guardians three IV for the investigation of our complete <unk> solution, including CCAR Prime 80, stent and switch guard neuro protection system and anticipate approval to initiate the study in the second quarter of this year.
Marvin Slosman: With more than 30,000 TCAR procedures performed in the U.S. annually, TCAR is a large market opportunity that remains strategically important as we build a comprehensive approach to carotid revascularization. Our ongoing investments in both CAF and PCAR are aimed at serving the broadest physician base, positioning us to lead as product innovation and procedural reimbursement continue to shift toward an endovascular first standard of care.
Web Campbell: With more than 30000 T car procedures performed in the U S annually CCAR is a large market opportunity that remains strategically important as we build a comprehensive approach to carotid revascularization.
Web Campbell: Our ongoing investments in both cash antique car are aimed at serving the broadest physician base positioning us to lead.
Web Campbell: Product innovation and procedural reimbursement continued to shift toward an endovascular first standard of care at.
Craig Shore: At this point, I'd like to turn the call over to Craig to review the financials. Craig. Thanks, Marvin. For the fourth quarter of 2024, total revenue increased 10.6% to $1.9 million from $1.7 million during the fourth quarter of 2023. This increase was predominantly driven by growth in existing and new markets.
Web Campbell: At this point I'd like to turn the call over to Craig to review the financials Craig.
Craig Shore: Thanks, Marvin for the fourth quarter of 2024 total revenue increased 10, 6% to $1 $9 million from $1 7 million during the fourth quarter of 2023. This increase was predominantly driven by growth in existing and new markets.
Craig Shore: Gross profit for the fourth quarter of 2024 decreased by $36,000 or 7.1% to $469,000 compared to a gross profit of $505,000 for the fourth quarter of 2023. This decrease in gross profit resulted from an increase in cost of goods sold. The increase was primarily due to an increase in material and labor costs, driven mainly to higher sales volume and increased compensation expense for new and current employees. The increase of goods sold was offset by an increase of revenues. Gross margin decreased to 24.1% during the three-month end of December 31st, 2024, from 28.7% during the three-month end of December 31st, 2023, for reasons just mentioned.
Craig Shore: Gross profit for the fourth quarter of 2024 decreased by $36000 or seven 1% to $469000 compared to a gross profit of $505000 for the fourth quarter of 2023. This decrease in gross profit resulted from an increase in cost of goods.
Craig Shore: The increase was primarily due to an increase in material and labor costs, driven mainly to higher sales volume and increased compensation expense for new and current employees. The increase of goods sold was offset by an increase of revenues.
Craig Shore: Gross margin decreased to 24, 1% during the three months ended December 31, 2024 from 28, 7% during the three months ended December 31, 2023 her reasons just mentioned.
Craig Shore: Total operating expenses for the fourth quarter of 2024 were $9.8 million, an increase of $3.5 million, or 55.8%, compared to $6.3 million for the fourth quarter of 2023. This increase was primarily due to increasing expenses related to salaries and share-based compensation associated with our expected launch into the U.S. market, offset by a reduction in clinical trial expenses as we near completion of the Sea Guardians trial.
Craig Shore: Total operating expenses for the fourth quarter of 2024 were $9 $8 million, an increase of $3 $5 million or 55, 8% compared to $6 $3 million for the fourth quarter of 2023. This increase was primarily due to an increase in expenses.
Craig Shore: <unk> to salaries and share based compensation associated with our expected launch into the U S market offset by a reduction in clinical trial expenses as we near completion of the C Guardians trial.
Craig Shore: Total financial income for the fourth quarter of 2024 was $252,000, a decrease of $216,000, or 46.1%, compared to $468,000 for the fourth quarter of 2023. This decrease was primarily due to less interest income from investments in marketable securities and money market funds. Net loss for the fourth quarter of 2024 totaled $9.1 million, or 19 cents per basic and diluted share, compared to a net loss of $5.4 million, or 16 cents per basic and diluted share, for the same period in 2023.
Craig Shore: Financial income for the fourth quarter of 2024 with $252000, a decrease of $216000 or 46, 1% compared to $468000 for the fourth quarter of 2023. This decrease was primarily due to less interest income from.
Craig Shore: Investments in marketable securities and money market funds.
Craig Shore: Net loss for the fourth quarter of 2024 totaled $9 $1 million for 19 cents per basic and diluted share compared to a net loss of $5 $4 million or 16 cents per basic and diluted share for the same period in 2023 for.
Craig Shore: For the full year 2024, total revenue increased 13% to $7 million, from $6.2 million during the full year of 2023. This increase was primarily driven by growth in existing and new markets.
Craig Shore: For the full year 2024, total revenue increased 13% to $7 million from $6 $2 million during the full year of 2023.
Craig Shore: Kris was primarily driven by growth in existing and new markets gross profit for the full year 2024 decreased by $301000 or 16, 7% to $1.5 million compared to a gross profit of $1 $8 million for the full year of 2020.
Craig Shore: Gross profit for the full year 2024 decreased by $301,000, or 16.7%, to $1.5 million, compared to a gross profit of $1.8 million for the full year of 2023. This decrease in gross profit resulted from an increase in cost of goods sold. This increase was primarily due to an increase in material and labor costs, driven mainly to higher sales volume and increased compensation expenses for new and current employees. The increase of cost of goods sold was offset by an increase of the revenues. Gross margin decreased to 21.5% for the full year 2024 from 29.1% during the full year 2023 for reasons just mentioned.
Craig Shore: Three this.
Craig Shore: This decrease in gross profit resulted from an increase in cost of goods sold. This increase was primarily due to an increase in material and labor cost driven mainly to higher sales volume and increased compensation expenses for new and current employees. The increase of cost of goods sold was offset by an increase of the Rev.
Craig Shore: <unk>.
Gross margin decreased to 21, 5% for the full year 2024 from 29, 1% during the full year of 2023 for reasons just mentioned.
Craig Shore: Total operating expenses for the full year 2024 were $35 million, an increase of $12 million, or 52.5%, compared to $22.9 million for the full year 2023. This increase was primarily due to increases in expenses related to the salaries and share-based compensation associated with our expected launch into the U.S. market, offset by a reduction in clinical trial expenses as we near completion of the Sea Guardians trial.
Craig Shore: Total operating expenses for the full year 2024 were $35 million, an increase of $12 million or 52, 5% compared to $22 $9 million for the full year 2023. This increase was primarily due to increases in expenses related to the <unk>.
Salaries and share based compensation associated with our expected launch into the U S market offset by a reduction in clinical trial expenses as we near completion, obviously Guardians trial total financial income for the full year 2024 was $1 $6 million an increase of 260 <unk>.
Craig Shore: Total financial income for the full year 2024 was $1.6 million, an increase of $265,000, or 20.5%, compared to $1.3 million for the full year 2023. This increase was primarily due to an increase in interest income from investments in marketable securities and money market funds. Net loss for the full year 2024 totaled $32 million or $0.76 per basic and diluted share compared to a net loss of $19.9 million or $0.82 per basic and diluted share for the full year 2023.
Craig Shore: $5000 or 25% compared to $1 $3 million for the full year 2023. This increase was primarily due to an increase in interest income from investments in marketable securities and money market funds.
Craig Shore: Net loss for the full year 2024 totaled $32 million or 76 cents per basic and diluted share compared to a net loss of $19 $9 million or <unk> 82 cents per basic and diluted share for the full year 2023.
Craig Shore: As of December 31st, 2024, cash and cash equivalents and marketable securities were $34.7 million compared to $39 million as of December 31st, 2023.
Craig Shore: As of December 31st 2024, cash and cash equivalents in marketable securities with $34 $7 million compared to $39 million as of December 31st 2023.
Craig Shore: Regarding our future expectations in Roadmap for Growth, we're optimistic for an exciting year ahead. However, please note that we're not providing any forward-looking revenue guidance today. We look forward to doing so as our catalyst pathway advances following a potential U.S. FDA approval in the first half of the year.
Craig Shore: Regarding our future expectations and roadmap for growth we're optimistic for an exciting year ahead. However, please note that we're not providing any forward looking revenue guidance today, we look forward to doing so as a catalyst pathway advances following a potential U S. FDA approval in the first half of the year. This can.
Unknown Executive: This concludes our prepared remarks.
Including our prepared remarks, we'll now open the call for questions for the Q&A segment will be joined by showing Gleason inspire and these chief commercial officer operator.
Unknown Executive: We'll now open the call for questions.
Unknown Executive: For the Q&A segment, we'll be joined by Shane Gleason, InspireMD's Chief Commercial Officer. Operator? Thank you.
Speaker Change: Thank you and as a reminder, ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone keypad. If you would like to remove yourself from the queue. Please press star two and again that is star one for a question well that queue builds we'll take our first question from Adam meter from Piper Sandler. Please go ahead.
Unknown Executive: And as a reminder, ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypads. If you would like to remove yourself from the queue, please press star two. And again, that is star one for a question.
Adam Meeder: While that queue builds, we'll take our first question from Adam Meeder from Piper Sandler. Please go ahead. Hi, good morning, Marvin, Craig, Shane, thanks for taking the questions. Congrats on the quarter and the progress in 2024.
Speaker Change: Hi, Good morning, Marvin Craig Shane Thanks for taking the questions congrats on the quarter and the progress in 2024.
Marvin Slosman: A couple from me, you know, maybe just to start on US approval timing for SeaGuard Prime, the STEM product. You know, just wanted to See if there's anything more you can really kind of share around, you know, visibility into approval, the dialogue or discussion that you're having with reviewers and, you know, anything to, you know, mention or call out just given some of the You know, the macro backdrop and the headlines, you know, with potential changes at FDA. Should we expect an impact of timing or still feeling pretty good about, you know, first half 2025 and I had a couple follow ups.
Speaker Change: A couple from me.
Maybe just to start on.
Speaker Change: U S approval timing for CCAR, Brian the stent product.
Speaker Change: Just wanted to.
Speaker Change: See if there's anything more you can really kind of share around visit.
Speaker Change: Visibility.
Speaker Change: And to approve all the dialogue or discussion that youre, having with reviewers.
Speaker Change: Anything to mention or call out just given some of the.
Speaker Change: The macro backdrop and the headlines with potential changes at FDA should we expect an impact of timing or still feeling pretty good about.
Speaker Change: First half 2025, and then I had a couple of follow ups. Thanks.
Marvin Slosman: Good morning, Adam. Thanks. Thanks for the question. Yeah, we remain optimistic on the first half approval, as we've previously noted. And of course, we're building our resources appropriately to, you know, build toward an effective launch following the approval. I would say that we've been having a very productive, interactive approach with FDA, which has been helpful, as has been the modular approach that we selected to take from the beginning, allows us to organize the PMA submission in an efficient manner. No direct impact related to sort of the macro view and some of the unprecedented things that FDA is going through, and nothing material other than just continue to work through what is generally a very complex process, as you know, for PMAs in general.
Speaker Change: Good morning, Adam. Thanks, Thanks for the question Yeah, we we remain optimistic on the first half approval as we've previously noted and of course, we're building our resources appropriately to.
Speaker Change: Bill toward an effective launch following the approval.
Speaker Change: I would say that we've been having a very productive interactive approach with the FDA, which has been helpful. As has been the modular approach that we selected to take.
From the beginning allows us to.
Speaker Change: Organize the PMA submission in an efficient manner.
Speaker Change: No direct impact related to sort of the macro view in some of the unprecedented.
Speaker Change: Things that FDA is going through and nothing material or other other than just continuing to work through what is generally a very complex process as you know.
Speaker Change: For PMA in general and so we remain committed to that timetable.
Marvin Slosman: And so we remain committed to that timetable. Okay, perfect. That's great to hear.
Speaker Change: Yes, okay, perfect that's great to hear.
Adam Meeder: And, you know, for the second question, You had some comments in the prepared remarks around Sea Guardians 2 and 3, but wanted to go a little bit deeper there. So in terms of Sea Guardians 2 enrollment, sounds like that's going well. In terms of timing for integration into the competitor neuroprotection system, is that still tracking to early 26? And then for the second part of the question, Sea Guardians 3 sounds like you're going to initiate that study in Q2 of this year. are, you know, is first half 26 still a good assumption for switchguard approval and launch in the US and then one more.
Speaker Change: For the second question.
Speaker Change: You had some comments in the prepared remarks around <unk>, two and three but wanted.
Speaker Change: So a little bit deeper there so in terms of C. Guardians two enrollment it sounds like thats going well.
Speaker Change: In terms of timing for integration into the competitor.
Speaker Change: There are protections just is that still tracking to early 'twenty six.
Speaker Change: And then for the second part of the question.
Speaker Change: She guardians three it sounds like Youre going to initiate that study in Q2 of this year.
Speaker Change: Sure.
Speaker Change: It's first half 'twenty six still a good assumption for switch guard.
Speaker Change: <unk> launch in the U S and then one more thanks.
Marvin Slosman: Yeah, so to answer the first question, Adam, enrollment is going well. And we're holding the timeline related to that supplement being approved in early 26 for commercial launch. We're still very enthusiastic about the feedback that we've received from the physicians using the product and look forward to entering the TCAR space with that strategy. So everything remains on track related to that piece. And for the second part, timeline also remains consistent on switch guard. And in the second half of 2026, again, we're anticipating an approval and initiating enrollment. Many of the same sites and physicians are going to be both enrolling in both of those.
Speaker Change: Yes, so to answer the first question to Adam enrollment is going well and where we're holding the timeline related to that supplement being approved in early 'twenty six for commercial launch we're still very enthusiastic about the feedback that we've received from the physicians using the product.
Speaker Change: And look forward to entering the T car space with that strategy. So everything remains on track.
Speaker Change: Related to that piece and for the second part a timeline also remains consistent on switch guard.
Speaker Change: In the second half of 2026 again were anticipating an approval and initiating enrollment.
Speaker Change: Many of the same sites and physicians are going to be both.
Speaker Change: Enrolling in both of those and so where.
Marvin Slosman: And so we're, we're enthusiastic and optimistic for both of those entries as we get closer to the TCAR space.
Speaker Change: We're enthusiastic and optimistic for both of those entries as we get closer to the CCAR space.
Marvin Slosman: Okay, fantastic. And Marvin, sorry, just one clarification for SwitchGuard. First half 26 approval and launch or second half? Second half, sorry, I was referring to initiating the trial part of this in the first half of twenty-five, I guess, had my years mixed up.
Okay, Fantastic and Marvin sorry, just one clarification for switch guard.
Speaker Change: First half 'twenty six.
Speaker Change: <unk> on launch or second half 'twenty six.
Speaker Change: Second half sorry, I was referring to initiating the trial part of this and in.
Speaker Change: The first half of 'twenty five I guess had my years mixed up.
Speaker Change: Okay.
Craig Shore: And, you know, just one last one on the guidance front. Yeah, let me I'll take a pass at that.
Speaker Change: And just one last one on the guidance front.
Speaker Change: Well, sorry, I know you don't give guidance, but just wanted to ask.
Speaker Change: How youre thinking about the business at a high level the international businesses has done well probably doesn't get enough attention.
Speaker Change: Obviously, a lot of the focus on the U S and are getting closer and closer there but.
Speaker Change: How do we think about the business at a high level for 25 U S versus O U S. Just any color you could offer up there would be much appreciate it. Thanks again.
Speaker Change: Yeah, I mean, I'll take a pass at that and of course, you've got <unk> in the room here. So he can certainly offer color to that as well the O U S business continues to be strong and growing and we continue to focus our resources around that established market. It provides us a tremendous amount of value at many different levels.
Marvin Slosman: And of course, we've got Shane in the room here. So he can certainly offer color to that as well. The OUS business continues to be strong and growing. And we continue to focus our resources around that established market. It provides us a tremendous amount of value at many different levels. The shift toward the US focus will obviously continue. But the second half post approval of 2025 is really a foundational building time for us. We're getting, you know, new reps into territories, we're having to go through, you know, administrative VAC committees and otherwise. So I would sort of think about this as a foundational building time as we get through the second half of 25.
Speaker Change: This shift towards the U S focus will obviously continue but the second half post approval of 2025 is really a foundational building time for us we're getting new reps in the territories, we're having to go through.
Speaker Change: Administrative vac committees and otherwise so I would sort of.
Speaker Change: Think about this as a foundational building time as we get through the second half of 'twenty, five and and so we can get level set into 26. We're also building our commercial team with a pretty predictable cadence of training classes in Onboarding reps.
Adam Meeder: And, and so we can get level set into 26. We're also building our commercial team with a pretty predictable cadence of training classes and onboarding reps. So we we hope to take full advantage of the enthusiasm of Sea Guard Prime, and what the market has indicated, but at the same time have to remain realistic about how quickly we can actually get, you know, into hospitals and into cases. And we, of course, want to follow a very predictable approach to how those cases perform. Thank you. That's helpful. Thank you.
Speaker Change: We hope to take full advantage of the enthusiasm of C Guard Prime and what the market has indicated but at the same time have to remain realistic about how quickly we can actually get into hospitals and into cases, and we of course want to follow a very predictable approach to how those cases performed.
Speaker Change: Okay go ahead.
That's helpful. Thank you.
Speaker Change: Thank you and as a reminder, ladies and gentlemen that is star one for a question. We'll take our next question from Frank Jackman with Lake Street Capital markets. Please go ahead.
Unknown Executive: And as a reminder, ladies and gentlemen, that is star one for our question.
Frank Tachman: We'll take our next question from Frank Tachman with Lake Street Capital Market. Please go ahead. Alright, thanks for taking the questions. Congrats on the progress.
Frank Jackman: Alright, Thanks for taking my questions. Congrats on all the progress maybe.
Marvin Slosman: Maybe to start on kind of the commercial launch process of things, is there anything you can be doing with the value analysis committees today to start preparing for launch? And then kind of a separate but related question, once you are launched and on the market, maybe speak to kind of expectations around adoption at a specific site. Do you feel like they test it for a quarter or two? Or do they kind of jump in two feet first, given the clinical data that's out there and kind of shift over their whole business in one swoop?
Frank Jackman: Maybe just start on kind of the commercial launch process of things is there anything you can be doing with the value analysis committees today to start preparing for launch.
Frank Jackman: And then kind of a separate but related question. Once you are launched and on the market and maybe speak to kind of expectations around.
Adoption at a specific site do you feel like the test it for a quarter or two or do they kind of jumped in two feet first given the clinical data that's out there and kind of shift over their whole business in one swoop.
Shane Gleason: Good morning, Frank.
Good morning, Frank I'm going to let Shane handle that one.
Shane Gleason: I'm going to let Shane handle that one. Thanks, Marvin. Good morning.
Speaker Change: Thanks, Marvin and good morning, excuse me good morning, Frank.
Shane Gleason: Excuse me. Morning, Frank, and Adam.
Shane Gleason: So I think this is one of those places where I use a phrase I might overuse, which is all politics is local. And different hospitals act differently. What we can't do is go out and promote a product at this point. But as Marvin mentioned, we had our first cohort of salespeople go through training last week. And they are armed with some really good claims data in terms of knowing about fishing where the fish are, they know where the procedures are happening. And we're hiring people that have long standing relationships, knowledge of these accounts, who can start to, who can start to form their position in line for back reviews.
Speaker Change: Adam So I think this is one of those places where I use a phrase I might overuse, which is all politics is local.
Speaker Change: The different hospitals act differently.
Speaker Change: What we can't do is go out and promote our products at this point, but as Marvin mentioned, we had our first cohort of salespeople go through trading last week and they are armed with some really good claims data in terms of knowing.
Speaker Change: About fishing, where the fish are they know where the procedures are happening and we're hiring people that have longstanding relationships knowledge of these accounts, who can start to who can start to form their position in line for back reviews. So most hospitals will not consider a product in <unk>.
Shane Gleason: So most hospitals will not consider a product until it's approved. But we know when their next meetings are over the course of the next months and quarters. So in many cases, we're able to kind of hold a place in line, so that upon approval, we won't then be queuing up at the back of the line for consideration. So that's probably the best thing we could be doing at this point is holding our place so that we're closer to consideration at the time of approval.
Speaker Change: Its approved but we know when their next meetings are over the course of the next months and quarters. So in many cases, we were able to kind of hold their place in line so that upon approval.
Speaker Change: We will then be queuing up in the Bakken line for consideration. So that's probably the best thing we can be doing at this point is holding our place so that we're closer to consideration at the time of approval.
Shane Gleason: On the question about whether people will dabble or jump right in, again, it'll be a little bit of both, but we're seeing a lot of enthusiasm. We've been going to conferences for a couple of years here with this product. The data is becoming more and more understood, and there's more excitement about a next-generation dual-layer mesh-covered stent entering the market. So there are a lot of people at Sight Unseen have told us that they're excited to start using it and using it all the time. And of course, it's our job to go out there and solidify that and make that happen.
Speaker Change: On the question about whether people will dabble or jump right and again it'll be a little bit of both but we're seeing a lot of enthusiasm we've been going to conferences for a couple of years here with this product that data is becoming more and more understood and there is more excitement about our next generation.
Speaker Change: Dual layer mesh covered stent entering the market. So there are a lot of people with sight unseen have told us that they are excited to start using it and using it all the time.
Speaker Change: Of course, it's our job to go out there and solidify that and make that happen.
Shane Gleason: Okay, that's helpful. Appreciated the comments around the commercial infrastructure. I think you mentioned 14 personnel on boarded so far, and then you reference kind of a steady cadence of new additions.
Speaker Change: Okay. That's helpful. Appreciate the comments around the commercial infrastructure I think you mentioned 14 personnel on board and so far and then you referenced kind of a steady cadence of new additions.
Shane Gleason: Can you just maybe bring us a little bit into the split of that 14 of territory managers versus regional managers, and then that cadence of new rep and territory manager additions going forward? Yeah, so so we've got 13 people that were in here last week. And that includes the first four sales directors. West, Central, Northeast, Southeast, and it's their job to build the team going forward. So the rest of those are individual contributors. And that's where we'll continue our staffing for the balance of the year, both in territory manager and clinical specialist positions. Okay, that's helpful.
Speaker Change: He brings us a little bit into the split of that 14 of territory managers versus regional managers, and then that cadence of new scripts and territory manager manager.
Speaker Change: <unk> going forward.
Speaker Change: Yes. So we've got 13 people that were in here last week.
Speaker Change: And that includes the first four sales directors.
Speaker Change: <unk>.
Speaker Change: West Central northeast southeast and as their job to build the team going forward. So the rest of those are individual contributors and thats, where we will.
Speaker Change: Continue our staffing for the balance of the year, both in territory manager and clinical specialist physicians.
Speaker Change: Okay. That's helpful. And then just final one for me I was hoping I know you're not providing any guidance on the topline but was hoping you can maybe speak anecdotally to the opex structure.
Craig Shore: And then just final one, for me, was hoping, I know you're not providing any guidance on the top line, but was hoping you can maybe speak anecdotally to the OPEX structure as we as we go forward.
Speaker Change: Structure as we go forward, obviously, theres a lot of commercial hiring but.
Craig Shore: Obviously, there's a lot of commercial hiring, but how should we think about OPEX growth throughout 2025? Yeah, hi, it's Craig Shore, the CFO. As Shane just mentioned, there'll be significant growth in the sales organization, of course, through the hiring of the territory managers and sales reps. But we also will have growth in the R&D area as well. We're doing Sea Guardians 2, Sea Guardians 3, and we still have completion of Sea Guardians 1 and the PMA submission costs associated as well. So you will continue to see growth in the operating expenses. Okay, that's helpful. Thanks for taking the questions.
Speaker Change: How should we think about opex growth throughout 2025.
Craig Shore: Yeah, Hi, this is Craig shore the CFO.
Craig Shore: As Shane just mentioned there'll be significant growth in the sales organization of course due to the hiring of the territory managers and sales reps, but we will also we will have growth in the R&D area as well, where do we see guardians two cigar and <unk> three and we still have completions. The guardian's won in the PMA submission costs associated.
Craig Shore: As well so you will continue to see growth in the operating expenses.
Speaker Change: Okay. That's helpful. Thanks for taking the questions.
Unknown Executive: Thank you.
Speaker Change: Thank you and next we'll go to Richard Nesbitt with inspire M. D. Please go ahead.
Richard Nesbitt: And next we'll go to Richard Nesbitt with InspireMD. Please go ahead. I have one simple question for whoever wants to answer it. On a scale of 1 to 10, what are your expectations of meeting your goals for this year? Oh, our expectations are always 10. They were made inconsistently. We're always shooting for the top to meet the expectations we set for the group. That's all I wanted to know. You feel very positive about all that you're projecting. Am I correct? Indeed. Okay, thank you. Thank you. Perfect.
Richard Nesbitt: I have one simple question for whoever wants to answer it on a scale of one to 10, what are your expectations of meeting your goals for this year.
Richard Nesbitt: So our expectations are are always 10.
Richard Nesbitt: They were may and consistently.
Richard Nesbitt: We're always we're always shooting for the top to meet meet the expectations, we set for the group.
Richard Nesbitt: That's all I wanted to know.
Richard Nesbitt: You feel very positive about all with all of that Youre projecting.
Speaker Change: Am I correct.
Richard Nesbitt: Indeed.
Richard Nesbitt: Okay.
Richard Nesbitt: Okay. Thank you.
Richard Nesbitt: Thank you perfect.
Marvin Slosman: And now that our Q&A session has ended, I will now turn the call back over to Marvin Slosman for closing remarks. I'd like to thank everyone for joining the call and for the ongoing support of our mission to lead the carotid revascularization market. We're very pleased with our execution in 2024 and look forward to the many milestones ahead in 2025, including the potential U.S. approval and launch of C-GARD Prime. We believe InspireMD is uniquely positioned to transform stroke prevention by addressing vast unmet need with our differentiated technology and strong clinical foundation. With a clear path to market expansion and a commitment to improving patient outcomes, we believe the company is well equipped to drive meaningful impact for patients and providers alike, and we're excited for the opportunities ahead and remain committed to advancing care in this space.
Speaker Change: Now that work we own a session has ended I will now turn the call back over to Marvin salesman, it with for closing remarks.
I'd like to thank everyone for joining the call and for the ongoing support of our mission to lead the crowd to Revascularization market. We're very pleased with our execution in 2024 and look forward to the many milestones head in 2025, including the potential U S approval and launch of <unk> Prime we believe inspire MD is uniquely positioned to transform.
Speaker Change: Stroke prevention by addressing vast unmet need with our differentiated technology and strong clinical foundation with a clear path to market expansion and our commitment to improving patient outcomes. We believe the company is well equipped to drive meaningful impact for patients and providers alike, and we're excited for the opportunities ahead.
Speaker Change: And remain committed to advancing care in this space. Thank you.
Marvin Slosman: Thank you.
Unknown Executive: Thank you ladies and gentlemen, that does conclude today's conference. We appreciate your participation.
Speaker Change: Thank you ladies and gentlemen that does conclude today's conference. We appreciate your participation you may disconnect at any time.
Unknown Executive: You may disconnect at any time.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Yeah.
Yes.