Q2 2025 InspireMD Inc Earnings Call
Good morning and welcome to inspire MD's. Second quarter, 2025 earnings conference call.
Currently all participants are in a listen-only mode. We will be Felicity Felicity.
Felicity, a question and answer session will take place 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 Marissa Bash with the Gil Martin Group for introductory disclosures.
Thank you for joining us for the Inspire MD, second quarter of 2025 conference call.
Joining us today from Inspire MD, our Marvin, klausman chief executive officer and Mike Lawless Chief Financial Officer
During this 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 and Inspire MDS. Most recently filed periodic, reports on form, 10K and form 10 Q. Or any other updates in our current reports on Form 8K, filed with the US Securities and Exchange Commission and Inspire MD's, press release that accompanies. This call particularly the cautionary statements made in it.
This call contains time-sensitive information. That is accurate only. As of today, August 5th, 2025.
Except as required, by law, Inspire and deep, disclaims, any obligation to publicly update, or revise, any information to reflect events or circumstances that occur after this call.
To Marvin schlossman, chief executive officer. Marvin please go ahead.
Thank you and good morning, everyone. We're happy to welcome you to today's call at this exciting and transformative moment for our company.
Before we review our recent progress in second quarter results, I'd like to take a moment to formally. Welcome Mike Lawless our new Chief Financial Officer.
Mike brings Decades of financial leadership and deep expertise to inspire MD, as well as a clear commitment to our mission. And to the patients we serve
I'd also like to thank Craig Shore for his contribution and dedication over the past 15 years.
His impact on the company's foundation and trajectory has been invaluable and is a big part of why we're here today.
Turning to our recent progress as a business. Today's call comes just about a month after we received FDA pre-market approval, for our siegward Prime corded stent system, the most significant milestone in our company's history to date.
We are now commencing on our us commercial launch leveraging. Our wealth of experience from over 30 us markets with over 60,000 patients treated to date.
To take the first step toward our mission of leading the US karate Interventional Market.
I want to take a moment to reiterate, what sets us apart as we step into this immense opportunity.
Our mission is clear to transform the karate intervention market and deliver best-in-class patient outcomes through a stent first approach.
Over 3 million, people globally have been diagnosed with corded artery disease. With countless others remaining undiagnosed while only 1505 thousand are treated annually in the United States.
These patients are at risk of stroke with deadly and profound, debilitating outcomes.
We've invested years of effort and expertise to build an Innovative stent platform. Siegward Prime that redefined success for these patients and their providers, by lowering the risk of strokes and other major Adverse Events to levels, never achieved with stenting or surgery as validated with rigorous evidence. Proven clinical results and Real World experience,
We are the first company to invest in the broadest toolkit of crowded procedures supporting both cored artery stenting, known as Cass, and transcoded artery revascularization, known as Tacar, with an implant-first procedure or agnostic strategy.
Our approach is resonated strongly with Physicians, who are eager for Innovation to improve outcomes and practice performance while addressing the full scope of karate intervention.
In 2023 a CMS shift further. Catalyzed this opportunity positioning stenting as the emerging go-to treatment.
We've built a strong Foundation to capitalize on this shift with a world-class team. Solid infrastructure and a sizable balance sheet all. Fueling our momentum.
Thanks to our investors confidence in our strategy and plan.
We were funded and well prepared to commercialize at approval.
We're now building Traction in velocity to create and capture market demand.
At the core of our business. We have a stent platform, delivering Next. Level outcomes. Ready to transform the vascular Market.
With the assets, we've built the evidence, we've generated, and the team we've assembled. We are now well positioned to execute our us launched, with Excellence to drive growth expansion and shareholder value.
Turning to our launch progress in recent weeks, we've begun to strategically, execute our commercial Playbook and many US centers. Our sales team is taking a methodical approach, leveraging, claims, and Market data to Target accounts.
Early interest has been strong. As we navigate Value analysis, committee approvals and educate providers about our differentiated stance system.
As of today, we've successfully completed approvals orders and Commercial procedures and numerous accounts and Hospital systems or reflection of the enthusiasm and demand.
We are not simply executing a product launch. We are laying the foundation to redefine the karate intervention Market.
A successful launch starts with the right team. And we are proud of the exceptional group. We've assembled our sales and clinical support Specialists. Bring deep experience in the vascular markets established relationships with Physicians and administrators, and a proven ability to launch Innovative product successfully,
Nationwide.
We continue to receive overwhelming interests from highly experienced professionals. Eager to join our team.
This is a testament to the demand and awareness of seaguar Prime in the field. The promise of the talent we've already attracted and the sizeable opportunity and a stent. First corroded intervention
Our team experienced the enthusiasm of our technology firsthand just a few weeks ago at the Society of neuro, Interventional, surgeries annual meeting the energy surrounding seaguar. Prime was unmistakable.
Our booth was a constant Hub of activity. Drawing the attention of many prominent us Physicians. Eager to learn more about how our Innovation can transform karate care.
Time. And again, we're hearing from doctors who are genuinely excited to offer this technology to elevate the standard of care and improve the lives of their patients.
Moments like this reinforced our conviction and our technology.
And in our mission.
We have built the infrastructure assembled, the team and developed the operational Readiness to execute this launch with excellence and we look forward to updating you all on our progress as we move through Foundation. Building toward more, robust commercial scale, over the coming quarters,
Turning now, to our clinical pipeline, a critical component of our long long-term growth strategy, we continue to make steady progress on multiple fronts as we work to expand the reach of our technology.
Build clinical evidence and unlock the additional Market opportunities.
First, I'll update you on our pivotal studies in tar.
And see Guardians 2. We are evaluating siegward Prime in a catheter designed for tar. Procedures used with neuro protection systems that are already used commercially today. This study is designed to demonstrate the safety and effectiveness of sear, Prime and tar procedures and to open this important segment of the market to our platform.
we received FDA IDE approval, to initiate the study in late 2024, and I'm pleased to report that enrollment continues at a good Pace as we continue to work toward first, half of 26 approval,
At the same time we're advancing next phase of our tar, strategy with C Guardians 3 which evaluates our fully integrated tar solution. Combining a siegward prime 800 stent with our proprietary switch Gardener or protection system. This study is designed to showcase the full potential of our purpose-built solution for tcar offering physicians at comprehensive streamlined option that we believe can set a new standard in the field.
Given the variability of timeline surrounding clinical enrollment in FDA review. We Now anticipate clearance and launch in 2027
Together, these two pivotal studies are designed to strengthen our competitive position in the U.S. market, which already exceeds 30,000 procedures annually, and to demonstrate the versatility and clinical value of our differentiated platform.
we're also making progress in expanding the potential use of our technology into acute stroke care. Particularly our tandem lesion early feasibility study which were conducting in partnership with Dr. Adnan sadiki at the Jacobs Institute in Buffalo, New York, this study evaluates the use of seaguar prime and acute stroke patients with tandem lesions in conjunction with thrombectomy. These are highly complex high-risk cases, where embolic protection is critical and we believe our proprietary and micronet mesh technology is uniquely suited to deliver Superior outcomes in this setting.
To date enrollment is roughly halfway complete, initial physician interest underscores, the unmet need and potential impact of our technology in this challenging patient population.
Each of these clinical initiatives, reflect our commitment to advancing the standard of care and carotid and neurovascular disease, building evidence to support our differentiated portfolio and unlocking new Pathways for growth.
We believe our dual focus on CF and tar. Positions us to serve the broadest space and Physicians, while leading the shift toward a stent, first standard of care.
Before I turn the line to mic to review our Q2 performance, I want to highlight 2 major recent achievements that strengthen our balance sheet.
Last week, we successfully entered into a Securities purchase agreement with a group of leading institutional investors, raising 40.1 million dollars in Gross proceeds through a private placement.
In addition, we raised 17.9 million from the exercise of warrants that were triggered by FDA approval of siegward prime.
This is the second trunch of warrants that were originally issued as a part of the company's Milestone, based financing announced in May of 2023.
Art Prime in the US market.
First, they deepen the commitment of several of our largest existing shareholders while expanding our investor base with the addition of high-quality investors.
Second, a significant strengthening of our cash position.
Collectively bolstering, our Resources, by over 58 million. In proceeds, allowing us to invest in the commercial scale necessary to achieve key growth, milestones and execute toward long-term profitability. Now, we are even more confident in our ability to scale us commercial operations, effectively and position, Inspire MD to deliver, meaningful growth and value over the coming quarters and years.
Now, I'll turn the call over to Mike to walk us through the financials. Mike
Thanks Marvin. Before I begin. I'd like to briefly say how excited I am to join Inspire MD at such a pivotal moment in the company's trajectory. It's a tremendous opportunity to contribute to a team that's driving meaningful progress.
And I look forward to supporting our continued growth and success.
With that, let's turn to the second quarter results.
The second quarter of 2025 total revenue increased by 2% to 1.8 million.
This increase was predominantly driven by increased usage in our International markets, from the continued adoption of seaguar, technology and the positive impact of Foreign Exchange partially upset by decreased revenue from Russia and European Distributors. Managing siegward inventory levels in anticipation of the siegward Prime launched in Europe.
As expected, we did not recognize commercial Revenue in the US in Q2 as our FDA approval came in the last week of the quarter. However, we have done directing recognize us commercial sales. This quarter positioning us for sequential Revenue growth in Q3 and Beyond.
Our Q2 volumes add to the growing body of real world World Experience globally. We have sold more than 60,000 implants, to date the track record, reinforces our expertise validates. Our Innovative platform and highlights the strength of our global commercial infrastructure, all of which positioned us. Well, as we shift our Focus to the significant us opportunity,
gross profit for the second quarter of 2025 decreased by 18,000 or 5.7% to 313,000, compared to a gross profit of about 331,000 per second quarter of 2024.
This decrease in gross profit. Resulted from an increase in production variances partially offset by lower material and labor costs.
Gross margins decreased to 17.6% during the 3 months ended June 30, from 19.0% during the 3 months ending June 30, 2024, driven by the above factors.
Total operating expenses for the second quarter of 2025 were 13.3 million, an increase of 4.7 million or 55% compared to 8.6 million for the second quarter of 2024.
This increase was primarily due to increase in headcount related expenses as we continue to expand. Our us Personnel, particularly our commercial team to support the commercial launch of siegward Prime in the United States.
Can drive over our Opex, increase was occupancy and related expenses, related to the establishment of our US headquarters.
Financial income decreased by 483,000 to 132,000 of financial expense.
From 351,000 of financial income for the second quarter of 2024.
This decrease was primarily due to a 313,000 increase in financial expense related to changes in exchange rates and a 169,000 decrease in financial income from investments in marketable, Securities and money market funds.
Net loss for the second quarter of 2025 total 13.2 million or 26 cents per basic and diluted share compared with a net loss of 7.9 million or 22 cents per basic and diluted share for the same period in 2024.
As of June 30th 2025 cash and cash, equivalents and marketable, securities or 19.4 million compared to 26.1 million as of March 312022.
The June 30th cash balance does not include the 58 million. Gross proceeds from our previously mentioned financing events.
As mentioned about the receipt of pre-market approval from the FDA triggered. The second of 4 milestone-based financing tranches pursuant to the transformational private placement of up to 1, 1 3. 6, 6
Additional tranche financings, including 1, to completion of 4 quarters of commercial sales of siegward Prime in the United States, which we anticipate in the back, half of 2026 and 2 receipt of FDA clearance. For the switch group ecar neuro protection system along with the tar indicated siegward Prime stent.
While we are not providing guidance at this stage for our commercial launch, we look forward to sharing more about our progress, in Outlook, when we report our 23 results, please keep in mind that while we are excited about the opportunity ahead, we know that a strong adoption trajectory will not be achieved overnight.
We are executing a methodical launch to Marvin's earlier comments, and we'll spend the next few months laying the foundation for robust future expansion.
This concludes our prepared remarks, we will not open the call for
The Q&A segment, we will be joined by Shane Gleason. Inspiring these Chief commercial officer operator.
Thank you at this time. If you would like to ask a question, please press star and 1 on your telephone keypad. You may remove yourself from the Queue at any time by pressing star and 2. Once again that is star and 1. If you would like to ask a question in the interest of time, we do ask that you limit yourself to 1 question and 1 follow-up. We'll take our first question from Adam meter with Piper Sandler, please go ahead. Your line is now open.
Hey, good morning. Uh, thank you for taking the questions and congrats on the progress and uh to you Mike welcome and Craig wishing you. Uh the best in the in the future.
Um 2 for me. And I, I guess I'll start with the first 1, which is a little bit of a myopic question, but I just wanted to see if there's any more detail that you can share regarding your progress with us account openings, since FDA approval for seaguar. Prime in late June,
And you know, if we think about subsequent quarters and and even 2026 for that matter, are there any Targets or framework that you want to provide for the street? As we think about kind of initial launch whether that's Revenue market, share number of accounts, Etc. And then I did have 1 follow up. Thank you.
Uh, hi. I'm just saying I'll go ahead and start that 1 off and then maybe hand it off to, to Marvin for the second part of that. So we got our approval about 6 weeks or 6 weeks ago, this week, and we're really excited about the progress that we've made. Uh, as we've noted previously, we have uh, commercial organization in the US of around 20 people with a great majority of them in the field.
We plan to continue scaling that we're we're planning on, adding roughly 10 people to that number by the end of the year.
Having that group on board at the time of approval. Let us hit the ground running. I think it's common to see 6 weeks into an approval that very little, if anything has has occurred in the way of cases, we've actually done procedures with double digit Physicians. And we've even reached the point of beginning to secure shelf space uh with stocking orders in a number of those accounts. So uh I'd say the early reception has been exactly what we'd expected and hoped it to be and uh we're off to we're off to A Healthy Start.
Adam. Yeah, this is Marvin. I I think Shane, um, framed it perfectly, uh, I think that the, the opportunity for us was in our May 2023 financing. We, we were able to, to fuel, uh, a commercial team, a game plan, and a Playbook that allowed us to, to hit the road when we had, uh, when we had approval and we will continue to build off that momentum, we certainly understand that there's headwinds involved with building administrative approvals and all the things associated with Readiness, and we have to have some patience in that regard. But, uh, I think overall, we've hired to the standard of being able to build access to these facilities and Physicians and so far as Jake, said the uh the receptionist has been overwhelming and we really appreciate the fact that you know the market is is receiving C guard Prime as well as they have.
Okay, perfect. That's uh, that's great color there. Thanks for that. Marvin and Shane and, um, you know, for the follow-up. I I did want to ask about C Guardians 3 and
witch guard, uh, your your provider T car device, you know, if I heard correctly in the prepared remarks,
You know, now expect clearance and launch in 27, you know, a little bit of a wiggle, uh, from from late 26, which I think was the prior expectation. Um, just wanted to, I guess kind of better understand, you know, what's, what's driving, the change in expected timelines, you know, is it related to device design? Is it pinning down? Clinicals strategy, and trial construction. Is it, is it something else?
And the confidence in in getting clearance in, in 27, thank you.
Adam, thanks. Um, so so just, let's go back as a reminder, of our overall team car strategy. It was built around the entry into the market with a tar indicated catheter, first to unlock the potential of the implant first, which is most sought after by The Physicians and remains Phase 1. Um, which is in line with our prior timelines switch. Guard was designed as a Next Generation platform for neurop protection. And as such requires, the entirety of the development process from design to production build. And in parallel, we, we've also considered the clinical enrollment aspect FDA, regulatory requirements, statutory timelines. All those kinds of things. So, we're progressing exceptionally, well, and all of these areas, but just believe that the timeline should reflect a broader window to clearance. Um, you know, there's variability in all of these aspects and bringing new products to Market. And we're just trying to expand the window to give us room to deal with, you know, the uncertainties of those aspects of
Of all of these launch parameters, but, uh, nothing other than that, trying to to be realistic and and compensate for that as you've seen in the past. Uh, we previously demonstrated that we'll continue to find passive lease resistance and deliver accordingly and um, and timelines in in our world. Uh, you know, remain as aggressive as we can and hopes that we can beat expectations.
That's helpful. Thanks. Marvin.
Thank you, we'll take our next question from Frank. Takyon with Lake Street Capital markets. Please go ahead. Your line is open.
Great. Thanks for taking the questions. Uh, congrats on all the progress. I was hoping you could, uh, refresh us on some account metrics. I know we've talked about it in the past how many, uh, high high potential accounts. Do you see out there? How many do you intend to Target with the initial sales footprint? And then how does that kind of roll out progress as you bring on more reps?
Yeah, thanks Frank. This is Shane again. So 1 of the nice things here is that karate instead I think is an established Market. We have claims data that shows, we know that there are roughly 60,000 annualized procedures and growing their performed by 4,000 physicians. In the US, uh, we have planned status showing who they are, or where they are, where they practice and what their volumes are.
So in terms of, you know, the old fish where the fish are and we're putting, we're hiring our team selectively and locations that have the highest density of procedures. We're targeting the Physicians that do above average number of, uh, procedures obviously, and the busier accounts. So, what we're tracking early on obvious 1 is revenue. The other ones are just physicians in every stage of our sales funnel. Who's, who's expressed interest? Who's in their value? You know, committee who's, uh, who is, uh,
Evaluating the product and where have we secured business. So we're tracking all of those, uh, metrics in the early stages. And, uh, there they're, they're tracking in the in the direction that we expected them to, to do.
Got it, that's helpful. And then maybe uh also uh, partially a refresher. And just to kind of update on the the broader Market, the 60,000 procedures you talked about, um, my understanding is that's uh, trans femoral as well as tcar in that number and then there's approximately another 100 thousand or so that are still being completed open or kind of the latest trends in that mix. And then how do you think about that, uh, that Trend towards an endo? Vascular. First mindset progresses over the next few years.
Yeah, that's exactly right. We see the trend where the where it used to be 70%, plus surgery, that Gap is closed to where it's now less than 60% surgery. And uh, with the 40% plus being said, based switched to your point could be transferable could be trans radial could be tar. And, uh, we see those Lines continuing to converge. So we expect within the next year or so that we'll likely reach a 50/50 point for the first time. And then, uh, in the coming years for corded intervention to look, just like every other vascular intervention, um, in the, in the US where there are products, there's reimbursement and an endo, first standard of care,
Churches. But in the short term, uh, the the goal is to find those that have a use for our for our cast, indicated steps and, uh, Target those, uh, in the early stages here.
Okay, that's helpful. Thanks for taking the questions.
We have reached the end of our question.
Marks.
Great. I'd like to thank everyone for joining the call today and your continued support of our mission to lead and transform the karate intervention Market. We're proud of the strong execution. We delivered in the second quarter of 25 and even more excited about the Milestones ahead. As we enter the critical first quarter of our us commercial launch of seagard prime.
With a differentiated technology, strong clinical foundation and a clear strategy to expand the market and improve outcomes. We Believe Inspire and be as uniquely positioned to reshape stroke prevention in the United States.
As we execute on this launch and build momentum, our focus remains on driving meaningful impact for patients, physicians, and shareholders alike. We're confident in our path forward and energized about the opportunity ahead to expand provider treatment options, advance patient care, and establish CGuard Prime as the standard for product intervention. Thanks for joining today.
Thank you. This does conclude today's program. Thank you for your participation. You may disconnect at any time and have a wonderful day.