Q3 2025 InspireMD Inc Earnings Call
Good morning and welcome to inspires MD third quarter 2025 earnings conference. Call currently all participants are in a listen-only mode. We will facilitate 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 a webcam Bull from Gil. Martin group for introductory disclosures, please go ahead.
Thank you for joining us for the entire MD, third quarter 2025 conference call joining us today from Inspire MD, our Marvin Slauson chief executive officer, Mike Lawless Chief Financial Officer and Shane Gleason Chief commercial officer.
During this call management will make forward-looking statements, 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 risks factors described in Inspire MDS. Most recently filed periodic report on form, 10K and form 10 Q or any updates in its
current reports on form AK 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, November 4th, 2025,
Except as required, by law, Inspire, and the disclaims, any obligation to publicly update, or revise, any information to reflect events or circumstances that occur after this call.
It is now my pleasure to turn the call over to Marvin. Slauson chief executive officer. Marvin. Please go ahead.
Thank you and good morning everyone. I'm pleased to welcome you. To today's call joining me. On the line is Mike Lawless our Chief Financial Officer and chain Gleason. Our chief commercial officer
we are dialed in live from Vive the vascular Interventional advances conference in Las Vegas, where we're hosting many conversations on the introduction of car Prime, following our approval in June,
I will share more on our Market traction shortly, but want to start.
With a detailed overview of the results of the third quarter.
I'm happy to share that our business is advancing with velocity and intention.
In the third quarter, we reached 2.5 million in total revenue representing year-over-year growth of 39% and sequential growth of over 40% since the last quarter.
Our growth was driven by strong early momentum in the US and continued demand for our seagard stent platform in internationally.
Our strong performance was the result of months of significant internal preparation which positioned us to hit the ground running upon the FDA approval.
Following approval, which we received in late June, our team immediately activated our planned commercial efforts in the United States in July.
When we say commercial activation, we mean a focused and deliberate effort to make sure that our devices accessible to us providers and their patients who are at risk of stroke.
And are working through value analysis, committee, approvals, contract completions and case initiation.
We are building traction, methodically with the goal to drive sustainable penetration.
And growth in the market.
Demand for cigar Prime has been strong as of today. We've completed more than 100 cases in the US. And many of these procedures were performed within some of the largest idns in the country.
The demand and excitement for our technology, reflects the foundational work. We've done over the years establishing value and awareness for our best-in-class clinical results.
Globally. We are. Now approaching 70,000 stances sold to date as the Karate Interventional Market, shifts to a stent first approach.
We believed the established CMS reimbursement.
Combined with our Innovative protective mesh stent, design evidence, and Real World Experience, provide a pathway for us to lead the crowded Market.
We are equipped with High Caliber sales leadership and clinical support reflected in the remarkable progress. Our group has made in just a few months post to FDA approval
Their deep experience in vascular markets, and established relationships with Physicians and administrators combined with the best-in-class implant forms. The backbone of our early and Progressive success.
The team is tasked with our commitment to expanding treatment to the vast patient population who could benefit from our technology.
As a reminder, over 3 million, people globally are diagnosed with carotid artery disease. Yet only approximately 400,000 are treated annually.
This massive gap in treatment leaves patients vulnerable to catastrophic stroke events.
Seagard Prime aims aims to redefine success for these patients and their providers. By lowering the risk of strokes and other major Adverse Events to levels, never achieved with first generation stenting or surgery validated with rigorous evidence. Proven clinical results, reimbursement, and real world outcomes,
As I mentioned earlier, we are living the excitement of our technology firsthand here at Viva.
Today, we're here in Las Vegas with many members of our team and board of directors. Engaging with our physician Partners in Champions, as we continue to launch seagard, Prime in the US.
The energy of our commercial facing teams in the unmistakable. Momentum around endovascular intervention gives me incredible optimism for the future of our company.
Before I provide a detailed update on our clinical trial work, I wanted to take a moment to welcome our new chief medical officer, Dr. Peter sukus Dr. Sukus will oversee clinical and medical topics.
Further building on our best-in-class data as well as advancing awareness of our technology stent platform to The Physician community.
This transformational time for KRA intervention requires continually building, a world-class team and support and Dr. Sukus will be a tremendous contributor to our work ahead. We're thrilled to have Dr. Sukus join as our CMO
Now to the clinical pipeline, a critical piece of our long-term growth strategy, we continue to advance multiple programs in clinical studies as we work to expand our reach of our technology by building clinical evidence potentially unlocking additional Market opportunities.
Starting in par with C Guardians 2, which evaluates a short tar, indicated version of siegward prime designed to be compatible with neuro protection systems that are already in use in the field today. I'm pleased to report that we're on track to complete enrollment by the end of the year and potential approval anticipated in mid 2026.
Simultaneously. We're advancing sea Guardians 3, the next phase of our tar strategy, evaluating our fully integrated tar solution, combining the siegward prime 80 stent with our proprietary switch Gardener or protection system.
This study is designed to showcase the full potential of our purpose-built solution for tar. Offering Physicians a comprehensive streamlined option that we believe can set a new standard in the field. We currently expect FDA clearance and launched in mid 2027,
The impact of these 2 studies highlights diversity, and clinical value of our platform and our expected to give us extremely competitive position in tar. A US market that already exceeds 30,000 procedures annually.
Complete.
It is inspiring to hear Physicians excitement for having an option to treat this critical need with our technology and a challenging patient population.
Let me also mention our awareness of the upcoming Crest 2 Data that's scheduled to be presented at the V and svin meetings in the coming weeks.
We believe the culmination and sharing of this data is another reminder of the advancement of awareness of crowded intervention, and the importance of decoupling categories of therapy with specific implant based performance to demonstrate the specificity and granularity of results.
Clinical outcomes have been redefined with best-in-class evidence with siegward implant across a large population. Sample of both symptomatic and asymptomatic patient. Cohorts measured in both short and long-term outcomes. The Baseline of nearly 70,000 implants sold in 2,000 patients studied in peer-reviewed to date speaks volumes to the validation of our exceptional results.
Our strong performance in the third quarter combined with the establishment of a robust commercial Foundation. Gives me tremendous confidence in our ability 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 for the third quarter of 2025 total revenue increased by 39% to 2.5 million. This increase was predominantly driven by the launch of siegward Prime in the US increased penetration of international markets with siegward.
And the favorable impact of foreign exchange.
Us revenue for the third quarter was 497,000 driven by the launch of siegward prime. This is the first quarter, we recorded us commercial Revenue, following the FDA approval in late June.
International Revenue for the third quarter was 2.0 million and increase of 223,000 or 12% compared to 1.8 million. For the third quarter of 2024, driven by increased usage in over 30 markets and the favorable impact of foreign exchange.
Those profits for the third quarter of 2025 increased by 450,000 or over 100% to 864,000 compared to gross profit of 414,000 for the third quarter of 2024, this increase in gross profit resulted from higher revenue and a favorable shift in sales makes towards higher margin revenue from our commercial launch in the US partially offset by higher production variances and training costs.
Gross margin increased to 34.2% of Revenue during the third quarter of 2025 up from 22.9% of Revenue. During the third quarter of 2024, we have been primarily by the previously discussed, favorable Revenue, mix and volume leverage of fixed operating costs
We expect to continue to expansion of gross margins in future quarters. As our commercial sales ramp in the US drives continued favorable mix.
In volume Leverage.
Total operating expenses for the third quarter of 2025 were $13.9 million, an increase of $5.0 million, or 57%, compared to $8.9 million for the third quarter of 2024. This increase was primarily due to higher hit count-related expenses as we continue to expand our U.S. personnel.
Particularly our commercial team to drive the US. Commercial launch of cigar prime, a second driver of the increase in operating expenses was occupancy and infrastructure expense related to the establishment of our US headquarters
Financial income decreased by 229,000 to 343,000 from 572,000 in the third quarter of 2024. This decrease was primarily due to a 118,000 decrease in financial income from investments in marketable, Securities and money market funds and a 104,000 increase in
Financial expenses related to changes in exchange rates.
Net loss of the third quarter of 2025 was 12.7 million or 17 cents per basic and diluted share compared to a net loss of 7.9 million or 16 cents per basic and diluted share for the same period in 2024.
As of September 30 2025 cash and cash equivalents in Marble Securities, were 63.4 million compared to 19.4 million as of June 30th 2025.
The increase in cash. Resources is a result of 2 financing events with significant impact during Q3
A new investors second. We raised gross proceeds of 17.9 million from the exercise of the second of 4. Milestone based financing tranches, pursuant to our May 2023, Equity private placement.
The exercise of the warrants was triggered by the receipt of pre-market approval from FDA for our siegward Prime kured stent.
The 2 remaining tranches, are triggered by Future Milestone events, including first, the completion of 4 quarters of commercial sales of siegward Prime in the US which we anticipate in the back half of 2026 and second receipt of FDA clearance for the switch card tar, neuro protection system along with tar indicated siegward Prime stent, which we expect during 2027.
Returning to our, our financial Outlook, we're encouraged by the initial traction for sales of siegward Prime in the US and the continuing solid performance of siegward internationally for the fourth quarter. We expect sequential growth in Us sales and steady demand. Trends internationally resulting in revenue of approximately 2.5 to 3.0 million in the fourth quarter.
When we report our fourth quarter 2025 results, we will share our 2026 growth expectations, informed by insights from an additional quarter of U.S. launch progress.
This concludes our
prepared remarks. We will now open the call for questions for the Q&A segment. We will be joined by Shane Gleason. Inspiring these Chief commercial officer operator.
You if you'd like to ask a question please press star 1 on your keypad to leave the Queue at any time, press start to once again, that's star 1 to ask a question and we'll take our first question from Adam meter with Piper Sandler, please go ahead. Your line is open
Hi, good morning, Marvin Mike, Shane. Uh, thank you for taking the questions and congrats on. Uh, the progress. Can you hear me, okay.
We can Adam. Okay, perfect. I was getting a little bit of feedback there. Um, you know, maybe just to start would love to hear a little bit more about the initial position feedback that you're getting from us. Customers that have
Started to use siegward prime. Um, and then the second part of that is maybe it's a little bit early but curious how siegward is being used in the doctor's armamentarium, you know, is this kind of being uh you know used as kind of like the Workhorse Kate sent for customers and then I had a couple follow-ups. Thanks.
Adam, thanks for the question. Um, we're really enthusiastic in in the uh response from Physicians. I think that there has been a buildup to anticipating siegward crimes launched in the US because of uh, our Baseline of experience outside of the US. And and we purposefully launched this product over the many years outside, the US to build a very solid foundation of of best-in-class, clinical data and Real World Experience. Um, as you know this this world operates globally and and it was no secret anticipating, you know, this this coming launch so we're very enthusiastic about it.
Um frankly, we're trying to make sure that we follow a very deliberate controlled approach to things uh, to get on top of all the, the opportunity that we see in front of us but to do it the right way. And and deliberate deliberately, um, we're following our Playbook that was designed for a Long View and leadership in this space with their ability over time. But so I think the early days even though um, you know it's it's 1 quarter of data. Um, really give us a lot of enthusiasm and encouragement. I'm going to ask Shane to kind of jump into the second part of your question. In terms of where this fits in the arm material of, you know, our customers across a pretty broad base of karate users.
Yeah, thanks for the question, Adam. The the excitement's been really strong and as we mentioned earlier, we're at the Vive meeting, we're at the TCP TCT conference last week, there are a number of other ones upcoming, and the team is in the field every day having these conversations. So, the products been very well received and a lot of the discussion at the meetings has been exactly that. Where does this fit in to people's? Uh, uh, carotid. Uh, tool toolkit and up until now they're, they're tended to be trade-offs between different stent platforms. Uh, a lot of AD advocacy, for being comfortable with both and open cell stent, and a closed cell stent for various anatomies.
Okay, perfect. Yeah, appreciate all the color there, guys. And you know for the next question
Was hoping to just go a little bit deeper um into US launch and and wanted to see if you could share some metrics.
You know, I guess more specifically. Um,
You know, device ASP versus, uh, volume in the quarter. Uh, number of accounts that have implanted sea guard at this point. And, you know, visibility around vac process for how we should think about onboarding accounts in Q4.
Thanks, Adam. I'm I'm gonna let change jump in on on those topics. Um, again early days and early data points, but I think thus far the expectations across that spectrum that you just mentioned, um, have been really encouraging, it's sort of above expectations, but Shane, do you want to
Jump in on this. Yeah, I I'll say in terms of pricing our approach has been that we are coming in at a premium to the market, but not a sign, a prohibitive 1, uh, the conversations that we have frequently are, that's, you know, our major adverse event rates are a half or a third of what the first generation sense have. So, we could have taken the approach that we're 2 or 3 times as good. So, we're going to charge you at 2 or 3 times as much, uh, price at like a drug code of balloon or a truck drug coated stance, uh, newly into the market. Uh, but we know that
While that may eventually get us on the Shelf in some places, it would likely limit adoption certainly to being a Workhorse product. So our communication is that we're, you know, we're we're requesting a, I'll call it a modest premium, something versus the cast and take our sense. Something is a hundreds of dollars, not thousands of dollars and, uh, saying that we want it to be a Workhorse set. We don't want it to be priced to the point where you only use it in case of emergency, you only use it in the worst of your worst cases, uh, but we want to be used in all of their cases. So, uh, yeah, I'd say a, uh, a more modest premium to the market which has been well received by physicians and administrators as well.
That's helpful and and just any any color on accounts? Yeah. Sorry. Go ahead please. Yeah, I was just, uh, gonna clarify the other questions so uh, and we mentioned that we, we've done over 100 cases uh, since launch. Obviously that number is growing every day. And um in terms of accounts open, are we
yeah, we we've had about a dozen reps in the field until until very recently and I'll say that we
On average opened, several accounts per rep, even in the first quarter, which, uh, oh, we've outpaced expectations where you kind of think, you know, vax and product committees tend to be measured in quarters to years, not weeks or months, uh, but we've actually had, uh, a lot of approvals in in months, and not quarters. And, uh, We've we've done cases in a lot of the key, idms around the US. So we've made a lot of traction there, in terms of, uh, opening accounts. Yeah, item. I would just add that, you know, this is, uh, foundational build for us. When we talk about activation, it's all of those things. But the benefit of having a team on the field at approval, uh, thanks to our, our Capital strategy was really important for us so that we could get into that activation mode quickly. And uh, we'll obviously benefit as that continues to mature.
Sure, um, totally makes sense and appreciate the color and just 1 last 1. If if I may sneak 1 more in just, you know, I think you just mentioned Shane. Um, you know, 12 reps in in the field in the US until recently. Can you just remind us kind of how we should think about?
The Salesforce expansion plan. As we get into, you know, this quarter Q4 as well as 2026. Uh, I'll leave it there guys. And congrats again, and thanks for taking the questions.
Yeah, absolutely. So what we've communicated last time that we have a US commercial organization, that was, uh, north of 20 people with most of them in the field. I mentioned the number of reps just a minute ago, but that then you add in the sales directors and clinical Specialists. Uh, We've were exiting this year with more than 30 again with most of them in the field. And uh, the addition since then have all been uh, territory manager, you know, customer facing sales roles.
And then, and then scale accordingly as we uh, as we get into and through 2026.
Thank you.
thank you and the
You limit yourself to 1 question and 1, follow-up. And we'll take our next question. From Frank Tech again with Lake Street Capital markets, please go ahead. Your line is now open
Great. Thanks for taking the questions. Congrats on the solid initial launch.
Um, I was hoping to follow up on. I think there was a guide right at the end of 2 and a half to 3 million. I think I heard that was for total business. Um can you maybe help us uh parse out. Oh, US versus us and that 2 and a half to 3 and apologies if I missed it.
Yeah, sure. Hi Frank. This is Mike. Yeah. The, um, the, the the breakdown of the guys, really consists of of stable International sales relative to Q3 with, um, with expectations for some growth in the US market in, in Q4.
Perfect. Okay.
That's helpful. And then, um, maybe 1 I know it's probably early days here, but any comments around those who have started to use it, how they are, how they are ordering product. Initially, are they starting with a few units and then reordering or are they putting a, a half dozen units on the Shelf? How are they? Uh, generally speaking ordering product to start
Yes, I'm Frank. I'll I'll jump in there and, um, hand it off to Shane for the back half of that question. So far, patient outcomes are great. Um, to send performance is great. We're thrilled by the fact that expectations are certainly being met and those 2 parameters, which is what's most important and uh, consistent with, you know, how we've done this globally and how the stent has performed uh globally. Uh, let Shane kind of answer the the general theme that we're following in terms of of how we're stocking shelves. Um, doing cases and most importantly, how the Matrix of our products fits well into the, you know, into the size expectations that are on on the Shelf. Yeah. Thus far our goal is spent to we want our team in the cases as we launch. This product 1 of the nice things about this space is that eventually that won't be the requirement. Uh we know that's a question of, do you build a model where you need to be present every single 1 of your cases? I'd say in the short term as we as we launched the product, we want to be present in those cases.
And, uh, then as we open things up going forward, we won't need to be. So what that spells is that we're, uh, not stocking stocking shelves and running away and hoping they use it when we're not there. But, uh, primarily run in the cases out of, you know, rep stock, uh, with reps present in the cases, uh, as we, uh, as we get started and we make sure that
the users in the accounts that could, uh, that could use at our, uh, trained and familiar with it before we, uh,
Leave a bunch of product on customer shelves. Yeah, Frank, I think it's all about utilization at this point. We want to make sure that this is the go-to product and it's utilized effectively as such.
Got it that's helpful. And then maybe if I can just sneak 1 1, last 1 in gross margin commentary. How should we think about where gross margins can go with uh scale?
Yeah. Well I I think that, you know, as I mentioned on the call, the Clear driver of that is the increasing uh, mix of of Us sales as we go forward into the future. Uh, as our volumes grow, we'll get some scale leverage, just some higher Revenue, but we'll also get the benefit of the much higher margin mix of sales in the US market. Um, and so, I mean, I think, at this point I don't I don't want to start getting forward guidance on on margins, but but suffice it to say that, as, as us becomes a larger and larger percentage of our Revenue, we would expect that our margins would approach a, a a, you know, typical medical device type margins.
Okay. That's a couple. Thanks for taking the questions.
Thank you at this time. We've reached our a lot of time for questions. We'll now turn the call back over to Marvin Sloan. Please go ahead.
I'd like to thank everyone for joining today's call and the continued support for our mission to lead, and transform the karate intervention Market. We're really proud of the strong performance, the team delivered globally in the third quarter and especially here in the us. And our first commercial quarter as we advance our activation efforts in accelerating momentum. If you happen to be here in Las Vegas at Vivo, stop by the booth. We'd be happy to see you and look forward to a great progress on on our business. Thank you.
thank you, this does bring us to the end of today's meeting, we appreciate your time and participation you may now disconnect