InspireMD, Inc. (NSPR) Q4 2025 Earnings Report, Transcript and Summary

Good morning, and welcome to InspireMD's Fourth Quarter and Full Year 2025 Earnings Conference Call. [Operator Instructions] This call is being recorded for replay purposes. I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory disclosures.

Thank you for joining us for the InspireMD Fourth Quarter and Full Year 2025 Conference Call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer; and 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 risk factors described in InspireMD's most recently filed periodic report on Form 10-K and Form 10-Q or any updates in its current report on Form 8-K filed with the U.S. Securities and Exchange Commission and InspireMD'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, March 18, 2026. 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. 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, everyone. As I reflect on our performance over the past several quarters, I'm extremely proud of our team here at InspireMD and enthusiastic about the impact we are having on stroke prevention and the future of an endovascular standard of care, catalyzed by our breakthrough CGuard Prime carotid stent platform. Through the CGUARDIANS FDA clinical trial, along with our numerous multiyear studies of our CGuard implant, we have demonstrated unmatched clinical evidence reflected in the lowest adverse event rates and most durable stroke prevention, enabling our continued focus on achieving market leadership through a stent-first strategy. Becoming #1 in this highly competitive market will require strong operational, commercial and customer-focused excellence throughout our organization. To this end, we are focusing on operational expansion, establishing U.S.-based production, increasing our manufacturing capacity to keep pace with this growing U.S. demand. On the commercial side, we're building our coverage capacity and procedural support bandwidth. Since our approval in June 2025, we have architected, implemented and now accelerated the foundational requirements to deliver commercial sales in the U.S. market through VAC initiations and approvals, contract implementation, case completions and reorders, all building in our mission to dominate this space with our next-generation stent. Thus far, we are pleased with the physician support and pace toward these fundamental operational milestones, getting products on shelves and available to meet market demand. We met our 2025 objectives of building our U.S. commercial team to north of 30 people with the majority in the field, as we previously shared. We have now completed over 500 cases, gained approvals in some of the most prominent IDNs in the United States and established ourselves as the go-to device for many physicians who now have access to CGuard Prime. We remain committed to supporting the success of every procedure with strong case support and continuous improvement with the ease of use of our products. As I've stated previously, we have real-world experience with the CGuard stent in over 70,000 cases in our 30 OUS markets to date, which we are leveraging in our launch. As we have executed on our controlled rollout, we have observed opportunities to improve our delivery systems' technical success and enhance ease of use. We understand what is required to exceed our customer expectations, and we plan to introduce these improvements beginning in the fourth quarter. Now to our clinical pipeline and advanced indications for our CGuard implant, a critical piece of our long-term growth strategy. We continue to build on multiple programs in clinical studies as we work to expand the reach of our technology by leveraging clinical evidence, potentially unlocking additional market opportunities. Starting in TCAR with C-GUARDIANS II, evaluating CGuard Prime in a shorter delivery system, purpose-built for use in TCAR procedures and designed to be compatible with neuroprotection systems that are already in use in the market. I'm pleased to report that we have completed enrollment in this trial and submitted the request for approval to FDA, anticipating potential approval in Q3. This indication will boost our market opportunity for stent sales into the more than 35,000 current TCAR procedures annually. Simultaneously, we are rapidly advancing CGUARDIANS III, the next phase of our TCAR strategy, evaluating our fully integrated TCAR solution, combining the CGuard Prime 80 stent with our proprietary SwitchGuard Neuroprotection System. This study is designed to showcase the full potential of our purpose-built solution for TCAR, offering physicians a comprehensive, streamlined option that we believe can set a new standard in the field. We plan to begin enrollment in this study in Q2 with expected FDA clearance and launch in the second half of 2027. To recap expectations for 2026, we will deliver extraordinary quality and exceed expectations for our growing range of customers, build a sustainable foundation from which we can expand stenting market, utilize the CGuard's stent-first strategy to differentiate superior outcomes, serve the entirety of the market for all specialists treating carotid disease, boldly build a market-leading company worthy of lofty expectations from our customers and patients who benefit from our breakthrough technology. Finally, I would like to thank our entire team for their extraordinary commitment to our success, and I look forward to continuing to build our organizational strength with deep talent and expertise to advance our mission to prevent strokes and save lives. I'm incredibly excited about our future and look forward to sharing our progress over the coming year. Now I'll turn the call over to Mike to walk us through the financials. Mike?

Thanks, Marvin. For the fourth quarter of 2025, total revenue was $3.1 million, an increase of 62% compared to revenue of $1.9 million for the fourth quarter of 2024. This growth was driven by the launch of CGuard Prime in the U.S. and increased penetration of international markets with CGuard. U.S. revenue for the fourth quarter was $866,000, driven by the launch of CGuard Prime, representing 74% sequential growth versus the results of the third quarter. We are pleased with the trajectory of U.S. launch and anticipate continued progress in 2026. International revenue for the fourth quarter was $2.3 million, reflecting growth of 17% compared to $1.9 million for the fourth quarter of 2024. The majority of the international growth was driven by higher unit sales, while changes in foreign exchange rates contributed growth of about 7% to our international results. Gross profit for the fourth quarter of 2025 was $1.2 million or 37.5% of revenue compared to gross profit of $469,000 or 24.1% of revenue for the fourth quarter of 2024. This increase in gross margin resulted primarily from a favorable shift in revenue mix to U.S. sales, which carry a substantially higher margin than international sales. Our sales in the U.S. generated gross margins of about 70%, reflecting the strong pricing and value that we bring to our customers. Total operating expenses for the fourth quarter of 2025 were $13.3 million, an increase of $3.4 million compared to $9.8 million for the fourth quarter of 2024. This increase was primarily due to higher commercial staffing levels and marketing activities for the U.S. commercial launch of CGuard Prime. Financial income was $386,000, an increase of $134,000 compared to $252,000 for the fourth quarter of 2024, resulting from the increase in financial income from investments in marketable securities and money market funds. Net loss for the fourth quarter of 2025 was $11.8 million or $0.14 per basic and diluted share compared to a net loss of $9.2 million or $0.19 per basic and diluted share for the same period of 2024. As of December 31, 2025, cash and cash equivalents and marketable securities were $54.2 million compared to $34.6 million at the end of the prior year. As a reminder, we have 2 remaining milestone-based tranches pursuant to the private placement we closed in May of 2023. Each tranche provides gross proceeds of $17.9 million if fully exercised, and the remaining tranches are triggered by future milestone events. First, the completion of 4 quarters of commercial sales of CGuard Prime in the U.S., which we anticipate in the second half of 2026; and second, the completion of both the receipt of FDA approval for the TCAR indicated CGuard Prime stent, which we expect in the third quarter of 2026, and the FDA clearance of the SwitchGuard TCAR Neuroprotection System, which we expect in the second half of 2027. Turning to our 2026 outlook. InspireMD expects revenue for the full year 2026 to be in the range of $13 million to $15 million, reflecting growth of approximately 45% to 65% over full year 2025. We expect increasing sequential revenue growth in the second half of 2026 as our business gains momentum and U.S. sales growth accelerates from the anticipated label expansion by the FDA for the use of CGuard Prime in TCAR procedures and the introduction of the enhanced delivery system for CGuard Prime for use in CAS procedures. 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, InspireMD's Chief Commercial Officer. Operator?

[Operator Instructions] Our first question coming from the line of Adam Maeder with Piper Sandler.

Congrats on all the progress. A couple for me today, if that's okay. And maybe we could start on the guidance front. Mike, just trying to get a better understanding of the construction of the guidance that you put out for FY '26. Maybe you could kind of double-click on that, help us think through U.S., the U.S. business versus OUS. And then with the CGuard Prime integration into the Boston Silk Road system, what's kind of contemplated in the guidance from that new product launch? And then I had a couple of follow-ups.

Adam, thanks for the question. So first of all, for the OUS sales, we're continuing to expect sales that are in the range of what we've been able to perform in the last several quarters with some maybe some moderate growth there. So continued growing penetration of OUS markets. And then on the U.S. side, we're going to continue to sustain our controlled launch phase at this stage. So that would mean somewhat moderated growth in the U.S. for the first half. And then as we have those catalysts kicking in, in the second half, we would see some acceleration of the growth as a result of the anticipated TCAR indication, the anticipated enhanced clinical performance of the CGuard Prime for CAS, and then finally, just the maturing of approvals and contracts as we work through the VAC approval process.

That's helpful. I appreciate the color. And maybe a good segue into the next question, which is hoping for an update on kind of exactly where you stand from an account standpoint in the U.S. So looking for metrics like number of accounts, number of VACs that are in process, just trying to kind of take the temperature there, even if it's not explicit, just hoping to get kind of some broad strokes color around how that's progressing.

Yes. Adam, it's Marvin. I might hand that one off to Shane just to provide a little bit of color on that topic. Shane, if you don't mind grabbing that question.

Sure. So the questions around accounts and penetration, so we have done cases in -- and these are to date, not capped at Q4, but we've done cases in roughly 80 centers. And as we've mentioned, the VAC processes before, those are frequently not linear. So in some cases, there are evaluation cases before VAC approval. Sometimes the VAC approval has to happen before the first case can be performed. So that's kind of a mix of those, but 80-plus centers have done cases at this point, and tracking the number that are in our pipeline, there are north of 200 centers in the pipeline of -- between VAC and evaluation stage. So the team has been able to produce quite a lot of momentum. We have a lot in the funnel and the job is to drive them through the funnel and make them active ongoing customers from here.

Great. Very helpful color, Shane. I appreciate all that. And sorry, I know I'm asking a bunch of questions today. Just wanted to tick through some of these. Next, on the next-gen delivery system and enhanced ease of use. It sounds like you're targeting that for Q4 of this year. My takeaway there is that this is kind of opportunistic. It's an opportunity to make a great product even better versus like a pressure point or consternation from docs. But I wanted to confirm that is correct. And then what is needed from a regulatory standpoint to get the next-gen delivery system across the goal line?

Yes, Adam, thanks for that question. You're absolutely correct in your assumption there. Our CGuard stent is performing extraordinarily well as anticipated and consistent with all the work that we've done with 70,000-plus implants to date. When we launched the CGuard Prime with this differentiated new delivery system, we did so in a controlled manner to ensure that we're able to manage first use of this device in a market with new users unfamiliar with the delivery system and platform. So we intentionally sought feedback looking for areas to discover and improve, like all good companies do, and we'll continue to iterate and improve off of that feedback to ensure we're delivering these world-class technical success results to meet these -- the leadership goals for the company. So I think you're absolutely correct about your assumptions. And these fall into that continuous improvement approach that we'll continue to take. As far as submission is concerned, these are relatively minor changes, and we'll go to FDA in a 30-day review. So I think we're always looking for those opportunities to build more confidence into the delivery side of the device itself, but the implant is performing exactly according to plan.

Okay. Perfect. And if I could just ask one last one, I promise, I'll jump back in the queue. Just was hoping to better understand timing for the C-GUARDIANS II data specifically, when will we see that -- the data from that study as well as the CGuard cohort data from the CREST-2 trial. Just when should we expect those?

Yes, Shane, do you want to grab that one? I think you're probably latest up to date on the data.

Sure. So we have a slot that's been accepted at the Charing Cross Congress in the back half of April. That will be the first reveal of C-GUARDIANS II data. That will likely be the interim cut of the data, but it will be the first time that we see any of the clinical data from that trial.

Our next question coming from the line of Frank Takkinen with Lake Street Capital Markets.

Congrats on all the progress. I was hoping to start with a question around really account adoption and productivity metrics. So maybe first part of that, maybe any anecdotal patterns you can share when account does activate with CGuard, how are they first using the product? And have you seen any of your accounts really shift over to being an exclusive CGuard user? And then from a productivity standpoint, how should we think about how many accounts a rep can manage and maybe how many -- what peak productivity per account can look like over time?

Shane, do you want to grab that one, first part of it, and I can follow up?

Sure. Yes. So we have seen adoption. And I think the one thing that's important to our strategy is we know we have a premium product. We have priced it at a premium, but not at such a premium that we want it relegated to only be used in the most challenging cases. So our goal is to be able to become the everyday stent of the people who use it. And of those docs who have made it through the evaluation stage, we do have a growing number who are using it as their everyday stent. So that's the goal. When you look at what physicians perform, "the average" if you look at the number of procedures being performed and the number of physicians performing them, the average is somewhere in the neighborhood of 15 to maybe approaching 20 cases a year. So we really look at it more as how many cases can a rep support versus how many doctors or accounts can they support. So if the average physician does, by those numbers, 1 or 2 a month, if they're on the same day, you can cover them more efficiently than if they're spread out on separate days. So there's 20-plus selling days most months and our reps' goals are to be in cases darn near every working day and hopefully multiple cases in the same day. So we've got a lot of room to expand. And from there, it's just logistics.

Yes, Frank, let me expand on that a little bit as well. So we're taking a very deliberate approach to measuring productivity in the field as we build our commercial organization. We use a lot of claims data to measure and monitor that. So I think it's safe to assume that we're going to continue to be present in these cases to make sure that the experiences are those that we expect, and we'll be prepared to expand as we get to a productivity curve that looks to be reasonable as we need to grow the organization and build it out. But so far, we've been very pleased with that productivity ramp and we'll continue to watch that closely.

Very helpful. And then maybe following up on some of the points made in there. Appreciating case support is extremely important in the early days. Do you envision over a longer period of time, this is a product that can be on the shelf and just be the de facto stent that is used and not necessarily requiring rep support in every single case at a more mature state of the company?

Absolutely. Yes, I think there are different -- there are slightly different expectations in the market for when we get into the TCAR space, a higher percentage of those cases are supported by industry representatives than there are for the CAS cases. So we have a kind of model by specialty of what our expectations are. But absolutely, the goal is once someone is comfortable with the device to be able to have them have it on their shelf and use it when we're not around. We still like to be there to provide support, but we don't need to be the rate-limiting item there once physicians gain comfort with the system.

Perfect. And then the last one, any refresher you guys can provide on sales force hiring cadence would be great color.

Shane, do you want to grab that?

I can take it. So thanks, as the guys mentioned in the prepared remarks, we had last stated that our goal was to get to north of 30 people in the U.S. commercial organization by the end of the year with the majority in the field. We reached that. And at this point, our goal is to continue hiring opportunistically and selectively where we need increased penetration, where we need more support. But by and large, at this point, this is the group that's going to launch our first indication. Let this group kind of set down their roots, make their ways through those value analysis committees and processes. And then as we start to layer in additional indications when TCAR comes along, we expect that we'll probably pick that hiring back up. But our first goal was to get a somewhat uniform coverage of the major markets and let that group throw their roots down and climb that productivity curve that we've mentioned a few times now.

Our next question in queue coming from the line of Jeremy Pearlman with Maxim Group.

First one regarding your limited or as you called it, the commercial rollout. Is that -- the 200 centers that you said are in the pipeline, is that still part of this controlled launch? Or does that already now bleed into a broader commercial U.S. launch? And then maybe talk about what time line could we expect for that broader U.S. commercial launch?

Yes, Jeremy, let me grab the first part of that, and then Shane can add. I just want to make sure we clarify the nomenclature. It's not a limited launch. It's a controlled launch. So we're being very prescriptive about how we go about doing it, but growth is still the driver. And we will continue to build our pipeline and support cases with the objective of growing the business. So that's a key differentiation. I just wanted to clarify there. We want to make sure that all these experiences that these physicians have with this new device are ones that build a sustainable model for the long term. So we will continue to build off of that, and we'll continue to grow the pipeline of opportunities. And with this new indication coming in the second half of the year with TCAR, we'll certainly launch that as aggressively as possible as well. Shane, I didn't know if you had any additional comments to that or not for Jeremy?

Yes, that's really well said, Marvin. I think just a couple of additional points. One is when we look at the progress we've made, and I've mentioned the size of the sales organization, it's important to remember that roughly half of our territory managers started in Q4. So we had a group that was on board when we got approval last summer, but really half of our organization has been out there for a quarter. So we always talk about how these Value Analysis Committees tend to -- and contracts tend to measure their time lines in quarters, not months. So we don't work on things in serial or in series where you work on one until it's complete and then you start the next one. You get a whole lot of them moving at once in parallel, and they start to come to fruition on their own time schedules as we drive them through. So to your question of where does the controlled launch end and all systems go full bore launch pick up, many of those accounts that are in the pipeline now will be feeding into that full launch. So really well stated.

Okay. Understood. And then maybe any feedback you could share from the vascular surgeons? I know we've talked about in the past you have about shifting the whole market to a stent-first approach. The physicians that have adopted the CGuard Prime platform, have they echoed that sentiment that they see this as being now the first line of care?

Yes. Jeremy, let me grab the first part of that. Shane can jump in here as well. I think that the enthusiasm across the board, no matter what subspecialty, for a new innovative technology with these kinds of outcomes that are evidenced with the data that we have is just truly palpable. It's consistent across the board that this market has been looking for a new technology to advance an endovascular-first approach to carotid stenting regardless of specialty. But the feedback through the TCAR trial with the use of CGuard Prime has reiterated that to us, and we continue to have incredible enthusiasm on the part of all subspecialists, but in particular, the vascular surgeons are very keen on having an alternative to what up to this point has been only one device, 20-year-old device available to them. So it's really encouraging, and we're looking forward to taking advantage of the moment. Shane, anything from you there?

No, nothing to add.

Thanks, Jeremy. I'd like to thank everyone for joining today's call and for the continued support of our mission to lead and transform the carotid intervention market. CGuard is redefining outcomes for patients and their providers by lowering risk of stroke and other major adverse events to levels never achieved with first-generation stenting surgery or medical therapy alone, validated with rigorous evidence, proven clinical results, reimbursement and real-world outcomes. We're very excited for what the future has to hold for InspireMD. Thanks for joining the call today.

This concludes today's conference call. Thank you for your participation, and you may now disconnect.