InspireMD, Inc. (NSPR) Q2 2026 Earnings Call Transcript

Good morning, and welcome to InspireMD's second quarter 2026 earnings conference call. Currently, all participants are in 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. Joining us today from InspireMD are Marvin Slossman, Chief Executive Officer, and Mike Lawless, Chief Financial 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. More detailed information about the company and the risk factors that may affect the realization of forward-looking statements is set forth in the company's filing with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K, quarterly report on Form 10-Q, any updates in its current reports on Form 8K, as well as the FIRE MD's press release that accompanies this call, particularly the cautionary statements made in it. During the call today, the company may also discuss certain non-GAAP financial measures. For a more detailed discussion of these non-GAAP financial measures and historical reconciliation to the most closely comparable GAAP measures, please refer to the company's earnings release. This call contains time-sensitive information that is accurate only as of today, August 17th, 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 Slossman, Chief Executive Officer. Marvin, please go ahead.

Thank you, Operator, and good morning, everyone. the second quarter was an important period for inspire md while our reported financial results reflect the accounting impact of the voluntary recall of our approved seaguard prime 135 carotid stent system the quarter was defined by the actions we took to strengthen the business sharpen our execution and position our company for a successful return to the u.s market over the last several months we've remained focused on four priorities optimizing our international business advancing our key regulatory programs and milestones to u.s market re-entry implementing design enhancements to the seaguard prime delivery system and aligning our organization and cost structure around these priorities i believe we are making meaningful progress on each of these objectives notwithstanding our temporary absence from the u.s market our total revenue was essentially unchanged from the second quarter of last year it's important to note our international business continued to perform very well growing approximately 21 year over year reflecting continued physician adoption and strong demand for seaguard across our international markets At the same time, our reported U.S. revenue reflects customer credits associated with the voluntary recall announced at the beginning of May. Those credits more than offset gross U.S. product sales during the quarter and therefore obscure the underlying performance of the business. Importantly, our confidence in the Seaguard implant remains the foundation value driver of our business and will continue to be the asset that builds our market leadership, regardless of which delivery method is chosen for each patient's need. The clinical outcomes and evidence we've developed over many years has set a new standard of care, translating to physician enthusiasm and utilization, which remains strong, giving us confidence as we anticipate our U.S. relaunch. We continue to believe Seaguard is the most differentiated technology available for carotid revascularization and stroke prevention. Turning now to our SeaGuardians 2 submission of approval of our SeaGuard Prime 80 platform for TCAR. We recently announced an outstanding 30-day results from the trial, which we believe strengthen our pending submission. In fact, our latest discussions and feedback from FDA remain constructive and interactive, and all signals point to potential approval in the fourth quarter, as we previously indicated. Once approved, the Seaguard Prime 80 platform would essentially double our addressable market by offering our implant for TCAR in addition to CAF procedures. We also enrolled the first patient in Seaguardians 3, our pivotal study evaluating next generation SwitchGuard Neuroprotection System. Taken together, we're encouraged by the progress across our comprehensive TCAR programs. Also, as previously noted, our submission of the original Seaguard platform for CAS clinically proven in over 75,000 global U.S. cases continues and based on the progress to date we currently expect a decision from FDA in the fourth quarter of this year should these anticipated approvals be realized we would have both TCAR and CAS platforms commercially available before the end of the year giving us the opportunity to address the entirety of the approximately 75 000 annual stenting procedures in the u.s when we spoke to you last quarter we outlined a clear plan to address the improvements for the sea guard prime 135 cast delivery system since then we've identified the required design modifications initiated validation and performance testing and continue to work closely with the fda as we advance these improvements with a completed early submission of our pre-sub dossier these modifications and testing have gone exceedingly well and we're optimistic that the associated timelines of first half of 2027 for market re-entry of this platform has the potential for an earlier approval while this has clearly been a challenging time for the company i believe our ability to weather these setbacks has made us a stronger and more focused organization the cguard 135 delivery system modifications and remediation is well understood the path forward is clearly defined and our team remains fully focused on implementation during the quarter we also took decisive actions to better align our organization and cost structure with our near-term priorities these decisions allow us to focus our resources on the regulatory and commercial milestones that we believe will have the ability to create the greatest long-term value for our shareholders we also believe we've created a leaner more efficient and focused organization that is better positioned to execute not only to return seaguard to the u.s market but to expand access for our physicians and patients they treat before turning the call over to mike i'd like to leave you with four key messages first the underlying fundamentals of our business remain strong as demonstrated by continued international growth physician anticipation for our c guard implant as what we believe is the best treatment for carotid disease with clear line of sight for our u.s market relaunch second we believe voluntary recall is proving to be a well-defined and manageable event we understand the issue we've identified the solution and we're executing against a clear regulatory pathway to re-establish traction and growth third we continue to advance multiple regulatory catalyst including cguard prime 80 for tcar the redesign pre cguard prime 135 platform for cas the original cguard delivery system as well as our next generation switchguard neuroprotection system and finally we've aligned our organization and cost structure to support these priorities while positioning inspire md for long-term sustainable growth while we still have important work ahead of us i believe today we're a more focused and disciplined company and ultimately have better positioned ourselves for success with that i'll turn the call over to mike to review the financials mike thank you as marvin

described, the second quarter financial results need to be interpreted in the context of the voluntary recall that we announced at the beginning of May. For the second quarter of 2026, total revenue is $1.8 million, which was essentially flat with the revenue for the second quarter of 2025. The recall action affected our reported revenue in two ways. First, we ceased commercial sales of Seaguard Prime late in April, so we generated less than one month of sales in the U.S. before the recall took effect. Second, we booked a $734,000 credit for the return of the Seaguard Prime 135 product that had not yet been consumed by our customers. International revenue was $2.1 million, representing growth of 21% versus the same quarter a year ago. This performance continues to reflect the growing global demand for our Seaguard platform. The entirety of international growth was driven by continued demand while changes in foreign exchange rates were immaterial. Gross profit for the second quarter of 2026 was a loss of 0.8 million dollars or negative 43.7 percent of revenue compared to a gross profit of 0.3 million dollars or 17 17.6 percent of revenue for the second quarter of 2025. This decline in gross margin resulted primarily from the $734,000 credit to revenue that I described previously and a $612,000 impairment charge for Seaguard Prime 135 inventory on our books that was no longer commercially viable as a result of the recall. On a non-GAAP basis, which excludes the impact of the recall-related customer credits and impairment charge, adjusted gross profit was $0.6 million. A reconciliation of adjusted gross profit to gross profit, the most directly comparable GAAP measure, is included in today's earnings release and posted in the investor relations section of our website. Total operating expenses for the second quarter of 2026 were $13.7 million, an increase of $0.4 million compared to $13.3 million for the second quarter of 2025. The increase was primarily due to greater headcount-related expenses for the U.S. commercial team and higher development, clinical, and regulatory expenses related to SwitchGuard NPS and Seaguard Prime 80 for TCAR, partially offset by lower general and administrative compensation expenses. Financial income was $121,000 as compared to a loss of $132,000 for the second quarter of 2025. Net loss for the second quarter of 2026 totaled $14.3 million, or 17 cents per basic and diluted share, compared to a net loss of $13.2 million, or 26 cents per basic and diluted share for the same period in 2025. As of June 30, 2026, cash-in-cash equivalents and marketable securities were $30.4 million compared to $54.2 million at the end of 2025. As Marvin discussed, we have proactively taken actions to reduce our cost structure and improve our financial flexibility and operational efficiency. Included in these efforts was a workforce reduction action initiated in the third quarter that reduces the number of positions in our organization by almost 20 percent and saves the company approximately nine million dollars on an annual basis. We expect to incur a restructuring charge of between 900,000 and 1.2 million dollars in the third quarter to account for the severance and related costs associated with this workforce reduction event. This concludes our prepared remarks. We will now open the call for questions. Operator?

If you'd like to ask a question at this time, please press star one one on your touchtone phone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from Adam Mader with Piper Sandler.

Hi, good morning, Marvin. Mike, thank you for taking the questions. A couple from me, and maybe we can just start on the CAF side of the business. You know, so the first original Seaguard delivery system approval timing for U.S., if I heard correctly, was Q4. I think in the last earnings call, you mentioned Q3. So a little bit of a wiggle there versus prior expectations. And I don't mean to nitpick over a couple months, but can you just talk about kind of what's driving the shift there? Any color you can give us in your recent interactions with FDA? That's question one. and then I have another one or two for you guys.

Thanks, Adam. Thanks for the question. I think the wiggle, as you mentioned it, is we're just trying to be realistic about the regulatory timeframes as always, requests from FDA and just general timeframes. We have testing that has been required and is completed, and we're just trying to make sure that we're understanding, you know, a realistic approval timeline here relative to the workload, our responses to FDA, and so forth. So, I think we're on top of the details and what's necessary and required. So, it's really nothing more than that. We just want to be realistic about giving ourselves some room here on these responses and FDA's response back. Okay, perfect. Specific to the legacy system.

Yeah, yeah, perfect. Okay, thanks, Marvin. And then if we switch over to Seaguard Prime, the delivery system there, you know, good to hear you're still tracking towards first half 2027 approval for that technology. I guess my question is what's left to do before submission? And it would be really helpful if you could put a finer point on FDA submission timing, you know, as folks just try and understand, you know, how de-risk the first half 27 approval, you know, it truly is. And then I have one more for you guys. Thanks.

Sure. The progress on the 135 technical and the prime system on the 135 prime technical improvements is really solid, Adam. In fact, we feel confident that we've not only solved the delivery challenges but produced a solution that performs exactly as we anticipated with the trackability and even in challenging anatomy and so forth. And so the delivery mechanism performs well. We're in the process right now of doing DB testing and making sure that all of the technical work that we've done from the engineering group is now stacking up in terms of measured approach. So we're confident in this system. We're confident that we've solved it, and this is our platform for the future. So we originally guided around the first half 2027 approval. We think that that remains realistic. There's a couple of long polls in the tent that we're still sorting out related to biocomp testing, the statutory review process that FDA puts on these things. We have submitted early our pre-sub request to FDA to review all of the results to date and our anticipated response. We hope that that gives us a little more clarity and is more favorable but if we can eliminate some of these long pole items we believe that there is a possibility that we could pull that approval process in but right now we're calling the first half of 27 as being uh realistic and uh we're optimistic that we can we can make those approved improvements okay thanks for the color there um and maybe just one last one sorry it's a another kind of regulatory question, but just flipping over to SwitchGuard, which I think is important, your proprietary TCAR system.

So, I think in June, you enrolled the first patients in that study. Just any comments you can give us, color, you can give us, Marvin, on the enrollment progress there and kind of how that trial is advancing.

And just from a timeline standpoint i just want to confirm that you're still tracking to back half 2027 for uh for u.s approval and launch thank you yeah the the the enrollments thus far have have gone very well um we don't take any of that for granted obviously this is the first time switchguard has been used in in human applications so i think the investigators are very pleased with the performance and we continue to enroll in the trial our expansion of that trial uh will to a certain extent depend on the resources that are available to us but so far we have initiated sites that we believe are high volume and enthusiastic about switchguard and continue to to progress in um in those enrollments with the timeline that you had previously mentioned as as being what we're we're calling at this point obviously the um enrollment process will determine um you know timelines. But so far, we're really pleased about the responses and the performance of the device itself.

That's great to hear. I'll jump back in queue. Thank you. Thanks.

In comes from Frank Tachenen with Lake Street Capital Markets.

Great. Thank you for taking the questions. I wanted to follow up on the comments around some of the cost-saving initiatives. First, when should we expect those to be fully realized understanding there's going to be some restructuring expense that occurs in Q3 when should we see kind of the first quarter of the refreshed operating expense run rate and then you made a comment related to 20% reduction in headcount can you maybe talk to the distribution of where those 20% came from inside the organization yeah hi right um good questions so um in terms of the timing for when we'll realize those cost savings those those uh vast majority of those those actions that we described have already been

set in motion i would expect that um we should see the full impact of that uh those those cost savings in in q4 of this year uh there'll be some partial savings in q3 but there will be also some offsetting costs associated with restructuring. So from a clean standpoint, I would say a Q4 should be a good view of what the new cost structure looks like.

Frank, let me jump in on the second part of your question there. Obviously, we want to make sure that we're anticipating a very aggressive relaunch, and we've built a plan to enable that commercial readiness built for that momentum. So even though we're conserving our financial resources to extend the cash runway, we're trying to strike a balance in maintaining the commercial readiness to do so. So reducing these layers makes a lot of sense to us, but at the same time, I think we're continuing to maintain the strength of our commercial organization to make sure that we're ready in a fairly tight window here, that we're out of the gate relaunching and doing so properly with a great team on the field. So we feel good about the ability to do that.

Okay, very helpful. I just wanted to follow up on one of Adam's questions on the prime system. Just hoping you can put a little bit of a finer point on what the kind of key variable to sliding that timeline is. I know you've mentioned kind of maybe earlier part of first half 27 if you're able to accelerate that process a little bit, but you're remaining conservative to keep the first half 27 guidance. But what is the key variable that kind of changes that timeline, and is that something that's more in your control, or is that related to maybe how quickly the FDA can process?

Yeah, it's a great question, Frank. So, as I mentioned, there's two testing scenarios that we're looking at here. Biocomp testing, it takes a bit of time. We don't believe that is necessary, but we need to validate that with, obviously, with FDA and their review of this under the pre-sub scenario that we have set up. And then the statutory review process, we would be looking for more of an accelerated review of those changes that we've made to the prime. And if FDA agrees with that, those could pull those timelines in significantly. But, again, no commitments at this point. We're still guiding around all of those factors being as they are. So, first half of 27 is what we're calling at the moment. But given the fact that we believe we've solved this problem technically with minimal implications from a technical point of view, we're hopeful that FDA agrees with that assessment and that we can pull that in.

Okay. Very helpful.

Thank you.

Our next question comes from Marie Tybalt with BTIG.

Good morning. Thanks for taking the questions. I wanted to ask a question here on sort of the updated commercial strategy. If all goes well, you'll have the relaunch and then other launches to follow. Pretty quick succession here. So I know you have a new head of sales and marketing, maybe a smaller, tighter team on the commercial side. So just any updates on how you're thinking about the launches commercially, any changes to the strategy, any thoughts on that committee processes, all of those sorts of details would be helpful.

Sure. Thanks, Marie. Glad to have you on the call, by the way. So, I think what we've spent a lot of time doing over the last month or so is making sure that we are optimizing the structure of our field organization for the folks that performed really well on our initial launch. As you know, we take a very deliberate approach to where carotid procedures are through claims data and territory management. We're looking very closely at time to productivity of our team. So, this is a very deliberate and structured approach. The playbook for our commercial launch and relaunch has been looked at very closely. We have a new head of sales and marketing who has real clarity on how we go about doing that. And so, we're thrilled with the group that we have on the field, their ability to understand where their customers are and what the anticipated and pent-up demand is going to be. And so, obviously, that playbook will be executed, and we feel like that the group that's with us now will be able to reestablish our commercial presence quickly. VAC committees and otherwise, you know, we continue to look closely at where we have those approvals and making sure that customers understand timelines and our process here. So, that part of the work, we spent a lot of time looking at to make sure we get the full benefit of the value of our relaunch. We know that there is pent-up and anticipated demand for this product, and this voluntary recall gave us the opportunity to take a quick pause and make sure that we're being very efficient and realistic and aggressive about our relaunch plans. So, that feels very good.

Okay, that's wonderful to hear. A quick follow-up here. You mentioned, I think, International grew over 20% this quarter. What's been driving that? That's a really nice bright spot. I'm curious if that's a sustainable growth there. Thanks for taking the question.

Yeah, Marie, I think it's a great question. Our OUS business has matured very well over the last several years. Remember, we've been in the OUS markets now for years, sold over 75,000 implants. We think, first of all, the performance of this device drives, you know, world-class outcomes and that the physicians in our OUS markets are very accustomed to that being the new standard of care, which we hope to translate into the U.S. market as well. We've grown that OUS business significantly and nicely over time, but we also recognize the need to pivot a bit and look for higher margins and margin expansion in those markets. It's obviously not as a robust economic market as the U.S., and so we're beginning to look closely at fine-tuning those pricing and margin assumptions so that we can count on that business not only being a great top-line business, but being able to contribute at least partially on the bottom line. So we're thrilled to have the results that we do in our OUS market.

Great. Thank you. Our next question comes from Jeremy Perlman with Maxim Group.

Good morning. Thank you for taking my questions. First, are you in touch with the physicians who are using the recalled 135-centimeter delivery system, and what's their take on the timeline, and are they going to be happy to reengage with the company and the Seaguard Prime once it's hopefully recleared?

Yeah, Jeremy, great question. we are absolutely in touch with all of our customers, including the current users and new users. The anticipation in this marketplace is palpable. When we launched this product, we saw a terrific reaction to a new technology that came to market after 20 years of, you know, older technology. And we're, of course, in touch with all of those customers. I think they're excited and anticipating having this product back in their hands is unanimous. It's consistent, it's unanimous. That's why our sales team, we've kept them together and allowed them to continue to cultivate those relationships. And the expectation is as soon as we have approval of the 135 as well as the approval on the 80 for TCAR, we will be able to transfer that interest and enthusiasm into revenue in a a quick fashion. So that's the work of the sales organization right now is to prepare for that relaunch and the feedback from customers is excitement and enthusiasm for having it back in their hands.

Okay, that's great, Pierre. And then just last question from me, you know, regarding how important is the switch guard to the long-term T-Guard strategy, let's say, versus just the C-Guard 80? You know, I mean, how much is that, you know, obviously pending, FDA approval, how much does that materially expand your addressable TCAR market? And why would a physician, let's say, use the entire switch guard system versus a prior system with just the C-Guard 80 centimeter?

Yeah, it's very fundamental to our overall TCAR strategy. The fact is, is that for every TCAR procedure, there's an implant used, there's a stent used, and then a neuroprotection device that's also used in the procedure. and we felt it was important to have both. We've made some improvements on the current predicate in the market that's approved with our switch guard. So we think we will have a device that has some features and functions that the customers have been looking for that are otherwise unavailable. Obviously, the sales dollars and margin associated with that product are significant. And so the ability to address the entirety of the TCAR market with both the implant and the neuroprotection system here are really fundamental to our TCAR strategy overall. So, we think we benefit by better technology and obviously internally with higher revenue and margin opportunities. So, it remains a fundamental part of our overall plan.

Okay, great. Thanks for all that information. I'll have that on the key. Thank you, Jeremy.

That concludes today's question and answer session. I'd like to turn the call back to Marvin Slossman for closing remarks.

So I'd like to thank everyone again for joining the call today and the continued interest in InspireMD. We certainly recognize we have important work ahead of us, but we believe that we've made meaningful progress over the past several months. We've got a clear path forward, multiple important regulatory catalysts ahead, and a team that remains fully focused on execution. We appreciate the continued support and look forward to updating on our progress next quarter.

This concludes today's conference call. Thank you for participating. You may now disconnect.