Full Transcript: InspireMD Q2 2026 Earnings Call

InspireMD (NASDAQ: NSPR ) reported second-quarter financial results on Monday. The transcript from the company's second-quarter earnings call has been provided below. This transcript is brought to you APIs. For real-time access to our entire catalog, please visit for a consultation.

8 million for Q2 2026 compared to the same period last year, with international revenue growing by 21% due to strong demand, despite the impact of a voluntary recall which resulted in a $734,000 credit. S. S. market reentry by the first half of 2027.

InspireMD's strategic initiatives include advancing the C-GUARDIANS 2 and 3 trials, working towards FDA approval for the CGuard Prime 80 and the redesigned CGuard Prime 135 platforms, and reducing operational costs through a 20% workforce reduction to save approximately $9 million annually. Management expressed confidence in the CGuard technology as a differentiated solution for carotid revascularization and stroke prevention, with a clear regulatory pathway and a strong international market presence. 2 million in the third quarter to align the organization with strategic priorities.

Full Transcript OPERATOR 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 Slosman, 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. 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 8-K, as well as InspireMD'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 17, 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. Marvin Slosman, Chief Executive Officer Thank you, operator, and good morning, everyone.

The second quarter was an important period for InspireMD. S. market. S.

market reentry, implementing design enhancements to the CGuard 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. 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 CGuard across our international markets. S. revenue reflects customer credits associated with the voluntary recall announced at the beginning of May. S.

product sales during the quarter and therefore obscure the underlying performance of the business. Importantly, our confidence in the CGuard implant remains the foundation value driver of our business and will continue to be the asset that builds our market leadership. S. relaunch.

We continue to believe CGuard is the most differentiated technology available for carotid revascularization and stroke prevention. Turning now to our C-GUARDIANS 2 submission for approval of our CGuard Prime 80 platform for TCAR. We recently announced 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 CGuard Prime 80 platform would essentially double our addressable market by offering our implant for TCAR in addition to CAS procedures. We also enrolled the first patient in C-GUARDIANS 3, our pivotal study evaluating the 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 CGuard platform for CAS, clinically proven in over 75,000 global cases, continues and, based on the progress to date, we currently expect a decision from FDA in the fourth quarter of this year.

S. When we spoke to you last quarter, we outlined a clear plan to address the improvements for the CGuard Prime 135 CAS 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 reentry 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.

S. market but to expand access for our physicians and the patients they treat. Before turning the call over to Mike, I'd like to leave you with four key messages. S.

market relaunch. Second, we believe the voluntary recall is proving to be a well-defined and manageable event. We understand the issue, we've identified the solution, and we are executing against a clear regulatory pathway to reestablish traction and growth. Third, we continue to advance multiple regulatory catalysts including CGuard Prime 80 for TCAR, the redesigned 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 InspireMD for long-term sustainable growth. While we still have important work ahead of us, I believe today we are 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, Michael Lawless, Chief Financial Officer 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. 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. S.

before the recall took effect. Second, we booked a $734,000 credit for the return of the CGuard Prime 135 product that had not yet been consumed by our customers. 1 million, representing growth of 21% versus the same quarter a year ago. This performance continues to reflect the growing global demand for our CGuard stent platform.

The entirety of international growth was driven by continued demand, while changes in foreign exchange rates were immaterial. 6% 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 CGuard Prime 135 inventory on our books that was no longer commercially viable as a result of the recall. 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. 3 million for the second quarter of 2025. S. commercial team and higher development, clinical, and regulatory expenses related to SwitchGuard NPS and CGuard 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. 26 per basic and diluted share, for the same period in 2025. 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% and saves the company approximately $9 million on an annual basis. 2 million in the third quarter to account for the severance and related costs associated with this workforce reduction. This concludes our prepared remarks. We will now open the call for questions.

OPERATOR Operator, if you'd like to ask a question at this time, please press star 11 on your touchtone phone and wait for your name to be announced. To withdraw your question, please press star 11 again. Our first question comes from Adam Mater with Piper Sandler. Adam Mater, Analyst at 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 first, original CGuard delivery system approval timing for us, 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. Marvin Slosman, Chief Executive Officer 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.

Adam Mater, Analyst at Piper Sandler Okay, perfect. Specific to the legacy system. Yep, yep, perfect. Okay, thanks, Marvin.

And then if we switch over to CGuard 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-risked the first half '27 approval, you know, truly is.

And then I had one more for you guys. Marvin Slosman, Chief Executive Officer 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 poles 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 1H27 as being realistic and we're optimistic that we can make those improvements. Adam Mater, Analyst at Piper Sandler Okay, thanks for the color there, and maybe just one last one.

Sorry, it's 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. You know, 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.

S. approval and launch. Thank you. Marvin Slosman, Chief Executive Officer Yeah, the enrollments thus far have gone very well.

We don't take any of that for granted. Obviously, this is the first time SwitchGuard has been used in human application. And so I think the investigators are very pleased with the performance and we continue to enroll in the trial. Our expansion of that trial 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 progress in those enrollments with the timeline that you had previously mentioned as being what we're calling at this point.