InspireMD (NSPR) Q3 2026 Earnings Call Transcript

DATE

Thursday, Nov. 12, 2026

CALL PARTICIPANTS

• LifeSci Advisors - Alexandra Grossman
• Chief Executive Officer - Marvin Slosman
• Chief Financial Officer - Mike Lawless

TAKEAWAYS

• Revenue -- $2.2 million, representing an 11.1% decrease driven by the absence of U.S. sales following a voluntary product recall in May 2026.
• International Revenue -- $2.2 million, growing 9.1% or 10% on a constant currency basis, reflecting continued adoption of the CGuard platform in global markets.
• U.S. Revenue -- $32,000, primarily consisting of sales related to the CGUARDIANS III pivotal trial for the SwitchGuard neuroprotection system.
• Gross Profit -- $240,000, yielding a margin of 10.7% compared to 34.2% in the prior-year period, reflecting the U.S. market absence and a higher mix of lower-priced international sales.
• Operating Expenses -- $10.2 million, a 26.7% decrease due to a workforce reduction and a one-time non-cash credit from forfeited stock grants.
• Workforce Reduction -- 20% of the company's headcount, implemented during the third quarter to align the cost structure with commercialization priorities.
• Stock Compensation Reversal -- $1.8 million, representing a one-time reversal of expenses for share grants forfeited during the headcount reduction.
• Net Loss -- $9.8 million, or $0.12 per share, compared to a net loss of $12.7 million, or $0.17 per share, in the third quarter of 2025.
• Cash and Marketable Securities -- $19.2 million as of Sept. 30, 2026, compared to $54.2 million at the end of 2025.
• Addressable Market Expansion -- over 35,000 annual procedures, effectively doubling the U.S. market opportunity following the FDA approval of CGuard Prime for TCAR.
• Trial Success Rate -- 100% acute device success, with no deaths, strokes, or myocardial infarctions reported through 30 days in the CGUARDIANS II trial.
• Warrant Proceeds Potential -- $10 million, representing the potential net proceeds if amended Series J and K warrants are exercised following the FDA approval milestone.
• Global Procedure Volume -- 75,000 procedures, completed globally using the CGuard implant technology to date.
• PMA Supplement Submission -- planned for Dec. 2026, for the enhanced CGuard Prime 135 CAS delivery system following validation testing.
• Target Product Reentry -- first half of 2027, for the CGuard Prime 135 CAS delivery system, subject to regulatory review and approval.
• Micro Puncture Kit Release -- expected in the first quarter of 2027, to support vascular access during carotid procedures.
• Research and Development Expenses -- $3.3 million, compared to $3.6 million in the prior-year period.
• Selling and Marketing Expenses -- $2.4 million, compared to $4.4 million in the third quarter of 2025.
• General and Administrative Expenses -- $3.5 million, compared to $5.9 million in the prior-year period.
• Financial Income -- $191,000, compared to $343,000 in the third quarter of 2025.

Need a quote from a Motley Fool analyst? Email pr@fool.com

RISKS

• Lawless stated, "We also experienced lower-than-expected margins in international sales, primarily as a result of a higher mix of sales to countries with lower ASPs," noting the impact of geographic sales mix on overall profitability.

SUMMARY

InspireMD, Inc. (NASDAQ:NSPR) reported a strategic pivot toward U.S. commercial execution following the FDA approval of its CGuard Prime TransCarotid Stent System for TCAR procedures. Management stated that the company is returning to the U.S. market with a next-generation carotid implant supported by clinical evidence from the CGUARDIANS II pivotal trial. The company implemented a 20% workforce reduction to align its resources with regulatory and commercial priorities while reducing its operating expense base. Management reported that international demand for the CGuard platform remains strong, contributing to year-over-year growth in that segment despite a drag from foreign exchange fluctuations.

• CEO Slosman stated, "With FDA approval of our CGuard Prime TransCarotid Stent System for TCAR procedures, we are returning to the U.S. market with our next-generation carotid implant," marking the end of the company's market absence.
• Management confirmed that product shipping for the TCAR system commenced immediately following the regulatory approval.
• The company appointed Kathy Kennedy as Senior Vice President of Global Sales and Marketing to lead the U.S. commercial launch and account approval process.
• Management announced a proposed underwritten equity public offering but declined to comment on terms, pricing, or size during the call due to regulatory limitations.
• Enrollment in the CGUARDIANS III pivotal trial for the SwitchGuard neuroprotection system is progressing, with an expected regulatory approval target in late 2027.
• Management indicated that the legacy CGuard carotid stent system for CAS remains under FDA review, with feedback anticipated by the end of 2026.

INDUSTRY GLOSSARY

• ASP: Average Sales Price, the mean price at which a product is sold across various markets or distributors.
• CAS: Carotid Artery Stenting, a minimally invasive procedure where a stent is used to open narrowed carotid arteries.
• MicroNet: A proprietary mesh technology designed to provide embolic protection and prevent plaque protrusion through the stent.
• PMA: Premarket Approval, the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
• TCAR: Transcarotid Arterial Revascularization, a surgical procedure that uses a direct carotid access point and flow reversal to protect the brain during stenting.
• VAC Committee: Value Analysis Committee, a hospital group responsible for reviewing and approving new medical technologies for clinical use.

Full Conference Call Transcript

Operator: As a reminder, this conference call is being recorded. At this time, I would like to turn the conference over to Ms. Alexandra Grossman with LifeSci Advisors. Ma'am, please begin.

Alexandra Grossman: Thank you. 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 filings 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 8-K, as well as in 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, November 12, 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: Thank you, and good afternoon, everyone. The third quarter marked a turning point for InspireMD, and today I am pleased to discuss what we believe is one of the most significant milestones in the company's history. I first want to briefly address the financing announcement we issued today. As you saw in a separate press release issued this afternoon, we have announced a proposed underwritten equity public offering. This financing is intended to support the next phase of our growth, including the full commercialization of CGuard Prime in the U.S. and the broader execution of our strategic priorities.

Given that the offering process is ongoing, there are SEC-imposed limitations on what can be discussed beyond the information included in today's announcement. Thus, we are not commenting on the potential size, pricing, timing, and other terms of the transaction during this call. We appreciate your understanding and look forward to providing additional information through the appropriate public disclosures as it becomes available. As I just mentioned, today I'm pleased to discuss what we believe is one of the most significant milestones in our company's history.

With FDA approval of our CGuard Prime TransCarotid Stent System for TCAR procedures, we are returning to the U.S. market with our next-generation carotid implant, supported by a strong body of clinical evidence, which we believe positions us to significantly expand our market penetration and pursue our mission to lead the carotid revascularization field. Let me take a moment to thank the entire team at InspireMD, as well as the physician partners who have been instrumental in this approval. This return to the U.S. market represents more than a regulatory achievement.

We believe it reinforces the clinical value of our CGuard Prime carotid stent as the best-in-class device for treating patients and helping prevent stroke, and it marks the beginning of the next phase of InspireMD's evolution, shifting our focus back to growing our commercial presence in the U.S. market. As a reminder, our next-generation CGuard implant has demonstrated unmatched clinical evidence and results in over 75,000 procedures globally, and we believe these clinical results establish a new standard of care in stroke prevention.

When we spoke to you last quarter, we outlined a clear set of priorities centered on advancing our regulatory programs to approvals in the U.S., strengthening our international business, enhancing our CAS delivery system, and aligning our organization and cost structure. We've made meaningful progress against each of these objectives. The approval of the CGuard Prime TransCarotid Stent System was supported by the CGUARDIANS II pivotal trial, which demonstrated 100% acute device success among 50 patients with no deaths, strokes, or myocardial infarctions through 30 days, and complete stent patency at 30 days amongst evaluated patients. We believe these results reinforce the clinical value of our CGuard implant and its proprietary MicroNet mesh technology.

Our value proposition has always been centered on treating the lesion and providing durable protection against stroke. This TCAR indication expands our U.S. addressable market by approximately 40,000 annual procedures, effectively doubling our opportunity, which we plan to immediately pursue with a world-class commercial team on the field ready to execute. It also enables an indication for use of our implant in TCAR, a major carotid revascularization approach. Our strategy is to make CGuard available across both TCAR as well as transfemoral CAS procedures to address the broad range of patients and physician needs.

We believe we were the first company to focus on the entirety of the carotid field with an implant-first approach, building on the clinical evidence derived from our mesh-protected platform. With this approval, our focus now shifts to commercial execution. As we commence U.S. sales, we intend to build on the base and momentum of our account approvals, physician awareness, and enthusiasm we've developed for this technology. We will continue to follow our commercial playbook with a disciplined and direct approach to sales growth. Over the past few months, we prepared for this return with an emphasis on commercial readiness, physician engagement, training, and clinical support.

We strengthened our leadership with the appointment of Kathy Kennedy as Senior Vice President of Global Sales and Marketing, along with the promotion and addition of several key leaders on our engineering, clinical, regulatory, and operations functions to support this launch and prepare for future approvals and platform enhancements. We see this approval as only the beginning in the pursuit of our mission to lead this important and growing segment of vascular medicine with a comprehensive set of devices supported by clinical evidence. Sustained success will depend on consistent execution, physician confidence, and our ability to translate clinical differentiation into routine use, which we believe is achievable.

Our international business continued to grow, with third quarter revenues increasing approximately 9% year-over-year to $2.2 million. Through the first nine months of 2026, international revenue increased approximately 24% to $6.6 million, reflected continued adoption of our CGuard platform across our markets. While reported U.S. revenue remained affected by our absence from the market following the May voluntary recall of CGuard Prime 135 delivery system, international demand continues to demonstrate the underlying appeal of our implant technology. Beyond TCAR, we continue to advance programs designed to broaden our carotid intervention portfolio. Our original CGuard carotid stent system for CAS remains under FDA review.

We believe this platform, with its extensive history of international clinical sales and over 75,000 patients, could complement our offering and further expand access to our technology, subject to FDA approval. For the CGuard Prime 135 CAS delivery system, we have implemented design enhancements following the voluntary recall. Validation and performance testing are underway, and we currently anticipate an FDA submission before year's end. We continue to work toward reentry of this platform in the first half of 2027, subject to regulatory review and approval. Enrollment is progressing in our CGUARDIANS III pivotal trial, evaluating our proprietary SwitchGuard neuroprotection system for TCAR procedures.

We believe SwitchGuard represents an opportunity to complement our implant with a comprehensive set of proprietary tools and technology to expand our procedural reach. As a next step in expanding our capabilities into TCAR, we plan to introduce a proprietary micro puncture kit designed to support vascular access, which we currently expect in a planned release early Q1 2027. Together, these initiatives reflect our goal of building a more comprehensive carotid intervention platform, offering physicians a broad set of solutions across both TCAR and CAS. We remain focused on aligning our resources around the highest priority of regulatory and commercial opportunities.

During the third quarter, we implemented a workforce reduction of approximately 20%, which we expect will better align our resources with key product development, regulatory, and clinical commercialization priorities while reducing our overall operating expense base. We will remain financially disciplined as we fund our commercial reentry and advance our pipeline. Mike will provide additional details on the financial performance, liquidity, cost structure, and so forth in a few moments. Before turning the call over to Mike, I want to reinforce four key messages. First, FDA approval for TCAR represents a major milestone, returning CGuard Prime to the U.S. market with a next-generation implant and significantly expanding our addressable opportunity.

Second, we believe we are positioned to execute on our growth strategy and continue building toward profitability. Third, we are moving into a growth phase focused on commercial execution with an experienced team and a disciplined approach to driving physician adoption. Fourth, we continue to advance a differentiated portfolio across TCAR and CAS, including the original CGuard system, the enhanced Prime 135 delivery platform, SwitchGuard, and complementary procedural technologies. Finally, we have taken meaningful steps to streamline our global operations and align our cost structure with these priorities.

We recognize that important work remains ahead of us, but with a differentiated implant, a compelling clinical evidence base, an expanding product portfolio, and a more focused organization, we believe InspireMD is well-positioned for its next phase. With that, I will turn the call over to Mike to review the third quarter financials. Mike, go ahead.

Mike Lawless: Thank you, Marvin. For the third quarter of 2026, total revenue was $2.2 million, down $0.3 million, or 11%, from revenue in the third quarter of 2025. This decline was a result of the voluntary action that we took back in May to temporarily withdraw from the U.S. market until we could implement enhancements to the delivery system of CGuard Prime for CAS. International revenue was $2.2 million, representing growth of $0.2 million, or 9%, versus the same quarter a year ago. This performance reflects the continued strong performance of, and global demand for, our original CGuard stent platform. Changes in FX represented about a 1% drag on reported growth, so on a constant currency basis, international revenue grew 10%.

U.S. sales were about $32,000 in the quarter, resulting primarily from sales recorded as part of the CGUARDIANS III pivotal trial for the SwitchGuard neuroprotection system. Gross profit for the third quarter of 2026 was $0.2 million, or 10.7% of revenue, compared to a gross profit of $0.9 million, or 34.2% of revenue, for the third quarter of 2025. This variance resulted primarily from the absence of revenue from the U.S. resulting from the voluntary action we took in the second quarter. We also experienced lower-than-expected margins in international sales, primarily as a result of a higher mix of sales to countries with lower ASPs.

Total operating expenses for the third quarter of 2026 were $10.2 million, a decrease of $3.7 million, or 27%, compared to $13.9 million for the third quarter of 2025. This decrease was primarily due to the impact of the workforce reduction action that we took during the past quarter. About $1.8 million of this decrease is due to a one-time reversal of previously recognized stock compensation expense for share grants that were forfeited as part of the headcount reductions. The savings from the workforce reduction were partially offset by higher spending on the CGUARDIANS III clinical trial. Financial income was $191,000 as compared to income of $343,000 for the third quarter of 2025.

Net loss for the third quarter of 2026 totaled $9.8 million, or $0.12 per basic and diluted share, compared to a net loss of $12.7 million, or $0.17 per basic and diluted share, for the same period in 2025. As of September 30, 2026, cash and cash equivalents and marketable securities were $19.2 million compared to $54.2 million at the end of 2025. With our announcement today of the FDA approval of CGuard Prime for TCAR, we have triggered the 20-day expiration period for the amended Series J and K warrants, during which the holders can exercise their warrants. If exercised in full, these warrants could result in up to $10 million of net proceeds.

Following this 20-day period, the only remaining milestone-based warrants left in our cap table will be the original Series J warrants, which have an expiration period that is triggered by FDA approval of SwitchGuard, our neuroprotection system currently in phase III clinical trials. As Marvin discussed earlier, we also announced today that we have launched a potential financing transaction. If completed, we expect to use the proceeds to support, among other things, our commercial launch activities in the U.S. and our CGUARDIANS III pivotal trial for our SwitchGuard neuroprotection system. The terms of the potential transaction, including the amounts of proceeds, have not yet been determined. This concludes our prepared remarks. We will now open the call for questions. Operator?

Operator: Yes, sir. Ladies and gentlemen, if you have a question or comment at this time, please press star one on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press star one again. Again, if you have a question or comment at this time, please press star one on your telephone keypad. Please stand by while we compile the Q&A roster. Our first question or comment comes from the line of Adam Maeder from Piper Sandler. Mr. Maeder, your line is now open.

Adam Maeder: Hey, good afternoon. Thank you for taking the questions, and congrats on the short shaft CGuard approval. Maybe we could start there, Marvin. Would just love a little bit more color in terms of how you're thinking about potential uptake of that product. What does it look like in terms of VAC committee process, and is there an attach rate that you're targeting for those TCAR procedures? And then I had a follow-up. Thanks.

Marvin Slosman: Thanks for the question, Adam. I think the overall feeling here is that we want to pick up where we left off relative to our VAC approvals and traction in the marketplace. The sales organization has been continuing to work behind the scenes to make sure that we've got very well-laid account plans and targeting. Our previous recall of the Prime 135 system, it remained approved, and so we are able to take advantage of the previous momentum in terms of approvals, and we will continue to launch the short shaft system in the TCAR environment as such. So, we feel like that we will be able to build off of a warm start.

Adam Maeder: Okay, that's helpful, Marvin. Thank you for that. Then maybe just two more for me, if that's okay. I'll ask them both upfront. Was wondering if there was an update on timelines for the original CGuard delivery system. When do you expect that product to be available in the market? Then I heard you touch on the CGUARDIANS III clinical trial in the prepared remarks. I just wanted to confirm that's still targeting a back half 2027 approval. Thank you.

Marvin Slosman: Yeah. Thanks again, Adam. So, in terms of the legacy system, we still anticipate feedback from FDA by the end of the year, which was our original intention. All of the information has been provided to FDA, and they continue to evaluate the legacy system for approval, which we continue to anticipate according to those timelines. As far as CGUARDIANS III is concerned, we're actively enrolling in that trial and continue to build off of that momentum in terms of activating more sites. There's continued enthusiasm on the part of the vascular surgery community, especially those that have used our stent device in previous trials.

So, we're looking forward to continuing to accelerate those enrollments and those timelines that we discussed, end of 2027, continue to hold there.

Adam Maeder: Great to hear. Thank you.

Operator: Thank you. Our next question or comment comes from the line of Frank Takkinen from Lake Street Capital Markets. Mr. Takkinen, your line is now open.

Frank Takkinen: Great. Thanks for taking the questions. Was hoping to start with one on CGuard and TCAR as well. If you can maybe just talk through what is left that needs to be complete before you can actually start shipping product. Maybe talk through inventory. Have you built up some inventory? Do you think how meaningful of an inflection do you think we can see here at the end of the year? Or is it really just getting the CAS back up and running and laying the foundation for next year? Any additional info would be great. Thanks.

Marvin Slosman: Yeah, thanks for the question, Frank. We are ready, and product is being shipped as we speak. We prepared that well in advance of this approval. Now that we have the Miami facility in place, we're operationally set there, and so we expect that cases will begin immediately. We think that there is a lot of pent-up demand for this implant, a lot of enthusiasm within the vascular surgery community to have a differentiated product after being limited for a number of years on their opportunities to use other devices.

I would expect, as I discussed with Adam's question, we have approvals in place, we have a team in place, we've done a lot of account planning and operational readiness, and so we are not only ready to go, but past ready to go, and products are moving today.

Frank Takkinen: Okay, very helpful. Just for my second one, maybe for Mike. Can you just refresh us how we should be thinking about the go-forward OpEx profile now that the cost cuts have come out of the model? I think I heard, and maybe it wouldn't hurt to clarify, that you said there was a $1.8 million item that made OpEx look a little bit lower than it actually was. Can you maybe clarify on that a little bit, and then just how we should think about OpEx going forward? Thanks.

Mike Lawless: Yeah, sure. Good talking with you, Frank. In Q4, as part of the restructuring that we took, we had to, from an accounting standpoint, reverse some previously expensed stock comp expense. That amounted to $1.8 million in the quarter. That was a one-time item that will not repeat itself going forward, which served to reduce the overall level of OpEx that we reported. On a going-forward basis, I'd say that we've clearly reduced our cost structure as we described when we announced the restructuring.

I mean, at this time, we're not providing a lot of guidance, but I'd say that you should look to see incremental savings starting in Q4, and that would carry over into the first several quarters of next year as well. Depending on the sales ramp and the progress we make in launching CGuard Prime 80, we'll start to make some incremental investments again in sales and marketing in the back half of the year. But I think you'll see that there's a lower cost structure going forward, starting in Q4.

Frank Takkinen: Perfect. Thanks. Thanks for the questions.

Operator: Thank you. Again, ladies and gentlemen, if you have a question or comment at this time, please press star one on your telephone keypad. I'm showing no additional questions in the queue at this time. I'd like to turn the conference back over to management for any closing remarks.

Marvin Slosman: Thank you again for joining us today and the continued interest in InspireMD. While we still have important work ahead of us, we believe we've made meaningful progress over the last several months. We have a clear path forward, multiple important regulatory milestones ahead, and a team that remains fully focused on execution. We appreciate the continued support and look forward to updating the progress next quarter.

Operator: Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.

The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.