InspireMD, Inc. (NSPR) Earnings Call Transcript & Summary

Thanks. On today's call, management will provide forward-looking statements grounded in current expectations, beliefs, and projections from management — and by their very nature, many of these are inherently uncertain. Such forward-looking statements carry risks and uncertainties that could lead actual results to differ materially from what those statements express. You can find more detailed information about the company and the risk factors that might affect whether forward-looking statements are realized in the company's filings with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K, its quarterly report on Form 10-Q, any updates in its current reports on Form 8-K, and also in InspireMD's press release accompanying this call, particularly the cautionary statements contained in it. During today's call, the company might also cover some non-GAAP financial measures. For a fuller discussion of those non-GAAP figures and the historical reconciliation to the closest comparable GAAP measures, please see the company's earnings release. This call includes 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 occurring after this call. It is now my pleasure to hand the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

Thanks, and good afternoon, everyone. For InspireMD, the third quarter represented a turning point, and I'm glad today to talk about what we consider to be among the most important milestones in this company's history. First, a brief word on the financing announcement that came out today. As you saw in a separate press release this afternoon, we announced a proposed underwritten equity public offering. The purpose of this financing is to support the coming phase of our growth, which includes full commercialization of CGuard Prime in the U.S. as well as broader execution of our strategic priorities. Because the offering process is still underway, SEC-imposed limitations restrict what we can discuss beyond the information in today's announcement. During this call, we won’t discuss the possible size, pricing, timing, or other terms of the transaction. We appreciate your understanding and look forward to providing more information through the appropriate public disclosures when it becomes available. As I mentioned a moment ago, I’m pleased today to discuss what we regard as 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 back in the U.S. We're entering the U.S. market with our next-gen carotid implant, supported by substantial clinical evidence that we think puts us in position to grow our market share considerably and to keep pursuing our goal of heading the carotid revascularization space. I'd like to pause and express gratitude to the entire InspireMD team, as well as the physician partners whose contributions were instrumental in securing this approval. Coming back to the U.S. market means more than just a regulatory milestone. We think this strengthens the clinical value of our CGuard Prime carotid stent—the top-tier option for treating patients and aiding in stroke prevention—and it signals the beginning of InspireMD's next evolutionary stage, with our attention turning back to expanding our commercial footprint in the U.S. market. To reiterate, our next-generation CGuard implant has demonstrated unmatched clinical evidence and outcomes over 75,000-plus procedures worldwide, and we believe these clinical results establish a new standard of care for stroke prevention. During our last quarterly conversation, we set out a clear set of priorities focused on moving our regulatory programs forward toward the U.S. Our priorities were: securing approvals, growing the international side of the business, improving how we deliver CAS, and bringing our organization and cost structure into alignment. On each of those fronts, we have advanced in a meaningful way. The CGuard Prime TransCarotid Stent System's approval rested on the CGUARDIANS II pivotal trial. In that study, acute device success reached 100% across 50 patients, with zero deaths, strokes, or myocardial infarctions out to 30 days, and full stent patency at 30 days among patients who were evaluated; in our view, these findings underscore the clinical benefit of the CGuard implant and its proprietary MicroNet mesh technology. Treating the lesion and delivering lasting stroke protection has always been the heart of our value proposition. With this TCAR indication, our U.S. That expands the market we can reach by about 40,000 procedures annually, which essentially doubles the opportunity ahead of us, and we plan to pursue it immediately with a top-tier commercial team that is already in the field and prepared to execute. It also backs an indication for use of our implant in TCAR, a key approach to carotid revascularization. Our strategy is to make CGuard available for both TCAR and transfemoral CAS procedures so that we can serve the wide range of patients and physician needs. Our view is that no other company had concentrated on the whole carotid field with an implant-first strategy before us, and that effort rests on clinical evidence from our mesh-protected platform. With this approval in hand, commercial execution becomes our priority. As U.S. sales get underway, we plan to leverage the foundation and momentum created by our account approvals, the awareness among physicians, and the enthusiasm this technology has generated. Our commercial playbook will keep guiding us as we pursue sales growth in a disciplined, direct manner. During recent months, our preparations for this comeback centered on being commercially ready, involving physicians, training, and clinical assistance. We bolstered our leadership team by naming Kathy Kennedy Senior Vice President of Global Sales and Marketing, plus promoting and bringing in multiple important leaders across engineering, clinical, regulatory, and operations areas to back this launch and get ready for upcoming clearances and improvements to our platform. This approval represents just the start, in our view, as we work toward our goal of heading this significant and expanding area of vascular medicine with a full range of devices backed by clinical proof. Long-term success hinges on steady execution, doctors' trust, and converting our clinical advantages into everyday practice—something we think is within reach. Overseas, business kept expanding: Q3 revenue rose roughly 9% versus a year earlier, reaching $2.2 million. For the first nine months of 2026, international revenue climbed about 24% to $6.6 million, showing growing uptake of the CGuard platform in the markets we serve. U.S. reported revenue is still weighed down by our market absence after the May voluntary recall of the CGuard Prime 135 delivery system, yet demand abroad keeps showing the fundamental attractiveness of our implant technology. Outside of TCAR, we keep pushing forward on initiatives meant to expand our carotid intervention offerings. The CGuard carotid stent system, our original device for CAS, is still being reviewed by the FDA. We think this platform—backed by a long record of international clinical sales and more than 75,000 patients treated—could round out our portfolio and broaden access to our technology, assuming the FDA gives its approval. On the CGuard Prime 135 CAS delivery system, we've made design improvements in the wake of the voluntary recall. Validation and performance testing are in progress, and at this point we expect to submit to the FDA before the year is out; we're still aiming to bring this platform back to market during the first half of 2027, contingent on regulatory review and approval. Our CGUARDIANS III pivotal trial continues to enroll patients; that study is evaluating SwitchGuard, our proprietary neuroprotection system, for TCAR procedures. In our view, SwitchGuard presents an opportunity to pair with our implant through a full suite of proprietary tools and technology, which would extend the range of procedures we can address. To take the next step in growing our capabilities within TCAR, we plan to introduce a proprietary micro puncture kit designed to facilitate vascular access, and our current expectation is a planned release in early Q1 2027. Considered together, these efforts reflect our goal of constructing a more comprehensive platform for carotid intervention, providing physicians with a wide array of solutions spanning both TCAR and CAS. We remain focused on directing our resources toward the regulatory and commercial opportunities of greatest priority. During Q3, we implemented roughly a 20% cut to our workforce. We believe this will improve the fit between our resources and our top priorities in product development, regulatory work, and clinical commercialization, while also reducing our total operating expense base. We'll remain financially disciplined as we fund our commercial reentry and move our pipeline forward. Mike will soon provide more specifics regarding financial performance, liquidity, cost structure, and related matters. Before turning the call over to Mike, I'd like to underscore four key messages. First, FDA approval for TCAR represents a significant milestone—it returns CGuard Prime to the U.S. market with a next-generation implant and substantially broadens our addressable opportunity. Next, we think we're set up well to carry out our expansion plan and continue moving toward profitability. Also, we're starting a period of growth focused on commercial execution, backed by a seasoned team and a careful, disciplined method for encouraging physicians to adopt our products. On top of that, we keep moving forward a portfolio that stands apart in TCAR and CAS, covering the original CGuard system, the improved Prime 135 delivery platform, SwitchGuard, and supporting technologies used in procedures. To wrap up, we've made substantial progress in simplifying how we run the business worldwide and in bringing our spending in line with those priorities. We know there is still significant work to do, yet a differentiated implant, strong clinical evidence, a growing product lineup, and a leaner organization leave us confident that InspireMD is set up well for what comes next. I'll now hand things over to Mike for the third quarter financials. Mike, the floor is yours.

Thank you, Marvin. Turning to the third quarter of 2026, total revenue came in at $2.2 million, a decrease of $0.3 million, or 11%, compared with revenue during the third quarter of 2025. That drop stemmed from the voluntary step we took in May to pull back temporarily from the U.S. market until we were able to put in place improvements to how CGuard Prime is delivered for CAS. International revenue reached $2.2 million, which represents growth of $0.2 million, or 9%, against the same quarter last year. That result reflects the ongoing strong performance of, and worldwide demand for, our original CGuard stent platform. Foreign exchange movements created roughly a 1% drag on reported growth, meaning that on a constant currency basis, international revenue rose 10%. U.S. sales came to approximately $32,000 during the quarter, arising mainly from sales booked 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, versus a gross profit of $0.9 million, or 34.2% of revenue, in the third quarter of 2025; that variance came about mainly because no revenue was generated in the U.S. as a result of the voluntary step we took in the second quarter. We also saw margins in international sales that were below expectations, largely because of a greater mix of sales to countries with lower ASPs. Total operating expenses for the third quarter of 2026 were $10.2 million, a reduction of $3.7 million, or 27%, from $13.9 million in the third quarter of 2025. That reduction was driven chiefly by the effect of the workforce reduction action we carried out during the past quarter. Roughly $1.8 million of that reduction comes from a one-time reversal of previously recognized stock compensation expense tied to share grants that were forfeited under the headcount reductions. Savings from the workforce reduction were partly offset by increased spending on the CGUARDIANS III clinical trial. Financial income was $191,000, compared with income of $343,000 in the third quarter of 2025. Net loss for the third quarter of 2026 came to $9.8 million, or $0.12 per basic and diluted share, versus 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 stood at $19.2 million, compared with $54.2 million at the end of 2025. With today's announcement of FDA approval of CGuard Prime for TCAR, we have started the 20-day expiration period for the amended Series J and K warrants, during which holders are able to exercise their warrants. If exercised in full, those warrants could bring in up to $10 million of net proceeds. After this 20-day period, the only milestone-based warrants remaining in our cap table will be the original Series J warrants, whose expiration period is triggered by FDA approval of SwitchGuard, our neuroprotection system that is currently in phase III clinical trials. Just as Marvin mentioned before, we also shared today that a potential financing transaction has been launched. Should it be completed, we anticipate using the proceeds to back, among other things, our commercial launch activities within the U.S. as well as our CGUARDIANS III pivotal trial for the SwitchGuard neuroprotection system. Terms of this potential transaction, including how much in proceeds, are not yet determined. That wraps up our prepared remarks; we'll now open the call for questions. Operator?

Hi there, good afternoon. I appreciate you taking my questions, and congratulations on the CGuard short shaft approval. Perhaps we can begin with that, Marvin. I'd really like a bit more detail on how you're viewing possible uptake for that product. How does it look regarding the VAC committee process, and is there some attach rate you're aiming for with those TCAR procedures? Then I have one more question after that. Thanks.

Thank you for that question, Adam. My sense is that, broadly speaking, we're eager to resume from the point we reached before, in terms of our VAC approvals and our commercial traction. Our sales team has kept working quietly in the background to ensure we have really solid account plans and targeting in place. The Prime 135 system we recalled earlier stays approved, so we can capitalize on the momentum from those prior approvals, and we'll keep rolling out the short shaft system within the TCAR setting accordingly. As a result, we believe we can build on a warm start.

Alright, that's useful, Marvin, thanks. So perhaps just a couple more from me, if that works. I'll put both of them out there now. I was curious whether there's any news on the schedule for the original CGuard delivery system. At what point do you think that product will be on the market? And I believe you mentioned the CGUARDIANS III clinical trial during the prepared remarks. I simply wanted to check that it's still aiming at a back half 2027 approval. Thank you.

Yes. Thanks once more, Adam. So, regarding the legacy system, we still expect feedback from FDA before the year is out, which is what we originally intended. FDA has received all of the information, and it keeps reviewing the legacy system for approval, which we still expect to happen on those timelines. When it comes to CGUARDIANS III, enrollment is actively underway in that trial, and we keep building on that momentum by activating additional sites. The vascular surgery community remains enthusiastic, particularly those who have used our stent device in earlier trials. So we look forward to further speeding up those enrollments and the timelines we talked about, end of 2027, and those continue to hold.

Wonderful to hear that. Thanks very much.