Earnings call transcript: InspireMD Q1 2025 shows mixed results

InspireMD Inc. (NASDAQ:NSPR) reported its first-quarter 2025 earnings with a mixed performance, as the company exceeded earnings per share (EPS) expectations but fell short on revenue forecasts. The actual EPS was -$0.22, beating the forecast of -$0.31. However, revenue came in at $1.53 million, below the expected $1.79 million. Following the announcement, InspireMD’s stock decreased by 3.79% in aftermarket trading, closing at $2.501. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 5.28x, indicating robust short-term financial stability.

Key Takeaways

• InspireMD’s EPS beat expectations by $0.09 per share.
• Revenue fell short of forecasts, raising concerns among investors.
• The company is advancing its product pipeline with upcoming launches.
• Stock price dropped 3.79% in aftermarket trading.
• FDA approval timelines have been slightly extended.

Company Performance

InspireMD reported a year-over-year revenue growth of 1.2%, reaching $1.53 million. The company’s gross profit remained flat compared to the same quarter last year, while its gross margin stood at 19.1%. Despite these improvements, the company recorded a net loss of $11.166 million, or $0.22 per share, highlighting ongoing financial challenges. InvestingPro analysis shows the company’s Financial Health Score stands at 2.18 (Fair), with particularly strong momentum metrics. Subscribers can access 7 additional ProTips about NSPR’s financial position and growth prospects.

Financial Highlights

• Revenue: $1.53 million, up 1.2% year-over-year.
• Earnings per share: -$0.22, beating the forecast of -$0.31.
• Gross profit: $292,000, flat compared to Q1 2024.
• Cash and equivalents: $26.086 million as of March 31, 2025.

Earnings vs. Forecast

InspireMD’s actual EPS of -$0.22 exceeded the forecast of -$0.31, a positive surprise of $0.09 per share. However, the company’s revenue of $1.53 million fell short of the $1.79 million forecast, a 14.5% miss, which likely contributed to the negative market reaction.

Market Reaction

Despite the EPS beat, InspireMD’s stock fell by 3.79% in aftermarket trading, closing at $2.501. This decline suggests investor concerns over the revenue miss and the company’s ongoing net losses. The stock’s performance contrasts with its 52-week range, where it has fluctuated between $2.07 and $3.798. InvestingPro data reveals analyst targets ranging from $4.50 to $5.00 per share, suggesting potential upside. The stock is currently trading near its Fair Value, based on comprehensive analysis available in the Pro Research Report, which provides detailed insights for over 1,400 US stocks.

Outlook & Guidance

InspireMD is preparing for the U.S. launch of its CGuard Prime stent, anticipated to receive FDA approval in Q3 2025. The company is also targeting FDA approval for its CGuardians Two trial in the first half of 2026 and potential clearance for its Switchgard neuroprotection system in late 2026. These developments are expected to enhance the company’s market position. With a five-year revenue CAGR of 14% and holding more cash than debt on its balance sheet, the company appears positioned for its expansion plans, though InvestingPro analysis indicates rapid cash burn remains a key consideration for investors.

Executive Commentary

CEO Marvin Salzman expressed optimism about the company’s future, stating, "We firmly believe CGuard Prime is positioned to redefine the treatment of carotid disease and stroke prevention." He also highlighted the progress in clinical trials, noting, "Enrollment is going remarkably well," and emphasized the company’s proactive engagement with the FDA.

Risks and Challenges

• Revenue shortfall raises concerns about future financial performance.
• Extended FDA approval timelines may delay product launches.
• Competitive pressures in the carotid artery intervention market.
• Ongoing net losses could strain financial resources.
• Potential challenges in expanding U.S. manufacturing capabilities.

Q&A

During the earnings call, analysts queried the company about its FDA approval timelines, with executives acknowledging slight delays due to audit timing. Questions also focused on the company’s clinical trial progress and commercial strategy, with management affirming their commitment to expanding the commercial team methodically.

Full transcript - InspireMD Inc (NSPR) Q1 2025:

Conference Operator: Good morning and welcome to InspireMD’s First Quarter twenty twenty five Earnings Conference Call. Currently, all participants are in a listen only mode. We will be facilitating a question and answer session towards the end of today’s call. As a reminder, 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.

Webb Campbell, Investor Relations, Gilmartin Group: Thank you for joining us for the InspireMD First Quarter twenty twenty five Conference Call. Joining us today from InspireMD are Marvin Salzman, Chief Executive Officer and Craig Shore, Chief Financial Officer. During this call, management will be making forward looking statements, not historical facts, 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 INSPIRE MD’s most recently filed periodic reports on Form 10 ks and Form 10 Q and any updates in our current reports on Form eight ks 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, 05/09/2025. Except as required by law, InspireMD disclaims any intention or 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 Salzman, Chief Executive Officer.

Marvin, please go ahead.

Marvin Salzman, Chief Executive Officer, InspireMD: Thank you, and good morning. We’re pleased to welcome everyone to the call today. I’d like to start by highlighting our first quarter performance. CGuard revenue reached $1,530,000 reflecting a 1.2% growth year over year. This revenue translates to unit sales of 2,611 CGuard stents sold, providing world class treatment to thousands of patients suffering from carotid artery disease.

These results contribute to our growing body of real world experience with roughly 64,000 implants sold to date, underscoring our expertise in the space and global commercial foundation as we prepare for the anticipated U. S. Approval and launch of CGuard Prime. Turning to our CGuard Prime approval status. Based on our latest communication with FDA, we are optimistic for approval in the third quarter of twenty twenty five.

We are actively addressing feedback and remain confident in achieving this approval. Anticipating a positive outcome, we’re preparing for commercial launch with a growing world class team expecting significant demand for CGuard Prime as the only next generation proven carotid stent platform demonstrating best in class results and superior patient outcomes. To better illustrate the opportunity ahead in The U. S, using our current sales as a benchmark, during the first quarter, we sold 2,611 stents internationally. Had this volume been realized in The U.

S. At current market ASPs, it would have generated approximately $12,000,000 in revenue, assuming a balanced mix of CAS and TCAR procedures. The market growth of both CAS and TCAR remains significant with data suggesting the conversion of majority of the procedures from surgery to stenting is underway with endovascular procedures potentially representing the majority sometime next year. We believe the introduction of CGuard Prime will further catalyze this shift as it introduces true next generation performance and results. Given this strong starting point, we are highly confident that The U.

S. Launch of CGuard Prime combined with the potential introduction of our Switchgard neuroprotection system for TCAR will serve as a powerful catalyst for significant revenue expansion following regulatory approval. We remain committed to strategically expanding our commercial and clinical foundation throughout 2025, and we believe these investments will drive robust growth over the coming years. As we continue to engage with the FDA, we’ve been diligently building a world class commercial and operational engine to support our highly anticipated U. S.

Launch. We’ve onboarded and trained roughly 20 high powered sales and marketing professionals. Our cadence will continue adding talent to the team to address what we believe to be tremendous demand from our carotid technologies. Thus far, we’re thrilled by the caliber of individuals who bring extensive experience, deep relationships and proven track records of launching new products in the vascular space. Their expertise in this field along with their trusted connections to our customers builds a foundation of field presence across The United States ready to deliver results.

The overwhelming interest from highly talented seasoned professionals who are eager to join our organization at this pivotal time is a clear reflection of the excitement surrounding CGuard Prime and the broader shift taking place in carotid revascularization toward endovascular first solutions. Our sales organization will also leverage robust claims data along with their knowledge of market dynamics and relationships to inform strategic targeting and optimize opportunity capture. Our evolving data ecosystem is laying the groundwork for precision and execution. We are not just prepared for launch, we are ready to aggressively execute a comprehensive commercial launch. We firmly believe CGuard Prime is positioned to redefine the treatment of carotid disease and stroke prevention, and we intend to fully capitalize on the market’s momentum toward less invasive solutions.

We expect our state of the art facility in Miami, Florida to complement our commercial build out illustrating our commitment to scaling U. S. Operations. Domestic production will enable us to meet market demand efficiently, while also providing a diversified supply chain in the face of macroeconomic uncertainty. I was able to witness the excitement of our technology firsthand a few weeks ago at the Charing Cross International Symposium in London.

The focus on the carotid intervention and groundswell around our technology was palpable. With great interest at our booth, both from physicians already using CGuard and from those who are just learning of our story and want to be involved, including prominent U. S. Doctors. Additionally, there were about five hours of carotid programming plus two fully subscribed cast hands on workshops and a tremendous shift in focus from prior years.

Contingent upon U. S. Approval, we believe we are exceptionally well positioned to meet robust demand for CGuard Prime. With the infrastructure, operational readiness we’ve built, we are confident in our ability to drive significant and sustained success in The U. S.

Market. Shifting to our clinical pipeline where we continue to make strong progress. As a reminder, in October 2024, we received FDA approval for our investigational device exemption or IDE application to begin the CGuardians two pivotal study of our CGuard Prime carotid stent system in TCAR procedures. This important study is designed to evaluate the safety and effectiveness of our novel CGuard Prime stent platform in a short TCAR indicated version compatible with existing commercially available neuroprotection systems. I’m pleased to share our enrollment remains strong and growing with new sites participating and contributing, and we remain on track to achieve our clinical milestones with an anticipated first half of twenty twenty six approval.

At the same time, we’re advancing our broader TCAR strategy. We’re engaged with FDA and our CGuardian III IDE submission, which will study our fully integrated TCAR solution pairing the CGuard Prime 80 stent with our proprietary Switchgard neuroprotection system. We anticipate approval and initiation of our study in Q3 with possible FDA clearance in late twenty twenty six as we advance our TCAR focus with next generation Switchgard kit designs. TCAR represents a significant and growing opportunity with more than 30,000 procedures performed annually in The U. S.

As we expand our clinical footprint, we’re building a differentiated comprehensive solution for carotid revascularization, one we believe can meaningfully reshape the market and drive long term growth. Turning now to our other clinical initiatives, we’re excited to announce that we have successfully enrolled the first four patients in our tandem lesion early feasibility study. This study conducted in partnership with Doctor. Adnan Sadiki and the Jacobs Institute in Buffalo, New York focuses on evaluating CGuard Prime Stent in acute stroke patients with tandem lesions in conjunction with thrombectomy. As a reminder, the CGuard Prime Stent features a proprietary MicroNet mesh, which is designed to provide superior embolic protection during carotid artery stenting.

We believe this study will demonstrate the safety and feasibility of using our stent in these acute stroke procedures. This investment reflects our deep commitment to the neurovascular community and underscores a critical component of our long term growth strategy. Our ongoing focus of both CAS and TCAR technology positions us to serve the broadest physician base, while also preparing us to lead as procedural reimbursement and clinical practice increasingly shift toward an endovascular first standard of care. As a reminder, receipt of premarket approval from the FDA would trigger the second of four milestone based financing tranches pursuant to the transformational private placement of up to $113,600,000 that we originally announced in May of twenty twenty three. It fully exercised the second tranche would raise an additional $17,900,000 in gross proceeds.

After premarket approval, the remaining two milestones would each trigger additional tranche financings, including the receipt of FDA clearance of Switchgard TCAR neuroprotection system, along with the TCAR indication for the CGuard Prime stent and the completion of four full fiscal quarters of commercial sales of CGuard Prime in The United States, which we anticipate in the back half of twenty twenty six, pending the approvals I mentioned earlier and based on our current plans. This quarter has positioned us to hit the ground running as we move toward these transformational milestones. Now I’ll turn the call over to Craig to walk through the financials. Craig?

Craig Shore, Chief Financial Officer, InspireMD: Thank you, Marvin. For the first quarter of twenty twenty five, total revenue increased 1.2 to $1,529,000 This increase was driven by growth in existing markets offset by the impact of foreign exchange and distributors managing CGuard inventory levels in anticipation of CGuard Prime approval in Europe. Gross profit for the first quarter of twenty twenty five of $292,000 was flat compared to the first quarter of twenty twenty four. Gross margin during the three months ended 03/31/2025 was 19.1%. Total operating expenses for the first quarter of twenty twenty five were $11,752,000 an increase of $4,000,000 or 52.5% compared to $7,706,000 for the first quarter of twenty twenty four.

This increase was primarily due to higher salaries and share based compensation tied to U. S. Sales force expansion ahead of FDA approval. Additional increases stemmed from CGAR Prime launch preparation, US facility rent and CFO recruitment fees. Total financial income for the first quarter of twenty twenty five was $294,000 a decrease of $88,000 or 23% compared to $382,000 for the first quarter of twenty twenty four.

This decrease was primarily due to less interest income from investments in marketable securities and money market funds. Net loss for the first quarter of twenty twenty five totaled $11,166,000 or $0.22 per basic and diluted share compared to a net loss of $7,032,000 or $0.21 per basic and diluted share for the same period in 2024. As of 03/31/2025, cash and cash equivalents and marketable securities were $26,086,000 compared to 34,000,006 and $37,000 as of 12/31/2024. This concludes our pre prepared remarks. We will now open the call for questions for the Q and A segment.

We will be joined by Shane Gleeson, InspireMD’s Chief Commercial Officer. Operator?

Conference Operator: Thank We’ll take our first question from Adam Mater with Piper Sandler. Please go ahead.

Adam Mater, Analyst, Piper Sandler: Hi. Good morning, Marvin, Shane, Craig. Thank you for taking the questions. Just a couple from me and really kind of wanted to level set on timelines from the different products and maybe just starting with CGuard Prime, your transfemoral stents and just FDA approval. It looks like maybe a little bit of a push out on anticipated FDA approval now to Q3.

So what’s the primary reason for the slight change in timing? Certainly realize it’s unique times at the agency, but wanted to get some more color there. Just level of confidence that you’ll get across the regulatory goal line in Q3 and maybe just flesh out the latest dialogue with FDA and kind of what’s left to do from your side, if anything. And then I had a follow-up or two. Thanks.

Marvin Salzman, Chief Executive Officer, InspireMD: Great. Thanks, Adam, and good morning. I think it’s important to level set the context that in June of twenty twenty four, we submitted Module three of our PMA, which is the site inspection component. And subsequently, we filed the final PMA dossier on September. So, following the submission, we maintained active engagement with the FDA, including a successfully completed one hundred day meeting.

Key milestone obviously underscores the strength of our submission. And we’ve remained very interactive with the agency since that time. The facility site audit unfortunately could not be scheduled until February of twenty five and was only complete on February 18. So, less than a month before this one hundred and eighty day statutory review deadline. And so, the subsequent time required for FDA’s feedback, our responses and the necessary follow-up is just compressed that window for final approval.

We continue to engage interactively with FDA on the feedback and responses to the observations from the audit and continue to be very confident in the approval. We’re simply building some room into the approval timeline to accommodate these final steps, which given the current situation, as you noted, we believe is a prudent step to take. So, think on balance, the simple answer is that we’re very engaged with FDA and we feel that we’re on top of all the remaining details and topics. But we believe given the current circumstances, statutory response times and otherwise, we wanted to build in some additional room.

Adam Mater, Analyst, Piper Sandler: That’s really helpful color. I appreciate all that, Marvin. Thank you. And I guess for the follow ups, just wanted to see if we could get some more color on enrollment progress in CGuardians two. It sounds like that’s still tracking to first half twenty twenty six FDA approval.

I think I heard that in the prepared remarks. But yes, just maybe many just any more color you can provide in terms of enrollment in that trial and kind of how things are going. And then I had one more follow-up. Thanks.

Marvin Salzman, Chief Executive Officer, InspireMD: Sure. Thanks, Adam. Enrollment is going remarkably well. Most importantly, there’s tremendous enthusiasm for the users of CGuard Prime in this particular case, vascular surgeons who are using the product for the first time. The long pole in the tent was obviously a lot of administrative work building the number of sites and getting them online and active.

We have eight active sites currently. And so the cadence of enrollment continues to progress really nicely, and we believe will remain consistent with all those approvals that we’ve previously discussed. But as is always the case, one aspect is to perform a well executed trial. Most importantly, the feedback from the doctors has been resoundingly positive and enthusiastic about ultimately being able to use this device in TCAR procedures, which has been long overdue in many of their minds. So, we’re very enthusiastic on every level and continue to maintain our pace there.

Adam Mater, Analyst, Piper Sandler: Okay, perfect. Good color there. And just one last one for me, then I’ll jump back in queue. Just wanted to discuss Switchgard and the update there. So it sounds like you’re engaged with FDA regarding CGuardient’s resubmission.

Hopefully, I heard that right. I did hear possible clearance in late twenty twenty six for U. S. Is that a little bit of a wiggle, Marvin? Because in my notes, had mid-twenty six approval for Switchgard.

So did we have a little bit of a slide to timelines? And if so, what’s driving the revised timeline there? Thank you.

Marvin Salzman, Chief Executive Officer, InspireMD: Yes. Thanks, Adam. To answer that question specifically, we have resubmitted our IDE to FDA

somewhat undetermined until we get formal feedback from FDA. So, I think that window remains the right one to take, which is late twenty six clearance for the device there.

Conference Operator: Thank you. Thank you. We’ll take our next question from Frank Takinen with Lake Street Capital. Please go ahead.

Frank Takinen, Analyst, Lake Street Capital: Great. Thanks for taking the questions. And maybe I’ll kind of follow-up on Adam’s first question related to CRs of growth time in Q3. It sounds like it’s really just related to a matter of timing, but just given some of the cost cuts in the FDA and some of the layoffs there, just wanted to check one more time on have you had any change to your review team? Has there been any feedback that’s been coming slower, or is this really just things that’s taken a little bit longer than anticipated, but the team still remains intact and we’re still in good shape from an interaction perspective with the FDA?

Marvin Salzman, Chief Executive Officer, InspireMD: Frank, good morning. Thanks for the question. So I would characterize it this way. Everything that we have progressing on related to FDA, including the lead enroller or I’m sorry, the lead administrative contacted FDA remains consistent. In fact, we’re very positive and continually interactive with that group.

The follow-up that’s required is from the audit, which is a different group within FDA. And so, the combination of being able to communicate this information back and forth and provide all the evidence from the results of that audit continue to create time. And so the disruptions of the FDA have clearly impacted to a certain extent the overall program. But I would say within the context our submission, we remain confident that everything is on track. However, as you know, there are statutory requirements for certain timelines of responsiveness and otherwise.

We’ve completed all of our evidence responses, and we’re just trying to build in a reasonable bandwidth there in order to get that feedback processed and assimilated, given circumstances and resources and just being prudent about the timeline.

Frank Takinen, Analyst, Lake Street Capital: Okay, that’s helpful. And then I wanted to ask one commercial organization related. Obviously,

Marvin Salzman, Chief Executive Officer, InspireMD: you

Frank Takinen, Analyst, Lake Street Capital: guys have been ramping up a really high quality team in last couple of quarters in advance of the trial. Should we kind of think about your cadence of hiring with in light of some of the FDA commentary? Should we expect you to maybe moderate that a little bit until you get the approval? And how does that kind of maybe impact models as we’re thinking about operating expense throughout the year?

Marvin Salzman, Chief Executive Officer, InspireMD: I’ll take the first pass on that. We’ve got Shane on the line, and I’m sure he can add some additional color. I think we’ve established a tremendous foundation within the commercial organization thus far and are building a team of professionals that we think can launch the product very effectively. We always architected this plan around the consistency of the timelines that we just noted. I mean, clearly, we want to be very prudent about how fast we add additional resources.

But I think in terms of our establishment of architecting the right people in the right places, given the timeline and the launch sequence and our intention to aggressively launch the product into the market, we feel very comfortable that got the right start and the right foundation. And certainly, we’ll keep a close eye on next classes that are added to our training program. Maybe Shane can add additional to that.

Shane Gleeson, Chief Commercial Officer, InspireMD: Yeah, I think that’s exactly right. And good morning, Frank. The the the plan has been to get the the foundation built, training, marketing, sales operations, and the foundational members of the of the field team, and then to be able to scale in earnest upon approval. So that all remains unchanged.

Frank Takinen, Analyst, Lake Street Capital: Perfect. That’s helpful. And then maybe one related to Crest two. I know it’s it’s come up on conference calls in the past, but I think we’re looking for a read out of that trial in the second half of twenty twenty five. So maybe kind of help us or maybe reiterate how you think that could go and different market impacts we could see from that.

Marvin Salzman, Chief Executive Officer, InspireMD: So, Shane’s become our Crest two expert in the organization, not to put him on the spot, but maybe I’ll let Shane take that one if you don’t mind.

Shane Gleeson, Chief Commercial Officer, InspireMD: Yeah, I’d be happy to. So the enrollment’s been completed. Just as a reminder, CREST two is really two separate two separate trials. One was randomizing optimized medical therapy against carotid endarterectomy, and then a separate separate enrolling trial was randomizing optimized medical therapy to carotid stenting. And in both of those intervention parts, surgery and stenting, the patients also received doctoral medical therapy.

And as I’m starting to hear this discussed quite a bit, from the podium at the conferences, the tone seems to be that it all depends what the results look like, all depends on the types of patients that are enrolled. If a lot of patients who are unlikely to have strokes are enrolled patients with less severe disease, then there won’t be many strokes to prevent and the intervention won’t likely be overwhelmingly positive or superior there. Again, if you’re treating patients who are unlikely to have strokes within the follow-up window, there won’t be as many strokes to prevent. So the curves won’t be able to diverge. However, if patients that have more severe disease are enrolled time and time again in the studies, those patients are shown to have events if they’re not intervened upon.

And, if we treat if, the patients who were enrolled had more severe disease, then that’s gonna look more and more positive for the intervention arms. So I think we’re all kind of waiting to see what the, what the results are. There will be subset analysis. And, I think the expectations are that it won’t change practice much because the less severe patients are the ones in practice. Although the guidelines may allow treatment in practice, they typically are not treated until the disease gets more severe.

So I think the tone that I hear from the meetings is a lot of people kind of expect it to tell us exactly what we already know and not change practice in any meaningful way.

Frank Takinen, Analyst, Lake Street Capital: Got it. That’s helpful. Thank you. I’ll stop there.

Conference Operator: Thank you. And that does conclude our question and answer session. I’d now like to turn the call back to Marvin Salzman for closing remarks. Please go ahead.

Marvin Salzman, Chief Executive Officer, InspireMD: Yes, thank you very much. I’d like to thank everyone for joining the call and for the ongoing support of our mission to lead the carotid revascularization market at INSPIREMD. We’re very pleased with our execution in Q1 of twenty twenty five and look forward to the many milestones ahead, including potential emanate U. S. Approval and launch of CGuard Prime.

Thanks very much.

Conference Operator: Thank you. And this concludes today’s program. Thank you for your participation. You may disconnect at any time.

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