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InspireMD Inc. (NASDAQ: NSPR) reported its fourth-quarter 2024 financial results, surpassing revenue expectations and slightly exceeding earnings per share (EPS) forecasts. The company posted a net loss of $0.19 per share, better than the anticipated $0.20 loss. Revenue reached $1.9 million, beating the forecast of $1.83 million. Following the announcement, the stock rose 4.66% in premarket trading to $2.92. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 6.39, though it faces profitability challenges with negative earnings over the last twelve months.
Key Takeaways
- InspireMD’s Q4 2024 revenue of $1.9 million exceeded forecasts by $70,000.
- EPS loss of $0.19 per share was slightly better than the forecasted $0.20.
- The stock saw a 4.66% increase in premarket trading.
- The company is poised for the U.S. launch of CGuard Prime in 2025.
- InspireMD reported a gross margin decline to 24.1% from 28.7% the previous year.
Company Performance
InspireMD demonstrated robust revenue growth in Q4 2024, achieving a 10.6% increase compared to the same quarter in 2023. The full-year revenue for 2024 reached $7 million, marking a 13% rise year-over-year. InvestingPro analysis reveals a strong 5-year revenue CAGR of 11%, though the company faces profitability headwinds with a -56.19% return on assets. Despite the revenue growth, the company faced a decline in gross margin, which fell to 24.1% from 28.7% in the previous year. This reflects increased costs or pricing pressures in the market.
Financial Highlights
- Revenue: $1.9 million, up 10.6% from Q4 2023.
- EPS: Net loss of $0.19 per share, slightly better than forecast.
- Gross Margin: Decreased to 24.1% from 28.7% in Q4 2023.
- Cash and Equivalents: $34.7 million as of December 31, 2024.
Earnings vs. Forecast
InspireMD’s actual EPS of a $0.19 loss was slightly better than the forecasted $0.20 loss, marking a minor positive surprise. Revenue also exceeded expectations by $70,000, a notable achievement given the company’s focus on expanding its product line and market presence.
Market Reaction
Following the earnings announcement, InspireMD’s stock price increased by 4.66% in premarket trading, reaching $2.92. This positive movement indicates investor confidence in the company’s ability to meet future targets and capitalize on its upcoming product launches. The stock remains within its 52-week range of $1.81 to $3.798. Analyst consensus from InvestingPro shows strong buy recommendations with price targets ranging from $4.50 to $5.00, suggesting potential upside. Get access to 8 additional exclusive ProTips and comprehensive financial analysis through InvestingPro’s detailed research reports.
Outlook & Guidance
InspireMD is preparing for the U.S. launch of its CGuard Prime product in the first half of 2025, pending FDA approval. The company anticipates a potential second financing tranche of $17.9 million upon approval. Additionally, InspireMD is targeting the approval of its SwitchGuard TCAR neuroprotection system in the second half of 2026.
Executive Commentary
CEO Marvin Salzman expressed optimism about the company’s future, stating, "We remain optimistic on the first half approval" of CGuard Prime. Chief Commercial Officer Shane Gleeson noted the growing enthusiasm for the company’s products, highlighting the strategic expansion into the U.S. market.
Risks and Challenges
- Regulatory Approval: Delays in FDA approval for CGuard Prime could impact timelines.
- Market Competition: Increased competition in the carotid stent market may pressure margins.
- Economic Conditions: Macroeconomic factors could affect healthcare spending and investment.
- Product Launch: Successful U.S. market entry depends on effective commercial infrastructure.
Q&A
During the earnings call, analysts inquired about the FDA approval timeline for CGuard Prime, which InspireMD is confident will occur in the first half of 2025. The company also discussed its strategic approach to building a commercial team and preparing for hospital value analysis committee reviews.
Full transcript - InspireMD Inc (NSPR) Q4 2024:
Conference Operator: Hello, and welcome to InspireMD’s Fourth Quarter twenty twenty four 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. Please go ahead.
Webb Campbell, Gilmartin Group Representative, Gilmartin Group: Thank you for joining us for the InspireMD fourth quarter twenty twenty four conference call. Joining us today from InspireMD are Marvin Salsman, Chief Executive Officer and Craig Shore, Chief Financial Officer. During the 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 InspireMD’s most recently filed periodic reports on Form 10 K and Form 10 Q or any updates in our current reports on Form eight K 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, 03/12/2025. 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 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 strong fourth quarter and full year performance. CGuard revenue reached a new quarterly high of $1,950,000 in the fourth quarter, reflecting a 10.6% growth year over year with $7,000,000 in revenue for the full year 2024. Translating our momentum in unit sales of 3,512 CGuard stents sold for the quarter and 12,100 units for the full year, thus benefiting thousands of patients in our end market suffering from carotid artery disease.
These results contribute to more than sixty thousand implants sold to date as a testament to our strong global commercial foundation and real world experience as we build toward anticipated approval and launch of CGuard Prime in The United States. I’m pleased to share that we remain on track for an anticipated U. S. Approval and launch of CGuard Prime in the first half of twenty twenty five. With the potential approval, I’d like to illustrate how our global Q4 sales would translate in U.
S. Market revenue to help frame the potential opportunity. With 3,512 stents sold internationally during the fourth quarter, had this number of stents sold in The U. S, they would have generated over $16,000,000 in revenue, assuming a balanced mix between cats and TCAR sales at current U. S.
Market ASP. To put this in perspective, we estimate that more than 7,000 U. S. TCAR procedures were performed in the fourth quarter, making our global unit sales close to 50% of The U. S.
Only TCAR market before we’ve even entered the market with both cats and TCAR solutions. Therefore, with The U. S. Market entry of both cats and TCAR platforms, we are confident in the significant revenue expansion upon regulatory approval. To recap our regulatory status in The U.
S, in September 2024, we submitted the final module of our pre market approval or PMA application to FDA and have since engaged in an interactive review process. We are optimistic for a timely and positive decision, which would enable our U. S. Market launch of CGuard Prime triggering the commercialization of our best in class stent platform in The U. S.
While our review continues with FDA, we’ve been diligently building a world class commercial and operational engine to support our highly anticipated U. S. Launch. We are not just prepared, but ready to aggressively execute a robust commercial and operational launch plan. We believe CGuard Prime is poised to redefine carotid artery disease treatment and stroke prevention and plan to fully capitalize on the shift toward an endovascular first approach.
Our new headquarters in Miami, Florida is strategically positioned to support the anticipated U. S. Launch and commercialization of CGuard Prime upon approval. This state of the art facility represents our commitment to scaling operations in The U. S.
And further strengthens our ability to execute on a national level. Contingent upon U. S. Approval, we also believe we are well positioned to meet robust demand for CGuard Prime as our infrastructure and operations will support significant growth and success in The U. S.
Market. In addition to building the support functions of marketing and commercial operations, we have onboarded more than a dozen world class field sales professionals and will continue to build our field sales presence with intention over the next twenty four months. There is overwhelming interest from highly talented seasoned professionals interested in joining our organization at this pivotal time, reflecting the potential of CGuard Prime and the shifting change in the landscape of carotid revascularization. Given us confidence in our submission and the pending approval of CGuard Prime is the overwhelmingly positive one year data from the CGuardian’s pivotal clinical trial first presented at the LIGHTSIG interventional course in 2024. This trial evaluated the safety and efficacy of CGuard and CGuard Prime in treating carotid artery stenosis enrolling three sixteen patients across 24 trial sites in The U.
S. And Europe. The CGARDIAN’s results demonstrated an unprecedented primary endpoint with major adverse events rates of just zero point nine five percent through thirty days and one point nine five percent through twelve months post procedure making this the lowest event rate ever reported in a pivotal study of carotid stent or embolic protection device. As a reminder, receipt of premarket approval from the FDA would also 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. If fully exercised, the second tranche would raise an additional $17,900,000 in gross proceeds for the company like the first tranche, which was triggered this past July upon the presentation of positive one year SeaGuardian’s pivotal data.
After premarket approval, the remaining two milestones would each trigger additional tranche financings, including receipt of FDA clearance for the SwitchGuard TCAR neuroprotection system along with our TCAR indicated, CGard Prime stent and the completion of four 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. Shifting gears to our clinical pipeline, as a reminder, in October, we received the FDA approval for an investigational device exemption or IDE application to begin the CGuardians two pivotal study of our CGuard Prime carotid stent system and TCAR procedures. This study is intended to evaluate the safety and effectiveness of our novel CGuard Prime stent platform in a short TCAR indicated version compatible with commercially available neuroprotection systems for TCAR procedures. I’m pleased to share that we are enrolling very well in this study as we progress into 2025. We’ve also engaged with FDA in the filing of our cGuardian’s three IDE for the investigation of our complete TCAR solution, including the CGard Prime 80 stent and SwitchGuard neuroprotection system and anticipate approval to initiate the study in the second quarter of this year.
With more than 30,000 TCAR procedures performed in The U. S. Annually, TCAR is a large market opportunity that remains strategically important as we build a comprehensive approach to carotid revascularization. Our ongoing investments in both CAT and TCAR are aimed at serving the broadest physician base, positioning us to lead as product innovation and procedural reimbursement continue to shift toward an endovascular first standard of care. At this point, I’d like to turn the call over to Craig to review the financials.
Craig?
Craig Shore, Chief Financial Officer, InspireMD: Thanks, Marvin. For the fourth quarter of twenty twenty four, total revenue increased 10.6% to $1,900,000 from $1,700,000 during the fourth quarter of twenty twenty three. This increase was predominantly driven by growth in existing and new markets. Gross profit for the fourth quarter of twenty twenty four decreased by $36,000 or 7.1% to $469,000 compared to a gross profit of $505,000 for the fourth quarter of twenty twenty three. This decrease in gross profit resulted from an increase in cost of goods sold.
The increase was primarily due to an increase in material and labor costs, driven mainly to higher sales volume and increased compensation expense for new and current employees. The increase of goods sold was offset by an increase of revenues. Gross margin decreased to 24.1% during the three months ended 12/31/2024 from 28.7% during the three months ended 12/31/2023 for reasons just mentioned. Total operating expenses for the fourth quarter of twenty twenty four were $9,800,000 an increase of $3,500,000 or 55.8% compared to $6,300,000 for the fourth quarter of twenty twenty three. This increase was primarily due to increase in expenses related to salaries and share based compensation associated with our expected launch into The U.
S. Market, offset by a reduction in clinical trial expenses as we near completion of the SeaGuardians trial. Total financial income for the fourth quarter of twenty twenty four was $252,000 a decrease of $216,000 or 46.1% compared to $468,000 for the fourth quarter of twenty twenty three. This decrease was primarily due to less interest income from investments and marketable securities and money market funds. Net loss for the fourth quarter of twenty twenty four totaled $9,100,000 or $0.19 per basic and diluted share compared to a net loss of $5,400,000 or $0.16 per basic and diluted share for the same period in 2023.
For the full year 2024, total revenue increased 13% to $7,000,000 from $6,200,000 during the full year of 2023. This increase was primarily driven by growth in existing and new markets. Gross profit for the full year 2024 decreased by $301,000 or 16.7% to $1,500,000 compared to a gross profit of $1,800,000 for the full year of 2023. This decrease in gross profit resulted from an increase in cost of goods sold. This increase was primarily due to an increase in material and labor costs, driven mainly to higher sales volume and increased compensation expenses for new and current employees.
The increase of cost of goods sold was offset by an increase of the revenues. Gross margin decreased to 21.5% for the full year 2024 from from 29.1% during the full year 2023 for reasons just mentioned. Total operating expenses for the full year 2024 were $35,000,000 an increase of $12,000,000 or 52.5% compared to $22,900,000 for the full year 2023. This increase was primarily due to increases in expenses related to the salaries and share based compensation associated with our expected launch into The U. S.
Market, offset by a reduction in clinical trial expenses as we near completion of the SeaGuardian’s trial. Total financial income for the full year 2024 was $1,600,000 an increase of $265,000 or 20.5% compared to $1,300,000 for the full year 2023. This increase was primarily due to an increase in interest income from investments in marketable securities and money market funds. Net loss for the full year 2024 totaled $32,000,000 or $0.76 per basic and diluted share compared to a net loss of $19,900,000 or $0.82 per basic and diluted share for the full year 2023. As of 12/31/2024, cash and cash equivalents and marketable securities was $34,700,000 compared to $39,000,000 as of 12/31/2023.
Regarding our future expectations and roadmap for growth, we’re optimistic for an exciting year ahead. However, please note that we’re not providing any forward looking revenue guidance today. We look forward to doing so as our catalyst pathway advances following a potential U. S. FDA approval in the first half of the year.
This concludes our prepared remarks. We’ll now open the call for questions. For the Q and A segment, we’ll be joined by Shane Gleeson, InspireMD’s Chief Commercial Officer. Operator?
Conference Operator: Thank you. And we’ll take our first question from Adam Mehta from Piper Sandler. Please go ahead.
Adam Mehta, Analyst, Piper Sandler: Hi, good morning, Marvin, Craig, Shane. Thanks for taking the questions. Congrats on the quarter and the progress in 2024. A couple from the maybe just to start on U. S.
Approval timing for CGuard Prime, the stent product. Just wanted to see if there’s anything more you can really kind of share around visibility into approval, the dialogue or discussion that you’re having with reviewers and anything to mention or call out just given some of the macro backdrop and the headlines with potential changes at FDA? Should we expect an impact of timing or still feeling pretty good about first half twenty twenty five? And then I had a couple of follow ups. Thanks.
Marvin Salzman, Chief Executive Officer, InspireMD: Good morning, Adam. Thanks for the question. Yes, we remain optimistic on the first half approval as we’ve previously noted and of course are building our resources appropriately to to build toward an effective launch following the approval. I would say that we’ve been having a very productive interactive approach with FDA, which has been helpful as has been the modular approach that we selected to take from the beginning allows us to organize the PMA submission in an efficient manner. No direct impact related to sort of the macro view and some of the unprecedented things that FDA is going through and nothing material other than just continuing to work through what is generally a very complex process as you know for PMAs in general.
And so we remain committed to that timetable. Yes. Okay, perfect. That’s great
Adam Mehta, Analyst, Piper Sandler: to hear. And for the second question, you had some comments in the prepared remarks around SeaGuardians two and three, but wanted to go a little bit deeper there. So in terms of SeaGuardians two enrollment, sounds like that’s going well. In terms of timing for integration into the competitor neuroprotection system, is that still tracking to early twenty six? And then for the second part of the question, CGuardians three, sounds like you’re going to initiate that study in Q2 of this year.
Is first half twenty twenty six still a good assumption for SwitchGuard approval and launch in The U. S? And then I had one more. Thanks.
Marvin Salzman, Chief Executive Officer, InspireMD: Yes. So to answer the first question, Adam, enrollment is going well and we’re holding the timeline related to that supplement being approved in early twenty twenty six for commercial launch. We’re still very enthusiastic about the feedback that we’ve received from the physicians using the product and look forward to entering the TCAR space with that strategy. So everything remains on track related to that piece. And for the second part, timeline also remains consistent on SwitchGuard in the second half of twenty twenty six.
Again, we’re anticipating an approval and initiating enrollment. Many of the same sites and physicians are going to be both enrolling in both of those. And so we’re enthusiastic and optimistic for both of those entries as we get closer to the TCAR space.
Adam Mehta, Analyst, Piper Sandler: Okay, fantastic. And Marvin, sorry, just one clarification for SwitchGuard. First half twenty twenty six approval launch or second half twenty twenty six?
Marvin Salzman, Chief Executive Officer, InspireMD: Second half, sorry, I was referring to initiating the trial part of this in the first half of twenty twenty five, I guess, had my years mixed up.
Adam Mehta, Analyst, Piper Sandler: Okay. And just one last one on the guidance front. Well, sorry, I know you don’t have guidance, but just wanted to ask how you’re thinking about the business at a high level. The international business has done well, probably doesn’t get enough attention. Obviously, a lot of the focus is on The U.
S. And you’re getting closer and closer there. But just how do we think about the business at a high level for 25 U. S. Versus OUS?
Just any color you could offer up there would be much appreciated. Thanks again.
Marvin Salzman, Chief Executive Officer, InspireMD: Yes. Let me I’ll take a pass at that. And of course, you’ve got Shane in the room here. So he can certainly offer color to that as well. The OUS business continues to be strong and growing and we continue to focus our resources around that established market.
It provides us a tremendous amount of value at many different levels. The shift toward The U. S. Focus will obviously continue, but the second half post approval of 2025 is really a foundational building time for us. We’re getting new reps into territories.
We’re having to go through administrative VAT committees and otherwise. So I would sort of think about this as a foundational building time as we get through the second half of twenty twenty five. And so we can get level set into 2026. We’re also building our commercial team with a pretty predictable cadence of training classes and onboarding reps. So we hope to take full advantage of the enthusiasm of CGuard Prime and what the market has indicated, but at the same time have to remain realistic about how quickly we can actually get into hospitals and into cases and we of course want to follow a very predictable approach to how those cases perform.
Thank
Conference Operator: you. We’ll take our next question from Frank Tagnon with Lake Street Capital Markets. Please go ahead.
Frank Tagnon, Analyst, Lake Street Capital Markets: All right.
Analyst, Lake Street Capital Markets: Thanks for taking the questions. Congrats on the progress. Maybe just start on kind of the commercial launch process of things. Is there anything you can be doing with the value analysis committees today to start preparing for launch? And then kind of a separate but related question, once you are launched and on the market, maybe speak to kind of expectations around adoption at a specific site.
Do you feel like they test it for a quarter or two or do they kind of jump in two feet first given the clinical data that’s out there and kind of shift over their whole business in one swoop?
Marvin Salzman, Chief Executive Officer, InspireMD: Good morning, Frank. I’m going to let Shane handle that one.
Shane Gleeson, Chief Commercial Officer, InspireMD: Yes, thanks Marvin and good morning, excuse me, good morning, Frank and Adam. So I think this is one of those places where I use a phrase I might overuse, which is all politics is local and different hospitals act differently. What we can’t do is go out and promote a product at this point. But as Marvin mentioned, we had our first cohort of salespeople go through training last week and they are armed with some really good claims data in terms of knowing about fishing where the fish are, they know where the procedures are happening and we’re hiring people that have long standing relationships, knowledge of these accounts who can start to form their position in line for back reviews. So most hospitals will not consider a product until it’s approved, but we know when their next meetings are over the course of the next months and quarters.
So in many cases, we’re able to kind of hold the place in line, so that upon approval, we won’t then be queuing up at the back of the line for consideration. That’s probably the best thing we could be doing at this point is holding our place so that we’re closer to consideration at the time of approval. On the question about whether people will dabble or jump right in, Again, it’ll be a little bit of both, but we’re seeing a lot of enthusiasm. We’ve been going to conferences for a couple of years here with this product. The data is becoming more and more understood and there’s more excitement about a next generation dual layer mesh covered stent entering the market.
So there are a lot of people at sight unseen have told us that they’re excited to start using it and using it all the time. And of course, it’s our job to go out there and solidify that and make that happen.
Analyst, Lake Street Capital Markets: Okay. That’s helpful. Appreciated the comments around the commercial infrastructure. I think you mentioned 14 personnel onboarded so far and then you referenced kind of a steady cadence of new additions. Can Just maybe bring us a little bit into the split of that 14 of territory managers versus regional managers and then that cadence of new rep and territory manager additions going forward?
So
Shane Gleeson, Chief Commercial Officer, InspireMD: we’ve got 13 people that were in here last week and that includes the first four sales directors, West, Central, Northeast, Southeast and it’s their job to build the team going forward. So the rest of those are individual contributors and that’s where we’ll continue our staffing for the balance of the year, both in territory manager and clinical specialist positions.
Analyst, Lake Street Capital Markets: Okay. That’s helpful. And then just final one for me. I was hoping I know you’re not providing any guidance on the top line, but was hoping you can maybe speak anecdotally to the OpEx structure as we go forward. Obviously, there’s a lot of commercial hiring, but how should we think about OpEx growth throughout 2025?
Craig Shore, Chief Financial Officer, InspireMD: Yes. Hi, this is Craig Shore, the CFO. As Shane just mentioned, there will be significant growth in the sales organization, of course, through the hiring of the territory managers and the sales reps. But we will also will have growth in the R and D area as well. We’re doing SeaGuardians 2, SeaGuardians 3, and we still have completion of SeaGuardians one and the P and A submission costs associated as well.
So you will continue to see growth in the operating expenses.
Analyst, Lake Street Capital Markets: Okay. That’s helpful. Thanks for taking the questions.
Conference Operator: Thank you. And next we’ll go to Richard Nesbitt with InspireMD. Please go ahead.
Frank Tagnon, Analyst, Lake Street Capital Markets: I have one simple question for whoever wants to answer. On a scale of one to 10, what are your expectations of meeting your goals for this year?
Marvin Salzman, Chief Executive Officer, InspireMD: Our expectations are always 10. They remain 10 consistently. We’re always shooting for the top to meet the expectations we’ve set for the group.
Frank Tagnon, Analyst, Lake Street Capital Markets: That’s all I wanted to know. You feel very positive about all that you’re projecting. Am I correct? Indeed. Okay.
Thank you. Thank you.
Conference Operator: Perfect. And now that our Q and A session has ended, I will now turn the call back over to Marvin Salzman for closing remarks.
Marvin Salzman, Chief Executive Officer, InspireMD: I’d like to thank everyone for joining the call and for the ongoing support of our mission to lead the carotid revascularization market. We’re very pleased with our execution in 2024 and look forward to the many milestones ahead in 2025, including the potential U. S. Approval and launch of CGuard Prime. We believe InspireMD is uniquely positioned to transform stroke prevention by addressing vast unmet need with our differentiated technology and strong clinical foundation.
With a clear path to market expansion and a commitment to improving patient outcomes, we believe the company is well equipped to drive meaningful impact for patients and providers alike and we’re excited for the opportunities ahead and remain committed to advancing care in this space. Thank you.
Conference Operator: Thank you. Ladies and gentlemen, that does conclude today’s conference. We appreciate your participation. You may disconnect at any time.
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