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spk01: Greetings and welcome to the InspireMD first quarter 2024 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Chuck Padala. Thank you, sir. You may begin.
spk02: Thank you, Operator, and good morning, everyone. Thank you for joining us for the InspireMD first quarter financial results and corporate update conference call. Joining us today from InspireMD are CEO Marvin Slossman and CFO Craig Shore. 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 InspireMD's most recently filed periodic reports on Form 10-K and Form 10-Q or any updates in our corporate reports on Form 8-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, Tuesday, May 14, 2024. 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 CEO Marvin Slossman. Go ahead, Marvin, please.
spk03: Thank you, Chuck, and thanks to everyone for joining our call this morning. I'm pleased to report that during the first quarter of 2024, we were able to sustain momentum with which we exited 2023 as we advanced toward our mission to be a leader in the carotid revascularization market with our best-in-class Seaguard Carotid Stent platform. Craig will cover the financial shortly, but I wanted to touch on a few highlights from our first quarter performance. We generated total Seaguard revenue of $1.5 million, representing growth of nearly 22% over $1.2 million that we reported in the first quarter of 2023. With our formal recertification under MDR now granted, we've de-risked this topic and removed uncertainty in our ability to continue to sell in EU-certified countries while also enabling our product development pipeline provided under MDR as we continue to build our OUS markets in parallel with our growing U.S. focus. We sold 2,553 Seaguard stents during the first quarter of 2024, representing growth of 25.6% over the 2,033 stents sold during the first quarter of 2023. Our real-world experience with Seaguard now exceeds 50,000 stents sold to date. Turning now to our ongoing C-Guardian's pivotal U.S. trial, which is evaluating the safety and efficacy of the C-Guard carotid stent system for the treatment of carotid arterial stenosis. As a reminder, the primary endpoint of this trial is a composite of the incidence of major adverse events, including death, all-cause mortality, any stroke, or myocardial infarction, abbreviated SDSM. or ipsilateral stroke from day 31 to day 365 post-procedure. Between July 2021 and June 2023, 316 patients were prospectively enrolled in the single-arm study performed at 24 sites in the U.S. and Europe, utilizing the C-Guard carotid stent system, including our next-generation C-Guard Prime platform. We announced recently an abstract of the one-year outcomes from C-Guardians has been accepted for presentation at the Leipzig Interventional Course 2024, also known as LINC, which will be presented by Dr. Chris Metzger, System Vascular Chief at OhioHealth and Lead Investigator of the study. This presentation is scheduled on May 28th in Leipzig, Germany. Recall that the 30-day follow-up from the trial was presented in the fall of 2023 at VIVA, which demonstrated all-cause mortality, death, stroke, and myocardial infarction rate of just 0.95% in the intent-to-treat analysis population and 0.63% in the per-protocol analysis population. We believe results like these have the potential to position Seaguard with our innovative Micronet mesh to be the gold standard in carotid implants. Assuming the 12-month results are positive, we would be on track to submit a premarket approval application or PMA later this year while continuing to prepare for a U.S. commercial launch in the first half of 2025 if approved. This timeline is unchanged from our prior guidance. It's also worth noting that 12-month outcomes data from Sea Guardians would trigger the first tranche of the transformational financing of up to $113.6 million we announced last May. Recall that per the terms of the private placement, which was led by Marshall Weiss with participation from Orvimed, Rosalind, Nanahala, Solius, Velen, and certain InspireMD board members, we received $42.2 million up front with four tranches of $17.9 million, each tied to the exercise of warrants upon achievement of pre-specified milestones, the first of which is the public release of primary and secondary endpoints related to one-year follow-up study results from the Sea Guardians Pivotal Trial. As a brief reminder, the remaining three milestones that would potentially trigger subsequent funding tranches are the announcement of receipt of the premarket approval, PMA, from the FDA for the Sea Guardians Prime Carotid Stent System, which we've targeted for the first half of next year. receipt of FDA clearance for the SwitchGuard T-CAR kit to include our SeaGuard Prime stent, and the completion of four quarters of commercial sales of SeaGuard in the United States, which we anticipate in the back half of 2026. Our plan to study and submit our SwitchGuard neuroprotection system, accessory kit, and C-Guard T-CAR compatible stent platform remains on track, and if cleared, will enable our offering of a complete T-CAR tool set with next-generation enhancements, including the best-performing C-Guard Prime implant. As a reminder, the SwitchGuard MPS is designed to prevent embolic debris generated during a carotid stenting procedure from traveling to the brain, passing the blood through an integrated filter, and returning it to the patient in a closed circuit to minimize blood loss during the procedure. As we've said before, our ongoing investments in both CAS and TCAR methods and tools addressing the broadest patient population was done anticipating a time when technology innovation and procedural reimbursement further shifted the tides toward an endovascular first standard of care. Last year marked the beginning of what we believe is a shift away from surgery toward less invasive stenting procedures, highlighted by CMS's final national coverage decision last October, which expanded coverage of CAS and TCAR to include both asymptomatic and standard risk patients. With a best-in-class implant and C-Guard EPS, we believe we're very well positioned to be a leader in addressing this industry sea change. We were pleased to announce this past February that Dr. Patrick Garrity, Professor of Surgery and Radiology at Washington University School of Medicine in St. Louis, Missouri, and Dr. Pat Muck, Program Director and Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio, will be serving as our lead PIs. Together, Dr. Garrity and Dr. Muck bring a wealth of knowledge and experience in the field of TCAR carotid interventions, and we're very fortunate to be able to benefit from their extensive knowledge, insight, and direction as we build our leadership objectives and strategy. They join an established multidisciplinary group of thought leaders that are already providing guidance to us in these initiatives. We've also previously announced that we entered into a strategic agreement with the Jacobs Institute of the State University of New York and Buffalo with Dr. Adnan Siddiqui, Vice Chairman and Professor of Neurosurgery, to conduct an early feasibility study of C-Guard Prime for severe carotid stenosis or occlusion in conjunction with thrombectomy in patients presenting with acute ischemic stroke and tandem lesions. C-Guard Prime with its proprietary Micronet mesh is designed to provide superior embolic prevention during carotid stenting procedures. We believe that this study will demonstrate safety and feasibility of using our stent in these acute stroke procedures. Our investment in the study reflects our strong commitment to the neuro community and represents a critical component of our long-term growth strategy. The FDA has approved this study At this point, I'll turn the call over to Craig to review the financials. Craig?
spk00: Thanks, Marvin. For the first quarter of 2024, total revenue increased 22% to $1,511,000 from $1,239,000 during the first quarter of 2023. This increase was predominantly driven by growth in existing markets. Gross profit for the first quarter of 2024 was $292,000, a decrease of $81,000 for 21.6% from a gross profit of $373,000 for the first quarter of 2023. This decrease resulted primarily from higher training costs of new hires to build capacity for anticipated increased volume requirements. Gross margin decreased to 19.4% during the three months ended March 31st, 2024, from 30.1% during the three months ended March 31st, 2023. Total operating expenses for the first quarter of 2024 were $7.7 million. an increase of $2.9 million or 62.1% compared to $4.8 million for the first quarter of 2023. This increase was primarily due to higher share-based compensation resulting from the recognition of grants made during the second quarter of 2023 and the first quarter of 2024. Total financial income for the first quarter was $382,000, an increase of $257,000, or 206%, compared to $125,000 for the first quarter of 2023. This increase was primarily due to $264,000 increase in interest income from investments in marketable securities, money market funds, and short-term bank deposits. Net loss for the first quarter of 2024 totaled $7,032,000, or 21 cents per basic and diluted share, compared to a net loss of $4,256,000, or 53 cents per basic and diluted share, for the same period in 2023. As of March 31, 2024, cash, cash equivalents, and marketable securities were $34 million, compared to $39 million as of December 31, 2023. That concludes our prepared remarks. We will now open the call for questions. Operator?
spk01: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. And you may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Adam Meter with Piper Sandler. Please proceed with your question.
spk04: Hi. Good morning, Marvin and Craig. Thank you for taking the questions, and congrats on the progress here. Maybe to start, I wanted to... you know, ask about the Sea Guardians trial and the data set that we're going to see later this month at LINC. I guess the question is really more around, you know, how quickly can you package that information and submit to FDA, you know, just trying to get a better sense for when we could see the FDA review process and their clock start. And I had a couple follow-ups. Thanks.
spk03: Hi, Adam. Thanks. Thanks for the question. So as it relates to our approach with FDA, we've chosen a modular submission approach, which we felt like was the most efficient and expeditious that, you know, gives us the fastest pathway to approval. So once we present this data, it will then be processed and goes into the final module, which we anticipate to be shared with FDA sometime around the August or September timeframe right now. So that that right now seems to be the date that we've all landed on, and hopefully that submission will take place then. FDA is certainly familiar with our submission and our stint, and so we hope that this is the most efficient way to get to approval in the first half of next year.
spk04: Yep, I got it. Thanks for the extra color there, Marvin. And for the next question, I wanted to switch over to SwitchGuard or your TCAR product. I just wanted to confirm that those timelines continue to track. So are you still expecting to commence enrollment in the Sea Guardians 2 study by the end of the year? And then are you still anticipating a late calendar year 2025 approval for switchguard in the U.S.? Is that correct?
spk03: Yeah, so let me present the landscape, I guess, for all approvals here. So our plan is to have approval for the Seaguard Prime first half of 2025, our cast system, followed by a TCAR indication for Seaguard Prime in the second half of 2025. And finally, the clearance of switchguard neuroprotection with the full accessory kit in the first half of 2026. So we've gathered a lot of feedback from our vascular surgeons performing TCAR, and they've encouraged us to continue to build on the enhancements and feature set from our offering and to establish a new gold standard of what they believe they expect from their TCAR procedures. So we've built a little bit of time into that effort. And, of course, with the unknowns of the regulatory pathway, we feel comfortable with that approach and how we're handling the progression both from CAS and transition to our C-Guard Prime with the TCAR indication and then finally the switch guard.
spk04: I got it. Okay. And C-Guardians, too, is that still expected to start later this year by year end?
spk03: That's our plan that remains consistent. Yes.
spk04: Okay. Thanks for the clarification there. And then moving over to the tandem lesion early feasibility study, I think I heard correctly first patient enrollment is expected here in Q2. Maybe just can you confirm that? And then how quickly do you expect the trial to enroll and when should we expect to see that data? And then lastly, you know, these are very sick patients and maybe just kind of help the audience, Wall Street community kind of, you know, understand or level set, you know, what do good outcomes look like for a study like this? And then I had a couple more follow-ups. Thanks.
spk03: Yeah, thanks, Adam. Great question. So let me start with the fact that our focus through the EPS with the tandem trial is really to refocus the attention to the neuro community as a whole. So notwithstanding our objective in trying to look for a label specific to tandem, our goal is to make sure we continue to focus on the neuro community. So the EFS is scheduled around a 15 patient enrollment. and we anticipate that that first patient will be enrolled, as we said, in the second quarter. FDA has cleared that approach. It is a very different set of objectives, and as you mentioned, the standard by which we're measuring success is quite different because by the nature of these patients are in an acute stroke scenario. So we're trying to measure that obviously against what's considered to be sort of standard carotid stenting measured success. And we'll have to work through that because it's a really important segment of the population. I think it's become a big highlight of the neuro community with all the thrombectomy that's being done. But it definitely speaks to a different outcome in terms of how we define success in the protocol and what those outcomes look like. So we're going to work hard to make sure that that's clear and that as we present the data and get feedback, especially from the EFS, that we'll present that accordingly.
spk04: Good color there, Marvin. Just a couple more, if I may, just maybe switching over to the P&L. You know, gross margin for Q1 was, you know, just a little bit light. Anything to call out there? Should we expect that to kind of rebound to the high 20s, near 30% level, you know, in subsequent quarters? Just trying to think through the cadence of gross margin for 24. And then for 25, you know, any broad strokes that you want to offer up on gross margin at this juncture?
spk00: Yeah, I'll take that, Adam. We're starting to hire more people and train them for our increased forecast for growth. So that goes to the cost of goods sold, and that's the main reason for the increase in Q1. We are expecting an upturn in some of the later quarters. It'll actually get much higher in 2025 when we start launching in the United States, where the prices are much higher. Don't forget, we're currently selling via distributors in Europe. We're only getting 50% of the end-user price. When we go to the United States, we'll actually be selling directly. And we also have a much higher end-user price compared to Europe.
spk04: Yep. Yep, good color there, Craig. Thanks for that. And then just one more for you, just on the OPEX spend. You know, how aggressively are you going to kind of start to build up the sales force ahead of U.S. launch, you know, in the first half of 2025? I mean, how do we think about OPEX spend going forward, Craig? And I'll jump back in queue. Thanks again, guys, and congrats on the progress.
spk00: Yeah, it's definitely going to go higher as we get closer and closer to the launch in the United States. I mean, we're anticipating about a 60-person sales force over the next three years of operations in the states. So we'll be adding more and more people each quarter. But also manufacturing and people for the U.S. facility is also going to increase our OPEX costs as well.
spk03: Any other questions, operator?
spk01: At this time, we have no further questions. I would like to turn the floor back over to management for closing comments.
spk03: Thank you very much. I'd like to thank everyone for taking the time today to join the call and for the ongoing support. We've gone 2024 with significant momentum and look forward to continuing to create value as we get later in the year. Thanks for participating.
spk01: Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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