InspireMD - Q2 2024

Transcript

Operator (participant)

Good morning, and welcome to the InspireMD second quarter 2024 earnings call. Currently, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing the star and one on your telephone keypad. You may withdraw yourself from the queue by pressing star and two. Please note, this conference is being recorded. I will now turn the conference over to Chuck Padala with LifeSci Advisors. Thank you, and you may begin.

Chuck Padala (Managing Director and Head of Investor Relations)

Thank you, operator, and good morning, everyone. Thank you for joining us to the InspireMD second quarter financial results and corporate update conference call. Joining us today from InspireMD are Marvin Slosman, 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 InspireMD's most recently filed periodic reports on Form 10-K and 10-Q, or any updates in our current reports on Form 8-K filed with the US 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, August 6, 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 Marvin Slosman, Chief Executive Officer of InspireMD. Please go ahead, Marvin.

Marvin Slosman (CEO)

Thank you, Chuck, and thanks to everyone for joining our call this morning. I'd like to begin with a recap of perhaps the most significant milestone in the company's history, the presentation of one year outcomes data for our pivotal C-GUARDIANS clinical trial of the CGuard carotid stent system, presented at the Leipzig Interventional Course on May 28th. The data presented by our lead principal investigator, Dr. Chris Metzger, System Vascular Chief at OhioHealth, demonstrated an independently adjudicated major events rate of just 1.95% through 12-month post-procedure, which is the lowest such event rate of any carotid pivotal trial to date.

These results build on the 30 day DSMI results of 0.95%, first presented in October of last year, and establish a new high bar for clinical outcomes, which remains the focus of our patient-first, implant-driven strategy as we work toward an anticipated U.S. approval in the first half of 2025. As remarkable as these results are, it is important to note that they also closely mirror the results we've seen across multiple studies involving over 1,100 patients in the published peer-reviewed literature, showing that similarity of excellent patient outcomes can be achieved with CGuard in real-world treatment as we've seen in this FDA IDE trial.

With this data in hand, we are on track to submit a pre-market approval application, or PMA, to the FDA this quarter, which, if approved, would allow us to execute on a robust commercial launch of CGuard Prime in the U.S. beginning in the first half of 2025. CGuard's foundation of more than 55,000 devices sold to date has consistently demonstrated superior short- and long-term patient outcomes, which we believe has the potential to catalyze CGuard as the gold standard carotid implant. The presentation of these one-year results also triggered the first of four milestone-based financings pursuant to the transformational private placement of up to $113.6 million we announced in May of 2023.

We were pleased to announce just a few weeks ago the full exercise of Series H warrants, which raised $17.9 million in gross proceeds for the company. We are very grateful to the highly regarded institutional investors who continue to show their support for our company and our vision, including Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, as well as members of our board of directors. We continue to work tirelessly to achieve additional significant milestones, which would trigger the three remaining tranches and bring in an additional gross proceeds of $53.7 million. These milestones include, number one, an announcement of receipt of pre-market approval, PMA, from the FDA for the CGuard Prime carotid stent system, which we are targeting for the first half of next year. Number two, receipt of FDA clearance for SwitchGuard TCAR kit to include our CGuard Prime stent.

Number three, the completion of four quarters of commercial sales of CGuard in the United States, which we anticipate in the back half of 2026. Turning now to an update on our U.S. commercial preparedness activities. We engaged with one of the leading med tech search firms, The Mullings Group, to accelerate the build-out of our world-class operations and commercial teams. This process is ongoing, and we are very pleased to be onboarding several high-caliber candidates for critical roles to prepare the business for a robust market launch. We have also previously announced we will be establishing a U.S. headquarters in Southeast Florida, including production capacity and customer training and support. Our growing leadership team will drive execution in launching our CGuard Prime in the U.S. market with world-class operations, sales and sales support for both our CAS and TCAR programs.

Our plan to study and submit our SwitchGuard Neuroprotection System, Accessory Kit, and CGuard TCAR-compatible stent platform remains on track and, if cleared, will allow us to offer a complete TCAR tool set with next-generation enhancements, including the best-performing implant in CGuard Prime. As a reminder, the SwitchGuard NPS TCAR platform 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. Both C-GUARDIANS II and C-GUARDIANS III remain on track for submission and clinical enrollment from previous guidance.

As we've said before, our ongoing investment in both CAS and TCAR products and programs was intended to address the broadest physician base performing carotid revascularization and was done anticipating a time when product 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 toward a stent-first approach, ignited by CMS's final national coverage determination in October, which expanded coverage of CAS and TCAR to include both asymptomatic and standard-risk patients. With a best-in-class implant in CGuard, we believe we are very well positioned to be the leader in this C change. I would now like to provide a brief update on the ongoing CREST-2 clinical trial.

CREST-2 enrollment and randomization of 1,240 subjects across 142 trial sites in the United States, Canada, Spain, and Israel, evaluating transfemoral stenting, or CAS, plus intensive medical management, IMM, versus IMM alone, while also evaluating carotid endarterectomy plus IMM versus IMM alone. The primary endpoint is the composite of any stroke and death within 44 days following randomization and stroke ipsilateral to the target vessel thereafter, up to four years. This week, we announced that enrollment in these trials was now complete, a tremendous milestone for CREST-2, and we are very pleased to have had CGuard included as the only investigational device approved by FDA and used in 23 cases, despite being introduced late into the enrollment process with 82% complete at the time. We extend our congratulations to Dr. Brott, Dr. Meschia, and Dr. Lal, along with the entire CREST-2 executive committee, investigators, and sites in completing this tremendous study, and appreciate the opportunity to have contributed with our next-generation CGuard carotid stent platform. Turning now to our pipeline of expansion initiatives. We previously announced that we entered into a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo, and Dr. Adnan Siddiqui, Vice Chairman and Professor of Neurosurgery, to conduct an early feasibility study of CGuard Prime for severe carotid stenosis and occlusion in conjunction with thrombectomy in patients presenting with acute ischemic stroke and tandem lesions. As a reminder, CGuard Prime, with its proprietary MicroNet mesh, is designed to provide superior embolic prevention during the carotid artery stenting, and we believe that this study will demonstrate safety and feasibility of using our stent in these acute stroke procedures.

Our investment in this study reflects our strong commitment to the neuro community and represents a critical component of our long-term growth strategy. We anticipate that the first patient will be enrolled this quarter. Finally, we are pleased to announce total CGuard revenue for the quarter was $1.74 million, representing a growth of 5.4% over the second quarter of last year, including a significant growth quarter in production of devices to meet anticipated market demand. We sold 2,969 CGuard implants during the quarter, representing growth of nearly 6% over the same period last year. As we approach our potential approval for CGuard in the U.S., it is worth noting, for context, the difference in top-line revenue of our current served markets outside the U.S. and the potential of how these quarterly results would have translated in U.S. revenue.

Outside the U.S., we compete in a much smaller CAS market of approximately 40,000 total procedures versus 155,000 in the U.S. Without reimbursement for TCAR, pricing pressure through low reimbursement of an average sales price of $1,100 and distribution through channel partners, resulting in a $600 transfer price per system. Despite these limitations, our investment in these 30 markets has enabled us to build an incredible foundation of best-in-class results, establishing a new standard of care for carotid intervention with double-digit share in all markets served, along with the most robust clinical evidence in studies of over 1,100 patients, having sold over 55,000 devices to date. As we approach the possible FDA approval in the first half of 2025, it's worth a comparison of how our current unit volume would translate to top-line revenue.

On 2,969 stents sold in the US, revenues would have been approximately $13.6 million for the quarter, assuming an equal mix of CAS and TCAR sales at current ASPs. Further, to put these nearly 3,000 quarterly stents in perspective, we have a competitor with a TCAR-only business that reported $48.5 million in revenue on 6,700 procedures last quarter. So in terms of patients treated, our device would have treated nearly half the number of patients that they did without our device having even entered the US market. So we believe that our entry into the US market, along with the future introduction of our SwitchGuard NPS, sets us up very favorably for significant revenue growth beginning next year.

We know how to create and service demand, are building a world-class commercial team, and are thrilled about the opportunity to enter the biggest carotid market in the world. At this point, I'll turn the call over to Craig to review the financials. Craig?

Craig Shore (CFO)

Thanks, Marvin. For the second quarter ended June thirtieth, two thousand and twenty-four, revenue increased by $90,000, or 5.4%, to $1,739,000 from $1,649,000 during the second quarter ended June thirtieth, two thousand and twenty-three. This increase was driven by growth in existing and new markets, offsetting a decrease in clinical trial revenue, driven by the completion of the C-GUARDIANS enrollment in June of last year. For the three months ended June thirtieth, two thousand and twenty-four, gross profit decreased by $160,000, or 32.6% to $331,000 from $491,000 during the equivalent period last year.

This decrease in gross profit resulted from an increase in material and labor costs, mainly due to compensation expense for new and current employees, higher sales volume, additional space to build capacity for anticipated increased volume requirements, and additional training expenses as we begin to scale our capacity to accommodate the planned U.S. launch beginning next year, offset by an increase in revenue. Gross margin decreased to 19% during the three months ended June 30, 2024, from 29.8% during the three months ended June 30, 2023, driven by the factors just mentioned.

Total operating expenses for the second quarter of 2024 were $8,591,000, an increase of $2,785,000 or 48% compared to the $5,806,000 for the second quarter of 2023. This increase was primarily due to an increase in compensation and development expenses, with the vast majority being non-cash, share-based compensation-related expenses. Net loss for the second quarter of 2024 totaled $7,909,000, or $0.22 per basic and diluted share, compared to a net loss of $5,077,000, or $0.24 per basic and diluted share for the same period in 2023.

As of June 30, 2024, cash, cash equivalents, and marketable securities were $47.2 million, compared to $39 million as of December 31, 2023. This includes gross proceeds of $17.9 million from the exercise of the Series H warrants related to the announcement of the one-year follow-up from the C-GUARDIANS pivotal trial. This concludes our prepared remarks. We will now open up the call for questions. Operator?

Operator (participant)

Thank you. At this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may remove yourself from the queue at any time by pressing star and two, and we will pause for a moment to allow questions to queue. We will take our first question from Adam Maeder with Piper Sandler.

Adam Maeder (Managing Director and Senior Research Analyst)

Hi, good morning, guys. Thanks for taking the questions here. Congrats on the progress. Apologies, I was having some technical issues, so you may have covered some of this in the prepared remarks, Marvin, but you know, I guess the first question I wanted to ask was just around the full data from C-GUARDIANS that was presented at LINC. I'm curious, you know, what type of feedback you've gotten thus far? You know, obviously very low adverse event rates on the composite primary endpoint, you know, both at 30 days and 1 year. I think that's straightforward. But you know, I'm curious if there's other subtleties in the data that you think are worth kind of mentioning or calling out for investors. And then I had a handful of follow-ups. Thanks.

Marvin Slosman (CEO)

Yeah, thanks for the question, Adam. Obviously, we're pleased with the data as best in class and really first-time results. I think the thing that was remarkable to us as well was just the consistency of that data as it compared to our ongoing trials outside the U.S. and our real-world experience. You know, so in addition to being able to, I think, continue to bolster our confidence that we'll be able to get approval with these kinds of results and focused on the FDA effort, we're also pleased with just the overall consistency, having sold a lot of stents and studied them in markets outside of the U.S. work. So I think on balance, we were pleased on all those levels.

Adam Maeder (Managing Director and Senior Research Analyst)

Yeah, that's, that's good color. Appreciate that. And then I wanted to pivot over to the US launch, and, you know, specifically, you know, ask about kind of the US sales force hiring process. And, you know, I'm going to lump this in for... for Craig, too, just kind of OpEx spend going forward. So, you know, just remind us how you're thinking about US commercialization and headcount, for CGuard launch in the first half of 2025. And how do we think about kind of the OpEx spend as we, you know, go forward in subsequent quarters?

Marvin Slosman (CEO)

Well, I think it is the right question that we've all been asking and working on hard within the company. All of our focus right now is on U.S. readiness, not just commercially, but operationally as well. We established a great relationship with a couple of recruiting firms. I think the inbound interest in joining our company has also been overwhelming, which has been great. So I think we've got a great talent pool set up to both produce, support, and launch the product in the U.S. And over the next several months, we'll be building that and adding that. Obviously, the timing of this is important, especially on an OpEx basis. We want to time our hires appropriately and get the right infrastructure in place as well. We announced a U.S.-based headquarters in Southeast Florida.

We're beginning to build that process out. So I think on balance, we're trying to be ready for an appropriate, aggressive launch of the product when we get approval without overspending in the process. But I would say that in terms of talent and access and availability, we've been really overwhelmed by the levels of interest and quality of talent. So we're pleased by that and looking forward to adding those people to the team.

Adam Maeder (Managing Director and Senior Research Analyst)

That's helpful, Marvin.

Craig Shore (CFO)

Yeah. Hi, Adam.

Adam Maeder (Managing Director and Senior Research Analyst)

Yeah, go ahead. Go ahead, please.

Craig Shore (CFO)

Hi, Adam. It's Craig. So in regards to your question about operating expenses, there's two things going on right now. One is our C-GUARDIANS II and C-GUARDIANS III trial that we'll be starting shortly, and that's also going to add to our operating expenses in addition to the U.S. readiness. Shane, for example, will be adding salespeople, but we also have to be ready to start being able to produce in the United States as well. And also, we just signed a lease for our U.S. operations. So we should be seeing, you know, an increase, maybe 30%-40% on average next year over this year, which takes into account all those pieces that I just mentioned.

Adam Maeder (Managing Director and Senior Research Analyst)

That's helpful, Craig. Thanks for the incremental color there and quantifying it. Okay, great. And I guess just wanted to now ask about C-GUARDIANS, too, the TCAR study. You know, I think I saw or heard you in the prepared remarks, you know, that's expected to commence enrollment in the back half of this year. You know, just curious if you can kind of give any more, you know, color around the trial design, number of patients, length of follow-up. And then would also just love to hear some thoughts, you know, about the interest in working with InspireMD to the extent that you can share.

You know, obviously, there's a sizable TCAR player in the market today, you know, that's out there, but just wondering kind of what the receptivity has been to a potential second TCAR competitor, player, I guess I should say.

Yeah. Thanks.

Marvin Slosman (CEO)

Thanks, Adam. Great, great question. Let's start with the end question there. I think we've been overwhelmed at the amount of enthusiasm and interest by the vascular surgery community in particular. We had a great SVS meeting, and we're just again overwhelmed by the number of vascular surgeons that are interested in not only participating in the study effort, but looking forward to the next generation, best-in-class stent platform, as well as an NPS system and SwitchGuard, which also brings next-generation technology to them. So I think on balance, TCAR, you know, continues to be a priority for us, as it has been for a long time. And for both our CAS program and TCAR program, the goal has been to build feature sets and next-generation thought and technology into that in order to enable as many CGuard implants as possible.

That's really been the goal for quite some time. In terms of timing of trial enrollment and otherwise, we've been in touch with the FDA. We've submitted both of these programs to the FDA and are just waiting for their final approval so that we can get started. But we've already aligned ourselves with a CRO, are beginning the process of how we enroll both of these efforts for both the stent with a TCAR indication, as well as the broader SwitchGuard NPS kit, and do that as expeditiously as we can, but also keeping in mind that we want to run a very favorable trial. So all those timelines remain consistent with what we've said before with no change.

Adam Maeder (Managing Director and Senior Research Analyst)

Very helpful, Marvin. And if I could squeeze in just one last question. You know, would be curious to hear a little bit more about CREST-2. And, you know, I saw the press release from you guys, I think that was earlier this week. You know, I... The first question is, do you know kind of how the data is going to be, you know, presented in release? And will the data set be bifurcated by stent technology, I guess, is really the question, or you know, device manufacturer. So in other words, will you be able to compare C-Guard patients and how well they did versus, you know, the other patients in the study? I guess is the question I'm trying to ask.

Then, probably not a fair question, but I'll ask it anyways: Do you have a sense for when we could actually see the CREST-2 data presented or released publicly? Thanks so much for taking the question, guys.

Marvin Slosman (CEO)

Yeah, thanks, Adam. I'm actually going to hand that off to Shane Gleason, who's here in the room. He's been closest to the CREST-2 effort to give you the answer there.

Shane Gleason (Chief Commercial Officer)

And thanks, Marvin. Good morning, Adam. So the first analysis we expect to see will not include being split out by stent type. We know that they do plan to do that at some point. You know, our 23 stents represent... One way to look at it is that it's only about 4% of overall stent enrollment, so not enough to really move the needle in terms of overall results. But Marvin also mentioned that we were introduced when 82% of the trial had already been enrolled, so that's over 20% of the stents that were enrolled since then, and I know 13 of those were done in the last 5 months. So, in terms of the pace of enrollment, we really like how quickly it was adopted by the investigators.

We think that shows really favorably for our entry into the U.S. market, since the investigators are among the top CAS sites in the U.S. But back to your original question, our 4% of the overall stents, we expect the overall rates to be low, so we don't anticipate being able to see anything measurably different in the trial results. Certainly nothing that would approach statistical significance.

Adam Maeder (Managing Director and Senior Research Analyst)

Thanks for the color, Shane.

Shane Gleason (Chief Commercial Officer)

Sure.

Operator (participant)

Thank you. And our next question comes from Frank Takkinen with Lake Street Capital Markets.

Frank Takkinen (Senior Research Analyst Medical Device)

Great. Thanks for taking the questions. Maybe I'll just piggyback off Adam's questions at the end there on Crest. Was hoping you could kind of give us a broad strokes theorization of what the outcomes could look like from that and how that could impact the market? I know there's a theory out there that there's a potential for less treatment of asymptomatic patients. What could something like this cause to the mix of procedures out there, and how do you think you're positioned if this does come to fruition?

Shane Gleason (Chief Commercial Officer)

Yeah, Frank, this is Shane. I'll go ahead and keep going with CREST-2 here. Thanks for the question. So one thing that we recognize is that there are a very high percentage of patients diagnosed with asymptomatic carotid disease are not treated today. So the premise of the CREST-2 study was that intensive medical management has improved from the early days of carotid trials, but so is intervention. So what they're really looking at and why they're looking through 4 years as the primary endpoint is to see if the treatment effect is enough to merit doing the procedure up front? And the better your initial outcomes are, the more likely that is to happen. So we know in the CREST-2 registry, the event rates were below 3%, and that included symptomatic patients.

So we're anticipating that the overall event rates will be low, and therefore intensive medical management won't have a big head start in terms of the initial outcomes. And then through four years, especially with the inclusion of, you know, stents, a stent like ours, we know that will do nothing but benefit the results. So if you look at the overall, the possible outcomes, one is that stents don't show an improvement over intensive medical management, and there we think that the market looks like it does today. Remember that to be enrolled in the study, the investigator has to think that there's clinical equipoise for that patient. In other words, they need to think that that patient may be just as well off with drugs versus an intervention.

If it's a patient that the investigator, you know, quote, unquote, "knows that they need an intervention," that patient isn't randomized. So I think the majority of the patients that are really being treated in clinical practice today are not the ones being enrolled in CREST-2. So for those that are kind of a jump ball, we don't know if an intervention will benefit them. Those are patients that probably aren't getting interventions today, and that's gonna make up the majority of the patients who are enrolled. So really, the net outcome could be very favorable for stenting and for surgery, where more of those patients who are diagnosed but not treated today may be treated in the future.

If this comes out looking like where there's not a difference or even where drugs show better, it probably doesn't move the market 'cause it ends up looking a lot like it does already today.

Frank Takkinen (Senior Research Analyst Medical Device)

Got it. That's helpful color. And then maybe just one last one on the commercial strategy. I know there's been a fair amount of commentary on it, but I wanted to maybe follow up on one question related to VAC conversations. When can you start to have those conversations, and how do you think about getting through the different value analysis committees and after approval, during approval, or however that looks in 2025?

Shane Gleason (Chief Commercial Officer)

Great question. We know that entering the U.S. market, that that is the, the long pole in the tent frequently. You know, one thing I know is that creating demand with physicians will not be the hardest part of my team's job. It will be doing exactly what you just described. But we've had a lot of, I'd say, physicians volunteering to help with the process already due to their enthusiasm to get the new, the new technology. We are ramping up our IDN outreach efforts presently and checking with them to see what we can do and when.

Obviously, you can't pre-promote, but in terms of when a new technology is available, how do we get ourselves quickly into the queue and with built-in physician demand, where, you know, they won't go to bat for every new device, but the ones they really care about, they will. We're already getting that outreach from physicians who are excited to bring CGuard, CGuard Prime into their hospitals just from what they're hearing from the podium. So we're doing everything we can to be at the front of the line for those reviews when we get approval. And we plan to have a small team already hired and onboarded at the time of approval out in the field that can move those conversations through quickly.

Frank Takkinen (Senior Research Analyst Medical Device)

Got it. That's helpful. Thanks for taking the questions.

Shane Gleason (Chief Commercial Officer)

Thanks.

Frank Takkinen (Senior Research Analyst Medical Device)

Pleasure.

Marvin Slosman (CEO)

Thanks, Frank. Thanks for being on the call. I'd like to thank everyone for taking the time to join the call today and for the ongoing support. We're obviously very pleased with our progress through the first half of the year, and with our C-GUARDIANS data now in hand, believe that we've got line of sight for the approval for CGuard in the U.S. next year. Thanks for joining.

Operator (participant)

Thank you. This does conclude today's InspireMD second quarter 2024 earnings call. Thank you for your participation. You may disconnect at any time.