InspireMD, Inc. Q3 FY2024 Earnings Call

Good day, everyone, and welcome to the InspireMD Third 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. Please note, this conference is being recorded. I will now turn the conference over to Chuck Padala with LifeSci Advisors. Thank you. You may begin.

Thank you, operator, and good morning, everyone. Thank you for joining us for the InspireMD third 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. Shane Gleason, Chief Commercial Officer will also be available for Q&A. 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, November 12, 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's now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

Thank you, Chuck, and thanks to everyone for joining the call this morning. I'd like to begin with a review of our very strong Q3 financial results. We reported total CGuard revenue of $1.81 million representing growth of more than 16% over the third quarter of last year. Our results were driven by sales of over 3,100 CGuard implants during the quarter, representing growth of nearly 14% over the same period last year to the benefit of thousands of patients in our end markets suffering from carotid artery disease. We're particularly proud of these results, which demonstrate consistent quarter-over-quarter growth and solidify our strong commercial foundation with more than 60,000 implants sold to date. Our stent technology has now captured double-digit market share across 30 countries where we have enabled providers and patients to benefit from our best-in-class carotid stent with leading clinical outcomes. As we approach the potential approval and launch of CGuard Prime in the U.S., which we anticipate in the first half of 2025, we would once again like to offer a measure of how our global Q3 sales would have translated to U.S. revenue. We sold 3,129 implants in international markets during the quarter. If instead sold in the U.S., these units would have generated over $14 million in revenue, assuming an equal mix of CAS and TCAR sales at current U.S. market ASPs. To put our global sales volume in further perspective, the current U.S. TCAR market leader reported about $49 million in revenue on 6,700 procedures last quarter. So in terms of global patients treated, our devices are already reaching nearly half the number of patients as the TCAR market leader and we have not even entered the U.S. market yet. We continue to believe that our entry into the U.S. market, along with the future introduction of our SwitchGuard neuroprotection system for TCAR procedures, positions our business for significant revenue growth once cleared. As we look to 2025, we will continue investing in the U.S. market with the intention to drive significant growth in both sales and margins while establishing a new standard in carotid revascularization in both CAS and TCAR versions once approved. While staying on the topic of U.S. opportunity, during the third quarter we submitted our PMA premarket approval application to the FDA. We utilized a modular submission approach to facilitate an efficient review by the agency and with our submission now complete, we look forward to a timely decision which, if positive, would enable our U.S. market launch of CGuard Prime for the treatment of carotid artery disease and stroke prevention. Recall that our regulatory submission was based on the overwhelmingly positive one-year data from our CGuardians clinical trial presented at the Leipzig Interventional Course earlier this year. The CGuardians clinical trial evaluated the safety and efficacy of CGuard for the treatment of carotid artery stenosis and enrolled 316 patients across 24 trial sites in the U.S. and Europe. The results showed a primary endpoint of a major adverse event rate of 1.95% through 12 months post-procedure, which is the lowest such event rate reported for any carotid stent or embolic protection device to date. We received notification from the FDA that our PMA submission was accepted effective September 15, which then triggered a 180-day review period. Therefore, we anticipate a decision in early 2025, and we are prepared to aggressively execute on a robust commercial and operational launch plan if approved. As a reminder, receipt of the premarket approval from the FDA next year would trigger the second of four milestone-based financing tranches pursuant to the transformational private placement of up to $113.6 million that we announced in May 2023. If fully exercised, the second tranche would raise an additional $17.9 million in gross proceeds for the company, which is like the first tranche triggered this past July upon the presentation of positive CGuardians pivotal data. 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 Boards of Directors. After premarket approval, the remaining two milestones, which would trigger additional tranche financings, include receipt of FDA clearance for the SwitchGuard TCAR kit to include our CGuard Prime stent and the completion of four quarters of commercial sales of CGuard in the United States, which we anticipate in the back half of 2026, pending the approvals I mentioned earlier and based on our current plans. In parallel with the submission of our modular PMA, we've continued to build out what I consider to be a world-class commercial and operational engine to support our pending U.S. launch. Today, I'm especially pleased to share that we have strengthened our positioning by executing a seamless transition to a new world-class headquarters facility in Miami, Florida, from which we are reporting today. This new facility ideally positions us to support the anticipated U.S. launch and commercialization of CGuard Prime. South Florida has a rich history in medical device innovation and therefore provides us access to top-tier talent and other resources that support the ongoing build out of field sales, clinical support, and operational teams supporting infrastructure, all of which are ongoing. With our U.S. base now established, we are prepared to continue to build on our success outside of the U.S. while, contingent upon approval, fully serving the strong U.S. demand we anticipate for CGuard Prime and SwitchGuard neuroprotection system. Turning now to our pipeline. Last month we announced that the FDA approved our Investigational Device Exemption Application to initiate the CGuardians II pivotal study for our CGuard Prime TCAR indicated carotid stent system specifically developed for use during TCAR procedures. This represents a significant step forward for an offering of a complete TCAR toolset with next-generation enhancements including the best performing implant in CGuard Prime. As a reminder, the SwitchGuard neuroprotection 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. With input and support from the world's top vascular surgeons performing TCAR procedures, we've developed a next-generation tool set of TCAR features and accessories, which once cleared will provide next-level TCAR performance combined with the best carotid implant and CGuard Prime. 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. Turning now to our market growth 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 or 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 procedure, and we believe 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 imminently.

Thanks, Marvin. For the three months ended September 30, 2024, revenue increased by $254,000, or 16.3%, to $1,810,000 from $1,556,000 during the same period last year. This increase was driven by growth in existing and new markets. For the three months ended September 30, 2024, gross profit decreased by $24,000, or 5.6%, to $414,000 from $438,000 during the same period last year. This decrease in gross profit resulted from a $24,000 increase in miscellaneous expense. Gross margin decreased to 22.9% during the three months ended September 30, 2024, from 28.1% during the same period last year, driven by the factors I just mentioned. Total operating expenses for the third quarter of 2024 were $8.9 million, an increase of $2.8 million or 46.1%, compared to $6.1 million for the third quarter of 2023. This increase is primarily due to an increase in compensation, clinical, and development expenses. Financial income for the third quarter of 2024 was $572,000, an increase of $111,000, or 24.1%, compared to $461,000 for the third quarter of 2023. The increase in financial income primarily resulted from an increase in interest income from investments in marketable securities, money market funds, and short-term bank deposits. Net loss for the third quarter of 2024 totaled $7.9 million, or $0.16 per basic and diluted share, compared to a net loss of $5.2 million, or $0.15 per basic and diluted share for the same period in 2023. As of September 30, 2024, cash, cash equivalents, and marketable securities were $40.4 million, compared to $39 million as of December 31, 2023. This concludes our prepared remarks. We will now open the call for questions.

Thank you. We will take our first question from Adam Maeder with Piper Sandler. Please go ahead. Your line is open.

Hi Marvin, Craig, good morning and congrats on the nice quarter here in progress. Thanks for taking the questions. Maybe to start, wanted to ask about some of the kind of commercial activities that you're doing to get ready for U.S. launch and specifically U.S. sales force hiring. Can we get an update there? How is that going? Remind us of kind of how you're thinking about targeted headcount for U.S. launch? And then, would also ask about kind of the transition to the new headquarters in Miami and specifically around the ability to manufacture product just from a supply standpoint level of confidence that you'll be able to fully supply the market and hit the ground running. And then I had a couple follow-ups. Thanks.

Great. Thanks, Adam. Good to hear from you. So let me start with the last part of the question first. We're thrilled to be in the Miami facility. It's great to have a home base where we can gather our new talent together and operate as a unified company. And we've been overwhelmed by the amount of interest in our company and the level of talent. So we're really thrilled to have a base of operation here. In terms of our supply and the ability to meet the demands, we're obviously continuing to operate from our Tel Aviv facility and we have two other strategies that we're putting into place right now, one through a contract manufacturing approach and then building it on our own strategy. So I think the net result is that we're making significant plans and investments into making sure that we're going to meet these supply requirements from what we believe will be a significant demand from the market. So we've kind of got three legs of that stool that we're all working simultaneously to continue to keep pace with our market growth. Again, we're not operating flatfooted here. We've grown our business significantly over the years, so we feel like we've got a good formula that we can take advantage of. I've got Shane here in the room with me. Why don't I let him talk a bit to the commercial approach and how we're onboarding the team currently.

Yes. Thanks, Marvin, good morning. Good morning, Adam. So as you know, we've been predicting a CAS approval and launch in the first half of next year. So our game plan has been to build the commercial leadership team this year and then start to put the team on the field literally starting early next year. So we're well on our way there. I have four senior level commercial executives in various roles that have been hired and I'll just say, I've been in the cardiovascular space for over 20 years and I'm thrilled with really a lot of the best people in the business are interested in roles here and are some of those first four that we attracted. So I'd say we are on track and excited about the enthusiasm that we have for filling those other roles as we post them.

That's good color. Thanks, Marvin, and Shane for that. The next question I want to throw your way would be it's a commercial strategy question and specifically around kind of the U.S. commercial strategy, which accounts do you plan on targeting kind of initially out of the gate next year? Is there a certain number of accounts that you have in mind? And one question that I guess, I'm trying to think through is physician specialty, do you focus more on the vascular surgeons or the interventional cardiologists initially? And then I have one more follow-up for you guys. Thanks.

Yes. So taking the specialty piece, our first approval is going to be for CAS and we're going to go where those procedures are being performed, and that's most likely going to be with the interventional cardiologists and neurointerventionalists. So that's where we expect most of our time to be spent. As you know, we're going to be enrolling a TCAR study and when we get into the TCAR world more broadly, we'll get more pickup and more enthusiasm from the vascular surgery community for approved products. But I think early on it'll be with those who are doing the carotid stenting procedures, who will primarily be the interventionalists. We have claims data. We know where the procedures are being performed. We're in close contact with the thought leaders here. Our trial sites, I think without exception are excited to use the product as soon as it's made available to them commercially. So in terms of targeting what we know that we'll be targeting, we'll have an IBN focus to make sure that. One thing I've repeated is that the gaining physician enthusiasm in using this product is going to be among the easier parts of our job. The physicians really are interested in using this product. So a lot of our early efforts will be on navigating those product committees and getting approvals so that we can make the product available to them.

Yes. Adam, let me just add also, I think you picked up in my comments that our focus also is on the neuro community specifically. We know that there is a lot of Transfemoral CAS procedures being done currently in the neuro community, in many cases without a specific label. That's part of why we invested in the tandem early feasibility study. But more broadly, we're also focusing a lot of attention and energy on that community, understanding that they're currently stenting. And we think that CGuard is optimally suited in that setting. So anything that's Transfemoral related out of the gate, as Shane said, will be our initial focus with continued investment in the TCAR side.

Yes, good color there, guys. Makes sense. And for the last one for me, just a good segue into the TCAR initiative that you have ongoing. So CGuardians II, that IDE study, what can you tell us about the trial design, pace of enrollments, and potential approval? And then I'd also be curious to just try and learn a little bit more about the SwitchGuard product in terms of the features and potential differentiation that you guys are trying to bring to the marketplace. I'll leave it there and hop back into queue. Thank you.

CGuardians II has received IDE approval and is listed on clinicaltrials.gov. Our approach is divided into two phases. CGuardians II involves using the CGuard Prime with a short delivery system specifically designed for the TCAR procedure alongside the available TCAR NPS. Following that, we will move on to CGuardians III, which will utilize the same CGuard Prime stent but with the SwitchGuard NPS. The CGuardians II trial will include 50 patients using the commercially available NPS, and we are currently finalizing contracts with our sites. We anticipate the first patient enrollments to occur before the year ends. Regarding SwitchGuard in CGuardians III, we are currently focused on enhancing usability, access, and deliverability of the system, although we are not yet discussing specific features. I attended our preclinical GLP study this summer, where three leading vascular surgeons participated, and the initial feedback suggests we have successfully improved usability and deliverability compared to existing products.

I'd only add to that as it relates to our SwitchGuard strategy. We like the second mover advantage in being able to assess the experience level of over 100,000 TCAR procedures that have been performed with a lot of great feedback from our customers as to what they'd like to have and how we can improve that feature set to make these procedures more efficient and effective. And so we've really taken that information to heart and designed those feature sets into our launch program. So that will be our plan is to come out with not just a 'me too' product, but one that really performs at the next level.

Thank you. And we show no further questions at this time. I will turn the call back to Marvin for closing comments.

Great. Thank you very much. I'd like to thank everyone for joining the call today and for the ongoing support of our mission to lead the carotid revascularization market with our novel technology. We're very pleased with the progress. And we look forward to this U.S. approval and launch of CGuard next year. Thank you.

Thank you. And this does conclude today's program. Thank you for your participation. You may disconnect at any time.