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spk04: Good day and welcome to InspireMD first quarter 2023 earnings call. All participants will be in listen-only mode. If you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note that this event is being recorded. I would like to turn the call over to Mr. Glenn Carmon with Life Science Advisors. Please go ahead, sir.
spk02: Thank you, operator, and good morning, everyone. Thank you for joining us for the InspireMD first quarter 2023 financial results and corporate update conference call. Joining us today from InspireMD are Marvin Slossman, Chief Executive Officer, and Craig Shore, Chief Financial Officer. During this call, management will be making forward-looking statements, which are not historical facts and are based upon management's current expectations, beliefs, and projections, many of which by their nature are inherently uncertain. They involve risks and uncertainties that may cause actual results to differ materially from those expressed in the 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 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. The call contains time-sensitive information that is accurate only as of today, May 16th, 2023. 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 Slossman, Chief Executive Officer. Marvin, please go ahead.
spk03: Thank you, Glenn, and thanks to everyone for joining the call this morning. Without a doubt, the most significant development since our last quarterly update and one of the most significant milestones in InspireMD's history is our completion of a transformational financing through a private placement of up to $113 million. The financing was led by Marshall Weiss, with participations by Orbimed, Tolias, Nanahala, Rosalind, and Velen Capital. These are amongst the most highly regarded medical technology institutional investors, It's also worth noting that a certain number of our board members have also elected to participate in the offering. We are both inspired and humbled by this vote of confidence, which fuels our company's growth and enables our strategic goal to change the therapeutic standard of care in the carotid disease market. Pursuant to the engagement, we received an initial $42.2 million in gross upfront capital, with an additional four tranches of $17.9 million each, tied to milestones totaling $113.6 million fully exercised. The warrants are tied to the following milestones. First, the readout of top-line 12-month data from our ongoing FDA Sea Guardians IDE clinical trial. Second, receipt of premarket approval, PMA, from the FDA for the SeaGuard Prime Carotid Stent System. Third, the announcement of receipt of FDA approval for the SwitchGuard Transcarotid System and SeaGuard Prime ADCM. And fourth, the first five quarters of commercial sales in the U.S. market. The funds are intended to further catalyze our milestone execution, including approval and launching our new products in the U.S. and in our current served countries, including the CE-MARC territories, advancing our tandem lesion indication for C-MARC, and establishing a U.S.-based business operations and commercial architecture. With our balance sheet significantly strengthened, we can accelerate our plan to drive value inflection by way of advancing C-Guard EPS through the U.S. regulatory pathway while commencing the build out of a world-class commercial infrastructure deeply committed to making C-Guard broadly available to the many patients with carotid artery disease who stand to benefit from this novel advancement in fencing technology. The mission of our business remains unchanged, which is to focus on implant performance and positive patient outcomes. As a reminder of the superiority of our unmatched data from nine rigorously designed peer-reviewed clinical studies that have enrolled approximately 1,850 patients, C-Guard EPS demonstrated superior short- and long-term clinical outcomes measured by the lowest complication rates of death, stroke, and myocardial infarction as compared to both competing first-generation stent systems as well as surgical endarterectomy. Turning now to the quarter. We generated total revenue of $1.2 million, representing growth of 4.7% over the first quarter of 2022. This was driven by a 6.7% increase in sales of Seaguard EPS in our 30 served markets. As we shared in our last quarterly reporting, our temporary restriction of sales due to the loss of MDD certification in November 2022 created a gap in sales and shipments, which was resolved in the second half of the first quarter. It is significant to note that we were able to generate year-over-year revenue growth despite this restriction, but more importantly, we're able to successfully maintain sufficient inventory in our channels to avoid loss of procedural volume and access for patients to our C-Guard stent for best patient care. It is a testament to the tireless work and focus of the entire InspireMD team that we were able to maintain availability in our markets and address patient needs despite this temporary interruption of shipments. Recall that in November 12th of last year, our CE-MARC certification temporarily lapsed as European regulators transitioned from the existing MDD directive regulatory framework, which governs the marketing approval and sale of medical devices in the EU, to the Medical Device Regulation Framework, or MDR. This transition resulted in well-documented and significant delays by the European regulatory bodies in processing of application and audits under the new MDR certification. The MDR deadline for transition to updated certification has taken more than three years with multiple revisions, delays, and requirement changes, putting the entire medical device industry serving the EU markets at risk. This complexity, combined with constantly changing requirements and deadlines, has made this a challenging undertaking for all medical device companies that fall under the MDD purview. In anticipation, we proactively worked with our distributor partners to provide as much available inventory as possible to avoid shortages while continuing to complete the MDR process to re-establish sales, which we have successfully done and are now able to resume normal cadence in our sales effort. As a reminder, we enjoy greater than 25% market share in over half of our served CE marked territories, with some exceeding 80%. We believe our continued efforts on the ground, together with the launch of two new stent delivery platforms, will enable share growth and accelerate the conversion of surgeries to endovascular standard of care with the C-Guard Stent System. Our mission remains unchanged to convert the last surgery first segment of vascular medicine to an endovascular first-line standard with the best-in-class implant, the C-Guard EPS. With a full range of delivery options serving the broadest multidisciplinary physician base, we believe we are uniquely positioned to accelerate this conversion. And turning now to our U.S. regulatory activities, our C-Guardian U.S. IDE trial continues. at a robust pace for enrollment, with 20 active trial sites recruiting and treating patients. We recently announced that on May 1st, the first patient was successfully treated in our Seaguard PANS trial utilizing Seaguard Prime, the company's next generation cat stent platform. This marks a very significant milestone for the company, with Seaguard Prime used in a clinical setting, marking a significant step forward in advancing more stenting procedures. Since that first case, we've continued to rapidly enroll in the final patient set with C-Guard Prime, anticipating completion of enrollment by the end of this quarter. As a reminder, the new C-Guard Prime offers numerous benefits and advantages to physicians performing carotid revascularization, including an innovative handle design and catheter and tip construction, which makes stent trackability and deployment much easier. This gives physicians and staff a much higher degree of confidence, which we believe will contribute to its confidence and stent utilization once approved and launched. After completing enrollment in Sea Guardians, we will advance our PMA submission and approval process to get us closer to the potential launch of Sea Guard Prime in the U.S. market. In parallel, we've commenced critical commercial readiness activities in the U.S., including the hiring of Shane Gleason, a seasoned commercial executive, in the vascular space to lead our go-to-market preparation as the GM of the Americas. In terms of product pipeline, the Seaguard EPS Stent Platform remains the core of our business as we focus on the value of the implant as the single most important variable in patient outcomes. To fully realize the full potential of Seaguard, however, we've developed two new delivery platforms to drive utilization across the broadest vascular specialist community. As noted earlier, we continue to advance development, regulatory approval, and launch plans for our CAST platform, T-Guard Prime, which will be available in both standard and short-shaft versions, compatibility with development of SwitchGuard, our T-Card neuroprotection platform. In combination, we believe our transcarotid kit will enhance T-Card utilization with the best implant. We believe the breadth of our total tool set with a stent-centric focus will be a key differentiator for us as we work to unlock the tremendous potential of this rapidly evolving market segment. The winds of change and focus on endovascular first and carotid revascularization reinforce that our investment in this space will yield tremendous value as we work to lead this market transition. In summary, we're incredibly proud of this financing, which serves as a proxy of our direction and it's a transformational time for our company as we look for a bright future. With that, I'll turn the call over to Craig for a view of the first quarter's financials. Craig.
spk00: Thank you, Marvin. I would like to begin this morning with a review of our recent financing. We entered into a securities purchase agreement led by Marshall Weiss with a significant participation by other highly regarded healthcare investors for the sale of common shares or pre-funded warrants at each investor's election and warrants that in aggregate can bring in up to $113.6 million. As Marvin indicated, we received an initial $42.2 million gross upfront with an additional four tranches of approximately $17.9 million each, tied to milestone-driven warrants totaling $71.4 million if the warrants are fully exercised for cash. This would bring us to a grand total of $113.6 million. The warrants are tied to the following milestones, including the reporting of a 12-month data from our ongoing FDA C-Guardians IDE clinical trial, the receipt of premarket approval, PMA, from the FDA for the C-Guard Prime carotid stem system, receipt of FDA approval for the SwitchGuard Trans carotid system, and C-Guard Prime 80 centimeters. And the first five quarters, the commercial sales in the United States market. Turning now to the quarter, we generated total revenue of $1,239,000, a 4.7% increase over $1,183,000 for the first quarter of 2022. This increase was driven by a 6.7% increase in sales of CLARD EPS. During the second half of the quarter, the company's CE mark was reinstated under the MDG directive, allowing the company to resume sales and shipments to the EU countries. The company worked the remainder of the quarter shipping products to reduce the backload of orders that accumulated over the past few months. InspireMD believes that the quarter-over-quarter increase in revenue during the first quarter of 2023 is not representative of the real underlying market demand for CRDPS, Due to the company's inability to ship product for the first half of the quarter, we entered the quarter with a remaining backlog of approximately $600,000 due to the temporary expiration of our CE mark. The company continues to work to expedite the review process for recertification under the MDR. For the three months ended March 31st, 2023, gross profit increased by $251,000. or 206 percent to $3073,000 from $122,000 during the three months ended March 31, 2022. This increase in gross profit resulted from a decrease in write-offs of $184,000 and a $71,000 increase in revenues, as previously mentioned, less the associated related material and labor. Gross margin increased to 30.1% during the three months ended March 31st, 2023, from 10.3% during the three months ended March 31st, 2022, driven by the factors just mentioned. Total operating expenses for the first quarter of 2023 were $4,754,000, an increase of $146,000, or 3.2%, compared to $4,608,000 for the first quarter of 2022. This increase was primarily due to increases in expenses related to CRD and FDA study, sales and marketing expenses, and regulatory expenses. Net loss for the first quarter of 2023 totaled $4,256,000 or 53 cents per basic and diluted share compared to a net loss of $4,481,000 or 57 cents per basic and diluted share for the same period in 2022. As of March 31st, 2023, cash, cash equivalents, and short-term bank deposits were $12.9 million, compared to $17.8 million as of December 31st, 2022. This, of course, excludes the transformational financing just described as the transaction closed subsequent to the end of the first quarter. That concludes the financial review. We'll now open the call for Q&A. Operator?
spk04: Thank you. We'll now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2.
spk01: This time we'll pause momentarily to assemble the roster. Thank you. First question will be from Benjamin Maynor of Alliance Global Partners.
spk04: Please go ahead.
spk05: Good morning, gentlemen. Thanks for taking the questions, and congrats on the financing. First off, for me, just with the capital rates, can you talk maybe a little bit about how it might accelerate other indications, particularly NGARD? and any other R&D products that it could impact?
spk03: Hi, Ben. Thanks. Appreciate the question. It's an excellent thought there. We consider this financing to be transformational for a number of different reasons, but I think you highlighted exactly the point, which is we've got a number of R&D projects which we're working on continuously as well as new indications. And this gives us the capital to be able to fuel those and accelerate those, I think, into a timeframe that gives us a good pathway. And we're really excited about the possibilities of having that capital that move things forward. We've mentioned one in particular, which is this indication for acute stroke, for tandem lesions and acute stroke, which we've been working on for quite some time. So we've mentioned that in prior calls. And that's just one example of the opportunity to move things forward so that we get the best of what C-Guard can offer in the marketplace. So this is a great opportunity for us.
spk05: Got it. And then, you know, do you have kind of a thought on what a trial design might look like in that indication?
spk03: Yeah, it's still working right now. Yeah, we're working right now with FDA on a pre-sub to submit our expectations of a protocol and a pathway to that, and we'll have good information for you shortly as that unfolds. Obviously, this financing allows us to advance that effort more aggressively, so we'll be back to the market shortly on that one, but in the process of touching up the protocol and submission to FDA.
spk05: Okay, got it. So stay tuned there. And then on the commercial readiness, what activities do you have kind of ongoing now? What's scheduled upcoming here? What should we be expecting to hear on that front?
spk03: Yeah, so as we mentioned, we hired Shane Gleason as the GM of the U.S. business. Shane comes with a a real depth of skills and knowledge and experience in this marketplace and has already begun the process of outreach to many of the leading physicians in the space, both on the vascular surgery side as well as the interventional side of our business. And so over the next few months, you can imagine there's a lot of architecture that goes into building a strong sales organization and strong presence in the market. One of the things we're proud of is the fact that we're currently participating in our IDE trial with about 20 sites in the US. And so we have a baseline of both contractual understanding with these hospital systems as well as these physicians. So it gives us a great start Just in terms of the administrative effort and how we think about leading into market launch on post approval So there's a lot to be done, you know between now and that point but we have a very clear understanding of what it takes to architect and Implement a plan so that we hit the ground running once approval takes place Okay, got it and then
spk05: You know, on the warrant triggers, it's just curious. I mean, it seems to me like the switch guard and the C guard prime 80 centimeter clearances could be the first one, the first warrant trigger that you hit. Is that a fair assessment? And, you know, how soon could that come?
spk03: So I think sequentially, if you take a look at the first one, it would be on the readout of top line data. So we think that that one is obviously in the closest future point, if you will. The second would be on approval of the current IDE, the PMA for the current IDE for Seaguard Prime. And then the third, obviously, is for our TCAR solution with SwitchGuard and the short shaft Seaguard Prime as well. So I think if you just look at the sequence over time, that's the general timeframe that we see things occurring in. And obviously we've been able to separate those four milestones.
spk05: Okay, got it. And then lastly, just a point of clarification for me. It sounds like you resolved any backlog that you had during Q1. Is that the right way to think about it and there shouldn't be any impact for the current quarter?
spk03: Yeah, I think that's the right way to think about it, Ben. Obviously, being able to complete those shipments and clear that backlog is a process in and of itself. We've prioritized all the major distributors and accounts in our European markets to make sure that everyone has sufficient inventory, and we'll continue to work through that backlog process. as well as new orders that are coming in and being able to get back to a normal cadence with demand. So I think you're correct there. We're working through that as quickly as possible. Although we were not in the market for a period of time, our production continued, and we had a readiness for the point where we're at now, which is to be able to ship freely and sell into the European space.
spk05: Okay. That's helpful. That's it for me. Thanks for taking the questions, gentlemen, and congrats again on the financing.
spk01: Thanks, Ben. Thank you. We'll now turn the call back over to Mr. Marvin Schlossman for calls and remarks.
spk03: Thank you. I'd like to thank everyone for taking the time today to join the call and for the ongoing continued support. I'm extremely excited about what is the transformational financing and what that will allow us to achieve. More than at any other point in the company's history, we're extremely well positioned to execute on our plans to benefit patients and shareholders alike, and we appreciate the ongoing support. Have a good day.
spk04: Thank you. Conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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