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spk00: Greetings and welcome to InspireMD fourth quarter and full year 2021 earnings call. At this time, all participants are in a listen-only mode. A 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. Please note this conference is being recorded. I would now like to turn this conference over to Chuck Padala with LifeSci Advisors. Thank you. You may begin.
spk02: Thank you, Operator, and good morning, everyone. Thank you for joining us for the InspireMD fourth quarter and full year 2021 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, not historical facts. These are based on management's current expectations, beliefs, and projections, which may, uh, 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 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. Security and Exchange Commission. and InspireMD's press release that accompanies that call, particularly the cautionary statements made in it. The call contains time-sensitive information that is accurate only as of today, March 8th, 2022. 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. Good morning.
spk03: Let's begin with a reiteration of our mission at InspireMD to establish C-Guard EPS as the standard of care solution to change the way carotid artery disease is managed and strokes are prevented. The C-Guard carotid stent system enables this change through its unique design and proprietary Micronet mesh protection, which has yielded an unmatched and growing body of clinical evidence in real-world practice, as well as ongoing clinical studies. We serve equally all physician specialists treating carotid artery disease with focus on the stent system and patient outcomes. As we create greater awareness of the advantages of C-Guard as a first-line option for preventing brain embolization, not simply during the carotid stenting, but also after the procedure, our scientifically validated Micronet mesh feature enables this unique clinical advantage, and in combination with our next-generation delivery system, along with our new trans carotid accessory solution, we believe we can enable the conversion of this surgical dominated $5 billion global total addressable market to a less invasive endovascular standard of care. We will advance this topic later in the discussion. 2021 proved to be a year of change with more commercially focused on our increased C-Guard users and procedures in our 40 served markets to create awareness and experience within the US physician community through utilization in the C-Guardians FDA trial and our extensive studies of the device with numerous clinical trials, which continue to demonstrate solid clinical evidence of C-Guard's superior clinical results to an ever-expanding endovascular focus market, which has yielded many new users and foundationally grown C-Guard as a leader in the carotid stenting field. C-Guard's unique and proprietary design makes it the most advanced treatment for carotid artery disease. over all other stent technologies and surgical endarterectomy, a highly invasive surgical procedure. Execution of our strategic priorities, financial stability, and the growth of our commercial footprint all continue with focused determination as we enter 2022. As for 2021 results, our commercial business grew 56% year-over-year in C-Guard sales, representing shipments for procedures of approximately 7,000 units. Sales in our top eight markets grew by 67%, driven primarily by increases in market share. For example, in Italy, we achieved 36% market share of the existing cast implants, up from 26% the prior year. Procedural volume reflects an important measure of the strength and size of our business, as we currently share a portion of the average sales price in major markets with our distributor partners, further emphasizing our priority to convert more markets to a direct sales approach to fully capture top line revenue recognition. To date, we have sold over 28,000 Seaguard EPS systems, building a strong foundation of unmatched clinical data, both short and long term, as the best performing, most studied, and safest carotid stent in the market. Our advancing enrollment in SeaGuardian's FDA IDE trial continues with 12 sites currently enrolling in the U.S. with plans to start three more along with four in Europe during the second quarter. Our patient enrollment over the past 60 days has accelerated rapidly with more investigator experience and confidence in SeaGuard yielding continuous enrollments at sites following the initial launch. We have invested in a world-class team and partners to drive enrollment and study execution, and thus far we are pleased with our rapidly growing case results. Our current outlook is to complete the enrollment of the trial in Q1 2023. Principal Investigator Dr. Chris Metzger at Ballad Health System in Eastern Tennessee continues to lead the enrollment with 50 cases to date and guides our direction. As we previously discussed, in 2020, we successfully raised sufficient capital to fund our strategic plans, providing sufficient runway to complete what we believe to be significant milestones in 2022 and 2023. In Europe, we continue to build a momentum in France as our most recent country to be approved and reimbursed for Sea Guard, and we have hired direct sales representation to capture the momentum of this latest launch. Concurrently, we continue to accelerate our plans to advance our direct sales effort in other selective strategic locations to capture higher average sales price and enable greater control of the sales process to drive growth with focused attention to new tools and accessories, as we have demonstrated in the UK and France. Our strategy in Asia continues, including talks in Japan with distributor partners interested in representing SeaGuard. As we noted previously and consistent with our agreement in China, we believe the Asia market offers an opportunity for C-Guard as the existing standard of care for procedural intervention is predominantly endovascular and less surgically dominated. Our strategic commercial pathway for C-Guard continues with a new transfemoral delivery system, C-Guard Prime, offering greater navigation and flexibility to address more challenging patient anatomy as well as a broader set of evolving indications. We will offer C-Guard Prime in both standard and short-shaft versions compatible with our development of our TCAR accessory device, enabling a trans-carotid solution designed for conversion of vascular surgeons who perform the vast number of carotid revascularizations. Both devices are planned to launch in late 2022, early 2023. and we believe will foundationally change the landscape of C-Guard utilization to the broadest group of specialists performing endovascular procedures. Our mission is to serve all who treat carotid artery disease with tools to enable C-Guard stent placements for best patient outcomes. As we chart a new course for how carotid stenosis is managed and how strokes are prevented with our clinically proven C-Guard EPS system, our mission is to provide the best patient outcomes and broad set of tools to unlock the tremendous potential of this rapidly evolving market segment. With that, I'll turn the call over to Craig to review our financial results.
spk01: Thank you, Marvin. Revenue for the fourth quarter of 2021 was $1,380,000. an increase of $1,222,000, or 774%, compared to $158,000 in the fourth quarter of 2020. Excluding the $580,000 negative impact on revenue from our settlement of litigation with a former distributor from 2014 in the fourth quarter of 2020, total revenue increased by $642,000, or 87%. to $1,380,000 from $738,000 during the fourth quarter of 2020. This increase was predominantly driven by an increase in revenue of Seagard EPS by $603,000 or 88% to $1,291,000 for the fourth quarter of 2021 from $689,000 during the fourth quarter of 2020. This increase is mainly due to the growth in market share in major markets into new markets and due to the fact that in the fourth quarter of 2021, procedures with C-Guard EPS, which are generally scheduled for non-emergency procedures, began to return to normal levels as compared to the fourth quarter of 2020 when procedures with C-Guard EPS were postponed as hospitals shifted resources to patients affected by COVID-19 beginning in February 2020. For the fourth quarter of 2021, Gross profits increased 600 by $684,000 to $294,000 compared to a gross loss of $390,000 for the fourth quarter of 2020. This increase in gross profit resulted from the impact of the $580,000 settlement with our former distributor in 2014, which was recorded in the three months ended December 31st, 2020, as previously mentioned. as well as $207,000 increase in revenues less the related material and labor costs. Gross margin increased to 21.3% during the fourth quarter of 2021, from a negative 247% during the fourth quarter of 2020, driven by reasons previously mentioned. For the fourth quarter of 2021, total operating expenses were $4,225,000, an increase of $897,000, or 27%, compared to $3,328,000 for the fourth quarter of 2020. This increase was primarily due to increases in expenses related to the commencement of Sea Guardians' FDA study, share-based compensation-related expenses due to the recognition of grants made since August 31, 2020, and sales and marketing expenses associated with expansion of existing and new markets. For the fourth quarter of 2021, financial expenses decreased by 7.6% for $10,000 to $121,000 from $131,000 during the fourth quarter of 2020. Net loss for the fourth quarter of 2021 totaled $4,097,000 of 53 cents per basic and diluted share compared to a net loss of $3,853,000 or $1.52 per basic and diluted share for the same period in 2020. The average amount of shares outstanding use for the earnings per share calculation were $7,796,027 in the fourth quarter of 2021 and $2,533,936 in the fourth quarter of 2020. both adjusted to reflect the one-for-15 reverse split affected by us on April 26, 2021. As of December 30, 2021, cash, cash equivalents, and short-term dying deposits were $34 million, compared to $12.6 million as of December 31, 2020. This concludes our commercial remarks. I will now turn the call back to the operator for Q&A.
spk00: At this time, we will 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 symbol will indicate your line is in the question queue. You may press star 2 to remove your question from the queue. For participants using speaker equipment, it may be necessary for you to pick up your handset before pressing the star keys. One moment while we poll for questions. Our first question comes from the line of... Ben Hainor with Alliance Global. You may proceed with your question.
spk04: Good day, gentlemen.
spk00: Can you hear me all right?
spk04: We can, Ben. Thanks. Excellent. So just to start off, congrats on the inclusion in CREST 2. There's not a ton of similarly large trials that have happened in the past, I suppose. And so it's kind of a small sample size. But Are you guys aware of a similar situation where a device that hasn't gained regulatory clearance has been included in a trial of a similar profile?
spk03: It's a really good question, Ben. We're not aware of that, and we think it's a great proxy to the fact that C-Guard was allowed to be included in something as important as the CREST-2 effort. So, from our perspective, this was a a great accomplishment to be able to have a stent technology that's not yet approved be included in such a meaningful effort. So, we're very proud of that and think it's a good indication of the value of C-Guard.
spk04: I mean, congrats on that. That makes a lot of sense. So then, you know, my understanding is the scenting arm is running a little bit behind the CEA arm. Do you have a sense of how many CEA arms could be used in CREST 2?
spk03: Yeah, at this point, we're really trying to understand the number of devices that we could participate in. And we're working, obviously, closely with the CREST 2 Executive Committee to get things launched and put together. We hope to be able to participate you know, as completely as possible, you know, within the context of the current stenting arm and the people that are enrolling in that. And we think that by offering this next generation technology, there will be a resurgence of interest in being able to use C-Guard and continue along the path of stenting. So at this point, we don't have a quantified number for you, but we certainly believe that this news will invigorate the interest in those who are interested in stenting and using C-Guard.
spk04: Okay, that makes sense. And then you've got, I think you'll have, what, 19, 20 sites up and running here in the C-Guardians trial. By the end of Q2, it sounds like You know, I think there's 140, 150 CREST 2 sites. You know, do you have a sense of how broad you could go in CREST 2 in terms of number of sites and how much overlap is there between SeaGuardians and CREST 2?
spk03: Sure. No, really good question. And we're working, again, with the CRES II Executive Committee to figure out what the best pathway is related to both sites that are currently participating in Sea Guardians and those that are participating in CRES II. So, obviously, we're looking at those sites that are currently Sea Guardian sites and seeing if they would participate in CRES II and then CRES II sites that may be interested in becoming Sea Guardian sites. Those are the easiest pathway to progress in. And then, obviously, outside of that, there's more sites that we could bring in. But, you know, for the value of being able to get ones that are ready, those two categories seem to be the easiest path to follow at this point. Okay.
spk04: Got it. And then, you know, just kind of on the numbers question, you've got the You know, the CCAR development advancing, you've got the CCAR trial enrolling. You know, what is R&D or I guess how do you see R&D expenses tracking throughout the year?
spk01: Hi, Ben, it's Craig. So as we progress with the FDA trial, you should see more expenses going up with R&D as we continue to recruit and activate new sites. and also with some of the development work for the new products that Marvin mentioned. And then you should see a decline coming in the next couple years as we start to wind down the FDA trial.
spk04: Okay. That makes sense. I think that's all I had, guys. Congrats on the progress, and thanks for taking the questions. Thanks, Ben.
spk00: Thank you. We are only taking questions from covering analysts today. We have reached the end of today's question and answer session. I would like to turn this call back over to Mr. Marvin Fossman for closing remarks.
spk03: Great. Thank you. I'd like to thank everyone for taking the time to join the call today. We're extremely proud of the accomplishments of our global team in 2021 and certainly look forward to, with great anticipation, our progress in 2022 with focus and growth and market expansions. Thanks for taking the time to join the call.
spk00: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. Enjoy the rest of your day.
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