InspireMD, Inc. (NSPR) Q2 2021 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Good morning, and welcome to the InspireMD First Quarter 2021 Financial Results and Corporate Update Conference Call. [Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and also is being recorded for playback purposes. Webcast replay of the call will be available approximately 1 hour after the end of the call through November 10, 2021. Now I'd like to turn the call over to Mr. Jules Abraham of CORE IR, company's Investor Relations firm. Please go ahead, sir.

Thank you, Nick, and good morning, everyone. Thank you for joining us for the InspireMD Second Quarter 2021 Financial Results and Corporate Update Conference Call. Joining us today from InspireMD are Martin Slosman -- Marvin Slosman, excuse me, Chief Executive Officer of InspireMD; and Craig Shore, Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address InspireMD's expectations for future performance or operational results, particularly in light of the COVID-19 pandemic. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those 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 and the Form 8-K filed with the SEC today and InspireMD's press release that accompanies this call, particularly the cautionary statements in it. The content of this call contains time-sensitive information that is accurate only as of today, August 10, 2021. 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?

Thank you, Jules. Good morning, and thank you all for joining the second quarter 2021 call and webcast. Also joining me today is Craig Shore, our Chief Financial Officer. At InspireMD, our mission remains clear: to establish CGuard EPS as the standard of care solution to change the way carotid artery disease is managed and strokes are prevented. The CGuard 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 and 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 CGuard as a first-line option to broad physician base as well as advanced new delivery systems and accessory solutions, we believe we can enable the conversion of this surgically dominated $1 billion global market with a less invasive endovascular standard of care. The second quarter of 2021 proved highly productive for InspireMD, gaining traction in our execution milestones of global expansion, commercial growth and development of new pipeline offerings. Revenue performance for the second quarter showed consistent improvement as elective procedures normalized and our commercial momentum grew. We achieved revenue of $1.037 million for the quarter, a 231% growth year-over-year. During the quarter, we sold 1,660 devices, an increase of 210% as compared to the second quarter of 2020 with renewal of scheduled procedures and return to pre-pandemic levels. Of our top stated priorities for 2021, most notably, we began steps in the path toward commercial registration of CGuard in the United States with the initiation of our C-Guardians pivotal trial. We've completed 12 cases of the targeted 315 total enrollment in the first 3 weeks, led by our global principal investigator, Dr. Chris Metzger at Ballad Health System in Eastern Tennessee. As we launched the trial in the United States at 15 planned sites and with the top carotid stent leaders, we look to establish a foundation of awareness and credibility through the utilization of CGuard, which will position us for a successful and accelerated post-approval commercial launch. In terms of global expansion, we continue our progress in China, working with our distributor partners on the regulatory trial execution plans, along with progress and expansion into new markets in Asia, such as Japan, Taiwan and Korea. We believe these markets offer an accelerated opportunity for CGuard as the existing standard of care for procedural intervention is predominantly endovascular focused and less surgically dominated. In France, we've received clinical approval for CGuard from the French National Authority of Health and are anticipating reimbursement approval in the coming weeks to enable our plans to launch our next direct sales market along with the U.K. We are evaluating the other direct sales possibilities to drive higher average sales price and more control of current and developing offerings. To enhance our growing commercialization efforts globally, we appointed a new member of our Board of Directors and for the Medical Advisory Committee with key opinion leaders to guide our progress. Seasoned medtech marketing executive, Katie Arnold, with more than 2 decades of strategy and commercialization in the medical device industry joined our Board of Directors. Katie's knowledge and leadership will be invaluable in helping our company shape our strategic plan and expand commercially in business development. We also appointed a claimed interventional cardiologist, Dr. Kenneth Rosenfield, as the Chair of the new Medical Advisory Board. The Board will provide guidance and direction on clinical need, technology advancements and planning the company's growth in strategic direction. We continue to invest heavily in our pipeline of innovation and advancing platforms that enable more cash procedures. We have in development 2 new delivery systems advancing to a possible approval in 2022, which we believe will facilitate greater accelerated access to the overall global market potential and specifically address the conversion of surgical procedures to endovascular stenting. To summarize, we are pleased with our progress focusing on establishing CGuard carotid stent system as the foundational enabler of the stent market conversion. Our commercial focus and execution in our current 33 served markets, along with building market experience and awareness of CGuard in the United States and Asia through the regulatory trial process, are building foundations for future success. As we chart a new course in how carotid artery disease is managed and stroke is prevented with our clinically proven CGuard EPS system demonstrating superior clinical outcomes for patients compared to alternative carotid stent types, conventional or next-generation double-layer stents as well as invasive surgical procedures, such as endarterectomy, we are encouraged by our progress in mission, and we continue to invest in our future to leverage and unlock the tremendous potential to change the way carotid artery disease is managed and stroke is prevented. With that, I'll turn the call over to Craig to review our first quarter financials. Craig?

Thank you, Marvin, and to everyone for joining today. Here are some key financial highlights for the second quarter ended June 30, 2021. Total revenue for the quarter was $1.038 million, an increase of 232% compared to $313,000 during the 3 months ended June 30, 2020. CGuard EPS had revenue of $1.019 million, an increase of 276% from $271,000 for the same period last year. This sales increase was mainly due to procedures with CGuard EPS, which are generally scheduled for nonemergency cases began this quarter to return to normal levels as compared to the 3 months ended June 30, 2020, when procedures with CGuard EPS were mostly postponed as hospitals shifted resources to patients affected by COVID-19. This increase in sales of CGuard was partially offset by a decrease of 55% in sales of MGuard Prime EPS from $42,000 during the 3 months ended June 30, 2020, to $19,000 during the 3 months ended June 30, 2021. For the 3 months ended June 30, 2021, we had a gross profit of $262,000 compared to a gross loss of $120,000 during the 3 months in the same period last year. This increase in gross profit primarily resulted from a $237,000 increase in revenues less the related material and labor costs and a decrease in write-offs of $144,000, which were driven mainly by changes related to component supply issues. Gross margin increased to 25.2% during the 3 months ended June 30, 2021, from a negative 38.3% during the 3 months ended June 30, 2020, for similar reasons as I just stated. Total operating expenses for the quarter were $3.7 million, an increase of 59% compared to $2.3 million for the same period in 2020. This increase was primarily due to increases of $705,000 in salary expenses and related accrual expenses, mainly driven by temporary salary reductions during the 3 months ended June 30, 2020, that were implemented in response to the COVID-19 effect on revenues as well as additional resources, mainly in our product development and sales infrastructure; $437,000 in expenses related to the commencement of the C-Guardians FDA study; $315,000 in share-based compensation expenses due to the expense recognition of grants made after June 30, 2020; $297,000 in development expenses associated with CGuard EPS accessory solutions; and $108,000 of Directors and Officers Liability Insurance expense due to the increased premiums caused by recent trends in the overall insurance industry. This increase was partially offset by a decrease of $400,000 relating to a settlement agreement with an underwriter of our prior offerings, which occurred in the 3 months ended June 30, 2020, and a reduction of $86,000 of miscellaneous expense. Net loss for the second quarter totaled $3.507 million or $0.46 per basic and diluted share compared to a net loss of $2.48 million or $2.93 per basic and diluted share for the same period in 2020. The average amount of shares outstanding used for the earnings per share calculation were 7.7 million in Q2 2021 and 845,000 in Q2 2020, both adjusted to reflect the 1:15 reverse split effected by us on April 26, 2021. As of June 30, 2021, cash and cash equivalents were $41.4 million compared to $12.6 million as of December 31, 2020. With that, I would now like to turn the call over for questions. Operator, please go ahead.

[Operator Instructions] Our first question comes from Ben Haynor, Alliance Global Partners.

First off for me, just on the -- well, first, congratulations on getting the C-Guardians trial started and that's great to see. On the dozen or so patients that you've enrolled so far, I would imagine -- I don't know if you can talk about procedural success at all, but are there any kind of nonoutcome measures, procedure times, how these cases are scheduled, things of that nature that you might be able to share?

Yes, Ben, thanks for the question. So so far, the enrollment has gone accordingly, and we're actually thrilled by the number of cases in this particular case that Dr. Chris Metzger has scheduled. I mean it's an aggressive schedule, and he's quite excited to use CGuard with as many appropriate cases as possible. So we're looking forward to that trend continuing and the cases continuing to enroll in an accelerated pace, which was always our hope and our intention to try to get the enrollment phase of this trial completed as soon as possible. So so far, it's been -- it's really exceeded our expectations in terms of the usefulness of CGuard in a number of cases that have been enrolled, and we plan to bring 2 or 3 more sites on within the next month. So it's now a move to get more people enrolling. So so far, so good.

Okay. Well, I mean, geez, it looks like Dr. Metzger could almost enroll by himself the way he's going with it.

He certainly has the cases, right?

Okay. So that's not just -- I know they're not necessarily completely elective procedures, but there are things that can be postponed a little bit. Was there kind of a backlog that he's working through on those first 11 or so cases that you mentioned?

No, he obviously wants to find the appropriate cases to be done related to the trial, but he has that kind of volume. But we certainly want to spread out the work amongst the 15 other operators in the U.S., so that we get a nice diversity within the community. So he just has that number of cases that he's often doing.

Okay. And maybe I'm asking too many questions on this. And does he kind of schedule like a CGuard day or each week or how does he tend to do them?

Yes. Most of it is specific patient related and case related. So he evaluates his patients. And as you said, the majority of these are elective. And so he's able to do a thorough evaluation, and it goes to a committee for review. It's a very defined process of which cases get enrolled. And so he has a high volume and schedules accordingly. So it just happens to be that the volume is significant.

Okay. That makes sense. And then it's nice to hear about the CGuard Prime and the new embolic protection device. What are the thoughts there on kind of capturing a greater share of the procedure? I assume it's the plan with the embolic protection device, and then I assume it's the improvements in the transfemoral device delivery system there. Is that just to make it easier on docs? Just kind of the color that you can offer there?

Sure, Ben. It's a great question. As I've mentioned in previous calls, our objective is to make sure that we have the appropriate delivery systems for any specialist that's interested in managing carotid artery disease, whether they're interventional or kind of surgery focused. So we're continuing to make sure that our delivery systems match those objectives in CGuard Prime is that next-generation transfemoral system that we believe that will just make the delivery process in a transfemoral approach easier for the physicians. It's just that next-generation device that we always look to make improvements in the feature set in the pipeline. In terms of the other device, it's a little premature at this point to share the specifics of the details of the delivery system, but let's just say that we're incredibly pleased by the progress. And we believe that this will, in particular, enable this conversion of vascular surgery over to endovascular procedures, which is really a significant goal for the company, as you know. So we are all about focusing on the stent system and patient outcomes and want to make sure that our delivery systems are available to whatever subspecialists. We don't discriminate amongst groups. If they're involved with carotid artery disease management, we want to make sure that we're their first line solution with CGuard.

Okay. That makes a lot of sense. And then maybe just digging a little bit deeper on the improvements of the transfemoral device. I mean, are those kind of ergonomic improvements? Are they -- what sort of improvements are -- have been made on the device, if you can share?

Yes. We've taken kind of an end-to-end solution in any multi-generational product development plan that every good company has. We've tried to look at every feature and aspect of the device from the catheter tracking through the handle design and device. And so we're really trying to just step up the delivery system from end to end to make sure that it's as functional as possible and that it makes delivery of the CGuard as easy as possible even under acute cases or symptomatic cases where physicians are just very comfortable with the device and how it performs. So it's really been a comprehensive end-to-end look at making sure that the device is as it should be. And we've been guided and get direct feedback from our physicians, obviously, on those things that we wish to improve, which is the way it should be.

Okay. Great. And then just lastly for me, I guess. You mentioned regulatory approvals in 2022. Does that encompass kind of, outside the U.S., I would imagine CE Mark, for sure? But are those also kind of 510(k) products that you could get cleared by the FDA as well prior to the clearance of CGuard? Or what's the thought there?

Yes, we're evaluating all the options at this point, Ben. As you know, the MDR conversion in the CE mark in Europe has changed a lot of the regulatory landscape, but we are certainly looking at a comprehensive regulatory solution for both of these devices and making sure that we're keeping up with the markets as they evolve and unfold. So we're looking at both in terms of the possibility and potential.

This concludes our question-and-answer session of the call. I'll now return the call to Mr. Marvin Slosman for closing remarks.

Thank you. I'd like to thank everyone for taking the time to join today and your ongoing support. InspireMD is fundamentally a stronger company today than ever before. And I'm very proud of the extraordinary efforts of our expanding team and creating excitement for the future for the company and look forward to updating everyone on the third quarter results in the future. Thanks very much.

Conference has now concluded. Thank you for attending today's presentation. You may now disconnect.