InspireMD Inc (NSPR) 2021 Q1 法說會逐字稿

Good morning, and welcome to the InspireMD First Quarter 2021 Financial Results and Corporate Update Conference Call. (Operator Instructions) A webcast replay of the call will be available approximately 1 hour after the end of the call through May 25, 2021.

I would now like to turn the call over to Scott Gordon, President of CORE IR, the company's Investor Relations firm. Please go ahead, sir.

Thank you, Chad, and good morning, everyone. Thank you for joining us for the InspireMD First Quarter 2021 Financial Results and Corporate Update Conference Call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer of Inspire; 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, Form 10-Q, 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, May 11, 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 is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

Thank you, Scott, and thank you all for joining the call and webcast today. The first quarter of 2021 was a very productive period for InspireMD with persistence and tireless focus on executing our milestones, ranging from expanding our already unmatched clinical body of evidence global expansion, commercial growth and development of new pipeline offerings. Our execution strategy remains sound and our mission remains the same. To demonstrate that CGuard EPS with its unique and proprietary design is the most advanced treatment of carotid artery disease or CAD and stroke prevention above all other stent systems in the market and to establish CGuard as the carotid device of choice amongst physicians across multiple clinical specialties that treat carotid artery disease.

Revenue performance for the first quarter showed improvement, although with some residual effects of the pandemic, as many of our served geographies continue to struggle with full access to elective procedures but we expect revenue to normalize as we moved through the year. Of the many milestones we achieved during the first quarter, we believe one of the key events was the shareholder approval for a reverse split of our stock. We worked hard to accomplish a 1 for 15 reverse stock split, reducing the number of outstanding shares from 118 million to 7.9 million shares, which took effect at the close of trading on April 26, 2021.

The reverse stock split was important and allowed us to pursue the newly announced listing on the NASDAQ capital market. Our stock will begin trading on NASDAQ under the same ticker symbol NSPR, starting May 21. We believe that the uplisting to NASDAQ will make our shares more attractive to a broader range of investors, particularly institutional and fundamental investors. One of our top priorities for 2021 is to initiate steps in the path toward commercial registration of CGuard in the U.S. with the start of our pivotal trial, now known as CGuardian. We announced that leading interventional cardiologists, Chris Metzger, System Chair of Clinical Research at Ballard Health System in Eastern Tennessee has accepted the role as principal investigator in the U.S., along with Piotr Musialek, who will serve as co-principal investigator, focusing on the European enrollment for the trial. Hart Clinical Consultants, a leading Contract Research Organization will spearhead the effort, managing the trial execution.

The U.S. is one of the largest markets in the world for our device and establishing a base of awareness and credibility through the trial execution will position us for a successful and accelerated post-approval commercial launch. I'm pleased to share that all of the initial sites, both in the U.S. and Europe, have accepted our invitation to participate, and I believe we have the most robust group of leading centers and investigators on board for this important effort anticipated to begin enrollment in July.

In terms of global expansion, we continue to progress in China following the announcement of our agreement and are working diligently with our partners on next steps for regulatory approval and distribution for CGuard EPS in Mainland China. Stroke is a leading cause of death in China, and the country is believed to be the second-fastest-growing market in peripheral stent procedures. We view our entry into the Chinese market as a pillar of our Asian growth plan as we work toward expansion in new markets, such as Japan, Taiwan and Korea. In Europe, we filed for registration and reimbursement in France and plan to establish a direct sales strategy, along with our current direct sales market in the U.K. We currently share a portion of our revenue in the form of transfer pricing with our distributors. And therefore, under a direct sales model, our top line revenue will increase by capturing the full ASP from customers.

Additionally, we value the direct model and our ability to control the sales process to drive accelerated growth and adoption of new tools and devices. This is an important point of reference as we move forward in direct sales in certain markets.

Finally, during the first quarter, we completed an upsized underwritten public offering, which, along with other supported financial transactions, raised a total of $35.1 million net and accordingly, strengthened our balance sheet and cash reserves to fund our operations through mid-2023, assuming normal course of business.

We are now well positioned and believe that we have the necessary resources to fund the CGuardian trial, our continued global commercial expansion and to advance development of pipeline of new products, including new tools, accessories, stent delivery solutions and portfolio additions to facilitate broader and greater utilization of CGuard.

We are working diligently on our commercial goals to increase awareness of our CGuard proprietary stent system focusing on the conversion of vascular surgeons who perform the majority of carotid revascularizations in our current served markets as well as growth target markets. We continue to expand our online training and proctoring efforts along with reinstating our centers of excellence, or COE programs in our existing markets and educational support of new users for the CGuard platform. We remain firmly committed to change how CAD is managed and stroke is prevented with our clinically proven CGuard EPS system. In the past, physicians have had to make inherent compromises in choosing a carotid artery stent with either open or closed-cell design. CGuard EPS eliminates those compromises as it offers the best of both worlds by simultaneously providing open and closed cell features and performance with what we believe to be the most advanced protection from embolic events as the leading cause of stroke.

CGuard's unique MicroNet technology mitigates the prolapse of plaque into the lumen of the artery and thus prevent associated embolization. It continues to demonstrate superior clinical outcomes for patients compared to alternative carotid stent types, conventional and next-generation double-layer stents as well as invasive surgical procedures, such as endarterectomy.

CGuard has demonstrated clinical superiority and protected treatment of CAD with the potential to firmly establish a new standard of care for carotid artery disease.

And 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 first quarter of 2021. Total revenue for the 3 months ended March 31, 2021, was $1,006,000 a decrease of 2.7% compared to $1,034,000 during the 3 months ended March 31, 2020. CGuard revenue remained essentially unchanged at $970,000, during the 3 months ended March 31, 2021, as compared to $971,000 during the same period last year. In spite of the continued postponement of many elective procedures as a result of the residual COVID redirected resources. However, MGuard Prime EPS revenue decreased by 41.3% from $63,000 during the 3 months ended March 31, 2020 to $37,000 during the 3 months ended March 31, 2021, largely driven by the predominant industry preferences favoring drug-eluting stents rather than the bare metal stents, such as MGuard Prime EPS.

For the 3 months ended March 31, 2021, we had a gross profit of $106,000 compared to a gross profit of $295,000 during the same period last year. This decrease in gross profit resulted from an increase in write-off of $156,000, which were driven mainly by a component supply issue and an increase of $33,000 in miscellaneous expenses. Gross margin decreased to 10.5% during the 3 months ended March 31, 2021, compared to 28.5% during the 3 months ended March 31, 2020, driven by the factors just mentioned. Total operating expenses for the quarter ended March 31, 2021, were $3.4 million, an increase of 47.7% compared to $2.3 million for the same period in 2020. This increase was primarily due to an increase of $430,000 in salary expenses and related accrual expenses mainly driven by additional resources in our product development and sales infrastructure.

$248,000 in share-based compensation-related expenses due to the expense recognition of grants made in the second half of 2020, $136,000 in development expenses associated with CGuard EPS, mainly related to the new advanced delivery system and accessories, $118,000 of directors and officers liability insurance expense due to increased premiums caused by recent trends in the overall insurance industry, an increase of $108,000 in shareholder related expenses due to the special shareholder meeting and $64,000 in miscellaneous expense.

For the 3 months ended March 31, 2021, financial income increased by 65.1% to $71,000 from $43,000 during the same period last year. The increase of financial income primarily resulted from exchange -- changes in exchange rates. Net loss for the first quarter of 2021 totaled $3.2 million or $0.53 per basic and diluted share compared to a net loss of $2 million or $6.42 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 6.1 million in Q1 2021 and 300,000 in Q1 2020, with both numbers having been adjusted for the reverse split.

As of March 31, 2021, cash and cash equivalents were $44 million compared to $12.6 million as of December 31, 2020. During the first quarter of 2021, as Marvin mentioned, the company raised $35.1 million net through various equity transactions.

With that, I'd like to turn the call over for questions. Operator, please go ahead.

(Operator Instructions) And the first question is from Ben Haynor with Alliance Global Partners.

First for me, can you talk a little bit more about the input that you expect from the scientific advisory Board, I noticed you got Dr. Rosenfield as Chair. Can you talk about what type of input that you see them providing, kind of how that will help advance CGuard? And then anything on the other product development that they may be able to help out with? I know they haven't all been named yet. But just looking for more color on that.

Sure. Ben, thanks for the question. Yes, I think the SAB has been long overdue in terms of getting a formal group together, and we have a cross-discipline -- a great cross disciplined group both interventionalists as well as surgeons that we're building a nice team. They will help advise the company, both in pipeline opportunities that we're building within the organization to make sure that they're relevant and valid and provide that clinical utility that we believe.

But I think it's just a great barometer to make sure that we're right on track both proactively as well as in our development cycles to make sure that when our products are announced and do come to market, that they're relevant and meaningful and have an immediate commercial impact. So we're really pleased to have this group of supporters on board with us, and it's a very practical forum to use for us.

And you guys have sort of punched above your weight, so to speak, in attracting a lot of these folks that are kind of I don't know if name brands is the right term, but highly respected, certainly to the company and to further your development. So that's great.

On the pipeline of new products and making sure that they're relevant, valid providing clinical utility, like you mentioned. When might we start to hear more specifics on what you guys are working on?

Yes, Ben, I think, hopefully, we're going to be able to talk more specifics over the next quarter or so. We certainly want to make sure that we have everything lined up accordingly and the development process has been going remarkably well. We're getting some validated feedback now. We're obviously working a regulatory path in addition to our engineering efforts. So I'm encouraged by the progress and hopefully, within the next quarter or so, we'll be able to talk more specifically about what we have in the pipeline and what we plan to launch.

Okay. Great. And then just thinking about kind of the expense line items and the R&D activities related to the CGuardian trial, it hasn't really shown up too much yet in the reported numbers, but kind of what should we be looking for in terms of magnitude of a step-up and when that might occur?

Craig, do you want to take this one?

Can you just repeat it a little? I wasn't following?

Yes, no problem. So as far as R&D goes, not a lot of the CGuardian trial has shown up the reported numbers. What should we be looking for? And kind of in terms of magnitude and when that step-up will occur, both the magnitude and the timing of the step-up that will occur as you get into the trial?

Okay. So as Marvin said, we're expecting our first patient to be recruited sometime in the summer. So most of our expenses will be over -- most of our expenses have to do with the recruitment of patients. So we should see a pickup in expenses in Q2 following Q3, even next year, throughout the full year. And then we should start to see them coming back to normal sometimes in 2023 as we finish enrollment in the 1-year follow-up.

Okay. That makes sense. And then finally for me, there's another player in the credit stenting market that's out there. They've recently spoken of kind of refocusing their efforts on physicians that have already been trained on their procedures, it looks like about 3/4 or more of the procedures that are being done are being done by doctors who were trained over a year ago, which is (inaudible).

But it kind of seems like some of the docs that we talked to, I think it's a fairly complex procedure. Do you think that's difficult to kind of broaden to be get adoption of? And how do you guys see kind of the CGuard procedure stacking up in comparison to the TCAR procedure that's out there?

Sure, Ben. Good question. We are fundamentally a stent-driven and focused company, and we believe that ultimately, the stent is the difference maker in terms of clinical performance in patient outcomes and we will continue to remain focused on that. Regardless of delivery system, ultimately we don't want to discriminate with 1 sector of physician group. We want to appeal to all of them and make sure that we have delivery systems that are consistent with what they choose to use. But ultimately, our goal is to make sure that CGuard is the focus and that the stent, the residual stent is really what matters.

So we will continue to build systems and mechanisms that allow CGuard to be placed, and we'll continue to focus on outcomes and evidence that show superior clinical results for patients. So I think ultimately, that the goal is to continue to make CGuard ubiquitous across every discipline in every specialty that chooses to do carotid artery stenting. And I think that's fundamentally the difference that we have.

Okay. So in other words, your view of the world is it's the stent that is what matters rather than how it gets delivered?

I think that's clear and consistent. And we certainly want to create mechanisms for delivering the stent and give people options, and we will continue to work on optimizing those. But ultimately, our business is based on CGuard and based on the stent, correct.

Ladies and gentlemen, this concludes the question-and-answer session of the call. I will now return the call to Marvin Slosman for closing remarks.

Great. Thank you. I'd like to thank everyone for taking the time to join the call today and the ongoing support for InspireMD. We are fundamentally a stronger company today than ever before, and I'm very proud of the extraordinary efforts that our team has gone through an expanding and creating an exciting future for the company, and thank you for joining.

And thank you, sir. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

Thank you.