InspireMD Inc.

And welcome to the InspireMD first quarter 2020 earnings conference call. At this time, all participants are in listen-only mode. The question and answer session will follow in the form of presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Jeremy Pfeffer, Investor Relations. Please go ahead, sir.

Thank you, Jerry. Good morning, everyone, and thank you for joining us for the InspireMD First Quarter 2020 Business Update Conference Call. On the line with us today are Marvin Slosman, Chief Executive Officer of InspireMD, and Craig Shore, Chief Financial Officer. We will start with an overview of the company results and our recent highlights, and we will then open up your call for questions. Before we begin, let me take a minute to note that this conference call may contain forward-looking statements. Forward-looking statements address future events and conditions and therefore involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. Such information is subject to known and unknown risks, uncertainties, and other factors that can influence actual results or events and cause actual results or events to differ materially from those stated, anticipated, or implied in the forward-looking information. Listeners are cautioned not to place undue reliance on forward-looking information, as no assurance can be given after the future results, levels of activity, or achievements. Having addressed that, it's my pleasure to turn the call over to Marvin Slosman. Please go ahead, Marvin. Thank you, Jeremy, and thank you all for joining the call and the webcast today. The first quarter of 2020 started with tremendous momentum and great promise, only to end with a global challenge no one could have anticipated. Our team rallied and adapted with great poise and unwavering commitment to our customers' needs, along with the safety and well-being of our staff. Our team understands that we are more than observers in this global pandemic, but a part of a greater healthcare system, serving those who are on the front lines of battling this virus and saving lives. I'm very proud of all and more enthusiastic than ever about the potential of C-Guard EPS and its novel Micronet technology to fundamentally disrupt the current standard of care in carotid artery disease. We look forward to regaining our momentum as elective procedures restart, continuing to build on our share position in existing markets with C-Guard EPS while planning expansion and growth markets in South America, Asia Pacific, and of course the U.S. I also see numerous opportunities for growing our pipeline, leveraging new indications for use of Seaguard and Micronet, along with our research into proximal protection devices using our reverse flow technology and capabilities. I will spend my time this morning recapping our progress since the beginning of the year and reiterate my vision for the future that I first introduced in the March call. I'd like to take a moment to address a bit more about the ongoing COVID-19 pandemic and its impact on our business. First and foremost, let me say that the health and safety of our employees remains our top priority, and we've incorporated all of the procedures and technologies necessary to ensure a seamless transition to an environment where many of our associates are working remotely. So while the pandemic has clearly caused unprecedented business disruptions around the world, our team continues to work toward our collective goal of delivering next generation vascular solutions. During the first quarter, it became clear that the virus was spreading and transitioning from a localized epidemic to a global pandemic. Healthcare systems around the world experienced unprecedented strain on availability and capacity and resources due to the severity of symptoms experienced by many patients. especially those in high-risk categories, older, already compromised immune systems, and other underlying health conditions. As a result, since most of carotid stenosis treatment is elective, at least in terms of timing, we began to experience a decline in procedure volume in our key territories, which include Italy and Spain, which have been particularly hard hit by the virus. We are using this time to ensure that both our support organization as well as our ability to supply product remains firmly intact. Our goal is to immediately fulfill the needs of our distributor partners, physicians, and their patients as a more normalized healthcare system reemerges. It is worth noting that as I speak today, there are indications that certain European healthcare systems are beginning to reopen to elective procedures, which is encouraging that the worst may be behind us. To ensure that our company emerges from this crisis as strong as possible, senior leadership, the majority of our employees, and the board of directors have agreed to a temporary reduction in cash compensation. This action, combined with additional cost-cutting measures that have been implemented, will extend our cash runway and enable us to continue to maintain staff levels so that we're prepared to respond quickly when our procedural volumes pick up. We will continue to look for efficiencies in all facets of our organization. Now for some good news. We generated total revenues of $1,034,000 during the first quarter, representing an increase of 149% over first quarter 2019 revenue of $415,000. Recall that during the first quarter of 2019, our sterilization partner at the time experienced equipment issues that resulted in us being unable to sterilize or ship product for most of the quarter. Based on our backlog, we estimated the impact to be approximately $600,000 of sales that were ultimately deferred into subsequent quarters. Our revenue growth, even with the sterilization issue previously measured, was again driven by continued strong uptake with C-Guard, in particular in key markets such as Italy, Poland, and Spain. Total C-Guard revenue in the first quarter of 2020 was $971,000, an increase of 158%. over $376,000 that we generated a year ago. Of course, this growth was partially reflective of the sterilization issue in the year ago period that I just alluded to, but it is worth noting that even if we normalize first quarter 2019 C-Guard revenue to exclude the estimated impact of the sterilization-related sales delays and subsequent backlog, revenue would have still increased more than 11% from the prior year period. We're pleased with this result, particularly as we started to see more deceleration and procedural volumes toward the end of the quarter. Craig will elaborate more on the financials in a moment. Taking a step back, for those who may be new to the story, the C-Guard Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open cell stent with what we believe to be the most advanced protection from periprocedural and postprocedural embolic events. caused by plaque prolapse through the stent strut, which can lead to stroke. C-Guard's unique Micronet technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional or next generation double layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure. C-Guard has created a new dimension in protection treatment of carotid artery disease with the potential to truly establish a new standard of care for management of carotid artery disease and stroke prevention. In January, at the last conference we were able to attend due to the COVID-19 shutdown, we were invited for the third consecutive year to showcase C-Guard in a live clinical case format at the Link Conference, which brings together leading interventionists, and vascular surgeons from around the world. The case selected for C-Guard was very challenging involving an 82-year-old patient presented with symptomatic high-risk carotid artery disease. The procedure lasted approximately 20 minutes and had an excellent outcome and angiographic result. The Ling case demonstrated that the ease of use and exceptional patient safety features of C-Guard. I also had an opportunity to attend a number of presentations at Ling that highlighted the clinical superiority of C-Guard The IronGuard II trial, which enrolled 729 patients with carotid artery disease in their real-world, large, multi-center, multi-specialist analysis, suggested the use of C-Guard EPS and routine clinical practice is associated with no major periprocedural or 30-day neurological complications. Additional, the Paradigm Xtend trial conducted by Professor Nieslick of Krakow University Hospital, the largest running C-Guard EPS study thus far, showed no procedural-related or device-related events out to five years, indicating long-term safety and sustained benefit. Participation in high-visibility medical conferences such as LINC helped drive awareness and growth. To put some context around the potential of C-Guard within our addressable market, it may be helpful to understand the market conversions of vascular treatments from surgery to minimally invasive endovascular procedures. When you look at cerebral aneurysms, coronary artery disease, thoracic, abdominal aortic aneurysms, and peripheral artery disease, the vast majority of these treatments for those conditions are now endovascular, not surgical. Carotid artery disease remains the last frontier of converting from surgery, creating tremendous growth potential for C-GARD. Hager suggested as many as 80% of CAD treatments are still performed via carotid endarterectomy. So given the other conditions I just listed, we believe there is a sea change towards stenting with our Micronet protected solution combined with the clinical advantages over traditional unprotected, open strut carotid stents. We believe the market to be very robust. This is why the vascular surgeon community remains a priority and we continue to build strategic adjunctive solutions such as reverse flow into our growth plan. We have what we believe is a superior technology platform in a market segment that is poised for rapid expansion in the coming years. Our immediate focus remains creating awareness of the superior patient outcomes being reported with Seaguard. We continue to prioritize commercial execution in our key European markets, including Germany, Italy, Spain, and Poland, where our market share has been growing rapidly prior to the pandemic. Our Seaguard commercial strategy can includes cultivation of our physician outreach and education efforts in parallel with growing our Centers of Excellence program, or COEs. Our COE program has been established across Europe, and we're working to expand the program into India and South America. As a result of this initiative and growing interest of key physicians to which to participate in COEs, along with the adjustments necessary with the COVID-19 restrictions, we're scheduling more online interactive programs to maintain the momentum of our hands-on program, which will remain as an ongoing option. It is our goal to make C-Guard available to the broadest possible patient population, and our Centers of Excellence program will go a long way toward making this happen by driving awareness and utilization, particular in the vascular surgeon community. We continue to develop additional product registrations and distribution contracts with channel partners in other countries in Europe, Asia, and Latin America, and while the timelines associated with these efforts have been elongated by COVID-19, we have been continuing our internal work to achieve these approvals and key milestones for growth. Brazil represents the fifth largest carotid artery disease market in the world and is therefore important to our growth. We have provided health authorities with all the information required for registration and are optimistically waiting for an imminent approval. We believe Brazil and Latin America in general have great growth potential for us. The French market remains a pillar of growth in our European strategy, but unfortunately has been particularly hard hit by the pandemic, delaying our discussions with French health authorities regarding special reimbursement for C-Guard. We continue to focus our work on advancing this approval for increased reimbursement. In China, our discussions with potential strategic partners continue to progress, and we both We hope to have both positive news on that front in the near future. Both China and Japan represent more than double our current addressable market, and as such, these markets are another priority for the business. An overriding strategic objective is the completion of the IDE approval process that will allow us to initiate a trial to support an eventual commercial launch of Seaguard EPS in the United States. We believe we have now successfully completed all bench testing required to satisfy the FDA's information requests. We previously indicated that the FDA had concurred with our clinical study design and data requirements to support the market approval of our device. So we are now eagerly awaiting the agency's response, which, if favorable, would be an important step in commencing development and gaining regulatory approval in the all-important U.S. market. In terms of future business development, we continue to explore opportunities to expand indications for C-Guard EPS outside of carotid artery disease, as well as broadening our portfolio within CAD in stroke treatment. The investigator-initiated research presented at length demonstrated the potential of C-Guard to be used effectively in other indications, such as treatment of iliac artery disease, subclavian artery disease, saphenous vein grafts or SVGs, as well as other peripheral conditions. We noted these results and have begun to work closely with clinicians who have made these important observations. We've used this time of COVID-19 procedural reduction to work with our KOLs on study design and positioning of C-Guard EPS in these expanded applications. Additionally, as mentioned previously, central to our growth within the CAD franchise is our continued to focus on vascular surgeons and their use of C-Guard EPS as a viable alternative to endarterectomy. Part of that strategy includes exploring and adding a periprocedural protection device to our portfolio, incorporating the principles of reverse flow as an adjunctive alternative to femoral access. We look forward to advancing our efforts in this initiative and working with leading vascular surgeons on this strategic pathway. In 2019, was a prolific year for us in terms of further bolstering our intellectual property franchise. We had four patents issued in the U.S. and 11 issued globally. More importantly, patents that issued in the second half of 2019 were brought in coverage, in particular Seaguard, but also bolstered protection and potential pipeline products. In 2020, we will continue to build on our intellectual property to protect and expand on what we believe is one of the most unique and Elegantly Simple Solutions to Treat Vascular Disease. I'm pleased to share that our commercial team has been working through a process to further refine our messaging of C-Guard EPS as a uniquely advanced technology platform demonstrating clinical superiority and segmented differentiation in addressing the CAD market. The unique advantage of C-Guard EPS and the Micronet solution deserve a level of definition and standard of care we refer to as Micronet-protected CAS. With over 18,000 devices sold and an unmatched clinical performance record, we believe that Micronet-protected CAS as a category definition will be meaningful to our positioning and product performance. We look forward to this and other advancements in new and comprehensive branding and marketing awareness in our campaign in 2020. With that, I'll turn the call over to Craig to review our financials. Craig?

Thanks, Marvin. For the three months ended March 31st, 2020, revenue increased by $619,000, or 149%, to $1,034,000. From $415,000 during the three months ended March 31st, 2019. This increase was predominantly driven by a 158% increase in sales volume of Seagate EPS from $376,000 during the three months ended March 31, 2019 to $971,000 during the three months ended March 31, 2020, mainly due to the company's previous third-party sterilizer equipment failures, which caused a significant interruption in sterilized product supply for the majority of the first quarter, 2019, as well as the company's continued focus in expanding revenue base in the company's major markets. In addition, MGuard Prime EPS sales increased from $39,000 during the three-month end of March 31, 2019 to $63,000 during the three-month end of March 31, 2020 due to the delayed shipments of sterilized products during the three-month end of March 31, 2019, as previously mentioned. The company's gross profit for the quarter ended March 31, 2020 with $295,000 compared to a gross loss of $73,000 for the same period in 2019. This increase in gross profit was primarily driven by a higher volume of sales of Seaguar DPS less the related material labor costs and a decrease in write-offs of inventory during the three months ended March 31st, 2020 due to the sterilization equipment failures as previously mentioned. Gross margin increased to 28.5% in the first quarter of 2020 from a negative 17.6% for the same period in 2019. Total operating expenses for the quarter ended March 31, 2020 with $2,316,000, a decrease of 24% compared to $3,057,000 for the same period in 2019. This decrease was primarily due to a reduction of $328,000 in clinical expenses associated with Seagard EPF, mainly related to the IDE approval process. The decrease of $354,000 due to settlement expenses made to a former service provider pursuant to a settlement agreement during the three months ended March 31st, 2019, which not occur during the three months ended March 31st, 2020, as well as $59,000 of miscellaneous expense reductions. Financial income for the quarter ended March 31st, 2020, with $43,000 compared to financial expenses of $77,000 for the same period in 2019. This increase in income of $120,000 was predominantly due to changes in exchange rates. Net loss for the fourth quarter of 2020 totaled $1,978,000 or 43 cents per basic and diluted share compared to a net loss of $3,207,000 for $3.82 per basic and diluted share for the same period in 2019. As of March 31, 2020, cash and cash equivalents were $3,141,000 compared to $5,514,000 at December 31, 2019. At this point, we'll turn the call over to the operators for questions. Operator? Thank you. At this time, we'll be conducting a question and answer session.