Earnings Call Transcript - NSPR Q3 2020

Operator, Operator

Ladies and gentlemen, thank you for standing by. Good morning, and welcome to InspireMD Third Quarter 2020 Financial Results and Corporate Update Conference Call. Participants of this call are advised that the audio of this conference is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately 1 hour after the call ends through February 9, 2021. I'd now like to turn the call over to Mr. Scott Gordon, President of Core IR, the company's Investor Relations firm. Please go ahead.

Scott Gordon, President, Core IR

Thank you, Nick, and good morning, everyone. Thank you for joining us for the InspireMD Third Quarter 2020 Financial Results and Corporate Update Conference Call. Joining us today from InspireMD are Marvin Slosman, 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, 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, November 9, 2020. 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. Marvin, please go ahead.

Marvin Slosman, CEO

Thank you. Great. Thank you, Scott, and thank you all for joining the call on the webcast today. While we remain in uncertain times due to the ongoing COVID-19 pandemic, revenues for the third quarter of 2020 grew both quarter-over-quarter from 2019 levels and sequentially versus Q2 2020 levels, thus restoring cautious optimism in our business direction and market recovery. We understand the unpredictable nature of how this pandemic will affect our customers going forward but feel more prepared to address market needs, having accelerated a higher level of awareness and communication with our channel partners. Investing time over the last two quarters in online training and customer outreach programs has provided us with a stronger foundation and transfer of knowledge, which we will continue during this recovery. Through it all, our team remains committed and optimistic, and we are thrilled to have announced the addition of new leadership to drive goal attainment and growth objectives. As for the third quarter, this resurgence of elective procedures in our key markets yielded a 213% increase in total third-quarter sales versus the second quarter of 2020, with nearly 50% of those sales occurring in the third month of the quarter. This in no way relaxes our resolve to continue to implement proactive policies and procedures to ensure continued strong performance, including the ongoing search for more efficient operations and cash management. However, this reinforces our assumption that CAS procedures remain a necessity, notwithstanding the timing delays associated with the COVID-19 outbreak. As for other meaningful milestones, on June 25, 2020, the U.S. FDA granted conditional approval of our Investigational Device Exemption, or IDE, application to initiate a pivotal study of CGuard EPS. During this quarter, we received the final approval of the IDE application and have begun preparations for the pivotal trial in the United States for CGuard EPS carotid artery stent. Shortly after the approval, we announced the initiation of our strategic advisory relationship with Dr. Christina Brennan to assist with the planning and execution of the CGuard pivotal study, CARENET-III in the United States. Dr. Brennan brings a wealth of experience to InspireMD and has specific expertise in vascular and stent-related research and clinical trial development and execution. With more than 20 years of extensive clinical research experience, particularly in the area of carotid artery disease, her leadership will be invaluable now and as we progress on a successful trial effort. I'll return to our clinical development program in a moment. But first, I wanted to mention two more recent key hires. First, we welcome Patrick Jamnik as our new Vice President of Business Development and Strategic Initiatives. Patrick will oversee the company's business development activities and play a key role in advancing our short- and long-term strategic goals, much of which will focus on the U.S. market. As we gain traction and leverage the superior clinical results of our CGuard EPS stent platform, we will continue to develop new strategic pathways for growth and look to Patrick's leadership to help get us there. The second hire is our new Senior Vice President of Global Sales and Marketing, Andrea Tommasoli. Andrea's leadership of our global sales and marketing effort is an investment in our customer and commercial focus and provides the essential leadership needed to elevate our growth and acceleration of standard of care of CGuard EPS. Andrea's experience in leading commercial teams, particularly indirect channel partners globally, adds immediate value to our geographic expansion and higher performance in served markets. And finally, our announcement and appointment of Dr. Gary Roubin to our Board of Directors has reiterated tremendous credibility for our company's direction by the endorsement, active contribution, and financial investment of one of the most renowned and internationally recognized interventional cardiologists in Dr. Roubin. In addition to his formidable achievements in Vascular Medicine, Dr. Roubin's pioneering work in carotid stenting and embolic protection devices brings a depth of experience and expertise to our business that will be invaluable in our future direction and focus. During his tenure as Chief of Interventional Cardiology at The University of Alabama at Birmingham and later as Department Chairman and Chief of Services at Lenox Hill Hospital Cardiac and Vascular programs in New York, he helped bring both programs to international standing in peripheral neurovascular and cardiac interventions. Dr. Roubin's vast experience has enabled him to recognize advanced technical innovations and improve patient outcomes. I could expound on Gary's numerous accomplishments and why we're so thrilled to have him as a part of the Board. Ultimately, it's Dr. Roubin's peerless reputation as a clinical scientist, innovator, and interventional cardiologist that lends important validation to our MicroNet technology and the CGuard stent system. We believe his presence on the Board will also provide meaningful insight, thoughtful direction, and unmatched perspectives in our focus to change the way carotid artery disease is treated and strokes are prevented. He has expressed his confidence in our differentiated CGuard EPS platform and in our direction that we have undertaken for the business, which is a tremendous vote of confidence. We are very fortunate to have him join as a director. I would like to turn now to our third quarter results. For the three months ended September 30, 2020, we generated total revenues of $980,000 as compared to $939,000 for the same period a year ago and compared to $313,000 during the last quarter. This represents a 213% increase sequentially versus last quarter. These results return us to pre-COVID revenue levels. While we remain cautiously optimistic about the fourth quarter, we're seeing new restrictions instituted to combat the spread of COVID-19, leading to uncertainty regarding this market impact. Taking a step back as a reminder of the value of our story and foundation of our value proposition, the CGuard 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 post-procedural embolic events created by plaque prolapse through the stent strut, which can lead to stroke. CGuard's unique MicroNet technology mitigates the prolapse and associated embolization and continues to demonstrate 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. CGuard has created a new dimension in the protected treatment of carotid artery disease, with the potential to truly establish a new standard of care for the management of carotid artery disease and stroke prevention. Our strategic pathway to business growth for CGuard EPS is robust, rooted in broadening market share in endovascular CAS procedures in our served markets, expansion of CGuard EPS as a first-line stent solution, and focusing on ongoing conversions with vascular surgeons to CAS, who perform the vast number of carotid revascularization procedures, more than 80% through carotid endarterectomy. We view carotid artery disease as the next significant vascular condition to advance toward an endovascular standard of care, much like cerebral aneurysms, coronary artery disease, thoracic abdominal aortic aneurysms, and peripheral artery disease have. This is why the vascular surgeon and interventional neuroradiology communities remain a top priority. The most critical step in procedural success is the stent system, which protects the patient just after the procedure, but more importantly, after they leave the hospital. CGuard EPS continues to demonstrate superiority against all of their open-cell and second-generation covered stent systems and remains the core of our value proposition. We continue to advance our development of a toolset of adjunctive delivery systems and supporting solutions to provide each clinical subspecialty and clinician with a range of options to bolster the use of CGuard EPS as a stent platform, including new next-generation transfemoral and transcarotid delivery platforms. We look to advance our efforts in these initiatives as we continue to work with our key opinion leaders, including vascular surgeons, on this strategic direction. Now a word on global expansion. China and Japan represent more than double our current addressable market, and as such, these markets remain a high priority for the business. We continue discussions with potential distribution partners in both of these regions to expand into these highly valuable Asian markets and look forward to announcing our future progress. In Europe, we are progressing on our application for reimbursement approval in France, which we plan to be a direct sales market once registration is complete. In Brazil, following registration approval last quarter, we've received orders from our distributor partners, completed our training, and successfully completed our first CGuard EPS stent procedure. These combined efforts of global expansion, including approval in the U.S. market, remain a priority and a pillar of our commercial focus and growth. With that, I'll turn the call over to Craig to review our third quarter financials. Craig?

Craig Shore, CFO

Thank you, Marvin, and to everyone for joining today. Here are some key financial highlights for the third quarter of 2020. Revenues for the three months ended September 30, 2020, were $980,000, an increase of 4.4% or $41,000 compared to $939,000 for the three months ended September 30, 2019. This increase was mainly driven by a 69% increase in sales volume of MGuard EPS from $87,000 during the three months ended September 30, 2019, to $147,000 during the three months ended September 30, 2020. This increase was largely due to the timing of shipments to one of the distributors for a tender recently won. This increase was offset in part by a 2.2% decrease in sales volume of CGuard Prime EPS from $852,000 during the three months ended September 30, 2019, to $833,000 during the three months ended September 30, 2020, largely driven by procedures for CGuard EPS, which are generally scheduled or non-emergency procedures, only beginning to return to normal levels towards the end of the quarter as hospitals began to re-shift resources to non-COVID-19 patients. Gross profit for the three months ended September 30, 2020, was $298,000, an increase of 133% or $170,000 compared to $128,000 for the three months ended September 30, 2019. This increase in gross profit resulted from a $94,000 increase in revenues for reasons I just described, less the related material and labor costs; a $56,000 decrease in write-offs, which were driven by a component supply issue during the three months ended September 30, 2019, which did not reoccur during the three months ended September 30, 2020; and a decrease of $20,000 in miscellaneous expenses during this quarter. Gross margin increased to 30.4% during the three months ended September 30, 2020, from 13.6% during the three months ended September 30, 2019, driven by the factors just mentioned. Total operating expenses for the quarter ended September 30, 2020, were $2.5 million, an increase of 17.3% compared to $2.1 million for the same period in 2019. This increase was primarily due to an increase of $127,000 in compensation expenses; $116,000 in development expenses associated with CGuard EPS, mainly related to the new advanced delivery system; $92,000 of directors' and officers' liability insurance expense due to recent economic changes in the insurance industry; $71,000 in regulatory expenses associated with compliance to new European Union standards; $60,000 mainly due to the timing of our annual shareholders' meeting; and $79,000 of miscellaneous expenses. These increases were partially offset by a decrease in travel expenses of $177,000 in light of restrictions imposed by governments worldwide in order to mitigate the spread of COVID-19. Financial expenses for the quarter ended September 30, 2020, were $38,000, a decrease of 48% compared to $73,000 for the same period in 2019. The decrease in financial expenses primarily resulted from changes in exchange rates. Net loss for the third quarter of 2020 totaled $2,233,000 or $0.06 per basic and diluted share compared to a net loss of $2,070,000 or $1.26 per basic and diluted share for the same period in 2019. As of September 30, 2020, cash and cash equivalents were $10,882,000 compared to $5,514,000 as of December 31, 2019. With that, I would now like to turn the call over for questions. Nick, please go ahead.

Operator, Operator

First question comes from Benjamin Haynor of Alliance Global Partners.

Benjamin Haynor, Analyst

First for me. Congrats on all the personnel additions. It seems like quite the roster you've been able to assemble there. And I know Dr. Roubin, that's pretty high profile. I think investors in the space know him or know of him. Can you talk a little bit about how that came about? How were you able to get him on the Board and as an investor?

Marvin Slosman, CEO

Yes, thanks, Ben, and thank you for the question. We're excited to have Gary Roubin join the organization as a director. The introduction came through Christina Brennan, whom I've known for several years. Gary Roubin is well-known in this industry, either personally or by reputation. Christina and Gary have a long history and have collaborated in the past. After connecting with Christina, we had some follow-up discussions, and I spoke with Dr. Roubin, whose interest and insights were incredibly valuable. As our conversations progressed, it became clear that he had a significant interest in our company. We believe his extensive experience and knowledge in the industry will be a fantastic addition to the Board. We're really pleased to have him on board, and as you mentioned, our talented team continues to grow as we aim to enhance all aspects of our organization.

Benjamin Haynor, Analyst

Excellent. And then it sounds like you have a little bit more read-through than you've had in the past from your distributor customers or your channel partners. Can you talk about how that might change how you strategically move the business during COVID or otherwise?

Marvin Slosman, CEO

Yes, Ben. I think we have always set into place a strategic direction in the beginning of the year to be a commercially focused, customer-driven, outwardly thinking company. I think this is just the next step and next level in both bringing talent to the organization that understands the distribution model. Most importantly, the COVID-19 scenario has given us an opportunity to really dig deeply into making sure that the served markets that we're in are being covered by the best partners available and go into a depth of knowledge and understanding to ensure that CGuard EPS rises to the top of the bag and our partners' list of opportunities. Absolutely the right pickup here, which is a fundamentally R&D-based company. We're making a shift to a commercially-focused organization. A lot of that is on the backbone of all of the clinical results and value coming from our studies. We have a great storyline to tell, and we need to do a much better job of getting that information disseminated through our channel partners ultimately to the customer. That will continue to be a priority for Andrea, in particular, as he leads the sales and marketing group going forward.

Benjamin Haynor, Analyst

Okay, and that's helpful. And then does that also help you kind of convert surgeons from carotid endarterectomy over to CAS or doesn't that necessarily help you at all?

Marvin Slosman, CEO

Yes. I think it certainly does, Ben. I mean, this is a tough business, and we all understand that this is one customer at a time, one procedure at a time. The credibility of what we sell and what we do has really manifested itself in how we connect directly with customers to make a change in their practice. We are definitely focused on the surgery community, the interventional neuro radiology community, and cardiology as well. It's an interesting setup because we have a very broad range of operators who sort of follow carotid artery disease as a primary part of their practice, and they use different tools to get there. Our goal is to ensure that CGuard is the stent that's used and that CAS is promoted and developed as a first-line therapy for the disease. Our priority continues to certainly be on our existing customer base and also on the vascular surgeon community.

Benjamin Haynor, Analyst

Okay. Got it. And then you mentioned in the press release the advanced tool set of adjunctive delivery options that you're working on. I guess, how far have these advanced tools advanced in development? Are these things that could see regulatory clearances and be marketed in the geographies that you're in, say, next year? What does the timeline look like at this point?

Marvin Slosman, CEO

Yes, Ben, fundamentally, InspireMD has done its best work as an R&D organization. We have a great team of people that are constantly looking at our toolset and products, trying to develop those next-generation levels, whether within an existing part of the portfolio or something outside of that. We have this multi-generational product development plan underway for a variety of different areas, and we certainly hope to have those products to market in a timeframe that's meaningful within 2021 potentially. It really depends on the area we're talking about. We've been working on a new transfemoral delivery system for a while and are making great progress on that. We look to be able to provide the next level of detail in terms of how that rollout will occur, but we're making significant progress in several different areas to drive CGuard as the primary stent.

Benjamin Haynor, Analyst

Okay. Got it. And then just with the FDA trial, I know that you got the IDE in place. When do you expect the CGuard trial to kind of enroll the first patient? Excuse me.

Marvin Slosman, CEO

So we're in the final touches of being able to make some decisions on a CRO partner as well as a principal investigator for the trial and also site selection, what percentage we'll use in the U.S. versus Europe and otherwise. We're down to the last details on making those selections, then we'll have a much clearer schedule for how we begin patient enrollment. We fundamentally wanted to get all of these pieces solidly in place because the performance of the trial really depends on how well you prioritize this on the front end. We've got some tremendous names being discussed right now regarding principal investigators and people very interested in participating and enrolling. We hope to have a detailed schedule for how that rollout looks for patient enrollment very soon. We're making great progress in identifying the right pieces and putting them in place with our CRO partner and investigators.

Benjamin Haynor, Analyst

Sure. That's helpful. And then obviously, I would imagine from the additions that you've made on the personnel front that the Rolodex is there to get you in front of the right people.

Marvin Slosman, CEO

It's very comprehensive. So it's good and bad. A lot of people are interested, so we're really excited about having the interest coming through.

Operator, Operator

This concludes our question-and-answer session, and I'd like to turn the conference back over to Mr. Marvin Slosman. Please go ahead.

Marvin Slosman, CEO

Great. Thank you. Let me conclude by saying that in spite of the setbacks associated with COVID-19, we are tremendously optimistic for our future. CGuard EPS continues to outperform other competitive carotid stents, and we will continue to drive this awareness with our customers to provide the absolute best clinical and patient outcomes. We're investing in a very bright future and are singularly focused as a company on maintaining our commitment to offering these best options for stroke prevention and carotid artery disease management. Thank you very much for the call today and for your support.

Operator, Operator

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