InspireMD, Inc. (NSPR) Q1 2017 Earnings Report, Transcript and Summary

Good day ladies and gentlemen, and welcome to the InspireMD First Quarter 2017 Conference Call and Business Update. [Operator Instructions] At this time it is my pleasure to turn the floor over to your host David Waldman with Crescendo Communications. Sir, the floor is yours.

Good morning, and thank you for joining InspireMD's first quarter 2017 business update conference call. On the call with us today is Jim Barry, Chief Executive Officer of InspireMD; and Craig Shore, Chief Financial Officer. At the conclusion of today's prepared remarks, we will open the call for your questions. If anyone has any questions after the call please contact Crescendo Communications at 212-671-1021. Before we begin, let me take a minute to note that this conference call may contain forward-looking statements. Forward-looking statement address future events and conditions and therefore involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statement. Such information is subject to known and unknown risks and uncertainties and other factors that could influence our 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 assurances can be given after the future results, levels of activity or achievements. With that out of the way, let me now turn the call over to Jim Barry, CEO. Please go ahead, Jim.

Thanks David. Good morning everybody, and thanks for joining us for today's conference call. It’s been a little while since we last spoke, so we thought it would be worthwhile not only discussing our first quarter financial performance but also update you on our business progress in general. First, I'd like to touch on the strategic decision we made at beginning of this year which was a transition of our European distribution of CGuard and BioProtection System for the treatment of carotid artery disease from Penumbra to our own direct distribution model managed directly by us. To remind you, in 2015 the company announced an exclusive distribution agreement with Penumbra covering 18 European countries. At the time, this seemed like it was a good step and we had just eliminated our direct sales for us and Penumbra was growing their European sales force. Additionally, Penumbra has a very positive track record as a medical device company serving the neurovascular market. Given the [numbers] enthusiasm for the CGuard and recognizing it's unique benefits in treating carotid arteries disease, our mutual desire was to take advantage of their growing sales force in Europe but we failed to fully appreciate was their focus on the narrow interventional radiologist who happens to be their primary customer but represents only one of the four clinical specialties we served with our device. After taking the CEO role in June of last year and recognizing our sales were well below expectations, we quickly conducted a comprehensive top to bottom analysis of our markets and determined the best approach to reach our targeted end-users more effectively. As such, we spent a fair amount of time at Penumbra and having gained a much better feel for what was happening in Europe, we mutually agreed that it made sense for InspireMD to transition our distribution in Europe to ensure a focus on sales to all four clinical specialties through local distribution partners and our own internal sales initiative. This local distribution strategy was validated by the results we saw in 2015 in which we achieved an annual increase in sales of 67% in select markets where this distribution strategy is already in place and managed by InspireMD. We have seen even stronger results in these markets in Q1 which I'll come back to you in a moment. In the first quarter of this year we announced numerous distribution agreement covering markets across Europe, Asia and South America fulfilling our commitment to relaunch both more broadly in Europe, as well as expanding our global footprint. In March, we announced that we have signed agreements with distributors in the Baltic State, as well as Nerin Assets OU, a leading regional distributor covering the Russian Federation to distribute CGuard. Nerin has relationships with the top physicians from all clinical specialty treating carotid arteries disease enabling us to penetrate all market segments in Russia. The agreement includes minimum required purchases. Additionally, Nerin plans to expand its sales force and clinical specialist to focus on the sales and support of CGuard. We also announced the distribution agreement with [Synopsis] a leading medical device distribution partner for Hong Kong which represent an important step in our planned expansion into the Asian market. Our partner has a strong physician network across all the relevant clinical specialties that treat carotid artery disease. Moreover, this agreement also includes minimum required purchases for CGuard which reinforces their confident in the market potential. We look forward to announcing additional distributor agreement across Asia throughout this year. We continue to add distributors throughout the world. Most recently we added distributors in Turkey, in Netherlands and Germany. In Germany we signed an agreement with AB Medica, a leading distributor in the peripheral and vascular medical device sector. AB Medica is an ideal partner as it is a long-standing relationships with all the major group purchasing organizations in Germany covering all the relevant clinical specialist that use carotid stents. AB Medica also has established relationships with Germany's top KOLs including interventional neuroradiologists, vascular surgeons, interventional cardiologists and interventional radiologists. AB Medica will immediately assume all the existing accounts previously supported by Penumbra with plans to at least double the number of centers utilizing our device in Germany over the next year. So far the transition from Penumbra has been seamless and we appreciate their support. It is important to note that Germany is the largest carotid artery stent marketing in Europe and given the strong growth we saw in 2016 in the markets where our new model has been in place and managed by InspireMD, we are very optimistic about the market potential for our products in Germany. In the short time since implementing our new strategy, we are encouraged by the early success. In the first quarter of 2017, we saw an 84% sequential increase in CGuard sales versus the fourth quarter of 2016 despite the distribution transition in the back half of the first quarter reflecting the beginning of a turnaround. Even more impressive was the fact that sequential growth for the non-number of countries was 117%. This is clear evidence that our strategy is working. Our transition from Penumbra is in its final stages and will be completed very shortly. We have also received encouraging feedback from end-users. As part of our strategy, each of our new distributors is targeting key opinion leaders in their respective markets and response from the KOLs has been extremely positive. In fact many of these KOLs who have not had assets - until now have become strong advocacy for the CGuard device and have begun to present at leading industry competes such as ICCA Stroke 2017, out of the Vishnevsky Institute of Surgery of the Ministry of Public Health in Moscow, Russia. We were extremely pleased with the attendance and enthusiastic interest in the presentations, panel discussion and case presentations on CGuard at the ICCA Stroke events. CGuard was also featured in three tracks at the Leipzig Interventional Course 2017 in Germany where Dr. Andrej Schmidt and Dr. Sven Bräunlich from the Department of Angiology, University Hospital Leipzig, Division of Interventional Angiology performed a live stent endovascular interventional procedure featuring the CGuard that was transmitted real time to the Congress. Furthermore, next week we will a transmission of another live CGuard procedure at EuroPCR which will be performed by Dr. Alberto Cremonesi, a leading European interventional cardiologist and his team at the Maria Cecilia Hospital in Cotignola, Italy. Dr. Cremonesi is one of Europe's most Foremost Authority on carotid stenting. EuroPCR is the largest interventional cardiovascular meeting in Europe. Heading into the second quarter and balance of the year, we expect to generate both sequential and year-over-year sales in CGuard as we continue adding key hospitals and KOLs to our customer base around the world. As the device is put into the hands of new KOLs, this will lead to broader market adoption over time. As such, we expect more meaningful growth towards the end of this year and into 2018 as our primary customers shift from the small population of KOLs to the mainstream group of vascular surgeons, interventional cardiologists, interventional radiologists and interventional neuroradiologists. We continue to see CGuard as part of a multibillion-dollar opportunity for our MicroNet technology platform across multiple vascular markets. Current stents do not adequately address the risk of postprocedure embolization and other complex vascular disease. Additionally, we believe that this time CGuard has the potential to become standard of care in treating carotid artery disease. In fact two recent independent studies showed 100% in implanting the CGuard EPS, and superior outcomes for patients including those with complex disease who would ordinarily have undergone surgery. We believe this is a major validation of our technology. We've not neglected MGuard either, but we recognize there has been a market shift towards drug eluting stent. In light of this, we are actively seeking drug eluting stent manufacturers as partners, and look forward to providing further updates as we advance the strategy. I appreciate the patience and support of our shareholders. We continue to manage our cash with good financial discipline, and we remain laser focused on driving sales. I’m confident that we have the right strategy in place and remain extremely excited about the outlook for our business. At this point, I'd like to turn the call over to our CFO, Craig Shore, who will review our financial performance in detail.

Thanks, Jim. Revenue for the first quarter ended March 31 2017 was $569,000 compared to $563,000 during the same period in 2016. The increase was primarily due to sales of CGuard, as we entered new regional markets while transitioning from our prior exclusive distribution partner for most of Europe to a local distribution strategy. As mentioned by Jim, the transition to local distributors reflect an effort to broaden our sales efforts from interventional neurologists, to include vascular surgeons, interventional cardiologist, and interventional radiologist as well. The increase of sales of CGuard was partially offset by a decrease in MGuard prime associated with the trend of doctors increasingly using drug eluting stents rather than bare metal stents in sanitation. Total operating expenses for the quarter was $2.5 million, an increase of 18% compared to 2.1 million for the same period in 2016. This increase was primarily due to an increase in sales and marketing expenses to support the commercialization of CGuard, as well as increase in corporate related expenses. Net loss for the quarter ended March 31 2017 totaled $2.6 million or $0.81 per basic and diluted share compared to a net loss of 2.3 million or $7 per basic and diluted share in the same period in 2016. As of March 31 2017, cash and cash equivalents were $8.6 million compared to $7.5 million as of December 31 2016. In March, we closed a public offering of approximately $6.8 million. We also announced that we have repaid ahead of schedule the remaining balance of $1.2 million on a long facility, Hercules Technology Growth Capital. We now have now remaining debt which results in a monthly cash savings of almost $400,000. We continue to carefully manage expenses of pursuing a cost effective yet aggressive sales and marketing strategy for CGuard to distributions partners across Europe and around the world. At this point, we’d like to open the call up for question.

[Operator Instructions] We have our first question from [Tim Memon] from Intellect Research. Tim, state your question.

A quick question. I'd like to know, change is not going down a little bit backtrack going down over the course of dilution we have in the offering. Does the company anticipate to have more offerings to dilutive shareholders.

We don’t have a lot of control over the stock obviously. And I think what we think is going to happen is if we continue to stay focused on our revenue growth, and I think if this continues going the way it has, we’ve changed our strategy, we think this quarter has demonstrated that this is a strategy that worked and that's bearing out in the numbers from Q4 to Q1, we think any additional fundraise that go on should be quite positive.

What we would do - CGuard that we shouldn’t have any dilution for the present shareholder.

I mean, I’m not sure. I’m sort of having a little trouble understanding the question. Say it again.

Every time we have a offering, then we the stock price will go down because you're diluting the shareholder - wasn’t it to do the CGuard present shareholders that they should be able to kept something out of their investment?

Yes, look I think we just have to continue to stay laser focus on our strategy right now. We have to continue to show the market that this device is highly desirable across all four specialties. To-date the primary focus has been one specialty through our previous European distributor that happens to be the smallest segment of the individuals that implant carotid artery stents. So I think if we continue to mind our netting the way we are and we continue to show results like we have basically in just a half quarter I think that’s going to be CGuard?

Okay. Thank you.

The next question comes from [Jerry Gieser], Private Investor. Jerry state your question.

When is this FDA application going to be submitted you have any timeframe I know you had appointment of new money coming in I thought some of them will be outdated for that purpose. Can you give me a timeframe or say that you’re going to put us through the FDA?

So Jerry it’s a good question. I will tell you we actually did go down and meet with the FDA literally just two weeks ago. So our plan had always been even prior to the previous fund raise to talk to FDA, put our plan in place with them to make sure that they concurred with it which they did which was really good news. So we had a very positive meeting with FDA. We know exactly what we need to do to get the submission in but as you also know - we came a little bit short in last fund raising. So the FDA the actual submission will probably wait a little while. So I can't give you an exact timeframe, but I could tell you if the money had been in place we could have been able to file that before the end of this year.

Okay. So you’re saying that the money isn’t in place to that - how much will it cost and I think that goes to the prior question of dilution, are you going raise more capital looking to do and FDA application or not?

Yes, I think look again right now where we are, we have got to stay focused on revenue and that's where we’re going to stay focused and if we do stay focused on revenue and we have to do another financing hopefully that won’t be dilutive and hopefully that will give us the cash to actually bring this into the U.S.

And another question, when are we going to see substantial sales increase. I know you said 12% over but these are from depressed very depressed level. When are we going to see cash flow positive with all these agreements as far as revenue goes and sales?

Look I can’t comment on cash flow positive right now. Like I said our objective is to continue on the swing that we just started on this quarter and let's see how next quarter goes which again we think will, as I told you I think we're going to be quarter-over-quarter, year-over-year improvements. And we think they're going to be meaningful now because the other thing we haven’t seen is we just had not happens to the entire clinical segments that can use CGuard. So that's the way we’re going to stay focused on.

And one last question, since you guys have such great outlook for the company. Are insiders going to make any purchases of the stock in the open market. Are they planning or they have to give the shareholder confidence in this company?

Look I think we always look at that as a possibility but again we always have to review that based on when and if legally we can actually do that but absolutely people are looking at that all the time.

Okay. All right thank you guys. Good luck.

Our next question comes from [Alan Lisbon] from First Capital. Alan state your question.

Thank you great job guys and congratulations on the rapid turnaround in new distributor in Germany. I know that Germany was a major target markets for Penumbra how is the transition going?

The transition is going good as I told you there have been incredibly cooperative to the whole transition. And you're right, Germany is an important market to them. They have a lot of important customers there and we've been working very closely with them to make sure that that transition goes according to plan for both of us because remember their customers today are our customers tomorrow. So we've been somewhat - almost methodical about the transition and I would say it couldn't be going better.

Okay great. That’s great to hear. Thank you so much.

[Operator Instructions] And there appears to be no questions in the queue. I like to turn it over to management.

Okay. Thank you. So, thanks again everybody for joining us this morning. I just want to again reiterate our appreciation for the continued support of the shareholders. We strong believe we can now grow shareholder value with the right strategy and the right team and putting in place in place the right partners, which we continue to do. So again thank you for your time this morning. We’ll talk to you soon.