InspireMD, Inc. (NSPR) Q1 2015 Earnings Report, Transcript and Summary

Hello and welcome to the InspireMD First Quarter Ended March 31, 2015 Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Vivian Cervantes Investor Relations. Please go ahead Ma'am.

Thank you, Keith. Good morning and welcome to InspireMD's conference call and webcast for the first quarter ended March 31, 2015 results. For today's call we have InspireMD's CEO, Alan Milinazzo; CFO, Craig Shore and COO, Jim Barry. During this call, the company will be making forward-looking statements. These statements call obviously differ from actual results, which relied on them is subject to risk. Factors that could cause forward-looking statements in this call to differ materially from actual results are discussed in the company's Form 10-K for the year ended December 31, 2014 and any subsequent filing with the SEC. At this time, I will turn the call over to Alan.

Thank you, Vivian. Good morning everyone and thank you for joining our conference call for the first quarter and three month period ended March 31, 2015. During the call we will review our results for the quarter, our 2015 agenda and how we are executing against our overall plans for the year. As mentioned in prior calls, we have a four part plan to restore momentum to the business. Number one, gain financial flexibility to execute on our plans. Number two, to align our expenses to extend our runway. Number three, selectively develop our pipeline and number four, reaccelerate revenue with a focus on our emerging carotid product opportunity. We’re pleased to note that we've made steady progress during the quarter. We strengthened our balance sheet with a $13.7 million of gross proceeds from the public offering in March executed on our sales realignment to distributor from direct sales efforts, a process that we began in January and completed in late March. And we commercialized the rapid exchange version of our CGuard carotid and embolic prevention system that received CE Mark in January, making us that much more comparative in the $500 million global carotid stent market. We also submitted to and are pleased with New York Stock Exchange's acceptance of our plan for regaining compliance with the New York Stock Exchange market listing requirements. Subsequent to the quarter's close, we announced MGuard Prime's approval in Brazil, the largest coronary stent market in Latin America and traditionally a very strong market for us. Building on this, we recently received approval to market MGuard Prime in another Latin American Country, Columbia. These two approvals demonstrate that our decision to maintain sales focus and resources in Latin America were correct and will improve the revenue outlook as the year progresses. That said, 2015 is a transition year for us and this was evident by the disappointing revenue we reported for the first quarter. We noted during our year end call in yearly March that we expect 2015 revenues to be non-linear as we shifted distribution strategies at the beginning of the quarter. Obviously the shift to independent third party distribution was not smooth during the first quarter and did not meet our expectations as we reported roughly $500,000 in total revenues. Orders for MGuard Prime were soft as distributors are more vary of over stocking as their hospital asses the near term impact of the European guidelines for drug-eluting stent used in STEMI patients. Having said that, our sales force transition is behind us and we do expect MGuard revenues to improve, while CGuard revenues simultaneously begin to ramp as our production capacity improves month by month. Greg will cover our first quarter financial results in detail in a movement, but I’d like to highlight that we continue to align our business in operations and our cash projections remain on track for the full year. As noted during our March 9 public offering raised us gross proceeds of $13.7 million with insiders taking roughly 10% of the total offering. While we found our financing activity difficult, it did allow us to gain flexibility and return to stronger putting. In the past we’ve talked about partnering activities for our MicroNet technology for using combination with coronary drug-eluting stent platforms. These efforts became more complicated given our weakened balance sheet position. With our financial flexibility now improved we're continuing these discussions with our confidence also bolstered by positive pharmacokinetic data in our drug-eluting stent program which we discussed last quarter setting the stage for future collaborations. Based on work, we’ve done today in coronary and now in the carotid and neurovascular markets we continue to expect to be in a position to execute an agreement later this quarter or early in Q3 as we have previously stated. Let me now spend a few minutes on the second part of our strategy which is to align our cost structure to support our new strategy. In late March we completed our sales restructuring program that will begin in early January to conserve capital and align resources of our organization to distributor base commercial strategy, exploiting the immediate carotid opportunity. This shift in strategy resulted in significant headcount reductions and some obvious disruptions to our Q1 selling efforts. However, the distribution plain is now in place and the transition is complete and we'll now seek to optimize our independent distribution relationships country by country. In fact I have face to face business review meetings with our top 12 distribution partners over the next 10 days during my upcoming travel to Europe. Beyond the sales restructure, we’ve gone through each functional area of the company and align the resources to the new strategy as well. This has allowed us to support the critical development programs, while eliminating spending in areas that are not central to our new strategy. Virtually all functional and corporate spending was dramatically reduced as Greg will further define during his comments. Nonetheless, we will continue to explore opportunities to further reduce our expenses and extent our cash which is well facilitated by our streamlined strategy. The third part of our strategy is that we reset our development activities to cost effectively pursue impactful indications for the MicroNet technology. We remain focused on entering into capital efficient collaborations in the pursuit of a drug-eluting coronary platform and target the organic development of additional near term product opportunities such as in the neurovascular space. Let me take this opportunity to reintroduce Jim Barry our Chief Operating Officer to provide a bit more color on our development activities and progress for making on near term opportunities. Jim?

Thanks Alan and good to speak with you all again. As Alan mentioned, we’ve gone through an organizational realignment of the business. This included changes in R&D, clinical sciences, quality, regulatory and manufacturing all consistent with the needs of the business going forward. Our internal resources remain highly focused on our priorities. Where and when we find gaps will leverage those with external partners or support functions on an as needed basis to achieve our objectives. With the let me first briefly touch on our drug-eluting stent program. As you'll recall our drug-eluting stent strategy was and continuous to be a partnership. Our initial preclinical testing went as we expected which showed that the MicroNet did not impact the performance of the drug-eluting stent. However we’ve stopped all amount of work until we finalize an agreement with one or more of our partners. We believe this is the right approach to focus our resources on our organic development in the carotid and neurovascular space. Our focus in priority start with CGuard. In 2014, we introduced the CGuard carotid and embolic protection system for treating carotid artery disease in a minimally invasive manner. The initial impact to this breakthrough product was seen with a 30-day candidate 1 data reported at last year's PCT Meeting and was further supported by the long term six-month follow-up data. Right on the heels of our clinical data supporting the benefit of CGuard stent, we attained CE Mark for the rapid exchange delivery system in January of this year. I’m just returning from two weeks on the road where I spend time at the important Charing Cross Meeting in London as well as with our European sales, support team and our entire team in Tel Aviv. I had the opportunity to only meet with physicians who have used our CGuard product but I met with several companies in the carotid space and the neurovascular space. While we're still early in our rollout; CGuard continues to perform well and has been very well received. Today we have over 140 successful CGuard implant in eight countries with 39 different physicians across four specialties. Interventional cardiology, Interventional radiology, Interventional Neuroradiology and vascular surgery. Since the approval of the rapid exchange delivery system in January 24, physicians across six countries and the four specialties have been trained and are implanting with 34 CGuard rapid exchange delivery systems used today. It is also clear from my discussions with a range of companies in the medical device space that the MicroNet is received as a potential breakthrough solution to treating carotid disease and other neurovascular disease. To that end, we continue to leverage the MicroNet technology for other indications. Having noted in the past the technology is potential for use in devices from head to toe. We have demonstrate the benefit of this technology with meaningful clinical data in the treatment of both Acute Coronary Syndromes such as STEMI and more recently carotid artery disease. Today building on our early clinical success we are incorporating the benefits of the MicroNet technology into devices used to treat conditions of the brain. Neurovascular is a highly attractive and high growth market with per device prices of roughly $9,000 each. In this market flow diverters are being used more frequently to treat unruptured brain aneurysm and we believe in MicroNet based flow diverters may have distinct advantages over current devices in terms of flexibility and deliverability. Current flow diverters are challenged by several factors, including delivery, locking side branch flow and providing future access to the aneurysm should it not seal. By comparison MicroNet should offer the same advantage and rewriting flow but done so with a highly open cell metal structure on which the MicroNet can be attached. This should provide better flexibility, similar if not better profile and thus better device delivery all without impacting aneurysm sealing, side branch flow, and still allow for aneurysm access at a later time through the MicroNet if required. Our optimism for success in this application also stems from the use of MGuard and MGuard Prime in coronary aneurysms. There are already several case reports in the literature indicating the successful use of the MGuard platform to affectively seal a coronary aneurysm in a short period of time. Further we have noted from both interventional neuroradiologists as well as device companies in the neurovascular space that most patients presenting to the interventional neuroradiologist with acute stroke have carotid artery disease. As such the interventional neuroradiologist has begun to simply implant carotid stents in these patients concurrent with treating the stroke. This practice appears to be growing and is one of the key messages I took away from my time at the Charing Cross Meeting. With all this said, I am pleased to note that the R&D team at InspireMD has advanced it's development program nicely demonstrating the ability to easily attach MicroNet to several designs of highly open cell low metal to artery ratio intracranial stent platforms and have already made progress with the delivery system. While we are targeting early to mid 2016 to file for a CE Mark submission for a neurovascular product, we're cautiously optimistic we may be able to achieve this milestone sooner. Lastly, I want to mention one area that we refused to be impacted by financial constrains and that is our intellectual property. It is clear to us that MicroNet provides a competitive advantage and we will continue to be levering multiple -- it will be leveraged in multiple next generation devices including those used to protect against embolization or vascular weakening. We continue to preserve and expand the proprietary nature of our technology and products with steady intellectual property investments that will benefit us today and well into the future. With that I’ll turn it over to Craig to discuss the first quarter financial results.

Thank you, Jim and thank you all for joining us. Let me begin with revenue. For the first quarter ended March 31, 2015, revenues were approximately $500,000 compared to $1.5 million during the same period in 2014. The 2015 period included an expected decline in sales volume associated with a trend of doctors increasingly using drug-eluting stents rather than the bare-metal stents in STEMI patients and the impact of the transition to a new commercial strategy due to using a third-party distributors for our products. The gross loss for the quarter was $37,000 a decrease of 104%, compared to a gross profit of $900,000 for the same period in 2014. This decrease in gross profit was largely attributable to the decrease in product revenues and write-offs of inventory due to the trend of increased usage of the ES stent, longer shelf life requirements for third-party distributors and the transition to the rapid exchange delivery systems for CGuard from the over the wire platform. Total operating expenses for the quarter were $4.9 million, a decrease of 24%, compared to $6.4 million for the same period in 2013. This decrease was primarily due to a reduction of clinical and development expenses related to our bare metal stent product, a decrease in compensation related expenses and other costs savings associated with our cost reduction plan offset by onetime restructuring impairment expenses of approximately $500,000. In order to give you a better perspective on the immediate impact of our cost saving initiatives when you look at Q4 2014 to Q1 2015 and when you adjust for onetime restructuring expenses in non-recurring accounting adjustments over the past two quarters, expenses in Q1 2015 were approximately $1.2 million lower than Q4 2014. The loss from operations for the quarter ended March 31, 2015, was $4.9 million a decrease of 12% compared to a loss of $5.5 million for the same period in 2013. As just explained, this decrease in loss was a result of cost-containment initiatives in R&D and other cost reductions. Financial expenses for the quarter ended March 31, 2015, decreased 26% to $300,000 from $400,000 during the same period in 2014. The net loss for the quarter ended March 31, 2015, totaled $5.2 million or $0.10 per basic and diluted share, compared to a net loss of $6 million or $0.18 per basic and diluted share in the same period in 2014. Non-GAAP net loss for the quarter ended March 31, 2015, was $3.8 million or $0.08 per basic and diluted share a decrease of 22%, compared to a non-GAAP net loss of $4.9 million or $0.15 per basic and diluted share for the same period in 2014. The non-GAAP net loss for the quarter ended March 31, 2015, primarily excludes $1 million of share-based compensation and $300,000 of expenses related to an impairment of our royalties buyout options associated with our MGuard product. The non-GAAP net loss for the quarter ended March 31, 2014, primarily excludes $1 million in share-based compensation expenses. A reconciliation table for these non-GAAP financials is included in the press release issued earlier today. Turning to the balance sheet, as of March 31, 2015, cash and cash equivalents were $13.2 million. This includes the $13.7 million in gross proceeds following the completion of our public offering in March. As mentioned, we remain on track with our previously stated cash projections for 2015. In late 2014 we began a series of cost-cutting initiatives to realign our organization with our revised strategy. We continue to maintain our disciplined focus on cash management. We plan to continue with our expense management process and invest accordingly as the business improves. With that, I'll now turn the call back over to Alan.

Thank you, Craig. Let me now discuss part four of strategy, which is to reaccelerate our revenue. Or CGuard rollout is accelerating across all the markets we serve with training across four clinical specialties; interventional cardiology, interventional radiology, interventional neuroradiology and vascular surgery. The rollout has been methodical to ensure the best outcome when our customers begin to use the platform on a routine basis. As noted, feedback remains quite positive and we expect physicians to be reporting on their clinical experiences in multiple upcoming conferences this year. In fact we have seven podium presentations on our MicroNet Technology at the upcoming Euro PCR beginning in Paris on May 18. As Jim noted earlier, we have over a 140 successful CGuard implants across eight countries with 39 individual physicians trained. Turning to the coronary business, we continue to note the definitive trend toward drug-eluting stent usage in STEMI patients particularly in Europe. However, we're pleased with recent regulatory approvals in Brazil and Columbia as previously noted. Brazil has traditionally been a very strong market for us with support from a number of leading interventional cardiologists in the region and with larger bare-metal stent market usage versus drug-eluting stent. We continue to expect less linear return to growth for MGuard throughout 2015, but are optimistic about our returned revenue growth for the full year. Before opening the call of questions, I would like to note as mentioned a few minutes ago that we have our most important customer and partner event beginning this coming Monday, May 18, in Paris at the Euro PCR Meeting. As many of you know, this is the major Annual Meeting for InspireMD and we have a very busy schedule as meetings with customers, distributors, and future partners. Further as noted we have seven clinical presentations featuring MicroNet Technology and we expect to come out of the Euro PCR with momentum on all four of our strategic areas of focus. With that, operator I would like to open the call for questions at this time.

Yes thank you. We will now begin the question-and-answer session. [Operator Instructions] And the first question comes from Josh Jennings with Cowen & Company.

Thanks and good morning. I just wanted to start up just on the distribution strategy here. Could you just talk about how we should -- what your expectations are for revenue ramp in back-half of the year here and then secondarily is there any impact to the launch of CGuard with the distribution strategy in place versus going direct? How should we think about that balance?

So Josh, obviously in Q1, we were lighter than we had expected. So although we expect non linear because Q3 typically is a softer quarter just given concentration of European business, but we expect an improving outlook every quarter for CGuard. I think MGuard will see a little bit lumpiness throughout the year. We do expect Q4 however to be our best quarter of the year based on ramping inventory of CGuard, expanding utilization for CGuard from those accounts that are using the product after we’ve done the training. And we think that the MGuard -- the shift to the DES STEMI usage will probably settle in I would say by the middle of this year. It will be almost a full year that the guidelines are in place. So I would look for improving revenue throughout the year for CGuard, a little bit of lumpiness with MGuard. The distribution strategy obviously we no longer have the benefit of ASPs from some of those direct markets. So Germany, France couple of other markets in Europe where we were starting to get traction, we're going to -- we’re taking a haircut because we're transferring product at lower prices. So we will have some of that impact but again what I commented on factors in the lower transfer pricing as well.

Okay. And just moving to your drug eluding stent program, post the financing in March, can you comment at all on how discussions with potential partners have changed?

Yes so we went into the program the drug-eluding stent program anticipating that we would bear a reasonable amount of that development cost with the partner and given the financial situation of the company, we really can’t do that. And so the negotiations have had to shift to us essentially not supporting on a day-to-day, month-to-month basis, the spending on DES development. So the burden has to shift to our partner or partners. We remain in discussions around both a private label strategy as well as a license strategy either or both of those we expect to still materialize. But our ability to invest along side of partner has changed and so that's changed the dynamics of the discussions. So we're encouraged, but the discussion change has given the financial outlook of the company.

Great and my last question just on the neurovascular platform is actually update, what type of clinical data do you plan on generating in front of CE Mark approval and in what type of level of evidence do you think is needed for international clinician adoption, thanks a lot.

Yes so Josh we are still going to work -- we're still working through the clinical strategy but we're going to have traditional bench testing that will have to be done to support CE Mark pretty typical preclinical studies that would have to be done. We know there are pre-clinical animal models out there that should support aneurysm sealing, blockages of side ranches and obviously things such as profile and delivery systems. So still working through what the clinical strategy will be. Still open to the possibility of obtaining the CE Mark possibility without having to get a -- do a clinical trial for registration but again still work in progress.

Thank you.

Thanks Josh.

Thank you. And the next question comes from Steve Lichtman of Oppenheimer & Company.

Thank you, hi guys.

Hi Steve.

So Alan just on the CGuard you mentioned obviously a number of patients already been implanted and there is going to be some papers presented by individual centers. When you talk to good potential customers, is there any sort of need from those customers to see any larger clinical trials? Have you talked about perhaps doing any sort of post market registry of anything like that to sort of further from up to date that we have seen so far?

So Steve its great question. There is a huge amount of interest in studying the device at centers and in a broader study. U.S. physicians in fact are very excited about us getting in front of the FDA but no, the interest in the product is very high and no one has said I got to wait for more data, no one has said that to us. In fact we're really trying to sort of keep people from using this in situations where we haven’t yet studied it but we know that's going to change little bit when physicians get their hands on the device after the initial training and through the distribution partners. The clinical data has been very well received. The six month data was certainly very comforting and reinforced the benefit -- the longer term benefit of the product, but we anticipate doing more clinical work, but we're evaluating what that looks like and really would love to do with a context of the FDA strategy in mind.

Got it, great and then just secondly in terms of the ongoing agreement process, could you have more than one agreement in place? Could you remind us are you looking to ultimately establish one or two and could we have one private label, one license, how are you thinking about how you are approaching this overall?

So I would sort of separate drug-eluding stents from our other portfolio because we have had a lot of interest in the past several months around our access to the MicroNet for other applications including you saw in other extend stent systems, neurovascular applications, peripheral vascular applications and so really Jim is trying to sort it through what those could look like, so interesting co-development opportunities are under review as well. On the coronary side, we really continue to think that a private label and/or a license agreement with one company probably makes the most sense. And for us we would love to have both of those where we could actually go back out to our markets where we do have very loyal distributors. But they need to have a drug-eluding stent program to go back and tap in to that 30% of the AMI market. We still have an access -- we saw access to lot of these customers but with the DES guidelines changing. So we would like to see both, but we would be happy with one or the other and our expectation is by the end of this quarter, early into Q3 we should be able to talk with you about that.

Okay, great. Thanks Alan.

Thanks Steve.

Thank you. [Operator Instructions] All right. If there is nothing else at the present time, I would like to turn the call back over to Management for any closing comments.

Thank you, Keith and thanks everyone for joining us. We’re excited about our prospects ahead, believe the company today is in a much different and much better position and executing on a strategy that is still evolving, but different than what we were executing on eight to nine months ago. We’re leveraging our financial flexibility to fund our return to growth programs. We’ve entered a very attractive $500 million global carotid market with very strong market reception to our product. We have a focused approach to our coronary program and entering new markets as evidenced by the Brazil and Colombia approvals. And we’ve reorganized the company to align our business with our new strategy and extend our cash. Our product development pipeline looks very robust and we’re excited about the early results in our neurovascular activities. We appreciate the ongoing support in the patients for the couple of quarters and look forward to keeping you updated on our progress. Thanks for dialing in today.

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