MBOT - NASDAQ

Welcome to Microbot Medical's Second Quarter 2017 Investor Conference Call. Today's conference is being recorded. At this time, I'd like to turn the conference over to Michael Polyviou. Please go ahead, sir.

Thank you, Shannon. I also want to thank everyone for joining us today on Microbot Medical's conference call and webcast to review the company's progress and provide an update on the latest developments. On today's call from Microbot Medical are Harel Gadot, Chief Executive Officer, President and Chairman; Hezi Himelfarb, General Manager and Chief Operating Officer; and David Ben Naim, Chief Financial Officer. The call is being webcast live over the Internet for all interested parties, and the webcast will be archived on the Investor page of the company's website, www.microbotmedical.com, under Presentations and Resources. Before turning the call over to Harel, I'd like to make the following remarks concerning forward-looking statements. All statements in this conference call other than historical facts are forward-looking statements. These forward-looking statements are not guarantees of future performance, and may involve and are subject to risks and uncertainties and other factors that may affect Microbot Medical's business, financial condition and other operating results, which include but are not limited to the risk factors and other qualifications contained in the company's Form 10-K that was filed with the Securities and Exchange Commission on 21st March, and the 10-Q which was filed earlier today, as well as other documents filed with the SEC. Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. Microbot Medical expresses or disclaims any intent or obligation to update these forward-looking statements, except as otherwise may be required by applicable law. Finally, after management makes the prepared remarks, we'll conduct the question-and-answer session. With that, I'll turn the call over to Harel Gadot. Harel, please go ahead.

Thank you, Michael. I also want to thank our shareholders, interested investors and analysts who are joining the call today. I hope everyone is enjoying the summer. I also want to welcome to this call, for the first time since we became public, Mr. Hezi Himelfarb, who is our Chief Operating Officer and General Manager, as well as David Ben Naim, our CFO. As I mentioned in earlier calls, one of the strengths of our company is the leadership team, and it is important for me as well as our leadership team that you will have the exposure to these people and they will have the exposure to you. Since becoming a public company less than 9 months ago, we already executed the following milestones and achieved the initial goals we set for the company as we became public. So 9 months of pregnancy delivered the following: We strengthened our asset position by expanding our IP portfolio, and we are talking about IP delivering from both of our TipCAT and ViRob platforms. We also initiated the preclinical study of our initial product, the Self-Cleaning Shunt. We enhanced our Board of Directors with seasoned medical device experts, Martin Madden, the previous VP R&D at Johnson & Johnson Medical, just to name one. And last, but not least, we strengthened our balance sheet to assist us in creating future value to the company, which I'll discuss in more detail a little bit later. Let's talk about the medical robotic space because it's been all over the news lately. Minimally invasive surgical procedures are expected to grow to roughly $50 billion by 2019. That's less than 2 years away. And we have a strong belief it's going to be higher, and here's why. Most, if not all, of the major medical companies have been putting major efforts to establish core capabilities when it comes to medical robotics. If it's Medtronic through the collaboration with Mazor Robotics, the J&J and Google collaboration, all the way to the recent transaction by Globus Medical, just to name a few. At Microbot, we have already established such core capabilities that everyone is looking for over the past 7 years, which allows us to execute flawlessly against our milestones and objectives. On top of that, we have an extensive IP portfolio and the know-how, which we believe will allow us to have a competitive advantage and seek a leadership position. Where others will focus on integrating and looking for core capabilities, we will build upon our core capabilities and leverage them to reach our milestones and create value for our shareholders. For those of you who are joining the call for the first time, I will briefly review our current assets, which currently are based on 2 technology platforms. Our first technology platform is the ViRob, which is a revolutionary, autonomous crawling micro-robot, which can be controlled remotely from either outside or within the body. Our second technology platform is the TipCAT, a sell-propelled, flexible and semi-disposable endoscope providing see-and-treat capabilities. On top of being breakthrough technologies, the uniqueness of these technologies is the ability to leverage each technology separately, or in combination, for use in multiple medical applications. I'll just give you one example why we're so excited about the opportunities that are ahead of us from this -- just from these technologies. As you may recall from our recent presentation, we are aiming to utilize both the natural and artificial lumen in the body to turn surgery into treatment. Now, it took me a while to understand what lumens are. But by lumen, we are referring to structures such as blood vessels, urinary tracts and sinuses. Those are just few of the body's natural openings. When speaking of artificial lumens, we're primarily speaking of shunts, which are usually made of silicon and divert fluids from point A to point B and can be found in almost every medical space, cardiovascular, neuro, urology, dialysis, and many, many others. We believe that every year, there are hundreds of thousands, if not millions, of shunts placed annually in the U.S. alone. One common denominator for many of these shunts is that they get blocked and need to be replaced, many through surgical intervention, which brings me to our point product under development, the Self-Cleaning Shunt. At its first application, it is intended for the hydrocephalus, where it is estimated that over 1 million people in the United States currently live with hydrocephalus; and NPH, Normal Pressure Hydrocephalus, where it is estimated that more than 700,000 Americans have NPH. Large markets by all means, but it is just 1 little piece within just this shunt. And if we're talking about failure rates, why do we need our technology, not us, but the market? The failure rate is 50% within the first 2 years. 80% of all patients will go through 3 shunt placements within the first 10 years since the implementation of their first shunt. And the most amazing thing, with all these failures, nothing changed since the 1950s in that space. And why aren't all the big companies who play in that space don't innovate, Medtronic, J&J, Integra? Back to the word core capabilities. People are looking for different core capabilities. However, as we move forward, we will leverage our Self-Cleaning Shunt platform to target other shunts for other areas of the body. So it's not just the 1 million patients that we've estimated to live in the U.S. currently with hydrocephalus. Not just the 700,000 with NPH, but potentially every shunt, every shunt, and this is just the artificial lumens in the body. Our ViRob technology platform can potentially be used for many other unmet medical needs, which is also true for our TipCAT platform, which we are currently developing to address a true unmet need in the colonoscopy space. But as we have the Self-Cleaning Shunt platform and the ViRob technology, these 2 can be used for many other applications. As we want to focus right now on the development milestones that we reached, I would like to ask Mr. Hezi Himelfarb, Our Chief Operating Officer and General Manager, to discuss the current development efforts of our Self-Cleaning Shunt and the TipCAT. Hezi?

Thank you, Harel. So I'm in charge of the operations, and the company's operations are mostly in the Israeli subsidiary, where we do the R&D and the business development work. When I say R&D, R, research, refers to our 2 technologies, ViRob and TipCAT, and the D, development, refers to our products under development. I'm excited to say a few words, first, on our leading product that was mentioned by Harel, the Self-Cleaning Shunt. Two unique studies are currently running in parallel. The first one is the animal study in Washington University, St. Louis, led by Professor Pat McAllister, and the second one is the in vitro study in the Wayne State University in Detroit, led by Dr. Carolyn Harris. Professor McAllister is a well-known world expert in research of hydrocephalus, and he developed a unique model for creation of hydrocephalus in piglets, and moreover, increasing the brain ventricles of the animal so the shunt can be deployed in a similar way as neurosurgeon do in human. Professor McAllister's groundbreaking research in hydrocephalus will be presenting 3 -- in 3 oral presentations in the international hydrocephalus conference that will be held in late September, this September, in Kobe, Japan. And his first presentation would bring, for the first time, some data from the animal study with our shunt, our Self-Cleaning Shunt. At the same time, Dr. Carolyn Harris developed a unique lab test by building a system that simulates the human brain with all its biological ingredients. It uses human cells that grow and flow around various types of shunts. One of them is of the Microbot's Self-Cleaning Shunt. So these 2 studies are very innovative in terms of the concept and also the contribution to Microbot's ability to test and validate the safety of the Microbot's Self-Cleaning Shunt that should be submitted to FDA, and later, also the efficacy of the shunt. In parallel, we continue to check the viability of our products in the marketplace. As you know, it is not enough to have the mechanics and electronics work. It's not enough to have a product that you claim you can sell. You need that someone will be willing to pay -- to buy and pay for that. That's why we continue to check the fit of our products to the dynamic marketplace in terms of usability, cost and reimbursement. We also look for complementary technologies and products that can leverage our 2 original technologies, the TipCAT and ViRob, or create synergy between several products and technologies, that you can combine them together. We also continue to respond to the growing interest in our technologies and intellectual property by companies, some of them are leading medical device companies, in order to pursue various types of collaborations. This refers to both technologies and actually, this is the right time to tell you that the TipCAT activity continues with full force in the GI space, but also in other areas that are mentioned by the companies that understand the potential in our technology and in our products. So to summarize, we continue to execute our plans, current and future plans, that we believe in the potential and are very excited to all the company's activities. Thank you, and back to you Harel.

Thanks, Hezi. As Hezi mentioned, so far, we lived up to all of our milestones and executing flawlessly against them. On top of our exciting developments, which Hezi just shared with you, we have been exploring multiple opportunities to add assets that are adjacent to our technology's platform and allow us to enter additional medical spaces and applications where there are significant unmet medical needs present. As such, our leadership team is committed to continue making wide and valuable accretive decisions, one of which was in June of this year, when we strengthened our cash position to accelerate our current opportunities and add value as we move forward. I'm now going to ask David Ben Naim, our CFO, to provide some financial overview. David?

Okay. This is David. So a quick look in the balance sheet. We can see that we have $13 million in our bank account, mainly from the last round that we had. And looking at the P&L, the research and development expenses for the 6-months period were approximately $561,000 compared to $263,000. The increase was from -- for the 6 months was from mainly payroll, materials and professional services relating to the research and development and preclinical and clinical trial. Looking onto general items and administrative expenses for the 6 months, we have approximately $1.9 million comparing to $140,000. This increase is mainly from becoming a public company and incurred higher professional skill as a public company like audits expenses, internal audit, external audit, and et cetera. The financial expenses for the 6 months was approximately $2.3 million comparing to $37,000. This increased financial expenses for the 6 months is mainly from re-evaluation and extinguishment of convertible note and change in fair value of the repeat warranty liability. Just to emphasize, this is not -- this is an accounting transaction and it is not a cash one. So based on all that, the amount that we have in the bank account, and based on the planning we now are planning, we are covered for at least 24 or until 30 months from now.

Thank you, David. So as David mentioned, based on our current plans, we have enough cash in the bank for the next 24 to 30 months, and we keep an eye on this as part of our plans moving forward. Before we open the call to Q&A, let's talk about what should you expect from Microbot in the next few months. So the expectation for the previous 9 months, we shared with you since we became public and we're very happy to show you that we execute against those expectations. And therefore, it is important for us to set up the expectation for the next few months and deliver against them. The first one is completing the company Self-Cleaning Shunt studies at Washington University, St. Louis and Wayne State University in Detroit. Hand in hand is to make sure that we present or Professor McAllister, as we mentioned, present the initial data supporting Microbot's Self-Cleaning Shunt at the International Society for Hydrocephalus, which will be held in Japan in late September. Now this is really important. Although it's being held in Japan, this is probably the leading international hydrocephalus convention. This is a great opportunity for us to grow our support group of physicians who believe in that solution, who know the problem, and see where the company is going. We're also looking to leverage the company's strong balance sheet, at least from our perspective, to pursue merger and acquisitions, collaborations and partnership opportunities to increase addressable market opportunities. And we will continue strengthening the company's leadership team with seasoned medical device experts, and it can be both for our Board of Director as well as filling important position within mostly the R&D team in order to meet the milestones and explore additional opportunities that we have. We look forward to updating you on our progress in the coming quarters. I appreciate all of your time. And Michael?

Shannon, we are now ready to take our first question.

[Operator Instructions] We first move to Jeffrey Cohen with Ladenburg Thalmann.

Okay. So firstly, I guess, a question for David. If you could just kind of walk through some assumptions and what we may expect as far as OpEx levels over the next couple of years, both R&D as well as G&A, please?

Yes, I think based on what I said before, our cash provided to 24 to 30 months. I think we have -- we should expect a burn rate approximately for $1 million per year. It's split between G&A and R&D, like Hezi explained before. So I don't expect any other expenses that we're not planning for.

Okay. And as far as the composition of G&A versus R&D, is it 3:1, 4:1?

I would expect that it will be even less, because when we become a public company, naturally, the most -- our spend [ dollars ] on the legal advisers and all fees to be announced [indiscernible], et cetera. I don't think and I don't expect that this will be the same volume that we had in the last 6 months. So with respect to that, I think we have less amount to spend in the G&A. But relating to the R&D, it's very dependent on the progress based on the planning that we have in the TipCAT. So typically, I think, like I said before, like according to our plan, 2 years, 3 years from now, our cash will be enough splitting between the R&D and the general and administrative expense.

Okay. Got it. As far as the outcome of hydrocephalus conference in Japan, you mentioned 3 studies. So can you elaborate a little further on the 3 studies? Can you talk about maybe on the study from Washington, Wayne State, what might be the third? And could you talk a little bit about the types of data that we expect to see from each of the universities or what you'd expect at this point in time?

Hezi?

So we talked about 2 studies, not 3. We talked about the study of the hydrocephalus in animals and the study of the hydrocephalus in vitro study. Now with regard to the data, we spent the first 6 months in the animal study actually to adjust the nature of the model actually to our shunt. What Professor McAllister will present in Japan in September is the first results of using his models together with our shunt. I cannot elaborate right now exactly about what he is going to present. This is a university study that is actually led by Professor McAllister as the primary investigator, but we expect that for the first time, he will actually educate the audience both about the model, and also about the combination of this model with our shunt. We have also the in vitro study. Then this is something that is -- actually takes more time to do the calibration, and we actually already are running this study. The results will probably be published later after this conference. But as Harel said, we see this conference is a major event not only because we published this, we will also be presenting the technology and the product and the concept to all the researchers and physicians that are going to be presenting and listening to this conference. And we believe that it will increase the support of the neurosurgery community to our innovative design.

Okay. And furthermore, Hezi, could you talk about -- at this point, obviously, you have a particularly large patent portfolio. Has that expanded at all over the past few months on the Self-Cleaning Shunt? And thus far, is the design work locked down as far as the design? Or is this still kind of a working model for the next 2 or 3 quarters prior to a submission to the FDA?

So with regard to the Self-Cleaning Shunt, although it's obvious that this is our leading product and we are focused on the development of this product, it is also known that our covering and protecting intellectual property is very, very good. And we are going to take advantage of this and try to leverage this unique technology also to be used in other applications. So this will be true both for the Self-Cleaning Shunt technology, which is now implemented for neurosurgery, but can be implemented in other areas in the body, in the lumens that Harel mentioned, but also referring to the TipCAT technology that is still generic, but can be used in many, many applications. We mentioned GI, but it can be used and will be tested also in others in the next few months.

Great. But in the case specifically for shunts for hydrocephalus, is the design work being locked down? Or it's continuing to be worked upon?

No. It's continuing to work upon.

Okay. And Harel, I think you mentioned a number of months ago that you would expect latter part of '18 or early part of '19 for an FDA submission for hydrocephalus?

Correct. We are still on target for the later part of 2018 for FDA submission. Correct.

Next question comes from [ George Goodman ] with [ Jericho Partners ].

Is there any thought given to using your significant IP portfolio and perhaps bringing in bigger companies to exploit it? They may be able to do it faster and easier and they will bear the burden of the cost.

So it's a great question and I love that question because we are exploring such partnership, as we shared in the past and we shared today. Unfortunately, I don't think that they are at the point where I can discuss anything further. We are exploring, continue exploring. The one thing I want to comment on what you said, the fact that they have money doesn't mean that they can bring things to market quicker. And that goes back -- again, me, especially me as a graduate of Ethicon running the strategic marketing, I can tell you that money doesn't buy capabilities. And one of the things that actually -- it's not us speaking to them, it's more them speaking to us because they have the money, we have the core capabilities. So the combination of our core capabilities and their money can bring the product to market. We are exploring it. Unfortunately, at this stage I cannot discuss any further.

And I'm sure you can't discuss this either. One of the problems, obviously, the stock faces is these periodic money raises. I know that the company can't continue without them, so congratulations on having money through 2019. Is there any way that you can tell us if these money raises are done with until 2019? Or if something good comes along, you'll still consider it?

So the reason we did the transaction back in June is because we leveraged an opportunity in the market to get the funds that we need for the next 24 months. So the planning...

Yes, congratulations to you all for doing it such a great price.

Sorry. We just got off. As the leadership team, we're always going to explore opportunities that's going to be out there. That will increase the value for our shareholders. Now one thing that I do want to mention is our company got grants from the Israeli government which are nondilutive. And they're really helping push the development further, and we are exploring those opportunities since they are nondilutive to all the shareholders but are bringing cash to the company. We will explore them further. In regards to, are we going for another financing round. Right now, that's why we went through the June transaction. We raised the funds that we believe will be sufficient for the next 24 to 30 months to execute both of our current development as well as at least 1 additional either collaboration or an M&A transaction that we're exploring. But those, again, are things that we will wait and see how -- what the future brings, what the right opportunity is for the company and what will bring the most value for the shareholders.

I'm sorry if the following question was already asked. Regarding FDA approval, do you have any best guesses how long these things take?

Yes, and that's fine. You can ask as many questions as you want around the FDA, and I will try to answer my best, as long as we all know that the FDA is unpredictable. I live in New England, and I think the weather there is more predictable than the FDA. But we had a meeting with the FDA. So one of the things that we believe in the company is full transparency, and one of the things we had -- we went to the FDA as soon as we had -- I don't want to say design freeze, but once we knew what our product is going to look like, that was towards the end of 2014, we went to Maryland, Bethesda, and we met with the FDA. The FDA, after meeting with us, and I think we shared that in the past, we agreed with the FDA that we are going to do preclinical studies in animals. And we're going to show the safety profile of our product, and then we're going to bring it back to the FDA under what they call the 510(k) process or as a novel 510(k). What it means if we are under the 510(k), that it's usually, once we submit it, the FDA needs to get back to us within 30 to 90 days. If it's the novel 510(k), it may take another couple of months more than this. But as long as the FDA and us, we'll see that the results are sufficient, and we do not need to execute human studies pre-marketing, potentially post-marketing, or most likely, then we shouldn't expect more than probably 6 months post our submission to either -- to propagate their approval. If there's going to be any questions or rejection, we're probably going to know before that. But again, pending FDA unpredictability. And it's 2018, they're going to view it the same way they viewed it in 2014.

Right. What competitors out there do you face? [indiscernible]

So let's define competitors because I think that's a great question again. There is direct competitors and there is nondirect. So every shunt out there is a competitor, right? A simple silicon tube that gets occluded. We had -- one of our members came back from one of the convention and he saw this 21-year-old girl who had close to 100 procedures, 100. That's 100 brain surgeries on a 21-year old. So I don't really want to define them as competitors. If we're talking about the direct competitors, something that will prevent occlusion, there is really, really nothing out there. There is one other company, which is out in Seattle -- well, this initiated from Seattle. They are now in California, but they're really not focusing on the development of a self-cleaning shunt. So we're really playing in a blue ocean right now, where we can -- if we can bring the value, then we are the leaders in that space.

Okay. So that's great. The reason why I actually asked that is because I was hoping that there'd be nobody out there with deeper pockets, that you wouldn't have to [indiscernible] bank again.

So [ George ], the big companies actually not only they don't have deeper pockets, but recently Codman was bought by Integra. So one of the competitors is out of the market, integrated into Integra. Codman was neurosurgery division. Now there are a couple of IPs that are in academic settings, but nothing is happening with them. So we probably have a 5-year head start on any other competitor.

Okay. I recently became a shareholder. And I expect to become a bigger shareholder.

We hope to bring value to you.

[Operator Instructions] We next move to [ Brad Williams ] with the Freedom Investors Corporation.

A lot of my questions have already been answered here, but I want to drill down on a couple areas here. First of all, as we all know, as you mentioned, you raised about $10 million about a couple of months ago, Harel. Congratulations on that.

Thank you.

You ended up with about $9.2 million. You mentioned you've got about $13 million in the bank, which will last 24 to 36 months. Now to make the funds last, your burn rate [indiscernible] over the last 6 months, so it's a little over $4 million, is going to have to be reduced. Or you're going to have to get additional revenue in the door to be able to handle that burn. Now is your burn actually going to go down? Or are you expecting to be able to partner in some way, shape or form that will bring revenue in?

Yes. So I will let David answer some of these, but I will start with a couple of clarification, if I may. One is, we believe that the cash that we have on hand, which is actually a little bit over $13 million and we have another $400,000 in escrow from our transaction that we did back in December, I believe, when we sold the asset to Stem, that should last us between 24 to 30 months, not 36 months. Additional thing that I'm going to let David address it as well, out of the $4 million you mentioned, about $700,000, for example, were fees that paid for the investment bank taking care of our transaction -- our second transaction. There was additional money paid for the banks that took care of our January transaction. So we had a lot of probably onetime transactions that I don't expect to see them incurring again, including the fees [ of the ramp up ]. But I'm going to let David take it from here.

Like you said, Harel, but just to emphasize, the $4.0 million that you see in the P&L, it's not necessarily cash flow. Like I said and explained before, $2.3 million from that amount is financial expenses and accounting transaction, and not a cash one, that was from convertible notes and change in the fair value derivative warrant. So actually the burn rate that you can see, or if you have in front of you the financial statement once we file today, you can see that our burn rate is approximately $4 million per year, [ $2.2 million ] for the 6 months. Now on top of that, we're expecting to be even more -- even less than that in the next month because we have already the learning curve. So I don't expect that those amounts and those expenses, especially in the G&A, will be increased.

Do the convertible notes have a floor on them? And are there any left?

The convertible notes? No. There is no convertible note in the balance sheet. It's all converted.

It's all converted now. Okay. Okay. Your Self-Cleaning Shunt, is it fully developed and complete development-wise?

No. As Hezi -- Hezi, go ahead.

Okay. So nothing is fully developed until you complete all the testing. So like every product that is under development, we finished the initial design and the testing in our labs. Now we do the studies. And we believe that our design is close to be final, if not final. But we will know it after we have initial and temporary results, and of course, the final results. We believe that we are very close to have a product. We may have to do some changes if we find it actually need it after getting the results.

I just want to add one more thing to that comment from Hezi. We do not work in a vacuum. So when Hezi mentioned we did it in our lab, it's not like R&D people. We actually had few physician involved in this process, including a physician that implemented those -- implanted those shunts in animals to ensure that from the way the physician works, it feels comfortable, they feel like it's a regular shunt. So as Hezi said, what's left for us now is really to take them into the study and see if there is any design review we need to do after that.

Great, guys. That's the answer I wanted to hear. Unfortunately, one last question here. You had mentioned grants from the Israeli government. Have you received any grants so far for the Self-Cleaning Shunt? And are you able to get more for that? Or do you -- does it have to be a completely new product?

We have received grants for the Self-Cleaning Shunt. I believe we received 3 years of grants in the past. I believe we just filed for the fourth year, so we can continue asking or looking -- aiming for grants from the government. The beautiful thing about grants from the Israeli government is that you get it per project, not per company. So as we develop additional projects, if we find it's the right thing for the company to do and for our shareholders, of course, as we develop additional project, we may seek additional grants for our additional projects. Well, I see there are no other questions. I really appreciate everybody's time. I want to mention that we are going to hold our Annual Shareholder Meeting on September 12 at 11:00 a.m. I personally insisted that we are going to hold the shareholder meeting in New York City, and the reason is, it's because I want to try and have the opportunity to have as many shareholders who want to attend in person to be there. So on September 12, 11:00 a.m. Eastern Time, we will hold our Annual Shareholder Meeting in New York. Anybody who wants to meet and -- meet me in person, meet some of the leadership team in person, meet most of our Board of Directors that will be here in person, is welcome to. We will definitely welcome the opportunity to share with you where we are, to see the team. And we are excited on how we can bring value to you in the next couple of years. Michael?

Right. And just a couple of other items. If you're not able to attend the annual meeting in person, we will be webcasting part of the meeting, and both Harel and Hezi will both be in New York City in September. Hezi will be presenting at the Rodman and Renshaw Healthcare Conference being held in New York on September 11 and 12, and Harel will also be presenting at the Ladenburg Healthcare conference, also in New York, on September 26. We hope to see you there. We hope to see you at the annual meeting. If not, we hope you listen via webcast. Shannon, that's the conclusion of today's call.