Earnings Labs

ClearPoint Neuro, Inc. (CLPT)

Q2 2013 Earnings Call· Tue, Aug 13, 2013

$11.02

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Transcript

Operator

Operator

Greetings, and welcome to the MRI Interventions Second Quarter 2013 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Oscar Thomas, Vice President of Business Affairs. Thank you sir. You may begin.

Oscar Thomas

Management

Thanks Jane, and good afternoon, everyone. Thank you for joining us today for MRI Interventions second quarter 2013 financial results conference call. As Jane said, my name is Oscar Thomas, I am the Vice President of Business Affairs for MRI Interventions. With me this afternoon are Kim Jenkins, our CEO; and David Carlson, our CFO. Before we begin with our presentation, I do want to point out that some statements we make during today’s call will be forward-looking statements within the meaning of the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, for example, statements we make of our plans and objectives relating to our commercialization efforts for our ClearPoint system. Forward-looking statements often can be identified by words such anticipates, believes, could, estimates, expects, intends, may, plans, potential, predicts, projects, should, will, would, and other words of similar meaning. Forward-looking statements by their nature address the matters that to different degrees are uncertain and involve risk, and they are made based on the current beliefs of MRI Interventions’ management. Uncertainties and risks may cause our actual results and the timing of events to differ materially from those expressed or implied in forward-looking statements we make today. Detailed information regarding the risks, uncertainties and other factors that could affect MRI Interventions actual results and the timing of events are described in the Risk Factor section of our Annual Report on Form 10-Q that we filed with the SEC on March 11, 2013. You can find that SEC filings in the Investor Section of our website at www.mriinterventions com. And with that, I’ll turn the call over to Kim.

Kimble Jenkins

Management

Thanks, Oscar, and good afternoon, everyone. Thank you for joining us for our second quarter earnings call. On behalf of the management team and the employees of MRI Interventions, we appreciate your interest in our company. And for those of you who are shareholders, thank you for your support. We’re honored to be working for you in building this great company. David Carlson, our CFO, will walk you through our first quarter numbers in a minute. But before he does that, let me comment that I’m very pleased with our results for the quarter. We reported record sales for our disposable products which is the key driver for our business model with 98% growth over the prior year second quarter. We increased the number of ClearPoint size. We expanded our sales and marketing capabilities. We saw higher acceleration in ClearPoint awareness amongst clinicians. We advanced our activities in drug delivery clinical trials, and we strengthened our board of directors. It was another successful quarter for us and the result, our commercial enterprise is continuing to grow. Now I'll turn it over to David to review our second quarter numbers and then come back to you with some further comments.

David Carlson

Management

Thanks, Kim. We're pleased to report another solid quarter. I will cover the results of the first quarter and then we'll talk about what happened in the first half of the year. For the quarter, we reported product revenues of $497,000 compared with $291,000 in Q2 of 2012. Disposable product revenues grew from $204,000 in Q2 of 2012 to $404,000 in the second quarter of this year, almost doubling with growth of 98%. We recognized $93,000 in product revenue in Q2 of this year related to our capital products compared with $87,000 for the Q2 of last year. Q2 of 2012 included recognition of $650,000 in license fee revenues. License fee revenues relates to amounts we received previously under our agreement with Boston Scientific. The revenue recognition period for those fees ended in March 2013 and therefore all revenues related to the license fees we received in 2008 were recognized as of the end of the first quarter. Overall revenues also included development service revenues of $65,000 for Q2 of 2013 and $142,000 for Q2 of 2012. These development services were performed on a contract basis for one of our strategic partners and the decrease reflects the winding down of the development project we have been working on with them. In the aggregate, the Company recorded revenues of about $162,000 for Q2 of 2013 compared with $1.1 million in Q2 of 2012. The decrease resulting from the expiration of the revenue recognition period for the license fees the Company has actually received back in 2008. Also, product revenues was $296,000 for Q2 of 2013 compared with $157,000 for the second quarter of last year, an increase of 89%. The increase in cost to product revenues was greater and the increase in product revenues was primarily due to inventory write-offs related…

Kimble Jenkins

Management

Thank you, David. So we're very pleased with the progress we made in the quarter. I'd like to take a few minutes to provide you with additional color and a few highlights. We increased our number of ClearPoint sites adding three new hospitals to our installed base. And these sites included the Mayo Clinic in Jacksonville, City of Hope Hospital in Los Angeles, and the Oregon Health and Science University in Portland. We ended the quarter with 25 installed sites – that's 23 in the United States and two in Europe. Physicians performed first ClearPoint procedures at Brigham and Women's Hospital in Boston, at Spectrum Health in Grand Rapids, the Mayo Clinic in Jacksonville, in Brodnowski Regional Hospital in Warsaw, Poland. Of note, our first cases in Warsaw generated a significant amount of public interest with a portion of one of the ClearPoint cases of being broadcast on live network television. The success the ClearPoint procedure prompted an invitation to the Presidential Palace for the Neurosurgeons. ClearPoint cases are going well. In the scope of the ClearPoint platform, it's continuing to expand. During the quarter, physicians performed the first cases utilizing our new ClearPoint Keyhole component. The Keyhole components are procedures to be performed through a hole as small as 2 millimeters in diameter. During the quarter, our physicians performed the first step electrode placement procedure with ClearPoint for mapping epileptic foci in epilepsy patients. We expanded the ClearPoint system capabilities within the IMRIS VISIUS Surgical Theatre with physicians successfully performing gene delivery and laser ablation procedures in that environment. During the quarter, we are pleased to see neurosurgeons give talks of their clinical experiences with ClearPoint at a number of medical conferences around the world. And I want to point out that these presenting neurosurgeons are not paid consultants…

Operator

Operator

Ladies and gentlemen, we will now be conducting the question-and-answer session. (Operator Instructions) Your first question comes from the line of Greg Chodaczek with First Analysis. Please proceed with your question. Greg Chodaczek – First Analysis: Thank you. Good afternoon, guys. I have a handful of questions I'll just try to pick the most important ones here. Based on your results utilization rate picked up a little bit. Can you talk about utilization of ClearPoint when it – can you prepare it from day one when it goes into the hospital compared to month number six or seven, and how that's changing over time?

Kimble Jenkins

Management

What we're doing, as you know, in connection with commercializing ClearPoint, our sales and support team have two objectives. One is to get systems in place, to get systems installed; and secondly, to increase utilization. And we split our time between those two efforts. What we're doing on the utilization front is we start with a target really of doing a couple of procedures. In the first month or so, let the neurosurgeon find his leg, if you will, get comfortable that the system works as he expects, that his patients are doing well. And that we want to see that utilization pick up over time. In our investor deck, our investor deck, we have a slide that speaks to a case study from one of our hospitals. And it outlines what we call our immersion strategy. Again, following those first couple of successful cases, we then send our people in there to talk with the surgeon the procedure as well as his other colleagues to explain to them the diff things they can do with ClearPoint, the different patients they can treat. What we found in this immersion strategy is success in enrolling the procedure. So in this case study hospital, we went from initially one to two cases a month, and now we're over six, in excess of six per month. So our goal now, Greg, is to replicate the success we're having at that hospital across the platform, the footprint of sites that we've got. That's under way. We've got success at several sites already and we're seeing that followed over across the platform, across the footprint as the year advances. So really it's a process of just spending some time at the site. It's a process of education. But when we apply that effort, we're getting excellent results. Greg Chodaczek – First Analysis: Thanks, Kim, another question. Looking at the hospitals out there and the potential for ClearPoint, what's your number of potential sites you think you can put this in?

Kimble Jenkins

Management

When we think of the potential for ClearPoint, we really think about neurosurgeons rather than hospitals. They're the guys that, again we don't care if we're in one hospital, if they run neurosurgeon time, if they send neurosurgeons all the better, right? There are 3,500 neurosurgeons in the United States. Some of those neurosurgeons are performing just back surgeries and those aren't a target for us. But a nice chunk of them are performing cranial surgeries and those are all within our real house. Now, the center of the bull's eye are those neurosurgeons performing functional and stereotactic neurosurgical procedures. That's about 10% of the total number or 350 neurosurgeons. That's the center of the bull's eye and it grows out towards that 3,500 number. Greg Chodaczek – First Analysis: Roughly, how many hospitals do you think? 200?

Kimble Jenkins

Management

At least. I would say several hundred would be the right number. Greg Chodaczek – First Analysis: Okay. It was nice that you showed the five studies with drug delivery. Can you remind us that all these studies used ClearPoint and ClearPoint is based in those studies? So if we have one successful study ClearPoint has to be used, actually give a label to what I'm going for, right?

Kimble Jenkins

Management

Again, as I've mentioned in my prepared notes, we're very excited about the drug delivery application for this. As you heard with a few of the quotes I read, it's really a game-changer for drug delivery. We really hope to, in our process of revolutionizing needle-invasive neurosurgery, we hope to have a similar impact on drug delivery into targets inside of the brain. The challenging of delivering drugs to targets in the brain is enormous. And we solved that problem. So what you see in those five trials is we have partnered, if you will, with those – with the drug companies that are making those, they are using our technology to deliver the drug to those targets. The drug companies, the researchers believe that they need the precision that – therapy requires the precision provided by ClearPoint and so that’s why we are involved. So yes, with – as the trials proceed if the drugs fail and they fail, but if they succeed, then we will be the delivery platform for those drugs which represents an enormous revenue opportunity for us. The business model as we spelled out before is very simple, the drug company makes whatever money it makes, it gets all the revenue from the drugs and we get the revenue from the sale of the disposable components used to deliver the drug. Greg Chodaczek – First Analysis: And it will be very similar to a DBS procedure?

Kimble Jenkins

Management

Yes, that’s what we create – look, the workflow is almost identical, if neurosurgeon is doing – using ClearPoint to enable DBS lead placement procedure, if they are using it to enable the direct delivery of drugs, if they are using it to oblate tissue, if they are using it for a biopsy, if they are using it for points of [deflector] all of those are essentially the exact same workflow. So once a neurosurgeon learned how to do this, there’re very minor differences between these different procedures types that I have described to you. Greg Chodaczek – First Analysis: ClearPoint placement program, can you talk about it how successful is it going, what’s the time that you convert a placement from this program to a capital sale?

Kimble Jenkins

Management

As you know the driver for our business is the sale of the disposables. We need to get the capital into a hospital to generate that revenue stream from the sale of the disposables, and so of course, that’s the first necessary step. We – under the ClearPoint placement program, and there’s a couple different versions of it but generally speaking we are providing the capital components to the hospitals on a time limited evaluation basis. And then during that period, this evaluation period, the hospital is paying us full fare for the disposables that they use during the period. So we are generating revenue from that throughout the evaluation period. At the end of it, the hospital either buys the equipment or we take it back. The timing varies with these hospitals, it can be six months, it can be a year, frankly, as long as the procedures are happening, then we are pretty happy. What we found in this day and age of intense scrutiny on hospital budgets and these small windows when hospitals have capital allocated for these kind of programs, it’s really helpful to give to the hospital lot of flexibility on the way to get into ClearPoint. Greg Chodaczek – First Analysis: I guess my last question is based on the number of placements or total 25 out there, would you give the number of placements, those are net placements. So if something doesn’t work out, you take something back, those would be reflected in your numbers?

Kimble Jenkins

Management

That’s right. Greg Chodaczek – First Analysis: Eventually I am assuming it’s not going to happen but eventually it could happen.

Kimble Jenkins

Management

That’s right.

Operator

Operator

Our next question comes from the line of Raymond Pirrello with Pendulum Capital Markets. Raymond Pirrello – Pendulum Capital Markets: Any update on the shape of the [market] goals for this year and for next year in terms of the amount of new sites that you guys would like to achieve?

Kimble Jenkins

Management

We decided to – this is our – as I mentioned before this is our first maiden voyage into guidance, and we restricted our guidance to the – what we provided to you. We do not break out the number of sites, so I won’t elaborate on that. What I can tell you is that we’ve got a meaningful interest among hospitals for bringing ClearPoint in, we want to continue to do that, we want to continue to expand the geographic footprint that we’ve got in our hospitals as we have done so far this year, we want to split our sales and marketing and support teams’ time between getting new sites and increasing utilization. And so we sort of balance that each month deciding where we want to spend more and more of our time. But now we expect to see a continued growth in that footprint but we didn’t lay out a specific number.

Operator

Operator

Our next question comes from the line of [Don Duncan with CST].

Unidentified Analyst

Analyst

My question is will you be doing equity financing in the next six months or a year?

Kimble Jenkins

Management

I would take a minute to talk about our cash which is sort of – what you are asking here. The cash on hand at the end of Q2 was $7 million. If you look at our numbers you will see the burn rate for this prior quarter was about $700,000 per month. I know from talking with some investors, there has been a concern about the potential for dilution at the current stock price, look, to the extent we need additional funds to get our ClearPoint business to breakeven we do not intend to sell equity, at the current price of our stock that we don’t want to incur additional dilution for our company and for our investors.

Unidentified Analyst

Analyst

How would you finance – you do some debt down or what will you do to get the money?

Kimble Jenkins

Management

So that would be one of the possibilities, that’s right.

Operator

Operator

Our next question comes from the line of [Nick Shangle with Curation].

Unidentified Analyst

Analyst

Just a couple of things, so clearly there is going to be no problem regarding the top line, right, 87% growing. Clearly the product works and – so we understand this is a great story. I think what I still don’t understand is whether a great story translates to great profitability, because I don’t understand cost of sales because sometimes to get into the hospital you are financing it and obviously there is a cost of sales in terms of training people and getting your sales force to hold their hands, what they are getting them to use it, can you give us any idea of the sort of margins that you would expect from the top line once you sort of get this enormous uplift?

David Carlson

Management

This is David, Nick. From a contribution standpoint, working down just the product costs, over time as our revenues ramp up to get some critical mass, I think from a gross margin standpoint you should expect to see kind of what you would typically see with other medical device companies. Our disposable sales over time and again will become – than they do now, the capital sales. On the capital sales, our margins – we just really are focused on getting the systems placed and so our focus is really on to profitability through our capital sales. From a gross margin standpoint, what you see other medical device companies here in the U.S. I think it would be consistent with what you expect to see from us and again, at this point we are making an investment in our sales and marketing effort and so those costs are going to be relatively high as a percentage of revenue but over the course of time as we get some critical mass on the top line, then we will be able to leverage those selling and marketing expenses and we will look to see them a bit into a pattern like what you again would expect to see in other medical device companies that have some critical mass in terms of revenue.

Unidentified Analyst

Analyst

Please forgive me, but there is number one on the America but there is number two, I don’t own any of the medical device companies. Can you tell me what a typical medical device company – what that margin is for a typical medical device company?

David Carlson

Management

I would say just kind of a range in from a gross margin standpoint, this is not an operating income contribution but somewhere in the 65% to 75%, 80% range would be what you would see as you look at medical device companies here, mature medical device companies.

Kimble Jenkins

Management

It’s Kim, let me elaborate just a bit. The one thing that I think is meaningful about our company is there is an inherent leverage in this business model. If you are a medical device company and you are selling widgets and you make all your money selling a widget to a hospital and then you move on with no recurring revenue stream, your sales guys are essentially starting from scratch every time. Your spending can be fairly high in getting through the capital budget cycle at each account. We’ve got an advantage there because we get into hospital and that’s really when – and sure there are some time and effort, money involved in getting into the hospital and getting through the various committees and what not. Once we are through that, when a hospital does from doing a case a month to three cases a month, to six cases a month and beyond, there’s enormous leverage in that for us. And as David said, we’ve got a very attractive margins on our disposable products which over time will be more and more of our total revenues – I talked about sort of having attractive business model, and that’s what I mean by it.

Unidentified Analyst

Analyst

And you described the target number of hospitals is several hundreds, if I set the number 200 to 300, right? What sort of number of hospitals can one sales guy cover or how many sort of – how many people do you think you need to hire to cover your target market I guess is –

Kimble Jenkins

Management

What we found so far is it varies by geography, right? And in the north-eastern United States, you’ve got a lot of hospitals, if you live in Manhattan, there is an awful lot of hospitals that are doing neurosurgical procedures within 50 miles. If you go to – and so that person for us can cover more hospitals efficiently. If you move up to Texas, it’s a little more spread out, if you move to the Midwest, it really becomes very spread out. So right now it varies – it varies so much that I really don’t think I have a meaningful average to give to you. What you see across our sales guys and our support people is pretty significant difference in the number of hospitals covered by our East Coast folks versus our Southwest guys.

Unidentified Analyst

Analyst

And if I can indulge in one final question, which is it just sort of occurred to me that if I was doing any trials of any drug relating to the brain, the literature that I have read from the doctors suggests that it’s very, very important to know what is the delivery and where it’s going and what is the actual drug and which one of those things you need to modify. That would suggest to me that anyone that was conducting a clinical trial into anything that was going into the head would be empowered by your product because the data that they receive would be more powerful, is that correct and does that – is that a new market of clinical trials?

Kimble Jenkins

Management

It’s not opinion that delivering drugs to target locations in the brain is an enormous issue. If you look over the last 10 or 15 years, and you look at the number of drugs, new drugs, that have been approved for treating neuro-diseases in the brain or neuro-trauma, it’s tiny, it’s a trickle. One of the primary reasons we believe the primary reason for that paltry number of new drugs is this delivery problem, right? The brains are the body’s natural defense mechanism for keeping toxins out of the brain, what brain barrier is unfortunately very effective in keeping drugs out of the brain, out of the neurological target, out of brain tumors, out of the attainment for Parkinson’s disease, et cetera. So yes, I completely agree with your statement. I think we have an opportunity to really have a dramatic impact on the drugs that can – that will affect, that will eventually be successful in treating neurological diseases here over the coming years. Yeah, I think we changed – it’s a dramatic change.

Unidentified Analyst

Analyst

And presumably I mean given how litigious medicine is in America, if you were delivering a drug that had already been passed by the FDA but you aren’t using the best delivery mechanism available, you would be excused of not using best market practice at this point in time, is that stretched or no?

Kimble Jenkins

Management

I can’t disagree with that, sure.

Unidentified Analyst

Analyst

I mean there must be some litigation risk to people that don’t use it?

Kimble Jenkins

Management

It’s been a lot of fun talking with the biotech companies and the drug companies about our capability. If you are a drug company and you’ve got promising drug, you’ve got one question, does the drug work? And secondly, can you get the drug to the target? Thirdly, what sort of side effects will this drug cause that you don’t – that you didn’t want to achieve or you didn’t want to cause? We can have any – we are not in a drug business. So we don’t know whether drugs work or not but we can solve problems two and three, we can reliably get a drug to the target locations every time, and we make the statement that is 100% of the time because the surgeon can see what the drug does, it’s on the target. And secondly, because the drug is only going to the target, we dramatically reduce any systemic side effects that would be associated with that drug. You don’t have liver toxicity for example if the drug never gets to the liver, if it’s only in the brain tumor. You don’t have heart valve problems for a drug that’s only delivered into the neurological target.

Operator

Operator

Our next question comes from the line of [Edward Anders], private investor.

Unidentified Analyst

Analyst

I would like to understand little bit more how the cost sharing economics of your clinical trial participation affects your R&D costs or your cost of goods, going into – is the total cost bear by MRI Interventions or is your some sort of reimbursement of the cost sharing for cost of goods things of that nature?

Kimble Jenkins

Management

Unfortunately the drug companies pay for these trials.

Unidentified Analyst

Analyst

So do they a – so the more specifically, they are clearly paying for the trial but is there any reimbursement to the company for the cost of the disposables?

Kimble Jenkins

Management

Yes, and there is a little variation between the five trials but generally speaking, yes we get paid for our devices used in the clinical trials.

Operator

Operator

Our next question comes from the line of Gary Peller, private investor.

Unidentified Analyst

Analyst

My question is, you mentioned there is about 350 target neurosurgeons in the country, that you are kind of focused on, based on all the medical meetings that you have presented at and just a general literature would you assume and then of course your own marketing, would you assume that most if not all of these neurosurgeons know of your technology today?

Kimble Jenkins

Management

That’s a good question. Yeah, certainly most, I don’t think all of them do, but most of them do. One thing – we have been talking about ClearPoint for the last several years, we’ve been attending these meetings for the last several years, surgeons have been presenting on ClearPoint and a predecessor system for a number of years, and so I think the knowledge awareness of our technology is pretty broad and I would say that certainly of those 350 most of them are aware of ClearPoint. Now just to clarify 350 is the center of the bull’s eye for us, however we are going – surgeons outside of that bull’s eye are interested in ClearPoint and we are interested in them, give you an example, we are at one of the hospitals we are in, I don’t give it by name but it’s up in the northeast, that hospital brought the system in for – i-connection with the functional program, DBS lead placement program and specifically the surgeon there was a functional neuro-surgeon, one of these 350, we are doing the emergent program that I discussed earlier, one of the – in response to one of the questions earlier, and in that emergent we talked to a tumor doctor who is not one of our 350, he said, hey, that’s really neat and I am interested – I would be interested in looking at ClearPoint. He came, observed the procedure and is now doing procedures. So although the 350 is the center of the bull’s eye for us that we are reaching now beyond those into the broader group of neurosurgeons which is about 3500.

Unidentified Analyst

Analyst

Approximately how many separate hospital facilities would the 350 be spread over, assuming there is some hospitals have two or three of these 350 whereas others may just have one, I am just wondering –

Kimble Jenkins

Management

I just don’t know, as we mentioned earlier we really think –we think about the market in terms of the number of neurosurgeons rather than the number of hospitals and so our business model is driven on the disposables. I think it was said earlier though I mentioned is probably in the aggregate of couple of hundred hospitals that would be ideal candidate hospitals for ClearPoint. And that’s a US number.

Operator

Operator

Ladies and gentlemen at this time, I would like to turn the floor back over to management for any closing comments.

Kimble Jenkins

Management

Thank you. Listen, thanks everyone for your time, for your interest. We are working hard at building your company. We are having good success. We are happy with the way things are going, I guess mostly with the fact that we are continuing to impact every quarter a larger and larger group of patients who need therapies that we can – for which we can enable the delivery of whether it be to Parkinson’s patients, or tumor patients or epilepsy patients et cetera. So thank you for your support and we appreciate your time.

Operator

Operator

Thank you. Ladies and gentlemen this concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.