Earnings Labs

ClearPoint Neuro, Inc. (CLPT)

Q1 2013 Earnings Call· Thu, May 9, 2013

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Transcript

Operator

Operator

Greetings, and welcome to the MRI Interventions First 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, Mr. Thomas. You may begin.

Oscar L. Thomas

Management

Thanks Bob, and good afternoon, everyone. Thank you for joining us today for MRI Interventions first quarter 2013 financial results conference call. As Bob said, this is Oscar Thomas, 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 L. Jenkins

Management

Thanks, Oscar, and good afternoon, everyone. Thank you for joining us for our first 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. But before he does that, let me comment that I’m very pleased with our results for the quarter, we are reporting growth in our revenues, growth in our product and service numbers and growth in our recurring revenues and sales disposable. We increased the number of ClearPoint size. We expanded our sales and marketing capabilities. We introduced improvements to our ClearPoint product lines. We expanded our involvement in drug delivery clinical trials and we added to our extensive patent guidance portfolio. It was a successful quarter and we worked hard and as a result our commercial enterprise is running. Now with that, I’ll turn it over to David to review our first quarter numbers and then come back to you with some further comments.

David W. Carlson

Management

Thanks, Kim. I apologize in advance for the raspy voice as I have a bit of a spring cold. We are pleased to report a solid first quarter. We recorded revenues of $1.3 million compared with $980,000 in Q1 of 2012 results for both quarters included recognition of $650,000 in license fee revenues. The license fee revenues recognized in both quarters relates to amounts we previously received under our agreements with Boston Scientific. Product revenues were $460,000 in the first quarter of 2013 compared with $222,000 for the same period in 2012, an increase of 107%. Disposable products’ revenues grew from $222,000 in Q1 of 2012 to $347,000 in the first quarter of this year, an increase of 56%. In addition, we recognized $113,000 in product revenue related to the sale of one ClearPoint system in the first quarter of 2013. Overall, revenues also included development service revenues of $154,000 for Q1 of 2013 and $108,000 for Q1 of 2012. These development services were performed on a contract basis for one of our strategic partners. Our gross margin on product revenues was 51% in Q1 of 2013, compared with 54% in Q1 of 2012. The change relates to change in mix as our margins on disposable products are higher than on capital product sales. In addition, margins were impacted by an increase in depreciation on ClearPoint systems installed under our ClearPoint Placement Program. R&D costs for the first quarter of 2013 were $771,000 compared to $690,000 for Q1 of 2012. The primary drivers for the quarter-over-quarter increase related to higher software development expenses associated with product enhancements, which were $93,000 and sponsored research costs, which increased $80,000. These increases were partially offset by a decrease of $121,000 related to our Key Personnel Incentive Program. SG&A expenses for the first quarter…

Kimble L. Jenkins

Management

Thanks, David. So I’m very pleased with the progress we made in the quarter and again, let me repeat, we grew our revenues, we added to our installed base, we made significant progress in building up the sales and marketing capabilities that we need to support accelerated growth in our business going forward. Now let me take a few minutes to elaborate on these points. During the first quarter and since then we continued to expand the company’s sales and marketing presence. Of note, we continued to add to our sales and clinical support capabilities, today we now have ten professionals in sales and support roles that’s up from three back in September. Our Rob Korn, our VP of Sales is doing a great job building up team. We’ve expanded our presence in conferencing during the quarter, adding activation disease American Academy of Neurology Annual Meeting, The Intraoperative Imaging Society Annual Meeting. For 2013, Winter Clinics for Cranial & Spinal Surgery So in addition, over the last couple of weeks we exhibited at the American Association of Neurological Surgeons Annual Meeting, and the 2013 Targeted Drug Delivery Conference. I am very happy why these conference are going, but importantly surgeons are using – talking about ClearPoint at the podium speaking of the positive experience that they have in using a system, but describing our successes in treating patients with Parkinson’s disease, dystonia, pediatric dystonia pain, (inaudible) and brain tumors. But the Targeted Drug Delivery Conference is San Francisco there were three back-to-back talks, 30 minutes each is striving use of ClearPoint to drug deliveries. All these conference as they are excellent interest in the ClearPoint platform is very high. I’m happy with the three new ClearPoint sites we added disorder. In addition of breaking the one top is noteworthy, but…

Operator

Operator

Thank you, we’ll now be conducting a question-and-answer session. (Operator Instructions) Our first question comes from the line of Raymond Pirrello with Pendulum Capital Markets. Please proceed with your question. Raymond Pirrello – Pendulum Capital Markets: Based on your data, Kim – great quarter. Based on your data for the clinical trial, so basically 50% up to 100% in terms of delivery, do you think it’s a possibility or even in the cards where the FDA will require these companies to start using the ClearPoint system to do their FDA Phase for studies for the drug delivery?

Kimble L. Jenkins

Management

Hi, Ray. How are you? It’s an interesting question. I certainly can’t speak for the FDA, no one I can. We believe the data is very strong as evidenced by the John Sampson article in the Journal of Neurosurgery that I just quoted. Similar papers have reached the same conclusion. For example, the Lancet article describing the results with a neurologic trial, recently the failed Ceregene trial for CERE-120, a therapy for Parkinson’s disease. So we think the data is pretty strong, very strong as to what the FDA may do require, I really can’t speak to that. Raymond Pirrello – Pendulum Capital Markets: In terms of new locations, great job signing up some more in the first quarter, is there anything at this point in mind up already for the second quarter?

Unidentified Company Representative

Analyst

We’re sure taking this one step at a time, Ray. Speaking to what we did in the first quarter, we haven’t talked about the second quarter. We got a nice team in place as I talked about. We’re pleased with the work those guys are doing and we’re focused on continuing great business. Raymond Pirrello – Pendulum Capital Markets: Are any of the partnerships that you guys had before, you know, this new force came in to play, a new sales force journey, are there any types of movements there in terms of, then bring us anything from Brainlab, and I believe there is somebody else as well?

Unidentified Company Representative

Analyst

Sure. so, Brainlab in particular is our non-exclusive accounting distribution partner, particularly helping us in Europe. And that’s a strong relationship. We spend a lot of time with those guys and with them just last week at the Dublin. So it’s a good relationship and we’re getting benefit from that. Raymond Pirrello – Pendulum Capital Markets: So, are you happy with outlines at this point?

Unidentified Company Representative

Analyst

Yes. Raymond Pirrello – Pendulum Capital Markets: Okay. and the last question is on a hospital-by-hospital basis, joining pattern of gross indisposables being ordered based on time. so if you had some of your earlier hospitals. Are you started to see a pattern of increases of cases on a hospital-by-hospital basis based on then getting comfortable with the new device.

Unidentified Company Representative

Analyst

We are seeing increased utilization. as far the pattern, I’m sure we’re seeing the pineapple pattern yet. but again, we are seeing the increased utilization with, as I talked about in earlier comments, one we got to do is we got to be keep rolling that clinical field support staffs. so that’s not a moderator on utilization, but we’re working on that, but it’s hard to pattern, I’m not sure I know the pattern. All right. I appreciate you dialing into the call. Raymond Pirrello – Pendulum Capital Markets: Thanks again.

Operator

Operator

Thank you. Our next question comes from the line of Gary Peller who is the Private Investor. Please proceed with your question.

Unidentified Analyst

Analyst · your question.

Yeah. This is Gary. Can you hear me?

Unidentified Company Representative

Analyst · your question.

Yes, I hear.

Unidentified Analyst

Analyst · your question.

Just one quick question on these latest three installations you announced today, from the time that your team first met with all three of the parties to the time that contracts were signed for the installation. what is the average amount of time for those just those latest three?

Unidentified Company Representative

Analyst · your question.

Let’s say, so I’m just saying for a minute, what we see Gary, and I think this would be consistent with these sites, our sales cycle is about six months, and it’s interesting, it really doesn’t take a lot of time to get a neurosurgeon interested in bringing in a clear point. However, there is a lot of processes as you know in our hospital, there are committees, there’s a new products committee, the neuro committee, the sterility committee et cetera and that seems to happen on a serial basis in parallel. I think about six months, is the average and would be consistent with these sites.

Unidentified Analyst

Analyst · your question.

And about how many, a follow-up question about how many facilities separate new facilities, would you be meeting with representatives at this time on an ongoing basis or are you always meeting with at least 10 new facilities or 15 or 20, I mean there is 1000s of hospitals, I’m just wondering?

Unidentified Company Representative

Analyst · your question.

Sure. Gary we’re always meeting with quite a few folks, and actually it’s interesting this week is really we’re following up on a very active and very productive conference at the Dublin asset now in New Orleans. And so measuring by this week, I’d say it’s the higher number than really what you’re talking about. but generally yeah the work, our guys are staying busy. they don’t have any shortage of hospitals to be interacting with right now, which we’re pleased about, thus far we’re working hard to grow the sales and marketing infrastructure.

Unidentified Analyst

Analyst · your question.

Okay, thank you.

Unidentified Company Representative

Analyst · your question.

Thank you.

Operator

Operator

Thank you. Our next question comes from the line of (inaudible). Please proceed with your question. Andrew your line is live for question. Okay, let’s move on to our next question, comes from the line of John (inaudible) with Sterne Agee & Leach. Please proceed with your question.

Unidentified Analyst

Analyst

Hey, Kimble. It’s John (inaudible) Birmingham. How are you doing?

Kimble L. Jenkins

Management

Hi, John how are you doing?

Unidentified Analyst

Analyst

I’m good, I’m good, great quarter. I just had two questions one, what is the call stop, the disposable device to the hospital and the next question is do you all have any idea of what your cash burn maybe in the second quarter, third quarter, is there any kind of model on that?

Kimble L. Jenkins

Management

Sure, so first of all, with regard to the disposable costs, we look at it on sort of an average selling price procedure.

Unidentified Analyst

Analyst

Right.

Kimble L. Jenkins

Management

And that ASP procedure is approximately $7,300. As we said before, our margins on the product during kind of the 75% to 80% and so we make approximately $6,000 a case. As far as the cash burn goes, so we ended Q1 with a burn rate of about $600,000 a month. You’ll know if you look to the numbers that we use about $2.2 million in cash during the quarter. Now that included around $400,000 in payments that will not recur again in 2013. So now going forward, I guess there is two significant components one is as we talked about, we are growing the sales and marketing team and capability. To offset that we hope that the team will continue to increase the revenue.

Unidentified Analyst

Analyst

Right okay well that answers my question, I appreciate it.

Unidentified Company Representative

Analyst

John thank you every much.

Unidentified Analyst

Analyst

Thank you.

Operator

Operator

Thank you. Our next question comes from the line of John (inaudible) who is a Private Investor. Please proceed with your question.

Unidentified Analyst

Analyst

Yes Kim, I’ve two questions. One can you give an close track of all the renewals we best train so far, is position and raised into additional neuroscience and second question the clear things, what’s your timetable on that and what are you thinking at that?

Unidentified Company Representative

Analyst

Sure, so I don’t know at the top of my head what the number of doctors that are trained to do a clear point. I can estimate it though. The hospitals that were – tend to have, if some have one, many of them have two and the other surgeons that do these procedures few of them have more than two. We are in 23 facilities now. So my guess would be on the order of I get probably 45, would be my guess. Maybe a larger number actually because one of the things it’s nice, at the hospital that we’re in, for example an M&A or USCS these are teaching hospitals and so they’ve got a steady stream of followers they go through there every year, and those men and women and go out to set up their practices and that’s a nice opportunity for us and sometimes that number can be, at least several people per hospital. With regard to your question on ClearTrace, Jack, we don’t have. We’ve not set a timetable on ClearTrace. As we’ve talked about, as I think we mentioned before, our focus is really on ClearPoint growing that business as aggressively as we can, growing that commercialization effort. That said, and so we are not focused on the commercialization around ClearTrace. That said, just a few weeks ago I was out at the University of Utah, which is a kind of our primary research center for ClearTrace and meeting with the team there. They are continuing to work in the area having a good success in this area. And actually anecdotally, the Heart Rhythm Society meeting is taking place this week in Denver, and of now I‘ve an email just a little while ago that one of the doctors that has been very involved in MRI guided cardiac EP gave a talk today on the use of MR in connection with treating AFib patients and complex arrhythmia patient. So I think the short answer, Jack, is that is, we really – we don’t a have specific time table right now. We are focused on ClearPoint, but maybe to run that out a bit, there is – we are in a good position with that products, we are excited about the potential to really change, really revolutionize that field as we believe we are doing on neuro side and we are happy that the research community and the clinical community awareness of the value of the MR and EP continues to grow. And operator if that’s left, then we will wrap up.

Operator

Operator

We do have a final question coming from the line of (inaudible) with Lennox. Please proceed with your question.

Unidentified Analyst

Analyst

Hi, Kim, how are you? It’s Andrew from New York.

Kimble L. Jenkins

Management

Andrew, how are you?

Unidentified Analyst

Analyst

Great. I just had a question for you. Do you know how many cases on a monthly or quarterly basis a side is performing on average?

Kimble L. Jenkins

Management

So we have, again, we are still early in the roll out. We’ve got a lot of new sites and they come on line some this quarter, some last question. The – our goal or sort of our approach to utilization is to get the system installed and then tell the neurosurgeon do a couple of cases, see how the patients do, see how your team likes it, all those things. They will do those couple of patients typically. They will sit back and see how the patients do and then they will come back and start looking additional cases. Our near term goal has been to drive size towards a – to four cases a month cases a month or essentially a case a week, that’s not an end goal but it’s a near term goal and it’s really what I am marching the sales as we deal support people to do at this point.

Unidentified Analyst

Analyst

Got you. Thank you very much.

Unidentified Company Representative

Analyst

Andrew thanks so much, and let me wrap up. Again, we really appreciate your support and interest in our company and we think we’ve got a great product. We think we’re building a great company; it wouldn’t happen if we didn’t have the support of our shareholders. So thank you for that. And have a good afternoon.

Operator

Operator

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