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ClearPoint Neuro, Inc. (CLPT)

Q1 2014 Earnings Call· Thu, May 8, 2014

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Transcript

Operator

Operator

Greetings, and welcome to the MRI Interventions’ First Quarter 2014 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. I would now like to turn the conference over to Oscar Thomas, Vice President, Business Affairs for MRI Interventions. Thank you. You may begin.

Oscar Thomas

Management

Good afternoon. This is Oscar Thomas, Vice President, Business Affairs for MRI Interventions. With me are Kim Jenkins, our CEO; and David Carlson, our CFO. Before we begin with our prepared comments this afternoon, I want to point out that some statements we make during today’s call will be forward-looking statements. Forward-looking statements by their nature address matters that, to different degrees are uncertain and involve risks 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 and uncertainties that could affect our actual results and the timing of events are described in the Risk Factors section of the Form 10-Q that we filed with the SEC on March 20, 2014. You can find our SEC filings in the Investors section of our website at mriinterventions.com. With that, I’ll now turn the call over to Kim.

Kim Jenkins

Management

Thanks, Oscar. Good afternoon, everyone. Thank you for joining us for our Q1 2014 earnings call. On behalf of the management team and the employees of MRI Interventions, we appreciate your interest in our company. For those of you who are shareholders, thank you very much for your support. We’re honored to be working for you in building this great company. We had another very productive quarter. Growing our ClearPoint business, improving the ClearPoint product, partly reducing cash used in our operations, adding a fifth drug delivery trail, strengthening our financial positions and advancing our ClearTrace program. I’ll cover some additional details regarding the quarter with you shortly, but first, David Carlson, our CFO is going to walk you through our first quarter numbers. David?

David Carlson

Management

Thanks Kim. For the quarter, we recorded total revenues of $823,000 compared with $1.3 million for the first quarter of last year. The Q1 2013 amount included recognition of $650,000 in license fee revenues. These license fee revenues relates to amounts we received in 2008 under our agreements 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 previously were recognized as of the end of the first quarter of 2013. For the quarter, we recorded product and other services revenues of $724,000, compared with $460,000 in Q1 of 2013, representing growth of 57%. Disposable product revenues were $565,000 in Q1 of 2014, compared to $347,000 in the first quarter of last year. That represents growth of 63%. We recognized $92,000 in product revenue in Q1 2014 related to our ClearPoint capital product versus $113,000 in Q1 of 2013. Product revenues for the first quarter of 2014 included $56,000 in ClearTrace System components sold to a site for research use. Other service revenues related to installation services and ClearPoint service agreements were $11,000 for the first quarter of 2014, and no such revenues were recorded during the same period last year. Development service revenues were $154,000 in Q1 of last year and $99,000 in the first quarter of 2014. These development services were performed on a contract basis for a third-party, and the decrease reflects the winding down of the development project we’ve been working on for them. Gross margin on product revenues was 51% for the first quarter, above 2014 and 2013. R&D costs for the first quarter of 2014 were $818,000 compared to $771,000 for Q1 of 2013. The primary driver for the increase was an increase in expenses related to the company’s…

Kim Jenkins

Management

Thanks David. So we had another great productive quarter. And I’d like to take a minute to provide some additional color on a few of the items. First, we’re continuing our success in building the ClearPoint business. During the quarter, we expanded our ClearPoint footprint adding three sites in Q1. Those are Akron General Medical Center, Le Bonheur Children’s Hospital and Swedish Medical Center. All great hospitals bringing our total amount of ClearPoint sites to 34, with 32 in United States and two in Europe. As David mentioned, our disposable product revenues in the quarter were $565,000, up 63% versus Q1 of last year. On a sequential basis, our disposable revenues were up slightly, which is good, but reflects lower quarterly sequential growth in what we have delivered in recent periods. As mentioned in our earnings release just earlier today, growth in our product revenues was moderated by decision we made to implement improvements in our ClearPoint workflow, our ClearPoint software and the fixation of our SmartFrame device to the patient. We made these changes based on feedback we received from our ongoing interactions with neurosurgeons. The primary purpose of the changes was to enable our ClearPoint system to accommodate a broader range of patient positioning for certain procedures such as procedures for laser ablation. To be more specific, to enable reaching several targets in the brain, neurosurgeons wanted to position a patients’ bone rather than to spine [ph], I mean on their stomachs instead of their backs. Our ClearPoint system was originally designed for patients to be positioned on their back. So we needed to make changes to ClearPoint to facilitate a smooth procedure with patients positioned on their stomach. Although this may sound like a simple change, it wasn’t. And as noted before it required changes to multiple…

Operator

Operator

Thank you. At this time, we will be conducting a question-and-answer session. (Operator Instructions) Our first question is from Lawrence Burnett [ph] from SWF [ph]. Please state your question. Lawrence Burnett [ph] – SWF [ph]: Kim, congratulations on another good quarter. I would like for you to, can you estimate how much revenue was lost due to the changeover, or adding the additional procedure?

Kim Jenkins

Management

Sure, Lawrence [ph]. Thanks for the question, and appreciate you dialing in. As we said on in our prepared remarks, the changes we made were driven by feedback and input that we got from neurosurgeons who were using the system. And we knew it was the right decision because it’s enabling us to treat – our physicians to treat a wider range of patients. One thing you’ve heard us talk about over the last number of quarters is ClearPoint is a platform. And that’s what we envisioned years ago. It’s a product that could treat and really I can change neurosurgery and put in a hand of neurosurgeon a very powerful tool to deliver range of difference therapies for a wide range of different patients. And that said, and I think we had a pretty good vision on it years ago. That said, when neurosurgeons came back to us and said, look, we really want to start doing these patients on their stomach – so some of these patients on their stomach instead of just on their back, it took us by surprise. And it did take a significant effort on the part of many folks in our company to enable that, and to enable it quickly. And we really sort of worked around the clock to get this change made. It certainly reduced the number of cases that we were able to perform, again as I mentioned before, we know specifically that some of our sites including one of our highest volume sites held back on cases, just waiting for us to complete this project. In addition, again I know first opinion of several folks that are potential customers looking at bringing ClearPoint to their hospitals that also said, let me – I just want to see you get this work done. So we know it impacted the business, we know it reduced the case volume. We know that it slowed some progress with some potential sites. The specific number, I’m not sure it’s really possible to calculate, but again we know it dinged us. Now, and also just to reiterate, we’re pleased to have completed the work. We’ve implementing these changes, we’ve implemented them and it’s in our rearview mirror, so we’re glad to get to be done with this. And as I said before, we’re confident that we’re back on track. And when I say back on track, I mean sort of consistent with the growth rates we were seeing the second half of last year. Lawrence Burnett [ph] – SWF [ph]: I can appreciate as you as it’s difficult to estimate the amount of revenue lost, which I guess is what you were seeing. Is it possible – or how long did it take for the implementation for the redirection to on-the-stomach procedure?

Kim Jenkins

Management

It was an effort that went on throughout the quarter. So it was across the majority of the quarter. Lawrence Burnett [ph] – SWF [ph]: It happened entire quarter then?

Kim Jenkins

Management

Yes, again I am trying to remember, Lawrence [ph], it’s pretty hot around here and we just can run together but yes, it was – I believe it was the entire quarter. Lawrence Burnett [ph] – SWF [ph]: Thank you.

Kim Jenkins

Management

That’s majority of the quarter. Lawrence Burnett [ph] – SWF [ph]: Thanks very much, and congratulations on the good work.

Kim Jenkins

Management

Hi Lawrence [ph], thank you for dialing in.

Operator

Operator

Our next question is from Steve Schwartz of First Analysis. Please state. Steve Schwartz – First Analysis: Good afternoon guys.

Kim Jenkins

Management

Hi Steve, how are you? Steve Schwartz – First Analysis: Good, thanks. So Kim the way you described that, it almost sounds like there was this element of the market that you guys didn’t quite realize was out there, but there is certainly a demand for. So how much do you think this opens up in terms of an opportunity for you?

Kim Jenkins

Management

So that’s a great question. The kinds of procedures that we’ve envisioned are consistent, right. So we’re still talking about electrode placement. We’re still talking about catheter placement for drug delivery. We’re still talking about laser ablation and biopsies. What we found though is that the best way to get to some of those targets was to patient of. It’s just more a patient worked better, as with doctors were telling us they want to do. So at one level, I’d say my answer is that it’s the same population that we’re going after. However, on another level, we have been pleased to learn that by making this additional capability available that there appear to be other things that can be done with ClearPoint. And so I don’t know that we’ve quantified that, but this platform notion of ClearPoint is a powerful idea. The number of treatment resistant neuro disease patients is very large and this puts us in a better position to take care of more of those patients. Steve Schwartz – First Analysis: Okay. Yes, it certainly sounds positive, so good to hear. No problem taking a short-term hit like this if there is long-term benefit.

Kim Jenkins

Management

And that’s what we thought. You hate to take the short-term hit, but on the other hand, as I said before, it was absolutely the right decision for us to make. Steve Schwartz – First Analysis: Okay. Thank you for the color.

Kim Jenkins

Management

Thank you, Steve.

Operator

Operator

Our next question is from Craig Stone [ph], Private Investor. Please state your question. Craig Stone [ph] – Private Investor: Hi Kim. Thanks for the great results here. The question I have is on getting other people to help us sell little bit faster. And my question is with the re-regulation of the insurance industry, it would seem like it’s in the benefit in the interest of insurance companies to be helping us to sell with the hospitals. Have you guys been able to reach out to any insurance companies to help, or does that make any sense at all?

Kim Jenkins

Management

Thanks for the comment and question. So the short answer is it’s very early for that for us. But a little longer answer is that this is a thing we’re hearing. We’re hearing this from neurosurgeons and we’re hearing it from hospital administrators alike. And I think you’re absolutely right spot on. What’s interesting in the drive and all the changes that are going on in healthcare, there is a renewed interest or a heightened interest in the delivering the most cost effective solutions to treating patients possible and tracking that and making people accountable for that, making hospital who are dealing two procedures and now are warding two procedure to treat a patient. And I think, hi, when you do a second treatment on a patient, you’re going to have to pay for that one. So all of those themes I think are good themes and powerful themes for us. Why do I say that? So if you look at DBS electrode placements for a Parkinson’s patient. There have been some studies, I don’t have them at my fingertips, but there have been studies on that say when a Parkinson’s patient undergoes undertakes DBS therapy and receives DBS therapy, there the cost of that patient over the next five years – it may have been a 10-year study or five year study, the cost of taking care of that patient goes down. And the productivity of that patient goes up. And so there is an effort, I know from Medtronic in one example, to make sure that ensure the company is realized it. There is a real positive economic delta in some of these therapies, these therapies for treatment resistant neuro diseases. Another example is epilepsy. So epilepsies of – certainly treatment-resistant epilepsies are very debilitating disease, just awful for quality of life for patients and has an impact of making hard for them to work, and in many cases they can’t work. And so to the extent you can deliver a treatment for them unlike laser ablation. And return a lot of that quality of life, return those patients to be more productive. Then that’s how great. Now so they’re going off on this, I don’t know, 10 or 15 years ago, I don’t think insurance companies were tracking this, not as closely as they are doing today. So this is a theme, as we established ClearPoint as a more broad-based therapy, one that’s in more and more hospitals, more and more common, we absolutely intend to make these points clear to all of the relevant parties including the insurers. Did I put you to sleep with that answer? Craig Stone [ph] – Private Investor: No, you’re good. Just, with the changes in the industry, it would seem like the insurers are at the front or forefront of helping hospitals manage their costs down now, and we got a great product to help them with that, right?

Kim Jenkins

Management

Again I couldn’t agree with you more, absolutely. Craig Stone [ph] – Private Investor: Yes. If we could get those insurance companies helping us when they negotiate their reimbursement rates with hospitals, momentum in our product, it would be huge.

Kim Jenkins

Management

Yes, it’s one of the things that – one of the reasons why it’s so important that we continue to grow the footprint, to grow the utilization, to grow the awareness. As I’ve said over and over again, we’re the pioneers in this field. We are the pioneer in this field. We’re out on a forefront here. And we’re changing an area of medicine, and in doing that, comes the opportunity to educate folks. And the further we go, the more momentum we build I think so the bigger of impact can be and [indiscernible] is on us as we you take folks like these insurance companies and say, look, hi, this is a big deal to you. This now impacts you. This can be a benefit to you and your insured population. Craig Stone [ph] – Private Investor: Yes. Thanks.

Kim Jenkins

Management

Thank You, Craig [ph].

Operator

Operator

(Operator Instructions) There are no more questions at this time. And I’d like to turn the call back over to Kim Jenkins for closing comments.

Kim Jenkins

Management

Thanks so much. As always we very much appreciate your interest in our company. We very much appreciate your support. Please know that we are working hard to deliver value for our patients, for the doctors and most importantly and very importantly for our stakeholders. So we wouldn’t be here without you. Thank you for your support. And hope you have a good evening.

Operator

Operator

Thank you. This does conclude the teleconference. Thank you for your participation.