ClearPoint Neuro, Inc. (CLPT) Q3 2015 Earnings Report, Transcript and Summary

Greetings and welcome to the MRI Interventions Incorporated 2015 Third Quarter 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 your host today, Mr. Frank Grillo, the CEO of MRI Interventions Incorporated. Thank you, sir, you may begin.

Thank you. Good afternoon everyone, thank you for joining us for our 2015 Q3 earnings call. With me for today's call is Harold Hurwitz, our CFO. On behalf of the management team and 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 are honored to be working for you in building this great company and we are proud of the care patients are receiving as a result of the continued adoption of our products and technology. To open this call, let me start by saying we are pleased with our progress in Q3 on many fronts. Revenues were up nearly 100% from a year ago, cash burn was down, nearly 40% from the last couple of quarters, and we are making great progress in many aspects of the business. Let me turn the call over to Hal for review of our first quarter -- I'm sorry, our third quarter and nine month financial results. And I will provide further contacts regarding our progress after he goes through that. Hal?

Thank you, Frank. Before we begin, I want to point out that the comments made on this call may include statements that are forward-looking within the meaning of Securities Laws. These forward-looking statements may include without limitation statements related to anticipated industry trend, the company's plans, prospects, and strategies both, preliminary and projected; and management expectations, beliefs, estimates, or projections regarding future results of operation. Actual results or trends could differ materially. We undertake no obligation to revise forward looking statements in light of new information of our future events. For more information please refer to the risk factors discussed in our Form 10-K for the year ended December 31, 2014, and the Form 10-Q for the quarter ended June 30, 2015, both of which have been filed with the SEC, as well as Form 10-Q for the quarter ended September 30, 2015, that we will be filing with the SEC shortly. All our filings can be obtained from the SEC or by visiting our website at www.mriinterventions.com. Let's just cover the three month period ended September 30, 2015. Revenues were $1.2 million for the three months ended September 30, 2015 and $633,000 for the same period in 2014. An increase of $613,000 or 97% attributable to increases in our ClearPoint System reusable and disposable products. ClearPoint disposable product sales for the three months ended September 30, 2015 were $970,000, compared with $577,000 for the same period in 2014, representing an increase of $393,000, or 68%. This increase was due primarily to a greater number of procedures performed using the ClearPoint system within a larger installed base for ClearPoint, relative to the 2014 period. ClearPoint reusable product sales for the three months ended September 30, 2015 were $239,000, and $11,000 for the same period in 2014. Reusable products consist primarily of computer hardware and software bearing sales prices that are appreciably higher than those for disposable products, and historically have fluctuated from quarter to quarter. Gross margin on product revenues was 54% for the three months period ended September 30, 2015, compared to 46% for the same period in 2014. The improvement was attributable primarily to increased average unit selling prices, decreased unit costs and greater production efficiencies arising from increased volume in the 2015 period, relative rather to the 2014 period. Research and development costs were $480,000 for the three months ended September 30, 2015, compared to $873,000 for the same period last year, a decrease of $393,000, or 45%. Approximately $229,000 of the decrease related to reduced spending on the ClearTrace development program, and $61,000 related to reductions in sponsored research. Selling, general and administrative expenses were $2.1 million for each of the three month periods ended September 30, 2015 and 2014. During the three months ended September 30, 2015, we recorded a gain of $1.95 million, and during the three months ended September 30, 2014, we recorded a loss of $781,000, from changes in the fair value of derivative liabilities associated with certain warrants we issued in private placement transactions. Now let's turn our attention to the nine months ended September 30, 2015. Revenues were $3.1 million for the nine months ended September 30, 2015, and $2.6 million for the same period in 2014, an increase of $438,000, or 17%, primarily attributable to growth in our disposable products sales, driven by growth in ClearPoint enabled procedures. ClearPoint disposable product sales for the nine months ended September 30, 2015 were $2.5 million, compared with $1.9 million for the same period in 2014, representing an increase of $580,000, or 30%. This increase is due primarily to the aforementioned growth in procedures and the size of the ClearPoint system installed base. ClearPoint reusable product sales for the nine months ended September 30, 2015 were $469,000, compared with $492,000 for the same period in 2014, representing a decrease of $23,000, or 5%. Gross margin on product revenues for the nine months ended September 30, 2015 was 55% compared to gross margin of 49% for the corresponding period in 2014. The improvement was attributable primarily to increased average unit selling prices, decreased unit costs and greater production efficiencies arising from increased volume in the 2015 period, relative to the 2014 period. Research and development costs were $1.4 million for the nine months ended September 30, 2015, compared to $2.6 million for the same period in 2014, a decrease of $1.2 million, or 45%. Approximately $592,000 of the decrease related to a reduction in spending on the ClearTrace development program, and $200,000 related to reductions in sponsored research. Selling, general and administrative expenses were $6.6 million for the nine months ended September 30, 2015 compared with $5.8 million for the same period last year, an increase of $817,000 or 14%. The increase was primarily attributable to an increase during the nine months ended September 30, 2015 in cash compensation costs of approximately $466,000, a portion of which was associated with overlapping executives' terms of employment so as to provide for a coordinated transition of duties during the period in which we, as previously announced, consolidated our business functions into our Irvine, California headquarters and closed our executive offices in Memphis, Tennessee. Also contributing to the increase was an increase in share-based compensation of $417,000. In March 2015, we announced the consolidation of all major business functions into our Irvine, California headquarters. In connection with this consolidation, we closed our Memphis, Tennessee office in May 2015. We did not retain any of the Memphis-based employees. A total of seven employees were impacted by the consolidation, including three executives, whose termination of employment triggered a modification in the terms of stock options previously granted to them. In connection with this consolidation, we recorded restructuring charges of $1.3 million during the nine months ended September 30, 2015, primarily related to severance costs, and to the revaluation of the stock options with modified terms and the resulting accrual of additional share-based compensation expense. During the nine months ended September 30, 2014, we recorded a gain of $4.3 million related to the sale of certain intellectual property to Boston Scientific. The purchase price was satisfied through the cancellation of related party convertible notes payable we previously issued to Boston Scientific in the aggregate principal amount of $4.3 million. We recorded a gain equal to the purchase price, as the assets sold had not been previously recorded on our balance sheet. During the nine months ended September 30, 2015 and 2014, we recorded gains of $981,000 and $578,000 respectively, resulting from changes in the fair value of derivative liabilities associated with certain warrants we issued in private placement transactions. I will now turn the call back over to Frank.

All right Hal, thanks for the update on the financials. As I stated earlier, we are pleased with the progress we made this quarter. Revenues came in at about came in at about $1.25 million in the third quarter, and as Hal mentioned, that was an increase of 97% over a year ago. More importantly, we achieved record procedures and disposable sales this quarter. To talk about procedures for a moment, TDS cases were strong this quarter and continue to be the largest portion of our cases overall. These cases are going very smoothly and case times continue to fall often too well under four hours for bilateral case, and under three hours for unilateral case which compares favorably to stereotactic cases. In addition, the patient is not locked into a head frame for eight to ten hours which is often the case for stereotactic approach. Laser Ablation trends were also encouraging to us this quarter. About a quarter of our cases where -- in Q3 were laser ablation cases similar to Q2 and Q4 has started off with an even higher mix of laser. In Q3 we had a couple of sites come on-board and ramp up for laser ablation of tumors while others continue to utilize laser ablation for hippocampal ablation. At this point, I believe we're doing about the same number of cases with monitors and visual aids, and these cases are going better and better with better accuracy and shorter case times as accounts come up to speed. Our value proposition in the laser is strong based upon the accuracy in real-time visualization of the placement of the laser fiber that is possible with our ClearPoint System while eliminating the need to transport the patient through the hospital hallways, from the operating room to the MRI suite with a hole in his or her head. We believe ClearPoint is the ideal neuro navigation system for laser ablation and expect that this new procedure will drive growth for us for some time to come. In addition, we continue to see progress in the use of our system for variety of other case types as well. For instance we are to an interesting story from one of our surgeons in the Northeast regarding a brain tumor biopsy. Earlier last month he was on call and a patient presented with a mask that required biopsy. As Head of Stereotactic and Functional Surgery, his institution -- he did the biopsy stereotactically which means he did not use ClearPoint and did not have real-time MRI guidance. Typically such a procedure would take two to three hours, however the procedure took over seven hours and specimen after specimen did not yield a diagnostic sample indicating an error in the targeting because we could not see the tumor in real-time. A few days later, the same surgeon redid the biopsy utilizing the ClearPoint System. The entire ClearPoint procedure took only a little over two hours and with the ClearPoint accuracy and the real-time visualization in the MRI he was able to obtain a diagnostic biopsy sample with confidence on its first attempt. These kind of stories combined with peer reviewed articles such as the article in The Journal of Neurosurgery which we've highlighted in our press release yesterday are proof that we have a great technology and that surgeons are realizing the same thing. In drug delivery, we began conversations with a few additional pharma and biotech companies this quarter regarding using our ClearPoint System and additional drug delivery trials. We are excited by these early discussions. These companies are coming to us with their problem, they need to ensure the drugs they are delivering reach their targets and do not simply reflux back up the needle track. The combination of our ClearPoint System for navigation and our proprietary drug delivery cannulas are great solution to these needs. And we intend to initiate as many partnerships as possible in this area. Drug delivery is also generating interest for technology around the world. This quarter we sold a system to an account in Warsaw Poland where the neurosurgeon is very involved in local drug delivery trials. The hospital is building a new intraoperative MRI center devoted to narrow interventions. And for use in these kinds of drug delivery trials and specified having ClearPoint has part of the new center. Now, I should caution we have not actually recognized the revenue from the sale even though we have received the purchase order and shipped the system, as the installation is not yet complete but we are excited about having this account come up to speed. We expect the installed to be completed in Q4 at which time we'll recognize the revenue and the first cases to occur in Q1 of next year. It's also interesting to note as we look across our account base that nine of our Top Ten accounts are now using ClearPoint for multiple types of procedures and seven of our Top Ten now have multiple surgeons using our technology. The surgeons and their colleagues typically start with just one procedure in mind, and then when they see the utility of the ClearPoint System they proceed to use it in multiple types of procedures. This is exactly the kind of trend we'd like to see. On the capital side, we had two capital sales in the third quarter, and we had two additional new accounts signed up to evaluate ClearPoint. In addition, we pulled systems from two sites where we expect to where the evaluations did not look like they would turn into a capital purchase. So we pulled them after the 90-day. When you wrap it all up, we ended Q3 with 39 sites and better and better utilization at these site, including all sites in the U.S. we have 39 ClearPoint sites and strong interest from additional new customers continues, and we expect Q4 to be a good quarter for us in terms of eve-outs, sales and growth in our revenue. Marketing, during this quarter we had one of our two biggest trade shows of the year, the Congress of Neurological Surgeons held in New Orleans, Louisiana. We supported several events at this meeting, the highlight of which was a lunch and lecture we co-sponsored with Medtronic entitled, the emergence of real-time imaging and neurosurgery. How MRI guided navigation and laser ablation are increasing minimally invasive surgical options. Over 140 attendees heard lectures regarding the use of real-time MRI for a variety of neurological procedures with a focus on laser ablation and also a discussion around drug delivery. The session was very well received and is evidence of the growing interest in our technology. Let me turn to the expense side of our business. As we mentioned on the last call and as Hal has mentioned, we've completed the consolidation of our Memphis facility into Irvine, California. All of the restructuring charges are pretty much behind us and the benefits of a more focused and streamlined organization are showing up in our day to day business activities, and also in our use of cash. Our cash use in operations this quarter was $1.6 million which compares to cash used in operations of $2.8 million and $2.9 million in Q1 and Q2 respectively. This reduction of over 40% and use of cash is reflective of our new streamlined operating expenses. With our expectation of rising revenues and a few further cost reductions going forward, we expect to see this net use of cash continue to decline over the next several quarters. We aim to be excellent stewards of investor cash, and with a disposable product line with 65% to 70% gross margins, revenue growth goes a long way in reducing cash burn. So in summary, we're pleased with the progress we made this quarter. Cases are going well and we are seeing more and more excitement around laser for both, tumor and hippocampal ablations. We have a great CNS and encouraging discussions with a number of drug delivery companies regarding new studies. Our sales and clinical special teams are driving hard and we appreciate the interest in our technology we are receiving from more and more potential customers. We are changing how neurosurgery is done, where it is done, and in some instances what can be done. We are confident with the benefits of our technology brings to patient care and we are committed to bringing these benefits to more and more hospitals, surgeons and patients, and the marketplace is responding with growing interest and use of our products. With that, I'd like to open the call for questions.

Thank you. [Operator Instructions] Our first question comes from Bruce Calmway [ph], a private investor. Please proceed with your question.

Thank you. Frank, I just want to comment that's impressive revenue growth in Q3. Can you tell us how October is doing? Are we having a good follow-through on that turnaround?

Thank you for the question, Bruce. As always, I have to be a little careful about how much we say given forward-looking statements. But October has been a good month for us, we've seen a very nice and continued increase in laser ablation growth and it's been a great way to start off the quarter. So we've been pleased with the quarter-to-date in Q4 and will certainly provide a full update when the quarter concludes.

Great, and just one follow-up question. It seems like we're becoming more an ablation company, the growth there is really picking up. Don't lasers have to be done in MRI suite?

So what we're finding with the laser side of the business is exceptionally picking up nicely and we're getting traction with both laser companies, Visual Aids and Monteris. Those procedures as we've discussed on prior calls, often start in the operating room but have to be concluded in the MRI as the thermal mapping you can get in an MRI while during the ablation is needed for the procedure. So what we're finding in hospitals is rather than transporting a patient from the operating room to the MRI, they are really starting to see the advantage of doing the whole procedure in the MRI, being able to get much better accuracy when they are placing the fiber in -- with real-time MRI visualization. And the other advantage with our system is if multiple trajectories are required that can also be done with real-time guidance under the MRI rather than trying to go back and forth to the operating room to replace the laser. So the value proposition in laser is very strong, and it is starting to really drive the growth through the company and we do expect to see that happen more so in the future.

That's great and just one last question on that. You mentioned accuracy, are you getting comments from the doctors that both month Monteris are visual aids stopped the improvement and accuracy from using us?

We are definitely getting those kind of comments from doctors, not only in laser ablation cases where obviously -- we're getting in those accuracy comments across the Board. In laser, particularly for the hippocampal ablations where it's a long thin structure you're trying to ablate, and you are destroying tissue in that instance, accuracy is really critical, I mean it is brain surgery after all. Secondly, I sighted this example of the biopsy we heard about in the northeast this quarter where using stereotactic equipment in the operating room they kept missing the sample -- kept missing the target. And then once they were in the MRI, a few days later with ClearPoint and the real-time. MRI visualization, they were able to accurately get to target and get the sample without a problem. So we continue to hear many comments on accuracy that relates to being able to power system enabling the real-time MRI guidance.

Great. I assume that we're getting around. Thank you for a great quarter.

Thanks.

Thank you. Our next question is from Alberto Fernandez with Information Capital [ph]. Please proceed with your question. Our next question comes from Ben Jacmel [ph], a private investor. Places proceed with your question.

Hey guys, how are you?

Good. Thanks for joining the call Ben.

Excellent -- now thank you very much for having the call. Excellent quarter, nice work and I realize as you guys are just kind of starting out there in your first year -- probably will not be the fastest sales growth that we'll experience under your new management but an overall -- commend you guys on a great quarter. My question is more on the -- not revenue side but actually on the cash situation at the company. Do you have any color on the cash situation? I know you talked about the burn rate coming down to 1.5% to 1.6% this quarter. Can you talk a little bit more about what your goals are for cash burn for the for the year not unlike -- if sales were to say stagnate for instance or something like that. Overall, do you guys have a target for the year at all?

Ben, we do have internal targets but as you are likely very aware, we do refrain from giving guidance. So I can't respond to the totality of that question. As you can tell from our prepared remarks, we're certainly in touch with where we are from a cash standpoint and we look forward to communicating developments with respect to that in the future.

Okay. Thank you. Is there -- by the way that you could disclose what like what the cash position is before the 10-Q comes out?

Yes, the balance sheet, the financial statements in total were appended to the press release. So what you'll see there is that we had the cash balance at the end of the quarter of $1.8 million.

The total cash is $1.8 million?

Correct.

Thanks, guys.

Thank you, Ben.

[Operator Instructions] Our next question comes from Alberto Fernandez [ph] with Information Capital. Please proceed with your question.

I'm sorry, my mic was off. Thanks for your information on this last quarter. I have a question concerning the number and growth of CP sites. Can you tell me what the number of growth is year-on-year and in the last quarter?

So the number of sites we have now Alberto, we have 39 sites in the United States versus a year ago it's actually about flat as we've been fairly aggressive on removing equipment from the hospitals where the evaluations were not heading towards purchase. So I think it's somewhere in the range of eight up and eight down. I would expect over the next few quarters that there is not very many sites now that are in evaluation where we do not expect them to come to close. So I think we'll start to see the sights grow going forward.

So you're saying that you're basically flat, is that it?

For installed base, yes. Procedures as you can tell from the disposable product revenue are up significantly.

Right. Thank you very much.

There are no further questions in queue at this time. I would like to turn the call back over to management for closing comment.

All right, thank you to Dana [ph] for your assistance on the call. And thank you everyone for your participation and your continued interest and support. We look forward to reporting our fiscal year 2015 results in early 2016 and appreciate your support of the company. B'bye.

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time and have a great day.