Greetings and welcome to the ClearPoint Neuro Inc. Third Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

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 trends; the company’s plans, prospects, and strategies, both preliminary and projected; and management’s expectations, beliefs, estimates, or projections regarding future results of operations. Actual results or trends could differ materially.

The company undertakes no obligation to revise forward-looking statements for new information or future events.

For more information, please refer to the company’s Annual Report on Form 10-K for the year ended December 31, 2020, and the company's quarterly report on Form 10-Q for the quarter ended June 30, 2021 both of which have been filed with the Securities and Exchange Commission, and the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2021, which the company intends to file with the Securities and Exchange Commission on or before November 15, 2021.

All the company’s filings may be obtained from the SEC or the company’s website at www.clearpointneuro.com. At this time, I would like to turn the floor over to Mr. Joe Burnett, Chief Executive Officer. Thank you, sir. Please go ahead..

Thank you, Kate, and thank you to all of the investors and analysts on today's call for being a part of the ClearPoint vision and journey. Our mission and our priority is to help restore quality of life to patients and their families who are suffering from some of the most debilitating neurological disorders imaginable.

In the third quarter of 2021, we have continued to make progress against our four pillars of growth, including functional neurosurgery navigation, biologics & drug delivery therapy and access products, and achieving global scale.

While elective case volume was once again impacted this time by the Delta variant in August and September, we still achieved record revenue overall. We also added new partners, both on our medical device navigation portfolio and in our biologics and drug delivery portfolio.

These two distinct market categories are both served by the same ClearPoint platform, and we estimate that they each have total annual addressable markets of more than $1 billion each in the years ahead.

I will now turn the call over to Danilo, our CFO, to review our financial performance in the quarter after which I will add some details to our four pillar growth strategy.

Danilo?.

Thank you, Joe and thank you all for joining us today. Looking at the third quarter 2021 results, total revenue was $4.6 million in the third quarter of 2021 compared to $3.5 million in the third quarter of 2020, an increase of $1.1 million or 30%.

Our revenue is made up of three components, functional neurosurgery navigation therapy, biologics & drug delivery, and capital equipment and software.

Functional Neurosurgery Navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the ClearPoint system to deliver medical device therapy to the proper target.

This revenue segment increased 17% to $2.2 million for the three months ended September 30th, 2021 or $1.8 million for the same period in 2020. Biologic & Drug Delivery revenue includes sales of disposable products and services related to customer sponsored preclinical and clinical trials utilizing our products.

Biologic & Drug Delivery sales increased 39% to $2.1 million in the third quarter of 2021 from $1.5 million for the same period in 2020. This increase is attributable to increase investments by both new and existing partners, as we've progressed together through the regulatory process for these new exciting gene and stem cell therapies.

Capital equipment and software revenue consisting of sales of ClearPoint reusable hardware and software, and of related services was $0.4 million for the third quarter, a 78% increase versus the same period in 2020. Revenue from this product line historically has varying from quarter to quarter.

We have started to see a return of some capital spending on systems and service contracts, although delay in capital spending caused by COVID, uncertainty still lingers. Gross margin for the three months ended September 30th, 2021 was 68% compared to 74% for the same period in 2020.

This decrease was due primarily to an increase in the excess and obsolete inventory reserve of $0.1 million and to an increase in overhead costs allocated to cost of sales during the third quarter.

Research and development costs were $2.6 million for the third quarter 2021 compared to $1.1 million for the same period in 2020, an increase of $1.5 million or 130%.

This increase was due primarily to increases in personnel costs, including headcounts and increased investments in our product and software development, both increases reflect the acceleration of our pipeline development efforts as communicated in our use proceeds summary during our last financing in February of 2021.

We have been very successful attracting talented hardware, software and quality engineers during the past six months. Sales and marketing expenses were $1.8 million in the third quarter of 2021 compared to $1.5 million for the same period in 2020, an increase of $0.3 million or 22%.

The increase reflects increased level of marketing activities and travel expenses for our clinical team, as procedure volume continues to grow and we train our new hire clinical specialists.

General and administrative expenses were $2.4 million for the third quarter 2021 compared to $1.3 million for the same period in 2020, an increase of $1.2 million. This increase was due primarily to increases in personnel costs, share-based compensation, insurance expenses, occupancy costs, IT and other professional expenses.

As a benefit of our last round of financing, we have hired 20 new employees across the organization since the beginning of the year to accelerate product development efforts, commercial support and global expansion.

At September 30th, 2021, we have cash and cash equivalents totaling $57.7 million as compared to $20.1 million at December 31st, 2020, with the increase resulting primarily from the completion of a public offering of the company's common stock in February, 2021. I would like to turn now the call back to Joe..

Thanks Danilo.

The third quarter was a successful quarter for our team across our four pillar growth strategy, headlined by record revenue of $4.6 million for the quarter, new partnerships in both our medical device and drug delivery businesses, and the successful hiring of talented new employees across product development, quality, clinical support, and even a new board member has just announced last week.

Let's break that progress down into our four pillars of growth. Starting with functional neurosurgery navigation. We achieved record revenue of $2.2 million during the quarter and 227 cases supported by our clinical team.

While case volume declined slightly versus our record second quarter, we did see disposable purchasing increase to replenish inventory and to prepare for future procedures that have been scheduled here in the fourth quarter. The Delta variant did impact elective procedures at about 20% of our hospitals in August and September.

However, in October, we saw the majority of those impacted hospitals resume elective procedures.

The new and somewhat unforeseen symptom of COVID has been hospital staffing shortages at hospitals across the country, where a hospital may have plenty of ICU beds available for elective procedures, that same hospital may not have enough nurses and other staff members to support the procedure and the recovery of that patient.

Now, speaking of patients. In the third quarter, we launched our first program designed to educate patients and their families about their options for deep brain stimulation treatment. Our first patient testimonial video featured Susan O'Rourke DBS journey with an MRI guided DBS placement under general anesthesia, otherwise known as a sleep DBS.

At ClearPoint, we always put the patient first. So, we would encourage each patient to speak directly with their physician about DBS treatment options, which could be an awake MER guided procedure performed in the operating room or an MRI guided procedure under general anesthesia using ClearPoint.

In the future ClearPoint plans to offer devices for both alternatives, allowing each hospital and each surgeon to match the appropriate technique for every individual patient. With the ClearPoint portfolio, hospitals and surgeons will have both options available to them.

From a development standpoint, we continued progress across our portfolio and solidified budgets, schedules and team members using the significant capital infusion in the first quarter of this year.

As mentioned on the call, we did receive FDA clearance for the SmartFrame Array, which is meant to streamline workflows and help ClearPoint to across over into the operating room. We will continue our limited market release through the second half of 2021 and remain on track for a full market release in the first half of 2022.

We have continued development across the rest of our pipeline as well, including the 2.1 ClearPoint software, the Maestro Brain Model, the Orchestra multi trajectory head frame our co-developed MER system in collaboration with Blackrock, and our robotic-assisted system called Revolution, in partnership with D&K Engineering.

We feel that we have an exciting cadence of new and improved products over the next few years, which will continue to demonstrate ClearPoint as one of the true innovative companies in the neurosurgery space.

Our previous timelines remain intact and after completing our first clinical cases with SmartFrame Array, which was accomplished in the second quarter, we continue to expect first cases of ClearPoint 2.1 and Maestro software in 2022 and Orchestra, MER and Revolution in 2023.

Our recent announcement to enter the brain computer interface navigation segment with Blackrock Neurotech is a very exciting one. There's tremendous potential around the future of BCIs, both for medical and communication purposes as you can tell by the significant investment taking place in this space.

Blackrock is one of the first and most experienced BCI implant companies, with 29 cortical implants completed today in human subjects over the past seven years.

Under this agreement, we are leveraging our existing ClearPoint platform to build a custom SmartFrame solution and software to make the BCI implementation faster, more precise, and more repeatable across multiple surgeons and hospital centers.

This partnership is very similar to the work we do with our pharma partners, where we provide a system, disposables and clinical support during the infusion of a drug. In this example, we are placing the BCI as a target instead of the infusion cannular, but the business relationship is very similar.

Our intention is to sell this navigation system directly to hospitals through our commercial channel and see this as another disposable spoke on the ClearPoint hub platform. Another reason that every modern neurosurgery center of excellence should have ClearPoint in the future.

Importantly, while MRI images are used for many, if not all BCI applications, the surgery itself is designed to take place in the operating room. So, this is another application that we are focused on that is not reliant on MRI access, but rather an additional crossover technology for ClearPoint into the operating room.

If you add up all of the potential addressable markets for our neurosurgery navigation platform, both in the MRI and in the operating room, including deep brain stimulation navigation, brain computer interface navigation, laser ablation, microelectric recording and brain modeling, we believe this future annual total addressable market to be an excess of $1 billion.

This includes both existing and future DBS applications, including epilepsy and depression, as well as new studies being planned for BCI, including the restoration of communication, movement, hearing, and even site. Our second pillar in Biologics & Drug Delivery, our team continued to add additional partners and services here in the second quarter.

We currently have approximately 40 individual pharma and academic partnerships across multiple indications up from approximately 35 just a quarter ago. As a reminder, it is common that each customer or partner has a drug platform of their own, meaning they are not planning to use their drug or vector for only one indication.

Our decision to expand into Europe has already helped us to win additional European based pharma business and academic researchers. We plan to continue adding partners and still believe that an initial commercial gene therapy approval for neuro could take place in 2022.

As you have likely seen from recent press releases, the enrollment of patients into these trials has restarted after COVID, and we expect multiple partners to continue enrollment in Phase 1 and Phase 2 trials in the second half of 2021 and to initiate new trials throughout 2022.

It is also important to note that the majority of our investment into the navigation system itself mentioned in pillar one applies to Biologics & Drug Delivery as well. That is the beauty of our platform strategy, as much of the investment is applied across many indications in both biologics and medical device navigation.

This is crucial from a training standpoint as well. Every biopsy case, laser ablation case or DBS case, a hospital does with ClearPoint today is in fact training and preparing them to do biologics cases in the future.

For our third pillar, our therapeutic products and access to devices, we have continued our development progress and remain on schedule for our previously communicated timelines. The ClearPoint exclusive laser ablation system that is in development with CLS in Sweden and IGT in France continues to make progress and collect data.

And we are still planning for a submission in the second half of 2021 to the FDA, despite some COVID related delays. We did announce an installation and clinical partnership in Paris at Rothschild Hospital a couple of weeks ago.

The primary clinical data that will be collected will be on pediatric tumors using the complete ClearPoint CLS IGT laser solution with the expectation of patients being enrolled in the first half of 2022. In the third quarter, we also executed an agreement with adeor, a leader in surgical drill solutions based in Germany.

This partnership has two important elements. First, a distribution agreement allowing ClearPoint to sell and support the adeor portfolio of power drills designed for the operating room here in the United States.

This is an impressive portfolio of products that has been quite successful across Europe and just recently gained FDA clearance earlier this year. We expect training and limited market release activities to begin in the fourth quarter of 2021, with a full market release in the first half of 2022.

The second element of our agreement with adeor is that adeor will build an MRI conditional device based on their current Velocity Alpha design and upon this successful development ClearPoint will be the worldwide exclusive distributor of the MRI conditional drill.

This drill is an important addition to our portfolio as it is designed to eliminate the need for a slower hand-twist drill and could save anywhere from 15 minutes to more than an hour of surgical time during each procedure depending on the numbers of trajectories.

This is especially relevant for our drug delivery partners as multiple trajectories and infusions are quite common. Like in the Blackrock agreement, this also provides yet another crossover technology for ClearPoint to help penetrate the operating room. Finally, our fourth pillar of achieving global scale has made progress as well.

Our quality system has been successfully updated to be compliant with the new European MDR rules that went into effect in may of this year. This is not a small task and has been daunting enough to some companies that they have decided not to sell certain products in Europe under these new regulations.

Although, compliance is challenging, we believe our investment is the right one. And the simple fact that we have one of our clinical specialists present at our procedures helps us with that compliance and market surveillance. We have also achieved approval for a full suite of navigation and drug delivery products in Israel.

Israel is an important market for innovation across devices and biologics, and having a presence with our products there will enable a new therapies and trials to be performed using ClearPoint. We have been successful thus far in securing additional inventory ahead of the supply chain challenges that have been very real and very challenging.

We have used our existing capital to purchase materials ahead of time, which you can see by the expansion of inventory investment on our balance sheet. The vast majority of our supply base is domestic however. We are delighted to add to our Board of Directors, a highly regarded neurosurgeon and Dr. Linda Liau, who is the Chair of Neurosurgery at UCLA.

Linda is not only a practicing neurosurgeon, specializing in tumor related procedures, but she has also led multiple biologics and drug delivery programs inside of UCLA. That practical experience as a surgeon and administrative responsibility as Chair will absolutely impact our strategy moving forward. And we are thrilled to have her join the team.

At this point, we are reiterating our full year 2021 revenue guidance of between $16 million and $17.5 million, which corresponds to a range of 900 to 1,000 cases covered by our clinical team and consistent with our forecast from the beginning of this year. With that, I would like to open up the call to any questions..

Thank you. The floor is now open for questions. [Operator Instructions] Our first question comes from Frank Takkinen. Please state your question..

Joe, Danilo, thanks for taking my questions. Congrats on a solid quarter. For starters, can you give ….

Hi, Frank..

Yeah, absolutely. Can you give a little bit more color into the guidance range? I'm looking at the results.

And from low end to top end, can mean both sequentially down as well as sequentially up for Q4 revenue? So maybe give us some assumptions around the guide as well as what type of COVID-related impacts, whether that be a shortage of staffing at hospitals is baked into the guidance for the full year..

Yeah. Frank, thanks for the question. And I think you said it right there. One of the reasons we're hesitant to go a little deeper in the revenue forecasting is that, COVID could in fact rear its ugly head yet again. But your math is absolutely right.

And I think it certainly assumes that we would be doing somewhere between $4 million and $5.5 million for the rest of the year or in the fourth quarter. I think it's fair to expect that, assuming COVID does not have a significant impact, we probably expect something in the $4.5 million range or so given where we are today, given our forecast..

Got it. That's helpful. And just thought I'd try to give a little bit more color on how you're thinking about 2022. I realized there's no guidance out there yet, but maybe speak to how you're thinking about the growth profile of the company.

As we look into 2022, obviously COVID is a large variable in this situation, but maybe just give us some thoughts on how we should start to think about 2022 growth..

Yeah. Without going too far into the numbers, let's kind of talk pillar by pillar. We would expect really all four of our pillars to experience growth in 2022. Starting with functional neurosurgery, I think there's been some pent-up demand.

And certainly some patients who have been put on hold for their surgery that have not been able to go in whether it was from the Delta variant in August, in September or from some of these staffing shortages that you see here.

But we do hear from a number of our customers, that there is a significant backlog of patients that are waiting to be treated. So, we certainly expected those to start to flow out in 2022. Not to mention the backlog of interested parties that have not been able to purchase the ClearPoint system.

So we really have not placed many systems this year at all. And we do expect that placement that start to accelerate here in the fourth quarter, as well as throughout 2022.

Now in the fourth quarter, I don't know that that much capital will come in, given the typical timing around an evaluation, but certainly we see capital as a significant opportunity for growth in 2022 as well. And then, on the biologic side of things, we do expect that to continue to grow.

We've added, I believe, 15 additional partnerships this year already, and we do have a number of additional ones in the queue. And each partnership generally starts with a smaller investment in consulting services and benchtop testing with any one of our pharma partners.

And then as the -- let's say, the partnership begins to mature and the regulatory process starts to unfold for our partner, then they start purchasing more devices for preclinical studies for Phase 1, Phase 2 trials, and in some cases for inventory security and things like that.

So, whereas we do have a number of new partners that are just getting started with us. We also have many other partners that are much more advanced that we're expecting to have additional development services and revenue coming from Phase 1, Phase 2 and even Phase 3 trials next year.

And I think the last point I think I didn't touch on was, was the therapy side of things where I don't expect therapy and access to be a huge contributor in 2022.

Although, if our timeline stay intact for our own laser system, then in the second half of next year, we would expect to start seeing our first sales, and our partnership with adeor is something that we're pretty excited about as well that we should be able to start seeing sales throughout 2022.

So, whereas that therapy number I believe was zero here in the third quarter, in 2022 we'll be really collecting our first revenue in that segment..

Got it. That's helpful. That's great color, a lot of different growth opportunities there. Last one for me. I think on the last call, there was some reference to PTC, isn't the only partner that has a potential 2022 FDA approval.

One, was that correct? And two, can you maybe frame up just how many of your partners could be submitting for approval in 2022? Just trying to get a sense for shots on goal?.

Yeah. I would say there's two or three in there, that could fall into the category as you describe it that are using either a cannula or a navigation system or both. And they actually stretch across a few different disorders. So, it's three different indications that are potential ones. I believe PTC is still the most mature.

I believe they've recently mentioned that their BLA is expected to go here in the U.S. early in Q1 of next year. I believe the most recent information, which could still have them on track for 2022 FDA clearance. It's also likely they could have a European or a CMR clearance in 2022 ahead of the FDA clearance too.

So, we still think that's the most advanced one. However, there are a couple others that could go in. And again, in these -- in all three of these situations, these are very rare childhood genetic disorders where there's really no alternative for these patients. So, any of the regulatory bodies want to feel like we've got a shot to help these folks.

And because the number of patients is relatively small compared to massive opportunities like Parkinson's disease and tumor and essential tremor, it's easier to track these patients even in a commercial setting and just do it through market surveillance instead of a clinical trial.

So, that's why we think there is the potential for some of that flexibility. However, a lot of the examinations and inspections that the FDA or notified bodies will have to do of the manufacturing processes of these sites still have to go very well. So, there's a lot of work still left to do..

Got it. That's helpful. Appreciate all the color. Thanks..

Sure..

Okay. Our next question comes from Bjorn Ng. Please state your question..

Hey, Joe, it is good to hear voice again. Congratulations on an outstanding quarter and by the way, congrats on the grand opening of the CarePoint Global Training & Innovation Center in Solana Beach. I love the coast Mueller and the story behind it..

Thank you, Bjorn..

Yeah. Thanks Joe. In an earlier call, you shared that laser ablation cases two to three times revenue opportunity and that it makes up about 35% of our total cases.

So, do you see an opportunity of laser ablation cases to make up a higher percentage of total cases taking into account the partnership with CLS and IGT SLSP [ph] cranial and spine opportunities?.

I do. I think it does have a very good opportunity to grow as a percentage of our cases. And the reason I say that is I believe the laser ablation procedure or the overall market seems to be growing a bit faster than the DBS market today. Now it's a much smaller market than DBS.

There's many fewer procedures, but from what we can tell that market seems to be growing anywhere from 15% to 20% plus versus the DBS market is closer to the 5% to 10% range.

So, as that grows and as we launch more advanced products to participate in that market and the share of those cases as a percentage of overall ClearPoint cases should also grow. Now that being said, we're also very excited about a number of the new clinical trial work that's being done for deep brain stimulation.

There's more and more epilepsy cases that are being done with a Medtronic system, as well as with neuro pace and a few more that are on the horizon. And many of these DBS systems are also going after much larger potential markets as well, including Alzheimer's disease, chronic drug resistant depression, things like that too.

So, whereas those are going to take some time to develop, they have to go through the clinical trial process. It's great to see the research community embracing DBS as a very real potential solution..

Got it. So, in terms of the expansion to Europe, could you share some colors on the pipeline for installation CLS enrollment of clinical trials in U.K. sites for next year? I remember you shared that you expect to have another two to three installations this year as well..

That's correct. Yeah. So, we are continuing to push evaluation agreements and install agreements. Again, our strategy in Europe is not to try to place a ClearPoint system at every local hospital, but really to focus again on the centers of excellence. So maybe two or three per country is the direction that we're going today.

So where it's hard to commit to the exact month that an install takes place, because of sometimes some construction is needed for air circulation. Sometimes there's additional anesthesia equipment that's required for the MRI suite.

So, those things -- just have typical vendor delays, but I would expect that by the end of next year, we have anywhere from five to 10 installations across Europe and Israel..

Thanks. That's helpful. So, the last question I have is I think it's super that Dr. Linda Liau joined ClearPoint's Board of Directors. It's definitely a sign on validation of ClearPoint solutions.

So, how has she help to increase adoption and use ClearPoint solution amongst neurosurgeons?.

Well, I think she's going to be able to do a number of things for us. Number one is provide some excellent input on training and how to get the attention of a neurosurgical team. Again, she's not only speaking from the arena of being a neurosurgeon, but also responsible for the training of a series of fellows as well.

So, being able to understand the individual surgeon's needs as well as the needs of the department, I think is something it's nice to have someone on the inside that that can share that perspective.

Similarly, she's been involved and spoken with a number of researchers around the world, working on biologics and drug delivery, primarily on the tumor side of things, but she also has experienced beyond tumors into functional disease too.

And I think some of the introductions that she is able to make, and really helps to connect the dots of what drug partners out there would really be able to benefit from our navigation, from our cannulas, or even from some new routes of administration that we're developing to reach different parts of the central nervous system.

I think her being able to work with our biologics team and sort of circle and highlight the company that will absolutely benefit from ClearPoint technology..

Got it. Thanks, Joe. There's all the questions I have and I would just like to commend you and your team on your efforts over the quarter. It must not be easy to navigate the impact of the Delta variant. Looking forward to continuing on this journey together with you for the long-term..

That's great. Thank you, Bjorn..

That was our final question. I'll turn it back over to Joe for closing remarks..

All right. Well, once again, thank you everyone for being interested and being a part of our team's story here at ClearPoint. We believe that we're all doing very important work and we'll continue to put the patients and their family first, as we take on greater and greater responsibility for the treatment across our portfolio. Good night everyone..

Thank you. This concludes today's conference call. We thank you for your participation. You may disconnect your lines at this time and have a great day..