Greetings. Welcome to the ClearPoint Neuro, Inc.’s First Quarter Financial Results Conference Call. At this time all participants are in a listen-only mode. [Operator instructions] Please note 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, which has been filed with the Securities and Exchange Commission, and the company’s quarterly report on Form 10-Q for the quarter ended March 31, 2021, which the company intends to file with the Securities and Exchange Commission on or before May 17, 2021.

All the company’s filings may be obtained from the SEC or the company’s website at www.clearpointneuro.com. I would now like to turn the conference over to your host Mr. Joe Burnett, Chief Executive Officer. Thank you. You may begin..

Thank you, Devin. And thank you to all of the investors and analysts on the call today for being a part of the ClearPoint vision and journey. We are here 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 first quarter of 2021, we made substantial progress across all four of our pillars of growth, including functional neurosurgery navigation, biologics and drug delivery, ClearPoint owned therapeutic products and achieving global scale.

Importantly, we made this progress in our portfolio against the backdrop of record revenue in the quarter, the resumption of elective procedures as a majority of our hospitals and the addition of multiple pharma partners to our growing list of active customers.

The significant infusion of capital that we closed in the quarter also supports not only in the expansion and acceleration of our product portfolio, but also our geographic and quality system expansion to a more global scale.

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 additional detail to our four pillar growth strategy.

Danilo?.

Thank you, Joe. And thank you for joining us today. Looking at the first quarter of 2021 results, total revenue was $4 million for the three months ended March 31, 2021, and $3.1 million for the three months ended March 31, 2020, which represents an increase of $0.9 million or 29%.

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

Functional neurosurgery navigation revenue, which consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 10% to $1.9 million for the three months ended March 31, 2021, from $1.7 million for the same period in 2020.

This increase reflects the resumption in the three months ended March 31, 2021, of elective surgical procedures, which were postponed or cancelled over the past months due to the COVID-19 pandemic. Case volume increased each month in the quarter.

Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored clinical trials utilizing our products, increased 61% to $1.7 million for the three months ended March 31, from $1 million for the same period in 2020, due primarily to the resumption of clinical trial activities that led to increased sales of biologics and drug delivery products.

Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, increased 31% to $0.5 million for the three months ended March 31, from $0.3 million for the same period in 2020.

While revenue from this product line historically has varied from quarter-to-quarter, we believe that the increase represents the partial resumption of hospitals’ capital equipment acquisition activities following the onset of the COVID-19 pandemic.

While hospital budget constraints caused by the pandemic continue to be a real headwind, the current funnel of potential installs is very healthy. Gross margin for the three months ended March 31 was 65%, compared to 70% for the same period in 2020.

This decrease primarily due to a greater contribution in the first quarter of 2020 to total sales of service revenue, which contribute higher gross margins in comparison to other product lines, and portion of overhead allocated to cost of revenue resulting from larger production output volume during the three months ended March 31, 2021, relative to the same period in 2020.

Research and development costs were $1.6 million for the three months ended March 31, compared to $0.8 million for the same period in 2020, an increase of $0.8 million, or 91%. Sales and marketing expenses were $1.6 million for the three months ended March 31, compared to $1.3 million for the same period in 2020, an increase of $0.3 million, or 21%.

Both these increases reflect additions in key areas to our team, as it builds the infrastructure necessary to expand product lines, launch new indications, and comply with global standards as we plan our international expansion.

General and administrative expenses were $1.7 million for the three months ended March 31, 2021, compared to $1.3 million for the same period in 2020, an increase of $0.4 million, or 30%. This increase was due primarily to increases in insurance, occupancy costs, and incentive-based and share-based compensation.

At March 31, 2021, we had cash and cash equivalents totaling $64.9 million as compared to $20.1 million at March 31, 2020, with the increase resulting primarily from the completion of a public offering of the company’s common stock in February 2021. I will now turn the call back to Joe..

Thanks Danilo. As mentioned, our commercial team enjoyed a record quarter supported by recovering elective case volumes, new biologics partners added to the funnel and even capital sales and service agreements. Let’s break down that progress into our four growth pillars.

First functional neurosurgery navigation continued to rebound with 214 cases covered by our specialist team in the quarter versus our prior estimate of 190 to 200. The deviation versus our earlier expectation came in the last few weeks of the quarter.

As many of our hospitals that had halted elective procedures in January and February returned to action. It is encouraging that March was our highest month of the quarter and gives us confidence that U.S. case volume is returning to pre-pandemic levels.

From a development standpoint, we continued progress across our portfolio and solidified budgets, schedules and team members using the capital infusion in the first quarter. Importantly, we achieved FDA clearance for our Array navigation system, and they’re in the process of starting our limited market release for the product.

As a reminder, the Array is designed to not only streamline the workflow and reduce time, but it’s also the first product designed by ClearPoint to be used in both the MRI suite and the operating room.

This is an important step in our strategy of becoming a true neurosurgery platform that can be used with multiple imaging modalities and not only the MRI. We expect first cases to be performed here in the second quarter and the limited market release to extend throughout the second half of 2021.

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 Headframe, our co-developed MER system in collaboration with Blackrock and our robotics assisted system, which was announced yesterday.

And we are building 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 of the true innovative companies in the neurosurgery space.

With our additional funding, we are now better able to communicate estimated timelines for the first human cases with each of these products. For example, we expect first cases of SmartFrame Array in 2021, ClearPoint 2.1 and Maestro in 2022, and orchestra MER and the robotics platform in 2023.

Second, our biologics and drug delivery team continue to add additional partners and capabilities to the team in the first quarter. By the end of Q1, we hit the threshold of 30 active customers in the biologic space, adding an additional indication and shots on goal in gene-therapy and cell delivery programs.

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 drugs only for 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 initial commercial gene-therapy approval for neuro could takes place in 2022. It is also important to note that the majority of our investment into the navigation system mentioned in pillar one applies also to biologics and drug delivery.

That is the beauty of the platform strategy as much of this investment is applied across many indications in both biologics and medical device navigation. For our third pillar, which is our own therapeutic products are primarily development activities today.

The laser program in concert with CLS in Sweden and IGT in France continues to make progress as we prepare for an FDA submission in the second half of 2021. We expect first clinical cases with the complete neuro system in 2022.

After laser our biopsy and smart biopsy programs continue to progress, and we expect first clinical uses of these products in 2022 and 2023 respectively. Finally, our fourth pillar of achieving global scale has made progress as well.

Most substantially, the new European MDR guidelines are meant to go into effect later this month, our project to update our quality system to ensure compliance with the new directive has been successful. And we fully expect to meet these new guidelines. This is a tall order for many companies.

And while the investment into our quality system has been extensive, we believe the fact that we made and we’ll continue that investments, that creates another barrier where many companies have decided not to continue in Europe for certain product lines. We want to be there to fill the void for hospitals and patients that need ClearPoint.

We also obtained CE Mark for our 4 Fr, 5 Fr and 7 Fr Accessory Kits showing that we continue to demonstrate the capability of getting new products of CE Mark, even in this challenging environment. As many of you are aware of the pandemic has continued to rage in Europe across the first quarter.

So our case volume and installation schedule was put on pause. However, we are encouraged by the more aggressive vaccination distribution across Western Europe, which is our next focus for expansion. As it appears, elective case volume is rebounding and some of our pharma partners have resumed clinical trial work.

We are more comfortable providing a forecast for the full year of 2021. We believe revenue will be in the range of $16 million to $17.5 million for the year and case volume supported by our clinical teams will be in the range of 900 to 1000 cases.

While we are encouraged by the return of cases, the wider than usual range is primarily driven by two things.

First, the timing of capital, while we do expect the resumption of a number of evaluation systems being installed in the second half of 2021, the timing of turning an eval into a formal purchase order has slowed and there is a chance that sales might cross over into 2022.

Second, the timing of the initiation of new pharma trials, we are encouraged as a number of our partners, continue to progress through the FDA protocol review and internal hospital IRB. However, the comprehensive review of protocols, delivery, drug manufacturing and storage are all hurdles that certainly need to take place beforehand.

With that, I would like to open up the call to any questions..

[Operator Instructions] Our first question comes from the line of Andrew D’Silva with B. Riley Securities. Please proceed with your question..

Hey, good afternoon. Congrats on the progress and thanks for taking my questions. So I just opened up your 10-Q and, I was actually surprised on the biologics and drug delivery side of the business and the strength it really looked like it was almost completely tied to the disposable side of the business.

Can you give a little color on why that has such a big uptick? I didn’t see any commercial activity that would drive that it wasn’t just off the new partners or anything there would be useful from a caller standpoint..

Yes, I mean the one – thanks for the question, Andrew. I think the one comment I’d make on this topic is that we still enjoyed a significant part of that revenue being service-based. So, I think that did continue.

What we sight-see added is as you pointed out the resumption of some of these clinical trials that have started to take place again, and some of the preclinical work that often happens behind the scene.

So, where we saw, I think an increase here in the first quarter was many of the toxicology studies that might be done as certain preclinical labs and CROs. Those started to return both based on new customers, as well as existing customers as well.

So, I think the primary uptake you there and change to the mix was a number of SmartFlow cannula for example or custom cannulas that were delivered to these labs to perform these preclinical tests prior to, a submission to an FDA for a new protocol..

Okay.

And with your guidance as it relates to the biologics and drug delivery disposable side of the business, is your guidance kind of figuring 1Q, the numbers are fairly stable for the remaining three quarters, as it relates to disposables or is there other kind of variances in there that we should be thinking about?.

Yes. I mean, some of the biologic revenue often comes in sort of buckets similar to capital deals closing. So for example, we might hit a milestone for a development revenue for a project in one corner.

So for example, if we’re making a custom device for one of our partners, we might get a significant milestone payment in one quarter, but then we won’t cross a milestone in the next quarter. So that one would be zero, or vice versa.

So that can be a little bit choppy similarly, these large orders that you can sometimes see for toxicology studies, it could be a $200,000 order because they’re ordering, a 100 catheters or so, and they’re doing all of that testing in the quarter, but the next quarter, it might just be protocol writing, preparing for an FDA submission.

So, as we continue to add partners, I think those numbers will absolutely be stabilized. But for those – for the time being, as we’re still early with some of these new partners, it can be a little choppy quarter-to-quarter..

Okay, great. I got one more on the biologic drug delivery and then one on at DBS. So, I think you touched on this in your prepared comments, but I’m assuming you’re still preparing for a potential commercial launch by the end of this year or early next year for your first drug delivery partner.

And if that’s correct, can you just give us a little color and how the infrastructure readiness is going as it relates to some of the international and domestic needs for the translational services that you intend to offer there?.

Yes. So to answer your first question, yes, we are still in preparation and supporting multiple partners on their first commercial release. I believe PTC set on their earnings call last week that they have delayed the U.S. BLA application by about three months as related to sort of some of the – delays that we’re all experiencing.

But, as I touched on, certainly we, at this point, believe that things are on track for a 2022 commercial release. Sometimes hopefully in the first half of the year is sort of what we’re thinking, but we’re still putting a lot of energy into the preparation of getting ready for that.

And some of that preparation can be identification of potential patients, communication with pharmacy all those different things. And to be clear, these are not things that we do alone, the large – much larger pharma companies that we partner with have teams associated with as well.

And we’re trying to handle as much of the device training and education that we possibly can when necessary.

So, I think that’s kind of one side on the biologic side, and I’m sorry, Andrew, what was the second question, I think?.

No, you answered that, I was actually going to have a DBS follow-up and it just related to where you are in the sleep procedure protocols as far as either your partners running tests, or you have start a clinical trial.

I’m just really curious where you are and getting the sleep procedure label and what the next steps are?.

Yes, I mean, in some ways we’re, it’s sort of twofold, one there’s preparation work that we can do and are doing organizing all of the clinical evidence that supports both awake and sleep procedures. Again, this is early up to the surgeon on how they want to pursue treating an individual patient. So, we support them in either manner.

That being said, we’re also developing the rest of the portfolio that would support these types of procedures as well.

So some of the products that I mentioned in my prepared remarks around MER, around the Array system that can be used in the operating room around the Maestro Brain Model, it’s all of these tools together that are going to create an excellent workflow, both for awake procedures and sleep procedures.

But, as we continue to see, a higher percentage of sleep procedures being done, it’s quickly becoming sort of, I don’t want say the standard of care, but certainly an accepted practice at this point. And as that progresses, I think that helps. As we shared before, we have an indication for MRI guided lead placement.

So, that’s what we particularly do, but because we are not the DBS company itself. We kind of rely on these specific labeling of the DBS companies. And, I think you can see from a number of communications from DBS companies that image guided placement of DBS systems is certainly becoming more and more prominent in the training and education.

And as that continues to evolve, we will certainly be evolving with it..

Okay, great..

To answer one of your question, so at this point, we don’t believe that a clinical trial of any kind would be or at least a prospective clinical trial would necessarily be required to get that sort of indication for some training materials.

We think there’s significant data all the way already out there that shows the safety and efficacy of these procedures..

Right, I remember you talked about that a bit in the last quarter. That’s useful context. Thank you very much for all the color and best of luck on board..

All right. Thank you, Andrew..

Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed with your question..

Hey guys, thanks for taking my questions and congrats on the progress this quarter..

All right, thanks Frank..

Yes. Starting with the FDA clearance of SmartFrame Array, I was hoping you could just take us a little bit deeper on the importance of that SmartFrame. I heard your comments about a little bit of a limited launch throughout this year.

Maybe you could talk to how you anticipate this scaling in further out years, and then just kind of explain the importance of the increased automation and enabling software and how this could more broadly expand your TAM in this area?.

Yes, happy to. As a quick reminder, we currently really do not do any DBS work in Europe or outside of the U.S. and even in the U.S., we have less than 10% market share today of total DBS procedures.

So really what that means is less than 10% of the procedures are done in the MRI, and more than 90% today are still done in the operating room using optical navigation, CT guidance or EM navigation, if that’s something other than the MRI. So, we’ll kind of put it that way.

So really what this tool allows us to do is instead of only focusing our efforts on taking a customer, that’s used to doing an operating room procedure for the past, maybe 20 years, and trying to convince them as an entirely new workflow in the MRI suite.

This is a tool that will allow us to offer them a tool designed for the operating room as well, where we can sit there with that customer. We can say, look, we know, ClearPoint has worked to develop incredible algorithms, navigation tools, very precise movements on our disposable frames. In the past, you could only experience that in the MRI suite.

Now we’ve got something that you can try in the operating room as well. So that’s really the power of what this product is. And again, it’s 95% of the workflow and the navigation steps and the pre-planning and the importation of different data in the fusion.

If that can all be the same between both environments, it becomes much more likely that once our system is in the operating room, that some of the surgeons at that hospital would be willing to give it a try in the MRI suite as well.

So that’s really the, the primary part of the strategy, but from a platform standpoint, it’s crucial to what we want to do, because we don’t want to be known as only MRI company, We want to be the neurosurgery platform company, the therapy enabling company. And this just gives us, I think, a very powerful tool set to do it.

Your second comment was sort of around the scaling of this, as with anything with neurosurgery, we want to be incredibly careful because the stakes are incredibly high. So, we planned on taking kind of, a metered approach as we roll this out first in labs that want to do the procedure and the MRI where we learn.

And we have plenty of experience as well. After that procedures that are in more of a hybrid workflow, where they can actually transition when an interoperative MRI from the operating room to the MRI, with that same patients and our system in place.

And then the final step of that would be to do an operating only procedure where the entire navigation would be done both either bio-optical navigation or CT or something like that.

So there’s a progression in the rollout of this, and we’re going to do it in a, an organized fashion, which allows us to create white papers, to create case reviews, training materials, et cetera, for a more broader rollout early of 2022..

Got it. That makes sense. And then sticking with functional neurosurgery, just wanted to ask in a little bit more depth about the D&K Engineering partnership you guys announced.

Can you talk to exactly what pieces of the procedure you’re looking to roboticize and exactly what this could do for a surgeon, as far as patient throughput or procedural times and how impactful that could be once that’s launched and in a few years?.

Yes. And I’m happy to, so there’s a couple of different phases that we’re sort of rolling out and to be very clear, this is not the most ambitious robotic system that we are not attempting to build the Da Vinci robot for the MRI suite, that’s not the intent here.

It is really the automation of some of the more mundane parts of the procedure that as you pointed out can certainly save some time and save some improved precision and accuracy as well.

So, try not to go into too much detail, but, I know you’ve been following us and you’ve seen the technology, what we’re trying to do is one of the steps of our procedure that delivers our precision is that you make a fine tune adjustment with our thumbwheel, and then you take an additional image and then the image would be taken.

Our software will automatically calculate how much more you need to adjust those turns. And then the surgeon would stand up, walk over to the MRI suite, make those turns and then take another scan. So it’s repetitive process that allows you to continuously get closer and closer and closer to your target, which is how we are so precise.

The reality of what a surgeon experiences is sometimes they have to get up, three or four times for each trajectory and run three or four scans for each trajectory. And each scan could be a minute to two or three minutes as an example.

So, if you add all of those up, we’re probably spending on a simple procedure, maybe 15 minutes to 20 minutes on this navigation steps and a more complicated multi trajectory, drug delivery case. We could be spending an hour to an hour and a half on that particular step. So you enter in the robotics platform and it does a few things for you.

Number one, is that the surgeon doesn’t have to get up anymore to make those adjustments. They can do it from the control room, buy it with a simple push of a button. So that limits a few, annoying parts of the procedures you could say.

The second step and improvement that it makes is that a human being, trying to turn a thumbwheel one eighth of a turn is not going to be quite as precise as a robotics motor that can turn it and exactly the amount.

So, we think the number of times that the surgeon or fellow sort of overestimate the turn or underestimate the turn, we think that’ll be resolved. So there’ll be fewer adjustments that need to be made. And the third step is actually to communicate directly with the scanner itself.

So what that means is that instead of making the adjustments with the robotic system and then manually having to take an additional scan, the computer and the scanner will talk to each other, so that the surgeon will inevitably be able to just simply push a button.

And then, five, 10 minutes later, all of the adjustments and additional scans will already have taken place. So the surgeon will simply have to come back into the room sort of confirm that final trajectory before insertion, and then everything will be lined up.

So there’s kind of a series of phases here that are both hardware on the robotic side and software navigation that are important to the projects. And that’s really where D&K is expertise is. So, they’re sort of a supplement to our existing team to kind of accelerate the program, as we said..

Got it. That makes sense.

And then just the last one for me hopping over to the biologic side, and maybe this has came up on previous calls, but I think it’s worth revisiting, given the approval from PTC is given the near to intermediate term, we’ll call it, one PTC is going through the approval process are they specifically writing into the documentation that the delivery is required to be done? So either a SmartFrame or SmartFlow Cannula or how does the documentation look for a partner’s asset once it’s approved on the market?.

So that’s a good question. I don’t want to go into details on the PTC sort of exact example. I think that’s we want to make sure we’re protecting their documentation and strategy too.

I’m sure if he can ask to, he’d be, he might answer for you, but if I were to speak in generalities, as we look across all of our partnerships and sort of what we expect is going to be commonplace is that, number one, as you pointed out, there’s two parts of our procedure and how are we add value? The first one is the navigation system itself, and I think it’s common that companies will submit a protocol that provides sort of an open-ended part for navigation, where it would come in to say any commercially approved Neuro Navigation System can be used to deliver the device.

Okay? And whether the FDA agrees with that or regulatory bodies agrees with that, in some cases, they might say, yes, that’s appropriate because of the level of precision that you want.

In some cases they might say, we appreciate you on an open label, but you actually, enrolled every single patient in your trial using something like ClearPoint under MRI guidance. So it remains to be seen exactly what decision the FDA makes.

In between, in many of these trials that would certainly benefit us is if the FDA were to say, you can use any MRI guided navigation system, because obviously that’s a less crowded market and one that, we are the kind of the dominant player in today. So that’s one side of the navigation.

On the Cannula side, it’s an incredibly common that as a company goes through the regulatory process, they are doing an extensive number of flow tests and toxicology tests and preclinical testing, bench-top flow rates, infusion rates and everything else you can imagine a lot of these clinical services that we are now offering today.

If you submit that to the FDA, it’s a very common that you would say, we plan and are using the SmartFlow Cannula manufactured by ClearPoint Neuro Irvine, California. And that does get in fact written into the protocol.

And in many cases, that’s the benefit to the pharma company because it allows them to get through the FDA review quicker because the FDA has already seen our cannula so many times and prior protocols that they’ve already reviewed it. And they kind of understand where that fits.

It’s not a surprise or not any new device that they then have to review independently. So, I think that’s the benefit. So, if you think about a co-labeled or co-registered device to the drug itself, I would say that the likelihood that happens with our cannula is, very high and higher than it would be from a navigation standpoint.

But again, nothing has been approved yet. So whatever the company actually puts into the labeling doesn’t necessarily mean that the FDA or the European notified bodies is going to deliver the same information..

Got it. Perfect. Thanks for taking all my questions..

Yes, sure. Thanks..

Our next question comes from the line of [indiscernible] with Ten Times Capital. Please proceed with your question..

Hey, Joe congrats on a great quarter. I think that you’re amazing CEO, the growth pillars you are set up for ClearPoint is to achieve is very well thought out. I’m looking forward to the continued growth our ClearPoint under your leadership..

Thank you..

Yes. Hey, Joe. So during the last earnings call, you pointed out there, you have identified 75 additional potential customers for the biologics and drug delivery growth pillar.

Could you share some updates on the progress on the kind of conversations and what we are doing with them and was the five new biologics partner from these 75 additional potential partners?.

Yes, so thanks for the question. I really appreciate it. And I think it’s an important one.

So, it’s the way that we measure partnerships, I think it’s important to think about, effectively, we said, who is an active customer, who has purchased products and services from us in, recent history let’s say in the last 12 months to 18 months, that sort of thing.

So, we try to keep this common count, but it’s also possible that we have a partner that comes in that only orders, five cannulas to do initial testing. That’s not something we would count as a partner or a customer, because it’s just a tiny little entrance into a relationship.

Similarly, in some cases, a company might acquire that we’re working with might acquire another company. In which case, you have two platforms inside one company, which has happened as well. So, we don’t want to give an exact thing account because we don’t want on a weekly basis be saying, we added two and subtracted one, it gets a little tricky.

So whereas in the past we said 25 active accounts in the first quarter of this year, we crossed that 30 threshold, which is why we sort of updated that number. I think it’s a very fair statement that you made in that these additional five partners would have come from the 75 plus additional targets that we had in our funnel.

So, we plan to continue to add biologics customers to the top part of the funnel, and then continue to convert customers already in the funnel to a formal partnership. After, we at least have some significant agreement or a master services agreement or some something in place that kind of justifies that transition..

All right. Thanks a lot, Joe. And got it. I just want to touch a little on the functional neurosurgery site, so it’s great to see that our cases are rebounding nicely, and we have been successful in attending certain cases via pilot support program.

So, given our current head counts, how many procedures, do you think we are able to do on a yearly basis should COVID-19 gets lifted off? And how would you think remote support program would help to increase the number of cases we can attend to moving forward as well?.

Sure. Yes. I mean, if you simply did the math across our entire team of folks that are either hired or positions that we are openly recruiting for, that math would say that we have the capacity to do, let’s say about 3000 procedures, right? That’s the number that we’re sort of built to do.

And as I mentioned in our forecast, we’re planning on doing about 900 to 1000 this year.

So, we are building excess capacity, not just for a full return to elective procedures after COVID, but also because we are planning on adding these new products to our portfolio, like Array, like MER, like the robotics platform, some of these we’ll expand our presence in an individual hospital into multiple rooms.

So, we’re going to continue to hire sort of ahead of the curve there. The pilot program we’re doing for remote support is designed to solve the couple needs. Number one is, that there are certain situations where we simply – the procedure is a very quick procedure, a biopsy possibly, for example, for a relatively large target.

It’s very common that the surgeons discuss what the need is with our team prior to that surgery taking place. And I think it’s very likely that in some cases the surgeon would say, yes, this is going to be a quick procedure, we actually don’t need the ClearPoint person to be here.

This gives us a chance to cover that remotely and not have to pay the expense of flying someone in some cases, et cetera. So, that’s one reason for the pilot program. The second reason for the pilot program is that in some cases we do get something added on in the last minute.

As I mentioned in our remarks, the last three weeks of March led to a significant increase in case volume. And in some cases we found out about a case the night before.

So in those circumstances, if it’s in a more remote hospital and it’s difficult for us to get to, in that case, we might be able to offer this remote service where to say, sorry, we couldn’t get there in person, it was so less notice, but we – you’re not going to be alone for this procedure if you do need, if it’s a challenging one and you do need some help.

So those are really the things that we can do. The third part that the remote system offers us is the ability to bring new clinical specialists up to speed quickly. So, one of the value propositions of our team is having someone there to help you troubleshoot. And that’s not something you can learn in a textbook.

That’s something where you really need to see cases. You need to see how different surgeons respond to challenges so that you can share other surgical experiences with folks. What this would allow you to do is that instead of only attending actual live cases, you would be able to sort of beam into additional cases for your education too.

So there’s really three reasons that we’re piloting that program and we think it will become a bigger part our future..

Great. Thanks a lot, Joe. So, I just got one last question. I’ve listened to the, one of the podcasts where Jacqueline Keller, our VP of Marketing spoke about how she got to know you and how capable you are as a leader. So, could you just share thoughts about the culture you are building a ClearPoint..

It’s a wonderful question. And thanks for asking. A culture is something that I think, CEO can help put guard rails on, but it’s up to the company to actually build it. It’s not something that you want to be totally top-down money stretch to the imagination. It really has to come from the ground up.

So it really starts with number one, attracting just some of the top talent that you can imagine, people that are self motivated and want to win and share that common purpose. And I think that’s something that I think was already here at MRI interventions before we became ClearPoint. And certainly it will become more prominent as well.

So, I think that’s a very important part of it. And the other one is really an element of trust as well, and understanding, how you can rely on your fellow teammates to come through when you need to and share in that excitement and that that sense of responsibility too.

And I think that the thing that really unites us all is that common purpose that we talk about all the time, which is, we recognize the people we are helping.

The stakes are incredibly high, and these people are truly – these patients are truly suffering, and that’s something that, we absolutely all have in common is that we want to help those people. And we recognize every day that we waste is another patient that we could have helped and maybe didn’t so that’s the common element I would say..

Great. That’s awesome, Joe. Thanks a lot for sharing. I have no doubt that ClearPoint will be the standard go-to option for neurosurgery in the future. It’s a privilege to be your shareholder and we are supporting you all the way. Thank you for all your hard work..

Thank you..

[Operator Instructions] Our next question comes from Michael Lipka with [indiscernible]. Please proceed with your question..

Hey, Joe, it’s good to talk to you again..

Hey Mike..

Hey, I had a question about the general counsel that you had hired is that related to negotiating any kind of royalty agreements? I know you discussed that in the last conference call – sorry.

And then have you done any – have you guys negotiated any royalty or milestone agreements with any of your trial partners?.

Gotcha. It’s a great question. I would say Ellisa, our General Counsel was hired because she’s amazing not just for that, that one topic.

So, while I think she has that expertise and she certainly has a network to call in when we are encountered with something that we haven’t seen before, not just on the device side, but on the pharma side, that’s the type of resourcefulness that she certainly shows. So, I’ve no doubt that we have added that capability here.

To date, I would say we’re still in the exploration phase of exactly what you described, and part of it becomes the type of partner that we’re dealing with, if it’s a customer with a market cap, over $10 billion, maybe even higher, certainly higher than that. They have a different appetite for the spending.

They can provide relative to the development versus the way that they would protect royalties on the other end or milestones. You compare that to many other startup companies that we work with that, have zero revenue has significant funding, but would still like to share the risk in some fashion in which I would say that we’re prepared to do.

So, we’ve certainly had exploratory conversations on these, but, at this point, I wouldn’t point to any substantive agreement that we have in place just yet and put it that way..

Okay.

And then a little bit bigger picture, I wanted to see if you guys have any targets in minds about, let’s say the next two to four years for revenue and EBITDA margins and anything that we could kind of model out?.

Yes. We’re in a tough spot where we’re not quite prepared to do that. I just got over the hump with my board to do guidance or a forecast for this year.

So, I got a work slowly at that, I think we absolutely have our internal budgets, but I think like you see from maybe some of the analyst reports or some of our prior comments, as well as that, we’ve got two ways to look at our business.

The way – one way is to really say let’s, we’ve got a base business, based in navigation where we can continue to place new sites. We can continue to grow utilization a little bit each year. And those things together will continue to grow that base, 15% to 20% over the next five years. Right.

So that’s sort of kind of the known predictable elements of the business itself. But becomes a little trickier is when you have these potentially in much larger revenue driving milestones that can sort of flip a switch and make us move faster.

So the approval of a laser system or the approval of one or two gene-therapy commercial partners or the addition of one or two significant Phase 3 clinical trials or these new products getting approved for MER or biopsy or smart biopsy needles and things like that.

So, we’ve got a number of different things that are a little bit harder to predict exactly when those have and what year, but would certainly add to that sort of basis.

So, without getting into the questions around, when exactly is this going to hit in 2022, and therefore when does that revenue hit? We’re just not – we’re not quite prepared or sophisticated enough from that planning standpoint to understand that timing perfectly..

Okay. And then I guess on EBITDA margins and just overhead costs in general, do you have any like frame of reference for, let’s say if you hit $50 million or $100 million, what we could expect for those.

I’m just trying to figure out as you scale, what is the SG&A look like?.

Yes. I mean, I think of it as a few different buckets. So, number one, the two primary investments that we’re making right now after the infusion of capital, we had in February. Number one is on the product development side of things, both through partnerships like D&K, which you already saw as well as internal hiring.

So, the way we think it is because we brought that extra $46 million into the company and our investors clearly want us to put that capital to use. What we’re doing is we’re almost planning to spend to bring in that that sort of steady state from an R&D standpoint, a couple of years, faster than we would have otherwise.

So instead of waiting and slowly hiring 2021, 2022, 2023, this gives us a chance to hire a bolus of really good people here in the latter half of 2022, and then kind of ride that team for the next few years, so, again accelerating hiring.

And then similarly to do, where we can’t hire the expertise or don’t want to build that capability in house, because it could be massive. We do a deal like with D&K, where we can leverage their company or do a deal like we did with Philips where we don’t have to hire an entire artificial intelligence machine learning team.

We can tap into the Philips team through a joint development effort. So those are the types of things on the development side that we’re investing in. Similarly on the clinical specialist side as we continue to grow and add products, we need to increase our capacity for a couple of reasons.

Number one is, simple case volume, right? You have to do the math and figure out how many cases the clinical can cover in a given year? How do you make sure that there’s extra time left over for PTO and maternity and paternity leaves and things like that. So that’s more of a math problem.

The other one is a development problem as well, as we want to make sure that, as clinical specialists join our team they have a place that they can grow and they’re not expected to sort of be a clinical for 20 years.

So that’s something as well where we’re doing our best to cycle our clinical team and to other functional parts of the company and then replenish that team and some of that case volume with new folks that are very excited to join. But that’s a long-weighted answer to your question, but it’s really meant to show that the capital that we’re using.

We are going to increase our spending here over the next 18 months or so, but it’s not something that kind of lives on forever as far as the speed of that growth. And I think, you start getting into 2023, 2024, and certainly by the time we get to a $50 million revenue ramp, by then, we would certainly be in the block..

Okay..

Michael, one other comment I would make there too, is it’s an important one is again, a big part of our strategy is not try to be in a 1000 hospitals around the world, because we don’t see that as the future of neurosurgery. We see it concentrated into more select centers where patients are willing to travel to, to get these procedures done.

So what that means? Is that where we do need a strong and incredibly talented clinical specialist team, it does not necessarily mean that we need a massive sales organization. So for example, if you’re calling on 100, 150 sites around the world, you certainly don’t need a 100 sales people to do that.

You need a smaller group of organized, competent folks that leverage the clinical team who’s there and is their eyes in the room. So, I think all the money we would save instead of hiring a massive sales team, allows us to reinvest that money either into supporting R&D and clinical specialists or into EBITDA margin..

Okay.

And then the last question I had was about the Maestro, what’s the general purpose of this and, is it to speed up surgery times? And then could you maybe give an example of how it would work in a procedure and what the revenue model or margins might look like on those?.

Yes, I’ll do my best. The one part I can definitely answer is how it works? And what’s it going to do? So I’ll start there.

The Maestro is designed to really be the engine of our navigation system in the future, so instead of really relying on 2D and three-dimensional images that are ported over from the CT scanner or from the MRI side, what we can do is take those images and just make them all much more informative and add applications to it.

So, what I mean by that is, with a push of a button, being able to take a three-dimensional MRI image and turn that into a tool that has all 22 of the subcortical structures already identified sort of defined from a shape and volume standpoint so that the surgeon can actually see what they’re doing in a much more detailed fashion and not having to use their own eyes to figure out exactly where the boundaries of the structures are.

So that’s sort of the base element of what the tool will do.

The applications that we add to that are much more significant, right? So, what we’re able to do for example, is not only highlight the primary structures of the brain, but for example, be able to add the sub nuclei, which are the targets that you would go to from a deep brain stimulation standpoint. This is really what the surgeon is looking for.

This is sometimes difficult to identify on MRI and certainly difficult to identify on CT, being able to automatically find those for you, call out the boundaries and later confirmed that your lead is actually in the subthalamic nucleus as an example, is something that I think will be very beneficial and something that’ll speed up procedures.

One of the other very important aspects and tools that we’re working on is sort of an infusion finder for our drug delivery partners.

So, what I mean by that is it’s incredibly common that when you write the protocols for a gene therapy or a stem cell infusion, you say that your goal is to achieve 50% or 60% or 80% coverage of a particular structure of the brain.

Well, as a surgeon, how are you actually going to calculate that during that procedure and ensure that, you know, you’ve achieved with the protocol demanded? So, what the brain model can do is, not only identify the structure that is your target, but it can provide an envelope around the infusion itself and be able to give you a calculation saying you’re at 21%, you’re at 27%, green light you’re at 60%, you did what you set out to do as a surgeon.

Now you can go ahead and close up that patient and send them home.

So that has so much importance across a number of different reasons, not just for a successful clinical trial, but imagine you have this very expensive gene therapy that you’re commercializing, and you have a patients that did not respond to the treatment, and now you’re talking to an insurance company and trying to figure out, well, how am I going to justify payment for this patient that did respond? How important is it to have a complete patient record that shows your trajectory, the safety of the approach, the tip of the infusion cannula at the target, the complete infusion measured and calculated on the successful close.

The surgeon, you can then show that exactly all of that detail to anyone who wants to know and say, look, I did everything I possibly could for this patient, so that the documentation that the brain model can offer, there’s another incredibly significant part of our strategy..

Right? It makes sense.

So then on the revenue model, is it, well – I guess, is this something that’s running throughout the entire procedure or are there kind of like stop points where it runs a scan?.

There would be – it depends on certain use cases, but which I think, as far as I know unique about our system and what it’s designed to do is the speed of which the calculation takes place.

There are similar Atlas type technologies that can certainly be used and can identify box souls and create boundaries, but those are commonly require much larger, more powerful computers.

And in many cases they can take eight, 10, 12, 15 minutes for each calculation and assess that if that’s the case, it obviously is not really a peri-procedural tool that could be used during the case. It would just be taking too long.

We think we can get these calculations down into the sub 15, maybe sub 22 range, in which case, now, every time you run a scan with ClearPoint, you could be plugging it into the model and the model could be adjusting as well.

So those are the types of things, but like I said, it depends on the used case for a pharmaceutical drug delivery infusions that’s something you absolutely want to continue to update during the procedure for something like a DBS procedure where everything is static the whole time, it really doesn’t make sense to constantly do the updates you really just want to do kind of a pre and post for the confirmation standpoint..

Okay.

And then would this just be like an added fee to the total procedure revenue?.

Yes, there’s a number of – so it could be a combination of capital and sort of single-use software or it could be an addition to the ASP of the disposables used in the procedure, or in there’s some situations, so imagine a pharmaceutical trial, and you’re trying to track an individual patient over time to see how they’re responding to drugs and forget about surgery, for example, for a second, this is just a drug based therapy to treat a patient with traumatic brain injury or whatever it happens to be, having a brain model that can calculate everything the exact same way on that same patient longitudinally to show change caused by the drug or the placebo.

That’s another way it could be used where it might not necessarily have our disposable in that particular element. So there’s a number of different ways and different circumstances where we think this tool can be used. And then the commercial model might change based on what it is we’re trying to accomplish..

All right. Great. I’ll hop off. Thanks so much for answering my question..

Thank you, Mike..

Ladies and gentlemen, we have reached the end of our question-and-answer session. And now I’d like to turn the call back over to Mr. Burnett for any closing remarks..

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

This concludes today’s teleconference. You may now disconnect your lines at this time. Thank you for your participation. And have a wonderful day..