Greetings, and welcome to the ClearPoint Neuro Fourth Quarter and Full Year 2022 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 call 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; the size of total addressable markets or the market opportunity for the company's products and services 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, 2021, and the company's quarterly report on Form 10-Q for the 3 months ended September 30, 2022, both of which have been filed with the Securities and Exchange Commission and the company's annual report on Form 10-K for the year ended December 31, 2022, which the company intends to file with the Securities and Exchange Commission on or before March 31, 2023.

All of the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. I will now turn the call over to Joe Burnett, Chief Executive Officer..

Thank you, Maria, 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 fourth quarter and full year 2022 we have continued to make progress across our four pillar growth strategy, including biologics and drug delivery, functional neurosurgery navigation, therapy and access products and in achieving global scale.

We are excited to continue this momentum into 2023, where we again expect more than 20% growth and further progress in all four of those same growth pillars.

I will now turn the call over to Danilo D’Alessandro, our CFO, to review our financial performance in the fourth quarter and full year 2022, after which I will add some additional detail to our four pillar growth strategy moving forward.

Danilo?.

functional neurosurgery navigation and therapy, biologics and 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 intended target.

This revenue segment increased 13% to $9.1 million for the year 2022, up from $8.1 million in 2021. Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products.

Biologics and drug delivery revenue increased 34% to $9.1 million in 2022, up from $6.8 million in 2021. This increase was due to both an increase in commitments by our current partners and new pharmaceutical partners.

Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services was $2.3 million for the year 2022, a 61% increase compared to 2021. Gross margin for the full year 2022 was 66% compared to 68% in 2021.

This decrease was due primarily to an increase in indirect labor costs in 2022 as compared to 2021 as well as an increase in excess and obsolete inventory reserves. Research and development costs were $10.9 million for the year 2022 compared to $9.3 million in 2021, an increase of $1.6 million or 17%.

The increase was due primarily to increases in personnel costs, including share-based compensation expense of $1.4 million due to growth in headcount and a $0.1million increase in regulatory fees. Sales and marketing expenses were $9.4 million for the year 2022 compared to $7.2 million in 2021, an increase of $2.1 million or 30%.

This increase was primarily due to increases in personnel costs, including share-based compensation expense of $1.5 million, resulting from increase in headcount in our clinical and marketing teams, increases in travel expenses of $0.3 million and increases in marketing activities of $0.2 million.

General and administrative expenses were $9.6 million for the year 2022 compared to $8 million in 2021, an increase of $1.6 million or 20%.

This increase was due primarily to increases in personnel costs and share-based compensation of $1.5 million; IT costs of $0.3 million, insurance costs of $0.2 million, offset by a decrease in bad debt expense of $0.3 million.

Net interest expense for the year 2022 was $0.1 million compared to $1 million in 2021 due to the conversion into equity of two tranches of convertible debt in May 2021 and November 2021.

Additionally, interest expense was partially offset by higher interest income in 2022 as a result of the increasing interest rates and the company's investment in U.S. government debt securities. I will now turn to the fourth quarter 2022 results.

Total revenues were $5.2 million for the 3 months ended December 31, 2022, an increase of 21% over $4.3 million in the fourth quarter of 2021. Functional neurosurgery and therapy revenue increased 7% to $2.3 million for the fourth quarter of 2022 from $2.1 million for the same period in 2021.

Biologics and drug delivery revenue increased 37% to $2.3 million in the fourth quarter of 2022 from $1.7 million in the same period in 2021. The increase was predominantly due to a 79% increase in biologics and drug delivery service revenue partially offset by a slight decrease in product revenue.

Capital equipment product and related service revenue increased 25% to $0.6 million for the fourth quarter of 2022, as compared with $0.5 million in the same period of 2021 due to an increase in the placement of ClearPoint Capital and software.

Gross margin was 64% for the fourth quarter of 2022 compared to a gross margin of 77% for the fourth -- for the same period in 2021. The decrease in gross margin was due primarily to higher overhead expenses and inventory reserves.

Operating expenses for the fourth quarter of 2022 were $7.8 million compared to $7.3 million for the fourth quarter of 2021. The increase was mainly driven by the increase in headcount across the organization and share-based compensation.

The fourth quarter operating expenses include a onetime year-to-date reclassification of $1.9 million to classify share-based compensation in the same income statement line items as the cash compensation paid to those employees rather than in general and administrative expense.

With respect to our cash position at the end of December 2022, we held cash, cash equivalents and short-term investment balances of $37.5 million compared to $54.1 million at the end of 2021. Our cash decrease resulted primarily from our operating cash needs.

Net cash flows used in operating activities for the year ended 2022 were $16.2 million, an increase of $3.5 million from the year ended 2021. The increase in operating cash need was primarily driven by $4.4 million in additional inventory purchases to mitigate any risk to our supply chain.

In the fourth quarter, our cash burn was approximately $3 million, the lowest quarterly cash burn since Q1 2021. I'd like to turn the call back to Joe..

Thanks, Danilo. 2022 was a successful year for our team across our four pillar growth strategy, which has remained in place for the past 5 years and headlined by record revenue of $20.6 million and 26% growth.

Over the past 2 years, we have solidified our leadership team with amazing hires and operations, finance, legal, quality, regulatory, preclinical and clinical research using the funds available from our capital raise back in early2021.

We now have the foundation to drive scale and productivity with the expectation that sales will start to outpace expense growth in the years ahead. Now let's break that progress down into our four growth pillars. First, our biologics and drug delivery team continued to add new pharma partners and services throughout 2022.

At present, we currently have more than 50 active partners in this space and have been able to maintain the pace of approximately one new partner added each month. We continue to expect that biologics and drug delivery will be one of our fastest-growing segments as we have prepared for growth along three major axes.

First, we will continue to add new partners in 2023 as we have not yet achieved even 50% of the partnerships where we believe our technology can help their platform. Second, we continue to add new services, expanding the menu of available projects that our team has the capability to provide to these partners.

And third, we expect the majority of our partners to continue to progress through the regulatory pathway from bench to preclinical and eventually clinical trial and commercialization. At present, we do expect the initiation of multiple clinical trials through our partnerships this calendar year.

Now as a reminder, if one partner were to use ClearPoint for our entire portfolio of products and services, that represents approximately an $8 million to $10 million in revenue potential over a 5-year period.

Multiply that opportunity times our 50 plus partners and that is potentially a few hundred million in addressable market before any drug product is even commercialized. This is a primary driver as to why we feel our company can achieve cash breakeven without the requirement of any meaningful revenue from approved and commercialized drugs.

Speaking of commercialization, our team achieved a very significant milestone in 2022 in the co-labeling in Europe for our SmartFlow cannula with the very first neuro gene therapy approved anywhere in the world Upstaza made by PTC Therapeutics.

The approved labeling of this drug includes the requirement of using our cannula when dosing patients and is the result of robust preclinical and clinical testing data that continues to be collected today.

While commercialization of other drugs will take some time, I cannot stress the importance and the potential if many, if not all, of our partners eventually achieve regulatory clearance with similar co-labeling with our devices. For our second pillar of growth, let's now turn to functional neurosurgery navigation.

Many of the challenges we saw in 2020 and 2021 persisted into 2022, contributing to an elevated cancellation and postponement rate for elective procedures, including flu and COVID infections, staffing shortages and supply chain issues contributing to equipment back orders and delayed repairs.

Now while we invested in additional inventory and did not experience any substantial supply shortages, we are still only the navigation portion of the procedure and a backorder for another company's therapy product can also contribute to a cancellation for a ClearPoint procedure.

That being said, we still see strong demand for our navigation products where we placed a record 11 new systems in 2022. In fact, here in 2023, we have already installed three systems year-to-date and believe we will place a total of at least 10 systems this calendar year keeping us on track to achieve 100 systems by 2025.

And when we do perform an installation, new sites are getting a much more advanced solution in 2023 as we achieved multiple FDA clearances for new hardware and software, including ClearPoint version 2.2 software, Array version 1.1 software, Maestro segmentation tools, inflection head frames and more.

A first experience with ClearPoint today is very different than years ago. The ability to accelerate to two procedures a day is driving our surgical efficiency faster than ever.

We expect additional submissions and potential clearances this year in 2023 and believe with the size of our software and data scientist teams that we can deliver a cadence of at least one new software release each year for the foreseeable future.

We also expect FDA submission in 2023 for two additional hardware offerings, including our Orchestra Head Fixation Frame and the Smart Brain Cortex, which will be used for the implantation of brain computer interfaces to the cortical surface of the brain, primarily in clinical trial.

For pillar #3, therapy and access devices, we achieved a major milestone in 2022 with the FDA clearance of the Prism Laser Therapy System marking the first therapy product in our portfolio. Initial experience with Prism has been positive with early cases now performed in the United States and in Europe.

We expect to remain in a limited market release with relatively modest revenue in 2023, while we continue to gain experience with the product and prepare marketing and training materials to highlight the advantages of the Prism Laser System.

We then expect to move to a full market release in 2024 after receiving FDA clearance for the 1.5 Tesla scanner labeling to our product. Finally, our fourth pillar of growth, achieving global scale, has made great progress as well.

As previously mentioned, we have signed a lease for a new 20,000 square foot manufacturing and development facility in Carlsbad, California, where we expect to be fully operational and producing product by the end of 2023.

This facility will serve as a product showcase for pharma partners, will be designed for improved product and manufacturing flow and eventually margin improvements in the years ahead.

We believe the capacity of the site will support the next 5 to 10 years of growth from a production standpoint in addition to adding new testing and preclinical services to support our 50 plus pharma partners. Our expansion outside the United States has continued with a total of 10 OUS sites now installed and ready to do cases.

In 2023, we expect between 50 and 100 cases will be performed in non-U.S. hospitals, which again is crucial for winning contracts with pharma partners outside the U.S. that want to run clinical trials on their home field.

For 2023, we continue to expect revenue in the range of $25 million to $27 million for the year, representing growth between 21% and 31% year-over-year.

Revenue in Q1 will likely be in the range of $5 million to $5.5million and subsequent quarters growing more rapidly based on our capital sales pipeline, laser therapy revenue and timing of preclinical services, which are going to contribute more in the second half of 2023.

From a cash standpoint, Danilo mentioned, we ended the year at $37.5 million in cash and short-term investments.

Based on our current projections, we expect our operational cash burn in 2023 to improve slightly compared to 2022 as we see an inflection point more in 2024, where revenue will outpace expenses and our new manufacturing facility will be up and running.

In the near-term, similar to 2022, we expect a comparable cash flow seasonality and of a larger cash burn in the first half of 2023 when one-time annual expenses like bonuses, corporate fees and insurance are paid, followed by a slower cash burn in the second half of 2023.

As we look at timing for what cash breakeven looks like for the company, we have run a number of scenarios. Based on our current projections, we feel that as a company, we can achieve cash breakeven when we get to the milestone of 50 hospitals each doing 50 cases a year or on average, one case per week at these 50 centers of excellence.

This combined with capital sales and service assumption at those 50 hospitals, and modest growth in our preclinical services would deliver approximately $50million in revenue and support operational cash breakeven.

The good news is that we are already installed at approximately 70 centers around the world and will add approximately 10 additional this year so that we have the installed base to support this next phase as our portfolio fills out.

At a single hospital, if we can get 30 DBS cases a year, 15 laser cases a year and 5 biologics and drug delivery clinical trial patients each year, then that is a credible path to the volume we need to achieve.

Again, this would require only one day a week of MRI or operating room time, which is reasonable and can be supported by the portfolio of products that we certain to have -- certain -- that we expect to have available by 2025.

Our internal projections and expectations support us achieving an operational cash breakeven by the fourth quarter of 2025 and a full year cash breakeven in 2026 if our strategy holds and barring any significant disruptions to patient demand, inorganic investments or delays to our planned product launches.

We believe to have line of sight to this milestone and importantly, don't need massive patient demand increases or even commercial approval of large gene and cell therapy indications in that time frame. With that, I would like to open up the call to any questions that you might have..

[Operator Instructions] Our first question is from Frank Takkinen with Lake Street Capital Markets. Please proceed with your question..

Perfect. Thanks. Hey, I wanted to start with one on the comment about multiple clinical trials likely to launch at some point this year.

Maybe talk a little bit more through those and how it relates to the total revenue potential of a partner in what stage those clinical trials may be in, and how that could affect the model as we look at 2023?.

Sure. Yes. Thanks for the question, Frank. Yes, so if you think about 2023 and some of the trials that our partners have communicated the schedules for to us and again, we are going to keep who the partners are confidential, just to make sure we are respecting our agreements that we have.

But what I can tell you is that some of these trials will start -- will continue, I would say, in the rare childhood genetic range of things, which as we've seen with our partner, PTC, often requires a less rigorous clinical trial protocol, meaning that you can follow a BLA process and submit data without necessarily a pivotal study or a randomized [indiscernible] controlled study or something like that.

So we do expect some of those to start here in 2023. However, we also expect the initiation of much larger potential indications for studies like Parkinson's disease and more adult disorders, which will include a longer clinical trial pathway. However, it will also include a larger number of patients that need to be enrolled to show that.

I think as we've discussed in the past, some of the Phase II and Phase III trial design that we've seen in the past to show full efficacy and be required by the FDA, could include as many as 200 patients in those trials. And in some of these particular studies, we can contribute anywhere from $10,000 to even $20,000 or more per patient.

So an individual clinical trial that's probably run over a couple of years, could contribute anywhere from $2 million to $4 million just with one of those pivotal trials. So we do expect the initiation of hopefully a couple of those larger indications to happen sometime in 2023..

And as a follow-up directly to that, how much of that is baked into the guide right now where would one of those trials kicking off in 2023 be upside to the guidance?.

I would say that we’ve very little in the guidance at this point. I mean our guidance is a range, right? So we've said $25 million to $27 million. So I would say the high-end of the range would include more patients being enrolled. But at the low end of the range, I'd say it's very small.

It's almost like the assumption that a few patients will be enrolled by the end of the year for some of these trials. So it's really not meaningful and does present some upside..

Okay. That's helpful. And then I wanted to shift over to the laser.

Curious how many centers you have tested that laser in the initial commercial launch at this point? And how has the feedback been versus the competing lasers on the market?.

Yes. would say the feedback has been very strong. Most of the patients that have been enrolled -- I don't want to say enrolled so far that have been treated so far have been done in a clinical trial protocol in Europe and this has been focused primarily on tumor patients or really exclusively on tumor patients today.

Those cases that have been performed there, the device has performed exceptionally well. We are very, very pleased with the results.

And as I said in my statements, we are using this time to sort of prepare additional training and marketing materials because there are some meaningful differences between the products currently on the market and what Prism has to offer.

In the United States, we've done cases at one center so far in the United States, and we are in the process of installing at multiple additional centers as well.

Similar to some of the things that we've talked about in the past, any time you're bringing a new piece of hardware and software into a hospital today, the sort of delays, which aren't even delays anymore, they're becoming expected of getting a new technology approved through IT at a hospital, has just been more complicated than it's ever been before.

And those teams don't always meet on a weekly basis, sometimes it's only a monthly basis. So that's something that's -- the pace of installation has been a little slower than we expect, but it's not because people are not interested in trying the product.

It's really just going through the hurdles that are a necessary part of getting a new technology into a hospital in 2023..

Okay. And then last one for me. It sounded like at the end of 2022 there in the last couple of weeks of 2022, there were some cancellations or postponements at least to 2023.

Any update on those?.

Yes, I mean I think the biggest drivers of that, I would say, the most substantial ones were in a couple of buckets. The biggest one just being the timing of some of the preclinical services and the way that we recognize revenue. You noticed in Q4, as Danilo mentioned, our cash burn was only $3 million.

And part of the contributor to that is some of our pharma partners that are effectively prepaying for services because they do understand the risk and time lines of certain services being ready. We can't perform a certain test, for example, if we don't get the drug delivered to us.

So what we have asked and been successful in asking is that the pharma partners can provide some of the cash up front. So even if there is a delay, we are not losing our time and energy on it. From a revenue standpoint, however, that means we don't always recognize the revenue.

And I think that’s some of the -- those were the primary delays that we saw in Q4 of last year. And just honestly, it's going to be a part of normal. The plan that we have is that across 50 different partners and a number of different programs that there will be some delays.

However, there's enough shots on goal in any given quarter that will perform the services to keep the revenue growing. So I think that was one of the primary contributors is -- and it's something that there's nothing I would say that we lost in 2022 that we don't expect to regain in 2023. So it really is a timing issue.

The other side of the equation is that there were some definite postponements and high cancellation rates, especially around the last few weeks of December, which contributed probably to another $100,000 to $150,000 of case postponements. Again, as we've shared in the past, some of the -- there's good and bad parts of that.

The good part is that it's very rare that a case is canceled outright. It's normally postponed, whether if patient is sick or a surgeon is sick or there's a temporary insurance denial that gets sorted out with a new letter from the doctor or something like that. So the good news is that these patients still have a chance to get treated.

The challenging part for our current model is that just because it's postponed, it doesn't necessarily mean that there's more MRI access time in the future. So if you still only have that one slot, it takes a little time to recoup and get that patient scheduled.

So as we've discussed in the past, a big part of our strategy is evolving out of the MRI and into the operating room which will allow us to recoup some of these postponements faster because we will have two different arenas in which we can treat that patient..

Got it. Okay. That’s helpful. I will stop there. Thanks for taking the questions and congrats on all the progress..

Thanks, Frank..

[Operator Instructions] Our next question comes from Neil Chatterji with B. Riley Securities. Please proceed with your question..

Hey, guys. Good afternoon and thanks for taking the questions..

Thanks, Neil..

Maybe on that topic on the cancellations and postponements. Just if I missed it there, on what you said, but in terms of just the level or the rates, I think it was recently as high as like say, 30% versus that 8% to 12% historically.

So where is that kind of sitting currently?.

Yes. So the data that we have is we are currently in that 25% to 28% range. I would say if you look back the last rolling 6 months, give or take, and you compare that to a historical number that we had prior to COVID, the COVID initiation, let's call it, that number was in the 10% to 15% range.

So effectively, since COVID has come about, for whatever the reason of the cancellations, the impact has totally been pretty much double the cancellation and postponement rate. And we're still seeing some of that persist here in 2023 as well. But that's that was kind of expected and part of our plan.

If you think about the guidance that we provided of $25 million to $27million, that includes the expectation that this cancellation rate of above 20% is going to persist as well..

Got it. That’s helpful color. Great. And then in terms of the -- just on the BDD side, in terms of just conversations with potential new partners, just curious how the success to date you've had with the PTC's partnership.

Has that helped kind of create the wheels in some of those conversations?.

I think it definitely has. Again, one of the big advantages that we can provide to a pharma partner is the experience with our products being both the navigation and doing these procedures under live MRI guidance, which we certainly believe is the most precise and accurate way to do it.

But also the experience that the FDA has with our array of different cannula and drug delivery tools.

And if you -- again, if you're a pharma partner and if you have a chance to get in front of the FDA to present your protocol, I can tell you, in our experience, things go a lot smoother when you're using the SmartFlow cannula because the FDA reviewer can say, Oh, yes, I've approved ClearPoint SmartFlow before I understand this device, it's not simple, but check let's move on to the next question as opposed to that same pharma company having to say, well, wait a second.

This thing is not FDA cleared. We don't have any experience. We've never approved a protocol with this device used before. If we -- as a company can help save 3 months or 6 months of negotiation with the FDA that's real time and real money to a pharma partner.

And I think that's one of the primary reasons they continue to come and work with us in addition to all the clinical services and things that we provide. And to answer your question, the fact that PTC has now been successful in getting a drug approved in Europe, and it's approved as a combination device.

That is definitely another feather that we can put in our hat to say, Hey, we are the one device that's been able to navigate one of these regulatory pathways. And if it can happen here in the United States under FDA clearance as well, I think that will be another significant milestone and very significant marketing tool that we will be able to use..

Got it. Great. Thanks for that. And then just one question on just in terms of the guidance for '23. Just kind of curious if there's any way to add any color in terms of just parsing out the different segments.

So how do we think about the growth for BDD, functional neuro, and capital software in '23?.

Yes, it's interesting. There's a lot of moving parts on timing and things like that. But when we look at our model and what gave us confidence in providing that range, it really includes all three of those different buckets that Danilo presented experiencing growth.

So if you think biologics and drug delivery, as far as a magnitude of gross dollars, don't think about a percentage but an actual growth, magnitude, we do expect that to be the largest growth contributor based on POs that we've already received and capabilities that we can now offer. So I think that will still be the highlight one.

However, we also do expect our functional neurosurgery and therapy business as well as our capital business to certainly grow in that 15% to 20% plus range as well. So we do expect all three buckets to be contributing to growth this year..

Great. And -- just one last question for me.

So just curious if you could just kind of talk a little bit about your international expansion plans and just any updates for Europe or China?.

Yes. So I mentioned that we've placed three additional systems so far this year in 2023. Actually, all three of those happen to be OUS. So two of those were placed in Europe. One was placed in Brazil, so our very first installation in South America.

And we believe this is an important part now if we were just a neuro navigation company or even a laser therapy company, Brazil is probably not the first country we would go to, for example, right? It's a massive population, but certainly a long ways away from where we are today.

The support that we get from companies like PTC that have large drug potential sales opportunities in countries like Brazil and Singapore, Taiwan, a bunch of different countries, that is really helping fuel the acceleration and how quickly we would go maybe where if we were just a device company, we'd probably go a little bit slower.

So it's doing two things worth. One, it is getting us experience in these new geographies, and that helps drive some of the device business as well because even if we get approval with the goal of treating patients with one of our pharma partners, we're very, very clear that a complicated gene therapy infusion case should not be your first case.

So what commonly happens is we say, yes, we're going to do that eventually, but we're going to start on some simple biopsies, DBS [ph] procedures, maybe some laser procedures as well to get familiar with the overall system and prepare for these trials down the road. So we get that benefit.

Secondarily, we get the benefit of putting up additional sort of walls and moats around our company and around our technology. It's very hard to get approval for a cannula, for example, in the United States. It's very hard to get it approved in Europe as well.

Many companies that would maybe compete with us in the future might even just stop at those two locations.

But if we can actually have approval for our devices in a number of different geographies, that's just one more reason that a pharma company should be working with us because we can actually cover a much broader population of the world, which is honestly more how pharma companies think than device companies. So again, it's a little expensive.

It's contributed to some of our cash burn during this regulatory work, et cetera. However, again, it's just like know-how and team hiring and IT investment, this regulatory and quality investment is something that we think is going to protect us in the future..

Great. Again, congrats on the quarter, and that’s it for me..

Okay. Thank you, Neil..

There are no further questions at this time. I would now like to turn the floor back over to Joe Burnett for closing comments..

Thank you, Maria. And once again, thank you to everyone interested in being a part of this team's journey here at ClearPoint.

We recognize the challenging global environment that we are all forced to live in today, and we assure you that we are going to help patients around the world as best as we possibly can by keeping our heads down, staying focused and executing against our four pillar growth strategy to develop products that truly improve the quality of life for our patients and their families.

Hope you all have a great night. Good bye..

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