Q2 2024 ClearPoint Neuro Inc Earnings Call

Speaker Change: Greetings and welcome to the Clearpoint Neuro Inc. second quarter 2024 financial results conference call.

Operator: 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. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad.

Speaker Change: At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.

Operator: 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, the size of the total addressable markets or the market opportunity for the company's products and services, and management's expectations, beliefs, estimates, or projections regarding future revenue, results of operations, or the adequacy of cash and cash-equivalent balances to support operations and new future obligations However, actual results or trends could differ materially.

Speaker Change: Comments made on this call may include statements that are forward-looking within the meaning of securities laws.

Speaker Change: These forward-looking statements may include, without limitation, statements related to anticipated industry trends.

Speaker Change: the company's plans, prospects, and strategies.

Speaker Change: Both preliminary and projected. The size of the total addressable markets or the market opportunity for the company's products and services.

Speaker Change: and Management's Expectations, Beliefs, Estimates, or Projections regarding Future Revenue, Results of Operations, or the Adequacy of Cash and Cash-Equivalent Balances to Support Operations and Meet Future Obligations. Actual results or trends could differ materially.

Operator: 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, 2023, and the company's quarterly report on Form 10-Q for the three months ended March 31, 2024, both of which have been filed with the Securities and Exchange Commission, and the company's quarterly report on Form 10-Q for the three months ended June 30, 2024, which the company intends to file with the SEC on or before August 14, 2024. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. And it is now my pleasure to introduce your host, Joe Burnett, Chief Executive Officer. Thank you, Joe. You may begin.

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

Speaker Change: For more information, please refer to the company's annual report on Form 10-K for the year ended December 31st.

Speaker Change: 2023, and the company's quarterly report on Form 10-Q for the three months ended March 31,

Speaker Change: 2024, both of which have been filed with the Securities and Exchange Commission, and the company's quarterly report on Form 10-Q for the three months ended June 30, 2024, which the company intends to file with the Securities and Exchange Commission on or before August 14, 2024.

Speaker Change: All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com

Joseph Burnett: Thank you, Morgan. And thank you to all of the investors and analysts on today's call for being a part of the Clearpoint Neuro 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 second quarter of 2024, the entire Clearpoint Neuro team contributed to a record revenue quarter of $7.9 million, and in our view, the strongest financial and strategic performance in our history.

Speaker Change: And it is now my pleasure to introduce your host, Joe Burnett, Chief Executive Officer. Thank you, Joe. You may begin.

Joe Burnett: Thank you, Morgan, and thank you to all of the investors and analysts on today's call for being a part of the Clearpoint Neuro 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.

Joe Burnett: In the second quarter of 2024, the entire Clearpoint Neuro team contributed to a record revenue quarter of $7.9 million, and in our view, the strongest financial and strategic performance in our history.

Joe Burnett: We made significant progress across all four of our growth pillars, including number one, biologics and drug delivery, number two, neurosurgery navigation, number three, therapy and access products, and number four, in achieving global scale.

Joseph Burnett: We made significant progress across all four of our growth pillars, including number one, biologics and drug delivery, number two, neurosurgery navigation, number three, therapy and access products, and number four, achieving global scale. Before we get started, I would like to frame the call by reminding everyone a bit about our history and why these four individual growth pillars are important. When we started our journey, our journey here at Clearpoint, we were reliant on just one of these four pillars, which was neurosurgery navigation. We were an MRI navigation company focused on guiding the placement of deep brain stimulation leads, and that was about it. As leaders, we're always looking for the best analogy to help tell our story.

Joe Burnett: Before we get started, I would like to frame the call by reminding everyone a bit about our history and why these four individual growth pillars are important.

Joe Burnett: When we started our journey here at Clearpoint, we were reliant on just one of these four pillars, which was neurosurgery navigation.

Joe Burnett: We were an MRI navigation company focused on guiding placement of deep brain stimulation leads, and that was about it.

Joe Burnett: As leaders, we're always looking for that best analogy to help tell our story.

Joseph Burnett: Instead of pillars, maybe we should think about a growth engine. And back four years ago, we were essentially a one-cylinder engine. If that cylinder or piston was firing, then we were on the move. But if anything happened to that one cylinder, we were stopped in our tracks, as we saw at times in our history with COVID case cancellations and limited MRI access. As a team, we set out to improve the performance of this engine.

Joe Burnett: Instead of pillars, maybe we should think about a growth engine. And back four years ago, we were essentially a one-cylinder engine. If that cylinder or piston was firing, then we were on the move.

Joe Burnett: If anything happened to that one cylinder, we were stopped in our tracks, as we saw at times in our history with COVID case cancellations and limited MRI access.

Joseph Burnett: We invested first in catheter and cannula technology to focus on products for clinical trials sold directly to pharmaceutical partners. We added preclinical services to incorporate our technology into the drug discovery process and to build relationships with pharmaceutical companies well in advance of those first patients being treated. We added laser therapy to control larger portions of the procedure and offer not only surgical navigation but also the therapy itself. However, we realized that MRI access can be a barrier at some hospitals.

Joe Burnett: As a team, we set out to improve the performance of this engine. We invested first in catheter and cannula technology to focus on products for clinical trials sold directly to pharmaceutical partners.

Joe Burnett: We added preclinical services to incorporate our technology into the drug discovery process and to build relationships with pharmaceutical companies well in advance of those first patients being treated.

Joe Burnett: We added laser therapy to control larger portions of the procedure and offer not only the surgical navigation, but also the therapy itself.

Joseph Burnett: So we added technology to enable our platform to work not only in the MRI but also in the operating room using CT as the primary imaging tool. We partnered with technology companies to build out unique software and artificial intelligence modeling capabilities to aid in precisely delivering therapeutics and also grow our installed base. We invested in regulatory submissions to expand access to our technology beyond the United States by growing into the European Union, Asia Pacific, and other countries to further support the growing cell and gene therapy market.

Joe Burnett: We realized that MRI access can be a barrier at some hospitals, so we added technology to enable our platform to work not only in the MRI, but also in the operating room using CT as the primary imaging tool.

Joe Burnett: We've partnered with technology companies to build out unique software and artificial intelligence modeling capabilities to aid in precisely delivering therapeutics and also grow our installed base.

Joe Burnett: We invested in regulatory submissions to expand access to our technology beyond the United States by growing into the European Union, Asia Pacific, and other countries to further support the growing cell and gene therapy market.

Joseph Burnett: We now feel that we have successfully added additional cylinders to our company's growth engine, as our year-to-date 2024 results show. The expansion and increased depth of our products and services portfolio will not only help us accelerate our growth but also allow us to diversify our revenue streams and reach more patients. We are no longer that one-cylinder engine but rather a multi-cylinder engine that is ready for the next stage of our journey.

Joe Burnett: We now feel that we have successfully added additional cylinders to our company's growth engine, as our year-to-date 2024 results show.

Speaker Change: The expansion and increased depth of our products and services portfolio will not only help us accelerate our growth, but also allow us to diversify our revenue streams and reach more patients. We are no longer that one-cylinder engine, but rather a multi-cylinder engine that is ready for the next stage of our journey.

Joseph Burnett: What we have seen here in the second quarter has been the start of that next phase of Clearpoint, where we are now seeing the contribution of all of these cylinders starting to ramp up and propel us forward. 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 and expectations for the second half of 2024. Danilo? Thank you, Jeff.

Speaker Change: What we have seen here in the second quarter has been the start of that next phase of Clearpoint, where we are now seeing the contribution of all of these cylinders starting to ramp up and to propel us forward.

Speaker Change: 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 and expectations for the second half of 2024. Danilo? Danilo?

Danilo DAlessandro: Thank you, Joe. And good afternoon, everyone.

Danilo DAlessandro: Looking at the second quarter 2024 results, total revenue was $7.9 million for the three months ended June 30, 2024, and $6 million for the three months ended June 30, 2023, which represents 32% growth versus the second quarter of 2022. As a reminder, our revenue is made up of three components, biologics and drug delivery, neurosurgery, navigation, and therapy, and capital equipment and software. 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 28 percent to $4.3 million in the second quarter, up from $3.4 million in 2023.

Danilo: Thank you, Joe, and good afternoon, everyone.

Danilo DAlessandro: This increase was fueled by $1.3 million, or a 383 percent increase in biologics and drug delivery product revenue as multiple pharmaceutical customers progress in their preclinical and clinical development. The biologics and drug delivery growth was partially offset by a $0.4 million decrease in service revenue. Neurosurgery Navigation Revenue consists of commercial sales of disposable products related to cases utilizing the Clearpoint system, the PRISM laser system, or Smart Frame OR.

Danilo: Looking at the second quarter 2024 results, total revenue was $7.9 million for the three months ended June 30th, 2024, and $6 million for the three months ended June 30th, 2023, which represents 32% growth versus the second quarter of 2023.

Speaker Change: As a reminder, our revenue is made up of three components, biologics and drug delivery, neurosurgery, navigation and therapy, and capital equipment and software.

Speaker Change: Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products.

Speaker Change: Biologics and drug delivery revenue increased 28% to $4.3 million in the second quarter, up from $3.4 million in 2023.

Speaker Change: This increase was fueled by $1.3 million, or 383% increase in biologics and drug delivery product revenue, as multiple pharmaceutical customers progress in their preclinical and clinical development.

Speaker Change: The biologics and drug delivery growth was partially set by a $0.4 million decrease in service revenue.

Speaker Change: Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the Clearpoint system, the PRISM laser system, or SmartFrame OR.

Danilo DAlessandro: This revenue segment increased 17% to $2.6 million for the second quarter of 2024. The revenue growth is primarily attributable to our new product offerings and our recent acquisition. Capital equipment and software revenue consisting of sales of Clearpoint reusable hardware and software and related services increased 148% to $0.9 million in the quarter from $0.4 million for the same period in 2023 due to an increase in the placement of Clearpoint navigation hardware and software and prism laser units. Gross margin for the second quarter of 2024 was 63% as compared to a gross margin of 53% for the second quarter of 2023.

Speaker Change: This revenue segment increases 17% to $2.6 million for the second quarter of 2024. The revenue growth is primarily attributable to our new product offerings and our new recent placements.

Speaker Change: Capital equipment and software revenue consisting of sales of Clearpoint reusable hardware and software and of related services increased 148% to $0.9 million in the quarter, from $0.4 million for the same period in 2023.

Speaker Change: due to an increase in the placements of Clearpoint Navigation Capital and Software and PRISM laser units.

Speaker Change: gross margin for the second quarter two thousand and twenty-four was sixty-three percent as compared to a gross margin of fifty-three percent for the second quarter of two thousand andtwenty-three

Danilo DAlessandro: The increase in gross margin was primarily due to lower costs for the three months ended June 30, 2024, due to the transition to the new manufacturing facility occurring in 2023 and higher volumes in 2024. In the second quarter of 2024, our operating expenses were $9.7 million, compared to $10.3 million for the second quarter of 2023, as we continue to gain operating leverage. Research and development costs were $3.1 million for the three months ended June 30, 2024, compared to $3.6 million for the same period in 2023, a decrease of $0.5 million, or 13%.

Speaker Change: The increase in gross margin was primarily due to lower costs for the three months ended June 30, 2024, due to the transition to the new manufacturing facility occurring in 2023 and higher volumes in 2024.

Danilo DAlessandro: The decrease was due primarily to lower product and software development costs of $1 million as a result of the reprioritization of certain research and development initiatives, partially offset by increased personal costs of $0.3 million and trial costs of $0.2 million. Sales and marketing expenses were $3.8 million for the second quarter compared to $3.5 million for the same period in 2023, an increase of $0.4 million, or 10%. This increase is due to additional personal costs and travel expenses as we expand our commercial reach, as we execute on our new product launches and prepare for increased procedural volume.

Speaker Change: In the second quarter of 2024, our operating expenses were $9.7 million, compared to $10.3 million for the second quarter of 2023, as we continue to gain operating leverage.

Speaker Change: researchand development costs were three point one milliondollars for the months jethirtieth two y four compared to three point six milliondollars for ared two thousand three a decrease of point five million dollars or thirteen percent

Speaker Change: The decrease was due primarily to lower product and software development cost of $1 million as a result of reprioritization of certain research and development initiatives, partially offset by increased personal cost of $0.3 million and trial cost of $0.2 million.

Speaker Change: Sales and marketing expenses were $3.8 million for the second quarter, compared to $3.5 million for the same period in 2023, an increase of $0.4 million, or 10%.

Speaker Change: This increase was due to additional personal costs and travel expenses as we expand our commercial reach, as we execute on our new product launches and prepare for increased procedural volume.

Danilo DAlessandro: General and administrative expenses were $2.8 million for the second quarter, compared to $3.2 million for the same period in 2023, a decrease of $0.4 million, or 13%. This decrease was due primarily to lower bad debt expense of $0.7 million, mainly as a result of subsequent recoveries, partially offset by higher personal costs and share-based compensation of $0.2 million. As of June 30, 2024, our year-to-date operating expenses were about 4% lower than our operating expenses in the same period of the prior year, despite growing our revenue 36% in the first half of 2024.

Speaker Change: General and administrative expenses were $2.8 million for the second quarter, compared to $3.2 million for the same period in 2023, a decrease of $0.4 million, or 13%.

Speaker Change: This decrease was due primarily to lower bad debt expense of $0.7 million, mainly as a result of subsequent recoveries, partially offset by higher personal costs and share-based compensation of $0.2 million.

Speaker Change: As of June 30, 2024, our year-to-date operating expenses were about 4% lower than our operating expenses in the same period of the prior year, despite growing our revenue 36% in the first half of 2024.

Danilo DAlessandro: With respect to our cash position, as of June 30, 2024, we held cash and cash equivalents of $32.8 million compared to $23.1 million as of December 31, 2023. In line with the prior quarters, we continue to meaningfully reduce our operational cash burn. Our operational cash burn in the second quarter of 2024 was $2.7 million, or 47% lower than our operational cash burn in Q2 2023. For the past trailing 12 months, our operational cash burn was $9.5 million. This represents a 46% reduction compared to the corresponding prior 12-month period, that is, from July 2022 to June 2023. With that, I'd like now to turn the call back to Joe.

Speaker Change: With respect to our cash position, as of June 30, 2024, we held cash and cash equivalents of $32.8 million compared to $23.1 million as of December 31, 2023.

Speaker Change: in line with the prior quarters we continue to meaningfully reduce our operational cash burn our operational cashburn in the second quarter of two thousand andtwenty four was two points seven million dollars or forty-seven percent lower than our operational cash burn in q two two thousand and twenty-three

Speaker Change: In the past trailing 12 months, our operational cash burn was $9.5 million. This represents a 46% reduction compared to the corresponding prior 12-month period, that is from July 22, 2022 to June 2023.

Joe Burnett: With that, I'd like now to turn the call back to Joe.

Joseph Burnett: As mentioned previously, 2024 is off to a great start with a 36% increase in revenue, a 39% reduction in operational cash burn, multiple new product launches, additional long-term pharmaceutical partnerships, global expansion of our portfolio, and a strong cash position and balance. As always, let's now break down that progress into our four growth pillars. Starting with pillar number one, biologics and drug delivery. We have had a terrific quarter on numerous fronts.

Speaker Change: Thanks, you know.

Speaker Change: As mentioned previously, 2024 is off to a great start with a 36% increase in revenue, a 39% reduction in operational cash burn, multiple new product launches, additional long-term pharma partnerships, global expansion of our portfolio, and a strong cash position and balance sheet.

Speaker Change: As always, let's now break down that progress into our four growth pillars.

Speaker Change: Starting with pillar number one, biologics and drug delivery. We had a terrific quarter on numerous fronts. Let's talk about four recent key milestones in our gene and cell therapy business.

Joseph Burnett: Let's talk about four recent key milestones in our gene and cell therapy business. First, as Danilo mentioned, we saw a significant increase in product sales to pharmaceutical partners, representing $1.3 million of growth for the quarter. This is very important as it shows the progression of our partners who are advancing along the regulatory pathway and moving beyond the benchtop, where product sales are limited, and into large multi-subject GLP preclinical trials and first in human clinical trials.

Speaker Change: First, as Danilo mentioned, we saw a significant increase in product sales to pharma partners, representing 1.3 million dollars of growth for the quarter.

Speaker Change: This is very important as it shows the progression of our partners who are advancing along the regulatory pathway and moving beyond the benchtop where product sales are limited and into large multi-subject GLP preclinical trials and first in human clinical trials.

Joseph Burnett: Second, we have now seen multiple partners selected for various accelerated FDA pathways designed to speed the clinical trial execution and eventual regulatory approval of these new-to-world cell and gene therapies, often referred to as regenerative therapies. We now have seven partnered programs that have been designated as Fast-Track, Priority Review, or RMAT, which highlights the importance that the FDA has placed on the entire cell and gene therapy market and the recognition of the life-altering impact these drugs may have on patients.

Speaker Change: Second, we have now seen multiple partners selected for various accelerated SDA pathways designed to speed the clinical trial execution and eventual regulatory approval of these new-to-world cell and gene therapies, often referred to as regenerative therapies.

Speaker Change: We now have seven partnered programs that have been designated as Fast-Track, Priority Review, or RMAT, which highlights the importance that the FDA has placed on the entire cell and gene therapy market and the recognition of the life-altering impact these drugs may have to patients.

Joseph Burnett: While there's never a guarantee of timeline or approval, it is very reassuring and exciting that the FDA has created these accelerated pathways and that many of our partners have demonstrated significant enough progress and clinical results to be eligible for these programs. In total, if we added together all of the indications that are now included in these expedited programs, the total patient prevalence is measured in millions of patients globally. Third, we continue to make progress expanding our preclinical services and capacity, with the next strategic goal to be GLP ready this year and to commence our initial GLP studies in 2025.

Speaker Change: While there is never a guarantee of timeline or approval, it is very reassuring and exciting that the FDA has created these accelerated pathways and that many of our partners have demonstrated significant enough progress and clinical results to be eligible for these programs.

Speaker Change: In total, if we added together all of the indications that are now included in these expedited programs, the total patient prevalence is measured in the millions of patients globally.

Speaker Change: Third, we continue to make progress expanding our preclinical services and capacity with the next strategic goal to be GLP ready this year and to commence with our initial GLP studies in 2025.

Joseph Burnett: Our team continues to feel confident in the demand for our products and services, as well as our team's unique expertise. We believe in our ability to execute larger studies under GLP compliant procedures and in GLP facilities.

Speaker Change: Our team continues to feel confident in the demand for our products and services, as well as our team's unique expertise.

Speaker Change: We believe in our ability to execute larger studies under GLP compliant procedures and in GLP facilities.

Joseph Burnett: This further evolution of our drug delivery business will continue to expand not just the value that we provide but also help us build even stronger long-term relationships with the pharmaceutical industry and Forrest. Speaking of those relationships with pharma, we are excited to share that we have now executed strategic agreements across all of our desired frameworks, proving that we do, in fact, provide unique capabilities that are valued by the cell and gene therapy community. These frameworks also demonstrate our creativity and flexibility in how we can partner based on the needs of each individual pharma partner. We obviously cannot provide detailed pricing or confidential strategic information.

Speaker Change: This further evolution of our drug delivery business will continue to expand, not just the value that we provide, but also help us build even stronger long-term relationships with the pharmaceutical industry.

Joseph Burnett: But what I can share is that we now have successful signed agreements representing four different parameters and sometimes a combination of those. So, for example, number one, co-development, where a partner pays a development fee and development milestones to Clearpoint for custom development of a delivery device or software that will be used in their preclinical and clinical trials. Number two, commercial pricing, where a partner intends to provide their drug in a kit with the Clearpoint Neuro technology to simplify the commercial delivery of the product and purchase the devices directly from Clearpoint instead of Clearpoint having to sell the product to hospitals.

Joseph Burnett: The commercial pricing is at a premium when compared to the bench and preclinical trial patients. Number three, clinical milestones, whereby Clearpoint Neuro gets a cash payment upon progression of a drug through the regulatory pathway. For example, approval of an IDE or IND study protocol being granted by the FDA, or the first patient enrolled in a clinical trial. Importantly, these milestones can happen during the drug discovery and regulatory process and do not have to take place at the very end with commercial approval.

Speaker Change: and Forrest.

Speaker Change: Speaking of those relationships with pharma, we are excited to share that we have now executed strategic agreements across all of our desired frameworks proving that we do in fact provide unique capabilities that are valued by the cell and gene therapy community.

Joseph Burnett: And finally, number four, a royalty payment to Clearpoint Neuro based on the drug itself and the commercial sales of that cell or gene therapy, which is delivered using the Clearpoint delivery device. As a reminder, while not certain, we believe it is likely that these new-to-world drugs will be approved as combination devices with the Clearpoint Neuro cannulas and catheters, as was seen in the European Union for the very first neurogene therapy already approved.

Speaker Change: These frameworks also demonstrate our creativity and flexibility on how we can partner based on the needs of each individual pharma partner.

Speaker Change: We obviously cannot provide detailed pricing or confidential strategic information, but what I can share is that we now have successful signed agreements representing four different parameters and sometimes a combination of those.

Speaker Change: So, for example, number one, co-development, where a partner pays a development fee and development milestones to Clearpoint for custom development of a delivery device or software that will be used in their preclinical and clinical trials.

Speaker Change: Number two, commercial pricing, where a partner intends to provide their drug in a kit with the Clearpoint Neuro technology to simplify the commercial delivery of the product and purchase the devices directly from Clearpoint instead of Clearpoint having to sell the product to hospitals.

Speaker Change: The commercial pricing is at a premium when compared to the bench and preclinical trial patient.

Speaker Change: Number three, clinical milestones whereby Clearpoint Neuro gets a cash payment upon progression of a drug through the regulatory pathway. For example, approval of an IDE or IND study protocol being granted by the FDA or the first patient enrolled in a clinical trial.

Speaker Change: Importantly, these milestones can happen during the drug discovery and regulatory process and do not have to take place at the very end with commercial approval.

Speaker Change: And finally, number four, a royalty payment to Clearpoint Neuro based on the drug itself and the commercial sales of that cell or gene therapy, which is delivered using the Clearpoint delivery devices.

Speaker Change: As a reminder, while not assured, we believe it is likely that these new-to-world drugs will be approved as combination devices with the Clearpoint Neuro cannulas and catheters as was seen in the European Union for the very first neurogene therapy already approved.

Joseph Burnett: Our company therefore becomes an essential supplier to our pharma partners. As a result, our partners are looking for very long-term agreements, assurances of supply, access to Clearpoint Neuro's unique intellectual property, redundancy of manufacturing, and more. It is this long-term need and partnership that puts us in a position to earn more than just an arm's-length transaction for our province. Moving on to pillar number two, which is neurosurgery navigation. We saw accelerated customer site activations and product sales in the quarter, fueled by both placements of our traditional MRI guided navigation system as well as the full market release of our SmartFrame OR system designed for use with CT scanners.

Speaker Change: Our company, therefore, becomes an essential supplier to our pharma partners.

Speaker Change: As a result, our partners are looking for very long-term agreements.

Speaker Change: assurances of supply, access to Clearpoint Neuro's unique intellectual property, redundancy of manufacturing, and more. It is this long-term need and partnership that puts us in a position to earn more than just an arm's-length transaction for our product.

Speaker Change: Moving on to pillar number two, which is neurosurgery navigation. We saw accelerated customer site activations and product sales in the quarter, fueled by both placements of our traditional MRI guided navigation system, as well as the full market release of our SmartFrame OR system, designed for use with CT scanners.

Speaker Change: I think we're having a couple...

Joseph Burnett: Sorry, I think we're having a couple of technical issues. Can you hear me now? Yes, you can. Your audio is back, sir.

Speaker Change: technical issues. Can you hear me now?

Speaker Change: Your audio is back, sir.

Speaker Change: well

Joseph Burnett: All right, everybody. Sorry about the technical issues.

Speaker Change: all everybody sorry about the technical su i'm going to go a and pickup the scri left to

Joseph Burnett: I'm going to go ahead and pick up the script where I left off. So, as a reminder, in Q1 of this year, we activated eight new customers, which was by far a new record. In fact, in prior years, opening eight new sites would take a full 12 months, and we accomplished that in the first quarter alone. In Q2, we followed on that success with an additional six customer activations, bringing our total to 14 so far this year.

Speaker Change: So as a reminder, in Q1 of this year, we activated 8 new customers, which was by far a new record.

Speaker Change: In fact, in prior years, opening eight new sites would take a full 12 months, and we accomplished that in the first quarter alone.

Speaker Change: In Q2, we followed on that success with an additional 6 customer activations, bringing our total to 14 so far this year.

Joseph Burnett: These accelerated placements have helped fuel not only our disposable product sales, which we will talk about in a second, but also capital rental and service sales, which more than doubled versus a year ago. We believe that we have a strong funnel of additional qualified global targets, giving us plenty of shots on goal to achieve 100 global sites by the end of 2025, if not sooner. The SmartFrame OR platform continues to gain traction with additional cases and experience.

Speaker Change: These accelerated placements have helped fuel not only our disposable product sales, which we will talk about in a second, but also capital rental and service sales, which more than doubled versus a year ago.

Speaker Change: We believe that we have a strong funnel of additional qualified global targets, giving us plenty of shots on goal to achieve 100 global sites by the end of 2025, if not sooner.

Speaker Change: The SmartFrame OR platform continues to gain traction with additional cases and experience.

Joseph Burnett: The early feedback we got from our limited market release gave us enough confidence to move quickly into full market release in concert with the ASSFN meeting in Nashville in June. We currently have the SmartFrame OR going through multiple VAC or VAC committee reviews around the country and expect additional growth here in the second half. I invite you to join our webinar led by Dr. Connor at the University of Oklahoma later this quarter, where he will share his early experiences with the SmartFrame OR product and how it has changed his practice at the university.

Speaker Change: The early feedback we got from our limited market release gave us enough confidence to move quickly into full market release, in concert with the ASSFN meeting in Nashville in June .

Speaker Change: We currently have the SmartFrame OR going through multiple VAC or VAC committee reviews around the country and expect additional growth here in the second half.

Speaker Change: I invite you to join our webinar, led by Dr. Connor at the University of Oklahoma later this quarter, where he will share his early experiences with the SmartFrame OR product and how it has changed his practice at the university.

Joseph Burnett: Next, let's move on to pillar number three, which is therapy and access products. In the quarter, we obtained FDA clearance for the PRISM anchor bolt accessory, which has opened the door to use of our PRISM laser system with some existing robotic systems at sites that simply prefer to use robotic navigation in place of our Clearpoint navigation. We have performed the first cases using the standardized workflow, which enabled us to move into full market release for the PRISM system.

Speaker Change: Next, let's move on to pillar number three, which is therapy and access products.

Speaker Change: In the quarter, we obtained FDA clearance for the PRISM anchor bolt accessory, which has opened the door for use of our PRISM laser system with some existing robotic systems at sites that simply prefer to use the robotic navigation in place of our Clearpoint navigation.

Speaker Change: We have performed first cases using the standardized workflow, which enabled us to move into full market release for the PRISM system.

Joseph Burnett: While we do not expect some of these bold customers to eventually move to a full Clearpoint navigated workflow for laser, it's an important first step to offer a solution that fits into their existing workflow so that we are not asking for too much change to their procedure flow on day one. Similar to the SmartFrame OR, we have a number of evaluations and VAC committee approvals underway.

Speaker Change: While we do not expect some of these bold customers to eventually— I'm sorry, while we do expect some of these bold customers to eventually move to a full Clearpoint-navigated workflow for LASER, it's an important first step to offer a solution that fits into their existing workflow so that we are not asking for too much change to their procedure flow on day one.

Speaker Change: Similar to the SmartFrame OR, we have a number of evaluations and VAC committee approvals underway.

Joseph Burnett: And we expect to see accelerated growth of these disposable laser fibers here in the second half. However, we do remain somewhat limited to about half of the laser market today, as our system is currently only approved for three Tesla scanners. However, there are plenty of target hospitals to keep us busy while we develop the regulatory pathway for the other half of the market responsible today for 1.5 Tesla scanners, which that approval we anticipate in 2025.

Speaker Change: And we expect to see accelerated growth of these disposable laser fibers here in the second half.

Speaker Change: We do remain somewhat limited to about half of the laser market today as our system is currently only approved for three tesla scanners

Speaker Change: However, there are plenty of target hospitals to keep us busy while we develop the regulatory pathway for the other half of the market, responsible today by 1.5 tesla scanners, which that approval we anticipate in 2025.

Joseph Burnett: We've also made significant progress on our MRI-conditional power drill, which we believe will be a powerful complement to our therapy and access product portfolio. This tool, in partnership with Adior Medical, is designed to provide significantly faster access for surgeons than our current hand drill and has the potential to meaningfully reduce procedure time.

Speaker Change: We've also made significant progress on our MRI conditional power drill, which we believe will be a powerful complement to our therapy and access product portfolio.

Speaker Change: This tool, in partnership with Addyor Medical, is designed to provide significantly faster access for surgeons than our current hand drill, and has the potential to meaningfully reduce procedure time.

Joseph Burnett: Our current plan is to submit this product before the end of the year with a commercial introduction sometime in 2025. Now, when we report numbers for neurosurgery navigation and therapy, we bucket them together into medical device disposables. As Danilo mentioned, this segment grew 17% in the quarter. It is important to note that this growth was despite $400,000 in services from our Brain-Computer Interface partners, which were not repeated here in 2024. Without the Brain-Computer Interface service revenue from 2023 and only comparing product sales, the neurosurgery navigation and therapy segment actually grew 42% year over year and even grew 34% compared to last quarter alone.

Speaker Change: Our current plan is to submit this product before the end of the year with a commercial introduction sometime in 2025.

Speaker Change: Now, when we report numbers for neurosurgery navigation and therapy, we bucket them together into medical device disposables.

Speaker Change: As Danilo mentioned, this segment grew 17% in the quarter. It is important to note that this growth was despite $400,000 in services from our Brain-Computer Interface partners, which was not repeated here in 2024.

Speaker Change: Without the brain-computer interface service revenue from 2023, and only comparing product sales, the neurosurgery navigation and therapy segment actually grew 42% year-over-year, and even grew 34% compared to last quarter alone.

Joseph Burnett: Overall, our product sales more than doubled versus a year ago, which has had a positive impact on gross margin due to the increased throughput at our factory. Speaking of which, let's talk about pillar number four, which is achieving global scale.

Speaker Change: Overall, our product sales more than doubled versus a year ago, which has a positive impact on gross margin due to the increased throughput at our factory.

Speaker Change: Speaking of which, let's talk about pillar number four, which is in achieving global scale.

Operator: This was another disciplined quarter from a spending standpoint that saw 32% revenue growth while keeping operating expenses generally flat. Our gross margin also expanded to 63%, which resulted in an operating cash burn reduction of 47% in the quarter, demonstrating our continued progress towards cash flow breaking. We continue to believe that a cash flow breakeven quarter by the end of 2025 is possible and feel like we are in a strong cash position today with over $32 million in cash and cash equivalents.

Speaker Change: This was another disciplined quarter from a spending standpoint that saw 32% revenue growth while keeping operating expenses generally flat.

Speaker Change: Our gross margin also expanded to 63%, which resulted in an operating cash burn reduction of 47% in the quarter, demonstrating our continued progress towards cash flow breakeven.

Speaker Change: We continue to believe that a cash flow breakeven quarter by the end of 2025 is possible and feel like we are in a strong cash position today with over 32 million in cash and cash equivalent.

Operator: Based on the strong first half performance of the team, we feel comfortable increasing our revenue guidance for the year to a new range of between 30 and 33 million in total revenue, representing growth of between 25 and 38% for the year. With that, we will now open up the call to any questions.

Speaker Change: Based on the strong first half performance of the team, we feel comfortable increasing our revenue guidance for the year to a new range of between $30 and $33 million in total revenue, representing growth of between 25 and 38% for the year.

Speaker Change: With that, we will now open up the call to any questions.

Operator: If you would like to ask a question at this time, please press star then the number 1 on your telephone keypad now, and you will be placed in the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, press star, then the number one, on your telephone keypad now. Your first question comes from Frank Takkinen with Lake Street Capital. Your line is open.

Speaker Change: If you would like to ask a question at this time, please press star then the number 1 on your telephone keypad now and you will be placed in the queue in the order received. Please be prepared to ask your question when prompted.

Frank Takkinen: Great, thanks for taking the questions and congrats on the great progress across the entire board. Congratulations on the increased guidance. Maybe you wanted to start there.

Joseph Burnett: Just curious what's contemplated versus the low end of the guidance versus the high end of the guidance. Obviously, an impressive growth profile regardless of where that comes into play. But just was curious what you're thinking about needs to occur for the top end versus the low end.

Speaker Change: Once again, if you would like to ask a question, press star then the number 1 on your telephone keypad now.

Speaker Change: Your first question comes from Frank Takkinen with Lake Street Capital. Your line is open.

Frank Takkinen: Great, thanks for taking the questions and congrats on really...

Frank Takinen: the great progress really across the the entire board. Congrats on the increased guidance. Maybe wanted to start there. Just curious what's contemplated versus the low end of the guidance versus the high end of the guidance. Obviously impressive growth profile regardless of where that comes into but just was curious what you're thinking about needs to occur for the top end versus low end.

Joseph Burnett: Yeah, happy to, happy to. And thanks for the question, Frank.

Speaker Change: Yeah, happy to answer. Thanks for the question, Frank. Yeah, by going from 30 to 33, we still leave a large enough window that I think...

Speaker Change: sort of appropriately reflect some of the uncertainty that can happen from quarter to quarter. So, you know, as an example, like we've talked about in the past,

Joseph Burnett: Yeah, by going from 30 to 33, we still leave a large enough window that I think sort of appropriately reflects some of the uncertainty that can happen from quarter to quarter. So, you know, as an example, like we've talked about in the past, we are, I don't say routinely, but we have in our forecast a number of sort of preclinical services for our pharma partners where any one of those services or trial support mechanisms could top a million, maybe even a million and a half dollars today.

Speaker Change: We are, I don't say routinely, but we have in our forecast.

Speaker Change: a number of sort of preclinical services for our pharma partners.

Speaker Change: where any one of those services or trial support mechanisms could top a million, maybe even a million and a half dollars today.

Joseph Burnett: And based on the timing of our partner, if that were to happen in December versus January of next year, you know, you could see a one to one and a half million dollar swing. So that's really the difference. You know, our view is that, you know, we feel like we've got a strong forecast to the, you know, certainly to the middle of the guidance that we've just adjusted, and the top and bottom range really reflect the timing more on the pharmaceutical side of things.

Speaker Change: And based on the timing of our partner, if that were to happen in December versus January of next year, you know, you can see a $1 to $1.5 million swing. So that's really the difference. You know, our view is that, you know, we feel like we've got a strong forecast to the, you know, certainly to the middle of the guidance that we've just adjusted.

Speaker Change: and the top and bottom range really reflect the timing more on the pharmaceutical side of anything.

Joseph Burnett: Got it, that's helpful. And then, maybe for my second one, I just wanted to ask about the new sites that have been activated. Obviously, Q1 was strong at 8, Q2 strong again at 6. Maybe talk about that onboarding process, how that went with this many new sites being activated in a short period of time, how quickly they can scale up, and start ordering product. And then maybe, as a last part to that question, any color related to how many of those sites have been adopted for both Classic Clearpoint, as well as the laser system.

Speaker Change: Got it, that's helpful. And then maybe for my second one just wanted to ask about the new sites activated. Obviously Q1 strong at 8, Q2 strong again at 6. Maybe talk about that onboarding process, how that has gone with this many new sites being activated in a short period of time, how quickly they can scale up, start ordering product, and then maybe as a last part to that question, any color related to how many of those sites adopted for both classic Clearpoint as well as the laser system.

Joseph Burnett: Yeah, sure. But as we think about those sites, the majority of the placements of those 14 we've seen this year have still been traditional MRI navigation sites. So, there was pent up demand in certain circumstances. Some were driven by interest in our laser platform that prompted them to bring our navigation system along as well. In some cases, it's hospitals that are preparing to participate in certain clinical trials down the road in the gene and cell therapy space and are getting the system installed and their staff up and running and familiar with the technology. So, you know, really what that mechanism looks like is that a hospital never wants to do its very first clinical trial patient and have that also be its very first Clearpoint patient.

Speaker Change: Yeah, sure. So, you know, as we think about those sites, the majority of the placements of those 14 we've seen this year have still been the traditional MRI navigation sites.

Speaker Change: So these were pent-up demand in certain circumstances, some were driven by interest in our laser platform that drove them to bring our navigation system along as well.

Speaker Change: In some cases, it's hospitals that are preparing to participate in certain clinical trials down the road in the gene and cell therapy space.

Speaker Change: and are, you know, getting the system installed and their staff.

Speaker Change: up and running and familiar with the technology. So, you know, really what that mechanism looks like is, you know, a hospital never wants to do their very first clinical trial patient and have that also be their very first Clearpoint patient.

Joseph Burnett: You know, so what happens more commonly is a hospital is very interested in cell and gene therapy. They see our Clearpoint system as a necessary component to participate. And they start their practice by doing simpler biopsy procedures, laser procedures, and DBS procedures to become familiar with the technology before they start enrolling these incredibly expensive and important cell and gene therapy trial patients. So, that's really where, you know, most of the demand has been. You know, the caveat to that, which is, I think, is an important one, Frank, is that, you know, we're really not seeing much of the impact just yet from SmartFrame OR.

Speaker Change: You know, so what happens more commonly is...

Speaker Change: The hospital is very interested in cell and gene therapy. They see our Clearpoint system as a necessary component to participate.

Speaker Change: And they start their practice by doing simpler biopsy procedures, laser procedures, DVS procedures to become familiar with the technology before they start enrolling these incredibly expensive and important cell and gene therapy trial patients. So that's really where most of the demand has been.

Speaker Change: The caveat to that, which I think is an important one, Frank, is that we're really not seeing much of the impact just yet from SmartFrame OR.

Joseph Burnett: So, as I mentioned in the prepared remarks, we actively have our system and our economic justification in front of the value committees at various hospitals. But, you know, even getting just a disposable system sometimes takes a little bit of time. You have to justify each and every expenditure the hospital makes these days. So we're currently going through the process. But what I would say is, you know, we haven't found a solution. We don't have an instance where a back committee has rejected us.

Speaker Change: So, as I mentioned in the prepared remarks, we are actively have our system and our economic justification in front of the value committees at various hospitals.

Speaker Change: Joseph Burnett, M.D.: But, you know, even, even getting just a disposable system sometimes takes a little bit of time. You have to justify each and every spend the hospital makes these days.

Joseph Burnett: Yes, it's really a situation where the meeting might only take place once a month or once every 2 months. And that's the slowing factor.

Speaker Change: so we're currently going through the process but what i would say is we haven't found we don't have an instance where a back committee has rejected up yes

Speaker Change: It's really a situation where, you know, the meeting might only take place once a month or once every two months, and that's the slowing factor.

Joseph Burnett: But once we have a community, what I say is, once we have approval from a back committee, either for an MRI-guided system or for the operating room system, you know, we've got ample supply. We've hired additional clinical specialists that are in training right now to prepare for this demand. And if you look at our inventory levels, they're still somewhat elevated because we do have product ready to be installed on the capital side. So we can move pretty quickly. Once we get the green light from the hospital,

Speaker Change: But once we have community

Speaker Change: What I'd say is once we have approval from a BAC committee, either for an MRI-guided system or for the operating room system,

Speaker Change: You know we've got ample supply, we've hired additional clinical specialists that are in training right now to prepare for this demand.

Speaker Change: And if you look at our inventory levels, they're still somewhat elevated because we do have product ready to be installed on the capital side. So we can move pretty quickly. Quickly. Once we get the green light from the hospital.

Joseph Burnett: Got it. That's helpful. Thanks and congrats again.

Speaker Change: Got it. That's helpful. Thanks and congrats again.

Operator: Your next question comes from Kyle Bauser with B. Reilly. Your line is open.

Speaker Change: as i think

Speaker Change: Your next question comes from Kyle Bowser with B. Riley. Your line is open.

Kyle Bauser: Great. Thanks for taking my questions. And I'll echo Frank's comments. A really strong and clean quarter all around. So congratulations.

Kyle Bowser: Great, thanks for taking my questions and I'll echo Frank's comments. A really strong and clean quarter all around, so congrats. As you march towards cash flow positive territory, the biologics business will of course be a key contributor.

Joseph Burnett: As you march towards cash flow positive territory, the biologics business will, of course, be a key contributor. I know that as a project matures in this business, you generate more revenues, but can you talk about economies of scale across these projects? I know you're focusing on a lot of different indications, but presumably, you aren't having to start from scratch on every new project. So I was just kind of curious if you could talk a little bit more about how this business will be a key driver of margin expansion.

Speaker Change: I know as a project matures in this business, you generate more revenues, but can you talk about economies of scale across these projects?

Speaker Change: I know you're focusing on a lot of different indications, but presumably you aren't having to start from scratch on every new project, so just kind of curious if you could talk a little bit more about how this business will be a key driver of margin expansion.

Joseph Burnett: Yeah, happy to, you know. I'll give you a few examples here and there as well. But, you know, the biggest benefit that we get that's clear, clearly number one, is the fact that the same Clearpoint platform and navigation system support all of these different procedure types that we talked about, whether it's biopsy or deep brain stimulation, or laser ablation, or drug delivery; you're still talking about navigating with our same system and our same software.

Speaker Change: Yeah, happy to. I'll give you a few examples here and there as well, but, you know, the biggest benefit that we get, that's clearly number one, is the fact that the same Clearpoint platform and navigation system

Speaker Change: supports all of these different procedure types that we talked about, whether it's biopsy or deep brain stimulation or laser ablation or drug delivery. You're still talking about navigating with our same system and our same software, and the, uh, the disposable elements, the capital elements, even the software workflow is probably 90 to 95 percent identical across each one of those different things. So as we talked about with Frank's question, you know, bringing a new site up and running is easy to do, because they can practice on simpler procedures like biopsies to prepare them for more complex gene therapy ones. So.

Joseph Burnett: And the disposable elements, the capital elements, even the software workflow is probably 90 to 95% identical across each one of those different things. So, as we talked about with Frank's question, bringing a new site up and running is easy to do because they can practice on simpler procedures like biopsies to prepare them for more complex gene therapy ones. So, you know, we get economies of scale on the fact that it's the same capital equipment and the same navigation headframe that goes in, as well as the training and education of the site.

Speaker Change: We get economies of scale on the fact that it's the same capital equipment and the same navigation headframe that goes in, as well as the training and education of the site. So I think that's absolutely an important component.

Joseph Burnett: So I think that's absolutely an important component. The second one is that, you know, as we get into these larger preclinical and clinical trials, a hospital is not buying five or 10, you know, prototype cannulas at this point, but rather they're purchasing maybe 100, 200 cannulas and navigation systems, sometimes all at once, which we can then produce in a batch manner, as opposed to doing these small little shipments through sterilization and everything else.

Speaker Change: The second one is that, you know, as we get into these larger preclinical and clinical trials,

Speaker Change: A hospital is not buying, or a pharma company is not buying 5 or 10, you know, prototype cannulas at this point, but rather they're purchasing maybe 100, 200 cannulas and navigation systems, sometimes all at once, which we can then produce in a batch manner, as opposed to doing these small little shipments through sterilization and everything else. So, as we get into these larger studies,

Joseph Burnett: So, as we get into these larger studies, we absolutely get margin expansion there because we are producing many more products at the same time as part of the same batch. So, there are more examples than that, but those are the two that certainly pop in front of mind.

Speaker Change: We absolutely get margin expansion there because we are producing many more products at the same time as part of the same batch. There's more examples than that, but those are the two that certainly pop in front of mind.

Joseph Burnett: Got it, I appreciate that. Maybe sticking with the biologics business, so you've talked about adding new preclinical and clinical trial services, and in your prepared remarks, you talked about GLP-ready studies, which is great, a big new area. Can you provide a little bit more color here and talk about examples of other services that you could add? Are these mostly based on feedback you're receiving from your existing customers, or just kind of obvious areas to move into? Thank you.

Speaker Change: Got it. I appreciate that. And maybe sticking with the biologics business, so you've talked about adding new preclinical and clinical trial services, and your prepared remarks talked about GLP-ready studies, which is great, a big new area. Can you...

Speaker Change: provide a little bit more color here and talk about examples of other services that you

Speaker Change: Are these mostly based on feedback you're receiving from your existing customers or just kind of obvious areas to move into? Thank you.

Joseph Burnett: Yeah, no, I think, you know, this has been a place where I think Clearpoint has been somewhat disciplined in our spending approach, where we try not to make these large investments until we know that the demand is solid for them. So sort of the field of dreams, if you build it, they will come. This is kind of the opposite of it, you know; we're not building the fields until the team's ready to go.

Speaker Change: Yeah, no, I think, you know, this has been a place where I think, you know, Clearpoint has been somewhat disciplined in our spending approach where we try not to make these large investments.

Speaker Change: until we know that the demand is solid for them.

Speaker Change: So sort of the field of dreams, if you build it, they will come. This is kind of the opposite of it. You know, we're not building the field until the team's ready to go.

Speaker Change: So, you know, so I'd say we're very confident that any additional investment we're making right now into added capacity or added services or new quality control expertise to facilitate a GLP study

Joseph Burnett: So, you know, I'd say we're very confident that any additional investment we're making right now into added capacity, or added services, or new quality control expertise to facilitate a GLP study, all those types of things, we wouldn't be making that investment now if we didn't see kind of a clear line of sight, not just to the value or the revenue we can generate as part of the GLP studies. But again, that intimate relationship we then have with the farmer partners to, you know, be working with them for the next 10, 15, 20 years throughout the entire drug discovery and commercialization process.

Speaker Change: all those types of things.

Speaker Change: know we wouldn't be making that investment now if we didn't we didn't see kind of a clear line of site not just to the value or the revenue we can generate as part of the g p studies but again that intimate relationship we' then have with the farmer partner to you be working with them for the next ten fifteen twenty years throughout the entire drug discovery and commercialization process

Joseph Burnett: So, You know, for concrete examples, you know, it's not it's nothing too much different than we already offer today. It's really the simple fact that having a GLP compliant facility is something that enables much larger studies. To your point, or to your question before about gross margin, the same is true for these procedures as well, these GLP procedures, because again, you're bashing them. You do many more subjects, sometimes 50, 60 subjects at a time, all over the course of six weeks, as opposed to one or two subjects here and there. So I think we'd be able to see some gross margin expansion driven by this GLP presence as well.

Speaker Change: Thank you.

Speaker Change: You know for concrete examples, you know, it's not it's nothing too much different than we already offer today

Speaker Change: It's really the simple fact that having a GLP-compliant facility

Speaker Change: is something that enables much larger studies that, you know, to your point or to your question before about gross margin, the same is true on these procedures as well, these GLP procedures, because, again, you're bashing them, you're doing many more subjects, sometimes 50, 60 subjects at a time, all over the course of six weeks, as opposed to one or two subjects here and there. So I think we'd be able to see some gross margin expansion driven by this GLP presence as well.

Joseph Burnett: Okay, got it. I appreciate that. Well, congrats again. I'll jump back in the queue.

Speaker Change: Okay, got it. I appreciate that. Well, congrats again. I'll jump back in queue.

Operator: Once again, to ask a question, press star, then the number one on your telephone keypad. Our next question comes from Matt Blackman on Stiefel. Your line is open.

Speaker Change: Thanks, pal.

Speaker Change: once again to ask a question press star than the number one on your telephone kepad

Speaker Change: Our next question comes from Matt Blackman with Stiefel. Your line is open.

Operator: Hi, this is Emily on format. Congratulations on a great quarter, guys. Thanks, Emily.

Speaker Change: Hi this is Emily on format. Congrats on a great quarter guys.

Emily Christy: Just a couple for me. In terms of... I'm kind of zooming out a bit on the health of biopharma companies. A company reported this morning citing some weakness there. I'm just wondering if you've seen any of that. Obviously, you're still signing contracts, but any projects being paused in your pipeline, anything along those lines?

Emily: Just a couple for me. In terms of...

Matt Blackman: kind of zooming out a bit for the health of biopharma companies. Company reported this morning citing some weakness there. I'm just wondering if you've seen any of that. Obviously you're still signing contracts but any projects being paused in your pipeline? Anything along those lines?

Joseph Burnett: No, I mean, if you look back to the start of this year, I'd say it's been the opposite. You know, barring the craziness of Monday earlier this week, I think funding has actually been pretty healthy coming into this particular space. And, you know, the simple fact on our end at this point is, if you think about the meetings we're having here at our headquarters in San Diego or meetings we're having up in San Francisco and in Europe and other places as well, we've got a very diversified base of partners, you know, anything from small startup biotech companies to some of the largest pharmaceutical companies in the world. And obviously, the smaller companies have a little bit more risk there, but, you know, these large pharmaceutical companies are very, very cash-flow, cash fluid, let's call it that.

Speaker Change: No, I mean if you if you look back to the start of this year I'd say it's been the opposite. You know, barring the craziness of Monday earlier this week, you know, I think funding has actually been pretty healthy coming into this particular space.

Speaker Change: And, you know, the simple fact on our end at this point is, if you think about the

Speaker Change: We've got a very diversified base of partners, anything from small start-up biotech companies to some of the largest pharmaceutical companies in the world.

Speaker Change: And obviously, the smaller companies have a little bit more risk there, but these large pharmaceutical companies are very cash fluid, let's call it, so we really have not seen any of those issues. Certainly not like we've seen over the last two or three years. This has been the healthiest it's been in quite some time.

Joseph Burnett: So we, we really have not seen any of those issues. Certainly not like we've seen over the last two or three years. This has been the healthiest it's been in quite some time.

Joseph Burnett: Okay, great. And in terms of the biologics partners, you had a couple kind of advance in their trials to phase one, phase two. At that point in a trial, aside from the product purchases, the batch purchases that you talked about, are you involved in other kinds of service revenue like regulatory prep, data collection? I know you've talked a little bit about that in the past; I'm just wondering kind of how you're involved as they are in that stage.

Speaker Change: okay great

Speaker Change: And in terms of the biologics partners, you had a couple kind of advance in their trials to phase one, phase two.

Speaker Change: At that point in a trial, aside from the product purchases, the batch purchases that you talked about, are you involved in other kind of service revenue like regulatory prep, data collection? I know you've talked a little bit about that in the past, so I'm just wondering kind of how you're involved as they are in that stage.

Joseph Burnett: Yeah, once they get to that stage, you know, we are not acting today as clinical trial monitors, for example, so that's something I think if we wanted to build a team around that, we could probably use our sort of unique neuro focus and expertise to be successful there, but it's not an investment we're making today. And it's not something we've moved forward with yet.

Speaker Change: Yeah, once they get to that stage, you know, we are not acting today as clinical trial monitors, for example, you know, so that's something I think if we wanted to build a team around that we could we could probably use our

Speaker Change: focus and expertise to be successful there, but it's not an investment we're making today, and it's not something we've moved forward with yet. But I, you know, I, I'd say it would be a nice adjacent service that we could go into.

Joseph Burnett: But I, you know, I'd say it'd be a nice adjacent service that we could go into. The primary role that we played during those studies was the product, which is pointed out, as well as clinical education and support of the site. You know, there are two primary components of these procedures. There's the part that has to do with the drug, which the pharmacy has to transport the drug in, thaw it out in the appropriate period of time, mix it, in certain cases, and have it ready for distribution to the patient.

Speaker Change: The primary role that we played during those studies is the product, as you pointed out, as well as the clinical education and support of the site.

Speaker Change: There's two primary components of these procedures. There's...

Speaker Change: The part that has to do with the drug, which, you know, the pharmacy has to transport the drug in, thaw it out in the appropriate period of time, mix it in certain cases, and have it ready for distribution into the patient.

Speaker Change: And then there's the surgical procedure itself, which includes the drilling, the pump that puts the drug in, the cannula that we make through which the drug is delivered, the navigation that gets it to the target, the software that monitors the infusion and tells the surgeon, yes, everything's great, you can go ahead and close the patient.

Joseph Burnett: And then there's the surgical procedure itself, which includes the drilling, the pump that puts the drug in the cannula that we make, through which the drug is delivered, the navigation that gets to the target, the software that monitors the infusion and tells the surgeon, yes, everything's great, you can go ahead and close the patient. That's really the part of the ecosystem that we're trying to control. And, you know, we're getting more involved in training on pumps and, you know, everything required the day of the surgery.

Speaker Change: That's really the part of the ecosystem that we're trying to control and, you know, we're getting more involved in training on pumps and, you know, everything required the day of the surgery. So if there's a clinical service that we provide, again, it's not monitoring of the trial.

Speaker Change: but you know making sure everything the day of the surgery even if it's a little bit beyond what the clo clear point product does some companies are hiring us to do additional services like a grrenand pump infusions and things like that hopefully the trumple

Joseph Burnett: So if there's a clinical service that we provide, again, it's not monitoring of the trial but, you know, making sure everything goes well the day of the surgery, even if it's a little bit beyond what the ClearPoint product does, some companies are hiring us to do additional services like around pump infusions and things like that. So hopefully that's helpful.

Joseph Burnett: Got it, yeah, that's great. And then just one last one, in terms of the contract types that you're now kind of spreading your wings with royalties and such, is there anything we should think about in terms of revenue cadence for those? I mean, is it going to remove some of the lumpiness with the more long-term nature of some of those things? How should we be thinking about how the revenue is going to flow with your mix right now?

Speaker Change: got it yeah that's great and then just one last one in terms of the contract types that you're now kind of spreading your wings of royalties and such

Speaker Change: is there anything we should think about in terms of revenue cadence for those i mean is it going to remove some ofthelumpiness with more the long term nature some of those things how should we be thinking about how the government is going to flow with your mix right now

Joseph Burnett: Yeah, it's probably the opposite of removing the lumpiness. If anything, it's going to create more for a period of time. You know, the good news is, like we said, we've got seven of these partners that are in these fast-track expedited designations from the FDA. So, you know, certain milestones will come. We have some other large pharmaceutical companies that are deep into the GLT process and will likely be starting their clinical trials here towards the end of 2024 and into 2025.

Speaker Change: 's probably the opposite of removing the umpiness that anything it's going to create more for period on you know the good news like we said we've got seven these partners that arein the fast track expedited designations from the s d so you know certain milestilones will come we have some other large pharmaceutical companies that are de f into the l process and will likely be starting theretheir clinical trials here towards the end oftwo thousand andtwentyfour and intotwo thousand and twenty five so that's where you're going to start to see you know where one particular courarter you know we could get a nice nice cash milestone which also be one hundred percent growross margin very exampleand the next quarter not have one at allalso soif you don't like you know shopping iness quarter to quarter you know we might frustr

Joseph Burnett: So that's where you're going to start to see, you know, where one particular quarter, you know, we could get a nice cash milestone, which would also be 100% gross margin, for example, and the next quarter wouldn't have one at all. So if you don't like, you know, chopping this quarter to quarter, we might frustrate you a little bit. But again, if you look at the, you know, six-month periods, 12-month periods, things like that, the trend of growth is certainly going to be there, along with gross margins, too.

Speaker Change: itbut again if you look at the united sixmonth period twelve month period things like that you know with the trend of growth iss certainly going to be there along with gross margins do

Joseph Burnett: So, you know, where I think it does start to even out here, whereas, you know, if we have multiple partners that are all in clinical trials, and those are in that phase two, phase three standpoint, maybe two, couple, two, three years from now, you know, that's where I think we're just going to have enough volume there that one individual milestone isn't going to swing things positive or negative because, you know, these milestone I got it.

Speaker Change: So, you know, where I think it does start to even out, where, you know, if we have...

Speaker Change: multiple partners that are all in clinical trials and those are in that phase two, phase three standpoint maybe two, couple, two, three years from now.

Speaker Change: you know that's where i we're justgoing tohave enough of volume there that one individual milestone ifn' going ofswing things positive or negative because you know these these you know these milestones roties whatever happened to beyou're going to start to do thingsout

Joseph Burnett: Got it. Great. Thank you. Sure.

Speaker Change: Got it. Great.

Joseph Burnett: At this time, there are no further questions in queue. I'd like to turn the call back over to Mr. Burnett for any further remarks.

Emily: Sure. Thanks, Emily.

Speaker Change: At this time, there are no further questions in queue. I'd like to turn the call back over to Mr. Burnett for any further remarks.

Joseph Burnett: Thanks again, Morgan. And once again, thank you to everyone interested in being a part of our team's journey here at Clearpoint. This is an exciting time as we plan for new product and service launches across all four of our growth pillars, as well as additional first in human trials to initiate in the exciting cell and gene therapy market. We've worked very hard to get to this point and are very excited about our entire team.

Joseph Burnett: But we are even more excited for the patients that we hope to treat with these new devices and therapies in the near future. The patient and their family are why we are here, and they are ultimately who we are working for. Thank you.

Mr. Burnett: Thanks again, Morgan. And once again, thank you to everyone interested in being a part of our team's journey here at Clearpoint. This is an exciting time as we plan for new product and service launches across all four of our growth pillars, as well as additional first-in-human trials to initiate in the exciting cell and gene therapy market.

Speaker Change: We've worked very hard to get to this point and are very excited for our entire team. But we are even more excited for the patients that we hope to treat with these new devices and therapies in the near future.

Speaker Change: The patient and their family are why we are here, and they are ultimately who we are working for. Thank you, and good night.

Operator: This concludes the Clearpoint Neuro second quarter fiscal 2024 earnings call. Thank you for attending, and have a great rest of your day.

Speaker Change: This concludes the Clearpoint Neuro second quarter fiscal 2024 earnings call. Thank you for attending and have a great rest of your day.

Speaker Change: ?? ?? ?? ?? ?? ??

Speaker Change: ang