Clearpoint Neuro (CLPT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Joseph Burnett - President and Chief Executive OfficerDanilo D’Alessandro - CFOMathew Blackman - Managing Director Conference Call Participants Frank Takkinen - Senior Research AnalystAnderson Schock - Research Analyst Operator Please note this conference is being recorded. Comments made on this call may include statements that are forward looking within the meaning of securities laws. These forward looking statement ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $8.5 million, an 11% increase from $7.6 million in Q1 2024 [7] - Gross margin improved to 60%, up from 59% in Q1 2024 [9] - Cash and cash equivalents decreased to $12.4 million from $20.1 million at the end of 2024 [10] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 9% to $4.7 million, driven by a $1.2 million increase in product revenue [7][8] - Neurosurgery Navigation revenue grew 70% to $3.3 million, attributed to higher sales of new product offerings [8] - Capital Equipment and Software revenue decreased 63% to $500,000 due to fewer new placements of navigation and laser units [9] Market Data and Key Metrics Changes - The company activated two new sites in Q1 2025, expanding its installed base [19][50] - The single-use consumables business saw a growth rate of 104%, driven by increased orders from biopharma partners [13] Company Strategy and Development Direction - The company aims to extend its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4] - Plans to evolve the product portfolio to enhance hospital efficiency and throughput [5] - The company is focused on expanding its global installed base and generating scale for novel treatments [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for additional cell and gene therapy platforms to gain regulatory approval within two years [15] - The recent partnership with Overland Capital provides the company with foundational funding to execute its strategy [6][12] - Management anticipates that revenue growth will outpace expense growth for the full year [11][56] Other Important Information - The company has implemented a new subscription program called Pathfinder, allowing hospitals to access technology through an annual fee [21] - The Pathfinder program will smooth out capital revenue recognition over time [22] Q&A Session Summary Question: Opportunities with Incremental Capital - Management sees opportunities to accelerate hiring and expand preclinical resources in response to pharma partners' requests [29] Question: Neuro Franchise Growth Expectations - Management believes the neuro franchise can grow significantly more than 20% throughout the year, with potential upside based on product adoption [33] Question: MRI vs. OR Procedure Mix - Management anticipates a shift towards more procedures being performed in the operating room, especially as new drug therapies are introduced [39] Question: GLP Certification Timeline - Management expects to achieve GLP certification by the end of the year, with pent-up demand from pharma partners for studies once certified [42][44]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $8.5 million, an 11% increase from $7.6 million in Q1 2024 [7] - Gross margin improved to 60%, up from 59% in Q1 2024 [10] - Cash and cash equivalents decreased to $12.4 million from $20.1 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 9% to $4.7 million, driven by a $1.2 million increase in product revenue [8] - Neurosurgery Navigation revenue surged 70% to $3.3 million, attributed to higher sales of new product offerings [9] - Capital Equipment and Software revenue fell 63% to $500,000 due to fewer new placements of navigation and laser units [10] Market Data and Key Metrics Changes - The company activated two new sites in Q1 2025, which were both capital placements [51] - The introduction of the three point zero navigation software has allowed expansion into operating rooms, enhancing market reach [14] Company Strategy and Development Direction - The company aims to extend its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4] - Plans to evolve the product portfolio to focus on fast, simple, and predictable workflows to increase hospital efficiency [5] - The company is pursuing global scale by expanding its installed base and generating more access to its ecosystem [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for additional cell and gene therapy platforms to gain approvals in the next two years [16] - The recent partnership with Overland Capital provides the company with the necessary funding to execute its strategy [6] - Management anticipates that operational cash burn will continue to increase but expects to generate meaningful cash flow as new drugs come online [31] Other Important Information - The company has implemented a Pathfinder subscription program to smooth capital revenue recognition over time [22] - The three point zero navigation software has been well received, with positive feedback from surgeons regarding efficiency and accuracy [18] Q&A Session Questions and Answers Question: Are there initiatives that can be prioritized now with access to incremental capital? - Management confirmed that there are opportunities to accelerate hiring and expand preclinical resources in response to partner requests [29] Question: How does the new capital runway relate to achieving sustained breakeven? - Management believes the new debt facility can support the company towards cash breakeven, especially with the flexibility of an interest-only period [31] Question: How is the neuro franchise tracking relative to expectations? - Management stated that the neuro franchise is on plan and expects significant growth throughout the year, with potential upside from new product launches [34] Question: What is the expected mix of MRI versus OR procedures in the future? - Management indicated that while MRI procedures currently dominate, there is potential for OR procedures to grow faster as new therapies are introduced [40] Question: What is the status of GLP certification and customer interest? - Management confirmed that they are on track for GLP certification by the end of the year and noted strong interest from pharma partners for studies once certified [42][46]