ClearPoint Neuro, Inc. Q2 FY2025 earnings call

2025 marks the start of ClearPoint Neuro's 'Fast. Forward' phase with three primary tenets. First, extend lead in cell and gene therapy by leveraging the complete drug delivery ecosystem including navigation hardware, software, cannula-based routes, preclinical/clinical services, and field personnel. Second, evolve portfolio to focus on fast, simple, predictable workflows with new products like 3.0 ClearPoint ICT navigation software and PRISM Laser Therapy system. Third, expand global installed base. Financially, revenue grew across segments. Biologics and drug delivery supports over 60 active biopharma partners, with a new preclinical research facility under construction. Neurosurgery navigation saw growth due to new product offerings. Global installed base has regulatory clearances in 36 countries and aims for 15 - 20 new site activations in 2025.

Total revenue for the second quarter of 2025 was $9.2 million, representing a 17% growth compared to the second quarter of 2024 which was $7.9 million. Revenue is composed of three segments. Biologics and drug delivery revenue increased 10% to $4.7 million in the second quarter of 2025, up from $4.3 million in 2024. This was fueled by a 12% increase in biologics and drug delivery product revenue and an 8% increase in service revenue. Neurosurgery navigation revenue saw a 33% increase to $3.4 million for the second quarter of 2025, primarily due to new product offerings and recent additional placements. Capital equipment and software revenue increased 11% to $1 million in the quarter, driven by an increase in service revenue.

Management expects total 2025 activations to be between 15 and 20 new sites, with 11 - 16 activated in the second half. There is progress in global regulatory clearances including in Canada, Japan, and China. Expectation of additional cell and gene therapy platforms being approved within 2 - 3 years.

Forward - looking statements may differ materially from actual results. Actual results or trends could differ materially. The company is not obligated to revise forward - looking statements for new information or future events.

Q: Refresh on revenue contribution from KEBILIDI and thoughts on uniQure.

A: KEBILIDI and REGENXBIO are for rare disorders. UniQure's Huntington's disease has a larger patient scale.

Q: Color on ClearPoint 3.0 rollout and margin impact.

A: 35 sites have 3.0/3.01 software, 21 - 22 have done procedures, no immediate margin impact as capital component is lower.

Q: Cell and gene therapy partners' guidance method.

A: Depends, some under live MRI, some in OR under CT, with focus on efficiency and MRI expansion.

Q: Update on GLP compliance at expanded preclinical facility.

A: Will have a sense soon, may do first GLP study late 2025 or Q1 2026, with facility and quality system being set up.