ClearPoint Neuro, Inc. Q1 FY2025 earnings call

• Entered the 'fast forward' phase with three tenets: extend lead in cell and gene therapy via drug delivery ecosystem, evolve portfolio for efficiency, and expand global install base.
• Biologics and drug delivery: Support over 60 biopharma partners, submitted 510 for SmartFlow cannula, RGX-121 BLA accepted by FDA.
• Neurosurgery, navigation, and laser ablation: Single use consumables grew 70%, 3.0 navigation software well-received, PRISM Laser market share gains.
• Global scale: Implemented Pathfinder subscription program, expects 15-20 new site activations in 2025, more capital revenue in Q2 than Q1.

Total revenue for the first quarter of 2025 was $8.5 million, up 11% from $7.6 million in Q1 2024. Biologics and drug delivery revenue was $4.7 million, a 9% increase from $4.3 million in 2024, contributing approximately 55.29% of total revenue. Neurosurgery navigation revenue was $3.3 million, a 70% increase from $1.94 million in 2024, contributing ~38.82% of total revenue. Capital equipment and software revenue was $0.5 million, a 63% decrease from $1.4 million in 2024, contributing ~5.88% of total revenue. Gross margin was 60% in Q1 2025, up 1% from 59% in Q1 2024. R&D costs were $3.4 million (up 29% from $2.6 million), sales and marketing expenses were $3.8 million (up 17% from $3.3 million), and general and administrative expenses were $4.1 million (up 44% from $2.8 million). Cash and cash equivalents at March 31, 2025, were $12.4 million.

• Full year expense growth expected to be lower than revenue growth, achieving operating leverage.
• New credit facility and equity investment from Oberland Capital provides $32 million net proceeds, with $25 million additional credit available by Dec 2026.
• Believes company could generate meaningful cash flow when new drugs come online in next 2-4 years, aiding debt repayment.

• Choppy capital placements and revenue from quarter to quarter.
• Uncertainty in market conditions affecting investment and revenue recognition.
• Dependence on successful regulatory approvals and commercialization of cell and gene therapies.

Q: What initiatives can be accelerated with new capital?

A: Hiring preclinical and field support, expanding preclinical capacity.

Q: Neuro franchise trajectory?

A: On plan, expects significant growth in remainder of year, potential upside with laser adoption.

Q: Site activations and agreements?

A: Two new sites were capital sales; PRISM systems and software upgrades were Pathfinder or existing customer upgrades.

Q: OpEx growth and R&D?

A: Accelerated investments in preclinical, software, and pharma support, expecting revenue growth to outpace expenses.