CeriBell, Inc. Q3 FY2025 earnings call

• Total revenue for Q3 2025 was $22.6 million, marking 30th consecutive quarter of sequential revenue growth. Full-year 2025 revenue guidance is raised to $87 million to $89 million, representing 34% year-over-year growth at the midpoint.
• Expanded patient access with 615 active accounts as of September 30, 2025, an increase of 31 accounts from the prior quarter. Received FedRAMP High Authorization for VA system access and plan to expand usage there.
• Advanced product pipeline: received 510(k) clearance for pediatric Clarity, with ongoing pilot in pediatric population and full launch anticipated in 2026. Clinical data from pediatric Clarity showed strong performance in detecting suspected status epilepticus in pediatric patients.
• Strengthened supply chain: established manufacturing line in Vietnam to reduce exposure to China-based tariffs, aiming for mid-80% gross margins in 2026 assuming no changes to proposed tariffs.

Total revenue for the third quarter of 2025 was $22.6 million, reflecting a 31% growth compared to the same period in 2024. Product revenue for Q3 2025 was $17 million, which is a 28% increase from $13.3 million in Q3 2024. Subscription revenue was $5.6 million, representing a 44% increase from $3.9 million in Q3 2024. The revenue growth is driven by increased adoption of the Ceribell system across new and existing accounts, with product revenue contributing the majority and subscription revenue showing strong growth.

• Full-year 2025 revenue guidance revised to $87 million to $89 million, up from prior guidance of $85 million to $88 million.
• Expect mid-80% gross margins in Q4 2025 and full-year 2026.
• Confident in achieving cash flow breakeven with current cash position and balance sheet strength.

• Competition: Continued competition activities, though not meaningfully impacting performance.
• ITC litigation: Anticipated delay in ITC decision due to government shutdown, with ITC expected to update timeline once government reopens.
• Supply chain tariffs: Potential impact on gross margins if tariff policies change.

Q: Travis Steed from Bank of America asked about 2026 guidance, pricing, and neonatal launch.

A: Scott Blumberg mentioned no 2026 commentary yet, emphasizing consistent drivers of account adds and usage, and consistent pricing on Headband with Clarity ASP increase. Xingjuan Chao stated neonatal launch involves both new accounts and existing ones, with existing installed base in NICUs.

Q: Robbie Marcus from JPMorgan asked about penetrating accounts and expense growth.

A: Xingjuan Chao discussed continued growth from protocolization, departmental expansion, and CAM team efforts. Scott Blumberg talked about investment in sales infrastructure and cash flow breakeven.

Q: Brandon Vazquez from William Blair asked about utilization growth in tenured accounts and neonatal headcap clearance.

A: Xingjuan Chao said utilization growth in tenured accounts comes from protocolization, departmental expansion, and CAM training. The neonatal headcap clearance is for preterm and term neonates, improving commercial readiness for full launch.

Q: Josh Jennings from TD Cowen asked about customer account pipeline and IDN partnerships.

A: Scott Blumberg said the funnel is growing due to commercial org investments and need appreciation. Xingjuan Chao discussed hospital system sales team building for IDN partnerships.

Q: William Plovanic from Canaccord Genuity asked about guidance range, sales force, competition, IP litigation, and manufacturing shift.

A: Scott Blumberg explained guidance range as risk calibration. Scott and Xingjuan discussed sales force status, competition not impacting performance, ITC litigation delay, and manufacturing shift impact on gross margins.

Q: Jeffrey Cohen from Ladenburg Thalmann asked about VA channel expansion and neonate hardware utilization.

A: Xingjuan Chao talked about VA rollout of larger cohorts and positive reception of neonate hardware without Clarity pilots.

Q: Elaine from Raymond James asked about utilization growth excluding stocking impact and departmental drivers.

A: Scott Blumberg said utilization growth would have been stronger without Q3 2024 stocking. Xingjuan Chao mentioned broad growth drivers including ED and ICU, departmental expansion