Ceribell, Inc. Q4 FY2024 earnings call

• 2024 was a transformational year with over 200,000 patients using the technology, likely saving thousands of lives and avoiding unnecessary medical procedures. - A patient story was shared illustrating the real-world impact of the technology. - Commercial performance: 529 active accounts as of December 31, 2024, with plans to expand the commercial organization, promoting Sean Manni to Chief Revenue Officer, and aiming to expand the account acquisition team to 55 territory managers by mid-2025. - R&D pipeline: Focus on expanding indications, including pediatric Clarity indication submission to FDA in late 2024, neonate Clarity algorithm development, and work on delirium indication with FDA breakthrough device designation, aiming to make EEG a new vital sign.

For the fourth quarter of 2024, revenue was $18.5 million, with product revenue at $14.1 million and subscription revenue at $4.4 million, reflecting 41% growth from the prior year. For the full-year 2024, total revenue was $65.4 million, with product revenue at $50.1 million and subscription revenue at $15.4 million, representing 45% growth over 2023. Gross margin for the fourth quarter was 88% and for the full-year was 87%.

• Full-year 2025 total revenue expected to be in the range of $81 million to $85 million, representing 24%-30% growth over 2024. - Gross margins expected to normalize to mid to high 80% range. - Expect to invest in R&D, with stock-based compensation contributing approximately $15 million to operating expenses for 2025. - Aim to achieve cash flow breakeven with strong balance sheet confidence.

Q: Could you elaborate on the guidance range for 2025 and assumptions like account adds, utilization, pricing? And any quarterly cadence considerations?

A: Guidance is conservatively set as 2025 revenue range is $81M-$85M. Growth driven by continued investment in sales infrastructure. No year-end seasonality like elective procedures, with slight volume increase in Q4 and Q1 due to higher ICU census in winter months.

Q: Talk about the strength of account adds in Q4 and Q1 traction?

A: Q4 account adds were ahead of expectations due to good planning and customers launching early. Q1 should be roughly an approximation of Q4 as some Q4 launches were pulled forward.

Q: Thoughts on new account adds and deepening utilization?

A: Continue to expand territory managers to 55 by mid-2025. On utilization, multi-pronged approach including educating physicians in low-awareness areas and helping nursing teams standardize rapid EEG into protocols.

Q: Details on stroke algorithm development and delirium submission requirements?

A: Stroke study has over 200 patients with encouraging data, planning to expand enrollment speed. For delirium, FDA requires algorithm performance comparison to standard of care (CAM ICU), working to improve algorithm and prepare submission, with clarity on 510(k) or de novo path later this year.

Q: Utilization trends, account penetration, and VA hospital system update?

A: Utilization has an upward trajectory with seasonality factors. Account penetration is low (25%-30%) in active account base. Dedicated sales director focusing on VA hospital system with gained interest and optimism for future milestones.