Summary of CeriBell (CBLL) FY Conference - June 03, 2025 Company Overview - CeriBell is focused on developing an AI-driven neural monitoring platform for seizure detection in acute care settings, specifically in ICUs and emergency departments [2][5] - The company has a total addressable market (TAM) of over $2 billion in the U.S. for seizure detection alone [5] Core Product and Technology - CeriBell's platform includes hardware and an AI-powered seizure detection algorithm, allowing for rapid EEG setup and monitoring [4][23] - The AI algorithm, named Clarity, continuously monitors EEG signals and alerts medical staff in real-time about seizure activity [23][24] - The system can set up EEG in minutes, contrasting with traditional methods that can take hours or days [23][25] Clinical Need and Impact - Seizures in ICU patients often go unnoticed due to the lack of symptoms, leading to high mortality rates if not detected early [7][11] - Early detection is critical; mortality rates increase significantly with delays in treatment [12][11] - CeriBell's technology addresses the bottlenecks of traditional EEG monitoring, which requires specialized technicians and can lead to delays in patient care [15][17] Commercial Performance - CeriBell reported $20.5 million in revenue last quarter, representing a 42% year-over-year growth [5] - The company is currently trending towards 600 hospitals, with a gross margin of 88% [5] - The revenue model consists of 25% from AI subscription fees and 75% from disposable headband sales [40][41] Market Expansion and Future Pipeline - CeriBell has expanded its TAM by qualifying for cloud-based operations in VA facilities and gaining FDA clearance for pediatric applications [49][50] - Future plans include submitting applications for neonate clarity and using EEG for other indications like delirium and stroke [58] Health Economics and Clinical Evidence - CeriBell's technology has shown to reduce unnecessary patient transfers by 94-100% and decrease length of stay in hospitals by an average of 4.1 days [36][37] - The company qualifies for existing EEG CPT codes, enhancing hospital reimbursement opportunities [38] - CeriBell has published over 35 peer-reviewed journals, demonstrating strong clinical evidence for its impact [39] Sales and Marketing Strategy - The sales force is divided into territory managers for account acquisition and clinical account managers for existing accounts [42] - The business model is characterized by high customer retention and consistent usage, making it difficult for competitors to lure away clients [44][46] Conclusion - CeriBell's innovative approach to seizure detection in acute care settings has the potential to significantly improve patient outcomes while also providing economic benefits to hospitals [60] - The company is well-positioned for future growth with a strong focus on expanding its technology and market reach [60]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $18.5 million, reflecting a 41% growth compared to $13.1 million in Q4 2023 [31] - Full-year revenue totaled $65.4 million, representing a 45% growth over 2023 [33] - Gross margin for Q4 2024 was 88%, up from 85% in the prior year, while full-year gross margin was 87%, compared to 84% in 2023 [34][35] - Net loss for Q4 2024 was $12.6 million, or a loss of $0.40 per share, compared to a loss of $8.3 million, or a loss of $1.53 per share in Q4 2023 [36] Business Line Data and Key Metrics Changes - Product revenue for Q4 2024 was $14.1 million, a 41% increase from $10.0 million in Q4 2023 [32] - Subscription revenue for Q4 2024 was $4.4 million, representing a 40% increase from $3.1 million in Q4 2023 [32] - Active accounts increased to 529 as of December 31, 2024, an increase of 25 accounts during the quarter [16] Market Data and Key Metrics Changes - The company estimates there are 6,000 acute care facilities in the U.S. that could benefit from its offerings, with plans to target approximately 5,500 remaining prospective accounts [17] - The company is focused on expanding its market presence within the current $2 billion market in the U.S. for seizure detection and management in acute care settings [29] Company Strategy and Development Direction - The company aims to maintain its focus on commercial growth and expand its R&D pipeline, with a goal of becoming the standard of care for seizure management in acute care settings [22] - Plans for 2025 include expanding the account acquisition team to 55 territory managers and increasing awareness of the clinical and economic benefits of rapid EEG monitoring [21] - The company envisions expanding its product indications beyond seizure detection, including developing algorithms for delirium and stroke detection [25][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven and highlighted the strength of the balance sheet following a successful IPO [41] - The company anticipates total revenue for 2025 to be in the range of $81 million to $85 million, representing annual growth of 24% to 30% over 2024 [37] - Management noted that while accelerated initiatives may not drive immediate revenue, they are expected to have long-term impacts [40] Other Important Information - The company has received breakthrough device designation from the FDA for its delirium detection algorithm, with plans to submit an application later this year [25] - The transition to operating as a public company has increased stock-based compensation costs, expected to contribute approximately $15 million to operating expenses for the full year 2025 [41] Q&A Session Summary Question: Can you elaborate on the guidance for this year and the underlying assumptions? - Management indicated that guidance reflects continued investment in sales infrastructure, which is expected to accelerate growth in 2026 and beyond [46] Question: What are your thoughts on gross margin and OpEx spend in 2025? - Management noted that gross margins are expected to normalize in the mid to high 80% range due to increased tariffs and that R&D expenses are expected to increase by 40% to 60% year-over-year [54][56] Question: Can you provide updates on the stroke opportunity and the algorithm development? - Management expressed satisfaction with the progress in the stroke trial and plans to expand enrollment speed to gather more data for algorithm training [70] Question: How do you see utilization picking up with the new indications? - Management explained that the new indications will work synergistically to help doctors differentiate between various neurological conditions, enhancing overall patient care [83]