Clarity algorithm

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CeriBell, Inc.(CBLL) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:32
Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $20.5 million, reflecting a 42% increase from $14.4 million in Q1 2024 and an 11% increase from Q4 2024 [7][24] - Gross margin for Q1 2025 was 88%, compared to 86% in the prior year [25] - Net loss for Q1 2025 was $12.8 million, or a loss of $0.36 per share, compared to a loss of $8.5 million, or a loss of $1.56 per share in Q1 2024 [27] Business Line Data and Key Metrics Changes - Product revenue for Q1 2025 was $15.6 million, a 41% increase from $11 million in Q1 2024 [25] - Subscription revenue for Q1 2025 was $4.9 million, representing a 45% increase from $3.4 million in Q1 2024 [25] Market Data and Key Metrics Changes - As of March 31, 2025, the company had 558 active accounts, an increase of 29 during the first quarter [9] - The company estimates it currently serves about 3% of the U.S. population that could benefit from its technology [12] Company Strategy and Development Direction - The company aims to expand its account acquisition team to 55 territory managers by mid-2025 [13] - The focus remains on increasing awareness of the clinical and economic benefits of its products through direct engagement with clinicians and marketing initiatives [14] - The company plans to conduct a limited commercial release of its pediatric algorithm, with a full launch anticipated in subsequent years [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability using current cash on hand despite a dynamic trade environment [9] - The company expects full-year 2025 total revenue to range from $83 million to $87 million, up from prior guidance of $81 million to $85 million [28] - Management acknowledged potential impacts from increased tariffs but remains confident in maintaining gross margins in the mid-80% range [29][30] Other Important Information - The company received FDA clearance for its pediatric seizure detection algorithm, expanding its addressable patient population [15] - The company is one of only 51 companies to receive FedRAMP high authorization, validating its cybersecurity standards [10] Q&A Session Summary Question: What is driving the raise in guidance by more than the beat? - Management indicated that greater confidence in account acquisition and management strategies led to the guidance increase [35] Question: Can you elaborate on potential mitigation actions regarding tariffs? - Management mentioned strategies such as automation, cost negotiation with vendors, and potential reshoring plans to mitigate tariff impacts [41] Question: Will pediatric clarity contribute to the 2025 guidance? - Management confirmed that pediatric clarity will not impact the 2025 guidance but sees meaningful expansion potential in future years [48] Question: What is the opportunity for expansion within the customer base? - Management estimates a 70% opportunity for further penetration within existing accounts [66] Question: How is the competitive landscape? - Management stated that while there are emerging competitors, the company remains a clear category leader with unmatched technology and clinical evidence [70]
CBLL Stock Falls Despite FDA Clearance for Pediatric Clarity Algorithm
ZACKS· 2025-04-16 15:40
Ceribell, Inc. (CBLL) recently announced that it has received FDA clearance for the Clarity algorithm for use in pediatric patients. This breakthrough expands the utility of Ceribell’s rapid electroencephalography (“EEG”) system, enabling faster seizure detection and treatment in critically ill children.With this clearance, Ceribell strengthens its position in the neurodiagnostic space by addressing a critical gap in pediatric care. The Clarity algorithm is designed to support timely clinical decisions, imp ...