SUNNYVALE, Calif., April 24, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that it will release financial results for the first quarter of 2025 after the close of trading on Thursday, May 8, 2025. Company management will host a conference call to discuss financial results beginning at 1:30 p.m. PT / 4:30 p.m. ET on May 8, 2025. Investors i ...

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 ...

References Forward-Looking Statements SUNNYVALE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) ("Ceribell"), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next generation Ceribell Clarity™ algorithm for the detection of electrographic seizures in patients ages 1 and older. This makes Ceribell the ...

Core Insights - Ceribell, Inc. has received FDA 510(k) clearance for its Ceribell Clarity™ algorithm, making it the first AI-powered point-of-care EEG system capable of detecting electrographic seizures in patients aged 1 and older [1][2][3] - The Clarity algorithm is designed to provide comprehensive seizure detection across the largest age range ever addressed by such technology, enhancing the capabilities of hospitals, particularly in emergency departments and ICUs [1][3] - The pediatric clearance was supported by EEG data from over 1,700 patients, marking it as the largest validation dataset for FDA clearance of a seizure detection system [1][3] Company Overview - Ceribell is a medical technology company focused on improving the diagnosis and management of serious neurological conditions through its innovative EEG platform [6] - The Ceribell System combines portable hardware with AI-powered algorithms to enable rapid diagnosis and continuous monitoring of neurological conditions, currently utilized in intensive care units and emergency rooms across the U.S. [6] Industry Impact - The FDA clearance is expected to significantly impact the lives of critically ill children, who are at high risk for preventable brain injury due to seizures [3] - Non-convulsive seizures, which can only be detected through EEG, require prompt identification and treatment to prevent brain injury, highlighting the importance of rapid EEG access [3]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $18.5 million, reflecting a 41% increase from $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%, compared to 85% in the prior year [34] - 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 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 [17] - The current market for seizure detection and management in the acute care setting is valued at $2 billion in the U.S. [29] Company Strategy and Development Direction - The company plans to expand its account acquisition team to 55 territory managers by mid-2025 [20] - Focus on optimizing algorithm performance and user experience while expanding indications beyond seizure management [22] - The company aims to make EEG a new vital sign, targeting various neurological conditions [24][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven with the current cash on hand and the strength of the balance sheet [41] - The company anticipates full-year 2025 total revenue to be in the range of $81 million to $85 million, representing annual growth of 24% to 30% over 2024 [37] - Management highlighted the importance of maintaining a strong margin profile despite increased operating expenses due to public company status [34][41] Other Important Information - The company has made significant strides in commercial growth and R&D pipeline development, impacting tens of thousands of patients [7][9] - The company has received breakthrough device designation from the FDA for its delirium detection algorithm [25] Q&A Session Summary Question: Guidance for 2025 and underlying assumptions - Management indicated that guidance reflects continued investment in sales infrastructure, expecting growth to be consistent with 2024 [46] Question: Strength of new account adds in Q4 - Management noted that the strength of account adds was due to good planning and early launches [50] Question: Thoughts on gross margin and OpEx spend in 2025 - Management expects gross margins to normalize in the mid to high 80% range and anticipates a significant increase in R&D expenses [54][56] Question: Update on stroke detection algorithm - Management reported encouraging results from the stroke study and plans to expand enrollment speed for data collection [70] Question: Utilization of headbands per account - Management expects an upward trajectory in usage, although purchasing patterns may vary [90] Question: Update on VA facilities - Management expressed optimism regarding interest from VA hospitals and hopes to share tangible milestones in the next quarter [97]

CeriBell, Inc. (NASDAQ:CBLL) Q4 2024 Earnings Conference Call February 25, 2025 4:30 PM ET Company Participants Brian Johnston - Gilmartin Group Xingjuan Chao - President and Chief Executive Officer Scott Blumberg - Chief Financial Officer Conference Call Participants Stephanie Piazzola - Bank of America Robert Marcus - JPMorgan Chase & Co. Macauley Kilbane - William Blair & Company Joshua Jennings - TD Cowen William Plovanic - Canaccord Genuity Corp. Operator Operator Hello, and thank you for standing by. ...

CeriBell (CBLL) Q4 2024 Earnings Call February 25, 2025 04:30 PM ET Company Participants Brian Johnston - Investor RelationsXingjuan Chao - Co-Founder, President, CEO & DirectorScott Blumberg - Chief Financial OfficerStephanie Piazzola - VP - Equity ResearchMacauley Kilbane - Equity Research AssociateJoshua Jennings - Managing DirectorWilliam Plovanic - Managing Director - Equity Research Conference Call Participants Robert Marcus - Analyst Operator thank you for standing by. At this time, I would like to w ...

Financial Performance - For the fiscal years ended December 31, 2024 and 2023, the company incurred net losses of $40.5 million and $29.5 million, respectively, with an accumulated deficit of $166.9 million as of December 31, 2024[156]. - The company has experienced fluctuations in quarterly revenues since its commercial launch, indicating potential volatility in future financial results[154]. - Macroeconomic conditions, including high inflation and interest rates, could adversely affect demand for the company's products and overall financial performance[193]. - Hospitals are under financial pressure due to staffing shortages and high inflation, which may impact their spending on equipment, affecting the company's sales[196]. - The company relies on adequate reimbursement from third-party payers for the sales of its products, and any changes in reimbursement policies could negatively impact sales[198]. - There is uncertainty regarding the future coverage and reimbursement for the company's products, which could limit marketability and revenue generation[202]. Operational Challenges - The company expects operating expenses to increase significantly over the next several years as it continues to expand operations and develop the Ceribell System and related algorithms[157]. - The company may face challenges in managing inventory levels, which could lead to excess inventory and impact gross margins[163]. - The company has grown to 281 employees in 2024, reflecting significant operational milestones since its founding in 2014[154]. - The company faces intense competition for qualified personnel, particularly in the medical device and EEG fields, which could affect its ability to attract and retain key talent[177]. - The company has experienced rapid growth, which could strain its personnel resources and infrastructure, potentially impacting its operational efficiency and costs[192]. Market Dynamics - Revenue from sales of the Ceribell System is expected to account for almost all of the company's revenue for the foreseeable future, making market acceptance critical for future success[159]. - The company faces competition from established conventional EEG systems, which have greater market share and resources, potentially impacting its market position[161]. - Estimates of the addressable market for the company's products may be overly optimistic, potentially leading to a smaller market than anticipated[189]. - The company may face decreased demand for its products if alternative therapies or technologies are discovered that are perceived as more effective or cost-efficient[190]. Regulatory and Compliance Issues - The company must comply with extensive FDA regulations for medical devices, which can be complex and burdensome, affecting operational capabilities[221]. - The company is subject to various healthcare fraud and abuse laws, and any non-compliance could result in significant penalties and adverse publicity[207]. - The company faces significant regulatory scrutiny regarding compliance with federal and state healthcare laws, which may restrict various business arrangements and incur substantial costs[209]. - Increased investigations and enforcement actions in the healthcare industry could lead to costly responses and management distraction, with potential liabilities under the federal False Claims Act[210]. - Non-compliance with healthcare laws may result in severe penalties, including fines, exclusion from government programs, and operational curtailment[211]. Supply Chain Risks - The company relies on international manufacturers and suppliers, exposing it to risks such as product delays and higher component prices[164]. - The company sources and manufactures a substantial number of products from third-party suppliers in China, relying on two primary contract manufacturers for headband production[169]. - The company relies on third-party manufacturers for components, which could lead to supply chain issues and affect the ability to meet demand[259]. - There are relatively few alternative sources for critical components and sub-assemblies, which could lead to significant delays in manufacturing operations[265]. - The company may face delays in the delivery of medical devices due to third-party manufacturers not complying with applicable regulations[243]. Intellectual Property Concerns - The company’s ability to protect its intellectual property rights is crucial for maintaining competitive advantage, with potential risks if patents cannot be adequately enforced[299]. - The patent prosecution process is complex and costly, with no guarantee that current or future applications will result in enforceable patents[303]. - The company may encounter difficulties in enforcing its intellectual property rights in foreign jurisdictions, which may not provide the same level of protection as U.S. laws[321]. - The company relies on licensed intellectual property rights, such as the "brain stethoscope" EEG sonification technology from Stanford University, which is crucial for its product development[342]. - The company may struggle to acquire necessary third-party intellectual property rights, which could hinder its ability to develop and commercialize products[344]. Technology and Innovation - The company must continuously innovate and develop new technologies to remain competitive, particularly in the rapidly evolving AI sector[173]. - The company is making significant investments in AI Technologies, including proprietary algorithms and models, to enhance the performance of its products like the Ceribell System[282]. - Future investments in AI Technologies are expected to increase, with no assurance that these investments will always enhance product efficiency or operational results[283]. - The regulatory framework for AI Technologies is rapidly evolving, which may lead to uncertainties in compliance and operational standards[288]. Marketing and Customer Education - The company must effectively educate healthcare professionals on the benefits of the Ceribell System to drive market acceptance and customer retention[160]. - Marketing initiatives are crucial for increasing market awareness of the Ceribell System, but there is a risk that these efforts may not yield the expected return on investment[182]. Clinical and Testing Challenges - Clinical testing for the Ceribell System is complex, lengthy, and expensive, with uncertain outcomes that may not replicate previous positive results[230]. - Patient enrollment and retention in clinical trials are influenced by various factors, and delays in these processes could increase costs and affect trial outcomes[233]. - The company relies on third-party researchers and clinical trial sites, and their performance is critical for timely and compliant trial execution[235].

Revenue Growth - Total revenue for Q4 2024 was $18.5 million, a 41% increase from $13.1 million in Q4 2023[4] - Full year 2024 revenue reached $65.4 million, a 45% increase compared to $45.2 million in 2023[8] - Product revenue for Q4 2024 was $14.1 million, up 41% from $10.0 million in Q4 2023[4] - Subscription revenue for Q4 2024 was $4.4 million, representing a 40% increase from $3.1 million in Q4 2023[4] - The company expects 2025 revenue to be in the range of $81 million to $85 million, representing growth of approximately 24% to 30%[13] Profitability and Loss - Gross profit for Q4 2024 was $16.2 million, with a gross margin of 88%, compared to 85% in Q4 2023[5] - Operating expenses for Q4 2024 were $29.1 million, a 49% increase from $19.5 million in Q4 2023[6] - Net loss for Q4 2024 was $12.6 million, or $0.40 per share, compared to a net loss of $8.3 million, or $1.53 per share, in Q4 2023[7] Financial Position - Total current assets increased significantly to $217,272 million in 2024 from $51,963 million in 2023, representing a growth of approximately 318%[22] - Cash and cash equivalents rose to $194,370 million in 2024, up from $34,495 million in 2023, marking an increase of about 465%[22] - Total liabilities increased to $34,247 million in 2024, compared to $23,762 million in 2023, reflecting a growth of approximately 44%[22] - The company reported an accumulated deficit of $(166,944) million in 2024, worsening from $(126,489) million in 2023[22] - Total stockholders' deficit expanded to $191,165 million in 2024, compared to $(112,252) million in 2023, indicating a significant increase in financial strain[22] - The number of issued and outstanding common shares increased to 35,850,606 in 2024 from 5,430,298 in 2023, representing a growth of approximately 560%[22] - Additional paid-in capital surged to $358,073 million in 2024, up from $14,232 million in 2023, indicating a substantial increase in equity financing[22] - Current liabilities decreased to $12,989 million in 2024 from $21,600 million in 2023, a reduction of approximately 40%[22] - Long-term liabilities rose to $21,258 million in 2024, compared to $2,162 million in 2023, reflecting an increase of about 884%[22] - The company has no redeemable convertible preferred stock as of December 31, 2024, compared to a liquidation preference of $152,590 million in 2023[22] Operational Highlights - The company ended 2024 with 529 total active accounts[8] - The company submitted a 510(k) application for the pediatric Clarity™ algorithm to the U.S. FDA[8]

Core Insights - Ceribell, Inc. reported a transformative year in 2024, focusing on becoming the standard of care for seizure management and executing key strategic initiatives, including an initial public offering [3] - The company aims to improve clinical outcomes for neurology patients and expand its indications to address unmet needs [3] Fourth Quarter 2024 Financial Results - Total revenue for Q4 2024 was $18.5 million, a 41% increase from $13.1 million in Q4 2023, driven by new account adoption and expansion within existing accounts [4] - Product revenue in Q4 2024 was $14.1 million, up 41% from $10.0 million in Q4 2023, while subscription revenue reached $4.4 million, a 40% increase from $3.1 million in Q4 2023 [4] - Gross profit for Q4 2024 was $16.2 million, with a gross margin of 88%, compared to $11.1 million and 85% in Q4 2023 [5] Operating Expenses and Net Loss - Operating expenses in Q4 2024 were $29.1 million, a 49% increase from $19.5 million in Q4 2023, primarily due to investments in the commercial organization and increased headcount [6] - The net loss for Q4 2024 was $12.6 million, or $0.40 per share, compared to a net loss of $8.3 million, or $1.53 per share, in Q4 2023 [7] Full Year 2024 Financial Results - Total revenue for the full year 2024 was $65.4 million, a 45% increase from $45.2 million in 2023, with product revenue at $50.1 million and subscription revenue at $15.4 million [8] - Gross profit for the full year 2024 was $56.8 million, with a gross margin of 87%, compared to $38.2 million and 84% in 2023 [9] - Operating expenses for the full year 2024 were $96.5 million, a 41% increase from $68.2 million in 2023, leading to a net loss of $40.5 million, or $3.39 per share [10] Cash Position - As of December 31, 2024, Ceribell had cash and cash equivalents totaling $194.4 million, a significant increase from $34.5 million at the end of 2023 [10] 2025 Financial Outlook - Ceribell expects revenue for the full year 2025 to be in the range of $81 million to $85 million, representing growth of approximately 24% to 30% over the previous year [11]