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Medtech Leader Erica Rogers Joins Ceribell Board of Directors
Globenewswire· 2025-09-22 12:00
Accomplished innovator and healthcare executive brings proven strategic leadership and expertise in scaling high-growth healthcare companiesSUNNYVALE, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell” or the “Company”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced the appointment of Erica Rogers to its Board of Directors. Ms. Rogers brings over three decades of experience ...
CeriBell (CBLL) FY Conference Transcript
2025-08-12 19:00
Summary of CeriBell (CBLL) FY Conference Call - August 12, 2025 Company Overview - **Company**: CeriBell (CBLL) - **Industry**: Medical Devices, specifically in neural monitoring and EEG technology - **Key Product**: Clarity, an AI-powered EEG hardware platform for seizure detection in acute care settings [2][3] Core Points and Arguments - **Market Opportunity**: The total addressable market (TAM) for seizure detection in the U.S. is over $2 billion, with a focus on ICU and emergency departments (ED) [3][4] - **Revenue Growth**: Last quarter's revenue was $21.2 million, with a year-over-year growth of 38% and a gross margin of 88% [3][4] - **Unmet Need**: Early and accurate seizure detection is critical, as one-third of neurological patients experience seizures, often without symptoms [4][5] - **Clinical Impact**: The device has shown to change physician decisions 40-50% of the time, significantly reducing ICU length of stay and patient transfers [11][12] - **Future Pipeline**: Plans to expand beyond seizure detection to include stroke, delirium, and potentially other neurological and psychiatric disorders [13][14] Financial Insights - **Growth Strategy**: The company is focused on account acquisition and same-store growth, with a current penetration of only 3% in the U.S. market [12][13] - **Investment in R&D**: Significant investments are being made in research and development to enhance product offerings and clinical evidence [57][58] Competitive Landscape - **Market Position**: CeriBell is the dominant player in the EEG market, having created the category and maintained leadership through superior product quality and clinical evidence [26][27] - **AI Advantage**: The company has accumulated data from over 200,000 patients, providing a strong foundation for its AI algorithms, which are continuously improved based on user feedback [29][30] Product Development - **New Features**: Plans to add features such as a camera for neonatal applications to improve EEG reading accuracy [32][34] - **Pediatric and Neonate Focus**: The company is targeting pediatric and neonatal populations, with significant opportunities in emergency departments [50][52] Sales and Marketing Strategy - **Sales Force Expansion**: The company has ramped up its sales force post-IPO, with a focus on training and productivity to drive account acquisition [36][39] - **Clinical Account Managers**: These managers are responsible for driving usage and educating hospital staff on the need for EEG monitoring [42][44] Barriers to Adoption - **Awareness and Approval Processes**: The main barriers to adoption include a lack of awareness and the lengthy hospital approval processes [54][55] Future Outlook - **Standard of Care**: The goal is to make EEG monitoring a standard vital sign in hospitals, supported by clinical evidence and partnerships [56][58] - **Cash Utilization**: The company plans to use its cash reserves to grow its commercial infrastructure, invest in R&D, and generate clinical evidence [57][58]
CeriBell (CBLL) Q2 Revenue Jumps 38%
The Motley Fool· 2025-08-06 18:52
CeriBell (CBLL -22.88%), the neurotechnology company specializing in rapid electroencephalography (EEG) and artificial intelligence for seizure detection, announced its results for Q2 2025 on August 5, 2025. The company’s revenue (GAAP) reached $21.2 million, up from $15.3 million in Q2 2024, outpacing the analyst consensus of $20.45 million (GAAP). Earnings per share (EPS, GAAP) were $(0.38), also better than the expected $(0.40) (GAAP). Despite significant top-line gains and a gross margin increase to 88% ...
CeriBell, Inc.(CBLL) - 2025 Q2 - Earnings Call Transcript
2025-08-05 21:30
Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $21.2 million, reflecting a 38% growth compared to $15.3 million in the same period last year [5][24] - Product revenue for 2025 was $15.9 million, representing a 38% increase from $11.6 million in 2024 [25] - Subscription revenue for 2025 was $5.3 million, showing a 41% increase from $3.7 million in 2024 [25] - Gross margin for 2025 was 88%, up from 86% in the prior year [26] - Net loss for 2025 was $13.6 million, or a loss of $0.38 per share, compared to a loss of $8.9 million, or a loss of $1.61 per share in 2024 [28] Business Line Data and Key Metrics Changes - The company had 584 active accounts as of June 30, 2025, an increase of 26 accounts during Q2 [6] - The core commercial strategy focuses on account acquisition and increased utilization of the seizure detection system [6][7] Market Data and Key Metrics Changes - The company is on track to expand coverage to 55 territories by the end of the month [7] - The company aims to become the standard of care for seizure management in the acute care setting, representing a $2 billion annual revenue opportunity in the U.S. alone [18] Company Strategy and Development Direction - The company is raising its full-year 2025 revenue guidance to between $85 million and $88 million, up from a previous range of $83 million to $87 million [9][28] - Investments are being made in commercial infrastructure and clinical account managers to support account launch and utilization expansion [7][9] - The company is also advancing efforts to expand awareness of its technology through clinician engagement and marketing initiatives [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the near and long-term growth trajectory, citing strong performance year-to-date [8] - The company is committed to achieving cash flow breakeven and believes its balance sheet supports this goal [28] - Management highlighted the importance of real-world value and clinical evidence in driving adoption of their technology [12][22] Other Important Information - The company filed a complaint against Natus Medical for patent infringement, seeking damages and injunctions [20][21] - The company is diversifying its supply chain by establishing a production line in Vietnam to mitigate trade risks [29] Q&A Session Summary Question: Update on account ads and utilization growth - Management noted good momentum in account acquisition but expects tangible growth to materialize next year due to the sales cycle [38] Question: Gross margin outlook - Management indicated that both mitigation strategies and favorable tariff rates are contributing to improved gross margins [40] Question: Seasonality in EEG utilization - Management confirmed reduced seasonal usage in Q2 and Q3, aligning with ICU census data [46] Question: Expense control and sales force deployment - Management stated that investments from the IPO will drive future growth, with a focus on maintaining consistent territory manager counts [50] Question: Utilization growth segmentation - Management explained that utilization growth is driven by departmental penetration, physician training, and protocolization initiatives [54] Question: Pediatric market updates - Management shared that they are making progress in pediatric hospitals and emergency departments, focusing on quality improvement projects [58] Question: Economic value proposition for delirium indication - Management highlighted parallels in health economics benefits between delirium and seizure management, focusing on reducing length of stay [63] Question: Legal costs related to ongoing litigation - Management expects ongoing legal costs to remain elevated in the coming quarters [72] Question: Manufacturing shift to Vietnam - Management clarified that the Vietnam facility will serve as an additional line to de-risk supply chain reliance on a single country [82]
CeriBell, Inc.(CBLL) - 2025 Q2 - Quarterly Report
2025-08-05 20:40
[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides CeriBell, Inc.'s unaudited condensed financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents CeriBell, Inc.'s unaudited condensed financial statements, including balance sheets, statements of operations and comprehensive loss, stockholders' equity, redeemable convertible preferred stock and stockholders' deficit, and cash flows, along with detailed notes explaining significant accounting policies, revenue recognition, fair value measurements, balance sheet details, employee benefits, commitments, leases, debt, warrants, stockholders' equity, net loss per share, and income taxes for the periods ended June 30, 2025, and December 31, 2024 [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time Balance Sheet Summary (in millions) | Assets/Liabilities | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :----------------- | :-------------------------- | :------------------------------ | | Total assets | $207.7 | $225.4 | | Total liabilities | $35.5 | $34.2 | | Total stockholders' equity | $172.2 | $191.2 | - Total assets decreased by **$17.7 million** from December 31, 2024, to June 30, 2025, primarily due to a significant reduction in cash and cash equivalents, partially offset by the introduction of marketable securities[19](index=19&type=chunk) - Cash and cash equivalents decreased from **$194.4 million** at December 31, 2024, to **$40.1 million** at June 30, 2025, while marketable securities increased from zero to **$137.3 million**[19](index=19&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance over specific periods, including revenue, gross profit, operating loss, and net loss Operations and Comprehensive Loss Summary (in millions, except per share data) | Metric (in millions) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenue | $21.2 | $15.3 | $41.7 | $29.7 | | Gross profit | $18.7 | $13.2 | $36.7 | $25.5 | | Loss from operations | $(15.0) | $(8.4) | $(29.2) | $(16.9) | | Net loss | $(13.6) | $(8.9) | $(26.4) | $(17.5) | | Basic and diluted net loss per share | $(0.38) | $(1.61) | $(0.73) | $(3.17) | - Total revenue increased by **38%** for the three months and **40%** for the six months ended June 30, 2025, compared to the same periods in 2024[21](index=21&type=chunk) - Net loss increased by **53%** for the three months and **51%** for the six months ended June 30, 2025, compared to the same periods in 2024, primarily due to higher operating expenses[21](index=21&type=chunk) [Condensed Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in the company's equity over time, reflecting net income/loss, stock issuances, and other equity transactions Stockholders' Equity Summary (in millions) | Metric (in millions) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Total Stockholders' Equity | $191.2 | $172.2 | | Accumulated Deficit | $(166.9) | $(193.4) | | Additional Paid-in Capital | $358.1 | $365.5 | - Stockholders' equity decreased by **$19.0 million** from December 31, 2024, to June 30, 2025, mainly due to a net loss of **$26.4 million**, partially offset by stock-based compensation and common stock issuances[24](index=24&type=chunk) [Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Deficit](index=9&type=section&id=Condensed%20Statements%20of%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Deficit) This section details the company's redeemable convertible preferred stock and the accumulated deficit, reflecting historical losses Redeemable Convertible Preferred Stock and Stockholders' Deficit Summary (in millions) | Metric (in millions) | December 31, 2023 | June 30, 2024 | | :-------------------- | :---------------- | :------------ | | Redeemable Convertible Preferred Stock Amount | $147.4 | $147.4 | | Total Stockholders' Deficit | $(112.3) | $(127.3) | | Accumulated Deficit | $(126.5) | $(144.0) | - The accumulated deficit increased from **$126.5 million** at December 31, 2023, to **$144.0 million** at June 30, 2024, primarily due to net losses incurred during the period[26](index=26&type=chunk) [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section presents the cash inflows and outflows from operating, investing, and financing activities over specific periods Cash Flow Summary (in millions) | Cash Flow Activity (in millions) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(18.9) | $(16.5) | | Net cash used in investing activities | $(137.3) | $(1.3) | | Net cash provided by financing activities | $2.0 | $7.7 | | Net decrease in cash and cash equivalents | $(154.2) | $(10.1) | | Cash and cash equivalents, end of period | $40.1 | $24.4 | - Net cash used in investing activities significantly increased in 2025 due to substantial purchases of marketable securities[29](index=29&type=chunk) - Net cash provided by financing activities decreased in 2025 compared to 2024, as 2024 included proceeds from debt issuance[29](index=29&type=chunk) [Notes to Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed financial statements, including accounting policies and specific account breakdowns [1. The Company](index=11&type=section&id=1.%20The%20Company) This note describes CeriBell, Inc.'s business, its financial position, and the inherent risks associated with its operations in the medical technology industry - CeriBell, Inc. is a commercial-stage medical technology company focused on neurological conditions, utilizing its Ceribell System, an AI-powered EEG platform for rapid diagnosis and continuous monitoring in acute care settings[31](index=31&type=chunk)[32](index=32&type=chunk)[115](index=115&type=chunk) - As of June 30, 2025, the Company had **$177.4 million** in cash and cash equivalents and marketable securities, and an accumulated deficit of **$193.4 million**, expecting to incur near-term losses due to product development and sales/marketing[33](index=33&type=chunk)[34](index=34&type=chunk)[121](index=121&type=chunk) - The Company faces risks common to the medical device industry, including technological innovations, third-party payer dependence, supply chain pressures, and adverse economic conditions, which could impact financial results[37](index=37&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk) [2. Summary of Significant Accounting Policies](index=13&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements, ensuring consistency and comparability - The financial statements are prepared in accordance with GAAP and SEC rules, reflecting normal recurring adjustments[43](index=43&type=chunk)[44](index=44&type=chunk) - A **1-for-2.57 reverse stock split** was effected on October 4, 2024, retroactively adjusting all share and per-share amounts[45](index=45&type=chunk) - The Company operates as one reportable segment, with all revenue generated in the United States[52](index=52&type=chunk)[53](index=53&type=chunk) - The Company extended the exclusivity of licensed patents from Stanford University to May 2036 for a **$0.25 million** fee, amortized to cost of revenue[54](index=54&type=chunk) [3. Revenue](index=17&type=section&id=3.%20Revenue) This note disaggregates revenue by type, detailing product and subscription revenue, and explains related accounting policies like contract costs Revenue by Type (in millions) | Revenue Type (in millions) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | EEG headbands | $15.9 | $11.6 | $31.5 | $22.6 | | EEG portal and Clarity subscriptions | $5.3 | $3.7 | $10.2 | $7.1 | | Total Revenue | $21.2 | $15.3 | $41.7 | $29.7 | - Product revenue increased by **38%** and subscription revenue by **41%** for the three months ended June 30, 2025, compared to the prior year[58](index=58&type=chunk) - Capitalized contract costs (sales commissions) increased to **$3.7 million** as of June 30, 2025, from **$2.9 million** as of June 30, 2024, amortized over an estimated three-year customer life[61](index=61&type=chunk) [4. Fair Value Measurements](index=18&type=section&id=4.%20Fair%20Value%20Measurements) This note provides information on assets and liabilities measured at fair value, categorized by valuation inputs (Level 1, 2, or 3) Fair Value of Assets (in millions) | Asset Type (in millions) | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :------------------------ | :------------------------- | :----------------------------- | | Money market funds (Level 1) | $36.2 | $178.9 | | U.S. Treasury Bills (Level 1/2) | $66.7 | — | | U.S. Notes and Bonds (Level 1/2) | $70.6 | — | | Total assets, at fair value | $173.5 | $178.9 | - The Company diversified its cash equivalents into marketable securities (U.S. Treasury Bills and Notes/Bonds) by June 30, 2025, which were not present at December 31, 2024[68](index=68&type=chunk)[70](index=70&type=chunk) [5. Balance Sheet Details](index=19&type=section&id=5.%20Balance%20Sheet%20Details) This note provides a detailed breakdown of specific balance sheet accounts, including inventory, property and equipment, and accrued liabilities Selected Balance Sheet Items (in millions) | Item (in millions) | June 30, 2025 | December 31, 2024 | | :------------------ | :------------ | :---------------- | | Inventory | $6.0 | $6.9 | | Property and Equipment, Net | $2.1 | $2.3 | | Other Non-Current Assets | $2.5 | $2.2 | | Accrued Liabilities | $10.4 | $10.1 | - Inventory decreased by **$0.9 million**, primarily in finished goods, from December 31, 2024, to June 30, 2025[71](index=71&type=chunk) - Accrued liabilities increased by **$0.4 million**, driven by higher professional fees and employee stock purchase plan liability, partially offset by lower accrued bonuses and commissions[75](index=75&type=chunk) [6. Employee Benefit Plan](index=21&type=section&id=6.%20Employee%20Benefit%20Plan) This note describes the company's employee benefit plan, including 401(k) contributions and related expenses - The Company began providing a **50% match** for employee 401(k) contributions starting March 1, 2025, contributing **$0.3 million** for the three months and **$0.5 million** for the six months ended June 30, 2025[76](index=76&type=chunk) [7. Commitments and Contingencies](index=21&type=section&id=7.%20Commitments%20and%20Contingencies) This note discloses the company's commitments and potential liabilities arising from legal proceedings or other contractual obligations - As of June 30, 2025, and December 31, 2024, there were no litigation liabilities recorded[77](index=77&type=chunk) [8. Leases](index=21&type=section&id=8.%20Leases) This note provides details on the company's operating leases, including right-of-use assets, lease liabilities, and lease expenses Lease Metrics (in millions, except years) | Lease Metric (in millions) | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Operating lease right-of-use asset | $1.7 | $2.1 | | Total operating lease liabilities | $1.9 | $2.4 | | Weighted average remaining lease term (years) | 1.6 | 2.1 | | Total lease expense (six months) | $0.7 | $0.6 | - Total operating lease liabilities decreased by **$0.53 million** from December 31, 2024, to June 30, 2025, with a weighted average remaining lease term of **1.6 years**[78](index=78&type=chunk) [9. Term Loan](index=23&type=section&id=9.%20Term%20Loan) This note details the company's term loan and revolving facility, including terms, interest rates, and collateral - The Company refinanced its existing term loan in February 2024 with a new Venture Loan and Security Agreement (VLSA) for **$20.0 million**, maturing in March 2029, and secured by all Company assets excluding intellectual property[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - The VLSA includes variable interest rates (Prime Rate for SVB Loan, Prime Rate + 2.75% for Horizon Loan) and end-of-term fees of **4.0%** per tranche[83](index=83&type=chunk) - A Senior Revolving Facility of up to **$10.0 million** was also executed, maturing in February 2026, with no amounts drawn as of June 30, 2025[86](index=86&type=chunk)[91](index=91&type=chunk) Notes Payable (in millions) | Notes Payable (in millions) | June 30, 2025 | December 31, 2024 | | :--------------------------- | :------------ | :---------------- | | Principal of notes payable | $20.0 | $20.0 | | Carrying value of Notes Payable | $19.7 | $19.6 | [10. Warrants](index=25&type=section&id=10.%20Warrants) This note provides information on warrants issued, their exercise price, and their conversion to common stock warrants - Warrants to purchase **41,345 shares** of Series C-1 Preferred Stock were issued in February 2024 as part of a **$60.0 million** financing commitment, with an exercise price of **$11.49** per share[93](index=93&type=chunk) - All warrants converted to common stock warrants immediately prior to the IPO on October 15, 2024, and are included in Additional paid-in capital[95](index=95&type=chunk)[94](index=94&type=chunk) Warrants Outstanding (shares) | Warrants (shares) | December 31, 2024 | June 30, 2025 | | :---------------- | :---------------- | :------------ | | Total warrants | 102,299 | 102,299 | [11. Stockholders' Equity](index=25&type=section&id=11.%20Stockholders'%20Equity) This note details the company's common stock authorization, shares reserved for equity plans, and stock-based compensation expense - The Company is authorized to issue **500 million shares** of $0.001 par value common stock[97](index=97&type=chunk) Reserved Common Stock (shares) | Reserved Common Stock (shares) | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Conversion of outstanding warrants | 102,299 | 102,299 | | Outstanding options | 4,907,780 | 5,708,070 | | Outstanding RSUs | 1,328,240 | 335,511 | | Shares reserved for future issuance under equity plans | 5,625,849 | 3,964,620 | | Total | 11,964,168 | 10,110,500 | - Total stock-based compensation expense for the six months ended June 30, 2025, was **$5.5 million**, a significant increase from **$1.8 million** in the prior year, reflecting increased headcount and public company costs[105](index=105&type=chunk) - The Company adopted an Employee Stock Purchase Plan (ESPP) in February 2025, with **810,195 shares** available for purchase as of June 30, 2025[106](index=106&type=chunk)[107](index=107&type=chunk) [12. Net loss attributable to common stockholders](index=29&type=section&id=12.%20Net%20loss%20attributable%20to%20common%20stockholders) This note presents the calculation of net loss per share, basic and diluted, for common stockholders Net Loss Attributable to Common Stockholders (in millions, except per share and share data) | Metric (in millions, except per share) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss attributable to common stockholders | $(13.6) | $(8.9) | $(26.4) | $(17.5) | | Weighted-average shares outstanding | 36,294 | 5,560 | 36,088 | 5,507 | | Net loss per share, basic and diluted | $(0.38) | $(1.61) | $(0.73) | $(3.17) | - Diluted net loss per share is the same as basic net loss per share due to the Company's net loss position, making potentially dilutive items anti-dilutive[108](index=108&type=chunk) [13. Income Taxes](index=31&type=section&id=13.%20Income%20Taxes) This note explains the company's income tax position, including its effective tax rate, valuation allowance, and the impact of recent tax legislation - The Company had an effective tax rate of **0.0%** for the three and six months ended June 30, 2025 and 2024, due to incurring operating losses[110](index=110&type=chunk) - A full valuation allowance is maintained against net deferred tax assets due to uncertainties surrounding their realization[111](index=111&type=chunk) - The recently enacted One Big Beautiful Bill Act (OBBB Act) on July 4, 2025, will introduce U.S. tax law amendments, the financial impact of which is currently being assessed[112](index=112&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on CeriBell, Inc.'s financial condition and operational results, highlighting the company's focus on its AI-powered Ceribell System for neurological conditions, key factors influencing performance, and a detailed comparison of financial results for the three and six months ended June 30, 2025 and 2024. It also discusses liquidity, funding requirements, contractual obligations, and critical accounting estimates [Overview](index=32&type=section&id=Overview) This overview introduces CeriBell, Inc.'s core business, its Ceribell System, market adoption, and financial outlook including accumulated deficit and expected future losses - CeriBell, Inc. is a medical technology company transforming neurological diagnosis and management with its Ceribell System, a point-of-care EEG platform integrating portable hardware and AI-powered algorithms[115](index=115&type=chunk)[117](index=117&type=chunk) - The Ceribell System is adopted by over **550 active accounts** and has been used for over **200,000 patients**, primarily focused on seizure detection in acute care settings[116](index=116&type=chunk) - The Company had an accumulated deficit of **$193.4 million** as of June 30, 2025, and expects continued losses due to investments in R&D, sales & marketing, and public company infrastructure[121](index=121&type=chunk)[122](index=122&type=chunk) [Our Business Model](index=34&type=section&id=Our%20Business%20Model) This section describes the key drivers of the company's financial performance, including market adoption, utilization, R&D investment, and expansion strategies - Key factors affecting results include adoption of the Ceribell System in new accounts (over **550 active accounts** as of June 30, 2025), utilization within the existing customer base, and investment in R&D for innovation and market expansion[123](index=123&type=chunk) - The Company aims to expand its direct sales organization in the U.S. and pursue international market access, targeting approximately **6,000 acute care facilities** in the U.S.[118](index=118&type=chunk)[123](index=123&type=chunk) - R&D efforts focus on enhancing the Ceribell System and expanding its application to other neurological conditions beyond seizures[123](index=123&type=chunk) [Components of our Results of Operations](index=36&type=section&id=Components%20of%20our%20Results%20of%20Operations) This section breaks down the revenue streams and expense categories that constitute the company's financial results, outlining their nature and expected trends - Revenue is generated from disposable headband sales (product revenue, recognized at point of time) and monthly subscription fees for Clarity, recorders, and the portal (subscription revenue, recognized ratably)[124](index=124&type=chunk) - Cost of revenue includes materials, labor for headbands, recorder depreciation, third-party hosting fees, and personnel expenses[126](index=126&type=chunk) - Operating expenses (R&D, Sales & Marketing, G&A) are expected to increase due to continued product development, commercial expansion, and public company operating costs[130](index=130&type=chunk)[132](index=132&type=chunk)[134](index=134&type=chunk) [Results of Operations for the Three and Six Months Ended June 30, 2025 and 2024](index=39&type=section&id=Results%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section provides a comparative analysis of the company's financial performance for the three and six months ended June 30, 2025 and 2024, detailing revenue, gross profit, and net loss Three Months Ended June 30 (in millions) | Metric (in millions) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | % Change (YoY) | | :-------------------- | :------------------------------- | :------------------------------- | :------------- | | Total revenue | $21.2 | $15.3 | 38% | | Product revenue | $15.9 | $11.6 | 38% | | Subscription revenue | $5.3 | $3.7 | 41% | | Gross profit | $18.7 | $13.2 | 42% | | Gross margin | 88% | 86% | 2% pts | | Loss from operations | $(15.0) | $(8.4) | 77% | | Net loss | $(13.6) | $(8.9) | 53% | Six Months Ended June 30 (in millions) | Metric (in millions) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | % Change (YoY) | | :-------------------- | :----------------------------- | :----------------------------- | :------------- | | Total revenue | $41.7 | $29.7 | 40% | | Product revenue | $31.5 | $22.6 | 39% | | Subscription revenue | $10.2 | $7.1 | 43% | | Gross profit | $36.7 | $25.5 | 44% | | Gross margin | 88% | 86% | 2% pts | | Loss from operations | $(29.2) | $(16.9) | 73% | | Net loss | $(26.4) | $(17.5) | 51% | - Sales and marketing expenses increased by **63%** for the three months and **67%** for the six months ended June 30, 2025, primarily due to increased headcount[146](index=146&type=chunk)[147](index=147&type=chunk) - General and administrative expenses rose by **49%** for the three months and **43%** for the six months, driven by increased personnel costs and professional fees related to public company operations and intellectual property enforcement[148](index=148&type=chunk)[149](index=149&type=chunk) - Interest and other income, net, significantly increased due to higher cash equivalents and marketable securities balances from IPO proceeds[150](index=150&type=chunk)[151](index=151&type=chunk) [Cash Flows](index=42&type=section&id=Cash%20Flows) This section analyzes the company's cash generation and usage across operating, investing, and financing activities for the reported periods Cash Flow Activities (in millions) | Cash Flow Activity (in millions) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(18.9) | $(16.5) | | Net cash used in investing activities | $(137.3) | $(1.3) | | Net cash provided by financing activities | $2.0 | $7.7 | - Net cash used in operating activities increased to **$18.9 million** in 2025, primarily due to the net loss, partially offset by non-cash charges[153](index=153&type=chunk) - Net cash used in investing activities surged to **$137.3 million** in 2025, mainly due to purchases of marketable securities[155](index=155&type=chunk) - Net cash provided by financing activities decreased to **$2.0 million** in 2025, compared to **$7.7 million** in 2024, which included significant debt issuance proceeds[156](index=156&type=chunk) [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its short-term and long-term financial obligations, including available cash, debt, and future funding needs - As of June 30, 2025, principal liquidity sources included **$177.4 million** in cash, cash equivalents, and marketable securities, and **$20.0 million** in term loans[160](index=160&type=chunk) - The Company believes existing cash and IPO proceeds will fund operations and capital expenditures for at least the next **12 months**, but may need additional capital for growth, R&D, or acquisitions[163](index=163&type=chunk) - Contractual obligations at June 30, 2025, included **$20.0 million** in long-term debt principal payments and **$2.0 million** in operating lease payments due within **19 months**[165](index=165&type=chunk) [Critical Accounting Estimates](index=46&type=section&id=Critical%20Accounting%20Estimates) This section highlights accounting estimates that require significant judgment and could materially impact the financial statements - The Company's financial statements rely on estimates and judgments, with no material changes to significant accounting policies or estimates during the six months ended June 30, 2025[166](index=166&type=chunk)[167](index=167&type=chunk) [Recently Issued Accounting Pronouncements](index=46&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section refers to the notes to financial statements for details on new accounting standards and their potential impact on the company - Refer to Note 2 of the financial statements for details on recently issued accounting pronouncements applicable to the Company[168](index=168&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to the Company for the reporting period - The Company has no applicable quantitative and qualitative disclosures about market risk for this reporting period[169](index=169&type=chunk) [Item 4. Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with CEO and CFO participation, evaluated the effectiveness of disclosure controls and procedures, concluding they were effective at a reasonable assurance level as of June 30, 2025. No material changes in internal control over financial reporting were identified, though the inherent limitations of control systems are acknowledged - Disclosure controls and procedures were evaluated as effective at a reasonable assurance level as of June 30, 2025[170](index=170&type=chunk) - No material changes in internal control over financial reporting were identified during the quarter ended June 30, 2025[171](index=171&type=chunk) - The effectiveness of internal controls is subject to inherent limitations, including judgment, human error, and potential for circumvention[172](index=172&type=chunk)[174](index=174&type=chunk) [PART II. OTHER INFORMATION](index=49&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and other disclosures [Item 1. Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) CeriBell, Inc. initiated patent infringement complaints against Natus Medical Incorporated on July 7, 2025, alleging infringement of six patents related to the Ceribell EEG headband and electrode design, and unfair competition. The Company seeks an exclusion order from the USITC and damages from the U.S. District Court - On July 7, 2025, CeriBell, Inc. filed patent infringement complaints against Natus Medical Incorporated with the USITC and the U.S. District Court for the District of Delaware[176](index=176&type=chunk) - The complaints allege infringement of **six patents** related to the Ceribell EEG headband and electrode design and unfair competition, seeking an exclusion order and damages[176](index=176&type=chunk) - The Company is not currently a party to any other litigation that would materially and adversely affect its business, but acknowledges that legal proceedings are costly and unpredictable[177](index=177&type=chunk) [Item 1A. Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks that could materially and adversely affect CeriBell, Inc.'s business, financial condition, results of operations, and prospects. These risks span business and industry challenges, regulatory compliance, reliance on third parties, data privacy, AI technology, intellectual property protection, financial and accounting matters, and common stock ownership [Business and Industry Risk Factors](index=49&type=section&id=Business%20and%20Industry%20Risk%20Factors) This section details risks related to the company's limited operating history, market acceptance, competitive landscape, supply chain, and macroeconomic conditions - The Company has a limited operating history and expects to incur substantial losses in the foreseeable future, with an accumulated deficit of **$193.4 million** as of June 30, 2025[179](index=179&type=chunk)[183](index=183&type=chunk) - Dependence on sales from the Ceribell System means failure to achieve substantial market acceptance or diminished confidence in products would harm the business[186](index=186&type=chunk) - The Company operates in a highly competitive industry, facing larger, more established conventional EEG providers and other rapid EEG system developers[190](index=190&type=chunk) - Reliance on international manufacturers and suppliers, particularly in China, exposes the Company to foreign operational risks, trade risks (e.g., tariffs, political instability), and supply chain disruptions[194](index=194&type=chunk)[195](index=195&type=chunk)[197](index=197&type=chunk)[202](index=202&type=chunk) - Inability to innovate at the pace of competitors, attract and retain key personnel, or manage rapid growth could adversely affect the business[205](index=205&type=chunk)[210](index=210&type=chunk)[223](index=223&type=chunk) - Macroeconomic conditions, including inflation and high interest rates, could negatively impact demand, increase costs, and affect hospital spending on equipment[227](index=227&type=chunk)[229](index=229&type=chunk)[230](index=230&type=chunk) [Risk Related to Regulatory Matters](index=65&type=section&id=Risk%20Related%20to%20Regulatory%20Matters) This section covers risks associated with healthcare reimbursement, fraud and abuse laws, FDA regulations, product safety, and international regulatory compliance - Adequate reimbursement for diagnostic tests using Ceribell System is critical; changes in coverage or reimbursement rates could diminish sales or profitability[232](index=232&type=chunk)[236](index=236&type=chunk) - The Company is subject to extensive federal and state fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA), and non-compliance could lead to substantial penalties, investigations, and reputational harm[241](index=241&type=chunk)[247](index=247&type=chunk) - Healthcare policy changes, including the Affordable Care Act and other cost-containment measures, could limit coverage or lower reimbursement for products[249](index=249&type=chunk)[252](index=252&type=chunk) - Failure to maintain marketing authorizations or timely obtain new ones for future products, or non-compliance with FDA regulations (e.g., QSR), could harm the business and lead to enforcement actions or product recalls[257](index=257&type=chunk)[275](index=275&type=chunk) - Products may cause adverse medical events (e.g., false alarms, skin irritation, infection hazards) requiring FDA reporting, and misuse or off-label use could lead to product liability suits and regulatory sanctions[276](index=276&type=chunk)[279](index=279&type=chunk)[283](index=283&type=chunk)[284](index=284&type=chunk) - Future international expansion will subject the Company to foreign regulatory requirements, which are complex and vary widely, potentially delaying market entry and increasing costs[289](index=289&type=chunk) [Risks Related to Our Reliance on Third Parties](index=85&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This section addresses risks stemming from dependence on third-party manufacturers, suppliers, clinical investigators, and service providers for critical aspects of the business - Manufacturing of the Ceribell System relies on third-party manufacturers in China and various component suppliers, exposing the Company to risks of supply chain disruptions, quality control issues, and increased costs[293](index=293&type=chunk)[294](index=294&type=chunk)[296](index=296&type=chunk) - Dependence on a limited number of single-source suppliers for critical components makes the Company vulnerable to supply shortages, price fluctuations, and delays in qualifying alternative sources[298](index=298&type=chunk)[299](index=299&type=chunk)[300](index=300&type=chunk) - Reliance on independent investigators and collaborators for preclinical studies and clinical trials means less direct control over conduct, timing, and data quality, potentially delaying marketing authorization[301](index=301&type=chunk)[302](index=302&type=chunk)[307](index=307&type=chunk) - The Company relies on contracted physicians for remote EEG reading services, and termination of these contracts could impact service provision to customers[309](index=309&type=chunk) [Data Privacy Risk Factors](index=89&type=section&id=Data%20Privacy%20Risk%20Factors) This section highlights risks related to evolving global data privacy laws, cybersecurity threats, data breaches, and the adequacy of insurance coverage - The Company is subject to evolving global data privacy and security laws (e.g., HIPAA, CCPA, EU GDPR, UK GDPR), and non-compliance could lead to significant penalties, reputational damage, and operational changes[310](index=310&type=chunk)[313](index=313&type=chunk)[314](index=314&type=chunk)[315](index=315&type=chunk) - Cybersecurity threats, information technology system failures, and data breaches could disrupt operations, lead to data loss, incur substantial costs for investigation and remediation, and harm reputation[329](index=329&type=chunk)[330](index=330&type=chunk)[332](index=332&type=chunk)[335](index=335&type=chunk) - Existing insurance policies may not fully cover potential claims related to security breaches, potentially exposing the Company to significant liabilities[336](index=336&type=chunk) [Risks Associated with AI and Machine Learning Models](index=93&type=section&id=Risks%20Associated%20with%20AI%20and%20Machine%20Learning%20Models) This section addresses risks inherent in the company's reliance on AI and machine learning models, including design flaws, data quality issues, misuse, and evolving regulatory frameworks - The Company's reliance on AI and machine learning models (e.g., Clarity algorithm) carries risks if models are incorrectly designed, trained on poor quality data, misused, or suffer unforeseen defects, potentially impacting product performance and reputation[319](index=319&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk) - An earlier version of the Clarity algorithm failed to detect seizures in certain ICU patients, highlighting performance limitations[323](index=323&type=chunk) - The regulatory framework for AI Technologies is rapidly evolving, with potential new laws and interpretations that could limit the Company's use of AI, increase operating expenses, and require significant resources for compliance[324](index=324&type=chunk)[328](index=328&type=chunk) [Risks Related to Our Intellectual Property](index=97&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section details risks concerning the company's ability to obtain, maintain, enforce, and protect its intellectual property, including patents, trade secrets, and licensed technology - Success depends on obtaining, maintaining, enforcing, and protecting intellectual property (patents, trademarks, trade secrets); failure could erode competitive advantage and harm the business[337](index=337&type=chunk)[338](index=338&type=chunk)[340](index=340&type=chunk) - Patent prosecution is expensive and uncertain; issued patents may be challenged, invalidated, or circumvented, and pending applications may not result in broad protection[339](index=339&type=chunk)[340](index=340&type=chunk)[345](index=345&type=chunk) - Changes in U.S. or foreign patent laws or their interpretations could diminish patent value and increase prosecution/enforcement costs[349](index=349&type=chunk)[352](index=352&type=chunk) - Enforcing intellectual property rights globally is challenging and expensive, as foreign laws may offer less protection, and proceedings can divert resources[357](index=357&type=chunk)[359](index=359&type=chunk)[361](index=361&type=chunk) - The Company may face intellectual property litigation or administrative proceedings, which are costly, time-consuming, and could result in substantial damages, injunctions, or invalidation of rights[362](index=362&type=chunk)[364](index=364&type=chunk)[365](index=365&type=chunk)[371](index=371&type=chunk) - Reliance on licensed intellectual property (e.g., from Stanford University) means rights are subject to license terms and potential termination, impacting product development and commercialization[378](index=378&type=chunk)[379](index=379&type=chunk) - Failure to protect trade secrets and confidential information through contracts and security measures could harm competitive position if disclosed or independently developed by competitors[383](index=383&type=chunk)[384](index=384&type=chunk)[387](index=387&type=chunk) - Use of third-party open source software components could require public disclosure of proprietary code or lead to litigation if license terms are not met[390](index=390&type=chunk)[391](index=391&type=chunk) - Licensed technology developed with U.S. government grants is subject to the Bayh-Dole Act, which includes domestic manufacturing requirements and potential 'march-in rights' that could limit exploitation[392](index=392&type=chunk)[393](index=393&type=chunk) [Risks Relating to Financial and Accounting Matters](index=118&type=section&id=Risks%20Relating%20to%20Financial%20and%20Accounting%20Matters) This section covers financial risks including limitations on NOL carryforwards, tax rate volatility, restrictive debt covenants, and exposure to uninsured cash deposits - The Company's ability to use its net operating loss (NOL) carryforwards (approximately **$127.1 million federal**, **$126.9 million state** as of December 31, 2024) may be limited by ownership changes under Sections 382 and 383 of the Internal Revenue Code[394](index=394&type=chunk)[396](index=396&type=chunk) - The effective tax rate may vary significantly due to changes in tax laws, regulations, accounting pronouncements, and the market price of common stock affecting share-based compensation tax benefits[397](index=397&type=chunk)[398](index=398&type=chunk) - Changes in tax laws, such as the Inflation Reduction Act and the OBBB Act, could adversely affect effective tax rates and financial condition[399](index=399&type=chunk)[400](index=400&type=chunk) - The venture loan and security agreement (VLSA) and revolving facility contain restrictive covenants that limit operational flexibility, and a breach could trigger immediate debt repayment[401](index=401&type=chunk)[402](index=402&type=chunk) - Cash deposits exceeding insured limits with financial institutions pose a risk of loss or delayed access to funds in case of institutional failure[403](index=403&type=chunk) [Risks Relating to Ownership of Our Common Stock](index=122&type=section&id=Risks%20Relating%20to%20Ownership%20of%20Our%20Common%20Stock) This section addresses risks for common stockholders, including market price volatility, dilution from future issuances, control by principal stockholders, and anti-takeover provisions - As an emerging growth company and smaller reporting company, reduced reporting requirements may make common stock less attractive to investors, potentially affecting market price and volatility[404](index=404&type=chunk)[406](index=406&type=chunk) - Operating as a public company incurs increased legal, accounting, and compliance costs, potentially lowering profits[409](index=409&type=chunk) - Failure to maintain effective internal control over financial reporting could erode investor confidence and lead to a decline in stock price[410](index=410&type=chunk) - The Company does not intend to pay dividends in the foreseeable future, meaning investor returns will depend on stock price appreciation[411](index=411&type=chunk) - Future securities issuances could significantly dilute existing stockholders' ownership and depress the market price of common stock[414](index=414&type=chunk) - Principal stockholders and management own approximately **60%** of common stock, enabling them to exert significant control over stockholder approval matters[416](index=416&type=chunk) - Provisions in charter documents and Delaware law could discourage takeovers and entrench management[417](index=417&type=chunk)[418](index=418&type=chunk) - The market price of common stock may be volatile due to various factors, including financial performance, competitor announcements, and general economic conditions[426](index=426&type=chunk) [General Risk Factors](index=131&type=section&id=General%20Risk%20Factors) This section covers broad risks such as those related to acquisitions, natural disasters, and the costs and unpredictability of legal and arbitration proceedings - Acquisitions or strategic partnerships could increase capital requirements, dilute stockholders, incur debt, and introduce integration risks[431](index=431&type=chunk)[432](index=432&type=chunk) - Natural disasters and catastrophic events, especially given facilities near earthquake faults in California, could severely disrupt operations and supply chains, with limited disaster recovery plans and no earthquake insurance[433](index=433&type=chunk)[437](index=437&type=chunk)[438](index=438&type=chunk) - Legal and arbitration proceedings may prevent business activities or incur significant costs, and insurance may not cover all potential losses[439](index=439&type=chunk)[440](index=440&type=chunk)[443](index=443&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=135&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports no unregistered sales of equity securities. It details the use of proceeds from the October 15, 2024 IPO, which generated $188.2 million net, allocated to sales and marketing, R&D (including delirium and ischemic stroke indications), and general corporate purposes, with no material change in intended use - No unregistered sales of equity securities occurred during the period[444](index=444&type=chunk) - The IPO on October 15, 2024, generated approximately **$188.2 million** in net proceeds[445](index=445&type=chunk) - IPO proceeds are used to fund sales and marketing, research and product development (including delirium and ischemic stroke indications), and general corporate purposes[446](index=446&type=chunk) - There has been no material change in the intended use of IPO proceeds[447](index=447&type=chunk) [Item 3. Defaults Upon Senior Securities](index=135&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities during the reporting period[448](index=448&type=chunk) [Item 4. Mine Safety Disclosures](index=135&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the Company - Mine safety disclosures are not applicable to the Company[449](index=449&type=chunk) [Item 5. Other Information](index=135&type=section&id=Item%205.%20Other%20Information) This section discloses Rule 10b5-1 trading plans adopted by certain officers. Dr. Josef Parvizi adopted and subsequently terminated a plan due to a clerical error, with no trades executed. Raymond Woo, Ph.D., adopted a plan for 120,008 shares Rule 10b5-1 Trading Plans | Name | Action | Date | Trading Arrangement | Total Shares to be Sold | Expiration Date | | :------------------------ | :---------- | :----------- | :------------------ | :---------------------- | :-------------- | | Josef Parvizi, M.D., Ph.D. | Adopt | May 22, 2025 | Rule 10b5-1 | 180,000 | April 30, 2026 | | Josef Parvizi, M.D., Ph.D. | Terminate | June 25, 2025| Rule 10b5-1 | 180,000 | April 30, 2026 | | Raymond Woo, Ph.D. | Adopt | May 28, 2025 | Rule 10b5-1 | 120,008 | May 19, 2026 | - Dr. Josef Parvizi's Rule 10b5-1 trading plan, adopted on May 22, 2025, was terminated on June 25, 2025, due to a clerical error, with no trades executed[450](index=450&type=chunk)[451](index=451&type=chunk) - Raymond Woo, Ph.D., Chief Technology Officer, adopted a Rule 10b5-1 trading plan on May 28, 2025, for **120,008 shares**[450](index=450&type=chunk) [Item 6. Exhibits](index=135&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including organizational documents, certifications, and XBRL-related documents. It notes that certain portions of Exhibit 10.1 have been omitted as non-material and confidential - Exhibits include Amended and Restated Certificate of Incorporation and Bylaws, Form of Common Stock Certificate, and an Amendment to the Exclusive (Equity) Agreement with Stanford University[452](index=452&type=chunk)[453](index=453&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer are included pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[453](index=453&type=chunk)[454](index=454&type=chunk) - XBRL Instance Document, Taxonomy Extension Schema, and Cover Page Interactive Data File are provided[453](index=453&type=chunk) [Signatures](index=138&type=section&id=Signatures) This section contains the required signatures for the Quarterly Report on Form 10-Q, affirming its submission on behalf of CeriBell, Inc. by its President and Chief Executive Officer, Xingjuan (Jane) Chao, Ph.D., and Chief Financial Officer, Scott Blumberg, on August 5, 2025 - The report is signed by Xingjuan (Jane) Chao, Ph.D., President and Chief Executive Officer, and Scott Blumberg, Chief Financial Officer, on August 5, 2025[458](index=458&type=chunk)[459](index=459&type=chunk)
CeriBell, Inc.(CBLL) - 2025 Q2 - Quarterly Results
2025-08-05 20:14
[Executive Summary & Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Highlights) Ceribell achieved strong Q2 2025 results with 584 active accounts and an 88% gross margin, anticipating continued growth in H2 2025 [Second Quarter 2025 & Recent Highlights](index=1&type=section&id=Second%20Quarter%202025%20%26%20Recent%20Highlights) Ceribell reported strong Q2 2025 results with 584 active accounts and 88% gross margin, projecting continued growth through H2 2025 - Ceribell reported strong second quarter results, reflecting successful commercial execution and accelerated adoption of the Ceribell System across new and existing accounts, aiming for continued growth in H2 2025 by reaching more patients, advancing its pipeline, reinforcing category leadership, and establishing EEG as a new vital sign[2](index=2&type=chunk) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :----- | :-------------------- | :-------------------- | :----------- | | Total Revenue | $21.2 | $15.3 | +38% | | Gross Margin | 88% | 86% | +2 ppts | | Total Active Accounts | 584 | N/A | N/A | [Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) Ceribell saw significant Q2 2025 financial growth with 38% revenue increase and 88% gross margin, despite a 56% rise in operating expenses leading to a higher net loss [Revenue Performance](index=1&type=section&id=Revenue%20Performance) Q2 2025 total revenue grew **38% to $21.2 million**, driven by strong product and subscription revenue from new and existing accounts | Revenue Type | Q2 2025 (in millions) | Q2 2024 (in millions) | YoY Growth | | :----------- | :-------------------- | :-------------------- | :--------- | | Total Revenue | $21.2 | $15.3 | 38% | | Product Revenue | $15.9 | $11.6 | 38% | | Subscription Revenue | $5.3 | $3.7 | 41% | [Gross Profit and Margin](index=1&type=section&id=Gross%20Profit%20and%20Margin) Q2 2025 gross profit rose to **$18.7 million**, with gross margin improving by **2 percentage points to 88%** | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YoY Change (in millions) | | :----- | :-------------------- | :-------------------- | :----------------------- | | Gross Profit | $18.7 | $13.2 | +$5.5 | | Gross Margin | 88% | 86% | +2 ppts | [Operating Expenses](index=1&type=section&id=Operating%20Expenses) Operating expenses surged **56% to $33.6 million** in Q2 2025, driven by commercial investments, headcount growth, legal costs, and public company operations | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YoY Change | | :----- | :-------------------- | :-------------------- | :--------- | | Operating Expenses | $33.6 | $21.6 | +56% | - The increase in operating expenses was primarily driven by investments in the commercial organization, increased headcount to support business growth, legal expenses, and costs related to operating as a public company[5](index=5&type=chunk) [Net Loss and Cash Position](index=1&type=section&id=Net%20Loss%20and%20Cash%20Position) Ceribell's Q2 2025 net loss increased to **$13.6 million**, while maintaining a strong liquidity position of **$177.4 million** in cash and equivalents | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | | :----- | :-------------------- | :-------------------- | | Net Loss | $(13.6) | $(8.9) | | Net Loss per Share | $(0.38) | $(1.61) | | Metric | As of June 30, 2025 (in millions) | | :----- | :-------------------------------- | | Cash, Cash Equivalents, and Marketable Securities | $177.4 | [2025 Financial Outlook](index=1&type=section&id=2025%20Financial%20Outlook) Ceribell raised its full-year 2025 revenue guidance to **$85 million - $88 million**, projecting **30% to 34%** year-over-year growth | Metric | Full Year 2025 Guidance (in millions) | YoY Growth | | :----- | :------------------------------------ | :--------- | | Total Revenue | $85 - $88 | 30% - 34% | [Webcast and Conference Call Details](index=1&type=section&id=Webcast%20and%20Conference%20Call%20Details) Ceribell held a conference call on August 5, 2025, to discuss Q2 2025 results, with webcast and call-in details provided - Ceribell hosted a conference call on August 5, 2025, at 1:30 p.m. PT / 4:30 p.m. ET to discuss Q2 2025 financial results, with access provided via dialing (800) 715-9871 (domestic) or (646) 307-1963 (international) with access code 7468193, and a webcast available on the investor relations section of their website[8](index=8&type=chunk)[9](index=9&type=chunk) [About Ceribell, Inc.](index=2&type=section&id=About%20CeriBell%2C%20Inc.) Ceribell is a medical technology company transforming neurological condition diagnosis and management with its FDA-cleared, AI-powered Ceribell System - Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions[11](index=11&type=chunk) - The company developed the Ceribell System, a novel, point-of-care EEG platform combining proprietary, highly portable, and rapidly deployable hardware with sophisticated AI-powered algorithms, FDA-cleared for detecting suspected seizure activity and utilized in ICUs and emergency rooms across the U.S[11](index=11&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements subject to risks and uncertainties, where actual results may differ materially from projections - The earnings release contains forward-looking statements regarding anticipated financial performance, business plans, and product expectations, which are subject to substantial risks, uncertainties, and potentially inaccurate assumptions, with factors such as limited operating history, market acceptance, competitive pressures, and regulatory compliance potentially causing actual results to differ, as detailed in SEC filings[10](index=10&type=chunk) [Investor and Media Contacts](index=2&type=section&id=Investor%20and%20Media%20Contacts) Contact information is provided for investor relations via Gilmartin Group and for media inquiries through Corrie Rose - For investor inquiries, contact Brian Johnston or Laine Morgan at Gilmartin Group via Investors@ceribell.com; for media inquiries, contact Corrie Rose via Press@ceribell.com[12](index=12&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) This section presents Ceribell's unaudited condensed financial statements, including Statements of Operations and Balance Sheets for specified periods [Condensed Statements of Operations and Comprehensive Loss](index=3&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Unaudited statements show a Q2 2025 net loss of **$13.6 million** and a six-month net loss of **$26.4 million**, driven by higher revenue and operating expenses | Metric (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Revenue | $21,199 | $15,315 | $41,690 | $29,715 | | Gross Profit | $18,682 | $13,159 | $36,689 | $25,501 | | Total Operating Expenses | $33,634 | $21,594 | $65,848 | $42,389 | | Loss from Operations | $(14,952) | $(8,435) | $(29,159) | $(16,888) | | Net Loss | $(13,643) | $(8,941) | $(26,420) | $(17,462) | | Basic and Diluted Net Loss per Share | $(0.38) | $(1.61) | $(0.73) | $(3.17) | [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Unaudited balance sheets show total assets of **$207.7 million** as of June 30, 2025, a decrease from year-end 2024, with reduced cash and increased marketable securities | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and Cash Equivalents | $40,141 | $194,370 | | Marketable Securities | $137,287 | $0 | | Total Current Assets | $199,786 | $217,272 | | Total Assets | $207,689 | $225,412 | | Total Current Liabilities | $15,014 | $12,989 | | Total Liabilities | $35,534 | $34,247 | | Total Stockholders' Equity | $172,155 | $191,165 |
Ceribell Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-05 20:05
SUNNYVALE, Calif., Aug. 05, 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 reported financial results for the quarter ended June 30, 2025. Second Quarter 2025 & Recent Highlights Reported total revenue of $21.2 million in the second quarter of 2025, a 38% increase compared to the same period in 2024Achieved gross margin of 88% in the second quarter ...
Ceribell to Participate in the Canaccord Genuity 45th Annual Growth Conference
Globenewswire· 2025-07-29 20:05
Company Overview - Ceribell, Inc. is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions [3] - The company has developed the Ceribell System, a novel point-of-care electroencephalography (EEG) platform designed for acute care settings [3] - The Ceribell System combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring of neurological conditions [3] - The system is FDA-cleared for detecting suspected seizure activity and is currently used in intensive care units and emergency rooms across the U.S. [3] Upcoming Event - Jane Chao, Ph.D., CEO and Co-founder of Ceribell, will present at the Canaccord Genuity 45 Annual Growth Conference [1] - The presentation is scheduled for Tuesday, August 12, 2025, at 11:00 a.m. Pacific Standard Time / 2:00 p.m. Eastern Standard Time [2] - A live and archived webcast of the presentation will be available on the Ceribell website [2]
Ceribell to Report Second Quarter 2025 Financial Results on August 5, 2025
Globenewswire· 2025-07-22 20:05
Company Overview - CeriBell, Inc. is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions [3] - The company has developed the Ceribell System, a novel point-of-care electroencephalography (EEG) platform designed for acute care settings [3] - The Ceribell System combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring of neurological conditions [3] - The system is FDA 510(k) cleared for indicating suspected seizure activity and is currently used in intensive care units and emergency rooms across the U.S. [3] Financial Results Announcement - CeriBell will release its financial results for the second quarter of 2025 after the close of trading on August 5, 2025 [1] - A conference call to discuss the financial results will begin at 1:30 p.m. PT / 4:30 p.m. ET on the same day [1] Investor Information - Investors can listen to the conference call by dialing (800) 715-9871 for domestic callers or (646) 307-1963 for international callers, using access code 7468193 [2] - A live and archived webcast of the event will be available in the "Investor Relations" section of the Ceribell website [2]
Ceribell Files Complaints Against Natus Medical Incorporated with the U.S. International Trade Commission and Federal Court in Delaware
Globenewswire· 2025-07-07 20:42
Core Viewpoint - Ceribell, Inc. has filed complaints against Natus Medical Incorporated for patent infringement related to point-of-care EEG technology, seeking an investigation and exclusion order from the USITC to prevent the importation of infringing products [1][2]. Company Overview - Ceribell is a medical technology company focused on transforming the diagnosis and management of serious neurological conditions, having developed a novel point-of-care EEG platform [5][6]. - The Ceribell System combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring of neurological conditions, and is FDA-cleared for indicating suspected seizure activity [5]. Legal Actions - Ceribell has filed a complaint with the U.S. International Trade Commission and the U.S. District Court in Delaware, alleging that Natus infringes on six of its patents related to EEG headband and electrode design [1][2]. - The company emphasizes its commitment to fair competition and the protection of its intellectual property to continue delivering innovative products [3].