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iCAD(ICAD) - 2025 Q1 - Quarterly Report
2025-05-13 20:33
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-09341 iCAD, Inc. (Exact name of registrant as specified in its charter) Delaware 02-0377419 (State or other ju ...
iCAD(ICAD) - 2025 Q1 - Quarterly Results
2025-05-13 20:11
Exhibit 99.1 iCAD Reports Financial Results for First Quarter Ended March 31, 2025 NASHUA, N.H. – May 13, 2025 – iCAD, Inc. (NASDAQ: ICAD) ("iCAD" or the "Company") a global leader on a mission to create a world where cancer can't hide by providing clinically proven AI-powered breast health solutions, today reported its financial and operating results for the three months ended March 31, 2025. First Quarter 2025 Highlights (Year over Year Performance): Dana Brown, President and CEO of iCAD commented, "We sa ...
iCAD Reports Financial Results for First Quarter Ended March 31, 2025
GlobeNewswire News Room· 2025-05-13 20:01
NASHUA, N.H., May 13, 2025 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD) ("iCAD" or the "Company") a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered breast health solutions, today reported its financial and operating results for the three months ended March 31, 2025. First Quarter 2025 Highlights (Year over Year Performance): Total ARR (Annual Recurring Revenue) was $10.7 million, up 18% year over yearQ1 total revenues of $4.9 millionGross Prof ...
iCAD Collaborates with Microsoft to provide access to its Mammography Solutions in Microsoft’s Precision Imaging Network (PIN)
Globenewswire· 2025-04-29 12:00
iCAD collaborates with Microsoft to offer radiology providers the option for automated patient reporting on mammography results through PowerScribe integration About iCAD, Inc. NASHUA, N.H., April 29, 2025 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD) ("iCAD" or the "Company"), a global leader in clinically proven AI-powered cancer detection solutions, announced today a collaboration with Microsoft, to include a set of AI-powered mammography solutions in iCAD's ProFound Breast Health Suite on Microsoft's Pr ...
$HAREHOLDER ALERT: The M&A Class Action Firm Investigates the Merger of iCAD, Inc. - ICAD
Prnewswire· 2025-04-16 22:20
Group 1 - Monteverde & Associates PC is investigating iCAD, Inc. in relation to its proposed merger with RadNet, Inc., where iCAD stockholders will receive 0.0677 shares of RadNet common stock for each share of iCAD common stock held at the closing of the merger [1] - Monteverde & Associates PC has a successful track record in recovering millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report [1] - The firm operates from the Empire State Building in New York City and is a national class action securities firm with experience in trial and appellate courts, including the U.S. Supreme Court [2][3] Group 2 - The firm encourages shareholders with concerns regarding iCAD, Inc. to visit their website or contact them for additional information free of charge [3] - Monteverde & Associates PC emphasizes that no company, director, or officer is above the law, reinforcing their commitment to shareholder rights [3] - The firm provides a platform for potential clients to inquire about their litigation history and success in recovering funds for shareholders [4]
RadNet, Inc. to Acquire iCAD, Inc. to Accelerate AI-Powered Early Detection and Diagnosis of Breast Cancer
Newsfilter· 2025-04-15 20:01
Core Viewpoint - RadNet, Inc. has announced a definitive merger agreement to acquire iCAD, Inc. in an all-stock transaction valued at approximately $103 million, representing a significant premium for iCAD stockholders [1][2]. Group 1: Merger Details - iCAD stockholders will receive 0.0677 shares of RadNet common stock for each share of iCAD common stock they hold at the closing of the merger, equating to about $3.61 per share on a fully diluted basis [2]. - The transaction is expected to close in the second or third quarter of 2025, pending approval from iCAD stockholders and other customary closing conditions [3]. Group 2: Strategic Rationale - The merger aims to enhance patient diagnosis and outcomes in breast cancer detection through the combined capabilities of iCAD's ProFound Breast Health Suite and RadNet's DeepHealth AI-powered solutions [3]. - The acquisition will expand RadNet's existing network, which includes over 1,500 healthcare provider locations and facilitates over 8 million annual mammograms across 50 countries [3][5]. Group 3: Leadership Comments - Dr. Howard Berger, CEO of RadNet, emphasized the potential to improve global breast cancer diagnosis and outcomes through this merger [3]. - Dana Brown, CEO of iCAD, highlighted the opportunity to redefine disease detection and treatment, aiming to enhance access to advanced tools and improve patient care [3]. Group 4: Future Plans - Following the acquisition, iCAD will be integrated into RadNet's DeepHealth portfolio, which is expected to accelerate growth and leadership in cancer screening and artificial intelligence [5]. - RadNet plans to host an investor conference call to discuss the transaction details, indicating a commitment to transparency and stakeholder engagement [4][5].
iCAD Expands Executive Leadership with Appointment of Mark Koeniguer as Chief Commercial Officer
Globenewswire· 2025-04-08 14:19
Core Viewpoint - iCAD, Inc. has appointed Mark Koeniguer as Chief Commercial Officer to drive global growth and enhance its AI-powered breast health solutions [1][2]. Company Overview - iCAD, Inc. is a leader in providing AI-powered solutions for early cancer detection, particularly in breast health, with its ProFound Breast Health Suite used in over 50 countries [5]. - The company has estimated that it has read more than 40 million mammograms in the last five years, with nearly 30% being tomosynthesis [5]. Leadership Appointment - Mark Koeniguer brings over 30 years of experience in MedTech, AI, and digital health, previously serving as CEO of ScreenPoint Medical, where he increased annual recurring revenue by 400% [3]. - In his role as CCO, Koeniguer will oversee commercial sales teams, partnerships, operations, and customer success, focusing on revenue growth in North America and globally [2][4]. Strategic Goals - The appointment of Koeniguer is aimed at better engaging with global health providers and enhancing clinical workflows and patient experiences [4]. - The leadership believes Koeniguer's expertise in radiological health and AI solutions will be instrumental in advancing iCAD's mission to transform breast cancer detection [4].
iCAD(ICAD) - 2024 Q4 - Annual Report
2025-03-31 21:07
Financial Performance - The Company incurred a net loss of approximately $5.6 million in 2024, with an accumulated deficit of approximately $277 million as of December 31, 2024[146]. - The Company's quarterly and annual operating and financial results are likely to fluctuate significantly due to various external factors[147]. - The Company expects its cash and cash equivalents of $17.2 million as of December 31, 2024, to fund operations for at least the next twelve months[148]. - The company reported goodwill of $8.4 million as of December 31, 2024, which is subject to impairment assessments that could adversely affect future earnings[172]. - Approximately 14% of the Company's revenue for the fiscal year ended 2024 was derived from customers outside of the U.S., primarily in Europe[182]. - The company sold 1,057,814 shares of its common stock at a weighted average price of $2.18 per share, resulting in cash proceeds of $2.0 million for the year ended December 31, 2023[243]. Revenue and Market Risks - The Company has paused U.S. sales of its ProFound AI® Risk product pending FDA regulatory clearance, which may impact future revenue[152]. - The markets for the Company's products may not develop as expected, leading to barriers in achieving broad market acceptance[156]. - The Company relies on a limited number of customers for a significant portion of its total revenue, making it vulnerable to the loss of key clients[146]. - The company's revenue from OEM partners accounted for 26% of total revenue in 2024, with GE Healthcare contributing 17%[170]. - The market for full field digital mammography systems and related products is crucial for the company's future growth, but may not develop as anticipated due to economic conditions and reimbursement issues[169]. - The healthcare industry consolidation could reduce the Company's potential customer base and demand for its systems, impacting revenue generation[188]. Operational and Compliance Risks - The Company faces legal, business, and operational risks associated with the use of AI and machine learning technologies in its offerings[146]. - The Company may be exposed to significant product liability claims, which could harm its reputation and financial condition[160]. - The Company must comply with Nasdaq's continued listing requirements, including maintaining a minimum closing bid price of $1.00 per share[196]. - The healthcare industry is subject to extensive regulation, and non-compliance could result in significant costs, including fines and exclusion from government healthcare programs[205]. - The Company’s CAD systems are classified as medical devices and are subject to extensive FDA regulation, which includes manufacturing operations and product labeling[214]. - Regulatory changes or challenges could adversely affect the Company’s ability to commercialize existing and future products, impacting revenue generation[212]. - The Company may face substantial costs related to compliance with evolving privacy and data protection laws, including HIPAA[226]. - The Company’s operations are subject to audits and investigations from government agencies, which could disrupt business and lead to significant defense costs[209]. - The Company may incur substantial expenses if claims arise regarding the wrongful use or disclosure of confidential information by its employees[187]. - Compliance with healthcare fraud and abuse laws could restrict the Company’s sales and marketing practices, leading to potential legal and financial repercussions[211]. Strategic and Developmental Challenges - The Company is transitioning to a software as a service (SaaS) model, which may impact revenue recognition and cash flow[141]. - The Company is transitioning to a subscription licensing model, which may lead to unpredictable revenue due to limited operating history with this model[171]. - The Company is developing a new product in collaboration with Solis to detect BAC using mammography, but regulatory approval and market acceptance are uncertain[164]. - The Company’s ability to adapt to evolving technologies is critical, as failure to do so may render its products obsolete and negatively impact business[176]. - Clinical trials are expensive and lengthy, with uncertain outcomes that could delay regulatory approvals and revenue generation[189]. - Strategic transactions, such as acquisitions or joint ventures, could disrupt operations and may not yield the anticipated benefits[220]. Financial and Market Conditions - The Company may need to seek additional capital sooner than planned to fund product development and commercialization[149]. - The Company may experience fluctuations in its effective tax rate due to various factors, including changes in geographic earnings mix and tax law changes[173]. - The Company is exposed to competitive pressures from larger firms with greater resources, which could adversely affect its market position[178]. - Changes in credit ratings could lead to increased borrowing costs and limit financing options, potentially affecting the Company's operational flexibility[253]. - Unfavorable global economic conditions, including geopolitical events and inflationary pressures, could weaken demand for the Company's products and impact capital raising efforts[254]. - The Trump administration's proposed tariffs on imports from various countries could significantly affect the U.S. healthcare industry, with potential downstream impacts on the Company[255]. Cybersecurity and Data Protection - The Company faces risks related to cybersecurity incidents that could compromise customer data and result in significant liabilities[247]. - The Company may face significant capital expenditures to protect against security breaches and hackers due to vulnerabilities in its infrastructure and systems[180]. - The European Union's General Data Protection Regulation (GDPR) imposes penalties of up to 4% of worldwide revenue for non-compliance[234]. - The EU AI Act, published in 2024, may impose fines of up to 7% of worldwide annual turnover for breaches related to AI regulations[232]. - The Company is subject to complex regulations regarding AI and machine learning, which may require operational changes and increase costs[232]. Management and Governance - The Company underwent management changes, including the Chief Executive Officer and Chief Financial Officer, during the year ended December 31, 2023[192]. - The Company is classified as a "smaller reporting company," which may make its stock less attractive to investors due to reduced disclosure requirements[244]. - Future issuances of common stock may cause significant dilution of existing shareholders' equity interests[242]. - The Company has the ability to issue up to 1,000,000 shares of preferred stock, which could affect existing stockholders' rights[237]. - The Company's stock price has experienced volatility, which may impair its ability to finance strategic transactions[240]. - The Company is required to assess the effectiveness of its internal controls over financial reporting as per Section 404 of the Sarbanes-Oxley Act, dedicating significant resources for compliance for the year ended December 31, 2024[252].
iCAD(ICAD) - 2024 Q4 - Earnings Call Transcript
2025-03-19 23:00
Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $5.4 million, an increase of 14% compared to Q4 2023, while full-year revenue reached $19.6 million, up from $17.3 million in 2023 [34] - Annual Recurring Revenue (ARR) grew to $9.8 million at the end of Q4 2024, up from $8.8 million at the end of Q4 2023, reflecting strong customer demand [31] - Gross profit margin for Q4 2024 was 86%, down from 91% in Q4 2023, primarily due to a one-time benefit in Q4 2023 and amortization of cloud product costs [36] Business Line Data and Key Metrics Changes - Product revenue for Q4 2024 was $3.7 million, a 24% increase year-over-year, while service revenue remained flat at $1.7 million [34] - Maintenance Services ARR declined to $6.4 million from $7.1 million year-over-year, driven by customer migration to subscription and cloud offerings [32] - Subscription ARR increased to $2.6 million from $1.7 million year-over-year, indicating a successful transition to recurring revenue models [32] Market Data and Key Metrics Changes - The adoption of AI in breast cancer detection is still low, with only 37% of mammography sites in the U.S. currently utilizing AI, but this is expected to change as providers recognize the benefits [8] - The company closed 106 deals in Q4 2024, including 54 perpetual, 33 subscription, and 19 cloud deals, indicating a growing preference for cloud solutions [12] Company Strategy and Development Direction - The company is focused on expanding its SaaS footprint and driving innovation in AI solutions, positioning itself for long-term growth [12][18] - The transition to a recurring revenue model is expected to enhance financial predictability and stability, despite potential short-term impacts on GAAP revenue recognition [21][22] - Partnerships with organizations like Olea and Koios Medical are aimed at enhancing the end-to-end AI-powered approach to breast cancer screening and detection [14][65] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term benefits of the SaaS transition, despite acknowledging short-term headwinds to revenue and cash flow [29][30] - The company anticipates continued momentum in cloud adoption and regulatory approvals, positioning itself to capture a growing share of the market [103][104] Other Important Information - The company received FDA clearance for ProFound Detection version 4.0, which improves cancer detection and reduces false positives, enhancing workflow efficiency [10][11] - The ProFound Cloud platform processed nearly 100,000 cases in its first two quarters of availability, demonstrating rapid adoption [24] Q&A Session Summary Question: Outlook for CapEx environment and cloud deal count - Management noted that Q4 had strong execution by the sales team, with some deals pulled forward from Q1, and expects continued momentum in cloud adoption [42][44] Question: Early reactions to ProFound Detection version 4.0 - Management reported that the accuracy of version 4.0 is performing better in clinical practice than during FDA submission, indicating positive early feedback [46][48] Question: Impact of partnerships on business - Management explained that partnerships are driven by customer requests and are aimed at enhancing the patient care journey, with ongoing evaluations of market dynamics [64][66] Question: Operating expenses outlook - Management indicated that operating expenses may not remain flat and that there are several initiatives planned for the future [72][75] Question: ARR dynamics and future growth - Management expects continued growth in ARR driven by cloud business and a shift in deal mix towards subscription and cloud offerings [79][80] Question: Adoption impact of ProFound Detection version 4.0 - Management anticipates better adoption due to improvements in accuracy and workflow efficiency, addressing customer requests [81][84] Question: Maintenance and support for version 4.0 - Customers current on maintenance agreements will receive the new version, while those not current will incur a fee to update [88][89]
iCAD(ICAD) - 2024 Q4 - Earnings Call Transcript
2025-03-19 20:30
iCAD (ICAD) Q4 2024 Earnings Call March 19, 2025 04:30 PM ET Company Participants Rosalyn Christian - Investor RelationsDana Brown - President, CEO & Chairman of the BoardEric Lonnqvist - CFOMarie Thibault - Managing Director Conference Call Participants Per Ostlund - Research AnalystYale Jen - Senior Managing Director & Senior Biotech AnalystGene Mannheimer - Managing Director, Senior Research Analyst Operator Greetings. Welcome to the iCAD Inc. Fourth Quarter and Full Year twenty twenty four Financial Res ...