NASHUA, N.H. – November 13, 2024 – 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 and nine months ended September 30, 2024. 

Third Quarter 2024 Highlights (Year over Year Performance):

  • Total ARR was $9.3 million, up 10% up year over year
  • Total revenue was $4.2 million, up 4% year over year
  • Gross Profit Margin was 86%, consistent with prior year
  • 13 cloud deals closed during the quarter; key wins include:
    • University California San Diego (UCSD) signed a 3-year Cloud deal
    • Charlotte Radiology signed a 3-year Cloud deal; another imaging provider for US Radiology, one of the country’s premier providers of diagnostic imaging services with more than 175 outpatient imaging centers across 13 states.
  • ProFound Detection v4.0 received FDA clearance, delivers 22% improvement in detecting challenging and aggressive cancer subtypes

“We made continued progress during the third quarter highlighted by growing market interest which resulted in the close of 52 perpetual deals, 20 subscription deals, and 13 cloud deals in the quarter. Our ProFound Cloud SaaS platform, launched at the end of the first quarter of 2024, is achieving adoption rates ahead of our expectations, and as a result, annual recurring revenue increased by 10% in the third quarter,” commented Dana Brown, President and CEO of iCAD. “Earlier this week, we also announced FDA clearance of ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT). This fourth-generation AI solution, powered by advanced deep learning convolutional neural networks, offers a 22% improvement in detecting challenging and aggressive cancer subtypes over prior Version 3, including enhanced accuracy for dense breast tissue. Additionally, ProFound Detection Version 4.0 achieves an 18% reduction in lesion markings, minimizing false positives and streamlining workflow. This milestone reinforces iCAD’s commitment to advancing breast health by delivering solutions that elevate clinical confidence, enhance the experience and confidence of our clinicians, and improve patient outcomes.

“Likewise, we expanded our presence across key markets to extend our geographic reach, reflecting new regulatory clearances in South Africa and partnerships in the Dominican Republic, France, Spain, Turkey, and the United Arab Emirates. Additionally, during the quarter, the FDA’s new regulations around breast density reporting in the U.S. came into effect, and we believe this development will bolster demand for our Density and Detection solutions. We remain focused on continuing to position iCAD to strengthen our market leadership in AI-powered breast cancer detection and drive the global scalability of our solutions.”

The chart below illustrates the growth of ARR (Annual Recurring Revenue) between the first quarter of 2022, when subscription sales first began, and the third quarter of 2024:

Three Months Ended September 30, 2024 Financial Results

Total revenue for the third quarter of 2024 was $4.2 million, an increase of $0.1 million, or 4%, as compared to the third quarter of 2023.

Gross Profit: Gross profit for the third quarter of 2024 was $3.6 million, or 86% of revenue, as compared to $3.5 million, or 86% of revenue, in the third quarter of 2023.

Operating Expenses: Total operating expenses for the third quarter of 2024 were $5.6 million, a 19% increase from $4.7 million in the third quarter of 2023.

GAAP Net Loss from continuing operations: Net loss from continuing operations for the third quarter of 2024 was ($1.8) million, or ($0.07) per diluted share, as compared to a net loss of ($1.0) million, or ($0.04) per diluted share, for the third quarter of 2023.

Non-GAAP Adjusted Net Loss from continuing operations: Non-GAAP Adjusted Net Loss from continuing operations, a non-GAAP financial measure as defined below, for the third quarter of 2024 was ($1.6) million, or ($0.07) per diluted share, as compared to a Non-GAAP Adjusted Net Loss of ($1.0) million, or ($0.04) per diluted share, for the third quarter of 2023. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss results for the three-month periods ended September 30, 2024 and 2023, respectively.

Non-GAAP Adjusted EBITDA: Non-GAAP Adjusted EBITDA, a non-GAAP financial measure as defined below, for the third quarter of 2024 was a loss of ($1.5) million compared to a loss of $(0.8) million in the third quarter of 2023. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA results for the three-month periods ended September 30, 2024 and 2023, respectively.  

Nine Months Ended September 30, 2024 Financial Results

Total revenue for the nine months ended September 30, 2024 was approximately $14.2 million, an increase of approximately $1.6 million, or 13%, as compared to the nine months ended September 30, 2023.

Gross Profit: Gross profit for the nine months ended September 30, 2024 was $12.0 million, or 84% of revenue, as compared to $10.5 million, or 83% of revenue, in the nine months ended September 30, 2023.

Operating Expenses: Total operating expenses for the nine months ended September 30, 2024 were $17.4 million, consistent with the nine months ended September 30, 2023.

GAAP Net Loss from continuing operations: Net loss from continuing operations for the nine months ended September 30, 2024 was ($4.8) million, or ($0.18) per diluted share, as compared to a net loss of ($6.5) million, or ($0.25) per diluted share, for the nine months ended September 30, 2023.

Non-GAAP Adjusted Net Loss from continuing operations: Non-GAAP Adjusted Net Loss from continuing operations, a non-GAAP financial measure as defined below, for the nine months ended September 30, 2024 was ($4.6) million, or ($0.18) per diluted share, as compared to a Non-GAAP Adjusted Net Loss of ($6.3) million, or ($0.25) per diluted share, for the nine months ended September 30, 2023. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss results for the nine-month periods ended September 30, 2024 and 2023, respectively.

Non-GAAP Adjusted EBITDA: Non-GAAP Adjusted EBITDA, a non-GAAP financial measure as defined below, for the nine months ended September 30, 2024 was a loss of ($3.9) million compared to a loss of $(5.4) million in the nine months ended September 30, 2023. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA results for the nine-month periods ended September 30, 2024 and 2023, respectively.

Cash and cash equivalents:  Cash and cash equivalents were $18.8 million as of September 30, 2024. iCAD believes it has sufficient cash resources to fund its planned operations with no need to raise additional funding.

Conference Call:   

The company will host a conference call at 4:30 PM Eastern Time on Wednesday, November 13, 2024.  

Earnings call details are as follows:  

Use of Non-GAAP Financial Measures

In its quarterly news releases, conference calls, slide presentations or webcasts, the Company may use or discuss non-GAAP financial measures as defined by SEC Regulation G. The GAAP financial measures most directly comparable to each non-GAAP financial measure used or discussed, and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure, are included in this press release after the condensed consolidated financial statements. When analyzing the Company’s operating performance, investors should not consider these non-GAAP measures as a substitute for the comparable financial measures prepared in accordance with GAAP. The Company’s quarterly news releases containing such non-GAAP reconciliations can be found on the Investors section of the Company’s website at www.icadmed.com

About iCAD, Inc.

iCAD, Inc. (NASDAQ: ICAD) is a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered solutions that enable medical providers to accurately and reliably detect cancer earlier and improve patient outcomes. Headquartered in Nashua, N.H., iCAD’s industry-leading ProFound Breast Health Suite provides AI-powered mammography analysis for breast cancer detection, density assessment and risk evaluation. Used by thousands of providers serving millions of patients, ProFound is available in over 50 countries. In the last five years alone, iCAD estimates reading more than 40 million mammograms worldwide, with nearly 30% being tomosynthesis.  For more information, including the latest in regulatory clearances, please visit www.icadmed.com.

Forward-Looking Statements

Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the expansion of access to the Company’s products, improvement of performance, acceleration of adoption, expected benefits of ProFound AI®, the benefits of the Company’s products, and future prospects for the Company’s technology platforms and products. Such forward-looking statements involve a number of known and unknown risks, uncertainties, and other factors that may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited, to the Company’s ability to achieve business and strategic objectives, the willingness of patients to undergo mammography screening, whether mammography screening will be treated as an essential procedure, whether ProFound AI will improve reading efficiency, improve specificity and sensitivity, reduce false positives and otherwise prove to be more beneficial for patients and clinicians, the impact of supply and manufacturing constraints or difficulties on our ability to fulfill our orders, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights, product market acceptance, possible technological obsolescence of products, increased competition, government regulation, changes in Medicare orother reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,” “continue,” “anticipate,” “likely,” “seek,” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at https://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

CONTACTS

Media inquiries:
pr@icadmed.com

Investor Inquiries:
John Nesbett/Rosalyn Christian
IMS Investor Relations
icad@imsinvestorrelations.com