iCAD Reports First Quarter 2020 Financial Results

• Recent Equity Offering Strengthens Balance Sheet and Increases Operating Flexibility with focus on Brain Cancer Initiatives
• Conference Call Today at 4:30 p.m. ET

NASHUA, N.H., May 11, 2020 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today reported its financial and operating results for the first quarter ended March 31, 2020.

Recent Highlights:

• Entered into a new credit facility and ended Q1 2020 with $14.3 million in cash followed by an equity offering with gross proceeds of $12.5 million in April 2020, strengthening balance sheet and increasing operational flexibility.
• Equity offering enables post market clinical studies to expand the use of Xoft IORT for the treatment of brain cancers.

• New Detection initiative positions Profound AI technology to assess risk and prioritize growing backlog of mammography screening.
• Provider evaluation of IORT emerging in response to changing guidelines that recommend shorter course treatments.

“In the face of the significant challenges posed by the ongoing COVID-19 global health pandemic, the iCAD team continues to find innovative solutions to support customer needs,” said Michael Klein, Chairman and Chief Executive Officer of iCAD, Inc. “As previously communicated, we are experiencing a disruption in ordering patterns due to circumstances associated with COVID-19, which is impacting shipping, logistics, service, installation, and training. However, importantly, we believe that fundamental demand for both our Detection and Therapy offerings has not diminished. In fact, we are seeing an increased appreciation of the need for AI-enabled imaging and 10-minute on demand radiation therapy, delivered simultaneously with surgical procedures. With a backlog of patients overdue for regular mammography screening exams, the need to appropriately schedule and prioritize patient care further highlights the value proposition for ProFound AI. With ProFound AI, radiologists will have the ability to review prior year mammograms and prioritize which patients should not delay breast cancer screening.”

“In addition, in April, we closed an equity offering with gross proceeds of $12.5 million,” continued Mr. Klein. “The proceeds from this offering will be dedicated in part to conducting post market studies for our Xoft IORT for glioblastoma and other brain cancers, as well as evaluating our commercial launch strategy. This follows the first use of Xoft IORT to treat brain cancer in the US in February, as well as the release last fall of data from a study conducted at the European Medical Center in Moscow.”

“Due to the current market dynamics, we have reprioritized certain initiatives and redeployed resources to focus on and leverage near-term objectives and trends. We are moving to an efficient commercialization and product development infrastructure that allows us to reduce costs, while continuing a precise and focused approach towards the shifting market dynamics. While these are unprecedented times, we strongly believe that iCAD’s business and world-class technology are well-positioned to thrive for years to come,” concluded Mr. Klein.

First Quarter 2020 Financial Results

Revenue: Total Detection and Therapy revenue for the first quarter of 2020 was $6.6 million, a decrease of $0.2 million, or 3%, compared to the first quarter of 2019, reflecting a 1% decrease in product revenue, and a 7% decrease in service and supplies revenue.

Cancer Detection revenue for the first quarter 2020, which includes the Company’s mammography, breast density, and the associated service and supplies revenue, increased by approximately $0.3 million, or 7%, as compared to the first quarter of 2019, driven by growth in both direct and OEM revenues with sales primarily in the Company’s 3D imaging and Density products. Therapy revenue for the first quarter of 2020, which includes Xoft^® Axxent® eBx^® System^® sales, as well as the associated service and supplies revenue, decreased by $0.5 million, or 20%, as compared to the first quarter of 2019.

Gross Profit: Gross profit for the first quarter of 2020 was $4.5 million, or 69% of revenue, as compared to $5.3 million, or 78% of revenue, in the first quarter of 2019.

Operating Expenses: Total operating expenses for the first quarter of 2020 were $8.4 million, a $2.1 million, or 33%, increase from $6.3 million in the first quarter of 2019. The increase was driven by increased marketing and sales expenses in support of the Company’s commercialization efforts to drive adoption of Profound AI, as well as an increase in general & administrative expenses during 2019, which remained in the first quarter of 2020.

GAAP Net Loss: Net loss for the first quarter of 2020 was ($11.8) million, or ($0.59) per diluted share, compared with a net loss of ($3.7) million, or ($0.22) per diluted share, for the first quarter of 2019.

Non-GAAP Adjusted Net loss: Non-GAAP adjusted net loss, a non-GAAP financial measure as defined below, for the first quarter of 2020 was ($3.9) million, or ($0.20) per diluted share, as compared to a Non-GAAP adjusted net loss of ($1.1) million, or ($0.07) per diluted share, for the first quarter of 2019. 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 March 31, 2020 and 2019, respectively.

Non-GAAP Adjusted EBITDA: Non-GAAP adjusted EBITDA, a non-GAAP financial measure as defined below, for the first quarter of 2020, was a loss of ($3.1) million, a $2.5 million increase compared to the first quarter 2019 non-GAAP adjusted EBITDA loss of ($0.6) million. 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 March 31, 2020 and 2019, respectively.

Cash and Cash Equivalents: As of March 31, 2020, the Company had cash and cash equivalents of $14.3 million, compared to cash and cash equivalents of $15.3 million at December 31, 2019. Subsequent to the close of the quarter, in April 2020, iCAD closed a registered direct offering for gross proceeds of approximately $12.5 million.

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.
Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions. For more information, visit www.icadmed.com.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which 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, increase sales and acceptance of products, adoption by CMS of a new payment model, and that such model will prove beneficial to the Company, which is not assured, implement expansion plans, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, to successfully defend itself in litigation matters, government regulation, changes in Medicare or other 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; the effects of a Global Pandemic, 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 http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

Contact:
Media Inquiries:
Jessica Burns, iCAD
+1-201-423-4492
jburns@icadmed.com

Investor Relations:
Jeremy Feffer, LifeSci Advisors
+ 1-212-915-2568
jeremy@lifesciadvisors.com