iCAD Reports 2013 Fourth Quarter and Full Year Financial Results

iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today reported financial results for the three and twelve months ended December 31, 2013.

“Our strong performance throughout 2013 demonstrates the progress we’ve made with our broadened oncology strategy and, in particular, our Therapy business. Significant revenue growth, combined with a balance of targeted investments and disciplined financial management, allowed us to post non-GAAP Adjusted EBITDA of $1.9 million for the year,” said Ken Ferry, President and CEO of iCAD.

“Our Therapy business delivered significant revenue growth with meaningful increases in both product placements and utilization. Revenue from the non-melanoma skin cancer indication was especially strong, with support from three-year clinical data, favorable reimbursement and, most importantly, effective patient outcomes. We will continue to invest in programs to accelerate the market adoption of the Xoft system for the treatment of both skin and early breast cancer. With an estimated U.S. market penetration of less than one percent in both indications, there is considerable room for continued growth. We remain committed to ongoing clinical studies, supporting reimbursement expansion and raising awareness of the clinical benefits of our electronic brachytherapy for a variety of cancer indications.

“The Detection business is delivering on its goal of leveraging our customer base with a balance of new product sales and recurring revenue. We are making progress towards long-term growth through recurring revenue from our service business, new customers and upgrades from our installed base for PowerLook, our next-generation mammography CAD platform, and from our MRI product offering with our strategic partner Invivo, a Philips Healthcare business. Looking forward, we believe the market transition from 2D digital to 3D digital mammography, or tomosynthesis, will provide a significant, multi-year market opportunity for our new 3D software workflow tools currently in development. We look forward to introducing the first product offering sometime later this year or early in 2015,” concluded Mr. Ferry.

Fourth Quarter Financial Results

Revenue: Total revenue for the fourth quarter of 2013 increased 16.8% to $9.1 million from $7.8 million for the fourth quarter of 2012, due to a 60.4% increase in Therapy revenue partially offset by an 11.9% decline in Cancer Detection revenue.

Therapy revenue included Xoft™ Axxent™ Electronic Brachytherapy System™ product sales, as well as the associated service and supply revenue. Cancer Detection revenue included film, digital mammography, MRI and CT CAD platforms, as well as service and supply revenue from these products.

Gross Margin: Gross profit for the fourth quarter of 2013 increased to $6.3 million, or 68.8% of revenue, from $5.6 million, or 71.0% of revenue, for the fourth quarter of 2012. The lower gross margin was primarily due to product mix, and the impact of the Medical Device Excise Tax, which went into effect in 2013.

Operating Expenses: Total operating expenses for the fourth quarter of 2013 increased to $6.9 million from $6.3 million for the same period in 2012, as a result of higher commercial and R&D investments, partially offset by ongoing cost-control measures.

Non-GAAP Adjusted EBITDA: Non-GAAP adjusted EBITDA, a non-GAAP financial measure as defined below, was $285,000 for the fourth quarter of 2013, compared with non-GAAP adjusted EBITDA of $102,000 for the same period in 2012.

Net Loss: The net loss for the fourth quarter of 2013 was $4.4 million, or $0.41 per share, compared with a net loss for the fourth quarter of 2012 of $2.7 million, or $0.25 per share.

Non-GAAP Adjusted Net Loss: The non-GAAP adjusted net loss, as defined below, for the fourth quarter of 2013 was $1.5 million, or $0.14 per share, compared with a non-GAAP adjusted net loss for the fourth quarter of 2012 of $1.7 million, or $0.15 per share.

Cash and Cash Flow: As of December 31, 2013, iCAD had cash and cash equivalents of $11.9 million, compared with $10.2 million as of September 30, 2013 and $13.9 million as of December 31, 2012. Net cash used by operations during 2013 was $1.4 million.

2013 Financial Results

Revenue: Total revenue for 2013 increased 17.0% to $33.1 million from $28.3 million for 2012, including a 46.8% increase in Therapy revenue offset by a 2.1% decline in Cancer Detection revenue.

Gross Margin: Gross profit for 2013 was $23.1 million, or 69.8% of revenue, compared with gross profit for 2012 of $20.0 million, or 70.8% of revenue.

Operating Expenses: Total operating expenses for 2013 decreased to $24.9 million from $25.4 million for 2012.

Non-GAAP Adjusted EBITDA: Non-GAAP adjusted EBITDA for 2013 was $1.9 million, compared with a non-GAAP adjusted EBITDA loss of $1.5 million for 2012.

Net Loss: The net loss for 2013 was $7.6 million, or $0.70 per share, compared with a net loss for 2012 of $9.4 million, or $0.87 per share.

Non-GAAP Adjusted Net Loss: The non-GAAP adjusted net loss for 2013 was $5.2 million, or $0.47 per share, compared with a non-GAAP adjusted net loss for 2012 of $8.8 million, or $0.81 per share.

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.

Conference Call

iCAD management will host an investment community conference call on Thursday, February 20, 2014 beginning at 8:00 a.m. Eastern time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 888-713-4211 (domestic) or 617-213-4864 (international) and entering passcode 49351643. The call also will be broadcast live on the Internet at www.streetevents.com and www.icadmed.com.

A replay of the conference call will be accessible two hours after its completion through February 26, 2014 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 49351643. The call will also be archived for 90 days at www.streetevents.com and www.icadmed.com.

About iCAD, Inc.

iCAD is an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of common cancers. iCAD’s Xoft System offers radiation treatment for early-stage breast cancer that can be administered in the form of intraoperative radiation therapy or accelerated partial breast irradiation. The Xoft System is also cleared for the treatment of non-melanoma skin cancer and endometrial cancer. iCAD offers a comprehensive range of high-performance, upgradeable CAD solutions for mammography and advanced image analysis and workflow solutions for Magnetic Resonance Imaging, for breast and prostate cancers and Computed Tomography for colorectal cancer. For more information, call 877-iCADnow, or 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 defend itself in litigation matters, to achieve business and strategic objectives, 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, litigation and/or 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; 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.

RECONCILIATION OF NON-GAAP FINANCIAL MEASURES TO COMPARABLE GAAP MEASURES
(Unaudited, in thousands, except per share amounts)

The following is a reconciliation of the non-GAAP financial measures used by the Company to describe the Company's financial results determined in accordance with United States generally accepted accounting principles (GAAP). An explanation of these measures is also included below under the heading "Explanation of Non-GAAP Financial Measures."

While management believes that these non-GAAP financial measures provide useful supplemental information to investors regarding the underlying performance of the Company's business operations, investors are reminded to consider these non-GAAP financial measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP. In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, and management may utilize other measures to illustrate performance in the future. Non-GAAP financial measures have limitations in that they do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP.

Explanation of Non-GAAP Financial Measures

The Company reports its financial results in accordance with United States generally accepted accounting principles, or GAAP. However, management believes that in order to properly understand the Company's short-term and long-term financial and operational trends, investors may wish to consider the impact of certain non-cash or non-recurring items, when used as a supplement to financial performance measures in accordance with GAAP. These items result from facts and circumstances that vary in frequency and/or impact on continuing operations. Management also uses results of operations before such items to evaluate the operating performance of the Company and compare it against past periods, make operating decisions, and serve as a basis for strategic planning. These non-GAAP financial measures provide management with additional means to understand and evaluate the operating results and trends in the Company's ongoing business by eliminating certain non-cash expenses and other items that management believes might otherwise make comparisons of the Company's ongoing business with prior periods more difficult, obscure trends in ongoing operations or reduce management's ability to make useful forecasts. Management believes that these non-GAAP financial measures provide additional means of evaluating period-over-period operating performance. In addition, management understands that some investors and financial analysts find this information helpful in analyzing the Company's financial and operational performance and comparing this performance to its peers and competitors.

Management defines "Non-GAAP Adjusted EBITDA" as the sum of GAAP net loss before provision for income taxes, acquisition-related expenses, total other (income) expense, stock-based compensation expense, depreciation and amortization, severance, gain on sale, loss on warrant, amortization of acquired intangibles, acquisition related, patent litigation and recall costs, contingent consideration, indemnification asset and goodwill impairment charges. Management considers this non-GAAP financial measure to be an important indicator of the Company's operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company's overall financial performance.

Management defines "Non-GAAP Adjusted Net Loss" as the sum of GAAP net loss before provision for the gain on sale of asset, severance, transaction, patent litigation and recall costs, contingent consideration, indemnification asset and goodwill impairment charges. Management considers this non-GAAP financial measure to be an important indicator of the Company's operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company's overall financial performance.

Management excludes each of the items identified below from the applicable non-GAAP financial measure referenced above for the reasons set forth with respect to that excluded item:

• Stock-based compensation expense: excluded as these are non-cash expenses that management does not consider part of ongoing operating results when assessing the performance of the Company's business, and also because the total amount of expense is partially outside of the Company's control as it is based on factors such as stock price volatility and interest rates, which may be unrelated to our performance during the period in which the expense is incurred.
• Amortization of acquired intangibles: acquisition-related expenses are reported at the time acquisition costs are incurred, and purchased intangibles are amortized over a period of several years after the acquisition and generally cannot be changed or influenced by management after the acquisition. Accordingly, these items are not considered by management in making operating decisions, and management believes that such expenses do not have a direct correlation to future business operations. Thus, including such charges does not accurately reflect the performance of the Company's ongoing operations for the period in which such charges are incurred.
• Interest expense: In January 2012, the Company entered into a five-year, $15 million debt facility agreement. The Company excludes interest expense from its non GAAP Adjusted EBITDA calculation.
• Severance: relates to costs incurred due to the termination of certain employees. The Company provides compensation to certain employees as an accommodation upon termination of employment without cause. Management believes that excluding severance costs from operating results provides investors with a better means for measuring current Company performance.
• Gain (loss) on Warrant: The Company issued warrants in connection with the financing and the value changes according to fair value. It is excluded as these are non-cash expenses that management does not consider part of ongoing operating results when assessing the performance of the Company's business, also because the total amount of gain or loss is partially outside of the Company's control as it is based on factors such as stock price volatility and interest rates, which may be unrelated to our performance during the period in which the gain or loss is incurred.

On occasion in the future, there may be other items, such as significant asset impairments, restructuring charges or significant gains or losses from contingencies that the Company may exclude if it believes that doing so is consistent with the goal of providing useful information to investors and management.