iCAD Reports Third Quarter 2015 Financial Results

NASHUA, N.H., Oct. 29, 2015 (GLOBE NEWSWIRE) -- 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 months and nine months ended September 30, 2015.

Third Quarter Highlights:

• Total revenue of $9.6 million, a decrease of 23.8% year-over year, driven by the general uncertainty related to reimbursement for non-melanoma skin cancer treatment in the United States
• Cancer Detection revenue of $5.2 million, an increase of 5.4% year-over-year, including 17.6% product revenue growth
• 13 Xoft Axxent system placements, including a record 8 international IORT systems
• Gross margin of 71.2%, a decline of 170 basis points year-over-year
• Non-GAAP adjusted EBITDA of $739,000, or 7.7% of revenue

"During the third quarter we continued to execute on our strategic initiatives to capitalize on the significant long-term opportunities in our Cancer Detection and Therapy businesses," said Ken Ferry, Chief Executive Officer. "Cancer Detection product revenue was up 17.6%, led by strong demand for upgrades to PowerLook, our 2D and 3D mammography platform, and iReveal, our breast density product, both of which we expect to double over 2014 results. We believe a main contributor to the momentum for PowerLook upgrades is our customer base preparing for the adoption of 3-D tomosynthesis and the workflow tools that we expect will significantly improve reader efficiency. In addition, we received positive feedback from customers on the launch of our iReveal breast density solution and plan to introduce a 3D capability by the end of the year, further enhancing the breast density market opportunity.

"In September, we completed a reader study in Europe for our breast tomosynthesis cancer detection solution. The results were very positive and we believe we are well positioned to receive CE Mark approval by the end of November. In the U.S., we launched a separate reader study that we expect to complete in December, followed by a PMA regulatory submission to the FDA in January 2016. Based on these timelines, we anticipate a commercial launch of our breast tomosynthesis cancer detection solution internationally during the first quarter of 2016, followed by a U.S. launch in the second quarter of 2016."

Mr. Ferry added, "In our Cancer Therapy business, while revenue was down versus the prior year, we had 13 XOFT system placements in the quarter, led by a record 8 international systems for IORT. We are seeing positive momentum in the breast IORT market, including new clinical data being presented at major industry tradeshows, increasing consumer media coverage, and we are on track for strong IORT procedure growth for the year. For skin therapy, we had 2 system placements in the U.S. during the quarter against a backdrop of continued uncertainty for reimbursement, which is impacting system sales and procedure volumes. Looking forward, we have provided comprehensive information to the eight regional Medicare Administrative Contractors in support of reimbursement coverage ahead of the implementation of a new dedicated skin code which takes effect January 1, 2016. We are hopeful that the growing favorable clinical data, which now includes more than 1,000 patients and almost 1,600 lesions treated, will enable us to begin to regain momentum in this business in early 2016."

Third Quarter 2015 Financial Results

Revenue: Total revenue for the third quarter of 2015 decreased 23.8% to $9.6 million from $12.6 million in the third quarter of 2014, reflecting a 1.9% decrease in product revenue and a 36.4% decrease in service revenue. The decrease in the Company's revenue in the third quarter was primarily driven by the negative impact of the general uncertainty related to reimbursement for non-melanoma skin cancer treatment in the United States. Service revenue for the third quarter of 2015 was approximately 53% of total revenues compared to approximately 63% of total revenues in the third quarter of 2014.

Total therapy revenue decreased by 42.6% which includes Xoft^® Axxent^® Electronic Brachytherapy System^® product sales, as well as the associated service revenue. Cancer detection revenue increased 5.4% which includes digital mammography, MRI and CT CAD platforms, as well as the associated service revenue.

Gross Profit: Gross profit for the third quarter of 2015 decreased to $6.8 million, or 71.2% of revenue, from $9.2 million, or 72.9% of revenue, for the third quarter of 2014. The decrease in gross profit was driven primarily by lower service revenue in the quarter.

Operating Expenses: Total operating expenses for the third quarter of 2015 decreased to $7.2 million, from $8.2 million for the third quarter of 2014. The year-over-year decline reflects the effect of the Company's cost reduction initiatives.

Non-GAAP Adjusted EBITDA: Non-GAAP adjusted EBITDA, a non-GAAP financial measure as defined below, was $739,000, or 7.7% of revenue, for the third quarter of 2015, compared with non-GAAP adjusted EBITDA of $2.6 million, or 20.3% of revenue, for the third quarter of 2014.

Net Loss: Net loss for the third quarter of 2015 was $(402,000), or $(0.03) per share, compared with net income of $274,000, or $0.02 per share, for the third quarter of 2014.

Non-GAAP Adjusted Net Income/Loss: Non-GAAP adjusted net loss, as defined below, for the third quarter of 2015 was $(402,000), or $(0.03) per share, compared with a non-GAAP adjusted net income of $590,000, or $0.04 per share, for the third quarter of 2014.

Cash and Cash Equivalents: As of September 30, 2015, the Company had cash and cash equivalents of $17.5 million, compared with $32.2 million as of December 31, 2014. The Company used $25,000 from operating activities in the first nine months of 2015.

First Nine Months 2015 Financial Results

Revenue: Total revenue for the nine months ended September 30, 2015 increased 10.4% to $33.9 million from $30.8 million in the nine months ended September 30, 2014, reflecting an 18.0% decrease in product revenue and a 34.4% increase in service revenue. The Company's revenue in the second and third quarters was impacted by the general uncertainty related to reimbursement for non-melanoma skin cancer treatment in the United States. Service revenue for the nine months ended September 30, 2015 was approximately 66% of total revenues compared to approximately 54% of total revenues for the nine months ended September 30, 2014.

Total therapy revenue increased by 13.0% which includes Xoft^® Axxent^® Electronic Brachytherapy System^® product sales, as well as the associated service revenue. Cancer detection revenue increased 7.2% which includes digital mammography, MRI and CT CAD platforms, as well as the associated service revenue.

Gross Profit: Gross profit for the nine months ended September 30, 2015 increased to $24.1 million, or 70.9% of revenue, from $21.9 million, or 71.3% of revenue, for the nine months ended September 30, 2014.

Operating Expenses: Total operating expenses for the nine months ended September 30, 2015 increased to $51.8 million, which includes $27.4 million of goodwill and long-lived asset impairment, from $21.6 million for the nine months ended September 30, 2014.

Non-GAAP Adjusted EBITDA: Non-GAAP adjusted EBITDA was $5.0 million, or 14.7% of revenue, for the nine months ended September 30, 2015, compared with non-GAAP adjusted EBITDA of $3.9 million, or 12.7% of revenue, for the nine months ended September 30, 2014.

Net Loss: Net loss for the nine months ended September 30, 2015 was $(30.0) million, or $(1.92) per share, compared with a net loss of $(913,000), or $(0.07) per share, for the nine months ended September 30, 2014.

Non-GAAP Adjusted Net Income/Loss: Non-GAAP adjusted net income, as defined below, for the nine months ended September 30, 2015 was $1,000, or $0.00 per share, compared with a non-GAAP adjusted net loss of $1.3 million, or $(0.10) per share, for the nine months ended September 30, 2014.

Financial Guidance

Due to general uncertainty related to reimbursement for non-melanoma skin cancer treatment in the United States, the Company is not providing financial guidance at this time.

Conference Call

iCAD management will host a conference call today beginning at 4:30 p.m. Eastern Time to discuss the financial results and provide a company update. The dial-in numbers are (855) 217-4501 for domestic callers and (716) 220-9431 for international callers. The conference ID is 58281174. A live webcast of the conference call will be available online at www.icadmed.com.

A replay of the webcast will remain on the Company's website until the Company releases its fourth quarter 2015 financial results. In addition, a telephonic replay of the conference call will be available until November 5, 2015. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The replay conference ID is 58281174.

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 delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD's Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is a painless, non-invasive technology that delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit www.icadmed.com or www.xoftinc.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 income (loss) before provision for taxes, acquisition-related expenses, total other (income) expense, stock-based compensation expense, depreciation and amortization, severance, gain on sale, loss on warrant, loss on extinguishment of debt, amortization of acquired intangibles, 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 Income (loss)" as the sum of GAAP net income (loss) before provision for the gain on sale of asset, severance, transaction, patent litigation and recall costs, contingent consideration, indemnification, loss on extinguishment of debt and 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: The Company excludes interest expense which includes interest from the facility agreement, interest on settlement obligations and interest on capital leases, 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.
• Loss on sale of assets relates to the loss incurred on the disposal of assets. The Company excludes this non-cash charge as this item is not considered by management in making operating decisions, and management believes that such expenses do not have a direct correlation to future business operations.
• Loss on extinguishment of debt: relates to the extinguishment of a portion of the $15 million debt facility agreement. It is excluded as this is an expense that management does not consider part of ongoing operating results when assessing the performance of the Company's business.
• Goodwill and long-lived impairment: 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.
• Gain (loss) on warrant: The Company issued warrants in connection with the January 2012 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. The warrants were exercised in April 2014.

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.

CONTACT: For iCAD investor relations:
         The Ruth Group
         Zack Kubow
         646-536-7020
         iCAD@theruthgroup.com
         or
         For iCAD media inquiries:
         Berry & Company Public Relations, LLC
         Lynn Granito, 212-253-8881
         lgranito@berrypr.com