UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period endedSeptember 30, 2015March 31, 2016

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 00001-093411-09341

 

 

iCAD, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 02-0377419

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

98 Spit Brook Road, Suite 100, Nashua, NH 03062
(Address of principal executive offices) (Zip Code)

(603) 882-5200

(Registrant’s telephone number, including area code)

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirement for the past 90 days.    YES  x    NO  ¨.

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    YES  x    NO  ¨.

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large Accelerated filer ¨  Accelerated filer x¨
Non-accelerated filer ¨  (do not check if a smaller reporting company)  Smaller reporting company ¨x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)    YES  ¨    NO  x.

As of the close of business on November 3, 2015May 9, 2016 there were 15,730,51815,895,731 shares outstanding of the registrant’s Common Stock, $.01 par value.

 

 

 


iCAD, Inc.

INDEX

 

     Page 

PART I

 

FINANCIAL INFORMATION

  

Item 1

 

Financial Statements (unaudited)

  
 

Condensed Consolidated Balance Sheets as of September 30, 2015March 31, 2016 and December 31, 20142015

   3  
 

Condensed Consolidated Statements of Operations for the three and nine months ended September  30,March 31, 2016 and March 31, 2015 and September 30, 2014

   4  
 

Condensed Consolidated Statements of Cash Flows for the ninethree months ended September  30,March 31, 2016 and March 31, 2015 and September 30, 2014

   5  
 

Notes to Condensed Consolidated Financial Statements

   6-256-24  

Item 2

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   26-3925-33  

Item 3

 

Quantitative and Qualitative Disclosures about Market Risk

   4034  

Item 4

 

Controls and Procedures

   4034  

PART II

 

OTHER INFORMATION

  

Item 1

 

Legal Proceedings

   4135  

Item 1A

 

Risk Factors

   4135  

Item 2

 

Unregistered Sales of Equity Securities and Use of Proceeds

   4135  

Item 6

 

Exhibits

   4136  
 

Signatures

   4337  

iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands except for share data)

 

  September 30, December 31,   March 31, December 31, 
  2015 2014   2016 2015 
Assets      

Current assets:

      

Cash and cash equivalents

  $17,536   $32,220    $12,867   $15,280  

Trade accounts receivable, net of allowance for doubtful accounts of $377 in 2015 and $203 in 2014

   8,481   9,642  

Trade accounts receivable, net of allowance for doubtful accounts of $295 in 2016 and $236 in 2015

   5,760   7,488  

Inventory, net

   3,746   2,214     4,546   4,315  

Prepaid expenses and other current assets

   684   540     715   684  
  

 

  

 

   

 

  

 

 

Total current assets

   30,447   44,616     23,888   27,767  
  

 

  

 

   

 

  

 

 

Property and equipment, net of accumulated depreciation of $5,135 in 2015 and $4,861 in 2014

   2,605   4,255  

Property and equipment, net of accumulated depreciation of $5,814 in 2016 and $5,475 in 2015

   2,161   2,307  

Other assets

   94   132     94   94  

Intangible assets, net of accumulated amortization of $10,694 in 2015 and $14,738 in 2014

   4,473   17,504  

Intangible assets, net of accumulated amortization of $11,132 in 2016 and $10,897 in 2015

   4,728   4,274  

Goodwill

   14,198   27,263     14,505   14,198  
  

 

  

 

   

 

  

 

 

Total assets

  $51,817   $93,770    $45,376   $48,640  
  

 

  

 

   

 

  

 

 
Liabilities and Stockholders’ Equity      

Current liabilities:

      

Accounts payable

  $1,557   $2,151    $1,633   $1,593  

Accrued and other expenses

   4,142   5,554     3,313   4,220  

Interest payable

   —     180  

Notes and lease payable - current portion

   1,157   5,044  

Lease payable - current portion

   715   969  

Deferred revenue

   8,020   9,120     7,145   7,497  
  

 

  

 

   

 

  

 

 

Total current liabilities

   14,876   22,049     12,806   14,279  
  

 

  

 

   

 

  

 

 

Deferred revenue, long-term portion

   1,438   1,525     1,270   1,079  

Other long-term liabilities

   661   795     450   450  

Capital lease - long-term portion

   245   1,020     22   86  

Notes payable - long-term portion

   —     5,602  
  

 

  

 

   

 

  

 

 

Total liabilities

   17,220   30,991     14,548   15,894  
  

 

  

 

   

 

  

 

 

Commitments and Contingencies (Note 6 and 8)

      

Stockholders’ equity:

      

Preferred stock, $.01 par value: authorized 1,000,000 shares; none issued.

   —      —    

Common stock, $.01 par value: authorized 20,000,000 shares; issued 15,916,349 in 2015 and 15,732,177 in 2014; outstanding 15,730,518 in 2015 and 15,546,346 in 2014

   159   157  

Preferred stock, $ .01 par value: authorized 1,000,000 shares; none issued.

   —      —    

Common stock, $ .01 par value: authorized 30,000,000 shares; issued 16,081,562 in 2016 and 15,923,349 in 2015; outstanding 15,895,731 in 2016 and 15,737,518 in 2015

   161   159  

Additional paid-in capital

   210,961   209,100     212,125   211,512  

Accumulated deficit

   (175,108 (145,063   (180,043 (177,510

Treasury stock at cost, 185,831 shares in 2015 and 2014

   (1,415 (1,415

Treasury stock at cost, 185,831 shares in 2016 and 2015

   (1,415 (1,415
  

 

  

 

   

 

  

 

 

Total stockholders’ equity

   34,597   62,779     30,828   32,746  
  

 

  

 

   

 

  

 

 

Total liabilities and stockholders’ equity

  $51,817   $93,770    $45,376   $48,640  
  

 

  

 

   

 

  

 

 

See accompanying notes to condensed consolidated financial statements.

iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands except for per share data)

 

  Three Months Ended September 30, Nine Months Ended September 30,   Three Months Ended March 31, 
  2015 2014 2015 2014   2016 2015 

Revenue:

        

Products

  $4,515   $4,603   $11,569   $14,106    $2,028   $3,958  

Service and supplies

   5,067   7,969   22,376   16,653     4,010   9,262  
  

 

  

 

  

 

  

 

   

 

  

 

 

Total revenue

   9,582   12,572   33,945   30,759     6,038   13,220  

Cost of revenue:

        

Products

   1,110   1,019   2,731   3,589     190   941  

Service and supplies

   1,362   1,859   5,722   4,038     1,359   2,278  

Amortization and depreciation

   289   527   1,431   1,201     303   639  
  

 

  

 

  

 

  

 

   

 

  

 

 

Total cost of revenue

   2,761   3,405   9,884   8,828     1,852   3,858  
  

 

  

 

  

 

  

 

   

 

  

 

 

Gross profit

   6,821   9,167   24,061   21,931     4,186   9,362  
  

 

  

 

  

 

  

 

   

 

  

 

 

Operating expenses:

        

Engineering and product development

   2,093   2,086   6,621   5,952     2,271   2,256  

Marketing and sales

   2,697   3,448   9,692   8,912     2,496   3,830  

General and administrative

   2,118   2,282   6,661   5,836     1,626   2,213  

Amortization and depreciation

   257   425   1,373   931     286   620  

Goodwill and long-lived asset impairment

   —      —     27,443    —    
  

 

  

 

  

 

  

 

   

 

  

 

 

Total operating expenses

   7,165   8,241   51,790   21,631     6,679   8,919  
  

 

  

 

  

 

  

 

   

 

  

 

 

Income (loss) from operations

   (344 926   (27,729 300     (2,493 443  

Loss from extinguishment of debt

   —      —     (1,723 (903   —     (1,723

Gain from change in fair value of warrant

   —      —      —     1,835  

Interest expense

   (46 (647 (623 (2,078   (23 (507

Other income

   4   11   18   27     5   9  
  

 

  

 

  

 

  

 

   

 

  

 

 

Other expense, net

   (42 (636 (2,328 (1,119   (18 (2,221

Income (loss) before income tax (expense) benefit

   (386 290   (30,057 (819

Loss before income tax expense

   (2,511 (1,778

Tax (expense) benefit

   (16 (16 12   (94

Tax expense

   (22 (79
  

 

  

 

  

 

  

 

   

 

  

 

 

Net income (loss) and comprehensive income (loss)

  $(402 $274   $(30,045 $(913

Net loss and comprehensive loss

  $(2,533 $(1,857
  

 

  

 

  

 

  

 

   

 

  

 

 

Net (loss) income per share:

        

Basic

  $(0.03 $0.02   $(1.92 $(0.07  $(0.16 $(0.12
  

 

  

 

  

 

  

 

   

 

  

 

 

Diluted

  $(0.03 $0.02   $(1.92 $(0.07  $(0.16 $(0.12
  

 

  

 

  

 

  

 

   

 

  

 

 

Weighted average number of shares used in computing loss (income) per share:

     

Weighted average number of shares used in computing loss per share:

   

Basic

   15,725   15,283   15,670   13,609     15,826   15,605  
  

 

  

 

  

 

  

 

 
  

 

  

 

 

Diluted

   15,725   16,348   15,670   13,609     15,826   15,605  
  

 

  

 

  

 

  

 

   

 

  

 

 

See accompanying notes to consolidated financial statements.

iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

  For the nine months ended
September 30,
 
  2015 2014   For the three months ended
March 31,
 
  (in thousands)   2016 2015 
  (in thousands) 

Cash flow from operating activities:

      

Net loss

  $(30,045 $(913  $(2,533 $(1,857

Adjustments to reconcile net loss to net cash used for operating activities:

      

Amortization

   1,565   1,312     247   774  

Depreciation

   1,239   820     342   485  

Bad debt provision

   341   27     102   32  

Stock-based compensation expense

   1,601   966     650   444  

Amortization of debt discount and debt costs

   337   908     (2 300  

Interest on settlement obligations

   124   161     23   45  

Deferred tax provision

   —     118  

Loss on extinguishment of debt

   1,723   903     —     1,723  

Gain from change in fair value of warrant

   —     (1,835

Goodwill and long-lived asset impairment

   27,443    —    

Gain from acquisition settlement

   (249  —    

Loss on disposal of assets

   125    —       1   102  

Changes in operating assets and liabilities (net of the effect of acquisitions):

   

Changes in operating assets and liabilities (net of the effect of acquistions):

   

Accounts receivable

   821   (2,665   1,690   (723

Inventory

   (1,418 (140   (223 (383

Prepaid and other current assets

   (197 (26   (31 (112

Accounts payable

   (593 (245   40   15  

Accrued expenses

   (1,904 142     (940 (1,562

Deferred revenue

   (1,187 437     (1,038 431  
  

 

  

 

   

 

  

 

 

Total adjustments

   30,020   765     612   1,689  
  

 

  

 

   

 

  

 

 

Net cash used for operating activities

   (25 (148   (1,921 (168
  

 

  

 

   

 

  

 

 

Cash flow from investing activities:

      

Additions to patents, technology and other

   (37 (59   (2 (11

Additions to property and equipment

   (889 (630   (133 (534

Acquisition of Radion Inc, and DermEbx

   —     (3,482

Acquisition of VuComp M-Vu Breast Density

   (1,700  —    

Acquisition of VuComp M-Vu CAD

   (6  —    
  

 

  

 

   

 

  

 

 

Net cash used for investing activities

   (2,626 (4,171   (141 (545
  

 

  

 

   

 

  

 

 

Cash flow from financing activities:

      

Issuance of common stock for cash, net

   —     28,214  

Stock option exercises

   349   616     10   291  

Warrant exercise

   —     1,575  

Taxes paid related to restricted stock issuance

   (87 (110   (45 (60

Principal payments of capital lease obligations

   (1,045 (313   (316 (214

Principal repayment of debt financing, net

   (11,250 (4,100   —     (11,250
  

 

  

 

   

 

  

 

 

Net cash provided by (used for) financing activities

   (12,033 25,882  

Net cash used for financing activities

   (351 (11,233
  

 

  

 

   

 

  

 

 

Increase (decrease) in cash and equivalents

   (14,684 21,563  

Decrease in cash and equivalents

   (2,413 (11,946

Cash and equivalents, beginning of period

   32,220   11,880     15,280   32,220  
  

 

  

 

   

 

  

 

 

Cash and equivalents, end of period

  $17,536   $33,443    $12,867   $20,274  
  

 

  

 

   

 

  

 

 

Supplemental disclosure of cash flow information:

      

Interest paid

  $521   $1,343    $28   $411  
  

 

  

 

   

 

  

 

 

Taxes paid

  $101   $125    $32   $38  
  

 

  

 

   

 

  

 

 

Non-cash items from investing and financing activities:

   

Settlement of warrant liability with purchase of common stock

  $—    $2,151  
  

 

  

 

 

Issuance of common stock related to acquisition of Radion, Inc and DermEbx

  $—     $8,556  
  

 

  

 

 

See accompanying notes to consolidated financial statements.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015March 31, 2016

Note 1 - Basis of Presentation and Significant Accounting Policies

The accompanying condensed consolidated financial statements of iCAD, Inc. and subsidiaries (“iCAD” or the “Company”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). In the opinion of management, these unaudited interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of the financial position of the Company at September 30, 2015,March 31, 2016, the results of operations of the Company for the three and nine month periods ended September 30,March 31, 2016 and 2015, and 2014, and cash flows of the Company for the ninethree month periods ended September 30, 2015March 31, 2016 and 2014.2015. Although the Company believes that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information normally included in the footnotes prepared in accordance with US GAAP has been omitted as permitted by the rules and regulations of the Securities and Exchange Commission (“SEC”). The accompanying financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10–K10-K for the fiscal year ended December 31, 20142015 filed with the SEC on March 13, 2015.11, 2016. The results for the three and nine month period ended September 30, 2015March 31, 2016 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2015,2016, or any future period.

Revenue Recognition

The Company recognizes revenue primarily from the sale of products and from the sale of services and supplies. Revenue is recognized when delivery has occurred, persuasive evidence of an arrangement exists, fees are fixed or determinable and collectability of the related receivable is probable. For product revenue, delivery has occurred upon shipment provided title and risk of loss have passed to the customer. Services and supplies revenue are considered to be delivered as the services are performed or over the estimated life of the supply agreement.

The Company recognizes revenue from the sale of its digital, film-based CAD and cancer therapy products and services in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Update No. 2009-13, “Multiple-Deliverable Revenue Arrangements” (“ASU 2009-13”) and ASC Update No. 2009-14, “Certain Arrangements That Contain Software Elements” (“ASU 2009-14”) and ASC 985-605, “Software” (“ASC 985-605”). Revenue from the sale of certain CAD products is recognized in accordance with ASC 840 “Leases” (“ASC 840”). For multiple element arrangements, revenue is allocated to all deliverables based on their relative selling prices. In such circumstances, a hierarchy is used to determine the selling price to be used for allocating revenue to deliverables as follows: (i) vendor-specific objective evidence of fair value (“VSOE”), (ii) third-party evidence of selling price (“TPE”) and (iii) best estimate of the selling price (“BESP”). VSOE generally exists only when the deliverable is sold separately and is the price actually charged for that deliverable. The process for determining BESP for deliverables without VSOE or TPE considers multiple factors

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015March 31, 2016

 

including relative selling prices;prices, competitive prices in the marketplace, and management judgment; however, these may vary depending upon the unique facts and circumstances related to each deliverable.

The Company uses customer purchase orders that are subject to the Company’s terms and conditions or, in the case of an Original Equipment Manufacturer (“OEM”) are governed by distribution agreements. In accordance with the Company’s distribution agreements, the OEM does not have a right of return, and title and risk of loss passes to the OEM upon shipment. The Company generally ships Free On Board shipping point and uses shipping documents and third-party proof of delivery to verify delivery and transfer of title. In addition, the Company assesses whether collection is probable by considering a number of factors, including past transaction history with the customer and the creditworthiness of the customer, as obtained from third party credit references.

If the terms of the sale include customer acceptance provisions and compliance with those provisions cannot be demonstrated, all revenue is deferred and not recognized until such acceptance occurs. The Company considers all relevant facts and circumstances in determining when to recognize revenue, including contractual obligations to the customer, the customer’s post-delivery acceptance provisions, if any, and the installation process.

The Company has determined that iCAD’s digital and film based sales generally follow the guidance of FASB ASC Topic 605 “Revenue Recognition” (“ASC 605”) as the software has been considered essential to the functionality of the product per the guidance of ASU 2009-14. Typically, the responsibility for the installation process lies with the OEM partner. On occasion, when iCAD is responsible for product installation, the installation element is considered a separate unit of accounting because the delivered product has stand-alone value to the customer. In these instances, the Company allocates revenue to the deliverables based on the framework established within ASU 2009-13. Therefore, the installation and training revenue is recognized as the services are performed according to the BESP of the element. Revenue from the digital and film based equipment, when there is installation, is recognized based on the relative selling price allocation of the BESP, when delivered.

Revenue from certain CAD products is recognized in accordance with ASC 985-605. Sales of this productour software products typically include training and PCS, and the Company has established VSOE for this element.these elements. Product revenue is determined based on the residual value in the arrangement and is recognized when delivered. Revenue for training is deferred and recognized when the training has been completed.

The Company recognizes post contract customer support revenue together with the initial licensing fee for certain MRI products in accordance with ASC 985-605-25-71.

Sales of the Company’s Therapy segment products typically include a controller, accessories, source agreements and services. The Company allocates revenue to the deliverables in the arrangement based on the BESP in accordance with ASU 2009-13.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

Product revenue is generally recognized when the product has been delivered and service and source revenue is typically recognized over the life of the service and source agreement. The Company includes the following in service and supplies revenue: the sale

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

of physics and management services, the lease of electronic brachytherapy equipment, development fees, supplies and the right to use the Company’s AxxentHub software. Physics and management services revenue and development fees are considered to be delivered as the services are performed or over the estimated life of the agreement. The Company typically bills items monthly over the life of the agreement except for development fees, which are generally billed in advance or over a 12 month period and the fee for treatment supplies which is generally billed in advance.

The Company defers revenue from the sale of certain service contracts and recognizes the related revenue on a straight-line basis in accordance with ASC Topic 605-20, “Services”. The Company provides for estimated warranty costs on original product warranties at the time of sale.

Cost of Revenue

Cost of revenue consists of the costs of products purchased for resale, costs relating to service including personnel costs for physicists, management services and radiation therapists, costs of service contracts to maintain equipment after the warranty period, product installation, training, customer support, certain warranty repair costs, inbound freight and duty, cost of supplies, manufacturing, warehousing, material movement, inspection, scrap, rework, amortization, depreciation and in-house product warranty repairs.

Medical Device Excise tax included in the cost of revenue is approximately $131,000 and $462,000, for the three and nine months ended September 30, 2015, respectively and $211,000 and $590,000 for the three and nine months ended September 30, 2014, respectively.

Segments

The Company reports the results of two segments,segments: Cancer Detection (“Detection”) and Cancer Therapy (“Therapy”). The Detection segment consists of our advanced image analysis and workflow products. The Therapy segment consists of our radiation therapy (“Axxent”) products, physics and management services, development fees, supplies, and the right to use the AxxentHub software platform.

Note 2 - Loss per Common Share

The Company’s basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the period.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015March 31, 2016

 

A summary of the Company’s calculation of net loss per share is as follows (in thousands except per share amounts):

 

  Three Months Ended   Nine Months Ended   Three Months Ended 
  September 30,   September 30,   March 31, 
  2015 2014   2015 2014   2016   2015 

Net loss

  $(402 $274    $(30,045 $(913  $(2,533  $(1,857
  

 

  

 

   

 

  

 

   

 

   

 

 

Basic and diluted shares used in the calculation of net loss per share

   15,725   15,283     15,670   13,609     15,826     15,605  

Effect of dilutive securities:

          

Stock options

   —     756     —      —       —       —    

Restricted stock

   —     309     —      —       —       —    
  

 

  

 

   

 

  

 

   

 

   

 

 

Diluted shares used in the calculation of net loss per share

   15,725   16,348     15,670   13,609     15,826     15,605  
  

 

  

 

   

 

  

 

   

 

   

 

 

Net loss per share - basic and diluted

  $(0.03 $0.02    $(1.92 $(0.07  $(0.16  $(0.12
  

 

   

 

 
  

 

  

 

   

 

  

 

 

Net loss per share - diluted

  $(0.03 $0.02    $(1.92 $(0.07  $(0.16  $(0.12
  

 

  

 

   

 

  

 

   

 

   

 

 

The shares of the Company’s common stock, issuable upon the exercise of stock options and vesting of restricted stock that were excluded from the calculation of diluted net loss per share because their effect would have been antidilutive is as follows:

 

   Nine Months Ended 
   September 30, 
   2015   2014 

Stock Options

   894,306     55,463  

Restricted Stock

   432,479     —    
  

 

 

   

 

 

 

Stock options and restricted stock

   1,326,785     55,463  
  

 

 

   

 

 

 
   Period Ended 
   March 31, 
   2016   2015 

Stock options

   1,559,998     1,521,607  

Restricted stock

   390,477     509,902  
  

 

 

   

 

 

 

Stock options and restricted stock

   1,950,475     2,031,509  
  

 

 

   

 

 

 

Note 3 – Business Combinations

Acquisition of VuComp Cancer detection portfolio

On January 13, 2016, the Company completed the acquisition of the VuCOMP cancer detection portfolio, including the M-Vu computer aided detection (CAD) technology platform. The acquisition includes an extensive library of related clinical data, VuCOMP’s key personnel and the customer base that existed at closing of the transaction. The acquisition of the key personnel and clinical data is expected to contribute to the ongoing development of the Company’s CAD technology which will be used for future cancer detection research and patents. As the Company considered this to be a business combination, the assets were valued in accordance with ASC Topic 805, “Business Combinations” (“ASC 805”).

As noted below, the Company acquired VuComp’s M-Vu Breast Density product in April 2015. In connection with the diligence of the January 2016 acquisition, VuComp disclosed that it had previously entered into a license agreement pursuant to which it issued an

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

irrevocable, royalty-free worldwide license to a third party. On December 24, 2015, iCAD notified VuComp of a claim under the April 2015 asset purchase agreement based on the disclosure of the third party license agreement, which iCAD believed constituted a breach of VuComp’s representation as to its exclusive ownership of its intellectual property at the time of the April 2015 transaction. In connection with the purchase of the VuComp cancer detection portfolio, the Company provided a release of the aforementioned claim. The Company determined that this claim was a component of the purchase price. The Company determined the value of litigation settlement as the excess of the fair value of the business acquired over the cash consideration paid. As a result the Company recorded a gain on litigation settlement of $249,000, which is a component of the purchase price as noted below:

Amount (000’s)

Cash

6

Litigation settlement

249

Purchase price

255

The amount allocated to the acquired assets was estimated primarily through the use of discounted cash flow valuation techniques. Appraisal assumptions utilized under this method include a forecast of estimated future net cash flows, as well as discounting the future net cash flows to their present value. The following is a summary of the preliminary allocation of the total purchase price based on the estimated fair values as of the date of the acquisition and the amortizable life:

Amount (000’s)Estimated
amortizable life

Current assets

70

Property and equipment

653 Years     

Identifiable intangible assets

6991-10 Years

Goodwill

307

Current liabilities

(280

Long-term liabilities

(606

Purchase price

255

The assets obtained in the acquisition of VuComp’s M-Vu Cancer detection portfolio and the anticipated future revenues are included in the Detection segment and, accordingly, the goodwill resulting from the purchase price allocation is included in goodwill of the Detection segment.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

Acquisition of VuComp M-Vu Breast Density Product

On April 29, 2015, pursuant to the terms of the Asset Purchase Agreement with VuComp, the Company purchased VuComp’s M-Vu Breast Density product for $1,700,000 in cash. The Company considered the acquisition to be an acquisition of a business as the Company acquired the Breast Density product and certain customer liabilities which were considered to be an integrated set of activities at acquisition. Under the terms of the agreement, the Company acquired the breast density intellectual property product, which has been integrated with the Company’s PowerLook Advanced Mammography Platform (AMP). PowerLook AMP is a modular solution designed to provide advanced tools for breast disease detection and analysis, including CAD for tomosynthesis. As the Company considered this to be a business combination, the assets were valued in accordance with ASC Topic 805, “Business Combinations” (“ASC 805”).

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

The amount allocated to the acquired assets was estimated primarily through the use of discounted cash flow valuation techniques. Appraisal assumptions utilized under this method include a forecast of estimated future net cash flows, as well as discounting the future net cash flows to their present value. The acquired technology is being amortized over the estimated useful life of approximately eight years and nine months from the closing of the transaction. The following is a summary of the preliminary allocation of the total purchase price based on the estimated fair values as of the date of the acquisition and the amortizable life:

 

   Amount   Estimated Amortizable Life

Developed Technology

   900    8 years 9 months

Goodwill

   800    
  

 

 

   

Purchase price

  $1,700    
  

 

 

   

The assets obtained in the acquisition of VuComp’s M-Vu Breast Density product and the anticipated future revenues are included in the Detection segment and, accordingly, the goodwill resulting from the purchase price allocation is included in goodwill of the Detection segment.

Acquisition of DermEbx and Radion

On July 15, 2014, the Company entered into two Asset Purchase Agreements, one with Radion, Inc. (“Radion”) the other with DermEbx, a series of Radion Capital Partners LLC (“DermEbx”) (the “Radion/DermEbx Acquisition”). Pursuant to the Asset Purchase Agreement with DermEbx, the Company purchased substantially all of the assets of DermEbx, including all of DermEbx’s intellectual property and customer contracts. The Company paid the following consideration to DermEbx: (i) $1,600,000 in cash and (ii) 600,000 restricted shares of the Company’s common stock, $0.01 par value per share. The 600,000 restricted shares were subject to the following provisions; 25% was locked up until the date that was two trading days after the Company announced its fourth quarter 2014 earnings, which occurred on March 2, 2015; 30% of the shares were to be locked up for a period of 24 months from the date of the agreement; and 30% of the shares were to be locked up for a period of 36 months from the date of the agreement. In addition the Company delivered the remaining 15%, or 90,000, of the restricted shares to US Bank, N.A., as escrow agent, which were to be held in escrow for a period of 18 months pursuant to the terms of an escrow agreement. The 90,000 escrow shares acted as the source of payment for the indemnification of the Company by DermEbx under the DermEbx Asset Purchase Agreement. On October 7, 2015, the Company and each of Radion and DermEbx entered into a working capital settlement agreement pursuant to which the restrictions on the shares were lifted, the escrow shares were released from escrow and the parties agreed to settle all amounts owed under the Asset Purchase Agreements.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015March 31, 2016

 

Pursuant to the terms of the Asset Purchase Agreement with Radion, the Company purchased substantially all of the assets of Radion, including all of Radion’s intellectual property and customer contracts. The Company paid the following consideration to Radion: (i) $2,382,000 in cash which included $182,000 payoff of an existing note payable and (ii) the issuance to Radion of 600,000 restricted shares of the Company’s common stock. The 600,000 restricted shares were subject to the following provisions; 25% of the shares were locked up until the date that was two trading days after the Company announces its fourth quarter 2014 earnings, which occurred on March 2, 2015; 30% of the shares shall be locked up for a period of 24 months from the date of the agreement; and 30% of the shares were to be locked up for a period of 36 months from the date of the agreement. In addition the Company delivered the remaining 15% or 90,000 of the restricted shares to US Bank, N.A., as escrow agent, which were to be held in escrow for a period of 18 months pursuant to the terms of an escrow agreement. The 90,000 escrow shares acted as the source of payment for the indemnification of the Company by Radion under the Radion Asset Purchase Agreement. On October 7, 2015, the Company and each of Radion and DermEbx entered into a working capital settlement agreement pursuant to which the restrictions on the shares were lifted, the escrow shares were released from escrow and the parties agreed to settle all amounts owed under the Asset Purchase Agreements.

Prior to the Radion DermEbx Acquisition in July 2014, the Sellers represented one of the Company’s significant customers in the Therapy segment. The Company recognized approximately $0.5 million of Therapy service revenue, for a total of $2.1 million related to Sellers, in the six months ended June 30, 2014, and these amounts are included in the results for the nine months ended September 30, 2014.

The amounts allocated to purchased and developed software, customer relationships, trade names, employee non-compete agreements and backlog were estimated primarily through the use of discounted cash flow valuation techniques. Appraisal assumptions utilized under these methods include a forecast of estimated future net cash flows, as well as discounting the future net cash flows to their present value. Acquired intangible assets are being amortized over the estimated useful lives as set forth in the following table. The following is a summary of the allocation of the total purchase price based on the estimated fair values of the assets acquired and liabilities assumed as of the date of the acquisition and the amortizable lives of the intangible assets:

   Amount   

Estimated Amortizable Life

Current assets

  $3,457    

Property and equipment

   2,625    3 – 7 Years

Identifiable intangible assets

   6,050    5 – 10 Years

Goodwill

   6,270    

Current liabilities

   (4,382  

Long-term liabilities

   (2,164  
  

 

 

   

Purchase price

  $11,856    
  

 

 

   

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

The assets obtained in the Radion/DermEbx Acquisition and the resulting revenues are included in the Therapy segment and, accordingly, the goodwill resulting from the purchase price allocation is included in goodwill of the Therapy segment. As discussed in Note 12, the Company recorded a goodwill impairment charge related to the Therapy segment of $14.0 million in the quarter ended June 30, 2015.

The goodwill is deductible for income tax purposes.

Note 4 – Inventory

The components of inventory, net of allowance for obsolete, unmarketable or slow-moving inventories, are summarized as follows:

 

  as of September 30,
2015
   as of December 31,
2014
   as of March 31,
2016
   as of December 31,
2015
 

Raw materials

  $2,488    $955    $3,317    $2,900  

Work in process

   161     54     108     154  

Finished Goods

   1,097     1,205     1,121     1,261  
  

 

   

 

   

 

   

 

 

Inventory

  $3,746    $2,214    $4,546    $4,315  
  

 

   

 

   

 

   

 

 

Note 5 – Long Term Debt

On March 31, 2015, the Company repaid in full the aggregate amount outstanding under the Deerfield Facility Agreement, dated as of December 29, 2011 (as amended, supplemented or otherwise modified to the date hereof, the “Facility Agreement”), by and among the Company, Deerfield Private Design Fund II, L.P., Deerfield Private Design International II, L.P., and Deerfield Special Situations Fund, L.P. and, for itself and as assignee of the obligations held by Deerfield Special Situations Fund International Master Fund, L.P. The Facility Agreement and related documents were terminated as of March 31, 2015. The Facility Agreement was to mature on December 29, 2016 and was able to be repaid prior to the maturity date at the Company’s option without penalty or premium. On

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

March 31, 2015, the Company used cash on hand to pay the $11.25 million outstanding principal amount due under the Facility Agreement and approximately $162,000 in accrued and unpaid interest on such principal amount.

The Company recorded a loss on the extinguishment of debt of approximately $1.7 million at the termination date in the quarter ended March 31, 2015.

The following amounts compose interest expense included in our consolidated statement of operations for the three and nine months ended September 30, 2015March 31, 2016 and 2014:2015: (in thousands)

 

  Three months ended September 30,   Three months ended March 31, 
  2015   2014   2016   2015 

Cash interest expense

  $—      $215    $—      $162  

Non-cash amortization of debt discount

   —       327     —       254  

Amortization of debt costs

   —       17     —       13  

Amortization of settlement obligations

   32     55     23     45  

Interest expense capital lease

   14     33     —       33  
  

 

   

 

   

 

   

 

 

Total interest expense

  $  46    $   647    $23    $507  
  

 

   

 

   

 

   

 

 
  Nine months ended September 30 
  2015   2014 

Cash interest expense

  $162    $1,009  

Non-cash amortization of debt discount

   254     775  

Amortization of debt costs

   13     93  

Amortization of settlement obligations

   124     161  

Interest expense capital lease

   70     40  
  

 

   

 

 

Total interest expense

  $623    $2,078  
  

 

   

 

 

Cash interest expense represents the amount of interest paid in cash under the Facility Agreement which represents the interest of 5.75% on the Facility Agreement through March 31, 2015. Non-cash amortization is the amortization of the discount on the Facility Agreement. The amortization of debt costs relates to the costs incurred with the financing, which is primarily a facility fee and a finder’s fee that were capitalized and are being

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

expensed using the effective interest method. The amortization of the settlement obligation represents the interest associated with the settlement agreements for both Carl Zeiss Meditec AG and Hologic, Inc (see Note 8). Interest expense capital lease represents interest related to the capital lease as described in Note 6.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

Note 6 – Lease Commitments

Operating leases

Facilities are leased under operating leases expiring at various dates through September, 2017.March, 2018. Certain of these leases contain renewal options. Rent expense under operating leases was $165,000 and $490,000$162,000 for each of the three month periods ended March 31, 2016 and nine month period ended September 30, 2015 and $150,000 and $476,000 for the three and nine month period ended September 30, 2014, respectively.March 31, 2015.

Future minimum lease payments as of September 30, 2015March 31, 2016 under operating leases are as follows: (in thousands)

 

Fiscal Year

  Operating Leases   Operating
Leases
 

2015

  $128  

2016

   499    $394  

2017

   255     289  

2018

   9  
  

 

   

 

 
  $882    $692  
  

 

   

 

 

Capital leases

The Company entered into a capital lease agreement for the purchase of certain equipment in August 2013 for approximately $409,000. Under the guidance of ASC Topic 840, “Leases” (“ASC 840”) the Company determined that the lease was a capital lease as it contained a bargain purchase option whereby the Company has the option to buy the equipment for $1 at the end of the lease term. Accordingly, the equipment has been capitalized and a liability has been recorded. The equipment cost of $409,000 is reflected as property and equipment in the balance sheet and is being depreciated over its useful life.

In connection with the Radion/DermEbx Acquisition, the Company assumed two separate equipment lease obligations with payments totaling approximately $2.6 million through May 2017. The leases were determined to be capital leases and accordingly the equipment was capitalized and a liability of $2.5 million was recorded. As of September 30, 2015,March 31, 2016, the outstanding liability for the acquired equipment leases was approximately $1.4$0.7 million.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

Future minimum lease payments under all outstanding capital leases are as follows: (in thousands)

 

Fiscal Year  Capital
Leases
   Capital
Leases
 

2015

  $386  

2016

   1,039     691  

2017

   89     89  
  

 

   

 

 

Subtotal minimum lease obligation

   1,514  

Less interest

   (112

subtotal minimum lease obligation

   780  

less interest

   (43
  

 

   

 

 

Total, net

   1,402     737  

Less current portion

   (1,157

less current portion

   (715
  

 

   

 

 

Long term portion

  $245    $22  
  

 

   

 

 

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

Related Party Lease:

Kamal Gogineni is an employee of one of the Company’s subsidiaries and a beneficial owner of more than 5%shareholder of the Company’s common stock. Additionally, Mr. Gogineni is a significant shareholder of Radion Capital Partners (“RCP”). RCP was the lessor under a lease between RCP and DermEbx (the “Lease”). In connection with the Company’s Radion/acquisition of assets of Radion and DermEbx acquisition that closed in July 2014, one of the assets and obligations that the Company acquired was the Lease. Pursuant to the Lease, the Company is obligated to pay a total of $664,000 as of September 30, 2015$0.3 million and the liability is included in the minimum lease payments above, with remaining annual payments of $192,000 for the remainder of 2015, $396,000$239,000 in 2016 and $76,000 in 2017.

Note 7 - Stock-Based Compensation

The Company follows the guidance in ASC Topic 718, “Compensation – Stock Compensation, (“ASC 718”).

The Company granted 40,000 and 358,000 options to purchase 1,000 shares of the Company’s stock in the three and nine months ended September 30, 2015.March 31, 2016. Options granted under the Company’s stock incentive plans were valued utilizing the Black-Scholes model using the following assumptions and had the following fair values:

 

  Three Months Ended  Nine Months Ended
  September 30,  September 30,  Three Months Ended
March 31,
  2015  2014  2015  2014  2016 2015

Average risk-free interest rate

  1.06%  0.93%  0.95%  0.84%   0.91 0.88%

Expected dividend yield

  None  None  None  None   None   None

Expected life

  3.5 years  3.5 years  3.5 years  3.5 years   3.5 years   3.5 years

Expected volatility

  74.6%  66.3% to 69.3%  60.5% to 74.6%  64.2% to 69.3%   75.3 65.3% to 67.1%

Weighted average exercise price

  $3.85  $8.74  $6.62  $8.02  $4.47   $9.45

Weighted average fair value

  $2.02  $4.29  $3.19  $3.80  $2.35   $4.43

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015March 31, 2016

 

The amounts included in the consolidated statement of operations relating to stock basedCompany’s stock-based compensation expense, areincluding options and restricted stock by category is as follows:follows (amounts in thousands):

 

  Three Months Ended   Nine Months Ended 
  September 30,   September 30,   Three Months Ended
March 31,
 
  2015   2014   2015   2014   2016   2015 

Cost of revenue

  $4    $3    $11    $10    $2    $4  

Engineering and product development

   53     43     165     126     111     51  

Marketing and sales

   162     97     495     237     173     130  

General and administrative

   318     217     930     593     364     259  
  

 

   

 

   

 

   

 

   

 

   

 

 
  $537    $360    $1,601    $966    $650    $444  
  

 

   

 

   

 

   

 

   

 

   

 

 

As of September 30, 2015March 31, 2016 unrecognized compensation cost (in thousands) related to unexercisable options and unvested restricted stock and the weighted average remaining period is as follows:

 

Remaining expense

  $4,039    $3,330    $5,115  

Weighted average term

   1.21 years     1.0 years     1.39 years  

The Company’s restricted stock awards typically vest in either one year or three equal annual installments with the first installment vesting one year from grant date. The Company granted 42,000 shares of restricted stock in the quarter ended March 31, 2016.

The Company’s aggregate intrinsic value for stock options and restricted stock outstanding is as follows (in thousands):

 

  Period Ended
September 30,
   Period Ended
March 31,
 

Aggregate intrinsic value

  2015   2014   2016   2015 

Stock options

  $584    $7,448    $1,842    $6,651  

Restricted stock

   1,470     3,047     1,991     4,885  

The intrinsic value of stock options exercised during the ninethree months ended September 30,March 31, 2016 and 2015 was $6,000 and 2014$0.2 million, respectively. The intrinsic value of restricted shares that vested in the quarter ended March 31, 2016 and 2015 was $0.3$0.7 million and $0.9$0.6 million, respectively.

Note 8 - Commitments and Contingencies

Foreign Tax Claim

In July 2007, a dissolved former Canadian subsidiary of the Company, CADx Medical Systems Inc. (“CADx Medical”), received a tax re-assessment of approximately $6,800,000

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

$6,800,000 from the Canada Revenue Agency (“CRA”) resulting from CRA’s audit of CADx Medical’s Canadian federal tax return for the year ended December 31, 2002. In February 2010 the CRA reviewed the matter and reduced the tax re-assessment to approximately $703,000, excluding interest and penalties. The Company believes that it is not liable for the re-assessment against CADx Medical and no accrual has been recorded for this matter as of September 30, 2015.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

March 31, 2016.

Settlement Obligations

In connection with the acquisition of Xoft in 2010, the Company recorded a royalty obligation pursuant to a settlement agreement entered into between Xoft and Hologic in August 2007. Xoft received a nonexclusive, irrevocable, perpetual, worldwide license, including the right to sublicense certain Hologic patents, and a non-compete covenant as well as an agreement not to seek further damages with respect to the alleged patent violations. In return, the Company has a remaining obligation to pay a minimum annual royalty payment to Hologic, of $250,000 payable through 2016. In addition to the minimum annual royalty payments, the litigation settlement agreement with Hologic also provided for payment of royalties based upon a specified percentage of future net sales on any products that utilize the licensed rights. The Company has a liability within accrued expenses and long-term settlement cost for future payment and for future minimum royalty obligations totaling $408,000.$429,000. The Company recorded interest expense of approximately $19,000 and $55,000$9,000 in the three and nine months ended September 30, 2015March 31, 2016 and $27,000 and $77,000$18,000 in the three and six months ended September 30, 2014, respectively,March 31, 2015 related to this obligation.

In December, 2011, the Company agreed to a settlement related to litigation with Carl Zeiss Meditec AG. The Company is obligated to pay the remaining amount of $0.5 million in June 2017. As of September 30, 2015,March 31, 2016, the remaining liability recorded within accrued expenses and long-term settlement cost for future payment and for future minimum royalty obligations is $408,000.$434,000. The Company recorded interest expense of approximately $13,000 and $69,000 in the three and nine months ended September 30, 2015March 31, 2016 and $28,000 and $84,000 in the three and nine months ended September 30, 2014, respectively,March 31, 2015, related to this obligation.

The Company was granted a non-exclusive license from Yeda Research which relates to the 3TP method for the detection of cancer and has a minimum obligation of $25,000 annually through 2032 for a total of approximately $0.4 million.

Other Commitments

The Company is obligated to pay approximately $2.3$0.6 million for firm purchase obligations to suppliers for future product deliverables.

Litigation

The Company is a party to various legal proceedings and claims arising out of the ordinary course of its business. Although the final results of all such matters and claims cannot be predicted with certainty, the Company currently believes that there are no current

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

proceedings or claims pending against it of which the ultimate resolution of which would have a material adverse effect on its financial condition or results of operations. However, should the Company fail to prevail in any legal matter or should several legal matters be resolved against the Company in the same reporting period, such matters could have a material adverse effect on our operating results and cash flows for that particular period. In all cases, at each reporting period, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under ASC 450, Contingencies. Legal costs are expensed as incurred.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

Note 9 - Fair Value Measurements

The Company follows the provisions of ASC Topic 820, “Fair Value Measurement and Disclosures”, (“ASC 820”). This topic defines fair value, establishes a framework for measuring fair value under US GAAP and enhances disclosures about fair value measurements. Fair value is defined under ASC 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset orassetor liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value under ASC 820 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following:

 

Level 1 - Quoted prices in active markets for identical assets or liabilities.

 

Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value.

A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

Our financial instruments include cash and cash equivalents, accounts receivable, accounts payable and certain accrued liabilities. The carrying amounts of our cash and cash equivalents (which are composed primarily of deposit and overnight sweep accounts), accounts receivable, accounts payable and certain accrued liabilities approximate fair value due to the short maturity of these instruments.

The Company’s assets that are measured at fair value on a recurring basis relate to the Company’s money market accounts.

The Company’s money market funds are included in cash and cash equivalents in the accompanying balance sheets, and are considered a Level 1 investment as they are valued at quoted market prices in active markets.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

The following table sets forth the Company’s assets and liabilities which are measured at fair value on a recurring basis by level within the fair value hierarchy.

 

Fair value measurements using: (000’s) as of December 31, 2014

 
   Level 1   Level 2   Level 3   Total 

Assets

        

Money market accounts

  $26,530    $—      $—      $26,530  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Assets

  $26,530    $—      $—      $26,530  
  

 

 

   

 

 

   

 

 

   

 

 

 

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

Fair value measurements using: (000’s) as of December 31, 2015

 
   Level 1   Level 2   Level 3   Total 

Assets

        

Money market accounts

  $13,577    $—      $—      $13,577  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Assets

  $13,577    $—      $—      $13,577  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

Fair value measurements using: (000’s) as of September 30, 2015

 
   Level 1   Level 2   Level 3   Total 

Assets

        

Money market accounts

  $13,573    $—      $—      $13,573  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Assets

  $13,573    $—      $—      $13,573  
  

 

 

   

 

 

   

 

 

   

 

 

 

Items Measured at Fair Value on a Nonrecurring Basis

Certain assets, including long-lived assets and goodwill, are measured at fair value on a nonrecurring basis. These assets are recognized at fair value when they are deemed to be impaired. The Company recorded a $27.4 million impairment consisting of $14.0 million related to goodwill and $13.4 million related to long-lived assets as discussed in Note 11 and Note 12 and re-measured long-lived assets and goodwill of the Therapy reporting unit at fair value as of the impairment date as noted in the following table. The fair values of long-lived assets and goodwill were measured using Level 3 inputs.

Fair value measurements using: (000’s) as of September 30, 2015

 
   Level 1   Level 2   Level 3   Total 

Non-recurring assets

        

Long-lived and intangible assets

  $—      $—      $3,195    $3,195  

Goodwill

   —       —       5,735     5,735  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Assets

  $—      $—      $8,930    $8,930  
  

 

 

   

 

 

   

 

 

   

 

 

 

Fair value measurements using: (000’s) as of March 31, 2016

 
   Level 1   Level 2   Level 3   Total 

Assets

        

Money market accounts

  $11,580    $—      $—      $11,580  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Assets

  $11,580    $—      $—      $11,580  
  

 

 

   

 

 

   

 

 

   

 

 

 

Note 10 - Income Taxes

The Company recorded an income tax provision of $16,000 and an income tax benefit of $12,000,$22,000 in the three and nine months ended September 30, 2015March 31, 2016 as compared to a provision of $16,000 and $94,000$79,000 in the three and nine months ended September 30, 2014, respectively. The income tax provision for the three months ended September 30, 2015March 31, 2015. The income tax provision relates primarily to state taxes. The income tax net benefit for the nine months ended September 30, 2015 primarily relates to a benefit from the reversal of a deferred tax liability relating to tax amortizable goodwill, offset by the state tax provision. Due to the Company’s goodwill impairment the tax basis in amortizable goodwill is greater than book basis which results in a deferred tax asset that is subject to a valuation allowance. At September 30, 2015,March 31, 2016, the Company had no material unrecognized tax benefits and no adjustments to liabilities or tax expense were required under ASC 740, “Income Taxes”. The Company does not expect that the unrecognized tax benefits will materially increase within the next twelve months. The Company did not recognize any interest or penalties related to uncertain tax positions at September 30, 2015.March 31, 2016. The Company files United States federal income tax returns and income tax returns in various states and local jurisdictions. The Company’s three preceding tax years remain subject to examination by federal and state taxing authorities. In addition, because the Company has net operating loss carry-forwards,

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

the Internal Revenue Service and state jurisdictions are permitted to audit earlier years and propose adjustments up to the amount of net operating loss generated in those years. The Company is not under examination by any federal or state jurisdiction for any tax years.

Note 11 – Long-lived assets

In accordance with FASB ASC Topic 360, “Property, Plant and Equipment”, (“ASC 360”), the Company assesseslong-lived assets for impairment if events and circumstances indicate it is more likely than not that the fair value of the asset group is less than the carrying value of the asset group.

ASC 360-10-35 uses “events and circumstances” criteria to determine when, if at all, an asset (or asset group) is evaluated for recoverability. Thus, there is no set interval or

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

frequency for recoverability evaluation. In accordance with ASC 360-10-35-21 the following factors are examples of events or changes in circumstances that indicate the carrying amount of an asset (asset group) may not be recoverable and thus is to be evaluated for recoverability.

 

A significant decrease in the market price of a long-lived asset (asset group);

 

A significant adverse change in the extent or manner in which a long-lived asset (asset group) is being used or in its physical condition;

 

A significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset (asset group), including an adverse action or assessment by a regulator;

 

An accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset (asset group);

 

A current period operating or cash flow loss combined with a history of operating or cash flow losses or a projection or forecast that demonstrates continuing losses associated with the use of a long-lived asset (asset group).

As a result of external factors and general uncertainty related to reimbursement for the treatment of non-melanoma skin cancer, the Company evaluated the long-livedWe did not consider any assets of the Therapy segment and reviewed them for potential impairment. The Company determined the “Asset Group” to be impaired in the assets of the Therapy segment, which the Company considered to be the lowest level for which the identifiable cash flows were largely independent of the cash flows of other assets and liabilities.

In accordance with ASC 360-10-35-17, if the carrying amount of an asset or asset group (in use or under development) is evaluated and found not to be fully recoverable (the carrying amount exceeds the estimated gross, undiscounted cash flows from use and disposition), then an impairment loss must be recognized. The impairment loss is measured as the excess of the carrying amount over the assets (or asset group’s) fair value.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

In connection with the preparation of the financial statements for the second quarter ended June 30, 2015, the Company completed its analysis pursuant to ASC 360-10-35-17 and determined that the carrying value of the Asset Group was approximately $36.8 million, which exceeded the undiscounted cash flows by approximately $2.8 million. Accordingly the Company completed the Step 2 analysis to determine the fair value of the asset group. The Company recorded long-lived asset impairment charges of approximately $13.4 million in the second quarter ended June 30, 2015 and as a result the long lived assets in the asset group were recorded at their current fair values.

A considerable amount of judgment and assumptions are required in performing the impairment tests, principally in determining the fair value of the asset group and the reporting unit. While the Company believes the judgments and assumptions are reasonable, different assumptions could change the estimated fair values and, therefore additional impairment charges could be required. Significant negative industry or economic trends, disruptions to the Company’s business, loss of significant customers, inability to effectively integrate acquired businesses, unexpected significant changes or planned changes in use of the assets may adversely impact the assumptions used in the fair value estimates and ultimately result in future impairment charges.March 31, 2016.

Note 12 - Goodwill

In accordance with FASB ASCAccounting Standards Codification (“ASC”) Topic 350-20, “Intangibles - Goodwill and Other”, (“ASC 350-20”), the Company tests goodwill for impairment on an annual basis and between annual tests if events and circumstances indicate it is more likely than not that the fair value of the Companyreporting unit is less than the carrying value of the Company.reporting unit.

Factors the Company considers important, which could trigger an impairment of such asset, include the following:

 

significant underperformance relative to historical or projected future operating results;

 

significant changes in the manner or use of the assets or the strategy for the Company’s overall business;

 

significant negative industry or economic trends;

 

significant decline in the Company’s stock price for a sustained period; and

 

a decline in the Company’s market capitalization below net book value.

The Company’s Chief Operating Decision Maker (“CODM”)Company would record an impairment charge if such an assessment were to indicate that the fair value of a reporting unit was less than the carrying value. In evaluating potential impairments outside of the annual measurement date, judgment is required in determining whether an event has occurred that may impair the Chief Executive Officer (“CEO”).value of goodwill or intangible assets. The two segmentsCompany utilizes either discounted cash flow models or other valuation models, such as comparative transactions and reporting units are Cancer Detection (“Detection”) and Cancer Therapy (“Therapy”). Each segment generates revenue frommarket multiples, to determine the sale of medical equipment and related services and/or sale of supplies.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015March 31, 2016

 

fair value of reporting units. The Company makes assumptions about future cash flows, future operating plans, discount rates, comparable companies, market multiples, purchase price premiums and other factors in those models. Different assumptions and judgment determinations could yield different conclusions that would result in an impairment charge to income in the period that such change or determination was made. We did not consider goodwill to be impaired in the quarter ended March 31, 2016.

The Company performed theits annual impairment assessment at October 1, 20142015 and compared the fair value of each of reporting unit to its carrying value as of this date. FairThe fair value of each reporting unit exceeded the carrycarrying value by approximately 315%584% for the Detection reporting unit and 255%144% for the Therapy reporting unit. The carrying values of the reporting units were determined based on an allocation of our assets and liabilities through specific allocation of certain assets and liabilities to the reporting units and an apportionment of the remaining net assets based on the relative size of the reporting units’ revenues and operating expenses compared to the Company as a whole. The determination of reporting units also requires management judgment. The Company’s next annual impairment assessment is October 1, 2015.

An impairment charge is recorded if such an assessment were to indicate that the fair value of a reporting unit was less than the carrying value. When the Company evaluates potential impairments outside of the annual measurement date, judgment is required in determining whether an event has occurred that may impair the value of goodwill or intangible assets. The Company utilizes either discounted cash flow models or other valuation models, such as comparative transactions and market multiples, to determine the fair value of the reporting unit. The Company makes assumptions about future cash flows, future operating plans, discount rates, comparable companies, market multiples, purchase price premiums and other factors in those models. Different assumptions and judgment determinations could yield different conclusions that would result in an impairment charge to income in the period that such change or determination was made.

As a result of external factors and general uncertainty related to reimbursement for non-melanoma skin cancer and in conjunction with the long-lived asset impairment testing, the Company performed an impairment assessment of the Therapy reporting unit as of June 30, 2015. As a result the Company recorded a goodwill impairment charge of $14.0 million during the quarter ended June 30, 2015.

The implied fair value of the Therapy reporting unit was determined in the same manner as the manner in which the amount of goodwill recognized in a business combination is determined. The excess of the fair value of the reporting unit over the amounts assigned to its assets and liabilities is the implied amount of goodwill. The Company identified the intangible assets that were valued during this process, including technology, customer relationships, trade-names, and the Company’s workforce. The allocation process was performed only for purposes of testing goodwill for impairment.

The Company determined the fair valuevalues for each reporting unit using a weighting of the Therapy reporting unitincome approach and the market approach. For purposes of the income approach, fair value is determined based on the present value of estimated future cash flows, discounted at an appropriate risk adjusted rate. This approach was selected as it measures the income producing assets, primarily technology and customer relationships. This method estimates the fair value based upon the ability to generate future cash flows, which is particularly applicable when future profit margins and growth are expected to vary significantly from historical operating results.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

The Company usesused internal forecasts to estimate future cash flows and includes an estimate of long-term future growth rates based on the most recent views of the long-term forecast for the reporting unit.each segment. Accordingly, actual results can differ from those assumed in the forecasts. The discount rate of approximately 17% is derived from a capital asset pricing model and analyzing published rates for industries relevant to the reporting unitunits to estimate the cost of equity financing. The Company uses discount rates that are commensurate with the risks and uncertainty inherent in the respective businesses and in the internally developed forecasts.

Other significant assumptions include terminal value margin rates, future capital expenditures,In the market approach, the Company uses a valuation technique in which values are derived based on market prices of publicly traded companies with similar operating characteristics and changesindustries. A market approach allows for comparison to actual market transactions and multiples. It can be somewhat limited in future working capital requirements. While there are inherent uncertainties relatedits application because the population of potential comparable publicly-traded companies can be limited due to differing characteristics of the comparative business and ours, as well as market data may not be available for divisions within larger conglomerates or non-public subsidiaries that could otherwise qualify as comparable, and the specific circumstances surrounding a market transaction (e.g., synergies between the parties, terms and conditions of the transaction, etc.) may be different or irrelevant with respect to the assumptionsbusiness.

The Company corroborated the total fair values of the reporting units using a market capitalization approach; however, this approach cannot be used and to the application of these assumptions to this analysis, the income approach provides a reasonable estimate ofdetermine the fair value of each reporting unit value. The blend of the Therapy reporting unit.income approach and market approach is more closely aligned to the business profile of the Company, including markets served and products available. In addition, required rates of return, along with uncertainties inherent

The Step 2 test resulted

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

in the forecast of future cash flows, are reflected in the selection of the discount rate. In addition, under the blended approach, reasonably likely scenarios and associated sensitivities can be developed for alternative future states that may not be reflected in an approximate fair valueobservable market price. The Company will assess each valuation methodology based upon the relevance and availability of goodwill of $5.7 million which resulted in a goodwill impairment loss of $14.0 million.the data at the time the valuation is performed and weight the methodologies appropriately.

As discussed in Note 3, in April 2015, the Company acquired VuComp’s M-Vu® Breast Density product for $1.7 million. The product will bewas integrated into the Company’s Powerlook AMP system, which is a component of the Detection reporting unit. The Company determined that the acquisition was a business combination and accordingly recorded goodwill of $0.8 million.million to the Detection segment. In January 2016, the Company completed the acquisition of VuComp’s M-Vu CAD and other assets for $6,000. The customers, related technology and clinical data acquired will be used for the Company’s Cancer Detection products and the Company recorded goodwill of $307,000 to the Detection segment.

A roll forward of goodwill activity by reporting unitreportable segment is as follows:

 

  Detection   Therapy   Total   Detection   Therapy   Total 

Accumulated Goodwill

  $—      $—      $47,937    $—      $—      $47,937  

Accumulated impairment

   —       —       (26,828   —       —       (26,828

Fair value allocation

   7,663     13,446     —       7,663     13,446     —    

Acquisition of DermEbx and Radion

   —       6,154     6,154     —       6,154     6,154  
  

 

   

 

   

 

   

 

   

 

   

 

 

Balance at December 31, 2014

   7,663     19,600     27,263     7,663     19,600     27,263  
  

 

   

 

   

 

 

Acquisition measurement period adjustments

   —       116     116     —       116     116  

Acquisition of VuComp

   800     —       800     800     —       800  

Impairment

   —       (13,981   (13,981   —       (13,981   (13,981
  

 

   

 

   

 

   

 

   

 

   

 

 

Balance at September 30, 2015

  $8,463    $5,735    $14,198  

Balance at December 31, 2015

   8,463     5,735     14,198  
  

 

   

 

   

 

   

 

   

 

   

 

 

Acquisition of VuComp

   307     —       307  

Impairment

   —         —    
  

 

   

 

   

 

 

Balance at March 31, 2016

  $8,770    $5,735    $14,505  
  

 

   

 

   

 

 

Accumulated Goodwill

   1,107     6,270     55,314  

Fair value allocation

   7,663     13,446     —    

Accumulated impairment

   —       (13,981   (40,809
  

 

   

 

   

 

 

Balance at March 31, 2016

  $8,770    $5,735    $14,505  
  

 

   

 

   

 

 

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

Note 13 – Segment Reporting

In accordance with FASB Topic ASC 280, “Segments”, operating segments, are defined as components of an enterprise that engage in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker CODM in deciding how to allocate resources and assess performance.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015

The Company’s CODM is the CEO. Each segment generates revenue from the sale of medical equipment and related services and/or sale of supplies. The Company has determined there are two segments, Cancer Detection and Cancer Therapy.

The Detection segment consists of our advanced image analysis and workflow products, and the Therapy segment consists of our radiation therapy Axxent products, and related services. The primary factors used by our CODM to allocate resources are based on revenues, gross profit, operating income, and earnings or loss before interest, taxes, depreciation, amortization, and other specific and non-recurring items (“Adjusted EBITDA”) of each segment. Included in segment operating income are stock compensation, amortization of technology and depreciation expense. There are no intersegment revenues.

Our CODM does not use asset information by segment to allocate resources or make operating decisions.

iCAD, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2015March 31, 2016

 

Segment revenues, gross profit, segment operating income or loss, and a reconciliation of segment operating income or loss to GAAP loss before income tax is as follows (in thousands):

 

  Three Months Ended
September 30,
   Nine Months Ended
September 30,
   Three Months Ended
March 31,
 
  2015   2014   2015   2014   2016   2015 

Segment revenues:

            

Detection

  $5,202    $4,936    $14,945    $13,943    $3,930    $4,788  

Therapy

   4,380     7,636     19,000     16,816     2,108     8,432  
  

 

   

 

   

 

   

 

   

 

   

 

 

Total Revenue

  $9,582    $12,572    $33,945    $30,759    $6,038    $13,220  
  

 

   

 

   

 

   

 

   

 

   

 

 

Segment gross profit:

            

Detection

  $4,423    $4,102    $12,460    $11,426    $3,449    $3,947  

Therapy

   2,398     5,065     11,601     10,505     737     5,415  
  

 

   

 

   

 

   

 

   

 

   

 

 

Segment gross profit

  $6,821    $9,167    $24,061    $21,931    $4,186    $9,362  
  

 

   

 

   

 

   

 

   

 

   

 

 

Segment operating income (loss):

            

Detection

   2,392     2,142     6,185     5,555     1,202     1,760  

Therapy

   (558   1,127     (27,070   759     (2,007   957  
  

 

   

 

   

 

   

 

   

 

   

 

 

Segment operating income

  $1,834    $3,269    $(20,885  $6,314    $(805  $2,717  
  

 

   

 

   

 

   

 

   

 

   

 

 

General, administrative, depreciation and amortization expense

  $(2,178  $(2,343  $(6,844  $(6,014  $(1,688  $(2,274

Interest expense

   (46   (647   (623   (2,078   (22   (507

Gain on fair value of warrant

   —       0     —       1,835  

Other income

   4     11     18     27     4     9  

Loss on debt extinguishment

   —       —       (1,723   (903   —       (1,723
  

 

   

 

   

 

   

 

   

 

   

 

 

Loss before income tax

  $(386  $290    $(30,057  $(819  $(2,511  $(1,778
  

 

   

 

   

 

   

 

   

 

   

 

 

Note 14 - Recent Accounting Pronouncements

In May 2014, the FASB issued ASUAccounting Standards Update (“ASU”) 2014-09 “Revenue from Contracts with Customers” (ASU 2014-09)(“ASU 2014-09”), which amends ASC 605 “Revenue Recognition” and creates a new Topic 606 “Revenue from Contracts with Customers.” This update provides guidance on how an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Upon initial application, the provisions of this update are required to be applied retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying this update recognized at the date of initial application. This update also expands the disclosure requirements surrounding revenue recorded from contracts with customers. This update is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016. In AprilAugust 2015, the FASB voted toissued ASU 2015-14 “Deferral of the Effective Date”. The amendments in this Update defer the effective date of this standardUpdate 2014-09 for all entities by one year. Public business entities, certain not-for-profit entities, and certain employee benefit plans should apply the guidance in Update

iCAD, INC. AND SUBSIDIARIES

Notes to yearsCondensed Consolidated Financial Statements

(Unaudited)

March 31, 2016

2014-09 to annual reporting periods beginning after December 15, 2017.2017, including interim reporting periods within that reporting period. Earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. We are currently evaluating the effect of this update on our financial statements and have not yet determined the method of initial application we will use.

In September 2015, the FASB issued ASU No. 2015-16: Simplifying the Accounting for Measurement-Period Adjustments, which eliminates the requirement for an acquirer in a business combination to account for measurement-period adjustments retrospectively. Under the ASU, acquirers must recognize measurement-period adjustments in the period in which they determine the amounts, including the effect on earnings of any amounts they would have recorded in previous periods if the accounting had been completed at the acquisition date. The acquirer still must disclose the amounts and reasons for adjustments to the provisional amounts. The acquirer also must disclose, by line item, the amount of the adjustment reflected in the current-period income statement that would have been recognized in previous periods if the adjustment to provisional amounts had been recognized as of the acquisition date. Alternatively, an acquirer may present those amounts separately on the face of the income statement. The ASU does not change the criteria for determining whether an adjustment qualifies as a measurement-period adjustment and does not change the length of the measurement period. The ASU results in differences between US GAAP and IFRS, which are currently aligned on this topic. The ASU is effective for public business entities for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. The Company adopted this standard and the update had no material impact on our consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, “Leases”. The standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. We are currently evaluating the impact of our pending adoption of the new standard on our consolidated financial statements.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Certain information included in this Item 2 and elsewhere in this Form 10-Q that are not historical facts contain forward looking statements that involve a number of known and unknown risks, uncertainties and other factors that could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievement expressed or implied by such forward looking statements. These risks and uncertainties include, but are not limited to, uncertainty of future sales and expense levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, regulatory changes and requirements applicable to our products, product market acceptance, possible technological obsolescence of products, increased competition, integration of the acquired businesses, the impact of litigation and/or government regulation, changes in Medicare reimbursement policies, competitive factors, the effects of a decline in the economy in markets served by the Company and other risks detailed in the Company’s other filings with the Securities and Exchange Commission. The words “believe”, “plan”, “intend”, “expect”, “estimate”, “anticipate”, “likely”, “seek”, “should”, “would”, “could” 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.

Results of Operations

Overview

iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and while enhancing patient care. 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.

The Company has grown primarily through acquisitions including CADx, Qualia Computing, CAD Sciences, Xoft, DermEbx, Radion and DermEbx and Radion.VuComp. The Radion/DermEbx acquisition extends the Company’s position as a larger player in the oncology market, including the components that enable dermatologists and radiation oncologists to develop, launch and manage their electronic brachytherapy (“eBx”) programs for the treatment of non-melanoma skin cancer. The VuComp acquisition includes an extensive library of related clinical data which we expect to use for future cancer detection research and patents, as well as key personnel and the existing customer base.

In the Detection segment, our industry-leading solutions include advanced image analysis and workflow solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing the most prevalent cancers earlier, a comprehensive range of high-performance, upgradeable Computer-Aided Detection (CAD) systems and workflow solutions for mammography, Magnetic Resonance Imaging (MRI) and Computed Tomography (CT).

The Company intends to continue the extension of its image analysis and clinical decision support solutions for mammography, MRI and CT imaging. The Company believes that advances in digital imaging techniques, such as 3D mammography, should bolster its efforts to develop additional commercially viable CAD/advanced image analysis and workflow products. In April 2015, the Company acquired VuComp’s M-Vu Breast Density product, which was integrated with the Company expects to integrate with ourCompany’s mammography products. The purchase price was $1.7 million which was paid in cash at closing. In January 2016, the Company completed the acquisition of VuComp’sM-Vu cancer detection portfolio including M-Vu CAD for $6,000. The acquisition provides clinical data for research and an additional customer install base to sell the Company’s cancer detection solutions.

In the Therapy segment, the Company offers an isotope-free cancer treatment platform technology. The Xoft Electronic Brachytherapy System (“Xoft eBx”) can be used for the treatment of early- stage breast cancer, endometrial cancer, cervical cancer and skin cancer. We believe the Xoft eBx system platform indications represent strategic opportunities in the United States and international markets to offer differentiated treatment alternatives. In addition, the Xoft eBx system generates additional recurring revenue for the sale of consumables and related accessories. With theThe acquisition of the assets of DermEbx and Radion allows the Company offersto offer solutions that enable dermatologists and radiation oncologists to develop launch and manage their eBx programs for the treatment of non-melanoma skin cancer (“NMSC”).

In May 2015 the Company announced that one of the regional Medicare Administrative Contractors instructed physicians to report CPT code (17999) rather than the established CPT code (0182T) for electronic brachytherapy for treatment of NMSC. This announcement resulted in a significant disruption in our Therapy segment as a result of the reimbursement uncertainty. RevenuesA new CPT code (0394T) for the threetreatment on non-melanoma skin cancer utilizing electronic brachytherapy went into effect January 1, 2016. Revenues were impacted in fiscal year 2015 and nine monthsthe impact extended in to the quarter ended September 30, 2015 were also negatively impactedMarch 31, 2016 as a result of the uncertainty. In addition,2015 the Company implemented expense reductions in response to the general uncertainty with respect to reimbursement levels. The Company is proactively addressing the situation in its dialogue with the regional provider and Centers for Medicare and Medicaid Services (“CMS”); however there is insufficient clarification to fully assess the long-term impact on our customers.

As we have discussed in our risk factors noted in our Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2014,2015, our business can be affected by coverage policies adopted by federal and state governmental authorities, such as Medicare and Medicaid, as well as private payers, which often follow the coverage policies of these public programs. Such policies may affect which products customers purchase and the prices customers are willing to pay for those products in a particular jurisdiction. The change in CPT codes in 2015 combined with reimbursement uncertainty for the new CPT code 0394T for the Company’s electronic brachytherapy treatment of NMSC had a negative impact on the Company’s revenues for the ninethree months ended September 30, 2015.March 31, 2016.

In connection with the preparation of the financial statements for the second quarter ended June 30, 2015, the Company evaluated the Therapy reporting unit for both long-lived asset and goodwill impairment. As a result of this assessment, the Company recorded material impairment charges in our Therapy reporting unit (see Note 11 to our condensed consolidated financial statements for a further discussion).unit.

The Company’s headquarters are located in Nashua, New Hampshire, with a manufacturing and contract manufacturing facilitiesfacility in New Hampshire and Massachusetts and an operations, research, development, manufacturing and warehousing facility in San Jose, California, which now includes the operations of Xoft, Radion and DermEbx.California.

Critical Accounting Policies

The Company’s discussion and analysis of its financial condition, results of operations, and cash flows are based on the Company’s consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On anon-going basis, the Company evaluates these estimates, including those related to accounts receivable allowance, inventory valuation and obsolescence, intangible assets, income taxes, warranty obligations, contingencies and litigation. Additionally, the Company uses assumptions and estimates in calculations to determine stock-based compensation. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. For a comprehensive list of the Company’s critical accounting policies, reference should be made to the Annual Report on Form 10-K for the year ended December 31, 20142015 filed on March 13, 2015.11, 2016.

Three months ended September 30, 2015March 31, 2016 compared to the three months ended September 30, 2014March 31, 2015

Revenue: (in thousands)

 

  Three months ended September 30,   Three months ended March 31, 
  2015   2014   Change   % Change   2016   2015   Change   % Change 

Detection revenue

                

Product revenue

  $3,230    $2,746    $484     17.6  $1,801    $2,873    $(1,072   (37.3)% 

Service revenue

   1,972     2,190     (218   (10.0)%    2,129     1,915     214     11.2
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Subtotal

   5,202     4,936     266     5.4   3,930     4,788     (858   (17.9)% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Therapy revenue

                

Product revenue

   1,285     1,857     (572   (30.8)%    227     1,085     (858   (79.1)% 

Service revenue

   3,095     5,779     (2,684   (46.4)%    1,881     7,347     (5,466   (74.4)% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Subtotal

   4,380     7,636     (3,256   (42.6)%    2,108     8,432     (6,324   (75.0)% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total revenue

  $9,582    $12,572    $(2,990   (23.8)%   $6,038    $13,220    $(7,182   (54.3)% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Three months ended September 30, 2015March 31, 2016 and 2014:2015:

Total revenue for the three month period ended September 30, 2015March 31, 2016 was $9.6$6.0 million compared with revenue of $12.6$13.2 million for the three month period ended September 30, 2014,March 31, 2015, a decrease of approximately $3.0$7.2 million, or 23.8%54.3%. The decrease in revenue was due to a $3.3$6.3 million decrease in Therapy revenue and an increasea decrease in Detection revenues of approximately $0.3$0.9 million. The Company believes these decreases are primarily the result of reimbursement uncertainty.

Detection product revenue increaseddecreased by approximately $0.5$1.1 million from $2.7$2.9 million to $3.2$1.8 million or 17.6%37.3% in the three months ended September 30, 2015March 31, 2016 as compared to the three months ended September 30, 2014.March 31, 2015. The increasedecrease is due primarily to an increasea decrease in CAD revenues of $0.7 million and a decrease in MRI revenue of approximately $0.2 million and an increase in CAD revenue of $0.3$0.4 million.

Detection service and supplies revenue decreasedincreased by approximately $0.2 million from $2.2$1.9 million in the three months ended September 30, 2014March 31, 2015 to $2.0$2.1 million in the three months ended September 30, 2015.March 31, 2016. Service and supplies revenue reflects the sale of service contracts to our installed base of customers. Service and supplies revenue related to our installed base of customers can vary from quarter to quarter.

Therapy product revenue was approximately $1.3$0.2 million for the three months ended September 30, 2015March 31, 2016 as compared to $1.9$1.1 million for the three months ended September 30, 2014.March 31, 2015. Therapy product revenue for the three months ended September 30, 2015March 31, 2016, was negatively impacted by customer reaction to the uncertainty of reimbursement rates in the United States. RevenueProduct revenue from the sale of our Axxent eBx systems can vary significantly due to an increase or decrease in the number of units sold which can cause a significant fluctuation in product revenue in the period.

Therapy service and supplies revenue decreased approximately $2.7$5.5 million from $5.8$7.3 million in the three months ended September 30, 2014March 31, 2015 to $3.1$1.9 million for the three months ended September 30, 2015.March 31, 2016. The decrease in Therapy service and supplies revenue is due primarily to a decrease in the services related to electronic brachytherapy for NMSC, which is related to reimbursement uncertainty.

Cost of Revenue and Gross Profit: (in thousands)

 

  Three months ended September 30,   Three months ended March 31, 
  2015 2014 Change   % Change   2016 2015 Change   % Change 

Products

  $1,110   $1,019   $91     8.9  $190   $941   $(751   (79.8)% 

Service & supply

   1,362   1,859   (497   (26.7)% 

Service and supplies

   1,359   2,278   (919   (40.3)% 

Amortization and depreciation

   289   527   (238   (45.2)%    303   639   (336   (52.6)% 
  

 

  

 

  

 

   

 

   

 

  

 

  

 

   

 

 

Total cost of revenue

  $2,761   $3,405   $(644   (18.9)%   $1,852   $3,858   $(2,006   (52.0)% 
  

 

  

 

  

 

   

 

   

 

  

 

  

 

   

 

 

Gross profit

  $6,821   $9,167   $(2,346   (25.6)%   $4,186   $9,362   $(5,176   (55.3)% 

Gross profit %

   71.2 72.9      69.3 70.8   

 

  Three months ended September 30,   Three months ended March 31, 
  2015 2014 Change   % Change   2016 2015 Change   % Change 

Detection gross profit

  $4,423   $4,102   $321     7.8  $3,449   $3,947   $(498   (12.6%) 

Therapy gross profit

   2,398   5,065   (2,667   (52.7%)    737   5,415   (4,678   (86.4%) 
  

 

  

 

  

 

   

 

   

 

  

 

  

 

   

 

 

Gross profit

   6,821   9,167   (2,346   (25.6%)    4,186   9,362   (5,176   (55.3%) 
  

 

  

 

  

 

   

 

   

 

  

 

  

 

   

 

 

Gross profit %

   71.2 72.9      69.3 70.8   

Gross profit for the three month period ended September 30, 2015March 31, 2016 was $6.8$4.2 million, or 71.2%69.3% of revenue as compared to $9.2$9.4 million or 72.9%70.8% of revenue in the three month period ended September 30, 2014.March 31, 2015. Gross profit percent changes are primarily due to changes in the mix of business, consulting costs related to non-recurring engineering revenue, additional manufacturing investments and amortization of acquired intangibles.

 

Cost of products increaseddecreased by approximately $91,000$0.7 from approximately $1.0$0.9 million for the three months ended September 30, 2014March 31, 2015 to approximately $1.1$0.2 million for the three months ended September 30, 2015,March 31, 2016, which is due primarily to the changea recovery of medical device excise tax as well as a reduction in product mix in product revenue. The Company had a one-time recovery of the now suspended medical device excise tax. The cost of product revenue as a percentage of product revenue was approximately 25%9% for the three months ended September 30, 2015March 31, 2016 as compared to 22%24% for the three months ended September 30, 2014.March 31, 2015. The decrease in cost of product revenue as a percentage of product revenue is due primarily to the recovery of medical device excise tax in 2016. Cost of product revenue can vary due to product mix.

 

The cost of service and supplies decreased by $0.5$0.9 million from $1.9$2.3 million in the three months ended September 30, 2014March 31, 2015 to $1.4 million in the three months ended September 30, 2015.March 31, 2016. The cost of service and supply revenue as a percentage of service and supply revenue was approximately 27%34% for the quarter ended September 30, 2015March 31, 2016 and 22%25% for the quarter ended September 30, 2014 The decrease in cost of service supplies is due primarily to the decrease in service and supply revenue.

March 31, 2015. The decrease in cost of service supplies is due primarily to the decrease in service and supply revenue. The increase in the cost of service and supply revenue as a percentage of revenue reflects the reduction in service and supply revenue due to the fixed costs in the cost of service and supply revenue.

 

Amortization and depreciation decreased by $238,000$336,000 from $527,000$639,000 in three months ended September 30, 2014March 31, 2015 to $289,000$303,000 for the three months ended September 30, 2015.March 31, 2016. In June 2015, the Company impaired intangible assets of the Therapy reporting unit and recorded amortization expense based on the revised values of the assetsassets; as a result amortization and depreciation for the intangibles decreased.

Operating Expenses: (in thousands)

 

  Three months ended September 30,   Three months ended March 31, 
  2015   2014   Change   Change %   2016   2015   Change   Change % 

Operating expenses:

                

Engineering and product development

  $2,093    $2,086    $7     0.3  $2,271    $2,256    $15     0.7

Marketing and sales

   2,697     3,448     (751   (21.8)%    2,496     3,830     (1,334   (34.8)% 

General and administrative

   2,118     2,282     (164   (7.2)%    1,626     2,213     (587   (26.5)% 

Amortization and depreciation

   257     425     (168   (39.5)%    286     620     (334   (53.9)% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total operating expenses

  $7,165    $8,241    $(1,076   (13.1)%   $6,679    $8,919    $(2,240   (25.1)% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Operating expenses decreased by approximately $1.1$2.2 million or 13.1%25.1% in the three months ended September 30, 2015.March 31, 2016. During the second quarter of 2015, the Company implemented cost reduction initiatives which impacted operating expenses in the third quarteras a result of 2015.reimbursement uncertainty.

Engineering and Product Development.Engineering and product development costs was $2.1approximately $2.3 million for each of the three month periods ended September 30,March 31, 2016 and March 31, 2015, and September 30, 2014, and increased by $7,000$15,000 or 0.3%0.7%. Therapy engineering and product development was $1.1costs decreased from $1.3 million in each of the three months ended September 30, 2014 and September 30, 2015.March 31, 2015 to $1.1 million for the three months ended March 31, 2016. Detection engineering and product development costs remained at approximately $1.0increased by $0.2 million to $1.2 million for the three months ended September 30, 2014 andMarch 31, 2016 from $1.0 for the three months ended September 30,March 31, 2015. The Company continues to invest in strategic initiatives such as the development of ongoing clinical evidence, development of breast tomosynthesis products and additional enhancements to our electronic brachytherapy products.

Marketing and Sales.Marketing and sales expenses decreased by $0.8$1.3 million or 21.8%34.8%, from $3.5$3.8 million in the three month period ended September 30, 2014March 31, 2015 to $2.7$2.5 million in the three month period ended September 30, 2015.March 31, 2016. Therapy marketing and sales expense decreased $0.7$1.2 million from $2.5$2.8 million in the three months ended September 30, 2014March 31, 2015 to $1.8$1.6 million for the three months ended September 30, 2015.March 31, 2016. The decrease in Therapy marketing and sales expenses was due primarily to decreases in salaries and wages and decreases in trade show costs, which vary from quarter to quarter.travel costs. Detection marketing and sales costs decreased slightly by $25,000 and were approximately $0.9$0.1 million from $1.0 million in each of the three months ended September 30, 2014 and September 30, 2015.March 31, 2015 to $0.9 million for the three months ended March 31, 2016.

General and Administrative.General and administrative expenses decreased by $164,000$0.6 million from $2.3$2.2 million in the three month period ended September 30, 2014March 31, 2015 to $2.1$1.6 million in the three month

period ended September 30, 2015.March 31, 2016. The decrease was due primarily to a decrease in consultingpersonnel costs as comparedand a $249,000 gain on settlement of litigation related to the three month period ended September 2014 offset by increasesacquisition of VuComp in bad debt and stock compensation expense.January 2016.

Amortization and Depreciation.Amortization and depreciation is primarily related to acquired intangible assets and depreciation related to machinery and equipment. Amortization and depreciation decreased by $168,000$334,000 from $425,000$620,000 in the three month period ended September 30,

2014March 31, 2015 to $257,000$286,000 in the three month period ended September 30, 2015.March 31, 2016. In June 2015, the Company impaired intangible assets of the Therapy reporting unit and recorded amortization and depreciation expense based on the revised values of the assets. As a result, amortization and depreciation for the quarter ended September 30, 2015 decreased.March 31, 2016 decreased as compared to the prior year.

Other Income and Expense: (in thousands)

 

  Three months ended September 30,   Three months ended March 31, 
  2015   2014   Change   Change %   2016   2015   Change   Change % 

Loss on extinguishment of debt

  $—      $(1,723   1,723     (100.0)% 

Interest expense

  $(46  $(647   601     (92.9)%    (23   (507   484     (95.5)% 

Interest income

   4     11     (7   (63.6)%    5     9     (4   (44.4)% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  $(42  $(636  $594     (93.4)%   $(18  $(2,221  $2,203     (99.2)% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Tax expense

   (16   (16   —       0.0   (22   (79   57     (72.2)% 

Interest expense. Interest expense of $46,000$22,000 decreased by $601,000$485,000 or 92.9%95.7% for the three month period ended September 30, 2015March 31, 2016 as compared to interest expense of $647,000$507,000 in the three month period ended September 30, 2014.March 31, 2015. The reduction in interest expense is due primarily to the reduction in interest related to the Deerfield facility agreement that was terminated in March 2015. Interest related to the Hologic and Zeiss settlement obligations was $32,000$22,000 in the three months ended September 30, 2015March 31, 2016 as compared to $55,000$45,000 in the same period in 2014.2015.

Interest income. Interest income of $4,000 and $11,000$9,000 for the three month periods ended September 30,March 31, 2016, and 2015, and 2014, respectively, reflects income earned from our money market accounts.

Tax benefit (expense).expense. Tax expense is due primarily to state non-income and franchise based taxes.

Nine months ended September 30, 2015 compared to the nine months ended September 30, 2014

Revenue: (in thousands)

   Nine months ended September 30, 
   2015   2014   Change   % Change 

Detection revenue

        

Product revenue

  $9,058    $7,619    $1,439     18.9

Service revenue

   5,887     6,324     (437   (6.9)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Subtotal

   14,945     13,943     1,002     7.2
  

 

 

   

 

 

   

 

 

   

 

 

 

Therapy revenue

        

Product revenue

   2,511     6,487     (3,976   (61.3)% 

Service revenue

   16,489     10,329     6,160     59.6
  

 

 

   

 

 

   

 

 

   

 

 

 

Subtotal

   19,000     16,816     2,184     13.0
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

  $33,945    $30,759    $3,186     10.4
  

 

 

   

 

 

   

 

 

   

 

 

 

Nine months ended September 30, 2015 and 2014:

Total revenue for the nine month period ended September 30, 2015 was $33.9 million compared with revenue of $30.8 million for the nine month period ended September 30, 2014, an increase of approximately $3.2 million, or 10.4%. The increase in revenue was due to a $2.2 million increase in Therapy revenue and an increase in Detection revenues of approximately $1.0 million.

Detection product revenue increased by approximately $1.4 million from $7.6 million to $9.1 million or 18.9% in the nine months ended September 30, 2015 as compared to the nine months ended September 30, 2014. The increase is due primarily to an increase in CAD revenue of approximately $0.8 million and an increase in MRI revenue of $1.0 million, offset by a decrease in analog products of $0.3 million.

Detection service and supplies revenue decreased approximately $0.4 million from $6.3 million in the nine months ended September 30, 2014 to $5.9 million in the nine months ended September 30, 2015. Service and supplies revenue reflects the sale of service contracts to our installed base of customers. The decrease in service and supplies revenue is due primarily to the decrease in OEM service contracts. Service and supplies revenue related to our installed base of customers can vary from quarter to quarter.

Therapy product revenue was approximately $2.5 million for the nine months ended September 30, 2015 as compared to $6.5 million for the nine months ended September 30, 2014. The decrease in product revenue was due primarily to the customer reaction to the uncertainty of reimbursement rates. Revenue from the sale of our Axxent eBx systems can vary significantly due to an increase or decrease in the number of units sold which can cause a significant fluctuation in product revenue in the period.

Therapy service and supplies revenue increased approximately $6.2 million from $10.3 million in the nine months ended September 30, 2014 to $16.5 million for the nine months ended September 30, 2015. The increase in Therapy service and supplies revenue is due to additional revenues resulting from the acquisition of DermEbx and Radion as the acquisition occurred in July 2014. Revenues for the nine months ended September 30, 2015 were impacted by reimbursement uncertainty.

In July 2014, we acquired the assets of DermEbx and Radion, each of which was a Therapy customer. Prior to the acquisition we recognized approximately $1.6 million of Therapy product revenue and $0.5 million of Therapy service and supplies revenue, for a total of approximately $2.1 million, related specifically to these two customers, which are reflected in the results for the nine months ended September 30, 2014.

Cost of Revenue and Gross Profit: (in thousands)

                                                                        
   Nine months ended September 30, 
   2015  2014  Change   % Change 

Products

  $2,731   $  3,589   $(858   (23.9)% 

Service & supply

   5,722    4,038    1,684     41.7

Amortization and depreciation

   1,431    1,201    230     19.2
  

 

 

  

 

 

  

 

 

   

 

 

 

Total cost of revenue

  $9,884   $8,828   $1,056     12.0
  

 

 

  

 

 

  

 

 

   

 

 

 

Gross profit

  $24,061   $21,931   $2,130     9.7

Gross profit %

   70.9  71.3   
   Nine months ended September 30, 
   2015  2014  Change   % Change 

Detection gross profit

  $12,460   $11,426   $1,034      9.0

Therapy gross profit

   11,601    10,505    1,096     10.4
  

 

 

  

 

 

  

 

 

   

 

 

 

Gross profit

    24,061     21,931     2,130     9.7
  

 

 

  

 

 

  

 

 

   

 

 

 

Gross profit %

   70.9  71.3   

Gross profit for the nine month period ended September 30, 2015 was $24.1 million, or 70.9% of revenue as compared to $22.0 million or 71.3% of revenue in the nine month period ended September 30, 2014. Gross profit percent changes are primarily due to changes in the mix of business, consulting costs related to non-recurring engineering revenue, additional manufacturing investments and amortization of acquired intangibles.

Cost of products decreased by approximately $0.9 million from approximately $3.6 million for the nine months ended September 30, 2014 to approximately $2.7 million for the nine months ended September 30, 2015, which is due primarily to the overall decrease in product revenue. The cost of product revenue as a percentage of product revenue was approximately 24% for the nine months ended September 30, 2015 as compared to 25% for the nine months ended September 30, 2014. Cost of product revenue can vary due primarily to product mix.

The cost of service and supplies increased by $1.7 million from $4.0 million in the nine months ended September 30, 2014 to $5.7 million in the nine months ended September 30, 2015. This increase is due primarily to the increase related to the acquisition of the assets of DermEbx and Radion and represents primarily personnel costs related to physics, radiation therapist and management services provided following the acquisition. The cost

of service and supply revenue as a percentage of service revenue was approximately 26% in the quarters ended September 30, 2015 as compared to 24% for the quarter ended September 30, 2014.

Amortization and depreciation increased by $0.2 million from $1.2 million for the nine months ended September 30, 2014 to $1.4 million for the nine months ended September 30, 2015. The increase in amortization and depreciation is due to amortization and depreciation for the acquired intangibles. In June 2015, the Company impaired intangible assets of the Therapy reporting unit and recorded amortization and depreciation expense based on the revised values of the assets.

Operating Expenses: (in thousands)

   Nine months ended September 30, 
   2015   2014   Change   Change % 

Operating expenses:

        

Engineering and product development

  $6,621    $5,952    $669     11.2

Marketing and sales

   9,692     8,912     780     8.8

General and administrative

   6,661     5,836     825     14.1

Amortization and depreciation

   1,373     931     442     47.5

Goodwill impairment

   27,443     —       27,443     100.0
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

  $51,790    $21,631    $30,159     139.4
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses increased by approximately $30.1 million or 139.4%, in the nine months ended September 30, 2015. The primary driver for the increase was the goodwill and long-lived asset impairment as well as additional personnel costs related to the acquisition of DermEbx and Radion. In the second quarter of 2015, the Company implemented cost reduction initiatives, and these cost cutting initiatives are reflected in operating expenses in the nine months ended September 30, 2015.

Engineering and Product Development. Engineering and product development costs for the nine month period ended September 30, 2015 increased by $0.7 million, or 11.2%, from $6.0 million in 2014 to $6.6 million in 2015. Therapy engineering and product development increased $0.5 million from $3.1 million in the nine months ended September 30, 2014 to $3.6 million for the nine months ended September 30, 2015. The increase in Therapy engineering and product development costs was due primarily to increases in salaries, consulting and clinical costs. Detection engineering and product development costs increased by approximately $0.2 million from $2.8 million for the nine months ended September 30, 2014 to $3.0 million for the nine months ended September 30, 2015.

Marketing and Sales. Marketing and sales expenses increased by $0.8 million or 8.8%, from $8.9 million in the nine month period ended September 30, 2014 to $9.7 million in the nine month period ended September 30, 2015. Therapy marketing and sales expense increased $0.5 million from $6.3 million in the nine months ended September 30, 2014 to $6.8 million for the nine months ended September 30, 2015. The increase in Therapy marketing and sales expenses was due primarily to increases in salaries and wages, consulting, trade shows and travel. For the nine months ended September 30, 2015, the Company incurred $0.5 million of severance payments in

the Therapy segment marketing and sales. Detection marketing and sales costs increased slightly by $0.3 million from $2.6 million in the nine months ended September 30, 2014 to $2.9 million for the nine months ended September 30, 2015. This increase is due primarily to $0.1 million of severance payments in the second quarter of 2015.

General and Administrative. General and administrative expenses increased by $0.8 million from $5.8 million in the nine month period ended September 30, 2014 to $6.7 million in the nine month period ended September 30, 2015. The increase was due primarily to increases in personnel, legal, accounting, consulting, travel and stock compensation expense.

Amortization and Depreciation. Amortization and depreciation is primarily related to acquired intangible assets and depreciation related to machinery and equipment. Amortization and depreciation increased by $0.4 million from $0.9 million in the nine month period ended September 30, 2014 to $1.4 million in the nine month period ended September 30, 2015. The increase in expense was due to amortization of the acquired intangible assets related to the DermEbx/ Radion acquisition. In June 2015, the Company impaired intangible assets of the Therapy reporting unit and recorded amortization and depreciation expense based on the revised values of the assets.

Goodwill and long-lived asset impairment. In connection with the preparation of the financial statements for the second quarter ended June 30, 2015, the Company evaluated the Therapy reporting unit for both long-lived asset and goodwill impairment and recorded an impairment charge of $14.0 million related to goodwill and an impairment charge of $13.4 related to long-lived assets for a total of $27.4 million.

Other Income and Expense: (in thousands)

   Nine months ended September 30, 
   2015   2014   Change   Change % 

Loss on extinguishment of debt

  $(1,723  $(903   (820   90.8

Loss from change in fair value of warrants

  $—      $1,835     (1,835   (100.0)% 

Interest expense

   (623   (2,078   1,455     (70.0)% 

Interest income

   18     27     (9   (33.3)% 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $(2,328  $(1,119  $(1,209   108.0
  

 

 

   

 

 

   

 

 

   

 

 

 

Tax benefit (expense)

   12     (94   106     (112.8)% 

Loss on extinguishment of debt. The loss of $1.7 million from the extinguishment of debt represents the loss associated with the payoff of the Deerfield facility agreement, which has now been terminated. On March 31, 2015, the Company paid $11.25 million which represented the entire obligation. The loss on extinguishment represents the unamortized discount on the Facility agreement, and the write-off of the deferred debt costs. The Facility Agreement was to mature on December 29, 2016 and was able to be repaid at the Company’s option without penalty or premium. The loss of $0.9 million from the extinguishment of debt represents the loss associated with the payoff of the Deerfield revenue purchase agreement, which was terminated in April 2014.

Gain from change in fair value of warrants.The gain of $1.8 million from the change in fair value of the warrants for the period ended September 30, 2014, resulted from change in the fair value of the warrants under the binomial lattice based valuation methodology, due primarily to changes in the Company’s stock price, and volatility which are the key assumptions in determining the value of the warrants. On April 30, 2014, the warrants were exercised in full and the Company issued 450,000 shares of common stock.

Interest expense. Interest expense of $0.6 million decreased by $1.5 million or 70.0% for the nine month period ended September 30, 2015 as compared to interest expense of $2.1 million in the nine month period ended September 30, 2014. The reduction in interest expense is due primarily to the reduction in interest related to the Deerfield facility agreement that was terminated on March 31, 2015. Interest related to the Hologic and Zeiss settlement obligations was $124,000 in the nine months ended September 30, 2015 as compared to $161,000 in the same period in 2014.

Interest income. Interest income of $18,000 and $27,000 for the nine month period ended September 30, 2015, and 2014, respectively, reflects income earned from our money market accounts.

Tax benefit (expense). The Company recorded a tax benefit of $12,000 as compared to tax expense of $94,000 for the nine month period ended September 30, 2015, and 2014, respectively. The tax benefit is due primarily to a deferred tax liability of approximately $117,000, offset by tax expense of approximately $105,000. The deferred liability was the result of tax amortizable goodwill that was recognized due to the impairment of goodwill. Tax expense is due primarily to state non-income and franchise based taxes.

Liquidity and Capital Resources

We believe that our current liquidity and capital resources are sufficient to sustain operations through at least the next 12 months, primarily due to cash on hand. Our projected cash needs include planned capital expenditures, lease and settlement commitments, and other long-term obligations.

As of September 30, 2015,March 31, 2016, the Company has current assets of $30.4$23.9 million which includes $17.5$12.9 of cash and cash equivalents. Current liabilities are $14.9$12.8 million and working capital is $15.6$11.1 million. The ratio of current assets to current liabilities was 2.04:1.86:1. On March 31, 2015 the

Company paid $11.3$11.25 million to repay the Deerfield facility agreement. In April 2015, we paid $1.7 million to acquire VuComp’s M-Vu Breast Density product which was paid in cash at closing.

In January 2016, the Company paid $6,000 to acquire the assets of VuComp cancer detection portfolio including M-Vu Cad.

  For the nine months ended September 30, 
  2015   2014   For the three months ended March 31, 
  2016   2015 

Net cash used for operating activities

  $(25  $(148  $(1,921  $(168

Net cash used for investing activities

   (141   (545

Net cash used for financing activities

   (351   (11,233
  

 

   

 

 

Net cash used for investing activities

   (2,626   (4,171

Decrease in cash and equivalents

  $(2,413  $(11,946
  

 

   

 

 

Net cash provided by (used for) financing activities

   (12,033   25,882  
  

 

   

 

 

Increase (decrease) in cash and equivalents

  $(14,684  $21,563  
  

 

   

 

 

Net cash used for operating activities for the ninethree month period ended September 30, 2015March 31, 2016 was $25,000,$1.9 million, compared to net cash used for operating activities of $148,000$168,000 for the ninethree month period ended September 30, 2014.March 31, 2015. The cash used for operating activities for the ninethree month period ended September 30, 2015March 31, 2016 resulted primarily from sources of cash due to working capital changes resulting from decreases in accounts receivable offset by an increase in inventory and decreases in accounts payable and accrued expenses. We expect that cash used for or provided by operating activities may fluctuate in future periods as a result of a number of factors, including fluctuations in our operating results, specifically the timing of when we recognize revenue, our accounts receivable collections and the timing of other payments.

The net cash used for investing activities for the ninethree month period ended September 30,March 31, 2016 and March 31, 2015 was $2.6 million; the Company$0.1 million and $0.5 million, respectively, which was primarily used approximately $0.9 million for purchases of property and equipment, and $1.7 million to acquire VuComp M-Vu Breast Density software. Cash used for investing activities was $4.2 million in the nine month period ended September 30, 2014. The Company paid approximately $3.5 million of cash related to the acquisition of DermEbx and Radion in the quarter ended September 30, 2014, and used approximately $0.7 million for purchases of purchases of property and equipment.

Net cash used for financing activities for the ninethree month period ended September 30, 2015March 31, 2016 was $12.0$0.4 million as compared to net cash provided by financing activities of $25.8 million for the nine month period ended September 30, 2014. The net cash used for financing activities of $12.0$11.2 million for the three month period ended March 31, 2015. Cash used for financing activities for the three months ended March 31, 2016 represents primarily repayments of capital leases. The net cash used of $11.2 million for the three months ended March 31, 2015 is primarily the repayment of the Deerfield Facility Agreement of $11.3 million and $1.0 million for capital leases, offset by cash received of approximately $0.3 million from stock option exercises. The cash provided by financing activities of $25.9 million for the nine month period ended September 30, 2014 includes the underwritten offering in March 2014 of 2.76 million shares at approximately $11.00 per share, with net proceeds of $28.2 million after deducting offering expenses and underwriting discounts.facility agreement.

Contractual Obligations

The following table summarizes, for the periods presented, our future estimated cash payments under existing contractual obligations (in thousands).

 

Contractual Obligations

  Payments due by period   Payments due by period 
  Total   Less than 1
year
   1-3 years   3-5 years   5+ years   Total   Less than 1
year
   1-3 years   3-5 years   5+ years 

Operating Lease Obligations

  $882    $502    $380    $—      $—      $692    $510    $182    $—      $—    

Capital Lease Obligations

   1,402    $1,157     245     —       —       737    $715     22     —       —    

Settlement Obligations

   1,425     275     800     50     300     1,425     525     550     50     300  

Other Commitments

   2,295     2,295     —       —       —       643     643     —       —       —    
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total Contractual Obligations

  $6,004    $4,229    $1,425    $50    $300    $3,497    $2,393    $754    $50    $300  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Operating lease obligations are the minimum payments due under these obligations. Capital lease obligations represent the principal payments due under the respective leases.

Settlement obligations represent the minimum payments attributable to the obligations related primarily to Zeiss, Hologic and Hologic.Yeda.

Other commitments represent firm purchase obligations to suppliers for future product deliverables.

Recent Accounting Pronouncements

See Note 14 to the Condensed Consolidated Financial Statements.

Item 3.Quantitative and Qualitative Disclosures about Market Risk

We believe we are not subject to material foreign currency exchange rate fluctuations, as substantially all of our sales and expenses are denominated in the U.S. dollar. We do not hold derivative securities and have not entered into contracts embedded with derivative instruments, such as foreign currency and interest rate swaps, options, forwards, futures, collars or warrants, either to hedge existing risks or for speculative purposes.

 

Item 4.Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based on this evaluation, as of September 30, 2015,March 31, 2016, the principal executive officer and principal financial officer concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934 (“(”Exchange Act”) were effective at the reasonable level of assurance.

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. We conduct periodic evaluations to enhance, where necessary our procedures and controls.

Our principal executive officer and principal financial officer conducted an evaluation of our internal control over financial reporting (as defined in Exchange Act Rule 13a-15(f)) to determine whether any changes in internal control over financial reporting occurred during the quarter ended September 30, 2015,March 31, 2016, that have materially affected or which are reasonably likely to materially affect internal control over financial reporting. Based on that evaluation, there has been no such change during such period.

PART IIOTHER INFORMATION

Item 1. Legal Proceedings

Please refer to the detailed discussion regarding litigation set forth in Note 8 of the Notes to Condensed Consolidated Financial Statements in this Form 10-Q.

The Company is involved in various legal matters that are in the process of litigation or settled in the ordinary course of business. Although the final results of all such matters and claims cannot be predicted with certainty, we believe that the ultimate resolution of all such matters and claims will not have a material adverse effect on our financial condition. However, such matters could have a material adverse effect on our operating results and cash flows for a particular period.

Item 1A. Risk Factors:

We operate in a changing environment that involves numerous known and unknown risks and uncertainties that could materially adversely affect our operations. Our risk factors are described in Part I, Item 1A of our Annual Report on Form 10-K filed with the SEC for the year ended December 31, 20142015 as filed with the SEC on March 13, 2015.11, 2016. There have been no material changes in the risks affecting iCAD since the filing of our Form 10-K.

 

Item 2.Unregistered Sales of Equity Securities and Use of Proceeds

 

Month of purchase

  Total number
of shares
purchased (1)
   Average
price paid per
share
   Total number of
shares
purchased as
part of publicly
announced plans
or programs
   Maximum dollar
value of shares
that may yet be
purchased under
the plans or
programs
 

July 1 - July 31, 2015

   —       —      $—      $—    

August 1 - August 31, 2015

   1,028    $3.15    $—      $—    

September 1 - September 30, 2015

   —       —      $—      $—    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

   1,028    $3.15    $—      $—    
  

 

 

   

 

 

   

 

 

   

 

 

 

Month of purchase

  Total number
of shares
purchased (1)
   Average
price paid per
share
   Total number of
shares
purchased as
part of publicly
announced plans
or programs
   Maximum dollar
value of shares
that may yet be
purchased under
the plans or
programs
 

January 1 - January 31, 2016

   3,196    $4.52    $—      $—    

February 1 - February 29, 2016

   7,261     4.18    $—      $—    

March 1 - March 31, 2016

   —       —      $—      $—    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

   10,457    $4.29    $—      $—    
  

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)Represents shares of common stock surrendered by employees to the Company to pay employee withholding taxes due upon the vesting of restricted stock.

Item 6.Exhibits

 

Exhibit
No.

  

Description

  10.1  Change of Control Bonus Agreement by and between the Company and Ken Ferry dated October 29, 2015.
  10.2Change of Control Bonus Agreement by and between the Company and Kevin Burns dated October 29, 2015.

  10.3Change of Control Bonus Agreement by and between the Company and Stacey Stevens dated October 29, 2015.2016 Stock Incentive Plan
  31.1  Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *
  31.2  Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *
  32.1  Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *
  32.2  Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *
101  The following materials formatted in XBRL (eXtensible Business Reporting Language); (i) Consolidated Balance Sheets as of September 30, 2015March 31, 2016 and December 31, 2014,2015, (ii) Consolidated Statements of Operations for the three and nine months ended September 30,March 31, 2016 and 2015, and 2014, (iii) Consolidated Statements of Cash Flows for the three and nine months ended September 30,March 31, 2016 and 2015, and 2014, and (iv) Notes to Consolidated Financial Statements.

Signatures

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

   

iCAD, Inc.

   (Registrant) (Registrant)

Date: 

November 4, 2015May 10, 2016

  By: 

/s/ Kenneth M. Ferry

    Kenneth M. Ferry
    Chief Executive Officer, Director
Date: 

November 4, 2015May 10, 2016

  By: 

/s/ Kevin C. Burns

    Kevin C. Burns
    President, Chief Operating Officer
Chief Financial Officer and Treasurer

 

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