Form 10-Q
Table of Contents

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 10-Q
(Mark One)
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2011
OR
     
o   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 1-9341
iCAD, Inc.
(Exact name of registrant as specified in its charter)
     
Delaware   02-0377419
   
(State or other jurisdiction   (I.R.S. Employer Identification No.)
of incorporation or organization)    
     
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 þ NO o.
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 o NO o.
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 o   Accelerated filer o   Non-accelerated filer o   Smaller reporting company þ
        (do not check if a smaller reporting company)    
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) YES o NO þ.
As of the close of business on May 10, 2011 there were 54,483,264 shares outstanding of the registrant’s Common Stock, $.01 par value.
 
 

 

 


 

iCAD, Inc.
INDEX
         
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    30  
 
       
 Exhibit 31.1
 Exhibit 31.2
 Exhibit 32.1
 Exhibit 32.2

 

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iCAD, INC. AND SUBSIDIARY
Consolidated Balance Sheets
(Unaudited)
(In thousands except for share data)
                 
    March 31,     December 31,  
    2011     2010  
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 11,312     $ 16,269  
Trade accounts receivable, net of allowance for doubtful accounts of $50 in 2011 and 2010
    4,075       3,389  
Inventory, net
    3,074       3,489  
Prepaid expenses and other current assets
    680       581  
 
           
Total current assets
    19,141       23,728  
 
           
 
               
Property and equipment, net of accumulated depreciation and amortization of $2,767 in 2011 and $2,852 in 2010
    2,555       2,774  
Other assets
    620       675  
Intangible assets, net of accumulated amortization of $7,269 in 2011 and $6,746 in 2010
    18,631       21,165  
Goodwill
    47,365       45,689  
 
           
Total assets
  $ 88,312     $ 94,031  
 
           
Liabilities and Stockholders’ Equity
               
Current liabilities:
               
Accounts payable
  $ 2,556     $ 2,500  
Accrued and other expenses
    4,138       5,902  
Deferred revenue
    4,781       4,906  
 
           
Total current liabilities
    11,475       13,308  
 
           
 
               
Contingent consideration
    4,900       5,000  
Deferred revenue long term portion
    1,601       961  
Other long-term liabilities
    1,085       1,552  
 
           
Total liabilities
    19,061       20,821  
 
           
 
               
Commitments and contingencies (Note 5)
               
Stockholders’ equity:
               
Preferred stock, $.01 par value:authorized 1,000,000 shares; none issued
           
Common stock, $.01 par value: authorized 85,000,000 shares; issued 54,551,140 in 2011 and 54,383,747 in 2010; outstanding 54,483,264 in 2011 and 54,315,871 in 2010
    545       544  
Additional paid-in capital
    163,342       163,101  
Accumulated deficit
    (93,686 )     (89,485 )
Treasury stock at cost (67,876 shares)
    (950 )     (950 )
 
           
Total stockholders’ equity
    69,251       73,210  
 
           
 
Total liabilities and stockholders’ equity
  $ 88,312     $ 94,031  
 
           
See accompanying notes to consolidated financial statements.

 

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iCAD, Inc.
Consolidated Statements of Operations
(Unaudited)
(In thousands except for share data)
                 
    Three Months Ended     Three Months Ended  
    March 31, 2011     March 31, 2010  
Revenue:
               
Products
  $ 5,240     $ 5,211  
Service and supplies
    2,104       1,309  
 
           
Total revenue
    7,344       6,520  
 
               
Cost of revenue:
               
Products
    1,207       667  
Service and supplies
    772       615  
Amortization of acquired technology
    233        
 
           
 
Total cost of revenue
    2,212       1,282  
 
           
Gross margin
    5,132       5,238  
 
           
 
               
Operating expenses:
               
Engineering and product development
    2,776       1,556  
Marketing and sales
    3,727       2,398  
General and administrative
    2,804       2,487  
 
           
 
Total operating expenses
    9,307       6,441  
 
           
 
               
Loss from operations
    (4,175 )     (1,203 )
 
               
Interest (expense) income — net
    (26 )     18  
 
           
 
               
Net loss
  $ (4,201 )   $ (1,185 )
 
           
 
               
Net loss per share:
               
Basic and diluted
  $ (0.08 )   $ (0.03 )
 
           
Weighted average number of shares used in computing loss per share:
               
Basic and diluted
    54,365,955       45,686,285  
 
           
See accompanying notes to consolidated financial statements.

 

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iCAD, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
(In thousands except for share data)
                 
    Three Months Ended     Three Months Ended  
    March 31, 2011     March 31, 2010  
Cash flows from operating activities:
               
Net loss
  $ (4,201 )   $ (1,185 )
 
           
Adjustments to reconcile net loss to net cash (used for) provided by operating activities:
               
Depreciation
    295       126  
Amortization
    524       292  
Loss on disposal of assets
    6        
Stock based compensation
    268       483  
Interest of royalty obligation
    36        
Changes in operating assets and liabilities:
               
Accounts receivable
    (686 )     469  
Inventory
    415       94  
Prepaid expenses, other current assets and deposits
    (99 )     (33 )
Accounts payable
    55       (75 )
Accrued salaries, warranty and other expenses
    (822 )     (227 )
Deferred revenue
    523       159  
 
           
 
               
Net cash (used for) provided by operating activities
    (3,686 )     103  
 
           
 
               
Cash flows from investing activities:
               
Disposals (additions) to patents, technology and other
    46       (9 )
Additions to property and equipment
    (82 )     (41 )
Cash paid for acquisition of Xoft
    (1,209 )      
 
           
Net cash used for investing activities
    (1,245 )     (50 )
 
           
 
               
Cash flows from financing activities:
               
Taxes paid related to restricted stock issuance
    (26 )     (5 )
 
           
Net cash used for financing activities
    (26 )     (5 )
 
           
 
               
Increase (decrease) in cash and equivalents
    (4,957 )     48  
Cash and equivalents, beginning of period
    16,269       16,248  
 
           
Cash and equivalents, end of period
  $ 11,312     $ 16,296  
 
           
See accompanying notes to consolidated financial statements.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited) March 31, 2011
Note 1 — Basis of Presentation and Significant Accounting Policies
The accompanying consolidated financial statements of 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 consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of the financial position at March 31, 2011, the results of operations for the three month periods ended March 31, 2011 and 2010, and cash flows for the three month periods ended March 31, 2011 and 2010. 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 generally accepted accounting principles 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-K for the fiscal year ended December 31, 2010 filed with the SEC on March 30, 2011. The results for the three month period ended March 31, 2011 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2011, or any future period. Interim period amounts are not necessarily indicative of the results of operations for the full fiscal year.
Subsequent Events
We evaluated all subsequent events that occurred after the balance sheet date through the date and time our financial statements were issued.
Revenue Recognition
In general the Company recognizes revenue when the product ships provided title and risk of loss has passed to the customer, persuasive evidence of an arrangement exists, fees are fixed and determinable, collectability is probable and there are no uncertainties regarding customer acceptance.
The Company recognizes revenue from the sale of certain of its MRI CAD products and services in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 985-605, “Software, Revenue Recognition” (“ASC 985-605”).

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 1 — Basis of Presentation and Significant Accounting Policies (continued)
The Company recognizes revenue from the sale of the digital, film-based CAD and electronic brachytherapy products and services in accordance with ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements(“ASU 2009-13”). This guidance replaced FASB ASC 605-25, Multiple Element Arrangements (formerly Emerging Issues Task Force (“EITF”) Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables), where the fair value of the undelivered elements were deferred and only the revenue related to the delivered elements was recognized if fair value had been established for the undelivered elements. If fair value had not been established for any undelivered elements, the entire order was deferred. In accordance with the new guidance of ASU 2009-13, fair value as the measurement criteria is replaced with the term selling price and establishes a hierarchy for determining the selling price of a deliverable. ASU 2009-13 also eliminates the use of the residual value method for determining the allocation of arrangement consideration. For multi-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 (“ESP”). VSOE generally exists only when the deliverable is sold separately and is the price actually charged for that deliverable. The process for determining an ESP for deliverables without VSOE or TPE considers multiple factors including relative selling prices, however these may vary depending upon the unique facts and circumstances related to each deliverable. Sales of the electronic brachytherapy product typically include several devices, accessories, service and supply. The Company generally allocates revenue to the deliverables in the arrangement based on the best estimate of selling price (ESP). Revenue is recognized when the product has been delivered, and service and supply revenue is recognized over the life of the service and supply agreement.
For most of iCAD’s Digital, MRI and film based sales, the responsibility for the installation process lies with its OEM partners, GE Healthcare, Siemens Medical and others. 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 the deliverables based on the framework established within ASU 2009-13. Therefore, the installation and training revenue is recognized as the services are performed. The adoption did not have a material effect on the financial condition or results of operations of the Company.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 1 — Basis of Presentation and Significant Accounting Policies (continued)
The Company generally recognizes revenue upon shipment of product to customers and the fulfillment of all contractual terms and conditions. The Company uses customer purchase orders that include all terms of the arrangement and in the case of OEM customers are also supported by distribution agreements. 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 reasonably assured 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 revenues are 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. There are no significant estimates or assumptions used in the Company’s revenue recognition.
The Company defers revenue from the sale of extended service contracts related to future periods and recognizes revenue on a straight-line basis in accordance with FASB ASC Topic 605-20, “Services”. The Company provides for estimated warranty costs on original product warranties at the time of sale.
The Company also adopted ASC Update No. 2009-14, Certain Arrangements That Contain Software Elements (Update No. 2009-14). This Update amended the scope of ASC Subtopic No. 985-605, Revenue Recognition, to exclude tangible products that include software and non-software components that function together to deliver the product’s essential functionality. The adoption of this standard did not have a material effect on its financial condition or results of operations.
The Company believes that revenue recognition is a critical accounting policy because it is governed by multiple complex accounting rules and it is important for readers of its financial statements to understand the basis upon which its revenues are recorded. In addition, the Company believes that its investors value the Company and track its progress based to a large extent upon revenues.
Cost of Revenue
Cost of revenue consists of the costs of products purchased for resale, cost relating to service including costs of service contracts to maintain equipment after the warranty period, product installation, training, customer support, certain warranty repair costs, inbound freight and duty, manufacturing, warehousing, material movement, inspection, scrap, rework, depreciation and in-house product warranty repairs. The Company has reclassified in the statement of operations for the three months ended March 31, 2010, the cost of product installation, training, customer support and certain warranty repair costs of approximately $435,000 that were previously included in sales and marketing expenses to cost of revenue to conform to current period classifications.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 2 — Net 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 and, if there are dilutive securities, diluted loss per share is computed by including common stock equivalents which includes shares issuable upon the exercise of stock options, net of shares assumed to have been purchased with the proceeds, using the treasury stock method.
A summary of the Company’s calculation of loss per share is as follows:
                 
    Three Months Ended  
    March 31,  
    2011     2010  
 
Net loss
  $ (4,201 )   $ (1,183 )
 
           
 
               
Basic shares used in the calculation of net loss per share
    54,365,955       45,686,285  
Effect of dilutive securities:
               
Stock options
           
Restricted stock
           
 
           
Diluted shares used in the calculation of net loss per share
    54,365,955       45,686,285  
 
           
 
               
Net loss per share — basic
  $ (0.08 )   $ (0.03 )
 
           
 
               
Net loss per share — diluted
  $ (0.08 )   $ (0.03 )
 
           
Stock options to purchase 5.2 million and 4.8 million shares of the Company’s common stock were excluded from the calculation of diluted net loss per share for the three months ended March 31, 2011 and 2010 because their effect would have been antidilutive. However these options could be dilutive in the future.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 3 — Acquisition of Xoft
On December 30, 2010, the Company completed its acquisition of Xoft, Inc. (“Xoft”), a privately held company based in California. Xoft designs, develops, manufactures, markets and sells electronic brachytherapy (eBx) products for the treatment of breast and other cancers, used in a broad range of clinical settings. The acquisition was made pursuant to an Agreement and Plan of Merger dated December 15, 2010, by and between the Company, XAC, Inc., a wholly-owned subsidiary of the Company (“The Merger Sub”), Xoft and Jeffrey Bird as the representative of the stockholders of Xoft (“The Merger Agreement”). Upon the terms of the Merger Agreement, Xoft was merged with and into the Merger Sub with the Merger Sub surviving the merger (the “Merger”).
The Company acquired 100% of the outstanding stock of Xoft in exchange for 8,348,501 shares of the Company’s common stock and approximately $1.2 million in cash, of which approximately $972,000 was accrued at December 31, 2010 and paid in January 2011, for a total consideration at closing of approximately $12.9 million based on a per share value of $1.40, the closing price of the Company’s common stock on the closing date. The Company also paid certain transaction expenses of Xoft totaling approximately $1.0 million in January 2011. Following completion of the Merger Xoft stockholders owned approximately 15.4% of the Company’s outstanding common stock.
Under the Merger Agreement, there is an additional earn-out potential for the sellers that is tied to cumulative net revenue of Xoft products over the next three years, payable at the end of that period. The threshold for earn-out consideration begins at $50 million of cumulative revenue of “Xoft Products” (as defined in the Merger Agreement) from January 1, 2011 through December 31, 2013. The “targeted” earn-out consideration of $20.0 million will occur at $76.0 million of cumulative revenue of Xoft Products and the maximum earn-out consideration of $40.0 million would be achieved at $104.0 million of cumulative revenue of Xoft Products over the three year period. The Company has estimated the fair value of this liability at approximately $4.9 million which is included in long-term liabilities.
At closing, 10% of the cash amount and 10% of the amount of the Company’s common stock comprising the merger consideration was placed in escrow. It will remain in escrow for a period of 15 months following the closing of the Merger to secure post-closing indemnification obligations of Xoft stockholders.
The purchase price of $17.8 million, which includes $12.9 million of merger consideration and $4.9 million of contingent consideration has been allocated to net assets acquired based upon the estimated fair value.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 3 — Acquisition of Xoft (continued)
The following is a summary of the preliminary 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:
                 
            Estimated  
    Amount     Amortizable  
    (000’s)     Life  
Current assets
  $ 4,030          
Property and equipment
    2,006          
Identifiable intangible assets
    13,700     15 Years  
Patent license
    100     6 Years  
Other assets
    643          
Goodwill
    3,850          
Current liabilities
    (4,959 )        
Long-term liabilities
    (1,591 )        
 
             
Purchase price
  $ 17,779          
 
             
The goodwill of $3.8 million is not expected to be deductible for income tax purposes.
The unaudited proforma operating results for the Company for the quarter ended March 31, 2010, assuming the acquisition of Xoft occurred as of January 1, 2010 are as follows:
         
Quarter ended March 31,   2010  
    (In thousands, except
for per share data)
 
Revenue
  $ 7,700  
Loss from operations
  $ (4,661 )
Net loss
  $ (4,775 )
Net loss per share:
       
Basic and diluted
  $ (0.09 )

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 4 — Stock-Based Compensation
The Company follows the guidance in FASB ASC Topic 718, “Compensation — Stock Compensation”, (“ASC 718”). The Company issued 933,667 stock options and 110,000 shares of restricted stock in the three months ended March 31, 2011. In accordance with ASC 718 the Company recorded $268,000 of stock-based compensation expense for the three months ended March 31, 2011. For the same period in 2010, the Company issued 75,899 stock options and 530,500 shares of restricted stock and recorded $483,162 for stock-based compensation.
Options granted under the stock incentive plans were valued utilizing the Black-Scholes model using the following assumptions and had the following fair values:
                 
    Three Months Ended  
    March 31,  
    2011     2010  
Average risk-free interest rate
    3.18 %     2.49 %
Expected dividend yield
  None     None  
Expected life
  3.5 years     3.5 years  
Expected volatility
    68.7 %     65.6 %
Weighted average exercise price
  $ 1.33     $ 1.50  
Weighted average fair value
  $ 0.63     $ 0.58  
As of March 31, 2011 there was approximately $1,421,000 of total unrecognized compensation cost related to unvested options and restricted stock. That cost is expected to be recognized over a weighted average period of three years.
The Company’s aggregate intrinsic value of options outstanding at March 31, 2011 was approximately $220,000. The aggregate intrinsic value of restricted stock outstanding at March 31, 2011, was approximately $933,000. The aggregate intrinsic value of restricted stock granted was $149,000 and $455,000 for the three months ended March 31, 2011 and 2010, respectively.

 

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CAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 5 — 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 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 was recorded as of March 31, 2011.
Royalty Obligation
As a result of the acquisition of Xoft, the Company recorded a royalty obligation pursuant to a settlement agreement entered into between Xoft and Hologic, Inc.(“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 of $250,000 annually 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 practice the licensed rights. The fair value of the royalty payment was estimated at $900,000. The additional amount will be recorded as interest expense over the life of the agreement. For the three months ended March 31, 2011, the Company recorded $36,000 of interest expense related to the liability. The obligation in excess of one year of approximately $686,000 has been recorded in long term liabilities. In addition, the Company recorded $100,000 to reflect the estimated fair value of the patent license and non-compete covenant. This asset will be amortized over the estimated useful life of approximately six years.
Litigation
On February 18, 2011, in the Orange County Superior Court (Docket No. 30-2011-00451816-CU-PL-CJC), named plaintiffs Jane Doe and John Doe filed a complaint against Xoft, the Company and Hoag Memorial Hospital Presbyterian asserting causes of action for general negligence, breach of warranty, and strict liability and seeking unlimited damages in excess of $25,000. On March 2, 2011, the Company received a Statement of Damages — specifying that the damages being sought aggregated an amount of at least approximately $14.5 million. On or about April 29, 2011, the Company received two additional complaints filed on behalf of six additional Jane Doe plaintiffs and two John Doe spouses.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 5 — Commitments and Contingencies (continued)
The complaints were filed in the Orange County Superior Court (Docket Nos. 30-2011 00465448-CU-MM-CJC & 30-2011-00468687-CU-MM-CJC) against Xoft, the Company and Hoag Memorial Hospital Presbyterian asserting causes of action for general negligence, breach of warranty, and strict liability and seeking unlimited damages in excess of $25,000. It is alleged that each plaintiff Jan Doe was a patient who was treated with the Axxent Electronic Brachytherapy System that incorporated the Axxent Flexishield Mini. The Company believes that all six patients were of the 29 patients treated using the Axxent Flexishield Mini as part of a clinical trial. The Axxent Flexishield Mini is the subject of a voluntary recall. Because of the preliminary nature of the complaints the Company is unable to evaluate the merits of the claims, however based upon its preliminary analysis; it plans to vigorously defend the lawsuits.
The Company recently acquired the Axxent Electronic Brachytherapy System and Axxent Flexishield Mini as part of its acquisition of Xoft in December 2010. Since the initial commercial sale of the Axxent Flexishield Mini in August 2009, this accessory has been sold on a very limited basis. The Company has developed a replacement for this accessory and has filed a 510(k) to FDA.
On April 16, 2010, Carl Zeiss Meditec Inc. and Carl Zeiss Surgical GmbH filed suit against Xoft in the Federal District Court of Delaware asserting infringement of 4 U.S. Patent Nos. The complaint requests the court to (1) make a declaration, (2) preliminarily and permanently adjoin Xoft from infringing the named patents, and (3) order the payment of unspecified damages and attorney’s fees in connection with such patent infringement allegations. The Company intends to vigorously defend the lawsuit and is currently unable to estimate the potential financial impact this action may have on the Company. Since the amount of potential damages in the event of an adverse result is not reasonably estimable, no expense has been recorded with respect to the contingent liability associated with this matter. In addition, the Merger Agreement provides for indemnity for certain losses relating to the Zeiss litigation, subject to limitations specified in the Merger Agreement.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 6 — Fair Value Measurements
On January 1, 2008, the Company adopted FASB ASC Topic 820, “Fair Value Measurement and Disclosures”, (“ASC 820”). This topic defines fair value, establishes a framework for measuring fair value under generally accepted accounting principles 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 or 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, marketable and non-marketable securities, accounts payable, notes payable, and certain accrued liabilities. The carrying amounts of our cash and cash equivalents (which are comprised 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 liabilities that are measured at fair value on a recurring basis relate to its contingent consideration and royalty obligation resulting from the acquisition of Xoft completed on December 30, 2010. The fair value measurements for these liabilities are valued using level 3 inputs. The Company recorded a contingent consideration liability of $4.9 million based upon the estimated fair value of the additional earn-out potential for the sellers that is tied to cumulative net revenue of Xoft products from January 1, 2011 through December 31, 2013, payable January, 2014. The Company determines the fair value of the contingent consideration liability based on a probability-weighted approach derived from earn-out criteria estimates and a probability assessment with respect to the likelihood of achieving the various earnout criteria. The measurement is based upon significant inputs not observable in the market.

 

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.iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 6 — Fair Value Measurements (continued)
The Company also recorded a royalty obligation of approximately $900,000 which was estimated based upon an income approach. The measurement is based upon significant inputs not observable in the market. Subsequent changes in the value of this liability will be recorded as interest expense in the statement of operations.
The following table sets forth Company’s liabilities which are measured at fair value on a recurring basis by level within the fair value hierarchy.
Fair value measurements using: (000’s)
                                 
                            Liabilities  
                            at Fair  
    Level 1     Level 2     Level 3     Value  
Contingent consideration
              $ 4,900     $ 4,900  
Royalty obligation
                900       900  
 
                       
Total
              $ 5,800     $ 5,800  
 
                       
The changes in the fair value of contingent consideration during the period are as follows:
         
Three months ended March 31, 2011  
Balance as of December 31, 2010
  $ 5,000  
Fair value adjustment
    (100 )
 
     
Balance as of March 31, 2011
  $ 4,900  
 
     
The changes in the fair value of the royalty obligation during the period are as follows:
         
Three months ended March 31, 2011  
Balance as of December 31, 2010
  $ 1,372  
Fair value adjustment
    (235 )
Interest expense
    36  
Royalty payment
    (240 )
 
     
Balance as of March 31, 2011
  $ 933  
 
     
Items Measured in Fair Value on a Nonrecurring Basis
Certain assets, including our goodwill, are measured at fair value on a nonrecurring basis. These assets are recognized at fair value when they are deemed to be impaired. We did not record any impairment charges for these assets during the three months ended March 31, 2011.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 7 — Income Taxes
At March 31, 2011, the Company had no material unrecognized tax benefits and no adjustments to liabilities or operations 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 March 31, 2011. The Company files United States federal income tax returns and income tax returns in various states and local jurisdictions. Generally, the Company’s three preceding tax years remain subject to examination by federal and state taxing authorities. The Company completed an examination by the Internal Revenue Service with respect to the 2008 tax year in January 2011, which resulted in no changes to the tax return originally filed. The Company is not under examination by any other federal or state jurisdiction for any tax years.
Note 8 — Goodwill
In accordance with FASB 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 Company is less than its carrying value. Events that would indicate impairment and trigger an interim impairment assessment include, but are not limited to, current economic and market conditions, changes in its results of operations and changes in its forecasts or market expectation relating to future results.
The Company’s goodwill arose in connection with its acquisitions in June 2002, December 2003 and December 2010. The Company operates in one segment and as one reporting unit since operations are supported by one central staff and the results of operations are evaluated as one business unit. In general the Company’s medical device products are similar in nature based on production, distribution, services provided and regulatory requirements. Therefore, the Company uses market capitalization as the best evidence of fair value (market capitalization is calculated using the quoted closing share price of the Company’s common stock at its annual impairment date of October 1, multiplied by the number of common shares outstanding) of the Company. The Company tests goodwill for impairment by comparing its market capitalization (fair value) to its carrying value. The fair value of the Company is compared to the carrying amount at the same date as the basis to determine if an impairment exists. The Company performed the step one fair value comparison as of October 1, 2010 and the Company’s market capitalization exceeded its carrying value. At March 31, 2011, there were no triggering events that would cause us to perform a step one fair value test for goodwill.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 8 — Goodwill (continued)
The changes in the carrying amount of goodwill for the quarter ended March 31, 2011, are as follows:
         
Three months ended March 31, 2011  
Balance as of December 31, 2010
  $ 45,689  
Purchase accounting adjustments
    1,676  
 
     
Balance as of March 31, 2011
  $ 47,365  
 
     
Purchase accounting adjustments, considered to be measurement period adjustments recorded, in the quarter ended March 31, 2011 consisted primarily of $1.5 million decrease of the acquired patent asset, a decrease of $500,000 in the acquired technology asset, a decrease in the fair value estimate of the royalty obligation of $200,000 and a decrease of $100,000 related to contingent consideration. The measurement period adjustments had no effect on the operations, results and an immaterial effect on the December 31, 2010 Balance Sheet. Accordingly, the adjustments were recorded in the period ended March 31, 2011.
Note 9 — Recent Accounting Pronouncements
In December 2010, the FASB issued ASC Update 2010-29, Business Combinations (Topic 805) - Disclosure of Supplementary Pro Forma Information for Business Combinations (Update No. 2010-29). This Update requires a public entity to disclose pro forma information for business combinations that occurred in the current reporting period. The disclosures include pro forma revenue and earnings of the combined entity for the current reporting period as though the acquisition date for all business combinations that occurred during the year had been as of the beginning of the annual reporting period. If comparative financial statements are presented, the pro forma revenue and earnings of the combined entity for the comparable prior reporting period should be reported as though the acquisition date for all business combinations that occurred during the current year had been as of the beginning of the comparable prior annual reporting period. This Update affects any public entity that enters into business combinations that are material on an individual or aggregate basis and is effective prospectively for business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2010. The Company elected to adopt this Update early as permitted, and disclosed pro forma financial information of the combined entity relating to its acquisition of Xoft.

 

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iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 9 — Recent Accounting Pronouncements (continued)
The Company also adopted ASC Update No. 2009-14, Certain Arrangements That Contain Software Elements (Update No. 2009-14). This Update amended the scope of ASC Subtopic No. 985-605, Revenue Recognition, to exclude tangible products that include software and non-software components that function together to deliver the product’s essential functionality. The adoption of this standard did not have a material effect on its financial condition or results of operations.

 

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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 levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare 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”, “demonstrate”, “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 is an industry-leading provider of advanced image analysis and workflow solutions that enable radiologists and other healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier. iCAD offers a comprehensive range of high-performance, expandable Computer-Aided Detection (CAD) systems and workflow solutions for mammography (film-based, digital radiography (DR) and computed radiography (CR), Magnetic Resonance Imaging (MRI), and Computed Tomography (CT)). iCAD’s solutions aid in the early detection of the most prevalent cancers including breast, prostate and colon cancer. Early detection of cancer is the key to better prognosis, less invasive and lower treatment costs, and higher survival rates. Performed as an adjunct to mammography screening, CAD has quickly become the standard of care in breast cancer detection, helping radiologists improve clinical outcomes while enhancing workflow. Computer-enhanced breast and prostate MRI analysis streamlines case interpretation workflow and generates more robust information for more effective patient treatment. CAD for mammography screening is also reimbursable in the U.S. under federal and most third-party insurance programs. Since receiving approval from the FDA for the Company’s first breast cancer detection product in January 2002, over 4,000 of iCAD’s CAD systems have been placed in mammography practices worldwide. iCAD is the only stand alone company offering CAD solutions for the early detection of breast cancer.
iCAD’s CAD mammography products have been shown to detect up to 72% of the cancers that biopsy proved were missed on the previous mammogram, an average of 15 months earlier. Our advanced pattern recognition technology analyzes images to identify patterns and then uses sophisticated mathematical analysis to mark suspicious areas.

 

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The Company’s CAD systems include proprietary algorithm and other technology together with standard computer and display equipment. CAD systems for the film-based analog mammography market also include a radiographic film digitizer, either manufactured by the Company or others for the digitization of film-based medical images.
The Company intends to apply its core competencies in pattern recognition and algorithm development in disease detection to its future product development efforts. Its focus is on the development and marketing of cancer detection products for disease states where there are established or emerging protocols for screening as a standard of care. iCAD expects to pursue development or acquisition of products for select disease states that demonstrate one or more of the following: it is clinically proven that screening has a significant positive impact on patient outcomes, where there is an opportunity to lower health care costs, where screening is non-invasive or minimally invasive and where public awareness is high. The Company also intends to pursue opportunities beyond CAD through possible strategic acquisitions as part of its growth strategy, as such the Company continues to actively evaluate strategic opportunities in the oncology market that could leverage its opportunities for growth beyond its historic core markets.
iCAD has applied its patented detection technology and algorithms to the development of CAD solutions for use with virtual colonoscopy or CT Colonography (CTC) to improve the detection of colonic polyps. The Company’s pattern recognition and image analysis expertise are readily applicable to colonic polyp detection and the Company has developed a CTC CAD solution. Virtual colonoscopy (CTC) is a technology that has evolved rapidly in recent years. Based on the results of the National CT Colonography trial, the Company expects that the market for virtual colonoscopy will grow along with the procedures for early detection of colon cancer. This trial demonstrated that CTC is highly accurate for the detection of intermediate and large polyps and that the accuracy of CTC is similar to a colonoscopy. CT Colonography or CTC is emerging as an alternative imaging procedure for evaluation of the colon. The Company has developed and commenced marketing VeralookÔ, a product for computer aided detection of polyps in the colon using CTC and completed the clinical testing of its CTC CAD product in the first quarter of 2009. The Company filed a 510(k) application with the FDA in May 2009 seeking FDA clearance to market Veralook in the U.S and received FDA clearance on August 4, 2010. Colorectal cancer has been shown to be highly preventable with early detection and removal of polyps.
In July 2008, the Company acquired pharmaco-kinetic based CAD products that aid in the interpretation of contrast enhanced MRI images of the breast and prostate and began marketing these products in the fourth quarter of 2008. The interpretation of MRI exams also benefits from advanced image analysis and clinical decision support tools. MRI is an excellent tool to detect breast cancer as well as prostate cancer. While MRI is a more expensive option than traditional mammography, it enables physicians to view tumors which may have been missed during routine screenings. MRI uses magnets and radio waves instead of x-rays to produce very detailed, cross-sectional images of the body, and can be used to look specifically at those areas.

 

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The acquisition of Xoft, Inc. (“Xoft”) on December 30, 2010, brings an isotope-free cancer treatment platform technology to the Company’s product line. Xoft designs, develops, manufactures, markets and sells electronic brachytherapy (eBx) products for the treatment of breast and other cancers, used in a broad range of clinical settings. The portable Axxent System which delivers electronically controlled radiation therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue is FDA-cleared. Electronic Brachytherapy (eBx™) is a type of brachytherapy that utilizes a miniaturized high dose rate X-ray source to apply radiation directly to the cancerous site. The goal is to direct the radiation dose to the size and shape of the cancerous area, sparing healthy tissue and organs. The Xoft technology delivers similar clinical dose rates to traditional radio-active systems. Electronic Brachytherapy can be delivered during an operative procedure and may be used as a primary or secondary modality over a course of days. This technology enables radiation oncology departments in hospitals, clinics and physician offices to perform traditional radiotherapy treatments and offer advanced treatments such as Intra-Operative Radiation Therapy (IORT). Current customers for the Xoft eBx system include university research and community hospitals, private and governmental institutions, doctors’ offices and cancer care clinics.
The Company’s headquarters are located in Nashua, New Hampshire, with manufacturing and contract manufacturing facilities in New Hampshire and Massachusetts, a research and development facility in Ohio and, with its acquisition of Xoft, an operation, research, development, manufacturing and warehousing facility in Sunnyvale, 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 an on-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.

 

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Quarter Ended March 31, 2011 compared to Quarter Ended March 31, 2010
Revenue. Total revenue for the three month period ended March 31, 2011 was $7.3 million compared with revenue of $6.5 million for the three month period ended March 31, 2010, an increase of $824,000 or 12.6%. The increase in revenue was primarily due to revenue from the Axxent eBx System and an increase in service and supply revenue offset by a decrease in digital and MRI CAD and film-based CAD revenue.
                                 
    Three months ended March 31,  
    2011     2010     Change     % Change  
Digital & MRI revenue
  $ 3,763     $ 4,165     $ (402 )     (9.7 %)
Film based revenue
    517       1,046       (529 )     (50.6 %)
Electronic brachytherapy
    960             960       100 %
Service & supply revenue
    2,104       1,309       795       60.7 %
 
                       
Total revenue
  $ 7,344     $ 6,520     $ 824       12.6 %
 
                       
Our digital and MRI CAD revenue for three month period ended March 31, 2011 decreased $402,000 or 9.7%, to $3.8 million compared to revenue of $4.2 million in the three month period ended March 31, 2010. This decrease was due primarily to lower demand for Full Field Digital Mammography (“FFDM”) systems and digital CAD technology for the detection of breast cancer, somewhat offset by an increase in sales of our MRI CAD products. We believe that the softening of the digital mammography market is temporary due to current economic conditions and deferred hospital spending.
Revenue from iCAD’s film based products decreased 50.6% or $529,000, to $517,000 in the three month period ended March 31, 2011 compared to $1.0 million three month period ended March 31, 2010. This decrease can also be attributed to the softening demand for FFDM systems primarily due to current economic conditions and deferred hospital spending, as the majority of film-based revenue is derived from sales of our TotalLook MammoAdvantage. The TotalLook MammoAdvantage product is used for digitizing film based prior mammography exams for comparative reading and is sold to further optimize workflow in a digital mammography environment. The TotalLook MammoAdvantage product is typically sold as sites are preparing to go digital. In addition, and as expected, the demand for film-based products and accessories continues to decline as the marketplace continues to transition to digital technologies.
Revenue of our newly acquired Axxent solution was $960,000 in the three month period ended March 31, 2011. We expect revenue of the electronic brachytherapy products to increase as we ramp up our sales efforts.
Service and supply revenue increased 60.7% or $795,000 in the three month period ended March 31, 2011, to $2.1 million compared to $1.3 million in the first quarter of 2010. The service and supply revenue includes approximately $360,000 related to the Axxent solution. Service and supply revenue relating to our digital CAD and TotalLookMammoAdvantge systems increased 32.8% as our installed base transitions from warranty to service contracts. We expect service and supply revenue for both digital CAD and electronic brachytherapy products to increase as our installed base continues to transition from warranty to service contracts.

 

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    Three months ended March 31,  
    2011     2010     Change     % Change  
Products
  $ 1,207     $ 667     $ 540       81.0 %
Service & supply
    772       615       157       25.5 %
Amortization of acquired technology
    233             233       100.0 %
 
                       
Total cost of revenue
  $ 2,212     $ 1,282     $ 930       72.5 %
 
                       
 
                               
Gross Margin
  $ 5,132     $ 5,238     $ (106 )     (2.0 )%
Gross Margin. Gross margin for the three month period ended March 31, 2011 was $5.1 million or 70.0% as compared to $5.2 million of 80.0% in the three month period ended March 31, 2010. The decrease was primarily due to sales of our Axxent solutions which currently have significantly lower margins than our CAD products. We are currently investigating manufacturing and supply chains programs to decrease cost and enhance margin. In addition, gross margin in the three months ended March 31, 2011 includes $233,000 in amortization expense relating to the Xoft acquisition as a cost of product revenue and this will be an ongoing expense.
Engineering and Product Development. Engineering and product development costs for the three month period ended March 31, 2011 increased by $1.2 million or 78.4%, from $1.6 million in 2010 to $2.8 million in 2011. The increase in engineering and product development costs was primarily due to the increase in personnel and related expenses and consulting costs of approximately $858,000 as a result of our acquisition of Xoft and approximately $205,000 relating to the recall of the Axxent Flexishield.
Marketing and Sales. Marketing and sales expenses for the three month period ended March 31, 2011 increased by $1.3 million or 55.4%, from $2.4 million in 2010 to $3.7 million in 2011. The increase in marketing and sales expense primarily resulted from personnel and related expenses and various administrative expenses totaling approximately $1.0 million as a result of our acquisition of Xoft.
General and Administrative. General and administrative expenses for the three month period ended March 31, 2011 increased by $318,000 or 12.8%, from $2.5 million in 2010 to $2.8 million in 2011. The increase in general and administrative expense during the first quarter of 2011 was due primarily to legal expenses relating to our patent litigation and an increase headcount related to the Xoft acquisition which is reflected in general and administrative expense.
Interest (Expense)/Income. Net interest expense for the three month period ended March 31, 2011 increased to $26,000, from interest income of $18,000 in 2010. This increase in expense is due primarily to the interest related to the Hologic Royalty obligation, offset by interest income earned from our money market accounts.
Net Loss. As a result of the foregoing, we recorded a net loss of $4.2 million or $0.08 per share for the first quarter of 2011 on revenue of $7.4 million, compared to a net loss of $1.2 million or $0.03 per share on revenue of $6.5 million for the same period in 2010.

 

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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 and projected cash generation from continuing operations. Our ability to generate cash adequate to meet our future capital requirements will depend primarily on operating cash flow. If sales or cash collections are reduced from current expectations, or if expenses and cash requirements are increased, we may require additional financing, although there are no guarantees that we will be able to obtain the financing if necessary.
As of March 31, 2011, the Company had current assets of $19.1 million, current liabilities of $11.4 million and working capital of $7.7 million. The ratio of current assets to current liabilities was 1.7:1.
Net cash used for operating activities for the three month period ended March 31, 2011 was $3.7 million, compared to net cash provided by operating activities of $103,000 for the three month period ended March 31, 2010. The cash used for operating activities for the three months ended March 31, 2011 resulted from the net loss of $4.2 million, increases in accounts receivable and prepaid expense totaling $785,000 and a decrease in accrued expenses of $822,000, which were partially offset by the decrease in inventory of $415,000 and increases in accounts payable and deferred revenue totaling $578,000, plus non-cash items including depreciation, amortization and loss on disposal of assets totaling $825,000 and stock based compensation of $268,000. We expect that cash 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 three month period ended March 31, 2011 was $1.2 million, which consisted of additions to property and equipment of $82,000 offset by the disposal of patents, technology and other assets of $46,000 and $1.2 million of cash paid for the acquisition of Xoft, compared to the additions to patents, technology and property and equipment totaling $50,000 for the three months ended March 31, 2010.
Net cash used for financing activities for the three month period ended March 31, 2011 was $26,000 relating to taxes paid in connection with restricted stock issuances, compared to $5,000 relating to taxes paid in connection with restricted stock issuances for the same period in 2010.

 

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Contractual Obligations
The following table summarizes, for the periods presented, our future estimated cash payments under existing contractual obligations.
                                         
    Payments due by period  
            Less than 1                    
Contractual Obligations   Total     year     1-3 years     3-5 years     5+ years  
 
                                       
Lease Obligations
  $ 1,823,533     $ 870,042     $ 953,491     $     $  
 
                                       
Royalty Obligation
  $ 1,496,945     $ 246,945     $ 750,000     $ 500,000     $  
 
                             
Total Contractual Obligations
  $ 3,320,478     $ 1,116,987     $ 1,703,491     $ 500,000     $  
 
                             
Recent Accounting Pronouncements
See Note 9 to the Condensed Consolidated Financial Statements.

 

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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 domestic and therefore 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, 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 the 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 March 31, 2011, 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.

 

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PART II OTHER INFORMATION
Item 1.  
Legal Proceedings
   
On February 18, 2011, in the Orange County Superior Court (Docket No. 30-2011-00451816-CU-PL-CJC), named plaintiffs Jane Doe and John Doe filed a complaint against Xoft, the Company and Hoag Memorial Hospital Presbyterian asserting causes of action for general negligence, breach of warranty, and strict liability and seeking unlimited damages in excess of $25,000. On March 2, 2011, we received a Statement of Damages specifying that the damages being sought aggregated an amount of at least approximately $14.5 million. On or about April 29, 2011, we received two additional complaints filed on behalf of six additional Jane Doe plaintiffs and two John Doe spouses.
   
The complaints were filed in the Orange County Superior Court (Docket Nos. 30-2011 00465448-CU-MM-CJC & 30-2011-00468687-CU-MM-CJC) against Xoft, the Company and Hoag Memorial Hospital Presbyterian asserting causes of action for general negligence, breach of warranty, and strict liability and seeking unlimited damages in excess of $25,000. It is alleged that each plaintiff Jan Doe was a patient who was treated with the Axxent Electronic Brachytherapy System that incorporated the Axxent Flexishield Mini. We believe that all six patients were one of the twenty nine patients treated using the Axxent Flexishield Mini as part of a clinical trial. The Axxent Flexishield Mini is the subject of a voluntary recall. Because of the preliminary nature of the complaints we are unable to evaluate the merits of the claims, however based upon our preliminary analysis; we plan to vigorously defend the lawsuits.
   
We recently acquired the Axxent Electronic Brachytherapy System and Axxent Flexishield Mini as part of our acquisition of Xoft in December 2010. Since the initial commercial sale of the Axxent Flexishield Mini in August 2009, this accessory has been sold on a very limited basis. We have developed a replacement for this accessory and have filed a 510(k) with the FDA.
   
On April 16, 2010, Carl Zeiss Meditec Inc. and Carl Zeiss Surgical GmbH filed suit against Xoft in the Federal District Court of Delaware asserting infringement of 4 U.S. Patent Nos. The complaint requests the court to (1) make a declaration, (2) preliminarily and permanently adjoin Xoft from infringing the named patents, and (3) order the payment of unspecified damages and attorney’s fees in connection with such patent infringement allegations. We intend to vigorously defend the lawsuit and are currently unable to estimate the potential financial impact this action may have. Since the amount of potential damages in the event of an adverse result is not reasonably estimable, no expense has been recorded with respect to the contingent liability associated with this matter. In addition, the Merger Agreement provides for indemnity for certain losses relating to the Zeiss litigation, subject to limitations specified in the Merger Agreement.

 

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Item 1A.  
Risk Factors
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, 2010. 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
The following table represents information with respect to purchases of common stock made by the Company during the three months ended March 31, 2011:
                                 
                    Total number of     Maximum dollar  
                    shares     value of shares  
                    purchased as     that may yet be  
    Total number     Average     part of publicly     purchaed under  
    of shares     price paid per     announced plans     the plans or  
Month of purchase   purchased (1)     share     or programs     programs  
January 1 - January 31, 2011
    2,073     $ 1.45     $     $  
February 1 - February 28, 2011
        $     $     $  
March 1 - March 31, 2011
    31,555     $ 1.19     $     $  
 
                       
Total
    33,628     $ 1.32     $     $  
 
                       
     
(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
       
 
  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.

 

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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)
 
 
Date: May 13, 2011   By:   /s/ Kenneth M. Ferry    
    Kenneth M. Ferry   
    President, Chief Executive Officer, Director   
     
Date: May 13, 2011   By:   /s/ Kevin C. Burns    
    Kevin C. Burns   
    Executive Vice President of Finance and Chief Financial Officer, Treasurer   
 

 

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