Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2010
OR
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o |
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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)
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Delaware
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02-0377419 |
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(State or other jurisdiction
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(I.R.S. Employer Identification No.) |
of incorporation or organization) |
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98 Spit Brook Road, Suite 100, Nashua, NH
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03062 |
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(Address of principal executive offices)
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(Zip Code) |
(603) 882-5200
(Registrants 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.
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Large Accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(do not check if a smaller reporting company) |
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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 November 8, 2010 there were 45,967,370 shares outstanding of
the registrant s Common Stock, $.01 par value.
iCAD, Inc.
Balance Sheets
(unaudited)
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September 30, |
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December 31, |
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2010 |
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2009 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
18,115,731 |
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$ |
16,248,031 |
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Trade accounts receivable, net of allowance for doubtful
accounts of $50,000 in 2010 and $84,000 in 2009 |
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3,118,398 |
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4,692,614 |
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Inventory, net |
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701,507 |
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1,094,115 |
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Prepaid expenses and other current assets |
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503,270 |
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393,490 |
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Total current assets |
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22,438,906 |
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22,428,250 |
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Property and equipment: |
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Equipment |
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2,848,598 |
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2,873,012 |
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Leasehold improvements |
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74,107 |
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72,612 |
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Furniture and fixtures |
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344,700 |
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344,700 |
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Marketing assets |
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292,613 |
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292,613 |
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3,560,018 |
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3,582,937 |
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Less accumulated depreciation and amortization |
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2,773,640 |
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2,661,083 |
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Net property and equipment |
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786,378 |
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921,854 |
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Other assets: |
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Deposits |
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32,126 |
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63,194 |
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Patents, net of accumulated amortization |
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118,536 |
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90,027 |
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Customer relationships, net of accumulated amortization |
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175,894 |
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200,407 |
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Technology intangibles, net of accumulated amortization |
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5,261,636 |
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6,093,294 |
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Tradename, net of accumulated amortization |
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80,600 |
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99,200 |
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Goodwill |
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43,515,285 |
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43,515,285 |
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Total other assets |
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49,184,077 |
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50,061,407 |
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Total assets |
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$ |
72,409,361 |
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$ |
73,411,511 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,109,758 |
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$ |
1,365,558 |
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Accrued salaries and other expenses |
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2,704,726 |
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2,199,286 |
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Deferred revenue |
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3,912,418 |
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3,139,567 |
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Total current liabilities |
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7,726,902 |
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6,704,411 |
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Long-term warranty expense |
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17,088 |
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23,275 |
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Long-term deferred revenue |
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479,035 |
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375,183 |
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Total liabilities |
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8,223,025 |
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7,102,869 |
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Commitments and contingencies (Note 5) |
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Stockholders equity: |
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Preferred stock, $ .01 par value: authorized 1,000,000 shares;
none issued |
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Common stock, $ .01 par value: authorized 85,000,000
shares; issued 46,012,496 in 2010 and 45,746,736 in 2009;
outstanding 45,944,620 in 2010 and 45,678,860 in 2009 |
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460,125 |
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457,467 |
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Additional paid-in capital |
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151,251,081 |
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150,062,733 |
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Accumulated deficit |
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(86,574,606 |
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(83,261,294 |
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Treasury stock at cost (67,876 shares) |
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(950,264 |
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(950,264 |
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Total stockholders equity |
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64,186,336 |
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66,308,642 |
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Total liabilities and stockholders equity |
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$ |
72,409,361 |
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$ |
73,411,511 |
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See accompanying notes to consolidated financial statements.
3
iCAD, Inc.
Statements of Operations
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2010 |
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2009 |
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2010 |
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2009 |
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Revenue |
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Products |
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$ |
4,059,327 |
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$ |
6,084,567 |
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$ |
13,987,413 |
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$ |
17,246,281 |
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Service and supplies |
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1,527,030 |
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1,021,703 |
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4,216,752 |
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2,754,874 |
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Total revenue |
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5,586,357 |
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7,106,270 |
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18,204,165 |
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20,001,155 |
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Cost of revenue |
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Products |
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544,767 |
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917,481 |
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1,769,402 |
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2,864,806 |
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Service and supplies |
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166,750 |
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164,505 |
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512,774 |
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527,201 |
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Total cost of revenue |
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711,517 |
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1,081,986 |
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2,282,176 |
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3,392,007 |
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Gross margin |
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4,874,840 |
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6,024,284 |
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15,921,989 |
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16,609,148 |
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Operating expenses: |
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Engineering and product development |
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1,714,474 |
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1,702,263 |
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4,795,946 |
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5,601,756 |
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Marketing and sales |
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2,766,646 |
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2,577,319 |
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8,641,393 |
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8,174,752 |
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General and administrative |
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1,804,926 |
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1,654,909 |
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6,131,079 |
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5,206,303 |
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Total operating expenses |
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6,286,046 |
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5,934,491 |
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19,568,418 |
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18,982,811 |
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Income (loss) from operations |
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(1,411,206 |
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89,793 |
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(3,646,429 |
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(2,373,663 |
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Other income |
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275,000 |
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Interest income (expense) net |
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18,620 |
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22,965 |
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58,117 |
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88,641 |
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Net income (loss) |
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$ |
(1,392,586 |
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$ |
112,758 |
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$ |
(3,313,312 |
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$ |
(2,285,022 |
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Net income (loss) per share |
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Basic and Diluted |
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$ |
(0.03 |
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$ |
0.00 |
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$ |
(0.07 |
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$ |
(0.05 |
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Diluted |
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$ |
(0.03 |
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$ |
0.00 |
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$ |
(0.07 |
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$ |
(0.05 |
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Weighted average number of shares used
in computing income (loss) per share |
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Basic |
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45,921,952 |
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45,620,763 |
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45,782,449 |
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45,463,078 |
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Diluted |
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45,921,952 |
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46,101,765 |
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45,782,449 |
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45,463,078 |
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See accompanying notes to consolidated financial statements.
4
iCAD, INC.
Statements of Cash Flows
(unaudited)
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Nine Months Ended |
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Nine Months Ended |
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September 30, 2010 |
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September 30, 2009 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(3,313,312 |
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$ |
(2,285,022 |
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Adjustments to reconcile net loss
to net cash provided by operating activities: |
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Depreciation |
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367,137 |
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604,095 |
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Amortization |
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874,839 |
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877,220 |
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Gain on sale of patent |
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(275,000 |
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Stock based compensation |
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1,261,225 |
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1,494,894 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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1,574,216 |
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1,186,459 |
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Inventory |
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392,608 |
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156,424 |
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Prepaid expenses, other current assets and deposits |
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(78,712 |
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(70,098 |
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Accounts payable |
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(255,800 |
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(1,206,057 |
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Accrued salaries, warranty and other expenses |
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499,253 |
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(1,012,598 |
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Deferred revenue |
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876,703 |
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813,885 |
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Total adjustments |
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5,236,469 |
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2,844,224 |
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Net cash provided by operating activities |
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1,923,157 |
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559,202 |
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Cash flows from investing activities: |
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Additions to patents, technology and other |
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(28,578 |
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(88,549 |
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Additions to property and equipment |
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(231,659 |
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(126,544 |
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Proceeds from sale of patent |
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275,000 |
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Net cash provided by (used for) investing activities |
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14,763 |
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(215,093 |
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Cash flows from financing activities: |
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Issuance of common stock for cash |
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23,494 |
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Taxes paid related to restricted stock issuance |
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(70,220 |
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Net cash provided by (used for) financing activities |
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(70,220 |
) |
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23,494 |
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Increase in cash and equivalents |
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1,867,700 |
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367,603 |
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Cash and equivalents, beginning of period |
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16,248,031 |
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13,115,715 |
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Cash and equivalents, end of period |
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$ |
18,115,731 |
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$ |
13,483,318 |
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|
See accompanying notes to consolidated financial statements.
5
iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
September 30, 2010
(1) |
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Basis of Presentation and Significant Accounting Policies |
Reference should be made to iCAD, Inc.s (iCAD, Company, we, our or us) Annual
Report on Form 10-K for the year ended December 31, 2009 for a comprehensive summary of
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
(generally accepted accounting principles). 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
September 30, 2010, the results of operations for the three and nine month periods ended
September 30, 2010 and 2009, and cash flows for the nine month periods ended September 30,
2010 and 2009. 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 Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2009 filed
with the SEC on March 23, 2010. The results for the three and nine month periods ended
September 30, 2010 are not necessarily indicative of the results that may be expected for
the fiscal year ending December 31, 2010, or any future period. Interim period amounts are
not necessarily indicative of the results of operations for the full fiscal year.
In February 2010, the Financial Accounting Standards Board (FASB) issued ASU 2010-09,
Subsequent Events (Topic 855) Amendments to Certain Recognition and Disclosure
Requirements (ASU 2010-09). ASU 2010-09 requires an entity that is an SEC filer to
evaluate subsequent events through the date that the financial statements are issued and
removes the requirement that an SEC filer disclose the date through which subsequent events
have been evaluated. ASC 2010-09 was effective upon issuance. The adoption of this
standard had no effect on our results of operation or our financial position.
6
iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
September 30, 2010
(2) |
|
Net (Loss) Income per Common Share |
The Companys basic net (loss) income per share is computed by dividing net loss or income
by the weighted average number of shares of common stock outstanding for the period and, if
there are dilutive securities, diluted income 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 Companys calculation of net (loss) income per share is as follows:
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Three Months Ended |
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Nine Months Ended |
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|
|
September 30, |
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(1,392,586 |
) |
|
$ |
112,758 |
|
|
$ |
(3,313,312 |
) |
|
$ |
(2,285,022 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic shares used in the
calculation of net (loss)
income per share |
|
|
45,921,952 |
|
|
|
45,620,763 |
|
|
|
45,782,449 |
|
|
|
45,463,078 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
327,574 |
|
|
|
|
|
|
|
|
|
Restricted stock |
|
|
|
|
|
|
153,428 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares used in the
calculation of net (loss)
income per share |
|
|
45,921,952 |
|
|
|
46,101,765 |
|
|
|
45,782,449 |
|
|
|
45,463,078 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic |
|
$ |
(0.03 |
) |
|
$ |
0.00 |
|
|
$ |
(0.07 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share diluted |
|
$ |
(0.03 |
) |
|
$ |
0.00 |
|
|
$ |
(0.07 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the number of shares of common stock for securities that were
not included in the calculation of diluted net (loss) income per share because such shares
are antidilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
5,239,307 |
|
|
|
3,157,678 |
|
|
|
5,239,307 |
|
|
|
5,341,355 |
|
Stock warrants |
|
|
|
|
|
|
936,111 |
|
|
|
|
|
|
|
936,111 |
|
Restricted stock |
|
|
800,242 |
|
|
|
31,500 |
|
|
|
800,242 |
|
|
|
496,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,039,549 |
|
|
|
4,125,289 |
|
|
|
6,039,549 |
|
|
|
6,773,953 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7
iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
September 30, 2010
(3) |
|
Stock-Based Compensation |
The Company follows FASB Accounting Standards Codification (ASC) Topic 718, Compensation
- Stock Compensation, (ASC 718), for all share-based compensation that was not vested as
of January 1, 2006. Under this application, the Company is required to record compensation
expense for all awards granted after the date of adoption and for the unvested portion of
previously granted awards that remain outstanding at the date of adoption.
The Company issued 530,500 shares of restricted stock and 186,018 stock options in the nine
months ended September 30, 2010. The restricted stock granted during the first nine months
of 2010 had a weighted average fair value of $1.41 per share. The options granted during the
first nine months of 2010 had a weighted average exercise price of $1.65 per share. The
weighted average fair value of options granted during this nine month period was $0.69 per
share and was estimated on the grant date using the Black-Scholes option-pricing model with
the following weighted average assumptions: expected volatility of 69.17%, expected term of
3.5 years, risk-free interest rate of 2.14%, and expected dividend yield of 0%. The average
expected life was calculated using the Companys historical average life. The risk-free rate
is based on the rate of U.S. Treasury zero-coupon issues with a remaining term equal to the
expected life of option grants. The Company recorded $1,261,225 for share-based compensation
for the nine months ended September 30, 2010.
For the same period in 2009, the Company issued 241,379 stock options. The Company did not
issue any shares of restricted stock during this nine month period in 2009. The options
granted during the first nine months of 2009 had a weighted average exercise price of $1.17
per share. The weighted average fair value of options granted during the nine month period
ended September 30, 2009 was $0.43 per share and was estimated on the grant date using the
Black-Scholes option-pricing model with the following weighted average assumptions: expected
volatility of 62.8%, expected term of 3.5 years, risk-free interest rate of 1.95%, and
expected dividend yield of 0%. The Company recorded $1,494,894 for share-based compensation
for the nine months ended September 30, 2009.
As of September 30, 2010, there was approximately $1,179,000 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 Companys aggregate intrinsic value of options outstanding at September 30, 2010 was
$488,616. The aggregate intrinsic value of restricted stock outstanding at September 30,
2010 was $1,400,424.
8
iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
September 30, 2010
(4) |
|
Fair Value Measurements |
FASB ASC Topic 820, Fair Value Measurement and Disclosures, (ASC 820) 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 instruments level within the fair value hierarchy is based on the lowest level
of any input that is significant to the fair value measurement.
In accordance with ASC 820, the Companys financial assets that are measured at fair value
on a recurring basis as of September 30, 2010 are cash equivalents. The cash equivalents
are measured using level one inputs.
(5) |
|
Commitments and Contingencies |
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 CRAs audit of CADx Medicals 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 CRA has the right to pursue the matter until July 2017. The Company believes
that it is not liable for the re-assessment against CADx Medical and no accrual was recorded
as of September 30, 2010.
9
iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
September 30, 2010
At September 30, 2010, 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 September 30, 2010. The Company files United States federal
income tax returns and income tax returns in various states and local jurisdictions. On July
8, 2010, the Company was notified by the Internal Revenue Service of its intent to examine
the tax returns for the 2008 tax year. Management cannot reasonably determine the results
of this examination, if any, at this time. The Company is not under examination for any
additional open tax years by the Internal Revenue Service or any other state and federal
jurisdictions.
In accordance with FASB ASC Topic 350-20, Intangibles Goodwill and Other, 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 Companys goodwill arose in connection with its acquisitions in June 2002 and in
December 2003. The Company operates in one segment and as one reporting unit since its
products perform the same basic function, have common sales channels and/or resellers, and
are developed and supported by one central staff. 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 Companys 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 Companys market capitalization
exceeded its carrying value.
10
iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
September 30, 2010
(8) |
|
Recent Accounting Pronouncements |
Effective January 1, 2009, the Company adopted guidance now codified as FASB ASC Topic 805,
Business Combinations (ASC 805). This topic requires an acquirer to recognize and
measure the identifiable assets acquired, the liabilities assumed, and any non-controlling
interest in the acquiree at their fair values as of the acquisition date. The topic requires
acquisition costs and any restructuring costs associated with the business combination to be
recognized separately from the fair value of the business combination. ASC 805 establishes
requirements for recognizing and measuring goodwill acquired in the business combination or
a gain from a bargain purchase as well as disclosure requirements designed to enable users
to better interpret the results of the business combination. Early adoption of this topic
was not permitted. The adoption of ASC 805 will impact the Companys financial position,
results of operations and cash flows to the extent it conducts acquisition-related
activities and/or consummates business combinations. In the first nine months of 2010, the
Company recorded expenses of approximately $1,140,000 primarily related to a potential
acquisition that was not consummated and another that was under evaluation.
11
Item 2. Managements 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 Companys
other filings with the SEC. The words believe, demonstrate, intend, expect, estimate,
anticipate, likely, seek, should 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)). iCADs 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 U.S. Food and Drug Administration (FDA) for the Companys first
breast cancer detection product in January 2002, over thirty nine hundred of iCADs 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.
iCADs CAD mammography products have been shown to detect up to 72 percent 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.
12
The Companys 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 adjacent markets 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 Companys 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 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.
The Companys headquarters are located in Nashua, New Hampshire, with manufacturing and contract
manufacturing facilities in New Hampshire and Massachusetts and a research and development facility
in Ohio.
13
Critical Accounting Policies
The Companys discussion and analysis of its financial condition, results of operations, and cash
flows are based on the Companys 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, we evaluate 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.
The Companys critical accounting policies are set forth in its Annual Report on Form 10-K for the
fiscal year ended December 31, 2009. The Company believes that revenue recognition is a critical
accounting policy because it is governed by multiple complex accounting rules; however, there are
no significant estimates or assumptions used in recording the Companys revenue.
Quarter Ended September 30, 2010 compared to Quarter Ended September 30, 2009 and Nine Months
Ended September 30, 2010 compared to Nine Months Ended September 30, 2009
Revenue. Total revenue for the three and nine month periods ended September 30, 2010 was $5,586,357
and $18,204,165, respectively, compared with revenue of $7,106,270 and $20,001,155 for the three
and nine month periods ended September 30, 2009, for a decrease of $1,519,913 and $1,796,990 or
21.4% and 9.0%, respectively. The decrease in revenue, for the three and nine month periods ended
September 30, 2010, was due primarily to the decrease in digital and MRI CAD and film-based
revenue partially offset by an increase in service and supply revenue.
The Companys digital and MRI CAD revenue for the three and nine month periods ended September 30,
2010 decreased $1,497,449 and $1,217,366, or 31.1% and 9.6%, respectively, to $3,311,234 and
$11,467,862, compared to sales of $4,808,683 and $12,685,228, respectively, in the same periods in
2009. The decrease in digital and MRI CAD revenue was largely the result of a combination of
having a key OEM customer out of the market awaiting FDA approval of their new digital mammography
system, and to the weakened economy as well as to continued budget constraints in healthcare
capital spending.
Revenue from iCADs film based products for the three and nine month periods ended September 30,
2010 decreased 41.4% and 44.8%, respectively, to $748,093 and $2,519,551, compared to $1,275,884
and $4,561,053 in the three and nine month periods ended September 30, 2009. This decrease can be
attributed to the softer demand for full field digital mammography systems which affects sales of
TotalLook MammoAdvantage, current economic conditions and constraints in
healthcare capital spending. The majority of film-based revenue is derived from sales of the
Companys 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
customers are preparing to go digital. In addition, the demand for film-based products and
accessories continues to decline as the marketplace continues to transition to digital
technologies.
14
Service and supply revenue for the three and nine month periods ended September 30, 2010 increased
49.5% and 53.1%, respectively, to $1,527,030 and $4,216,752, compared to $1,021,703 and $2,754,874
in the same periods in 2009. The increase in the Companys service and supply revenue is due
primarily to increased service contract revenue on the Companys growing installed base of products
as customers migrate from warranty to service contracts, and to renewed service contract
agreements. Service contract revenue as a percentage of the Companys total service and supply
revenue for the three and nine months ended September 30, 2010 represented 95% and 93%,
respectively, compared to 91% and 92% for the same periods of 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
Change |
|
|
% Change |
|
Digital & MRI CAD revenue |
|
$ |
3,311,234 |
|
|
$ |
4,808,683 |
|
|
$ |
(1,497,449 |
) |
|
|
-31.1 |
% |
Film based revenue |
|
|
748,093 |
|
|
|
1,275,884 |
|
|
|
(527,791 |
) |
|
|
-41.4 |
% |
Service & supply revenue |
|
|
1,527,030 |
|
|
|
1,021,703 |
|
|
|
505,327 |
|
|
|
49.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
5,586,357 |
|
|
$ |
7,106,270 |
|
|
$ |
(1,519,913 |
) |
|
|
-21.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
Change |
|
|
% Change |
|
Digital & MRI CAD revenue |
|
$ |
11,467,862 |
|
|
$ |
12,685,228 |
|
|
$ |
(1,217,366 |
) |
|
|
-9.6 |
% |
Film based revenue |
|
|
2,519,551 |
|
|
|
4,561,053 |
|
|
|
(2,041,502 |
) |
|
|
-44.8 |
% |
Service & supply revenue |
|
|
4,216,752 |
|
|
|
2,754,874 |
|
|
|
1,461,878 |
|
|
|
53.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
18,204,165 |
|
|
$ |
20,001,155 |
|
|
$ |
(1,796,990 |
) |
|
|
-9.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Margin. Gross margin increased to 87.3% and 87.5% for the three and nine month periods ended
September 30, 2010 compared to 84.8% and 83.0%, respectively, in the same three and nine month
periods in 2009. The increase in total gross margin is primarily attributable to component cost
reductions, the realization of some average selling price increases, and lower repair costs related
to service contracts on a growing installed base of products.
Engineering and Product Development. Engineering and product development costs for the three month
period ended September 30, 2010 increased slightly by $12,211, from $1,702,263 in 2009 to
$1,714,474 in 2010. The increase in engineering and product development costs during this three
month period was primarily due to the increase in subcontract services of $110,000, consulting
services of $77,000 and licensing, data collection and travel expenses of $18,000 principally
relating to new product development. These increases were partially offset by decreases in stock
based and other compensation related expenses of $140,000 resulting primarily from staff
reductions, as well as reductions in rent and legal expenses of $42,000, and various other expenses
totaling $11,000.
15
Engineering and Product Development. Engineering and product development costs for the nine month
period ended September 30, 2010 decreased by $805,810 or 14.4%, from $5,601,756 in 2009 to
$4,795,946 in 2010. The decrease in engineering and product development costs during this nine
month period was primarily due to decreases of $469,000 in stock based and other compensation
related expenses resulting primarily from staff reductions, and in subcontracting services of
$442,000 principally relating to the licensing and clinical trial costs for the Companys CT Colon
product which was completed in the first quarter of 2009. In addition, during the 2010 nine month
period, the Company recorded decreases in legal costs of $97,000, in rent expense of $65,000 and in
depreciation and various other expenses totaling $84,000. These decreases were partially offset by
increases in consulting expenses of $173,000, subcontracting services of $159,000 and licensing and
data collection expenses of $19,000, principally relating to new product development.
Marketing and Sales. Marketing and sales expense for the three and nine month periods ended
September 30, 2010 increased by $189,327 or 7.3% and $466,641 or 5.7%, respectively, from
$2,577,319 and $8,174,752 in 2009 to $2,766,646 and $8,641,393, respectively, in 2010. The increase
in marketing and sales expense during the three and nine month periods of 2010 was primarily due to
the increase in compensation related expenses for existing employees of $199,000 and $424,000,
respectively, an increase in sales commissions of $51,000 and $91,000 and increases in consulting,
advertising, education expenses and various marketing expenses totaling $16,000 and $174,000,
respectively, principally relating to marketing consulting services incurred in the second quarter
of 2010. These increases were partially offset by decreases in depreciation, freight and various
administrative expenses totaling $77,000 and $222,000, respectively.
General and Administrative. General and administrative expenses for the three and nine month
periods ended September 30, 2010 increased by $150,017 or 9.1%, and $924,776 or 17.8%,
respectively, from $1,654,909 and $5,206,303 in 2009 to $1,804,926 and $6,131,079, respectively, in
2010. The increase in general and administrative expense during this three and nine month periods
of 2010 was due primarily to an increase in legal and professional fees of $303,000 and $1,054,000
associated primarily with a potential acquisition that was not consummated and evaluation of
another potential acquisition, increases in compensation related expenses of $71,000 and $296,000,
and in provisions for taxes and various administrative expenses totaling $95,000 and $27,000,
respectively. The increases in general and administrative expense during this three and nine month
periods of 2010 were partially offset by a decrease in stock based compensation expense of $178,000
and $179,000, respectively, principally due to the completion of the three year vesting period on
the awards of restricted stock and stock options that were granted to the executive officers of the
Company in July 2007. In addition, during the three and nine month periods of 2010, the Company
recorded decreases in legal, professional and consulting services totaling $108,000 and $209,000,
respectively, and in insurance costs of $33,000 and $65,000, respectively.
16
Other Income: During the second quarter of 2010 the Company received a one-time payment of $275,000
related to the sale of a non-core patent that was acquired as part of the Qualia Computing, Inc.
acquisition in 2003. The patent is for technology that is outside of the medical device industry
and unrelated to the Companys core business.
Interest Income/Expense. Net interest income for the three and nine month periods ended September
30, 2010 decreased by $4,345 and $30,524, respectively, from $22,965 and $88,641 in 2009 to $18,620
and $58,117 in the same periods of 2010. The decrease in interest income is due primarily to the
reduction of the interest rate earned from the Companys money market accounts.
Net Income/(Loss). As a result of the foregoing, the Company recorded a net loss of ($1,392,586)
or ($0.03) per share for the three month period ended September 30, 2010 on revenue of $5,586,357,
compared to net income of $112,758 or $0.00 per diluted share for the three month period ended
September 30, 2009 on revenue of $7,106,270. The net loss for the nine months ended September 30,
2010 was ($3,313,312) or ($0.07) per share on revenue of $18,204,165, compared to a net loss of
($2,285,022) or ($0.05) per share on revenue of $20,001,155 for the nine months ended September 30,
2009.
Backlog. The Companys product backlog (excluding service and supplies) as of September 30, 2010
totaled approximately $483,000 as compared to $663,000 at September 30, 2009 and $583,000 at June
30, 2010. It is expected that the majority of the backlog at September 30, 2010 will be shipped
within the current fiscal year. Backlog as of any particular period should not be relied upon as
indicative of the Companys net revenues for any future period as a large amount of the Companys
product is booked and shipped within the same quarter.
Liquidity and Capital Resources
The Company believes that its 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
balances from continuing operations. The Companys ability to generate cash adequate to meet its
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, the Company may require additional financing, although there are no guarantees that the
Company will be able to obtain the financing if necessary. The Company will continue to closely
monitor its liquidity and the capital and credit markets.
At September 30, 2010, the Company had current assets of $22,438,906, current liabilities of
$7,726,902 and working capital of $14,712,004. The ratio of current assets to current liabilities
was 2.9:1.
Net cash provided by operating activities for the nine months ended September 30, 2010 was
$1,923,157, compared to net cash provided by operating activities of $559,202 for the same period
in 2009. The cash provided by operating activities for the nine months ended September 30, 2010
resulted from decreases in accounts receivable of $1,574,216, inventory of $392,608, accrued
expenses of $499,253 and deferred revenue of $876,703, plus non-cash items including
depreciation and amortization totaling $1,241,976 and stock based compensation of $1,261,225, which
were offset by the net loss of $3,313,312, the gain on the sale of a patent of $275,000, an
increase in prepaid expenses, other current assets and deposits of $78,712 and a decrease in
accounts payable of $255,800.
17
The net cash provided by investing activities for the nine months ended September 30, 2010 was
$14,763, which consisted of proceeds from the sale of a patent of $275,000 offset by additions to
patents, technology and other assets of $28,578 and additions to property and equipment of
$231,659, compared to net cash used for investing activities for the nine months ended September
30, 2009 of $215,093, which consisted of additions to patents, technology and other assets of
$88,549 and additions to property and equipment of $126,544.
Net cash used for financing activities for the nine months ended September 30, 2010 was $70,220
relating to taxes paid with respect to the issuance of restricted stock, compared to net cash
provided by financing activities for the nine months ended September 30, 2009 of $23,494 due to
cash received from the issuance of common stock relating to the exercise of stock options.
Contractual Obligations
The following table summarizes, for the periods presented, the Companys future estimated cash
payments under existing contractual obligations at September 30, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by period |
|
|
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
|
Contractual Obligations |
|
Total |
|
|
year |
|
|
1-3 years |
|
|
3-5 years |
|
|
5+ years |
|
Lease Obligations* |
|
$ |
423,745 |
|
|
$ |
131,425 |
|
|
$ |
292,320 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Contractual Obligations |
|
$ |
423,745 |
|
|
$ |
131,425 |
|
|
$ |
292,320 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
The Companys lease obligations is shown net of sublease amounts. |
Recent Accounting Pronouncements
Effective January 1, 2009, the Company adopted guidance now codified as FASB ASC Topic 805,
Business Combinations (ASC 805). This topic requires an acquirer to recognize and measure the
identifiable assets acquired, the liabilities assumed, and any non-controlling interest in the
acquiree at their fair values as of the acquisition date. The topic requires acquisition costs and
any restructuring costs associated with the business combination to be recognized separately from
the fair value of the business combination. ASC 805 establishes requirements for recognizing and
measuring goodwill acquired in the business combination or a gain from a bargain purchase as well
as disclosure requirements designed to enable users to better interpret the results of the business
combination. Early adoption of this topic was not permitted. The adoption of ASC 805 will impact
the Companys financial position, results of operations and cash flows to the extent it conducts
acquisition-related activities and/or consummates business combinations. In the first nine months
of 2010, the Company recorded expenses of approximately $1,140,000 primarily related to a potential
acquisition that was not consummated and another that was under evaluation.
18
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
Item 4. Controls and Procedures
The Company, under the supervision and with the participation of its management, including its
principal executive officer and principal financial officer, evaluated the effectiveness of the
design and operation of its 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 the Companys 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. The Company conducts periodic evaluations to enhance, where necessary its
procedures and controls.
The Companys principal executive officer and principal financial officer conducted an evaluation
of the Companys 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, 2010, 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.
19
PART II OTHER INFORMATION
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 September 30, 2010:
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total number of |
|
|
Maximum dollar |
|
|
|
|
|
|
|
|
|
|
|
shares purchased |
|
|
value of shares |
|
|
|
|
|
|
|
|
|
|
|
as part of |
|
|
that may yet be |
|
|
|
Total number |
|
|
Average |
|
|
publicly |
|
|
purchaed under |
|
|
|
of shares |
|
|
price paid per |
|
|
announced plans |
|
|
the plans or |
|
Month of purchase |
|
purchased (1) |
|
|
share |
|
|
or programs |
|
|
programs |
|
July 1 July 31, 2010 |
|
|
14,992 |
|
|
$ |
2.00 |
|
|
$ |
|
|
|
$ |
|
|
August 1 August 31, 2010 |
|
|
1,403 |
|
|
$ |
1.94 |
|
|
$ |
|
|
|
$ |
|
|
September 1 September
30, 2010 |
|
|
540 |
|
|
$ |
1.73 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
16,935 |
|
|
$ |
1.89 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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. |
20
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: November 9, 2010 |
By: |
/s/ Kenneth M. Ferry
|
|
|
|
Kenneth M. Ferry |
|
|
|
President, Chief Executive Officer, Director |
|
|
|
|
Date: November 9, 2010 |
By: |
/s/ Darlene M. Deptula-Hicks
|
|
|
|
Darlene M. Deptula-Hicks |
|
|
|
Executive Vice President of Finance
and Chief Financial Officer, Treasurer |
|
21