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 March 31, 2011
OR
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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 May 10, 2011 there were 54,483,264 shares outstanding of the
registrants Common Stock, $.01 par value.
iCAD, INC. AND SUBSIDIARY
Consolidated Balance Sheets
(Unaudited)
(In thousands except for share data)
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March 31, |
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December 31, |
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2011 |
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2010 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
11,312 |
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$ |
16,269 |
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Trade accounts receivable, net of allowance for doubtful
accounts of $50 in 2011 and 2010 |
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4,075 |
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3,389 |
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Inventory, net |
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3,074 |
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3,489 |
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Prepaid expenses and other current assets |
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680 |
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581 |
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Total current assets |
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19,141 |
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23,728 |
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Property and equipment, net of accumulated depreciation
and amortization of $2,767 in 2011 and $2,852 in 2010 |
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2,555 |
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2,774 |
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Other assets |
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620 |
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675 |
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Intangible assets, net of accumulated amortization
of $7,269 in 2011 and $6,746 in 2010 |
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18,631 |
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21,165 |
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Goodwill |
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47,365 |
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45,689 |
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Total assets |
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$ |
88,312 |
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$ |
94,031 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
2,556 |
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$ |
2,500 |
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Accrued and other expenses |
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4,138 |
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5,902 |
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Deferred revenue |
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4,781 |
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4,906 |
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Total current liabilities |
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11,475 |
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13,308 |
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Contingent consideration |
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4,900 |
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5,000 |
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Deferred revenue long term portion |
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1,601 |
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961 |
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Other long-term liabilities |
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1,085 |
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1,552 |
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Total liabilities |
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19,061 |
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20,821 |
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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, $.01 par value: authorized 85,000,000
shares; issued 54,551,140 in 2011 and 54,383,747 in 2010;
outstanding 54,483,264 in 2011 and 54,315,871 in 2010 |
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545 |
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544 |
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Additional paid-in capital |
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163,342 |
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163,101 |
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Accumulated deficit |
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(93,686 |
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(89,485 |
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Treasury stock at cost (67,876 shares) |
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(950 |
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(950 |
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Total stockholders equity |
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69,251 |
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73,210 |
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Total liabilities and stockholders equity |
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$ |
88,312 |
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$ |
94,031 |
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See accompanying notes to consolidated financial statements.
3
iCAD, Inc.
Consolidated Statements of Operations
(Unaudited)
(In thousands except for share data)
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Three Months Ended |
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Three Months Ended |
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March 31, 2011 |
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March 31, 2010 |
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Revenue: |
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Products |
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$ |
5,240 |
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$ |
5,211 |
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Service and supplies |
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2,104 |
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1,309 |
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Total revenue |
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7,344 |
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6,520 |
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Cost of revenue: |
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Products |
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1,207 |
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667 |
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Service and supplies |
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772 |
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615 |
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Amortization of acquired technology |
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233 |
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Total cost of revenue |
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2,212 |
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1,282 |
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Gross margin |
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5,132 |
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5,238 |
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Operating expenses: |
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Engineering and product development |
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2,776 |
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1,556 |
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Marketing and sales |
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3,727 |
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2,398 |
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General and administrative |
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2,804 |
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2,487 |
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Total operating expenses |
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9,307 |
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6,441 |
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Loss from operations |
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(4,175 |
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(1,203 |
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Interest (expense) income net |
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(26 |
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18 |
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Net loss |
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$ |
(4,201 |
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$ |
(1,185 |
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Net loss per share: |
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Basic and diluted |
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$ |
(0.08 |
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$ |
(0.03 |
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Weighted average number of shares used in
computing loss per share: |
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Basic and diluted |
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54,365,955 |
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45,686,285 |
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See accompanying notes to consolidated financial statements.
4
iCAD, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
(In thousands except for share data)
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Three Months Ended |
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Three Months Ended |
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March 31, 2011 |
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March 31, 2010 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(4,201 |
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$ |
(1,185 |
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Adjustments to reconcile net loss
to net cash (used for) provided by operating activities: |
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Depreciation |
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295 |
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126 |
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Amortization |
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524 |
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292 |
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Loss on disposal of assets |
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6 |
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Stock based compensation |
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268 |
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483 |
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Interest of royalty obligation |
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36 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(686 |
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469 |
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Inventory |
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415 |
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94 |
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Prepaid expenses, other current assets and deposits |
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(99 |
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(33 |
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Accounts payable |
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55 |
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(75 |
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Accrued salaries, warranty and other expenses |
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(822 |
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(227 |
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Deferred revenue |
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523 |
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159 |
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Net cash (used for) provided by operating activities |
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(3,686 |
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103 |
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Cash flows from investing activities: |
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Disposals (additions) to patents, technology and other |
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46 |
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(9 |
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Additions to property and equipment |
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(82 |
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(41 |
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Cash paid for acquisition of Xoft |
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(1,209 |
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Net cash used for investing activities |
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(1,245 |
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(50 |
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Cash flows from financing activities: |
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Taxes paid related to restricted stock issuance |
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(26 |
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(5 |
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Net cash used for financing activities |
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(26 |
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(5 |
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Increase (decrease) in cash and equivalents |
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(4,957 |
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48 |
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Cash and equivalents, beginning of period |
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16,269 |
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16,248 |
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Cash and equivalents, end of period |
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$ |
11,312 |
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$ |
16,296 |
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See accompanying notes to consolidated financial statements.
5
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 Companys 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).
6
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 iCADs 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.
7
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 customers post-delivery acceptance provisions, if any, and the installation process.
There are no significant estimates or assumptions used in the Companys 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 products 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 $435,000 that were previously included in sales and marketing expenses to cost of revenue
to conform to current period classifications.
8
iCAD, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
March 31, 2011
Note 2 Net Loss per Common Share
The Companys basic net loss per share is computed by dividing net loss by the weighted
average number of shares of common stock outstanding for the period and, if there are
dilutive securities, diluted loss per share is computed by including common stock
equivalents which includes shares issuable upon the exercise of stock options, net of shares
assumed to have been purchased with the proceeds, using the treasury stock method.
A summary of the Companys calculation of loss per share is as follows:
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Three Months Ended |
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March 31, |
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2011 |
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2010 |
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Net loss |
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$ |
(4,201 |
) |
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$ |
(1,183 |
) |
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Basic shares used in the calculation of net loss per share |
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54,365,955 |
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45,686,285 |
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Effect of dilutive securities: |
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Stock options |
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Restricted stock |
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Diluted shares used in the calculation of net loss per share |
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54,365,955 |
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45,686,285 |
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Net loss per share basic |
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$ |
(0.08 |
) |
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$ |
(0.03 |
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Net loss per share diluted |
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$ |
(0.08 |
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$ |
(0.03 |
) |
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Stock options to purchase 5.2 million and 4.8 million shares of the Companys 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.
9
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 Companys 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 Companys 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
Companys 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 Companys 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.
10
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 |
|
|
|
(000s) |
|
|
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 |
) |
11
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 Companys 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.
12
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 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 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.
13
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 attorneys 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.
14
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 instruments 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 Companys 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.
15
.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 Companys liabilities which are measured at fair value on a
recurring basis by level within the fair value hierarchy.
Fair value measurements using: (000s)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
16
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 Companys
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 Companys 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 Companys 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 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. At March 31, 2011, there were no triggering events that would cause us to
perform a step one fair value test for goodwill.
17
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.
18
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 products essential
functionality. The adoption of this standard did not have a material effect on its
financial condition or results of operations.
19
|
|
|
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 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)). 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 FDA for the Companys first breast cancer detection product in
January 2002, over 4,000 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% 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.
20
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 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 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 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.
21
The
acquisition of Xoft, Inc. (Xoft) on December 30, 2010, brings an isotope-free cancer treatment platform
technology to the Companys 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 Companys 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 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, 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.
22
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 iCADs 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.
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
24
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.
25
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.
26
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.
27
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 attorneys 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. |
28
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. |
|
|
|
|
|
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. |
29
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 |
|
|
30