ICAD INC - Quarter Report: 2011 June (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2011
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-9341
iCAD, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 02-0377419 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
98 Spit Brook Road, Suite 100, Nashua, NH | 03062 | |
(Address of principal executive offices) | (Zip Code) |
(603) 882-5200
(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 þ NO o.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
Large Accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act) YES o NO þ.
As
of the close of business on August 1, 2011 there were 54,677,554 shares outstanding of the
registrants Common Stock, $.01 par value.
iCAD, Inc.
INDEX
PAGE | ||||||||
PART I FINANCIAL INFORMATION |
||||||||
Item 1 Financial Statements (unaudited) |
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3 | ||||||||
4 | ||||||||
5 | ||||||||
6-18 | ||||||||
19-27 | ||||||||
28 | ||||||||
28 | ||||||||
29 | ||||||||
30 | ||||||||
30 | ||||||||
Item 4 [Removed and Reserved] |
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31 | ||||||||
32 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 | ||||||||
EX-101 INSTANCE DOCUMENT | ||||||||
EX-101 SCHEMA DOCUMENT | ||||||||
EX-101 CALCULATION LINKBASE DOCUMENT | ||||||||
EX-101 LABELS LINKBASE DOCUMENT | ||||||||
EX-101 PRESENTATION LINKBASE DOCUMENT |
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iCAD, INC. AND SUBSIDIARY
Consolidated Balance Sheets
(Unaudited)
(In thousands except for share data)
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 7,677 | $ | 16,269 | ||||
Trade accounts receivable, net of allowance for doubtful
accounts of $50 in 2011 and 2010 |
4,027 | 3,389 | ||||||
Inventory, net |
2,380 | 3,489 | ||||||
Prepaid expenses and other current assets |
587 | 581 | ||||||
Total current assets |
14,671 | 23,728 | ||||||
Property and equipment, net of accumulated depreciation
and amortization of $2,709 in 2011 and $2,852 in 2010 |
2,357 | 2,774 | ||||||
Other assets |
609 | 675 | ||||||
Intangible assets, net of accumulated amortization
of $7,793 in 2011 and $6,746 in 2010 |
18,107 | 21,165 | ||||||
Goodwill |
47,657 | 45,689 | ||||||
Total assets |
$ | 83,401 | $ | 94,031 | ||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,355 | $ | 2,500 | ||||
Accrued and other expenses |
4,989 | 5,902 | ||||||
Deferred revenue |
5,344 | 4,906 | ||||||
Total current liabilities |
12,688 | 13,308 | ||||||
Contingent consideration |
3,800 | 5,000 | ||||||
Deferred revenue, long-term portion |
1,378 | 961 | ||||||
Other long-term liabilities |
1,041 | 1,552 | ||||||
Total liabilities |
18,907 | 20,821 | ||||||
Commitments and Contingencies (see Note 5) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $ .01 par value: authorized 1,000,000 shares;
none issued |
| | ||||||
Common stock, $ .01 par value: authorized 85,000,000
shares; issued 54,745,430 in 2011 and 54,383,747 in 2010;
outstanding 54,677,554 in 2011 and 54,315,871 in 2010 |
547 | 544 | ||||||
Additional paid-in capital |
163,676 | 163,101 | ||||||
Accumulated deficit |
(98,779 | ) | (89,485 | ) | ||||
Treasury stock at cost (67,876 shares) |
(950 | ) | (950 | ) | ||||
Total stockholders equity |
64,494 | 73,210 | ||||||
Total liabilities and stockholders equity |
$ | 83,401 | $ | 94,031 | ||||
See accompanying notes to consolidated financial statements.
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iCAD, INC. AND SUBSIDIARY
Consolidated Statements of Operations
(Unaudited)
(In thousands except for per share data)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenue: |
||||||||||||||||
Products |
$ | 4,494 | $ | 4,716 | $ | 9,709 | $ | 9,928 | ||||||||
Service and supplies |
2,152 | 1,381 | 4,281 | 2,690 | ||||||||||||
Total revenue |
6,646 | 6,097 | 13,990 | 12,618 | ||||||||||||
Cost of revenue: |
||||||||||||||||
Products |
1,140 | 557 | 2,347 | 1,225 | ||||||||||||
Service and supplies |
769 | 591 | 1,541 | 1,205 | ||||||||||||
Amortization of acquired technology |
234 | | 467 | | ||||||||||||
Total cost of revenue |
2,143 | 1,148 | 4,355 | 2,430 | ||||||||||||
Gross profit |
4,503 | 4,949 | 9,635 | 10,188 | ||||||||||||
Operating expenses: |
||||||||||||||||
Engineering and product development |
3,303 | 1,525 | 6,079 | 3,081 | ||||||||||||
Marketing and sales |
3,945 | 2,617 | 7,672 | 5,016 | ||||||||||||
General and administrative |
2,312 | 1,839 | 5,116 | 4,326 | ||||||||||||
Total operating expenses |
9,560 | 5,981 | 18,867 | 12,423 | ||||||||||||
Loss from operations |
(5,057 | ) | (1,032 | ) | (9,232 | ) | (2,235 | ) | ||||||||
Gain on sale of patent |
| 275 | | 275 | ||||||||||||
Interest (expense) income net |
(36 | ) | 21 | (62 | ) | 39 | ||||||||||
Net loss |
$ | (5,093 | ) | $ | (736 | ) | $ | (9,294 | ) | $ | (1,921 | ) | ||||
Net loss per share: |
||||||||||||||||
Basic and diluted |
$ | (0.09 | ) | $ | (0.02 | ) | $ | (0.17 | ) | $ | (0.04 | ) | ||||
Weighted average number of shares used in
computing loss per share: |
||||||||||||||||
Basic and diluted |
54,550 | 45,737 | 54,458 | 45,712 | ||||||||||||
See accompanying notes to consolidated financial statements.
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iCAD, INC. AND SUBSIDIARY
Consolidated Statements of Cash Flows
(In thousands)
(unaudited)
Six Months Ended | Six Months Ended | |||||||
June 30, 2011 | June 30, 2010 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (9,294 | ) | $ | (1,921 | ) | ||
Adjustments to reconcile net loss
to net cash (used for) provided by operating activities: |
||||||||
Depreciation |
546 | 249 | ||||||
Amortization |
1,047 | 583 | ||||||
Loss on disposal of assets |
64 | 0 | ||||||
Stock based compensation |
584 | 981 | ||||||
Gain on sale of patent |
| (275 | ) | |||||
Interest on royalty obligation |
79 | | ||||||
Fair value of contingent consideration |
(1,100 | ) | | |||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
(638 | ) | 540 | |||||
Inventory |
1,109 | 229 | ||||||
Prepaid expenses, other current assets and deposits |
(6 | ) | (16 | ) | ||||
Accounts payable |
(145 | ) | (630 | ) | ||||
Accrued salaries, warranty and other expenses |
(445 | ) | 509 | |||||
Deferred revenue |
774 | 575 | ||||||
Net cash (used for) provided by operating activities |
(7,425 | ) | 824 | |||||
Cash flows from investing activities: |
||||||||
Disposals (additions) to patents, technology and other |
0 | (28 | ) | |||||
Additions to property and equipment |
(191 | ) | (85 | ) | ||||
Proceeds from sale of patent |
| 275 | ||||||
Cash paid for acquisition of Xoft |
(971 | ) | | |||||
Net cash (used for) provided by investing activities |
(1,162 | ) | 162 | |||||
Cash flows from financing activities: |
||||||||
Taxes paid related to restricted stock issuance |
(5 | ) | (37 | ) | ||||
Net cash used for financing activities |
(5 | ) | (37 | ) | ||||
Increase (decrease) in cash and equivalents |
(8,592 | ) | 949 | |||||
Cash and equivalents, beginning of period |
16,269 | 16,248 | ||||||
Cash and equivalents, end of period |
$ | 7,677 | $ | 17,197 | ||||
See accompanying notes to consolidated financial statements.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
June 30, 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 June 30, 2011, the results of
operations for the three and six month periods ended June 30, 2011 and 2010, and cash flows
for the six month periods ended June 30, 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 and six month period ended June 30, 2011 are not necessarily indicative of the
results that may be expected for the fiscal year ending December 31, 2011, or any future
period. Interim period amounts are not necessarily indicative of the results of operations
for the full fiscal year.
Subsequent Events
We evaluated all subsequent events that occurred after the balance sheet date through
the date and time our financial statements were issued.
Revenue Recognition
In general the Company recognizes revenue when the product ships provided title and risk of
loss has passed to the customer, persuasive evidence of an arrangement exists, fees are
fixed and determinable, collectability is probable and there are no uncertainties regarding
customer acceptance.
The Company recognizes revenue from the sale of certain of its MRI CAD products and services
in accordance with Financial Accounting Standards Board (FASB) Accounting Standards
Codification (ASC) 985-605, (Software, Revenue Recognition) (ASC 985-605).
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
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 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 (BESP). 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 BESP. 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 of ASU 2009-13 did not have a
material effect on the financial condition or results of operations of the Company.
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.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
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.
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.
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 on
the statement of operations for the three and six months ended June 30, 2010, the cost of
product installation, training, customer support and certain warranty repair costs of
approximately $424,000 and $859,000, respectively that were previously included in sales and
marketing expenses to cost of revenue to conform to current period classifications.
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.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
A summary of the Companys calculation of loss per share is as follows:
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Net loss |
$ | (5,093 | ) | $ | (736 | ) | $ | (9,294 | ) | $ | (1,921 | ) | ||||
Basic shares used in the calculation of net loss per share |
54,550 | 45,737 | 54,458 | 45,712 | ||||||||||||
Effect of dilutive securities: |
||||||||||||||||
Stock options |
| | | | ||||||||||||
Restricted stock |
| | | | ||||||||||||
Diluted shares used in the calculation of net loss per share |
54,550 | 45,737 | 54,458 | 45,712 | ||||||||||||
Net loss per share basic |
$ | (0.09 | ) | $ | (0.02 | ) | $ | (0.17 | ) | $ | (0.04 | ) | ||||
Net loss per share diluted |
$ | (0.09 | ) | $ | (0.02 | ) | $ | (0.17 | ) | $ | (0.04 | ) | ||||
As of June 30, 2011 and 2010, there were 6.1 million and 6.2 million shares of the Companys
common stock, respectively issuable upon the exercise of stock options and warrants and
vesting of restricted stock that were excluded from the calculation of diluted net loss per
share because their effect would have been antidilutive.
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
$0.9 million was accrued at December 31, 2010, and paid in
January 2011. The total
consideration at closing was 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 which were accrued as of December 31, 2010 and
paid in January 2011. Following completion of the Merger, Xoft stockholders owned approximately
15.4% of the Companys outstanding common stock.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
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 cash 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.
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 of those assets. At June 30, 2011 the Company has
estimated the fair value of the contingent consideration at approximately $3.8 million,
which is included in long term liabilities. The change in fair value of approximately $1.1
million has been included in the statement of operations for the three months ended June 30,
2011.
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 |
1,951 | |||||||
Identifiable intangible assets |
13,700 | 15 Years | ||||||
Patent license |
100 | 6 Years | ||||||
Other assets |
643 | |||||||
Goodwill |
4,142 | |||||||
Current liabilities |
(5,196 | ) | ||||||
Long-term liabilities |
(1,591 | ) | ||||||
Purchase price |
$ | 17,779 | ||||||
The goodwill of $4.1 million is not deductible for income tax purposes.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
The unaudited proforma operating results for the Company for the three and six months ended
June 30, 2010, assuming the acquisition of Xoft occurred as of January 1, 2010 are as
follows:
Three months | Six months | |||||||
ended June 30, | ended June 30, | |||||||
2010 | 2010 | |||||||
(In thousands, except for per share data) | ||||||||
Revenue |
$ | 8,353 | $ | 16,054 | ||||
Loss from operations |
(8,340 | ) | (12,746 | ) | ||||
Net loss |
(8,617 | ) | (13,137 | ) | ||||
Net loss per share: |
||||||||
Basic and Diluted |
$ | (0.16 | ) | $ | (0.24 | ) |
Note 4 | - Stock-Based Compensation |
The Company follows the guidance in FASB ASC Topic 718, Compensation Stock
Compensation", (ASC 718). The Company issued 997,250 and 1,930,917 stock options in the
three months and six months ended June 30, 2011, respectively. The Company issued 110,000
shares of restricted stock in the three months ended March 31, 2011. The Company did not
issue any shares of restricted stock in the three months ended June 30, 2011. In the three
and six months ended June 30, 2010, the Company issued 52,419 and 128,318 stock options,
respectively. The Company issued 530,500 shares of restricted stock in the three months
ended March 31, 2010. The Company did not issue any shares of restricted stock in the three
months ended June 30, 2010.
In accordance with ASC 718, the Company recorded $315,000 and $584,000 of stock-based
compensation expense for the three months and six months ended June 30, 2011, respectively,
and $498,000 and $981,000 in the three and six months ended June 30, 2010, respectively.
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 | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Average risk-free interest rate |
3.02 | % | 2.34 | % | 3.06 | % | 2.41 | % | ||||||||
Expected dividend yield |
None | None | None | None | ||||||||||||
Expected life |
3.5 years | 3.5 years | 3.5 years | 3.5 years | ||||||||||||
Expected volatility |
67.7% to 68.0% | 65.6% to 71.6% | 67.7% to 69.2% | 70.6% to 71.6% | ||||||||||||
Weighted average exercise price |
$ | 1.20 | $ | 1.70 | $ | 1.20 | $ | 1.58 | ||||||||
Weighted average fair value |
$ | 0.60 | $ | 0.73 | $ | 0.61 | $ | 0.64 |
As of June 30, 2011, there was approximately $1,623,000 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 1.36 years.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
The Companys aggregate intrinsic value of options outstanding at June 30, 2011 was
approximately $6,000. The aggregate intrinsic value of restricted stock outstanding at June
30, 2011, was approximately $563,000. The Companys aggregate intrinsic value of options
outstanding at June 30, 2010 was approximately $827,000. The aggregate intrinsic value of
restricted stock outstanding at June 30, 2010, was approximately $1.8 million
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 June 30, 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. Pursuant to the settlement agreement, 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
certain alleged patent violations. In return the Company has a remaining obligation to pay
a minimum annual royalty payment to Hologic 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. During the three and six months ended June 30, 2011, the Company
recorded approximately $39,000 and $79,000, respectively, of interest expense related to the
liability. The obligation in excess of one year of approximately $730,000 has been recorded
in long term liabilities. In addition, the Company recorded $235,000 in the quarter ended
March 31, 2011 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.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
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 April 6, 2011, plaintiffs Jane Doe and John Doe amended
their complaint alleging only medical malpractice against Hoag Memorial Hospital
Presbyterian. On April 8, 2011, another complaint was filed in the Orange County Superior
Court (Docket No. 30-2011 00465448-CU-MM-CJC) on behalf of four additional Jane Doe
plaintiffs and two John Doe spouses with identical allegations against the same defendants.
On April 19, 2011, a sixth Jane Doe plaintiff filed an identical complaint in the Orange
County Superior Court (Docket No. 30-2011-00468687-CU-MM-CJC), and on May 4, 2011, a seventh
Jane Doe and John Doe spouse filed another complaint in the Orange County Superior Court
(Docket No. 30-2011-00473120-CU-PO-CJC), again with identical allegations against the same
defendants. Court records indicate that two additional complaints have been filed in July
2011 in the Orange County Superior Court (Docket Nos. 30-2011-00491068-CU-PL-CJC and
30-2011-00491497-CU-PL-CJC) on behalf of two more Jane Doe plaintiffs and one John Doe
spouse.
It is alleged that each plaintiff Jane Doe was a patient who was treated with the Axxent
Electronic Brachytherapy System that incorporated the Axxent Flexishield Mini. The Company
believes that all of the Jane Doe plaintiffs 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. Accordingly, since the amount of the
potential damages in the event of an adverse result is not reasonably estimable, no expense
or purchase price adjustment has been recorded with respect to the contingent liability
associated with this matter.
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 the Axxent Radiation Shield Rigid
which is an optional radiation shielding accessory to the Axxent Electronic Brachytherapy
System intended to protect tissue and/or organs from unwanted radiation. It is a rigid
stainless steel pad placed over the area requiring shielding. It can be used on external
patient surfaces, such as skin, as well internally during Intraoperative Radiation Therapy
(IORT). The Axxent Radiation Shield Rigid was cleared by FDA on July 22, 2011.
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 or purchase price adjustment has been recorded with respect to the contingent
liability associated with this matter. In addition, the merger agreement provides for
indemnity for certain losses relating to the Zeiss litigation, subject to limitations
specified in the merger agreement.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 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, accounts
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. Subsequent changes in the value of this liability will be
recorded in the statement of operations.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
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) as of December 31, 2010
Liabilities | ||||||||||||||||
at Fair | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Value | |||||||||||||
Contingent consideration |
| | $ | 5,000 | $ | 5,000 | ||||||||||
Royalty obligation |
| | 1,372 | 1,372 | ||||||||||||
Total |
| | $ | 6,372 | $ | 6,372 | ||||||||||
Fair value measurements using: (000s) as of June 30, 2011
Liabilities | ||||||||||||||||
at Fair | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Value | |||||||||||||
Contingent consideration |
| | $ | 3,800 | $ | 3,800 | ||||||||||
Royalty obligation |
| | 971 | 971 | ||||||||||||
Total |
| | $ | 4,771 | $ | 4,771 | ||||||||||
The changes in the fair value of contingent consideration during the period are as
follows:
Six months ended June 30, 2011
Balance as of December 31, 2010 |
$ | 5,000 | ||
Fair value adjustment |
(100 | ) | ||
Mark to market |
(1,100 | ) | ||
Balance as of June 30, 2011 |
$ | 3,800 | ||
During the quarter ended June 30, 2011 the Company recorded the $1.1 million reduction
in the fair value of the contingent consideration in the statement of operations.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
The changes in the fair value of the royalty obligation during the period are as follows:
Six months ended June 30, 2011
Balance as of December 31, 2010 |
$ | 1,372 | ||
Fair value adjustment |
(235 | ) | ||
Interest expense |
79 | |||
Royalty payment |
(245 | ) | ||
Balance as of June 30, 2011 |
$ | 971 | ||
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 or six months ended June 30,
2011.
Note 7 | - Income Taxes |
At June 30, 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 June 30, 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 testing 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 June 30,
2011, management believes there were no triggering events that would cause us to perform a
step one fair value test for goodwill.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
The changes in the carrying amount of goodwill for the six months ended June 30, 2011,
are as follows:
Six months ended June 30, 2011
Balance as of December 31, 2010 |
$ | 45,689 | ||
Purchase accounting adjustments |
1,968 | |||
Balance as of June 30, 2011 |
$ | 47,657 | ||
Purchase accounting adjustments, considered to be measurement period adjustments, in
the six months ended June 30, 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 and an increase of approximately $300,000 related to
unrecorded liabilities. 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 during the six months ended June 30, 2011.
Note 9 | - Recent Accounting Pronouncements |
In June 2011, the FASB issued ASU 2011-05, Comprehensive Income (Topic 220): Presentation of
Comprehensive Income (ASU 2011-05). ASU 2011-05 increases the prominence of other
comprehensive income in financial statements. Under ASU 2011-05, companies will have the
option to present the components of net income and comprehensive income in either one or two
consecutive financial statements. ASU 2011-05 eliminates the option to present other
comprehensive income in the statement of changes in equity and is applied retrospectively.
For public companies, ASU 2011-05 is effective for fiscal years, and interim periods within
those years, beginning after December 15, 2011. The Company does not expect this to have a
material impact on its financial statements.
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iCAD, INC. AND SUBSIDIARY.
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
Notes to Consolidated Financial Statements
(Unaudited)
June 30, 2011
In January 2010, the FASB issued ASU No. 2010-06, Improving Disclosures about Fair Value
Measurements (Topic 820) Fair Value Measurements and Disclosures (ASU 2010-06) to add
additional disclosures about the different classes of assets and liabilities measured at
fair value, the valuation techniques and inputs used, the activity in Level 3 fair value
measurements, and transfers between Levels 1, 2, and 3. Levels 1, 2 and 3 of fair value
measurements are defined in Note 6 above. ASU 2010-06 were effective for interim reporting
periods beginning January 1, 2010, except for the provisions related to activity in Level 3
fair value measurements. Those provisions are effective for fiscal years beginning after
December 15, 2010, and for interim periods within those fiscal years. ASU 2010-06 impacts
disclosure only and therefore, did not, and is not expected to, have a material impact on
our financial statements.
In December 2010, the FASB issued ASU No. 2010-28, Intangibles Goodwill and Other (Topic
350): When to Perform Step 2 of the Goodwill Impairment Test for Reporting Units with Zero
or Negative Carrying Amounts (ASU 2010-28). ASU 2010-28 is effective for fiscal years
beginning after December 15, 2010 and amends the criteria for performing Step 2 of the
goodwill impairment test for reporting units with zero or negative carrying amounts and
requires performing Step 2 if qualitative factors indicate that it is more likely than not
that a goodwill impairment exists. We do not believe that this will have a material impact
on our consolidated financial statements.
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Table of Contents
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 and expense levels, protection of patents and other proprietary rights,
the impact of supply and manufacturing constraints or difficulties, regulatory changes and
requirements applicable to our products, product market acceptance, possible technological
obsolescence of products, increased competition, the impact of litigation and/or government
regulation, changes in Medicare reimbursement policies, competitive factors, the effects of a
decline in the economy in markets served by the Company and other risks detailed in the Companys
other filings with the Securities and Exchange Commission. The words believe, plan, intend,
expect, estimate, anticipate, likely, seek, should would, could and similar
expressions identify forward-looking statements. Readers are cautioned not to place undue reliance
on those forward-looking statements, which speak only as of the date the statement was made.
Results of Operations
Overview
iCAD 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.
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.
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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 completed in September 2008, 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, and is now commercially
available. Colorectal cancer has been shown to be highly preventable with early detection and
removal of polyps.
In July 2008, the Company acquired pharmaco-kinetic based CAD products that aid in the
interpretation of contrast enhanced MRI images of the breast and prostate and began marketing these
products in the fourth quarter of 2008. The interpretation of MRI exams also benefits from
advanced image analysis and clinical decision support tools. MRI is an excellent tool to detect
breast cancer as well as prostate cancer. While MRI is a more expensive option than traditional
mammography, it enables physicians to view tumors which may have been missed during routine
screenings. MRI uses magnets and radio waves instead of x-rays to produce very detailed,
cross-sectional images of the body, and can be used to look specifically at those areas.
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The acquisition of Xoft Inc. (Xoft), on December 30, 2010, brings an isotope-free cancer
treatment platform technology to the 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. For a comprehensive list of the Companys critical accounting policies, referenced
should be made to the Annual Report on Form 10-K for the year ended December 31, 2010.
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Three and six months ended June 30, 2011 compared to the three and six months ended June 30,
2010
Revenue:
Three months ended June 30:
Total revenue for the three month period ended June 30, 2011 was $6.6 million compared with revenue
of $6.1 million for the three month period ended June 30, 2010, an increase of $549,000 or 9.0%.
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 June 30, | ||||||||||||||||
2011 | 2010 | Change | % Change | |||||||||||||
Digital & MRI revenue |
$ | 3,197 | $ | 3,991 | $ | (794 | ) | (19.9 | )% | |||||||
Film based revenue |
537 | 725 | (188 | ) | (25.9 | )% | ||||||||||
Electronic brachytherapy |
760 | | 760 | | ||||||||||||
Service & supply revenue |
2,152 | 1,381 | 771 | 55.8 | % | |||||||||||
Total revenue |
$ | 6,646 | $ | 6,097 | $ | 549 | 9.0 | % | ||||||||
Our digital and MRI CAD revenue for three month period ended June 30, 2011 decreased $794,000
or 19.9%, to $3.2 million compared to revenue of $4.0 million in the three month period ended June,
2010. This decrease was due primarily to lower demand for Full Field Digital Mammography (FFDM)
and Computed Radiography (CR) systems and digital CAD technology for the detection of breast
cancer, somewhat offset by a 20% increase in sales of our MRI CAD products. We believe that the
decline in digital and MRI revenue is due partially to weak demand in the international market, as
well as deferred spending in the domestic market.
Revenue from iCADs film based products decreased 25.9% or $188,000, to $537,000 in the three month
period ended June 30, 2011 from $725,000 in three month period ended June 30, 2010. This decrease
is primarily attributed to the decline in 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 transition to digital
mammography. 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 $760,000 in the three month period ended June 30,
2011. We believe revenues related to the Axxent Electronic Brachytherapy (EBx) system were
impacted by the voluntary recall of our mini flexi-shield. In July, 2011, we received clearance
from the FDA for our new rigid shield.
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Service and supply revenue increased 55.8% or $771,000 in the three month period ended June 30,
2011, to $2.2 million compared to $1.4 million in three months ended June 30, 2010. Service and
supply revenue includes approximately $400,000 related to the Axxent solution. Service and supply
revenue relating to our digital CAD and TotalLookMammoAdvantge systems increased approximately 26%
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.
Six months ended June 30:
Total revenue for the six month period ended June 30, 2011 was $14.0 million compared with revenue
of $12.6 million for the six month period ended June 30, 2010, an increase of $1.4 million or
10.9%. The increase in revenue was primarily due to revenue from the Axxent eBx System and an
increase in service and supply revenue offset by an overall decrease in digital and MRI revenue and
film-based revenue.
Six months ended June 30, | ||||||||||||||||
2011 | 2010 | Change | % Change | |||||||||||||
Digital & MRI revenue |
$ | 6,960 | $ | 8,157 | $ | (1,197 | ) | (14.7 | )% | |||||||
Film based revenue |
1,054 | 1,771 | (717 | ) | (40.5 | )% | ||||||||||
Electronic brachytherapy |
1,695 | | 1,695 | | ||||||||||||
Service & supply revenue |
4,281 | 2,690 | 1,591 | 59.1 | % | |||||||||||
Total revenue |
$ | 13,990 | $ | 12,618 | $ | 1,372 | 10.9 | % | ||||||||
Our digital and MRI revenue for six month period ended June 30, 2011 decreased $1.2 million or
14.7%, to $7.0 million compared to revenue of $8.2 million in the six month period ended June,
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. Revenue for the six month period ended June 30, 2011
was impacted primarily by what we expect to be a temporary softening of the digital mammography
market and weak demand in the international market.
Revenue from iCADs film based products decreased 40.5% or $717,000, to $1.1 million in the six
month period ended June 30, 2011 compared to $1.8 million six month period ended June 30, 2010.
This decrease is primarily 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 transition to digital mammography. 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 from our newly acquired Axxent solution was $1.7 million in the six month period ended June
30, 2011. Year to date revenues were impacted by the recall of the mini flexi shield, offset by
sales in the veterinary and dermatology markets.
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Service and supply revenue increased 59.1% or $1.6 million in the six month period ended June 30,
2011, to $4.3 million compared to $2.7 million in the six month period ended June 30, 2010. The
service and supply revenue includes approximately $800,000 related to the Axxent solution which is
not reflected in the year to date results for 2010. Service and supply revenue relating to our
digital CAD and TotalLookMammoAdvantge systems increased approximately 30% due primarily to the
increase in our installed base of service contracts. We expect that service and supply revenue for
both digital CAD and electronic brachytherapy products will continue to increase as our installed
base continues to transition from warranty to service contracts.
Gross Margin:
Three months ended June 30, | ||||||||||||||||
2011 | 2010 | Change | % Change | |||||||||||||
Products |
$ | 1,140 | $ | 557 | $ | 583 | 104.7 | % | ||||||||
Service & supply |
769 | 591 | 178 | 30.1 | % | |||||||||||
Amortization of acquired technology |
233 | | 233 | 100.0 | % | |||||||||||
Total cost of revenue |
$ | 2,142 | $ | 1,148 | $ | 994 | 86.6 | % | ||||||||
Gross Margin |
$ | 4,504 | $ | 4,949 | $ | (445 | ) | (9.0 | )% |
Six months ended June 30, | ||||||||||||||||
2011 | 2010 | Change | % Change | |||||||||||||
Products |
$ | 2,347 | $ | 1,225 | $ | 1,122 | 91.6 | % | ||||||||
Service & supply |
1,541 | 1,205 | 336 | 27.9 | % | |||||||||||
Amortization of acquired technology |
467 | | 467 | 100.0 | % | |||||||||||
Total cost of revenue |
$ | 4,355 | $ | 2,430 | $ | 1,925 | 79.2 | % | ||||||||
Gross Margin |
$ | 9,635 | $ | 10,188 | $ | (553 | ) | (5.4 | )% |
Gross margin for the three month period ended June 30, 2011 was $4.5 million or 67.8% as
compared to $4.9 million of 81.2% in the three month period ended June 30, 2010. The decrease was
primarily due to sales of our Axxent solutions which currently have significantly lower margins
than our CAD products and amortization of acquired technology. Gross margin for the six month
period ended June 30, 2011 was $9.6 million or 68.9% as compared to $10.2 million or 80.7% in the
six month period ended June 30, 2010. The decline in gross margin is primarily attributable to
amortization of acquired technology, and increased costs related to the fixed cost of our
manufacturing operation. We expect margins to improve as revenues increase and absorb the fixed
manufacturing costs.
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Operating Expenses:
Three months ended June 30, | Six months ended June 30, | |||||||||||||||||||||||||||||||
2011 | 2010 | Change | Change % | 2011 | 2010 | Change | Change % | |||||||||||||||||||||||||
Operating expenses: |
||||||||||||||||||||||||||||||||
Engineering and product development |
$ | 3,304 | $ | 1,525 | $ | 1,779 | 117 | % | $ | 6,079 | $ | 3,081 | $ | 2,998 | 97 | % | ||||||||||||||||
Marketing and sales |
3,945 | 2,617 | 1,328 | 51 | % | 7,671 | 5,016 | 2,655 | 53 | % | ||||||||||||||||||||||
General and administrative |
2,313 | 1,839 | 474 | 26 | % | 5,117 | 4,326 | 791 | 18 | % | ||||||||||||||||||||||
Total operating expenses |
$ | 9,561 | $ | 5,981 | $ | 3,580 | 60 | % | $ | 18,867 | $ | 12,423 | $ | 6,444 | 52 | % | ||||||||||||||||
Engineering and Product Development. Engineering and product development costs for the three
month period ended June 30, 2011 increased by $1.8 million or 117%, from $1.5 million in 2010 to
$3.3 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 $980,000 as
a result of our acquisition of Xoft and approximately $800,000 related to reader studies. For the
six month period ended June 30, 2011 engineering and product development costs increased by $3.0
million or 97%, from $3.1 million in 2010 to $6.1 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 $1.8 million, as a result of our acquisition of Xoft,
approximately $800,000 related to reader studies, and approximately $205,000 of costs related to
the recall of our Axxent Flexishield.
Marketing and Sales. Marketing and sales expenses for the three month period ended June 30, 2011
increased by $1.3 million or 51%, from $2.6 million in 2010 to $3.9 million in 2011. The increase
in marketing and sales expense primarily resulted from personnel and related expenses and various
administrative expenses totaling approximately $1.2 million as a result of our acquisition of Xoft.
Marketing and sales expenses for the six month period ended June 30, 2011 increased by $2.7
million or 53%, from $5.0 million in 2010 to $7.7 million in 2011. The increase in marketing and
sales expense primarily resulted from personnel and related expenses and various administrative
expenses totaling approximately $2.5 million as a result of our acquisition of Xoft.
General and Administrative. General and administrative expenses for the three month period ended
June 30, 2011 increased by $474,000 or 26%, from $1.8 million in 2010 to $2.3 million in 2011. The
increase in general and administrative expense is primarily due to legal expenses relating to our
patent litigation and an increase cost of headcount of approximately $156,000 related to the Xoft
acquisition which is reflected in general and administrative expense, offset by $1.1 million
expense reduction due to an adjustment in the fair value of contingent consideration related to the
Xoft acquisition. General and administrative expenses for the six month period ended June 30, 2011
increased by $791,000 or 18%, from $4.3 million in 2010 to $5.1 million in 2011. The increase in
general and administrative expense for the six months is primarily due to legal expenses relating
to our patent litigation and general and administrative cost of approximately $400,000 related to
the Xoft acquisition, offset by $1.1 million expense reduction due to an adjustment in the fair
value of contingent consideration related to the Xoft acquisition.
Interest (Expense)/Income. Net interest expense for the three month period ended June 30, 2011 was
$36,000 versus interest income of $21,000 in 2010, and expense of $62,000 in the six months ended
June 30, 2011 versus interest income of $39,000 in the six months ended June 30, 2010. Interest
expense is due primarily to the interest related to the Hologic Royalty obligation, offset by
interest income earned from our money market accounts.
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Liquidity and Capital Resources
We believe that our current liquidity and capital resources are sufficient to sustain operations
through at least the next 12 months, primarily due to cash on hand and projected cash generation
from continuing operations. Our ability to generate cash adequate to meet our future capital
requirements will depend primarily on operating cash flow. If sales or cash collections are
reduced from current expectations, or if expenses and cash requirements are increased, we may
require additional financing, although there are no guarantees that we will be able to obtain the
financing if necessary, on acceptable terms or at all.
As of June 30, 2011, the Company had current assets of $14.7 million, current liabilities of $12.7
million and working capital of $2.0 million. The ratio of current assets to current liabilities was
1.2:1.
Net cash used for operating activities for the six month period ended June 30, 2011 was $7.2
million, compared to net cash provided by operating activities of $824,000 for the six month period
ended June 30, 2010. The cash used for operating activities for the six months ended June 30, 2011
resulted from the net loss of $9.3 million, increases in accounts receivable and prepaid expense
totaling $644,000 and a decrease in accrued expenses of $1.3 million, which were partially offset
by the decrease in inventory of $1.1 million and an increase in deferred revenue of $774,000, plus
non-cash items including depreciation, amortization and loss on disposal of assets totaling $1.6
million and stock based compensation of $584,000. 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 June, 2011 was $1.4
million, which consisted of additions to property and equipment of $191,000 offset by the disposal
of patents, technology and other assets of $57,000 and $1.3 million of cash paid for the
acquisition of Xoft, compared to the additions to patents, technology and property and equipment
totaling $162,000 for the six months ended June 30, 2010.
Net cash used for financing activities for the six month period ended June 30, 2011 was $5,000
relating to taxes paid in connection with restricted stock issuances, compared to $37,000 relating
to taxes paid in connection with restricted stock issuances for the same period in 2010.
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Contractual Obligations
The following table summarizes, for the periods presented, our future estimated cash payments under
existing contractual obligations (in thousands).
Payments due by period | ||||||||||||||||||||
Less than 1 | ||||||||||||||||||||
Contractual Obligations | Total | year | 1-3 years | 3-5 years | 5+ years | |||||||||||||||
Lease Obligations |
$ | 1,535 | $ | 1,062 | $ | 473 | $ | | $ | | ||||||||||
Royalty Obligation |
$ | 1,492 | $ | 242 | $ | 750 | $ | 500 | $ | | ||||||||||
Total Contractual Obligations |
$ | 3,027 | $ | 1,304 | $ | 1,223 | $ | 500 | $ | | ||||||||||
Recent Accounting Pronouncements
See Note 9 to the Condensed Consolidated Financial Statements.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk
We believe we are not subject to material foreign currency exchange rate fluctuations, as
substantially all of our sales and expenses are 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
June 30, 2011, that have materially affected or which are reasonably likely to materially affect
internal control over financial reporting. Based on that evaluation, there has been no such change
during such period.
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PART II OTHER INFORMATION
Item 1. | Legal Proceedings |
On February 18, 2011, in the Orange County Superior Court (Docket No.
30-2011-00451816-CU-PL-CJC), named plaintiffs Jane Doe and John Doe filed a complaint
against Xoft, the Company, and Hoag Memorial Hospital Presbyterian asserting causes of
action for general negligence, breach of warranty, and strict liability and seeking
unlimited damages in excess of $25,000. On March 2, 2011, the Company received a Statement
of Damages specifying that the damages being sought aggregated an amount of at least
approximately $14.5 million. On April 6, 2011, plaintiffs Jane Doe and John Doe amended
their complaint alleging only medical malpractice against Hoag Memorial Hospital
Presbyterian. On April 8, 2011, another complaint was filed in the Orange County Superior
Court (Docket No. 30-2011 00465448-CU-MM-CJC) on behalf of four additional Jane Doe
plaintiffs and two John Doe spouses with identical allegations against the same defendants.
On April 19, 2011, a sixth Jane Doe plaintiff filed an identical complaint in the Orange
County Superior Court (Docket No. 30-2011-00468687-CU-MM-CJC), and on May 4, 2011, a seventh
Jane Doe and John Doe spouse filed another complaint in the Orange County Superior Court
(Docket No. 30-2011-00473120-CU-PO-CJC), again with identical allegations against the same
defendants. Court records indicate that two additional complaints have been filed in July
2011 in the Orange County Superior Court (Docket Nos. 30-2011-00491068-CU-PL-CJC and
30-2011-00491497-CU-PL-CJC) on behalf of two more Jane Doe plaintiffs and one John Doe
spouse.
It is alleged that each plaintiff Jane Doe was a patient who was treated with the Axxent
Electronic Brachytherapy System that incorporated the Axxent Flexishield Mini. The Company
believes that all of the Jane Doe plaintiffs 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 the Axxent Radiation Shield Rigid
which is an optional radiation shielding accessory to the Axxent Electronic Brachytherapy
System intended to protect tissue and/or organs from unwanted radiation. It is a rigid
stainless steel pad placed over the area requiring shielding. It can be used on external
patient surfaces, such as skin, as well internally during Intraoperative Radiation Therapy
(IORT). The Axxent Radiation Shield Rigid was cleared by FDA on July 22, 2011
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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.
Item 1A. | Risk Factors |
Our risk factors are described in Part I, Item 1A of our Annual Report on Form 10-K filed with the
SEC for the year ended December 31, 2010. There have been no material changes in the risks
affecting iCAD since the filing of our Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table represents information with respect to purchases of common stock made by the
Company during the three months ended June 30, 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 | ||||||||||||
April 1 - April 30, 2011 |
| $ | | $ | | $ | | |||||||||
May 1 - May 31, 2011 |
| $ | | $ | | $ | | |||||||||
June 1 - June 30, 2011 |
21,959 | $ | 1.13 | $ | | $ | | |||||||||
Total |
21,959 | $ | 1.13 | $ | | $ | | |||||||||
(1) | Represents shares of common stock surrendered by employees to the Company to pay
employee withholding taxes due upon the vesting of restricted stock. |
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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. |
|||
101 | The following materials formatted in XBRL (eXtensible Business Reporting Language); (i)
Consolidated Balance Sheets as of June 30, 2011 and December 31, 2010, (ii) Consolidated
Statements of Operations for the three and six months ended June 30, 2011 and 2010, (iii)
Consolidated Statements of Cash Flows for the three and six months ended June 30, 2011 and
2010, and (iv) Notes to Consolidated Financial Statements**. |
** | Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are
deemed not filed or part of a registration statement or prospectus for purposes of Sections 11
or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to
liability under those sections. |
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Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
iCAD, Inc.
(Registrant) |
||||
Date: August 4, 2011 | By: | /s/ Kenneth M. Ferry | ||
Kenneth M. Ferry | ||||
President, Chief Executive Officer, Director | ||||
Date: August 4, 2011 | By: | /s/ Kevin C. Burns | ||
Kevin C. Burns | ||||
Executive Vice President of Finance
and Chief Financial Officer, Treasurer |
32