ICAD INC - Quarter Report: 2010 March (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 March 31, 2010
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 o NO o.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
Large Accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act) YES o NO þ.
As of the close of business on May 3, 2010 there were 45,691,012 shares outstanding of the
registrant s Common Stock, $.01 par value.
iCAD, Inc.
INDEX
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PART I FINANCIAL INFORMATION |
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Item 1 Financial Statements |
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3 | ||||||||
4 | ||||||||
5 | ||||||||
611 | ||||||||
1217 | ||||||||
18 | ||||||||
18 | ||||||||
19 | ||||||||
19 | ||||||||
20 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
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iCAD, Inc.
Balance Sheets
(unaudited)
(unaudited)
March 31, | December 31, | |||||||
2010 | 2009 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 16,295,969 | $ | 16,248,031 | ||||
Trade accounts receivable, net of allowance for doubtful
accounts of $50,000 in 2010 and $84,000 in 2009 |
4,223,084 | 4,692,614 | ||||||
Inventory, net |
1,000,573 | 1,094,115 | ||||||
Prepaid expenses and other current assets |
457,378 | 393,490 | ||||||
Total current assets |
21,977,004 | 22,428,250 | ||||||
Property and equipment: |
||||||||
Equipment |
2,799,475 | 2,873,012 | ||||||
Leasehold improvements |
72,612 | 72,612 | ||||||
Furniture and fixtures |
344,700 | 344,700 | ||||||
Marketing assets |
292,613 | 292,613 | ||||||
3,509,400 | 3,582,937 | |||||||
Less accumulated depreciation and amortization |
2,672,156 | 2,661,083 | ||||||
Net property and equipment |
837,244 | 921,854 | ||||||
Other assets: |
||||||||
Deposits |
32,126 | 63,194 | ||||||
Patents, net of accumulated amortization |
98,510 | 90,027 | ||||||
Customer relationships, net of accumulated amortization |
192,236 | 200,407 | ||||||
Technology intangibles, net of accumulated amortization |
5,816,074 | 6,093,294 | ||||||
Tradename, net of accumulated amortization |
93,000 | 99,200 | ||||||
Goodwill |
43,515,285 | 43,515,285 | ||||||
Total other assets |
49,747,231 | 50,061,407 | ||||||
Total assets |
$ | 72,561,479 | $ | 73,411,511 | ||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,290,439 | $ | 1,365,558 | ||||
Accrued salaries and other expenses |
1,974,206 | 2,199,286 | ||||||
Deferred revenue |
3,226,603 | 3,139,567 | ||||||
Total current liabilities |
6,491,248 | 6,704,411 | ||||||
Long-term warranty expense |
21,235 | 23,275 | ||||||
Long-term deferred revenue |
446,978 | 375,183 | ||||||
Total liabilities |
6,959,461 | 7,102,869 | ||||||
Commitments and contingencies (Note 5) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $ .01 par value: authorized 1,000,000 shares;
issues and outstanding 0 in 2010 and 2009 |
| | ||||||
Common stock, $ .01 par value: authorized 85,000,000
shares; issued 45,758,888 in 2010 and 45,746,736 in 2009;
outstanding 45,691,012 in 2010 and 45,678,860 in 2009 |
457,589 | 457,467 | ||||||
Additional paid-in capital |
150,540,594 | 150,062,733 | ||||||
Accumulated deficit |
(84,445,901 | ) | (83,261,294 | ) | ||||
Treasury stock at cost (67,876 shares) |
(950,264 | ) | (950,264 | ) | ||||
Total stockholders equity |
65,602,018 | 66,308,642 | ||||||
Total liabilities and stockholders equity |
$ | 72,561,479 | $ | 73,411,511 | ||||
See accompanying notes to consolidated financial statements.
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iCAD, Inc.
Statements of Operations
(unaudited)
(unaudited)
Three Months Ended | Three Months Ended | |||||||
March 31, 2010 | March 31, 2009 | |||||||
Revenue |
||||||||
Products |
$ | 5,211,652 | $ | 6,339,620 | ||||
Service and supplies |
1,308,844 | 825,378 | ||||||
Total revenue |
6,520,496 | 7,164,998 | ||||||
Cost of revenue |
||||||||
Products |
667,480 | 1,054,987 | ||||||
Service and supplies |
180,105 | 201,817 | ||||||
Total cost of revenue |
847,585 | 1,256,804 | ||||||
Gross margin |
5,672,911 | 5,908,194 | ||||||
Operating expenses: |
||||||||
Engineering and product development |
1,556,126 | 2,161,215 | ||||||
Marketing and sales |
2,833,163 | 2,945,121 | ||||||
General and administrative |
2,486,245 | 1,835,311 | ||||||
Total operating expenses |
6,875,534 | 6,941,647 | ||||||
Loss from operations |
(1,202,623 | ) | (1,033,453 | ) | ||||
Interest income net |
18,016 | 34,926 | ||||||
Net loss |
$ | (1,184,607 | ) | $ | (998,527 | ) | ||
Net loss per share: |
||||||||
Basic and Diluted |
$ | (0.03 | ) | $ | (0.02 | ) | ||
Weighted average number of shares used in
computing loss per share: |
||||||||
Basic and diluted |
45,686,285 | 45,352,954 | ||||||
See accompanying notes to consolidated financial statements.
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iCAD, Inc.
Statements of Cash Flows
(unaudited)
(unaudited)
Three Months Ended | Three Months Ended | |||||||
March 31, 2010 | March 31, 2009 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (1,184,607 | ) | $ | (998,527 | ) | ||
Adjustments to reconcile net loss
to net cash provided by (used for) operating activities: |
||||||||
Depreciation |
125,770 | 215,871 | ||||||
Amortization |
291,590 | 291,480 | ||||||
Stock based compensation |
483,162 | 500,035 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
469,530 | 618,236 | ||||||
Inventory |
93,542 | 171,135 | ||||||
Prepaid expenses, other current assets and deposits |
(32,820 | ) | (47,655 | ) | ||||
Accounts payable |
(75,119 | ) | (467,290 | ) | ||||
Accrued salaries, warranty and other expenses |
(227,120 | ) | (736,318 | ) | ||||
Deferred revenue |
158,831 | 314,623 | ||||||
Total adjustments |
1,287,366 | 860,117 | ||||||
Net cash provided by (used for) operating activities |
102,759 | (138,410 | ) | |||||
Cash flows from investing activities: |
||||||||
Additions to patents, technology and other |
(8,482 | ) | | |||||
Additions to property and equipment |
(41,160 | ) | (98,368 | ) | ||||
Net cash used for investing activities |
(49,642 | ) | (98,368 | ) | ||||
Cash flows from financing activities: |
||||||||
Taxes paid related to restricted stock issuance |
(5,179 | ) | | |||||
Net cash used for financing activities |
(5,179 | ) | | |||||
Increase (decrease) in cash and equivalents |
47,938 | (236,778 | ) | |||||
Cash and equivalents, beginning of period |
16,248,031 | 13,115,715 | ||||||
Cash and equivalents, end of period |
$ | 16,295,969 | $ | 12,878,937 | ||||
See accompanying notes to consolidated financial statements.
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iCAD, Inc.
Notes to Financial Statements
(Unaudited)
(Unaudited)
March 31, 2010
(1) | Basis of Presentation and Significant Accounting Policies |
Reference should be made to iCAD, Inc.s (iCAD, Company, we, our or us) Annual
Report on Form 10-K for the year ended December 31, 2009 for a comprehensive summary of
significant accounting policies.
The accompanying consolidated financial statements of the Company have been prepared in
accordance with accounting principles generally accepted in the United States of America
(generally accepted accounting principles). In the opinion of management, these unaudited
interim consolidated financial statements reflect all adjustments, consisting of normal
recurring adjustments, necessary for a fair presentation of the financial position at March
31, 2010, the results of operations for the three month periods ended March 31, 2010 and
2009, and cash flows for the three month periods ended March 31, 2010 and 2009. Although
the Company believes that the disclosures in these financial statements are adequate to make
the information presented not misleading, certain information normally included in the
footnotes prepared in accordance with generally accepted accounting principles has been
omitted as permitted by the rules and regulations of the Securities and Exchange Commission
(SEC). The accompanying financial statements should be read in conjunction with the
audited financial statements and notes thereto included in the Companys Annual Report on
Form 10-K for the fiscal year ended December 31, 2009 filed with the SEC on March 23, 2010.
The results for the three month period ended March 31, 2010 are not necessarily indicative
of the results that may be expected for the fiscal year ending December 31, 2010, or any
future period. Interim period amounts are not necessarily indicative of the results of
operations for the full fiscal year.
In February 2010, the Financial Accounting Standards Board (FASB) issued ASU 2010-09,
Subsequent Events (Topic 855) Amendments to Certain Recognition and Disclosure
Requirements. ASU 2010-09 requires an entity that is an SEC filer to evaluate subsequent
events through the date that the financial statements are issued and removes the requirement
that an SEC filer disclose the date through which subsequent events have been evaluated.
ASC 2010-09 was effective upon issuance. The adoption of this standard had no effect on our
results of operation or our financial position.
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iCAD, Inc.
Notes to Financial Statements
(Unaudited)
March 31, 2010
Notes to Financial Statements
(Unaudited)
March 31, 2010
(2) | Net (Loss) Income per Common Share |
The Companys basic net (loss) income per share is computed by dividing net loss or income
by the weighted average number of shares of common stock outstanding for the period and, if
there are dilutive securities, diluted income per share is computed by including common
stock equivalents which includes shares issuable upon the exercise of stock options, net of
shares assumed to have been purchased with the proceeds, using the treasury stock method.
A summary of the Companys calculation of net (loss) per share is as follows:
Three Months | ||||||||
March 31, | ||||||||
2010 | 2009 | |||||||
Net loss |
$ | (1,184,607 | ) | $ | (998,527 | ) | ||
Basic shares used in the calculation of net (loss) per share |
45,686,285 | 45,352,954 | ||||||
Effect of dilutive securities: |
||||||||
Stock options |
| | ||||||
Restricted stock |
| | ||||||
Diluted shares used in the calculation of net loss per share |
45,686,285 | 45,352,954 | ||||||
Net loss per share basic |
$ | (0.03 | ) | $ | (0.02 | ) | ||
Net loss per share diluted |
$ | (0.03 | ) | $ | (0.02 | ) | ||
The following table summarizes the number of shares of common stock for securities that
were not included in the calculation of diluted net loss per share because such shares are
antidilutive: |
Three Months | ||||||||
March 31, | ||||||||
2010 | 2009 | |||||||
Stock options |
5,235,021 | 5,235,398 | ||||||
Stock warrants |
| 936,111 | ||||||
Restricted stock |
1,096,243 | 790,324 | ||||||
Total |
6,331,264 | 6,961,833 | ||||||
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iCAD, Inc.
Notes to Financial Statements
(Unaudited)
March 31, 2010
Notes to Financial Statements
(Unaudited)
March 31, 2010
(3) | Stock-Based Compensation |
The Company follows Financial Accounting Standards Board (FASB) Accounting Standards
Codification (ASC) Topic 718, Compensation Stock Compensation, (ASC 718), for all
share-based compensation that was not vested as of January 1, 2006. The Company adopted ASC
718 using a modified prospective application, as permitted under ASC 718. Accordingly, prior
period amounts have not been restated. Under this application, the Company is required to
record compensation expense for all awards granted after the date of adoption and for the
unvested portion of previously granted awards that remain outstanding at the date of
adoption.
The Company issued 75,899 stock options and 530,500 shares of restricted stock in the three
months ended March 31, 2010. The options granted during the first three months of 2010 had
a weighted average exercise price of $1.50 per share. The weighted average fair value of
options granted during this three month period was $0.58 per share and was estimated on the
grant date using the Black-Scholes option-pricing model with the following weighted average
assumptions: expected volatility of 65.58%, expected term of 3.5 years, risk-free interest
rate of 2.49%, and expected dividend yield of 0%. Expected volatility is based on peer group
volatility, also using the Companys historical volatility within the peer group. The
average expected life was calculated using the Companys historical average life. The
risk-free rate is based on the rate of U.S. Treasury zero-coupon issues with a remaining
term equal to the expected life of option grants. The Company recorded $483,162 for
share-based compensation in accordance with ASC 718 for the three months ended March 31,
2010.
For the same period in 2009, the Company issued 91,921 stock options. The Company did not
issue any shares of restricted stock during this three month period in 2009. The options
granted during the first three months of 2009 had a weighted average exercise price of $1.23
per share. The weighted average fair value of options granted during the three month period
ended March 31, 2009 was $0.46 per share and was estimated on the grant date using the
Black-Scholes option-pricing model with the following weighted average assumptions: expected
volatility of 62.8%, expected term of 3.5 years, risk-free interest rate of 1.65%, and
expected dividend yield of 0%. The Company recorded $500,035 for share-based compensation in
accordance with ASC 718 for the three months ended March 31, 2009.
As of March 31, 2010 there was approximately $1,991,800 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.
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iCAD, Inc.
Notes to Financial Statements
(Unaudited)
March 31, 2010
Notes to Financial Statements
(Unaudited)
March 31, 2010
(3) | Stock-Based Compensation (continued) |
The Companys aggregate intrinsic value of options outstanding at March 31, 2010 was
$147,775. The aggregate intrinsic value of restricted stock outstanding at March 31, 2010,
was $1,666,289.
(4) | Fair Value Measurements |
FASB ASC Topic 820, Fair Value Measurement and Disclosures, (ASC 820) defines fair
value, establishes a framework for measuring fair value under generally accepted accounting
principles and enhances disclosures about fair value measurements. Fair value is defined
under ASC 820 as the exchange price that would be received for an asset or paid to transfer
a liability (an exit price) in the principal or most advantageous market for the asset or
liability in an orderly transaction between market participants on the measurement date.
Valuation techniques used to measure fair value under ASC 820 must maximize the use of
observable inputs and minimize the use of unobservable inputs. The standard describes a fair
value hierarchy based on three levels of inputs, of which the first two are considered
observable and the last unobservable, that may be used to measure fair value which are the
following:
| Level 1 Quoted prices in active markets for identical assets or liabilities. |
| Level 2 Inputs other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or liabilities; quoted prices
in markets that are not active; or other inputs that are observable or can be
corroborated by observable market data for substantially the full term of the
assets or liabilities. |
| Level 3 Unobservable inputs that are supported by little or no market activity
and that are significant to the fair value |
A financial instruments level within the fair value hierarchy is based on the lowest level
of any input that is significant to the fair value measurement.
In accordance with ASC 820, the Companys financial assets that are measured at fair value
on a recurring basis as of March 31, 2010 are cash equivalents. The cash equivalents are
measured using level one inputs.
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iCAD, Inc.
Notes to Financial Statements
(Unaudited)
March 31, 2010
Notes to Financial Statements
(Unaudited)
March 31, 2010
(5) | Commitments and Contingencies |
In July 2007, a dissolved former Canadian subsidiary of the Company, CADx Medical Systems
Inc. (CADx Medical), received a tax re-assessment of approximately $6,800,000 from the
Canada Revenue Agency (CRA) resulting from CRAs audit of CADx Medicals Canadian federal
tax return for the year ended December 31, 2002. In February 2010 the CRA reviewed the
matter and reduced the tax re-assessment to approximately $703,000, excluding interest and
penalties. The Company believes that it is not liable for the re-assessment against CADx
Medical and no accrual was recorded as of March 31, 2010.
(6) | Income Taxes |
At March 31, 2010, the Company had no material unrecognized tax benefits and no adjustments
to liabilities or operations were required under ASC 740, Income Taxes". The Company does
not expect that the unrecognized tax benefits will materially increase within the next
twelve months. The Company did not recognize any interest or penalties related to uncertain
tax positions at March 31, 2010. The Company files United States federal income tax returns
and income tax returns in various states and local jurisdictions. The Company currently is
not under examination by the Internal Revenue Service or other jurisdictions for any tax
years. The effective income tax rate is based upon the estimated income for the year.
(7) | 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.
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iCAD, Inc.
Notes to Financial Statements
(Unaudited)
March 31, 2010
Notes to Financial Statements
(Unaudited)
March 31, 2010
(7) | Goodwill (continued) |
The Companys goodwill arose in connection with its acquisitions in June 2002 and in
December 2003. The Company operates in one segment and as one reporting unit since its
products perform the same basic function, have common sales channels and resellers, and are
developed and supported by one central staff. Therefore, the Company uses market
capitalization as the best evidence of fair value (market capitalization is calculated using
the quoted closing share price of the Companys common stock at its annual impairment date
of October 1, multiplied by the number of common shares outstanding) of the Company. The
Company tests goodwill for impairment by comparing its market capitalization (fair value) to
its carrying value. The fair value of the Company is compared to the carrying amount at the
same date as the basis to determine if an impairment exists. The Company performed the step
one fair value comparison as of October 1, 2009 and the Companys market capitalization
exceeded its carrying value. At March 31, 2010, the Companys market capitalization exceeded
its carrying value.
(8) | Recent Accounting Pronouncements |
In September 2009, the FASB issued Update No. 2009-13, Multiple-Deliverable Revenue
Arrangementsa consensus of the FASB Emerging Issues Task Force (ASU 2009-13). It updates
the existing multiple-element revenue arrangements guidance currently included under ASC
605-25, which originated primarily from the guidance in Emerging Issues Task Force (EITF)
Issue No. 00-21, Revenue Arrangements with Multiple Deliverables (EITF 00-21). The
revised guidance primarily provides two significant changes: 1) eliminates the need for
objective and reliable evidence of the fair value for the undelivered element in order for a
delivered item to be treated as a separate unit of accounting, and 2) eliminates the
residual method to allocate the arrangement consideration. In addition, the guidance also
expands the disclosure requirements for revenue recognition. ASU 2009-13 will be effective
for the first annual reporting period beginning on or after June 15, 2010, with early
adoption permitted provided that the revised guidance is retroactively applied to the
beginning of the year of adoption. The Company is currently assessing the future impact of
this new accounting update to its consolidated financial statements.
Effective January 1, 2009, the Company adopted guidance now codified as FASB ASC Topic 805,
Business Combinations (ASC 805). This topic requires an acquirer to recognize and
measure the identifiable assets acquired, the liabilities assumed, and any non-controlling
interest in the acquiree at their fair values as of the acquisition date. The topic requires
acquisition costs and any restructuring costs associated with the business combination to be
recognized separately from the fair value of the business combination. ASC 805 establishes
requirements for recognizing and measuring goodwill acquired in the business combination or
a gain from a bargain purchase as well as disclosure requirements
designed to enable users to better interpret the results of the business combination. Early
adoption of this topic was not permitted. The adoption of ASC 805 will impact the Companys
financial position, results of operations and cash flows to the extent it conducts
acquisition-related activities and/or consummates business combinations. In the first
quarter of 2010, the Company recorded expenses of approximately $681,000 related to a
potential acquisition that was not consummated.
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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 and similar expressions
identify forward-looking statements. Readers are cautioned not to place undue reliance on those
forward-looking statements, which speak only as of the date the statement was made.
Results of Operations
Overview
iCAD is an industry-leading provider of advanced image analysis and workflow solutions that enable
radiologists and other healthcare professionals to better serve patients by identifying pathologies
and pinpointing cancer earlier. iCAD offers a comprehensive range of high-performance, expandable
Computer-Aided Detection (CAD) systems and workflow solutions for mammography (film-based, digital
radiography (DR) and computed radiography (CR), Magnetic Resonance Imaging (MRI), and Computed
Tomography (CT)). iCADs solutions aid in the early detection of the most prevalent cancers
including breast, prostate and colon cancer. Early detection of cancer is the key to better
prognosis, less invasive and lower treatment costs, and higher survival rates. Performed as an
adjunct to mammography screening, CAD has quickly become the standard of care in breast cancer
detection, helping radiologists improve clinical outcomes while enhancing workflow.
Computer-enhanced breast and prostate MRI analysis streamlines case interpretation workflow and
generates more robust information for more effective patient treatment. CAD for mammography
screening is also reimbursable in the U.S. under federal and most third-party insurance programs.
Since receiving approval from the U.S. Food and Drug Administration (FDA) for the Companys first
breast cancer detection product in January 2002, over thirty five hundred of iCADs CAD systems
have been placed in mammography practices worldwide. iCAD is the only stand alone company offering
CAD solutions for the early detection of breast cancer.
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iCADs CAD mammography products have been shown to detect up to 72 percent of the cancers that
biopsy proved were missed on the previous mammogram, an average of 15 months earlier.
Our advanced pattern recognition technology analyzes images to identify patterns and then uses
sophisticated mathematical analysis to mark suspicious areas.
The Companys CAD systems include proprietary algorithm and other technology together with standard
computer and display equipment. CAD systems for the film-based analog mammography market also
include a radiographic film digitizer, either manufactured by the Company or others for the
digitization of film-based medical images.
The Company intends to apply its core competencies in pattern recognition and algorithm development
in disease detection to its future product development efforts. Its focus is on the development and
marketing of cancer detection products for disease states where there are established or emerging
protocols for screening as a standard of care. iCAD expects to pursue development or acquisition
of products for select disease states that demonstrate one or more of the following: it is
clinically proven that screening has a significant positive impact on patient outcomes, where there
is an opportunity to lower health care costs, where screening is non-invasive or minimally invasive
and where public awareness is high. The Company also intends to pursue opportunities beyond CAD
through possible strategic acquisitions as part of its growth strategy, as such the Company
continues to actively evaluate strategic opportunities in adjacent markets that could leverage its
opportunities for growth beyond its historic core markets.
iCAD is applying 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 is developing a CTC CAD solution. Virtual
colonoscopy (CTC) is a technology that has evolved rapidly in recent years. Based on the results
of the National CT Colonography trial, the Company expects that the market for virtual colonoscopy
will grow along with the procedures for early detection of colon cancer. This trial demonstrated
that CTC is highly accurate for the detection of intermediate and large polyps and that the
accuracy of CTC is similar to a colonoscopy. CT Colonography or CTC is emerging as an alternative
imaging procedure for evaluation of the colon. The Company has developed VeralookÔ, a product
for computer aided detection of polyps in the colon using CTC and completed the clinical testing of
its CTC CAD product in the first quarter of 2009. The Company filed a 510(k) application with the
FDA in the second quarter of 2009 seeking FDA approval to market Veralook in the U.S. 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 Companys headquarters are located in Nashua, New Hampshire, with manufacturing and contract
manufacturing facilities in New Hampshire and Massachusetts and a research and development facility
in Ohio.
Critical Accounting Policies
The Companys discussion and analysis of its financial condition, results of operations, and cash
flows are based on the Companys consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States of America. The
preparation of these financial statements requires us to make estimates and judgments that affect
the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of
contingent assets and liabilities. On an on-going basis, we evaluate these estimates, including
those related to accounts receivable allowance, inventory valuation and obsolescence, intangible
assets, income taxes, warranty obligations, contingencies and litigation. Additionally, the Company
uses assumptions and estimates in calculations to determine stock-based compensation. The Company
bases its estimates on historical experience and on various other assumptions that it believes to
be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates under different assumptions or conditions.
The Companys critical accounting policies are set forth in its Annual Report on Form 10-K for the
fiscal year ended December 31, 2009. The Company believes that revenue recognition is a critical
accounting policy because it is governed by multiple complex accounting rules; however, there are
no significant estimates or assumptions used in recording the Companys revenue.
Quarter Ended March 31, 2010 compared to Quarter Ended March 31, 2009
Revenue. Total revenue for the three month period ended March 31, 2010 was $6,520,496 compared with
revenue of $7,164,998 for the three month period ended March 31, 2009, for a decrease of $644,502
or 9.0%. The decrease in revenue for the three month period ended March 31, 2010 was due primarily
to the decrease in digital and MRI CAD and film-based CAD revenue partially offset by an increase
in service and supply revenue.
The Companys digital and MRI CAD revenue for the three month period ended March 31, 2010 decreased
$611,839 or 12.8%, to $4,165,282 compared to sales of $4,777,121 in the same period of 2009. This
decrease is due primarily to soft demand for Full Field Digital Mammography (FFDM) systems and
digital CAD technology for the detection of breast cancer, somewhat offset by sales of the
Companys newer MRI CAD products. The Company believes that the softening of the digital
mammography market is temporary due to current economic conditions and deferred hospital spending,
as nearly 40% of the U.S. market has not yet converted to digital technology.
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Revenue from iCADs film based products decreased 33.0% or $516,129, to $1,046,370 in the first
quarter of 2010 compared to $1,562,499 in the first quarter of 2009. 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 the
Companys TotalLook MammoAdvantage. The TotalLook MammoAdvantage product is used for digitizing
film based prior mammography exams for comparative reading and is sold to further optimize workflow
in a digital mammography environment. The TotalLook MammoAdvantage product is typically sold as
sites are preparing to go digital. In addition, and as expected, the demand for film-based
products and accessories continue to decline as the marketplace continues to transition to digital
technologies. The Company believes that the demand for the TotalLook MammoAdvantage will grow as
the economy and hospital spending improves and the ongoing transition to digital mammography
continues.
Service and supply revenue increased 58.6% or $483,466 in the first quarter of 2010, to $1,308,844
compared to $825,378 in the first quarter in 2009. The increase in the Companys service and
supply revenue is due primarily to increased service contract revenue on the Companys growing
installed base of products as customers migrate from warranty to service contracts. Service
contract revenue represented 89% and 94% of the Companys total service and supply revenue for 2010
and 2009, respectively.
The table below presents the revenue attributable to different product and service, in 2010 and
2009:
Three months ended March 31, | ||||||||||||||||
2010 | 2009 | Change | % Change | |||||||||||||
Digital & MRI revenue |
$ | 4,165,282 | $ | 4,777,121 | $ | (611,839 | ) | -12.8 | % | |||||||
Film based revenue |
1,046,370 | 1,562,499 | (516,129 | ) | -33.0 | % | ||||||||||
Service & supply revenue |
1,308,844 | 825,378 | 483,466 | 58.6 | % | |||||||||||
Total revenue |
$ | 6,520,496 | $ | 7,164,998 | $ | (644,502 | ) | -9.0 | % | |||||||
Gross Margin. Gross margin increased to 87.0% for the three month period ended March 31, 2010
compared to 82.5% in the same three month period in 2009. The increase in total gross margin is
primarily attributable to cost reduction efforts, the realization of some average selling price
increases, component cost reductions and lower repair costs related to service contracts on a
growing installed base of digital products and the new TotalLook MammoAdvantage product. Gross
margin on product revenue increased to 87.2% for the three months ended March 31, 2010 compared to
83.4% in the same period in 2009. Gross margin on service and supply revenue increased to 86.2% for
the three month period ended March 31, 2010 compared to 75.5% in the same three month period in
2009.
Engineering and Product Development. Engineering and product development costs for the three month
period ended March 31, 2010 decreased by $605,089 or 28.0%, from $2,161,215 in 2009 to $1,556,126
in 2010. The decrease in engineering and product development costs was primarily due to $335,000 in
subcontracting services relating to the licensing and clinical trial costs for the Companys CT
Colon product which was completed in the first quarter of 2009, decreases in personnel and related
costs of $181,000, resulting from staff reductions, $44,000 in legal expenses, $33,000 in bonus
accruals and decreases in various other expenses totaling $12,000.
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Marketing and Sales. Marketing and sales expense for the three month period ended March 31, 2010
decreased by $111,958 or 3.8%, from $2,945,121 in 2009 to $2,833,163 in 2010. The decrease in
marketing and sales expense for the three month period ended March 31, 2010, primarily resulted
from decreases in advertising, promotional and consulting services totaling $196,000. These
decreases in marketing and sales expenses were offset by an increase of $56,000 in travel expense
and $28,000 related to the Company sponsored MRI educational seminars.
General and Administrative. General and administrative expenses for the three month period ended
March 31, 2010 increased by $649,684 or 35.4%, from $1,835,311 in 2009 to $2,484,995 in 2010. The
increase in general and administrative expense during the first quarter of 2010 was due primarily
to legal and professional fees of $681,000, associated with a potential acquisition that was not
consummated. This increase in general and administrative expenses was offset by decreases in
consulting, legal, and various other administrative expenses totaling $31,000.
Interest Income/Expense. Net interest income for the three month period ended March 31, 2010
decreased by $16,910, from $34,926 in the first quarter of 2009 to $18,016 in the same period of
2010. The decrease in interest income is due primarily to the reduction of the interest rate
earned from the Companys money market accounts.
Net Loss. As a result of the foregoing, the Company recorded a net loss of ($1,184,607)
or ($0.03) per share for the three month period ended March 31, 2010 on revenue of $6,520,496,
compared to a net loss of ($998,527) or ($0.02) per share on revenue of $7,164,998 for the three
months ended March 31, 2009.
Backlog. The Companys product backlog (excluding service and supplies) as of March 31, 2010
totaled approximately $762,000 as compared to $714,000 as of March 31, 2009 and $958,000 at
December 31, 2009. It is expected that the majority of the backlog at March 31, 2010 will be
shipped within the current fiscal year. Backlog as of any particular period should not be relied
upon as indicative of the Companys net revenues for any future period as a large amount of the
Companys product is booked and shipped within the same quarter.
Liquidity and Capital Resources
The Company believes that its current liquidity and capital resources are sufficient to sustain
operations through at least the next 12 months, primarily due to cash on hand and projected cash
balances from continuing operations. The Companys ability to generate cash adequate to meet its
future capital requirements will depend primarily on operating cash flow. If sales or cash
collections are reduced from current expectations, or if expenses and cash requirements are
increased, the Company may require additional financing, although there are no guarantees that the
Company will be able to obtain the financing if necessary. We will continue to closely monitor our
liquidity and the capital and credit markets.
At March 31, 2010, the Company had current assets of $21,977,004, current liabilities of $6,491,248
and working capital of $15,485,756. The ratio of current assets to current liabilities was 3.4:1.
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Net cash provided by operating activities for the three months ended March 31, 2010 was $102,759,
compared to net cash used for operating activities of $138,410 for the same period in 2009. The
cash provided by operating activities for the three months ended March 31, 2010 resulted from
decreases in accounts receivable of $469,530, inventory of $93,542 and deferred revenue of
$158,831, plus non-cash items including depreciation and amortization totaling $417,360 and stock
based compensation of $483,162, which were offset by the net loss of $1,184,607, an increase in
prepaid expenses, other current assets and deposits of $32,820, and decreases in accounts payable
of $75,119 and accrued expenses of $227,120.
The net cash used for investing activities for the three months ended March 31, 2010 was $49,642,
which consisted of additions to patents, technology and other assets of $8,482 and additions to
property and equipment of $41,160, compared to $98,368 in additions to property and equipment for
the three months ended March 31, 2009.
Net cash used for financing activities for the three months ended March 31, 2010 was $5,179
relating to taxes paid at restricted stock issuance, compared to $0 for the same period in 2009.
Contractual Obligations
The following table summarizes, for the periods presented, the Companys future estimated cash
payments under existing contractual obligations.
Payments due by period | ||||||||||||||||||||
Less than 1 | ||||||||||||||||||||
Total | year | 1-3 years | 3-5 years | 5+ years | ||||||||||||||||
Lease Obligations* |
$ | 686,594 | $ | 394,274 | $ | 292,320 | $ | | $ | | ||||||||||
Total Contractual
Obligations |
$ | 686,594 | $ | 394,274 | $ | 292,320 | $ | | $ | | ||||||||||
* | The Companys lease obligations is shown net of sublease amounts. |
Recent Accounting Pronouncements
In September 2009, the FASB issued Update No. 2009-13, Multiple-Deliverable Revenue Arrangementsa
consensus of the FASB Emerging Issues Task Force (ASU 2009-13). It updates the existing
multiple-element revenue arrangements guidance currently included under ASC 605-25, which
originated primarily from the guidance in Emerging Issues Task Force (EITF) Issue No. 00-21,
Revenue Arrangements with Multiple Deliverables (EITF 00-21). The revised guidance primarily
provides two significant changes: 1) eliminates the need for objective and reliable evidence of the
fair value for the undelivered element in order for a delivered item to be treated as a separate
unit of accounting, and 2) eliminates the residual method to allocate the arrangement
consideration. In addition, the guidance also expands the disclosure requirements for revenue
recognition. ASU 2009-13 will be effective for the first annual reporting period beginning on or
after June 15, 2010, with early adoption permitted provided that the revised guidance is
retroactively applied to the beginning of the year of adoption. The Company is currently assessing
the future impact of this new accounting update to its consolidated financial statements.
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Effective January 1, 2009, the Company adopted guidance now codified as FASB ASC Topic 805,
Business Combinations (ASC 805). This topic requires an acquirer to recognize and measure the
identifiable assets acquired, the liabilities assumed, and any non-controlling interest in the
acquiree at their fair values as of the acquisition date. The topic requires acquisition costs and
any restructuring costs associated with the business combination to be recognized separately from
the fair value of the business combination. ASC 805 establishes requirements for recognizing and
measuring goodwill acquired in the business combination or a gain from a bargain purchase as well
as disclosure requirements designed to enable users to better interpret the results of the business
combination. Early adoption of this topic was not permitted. The adoption of ASC 805 will impact
the Companys financial position, results of operations and cash flows to the extent it conducts
acquisition-related activities and/or consummates business combinations. In the first quarter of
2010, the Company recorded expenses of approximately $681,000 related to a potential acquisition
that was not consummated.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
Item 4. Controls and Procedures
The Company, under the supervision and with the participation of its management, including its
principal executive officer and principal financial officer, evaluated the effectiveness of the
design and operation of its disclosure controls and procedures as of the end of the period covered
by this report. Based on this evaluation, the principal executive officer and principal financial
officer concluded that the Companys disclosure controls and procedures (as defined in Rule
13a-15(e) of the Securities Exchange Act of 1934 (Exchange Act)) were effective at the reasonable
level of assurance.
A control system, no matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. Further, the design of a
control system must reflect the fact that there are resource constraints, and the benefits of
controls must be considered relative to their costs. Because of the inherent limitations in all
control systems, no evaluation of controls can provide absolute assurance that all control issues
and instances of fraud, if any, within the Company have been detected. Because of the inherent
limitations in a cost-effective control system, misstatements due to error or fraud may occur and
not be detected. The Company conducts periodic evaluations to enhance, where necessary its
procedures and controls.
The Companys principal executive officer and principal financial officer conducted an evaluation
of the Companys internal control over financial reporting (as defined in Exchange Act Rule
13a-15(f)) to determine whether any changes in internal control over financial reporting occurred
during the quarter ended March 31, 2010, that have materially affected or which are reasonably
likely to materially affect internal control over financial reporting. Based on that evaluation,
there has been no such change during such period.
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PART II OTHER INFORMATION
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table represents information with respect to purchases of common stock made by the
Company during the three months ended March 31, 2010:
Total number of | Maximum dollar | |||||||||||||||
shares purchased | value of shares | |||||||||||||||
as part of | that may yet be | |||||||||||||||
Total number | Average | publicly | purchased under | |||||||||||||
of shares | price paid per | announced plans | the plans or | |||||||||||||
Month of purchase | purchased (1) | share | or programs | programs | ||||||||||||
January 1 - January 31, 2010 |
2,506 | $ | 1.45 | $ | | $ | | |||||||||
February 1 - February 28, 2010 |
| $ | | $ | | $ | | |||||||||
March 1 - March 31, 2010 |
1,088 | $ | 1.42 | $ | | $ | | |||||||||
Total |
3,594 | $ | 1.44 | $ | | $ | | |||||||||
(1) | Represents shares of common stock surrendered by employees to the Company to
pay employee withholding taxes due upon the vesting of restricted stock. |
Item 6. Exhibits
Exhibit No. | Description | |||
31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002. |
|||
31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002. |
|||
32.1 | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002. |
|||
32.2 | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002. |
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Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
iCAD, Inc.
(Registrant) |
||||
Date: May 7, 2010 | By: | /s/ Kenneth M. Ferry | ||
Kenneth M. Ferry | ||||
President, Chief Executive Officer, Director | ||||
Date: May 7, 2010 | By: | /s/ Darlene M. Deptula-Hicks | ||
Darlene M. Deptula-Hicks | ||||
Executive Vice President of Finance and Chief Financial Officer, Treasurer |
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