Form 10-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the fiscal year ended December 31, 2009
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-9341
iCAD, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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02-0377419 |
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(State or other jurisdiction
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(I.R.S. Employer Identification No.) |
of incorporation or organization)
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98 Spit Brook Road, Suite 100, Nashua, New Hampshire
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03062 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (603) 882-5200
Securities registered pursuant to Section 12(b) of the Act:
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Title of Class
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Name of each exchange on which registered |
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Common Stock, $.01 par value
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The Nasdaq Stock Market LLC |
Securities registered pursuant to Section 12 (g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of
the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or
Section 15(d) of the Act. Yes o No þ
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 if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is
not contained herein, and will not be contained, to the best of registrants knowledge, in
definitive proxy or information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large Accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Act). Yes o No þ
The aggregate market value of the voting stock held by non-affiliates of the registrant, based upon
the closing price for the registrants Common Stock on June 30, 2009 was $46,487,365. Shares of
voting stock held by each officer and director and by each person who, as of June 30, 2009, may be
deemed to have beneficially owned more than 10% of the outstanding voting stock have been excluded.
This determination of affiliate status is not necessarily a conclusive determination of affiliate
status for any other purpose.
As of March 15, 2010, the registrant had 45,688,767 shares of Common Stock outstanding.
Documents Incorporated by Reference: None.
TABLE OF CONTENTS
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
Certain information included in this report on Form 10-K 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 this report and
in the Companys other filings with the United States Securities and Exchange Commission (SEC).
The words believe, demonstrate, intend, expect, estimate, anticipate, likely, seek
and similar expressions identify forward-looking statements. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the date the statement
was made. Unless the context otherwise requires, the terms iCAD, Company, we, our and us
means iCAD, Inc. and any consolidated subsidiaries.
PART I
Item 1. Business.
General
iCAD was founded in 1984 as Howtek, Inc. (Howtek). Howtek developed, manufactured and marketed
digitizing systems, also referred to as scanners. The scanners converted printed, photographic and
other hard copy images to digital form for use in the graphic arts, photo finishing and medical
industries. In 1987 Howtek began development of its first scanner with the goals of delivering a
smaller, easier to use and less costly alternative to traditional scanners on the market at that
time. Howtek followed with a series of products further improving the quality of digital imaging
while reducing the price and complexity of digitizing systems.
In 2001, foreseeing a decline in the graphic arts and photo finishing industries, the Company
elected to focus its efforts solely on the medical imaging industry with increased product
offerings. This goal was advanced in June 2002 with the Companys acquisition of Intelligent
Systems Software, Inc. (ISSI), a privately held company based in Florida offering an approved
Computer-Aided Detection system (CAD) for breast cancer. In December 2003, the Company also
acquired Qualia Computing, Inc. (Qualia), a privately held company based in Ohio, and its
subsidiaries, including CADx Systems, Inc. (together CADx). These acquisitions brought together
two of the three companies with clearance by the United States Food and Drug Administration (FDA)
to market CAD solutions for breast cancer in the United States (U.S.).
2
Since that time the Company established itself as an industry-leading provider of CAD solutions for
mammography. iCAD offers a comprehensive range of high-performance upgradeable products for use
with mammography (digital radiography, computed radiography and film-based). These solutions
enable radiologists to better serve patients by identifying pathologies and pinpointing cancer
earlier. 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. Since iCAD received FDA clearance for its first breast
cancer detection product in January 2002, more than 3,500 iCAD systems have been placed in
healthcare sites worldwide.
iCAD is also 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. The Company
completed clinical testing of its CTC CAD product in the first quarter of 2009. A 510K premarket
notification was submitted to the FDA in May 2009 and the Company is waiting for a response from
the FDA.
In July 2008, iCAD expanded its portfolio of products with the acquisition of substantially all of
the assets of 3TP LLC, dba CAD Sciences (CAD Sciences). The technology acquired is a
pharmacokinetic based CAD technology that aids in the interpretation of contrast enhanced Magnetic
Resonance Imaging (MRI) images. This acquisition extended iCADs position beyond mammography CAD
and provided the Company with a portfolio of advanced image analysis and workflow solutions for the
early detection of some of the most prevalent cancers using digital mammography, MRI and Computed
Tomography (CT). iCAD believes that advances in MRI and CT are creating opportunities in the
medical imaging sector. There is also significant synergy regarding customer call points, providing
the iCAD sales team with additional products to sell.
Today the Company is an industry-leading provider of advanced medical image analysis and workflow
solutions. iCADs solutions aid the radiologist in the early detection of the most prevalent and
treatable cancers, including breast and prostate cancer, and the Company anticipates that its
future products will aid in the detection of colon and lung cancer.
The iCAD website is www.icadmed.com. At this website the following documents are available
at no charge: annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form
8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 (Exchange Act), as soon as reasonably practicable after the
Company electronically files such material with, or furnishes it to, the SEC. The information on
the website listed above, is not and should not be considered part of this annual report on Form
10-K and is not incorporated by reference in this document.
The Company is headquartered in Nashua, New Hampshire with its principal research and development
(R&D) center located in Beavercreek, Ohio. The satellite R&D office in White Plains, New York was
closed in 2009 as these functions were integrated into the Nashua office.
3
Strategy
The Company intends to continue the extension of its superior image analysis and clinical decision
support solutions for MRI and CT imaging. iCAD believes that advances in digital imaging
techniques should bolster its efforts to develop additional commercially viable CAD advanced image
analysis and workflow products. In the future, the Company expects to pursue the development of CAD
products for select disease states that demonstrate one or more of the following attributes: it is
clinically proven that screening has a significant impact on patient outcomes; there is an
opportunity to lower health care costs; screening is non-invasive or minimally invasive; and public
awareness of the disease is high or growing. The Company also intends to pursue opportunities
beyond CAD through possible strategic acquisitions as part of its growth strategy. The Company is
actively evaluating strategic opportunities in adjacent markets that could leverage its
opportunities for growth beyond its historic core markets.
The Company is currently applying its patented detection technology, pharmacokinetics, and
algorithms to products used to detect disease states where pattern recognition, image analysis, and
clinical efficiency play a pivotal role. For breast imaging, the Company is developing CAD
solutions for tomosynthesis (3-D mammography) and developing a next-generation of breast MRI CAD to
help radiologists find cancer earlier and work more efficiently. The Company believes that CAD for
tomosynthesis has the potential to help radiologists better detect cancer and manage the workflow
issues created by large 3D tomosynthesis datasets. The pharmacokinetics or second generation
kinetics technology complements iCADs core competency in morphology (anatomy) based CAD solutions
providing a platform for iCAD to produce next-generation MRI products delivering both kinetics and
morphology technology in a single CAD solution. For colorectal cancer screening, iCAD is developing
a CAD solution to help radiologists detect colonic polyps during their review of CTC exams.
The Company believes that CAD for prostate imaging is an emerging growth opportunity. Nearly one in
six men over age 40 is afflicted with prostate cancer in the U.S. and 10% of those cases are
expected to be fatal. Current standards for detecting prostate cancer are considered, by many
medical professionals, to be antiquated and subject to accuracy issues. The current Prostate
Specific Antigen blood test has a false negative rate approaching 15%, while only approximately 12%
of men with abnormal tests actually have cancer. Biopsies miss at least 20% of all malignancies and
underestimate the disease aggressiveness in up to 30% of men. Scientific evidence is growing that
advanced imaging technologies will improve early detection, eliminate unnecessary procedures, and
provide accurate image guidance for biopsies. Leaders from the medical field and academia are
urging the current Presidential administration, Congress, the National Institutes of Health and the
Department of Defense to increase federal funding for research into imaging technologies for less
invasive and more accurate diagnosis of prostate cancer. Workflow efficiencies and interpretation
benefits associated with MRI CAD are also being realized in the emerging area of prostate MRI.
4
The Company is also exploring the role of MRI CAD in the early monitoring of cancer treatment.
Today, monitoring of therapy is solely based on tumor size and the response is assessed after the
fact, often resulting in patients and payers having to deal with ineffective treatment. The
Company believes that an early-stage therapy monitoring solution that is simple and widely
available could result in more effective cancer treatment plans.
Network connectivity, clinical workflow and timely processing of patient information are critical
issues for radiology departments. Healthcare providers are working to stay competitive in a
healthcare environment experiencing significant budget constraints. iCAD expects to continue to
provide powerful and flexible Digital Imaging and Communication in Medicine (DICOM) connectivity
solutions. Seamless integration of image analysis solutions with leading image processing systems,
review workstations, and Picture Archiving and Communication Systems (PACS), from multiple
vendors, will remain a focal point of the Companys product development efforts. Simpler and
easier integration with existing clinical systems and connectivity benefits that support
tele-radiology and remote viewing also remain focal points of its product development efforts. The
Company expects to continue to deliver digital technology workflow advantages by improving the
efficiencies of key processes, from the ease in which radiologists can read and interpret studies
or images to the speed at which large image datasets are managed, and high-priority images are
processed through the system.
Existing Markets and Market Opportunities
Mammography CAD systems use sophisticated algorithms to analyze image data and mark suspicious
areas in the image that may indicate cancer. The locations of the abnormalities are marked in a
manner that allows the reader of the image to reference the same areas in the original mammogram
for further review. The intent of CAD is to aid in the detection of potential abnormalities for
the radiologist to review. After initially reviewing the case films or digital images, a
radiologist reviews the CAD results and subsequently re-examines suspicious areas that warrant a
second look before making a final interpretation of the study. The radiologist determines if a
clinically significant abnormality exists and whether further diagnostic evaluation is warranted.
As a medical imaging tool, CAD is most prevalent as an adjunct to mammography given the documented
success of CAD for detecting breast cancer.
Approximately 37 million mammograms were performed in the U.S. in 2009. Although mammography is the
most effective method for early detection of breast cancer; studies have shown that an estimated
20% or more of all breast cancers go undetected in the screening stage. More than half of the
cancers missed are due to observational errors. CAD, when used in conjunction with mammography,
has been proven to help reduce the risk of these observational errors by as much as 20%. Earlier
cancer detection typically leads to more effective, less invasive, and less costly treatment
options which ultimately should translate into improved patient survival rates. CAD as an adjunct
to mammography screening is reimbursable in the U.S. under federal and most third party insurance
programs. This reimbursement provides economic support for the acquisition of CAD products by
womens healthcare providers. Market growth has also been driven in recent years by the
introduction of full field digital mammography (FFDM) systems.
5
In the U.S., approximately 8,700 facilities (with approximately 12,700 mammography systems) were
certified to provide mammography screening in 2009. Historically, these centers have used
conventional film-based medical imaging technologies to capture and analyze breast images. Of the
8,700 certified facilities, to date approximately 60% have acquired FFDM systems. A FFDM system
generates a digital image eliminating film used in conventional mammography. The number of
facilities converting to digital mammography systems continues to grow and has been fueled by the
results reported in 2005 in the New England Journal of Medicine from the American College of
Radiology Imaging Networks (ACRIN) Digital Mammographic Imaging Screening Trial (DMIST). The
trial showed that there was no difference in accuracy between the two modalities for screening
asymptomatic women in general. But for three subgroups of women (which represent over 60% of the
population in the study), digital mammography performed better than film-based mammography.
While a double reading protocol is currently advocated as a standard of care in most European
countries this is not the case in the U.S.. Double reading requires substantially more resources,
which are often not available considering the shortage of mammographers across the country. In view
of the frequency of missed cancers and of the lack of resources for double reading as a standard of
care, CAD in combination with review by a single radiologist is an alternative to double reading of
mammography and may further reduce breast cancer mortality.
Based on the report published by Frost and Sullivan entitled 2007 European Womens Healthcare
Imaging Markets, breast cancer is one of the most prevalent forms of cancer and it is also
responsible for the most number of cancer-related deaths among women in the European Union (EU).
The number of expected cancer cases will continue to rise as the incidence of cancer increases
steeply with age and life expectancy. According to the European Parliamentary Group on Breast
Cancer, they expect approximately 269,000 new breast cancer cases will be reported and over 87,000
deaths per year. On average 1 out of every 10 women in the EU is expected to develop breast cancer
at some point in their life. As a result, most countries in Western Europe have or are planning to
implement mammography screening programs resulting in an expected increase in the number of
mammograms performed in the coming years.
Market Size and Share
The total CAD mammography market in the U.S. was projected to exceed $100 million in 2007 according
to a Millennium Research Group report. According to this same report, iCAD had 45% of the U.S.
digital mammography CAD market with Hologic, Inc. holding a 54% share. Frost and Sullivan projects
the CAD mammography market in the U.S. will reach $333.5 million in 2012.
In a Scientific Paper presented by Dr. Vijay Rao at the 2009 RSNA Meeting, Dr. Rao concluded that
radiologists have embraced CAD. The use of CAD has grown rapidly and in 2007 it was used in two
thirds of all screening mammograms and nearly half of all diagnostic mammograms performed in the
U.S.
6
Frost and Sullivan and IMV, a market research company, both reported historical increases and
foresee continuing growth in breast MRI exams as published in their 2008 reports. According to IMV,
the use of MRI in the management of breast cancer doubled from 314,000 to 645,000
procedures from 2003 to 2007. Frost and Sullivan predict volumes will heighten to 2.9M by 2014.
Confirma, Inc. (acquired by Merge Healthcare, Inc. in September 2009) and Invivo Corporation have
been and currently remain the market leaders in breast MRI CAD.
New Market Opportunities
Computed Tomography Applications and Colonic Polyp Detection
CT is a well-established and widely used imaging technology that has evolved rapidly over the last
few years. CT equipment is used to image cross-sectional slices of various parts of the human
body. When combined, these slices provide detailed volumetric representations of the imaged
areas. The use of multi-detectors in CT equipment has progressed in just a few years from 4 slices
to 8, 16, 64 slices and beyond, resulting in vastly improved image quality. The image quality
improvements resulting from the increased number of slices per procedure and greatly increased
imaging speeds have expanded the use of CT imaging in both the number of procedures performed as
well as the applications for which it is utilized. It was estimated by Frost and Sullivan that over
70 million CT procedures would be performed in 2006 in the U.S. alone with an installed base of
approximately 9,600 machines. While the increased number of cross sectional slices provides
important and valuable diagnostic information, it adds to the challenge of managing and
interpreting the large volume of data generated. The Company believes that the challenges in CT
imaging presents it with opportunities to provide automated image analysis and clinical decision
support solutions.
According to the American Cancer Society over 50,000 Americans will die from colon cancer and
140,000 people will be diagnosed with colon cancer in 2010. It is the second leading cause of
cancer deaths in spite of being highly preventable with early identification and removal of
colorectal polyps. Several techniques including optical colonoscopy, which involves visualizing the
inside of the colon with a specialized scope, exist for the early identification of polyps. More
than 82 million Americans are over age 50, the recommended age for colorectal cancer screening.
However, this technique remains highly under utilized with less than half of this population being
tested. This reluctance can be directly linked to patients general discomfort with the invasive
nature of this screening procedure.
Abundant research has been performed and CT techniques have evolved over more than a decade, to the
point where CTC, as it is performed today, has demonstrated itself as a valid and highly effective
screening tool for colorectal cancer. ACRINs large multi-center National CT Colonography Trial of
a screening population published in the September 18th, 2008 issue of the New England
Journal of Medicine demonstrated that CTC is highly accurate for the detection of intermediate and
large polyps and that the accuracy of CTC is similar to colonoscopy. In March of 2008, new
consensus guidelines for screening for colorectal cancer (CRC) were jointly issued by the
American Cancer Society (ACS), the American College of Radiology (ACR), and the U.S.
Multi-Society Task Force on CRC. The guidelines include recommendations for the use of CTC for CRC
screening. Most surveys of patients that have had both traditional colonoscopy and CTC have also
shown greater patient preference for CTC with most patients preferring continued CTC surveillance
over traditional colonoscopic surveillance. The Company believes that the ACRIN Study coupled with
the 2008 consensus guidelines for screening for
CRC are likely to increase the utilization of CTC.
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CTC is a less invasive technique than traditional colonoscopy for imaging the colon. CTC is
performed with standard CT imaging of the abdomen while the colon is distended after subjecting the
patient to a colon cleansing regimen. Specialized software from third party display workstation
and PACS vendors is then used to reconstruct and visualize the internal surface of the colon and
review the CT slices. The process of reading a CTC exam can be lengthy and tedious as the
interpreting physician is often required to traverse the entire length of the colon multiple times.
CAD technology can play an important role in improving the accuracy and efficiency of reading CTC
cases by automatically identifying potential polyps. CAD technology has been developed to aid
radiologists in their review of CTC images as a means of improving polyp detection. The Company
anticipates that CAD will become an important adjunct to CTC.
Three new insurance procedure codes for CTC were approved and become effective January 1, 2010. The
codes include: 74263 Screening CTC without contrast, 74261 Diagnostic CTC without contrast, and
74262 Diagnostic CTC with contrast. While screening CTC is not covered by Medicare, coverage
continues to increase with approximately half of the U.S. states providing coverage for CTC
screening and some of the private payers currently covering CTC screening include: CIGNA, Anthem
BCBS (15 states), Kaiser Permanente, Carefirst BCBS, Healthlink, Horizon BCBS (NJ), Oxford Health
Plans, Independence BC (PA), Physicians Plus of WI, BCBS Delaware, WPS Health Insurance (WI), BCBS
AR, United Healthcare, BCBS N.C., and BCBS Wellmark
Magnetic Resonance Imaging (MRI) Applications Breast and Prostate Cancer Detection
In addition to mammography and CT imaging modalities, the interpretation of MRI exams also benefits
from advanced image analysis and clinical decision support tools. Radiologists turn to MRI to
examine the soft tissues, blood vessels, and organs in the head, neck, chest, abdomen, and pelvis
to help them diagnose and monitor tumors, heart problems, liver diseases and other organs, such as
breast and prostate for possible links to cancer. 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.
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. The first breast MRI product received FDA clearance in 1991
for use as an adjunct to mammography. The ACS published new guidelines in the March/April 2007 CA:
A Cancer Journal of Clinicians, recommending that women at high risk for breast cancer augment
their annual mammogram with an annual breast MRI. The guidelines recommended MRI scans for women
with a lifetime risk of breast cancer of 20%-25% or greater, including women with a strong family
history of breast or ovarian cancer and women who were treated for Hodgkins disease. The ACR and
SBI endorsed these recommendations in their recommendations published in the Journal of the
American College of Radiology 2010;7:18-27.
8
The Prostate Specific Antigen (PSA) in conjunction with digital rectal examination (DRE) and
pathologic information from biopsies are what urologists and radiation oncologists have
traditionally used to determine the extent and expected behavior of prostate cancer, which may
affect 1 out of 6 men over the course of their lifetime. While commonly used, and recommended by
the American Urological Association, PSA tests can be unreliable and potentially misleading.
Accurate staging of the disease is one of the biggest challenges with prostate cancer. Of the
230,000 men who are diagnosed with prostate cancer every year in the U.S., most have slow-growing
tumors that likely will not lead to death or require invasive treatment, though the diagnosis does
cause patient anxiety and requires close monitoring. Only a small percentage of the 230,000 men
present with aggressive tumors, and the ACS estimated that the disease would kill 27,000 men in the
U.S. in 2009.
Those men who are diagnosed with a non-aggressive cancer will be periodically monitored through
repeat PSA, DRE and, at times, biopsies. This monitoring is referred to as watchful waiting or
active surveillance. The goal of this watchful waiting is to monitor the indolent cancer and catch
it at an early stage before it progresses to a more aggressive state. This will theoretically allow
patients better treatment options, but because the current tests have their faults (false
negatives) by the time the disease has been identified, treatment options may be limited to a
prostatectomy. This radical procedure creates numerous morbidities such as impotence, incontinence
as well as psychological issues. Advanced imaging tools such as MRI, may play an important role in
this population to allow earlier detection and allow more choices for treatment options.
With advanced diagnostic imaging tools, physicians can more accurately stage the severity of the
prostate cancer and minimize a patients exposure to unnecessary and painful biopsies. Prostate
biopsies are typically done following an elevated PSA, suspicious DRE, or both. These biopsies are
usually performed by an urologist under the assistance of a portable ultrasound system. Anywhere
from a dozen to 30 or more samples are taken from the prostate. More than 1.2 million men have
transrectal ultrasound (TRUS) biopsies each year in the U.S. and less than 15 percent come back
positive for cancer. This translates into roughly $2 billion in cost to the healthcare system, not
to mention the psychological implications for patients worried they may have a deadly form of the
disease.
Without an optimal visual picture of the prostate and surrounding area, biopsy exams are
essentially conducted blindly. This can result in cancerous lesions being missed and other
sections of the prostate unnecessarily oversampled. Oversampling causes the patient pain and can
even lead to impotence or incontinence.
Historically, imaging the prostate has presented a challenge because of the vascularity of the
organ coupled with its location deep within the abdominal/pelvic cavity. Now other options are
available that can provide more accurate imaging of the prostate gland, including MRI with dynamic
contrast enhancement (DCE). Similar to MRI for breast cancer, prostate DCE MRI provides a more
thorough diagnostic assessment, and improved staging of the disease. A necessary component to this
technology is CAD which uses advanced algorithms to assist radiologists in determining malignant
versus benign tumors and to pinpoint tumor location and size.
9
In the future, MRI imaging may have an expanded role in the management of prostate cancer patients,
particularly for management strategies involving active surveillance. As more men
consider watchful waiting or delaying active treatment of their cancer, advances in imaging will
help make these decisions easier, based more on solid science than on the assumption that a mans
prostate cancer is slow growing.
Products and Product Development
The table below presents the revenue and percentage of revenue attributable to our different
product and services, in 2009, 2008 and 2007:
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For the year ended December 31, |
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2009 |
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% |
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2008 |
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% |
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2007 |
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% |
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Digital & MRI CAD revenue |
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$ |
18,289,780 |
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65.1 |
% |
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$ |
26,735,782 |
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71.3 |
% |
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$ |
16,429,450 |
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61.7 |
% |
Film based revenue |
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5,795,703 |
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20.6 |
% |
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7,436,529 |
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19.8 |
% |
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6,768,846 |
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25.4 |
% |
Service & supply revenue |
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4,023,782 |
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14.3 |
% |
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3,319,237 |
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8.9 |
% |
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3,414,116 |
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12.8 |
% |
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Total revenue |
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$ |
28,109,265 |
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$ |
37,491,548 |
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$ |
26,612,412 |
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Advanced Image Analysis and Workflow Solutions in Breast Imaging (Mammography)
iCAD develops and markets a comprehensive range of high-performance CAD solutions for digital and
film-based mammography systems. iCADs SecondLook systems are based on sophisticated patented
algorithms that analyze the data; automatically identifying and marking suspicious regions in the
images. The system provides the radiologist with a second look which helps the radiologist
detect up to 72% of actionable missed cancers an average of 15 months earlier than screening
mammography alone. SecondLook detects and identifies suspicious masses and micro-calcifications
utilizing image processing, pattern recognition and artificial intelligence techniques. Knowledge
from thousands of mammography images are incorporated in these algorithms enabling the product to
distinguish between characteristics of cancerous and normal tissue. The result is earlier
detection of hard-to-find cancers, improved workflow for radiologists, and higher quality patient
care.
The current version of the SecondLook product delivers the highest CAD performance in the Companys
history and provides clinical and workflow enhancements by improving mass detection performance and
reducing the number of false positive CAD marks.
iCAD continues to develop CAD products for additional digital imaging (FFDM and computed
radiography) providers including the release of solutions for Agfa Corporation, Sectra Medical
Systems and Planmed in Europe at the end of 2008. The Company is currently developing the next
generation of SecondLook Digital CAD. Under development are advances in performance and lesion
metrics that provide insight into CADs decision making process. Developmental work continues with
PACS companies and iCAD is focused on developing new, more efficient ways of integrating CAD into
PACS review workstations to create a streamlined workflow for mammography and potentially other
specialties.
10
SecondLook Digital
SecondLook Digital (SLD) is designed to function with leading digital mammography systems (FFDM and
computed radiography) including systems sold by GE Healthcare, Siemens Medical, Hologic, Inc.,
Sectra Medical Systems, Philips, IMS Giotto, Agfa Corporation, and Planmed. The system enables
optimal workflow for high volume clinics and facilities reading studies locally or remotely. In
addition, iCAD received FDA approval for its CAD product for use with Fujis Computer Radiography
(CR) system in April 2008. iCAD believes it has strong development partnerships with leading
imaging providers. The algorithms in SecondLook Digital products have been fine-tuned and optimized
for each digital imaging provider based upon characteristics of their unique detectors.
SecondLook Digital is a computer server residing on a customers network that receives patient
studies from the imaging modality, performs CAD analysis and sends the CAD results to PACS and/or
review workstations. Workflow and efficiency are critical in digital imaging environments therefore
iCAD has developed flexible, powerful DICOM integration capabilities that enable SecondLook Digital
to integrate seamlessly with leading PACS archives and review workstations from multiple providers.
iCAD has worked with its OEM partners to ensure CAD results are integrated and easily viewed using
each review workstations graphical user interface. To further improve efficiency and clinical
efficacy, the most urgent or important patient studies can be prioritized and analyzed with CAD
first.
SecondLook 300 and SecondLook 200
The SecondLook 300 and SecondLook 200 products are powerful film-based CAD systems combining
patented Clinical Information System digitizer technology with industry-leading cancer detection
algorithms. The compact design of these SecondLook systems provides flexibility and convenience to
meet constrained space requirements. These systems install quickly on-site and are supported by
iCADs customer support and service teams. Flexible DICOM integration options enable customized
configurations with leading PACS and Radiology Information System (RIS) systems.
The SecondLook 200 is a CAD solution providing early, accurate cancer detection for use at smaller
facilities with lower case volumes. iCADs ClickCAD program offers an alternative
fee-per-procedure financing option for SecondLook 200 users, enabling facilities of all sizes to
provide the benefits of CAD to their patients.
As the mammography market continues to migrate to digital systems, demand for analog CAD systems
will also continue to shift to digital CAD solutions.
11
Products for Converting Mammography Films to Digital Images
TotalLook MammoAdvantage
The TotalLook MammoAdvantage (TLMA) system is iCADs second generation mammography specific
digitizer. TLMA provides a comprehensive film-to-digital solution making it easier for facilities
to transition from film to digital mammography. The product converts prior mammography films to
digital images delivering high resolution digitized images to meet the critical specifications
required for conversion of prior films. The TLMAs unique configurable image resolution settings
enable the digitized and newly acquired digital images to
be displayed at the same time. In moving to one review workstation for comparative review, users
experience improvements in workflow, productivity and reduced discomfort associated with switching
between a light box and a computer screen to view images. Results from a study (Full Field Digital
Mammography Interpretation with Prior Analog versus Prior Digitized Analog Mammograms: Time for
Interpretation) presented at the 2009 RSNA meeting demonstrated a 30% reduction in time for image
interpretation with digitized analog mammograms.
The TLMA provides flexible DICOM connectivity for seamless integration with leading review
workstations, PACS and RIS systems. Specialized image compression techniques reduce files sizes up
to 80%, minimizing long-term storage requirements.
Advanced Image Analysis and Workflow Solutions in MRI Imaging Breast and Prostate
SpectraLook and VividLook
iCADs breast and prostate MRI analysis solutions, SpectraLook and VividLook, provide radiologists
with more diagnostic information by creating colorized images based on signal changes defined by
tumor physiology. Innovative model-based algorithms provide radiologists with accurate, timely, and
efficient contrast kinetic assessment of lesions.
The Companys All Time Point (ATP) analysis is a next-generation algorithm that uses near
continuous data sampling versus solutions that use only three fixed time points, which may omit
critical data from the analysis. The ATP analysis is based on an advanced pharmacokinetic model
that calculates numerical values of key physiological parameters, allowing the user to assess the
different biological processes taking place in malignant versus benign tumors. These key
physiological markers can aid in the analysis of large MRI datasets.
CADvue
CADvue image review and analysis software facilitates the analysis of ATP colorized images and
quantitative data. The user can create standard and customized reports used by radiologists to
communicate time-sensitive breast and prostate MRI study results to referring physicians. The
reports provide detailed and comprehensive information used in the identification and analysis of
abnormalities in the breast or prostate.
Advanced Image Analysis and Workflow Solutions in CT Colonography
VeraLook
iCAD is currently engaged in the development of a CAD solution, VeraLook, to support detection of
colonic polyps in conjunction with CTC. iCAD believes that CAD for CTC is a natural extension of
iCADs core competencies in image analysis and image processing. The Company expects this system
will likely be offered in conjunction with third party display workstations and PACS vendors.
Field testing of the product was initiated in 2008 and iCAD executed an agreement with ACR Image
Metrix, a division of the American College of Radiology (ACR), to conduct a multi-reader clinical
study of iCADs CT Colon CAD product, for use with CTC. With this partnership, iCAD worked with ACR
Image Metrix to develop and execute a clinical study to support FDA approval of a CT Colon CAD
product. ACR Image Metrix was launched by the ACR to leverage their thirty years of experience in
conducting clinical research in part through ACRIN. Both ACR and ACRIN have a proven history in
developing trials that standardize the use of imaging technologies, image transmission and archive,
reduce the size and cost of trials and produce more reliable results.
12
Results of the Companys clinical study, Performance of Computer-Aided Detection with Computed
Tomographic Colonography in a Large Clinical Trial with 19 Readers and 100 Patients demonstrated
that reader sensitivity improved 5.5% for patients with both small and large polyps with use of
CAD. Use of CAD reduced specificity of readers by 2.5%. The clinical relevance of this CAD program
was improved reader performance while maintaining high reader specificity. iCAD submitted the
required 510K premarket notification clinical data to the FDA in May 2009 and is currently under
review at the FDA.
Sales and Marketing
iCADs products for digital mammography, SecondLook Digital CAD and TotalLook MammoAdvantage
digitizer solutions for comparative reading of prior films, are sold through its direct regional
sales organization in the U.S. as well as through its OEM partners, including GE Healthcare, Fuji
Medical Systems and Siemens Medical. In Europe, iCAD distributes its mammography CAD solutions
through its direct sales organization and OEM partners such as GE Healthcare, Siemens Medical,
Philips Healthcare, Agfa Corporation, Sectra Medical Systems, Planmed, Fuji Medical Systems, and
IMS Giotto.
The Companys products are marketed on the basis of their clinical superiority and their ability to
help radiologists detect more cancers earlier, while seamlessly integrating into the clinical
workflow of the radiologist. In 2009 the Company built on the branding campaign launched in 2008,
signifying its expansion beyond mammography CAD with the addition of MRI and CTC advanced image
analysis and clinical decision support solutions. As part of its marketing efforts, iCAD has
developed and executed a variety of public relations and local outreach programs with numerous iCAD
customers. Further investments were made in cultivating relationships with the leaders in breast,
colon, and prostate CAD at national trade shows, including hosting a physician advisory dinner held
at the Radiological Society of North American (RSNA) meeting in December 2009, where industry
leaders discussed the future of CAD in these modalities. Funding supported attendance at more
regional trade shows. The Company expanded and further enhanced its presence at the RSNA 2009 by
hosting dinners and meetings with medical professionals, while maintaining a presence in the booths
of the Companys OEM partners.
In 2009, iCAD invested in a series of educational initiatives and advocacy efforts to advance the
use of MRI technologies in the diagnosis and management of prostate cancer. Innovations in
Imaging was a series of seminars focused on how MRI combined with an advanced quantitative image
analysis solution (VividLook) can support improved prostate cancer management. The seminars, were
intended to provide clinicians with a better understanding of how this imaging protocol supports
improved patient care, as well as how to incorporate it into their own practices. The series
included two webinars and one live satellite symposium in the fourth quarter. All sessions received
overwhelming responses resulting in oversubscribed events.
13
iCAD established a strategic partnership with the AdMeTech Foundation, a non-profit organization
with a mission to end prostate cancer as a patient care crisis and socio-economic problem as part
of its advocacy campaign in 2009. The Company will be joining the Industrial Liaison Board of
AdMeTechs International Prostate MRI Working Group, which fosters dialogue between leading
physicians, prostate cancer advocacy groups and industry to facilitate important technological
breakthroughs to provide men with more accurate diagnostics for early detection and treatment of
prostate cancer.
AdMeTechs research program was recently funded by Telemedicine and Advanced Technologies Research
Center of the Department of Defense through a peer review process. AdMeTech has developed the
International Prostate MRI Working group, modeled on the Breast Cancer MRI Working group, to
expedite advancement of MRI and Magnetic Resonance Spectroscopy (MRS) technologies and their
integration with the treatment of prostate cancer. iCAD hosted the last meeting of the Group,
which took place on November 29, 2009 in Chicago. The Company is a member of the working group,
providing access to its VividLookprostate analysis software. This technology, currently available
worldwide, enhances prostate MRI images and helps radiologists distinguish benign from malignant
lesions.
Competition
The Company currently faces direct competition in its mammography CAD business from Hologic, Inc.
(which acquired R2 Technology, Inc. in July 2006). Imaging equipment manufacturers such as GE
Healthcare, Siemens Medical, Philips Medical Systems and other medical imaging equipment
manufacturers have explored the possibility of introducing their own versions of CAD and
comparative reading products into the market, but thus far have not had a significant impact in the
market. The Company believes that current regulatory requirements present a significant barrier to
entry into this market.
Merge Healthcare, Inc. (which acquired Confirma, Inc. in September 2009) and InVivo Corporation
(Philips) are the market leaders in breast MRI CAD. Both companies also offer prostate MRI CAD
solutions following iCADs lead in entering this market in the U.S. The Company believes that its
market leadership in mammography CAD and prostate education provides it with a competitive
advantage with the breast and prostate imaging communities.
The Companys CT Colon solution faces competition from the traditional imaging CT equipment
manufacturers, 3D Rendering and Analysis firms, as well as from emerging CAD companies. Siemens
Medical, GE Healthcare, and Philips Medical Systems currently offer or are in the process of
developing polyp detection products. The Company expects that these companies will offer a colonic
polyp detection solution as an advanced feature of their image management and display products
typically sold with their CT equipment. Medicsight has a commercial product available in Europe and
Asia. In January 2009, the FDA requested additional information from Medicsight on its Colon CAD
product that had been submitted to the FDA at the end of 2008.
14
iCAD operates in highly competitive and rapidly changing markets with competitive products
available from nationally and internationally recognized companies. Many of these competitors have
significantly greater financial, technical and human resources than iCAD and they are well
established in the healthcare market. In addition, some companies have developed or may develop
technologies or products that could compete with the products we manufacture and distribute or that
would render our products obsolete or noncompetitive. Moreover, competitors may achieve patent
protection, regulatory approval, or product commercialization prior to us that would limit our
ability to compete with them. These and other competitive pressures could have a material adverse
effect on the Companys business.
Manufacturing and Professional Services
The Companys products are manufactured and assembled for it by a contract manufacturer of medical
devices. The Companys manufacturing efforts are generally limited to purchasing and supply chain
management, planning/scheduling, manufacturing engineering, service repairs, quality assurance,
inventory management, and warehousing. Once the product has shipped, it is usually installed by
one of the Companys OEM partners at the customer site. When a product sale is taken direct from
the end customer by iCAD, the product is installed by iCAD personnel at the customer site.
iCADs Professional Services staff is comprised of a team of trained and specialized individuals
providing comprehensive product support on a pre-sales and post-sales basis. This includes
pre-sale product demonstrations, product installations, applications training, and call center
management (or technical support). The support center is the single point of contact for the
customer, providing remote diagnostics, troubleshooting, training, and service dispatch. Service
repair efforts are generally performed at the customer site by third party service organizations or
in the Companys repair depot by the Companys repair technicians.
Government Regulation
The Companys CAD systems are medical devices subject to extensive regulation by the FDA under the
Federal Food, Drug, and Cosmetic Act with potentially significant costs for compliance. The FDAs
regulations govern, among other things, product development, product testing, product labeling,
product storage, pre-market clearance or approval, advertising and promotion, and sales and
distribution. The Companys devices are subject to FDA clearance or approval before they can be
marketed in the U.S. and may be subject to additional regulatory approvals before they can be
marketed outside the U.S.. There is no guarantee that future products or product modifications will
receive the necessary approvals.
The FDAs Quality System Regulations require that the Companys operations follow extensive design,
testing, control, documentation and other quality assurance procedures during the manufacturing
process. The Company is subject to FDA regulations covering labeling regulations and adverse event
reporting including the FDAs general prohibition of promoting products for unapproved or off-label
uses.
15
The Companys manufacturing facilities are subject to periodic unannounced inspections by the FDA
and corresponding state agencies. Compliance with international regulatory authorities with
extensive regulatory requirements is also required. Failure to fully comply with applicable
regulations could result in the Company receiving warning letters, non-approvals, suspensions of
existing approvals, civil penalties and criminal fines, product seizures and recalls, operating
restrictions, injunctions, and criminal prosecution.
Additionally, in order to market and sell its CAD products in certain countries outside of the
U.S., the Company must obtain and maintain regulatory approvals and comply with the regulations of
each specific country. These regulations, including the requirements for approvals, and the time
required for regulatory review vary by country.
Intellectual Property
The Company primarily relies on a combination of patents, trade secrets and copyright law,
third-party and employee confidentiality agreements, and other protective measures to protect its
intellectual property rights pertaining to our products and technologies.
Currently, the Company has 27 issued patents covering its CAD and scanner technologies in the U.S.
expiring between 2018 and 2026. These patents help the Company maintain a proprietary position in
its markets. Additionally, the Company has 15 patent applications pending domestically, some of
which have been also filed internationally, and it plans to file additional domestic and foreign
patent applications when it believes such protection will benefit the Company. These patents and
patent applications relate to current and future uses of iCADs CAD and digitizer technologies and
products, including CAD for CT colon and lung and CAD for MRI breast and prostate. In June 2006,
the Company secured a non-exclusive patent license from the National Institute of Health which
relates broadly to CAD in colonography. The Company believes it has all the necessary licenses
from third parties for software and other technologies in its products.
Sources and Availability of Materials
The Company depends upon a limited number of suppliers and manufacturers for its products, and
certain components in its products may be available from a sole or limited number of suppliers.
The Companys products are generally either manufactured and assembled for it by a sole
manufacturer, by a limited number of manufacturers or assembled by it from supplies it obtains from
a limited number of suppliers. Critical components required to manufacture these products, whether
by outside manufacturers or directly, may be available from a sole or limited number of component
suppliers. The Company generally does not have long-term arrangements with any of its
manufacturers or suppliers. The loss of a sole or key manufacturer or supplier would impair its
ability to deliver products to customers in a timely manner and would adversely affect its sales
and operating results. The Companys business would be harmed if any of its manufacturers or
suppliers could not meet its quality and performance specifications and quantity and delivery
requirements.
16
Major Customers
In 2009 the Company had two major customers GE Healthcare and Fuji Medical Systems, which accounted
for $8,754,414 and $4,819,874 or 31% and 17% of the Companys revenues, respectively. The Companys
two major customers in 2008 were GE Healthcare and Fuji Medical Systems, which accounted for
$9,986,179 and $7,063,325 or 27% and 19% of the Companys revenues, respectively. During the year
ended December 31, 2007, the Company had one major customer GE Healthcare, which accounted for
$7,609,313 or 29% of the Companys revenues.
Engineering and Product Development
The Company spent $7,217,146, $7,121,334, and $4,504,000 on research and development activities
during the years ended December 2009, 2008 and 2007, respectively. The research and development
expenses for 2009 are primarily attributed to the increase in personnel and relating costs
resulting from staff increases from the acquisition of the assets of CAD Sciences, staff increases
in the quality and regulatory function and subcontracting services relating to the clinical testing
for our CT Colon product.
Employees
At March 15, 2010 the Company had 103 employees, 99 full-time and 4 part-time co-op employees, with
35 involved in sales and marketing, 28 in research and development, 25 in service, technical
support and operations functions, and 15 in administrative functions. None of the Companys
employees are represented by labor organizations. The Company believes its relations with its
employees are good.
Backlog
The Companys product backlog (excluding service and supplies) was approximately $856,000 at
December 31, 2009 as compared to $1,137,000 on the corresponding date in 2008 and $663,000 at
September 30, 2009. The Company expects that the majority of the backlog at December 31, 2009 will
be shipped within the 2010 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.
Environmental Protection
Compliance with federal, state and local provisions which have been enacted or adopted regulating
the discharge of materials into the environment, or otherwise relating to the protection of the
environment, has not had a material effect upon the capital expenditures, earnings (losses) and
competitive position of the Company.
17
Financial Geographic Information
The Company markets its products for digital mammography in the U.S. through its direct regional
sales organization as well as through its OEM partners, including GE Healthcare, Fuji Medical
Systems and Siemens Medical. Outside the U.S. the Company markets its products for digital
mammography generally through its OEM partners, GE Healthcare, Siemens Medical, Agfa Corporation,
Sectra Medical Systems, Planmed Oy, Fuji Medical Systems and IMS Giotto. Total export sales
increased to approximately $3,702,000 or 13% of sales in 2009 as compared to $2,930,000 or 8% of
total sales in 2008 and $2,655,000 or 10% of total sales in 2007.
The Companys principal concentration of export sales is in Europe, which accounted for 64% of the
Companys export sales in 2009, 61% of export sales in 2008, and 81% of export sales in 2007. Of
these sales 36% in 2009, 33% in 2008 and 70% in 2007 were in France. The balance of the export
sales in 2009 were primarily into Canada, Saudi Arabia and Spain.
Foreign Regulations
International sales of the Companys products are subject to foreign government regulation, the
requirements of which vary substantially from country to country. The time required to obtain
approval by a foreign country may be longer or shorter than that required for FDA approval, and the
requirements may differ. Obtaining and maintaining foreign regulatory approvals is an expensive
and time consuming process. The Company cannot be certain that it will be able to obtain the
necessary regulatory approvals timely or at all in any foreign country in which it plans to market
its CAD products, and if it fails to receive such approvals, its ability to generate revenue may be
significantly diminished.
Product Liability Insurance
The Company believes that it maintains appropriate product liability insurance with respect to its
products. The Company cannot be certain that with respect to its current or future products, such
insurance coverage will continue to be available on terms acceptable to the Company or that such
coverage will be adequate for liabilities that may actually be incurred.
Item 1A. Risk Factors.
We operate in a changing environment that involves numerous known and unknown risks and
uncertainties that could materially adversely affect our operations. The following highlights some
of the factors that have affected, and/or in the future could affect, our operations.
18
We have incurred significant losses from inception through 2009 and there can be no assurance that
we will be able to achieve and sustain future profitability.
We have incurred significant losses since our inception, much of which were attributable to our
former business lines. We incurred a net loss of $1,967,624 during the fiscal year ended
December 31, 2009. We may not be able to achieve profitability.
A limited number of customers account for a significant portion of our total revenues. The loss of
a principal customer could seriously hurt our business.
Our principal sales distribution channel for our digital products is through our OEM partners. Our
digital product revenue accounted for 65% and 71% of our total revenue for the years ended December
31, 2009 and 2008, respectively. In 2009 we had two major customers, GE Healthcare and Fuji
Medical Systems, with 31% and 17% of our revenues, respectively. A limited number of major
customers have in the past and may continue in the future to account for a significant portion of
our revenues. The loss of our relationships with principal customers or a decline in sales to
principal customers could materially adversely affect our business and operating results.
Disruptions in the capital and credit markets related to the current national and worldwide
financial crisis, which may continue indefinitely or intensify, could adversely affect our results
of operations, cash flows and financial condition, or those of our customers and suppliers.
The current disruptions in the capital and credit markets may continue indefinitely or intensify,
and adversely impact our results of operations, cash flows and financial condition, or those of our
customers and suppliers. Disruptions in the capital and credit markets as a result of uncertainty,
changing or increased regulation, reduced alternatives or failures of significant financial
institutions could adversely affect our access to liquidity needed to conduct or expand our
business, conduct acquisitions or make other discretionary investments. Such disruptions may also
adversely impact the capital needs of our customers and suppliers, which, in turn, could adversely
affect our results of operations, cash flow and financial condition.
Our business is dependent upon future market growth of full field digital mammography systems and
digital computer aided detection products as well as advanced image analysis and workflow solutions
for use with MRI and CT.
Our future business is substantially dependent on the continued growth in the market for full field
digital mammography systems and digital computer aided detection products as well as advanced image
analysis and workflow solutions for use with MRI and CT. The market for these products may not
continue to develop or may develop at a slower rate than we anticipate due to a variety of factors,
including, general economic conditions, delays in hospital spending for capital equipment, the
significant cost associated with the procurement of full field digital mammography systems and CAD
products and MRI and CT systems and the reliance on third party insurance reimbursement. In
addition we may not be able to successfully develop or obtain FDA clearance for our proposed
product.
19
If goodwill and/or other intangible assets that we have recorded in connection with our
acquisitions become impaired, we could have to take significant charges against earnings.
In connection with the accounting for our acquisitions we have recorded a significant amount of
goodwill and other intangible assets. Under current accounting guidelines, we must assess, at
least annually and potentially more frequently, whether the value of goodwill and other intangible
assets has been impaired. Any reduction or impairment of the value of goodwill or other intangible
assets will result in a charge against earnings which could materially adversely affect our
reported results of operations in future periods.
We may not be able to obtain regulatory approval for any of the other products that we may consider
developing.
We have received FDA approvals only for our currently offered CAD products. Before we are able to
commercialize any other product, we must obtain regulatory approvals for each indicated use for
that product. The process for satisfying these regulatory requirements is lengthy and costly and
will require us to comply with complex standards for research and development, clinical trials,
testing, manufacturing, quality control, labeling, and promotion of products. We may not be able
to obtain FDA or other required regulatory approval and market any further products we may develop
during the time we anticipate, or at all.
Our products and manufacturing facilities are subject to extensive regulation with potentially
significant costs for compliance.
Our CAD systems for the computer aided detection of cancer are medical devices subject to extensive
regulation by the FDA under the Federal Food, Drug, and Cosmetic Act. In addition, our
manufacturing operations are subject to FDA regulation and we are also subject to FDA regulations
covering labeling, adverse event reporting, and the FDAs general prohibition against promoting
products for unapproved or off-label uses.
Our failure to fully comply with applicable regulations could result in the issuance of warning
letters, non-approvals, suspensions of existing approvals, civil penalties and criminal fines,
product seizures and recalls, operating restrictions, injunctions, and criminal prosecution.
Moreover, unanticipated changes in existing regulatory requirements or adoption of new requirements
could increase our application, operating and compliance burdens and adversely affect our business,
financial condition and results of operations.
Sales of our CAD products in certain countries outside of the U.S. are also subject to extensive
regulatory approvals. Obtaining and maintaining foreign regulatory approvals is an expensive and
time consuming process. We cannot be certain that we will be able to obtain the necessary
regulatory approvals timely or at all in any foreign country in which we plan to market our CAD
products, and if we fail to receive such approvals, our ability to generate revenue may be
significantly diminished.
20
Our products may be recalled even after we have received FDA or other governmental approval or
clearance.
If the safety or efficacy of our products is called into question, the FDA and similar governmental
authorities in other countries may require us to recall our products, even if our product received
approval or clearance by the FDA or a similar governmental body. Such a recall would divert the
focus of our management and our financial resources and could materially and adversely affect our
reputation with customers and our financial condition and results of operations.
Our quarterly operating and financial results and our gross margins are likely to fluctuate
significantly in future periods.
Our quarterly and annual operating and financial results are difficult to predict and may fluctuate
significantly from period to period. Our revenues and results of operations may fluctuate as a
result of a variety of factors that are outside of our control including, but not limited to,
general economic conditions, the timing of orders from our OEM partners, our OEM partners ability
to manufacture and ship their digital mammography systems, our timely receipt by the FDA for the
clearance to market our products, our ability to timely engage other OEM partners for the sale of
our products, the timing of product enhancements and new product introductions by us or our
competitors, the pricing of our products, changes in customers budgets, competitive conditions and
the possible deferral of revenue under our revenue recognition policies.
We may need additional financing to implement our strategy and expand our business.
We may need additional debt or equity financing beyond any amounts generally available to us to
pursue our strategy and increase revenue or to finance our business. Any additional financing that
we need may not be available and, if available, may not be available on terms that are acceptable
to us. Our failure to obtain financing on a timely basis, or on economically favorable terms, could
prevent us from continuing our strategy or from responding to changing business or economic
conditions, and could cause us to experience difficulty in withstanding adverse operating results
or prevent us from competing effectively.
Changes in or non-reimbursement of procedures by Medicare or other third-party payers may adversely
affect our business.
In the U.S., Medicare and a number of commercial third-party payers provide reimbursements for the
use of CAD in connection with mammography screening and diagnostics. In the future, however, these
reimbursements may be unavailable, reduced or inadequate due to changes in applicable legislation
or regulations, changes in attitudes toward the use of mammograms for broad screening to detect
breast cancer or due to changes in the reimbursement policies of third-party payers. In 2006, the
Center for Medicare Services announced an approximately 10% reduction for mammography CAD
reimbursement beginning in 2007. We anticipate there is a risk of further reductions. As a
result, healthcare providers may be unwilling to purchase our CAD products or any of our future
products, which could significantly harm our business, financial condition and operating results.
21
With respect to our proposed CTC CAD solution, we believe that the ACRIN Study coupled with the
2008 consensus guidelines for screening for CRC are likely to increase the utilization of CTC. The
U.S. Centers for Medicare and Medicaid has initiated a National Coverage Determination process for
CTC. A favorable determination is likely to increase the utilization of virtual colonoscopy or CTC
while an unfavorable determination will likely not increase the utilization or increase the
utilization at a slower pace which could adversely affect our proposed
CTC CAD solution.
There is no guaranty that any of the products which we are developing or are contemplating
developing will become eligible for reimbursements or health insurance coverage at favorable rates
or even at all or maintain eligibility.
We cannot be certain of the future effectiveness of our internal controls over financial reporting
or the impact of the same on our operations or the market price for our common stock.
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, we are required to include in our Annual
Report on Form 10-K our assessment of the effectiveness of our internal controls over financial
reporting. We have dedicated a significant amount of time and resources to ensure compliance with
this legislation for the year ended December 31, 2009 and will continue to do so for future fiscal
periods. Although we believe that we currently have adequate internal control procedures in place,
we cannot be certain that future material changes to our internal controls over financial reporting
will be effective. If we cannot adequately maintain the effectiveness of our internal controls over
financial reporting, we might be subject to sanctions or investigation by regulatory authorities,
such as the SEC. Any such action could adversely affect our financial results and the market price
of our common stock.
Our business is subject to The Health Insurance Portability and Accountability Act of 1996, or
HIPAA, and changes to or violations of these regulations could negatively impact our revenues.
HIPAA mandates, among other things, the adoption of standards to enhance the efficiency and
simplify the administration of the nations healthcare system. HIPAA requires the U.S. Department
of Health and Human Services to adopt standards for electronic transactions and code sets for basic
healthcare transactions such as payment, eligibility and remittance advices, or transaction
standards, privacy of individually identifiable health information, or privacy standards,
security of individually identifiable health information, or security standards, electronic
signatures, as well as unique identifiers for providers, employers, health plans and individuals
and enforcement. Final regulations have been issued by DHHS for the privacy standards, certain of
the transaction standards and security standards.
As a covered entity, we are required to comply in our operations with these standards and are
subject to significant civil and criminal penalties for failure to do so. In addition, in
connection with providing services to customers that also are healthcare providers, we are required
to provide satisfactory written assurances to those customers that we will provide those services
in accordance with the privacy standards and security standards. HIPAA has and will require
significant and costly changes for us and others in the healthcare industry. Compliance with the
privacy standards became mandatory in April 2003 and compliance with the security standards became
mandatory in April 2005.
Like other businesses subject to HIPAA regulations, we cannot fully predict the total financial or
other impact of these regulations on us. The costs associated with our ongoing compliance could be
substantial, which could negatively impact our profitability.
22
The markets for many of our products are subject to changing technology.
The markets for many products we sell are subject to changing technology, new product introductions
and product enhancements, and evolving industry standards. The introduction or enhancement of
products embodying new technology or the emergence of new industry standards could render our
existing products obsolete or result in short product life cycles or our inability to sell our
products without offering a significant discount. Accordingly, our ability to compete is in part
dependent on our ability to continually offer enhanced and improved products.
We depend upon a limited number of suppliers and manufacturers for our products, and certain
components in our products may be available from a sole or limited number of suppliers.
Our products are generally either manufactured and assembled for us by a sole manufacturer, by a
limited number of manufacturers or assembled by us from supplies we obtain from a limited number of
suppliers. Critical components required to manufacture our products, whether by outside
manufacturers or directly by us, may be available from a sole or limited number of component
suppliers. We generally do not have long-term arrangements with any of our manufacturers or
suppliers. The loss of a sole or key manufacturer or supplier would impair our ability to deliver
products to our customers in a timely manner and would adversely affect our sales and operating
results. Our business would be harmed if any of our manufacturers or suppliers could not meet our
quality and performance specifications and quantity and delivery requirements.
We rely on intellectual property and proprietary rights to maintain our competitive position and
may not be able to protect these rights.
We rely heavily on proprietary technology that we protect primarily through licensing arrangements,
patents, trade secrets, proprietary know-how and non-disclosure agreements. There can be no
assurance that any pending or future patent applications will be granted or that any current or
future patents, regardless of whether we are an owner or a licensee of the patent, will not be
challenged, rendered unenforceable, invalidated, or circumvented or that the rights will provide a
competitive advantage to us. There can also be no assurance that our trade secrets or
non-disclosure agreements will provide meaningful protection of our proprietary information. There
can also be no assurance that others will not independently develop similar technologies or
duplicate any technology developed by us or that our technology will not infringe upon patents or
other rights owned by others.
In addition, in the future, we may be required to assert infringement claims against third parties,
and there can be no assurance that one or more parties will not assert infringement claims against
us. Any resulting litigation or proceeding could result in significant expense to us and divert the
efforts of our management personnel, whether or not such litigation or proceeding is determined in
our favor. In addition, to the extent that any of our intellectual property and proprietary rights
were ever deemed to violate the proprietary rights of others in any litigation or proceeding or as
a result of any claim, we may be prevented from using them, which could cause a termination of our
ability to sell our products. Litigation could also result in a judgment or monetary damages
being levied against us.
23
We may be exposed to significant product liability for which we may not be able to procure
sufficient insurance coverage.
Our business exposes us to potential product liability risks which are inherent in the testing,
manufacturing, marketing and sale of medical devices. If available at all, product liability
insurance for the medical device industry generally is expensive. Our product liability and general
liability insurance coverage may not be adequate for us to avoid or limit our liability exposure
and adequate insurance coverage may not be available in sufficient amounts or at a reasonable cost
in the future. In any event, extensive product liability claims could be costly to defend and/or
costly to resolve and could harm our reputation and business.
Our future prospects depend on our ability to retain current key employees and attract additional
qualified personnel.
Our success depends in large part on the continued service of our executive officers and other key
employees. We may not be able to retain the services of our executive officers and other key
employees. The loss of executive officers or other key personnel could have a material adverse
effect on us.
In addition, in order to support our continued growth, we will be required to effectively recruit,
develop and retain additional qualified personnel. If we are unable to attract and retain
additional necessary personnel, it could delay or hinder our plans for growth. Competition for such
personnel is intense, and there can be no assurance that we will be able to successfully attract,
assimilate or retain sufficiently qualified personnel. The failure to retain and attract necessary
personnel could have a material adverse effect on our business, financial condition and results of
operations.
We distribute our products in highly competitive markets.
We operate in highly competitive and rapidly changing markets that contain competitive products
available from nationally and internationally recognized companies. Many of these competitors have
significantly greater financial, technical and human resources than us and are well established. In
addition, some companies have developed or may develop technologies or products that could compete
with the products we manufacture and distribute or that would render our products obsolete or
noncompetitive. In addition, our competitors may achieve patent protection, regulatory approval, or
product commercialization that would limit our ability to compete with them. These and other
competitive pressures could have a material adverse effect on our business.
24
Our international operations expose us to various risks, any number of which could harm our
business.
During the past year our sales of product outside of the U.S. has increased. We are subject to the
risks inherent in conducting business across national boundaries, any one of which could adversely
impact
our business. In addition to currency fluctuations, these risks include, among other things:
economic downturns; changes in or interpretations of local law, governmental policy or regulation;
restrictions on the transfer of funds into or out of the country; varying tax systems; and
government protectionism. One or more of the foregoing factors could impair our current or future
operations and, as a result, harm our overall business.
We do not anticipate paying cash dividends on our common stock.
We have not paid cash dividends on our common stock in the past, and we do not intend to do so in
the foreseeable future. Any payment of dividends will be in the sole discretion of our Board of
Directors.
The market price of our common stock has been, and may continue to be, volatile which could reduce
the market price of our common stock.
The publicly traded shares of our common stock have experienced, and may experience in the future,
significant price and volume fluctuations. This market volatility could reduce the market price of
our common stock without regard to our operating performance. In addition, the trading price of
our common stock could change significantly in response to actual or anticipated variations in our
quarterly operating results, announcements by us or our competitors, factors affecting the medical
imaging industry generally, changes in national or regional economic conditions, changes in
securities analysts estimates for us or our competitors or industrys future performance or
general market conditions, making it more difficult for shares of our common stock to be sold at a
favorable price or at all. The market price of our common stock could also be reduced by general
market price declines or market volatility in the future or future declines or volatility in the
prices of stocks for companies in our industry.
Future sales of shares of our common stock may cause the prevailing market price of our shares to
decrease and could harm our ability to raise additional capital.
We have previously issued a substantial number of shares of common stock, which are eligible for
resale under Rule 144 of the Securities Act of 1933, and may become freely tradable. In addition,
shares of our common stock issued upon conversion of our convertible debt are also eligible for
sale under Rule 144. We have also registered shares that are issuable upon the exercise of
options. If holders of options choose to exercise their purchase rights and sell shares of common
stock in the public market, or if holders of currently restricted common stock or common stock
issued upon conversion of convertible debt choose to sell such shares of common stock in the public
market under Rule 144 or otherwise, or attempt to publicly sell such shares all at once or in a
short time period, the prevailing market price for our common stock may decline. The sale of shares
of common stock issued upon the exercise of our securities could also dilute the holdings of our
existing stockholders.
25
Provisions in our corporate charter and in Delaware law could make it more difficult for a third
party to acquire us, discourage a takeover and adversely affect existing stockholders.
Our certificate of incorporation authorizes the board of directors to issue up to 1,000,000 shares
of preferred stock. The preferred stock may be issued in one or more series, the terms of which
may be determined at the time of issuance by our Board of Directors, without further action by
stockholders, and may include, among other things, voting rights (including the right to vote as a
series on particular matters), preferences as to dividends and liquidation, conversion and
redemption rights, and sinking fund provisions. Although there are currently no shares of
preferred stock outstanding, future holders of preferred stock may have rights superior to our
common stock and such rights could also be used to restrict our ability to merge with, or sell our
assets to a third party.
We are also subject to the provisions of Section 203 of the Delaware General Corporation Law, which
could prevent us from engaging in a business combination with a 15% or greater stockholder for a
period of three years from the date such person acquired that status unless appropriate board or
stockholder approvals are obtained.
These provisions could deter unsolicited takeovers or delay or prevent changes in our control or
management, including transactions in which stockholders might otherwise receive a premium for
their shares over the then current market price. These provisions may also limit the ability of
stockholders to approve transactions that they may deem to be in their best interests.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
The Companys executive offices are leased pursuant to a five-year lease (the Lease) that
commenced on December 15, 2006, consisting of approximately 11,000 square feet of office space
located at 98 Spit Brook Road, Suite 100 in Nashua, New Hampshire (the Premises). The Lease also
provides for annual base rent of $161,568 for the first year; $187,272 for the second year;
$198,288 for the third year; $209,304 for the fourth year and $220,320 for the fifth year.
Additionally, the Company is required to pay its proportionate share of the building and real
estate tax expenses and obtain insurance for the Premises. The Company also has the right to extend
the term of the Lease for an additional three year period at the then current market rent rate (but
not less than the last annual rent paid by the Company).
The Company leases an approximately 23,000 square foot facility for its research and development
group located at 2689 Commons Blvd, Suite 100, Beavercreek, Ohio for approximately $446,000 per
year pursuant to a lease which expires in December 2010. The lease may be renewed for two
additional terms of five years each. In November 2005, the Company subleased approximately 6,000
square feet of office space at the facility at an average rate of approximately $93,000 per year
through December 2010. In August 2007 the Company subleased approximately another 6,000 square
feet of office space at the facility at an average rate of approximately $84,000 per year through
December 2010.
26
In addition to the foregoing leases relating to its principal properties, the Company also has a
lease for an additional facility in Nashua, New Hampshire used for product repairs, manufacturing
and warehousing.
If the Company is required to seek additional or replacement facilities, it believes there are
adequate facilities available at commercially reasonable rates.
Item 3. Legal Proceedings.
The Company is not currently party to any material legal proceedings.
Item 4.
Reserved.
PART II
Item 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities.
The Companys common stock is traded on the NASDAQ Capital Market under the symbol ICAD. The
following table sets forth the range of high and low sale prices for each quarterly period during
2009 and 2008.
|
|
|
|
|
|
|
|
|
|
|
High |
|
|
Low |
|
Fiscal year ended
December 31, 2009 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
1.53 |
|
|
$ |
0.73 |
|
Second Quarter |
|
|
1.51 |
|
|
|
0.88 |
|
Third Quarter |
|
|
2.43 |
|
|
|
1.05 |
|
Fourth Quarter |
|
|
2.28 |
|
|
|
1.28 |
|
|
|
|
|
|
|
|
|
|
Fiscal year ended
December 31, 2008 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
2.75 |
|
|
$ |
1.62 |
|
Second Quarter |
|
|
3.85 |
|
|
|
2.40 |
|
Third Quarter |
|
|
4.60 |
|
|
|
2.51 |
|
Fourth Quarter |
|
|
3.16 |
|
|
|
0.90 |
|
27
As of March 15, 2010 there were 285 holders of record of the Companys common stock. In addition,
the Company believes that there are in excess of 560 holders of its common stock whose shares are
held in street name.
The Company has not paid any cash dividends on its common stock to date, and the Company does not
expect to pay cash dividends in the foreseeable future. Future dividend policy will depend on the
Companys earnings, capital requirements, financial condition, and other factors considered
relevant by the Companys Board of Directors. There are no non-statutory restrictions on the
Companys present ability to pay dividends.
See Item 12 of this Form 10-K for certain information with respect to the Companys equity
compensation plans in effect at December 31, 2009.
Item 6. Selected Financial Data.
Not applicable.
Item 7.
Managements Discussion and Analysis of Financial Condition and Results of Operations.
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 FDA approval 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.
28
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 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. The Company is actively
evaluating 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.
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.
29
Critical Accounting Policies
The Companys discussion and analysis of its financial condition, results of operations, and cash
flows are based on its consolidated financial statements, which have been prepared in accordance
with accounting principles generally accepted in the U.S.. The preparation of these financial
statements requires the Company 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.
The Companys critical accounting policies include:
|
|
|
Revenue recognition; |
|
|
|
|
Allowance for doubtful accounts; |
|
|
|
|
Inventory; |
|
|
|
|
Valuation of long-lived and intangible assets; |
|
|
|
|
Goodwill; |
|
|
|
|
Product warranties; |
|
|
|
|
Stock based compensation; |
|
|
|
|
Income taxes. |
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 or
determinable, collectability is probable and there are no uncertainties regarding customer
acceptance.
The Company recognizes revenue from the sale of its digital and film-based CAD products and
services in accordance with the Financial Accounting Standards Board (FASB) Accounting Standards
Codification (ASC) Topic 605, Revenue Recognition (ASC 605), inclusive of ASC 605-10-S99,
which includes the guidance of SEC Staff Accounting Bulletin No. 104, Topic 13, Revenue
Recognition in Financial Statements. The Company recognizes revenue from the sale of certain of
its MRI CAD products and services in accordance with FASB ASC 985-605, Software, Revenue
Recognition (ASC 985-605).
30
The Companys revenue transactions can, on occasion, include product sales with multiple element
arrangements, generally for installation and training. On those occasions the Company follows the
requirements in FASB ASC Topic 605-25 Multiple-Element Arrangements (ASC 605-25). For most of
iCADs product sales the responsibility for the installation process lies with its OEM partners, GE
Healthcare, Siemens Medical and others. 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 and there is objective and
reliable evidence of the fair value of the undelivered installation element. Fair value of the
installation is determined using entity specific and third party evidence.
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 (F.O.B.) shipping point and uses shipping documents and third-party proof of delivery to
verify delivery and transfer of title. In addition, the Company assesses whether collection is
reasonably assured by considering a number of factors, including past transaction history with the
customer and the creditworthiness of the customer, as obtained from third party credit references.
If the terms of the sale include customer acceptance provisions and compliance with those
provisions cannot be demonstrated, all revenues are deferred and not recognized until such
acceptance occurs. The Company considers all relevant facts and circumstances in determining when
to recognize revenue, including contractual obligations to the customer, the customers
post-delivery acceptance provisions, if any, and the installation process. There are no
significant estimates or assumptions used in the Companys revenue recognition.
The Company defers revenue from the sale of extended service contracts related to future periods
and recognizes revenue on a straight-line basis in accordance with FASB ASC Topic 605-20,
Services. The Company provides for estimated warranty costs on original product warranties at the
time of sale.
The Company believes that revenue recognition is a critical accounting policy because it is
governed by multiple complex accounting rules and it is important for readers of its financial
statements to understand the basis upon which its revenues are recorded. In addition, the Company
believes that its investors value the Company and track its progress based to a large extent upon
revenues.
31
Allowance for Doubtful Accounts
The Companys policy is to maintain allowances for estimated losses from the inability of its
customers to make required payments. Credit limits are established through a process of reviewing
the financial results, stability and payment history of each customer. Where appropriate, the
Company obtains credit rating reports and financial statements of customers when determining or
modifying credit limits. The Companys senior management reviews accounts receivable on a periodic
basis to determine if any receivables may potentially be
uncollectible. The Company includes any accounts receivable balances that it determines may likely
be uncollectible, along with a general reserve for estimated probable losses based on historical
experience, in its overall allowance for doubtful accounts. An amount would be written off against
the allowance after all attempts to collect the receivable had failed. Based on the information
available to the Company, it believes the allowance for doubtful accounts as of December 31, 2009
is adequate.
Inventory
Inventory is valued at the lower of cost or market value, with cost determined by the first-in,
first-out method. The Company regularly reviews inventory quantities on hand and records a
provision for excess and/or obsolete inventory primarily based upon estimated usage of its
inventory as well as other factors.
Long Lived Assets
Long-lived assets, other than goodwill, are evaluated for impairment when events or changes in
circumstances indicate that the carrying amount of the assets may not be recoverable through the
estimated undiscounted future cash flows from the use of these assets. When any such impairment
exists, the related assets are written down to fair value. Intangible assets subject to
amortization consist primarily of patents, technology intangibles and trade name purchased in the
acquisition of ISSI in June 2002, CADx in December 2003 and the acquisition of assets from CAD
Sciences in July 2008. These assets are amortized on a straight-line basis over their estimated
useful lives of 5 to 10 years.
Goodwill
The Company follows the provision of FASB ASC Topic 350-20, Intangibles Goodwill and Other
(ASC 350-20). ASC 350-20 requires companies to use the purchase method of accounting for all
business combinations initiated after June 30, 2001, and establishes specific criteria for the
recognition of intangible assets separately from goodwill. Goodwill and indefinite-lived intangible
assets are no longer amortized and are tested for impairment at least annually. In accordance with
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.
The Companys goodwill arose in connection with the acquisition of ISSI in June 2002 and with the
acquisition of CADx 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.
32
No goodwill impairment loss was recorded in 2009 or 2008. For 2009 and 2008, the Company performed
the step one fair value comparison as of October 1, 2009 and October 1, 2008. At both dates the
Companys market capitalization exceeded its carrying value. At December 31, 2009, the Companys
market capitalization exceeded its carrying value, as compared to December 31, 2008, when the
Companys market capitalization fell below its carrying value. The Company also includes a
reasonable control premium to its market capitalization to determine a reasonable fair value, which
exceeded the Companys carrying value for both years. The Company believes that its market
capitalization alone does not fully capture the fair value of its business as a whole, or the
substantial value that an acquirer would obtain from its ability to obtain control of the Company.
As such, as a method of determining fair value, the Company believes that including a control
premium, supported by transaction data in its industry, to its market capitalization would give
effect to the increased consideration a potential acquirer would be required to pay in order to
gain sufficient ownership to set policies, direct operations and make decisions related to the
Company.
The Company reviews fair value and goodwill impairment on a quarterly 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 stock price reached its 2009 high market capitalization
on September 23, 2009. The Company will continue to monitor its goodwill for impairment.
Product Warranties
The Company provides for the estimated cost of standard product warranty against defects in
material and workmanship based on historical warranty trends and costs, and the volume of product
returns during the warranty period.
Share Based Compensation
The Company maintains stock-based incentive plans, under which it provides stock incentives to
employees, directors and contractors. The Company grants to employees, directors and contractors,
restricted stock and/or options to purchase common stock at an option price equal to the market
value of the stock at the date of grant. The Company follows FASB 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.
33
The Company used the Black-Scholes and Lattice option pricing models which requires extensive use
of accounting judgment and financial estimates, including estimates of the expected term
participants will retain their vested stock options before exercising them, the
estimated volatility of its common stock price over the expected term, and the number of options
that will be forfeited prior to the completion of their vesting requirements. Application of
alternative assumptions could produce significantly different estimates of the fair value of
stock-based compensation and consequently, the related amounts recognized in the Consolidated
Statements of Operations. The provisions apply to new stock options and stock options outstanding,
but not yet vested, on the date of the Company adoption. Stock-based compensation expense was
included in applicable departmental expense categories in the Consolidated Statements of Operations
for the fiscal 2009, 2008 and 2007 periods.
Income Taxes
The Company follows the liability method under FASB Accounting Standards Codification Topic 740,
Income Taxes (ASC 740). The primary objectives of accounting for taxes under ASC 740 are to
(a) recognize the amount of tax payable for the current year and (b) recognize the amount of
deferred tax liability or asset for the future tax consequences of events that have been reflected
in the Companys financial statements or tax returns. The Company has provided a full valuation
allowance against its deferred tax assets at December 31, 2009 and 2008 as it is more likely than
not that the deferred tax asset will not be realized.
The Company adopted ASC 740-10 accounting for uncertainty in income taxes on January 1, 2007. ASC
740-10 clarifies the accounting for uncertainty in income taxes recognized in an enterprises
financial statements and prescribes a recognition threshold and measurement attribute for the
financial statement recognition and measurement of a tax position taken or expected to be taken in
a tax return. ASC 740-10 also provides guidance on de-recognition, classification, interest and
penalties, disclosure and transition. The adoption of the position did not have an impact on the
Companys financial statements.
Year Ended December 31, 2009 compared to Year Ended December 31, 2008
Revenue. Revenue for the year ended December 31, 2009 was $28,109,265 compared with revenue of
$37,491,548 for the year ended December 31, 2008, for a decrease of $9,382,283 or 25.0%. The
decrease in revenue is due primarily to the decrease in digital and MRI CAD and film-based revenue
partially offset by a slight increase in service and supply revenue.
The Companys digital and MRI CAD revenue for the year ended December 31, 2009 decreased $8,446,002
or 31.6%, to $18,289,780 compared to revenue of $26,735,782 in 2008. This decrease is due
primarily to the softening demand for Full Field Digital Mammography (FFDM) systems and digital
CAD technology for the detection of breast cancer. 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.
34
Revenue from iCADs film based products for the year ended December 31, 2009 decreased 22.1% to
$5,795,703 compared to $7,436,529 in 2008. This decrease is largely due to the softening demand
for FFDM systems primarily due to current economic conditions and deferred
hospital spending. The TotalLook MammoAdvantage product is used for digitizing film based prior
mammography exams for comparative reading with current mammography exams. The TotalLook
MammoAdvantage product is typically sold as sites are preparing to go digital. 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 for the year ended December 31, 2009 increased 21.2% to $4,023,782
compared to $3,319,237 in 2008. 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 91%
and 88% of the Companys total service and supply revenue for 2009 and 2008, respectively.
The table below presents the revenue attributable to different product and service, in 2009 and
2008:
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Change |
|
|
% Change |
|
Digital & MRI CAD revenue |
|
$ |
18,289,780 |
|
|
$ |
26,735,782 |
|
|
$ |
(8,446,002 |
) |
|
|
-31.6 |
% |
Film based revenue |
|
|
5,795,703 |
|
|
|
7,436,529 |
|
|
|
(1,640,826 |
) |
|
|
-22.1 |
% |
Service & supply revenue |
|
|
4,023,782 |
|
|
|
3,319,237 |
|
|
|
704,545 |
|
|
|
21.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
28,109,265 |
|
|
$ |
37,491,548 |
|
|
$ |
(9,382,283 |
) |
|
|
-25.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Margin. Gross margin increased slightly to 83.6% for the year ended December 31, 2009
compared to 83.5% for the year ended December 31, 2008. The increase in gross margin is primarily
attributable to cost reduction efforts and the realization of some average selling price increases
and component cost reductions.
Engineering and Product Development. Engineering and product development costs for the year ended
December 31, 2009 increased by $95,812 or 1.3%, from $7,121,334 in 2008 to $7,217,146 in 2009. The
increase in engineering and product development costs was primarily due to an increase in personnel
and related costs of $87,000 resulting from staff increases from the acquisition of the assets of
CAD Sciences and staff increases in the quality and regulatory function, $295,000 in amortization
expense relating to the acquisition of assets of CAD Sciences in the third quarter of 2008,
$175,000 in consulting and license fees and $55,000 from a combination of stock-based compensation
and legal expenses. These expenses were partially offset by a decrease of $161,000 in bonus
accrual, $160,000 in subcontracting costs primarily related to the clinical trial for the Companys
CT colon product, decreases of $100,000 in rent and various administrative expenses and $95,000 in
travel expenses.
35
Marketing and Sales. Marketing and sales expense for the year ended December 31, 2009 decreased by
$924,191 or 7.7%, from $11,961,907 in 2008 to $11,037,716 in 2009. The decrease in marketing and
sales expense was primarily due to the decreases of $786,000 in sales commissions due to the
decrease in revenue, $334,000 in marketing agency fees, consulting, subcontracted services,
advertising and promotional expenses, $177,000 in travel expenses and $155,000 in bonus expense. In
addition, during 2009 the Company recorded decreases in depreciation due to fully depreciated
assets, freight and various expenses totaling $236,000. These decreases were partially offset by
an increase of $682,000 in compensation and personnel related costs, and $82,000 in stock-based
compensation expense.
General and Administrative. General and administrative expenses for the year ended December 31,
2009 decreased by $112,903 or 1.5%, from $7,466,488 in 2008 to $7,353,585 in 2009. The decrease in
general and administrative expenses for the year ended December 31, 2009 was primarily due to the
decreases in bonus expense of $222,000, amortization expense of $63,000 due to fully amortized
patents, and decreases in professional services and various administrative expenses totaling
$370,000. These decreases were partially offset by an increase of $486,000 in legal and
professional fees associated with a potential acquisition that was not consummated. In addition,
the Company recorded increases in personnel and related expenses, including stock-based
compensation expense, totaling $57,000.
Other (Income) Expense Net. Net interest income for the year ended December 31, 2009 was $109,772
compared to interest expense of $174,600 in 2008. The decrease in interest expense in 2009 was due
primarily to the payment and conversion of the Companys outstanding convertible loans during the
second and third quarters of 2008 and an increase in interest income generated from the Companys
increased cash balance and associated interest earned from its money market accounts.
Provision (Benefit) for Income Taxes. The benefit from income taxes for the year ended December 31,
2009 amounted to $43,570, compared to an income tax provision of $235,000 in 2008. The current
year benefit was primarily due to a refundable R&D credit allowance.
Net Income/(Loss). As a result of the foregoing, the Company recorded a net loss of ($1,967,624)
or ($0.04) per basic and diluted share for the year ended December 31, 2009 on revenue of
$28,109,265, compared to net income of $4,356,189 or $0.10 per basic and diluted share on revenue
of $37,491,548 for the year ended December 31, 2008.
Backlog. The Companys product backlog (excluding service and supplies) was approximately $958,000
at December 31, 2009, as compared to $1,137,000 on the corresponding date in 2008 and $663,000 at
September 30, 2009. The Company expects that the majority of the backlog at December 31, 2009 will
be shipped within the 2010 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.
36
Year Ended December 31, 2008 compared to Year Ended December 31, 2007
Revenue. Revenue for the year ended December 31, 2008 was $37,491,548 compared with revenue of
$26,612,412 for the year ended December 31, 2007 for an increase of $10,879,136 or 40.9%. In 2008
sales of iCADs digital CAD solutions increased $10,306,332 or 62.7% to $26,735,782 compared to
sales of $16,429,450 in 2007. This increase was due primarily to the release, early in the second
quarter of 2008, of the Companys
SecondLook® Digital CAD for sale with Fujifilm
Computed Radiography for Mammography (FCRm) systems, of approximately $7,063,325, as well as an
increase in business from the Companys other OEM customers due to the continued increased global
demand for Full Field Digital Mammography (FFDM) systems and digital CAD technology for the
detection of breast cancer.
In April 2008 the Company announced that its SecondLook Digital CAD system for mammography received
approval from the FDA for sale with Fujis FCRm system. SecondLook Digital for FCRm was the first
CAD product approved and available in the U.S. for use with computer radiography.
Revenue from iCADs film based product increased 9.9% or $667,683 for the year ended December 31,
2008, to $7,436,529 in 2008 compared to $6,768,846 in 2007. While the transition to digital
technology had a significant positive impact on overall performance, the film based products were a
mature product line. However, film based product revenue benefited from demand for the Companys
TotalLook Mammo Advantage product that is used for digitizing film based prior mammography exams
for comparative reading with current mammography exams. In addition, a new version of the
Companys TotalLook product, the TotalLook Mammo Advantage, was introduced late in the first
quarter of 2008 and the Company received favorable customer response to this product.
Service and supply revenue decreased 2.8% for the year ended December 31, 2008, to $3,319,237
compared to $3,414,116 in 2007. The decrease in the Companys service revenue in 2008 was due
primarily to a reduction in time and material billings for repair services and related parts sales
due in part to certain of its older film based analog products no longer being supported, offset by
increased service contract revenue on the Companys digital and TotalLook products.
The table below presents the revenue attributable to different product and service, in 2008 and
2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
Change |
|
|
% Change |
|
Digital revenue |
|
$ |
26,735,782 |
|
|
$ |
16,429,450 |
|
|
$ |
10,306,332 |
|
|
|
62.7 |
% |
Film based revenue |
|
|
7,436,529 |
|
|
|
6,768,846 |
|
|
|
667,683 |
|
|
|
9.9 |
% |
Service & supply revenue |
|
|
3,319,237 |
|
|
|
3,414,116 |
|
|
|
(94,879 |
) |
|
|
-2.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
37,491,548 |
|
|
$ |
26,612,412 |
|
|
$ |
10,879,136 |
|
|
|
40.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Margin. Gross margin increased to 83.5% for the year ended December 31, 2008 compared to
80.2% for the year ended December 31, 2007. The increase in gross margin was primarily
attributable to increased volume of the Companys digital products which had a higher gross margin
than its film based products which include more hardware components and the realization of some
average selling price increases and some component cost reductions.
37
Engineering and Product Development. Engineering and product development costs for the year ended
December 31, 2008 increased by $2,617,334 or 58.1%, from $4,504,000 in 2007 to $7,121,334 in 2008.
The increase in engineering and product development costs was primarily due to an increase in
personnel and related costs of $1,267,000, resulting from staff increases to support the Companys
product development efforts, including its new MRI products, $847,000 in subcontracting services
relating to the clinical trial for its CT Colon product, $234,000 in amortization expense and
$47,000 in rent expense relating to the asset acquisition of CAD Sciences in the third quarter of
2008 and $67,000 in stock based compensation expense. In addition, during the 2008 period the
Company experienced an increase in rent, travel, telephone, data collection, depreciation, legal
and computer supplies totaling $246,000. These expenses were offset by decreases of $48,000 in
relocation expense and $34,000 in recruiting expense.
Marketing and Sales. Marketing and sales expense for the year ended December 31, 2008 increased by
$1,181,603 or 11.0%, from $10,780,304 in 2007 to $11,961,907 in 2008. The increase in marketing
and sales expense primarily resulted from an increase in personnel and related costs of $810,000,
increased sales commissions due to increased revenue of $515,000, increased advertising, trade show
and travel expenses of $348,000, rebranding cost associated with its new MRI CAD products of
$202,000 and stock based compensation of $82,000, which were offset by decreases in consulting and
subcontracted services of $451,000, warranty related costs of $200,000 and freight and depreciation
expenses totaling $105,000.
General and Administrative. General and administrative expenses for the year ended December 31,
2008 increased by $291,681 or 4.1%, from $7,174,807 in 2007 to $7,466,488 in 2008. The increase in
general and administrative expenses for the year ended December 31, 2008 was primarily due to an
increase in stock based compensation expense of approximately $462,000, additional wage related and
fringe benefit expenses of $102,000 and consulting services of $73,000, offset by decreases in
legal fees of $152,000, travel and telephone expenses of $119,000 and recruiting fees of $74,000.
Other (Income) Expense Net. Net interest expense for the year ended December 31, 2008 decreased
from $434,729 in 2007 to $174,600 in 2008. The decrease was due primarily to the conversion of the
Companys outstanding convertible loans during the second and third quarters of 2008 and the
decrease in the interest rate on the Companys Prior Loan Agreement with its former Chairman which
bore interest at the prime rate plus 1%. The interest rate decreased from approximately 9.25% in
2007 to approximately 6.25% in 2008.
Provision for Income Taxes. The provision for income taxes for the year ended December 31, 2008 of
$235,000 consists of an estimate for federal alternative minimum tax expense and various state
income taxes based upon the estimated effective income tax rate for the full fiscal year.
Net Income/(Loss). As a result of the foregoing, the Company recorded net income of $4,356,189 or
$0.10 per basic and diluted share for the year ended December 31, 2008 on revenue of $37,491,548,
compared to a net loss of ($1,606,292) or ($0.04) per basic share on revenue of $26,612,412 for the
year ended December 31, 2007.
38
Backlog. The Companys product backlog (excluding service and supplies) was approximately
$1,137,000 at December 31, 2008 as compared to $1,869,000 on the corresponding date in 2007 and
$1,019,000 at September 30, 2008. The Company expected that the majority of the backlog at
December 31, 2008 would be shipped within the 2009 fiscal year.
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.
On June 30, 2008, the Company entered into a Loan and Security Agreement (the RBS Loan Agreement)
with RBS Citizens, N.A. (RBS). The RBS Loan Agreement established a secured revolving credit
facility with a line of credit of up to $5,000,000. The RBS Loan Agreement expired on June 30,
2009. The Company did not borrow any amounts under the RBS Loan Agreement during the term and
elected not to renew the RBS Loan Agreement. The Company does not currently have a line of credit
available. The Company will continue to closely monitor its liquidity and capital resources and the
capital and credit markets.
Working capital increased by $1,945,527 to $15,700,564 at December 31, 2009 from $13,755,037 at
December 31, 2008. The ratio of current assets to current liabilities at December 31, 2009 and
2008 was 3.3 and 3.0, respectively. The increase in working capital is primarily due to the
increase in cash generated from operations.
Net cash provided by operating activities for the year ended December 31, 2009 was $3,442,860
compared to net cash provided of $9,777,931 for the same period in 2008. The cash provided by
operating activities for the year ended December 31, 2009 resulted from the net loss of $1,967,624,
decreases in accounts receivable, inventory and other current assets totaling $1,289,879 and an
increase in deferred revenue of $1,559,255, plus non-cash items including, depreciation and
amortization of $1,921,207 and stock based compensation of $1,993,935, partially offset by a
decrease in accounts payable of $823,535 and accrued expenses of $530,257.
The net cash used for investing activities for the year ended December 31, 2009 was $311,468 which
consisted of additions to patents, technology and other assets of $137,944 and property and
equipment of $173,524, compared to $2,620,941 for the comparable period in 2008 which consisted of
additions to patents, technology and other assets of $38,839 and property and equipment of $582,102
and $2,000,000 for the acquisition of assets of CAD Sciences.
39
Net cash provided by financing activities for the year ended December 31, 2009 was $924 consisting
of $23,494 due to cash received from the issuance of common stock relating to the exercise of stock
options, partially offset by $22,570 relating to taxes paid at restricted stock issuance, compared
to $1,609,996 for the same period in 2008, which consisted of $1,868,902 in cash received from the
issuance of common stock relating to the exercise of stock options, partially offset by the payment
of convertible notes payable in the amount of $258,906.
The following table summarizes as of December 31, 2009, for the periods presented, the Companys
future estimated cash payments under existing contractual obligations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by period |
|
|
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
|
Contractual Obligations |
|
Total |
|
|
year |
|
|
1-3 years |
|
|
3-5 years |
|
|
5+ years |
|
|
Lease Obligations* |
|
$ |
688,873 |
|
|
$ |
468,553 |
|
|
$ |
220,320 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Contractual Obligations |
|
$ |
688,873 |
|
|
$ |
468,553 |
|
|
$ |
220,320 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
The Companys lease obligations is shown net of sublease amounts. |
Effect of New Accounting Pronouncements
Effective July 1, 2009, the Company adopted The FASB Accounting Standards Codification and the
Hierarchy of Generally Accepted Accounting Principles (ASC 105). This standard establishes only two
levels of U.S. generally accepted accounting principles (GAAP), authoritative and
nonauthoritative. The FASB Accounting Standards Codification (the Codification) became the source
of authoritative, nongovernmental GAAP, except for rules and interpretive releases of the SEC,
which are sources of authoritative GAAP for SEC registrants. All other non-grandfathered, non-SEC
accounting literature not included in the Codification became nonauthoritative. The Company began
using the new guidelines and numbering system prescribed by the Codification when referring to GAAP
in the third quarter of fiscal 2009. As the Codification was not intended to change or alter
existing GAAP, it did not have any impact on the Companys consolidated financial statements.
In September 2009, the FASB issued Update No. 2009-13, Multiple-Deliverable Revenue Arrangements -
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 EITF Issue No. 00-21, Revenue Arrangements with Multiple
Deliverables. 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.
40
Effective July 1, 2009, the Company adopted FASB ASU No. 2009-05, Fair Value Measurements and
Disclosures (Topic 820), (ASU 2009-05). ASU 2009-05 provided amendments to ASC 820-10, Fair
Value Measurements and Disclosures Overall, for the fair value measurement of liabilities. ASU
2009-05 provides clarification that in circumstances in which a quoted price in an active market
for the identical liability is not available, a reporting entity is required to measure fair value
using certain techniques. ASU 2009-05 also clarifies that when estimating the fair value of a
liability, a reporting entity is not required to include a separate input or adjustment to other
inputs relating to the existence of a restriction that prevents the transfer of a liability. ASU
2009-05 also clarifies that both a quoted price in an active market for the identical liability at
the measurement date and the quoted price for the identical liability when traded as an asset in an
active market when no adjustments to the quoted price of the asset are required are Level 1 fair
value measurements. The adoption of ASU 2009-05 did not have any impact on the Companys financial
position, results of operations or cash flows.
Effective June 30, 2009, the Company adopted the FASB guidance now codified as FASB ASC Topic
855-10 Subsequent Events (ASC 855-10). This topic is intended to establish general standards of
accounting for and disclosure of events that occur after the balance sheet date but before
financial statements are issued or are available to be issued. In particular, this topic sets forth
the period after the balance sheet date during which management of a reporting entity should
evaluate events or transactions that may occur for potential recognition or disclosure in the
financial statements, the circumstances under which an entity should recognize events or
transactions occurring after the balance sheet date in its financial statements, and the
disclosures that an entity should make about events or transactions that occurred after the balance
sheet date. The adoption of ASC 855-10 did not have any impact on the Companys financial position,
results of operations or cash flows.
In April 2009, the Company adopted guidance now codified as FASB Topic 820-10-65, Fair Value
Measurements and Disclosures Overall Implementation and Guidance and Illustrations (ASC
820-10-65). ASC 820-10-65 provides guidelines for making fair value measurements more consistent.
ASC 820-10-65 provides additional authoritative guidance in determining whether a market is active
or inactive, and whether a transaction is distressed, is applicable to all assets and liabilities
(i.e. financial and non-financial) and requires enhanced disclosures. ASC 820-10-65 was effective
for all periods ending after June 15, 2009. The adoption of ASC 820-10-65 did not have any impact
on the Companys financial position, results of operations or cash flows.
In April 2009, the FASB issued guidance now codified as FASB ASC Topic 825, Financial Instruments
(ASC 825), which amends previous topic 825 guidance to require disclosures about fair value of
financial instruments in interim as well as in annual financial statements. ASC 825 is effective
for all reporting periods ending after June 15, 2009. The adoption of ASC 825 did not have any
impact on the Companys financial position, results of operations or cash flows.
Effective January 1, 2009, pursuant to the requirements of FASB ASC 820, the Company adopted the
provisions of topic ASC 820-10, Fair Value Measurements and Disclosures Overall (ASC 820-10),
with respect to all non-financial assets and non-financial liabilities, except for items that are
recognized or disclosed at fair value in the financial statements on a recurring basis (at least
annually), until January 1, 2009. These include goodwill and other non-amortizable intangible
assets. The adoption of ASC 820-10 did not have a material impact on the Companys financial
position, results of operations or cash flows.
41
Effective January 1, 2009, the Company adopted guidance now codified as FASB ASC Topic 350-30-35,
Intangibles Goodwill and Other (ASC 350-30-35). ASC 350 amends the factors that should be
considered in developing renewal or extension assumptions used to determine the useful life of a
recognized intangible asset. The adoption of ASC 350-30-35 did not have any impact on the
Companys financial position, results of operations or cash flows.
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.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk.
Not applicable.
Item 8. Financial Statements and Supplementary Data.
See Financial Statements and Schedule attached hereto.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A(T). Controls and Procedures.
Evaluation of Disclosure 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 Exchange Act) were effective.
42
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.
Managements Report on Internal Control Over Financial Reporting.
The Company, under the supervision and with the participation of its management, including its
principal executive officer and principal financial officer, is responsible for the preparation and
integrity of the Companys Consolidated Financial Statements, establishing and maintaining adequate
internal control over financial reporting (as defined in Exchange Act Rule 13a-15(f)) for the
Company and all related information appearing in this Annual Report on Form 10-K.
All internal control systems, no matter how well designed, have inherent limitations. Therefore,
even those systems determined to be effective can provide only reasonable assurance with respect to
financial statement preparation and presentation. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.
The Company employed the Internal Control-Integrated Framework founded by the Committee of
Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of the Companys
internal control over financial reporting. Management of the Company has assessed the Companys
internal control over financial reporting to be effective as of December 31, 2009.
This Annual Report on Form 10-K does not include an attestation report of the Companys registered
public accounting firm regarding internal control over financial reporting. Managements report was
not subject to attestation by the Companys registered public accounting firm pursuant to temporary
rules of the SEC that permit the Company to provide only managements report in this Annual Report
on Form 10-K.
Changes in Internal Control Over Financial Reporting.
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 December 31, 2009, 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.
43
Item 9B. Other Information.
None.
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The following information includes information each director and executive officer has given us
about his or her age, all positions he or she holds, his or her principal occupation and business
experience for the past five years, and the names of other publicly-held companies of which he or
she currently serves as a director or has served as a director during the past five years. In
addition to the information presented below regarding each directors specific experience,
qualifications, attributes and skills that led our Board to the conclusion that he or she should
serve as a director, we also believe that all of our directors have a reputation for integrity,
honesty and adherence to high ethical standards. They each have demonstrated business acumen and an
ability to exercise sound judgment, as well as a commitment of service to iCAD and our Board.
Information about the number of shares of common stock beneficially owned by each director appears
below under the heading Security Ownership of Certain Beneficial Owners and Management. There are
no family relationships among any of the directors and executive officers of iCAD.
|
|
|
|
|
|
|
|
|
|
|
|
|
Director/Officer |
Name |
|
Age |
|
Position with iCAD |
|
Since |
|
|
|
|
|
|
|
Dr. Lawrence Howard |
|
57 |
|
Chairman of the Board, and Director |
|
2006 |
Kenneth Ferry |
|
56 |
|
President, Chief Executive Officer,
and Director |
|
2006 |
Darlene Deptula-Hicks |
|
52 |
|
Executive Vice President of Finance,
Chief Financial Officer and Treasurer
and Secretary |
|
2006 |
Jeffrey Barnes |
|
48 |
|
Executive Vice
President of Global Commercial
Operations |
|
2006 |
Stacey Stevens |
|
42 |
|
Senior Vice President of Marketing and
Strategy |
|
2006 |
Jonathan Go |
|
47 |
|
Senior Vice President of
Research and Development |
|
2006 |
Rachel Brem, MD |
|
51 |
|
Director |
|
2004 |
Anthony Ecock |
|
48 |
|
Director |
|
2008 |
Steven Rappaport |
|
61 |
|
Director |
|
2006 |
Maha Sallam, PhD |
|
43 |
|
Director and Assistant Secretary |
|
2002 |
Elliot Sussman, MD |
|
58 |
|
Director |
|
2002 |
44
The Companys Certificate of Incorporation provides for the annual election of all of its
directors. The Board elects officers on an annual basis and our officers generally serve until
their successors are duly elected and qualified.
Dr. Lawrence Howard was appointed Chairman of the Board in 2007 and has been a director of the
Company since November 2006. Dr. Howard has been, since March 1997, a general partner of Hudson
Ventures, L.P. (formerly known as Hudson Partners, L.P.), a limited partnership that is the general
partner of Hudson Venture Partners, L.P. (HVP), a limited partnership that is qualified as a
small business investment company. Since March 1997, Dr. Howard has also been a managing member of
Hudson Management Associates LLC, a limited liability company that provides management services to
HVP. Since November 2000, Dr. Howard has been a General Partner of Hudson Venture Partners II, and
a limited partner of Hudson Venture II, L.P. He was a founder and has been since November 1987, and
continues to be, a director of Presstek, Inc. (Presstek), a public company which has developed
proprietary imaging and consumables technologies for the printing and graphic arts industries, and
served in various officer positions at Presstek from October 1987 to June 1993, lastly as its Chief
Executive Officer. We believe Dr. Howards qualifications to serve on our Board of Directors
include his financial expertise and his understanding of our products and market.
Kenneth Ferry has served as the Companys President and Chief Executive Officer since May
2006. He has over 25 years of experience in the healthcare technology field, with more than 10
years experience in senior management positions. Prior to joining the Company, from October 2003 to
May 2006, Mr. Ferry was Senior Vice President and General Manager for the Global Patient Monitoring
business for Philips Medical Systems, a leader in the medical imaging and patient monitoring
systems business. In this role he was responsible for Research & Development, Marketing, Business
Development, Supply Chain and Manufacturing, Quality and Regulatory, Finance and Human Resources.
From September 2001 to October 2003, Mr. Ferry served as a Senior Vice President in the North
America Field Organization of Philips Medical Systems. From 1983 to 2001, Mr. Ferry served in a
number of management positions with Hewlett Packard Company, a global provider of products,
technologies, software solutions and services to individual consumers and businesses and Agilent
Technologies, Inc., a provider of core bio-analytical and electronic measurement solutions to the
communications, electronics, life sciences and chemical analysis industries. We believe Mr. Ferrys
qualifications to serve on our Board of Directors include his global executive leadership skills
and significant experience as an executive in the healthcare industry.
45
Darlene Deptula-Hicks has served as the Companys Executive Vice President of Finance and
Chief Financial Officer and Treasurer since September 2006. She has more than 25 years experience
in financial management within the medical device and high technology industries. Prior to joining
the Company, from January 2002 to February 2006, Ms. Deptula-Hicks served as Executive Vice
President and Chief Financial Officer and Treasurer of ONI Medical Systems, Inc., a venture
capital-backed designer and manufacturer of high-field diagnostic imaging systems. From 1998 to
2001, Ms. Deptula-Hicks was Executive Vice President and Chief Financial Officer and Treasurer of
Implant Sciences Corporation, an early stage medical device company that had its initial public
offering (IPO) in June of 1999. Ms. Deptula-Hicks led the pre-IPO and post-IPO activities for the
company. Ms. Deptula-Hicks has also held various senior financial and accounting positions at
Abiomed, Incorporated; GCA Corporation; Edwards High Vacuum International and Puritan Bennett
Corporation. Ms. Deptula-Hicks also currently serves on the Board of Directors and as Chair of the
Audit Committee of USfalcon, Inc., a private information technology and professional services
company serving military, federal and commercial customers worldwide. Ms. Deptula-Hicks previously
served on the Board of Directors and as Chair of the Audit Committees of IMCOR Pharmaceutical
Company, a public biotech company and Technest Holdings, Inc. a public defense and homeland
security company. Ms. Deptula-Hicks received her Bachelor of Science degree in Accounting from
Southern New Hampshire University and her MBA degree from Rivier College.
Jeffrey Barnes was
promoted to Executive Vice President of Global Commercial Operations of the
Company in October 2009. Previous to that he served as the Companys Senior Vice President of
Sales since May 2006. As Executive Vice President of Commercial Operations, Mr. Barnes leads
iCADs Global Sales and Service Operations. For the 17 years prior to joining the Company, Mr.
Barnes served in a variety of sales and marketing management positions with Philips Medical
Systems, Agilent Technologies, Inc. and Hewlett Packard Healthcare Solutions Group (which was
acquired in 2001 by Philips Medical Systems). From November 2002 to May 2006, he was Vice
President Sales and National Sales Manager for Cardiac Resuscitation Solutions at Philips Medical
Systems, where he worked closely with iCADs Chief Executive Officer, Kenneth Ferry. Mr. Barnes
was responsible for sales and service operations at Philips market-leading defibrillation field
organization. From May 2000 to November 2002, Mr. Barnes served as Vice President of Marketing,
Americas, for the Cardiac and Monitoring Systems unit of Hewlett-Packard/Agilent and Philips
Medical Systems. He was responsible for all marketing activities and certain direct sales
activities for the North and South American field operation. Mr. Barnes earned a Bachelor of Arts
degree in Economics from St. Lawrence University and an MBA degree from New York Universitys
Leonard N. Stern School of Business.
Stacey Stevens has served as the Companys Senior Vice President of Marketing and Strategy
since June 2006. During the past 20 years, Ms. Stevens has served in a variety of sales, business
development, and marketing management positions with Philips Medical Systems, Agilent Technologies,
Inc. and Hewlett Packards Healthcare Solutions Group (which was acquired in 2001 by Philips
Medical Systems). From February 2005 until joining the Company she was Vice President, Marketing
Planning at Philips Medical Systems, where she was responsible for the leadership of all global
marketing planning functions for Philips Healthcare Business. From 2003 to January 2005, she was
Vice President of Marketing for the Cardiac and Monitoring Systems Business Unit of Philips where
she was responsible for all marketing and certain direct sales activities for the Americas Field
Operation. Prior to that, Ms. Stevens held several key marketing management positions in the
Ultrasound Business Unit of Hewlett-Packard/Agilent and Philips Medical Systems. Ms. Stevens earned
a Bachelor of Arts Degree in Political Science from the University of New Hampshire, and an MBA
from Boston Universitys Graduate School of Management.
46
Jonathan Go has served as the Companys Senior Vice President of Research and Development
since October 2006. Mr. Go brings more than twenty years of software development experience in the
medical industry to his position with the Company. From February 1998 to May 2006, Mr. Go served
as Vice President of Engineering at Merge eMed Inc., a provider of Radiology Information System and
Picture Archiving and Communication Systems solutions for imaging centers, specialty practices and
hospitals. At Merge eMed, Mr. Go was responsible for software development, product management,
testing, system integration and technical support for all of eMeds products. From July 1986 to
January 1998, Mr. Go held various development roles at Cedara Software Corp. in Toronto culminating
as Director of Engineering. Cedara Software is focused on the development of custom engineered
software applications and development tools for medical imaging manufacturers. At Cedara Mr. Go
built the workstation program, developing multiple specialty workstations that have been adopted by
a large number of partners. Mr. Go earned a Bachelor of Science in Electrical Engineering from the
University of Michigan and a Masters of Science in Electrical Engineering and Biomedical
Engineering from the University of Michigan.
Dr. Rachel Brem is currently the Professor and Vice Chairman in the Department of Radiology at
The George Washington University Medical Center and Associate Director of the George Washington
Cancer Institute. Dr. Brem has been at the George Washington University since 2000. From 1991 to
1999 Dr. Brem was at the John Hopkins Medical Institution where she introduced image guided
minimally invasive surgery and previously was the Director of Breast Imaging. Dr. Brem is a
nationally and internationally recognized expert in new technologies for the improved diagnosis of
breast cancer and has published over 80 manuscripts. We believe Dr. Brems qualifications to serve
on our Board of Directors include her expertise in the medical field specifically the diagnosis of
breast cancer as well as her understanding of our products and market.
Anthony Ecock has led the Resources Group at the private equity investment firm, Welsh,
Carson, Anderson & Stowe (WCAS), since 2007. Mr. Ecock has over 10 years of experience in the
healthcare technology field. At WCAS, Mr. Ecock leads a team that is responsible for helping
portfolio companies identify and implement growth, earnings and cash flow improvement
opportunities. Before joining WCAS, he served as Vice President and General Manager of General
Electric Healthcares Enterprise Sales organization, from 2003 to 2007. From 1999 to 2003 he
served as General Manager of Hewlett Packards Patient Monitoring Division, which was subsequently
spun off as part of Agilent Technologies and was then sold to Koninklijke Philips Electronics,
N.V., where Mr. Ecock was named a Senior Vice President. Prior to that, Mr. Ecock worked at the
consulting firm of Bain & Company for 12 years where he was a Partner, Practice Leader for
Information Technology and Program Director for Consultant Training. We believe Mr. Ecocks
qualifications to serve on our Board of Directors include his financial expertise and his years of
experience in the healthcare market.
47
Steven Rappaport has been a partner of RZ Capital, LLC since July 2002, a private investment
firm that also provides administrative services for a limited number of clients. From March 1995 to
July 2002, Mr. Rappaport was Director, President and Principal of Loanet, Inc., an online real-time
accounting service used by brokers and institutions to support domestic and international
securities borrowing and lending activities. Loanet, Inc. was acquired by SunGard Data Systems in
May 2001. From March 1992 to December 1994, Mr. Rappaport was Executive Vice President of
Metallurg, Inc. (Metallurg), a producer and seller of high quality specialty metals and alloys,
and President of Metallurgs subsidiary, Shieldalloy Corporation. He served as Director of
Metallurg from 1985 to 1998. From March 1987 to March 1992, Mr. Rappaport was Director, Executive
Vice President and Secretary of Telerate, Inc. (Telerate), an electronic distributor of financial
information. Telerate was acquired by Dow Jones over a number of years commencing in 1985 and
culminating in January 1990, when it became a wholly-owned subsidiary. Mr. Rappaport practiced
corporate and tax law at the New York law firm of Hartman & Craven from August 1974 to March 1987.
He became a partner in the firm in 1979. Mr. Rappaport is currently serving as an independent
director of Presstek and a number of open and closed end American Stock Exchange funds of which
Credit Suisse serves as the investment adviser and a number of closed end mutual funds of which
Aberdeen Investment Trust serves as the adviser. In addition, Mr. Rappaport serves as a director
of several privately owned businesses and a few not for profit organizations. We believe
Mr. Rappaports qualifications to serve on our Board of Directors include his extensive financial
and legal expertise combined with his experience as an executive officer, partner and director.
Maha Sallam, PhD, is President and Director of VuEssence, Inc., a development stage medical
device company focused on neuro-imaging applications. Dr. Sallam was a Vice President of iCAD from
July 2002 until September 2009. From 1997 until the Companys acquisition of Intelligent Systems
Software, Inc. (ISSI) in July 2002, Dr. Sallam served as Director and as President then Executive
Vice President of Regulatory Affairs and Clinical Testing at ISSI, and was one of ISSIs founders.
Dr. Sallam served iCAD as Vice President of Regulatory Affairs until 2003. Subsequently, she was
responsible for the Companys Advocacy and Research Grants program. In 2005, Dr. Sallam took
responsibility for new product initiatives in the Computed Tomography (CT) area and led the
Companys CT Colonography CAD program until September of 2009. Dr. Sallam holds a Ph.D. in
Computer Engineering from the University of South Florida and she has over 18 years of research and
medical device industry experience. We believe Dr. Sallams qualifications to serve on our Board of
Directors include her years of experience in regulatory matters in the healthcare industry, her
knowledge and understanding of our products and market, including as the founder of ISSI, and
formerly as our Vice President for several years.
Dr. Elliot Sussman is currently President and Chief Executive Officer of Lehigh Valley Health
Network, a position he has held since 1993. Dr. Sussman is the Leonard Parker Pool Professor of
Health Systems Management and Professor of Medicine at the University of South Florida College of
Medicine. Dr. Sussman served as a Fellow in General Medicine and a Robert Wood Johnson Clinical
Scholar at the University of Pennsylvania, and trained as a resident at the Hospital of the
University of Pennsylvania. Dr. Sussman is a director and the Chairperson of the compensation
committee of the Board of Directors of Universal Health Realty Income Trust, a public company
involved in real estate investment trust primarily engaged in investing in healthcare and human
service-related facilities. We believe Dr. Sussmans qualifications to serve on our Board of
Directors include his experience as a CEO of a leading healthcare network, combined with his
medical background and his understanding of our products and market.
48
Audit Committee and Audit Committee Financial Expert
Our Board of Directors maintains an Audit Committee which is comprised of Mr. Rappaport
(Chair), Mr. Ecock and Dr. Sussman. Our Board has determined that each member of the Audit
Committee meets the definition of an Independent Director under applicable NASDAQ Marketplace
Rules. In addition, the Board has determined that each member of the Audit Committee meets the
independence requirements of applicable SEC rules and that Mr. Rappaport qualifies as an audit
committee financial expert under applicable SEC rules.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the
Exchange Act requires certain of our officers and our directors, and
persons who own more than 10 percent of a registered class of our equity securities, to file
reports of ownership and changes in ownership with the SEC. Officers, directors, and greater than
10 percent stockholders are required by SEC regulation to furnish us with copies of all Section
16(a) forms they file.
Based solely on
our review of copies of such forms received by us, we believe that during the
year ended December 31, 2009, all filing requirements applicable to all of our officers,
directors, and greater than 10% beneficial stockholders were timely complied with, except for
Maha Sallam who filed a late Form 4 with respect to the
forfeiture of restricted shares of the
Companys common stock made on September 30, 2009.
Code of Ethics
We have developed and adopted a comprehensive Code of Business Conduct and Ethics to cover all
of our employees. Copies of the Code of Business Conduct and Ethics can be obtained, without
charge, upon written request, addressed to:
iCAD, Inc.
98 Spit Brook Road, Suite 100
Nashua, NH 03062
Attention: Corporate Secretary
Item 11. Executive Compensation.
The following table provides information on the compensation provided by us during fiscal
years 2009 and 2008 to (i) those persons who served in the capacity as our Chief Executive Officer,
and (ii) the two most highly compensated executive officers other than the Chief Executive Officer,
who served in such capacity during 2009 and at the end of 2009 whose total compensation exceeded
$100,000 (collectively the Named Executive Officers).
49
SUMMARY COMPENSATION TABLE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
Incentive Plan |
|
|
All Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonus |
|
|
Awards |
|
|
Compensation |
|
|
Compensation |
|
|
|
|
|
|
|
|
|
|
Salary |
|
|
(1) |
|
|
(2) |
|
|
(3) |
|
|
(4) |
|
|
Total |
|
Name and Principal Position |
|
Year |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Kenneth Ferry
President, Chief Executive Officer |
|
|
2009 |
|
|
|
356,314 |
|
|
|
120,000 |
|
|
|
|
|
|
|
|
|
|
|
29,536 |
|
|
|
505,849 |
|
|
|
|
2008 |
|
|
|
341,892 |
|
|
|
93,325 |
|
|
|
584,000 |
|
|
|
136,675 |
|
|
|
24,663 |
|
|
|
1,180,555 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Darlene Deptula-Hicks
Executive Vice President of Finance, Chief Financial Officer |
|
|
2009 |
|
|
|
235,869 |
|
|
|
60,000 |
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
|
|
313,869 |
|
|
|
|
2008 |
|
|
|
228,481 |
|
|
|
34,200 |
|
|
|
219,000 |
|
|
|
65,800 |
|
|
|
15,231 |
|
|
|
562,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jeffrey Barnes
Executive Vice President of Global Commercial Operations |
|
|
2009 |
|
|
|
215,796 |
|
|
|
85,000 |
|
|
|
200,000 |
|
|
|
|
|
|
|
18,000 |
|
|
|
518,796 |
|
|
|
|
2008 |
|
|
|
208,481 |
|
|
|
37,865 |
|
|
|
219,000 |
|
|
|
62,135 |
|
|
|
15,231 |
|
|
|
542,712 |
|
|
|
|
(1) |
|
Represents discretionary bonuses earned for 2008 and 2009 paid in 2009 and 2010, respectively,
that were awarded to the Named Executive Officers in lieu of or in addition to any incentive bonus
to which they were otherwise entitled to under the terms of their respective employment agreements. |
|
(2) |
|
The amounts included in the Stock Awards column represents the grant date fair value of the
restricted stock awards granted to the Named Executive Officers, computed in accordance with FASB
ASC Topic 718. |
|
(3) |
|
Represents performance-based cash incentive bonuses paid in 2009 that were earned in 2008
under the Named Executive Officers respective employment agreements. The 2008 performance target
for Messrs. Ferry and Barnes and Ms. Deptula-Hicks was the Companys achievement of approximately
$7.6 million of pretax profit before FAS123R expense, which represents 90% of the targeted pretax
profit before FAS123R expense established by the Board of Directors. In addition, the 2008
performance target for Mr. Barnes was the Companys achievement of approximately $37.5 million of
revenue, which represents 93% of the targeted revenue established by the Board of Directors. For
the year ended December 31, 2008, Messrs. Ferry and Barnes and Ms. Deptula-Hicks received cash
bonuses of $136,675, $62,135 and $65,800, respectively, pursuant to their employment agreements.
With respect to the year ended December 31, 2009, no performance-based cash incentive bonuses were
paid to Messrs. Ferry and Barnes and Ms. Deptula-Hicks as the Company did not achieve the revenue
and pretax profit before FAS123R expense targets of $32.5 million and $1.3 million, respectively,
established by the Board of Directors. In lieu of performance-based cash incentive bonuses Messrs.
Ferry and Barnes and Ms. Deptula-Hicks were paid discretionary bonuses as outlined in footnote 1. |
|
(4) |
|
The amounts shown in the All Other Compensation column for Mr. Ferry consists of an
automobile allowance of $26,400, and $22,523 for 2009 and 2008, respectively, and $3,136 and $2,140
of life insurance premiums paid by us each year. For the other Named Executive Officers the amounts
represent payments of an automobile allowance. |
Narrative Disclosure to Summary Compensation Table
Employment Contracts for our Named Executive Officers
In June 2008 we entered into the following employment agreements with our Named Executive
Officers and their compensation is determined, in part, based upon these employment agreements.
50
Mr. Kenneth Ferry, our President and Chief Executive Officer. On June 25, 2008, we entered
into a new employment agreement, as of June 1, 2008, with Mr. Ferry. This agreement replaced and
superseded the previous employment agreement entered into between us and Mr. Ferry in May 2006.
Mr. Ferrys employment agreement provides for his employment as our Chief Executive Officer and
President for an initial term through December 31, 2012, subject to automatic one-year renewals
after the expiration of the initial term under certain conditions, at an annual base salary of
$355,000 with such increases as determined by the Board. Mr. Ferry is also entitled to customary
benefits, including participation in employee benefit plans, and reasonable travel and
entertainment expenses as well as a monthly automobile allowance. The agreement also provides for
his eligibility to receive, during each employment year during the term of the agreement, a target
annual incentive bonus of 55% of his base salary if we achieve goals and objectives determined by
the Board. Mr. Ferry will also be eligible to receive such other cash bonuses and such other
compensation as may from time to time be awarded to him by the Board.
The employment agreement provides that if his employment is terminated without cause or if
he terminates his employment for good reason, Mr. Ferry will receive an amount equal to his base
salary then in effect for one (1) year plus the pro rata portion of any incentive bonus earned in
any employment year through the date of his termination. In the event that within six months of a
change in control, either (i) Mr. Ferry is terminated by the Company without cause or (ii) he
terminates his agreement for good reason, as all such terms are defined in the employment
agreement, he will be entitled to receive his base salary then in effect for two (2) years from the
date of termination plus any incentive bonus which otherwise would have been payable to him for any
employment year in which the date of his termination occurred.
Pursuant to his agreement, Mr. Ferry was also granted, in 2008, a restricted stock award of
100,000 shares of Common Stock. The restricted stock award vested as to 33,334 shares on May 31,
2009 with an additional 33,333 shares vesting on May 31, 2010 and the remaining 33,333 shares
vesting on May 31, 2011. The unvested portion of the award will automatically vest if Mr. Ferrys
employment is terminated without cause or for good reason within six (6) months of a change in
control.
On March 1, 2010, the Companys Board of Directors, upon the recommendation and approval of
the Compensation Committee of the Board, increased Mr. Ferrys annual base salary to $370,000 and
awarded him 150,000 shares of restricted common stock. The new restricted stock award will vest in
three equal annual installments with the first installment vesting on March 1, 2011.
Ms. Darlene Deptula-Hicks, our Executive Vice President of Finance and Chief Financial
Officer. On June 25, 2008, we entered into a new employment agreement, as of June 1, 2008, with
Ms. Deptula-Hicks. This agreement replaced and superseded the previous employment agreement entered
into between us and Ms. Deptula-Hicks in September 2006. Ms. Deptula-Hickss employment agreement
provides for her employment as our Executive Vice President of Finance and Chief Financial Officer
for an initial term through December 31, 2011, subject to automatic one-year renewals after the
expiration of the initial term under certain conditions, at an annual base salary of $235,000 with
such increases as determined by the Board. Ms. Deptula-Hicks is also entitled to customary
benefits, including participation in employee benefit plans, and reasonable travel and
entertainment expenses as well as a monthly automobile allowance. The agreement also provides for
her eligibility to receive, during each employment year during the term of the agreement, a target
annual incentive bonus of 40% of her base salary if we achieve goals and objectives determined by
the Board. Ms. Deptula-Hicks will also be eligible to receive such other cash bonuses and such
other compensation as may from time to time be awarded to her by the Board.
51
The employment agreement provides that if her employment is terminated without cause or if
she terminates her employment for good reason, Ms. Deptula-Hicks will receive an amount equal to
her base salary then in effect for one (1) year plus the pro rata portion of any incentive bonus
earned in any employment year through the date of her termination. In the event that within six
months of a change in control, either (i) Ms. Deptula-Hicks is terminated by the Company without
cause or (ii) she terminates her agreement for good reason, as all such terms are defined in
the employment agreement, she will be entitled to receive her base salary then in effect for one
(1) year from the date of termination plus any incentive bonus which otherwise would have been
payable to her for any employment year in which the date of her termination occurred.
Pursuant to her agreement, Ms. Deptula-Hicks was also granted, in 2008, a restricted stock
award of 37,500 shares of Common Stock. The restricted stock award vested as to 12,500 shares on
May 31, 2009 with an additional 12,500 shares vesting on May 31, 2010 and the remaining 12,500
shares vesting on May 31, 2011. The unvested portion of the award will automatically vest if Ms.
Deptula-Hickss employment is terminated without cause or for good reason within six (6) months of
a change in control.
On March 1, 2010, the Companys Board of Directors, upon the recommendation and approval of
the Compensation Committee of the Board, increased Ms. Deptula-Hickss annual base salary to
$245,000 and awarded her 50,000 shares of restricted common stock. The new restricted stock award
will vest in three equal annual installments with the first installment vesting on March 1, 2011.
Mr. Jeffrey Barnes, our Executive Vice President of Global Commercial Operations. On June 25, 2008, we entered into a
new employment agreement, as of June 1, 2008, with Mr. Barnes. This agreement replaced and
superseded the previous employment agreement entered into between us and Mr. Barnes in May 2006.
Mr. Barness employment agreement provides for his employment
for an initial term through December 31, 2011, subject to automatic one-year renewals after the
expiration of the initial term under certain conditions, at an annual base salary of $215,000 with
such increases as determined by the Board. Mr. Barnes is also entitled to customary benefits,
including participation in employee benefit plans, and reasonable travel and entertainment expenses
as well as a monthly automobile allowance. The agreement also provides for his eligibility to
receive, during each employment year during the term of the agreement, a target annual incentive
bonus of 40% of his base salary if we achieve goals and objectives determined by the Board. Mr.
Barnes will also be eligible to receive such other cash bonuses and such other compensation as may
from time to time be awarded to him by the Board.
52
The employment agreement provides that if his employment is terminated without cause or if
he terminates his employment for good reason, Mr. Barnes will receive an amount equal to his base
salary then in effect for one (1) year plus the pro rata portion of any incentive bonus earned in
any employment year through the date of his termination. In the event that within six months of a
change in control, either (i) Mr. Barnes is terminated by the Company without cause or (ii) he
terminates his agreement for good reason, as all such terms are defined in the employment
agreement, he will be entitled to receive his base salary then in effect for one (1) year from the
date of termination plus any incentive bonus which otherwise would have been payable to him for any
employment year in which the date of his termination occurred.
Pursuant to his agreement, Mr. Barnes was also granted, in 2008, a restricted stock award of
37,500 shares of Common Stock. The restricted stock award vested as to 12,500 shares on May 31,
2009 with an additional 12,500 shares vesting on May 31, 2010 and the remaining 12,500 shares
vesting on May 31, 2011. The unvested portion of the award will automatically vest if Mr. Barness
employment is terminated without cause or for good reason within six (6) months of a change in
control.
On October 13, 2009, Mr. Barnes was promoted from the position of Senior Vice President of
Sales to the position of Executive Vice President of Global Commercial Operations of the Company. The
Companys Board of Directors, upon the recommendation and approval of the Compensation Committee of
the Board, approved the following: (i) two cash bonuses of $50,000, with the first $50,000 to be
paid to Mr. Barnes on October 15, 2009 and the second $50,000 cash bonus to be paid to Mr. Barnes
on April 15, 2010, provided, however, that if Mr. Barnes employment with the Company is terminated
prior to the date that is six months after the payment of the first cash bonus or the second cash
bonus, as the case may be (other than a termination by the Company without cause or due to Mr.
Barnes death or disability), he will be required to repay to the Company the first cash bonus or
the second cash bonus, as the case may be; and (ii) an award under of 100,000 shares of the
Companys common stock which will vest in three equal annual installments with the first
installment vesting on October 11, 2010.
On March 1, 2010, the Companys Board of Directors, upon the recommendation and approval of
the Compensation Committee of the Board, increased Mr. Barness annual base salary to $225,000 and
awarded him 45,000 shares of restricted common stock. The new restricted stock award will vest in
three equal annual installments with the first installment vesting on March 1, 2011.
53
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END
The following table sets forth information regarding stock options and restricted stock held
by each of the Named Executive Officers at December 31, 2009.
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Option Awards |
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Stock Awards |
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Number of |
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Number of |
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Number of |
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Shares of |
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Market Value |
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Securities |
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Securities |
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Restricted |
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of Shares or |
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Underlying |
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Underlying |
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Stock That |
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Units of Stock |
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Unexercised |
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Unexercised |
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Option |
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Option |
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Have Not |
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That Have |
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Options (#) |
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Options (#) |
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Exercise Price |
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Expiration |
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Vested |
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Not Vested |
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Name |
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Exercisable |
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Unexercisable |
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($) |
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Date |
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(#) |
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($) |
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Kenneth Ferry |
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750,000 |
(1) |
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1.59 |
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3/15/2011 |
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133,333 |
(2) |
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66,667 |
(2) |
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3.89 |
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7/18/2012 |
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66,667 |
(3) |
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101,334 |
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133,333 |
(4) |
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202,666 |
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Darlene Deptula-Hicks |
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275,000 |
(1) |
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1.80 |
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9/11/2011 |
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66,666 |
(2) |
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33,334 |
(2) |
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3.89 |
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7/18/2012 |
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16,667 |
(3) |
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25,334 |
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50,000 |
(4) |
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76,000 |
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Jeffrey Barnes |
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225,000 |
(1) |
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1.59 |
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3/15/2011 |
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66,666 |
(2) |
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33,334 |
(2) |
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3.89 |
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7/18/2012 |
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16,667 |
(3) |
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25,334 |
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50,000 |
(4) |
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76,000 |
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100,000 |
(5) |
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152,000 |
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(1) |
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The foregoing options vested in five installments at various times between May 15, 2006 and
October 23, 2009. The first installment vested on the grant date of the option, the second
installment vested between 6 to 7 months following the grant date and the remaining three
installments vested annually on or about the grant date of each option. Vesting of the
options accelerated as to the shares to which the options become exercisable at the latest
date (to the extent any such shares remain unvested at the time), upon the closing sale price
of our common stock for a period of twenty (20) consecutive trading days exceeding (i) 200% of
the exercise price of the per share of the options; (ii) 300% of the exercise price per share
of the options or (iv) 400% of the exercise price per share of the options. |
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(2) |
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Each of these options vest in three equal annual installments with the first installment
vesting on July 18, 2008. |
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(3) |
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Each of these restricted stock awards vest in three equal annual installments with the
first installment vesting on July 18, 2008. |
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(4) |
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Each of these restricted stock awards vest in three equal annual installments with the
first installment vesting on May 31, 2009. |
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(5) |
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Each of these restricted stock awards vest in three equal annual installments with the
first installment vesting on October 11, 2010. |
COMPENSATION OF DIRECTORS
Compensation of Directors is determined by the Board in conjunction with recommendations made
by the Compensation Committee. The following is the 2009 compensation paid to those members of the
Board who are not employed by us or any of our subsidiaries and were not employed by us or any of
our subsidiaries at any time during 2009, our Non-Employee Directors.
54
DIRECTOR COMPENSATION
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Fees earned or |
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Option |
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paid in cash (1) |
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Awards (2) |
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Total |
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Name (3) |
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($) |
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($) |
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($) |
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Dr. Lawrence Howard |
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43,000 |
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7,905 |
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50,905 |
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Dr. Rachel Brem |
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33,634 |
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33,634 |
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Anthony Ecock |
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27,500 |
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7,905 |
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35,405 |
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Steven Rappaport |
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42,218 |
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42,218 |
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Maha Sallam |
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5,750 |
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2,085 |
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7,835 |
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Dr. Elliot Sussman |
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38,178 |
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38,178 |
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(1) |
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These amounts do not include fees that were earned but paid in options pursuant to the
election by certain directors to receive options in lieu of cash fees. |
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(2) |
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The amounts included in the Option Awards column represents the grant date fair value
of the stock option awards to directors, computed in accordance with FASB ASC Topic 718.
For a discussion of valuation assumptions, see Note 5 to our consolidated financial
statements. All options granted to directors in 2009 vested immediately. The amounts
included options that were issued in lieu of cash fees pursuant to an election made by
certain of the directors. |
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(3) |
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As of December 31, 2009, the aggregate number of unexercised stock options held by each
person who was a Non-Employee director was as follows: Dr. Howard 66,250; Dr. Brem
204,882; Mr. Ecock 47,500; Mr. Rappaport 161,040; Dr. Sussman 179,566. |
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters.
The following table sets forth certain information regarding our Common Stock owned on March 1,
2010 by (i) each person who is known to us to own beneficially more than 5% of the outstanding
shares of our Common Stock (ii) each of our Named Executive Officers, (iii) each of our directors
and (iv) all current executive officers and directors as a group. Unless otherwise indicated
below, the address of each beneficial owner is c/o iCAD, Inc. 98 Spit Brook Road, Suite 100,
Nashua, New Hampshire 03062.
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Number of Shares |
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Title |
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Name of |
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Beneficially |
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Percentage |
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of Class |
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Beneficial Owner |
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Owned (1) (2) |
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of Class |
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Common |
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Robert Howard |
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5,603,953 |
(3) |
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12.3 |
% |
Common |
|
Kopp Investment Advisors |
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3,096,615 |
(4) |
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6.8 |
% |
Common |
|
Dr. Lawrence Howard |
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1,738,353 |
(5) |
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|
3.8 |
% |
Common |
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Maha Sallam |
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1,301,471 |
(6) |
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|
2.8 |
% |
Common |
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Kenneth Ferry |
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1,371,333 |
(7) |
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|
2.9 |
% |
Common |
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Dr. Rachel Brem |
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220,325 |
(8) |
|
|
* |
|
Common |
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Anthony Ecock |
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51,250 |
(9) |
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* |
|
Common |
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Steven Rappaport |
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383,714 |
(10) |
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* |
|
Common |
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Dr. Elliot Sussman |
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312,610 |
(11) |
|
|
* |
|
Common |
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Jeffrey Barnes |
|
|
340,092 |
(12) |
|
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* |
|
Common |
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Darlene Deptula-Hicks |
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|
391,183 |
(13) |
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* |
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Common |
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All current
executive officers and directors as a group (11 persons) |
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6,682,423 |
(14) |
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13.8 |
% |
55
|
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|
1) |
|
A person is deemed to be the beneficial owner of securities that can be acquired by such
person within 60 days from March 1, 2010, upon (i) the exercise of options; (ii) vesting of
restricted stock; (iii) warrants or rights; (iv) through the conversion of a security; (v)
pursuant to the power to revoke a trust, discretionary account or similar arrangement; or (vi)
pursuant to the automatic termination of a trust, discretionary account or similar
arrangement. Each beneficial owners percentage ownership is determined by assuming that the
options or other rights to acquire beneficial ownership as described above, that are held by
such person (but not those held by any other person) and which are exercisable within 60 days
from March 1, 2010, have been exercised. |
|
2) |
|
Unless otherwise noted, we believe that the persons referred to in the table have sole voting
and investment power with respect to all shares reflected as beneficially owned by them. |
|
3) |
|
Includes options to purchase 15,000 shares of Common Stock at $2.82 per share, 3,750 shares
at $3.50 per share, 3,750 shares at $3.90 per share, 3,750 shares at $2.91 per share and
1,263 shares at $2.00 per shares and 20,000 shares beneficially owned by Mr. Howards wife.
The address of Mr. Howard is 145 East 57th Street, 4th Floor, New York,
NY 10022. |
|
4) |
|
The information is derived from a Schedule 13G filed by Kopp Investment Advisors on January
19, 2010. According to the Schedule 13G the Schedule was being filed by Kopp Investment
Advisors, LLC on behalf of it, its parent company, Kopp Holding Company, LLC (Holding) and
LeRoy C. Kopp who controls Holding. The address of the reporting persons is 7701 France
Avenue South, Suite 500, Edina, MN 55435. |
|
5) |
|
Includes options to purchase 25,000 shares of Common Stock at $2.82 per share, 3,750 shares
at $3.50 per share, 3,750 shares at $3.90 per share, 3,750 shares at $2.91 per share, 3,750
shares at $2.00 per share, 3,750 shares at $2.73 per share, 3,750 shares at $2.90 per share,
3,750 shares at $2.78 per share, 3,750 shares at $1.39 per share, 3,750 shares at $1.01 per
share, 3,750 shares at $1.22, 3,750 shares at $2.03 and 3,750 shares at 1.49 per share. Also
includes 11,500 shares beneficially owed by Dr. Howards wife and 156,000 shares beneficially
owned by Dr. Howards children. |
|
6) |
|
Includes options to purchase 3,750 shares of Common Stock at $1.49 per share and 183,625
shares beneficially owned by Dr. Sallams husband. |
|
7) |
|
Includes options to purchase 750,000 shares of Common Stock at $1.59 per share and 133,333
shares at $3.89 per share. |
|
8) |
|
Consists of options to purchase 45,000 shares of Common Stock at $3.35 per share, 25,000
shares at $2.82 per share, 9,111 shares at $3.50 per share, 7,854 shares at $3.90 per share,
8,860 shares at $2.91 per share, 12,040 shares at $2.00 per share, 9,813 shares at $2.73 per
share, 11,297 shares at $2.90 per share, 9,220 shares at $2.78 per share, 14,990 shares at
$1.39 per share, 20,454 shares at $1.01 per share, 18,564 shares at $1.22 per share, 12,679
shares at $2.03 and 15,443 shares at $1.49 per share. |
56
|
|
|
9) |
|
Consists of options to purchase 25,000 shares of Common Stock at $3.33 per share, 3,750
shares at $2.90 per share, 3,750 shares at $2.78 per share, 3,750 shares at $1.39 per share,
3,750 shares at $1.01 per share, 3,750 shares at $1.22 per share, 3,750 shares at $2.03 per
share and 3,750 shares at $1.49 per share. |
|
10) |
|
Includes options to purchase 25,000 shares of Common Stock at $3.18 per share, 3,750 shares
at $3.50 per share, 3,750 shares at $3.90 per share, 3,750 shares at $2.91 per share, 3,750
shares at $2.00 per share, 12,214 shares at $2.73 per share, 13,065 shares at $2.90 per share,
11,582 shares at $2.78 per share, 20,865 shares at $1.39 per share, 25,674 shares at $1.01 per
share, 21,698 shares at $1.22 per share, 15,942 shares at $2.03 per share and 20,615 shares at
$1.49 per share. |
|
11) |
|
Includes options to purchase 15,000 shares of Common Stock at $1.55 per share, 15,000 shares
at $2.82 per share, 10,068 shares at $3.50 per share, 7,683 shares at $3.90 per share, 9,325
shares at $2.91 per share, 13,422 shares at $2.00 per share, 10,571 shares at $2.73 per share,
12,004 shares at $2.90 per share, 10,463 shares at $2.78 per share, 18,566 shares at $1.39 per
share, 23,934 shares at $1.01 per share, 19,134 shares at $1.22 per share, 14,396 shares at
$2.03 per share and 18,591 shares at $1.49 per share. |
|
12) |
|
Includes options to purchase 225,000 shares of Common Stock at $1.59 per share and 66,666
shares at $3.89 per share. |
|
13) |
|
Includes options to purchase 275,000 shares of Common Stock at $1.80 per share and 66,666
shares at $3.89 per share. |
|
14) |
|
Includes options to purchase 77,562 shares of Common Stock at $1.01 per share, 66,896 shares
at $1.22 per share, 61,921 shares at $1.39 per share, 65,899 shares at $1.49 per share, 15,000
shares at $1.55 per share, 975,000 shares at $1.59 per share, 275,000 shares at $1.80 per
share, 135,000 shares at $1.98 per share, 32,962 shares at $2.00 per share, 50,517 shares at
$2.03 per share, 200,000 shares at $2.27 per share, 36,348 shares at $2.73 per share, 38,765
shares at $2.78 per share, 65,000 shares at $2.82 per share, 43,866 shares at $2.90 per share,
25,685 shares at $2.91 per share, 25,000 shares at $3.18 per share, 25,000 shares at $3.33 per
share, 45,000 shares at $3.35, 26,679 shares at $3.50 per share, 383,331 shares at $3.89 per
share and 23,037 share at $3.90 per share. |
57
Equity Compensation Plans
The following table provides certain information with respect to all of our equity
compensation plans in effect as of December 31, 2009.
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|
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Number of securities |
|
|
|
|
|
|
|
|
|
|
|
remaining available for |
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|
Number of securities to be |
|
|
Weighted-average |
|
|
issuance under equity |
|
|
|
issued upon exercise of |
|
|
exercise price of |
|
|
compensation plans (excluding |
|
|
|
outstanding options, warrants |
|
|
outstanding options, |
|
|
securities reflected in column |
|
Plan Category: |
|
and rights |
|
|
warrants and rights |
|
|
(a)) |
|
Equity compensation plans approved by security holders: |
|
|
3,574,122 |
|
|
$ |
2.83 |
|
|
|
2,944,657 |
|
Equity compensation plans not approved by security holders (1): |
|
|
1,585,000 |
|
|
$ |
1.75 |
|
|
|
-0- |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
5,159,122 |
|
|
$ |
2.50 |
|
|
|
2,944,657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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(1) |
|
Represents the aggregate number of shares of common stock issuable upon exercise of individual
arrangements with non-plan option holders. These options are five years in duration, expire at
various dates between April 15, 2011 and November 3, 2011, contain anti-dilution provisions
providing for adjustments of the exercise price under certain circumstances and have termination
provisions similar to options granted under stockholder approved plans. See Note 5 of Notes to our
consolidated financial statements for a description of our Stock Option and Stock Incentive Plans
and certain information regarding the terms of the non-plan options.
|
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Review, Approval or Ratification of Transactions with related persons
Our Audit Committee is responsible for reviewing and approving or ratifying related-persons
transactions. A related person is any executive officer, director, nominee for director or more
than 5% stockholder of the Company, including any of their immediate family members, and any entity
owned or controlled by such persons. In addition, pursuant to our Code of Business Conduct and
Ethics, all of our employees and directors who have become aware of a conflict or potential
conflict of interest, are required to notify our Chief Executive Officer. There are no written
procedures governing any review of related person transactions.
Independence of the Board of Directors
Our Board of Directors has three standing committees: an Audit Committee, a Compensation
Committee and a Nominating and Corporate Governance Committee. The Board of Directors has
determined that each current member of each committee meets the applicable rules and regulations
regarding independence for such committee, including those set forth in pertinent Nasdaq
Marketplace Rules.
58
Consistent with these considerations, the Board has determined that Messrs. Rappaport and Ecock and
Drs. Brem and Sussman, meet the director independence requirements under the applicable Marketplace
Rule of The Nasdaq Stock Market LLC. In reaching this conclusion the Board reviewed the definition
of independence under the applicable Nasdaq Marketplace Rule and the answers to annual
questionnaires completed by each of the independent directors.
Item 14. Principal Accounting Fees and Services.
The following is a summary of the fees billed to the Company by its independent registered
public accountants, BDO Seidman, LLP for professional services rendered for the years ended
December 31, 2009 and 2008:
Audit Fees. The aggregate fees billed by BDO Seidman, LLP for professional services rendered
for the audit of the Companys annual financial statements for the years ended December 31, 2009
and 2008, the review of the financial statements included in the Companys Forms 10-Q and consents
issued in connection with the Companys filings on Form S-3 and S-8 for 2009 and 2008 totaled
$257,000 and $370,000, respectively.
Audit-Related Fees. No audit-related fees were paid to BDO Seidman, LLP for the years ended
December 31, 2009 and 2008, that are not disclosed in the paragraph captions Audit Fees above.
Tax and all other Fees. No tax fees or other fees were paid to BDO Seidman, LLP for the years
ended December 31, 2009 and 2008.
Pre-Approval Policies and Procedures
The Audit Committee has established its pre-approval policies and procedures, pursuant to
which the Audit Committee approved the foregoing audit services provided by BDO Seidman, LLP in
2009. Consistent with the Audit Committees responsibility for engaging the Companys independent
auditors, all audit and permitted non-audit services require pre-approval by the Audit Committee.
The full Audit Committee pre-approves proposed services and fee estimates for these services. The
Audit Committee chairperson or their designee has been designated by the Audit Committee to
pre-approve any services arising during the year that were not pre-approved by the Audit
Committee. Services pre-approved by the Audit Committee chairperson are communicated to the full
Audit Committee at its next regular meeting and the Audit Committee reviews services and fees for
the fiscal year at each such meeting. Pursuant to these procedures, the Audit Committee
pre-approved the foregoing audit services provided by BDO Seidman, LLP.
59
PART IV
Item 15. Exhibits, Financial Statement Schedules.
a) The following documents are filed as part of this Annual Report on Form 10-K:
|
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|
|
|
|
i. |
|
|
Financial Statements See Index on page 68. |
|
|
|
|
|
ii.
|
|
Financial Statement Schedule See Index on
page 68. All other schedules for which provision is made in the
applicable accounting regulations of the Securities and Exchange
Commission are not required under the related instructions or are not
applicable and, therefore, have been omitted. |
|
|
|
|
|
iii.
|
|
Exhibits the following documents are filed as
exhibits to this Annual Report on Form 10-K: |
|
|
|
|
|
|
2 |
(a) |
|
Plan and Agreement of Merger dated February 15,
2002, by and among the Registrant, ISSI Acquisition Corp. and
Intelligent Systems Software, Inc., Maha Sallam, Kevin Woods and W. Kip
Speyer. [incorporated by reference to Annex A of the Companys proxy
statement/prospectus dated May 24, 2002 contained in the Registrants
Registration Statement on Form S-4, File No. 333-86454]. |
|
|
|
|
|
|
2 |
(b) |
|
Amended and Restated Plan and Agreement of
Merger dated as of December 15, 2003 among the Registrant, Qualia
Computing, Inc., Qualia Acquisition Corp., Steven K. Rogers, Thomas E.
Shoup and James Corbett [incorporated by reference to Exhibit 2(a) to
the Registrants Current Report on Form 8-K for the event dated
December 31, 2003]. |
|
|
|
|
|
|
2 |
(c) |
|
Asset Purchase Agreement as of dated June 20,
2008 between the Registrant and 3TP LLC dba CAD Sciences [incorporated
by reference to Exhibit 2.1 to the Registrants Current Report on Form
8-K for the event dated July 18, 2008]. ** |
|
|
|
|
|
|
3 |
(a) |
|
Certificate of Incorporation of the
Registrant as amended through July 18, 2007 [incorporated by reference
to Exhibit 3(i) to the Registrants Quarterly report on Form 10-Q for
the quarter ended June 30, 2007]. |
|
|
|
|
|
|
3 |
(b) |
|
Amended and Restated By-laws of the Registrant
[incorporated by reference to Exhibit 3 (b) to the Registrants Report
on Form 10-K for the year ended December 31, 2007]. |
60
|
|
|
|
|
|
10 |
(a) |
|
Revolving Loan and Security Agreement, and
Convertible Revolving Credit Promissory Note between Robert Howard and
Registrant dated October 26, 1987 (the Loan Agreement) [incorporated
by reference to Exhibit 10 to the Registrants Report on Form 10-Q for
the quarter ended September 30, 1987]. |
|
|
|
|
|
|
10 |
(b) |
|
Letter Agreement dated June 28, 2002, amending
the Revolving Loan and Security Agreement, and Convertible Revolving
Credit Promissory Note between Robert Howard and Registrant dated
October 26, 1987 [incorporated by reference to Exhibit 10(b) to the
Registrants Report on Form 10-K for the year ended December 31, 2002]. |
|
|
|
|
|
|
10 |
(c) |
|
Form of Secured Demand Notes between the
Registrant and Mr. Robert Howard. [incorporated by reference to Exhibit
10(e) to the Registrants Report on Form 10-K for the year ended
December 31, 1998]. |
|
|
|
|
|
|
10 |
(d) |
|
Form of Security Agreements between the
Registrant and Mr. Robert Howard [incorporated by reference to Exhibit
10(f) to the Registrants Report on Form 10-K for the year ended
December 31, 1998]. |
|
|
|
|
|
|
10 |
(e) |
|
1993 Stock Option Plan [incorporated by
reference to Exhibit A to the Registrants proxy statement on Schedule
14-A filed with the Securities and Exchange Commission on August 24,
1999].* |
|
|
|
|
|
|
10 |
(f) |
|
2001 Stock Option Plan [incorporated by
reference to Annex A of the Registrants proxy statement on Schedule
14-A filed with the Securities and Exchange Commission on June 29,
2001].* |
|
|
|
|
|
|
10 |
(g) |
|
2002 Stock Option Plan [incorporated by
reference to Annex F to the Registrants Registration Statement on Form
S-4 (File No. 333-86454)].* |
|
|
|
|
|
|
10 |
(h) |
|
Addendum No. 19, extending the Revolving Loan
and Security Agreement, and Convertible Revolving Credit Promissory
Note between Robert Howard and Registrant dated October 26, 1987
[incorporated by reference to Exhibit 10.1 of Registrants report on
Form 8-K filed with the SEC on March 1, 2007]. |
|
|
|
|
|
|
10 |
(i) |
|
2004 Stock Incentive Plan [incorporated by
reference to Exhibit B to the Registrants definitive proxy statement
on Schedule 14A filed with the SEC on May 28, 2004].* |
61
|
|
|
|
|
|
10 |
(j) |
|
Form of Option Agreement under the
Registrants 2001 Stock Option Plan [incorporated by reference to
Exhibit 10.1 to the Registrants quarterly report on Form 10-Q for the
quarter ended September 30, 2004].* |
|
|
|
|
|
|
10 |
(k) |
|
Form of Option Agreement under the
Registrants 2002 Stock Option Plan [incorporated by reference to
Exhibit 10.2 to the Registrants quarterly report on Form 10-Q for the
quarter ended September 30, 2004].* |
|
|
|
|
|
|
10 |
(l) |
|
Form of Option Agreement under the
Registrants 2004 Stock Incentive Plan [incorporated by reference to
Exhibit 10.3 to the Registrants quarterly report on Form 10-Q for the
quarter ended September 30, 2004].* |
|
|
|
|
|
|
10 |
(m) |
|
Intentionally omitted. |
|
|
|
|
|
|
10 |
(n) |
|
2005 Stock Incentive Plan [incorporated by
reference to Exhibit 10.1 to the Registrants report on Form 8-K filed
with the SEC on June 28, 2005].* |
|
|
|
|
|
|
10 |
(o) |
|
Form of Option Agreement under the
Registrants 2005 Stock Incentive Plan [incorporated by reference to
Exhibit 10.2 to the Registrants report on Form 8-K filed with the SEC
on June 28, 2005].* |
|
|
|
|
|
|
10 |
(p) |
|
Lease Agreement dated October 9, 2000 between
the Registrant and Mills-Morgan Development, LTD, of Beavercreek, OH
[incorporated by reference to Exhibit 10(v) to the Registrants Report
on Form 10-K for the year ended December 31, 2005]. |
|
|
|
|
|
|
10 |
(q) |
|
Lease Agreement dated October 9, 2000 between
the Registrant and Mills-Morgan Development, LTD, of Beavercreek, OH
[incorporated by reference to Exhibit 10(w) to the Registrants Report
on Form 10-K for the year ended December 31, 2005]. |
|
|
|
|
|
|
10 |
(r) |
|
Addendum No. 18 to the Revolving Loan and
Security Agreement, and Convertible Revolving Credit Promissory Note
between Robert Howard and the Registrant dated October 26, 1987
[incorporated by reference to Exhibit 10.1 of Registrants Quarterly
report on Form 10-Q for the quarter ended March 31, 2006]. |
62
|
|
|
|
|
|
10 |
(s) |
|
Employment Agreement dated April 19, 2006
between the Registrant and Kenneth Ferry [incorporated by reference to
Exhibit 10.1 of Registrants Quarterly report on Form 10-Q for the
quarter ended June 30, 2006].* |
|
|
|
|
|
|
10 |
(t) |
|
Employment Agreement dated April 19, 2006
between the Registrant and Jeffrey Barnes [incorporated by reference to
Exhibit 10.2 of Registrants Quarterly report on Form 10-Q for the
quarter ended June 30, 2006].* |
|
|
|
|
|
|
10 |
(u) |
|
Employment Agreement dated April 28, 2006
between the Registrant and Stacey Stevens [incorporated by reference to
Exhibit 10.3 of Registrants Quarterly report on Form 10-Q for the
quarter ended June 30, 2006].* |
|
|
|
|
|
|
10 |
(v) |
|
Intentionally omitted. |
|
|
|
|
|
|
10 |
(w) |
|
Note Purchase Agreement between Ken Ferry, the
Registrants Chief Executive Officer, and the Registrant dated June 19,
2006 [incorporated by reference to Exhibit 10.5 of Registrants
Quarterly report on Form 10-Q for the quarter ended June 30, 2006]. |
|
|
|
|
|
|
10 |
(x) |
|
Form of Indemnification Agreement with each of
the Registrants directors and officers [incorporated by reference to
Exhibit 10.6 of Registrants Quarterly report on Form 10-Q for the
quarter ended June 30, 2006]. |
|
|
|
|
|
|
10 |
(y) |
|
Employment Agreement dated September 8, 2006
between the Registrant and Darlene M. Deptula-Hicks [incorporated by
reference to Exhibit 10.1 of Registrants report on Form 8-K filed with
the SEC on September 13, 2006].* |
|
|
|
|
|
|
10 |
(z) |
|
Option Agreement dated September 8, 2006
between the Registrant and Darlene M. Deptula-Hicks [incorporated by
reference to Exhibit 10.2 of the Registrants report on Form 8-K filed
with the SEC on September 13, 2006].* |
|
|
|
|
|
|
10 |
(aa) |
|
Note Purchase Agreement between certain of the Registrants
Directors and Executive Officers and the Registrant dated September 12
and 14, 2006 [incorporated by reference to Exhibit 10.3 of the
Registrants Quarterly report on Form 10-Q for the quarter ended
September 30, 2006]. |
63
|
|
|
|
|
10(bb)
|
|
Form on Note Purchase Agreement between certain investors and the
Registrant dated September 19, 2006 [incorporated by reference to
Exhibit 10.4 of the Registrants Quarterly report on Form 10-Q for the
quarter ended September 30, 2006].* |
|
|
|
|
|
10(cc)
|
|
Option Agreement dated April 19, 2006 between the Registrant and
Kenneth Ferry [incorporated by reference to Exhibit 10.5 of the
Registrants Quarterly report on Form 10-Q for the quarter ended
September 30, 2006].* |
|
|
|
|
|
10(dd)
|
|
Option Agreement dated April 19, 2006 between the Registrant and
Jeffrey Barnes [incorporated by reference to Exhibit 10.6 of the
Registrants Quarterly report on Form 10-Q for the quarter ended
September 30, 2006].* |
|
|
|
|
|
10(ee)
|
|
Option Agreement dated April 19, 2006 between the Registrant and
Stacey Stevens [incorporated by reference to Exhibit 10.7 of the
Registrants Quarterly report on Form 10-Q for the quarter ended
September 30, 2006].* |
|
|
|
|
|
10(ff)
|
|
Addendum No. 19 dated March 1, 2007, extending the Revolving Loan and
Security Agreement, and Convertible Revolving Credit Promissory Note
between Robert Howard and the Registrant dated October 26, 1987
[incorporated by reference to Exhibit 10.1 of the Registrants report
on Form 8-K filed with the SEC on March 7, 2007]. |
|
|
|
|
|
10(gg)
|
|
Lease Agreement dated December 6, 2006 between the Registrant and
Gregory D. Stoyle and John J. Flatley, Trustees of the 1993 Flatley
Family Trust, of Nashua, NH [incorporated by reference to Exhibit
10(mm) to the Registrants Report on Form 10-K for the year ended
December 31, 2006]. |
|
|
|
|
|
10(hh)
|
|
Employment Agreement dated October 20, 2006 between the Registrant
and Jonathan Go [incorporated by reference to Exhibit 10(nn) to the
Registrants Report on Form 10-K for the year ended December 31,
2006].* |
|
|
|
|
|
10(ii)
|
|
Option Agreement dated November 3, 2006 between the Registrant and
Jonathan Go [incorporated by reference to Exhibit 10(oo) to the
Registrants Report on Form 10-K for the year ended December 31,
2006].* |
64
|
|
|
|
|
10(jj)
|
|
2007 Stock Incentive Plan, as amended [incorporated by reference to
Appendix A to the Companys definitive proxy statement on Schedule 14A
filed with the SEC on June 16, 2009]. * |
|
|
|
|
|
10(kk)
|
|
Addendum No. 20 dated May 6, 2008, extending the Revolving Loan and
Security Agreement, and Convertible Revolving Credit Promissory Note
between Robert Howard and the Registrant dated October 26, 1987
[incorporated by reference to Exhibit 10.1 of the Registrants
report on Form 10-Q filed with the SEC on May 8, 2008]. |
|
|
|
|
|
10(ll)
|
|
Escrow Agreement dated as of July 18, 2008 by and among the
Registrant, 3TP LLC dba CAD Sciences and U.S. Bank National Association
[incorporated by reference to Exhibit 10.1 to the Registrants Current
Report on Form 8-K for the event dated July 18, 2008]. |
|
|
|
|
|
10(mm)
|
|
Loan and Security Agreement dated June 30, 2008 by and between the
Registrant and RBS Citizens, N.A. [incorporated by reference to Exhibit
10.1 filed with the Registrants Current Report on Form 8-K for the event
dated June 30, 2008]. ** |
|
|
|
|
|
10(nn)
|
|
Revolving Note dated as of June 30, 2008 made by the Registrant in
favor of RBS Citizens, N.A. [incorporated by reference to Exhibit 10.2
filed with the Registrants Current Report on Form 8-K for the event
dated June 30, 2008]. |
|
|
|
|
|
10(oo)
|
|
Negative Pledge Agreement dated June 30, 2008 by the Registrant as
accepted by RBS Citizens, N.A. [incorporated by reference to Exhibit 10.3
filed with the Registrants Current Report on Form 8-K for the event
dated June 30, 2008]. |
|
|
|
|
|
10(pp)
|
|
Employment Agreement entered into as of June 1, 2008 between the
Registrant and Kenneth Ferry [incorporated by reference to Exhibit 10.5
of the Registrants report on Form 10-Q filed with the SEC on August 8,
2008] * |
|
|
|
|
|
10(qq)
|
|
Employment Agreement entered into as of June 1, 2008 between the
Registrant and Darlene Deptula-Hicks [incorporated by reference to
Exhibit 10.6 of the Registrants report on Form 10-Q filed with the SEC
on August 8, 2008] * |
|
|
|
|
|
10(rr)
|
|
Employment Agreement entered into as of June 1, 2008 between the
Registrant and Jeffrey Barnes [incorporated by reference to Exhibit 10.7
of the Registrants report on Form 10-Q filed with the SEC on August 8,
2008]. * |
65
|
|
|
|
|
10(ss)
|
|
Employment Agreement entered into as of June 1, 2008 between
the Registrant and Stacey Stevens [incorporated by reference to
Exhibit 10.8 of the Registrants report on Form 10-Q filed with the SEC
on August 8, 2008]. * |
|
|
|
|
|
10(tt)
|
|
Employment Agreement dated as of June 1, 2008 between the Registrant
and Jonathan Go [incorporated by reference to Exhibit 10.9 of the
Registrants report on Form 10-Q filed with the SEC on August 8, 2008]. * |
|
|
|
|
|
10(uu)
|
|
First Amendment dated as of April 22, 2009 to the June 30, 2008 Loan
and Security Agreement between the Registrant and RBS Citizens, N.A.
[incorporated by reference to Exhibit 10.1 of the Registrants report on
Form 10-Q filed with the SEC on August 7, 2009]. |
|
|
|
|
|
10(vv)
|
|
Form of Option Agreement under the Registrants 2007 Stock Incentive
Plan.* |
|
|
|
|
|
10(ww)
|
|
Form of Restricted Stock Agreement under the Registrants 2007 Stock
Incentive Plan.* |
|
|
|
|
|
|
23.1 |
|
|
Consent of BDO Seidman, LLP, Independent
Registered Public Accounting Firm. |
|
|
|
|
|
|
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. |
|
|
|
* |
|
Denotes a management compensation plan or arrangement. |
|
** |
|
The Registrant has omitted certain schedules and exhibits pursuant to Item
601(b)(2) of Regulation S-K and shall furnish supplementally to the SEC copies any of
the omitted schedules and exhibits upon request by the SEC. |
(b) Exhibits See (a) iii above.
(c) Financial Statement Schedule See (a) ii above.
66
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
|
|
Date: March 23, 2010
|
|
|
|
By: |
/s/ Kenneth Ferry
|
|
|
|
Kenneth Ferry |
|
|
|
President, Chief Executive Officer, Director |
|
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the capacities and on the
dates indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ Lawrence Howard
Dr. Lawrence Howard
|
|
Chairman of the Board,
Director
|
|
March 23, 2010 |
|
|
|
|
|
/s/ Kenneth Ferry
Kenneth Ferry
|
|
President, Chief Executive
Officer, Director (Principal
Executive Officer)
|
|
March 23, 2010 |
|
|
|
|
|
/s/ Darlene M. Deptula-Hicks
Darlene M. Deptula-Hicks
|
|
Executive Vice President of Finance,
Chief Financial Officer, Treasurer
(Principal Financial and Accounting
Officer)
|
|
March 23, 2010 |
|
|
|
|
|
/s/ Rachel Brem
|
|
Director
|
|
March 23, 2010 |
|
|
|
|
|
|
|
|
|
|
/s/ Anthony Ecock
|
|
Director
|
|
March 23, 2010 |
|
|
|
|
|
|
|
|
|
|
/s/ Steven Rappaport
|
|
Director
|
|
March 23, 2010 |
|
|
|
|
|
|
|
|
|
|
/s/ Maha Sallam
|
|
Director
|
|
March 23, 2010 |
|
|
|
|
|
|
|
|
|
|
/s/ Elliot Sussman
|
|
Director
|
|
March 23, 2010 |
|
|
|
|
|
67
INDEX TO FINANCIAL STATEMENTS
|
|
|
|
|
|
|
Page |
|
|
|
|
|
69 |
|
|
|
|
|
|
|
|
|
70 |
|
|
|
|
|
|
|
|
|
71 |
|
|
|
|
|
|
|
|
|
72 |
|
|
|
|
|
|
|
|
|
73 |
|
|
|
|
|
|
|
|
|
74-101 |
|
68
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of iCAD, Inc.,
Nashua, New Hampshire
We have audited the accompanying consolidated balance sheets of iCAD, Inc. and subsidiary (the
Company) as of December 31, 2009 and 2008, and the related consolidated statements of operations,
stockholders equity, and cash flows for each of the three years in the period ended December 31,
2009. These financial statements are the responsibility of the Companys management. Our
responsibility is to express an opinion on the financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. The
Company is not required to have, nor were we engaged to perform, an audit of its internal controls
over financial reporting. Our audits included consideration of internal control over financial
reporting as a basis for designing audit procedures that are appropriate in the circumstances, but
not for the purpose of expressing an opinion on the effectiveness of the Companys internal control
over financial reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and significant estimates made by management,
as well as evaluating the overall financial statement presentation. We believe that our audits
provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of iCAD, Inc. and subsidiary as of December 31, 2009 and
2008, and the results of their operations and their cash flows for each of the three years in the
period ended December 31, 2009 in conformity with accounting principles generally accepted in the
United States of America.
/s/ BDO Seidman, LLP
Boston, Massachusetts
March 23, 2010
69
iCAD,
INC. AND SUBSIDIARY
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
16,248,031 |
|
|
$ |
13,115,715 |
|
Trade accounts receivable, net of allowance for doubtful
accounts of $84,000 in 2009 and $50,000 in 2008 |
|
|
4,692,614 |
|
|
|
5,570,323 |
|
Inventory, net |
|
|
1,094,115 |
|
|
|
1,448,373 |
|
Prepaid and other current assets |
|
|
393,490 |
|
|
|
451,402 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
22,428,250 |
|
|
|
20,585,813 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment: |
|
|
|
|
|
|
|
|
Equipment |
|
|
2,873,012 |
|
|
|
3,492,977 |
|
Leasehold improvements |
|
|
72,612 |
|
|
|
75,590 |
|
Furniture and fixtures |
|
|
344,700 |
|
|
|
358,477 |
|
Marketing assets |
|
|
292,613 |
|
|
|
287,456 |
|
|
|
|
|
|
|
|
|
|
|
3,582,937 |
|
|
|
4,214,500 |
|
Less accumulated depreciation and amortization |
|
|
2,661,083 |
|
|
|
2,714,706 |
|
|
|
|
|
|
|
|
Net property and equipment |
|
|
921,854 |
|
|
|
1,499,794 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets: |
|
|
|
|
|
|
|
|
Deposits |
|
|
63,194 |
|
|
|
63,194 |
|
Patents, net of accumulated amortization |
|
|
90,027 |
|
|
|
22,349 |
|
Customer relationships, net of accumulated amortization |
|
|
200,407 |
|
|
|
236,634 |
|
Technology intangibles, net of accumulated amortization |
|
|
6,093,294 |
|
|
|
7,142,662 |
|
Tradename, net of accumulated amortization |
|
|
99,200 |
|
|
|
124,000 |
|
Goodwill |
|
|
43,515,285 |
|
|
|
43,515,285 |
|
|
|
|
|
|
|
|
Total other assets |
|
|
50,061,407 |
|
|
|
51,104,124 |
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
73,411,511 |
|
|
$ |
73,189,731 |
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,365,558 |
|
|
$ |
2,189,093 |
|
Accrued salaries and other expenses |
|
|
2,222,561 |
|
|
|
2,752,818 |
|
Deferred revenue |
|
|
3,139,567 |
|
|
|
1,888,865 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
6,727,686 |
|
|
|
6,830,776 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term deferred revenue |
|
|
375,183 |
|
|
|
66,630 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
7,102,869 |
|
|
|
6,897,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, $ .01 par value: authorized 1,000,000 shares;
issues and outstanding 0 in 2009 and 2008 |
|
|
|
|
|
|
|
|
Common stock, $ .01 par value: authorized 85,000,000
shares; issued 45,746,736 in 2009 and 45,411,384 in 2008;
outstanding 45,678,860 in 2009 and 45,343,508 in 2008 |
|
|
457,467 |
|
|
|
454,034 |
|
Additional paid-in capital |
|
|
150,062,733 |
|
|
|
148,082,225 |
|
Accumulated deficit |
|
|
(83,261,294 |
) |
|
|
(81,293,670 |
) |
Treasury stock at cost (67,876 shares) |
|
|
(950,264 |
) |
|
|
(950,264 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
66,308,642 |
|
|
|
66,292,325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
73,411,511 |
|
|
$ |
73,189,731 |
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
70
iCAD, INC. AND SUBSIDIARY
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
Products |
|
$ |
24,085,483 |
|
|
$ |
34,172,311 |
|
|
$ |
23,198,296 |
|
Service and supplies |
|
|
4,023,782 |
|
|
|
3,319,237 |
|
|
|
3,414,116 |
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
28,109,265 |
|
|
|
37,491,548 |
|
|
|
26,612,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
Products |
|
|
3,904,604 |
|
|
|
5,414,009 |
|
|
|
4,271,504 |
|
Service and supplies |
|
|
717,180 |
|
|
|
762,021 |
|
|
|
985,600 |
|
|
|
|
|
|
|
|
|
|
|
Total cost of revenue |
|
|
4,621,784 |
|
|
|
6,176,030 |
|
|
|
5,257,104 |
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
23,487,481 |
|
|
|
31,315,518 |
|
|
|
21,355,308 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Engineering and product development |
|
|
7,217,146 |
|
|
|
7,121,334 |
|
|
|
4,504,000 |
|
Marketing and sales |
|
|
11,037,716 |
|
|
|
11,961,907 |
|
|
|
10,780,304 |
|
General and administrative |
|
|
7,353,585 |
|
|
|
7,466,488 |
|
|
|
7,174,807 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
25,608,447 |
|
|
|
26,549,729 |
|
|
|
22,459,111 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from operations |
|
|
(2,120,966 |
) |
|
|
4,765,789 |
|
|
|
(1,103,803 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
119,103 |
|
|
|
106,032 |
|
|
|
74,145 |
|
Interest expense (includes $0, ($201,295)
and ($412,073), respectively, to related parties) |
|
|
(9,331 |
) |
|
|
(280,632 |
) |
|
|
(508,874 |
) |
|
|
|
|
|
|
|
|
|
|
Other expense, net |
|
|
109,772 |
|
|
|
(174,600 |
) |
|
|
(434,729 |
) |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before provision (benefit) for income taxes |
|
|
(2,011,194 |
) |
|
|
4,591,189 |
|
|
|
(1,538,532 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for income taxes |
|
|
(43,570 |
) |
|
|
235,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(1,967,624 |
) |
|
|
4,356,189 |
|
|
|
(1,538,532 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred dividends |
|
|
|
|
|
|
|
|
|
|
67,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) available to common stockholders |
|
$ |
(1,967,624 |
) |
|
$ |
4,356,189 |
|
|
$ |
(1,606,292 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.04 |
) |
|
$ |
0.10 |
|
|
$ |
(0.04 |
) |
Diluted |
|
$ |
(0.04 |
) |
|
$ |
0.10 |
|
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares used in
computing income (loss) per share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
45,511,883 |
|
|
|
41,704,374 |
|
|
|
38,351,345 |
|
Diluted |
|
|
45,511,883 |
|
|
|
42,748,052 |
|
|
|
38,351,345 |
|
See accompanying notes to consolidated financial statements.
71
iCAD, INC. AND SUBSIDIARY
Consolidated Statements of Stockholders Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-in |
|
|
Accumulated |
|
|
Treasury |
|
|
Stockholders |
|
|
|
Shares Issued |
|
|
Par Value |
|
|
Shares Issued |
|
|
Par Value |
|
|
Capital |
|
|
Deficit |
|
|
Stock |
|
|
Equity |
|
Balance at December 31, 2006 |
|
|
6,295 |
|
|
$ |
63 |
|
|
|
37,290,848 |
|
|
$ |
372,908 |
|
|
$ |
132,660,347 |
|
|
$ |
(84,111,327 |
) |
|
$ |
(950,264 |
) |
|
$ |
47,971,727 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant
to stock option plans |
|
|
|
|
|
|
|
|
|
|
860,860 |
|
|
|
8,609 |
|
|
|
1,231,488 |
|
|
|
|
|
|
|
|
|
|
|
1,240,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock relative to
conversion of preferred stock |
|
|
(6,295 |
) |
|
|
(63 |
) |
|
|
1,087,500 |
|
|
|
10,875 |
|
|
|
(10,812 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,242,155 |
|
|
|
|
|
|
|
|
|
|
|
1,242,155 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(67,760 |
) |
|
|
|
|
|
|
|
|
|
|
(67,760 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,538,532 |
) |
|
|
|
|
|
|
(1,538,532 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
39,239,208 |
|
|
|
392,392 |
|
|
|
135,055,418 |
|
|
|
(85,649,859 |
) |
|
|
(950,264 |
) |
|
|
48,847,687 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant
to stock option plans |
|
|
|
|
|
|
|
|
|
|
952,612 |
|
|
|
9,526 |
|
|
|
1,859,376 |
|
|
|
|
|
|
|
|
|
|
|
1,868,902 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock relative to
vesting of restricted stock, net of stock
forfeited for tax obligations |
|
|
|
|
|
|
|
|
|
|
110,007 |
|
|
|
1,100 |
|
|
|
(1,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock relative to
the asset acquisition |
|
|
|
|
|
|
|
|
|
|
1,086,957 |
|
|
|
10,870 |
|
|
|
2,989,130 |
|
|
|
|
|
|
|
|
|
|
|
3,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock relative to
conversion of loans payable |
|
|
|
|
|
|
|
|
|
|
4,022,600 |
|
|
|
40,226 |
|
|
|
6,316,691 |
|
|
|
|
|
|
|
|
|
|
|
6,356,917 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,862,630 |
|
|
|
|
|
|
|
|
|
|
|
1,862,630 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,356,189 |
|
|
|
|
|
|
|
4,356,189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
45,411,384 |
|
|
|
454,114 |
|
|
|
148,082,145 |
|
|
|
(81,293,670 |
) |
|
|
(950,264 |
) |
|
|
66,292,325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant
to stock option plans |
|
|
|
|
|
|
|
|
|
|
47,161 |
|
|
|
472 |
|
|
|
23,022 |
|
|
|
|
|
|
|
|
|
|
|
23,494 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock relative to
vesting of restricted stock, net of stock
forfeited for tax obligations |
|
|
|
|
|
|
|
|
|
|
292,147 |
|
|
|
2,921 |
|
|
|
(25,491 |
) |
|
|
|
|
|
|
|
|
|
|
(22,570 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Return of common stock relative to
the asset acquisition |
|
|
|
|
|
|
|
|
|
|
(3,956 |
) |
|
|
(40 |
) |
|
|
(10,878 |
) |
|
|
|
|
|
|
|
|
|
|
(10,918 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,993,935 |
|
|
|
|
|
|
|
|
|
|
|
1,993,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,967,624 |
) |
|
|
|
|
|
|
(1,967,624 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
|
|
|
$ |
|
|
|
|
45,746,736 |
|
|
$ |
457,467 |
|
|
$ |
150,062,733 |
|
|
$ |
(83,261,294 |
) |
|
$ |
(950,264 |
) |
|
$ |
66,308,642 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
72
iCAD, INC. AND SUBSIDIARY
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Cash flow from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(1,967,624 |
) |
|
$ |
4,356,189 |
|
|
$ |
(1,538,532 |
) |
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net income (loss) to net cash provided
by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
751,464 |
|
|
|
898,142 |
|
|
|
982,869 |
|
Amortization |
|
|
1,169,743 |
|
|
|
942,820 |
|
|
|
719,008 |
|
Loss on disposal of assets |
|
|
|
|
|
|
23,941 |
|
|
|
17,680 |
|
Stock based compensation expense |
|
|
1,993,935 |
|
|
|
1,862,630 |
|
|
|
1,242,155 |
|
Non-cash interest expense associated with discount on convertible
loans payable |
|
|
|
|
|
|
22,059 |
|
|
|
29,412 |
|
Changes in operating assets and liabilities, net of acquisition: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
877,709 |
|
|
|
1,030,295 |
|
|
|
(2,800,440 |
) |
Inventory |
|
|
354,258 |
|
|
|
349,870 |
|
|
|
1,233,752 |
|
Prepaid and other current assets |
|
|
57,912 |
|
|
|
(131,233 |
) |
|
|
(100,446 |
) |
Accounts payable |
|
|
(823,535 |
) |
|
|
10,928 |
|
|
|
(546,391 |
) |
Accrued interest |
|
|
|
|
|
|
181,082 |
|
|
|
454,785 |
|
Accrued salaries and other expenses |
|
|
(530,257 |
) |
|
|
(50,282 |
) |
|
|
(5,166 |
) |
Deferred revenue |
|
|
1,559,255 |
|
|
|
281,490 |
|
|
|
885,883 |
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
|
5,410,484 |
|
|
|
5,421,742 |
|
|
|
2,113,101 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
3,442,860 |
|
|
|
9,777,931 |
|
|
|
574,569 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Additions to patents, technology and other |
|
|
(137,944 |
) |
|
|
(38,839 |
) |
|
|
(2,750 |
) |
Additions to property and equipment |
|
|
(173,524 |
) |
|
|
(582,102 |
) |
|
|
(711,591 |
) |
Acquisition of CAD Sciences |
|
|
|
|
|
|
(2,000,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used by investing activities |
|
|
(311,468 |
) |
|
|
(2,620,941 |
) |
|
|
(714,341 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for cash |
|
|
23,494 |
|
|
|
1,868,902 |
|
|
|
1,240,097 |
|
Taxes paid related to restricted stock issuance |
|
|
(22,570 |
) |
|
|
|
|
|
|
|
|
Payment of convertible notes payable |
|
|
|
|
|
|
(258,906 |
) |
|
|
|
|
Payment of note payable |
|
|
|
|
|
|
|
|
|
|
(375,000 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
924 |
|
|
|
1,609,996 |
|
|
|
865,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in cash and equivalents |
|
|
3,132,316 |
|
|
|
8,766,986 |
|
|
|
725,325 |
|
Cash and equivalents, beginning of year |
|
|
13,115,715 |
|
|
|
4,348,729 |
|
|
|
3,623,404 |
|
|
|
|
|
|
|
|
|
|
|
Cash and equivalents, end of year |
|
$ |
16,248,031 |
|
|
$ |
13,115,715 |
|
|
$ |
4,348,729 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
9,331 |
|
|
$ |
55,598 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Taxes paid |
|
$ |
95,000 |
|
|
$ |
353,000 |
|
|
$ |
64,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash items from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Fair market value of iCAD common stock issued to acquire
assets of CAD Sciences |
|
$ |
|
|
|
$ |
3,000,000 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible notes payable and related accrued
interest into common stock |
|
$ |
|
|
|
$ |
6,356,917 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Return of
common stock from escrow related to asset acquisition |
|
$ |
10,918 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends payable with common stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
67,760 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
73
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements
(1) |
|
Summary of Significant Accounting Policies |
(a) Nature of Operations and Use of Estimates
iCAD, Inc. (the Company or iCAD) is a provider of Computer Aided Detection (CAD)
solutions that enable radiologists and other healthcare professionals to better serve
patients by identifying pathologies and pinpointing cancer earlier. CAD is performed as an
adjunct to certain medical screening procedures. CAD is reimbursable in the U.S. under
federal and most third-party insurance programs. In July 2008, through the asset
acquisition of 3TP LLC dba CAD Sciences (CAD Sciences), the Company acquired
pharmaco-kinetic based CAD products that aid in the interpretation of contrast enhanced MRI
images of the breast and prostate. iCAD is also developing CAD solutions for use with
virtual colonoscopy to improve the detection of colonic polyps while delivering improved
workflow for the radiologists, and higher quality patient care.
The Company considers itself a single reportable business segment. The Company sells its
products throughout the world through its direct sales organization as well as through
various OEMs partners, distributors and resellers. See Note 7 for geographical and major
customer information.
The preparation of financial statements in conformity with generally accepted accounting
principles in the United States of America requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the reporting period. Actual results could differ
from those estimates. Many of the Companys estimates and assumptions used in the
preparation of the financial statements relate to the Companys products, which are subject
to rapid technological change. It is reasonably possible that changes may occur in the near
term that would affect managements estimates with respect to assets and liabilities.
(b) Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its former
wholly-owned subsidiary, Qualia Acquisition Corporation. Any material inter-company
transactions and balances have been eliminated in consolidation. Qualia Acquisition
Corporation was dissolved in 2008.
(c) Cash Flow Information
For purposes of reporting cash flows, the Company defines cash and cash equivalents as all bank
transaction accounts, certificates of deposit, money market funds, deposits and other money market
instruments with original maturities of 90 days or less, which are
unrestricted as to withdrawal. The Company maintains its cash in bank deposit accounts,
which, at times, may exceed federally insured limits. At December 31, 2009, most of the
balance of cash and cash equivalents exceeded federally insured limits, but was maintained
in money market funds. The Company has not experienced any losses in such accounts and does
not believe it is exposed to any significant credit risk on cash.
74
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(d) Financial instruments
The carrying amounts of financial instruments, including cash and equivalents, accounts
receivable and accounts payable, approximated fair value as of December 31, 2009 and 2008
due to their short-term nature.
(e) Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable are customer obligations due under normal trade terms. Credit limits are
established through a process of reviewing the financial history and stability of each
customer. The Company performs continuing credit evaluations of its customers financial
condition and generally does not require collateral.
The Companys policy is to maintain allowances for estimated losses from the inability of
its customers to make required payments. Credit limits are established through a process of
reviewing the financial history and stability of each customer. Where appropriate, the
Company obtains credit rating reports and financial statements of customers when determining
or modifying credit limits. The Companys senior management reviews accounts receivable on
a periodic basis to determine if any receivables may potentially be uncollectible. The
Company includes any accounts receivable balances that it determines may likely be
uncollectible, along with a general reserve for estimated probable losses based on
historical experience, in its overall allowance for doubtful accounts. An amount would be
written off against the allowance after all attempts to collect the receivable had failed.
Based on the information available to the Company, it believes the allowance for doubtful
accounts as of December 31, 2009 is adequate. The Company reviews its reserve balance on a
quarterly basis.
(f) Inventory
Inventory is valued at the lower of cost or market value, with cost determined by the
first-in, first-out method. At December 31, inventory consisted of finished goods and raw
material of approximately $979,402 and $114,713, respectively, for 2009, and finished goods
and raw material of approximately $1,158,289 and $290,084, respectively, for
2008. The Company regularly reviews inventory quantities on hand and records a reserve for
excess and/or obsolete inventory primarily based upon the estimated usage of its inventory
as well as other factors.
75
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(g) Property and Equipment
Property and equipment are stated at cost and depreciated using the straight-line method
over the estimated useful lives of the various classes of assets (ranging from 3 to 5 years)
or the remaining lease term, whichever is shorter for leasehold improvements.
(h) Long Lived Assets
Long-lived assets, other than goodwill, are evaluated for impairment when events or changes
in circumstances indicate that the carrying amount of the assets may not be recoverable
through the estimated undiscounted future cash flows from the use of these assets. When any
such impairment exists, the related assets are written down to fair value. Intangible
assets subject to amortization consist primarily of patents, technology intangibles, trade
name, customer relationships and distribution agreements purchased in the Companys previous
acquisitions. These assets are amortized on a straight-line basis or the pattern of
economic benefit over their estimated useful lives of 5 to 10 years.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
Average |
|
For the years ended December 31, |
|
2009 |
|
|
2008 |
|
|
Useful Life |
|
Gross carrying amount: |
|
|
|
|
|
|
|
|
|
|
|
|
Patents |
|
$ |
480,651 |
|
|
$ |
412,829 |
|
|
5 years |
Customer relationships |
|
|
248,000 |
|
|
|
248,000 |
|
|
10 years |
Technology |
|
|
11,085,373 |
|
|
|
11,026,170 |
|
|
10 years |
Tradename |
|
|
248,000 |
|
|
|
248,000 |
|
|
10 years |
|
|
|
|
|
|
|
|
|
|
|
Total amortizable intangible assets |
|
|
12,062,024 |
|
|
|
11,934,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated amortization |
|
|
|
|
|
|
|
|
|
|
|
|
Patents |
|
|
390,624 |
|
|
|
390,480 |
|
|
|
|
|
Customer relationships |
|
|
47,593 |
|
|
|
11,366 |
|
|
|
|
|
Technology |
|
|
4,992,079 |
|
|
|
3,883,508 |
|
|
|
|
|
Tradename |
|
|
148,800 |
|
|
|
124,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total accumulated amortization |
|
|
5,579,096 |
|
|
|
4,409,354 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortizable intangible assets, net |
|
$ |
6,482,928 |
|
|
$ |
7,525,645 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
76
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(h) Long Lived Assets (continued)
Amortization expense related to intangible assets was approximately $1,170,000, $943,000 and
$719,000 for the years ended December 31, 2009, 2008, and 2007, respectively. Estimated
amortization of the Companys intangible assets for the next five fiscal years is as
follows:
|
|
|
|
|
|
|
Estimated |
|
|
|
amortization |
|
For the years ended December 31: |
|
expense |
|
2010 |
|
|
1,179,000 |
|
2011 |
|
|
1,179,000 |
|
2012 |
|
|
986,000 |
|
2013 |
|
|
792,000 |
|
2014 |
|
|
518,000 |
|
(i) Goodwill
At October 1, 2009 and October 1, 2008, the Companys consolidated balance sheet included
$43,515,285 in goodwill. Goodwill represents the excess purchase price over amounts assigned
to tangible or identifiable intangible assets acquired and liabilities assumed from its
acquisitions.
In accordance with FASB ASC 350-20, the Company tests its goodwill for impairment on an
annual basis, which it has determined to be the first business day of October each year. The
Company also tests its goodwill for impairment between annual tests if an event occurs or
circumstances change that would, more likely than not, reduce the fair value of the
reporting unit below its carrying value. ASC 350-20 requires a two-step method for
determining goodwill impairment. Step one is to compare the fair value of the reporting unit
with the units carrying amount, including goodwill. If this test indicates that the fair
value is less than the carrying value, then step two is required to compare the implied fair
value of the reporting units goodwill with the carrying amount of the reporting units
goodwill.
The Companys goodwill arose in connection with the acquisition of ISSI in June 2002 and
with the acquisition of CADx 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.
77
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(i) Goodwill
(continued)
No goodwill impairment loss was recorded in 2009 or 2008. For 2009 and 2008, the Company
performed the step one fair value comparison as of October 1, 2009 and October 1, 2008. At
both dates the Companys market capitalization exceeded its carrying value. At December 31,
2009 the Companys market capitalization exceeded its carrying value, as compared to
December 31, 2008, when the Companys market capitalization fell below its carrying value.
The Company also includes a reasonable control premium to its market capitalization to
determine a reasonable fair value, which exceeded the Companys carrying value for both
years. The Company believes that its market capitalization alone does not fully capture the
fair value of its business as a whole, or the substantial value that an acquirer would
obtain from its ability to obtain control of the Company. As such, as a method of
determining fair value, the Company believes that including a control premium, supported by
transaction data in its industry, to its market capitalization would give effect to the
increased consideration a potential acquirer would be required to pay in order to gain
sufficient ownership to set policies, direct operations and make decisions related to the
Company.
The Company reviews fair value and goodwill impairment on a quarterly basis and between
annual tests if events and circumstances indicate it is more likely than not that the fair
value of the Company is less than its carrying value. Events that would indicate impairment
and trigger an interim impairment assessment include, but are not limited to, current
economic and market conditions, changes in its results of operations and changes in its
forecasts or market expectation relating to future results. The Company will continue to
monitor its goodwill for impairment.
(j) 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 or determinable, collectability is probable and there are no uncertainties regarding
customer acceptance.
78
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(j) Revenue Recognition (continued)
The Company
recognizes revenue from the sale of its digital and film-based CAD products and
services in accordance with the Financial Accounting Standards Board (FASB) Accounting
Standards Codification (ASC) Topic 605, Revenue Recognition
(ASC 605), inclusive of
ASC 605-10-S99, which includes the guidance
of Securities and Exchange Commission (SEC) Staff Accounting Bulletin No. 104,
Topic 13, Revenue Recognition in Financial Statements. The Company recognizes revenue
from the sale of certain of its MRI CAD products and services in accordance with FASB ASC 985-605,
Software, Revenue Recognition (ASC 985-605).
The Companys revenue transactions can, on occasion, include product sales with multiple
element arrangements, generally for installation and training. On those occasions the
Company follows the requirements in FASB ASC Topic 605-25, Multiple-Element Arrangements
(ASC 605-25). For most of iCADs product sales, the responsibility for the installation
process lies with its OEM partners, GE Healthcare, Siemens Medical, and others. 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 and
there is objective and reliable evidence of the fair value of the undelivered installation
element. Fair value of the installation is determined using entity specific and third party
evidence.
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 F.O.B. 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.
79
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(j) Revenue Recognition (continued)
If the terms of the sale include customer acceptance provisions and compliance with those
provisions cannot be demonstrated, all revenues are deferred and not recognized until such
acceptance occurs. The Company considers all relevant facts and circumstances in
determining when to recognize revenue, including contractual obligations to the customer,
the customers post-delivery acceptance provisions, if any, and the installation
process. There are no significant estimates or assumptions used in the Companys revenue
recognition.
The Company defers revenue from the sale of extended service contracts related to future
periods and recognizes revenue on a straight-line basis in accordance with FASB ASC Topic
605-20 Services. The Company provides for estimated warranty costs on original product
warranties at the time of sale.
(k) 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, inbound freight and duty, manufacturing, warehousing, material movement, inspection,
scrap, rework, depreciation and in-house product warranty repairs. The Companys cost of
revenue may not be comparable to those of other entities, since some entities include the
cost of product installation, training and certain warranty repair costs in cost of revenue
while iCAD includes these costs in sales and marketing expenses.
(l) Warranty Costs
The Company provides for the estimated cost of standard product warranty against defects in
material and workmanship based on historical warranty trends, including in the volume and
cost of product returns during the warranty period. The Company established a warranty
reserve in the amount of $91,052 in 2009 and $146,503 in 2008. Warranty provisions and
claims for the years ended December 31, 2009 and 2008, were as follows:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Beginning balance |
|
$ |
146,503 |
|
|
$ |
202,836 |
|
Warranty provision |
|
|
12,554 |
|
|
|
58,030 |
|
Usage |
|
|
(68,005 |
) |
|
|
(114,363 |
) |
|
|
|
|
|
|
|
Ending balance |
|
$ |
91,052 |
|
|
$ |
146,503 |
|
|
|
|
|
|
|
|
80
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(m) Engineering and Product Development Costs
These costs relate to research and development efforts which are expensed as incurred.
(n) Advertising Costs
The Company expenses advertising costs as incurred. Advertising expense for the years ended
December 31, 2009, 2008 and 2007 was approximately $724,000, $761,000 and $675,000,
respectively.
(o) Net (Loss) Income Per Common Share
The Company follows FASB ASC 260-10, Earnings per Share, which requires the presentation
of both basic and diluted earning per share on the face of the Statements of Operations.
The Companys basic net income (loss) per share is computed by dividing net income or loss
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 treasure stock method.
A summary of the Companys calculation of net income (loss) per share is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(1,967,624 |
) |
|
$ |
4,356,189 |
|
|
$ |
(1,538,532 |
) |
Less preferred dividends |
|
|
|
|
|
|
|
|
|
|
67,760 |
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income available to common shareholders |
|
$ |
(1,967,624 |
) |
|
$ |
4,356,189 |
|
|
$ |
(1,606,292 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic shares used in the calculation of earnings per share |
|
|
45,511,883 |
|
|
|
41,704,374 |
|
|
|
38,351,345 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
1,007,428 |
|
|
|
|
|
Restricted stock |
|
|
|
|
|
|
36,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares used in the calculation of earnings per share |
|
|
45,511,883 |
|
|
|
42,748,052 |
|
|
|
38,351,345 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.04 |
) |
|
$ |
0.10 |
|
|
$ |
(0.04 |
) |
Diluted |
|
$ |
(0.04 |
) |
|
$ |
0.10 |
|
|
$ |
(0.04 |
) |
81
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(o) Net (Loss) Income Per Common Share (continued)
The following table summarizes the number of shares of common stock for securities that were
not included in the calculation of diluted net (loss) income per share because such shares
are antidilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock options |
|
|
5,159,122 |
|
|
|
2,265,389 |
|
|
|
5,644,818 |
|
Stock warrants |
|
|
|
|
|
|
936,111 |
|
|
|
1,003,311 |
|
Convertible Revolving Promissory Note |
|
|
|
|
|
|
2,219,934 |
|
|
|
1,507,482 |
|
Convertible loans payable |
|
|
|
|
|
|
|
|
|
|
2,098,039 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,159,122 |
|
|
|
5,421,434 |
|
|
|
10,253,650 |
|
|
|
|
|
|
|
|
|
|
|
The calculation of basic income (loss) per share for 2009, 2008 and 2007 does not include
592,155, 814,753 and 375,000 shares, respectively, of restricted common stock issued to
executive officers and employees of the Company as they are subject to time-based vesting.
These potential shares were excluded from the computation of basic income (loss) per share
as these shares are not considered outstanding until vested.
(p) Income Taxes
The Company follows the liability method under Accounting Standards Codification Topic 740,
Income Taxes, (ASC 740). The primary objectives of accounting for taxes under ASC 740
are to (a) recognize the amount of tax payable for the current year and (b) recognize the
amount of deferred tax liability or asset for the future tax consequences of events that
have been reflected in the Companys financial statements or tax returns. The Company has
provided a full valuation allowance against its deferred tax assets at December 31, 2009 and
2008 as it is more likely than not that the deferred tax asset will not be realized.
The Company adopted ASC 740-10 accounting for uncertainty in income taxes position on
January 1, 2007. ASC 740-10 clarifies the accounting for uncertainty in income taxes
recognized in an enterprises financial statements and prescribes a recognition threshold
and measurement attribute for the financial statement recognition and measurement of a tax
position taken or expected to be taken in a tax return. ASC 740-10 also provides guidance
on de-recognition, classification, interest and penalties, disclosure and transition. The
adoption of the position did not have a material impact on the Companys financial
statements.
82
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(q) Stock-Based Compensation
The Company maintains stock-based incentive plans, under which it provides stock incentives
to employees, directors and contractors. The Company grants to employees, directors and
contractors, restricted stock and/or options to purchase common stock at an option price
equal to the market value of the stock at the date of grant. The Company follows FASB ASC
Topic 718, Compensation Stock Compensation (ASC 718), for all share-based
compensation. Under this application the Company is required to record compensation expense
over the vesting period for all awards granted.
The Company used the Black-Scholes and Lattice option pricing models which requires
extensive use of accounting judgment and financial estimates, including estimates of the
expected term participants will retain their vested stock options before exercising them,
the estimated volatility of its common stock price over the expected term, and the number of
options that will be forfeited prior to the completion of their vesting requirements.
Application of alternative assumptions could produce significantly different estimates of
the fair value of stock-based compensation and consequently, the related amounts recognized
in the Consolidated Statements of Operations. Stock-based compensation expense was included
in applicable departmental expense categories in the Consolidated Statements of Operations
for the fiscal 2009, 2008 and 2007 periods.
(r) 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. |
83
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(r) Fair Value Measurements (continued)
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 December 31, 2009 are cash equivalents. The cash equivalents are
measured using level one inputs.
(s) Recently Issued Accounting Standards
Effective July 1, 2009, the Company adopted The FASB Accounting Standards Codification and
the Hierarchy of Generally Accepted Accounting Principles (ASC 105). This standard
establishes only two levels of U.S. generally accepted accounting principles (GAAP),
authoritative and nonauthoritative. The FASB Accounting Standards Codification (the
Codification) became the source of authoritative, nongovernmental GAAP, except for
rules and interpretive releases of the SEC, which are sources of authoritative GAAP for SEC
registrants. All other non-grandfathered, non-SEC accounting literature not included in the
Codification became nonauthoritative. The Company began using the new guidelines and
numbering system prescribed by the Codification when referring to GAAP in the third quarter
of fiscal 2009. As the Codification was not intended to change or alter existing GAAP, it
did not have any impact on the Companys consolidated financial statements.
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 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.
84
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(s) Recently
Issued Accounting Standards (continued)
Effective July 1, 2009, the Company adopted FASB ASU No. 2009-05, Fair Value Measurements
and Disclosures (Topic 820), (ASU 2009-05). ASU 2009-05 provided amendments to ASC
820-10, Fair Value Measurements and Disclosures Overall, for the fair value measurement
of liabilities. ASU 2009-05 provides clarification that in circumstances in which a quoted
price in an active market for the identical liability is not available, a reporting entity
is required to measure fair value using certain techniques. ASU 2009-05 also clarifies that
when estimating the fair value of a liability, a reporting entity is not required to include
a separate input or adjustment to other inputs relating to the existence of a restriction
that prevents the transfer of a liability. ASU 2009-05 also clarifies that both a quoted
price in an active market for the identical liability at the measurement date and the quoted
price for the identical liability when traded as an asset in an active market when no
adjustments to the quoted price of the asset are required are Level 1 fair value
measurements. The adoption of ASU 2009-05 did not have any impact on the Companys financial
position, results of operations or cash flows.
Effective June 30, 2009, the Company adopted the FASB guidance now codified as FASB ASC
Topic 855-10, Subsequent Events (ASC 855-10). This topic is intended to establish
general standards of accounting for and disclosure of events that occur after the balance
sheet date but before financial statements are issued or are available to be issued. In
particular, this topic sets forth the period after the balance sheet date during which
management of a reporting entity should evaluate events or transactions that may occur for
potential recognition or disclosure in the financial statements, the circumstances under
which an entity should recognize events or transactions occurring after the balance sheet
date in its financial statements, and the disclosures that an entity should make about
events or transactions that occurred after the balance sheet date. The adoption of ASC
855-10 did not have any impact on the Companys financial position, results of operations or
cash flows.
In April 2009, the Company adopted guidance now codified as FASB Topic 820-10-65, Fair
Value Measurements and Disclosures Overall Implementation and Guidance and
Illustrations (ASC 820-10-65). ASC 820-10-65 provides guidelines for making fair value
measurements more consistent. ASC 820-10-65 provides additional authoritative guidance in
determining whether a market is active or inactive, and whether
a transaction is distressed, is applicable to all assets and liabilities (i.e. financial and
non-financial) and requires enhanced disclosures. ASC 820-10-65 was effective for all
periods ending after June 15, 2009. The adoption of ASC 820-10-65 did not have any impact
on the Companys financial position, results of operations or cash flows.
85
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(1) |
|
Summary of Significant Accounting Policies (continued) |
(s) Recently
Issued Accounting Standards (continued)
Effective January 1, 2009, pursuant to the requirements of FASB ASC 820, the Company adopted
the provisions of topic ASC 820-10, Fair Value Measurements and Disclosures Overall
(ASC 820-10), with respect to all non-financial assets and non-financial liabilities,
except for items that are recognized or disclosed at fair value in the financial statements
on a recurring basis (at least annually), until January 1, 2009. These include goodwill and
other non-amortizable intangible assets. The adoption of ASC 820-10 did not have a material
impact on the Companys financial position, results of operations or cash flows.
Effective January 1, 2009, the Company adopted guidance now codified as FASB ASC Topic
350-30-35, Intangibles Goodwill and Other (ASC 350-30-35). ASC 350 amends the factors
that should be considered in developing renewal or extension assumptions used to determine
the useful life of a recognized intangible asset. The adoption of ASC 350-30-35 did not
have any impact on the Companys financial position, results of operations or cash flows.
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 second half of 2009, the Company
recorded expenses of approximately $486,000 related to a potential acquisition that was not consummated.
86
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
Asset Acquisition of CAD Sciences
On July 18, 2008, the Company completed the acquisition of substantially all of the assets
of 3TP LLC, dba CAD Sciences (CAD Sciences), a limited liability company based in New
York, offering pharmacokinetic based CAD technology that aids in the interpretation of
contrast enhanced MRI images, pursuant to an Asset Purchase Agreement (the Purchase
Agreement) dated June 20, 2008 between the Company and the seller. The Companys
operations reflect the operations of CAD Sciences since the date of the acquisition.
In accordance with the terms of the Purchase Agreement, the purchase price of $5,000,000
paid by the Company to CAD Sciences consisted of (i) $2,000,000 in cash and (ii) $3,000,000
in stock comprised of 815,217 restricted shares of the Companys common stock and an
additional 271,740 restricted shares of the Companys common stock held in escrow
(Shares). Simultaneously with the closing of the transactions contemplated by the
Purchase Agreement, the Company entered into an Escrow Agreement by and among the Company,
CAD Sciences and the Escrow Agent (the Escrow Agreement) pursuant to which 271,740 of the
Shares were deposited by the parties into an escrow account for a period of up to one year
to secure CAD Sciences indemnity obligations to the Company under the Purchase Agreement.
The Escrow Agreement provided that, of the escrowed Shares, 181,160 Shares held in
escrow for 6 months and the remaining escrow Shares be held in escrow for one year, in
each case subject to earlier disbursement (in accordance with the terms of the Escrow
Agreement) to the Company in satisfaction of any indemnification obligations arising under
the terms of the Purchase Agreement.
The Company
issued 271,240 shares in escrow which were included in the number of shares as
outstanding and included the fair value of the shares in the purchase price as of the
acquisition date, since the shares were considered to be issuable beyond a reasonable doubt.
The Company held back 3,956 shares due to a post closing settlement. The escrow account was
released in July 2009. The purchase price of $4,989,082 plus $184,082 in acquisition costs
incurred, has been allocated to net assets acquired based upon an appraisal of their fair
values. The following is a summary of the 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 asset acquisition and the amortizable lives of the intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortizable |
|
|
|
Amount |
|
|
Life |
|
Accounts receivable |
|
$ |
46,879 |
|
|
|
|
|
Property and equipment |
|
|
25,009 |
|
|
|
|
|
Technology asset |
|
|
4,924,551 |
|
|
10 Years |
Customer relationships |
|
|
248,000 |
|
|
10 Years |
Warranty liabilities |
|
|
(71,275 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase price |
|
$ |
5,173,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
The impact on operations of the acquisition was immaterial and accordingly no proforma
information has been provided for 2008 and 2007.
87
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(3) |
|
Financing Arrangements |
Loan and Security Agreement
On June 30, 2008, the Company entered into a Loan and Security Agreement (the RBS Loan
Agreement) with RBS Citizens, N.A. (RBS). The RBS Loan Agreement established a secured
revolving credit facility with a line of credit of up to $5,000,000. The borrowing base
under the RBS Loan Agreement was limited to 80% of eligible accounts receivable or, if
adjusted EBITDA for the quarter was greater than or equal to $1,250,000, then the Company
was not subject to a restriction as to availability of credit upon the borrowing base. The
RBS Loan Agreement expired on June 30, 2009. The Company did not borrow any amounts under
the RBS Loan Agreement during the term.
Convertible Revolving Loans Payable to Related Party
The Company had previously entered into a Revolving Loan and Security Agreement (the Prior
Loan Agreement) with Mr. Robert Howard, the former Chairman of the Board of Directors of
the Company, under which Mr. Howard had agreed to advance funds, or to provide guarantees of
advances made by third parties in an amount up to $5,000,000. As a condition to, and
simultaneously with, the execution of the RBS Loan Agreement, on June 30, 2008, the unpaid
principal amount and accrued interest of the Prior Loan Agreement, was extinguished as
follows: (1) a total of $2,000,000 principal amount under the Prior Loan Agreement,
together with $351,917 of accrued and unpaid interest on such principal amount, was
converted by Mr. Howard into 1,622,012 shares of the Companys common stock per the original
terms of the Prior Loan Agreement and (2) the remaining principal balance under the Prior
Loan Agreement of $258,906, together with accrued and unpaid interest of $55,598 on such
principal amount, was paid in cash to Mr. Howard. The outstanding indebtedness under the
Prior Loan Agreement has therefore, been fully repaid and satisfied and the Prior Loan
Agreement was terminated as of June 30, 2008.
Convertible Loans Payable to Related Parties
On June 19, 2006, the Company and Dr. Lawrence Howard, who subsequently became a director
and is currently the Chairman of the Board of Directors of the Company, entered into a Note
Purchase Agreement with respect to the purchase by Dr. Howard from the Company of an
aggregate of $200,000 principal amount of a 7% Convertible Note of the Company due June 19,
2008 (the Howard Note) at a purchase price of $200,000. Interest on the Howard Note was
payable on the due date. On June 19, 2008, the $200,000 principal amount under the Howard
Note, together with $28,000 of accrued and unpaid interest on such principal amount, was
converted by Dr. Howard into 152,000 shares of the Companys common stock at $1.50 per share
conversion price as set forth in the Howard Note. The Howard Note has, therefore, been
fully repaid and satisfied and was terminated as of June 19, 2008.
88
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(3) |
|
Financing Arrangements (continued) |
Convertible Loans Payable to Related Parties (continued)
On June 20, 2006, the Company and Mr. Kenneth Ferry, the Companys Chief Executive Officer,
entered into a Note Purchase Agreement with respect to the purchase by Mr. Ferry from the
Company of an aggregate of $300,000 principal amount of a 7% Convertible Note of the Company
due June 20, 2008 (the Ferry Note) at a purchase price of $300,000. Interest on the Ferry
Note was payable on the due date. On June 20, 2008, the $300,000 principal amount under the
Ferry Note, together with $42,000 of accrued and unpaid interest on such principal amount,
was converted by Mr. Ferry into 228,000 shares of the Companys common stock at $1.50 per
share conversion price as set forth in the Ferry Note. The Ferry Note has, therefore, been
fully repaid and satisfied and was terminated as of June 20, 2008.
On September 12, 14 and 19, 2006 the Company entered into Note Purchase Agreements with
respect to the purchase from the Company of a total of $2,300,000 principal amount of its
7.25% Convertible Promissory Notes (the Notes) by directors, former directors, officers
and employees of the Company, including the following: Mr. Robert Howard (as to $1,350,000),
former Chairman of the Board and director of the Company, Mr. James Harlan (as to $300,000),
former director of the Company and Dr. Elliott Sussman (as to $100,000), a director of the
Company, Mr. Steven Rappaport (as to $300,000) who subsequently became and is currently a
director of the Company and Dr. Lawrence Howard (as to $100,000) and $50,000 by each of the
following executive officers and/or employees of the Company: Mr. Jeffrey Barnes, Ms. Stacey
Stevens and Ms. Annette Heroux. The Notes were due two years from the date of issue. On
September 12, 14 and 19, 2008, the total principal amount of $2,300,000 under the Notes,
together with $333,500 of accrued and unpaid interest on such principal amount, were
converted into 1,549,117 shares of the Companys common stock at $1.70 per share conversion
price as set forth in the Notes. The Notes have, therefore, been fully repaid and satisfied
and were terminated as of September 12, 14 and 19, 2008, respectively.
Convertible Loans Payable to Non-Related Parties
On September 19, 2006 the Company entered into Note Purchase Agreements with respect to the
purchase from the Company of an aggregate of $700,000 principal amount of its 7.25%
Convertible Promissory Note (the September Notes) by two accredited outside investors,
pursuant to Note Purchase Agreements between the Company and each of the investors. The
loans were evidenced by the September Notes issued by the Company in favor of the
non-related parties. The September Notes were due two years from the date of issue. On
September 19, 2008, the total principal amount of $700,000 under the September Notes,
together with $101,500 of accrued and unpaid interest on such principal amounts, were
converted into 471,471 shares of the Companys common
stock at $1.70 per share conversion price as set forth in the September Notes. The September
Notes have, therefore, been fully repaid and satisfied and were terminated as of September
19, 2008.
89
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
Accrued expenses consist of the following at December 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Accrued salary and related expenses |
|
$ |
1,229,693 |
|
|
$ |
1,977,745 |
|
Accrued professional fees |
|
|
451,102 |
|
|
|
239,670 |
|
Accrued accounts payable |
|
|
277,685 |
|
|
|
161,890 |
|
Accrued warranty expense |
|
|
91,052 |
|
|
|
146,503 |
|
Accrued rent |
|
|
80,588 |
|
|
|
109,542 |
|
Other accrued expenses |
|
|
92,441 |
|
|
|
117,468 |
|
|
|
|
|
|
|
|
|
|
$ |
2,222,561 |
|
|
$ |
2,752,818 |
|
|
|
|
|
|
|
|
(a) Stock Options
The Company has five stock option or stock incentive plans, which are described as follows:
The 2001 Stock Option Plan (The 2001 Plan).
The 2001 Plan was adopted by the Companys stockholders in August 2001. The 2001 Plan
provides for the granting of non-qualifying and incentive stock options to employees and
other persons to purchase up to an aggregate of 1,200,000 shares of the Companys common
stock. The purchase price of each share for which an option is granted is determined by the
Board of Directors or the Committee appointed by the Board of Directors provided that the
purchase price of each share for which an incentive option is granted cannot be less than
the fair market value of the Companys common stock on the date of grant, except for options
granted to 10% stockholders for whom the exercise price cannot be less than 110% of the
market price. Incentive options granted to date under the 2001 Plan vest 100% over periods
extending from six months to five years from the date of grant and expire no later than ten
years after the date of grant, except for 10% holders whose options shall expire not later
than five years after the date of grant. Non-qualifying options granted under the 2001 Plan
are generally exercisable over a ten year period, vesting 1/3 each on the first, second, and
third anniversaries of the date of grant. At December 31, 2009 there are no further options
available for grant under this plan.
90
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(5) |
|
Stockholders Equity (continued) |
(a) Stock Options (continued)
The 2002 Stock Option Plan (The 2002 Plan).
The 2002 Plan was adopted by the Companys stockholders in June 2002. The 2002 Plan
provides for the granting of non-qualifying and incentive stock options to employees and
other persons to purchase up to an aggregate of 500,000 shares of the Companys common
stock. The purchase price of each share for which an option is granted is determined by the
Board of Directors or the Committee appointed by the Board of Directors provided that the
purchase price of each share for which an incentive option is granted cannot be less than
the fair market value of the Companys common stock on the date of grant, except for options
granted to 10% stockholders for whom the exercise price cannot be less than 110% of the
market price. Incentive options granted to date under the 2002 Plan vest 100% over periods
extending from six months to five years from the date of grant and expire no later than ten
years after the date of grant, except for 10% holders whose options expire not later than
five years after the date of grant. Non-qualifying options granted under the 2002 Plan are
generally exercisable over a ten year period, vesting 1/3 each on the first, second, and
third anniversaries of the date of grant. At December 31, 2009, there were 23,999 options
available for issuance under the 2002 Plan.
The 2004 Stock Incentive Plan (The 2004 Plan).
The 2004 Plan was adopted by the Companys stockholders in June 2004. The 2004 Plan
provides for the grant of any or all of the following types of awards: (a) stock options,
(b) restricted stock, (c) deferred stock and (d) other stock-based awards. The 2004 Plan
provides for the granting of non-qualifying and incentive stock options to employees and
other persons to purchase up to an aggregate of 1,000,000 shares of the Companys common
stock. The purchase price of each share for which an option is granted is determined by the
Board of Directors or the Committee appointed by the Board of Directors provided that the
purchase price of each share for which an option is granted cannot be less than the fair
market value of the Companys common stock on the date of grant, except for incentive
options granted to 10% stockholders for whom the exercise price cannot be less than 110% of
the market price. Incentive options granted under the 2004 Plan generally vest 100% over
periods extending from the date of grant to five years from the date of grant and expire not later than ten years after the date of grant, except
for 10% holders whose options expire not later than five years after the date of grant.
Non-qualifying options granted under the 2004 Plan are generally exercisable over a ten year
period, vesting 1/3 each on the first, second, and third anniversaries of the date of grant.
At December 31, 2009 there were 35,250 shares available for issuance under the 2004 Plan.
91
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(5) |
|
Stockholders Equity (continued) |
(a) Stock Options (continued)
The 2005 Stock Incentive Plan (The 2005 Plan).
The 2005 Plan was adopted by the Companys stockholders in June 2005. The 2005 Plan provides
for the grant of any or all of the following types of awards: (a) stock options, (b)
restricted stock, (c) deferred stock and (d) other stock-based awards. The 2005 Plan
provides for the granting of non-qualifying and incentive stock options to employees and
other persons to purchase up to an aggregate of 600,000 shares of the Companys common
stock. The purchase price of each share for which an option is granted is determined by the
Board of Directors or the Committee appointed by the Board of Directors provided that the
purchase price of each share for which an option is granted cannot be less than the fair
market value of the Companys common stock on the date of grant, except for incentive
options granted to 10% stockholders for whom the exercise price cannot be less than 110% of
the market price. Incentive options granted under the 2005 Plan generally vest 100% over
periods extending from the date of grant to three years from the date of grant and expire
not later than five years after the date of grant, except for 10% stockholders whose options
expire not later than five years after the date of grant. Non-qualifying options granted
under the 2005 Plan are generally exercisable over a ten year period, vesting 1/3 each on
the first, second, and third anniversaries of the date of grant. At December 31, 2009 there
were 32,087 shares available for issuance under the 2005 Plan.
The 2007 Stock Incentive Plan (The 2007 Plan).
The 2007 Plan was adopted by the Companys stockholders in July 2007 and amended in June
2009. The 2007 Plan provides for the grant of any or all of the following types of awards:
(a) stock options, (b) restricted stock, (c) deferred stock and (d) other stock-based
awards. Awards may be granted singly, in combination, or in tandem. Subject to anti-dilution
adjustments as provided in the 2007 Plan, (i) the 2007 Plan provides for a total of
5,250,000 shares of the Companys common stock to be available for distribution pursuant to
the 2007 Plan, and (ii) the maximum number of shares of the Companys common stock with
respect to which stock options, restricted stock, deferred stock, or other stock-based
awards may be granted to any participant under the 2007 Plan during any calendar year or
part of a year may not exceed 800,000 shares.
92
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(5) |
|
Stockholders Equity (continued) |
(a) Stock Options (continued)
The 2007 Plan provides that it will be administered by the Companys Board of Directors
(Board) or a committee of two or more members of the Board appointed by the Board.
The administrator will generally have the authority to administer the 2007 Plan, determine
participants who will be granted awards under the 2007 Plan, the size and types of awards,
the terms and conditions of awards and the form and content of the award agreements
representing awards. Awards under the 2007 Plan may be granted to employees, directors,
consultants and advisors of the Company and its subsidiaries. However, only employees of the
Company and its subsidiaries will be eligible to receive options that are designated as
incentive stock options.
With respect to options granted under the 2007 Plan, the exercise price must be at least
100% (110% in the case of an incentive stock option granted to a 10% stockholder) of the
fair market value of the common stock subject to the award, determined as of the date of
grant. Restricted stock awards are shares of common stock that are awarded subject to the
satisfaction of the terms and conditions established by the administrator. In general,
awards that do not require exercise may be made in exchange for such lawful consideration,
including services, as determined by the administrator. At December 31, 2009 there were
2,853,321 shares available for issuance under the 2007 Plan.
A summary of stock option activity for all stock option plans is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option |
|
|
Price range |
|
|
Weighted |
|
|
|
Shares |
|
|
per share |
|
|
Average |
|
Outstanding, January 1, 2007 |
|
|
5,628,730 |
|
|
$ |
0.80-$5.28 |
|
|
$ |
2.08 |
|
Granted |
|
|
1,133,529 |
|
|
$ |
2.00-$4.88 |
|
|
$ |
3.76 |
|
Exercised |
|
|
(860,860 |
) |
|
$ |
0.81-$2.82 |
|
|
$ |
1.51 |
|
Forfeited |
|
|
(250,688 |
) |
|
$ |
1.06-$4.88 |
|
|
$ |
2.82 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2007 |
|
|
5,650,711 |
|
|
$ |
0.80-$5.28 |
|
|
$ |
2.47 |
|
Granted |
|
|
558,501 |
|
|
$ |
1.37-$4.10 |
|
|
$ |
2.45 |
|
Exercised |
|
|
(952,612 |
) |
|
$ |
1.06-$3.49 |
|
|
$ |
2.01 |
|
Forfeited |
|
|
(97,874 |
) |
|
$ |
1.06-$3.90 |
|
|
$ |
2.73 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2008 |
|
|
5,158,726 |
|
|
$ |
0.80-$5.28 |
|
|
$ |
2.55 |
|
Granted |
|
|
291,896 |
|
|
$ |
0.86-$2.03 |
|
|
$ |
1.32 |
|
Exercised |
|
|
(80,249 |
) |
|
$ |
0.80-$1.45 |
|
|
$ |
0.85 |
|
Forfeited |
|
|
(211,251 |
) |
|
$ |
0.81-$4.88 |
|
|
$ |
2.84 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2009 |
|
|
5,159,122 |
|
|
$ |
0.80-$5.28 |
|
|
$ |
2.50 |
|
|
|
|
|
|
|
|
|
|
|
93
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(5) |
|
Stockholders Equity (continued) |
(a) Stock Options (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option |
|
|
Price range |
|
|
Weighted |
|
Exercisable at year-end |
|
Shares |
|
|
per share |
|
|
Average |
|
2007 |
|
|
4,023,658 |
|
|
$ |
0.80-$5.28 |
|
|
$ |
2.28 |
|
2008 |
|
|
3,979,248 |
|
|
$ |
0.80-$5.28 |
|
|
$ |
2.41 |
|
2009 |
|
|
4,631,324 |
|
|
$ |
0.80-$5.28 |
|
|
$ |
2.42 |
|
Available for future grants at December 31, 2009 from all plans: 2,944,657
The weighted-average remaining contractual life of stock options outstanding for all plans
at December 31, 2009 was 2.4 years.
During the year ended December 31, 2009, 2008 and 2007, the Company recorded $1,993,935,
$1,862,630 and $1,242,155, respectively, for share-based compensation in accordance with
FASB ASC 718. The Companys stock-based compensation expense by categories is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Cost of revenue |
|
$ |
42,764 |
|
|
$ |
42,408 |
|
|
$ |
33,211 |
|
Engineering and product development |
|
$ |
250,094 |
|
|
$ |
232,724 |
|
|
$ |
166,068 |
|
Marketing and sales |
|
$ |
327,067 |
|
|
$ |
241,187 |
|
|
$ |
162,347 |
|
General and administrative expense |
|
$ |
1,374,010 |
|
|
$ |
1,346,311 |
|
|
$ |
880,529 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,993,935 |
|
|
$ |
1,862,630 |
|
|
$ |
1,242,155 |
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2009, there was $1,691,542 of total unrecognized compensation costs
related to unvested options and restricted stock. That cost is expected to be recognized
over a weighted average period of 3 years.
Options granted under the stock incentive plans were valued utilizing the Black-Scholes
model using the following assumptions and had the following fair values:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Average risk-free interest rate |
|
|
2.03 |
% |
|
|
2.92 |
% |
|
|
4.57 |
% |
Expected dividend yield |
|
|
None |
|
|
|
None |
|
|
|
None |
|
Expected life |
|
|
3.5 years |
|
|
|
3.5 years |
|
|
|
3.5 years |
|
Expected volatility |
|
|
63.5 |
% |
|
|
62.8 |
% |
|
|
62.8 |
% |
Weighted average exercise price |
|
$ |
1.32 |
|
|
$ |
2.45 |
|
|
$ |
3.76 |
|
Weighted average fair value |
|
$ |
0.49 |
|
|
$ |
1.06 |
|
|
$ |
1.80 |
|
94
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(5) |
|
Stockholders Equity (continued) |
(a) Stock Options (continued)
The Companys expected volatility is based on the average of peer group volatility, which
includes the Companys historical volatility within the peer group. The average expected
life was calculated using the simplified method and other methods. 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 aggregate intrinsic value of options outstanding at December 31, 2009, 2008 and 2007 was
$145,798, $50,459 and $1,020,941. The aggregate intrinsic value of the options exercisable
at December 31, 2009, 2008 and 2007 was $132,799, $49,864 and $795,206. The aggregate
intrinsic value of stock options exercised during 2009, 2008 and 2007 was $53,484, $490 and
$465,076. The Company used the market price of $1.52, $1.13 and $2.02 at December 31, 2009,
2008 and 2007 versus the exercise price of each option, respectively, to determine the
aggregate intrinsic values.
(b) Restricted Stock
The Company granted 100,000, 564,750 and 375,000 shares of restricted shares in the years
ended December 31, 2009, 2008 and 2007, respectively, under the 2007 Plan. Each of these
restricted stock awards vests in three equal annual installments with the first installment
vesting one year from grant date. At December 31, 2009, there were 592,155 unvested
restricted stock awards outstanding.
The aggregate intrinsic value of restricted stock outstanding at December 31, 2009, 2008 and
2007 was $900,076, $920,671 and $757,500. The aggregate intrinsic value of restricted stock
vested during 2009, 2008 and 2007 was $444,063, $124,308 and $0. The Company used the
market price of $1.52, $1.13 and $2.02 at December 31, 2009, 2008 and 2007, respectively, to
determine the aggregate intrinsic values.
(c) Stock Subscription Warrants
At December 31, 2009, there were no warrants outstanding. No warrants were issued or
exercised in 2009, 2008 or 2007, and 936,111 warrants expired on December 15, 2009.
95
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
Deferred tax assets and liabilities are recognized for the expected future tax consequences
of net operating loss carryforwards, tax credits and temporary differences between the
financial statement carrying amounts and the income tax bases of assets and liabilities. A
valuation allowance is applied against any net deferred tax asset if, based on the weighted
available evidence, it is more likely than not that the deferred tax assets will not be
realized.
The benefit for income taxes for 2009 is primarily due to a refundable R&D credit allowance.
The provision for income taxes for 2008 is principally comprised of alternative minimum
taxes for federal purposes, which is subject to net operating loss limitations, and state
income taxes due in the states that the Company is subject to income tax. The Company
incurred losses from operations during 2007 and did not record an income tax benefit. The
Company recorded a valuation allowance against its net operating losses and other net
deferred tax assets due to uncertainties related to the realizability of these tax assets.
The significant components of income tax expense (benefit) for the years ended December 31,
2009, 2008 and 2007 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Current provision (benefit): |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
(55,968 |
) |
|
$ |
145,000 |
|
|
$ |
|
|
State |
|
|
12,398 |
|
|
|
90,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(43,570 |
) |
|
$ |
235,000 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income taxes reflect the impact of temporary differences between the amount of
assets and liabilities for financial reporting purposes and such amounts as measured by tax
laws and regulations. The Company has fully reserved the deferred tax assets, as it is more
likely than not that the deferred tax assets will not be utilized. Deferred tax liabilities
(assets) are comprised of the following at December 31:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Inventory (Section 263A) |
|
$ |
88,000 |
|
|
$ |
135,000 |
|
Inventory reserves |
|
|
52,000 |
|
|
|
24,000 |
|
Receivable reserves |
|
|
34,000 |
|
|
|
20,000 |
|
Other accruals |
|
|
123,000 |
|
|
|
156,000 |
|
Deferred revenue |
|
|
150,000 |
|
|
|
|
|
Accumulated depreciation/amortization |
|
|
(471,000 |
) |
|
|
(793,000 |
) |
Stock options |
|
|
1,406,000 |
|
|
|
1,336,000 |
|
Tax credits carryforwards |
|
|
1,193,000 |
|
|
|
1,184,000 |
|
Net operating loss carryforwards |
|
|
25,128,000 |
|
|
|
25,082,000 |
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
|
27,703,000 |
|
|
|
27,144,000 |
|
Valuation allowance |
|
|
(27,703,000 |
) |
|
|
(27,144,000 |
) |
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
96
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(6) |
|
Income Taxes (continued) |
During 2008, the Company performed a formal review of its net operating loss carryfowards
available from prior years, which included approximately $30 million in net operating losses
from an acquisition that took place in 2003. The acquired company has since been dissolved,
but based on all available information, the Company has determined that certain adjustments
are required to net operating losses previously presented in order to comply with the most
recent federal rules, regulations and limitations for net operating losses available to the
Company. The following represents a summary of the deferred tax assets available from net
operating losses, as previously presented, and the adjustments required in prior periods as
a result of the net operating losses that have been determined to be available from the
Companys acquisition in 2003:
|
|
|
|
|
|
|
2007 |
|
Net operating losses as previously stated |
|
$ |
16,104,000 |
|
Adjustment |
|
|
11,717,000 |
|
|
|
|
|
Net operating losses as adjusted |
|
$ |
27,821,000 |
|
|
|
|
|
As of December 31, 2009, the Company has net operating loss carryforwards totaling
approximately $66,718,000 expiring between 2011 and 2027. For the years ended December 31,
2009 and 2008, the Company utilized available net operating losses of approximately $565,000
and $5,664,000, respectively. The amount of the net operating loss carryforwards, which may
be utilized in any future period, may be subject to certain limitations based upon changes
in the ownership of the Company. In the event of a deemed changed in control, an annual
limitation imposed on the utilization of the net operating losses may result in the
expiration of all or a portion of the net operating loss carryforwards. The Company
currently has approximately $11,746,000 in net operating losses that are subject to
limitations and approximately $1,481,000 subject to be released from restriction annually
through 2017 and available to offset taxable income.
During 2008, the Company performed a formal review of its tax credits previously calculated
and available from prior years. Based on all available information, the Company has
determined that certain adjustments are required to tax credits in order to comply with the
most recent federal rules and regulations. The following represents a summary of tax credits
previously presented and adjustments required in prior periods:
|
|
|
|
|
|
|
2007 |
|
Tax credits as previously stated |
|
$ |
1,763,000 |
|
Adjustment |
|
|
(692,000 |
) |
|
|
|
|
Tax credits as adjusted |
|
$ |
1,071,000 |
|
|
|
|
|
The Company has available tax credit carryforwards (adjusted to reflect provisions of the
Tax Reform Act of 1986) to offset future income tax liabilities. The credits expire in
various years through 2028 and management believes approximately $1,193,000 will be
available to offset income tax in future periods.
97
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(6) |
|
Income Taxes (continued) |
The Company adopted ASC 740-10 accounting for uncertainty in income taxes on January 1,
2007. ASC 740-10 prescribes a recognition threshold and measurement attribute for the
financial statement recognition and measurement of a tax position taken or expected to be
taken in a tax return and also provides guidance on derecognition, classification, interest
and penalties, accounting in interim periods, disclosure, and transition.
At the adoption date and as of December 31, 2009, the Company had no material unrecognized
tax benefits and no adjustments to liabilities or operations were required under ASC 740-10.
The Companys practice was and continues to be to recognize interest and penalty expenses
related to uncertain tax positions in income tax expense, which were zero at the adoption
date and for the years ended December 31, 2009, 2008 and 2007. Tax years 2006 through 2009
are subject to examination by federal and state taxing authorities, as well as, the tax
years generating net operating loss and credit carryfowards. There are no income tax
examinations currently in process.
The Company does not anticipate that it is reasonably possible that unrecognized tax
benefits as of December 31, 2009 will significantly change within the next 12 months.
(7) |
|
Segment Reporting, Geographical Information and Major Customers |
(a) Segment Reporting
The Company follows FASB ASC 280-10, Segment Reporting, which establishes standards for
reporting information about operating segments. Operating segments are defined as
components of a company about which the chief operating decision maker evaluates regularly
in deciding how to allocate resources and in assessing performance. The Companys chief
operating decision maker is the Chief Executive Officer. The Company operates in one
segment and as one reporting unit for all years presented since its products perform the
same basic function, have common sales channels and resellers, and are developed and
supported by one central staff.
(b) Geographic Information
The Companys sales are made to distributors and dealers of mammography and other medical
equipment, and to foreign distributors of mammography medical equipment. Total export sales
increased to approximately $3,702,000 or 13% of sales in 2009 as compared to $2,930,000 or
8% of total sales in 2008 and $2,655,000 or 10% of total sales in 2007.
As of December 31, 2009 and 2008 the Company had outstanding receivables of $488,147 and
$703,574, respectively, from distributors of its products who are located outside of the
U.S..
98
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(7) |
|
Segment Reporting, Geographical Information and Major Customers (continued) |
(c) Major Customers
In 2009, the Company had two major customers GE Healthcare and Fuji Medical Systems, which
accounted for $8,754,414 and $4,819,874 or 31% and 17% of the Companys revenues,
respectively, with accounts receivable balances of $1,623,069 and $1,149,405, respectively.
The Companys two major customers in 2008 were GE Healthcare and Fuji Medical Systems, with
revenues of $9,986,179 and $7,063,325 or 27% and 19% of its revenues, respectively, with
accounts receivable balances of $2,297,377 and $598,134, respectively. During 2007, the
Companys major customer was GE Healthcare with revenues of $7,609,313 or 29% of its
revenues.
(8) |
|
Commitments and Contingencies |
(a) Lease Obligations
As of December 31, 2009, the Company had three lease obligations related to its facilities.
The Companys principal executive offices are located in Nashua, New Hampshire. The lease
provides for a five (5) year term commencing on the December 15, 2006. The lease also
provides for annual base rent of $176,256 for the first year (with a one month rent
allowance of $14,688 to be applied against the first months base rent payment); $187,272
for the second year; $198,288 for the third year; $209,304 for the fourth year and $220,320
for the fifth year. Additionally, the Company is required to pay its proportionate share of
the building and real estate tax expenses and obtain insurance for the premises. The lease
provides for the Company to pay the base rent and proportionate building and real estate tax
expenses in equal monthly installments. The Company also has the right to extend the term of
the lease for an additional three year period at the then current market rent rate (which
shall not be less than the last annual rent paid by the Company).
The Company leases a facility for its research and development group located in Beavercreek,
Ohio for approximately $446,000 per year pursuant to a lease which expires in December 2010.
The lease amount increases annually throughout the life of the lease. The lease may be
renewed for two additional terms of five years each. In November 2005, the Company
subleased some of this office space at an average rate of approximately $93,000 per year
through December 2010. In August 2007 the Company subleased additional office space at an
average rate of approximately $84,000 per year through December 2010.
99
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(8) |
|
Commitments and Contingencies (continued) |
(a) Lease Obligations (continued)
In addition to the foregoing leases relating to its principal properties, the Company also
has a lease for an additional facility in Nashua NH used for product repairs, manufacturing
and warehousing.
Rent expense for all leases for the years ended December 31, 2009, 2008 and 2007 was
$718,316, $797,283 and $730,062, net of sublease income of $197,594, $170,789, and $135,711,
respectively.
Future minimum rental payments due under these agreements and sublease agreements as of
December 31, 2009 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating |
|
|
Sublease |
|
|
Net |
|
Fiscal Year |
|
Leases |
|
|
Amount |
|
|
Amount |
|
2010 |
|
$ |
701,244 |
|
|
$ |
232,691 |
|
|
$ |
468,553 |
|
2011 |
|
|
220,320 |
|
|
|
|
|
|
|
220,320 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
921,564 |
|
|
$ |
232,691 |
|
|
$ |
688,873 |
|
|
|
|
|
|
|
|
|
|
|
(b) Employment Agreements
The Company has entered into employment agreements with certain key executives. The
employment agreements provide for minimum annual salaries and performance-based annual bonus
compensation as defined in their respective agreements. In addition, the employment
agreements provide that if employment is terminated without cause, the executive will
receive an amount equal to their respective base salary then in effect for the greater of
the remainder of the original term of employment or for Mr. Ferry a period of two years from
the date of termination and for all other executives a period of one year from the date of
termination plus the pro rata portion of any annual bonus earned in any employment year
through the date of termination.
(c) 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
without 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 December 31, 2009.
100
iCAD, INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (continued)
(9) |
|
Quarterly Financial Data (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
available |
|
|
|
Net |
|
|
Gross |
|
|
Net |
|
|
to common |
|
|
|
sales |
|
|
profit |
|
|
(loss) income |
|
|
stockholders |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First quarter |
|
$ |
7,164,998 |
|
|
$ |
5,908,194 |
|
|
$ |
(998,527 |
) |
|
$ |
(0.02 |
) |
Second quarter |
|
$ |
5,729,887 |
|
|
$ |
4,676,670 |
|
|
$ |
(1,399,253 |
) |
|
$ |
(0.03 |
) |
Third quarter |
|
$ |
7,106,270 |
|
|
$ |
6,024,284 |
|
|
$ |
112,758 |
|
|
$ |
0.00 |
|
Fourth quarter |
|
$ |
8,108,110 |
|
|
$ |
6,878,333 |
|
|
$ |
317,398 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First quarter |
|
$ |
6,432,016 |
|
|
$ |
5,293,831 |
|
|
$ |
(445,853 |
) |
|
$ |
(0.01 |
) |
Second quarter |
|
$ |
10,549,489 |
|
|
$ |
8,815,648 |
|
|
$ |
2,386,598 |
|
|
$ |
0.06 |
|
Third quarter |
|
$ |
11,193,631 |
|
|
$ |
9,411,680 |
|
|
$ |
2,094,575 |
|
|
$ |
0.05 |
|
Fourth quarter |
|
$ |
9,316,411 |
|
|
$ |
7,794,359 |
|
|
$ |
320,869 |
|
|
$ |
0.01 |
|
101