ICAD INC - Annual Report: 2007 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K
(Mark
One)
x |
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the
fiscal year ended December
31, 2007
OR
o |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the
transition period from _______________
to
________________
Commission
file number 1-9341
iCAD,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
02-0377419
|
|
(State
or other jurisdiction
of
incorporation
or organization)
|
(I.R.S.
Employer Identification No.)
|
98
Spit Brook Road, Suite 100, Nashua, New Hampshire
|
03062
|
|
(
Address of principal executive offices)
|
(Zip
Code)
|
Registrant's
telephone number, including area code: (603)
882-5200
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Class
|
Name
of each exchange on which registered
|
|
Common
Stock, $.01 par value
|
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 x.
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 x.
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 x
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 registrant's 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
definitions of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated filer o
|
Accelerated
filer x
|
|
Non-accelerated
filer o
|
|
Smaller
reporting company o
|
(do
not check if a smaller reporting company)
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act.) Yes o No x.
The
aggregate market value of the voting stock held by non-affiliates of the
registrant, based upon the closing price for the registrant's Common Stock
on
June 30, 2007 was $127,780,279. Shares of voting stock held by each officer
and director and by each person who, as of June 30, 2007, may be deemed to
have beneficially owned more than 5% 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 10, 2008, the registrant had 39,171,332 shares of Common Stock
outstanding.
Documents
Incorporated by Reference: Certain portions of the registrant’s definitive proxy
statement for its Annual Meeting of Stockholders to be held in 2008 to be filed
with the Commission are incorporated by reference into Part III of this
report.
“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 Company’s 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
its 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
Company’s 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.
3
Today
the
Company is an
industry-leading provider of CAD solutions that enable radiologists and other
healthcare professionals 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. CAD is also reimbursable in the
United States under federal and most third-party insurance programs. Since
receiving FDA clearance for its first breast cancer detection product in January
2002, over eighteen hundred of iCAD’s CAD systems have been placed in
mammography facilities worldwide. We are 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.
Our
website is www.icadmed.com.
At this
website the following documents are available at no charge: our 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 we electronically file such material with, or
furnish 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.
We
are
headquartered in Nashua, New Hampshire, and our principal research and
development center is located in Beavercreek, Ohio.
Strategy
The
Company intends to continue to expand its core competencies in pattern
recognition and algorithm development in disease detection. The Company’s focus
is on the development and marketing of cancer detection solutions for disease
states where there are established or emerging protocols for screening as a
standard of care. The Company expects to pursue the development of CAD products
for select disease states that demonstrate one or more of the following: 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 believes that the steady advancement of digital imaging bolsters its
efforts to develop additional commercially viable CAD products. Its intention
is
to broaden the Company’s extensive CAD capabilities across multiple imaging
modalities to develop or enhance products that will help clinicians detect
disease earlier, enhance patient care, and improve patient outcomes. The Company
is currently applying its patented detection technology and algorithm platform
to other disease states, such as colon and lung cancer, where it believes
pattern recognition, artificial intelligence, and image processing will play
a
pivotal role. For mammography, the Company is developing CAD solutions for
tomosynthesis (3-D mammography) that assist radiologists in detecting more
cancers earlier, while also analyzing the tremendous volume of data generated
by
3-D imaging. CAD solutions are also in development for use with virtual
colonoscopy to improve the detection of colonic polyps while delivering improved
workflow for the radiologist, and higher quality patient care. The Company
expects to have a commercial CAD product for use with virtual colonoscopy
available for sale in Europe by the end of 2008.
4
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 will continue to provide powerful and flexible Digital Imaging
and Communication in Medicine (“DICOM”) connectivity solutions. Seamless
integration of CAD with leading image processing systems, review workstations,
and Picture Archiving and Communication Systems (“PACS”), from multiple vendors,
will remain a focal point of its 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 to the speed
at which high-priority images are processed through the system.
The
Company has also increased its emphasis on the development and growth of
residual and continuing revenue sources. Fee per procedure purchase options
have
been implemented for the delivery of CAD solutions and the Company is also
pursuing additional revenue sources related to service and extended maintenance
revenue.
Virtual
colonoscopy (“CTC”) is a technology that has evolved rapidly in recent years.
The Company expects that the market for virtual colonoscopy will grow worldwide.
The anticipated growth is due to the increased demand for the procedures for
early detection of colon cancer, combined with the recent results of the
National
CT Colonography Trial demonstrating
that CTC is highly accurate for the detection of intermediate and large polyps
and that the accuracy of CTC is similar to colonoscopy.
Market
and Market Opportunities
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. CAD is most prevalent as an adjunct to
mammography given the documented success of CAD. Other major clinical
applications where CAD technology is of value include breast MRI, virtual
colonoscopy and chest and lung screening.
5
Approximately
35
million mammograms are performed annually in the United States.
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 United States under federal and most third party insurance
programs. This reimbursement provides economic support for the acquisition
of
CAD products by women’s healthcare providers. Market growth has also been driven
in recent years by the introduction of full field digital mammography (“FFDM”)
systems. According to the January 2007 National Electrical Manufacturers
Association Forecast Report, the mammography market in the United States was
forecasted to exceed $400 million in 2007 and projected to grow at least 10%
in
2008.
In
the
United States, approximately 8,800 facilities (with approximately 14,000
mammography systems) are certified to provide mammography screening.
Historically, these centers have used conventional film-based medical imaging
technologies to capture and analyze breast images. Of the 8,800 certified
facilities, approximately 30% 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 Network’s (“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), digital mammography performed better than film-based
mammography.
While
double reading protocol is currently advocated as a standard of care in most
European countries this is not the case in the United States. 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 possibly further reduce breast cancer
mortality.
Breast
cancer is one of the most prevalent forms of cancer and 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.
6
Market
Size and Share
The
total
CAD mammography market in the United States was projected to exceed $100 million
in 2007 according to a 2006 Market Report from the Millennium Research Group
(“MRG”). According to this same report, iCAD had 45% of the U.S. digital
mammography CAD market with Hologic/R2 holding a 54% share. Frost and Sullivan
projects the CAD mammography market in the United States will reach $333.5
million in 2012, growing at a compounded rate of approximately 20.2 percent
between 2005 and 2012.
New
Market Opportunities
Computed
Tomography Applications and Colonic Polyp Detection
Computed
Tomography (“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 United
States 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. These challenges in CT imaging present
opportunities for automated image analysis and CAD products that the Company
believes it is well positioned to develop and promote.
According
to the American Cancer Society, colorectal cancer is the fourth most common
type
of cancer in men and women in the United States, and 140,000 people will be
diagnosed with colon cancer this year. It is also 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 and are eligible for colorectal cancer screening however this
technique remains highly under utilized, due at least in part to the invasive
nature of this screening procedure.
CTC,
also
known as Virtual Colonoscopy, is a relatively new and 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; CAD is then used
to
identify potential polyps. Results from the ACRIN National CT Colonography
Trial
recently announced at the ACRIN 2007 fall meeting, demonstrated that CTC is
highly accurate for the detection of intermediate and large polyps and that
the
accuracy of CTC is similar to colonoscopy. The Company believes that this study
coupled with recent legislation introduced to establish Medicare reimbursement
for the procedure are likely to expand the options available for colorectal
cancer screening and increase utilization of Virtual Colonoscopy.
7
CTC
is
becoming more readily available and has gained health insurance coverage for
some diagnostic applications and in some limited cases for the screening
application in the United States. 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. The Company is in the process of
developing solutions for the detection of colonic polyps in CTC exams. The
Company initially plans to deliver its solution to end users through integration
with leading vendors who provide image display and visualization technology
specifically designed for CTC images.
Products
and Product Development
The
table
below presents the revenue and percentage of revenue attributable to our
different product and services, in 2007, 2006 and 2005:
For
the year ended December 31,
|
|||||||||||||||||||
2007
|
%
|
2006
|
%
|
2005
|
%
|
||||||||||||||
Digital
revenue
|
$
|
16,429,450
|
62%
|
|
$
|
10,287,510
|
52%
|
|
$
|
6,303,373
|
32%
|
|
|||||||
Film
based analog revenue
|
6,768,846
|
25%
|
|
6,519,503
|
33%
|
|
11,685,454
|
59%
|
|
||||||||||
Service
& supply revenue
|
3,414,116
|
13%
|
|
2,914,345
|
15%
|
|
1,780,995
|
9%
|
|
||||||||||
Total
revenue
|
$
|
26,612,412
|
$
|
19,721,358
|
$
|
19,769,822
|
Products
for Computer Aided Detection (CAD) in Mammography
iCAD
develops and actively markets a comprehensive range of high-performance CAD
solutions for both digital and film-based mammography systems. iCAD’s 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 tissues. 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 Company’s history and provides clinical and workflow enhancements by
improving mass detection performance and reducing the number of false positive
CAD marks.
8
In
2006,
we initiated development of CAD products for additional digital imaging
providers including Agfa Corporation, Sectra Medical Systems and Planmed Oy.
We
also initiated research and development activities to develop the next
generation of SecondLook CAD. This next product will provide improved
performance and increased ease of use to better support clinical decision making
and improve workflow. Developmental work continues with PACS companies and
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.
SecondLook
Digital
The
SecondLook Digital products are used in conjunction with digital mammography
imaging systems from leading manufacturers of direct digital and computed
radiography equipment - including GE Healthcare, Siemens Medical, Hologic,
Inc.,
and IMS Giotto. In addition, iCAD is awaiting FDA approval for its CAD product
for use with Fuji’s Computer Radiography (“CR”) system. 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.
iCAD is also developing individualized product designs to enable customized
CAD
functionality unique to the products of each imaging partner.
SecondLook
Digital is a computer server residing on a customer’s 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 partners to ensure CAD results
are
integrated and easily viewed using each review workstation’s 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
iCAD’s customer support and service teams. The SecondLook 300 viewer offers
optional features such as PowerLook® and iReveal® technology that provide
soft-copy reading and touch screen control of the image for fast, precise image
assessment. 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. iCAD’s 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.
9
Products
for Converting Mammography Films to Digital Images
The
TotalLook MammoAdvantageÔ
system
converts prior mammography films to digital images delivering high resolution
digitized images to meet the critical specifications required for conversion
of
prior films. TotalLook MammoAdvantage captures all of the detail without image
artifacts for comparative review on a single digital workstation. In moving
to
one review workstation, users experience improvements in workflow, productivity
and reduced discomfort associated with switching between a light box and a
computer screen to view images.
The
TotalLook MammoAdvantage provides a comprehensive film-to-digital solution
making it easier for facilities to transition from film to digital mammography.
iCAD’s technology provides full image fidelity for more accurate digitized
images, high reliability with no daily maintenance, and fast scan time for
improved throughput. The comprehensive, flexible DICOM connectivity solutions
delivered through TotalLook MammoAdvantage enable seamless integration with
PACS
and RIS systems, reducing redundant patient data entry. Intelligent image
compression provides excellent image quality while substantially minimizing
storage requirements and improving network transmission speed.
Products
for Computer Aided Detection of Colonic Polyps
iCAD
is
currently engaged in the development of a CAD solution to support detection
of
colonic polyps in conjunction with CTC (CT Colonography or Virtual Colonoscopy).
iCAD believes that CAD for CTC is a natural extension of iCAD’s core
competencies in image analysis and image processing. iCAD expects this system
will likely be offered in conjunction with third party display workstations
and
PACS vendors. iCAD expects to begin field testing the product in 2008 and has
executed an agreement with ACR Image Metrix to conduct a multi-reader clinical
study of our CT Colon product, for use with Virtual Colonoscopy. With this
partnership, iCAD will work with ACR Image Metrix to develop and execute a
clinical study to support FDA approval of CT Colon CAD. ACR Image Metrix was
launched by the American College of Radiology (“ACR”) to leverage their thirty
years of experience in conducting clinical research in part through the ACRIN.
The 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.
iCAD
believes this partnership represents a major step forward in the development
and
commercialization of its Colon CAD product. Our expectation is that working
with
ACR Image Metrix, a group with significant expertise in radiology clinical
trial
management, will put the Company in an optimal position to submit solid clinical
data to the FDA and meet the Company goals for this proposed product line.
Sales
and Marketing
iCAD’s
products for digital mammography are sold through its direct regional sales
organization in the United States as well as through its OEM partners, including
GE Healthcare, Siemens Medical, Agfa in Europe, and through IMS Giotto’s network
of distributors. In 2006, iCAD entered into a supplier agreement with Fuji
Medical to supply their SecondLook Digital CAD product for use with Fuji’s CR
system. The Company is currently awaiting FDA approval of the Company’s product
for use with the Fuji CR system. Additionally, Siemens Medical expanded their
agreement to distribute the TotalLook MammoAdvantage digitizer solution for
comparative reading of prior films and GE Healthcare and Fuji Medical are adding
TotalLook MammoAdvantage to their product portfolios.
10
The
iCAD
analog product line is sold direct through our regional sales managers and
through select distributor and manufacturer representative organizations.
The
Company’s expanded domestic sales team is comprised of experienced healthcare
sales professionals with significant track records of success within the
diagnostic imaging market. In early 2007 an experienced healthcare sales manager
with significant CAD experience based in Europe, was hired by the Company to
run
iCAD’s European sales and marketing operation.
The
Company’s 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 2007 the Company
continued to build upon the re-branding campaign launched at the end of 2006.
The Company developed and executed a variety of public relations and
local outreach programs with numerous iCAD customers including a Video News
release package. Further investments were made in cultivating relationships
with
the leaders in Mammography, Colon, and Lung CAD at national trade shows through
round table discussions about the future of CAD in these modalities. Funding
supported attendance at more regional trade shows that focused on mammography.
The Company expanded and further enhanced its presence at the RSNA (Radiological
Society of North America) 2007 while also establishing a presence in the booths
of the Company’s OEM partners.
Competition
The
Company currently faces direct competition in its CAD business from Hologic,
Inc. (which acquired R2 Technology, Inc. in July 2006) and, to a lesser
extent from Kodak Carestream. Imaging equipment manufacturers such as GE
Medical, Siemens Medical, Philips Healthcare 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 in this market.
The
Company anticipates additional competition in the CT Colon solutions market.
It
expects competition will come 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. Several emerging CAD companies have also introduced
solutions for colorectal polyp detection.
11
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 Company’s business.
Manufacturing
and Customer and Professional Service
The
Company’s products are manufactured and assembled for it by a contract
manufacturer of medical devices. The Company’s 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 Company’s 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.
The
Professional services organization of iCAD is comprised of a team of trained
and
specialized individuals providing comprehensive 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 Company’s repair depot by their
repair technicians .
Government
Regulation
The
Company’s 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 FDA’s 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 Company’s devices are subject to FDA clearance or approval before they can
be marketed in the United States and may be subject to additional regulatory
approvals before they can be marketed outside the United States. There is no
guarantee that future products or product modifications will receive the
necessary approvals.
The
FDA’s
Quality System Regulations require that the Company's manufacturing 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 FDA’s general prohibition of promoting products for unapproved or
off-label uses.
12
The
Company's 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
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 United States, 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 22
issued
patents covering its CAD and scanner technologies in the United States expiring
between 2019 and 2026. These patents help the Company maintain a proprietary
position in these markets. Additionally, the Company has 18 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 iCAD’s CAD and digitizer
technologies and products, including CAD for CT colon and lung. In June 2006,
the Company secured a non-exclusive patent license from the National Institute
of Health (“NIH”) which relates broadly to CAD
in
colonography. In February 2003 the Company secured a patent license to United
States, European, Canadian, and Japanese patents owned by Scanis, Inc., which
relate broadly to CAD for breast cancer.
The
Company believes it has all the necessary licenses from third parties for
software and other technologies in its current 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 Company's 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 Company’s business would be harmed if any of its
manufacturers or suppliers could not meet its quality and performance
specifications and quantity and timing requirements.
13
Major
Customers
The
Company’s major customer in 2007 was GE Healthcare with revenues of
$7,609,313 or 29%
of
its revenues.
During
the year ended December 31, 2006 the Company had revenues of $5,077,091 and
$2,462,225,
or 26%
and 12% of revenues, to GE Healthcare and Hologic, Inc., respectively.
These
were the Company’s two major customers in 2006. For the year ended December 31,
2005 the Company’s two major customers were SourceOne Healthcare and GE
Healthcare with revenues of $3,725,065 and $2,913,493 or 19% and 15% of revenues
in 2005.
Engineering
and Product Development
The
Company spent $4,504,000, $5,260,893, and $4,785,092 on research and development
activities during the years ended December 2007, 2006 and 2005,
respectively. The research and development expenses for 2007 are primarily
attributed to the development of the Company’s next generation SecondLook
digital mammography CAD product, support of additional digital mammography
devices on our current SecondLook CAD product, development of the Company’s CAD
product for CT Colon, development of the TotalLook MammoAdvantageÔ
system
for comparative reading and patent development.
Employees
At
March
1, 2008 the Company had 106 employees, 99 full-time, 5 co-ops and 2 part-time
employees, with 32 involved in sales and marketing, 34 in research and
development, 24 in service, technical support and operations functions, and
16
in administrative functions. None of the Company’s employees are represented by
labor organizations. The Company believes its relations with its employees
are
good.
Backlog
The
Company’s product backlog (excluding service and supplies) was approximately
$1,731,000 at December 31, 2007 as compared to $2,566,000 on the corresponding
date in 2006 and $1,716,000 at September 30, 2007. The Company expects that
the
majority of the backlog at December 31, 2007 will be shipped within the 2008
fiscal year. Backlog as of any particular period should not be relied upon
as
indicative of the Company’s net revenues for any future period as a large amount
of the Company’s product is booked and shipped within the same
quarter.
14
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.
Financial
Geographic Information
The
Company markets its products for digital mammography in the United States
through its direct regional sales organization as well as through its OEM
partners, including GE Healthcare and Siemens Medical. Outside the United States
the Company markets its products for digital mammography generally through
its
OEM partners, GE Healthcare and Siemens Medical. Total export sales increased
to
approximately $2,655,000 or 10% of sales in 2007 as compared to $1,022,000
or 5%
of total sales in 2006 and $1,747,000 or 9% of total sales in 2005.
The
Company’s principal concentration of export sales is in Europe, which accounted
for 81% of the Company’s export sales in 2007, 91% of export sales in 2006, and
44% of export sales is 2005. Of these sales 70% in 2007, 77% in 2006 and 47%
in
2005 were in France. The balance of the export sales in 2007 were primarily
into
Asia, Canada, Spain and Mexico.
Foreign
Regulations
International
sales of the Company’s 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.
15
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.
We
have incurred significant losses since inception 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 $1,538,532 and a net
loss available to common stockholders of $1,606,292 during the fiscal year
ended
December 31, 2007. 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 61.7% and 52.2% of
our
total revenue for the years
ended December 31, 2007 and 2006, respectively. Our principal sales
distribution channel for our analog products
is
through our direct regional sales organization and
distributors. Our analog products accounted
for 25.4% and 33.1% of our total revenue for the years
ended December 31, 2007 and 2006, respectively. A
limited
number of large customers may continue to account for a significant portion
of
our future
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.
Our
business is dependent upon future market growth and acceptance of digital
mammography systems and other digital computer aided detection (CAD) products.
Our
future
business is substantially dependent on the continued growth in
the
market for digital mammography systems and digital computer aided detection
(CAD) products.
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
the
large installed base of conventional film-based mammography systems in hospitals
and imaging centers, the significant cost associated with the procurement of
full field digital mammography systems and CAD products, and
the
reliance on third party insurance reimbursement.
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.
16
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, 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 any additional 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 competing
effectively.
Changes
in reimbursement procedures by Medicare or other third-party payers may
adversely affect our business.
In
the
United States, 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.
There
is
no guaranty that any of the products which we contemplate developing will become
eligible for reimbursements or health insurance coverage at favorable rates
or
even at all or maintain eligibility.
17
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.
Furthermore, our independent registered public accounting firm is required
to
audit our assessment of the effectiveness of our internal controls over
financial reporting and separately report on whether it believes we maintain,
in
all material respects, effective 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, 2007 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 nation’s healthcare system.
HIPAA requires the United States Department of Health and Human Services, or
DHHS 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
healthcare provider, 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, compliance with the transaction standards became mandatory in
October 2003 (although full implementation was delayed with respect to the
Medicare program until October 2005), 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.
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.
18
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.
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.
19
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 industry's
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.
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 FDA’s
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 United States 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.
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.
20
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.
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.
21
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.
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 issuable 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
and
warrants. If holders of options or warrants 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 issuable 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.
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 United States 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.
22
Item 1B. |
Unresolved
Staff Comments
|
None
Item 2. |
Properties
|
The
Company’s 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 $445,000 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 $90,000
per year through December 2010.
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.
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. |
Submission
of Matters to a Vote of Security Holders
|
None.
23
PART
II
Item 5. |
Market
for Registrant's Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity
Securities.
|
The
Company's 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 2007 and 2006.
|
High
|
Low
|
|||||
Fiscal
year ended
|
|||||||
December
31, 2007
|
|||||||
First
Quarter
|
$
|
5.06
|
$
|
2.85
|
|||
Second
Quarter
|
4.24
|
2.47
|
|||||
Third
Quarter
|
4.21
|
2.59
|
|||||
Fourth
Quarter
|
3.35
|
1.65
|
|||||
Fiscal
year ended
|
|||||||
December
31, 2006
|
|||||||
First
Quarter
|
$
|
2.05
|
$
|
1.20
|
|||
Second
Quarter
|
2.45
|
1.31
|
|||||
Third
Quarter
|
2.12
|
1.28
|
|||||
Fourth
Quarter
|
3.38
|
2.00
|
As
of
March 1, 2008 there were 254 holders of record of the Company's common stock.
In
addition, the Company believes that there are in excess of 525 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 Company's earnings, capital requirements,
financial condition, and other factors considered relevant to the Company's
Board of Directors. There are no non-statutory restrictions on the Company's
present or future ability to pay dividends.
During
2007 the Company had two outstanding Series of Preferred Stock that had dividend
rights that were senior to holders of common stock. During the second and third
quarters of 2007, 5,150 shares of the Company’s 7% Series A Convertible
Preferred Stock and 1,145 shares of the Company 7% Series B Convertible
Preferred Stock were converted by non-affiliate holders into 1,087,500 shares
of
the Company’s common stock, in accordance with the terms of a preferred stock
agreement. No compensation or fees were paid to solicit or induce the conversion
by the holders of the preferred stock. Issuance of the Company’s common stock
upon conversion of the preferred stock was made pursuant to an exemption from
registration under Section 3(a) (9) of the Securities Act of 1933, as amended.
At December 31, 2007 the Company had no outstanding shares of its 7% Series
A or
Series B Preferred Stock.
See
Item
12 of this Form 10-K for certain information with respect to the Company’s
equity compensation plans in effect at December 31, 2007.
24
Item 6. |
Selected
Financial Data.
|
The
financial data set forth below should be read in conjunction with Item 7 -
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations” and our audited financial statements as of and for the years ended
December 31, 2007, 2006 and 2005 and the related notes included elsewhere in
this report and in our prior reports on Form 10-K. The historical results of
operations are not necessarily indicative of future results.
Selected
Statement of Operations Data
Year
Ended December 31,
|
||||||||||||||||
2007
(1)
|
2006
(1)
|
2005
|
2004
|
2003
|
||||||||||||
Total
Revenue
|
$
|
26,612,412
|
$
|
19,721,358
|
$
|
19,769,822
|
$
|
23,308,462
|
$
|
6,520,306
|
||||||
Gross
margin
|
21,355,308
|
15,430,540
|
15,133,765
|
16,775,166
|
3,578,643
|
|||||||||||
Gross
margin %
|
80.2
|
%
|
78.2
|
%
|
76.5
|
%
|
72.0
|
%
|
54.9
|
%
|
||||||
Total
operating expenses
|
22,459,111
|
21,869,219
|
19,888,292
|
17,042,385
|
11,662,396
|
|||||||||||
Loss
from operations
|
(1,103,803
|
)
|
(6,438,679
|
)
|
(4,754,527
|
)
|
(267,219
|
)
|
(8,083,753
|
)
|
||||||
Interest
expense - net
|
434,729
|
199,279
|
3,961
|
561,044
|
114,655
|
|||||||||||
Net
loss
|
(1,538,532
|
)
|
(6,637,958
|
)
|
(4,758,488
|
)
|
(828,263
|
)
|
(8,198,408
|
)
|
||||||
Net
loss available to common stockholders
|
(1,606,292
|
)
|
(6,754,158
|
)
|
(4,880,218
|
)
|
(961,263
|
)
|
(8,342,666
|
)
|
||||||
Net
loss per share
|
(0.04
|
)
|
(0.18
|
)
|
(0.13
|
)
|
(0.03
|
)
|
(0.31
|
)
|
||||||
Weighted
average shares outstanding basic and diluted
|
38,351,345
|
36,911,742
|
36,627,696
|
34,057,775
|
26,958,324
|
(1)
iCAD,
Inc. adopted the provision of SFAS 123R, "Share Based Payment", effective Janury
1, 2006, the beginning of fiscal 2006. As a result, the results of operations
for fiscal 2007 and 2006 included incremental share-based payments over what
would have been recorded had the Company continued to account for share-based
compensensation under APB No. 25 "Accounting for Stock Issued to Employees".
See
Note 6 of the Notes to Consolidated Financial Statements.
Selected
Balance Sheet Data
As
of December 31,
|
||||||||||||||||
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
Cash
and cash equivalents
|
$
|
4,348,729
|
$
|
3,623,404
|
$
|
4,604,863
|
$
|
8,008,163
|
$
|
5,101,051
|
||||||
Total
current assets
|
12,950,759
|
10,558,300
|
11,256,855
|
14,289,588
|
11,115,003
|
|||||||||||
Total
assets
|
61,730,678
|
60,289,673
|
61,527,835
|
65,136,107
|
62,662,136
|
|||||||||||
Total
current liabilities
|
10,624,085
|
6,488,511
|
8,166,756
|
5,990,562
|
7,761,506
|
|||||||||||
Convertible
revolving loans payable to related party, including current
portion
|
2,258,906
|
2,258,906
|
258,906
|
300,000
|
3,630,000
|
|||||||||||
Convertible
loans payable to related parties, including current
portion
|
2,793,382
|
2,784,559
|
-
|
-
|
-
|
|||||||||||
Convertible
loans payable to non-related parties, including current
portion
|
684,559
|
663,970
|
-
|
-
|
-
|
|||||||||||
Note
payable, current
|
-
|
375,000
|
1,875,000
|
3,375,000
|
4,608,390
|
|||||||||||
Convertible
Subordinated Debentures
|
-
|
-
|
-
|
-
|
10,000
|
|||||||||||
Stockholders'
equity
|
48,847,687
|
47,971,727
|
52,727,173
|
56,970,545
|
47,895,630
|
25
Item 7. |
Management's
Discussion and Analysis of Financial Condition and
Results
of Operations.
|
Results
of Operations
Overview
iCAD
is
an industry-leading provider of computer aided detection solutions (“CAD”) that
enable radiologists and other healthcare professionals 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. CAD for
mammography screening is also reimbursable in the United States under federal
and most third-party insurance programs. Since receiving FDA approval for the
Company’s first breast cancer detection product in January 2002, over eighteen
hundred of our 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.
In
late
2005, the Company began to see a shift in sales from its film based analog
CAD
technology to its digital CAD technology. This shift has been primarily fueled
by the results reported in 2005 in the New England Journal of Medicine from
the
American College of Radiology Imaging Network’s (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), digital mammography performed better than film-based analog
mammography. Additionally, digital mammography offers better clinical images
combined with significant workflow improvements for the radiologist. CAD
technology is more often purchased for use with digital mammography equipment
than is purchased for use with analog mammography equipment. The Company
believes that the shift to digital CAD technology will continue and as such
it
will continue to have a positive impact on the Company’s overall financial
performance, primarily because as the number of facilities converting to digital
mammography systems continues to grow, the Company expects to realize higher
revenue of its digital products due to the higher adoption rate of digital
CAD
technology as compared to analog CAD technology and from higher gross margins
realized on the Company’s digital products.
iCAD’s
CAD 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.
26
The
Company intends to apply its core competencies in pattern recognition and
algorithm development in disease detection. Our 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 of products for select disease states where 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. Virtual
colonoscopy (CTC) is a technology that has evolved rapidly in recent years.
We
expect that the market for virtual colonoscopy will grow. The
anticipated growth is due to the increased
demand for the procedures for early detection of colon cancer, combined with
the
recent results of the National
CT Colonography Trial demonstrating
that CTC is highly accurate for the detection of intermediate and large polyps
and that the accuracy of CTC is similar to colonoscopy.
CT
Colonography or CTC is emerging as an alternative imaging procedure for
evaluation of the colon. The Company is developing a product for computer aided
detection of polyps using CTC. Colorectal cancer has been shown to be
highly preventable with early detection and removal of polyps.
The
Company’s CAD systems include proprietary algorithm technology together with
standard computer and display equipment. CAD systems for the film-based analog
mammography market also include a radiographic film digitizer, manufactured
by
the Company that utilizes the Company’s proprietary technology for the
digitization of film-based medical images. The Company’s headquarters are
located in southern New Hampshire, with manufacturing and contract manufacturing
facilities in New Hampshire and Massachusetts and a research and development
facility in Ohio.
Critical
Accounting Policies
The
Company’s 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 United States. 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
Company’s 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.
27
Revenue
Recognition
Revenue
is generally recognized 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 considers the guidance
for revenue recognition in the Financial Accounting Standards Board’s (“FASB”)
Emerging Issues Task Force Issue 00-21, “Accounting for Revenue Arrangements
with Multiple Deliverables”, EITF 00-21 and Staff Accounting Bulletin No. 104,
“Revenue Recognition in Financial Statements”. The Company’s revenue
transactions can on occasion include product sales with multiple element
arrangements, generally for installation. The elements are considered separate
units 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 items. Revenue under these arrangements is allocated to each element
based on its estimated relative fair market value. Fair market value is
determined using entity specific and third party evidence. A portion of the
arrangement consideration is recognized as revenue when the product is shipped
and a portion of the arrangement consideration is recognized as revenue when
the
installation service is performed. The value of the undelivered elements
includes the fair value of the installation.
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 customer’s post-delivery acceptance
provisions, if any, and the installation process. There are no significant
estimates or assumptions used in the Company’s revenue recognition.
The
Company defers revenue for extended service contracts related to future periods
and recognizes revenue on a straight-line basis in accordance with FASB
Technical Bulletin No. 90-1, "Accounting for Separately Priced Extended Warranty
and Product Maintenance Contracts." 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 our financial statements to understand the basis upon which
our
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.
28
Allowance
for Doubtful Accounts
The
Company’s 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 Company’s 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, 2007 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 and CADx in December 2003. 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 issued SFAS No. 141, “Business
Combinations” (“SFAS 141”), and No. 142 “Goodwill and Other Intangible Assets”
(“SFAS 142”). SFAS 141 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. SFAS 142 addresses the accounting for acquired
goodwill and intangible assets. Goodwill and indefinite-lived intangible assets
are no longer amortized and are tested for impairment at least annually.
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 assumes
market capitalization is the best evidence of fair value (market capitalization
is calculated using the quoted closing share price of its 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 in
accordance with paragraph 23 of SFAS 142, which notes that quoted
market prices in active markets are the best evidence of fair value and will
be
used as the basis for the measurement. 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. At October 1, 2007 the
Company’s market capitalization exceeded its carrying amount and it determined
that there was no impairment to its goodwill. Additionally, the Company reviews
fair value and goodwill impairment quarterly to determine if facts or
circumstances have occurred that would trigger impairment prior to the annual
impairment date. Since the Company’s carrying amount has not exceeded its fair
value, the second step of the goodwill impairment test has been unnecessary.
29
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.
Stock
Based Compensation
The
Company maintains stock-based incentive plans, under which it provides stock
incentives to employees and directors. The Company grants to employees and
directors, restricted stock and options to purchase common stock at an option
price equal to the market value of the stock at the date of grant. Prior
to the effective date of Statement
No. 123R, Share-Based Payment (“SFAS 123R”),
the
Company applied APB 25, and related interpretations, for its stock option
grants. APB 25 provides that the compensation expense relative to its stock
options is measured based on the intrinsic value of the stock option at date
of
grant.
Effective
the beginning of the first quarter of fiscal year 2006, the Company adopted
the
provisions of SFAS 123R using the modified prospective transition method. Under
this method, prior periods are not restated. 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 of SFAS 123R apply to new stock options and stock
options outstanding, but not yet vested, on the date the Company adopted SFAS
123R. Stock-based compensation expense was included in applicable departmental
expense categories in the Consolidated Statements of Operations for the fiscal
2007 and 2006 periods.
Income
Taxes
The
Company follows the liability method under SFAS No. 109, “Accounting for Income
Taxes” (“SFAS 109”). The primary objectives of accounting for taxes under SFAS
109 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 Company’s financial
statements or tax returns. The Company has provided a full valuation allowance
against its deferred tax assets at December 31, 2007, 2006 and 2005 as it is
more likely than not that the deferred tax asset will not be
realized.
30
The
Company adopted FASB Interpretation No. 48, "Accounting for Uncertainty in
Income Taxes—an interpretation of FASB Statement No. 109" ("FIN 48") on January
1, 2007. FIN 48 clarifies the accounting for uncertainty in income taxes
recognized in an enterprise's financial statements in accordance with FASB
Statement No. 109, "Accounting for Income Taxes." FIN 48 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. FIN 48 also provides guidance on de-recognition, classification,
interest and penalties, accounting in interim periods, disclosure, and
transition. The adoption of FIN 48 did not have a material impact on the
Company's consolidated financial statements.
Year
Ended December 31, 2007 compared to Year Ended December 31,
2006
Revenue.
Revenue
for the year ended December 31, 2007 was $26,612,412 compared with revenue
of
$19,721,358 for the year ended December 31, 2006 for an increase of $6,891,054
or 34.9%. In 2007 sales of iCAD’s digital CAD products increased $6,141,940 or
59.7% to $16,429,450, compared to sales of $10,287,510 in 2006. This is due
to a
substantial increase in the market adoption of Full Field Digital Mammography
(“FFDM”) equipment and strong continued demand for digital CAD technology for
the detection of breast cancer used in conjunction with FFDM.
This
shift in sales to FFDM and the associated CAD technology has generally slowed
sales of the Company’s film based analog technology. While the transition to
digital technology has had a significant positive impact on the Company’s
overall financial performance in 2007, the Company’s film based analog products
are a mature product line. Despite the overall market shift to digital CAD
equipment during 2007 the Company realized a strong demand for its
TotalLookÔ
product
that is used for digitizing the results of prior film based mammography exams,
for comparative reading with current digital mammography exams. The TotalLook
product, which is included in the Company’s film based analog revenue, provides
a comprehensive film-to-digital solution making it easier for mammography
facilities to transition from film to digital mammography. Sales of iCAD’s film
based analog products increased 3.8% or $249,343 to $6,768,846 for the year
ended December 31, 2007 compared to $6,519,503 for the year ended December
31,
2006.
Service
and supply revenue increased approximately $499,771 or 17.1% in the year ended
December 31, 2007 to $3,414,116 compared to $2,914,345 for the year ended
December 31, 2006. The increase in the Company’s service revenue is due
primarily to focused efforts by the Company to increase its service offerings
to
its customers, resulting in an increase in sales of contracts that provide
service on products beyond its warranty period.
The
table
below presents the revenue attributable to different product and service, in
2007 and 2006:
31
For
the year ended December 31,
|
|||||||||||||
2007
|
2006
|
Change
|
%
Change
|
||||||||||
Digital
revenue
|
$
|
16,429,450
|
$
|
10,287,510
|
$
|
6,141,940
|
59.7
|
%
|
|||||
Film
based analog revenue
|
6,768,846
|
6,519,503
|
249,343
|
3.8
|
%
|
||||||||
Service
& supply revenue
|
3,414,116
|
2,914,345
|
499,771
|
17.1
|
%
|
||||||||
Total
revenue
|
$
|
26,612,412
|
$
|
19,721,358
|
$
|
6,891,054
|
34.9
|
%
|
Gross
Margin. Gross
margin increased to 80.2% for the year ended December 31, 2007 compared to
78.2%
for the year ended December 31, 2006. The increase in gross margin is primarily
attributable to increased sales of the Company’s digital products, which have a
slightly higher gross margin than its film based analog products which include
more hardware components.
Engineering
and Product Development. Engineering
and product development costs for the year ended December 31, 2007 decreased
by
$756,893 or 14.4%, from $5,260,893 in 2006 to $4,504,000 in 2007. The decrease
in engineering and product development costs for the year ended December 31,
2007 was primarily due to a decrease in overall personnel and recruiting costs
resulting from staff reductions and a shift in personnel to the Company’s
marketing department and a decrease travel expense that was partially offset
by
an increase in bonus expense of approximately $459,000. In addition, during
the
2007 period the Company experienced a decrease in consulting, prototype and
regulatory expenses of approximately $390,000. The decrease in expenses were
partially offset by an increase in stock based compensation expense for the
year
ended December 31, 2007 of approximately $79,000 to $166,000 in 2007 compared
to
$87,000 for the same period in 2006.
Marketing
and Sales. Marketing
and sales expense for the year ended December 31, 2007 increased by $1,551,423
or 16.8%, from $9,228,881 in 2006 to $10,780,304 in 2007. The increase in
marketing and sales expense for the year ended 2007, primarily resulted from
the
actions taken by the Company’s new management to revamp the sales efforts
including the hiring of highly experienced sales and marketing professionals
and
a shift of several personnel from engineering to product marketing, which
resulted in increased personnel and related expenses of approximately
$1,352,000. In addition, the Company incurred additional expenses of
approximately $282,000 for public relations, advertising, travel, collateral
and
training materials. The increase in marketing and sales expense were partially
offset by a decrease in stock based compensation expense for the year ended
December 31, 2007 of approximately $83,000 to $162,000 in 2007 compared to
$245,000 for the same period in 2006.
32
General
and Administrative. General
and administrative expenses for the year ended December 31, 2007 decreased
by
$204,639 or 2.8%, from $7,379,446 in 2006 to $7,174,807 in 2007. The decrease
in
general and administrative expenses for the year ended December 31, 2007 was
due
primarily to severance and related separation costs of approximately $700,000
in
2006 in connection with the resignation of the Company’s former Chief Executive
Officer in May 2006. These costs included $258,000 in share-based compensation
under SFAS 123R due to the modification of options in connection with his
separation agreement with the Company. The decrease in general and
administrative expense in 2007, also includes a reduction of approximately
$489,000 in legal expenses principally associated with the Company’s patent
arbitration proceeding with R2 Technology, Inc. which was settled in April
of
2006 and a decrease of $200,000 in amortization expense due to fully amortized
assets associated with the Company’s acquisition of CADx in 2003. These
decreases in expenses were partially offset by increases in personnel and
salaries, employee bonus accrual and expenses associated with the Company’s new
office facility totaling approximately $854,000 and an increase of approximately
$136,000 in stock-based compensation expense, to $880,000 in 2007 compared
to
$744,000 for the same period in 2006.
Interest
Expense Net.
Net
interest expense for the year ended December 31, 2007 increased from $199,279
in
2006 to $434,729 in 2007. This increase is due primarily to a full year of
interest expense realized on the Convertible Promissory Notes issued by the
Company in June 2006 and September 2006 offset by interest income of $74,145
and
$102,963 in 2007 and 2006, respectively.
Net
Loss.
As a
result of the foregoing and including total stock based compensation expense
of
$1,242,155 in fiscal 2007, the Company recorded a net loss of ($1,538,208)
or
($0.04) per share for the year ended December 31, 2007 on revenue of
$26,612,412, compared to stock based compensation expense of $1,334,485 with
a
net loss of ($6,637,958) or ($0.18) per share for the same period in 2006 on
revenue of $19,721,358.
Backlog. The
Company’s product backlog (excluding service and supplies) as of December 31,
2007 totaled approximately $1,731,000 as compared to $2,566,000 as of December
31, 2006. It is expected that
the
majority of the backlog at December 31, 2007 will be shipped within the 2008
fiscal year. Backlog as of any particular period should not be relied upon
as
indicative of the Company’s net revenues for any future as much of the Company’s
product is booked and shipped within the same quarter.
Year
Ended December 31, 2006 compared to Year Ended December 31,
2005
Revenue.
Revenue
for the year ended December 31, 2006 was $19,721,358 compared with revenue
of
$19,769,822 for the year ended December 31, 2005 for a decrease of $48,464
or
0.2%. The rapid adoption of FFDM systems and its associated digital CAD
technology led to an increase in digital product revenues of $3,984,137 or
63.2%
to $10,287,510 for the year ended December 31, 2006. The increase in digital
revenue was offset by a decrease in analog product revenue of $5,165,951 or
44.2% to $6,519,503 in fiscal 2006, compared to revenue of $11,685,454 for
the
year ended December 31, 2005.
Service
and supply revenue increased approximately $1,133,350 or 63.6% in the year
ended
December 31, 2006 to $2,914,345, compared to $1,780,995 for the year ended
December 31, 2005. The increase in the Company’s service revenue was due
primarily to focused efforts by the Company to increase its service offerings
to
its customers.
33
For
the years ended December 31,
|
|||||||||||||
2006
|
2005
|
Change
|
%
Change
|
||||||||||
Digital
revenue
|
$
|
10,287,510
|
$
|
6,303,373
|
$
|
3,984,137
|
63.2
|
%
|
|||||
Analog
revenue
|
6,519,503
|
11,685,454
|
(5,165,951
|
)
|
-44.2
|
%
|
|||||||
Service
& supply revenue
|
2,914,345
|
1,780,995
|
1,133,350
|
63.6
|
%
|
||||||||
Total
revenue
|
$
|
19,721,358
|
$
|
19,769,822
|
$
|
(48,464
|
)
|
-0.2
|
%
|
Gross
Margin. Gross
margin increased to 78.2% for the year ended December 31, 2006 compared to
76.5%
for the year ended December 31, 2005. The increase in gross margin was primarily
attributable to higher gross margins realized on the Company’s digital products.
During the third quarter of 2006 the Company increased its inventory reserve
by
approximately $263,000 for identified excess and obsolete analog inventory.
Engineering
and Product Development. Engineering
and product development costs for the year ended December 31, 2006 increased
by
$475,801 or 9.9%, from $4,785,092 in 2005 to $5,260,893 in 2006. The increase
in
engineering and product development costs for the year ended December 31, 2006
was primarily due to product enhancements related to the Company’s breast cancer
detection algorithms, and the expansion of the Company’s efforts in product
development for CAD for CTC applications, primarily the early detection of
colonic polyps. In addition, approximately $150,000, relating to severance
and
recruiting costs was incurred during the second and third quarters of 2006.
The
increase in engineering and product development costs for the year ended 2006,
also included employee bonuses of approximately $117,000 and stock based
compensation expense in the amount of approximately $87,000 due to the impact
of
SFAS 123R.
Marketing
and Sales. Marketing
and sales expense for the year ended December 31, 2006 increased by $1,082,030
or 13.3%, from $8,146,850 in 2005 to $9,228,881 in 2006. The increase in
marketing and sales expense for the year ended 2006, primarily resulted from
the
actions taken by the new Company management to revamp the direct sales
organization including the hiring of highly experienced healthcare sales
professionals, development of channel partners and lead generation programs
and
the incurrence of approximately $565,000 for
the
re-branding and repositioning of the Company. The increase in marketing and
sales expense in 2006, also included employee bonuses of $266,000 and stock
based compensation expense in the amount of approximately $245,000 due to the
impact of SFAS 123R.
General
and Administrative. General
and administrative expenses for the year ended December 31, 2006 increased
by
$423,095 or 6.1%, from $6,956,350 in 2005 to $7,379,445 in 2006. The increase
in
general and administrative expenses for the year ended December 31, 2006 was
due
primarily to recruiting and severance expenses of approximately $843,000,
employee bonuses of $314,000, and stock-based compensation expense due to the
impact of SFAS 123R of approximately $1,002,000 associated principally with
the
Company’s transition to new management, a newly established compensation plan
for the Company’s Board of Directors and modification of the outstanding stock
options of the Company’s former Chief Executive Officer incurred in the second
quarter of 2006 in connection with his Separation Agreement. The increase in
expense was offset by a reduction in legal costs in 2006. The Company incurred
approximately $2,300,000 in legal costs during 2005 compared to approximately
$830,000 in 2006, principally associated with the Company’s patent arbitration
proceeding and associated merger discussions with R2 Technology, Inc. The
arbitration proceeding was concluded in April 2006.
34
Interest
Expense.
Net
interest expense for the year ended December 31, 2006 increased from $3,961
in
2005 to $199,279 in 2006. The $195,318 increase was due primarily to the
increase in loan balances for the Convertible Promissory Notes issued by the
Company during the second and third quarters of 2006.
Net
Loss.
As a
result of the foregoing and including total stock based compensation expense
of
$1,334,485 in fiscal 2006, the Company recorded a net loss of ($6,637,958)
or
($0.18) per share for the year ended December 31, 2006 on revenue of $19,721,358
compared to a net loss of ($4,758,488) or ($0.13) per share for the same period
in 2005 on revenue of $19,769,822.
Backlog.
The
Company’s product backlog (excluding service and supplies) as of December 31,
2006 totaled approximately $2,566,000 as compared to $788,000 as of December
31,
2005. Backlog as of any particular period should not be relied upon as
indicative of the Company’s net revenues for any future period.
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
expected to be generated from continuing operations and the availability of
a
$5,000,000 credit line under the Loan Agreement with its former Chairman, Mr.
Robert Howard, of which $2,741,094 was available for borrowing at December
31,
2007. The Loan Agreement expires March 31, 2008, subject to extension by the
parties, with an agreement from Mr. Howard that he will not request repayment
of
the principal balance of the note until March 31, 2009. Outstanding advances
are
collateralized by substantially all of the assets of the Company and bear
interest at the prime interest rate plus 1%, (8.25% at December 31, 2007).
Mr.
Howard has also agreed that while the Loan Agreement exists he will not convert
any outstanding advances under the Loan Agreement into shares of the Company’s
common stock that would exceed the available shares for issuance defined as
the
authorized shares of the Company’s common stock less issued and outstanding
common shares less any reserved shares for outstanding convertible preferred
stock, convertible notes payable, non-employee warrants and non-employee stock
options. The Company's 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. The
Company expects to obtain a line of credit from a commercial bank or extend
the
Revolving Loan and Security Agreement with Mr. Howard.
Working
capital decreased by $1,743,115 to $2,326,674 at December 31, 2007 from
$4,069,789 at December 31, 2006. The ratio of current assets to current
liabilities at December 31, 2007 and 2006 was 1.2 and 1.6, respectively. The
decrease in working capital is primarily due to the reclassification of the
two
year loan agreements completed in 2006 to short term liabilities from long
term
liabilities.
35
Net
cash
provided by operating activities for the year ended December 31, 2007 was
$574,569 compared to net cash used of $4,411,002 for the same period in 2006.
The cash provided by operating activities for the year ended December 31, 2007
resulted from a net loss of $1,538,532, an increase in accounts receivable
of
$2,800,440 and other current assets of $100,446 and a decrease in accounts
payable and accrued expenses totaling $551,557, offset by a decrease in
inventory of $1,233,752 and increases in accrued interest of $454,785 and
deferred revenue of $885,883, plus non-cash items including depreciation,
amortization, disposal of assets and interest expense associated with discount
on convertible loans payable of $1,748,969 and stock based compensation of
$1,242,155.
The
net
cash used for investing activities for the year ended December 31, 2007 was
$714,341 compared to $1,175,860 used for the same period in 2006. The cash
used
in investing activities in 2007 included the addition of $714,341 for furniture,
computer equipment, software, and marketing assets.
Net
cash
provided by financing activities for the year ended December 31, 2007 was
$865,097, compared to net cash provided by financing activities of $4,605,403
for the same period in 2006. The cash provided by financing activities during
2007 was due primarily to cash received from the issuance of common stock
relating to the exercise of stock options in the amount of $1,240,097 offset
by
the final payment of the note payable associated with the CADx acquisition
in
the amount of $375,000.
The
following table summarizes as of December 31, 2007, for the periods presented,
the Company’s future estimated cash payments under existing contractual
obligations.
|
Payments
due by period
|
|||||||||||||||
Contractual
Obligations
|
Total
|
Less
than 1 year
|
1-3
years
|
3-5
years
|
5+
years
|
|||||||||||
Convertible
revolving loan payable to related party
|
$
|
2,258,906
|
$
|
-
|
$
|
2,258,906
|
$
|
-
|
$
|
-
|
||||||
Convertible
loans payable to related parties
|
$
|
2,793,382
|
$
|
2,793,382
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Convertible
loans payable to investors
|
$
|
684,559
|
$
|
684,559
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Lease
Obligations*
|
$
|
1,732,808
|
$
|
505,324
|
$
|
1,007,164
|
$
|
220,320
|
$
|
-
|
||||||
Other
Obligations
|
$
|
175,762
|
$
|
175,762
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Interest
Obligation*
|
$
|
428,007
|
$
|
428,007
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Total
Contractual Obligations
|
$
|
8,073,424
|
$
|
4,587,034
|
$
|
3,266,070
|
$
|
220,320
|
$
|
-
|
*
The
Company’s lease obligations is shown net of sublease amounts and interest
obligation relating to the Loan Agreement with Mr. Howard, its former Chairman,
is not included in this table.
36
Effect
of New Accounting Pronouncements
In
September 2006, the FASB issued SFAS No. 157, “Fair Value
Measurements” (“SFAS 157”). SFAS 157 defines fair value, establishes a
framework for measuring fair value and expands disclosure of fair value
measurements. SFAS 157 applies under other accounting pronouncements that
require or permit fair value measurements and accordingly, does not require
any
new fair value measurements. SFAS 157 is effective for financial statements
issued for fiscal years beginning after November 15, 2007 and interim
periods within those fiscal years for financial assets and liabilities, as
well
as for any other assets and liabilities that are carried at fair value on a
recurring basis in financial statements. The FASB has provided a one year
deferral for the implementation for other non-financial assets and liabilities.
The Company is currently evaluating the impact of the adoption of SFAS 157
on
its consolidated financial statements.
In
February 2007, the FASB issued Statement No. 159, “The Fair Value Option
for Financial Assets and Financial Liabilities” (SFAS 159”), including an
amendment of FASB Statement No. 115, which allows an entity to elect to
record financial assets and liabilities at fair value upon their initial
recognition on a contract-by-contract basis. Subsequent changes in fair value
would be recognized in earnings as the changes occur. SFAS 159 also
establishes additional disclosure requirements for these items stated at fair
value. SFAS 159 is effective as of the beginning of an entity’s first
fiscal year that begins after November 15, 2007. The Company is currently
evaluating the impact of the adoption of SFAS 159 on its consolidated financial
statements.
In
December 2007, the FASB issued SFAS No. 141 (Revised 2007), “Business
Combinations” (“SFAS 141R”). SFAS 141R retains the fundamental requirements in
Statement 141 that the acquisition method of accounting (which Statement 141
called the purchase method) be used for all business combinations and for an
acquirer to be identified for each business combination. SFAS 141R requires
an
acquirer to recognize the assets acquired, the liabilities assumed, and any
noncontrolling interest in the acquiree at the acquisition date, measured at
their fair values as of that date, with limited exceptions specified in the
Statement. That replaces Statement 141’s cost-allocation process, which required
the cost of an acquisition to be allocated to the individual assets acquired
and
liabilities assumed based on their estimated fair values. SFAS 141R retains
the
guidance in Statement 141 for identifying and recognizing intangible assets
separately from goodwill. SFAS 141R will now require acquisition costs to be
expensed as incurred, restructuring costs associated with a business combination
must generally be expensed prior to the acquisition date and changes in deferred
tax asset valuation allowances and income tax uncertainties after the
acquisition date (including prior acquisitions) generally will affect income
tax
expense. SFAS 141R applies prospectively to business combinations for which
the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008 except for income taxes, as
noted
above. The Company is currently evaluating the impact of the adoption of SFAS
141R on its consolidated financial statements.
37
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. |
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 Company's disclosure controls and
procedures (as defined in Rule 13a-15(e) of the Exchange Act) were effective.
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.
Management’s
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 Company's Consolidated
Financial Statements, establishing and maintaining adequate internal control
over financial reporting (as defined in Exchange Act Rule 13a-(f)) for the
Company and all related information appearing in this Annual Report on Form
10-K.
38
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 Company's internal control over financial reporting.
Management of the Company has assessed the Company's internal control over
financial reporting to be effective as of December 31, 2007.
The
effectiveness of the Company’s internal control over financial reporting as of
December 31, 2007 has been audited by BDO Seidman, LLP, an independent
registered public accounting firm, as stated in its report which is included
below.
To
the Board of Directors and Stockholders of iCAD, Inc.
Nashua,
New Hampshire
To
the
Board of Directors and Stockholders of iCAD, Inc.
Nashua,
New Hampshire
We
have
audited iCAD, Inc.’s (the “Company”) internal control over financial reporting
as of December 31, 2007, based on criteria established in Internal Control
-
Integrated Framework issued by the Committee of Sponsoring Organizations of
the
Treadway Commission (the COSO criteria). iCAD, Inc.’s management is responsible
for maintaining effective internal control over financial reporting and for
its
assessment of the effectiveness of internal control over financial reporting,
included in the accompanying Item 9A, Management’s Report on Internal Control
Over Financial Reporting. Our responsibility is to express an opinion on the
Company’s internal control over financial reporting based on our audit.
We
conducted our audit 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 effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control
over
financial reporting, assessing the risk that a material weakness exists, and
testing and evaluating the design and operating effectiveness of internal
control based on the assessed risk. Our audit also included performing such
other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A
Company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain
to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors
of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial statements.
39
Because
of its inherent limitations, internal control over financial reporting may
not
prevent or detect misstatements. 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.
In
our
opinion, iCAD, Inc. maintained, in all material respects, effective internal
control over financial reporting as of December 31, 2007, based on the COSO
criteria.
We
also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of iCAD, Inc.
as of December 31, 2007 and 2006, and the related consolidated statements of
operations, stockholders’ equity, and cash flows for each of the three years in
the period ended December 31, 2007 and our report dated March 14, 2008 expressed
an unqualified opinion thereon.
/s/
BDO
Seidman, LLP
Boston,
Massachusetts
March
14,
2008
Changes in Internal Control Over Financial Reporting.
The
Company’s principal executive officer and principal financial officer conducted
an evaluation of the Company's 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, 2007, 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.
Item 9B. |
Other
Information.
|
On
March
12, 2008 the Board of Directors of the Company approved the Company’s Amended
and Restated By-laws (the “New By-Laws”) designed to, among other things, update
certain provisions in the By-laws to correspond to changes in the Delaware
General Corporation Law (“DGCL”), delete certain provisions that are
specifically covered by the DGCL and provide for procedures for stockholders
to
nominate directors and make proposals at meetings of the Company’s stockholders.
Among other things the New By-Laws: (i) deleted the old registered Delaware
office reference and allows officers of the Company to determine office
location; (ii) updated the stockholder meeting section regarding persons who
preside over stockholder meeting; (iii) provides that the notice of meeting
may
be mailed to stockholders not less than 10 nor more than 60 (rather than 50)
days prior to the meeting; (iv) added language regarding the possible use of
remote communications for adjourned meetings; (v) modified the Board committee
provisions; (vi) deleted the sections providing for written stockholder
consent without a meeting and the sections covering proxies and qualification
of
votes (which are covered by the DGCL; (vii) deleted the restriction that the
President and Secretary positions cannot be held by the same person; (viii)
conformed the notice of record date periods to those currently allowed by the
DGCL; (ix) provide for electronic transmission notice provisions as allowed
by
the DGCL; (x) deleted the provision prohibiting directors and allowing
stockholders to fill director vacancies where the director is removed for cause;
(xi) added a provision establishing specific advance notice and other procedures
which stockholders must follow in order for them to either nominate directors
for election at stockholders’ meetings or to make proposals at stockholders’
meetings; and (xii) added a provision to require a majority of the votes that
stockholders are entitled to cast to approve any stockholder proposal that
is
not approved by the Board of Directors.
40
The
description of the changes from the Company’s old By-laws effected by the New
By-Laws does not purport to be complete and is qualified in its entirety by
reference to the New By-Laws, a copy of which is attached as an exhibit to
this
Annual Report on Form 10-K.
41
PART
III
Item 10. |
Directors,
Executive Officers and Corporate Governance.
|
The
information required by this item concerning our directors and executive
officers is incorporated by reference from our 2008 Definitive Proxy Statement
to be filed with respect to our 2008 Annual Meeting of Shareholders (“2008
Definitive Proxy Statement”) to be filed not later than 120 days following the
close of the fiscal year ended December 31, 2007.
We
have
developed and adopted a comprehensive Code of Business Conduct and Ethics to
cover all 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
information required under this item is hereby incorporated by reference from
our 2008 Definitive Proxy Statement.
Item 12. |
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters.
|
The
information required under this item is hereby incorporated by reference from
our 2008 Definitive Proxy Statement.
Item 13. |
Certain
Relationships and Related Transactions, and Director
Independence.
|
The
information required under this item is hereby incorporated by reference from
our 2008 Definitive Proxy Statement.
Item 14. |
Principal
Accounting Fees and Services.
|
The
information required under this item is hereby incorporated by reference from
our 2008 Definitive Proxy Statement.
42
PART
IV
Item 15. |
Exhibits,
Financial Statement
Schedules.
|
a)
The
following documents are filed as part of this Annual Report on Form
10-K:
i. |
Financial
Statements - See Index on page 50.
|
ii.
|
Financial
Statement Schedule - See Index on page 50. 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 Company’s proxy statement/prospectus dated May 24, 2002
contained in the Registrant’s 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 Registrant's Current Report on Form
8-K
for the event dated December 31,
2003]
|
3 (a) |
Certificate
of Incorporation of the Registrant as
amended through July 18, 2007 [incorporated by reference to Exhibit
3(i)
to the Registrant's Quarterly report on Form 10-Q for the quarter
ended
June 30, 2007].
|
3(b) |
Amended
and Restated By-laws of the
Registrant.
|
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
Registrant's Report on Form 10-Q for the quarter ended September
30,
1987].
|
43
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 Registrant's 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 Registrant's 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 Registrant’s 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
Registrant’s 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
Registrant’s 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
Registrant’s 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 Registrant’s 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
Registrant’s definitive proxy statement on Schedule 14A filed with the SEC
on May 28, 2004].*
|
10(j) |
Form
of Option Agreement under the Registrant’s 2001 Stock Option Plan
[incorporated by reference to Exhibit 10.1 to the Registrant’s quarterly
report on Form 10-Q for the quarter ended September 30,
2004].*
|
10(k) |
Form
of Option Agreement under the Registrant’s 2002 Stock Option Plan
[incorporated by reference to Exhibit 10.2 to the Registrant’s quarterly
report on Form 10-Q for the quarter ended September 30,
2004].*
|
44
10(l) |
Form
of Option Agreement under the Registrant’s 2004 Stock Incentive Plan
[incorporated by reference to Exhibit 10.3 to the Registrant’s quarterly
report on Form 10-Q for the quarter ended September 30,
2004].*
|
10(m) |
Form
of warrant issued to investors in connection with the Registrant’s
December 15, 2004 private financing. [incorporated by reference to
Exhibit
10(q) to the Registrant’s Report on Form 10-K for the year ended December
31, 2004].
|
10(n)
|
2005
Stock Incentive Plan [incorporated by reference to Exhibit 10.1 to
the
Registrant’s report on Form 8-K filed with the SEC on June 28,
2005].*
|
10(o) |
Form
of Option Agreement under the Registrant’s 2005 Stock Incentive Plan
[incorporated by reference to Exhibit 10.2 to the Registrant’s 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 Registrant’s 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 Registrant’s 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
Registrant’s Quarterly report on Form 10-Q for the quarter ended March 31,
2006].
|
10(s)
|
Employment
Agreement dated April 19, 2006 between the Registrant and Kenneth
Ferry
[incorporated by reference to Exhibit 10.1 of Registrant’s 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 Registrant’s Quarterly
report on Form 10-Q for the quarter ended June 30,
2006].*
|
45
10(u)
|
Employment
Agreement dated April 28, 2006 between the Registrant and Stacey
Stevens
[incorporated by reference to Exhibit 10.3 of Registrant’s Quarterly
report on Form 10-Q for the quarter ended June 30,
2006].*
|
10(v)
|
Separation
agreement dated April 19, 2006 between the Registrant and W. Scott
Parr
[incorporated by reference to Exhibit 10.4 of Registrant’s Quarterly
report on Form 10-Q for the quarter ended June 30,
2006].
|
10(w)
|
Note
Purchase Agreement between Ken Ferry, the Registrant’s Chief Executive
Officer, and the Registrant dated June 19, 2006 [incorporated by
reference
to Exhibit 10.5 of Registrant’s Quarterly report on Form 10-Q for the
quarter ended June 30, 2006].
|
10(x)
|
Form
of Indemnification Agreement with each of the Registrant’s directors and
officers [incorporated by reference to Exhibit 10.6 of Registrant’s
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 Registrant’s
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
Registrant’s report on Form 8-K filed with the SEC on September 13,
2006].*
|
10(aa) |
Note
Purchase Agreement between certain of the Registrant’s Directors and
Executive Officers and the Registrant dated September 12 and 14,
2006
[incorporated by reference to Exhibit 10.3 of the Registrant’s Quarterly
report on Form 10-Q for the quarter ended September 30,
2006].
|
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
Registrant’s 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 Registrant’s Quarterly
report on Form 10-Q for the quarter ended September 30,
2006].*
|
46
10(dd)
|
Option
Agreement dated April 19, 2006 between the Registrant and Jeffrey
Barnes
[incorporated by reference to Exhibit 10.6 of the Registrant’s 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 Registrant’s 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 Registrant’s report on Form 8-K filed
with the SEC on March 7, 2007].
|
10(gg) |
Lease
Agreement dated November 22, 2006 between the Registrant and Gregory
D.
Stoyle and John J. Flatley, Trustees of the 1993 Flatley Family Trust,
of
Nashua, NH.
|
10(hh)
|
Employment
Agreement dated October 20, 2006 between the Registrant and Jonathan
Go.*
|
10(ii)
|
Option
Agreement dated September 8, 2006 between the Registrant and Jonathan
Go.*
|
10(jj)
|
Summary
Sheet of Certain Executive Officer Compensation [incorporated
by reference to Exhibit 10.2 of the Registrant’s Quarterly report on Form
10-Q for the quarter ended March 31, 2007].
*
|
10(kk) |
2007
Stock Incentive Plan [incorporated by reference to Appendix B to
the
Company’s definitive proxy statement on Schedule 14A filed with the SEC on
June 13, 2007]. *
|
21
|
Subsidiaries
|
23
|
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.
|
47
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.
(b)
Exhibits - See (a) iii above.
(c)
Financial Statement Schedule - See (a) ii above.
48
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 14, 2008
|
|||
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
|
Chairman
of the Board,
|
|||
Dr.
Lawrence Howard
|
Director
|
March
14, 2008
|
||
/s/
Kenneth Ferry
|
President,
Chief Executive
|
|||
Kenneth
Ferry
|
Officer,
Director (Principal
|
March
14, 2008
|
||
Executive
Officer)
|
||||
/s/
Darlene M. Deptula-Hicks
|
Executive
Vice President of Finance,
|
|||
Darlene
M. Deptula-Hicks
|
Chief
Financial Officer, Treasurer
|
|||
(Principal
Financial and Accounting Officer)
|
March
14, 2008
|
|||
/s/
James Harlan
|
Director
|
March
14, 2008
|
||
James
Harlan
|
||||
/s/
Maha Sallam
|
Director
|
March
14, 2008
|
||
Maha
Sallam, PhD
|
||||
/s/
Elliot Sussman
|
Director
|
March
14, 2008
|
||
Elliot
Sussman, M.D.
|
||||
/s/
Rachel Brem
|
Director
|
March
14, 2008
|
||
Rachel
Brem, M.D.
|
||||
/s/
Steven Rappaport
|
Director
|
March
14, 2008
|
||
Steven
Rappaport
|
49
INDEX
TO FINANCIAL STATEMENTS AND SCHEDULE
Page
|
|
Report
of Independent Registered Public Accounting Firm
|
51
|
Consolidated
Balance Sheets As of December 31, 2007 and 2006
|
52
|
Consolidated
Statements of Operations For the years ended December 31, 2007, 2006
and
2005
|
53
|
Consolidated
Statements of Stockholders' Equity For the years ended December 31,
2007,
2006 and 2005
|
54
|
Consolidated
Statements of Cash Flows For the years ended December 31, 2007, 2006
and
2005
|
55
|
Notes
to Consolidated Financial Statements
|
56-82
|
Schedule
II - Valuation and Qualifying Accounts and Reserves
|
83
|
50
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, 2007 and 2006, and the related
consolidated statements of operations, stockholders’ equity, and cash flows for
each of the three years in the period ended December 31, 2007. We have also
audited the financial statement schedule listed in the accompanying index.
These
financial statements and schedule are the responsibility of the Company’s
management. Our responsibility is to express an opinion on the financial
statements and schedule 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 and schedule are free of material misstatement. An audit includes
examining, on a test basis, evidence supporting the amounts and disclosures
in
the financial statements and schedule, assessing the accounting principles
used
and significant estimates made by management, as well as evaluating the overall
presentation of the financial statements and schedule. 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, 2007 and 2006, and the results of their operations and their
cash flows for each of the three years in the period ended December 31, 2007
in
conformity with accounting principles generally accepted in the United States
of
America.
Also,
in
our opinion, the schedule listed in the accompanying index when considered
in
relation to the basic consolidated financial statements taken as a whole,
presents fairly, in all material respects, the information set forth
therein.
As
described in Note 1(q) of the Notes to the Consolidated Financial
Statements, iCAD, Inc. adopted Statement of Financial Accounting Standards
No.
123 (R), “Share-Based
Payment”, effective
January 1, 2006.
We
also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), iCAD Inc.’s internal control over financial
reporting as of December 31, 2007, based on the criteria established in
Internal
Control - Integrated Framework
issued
by the Committee of Sponsoring Organizations of the Treadway Commission (COSO)
and our report dated March 14, 2008 expressed an unqualified opinion thereon.
/s/
BDO Seidman, LLP
Boston,
Massachusetts
March
14,
2008
51
Consolidated
Balance Sheets
December 31,
|
December 31,
|
||||||
|
2007
|
2006
|
|||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
4,348,729
|
$
|
3,623,404
|
|||
Trade
accounts receivable, net of allowance for doubtful accounts of $50,000
in
2007 and $88,000 in 2006
|
6,483,618
|
3,683,178
|
|||||
Inventory,
net
|
1,798,243
|
3,031,995
|
|||||
Prepaid
and other current assets
|
320,169
|
219,723
|
|||||
Total
current assets
|
12,950,759
|
10,558,300
|
|||||
Property
and equipment:
|
|||||||
Equipment
|
3,512,557
|
3,716,247
|
|||||
Leasehold
improvements
|
71,611
|
70,164
|
|||||
Furniture
and fixtures
|
330,077
|
296,170
|
|||||
Marketing
assets
|
323,873
|
290,282
|
|||||
4,238,118
|
4,372,863
|
||||||
Less
accumulated depreciation and amortization
|
2,369,590
|
2,269,139
|
|||||
Net
property and equipment
|
1,868,528
|
2,103,724
|
|||||
Other
assets:
|
|||||||
Deposits
|
63,194
|
60,444
|
|||||
Patents,
net of accumulated amortization
|
68,269
|
146,394
|
|||||
Technology
intangibles, net of accumulated amortization
|
3,115,843
|
3,731,926
|
|||||
Tradename,
net of accumulated amortization
|
148,800
|
173,600
|
|||||
Goodwill
|
43,515,285
|
43,515,285
|
|||||
Total
other assets
|
46,911,391
|
47,627,649
|
|||||
Total
assets
|
$
|
61,730,678
|
$
|
60,289,673
|
|||
Liabilities
and Stockholders' Equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
2,010,717
|
$
|
2,557,108
|
|||
Accrued
salaries and other expenses
|
3,461,422
|
2,768,281
|
|||||
Deferred
revenue
|
1,674,005
|
788,122
|
|||||
Convertible
loans payable to related parties
|
2,793,382
|
-
|
|||||
Convertible
loans payable to non-related parties
|
684,559
|
-
|
|||||
Current
maturities of notes payable
|
-
|
375,000
|
|||||
Total
current liabilities
|
10,624,085
|
6,488,511
|
|||||
Convertible
revolving loans payable to related party
|
2,258,906
|
2,258,906
|
|||||
Convertible
loans payable to related parties
|
-
|
2,784,559
|
|||||
Convertible
loans payable to non-related parties
|
-
|
663,970
|
|||||
Other
long term liabilities
|
-
|
122,000
|
|||||
Total
liabilities
|
12,882,991
|
12,317,946
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
equity:
|
|||||||
Preferred
stock, $ .01 par value: authorized 1,000,000 shares; issued and
outstanding 0 in 2007 and 6,295 in 2006, with an aggregate liquidation
value of $0 and $1,660,000 plus 7% annual dividend, in 2007 and 2006,
respectively.
|
-
|
63
|
|||||
Common
stock, $ .01 par value: authorized 85,000,000 shares in 2007 and
50,000,000 in 2006; issued 39,239,208 in 2007 and 37,290,848 shares
in
2006; outstanding 39,171,332 in 2007 and 37,222,971 shares in
2006
|
392,392
|
372,908
|
|||||
Additional
paid-in capital
|
135,055,418
|
132,660,347
|
|||||
Accumulated
deficit
|
(85,649,859
|
)
|
(84,111,327
|
)
|
|||
Treasury
stock at cost (67,876 shares)
|
(950,264
|
)
|
(950,264
|
)
|
|||
Total
Stockholders' equity
|
48,847,687
|
47,971,727
|
|||||
|
|||||||
Total
liabilities and stockholders' equity
|
$
|
61,730,678
|
$
|
60,289,673
|
See
accompanying notes to consolidated financial statements.
52
iCAD,
INC. AND SUBSIDIARY
Consolidated
Statements of Operations
For the Years Ended December 31,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
Revenue
|
||||||||||
Products
|
$
|
23,198,296
|
$
|
16,807,013
|
$
|
17,988,827
|
||||
Service
and supplies
|
3,414,116
|
2,914,345
|
1,780,995
|
|||||||
Total
Revenue
|
26,612,412
|
19,721,358
|
19,769,822
|
|||||||
Cost
of Revenue
|
||||||||||
Products
|
4,271,504
|
3,136,929
|
3,814,673
|
|||||||
Service
and supplies
|
985,600
|
1,153,889
|
821,384
|
|||||||
Total
Cost of revenue
|
5,257,104
|
4,290,818
|
4,636,057
|
|||||||
Gross
margin
|
21,355,308
|
15,430,540
|
15,133,765
|
|||||||
Operating
expenses:
|
||||||||||
Engineering
and product development
|
4,504,000
|
5,260,893
|
4,785,092
|
|||||||
Marketing
and sales
|
10,780,304
|
9,228,881
|
8,146,850
|
|||||||
General
and administrative
|
7,174,807
|
7,379,445
|
6,956,350
|
|||||||
Total
operating expenses
|
22,459,111
|
21,869,219
|
19,888,292
|
|||||||
Loss
from operations
|
(1,103,803
|
)
|
(6,438,679
|
)
|
(4,754,527
|
)
|
||||
Other
income (expense)
|
||||||||||
Interest
income
|
74,145
|
102,963
|
127,526
|
|||||||
Interest
expense (includes ($412,073), ($197,646) and $41,094, respectively,
to
related parties)
|
(508,874
|
)
|
(302,242
|
)
|
(131,487
|
)
|
||||
Other
expense, net
|
(434,729
|
)
|
(199,279
|
)
|
(3,961
|
)
|
||||
Net
loss
|
(1,538,532
|
)
|
(6,637,958
|
)
|
(4,758,488
|
)
|
||||
Preferred
dividends
|
67,760
|
116,200
|
121,730
|
|||||||
Net
loss available to common stockholders
|
$
|
(1,606,292
|
)
|
$
|
(6,754,158
|
)
|
$
|
(4,880,218
|
)
|
|
Net
loss per share
|
||||||||||
Basic
and diluted
|
$
|
(0.04
|
)
|
$
|
(0.18
|
)
|
$
|
(0.13
|
)
|
|
Weighted
average number of shares used in computing loss per share
|
||||||||||
Basic
and diluted
|
38,351,345
|
36,911,742
|
36,627,696
|
See
accompanying notes to consolidated financial statements.
53
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, 2004
|
7,435
|
74
|
36,410,170
|
364,101
|
130,271,515
|
(72,714,881
|
)
|
(950,264
|
)
|
56,970,545
|
|||||||||||||||
|
|||||||||||||||||||||||||
Issuance
of common stock pursuant to stock option plans
|
-
|
-
|
293,476
|
2,935
|
487,848
|
-
|
-
|
490,783
|
|||||||||||||||||
|
|||||||||||||||||||||||||
Issuance
of common stock relative to conversion of preferred stock
|
(1,061
|
)
|
(10
|
)
|
130,500
|
1,305
|
(1,295
|
)
|
-
|
-
|
-
|
||||||||||||||
|
|||||||||||||||||||||||||
Compensation
expense related to the issuance of stock options to advisory
board
|
-
|
-
|
-
|
-
|
24,333
|
-
|
-
|
24,333
|
|||||||||||||||||
|
|||||||||||||||||||||||||
Issuance
of common stock for payment of dividends to investors
|
-
|
-
|
97,116
|
971
|
120,759
|
-
|
-
|
121,730
|
|||||||||||||||||
Preferred
stock dividends
|
-
|
-
|
-
|
-
|
(121,730
|
)
|
-
|
-
|
(121,730
|
)
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(4,758,488
|
)
|
-
|
(4,758,488
|
)
|
|||||||||||||||
Balance
at December 31, 2005
|
6,374
|
64
|
36,931,262
|
369,312
|
130,781,430
|
(77,473,369
|
)
|
(950,264
|
)
|
52,727,173
|
|||||||||||||||
Issuance
of common stock pursuant to stock option plans
|
-
|
-
|
320,086
|
3,201
|
602,202
|
-
|
-
|
605,403
|
|||||||||||||||||
Issuance
of common stock relative to conversion of preferred stock
|
(79
|
)
|
(1
|
)
|
39,500
|
395
|
(394
|
)
|
-
|
-
|
-
|
||||||||||||||
Debt
discount for conversion feature of convertible loans
payable
|
58,824
|
58,824
|
|||||||||||||||||||||||
Share-based
compensation related to stock options in accordance with SFAS
123R
|
-
|
-
|
-
|
-
|
1,334,485
|
-
|
-
|
1,334,485
|
|||||||||||||||||
Preferred
stock dividends
|
-
|
-
|
-
|
-
|
(116,200
|
)
|
-
|
-
|
(116,200
|
)
|
|||||||||||||||
|
|||||||||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(6,637,958
|
)
|
-
|
(6,637,958
|
)
|
|||||||||||||||
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 related to stock options in accordance with SFAS
123R
|
-
|
-
|
-
|
-
|
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
|
0
|
$
|
0
|
39,239,208
|
$
|
392,392
|
$
|
135,055,418
|
$
|
(85,649,859
|
)
|
$
|
(950,264
|
)
|
$
|
48,847,687
|
See
accompanying notes to consolidated financial statements.
54
Consolidated
Statements of Cash Flows
For the Years Ended December 31,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
Cash
flow from operating activities:
|
||||||||||
Net
loss
|
$
|
(1,538,532
|
)
|
$
|
(6,637,958
|
)
|
$
|
(4,758,488
|
)
|
|
Adjustments
to reconcile net loss to net cash provided (used) by operating
activities:
|
||||||||||
Depreciation
|
982,869
|
745,415
|
579,603
|
|||||||
Amortization
|
719,008
|
919,340
|
1,052,341
|
|||||||
Loss
on disposal of assets
|
17,680
|
50,712
|
-
|
|||||||
Stock
based compensation expense
|
1,242,155
|
1,334,485
|
24,333
|
|||||||
Non-cash
interest expense associated with discount on convertible loans
payable
|
29,412
|
7,353
|
-
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
Accounts
receivable
|
(2,800,440
|
)
|
275,214
|
1,047,941
|
||||||
Inventory
|
1,233,752
|
(514,528
|
)
|
(1,503,661
|
)
|
|||||
Prepaid
and other current assets
|
(100,446
|
)
|
(43,590
|
)
|
85,153
|
|||||
Accounts
payable
|
(546,391
|
)
|
(1,693,466
|
)
|
2,244,074
|
|||||
Accrued
interest
|
454,785
|
172,883
|
(622,987
|
)
|
||||||
Accrued
expenses
|
(5,166
|
)
|
684,295
|
495,545
|
||||||
Deferred
revenue
|
885,883
|
288,843
|
59,562
|
|||||||
Total
adjustments
|
2,113,101
|
2,226,956
|
3,461,904
|
|||||||
Net
cash provided (used) by operating activities
|
574,569
|
(4,411,002
|
)
|
(1,296,584
|
)
|
|||||
Cash
flow from investing activities:
|
||||||||||
Additions
to patents, technology and other
|
(2,750
|
)
|
(60,444
|
)
|
-
|
|||||
Additions
to property and equipment
|
(711,591
|
)
|
(1,115,416
|
)
|
(1,056,405
|
)
|
||||
Net
cash used by investing activities
|
(714,341
|
)
|
(1,175,860
|
)
|
(1,056,405
|
)
|
||||
Cash
flow from financing activities:
|
||||||||||
Issuance
of common stock for cash
|
1,240,097
|
605,403
|
490,783
|
|||||||
Proceeds
from revolving convertible notes payable
|
-
|
2,000,000
|
-
|
|||||||
Proceeds
from convertible notes payable from related parties
|
-
|
2,800,000
|
(41,094
|
)
|
||||||
Proceeds
from convertible notes payable from non-related parties
|
-
|
700,000
|
-
|
|||||||
Payment
of note payable
|
(375,000
|
)
|
(1,500,000
|
)
|
(1,500,000
|
)
|
||||
Net
cash provided (used) by financing activities
|
865,097
|
4,605,403
|
(1,050,311
|
)
|
||||||
Increase
(decrease) in cash and equivalents
|
725,325
|
(981,459
|
)
|
(3,403,300
|
)
|
|||||
Cash
and equivalents, beginning of year
|
3,623,404
|
4,604,863
|
8,008,163
|
|||||||
Cash
and equivalents, end of year
|
$
|
4,348,729
|
$
|
3,623,404
|
$
|
4,604,863
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
-
|
$
|
111,493
|
$
|
764,875
|
||||
Non-cash
items from financing activities:
|
||||||||||
Dividends
payable with Common Stock
|
$
|
67,760
|
$
|
116,200
|
$
|
121,730
|
||||
Value
of beneficial conversion discount
|
$
|
-
|
$
|
51,471
|
$
|
-
|
See
accompanying notes to consolidated financial statements.
55
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. and its subsidiary (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
mammography screening. CAD is reimbursable in the United States under federal
and most third-party insurance programs. 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 various distributors, resellers
and
systems integrators. See Note 8 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 Company's estimates and assumptions used in the preparation of
the
financial statements relate to the Company's products, which are subject
to
rapid technological change. It is reasonably possible that changes may occur
in
the near term that would affect management's estimates with respect to assets
and liabilities.
(b)
Principles of Consolidation
The
consolidated financial statements include the accounts of the Company and
its
wholly-owned subsidiary, Qualia Acquisition Corporation. Any material
inter-company transactions and balances have been eliminated in
consolidation.
(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
and deposits, and other money market instruments with original maturities
of 90
days or less, which are unrestricted as to withdrawal.
56
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, accounts payable, accrued expenses, notes payable and
other
convertible debt approximated fair value as of December 31, 2007 and 2006.
(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
Company’s 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 Company’s 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, 2007 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 $1,311,000 and $487,000, respectively,
for 2007, and finished goods and raw material of approximately $1,313,000
and
$1,719,000, respectively, for 2006. 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.
(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.
57
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(1) Summary
of Significant Accounting Policies (continued)
(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 and distribution agreements
purchased in the Company’s acquisition of Intelligent Systems Software, Inc.
(“ISSI”) in June 2002 and Qualia Computing, Inc. and its subsidiaries, including
CADx Systems, Inc. (“CADx”) in December 2003. These assets are amortized on a
straight-line basis over their estimated useful lives of 5 to 10 years.
For the years ended December 31,
|
2007
|
2006
|
Weighted
Average
Useful Life
|
|||||||
Gross
carrying amount:
|
||||||||||
Patents
|
$
|
390,624
|
$
|
390,624
|
5
years
|
|||||
Technology
|
6,160,822
|
6,160,822
|
10
years
|
|||||||
Trade
name
|
248,000
|
248,000
|
10
years
|
|||||||
Total
amortizable intangible assets
|
$
|
6,799,446
|
$
|
6,799,446
|
||||||
Accumulated
amortization
|
||||||||||
Patents
|
322,355
|
244,230
|
||||||||
Technology
|
3,044,979
|
2,428,896
|
||||||||
Trade
name
|
99,200
|
74,400
|
||||||||
Total
Accumulated amortization
|
$
|
3,466,534
|
$
|
2,747,526
|
||||||
Amortizable
intangible assets, net
|
$
|
3,332,912
|
$
|
4,051,920
|
Amortization
expense related to intangible assets was approximately $719,000, $919,000
and
$1,052,000 for the years ended December 31, 2007, 2006, and 2005, respectively.
Estimated amortization of the Company’s intangible assets for the next five
fiscal years is as follows:
For the years ended
December 31:
|
Estimated
amortization
expense
|
|||
2008
|
$
|
709,000
|
||
2009
|
641,000
|
|||
2010
|
641,000
|
|||
2011
|
641,000
|
|||
2012
|
447,000
|
58
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(1) Summary
of Significant Accounting Policies (continued)
(i)
Goodwill
The
Company follows the provision of Financial Accounting Standards Board (FASB)
issued SFAS No. 141, “Business Combinations” and No. 142, “Goodwill and Other
Intangible Assets”. SFAS 141 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. SFAS 142 addresses the accounting for acquired
goodwill and intangible assets. Goodwill and indefinite-lived intangible
assets
are no longer amortized and are tested for impairment at least annually.
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
assumes
market capitalization is the best evidence of fair value (market capitalization
is calculated using the quoted closing share price of the Company’s 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 in
accordance with paragraph 23 of SFAS 142, which notes that quoted
market prices in active markets are the best evidence of fair value and shall
be
used as the basis for the measurement. 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. At October 1, 2007 and December
31,
2007 the
Company’s market capitalization exceeded its carrying amount and the Company
determined that there was no impairment to its goodwill. Additionally, the
Company reviews fair value and goodwill impairment quarterly to determine
if
facts or circumstances have occurred that would trigger impairment prior
to the
annual impairment date. Since the Company’s carrying amount has not exceeded its
fair value, the second step of the goodwill impairment test has been
unnecessary. Goodwill
arose in connection with the ISSI acquisition in June 2002 and with the CADx
acquisition in December 2003.
59
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(1)
Summary
of Significant Accounting Policies (continued)
(j) Revenue
Recognition
Revenue
is generally recognized 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 considers the
guidance
for revenue recognition in the Financial Accounting Standards Board’s Emerging
Issues Task Force Issue 00-21, Accounting
for Revenue Arrangements with Multiple Deliverables,
EITF
00-21 and Staff Accounting Bulletin
No. 104, Revenue
Recognition in Financial Statements.
The
Company’s revenue transactions can on occasion include product sales with
multiple element arrangements, generally for installation. The elements
are
considered separate units 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 items. Revenue under these arrangements is
allocated to each element based on its estimated relative fair market value.
Fair market value is determined using entity specific and third party evidence.
A portion of the arrangement consideration is recognized as revenue when
the
product is shipped and a portion of the arrangement consideration is recognized
as revenue when the installation service is performed. The value of the
undelivered elements includes the fair value of the installation.
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 customer’s post-delivery acceptance
provisions, if any, and the installation process. There are no significant
estimates or assumptions used in the Company’s revenue recognition.
The
Company defers revenue for extended service contracts related to future periods
and recognizes revenue on a straight-line basis in accordance with FASB
Technical Bulletin No. 90-1, "Accounting for Separately Priced Extended Warranty
and Product Maintenance Contracts." 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
Company’s 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 expense.
60
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(1)
Summary
of Significant Accounting Policies (continued)
(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 $202,836 in 2007
and
$299,034 in 2006. Warranty provisions and claims for the years ended December
31, 2007 and 2006, were as follows:
2007
|
2006
|
||||||
Beginning
balance
|
$
|
299,034
|
$
|
150,000
|
|||
Warranty
provision
|
281,932
|
|
637,354
|
||||
Usage
|
(378,130
|
)
|
(488,320
|
)
|
|||
Ending
balance
|
$
|
202,836
|
$
|
299,034
|
(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, 2007, 2006 and 2005 was $675,000, $660,000 and
$790,000, respectively.
(o)
Net Loss Per Common Share
The
Company follows SFAS No. 128, “Earnings per Share”, which requires the
presentation of both basic and diluted earning per share on the face of the
Statements of Operations. Conversion of subordinated debt and other convertible
debt and preferred stock and assumed exercise of options and warrants are
not
included in the calculation of diluted loss per share since the effect would
be
antidilutive. Accordingly, basic and diluted net loss per share do not differ
for any period presented. The following table summarizes the common stock
equivalent of securities that were outstanding as of December 31, 2007, 2006
and
2005, but not included in the calculation of diluted net loss per share because
such shares are antidilutive:
61
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(1)
Summary
of Significant Accounting Policies (continued)
(o)
Net Loss Per Common Share
(continued)
2007
|
2006
|
2005
|
||||||||
Common
stock options
|
5,644,818
|
5,628,730
|
4,249,763
|
|||||||
Common
stock warrants
|
1,003,311
|
1,003,311
|
1,003,311
|
|||||||
Convertible
revolving Promissory Note
|
1,507,482
|
1,467,075
|
256,410
|
|||||||
Convertible
loans payable
|
2,098,039
|
2,098,039
|
-
|
|||||||
Convertible
Series A Preferred Stock
|
-
|
515,000
|
515,000
|
|||||||
Convertible
Series B Preferred Stock
|
-
|
572,500
|
612,000
|
|||||||
10,253,650
|
11,284,655
|
6,636,484
|
The
calculation of basic earnings per share does not include 375,000 shares of
restricted common stock issued to the executive
officers of the Company and
subject to time-based vesting. These potential shares were excluded from
the
fiscal 2007 computation of basic and diluted earnings per share as these
shares
are not considered outstanding until vested.
(p)
Income Taxes
The
Company follows the liability method under SFAS No. 109, “Accounting for Income
Taxes”. The primary objectives of accounting for taxes under SFAS 109 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 Company’s financial statements or tax
returns. The Company has provided a full valuation allowance against its
deferred tax assets at December 31, 2007 and 2006 as it is more likely than
not
that the deferred tax asset will not be realized.
The
Company adopted FASB Interpretation No. 48, "Accounting for Uncertainty in
Income Taxes—an interpretation of FASB Statement No. 109" ("FIN 48") on January
1, 2007. FIN 48 clarifies the accounting for uncertainty in income taxes
recognized in an enterprise's financial statements in accordance with FASB
Statement No. 109, "Accounting for Income Taxes." FIN 48 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. FIN 48 also provides guidance on de-recognition, classification,
interest and penalties, accounting in interim periods, disclosure, and
transition. The adoption of FIN 48 did not have a material impact on the
Company's consolidated financial statements.
62
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(1)
Summary
of Significant Accounting Policies (continued)
(q)
Stock-Based Compensation
Effective
January 1, 2006, the Company adopted Statement No. 123R, Share-Based
Payment
(“SFAS
123R”), which requires companies to measure and recognize compensation expense
for all share-based payment awards made to employees and directors based
on
estimated fair values. SFAS 123R is being applied on the modified prospective
basis. Prior to the adoption of SFAS 123R, the Company accounted for its
stock-based
compensation plans under the recognition and measurement principles of
Accounting Principles Board (APB) Opinion No. 25, Accounting
for Stock Issued to Employees,
as
provided by SFAS 123, “Accounting for Stock Based Compensation” (“SFAS 123”) and
accordingly, recognized no compensation expense related to the stock-based
plans
as stock options exercise prices granted to employees and directors were
equal
to the fair market value of the underlying stock at the date of grant.
In March
2005, the SEC issued Staff Accounting Bulletin No. 107 (“SAB 107”) relating to
SFAS 123R. The Company has applied the provisions of SAB 107 in its adoption
of
SFAS 123R.
Under
the
modified prospective approach, SFAS 123R applies to new awards and to awards
that were outstanding on January 1, 2006 that are subsequently modified,
repurchased or cancelled. Under the modified prospective approach, compensation
cost recognized for fiscal years 2007 and 2006 also includes compensation
cost
for all share-based payments granted prior to, but not yet vested on, January
1,
2006, based on the grant-date fair value estimated in accordance with the
provisions of SFAS 123, and compensation cost for all share-based payments
granted subsequent to January 1, 2006, based on the grant-date fair value
estimated in accordance with the provisions of SFAS 123R. Prior periods were
not
restated to reflect the impact of adopting the new standard.
SFAS
123R
requires the presentation of the pro forma information for the comparative
periods prior to adoption as if the Company accounted for stock-based
compensation in accordance with SFAS 123 in fiscal 2005. The following table
illustrates the pro forma effect on net loss and net loss per
share:
2005
|
||||
Net
loss available to common stockholders as reported
|
$
|
(4,880,218
|
)
|
|
Deduct:
Total stock-based employee compensation determined under fair value
method
for all awards
|
$
|
(3,076,105
|
)
|
|
Pro
forma net loss
|
$
|
(7,956,323
|
)
|
|
Basic
and diluted loss per share
|
||||
As
reported
|
$
|
(0.13
|
)
|
|
Pro
forma
|
$
|
(0.22
|
)
|
For
2005
the Company calculated the fair value of each grant of options at the grant
date, using the Black-Scholes option-pricing model with the following
weighted-average assumptions for grants: no dividends paid on common shares;
expected volatility of 78.8%; risk-free interest rate of 4.04% and an average
expected life of 5 years.
63
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(1)
|
Summary
of Significant Accounting Policies (continued)
|
(q)
Stock-Based Compensation (continued)
The
weighted average grant-date fair value per share of options granted during
the
year was $1.65 for 2005.
In
December 2005, the Company’s Board of Directors approved accelerating the
vesting of unvested, “out-of-the-money” stock options to purchase approximately
836,000 shares of the Company’s common stock awarded to employees, officers and
directors under its stock option plans. The accelerated options have exercise
prices ranging from $1.64 to $5.28 and a weighted average exercise price
of
$3.93. The acceleration was unconditional to the employees, officers and
directors and was applied to all outstanding, unvested options priced above
the
closing price of iCAD’s common stock on December 30, 2005. Approximately
$1,362,000 of the 2005 pro forma expense listed above relates to options
included in this acceleration group.
Commencing
on September 22, 2006, the Company offered to its employees, members of its
Board of Directors and certain consultants of the Company, the opportunity
to
tender for cancellation, all outstanding options to purchase shares of the
Company’s common stock, $0.01 par value, previously granted to them under the
iCAD, Inc. 2001 Stock Option Plan, 2002 Stock Option Plan, 2004 Stock Option
Plan, the Intelligent Systems Software, Inc. 2001 Stock Option Plan and certain
Non-Plan Stock Options that were granted in connection with the Company’s
acquisition of Qualia Computing, Inc. and its CADx Systems, Inc. subsidiary,
having an exercise price in excess of $2.00 per share in exchange for new
options. There were options to purchase 1,692,065 shares of the Company’s common
stock outstanding and eligible for tender pursuant to the Offer to Exchange.
Under
the
option exchange program, participants who tendered their eligible options
for
exchange were granted new options, some of the key features of which included:
a.
|
The
number of shares of common stock subject to new options equaled
the same
number of shares subject to the cancelled eligible
options.
|
b.
|
The
vesting schedule of the cancelled eligible options carried over
to the new
options as all options were vested and the new options vested
immediately.
|
c. | The exercise price of the new options is $2.07 per share, subject to adjustment for any stock splits, stock dividends and similar events. |
d.
|
The
new options have a term of two
years.
|
e.
|
The
new options are “non qualified options” and not “incentive stock options”,
regardless of whether any of the cancelled eligible options were
incentive
stock options or non-qualified stock
options.
|
64
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(1)
|
Summary
of Significant Accounting Policies (continued)
|
(q)
Stock-Based Compensation (continued)
f.
|
The
new options otherwise contain other terms and conditions that are
substantially the same as those in the above mentioned stock option
plans,
as the case may be, that governed the eligible plan options surrendered.
|
This
offer to exchange was conditioned upon stockholder approval of the exchange
offer which was obtained at the Company’s 2006 Annual Meeting of Stockholders
held on October 20, 2006. Subject to the terms and conditions of the offer,
on
October 23, 2006, the Company granted new two-year options to purchase a
total
of 1,159,750 shares of its common stock at $2.07 per share in exchange for
the
eligible options tendered for exchange. The Company calculated the fair value
of
the option grants immediately before and after the option exchange and
determined that there was no incremental fair value and therefore no
compensation expense associated with the tender offer exchange.
(r)
Recently Issued Accounting Standards
In
September 2006, the FASB issued SFAS No. 157, “Fair Value
Measurements” (“SFAS 157”). SFAS 157 defines fair value, establishes a
framework for measuring fair value and expands disclosure of fair value
measurements. SFAS 157 applies under other accounting pronouncements that
require or permit fair value measurements and accordingly, does not require
any
new fair value measurements. SFAS 157 is effective for financial statements
issued for fiscal years beginning after November 15, 2007 and interim
periods within those fiscal years for financial assets and liabilities, as
well
as for any other assets and liabilities that are carried at fair value on
a
recurring basis in financial statements. The FASB has provided a one year
deferral for the implementation for other non-financial assets and liabilities.
The Company is currently evaluating the impact of the adoption of SFAS 157
on
its consolidated financial statements.
In
February 2007, the FASB issued Statement No. 159, “The Fair Value Option
for Financial Assets and Financial Liabilities” (SFAS 159”), including an
amendment of FASB Statement No. 115, which allows an entity to elect to
record financial assets and liabilities at fair value upon their initial
recognition on a contract-by-contract basis. Subsequent changes in fair value
would be recognized in earnings as the changes occur. SFAS 159 also
establishes additional disclosure requirements for these items stated at
fair
value. SFAS 159 is effective as of the beginning of an entity’s first
fiscal year that begins after November 15, 2007. The Company is currently
evaluating the impact of the adoption of SFAS 159 on its consolidated financial
statements.
65
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(1)
|
Summary
of Significant Accounting Policies (continued)
|
(r)
Recently Issued Accounting Standards (continued)
In
December 2007, the FASB issued SFAS No. 141 (Revised 2007), “Business
Combinations” (“SFAS 141R”). SFAS 141R retains the fundamental requirements in
Statement 141 that the acquisition method of accounting (which Statement
141
called the purchase method) be used for all business combinations and for
an
acquirer to be identified for each business combination. SFAS 141R requires
an
acquirer to recognize the assets acquired, the liabilities assumed, and any
noncontrolling interest in the acquiree at the acquisition date, measured
at
their fair values as of that date, with limited exceptions specified in the
Statement. That replaces Statement 141’s cost-allocation process, which required
the cost of an acquisition to be allocated to the individual assets acquired
and
liabilities assumed based on their estimated fair values. SFAS 141R retains
the
guidance in Statement 141 for identifying and recognizing intangible assets
separately from goodwill. SFAS 141R will now require acquisition costs to
be
expensed as incurred, restructuring costs associated with a business combination
must generally be expensed prior to the acquisition date and changes in deferred
tax asset valuation allowances and income tax uncertainties after the
acquisition date (including prior acquisitions) generally will affect income
tax
expense. SFAS 141R applies prospectively to business combinations for which
the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008 except for income taxes, as
noted
above. The Company is currently evaluating the impact of the adoption of
SFAS
141R on its consolidated financial statements.
(2)
Restructuring
Charges
Closure
of Tampa Office
During
the first quarter of 2004, the Company took action following its acquisition
of
CADx to reduce its workforce and close its office located in Tampa, Florida.
In
connection with these measures, the Company incurred approximately $280,000
in
engineering severance benefits and office closure expenses with approximately
$180,000 due under the non-cancelable operating lease for the facility. The
total charge was included in engineering and product development costs in
the
2004 consolidated statement of operations. As of December 31, 2005 approximately
$174,000 of severance and closing costs were paid and charged against the
liability and approximately $81,000 was recovered through a sublease arrangement
negotiated in June 2005. Accordingly, the Company reduced the accrual by
approximately $81,000 in 2005, which was recorded as a reduction of rent
expense
in fiscal 2005. The remaining $9,401 of the facility closing cost previously
accrued was paid in 2007.
66
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(3)
Financing
Arrangements
Convertible
Revolving Loans Payable to Related Party
The
Company has a Revolving Loan and Security Agreement (the "Loan Agreement")
with
Mr. Robert Howard, former Chairman of the Board of Directors of the Company,
under which Mr. Howard has agreed to advance funds, or to provide guarantees
of
advances made by third parties in an amount up to $5,000,000. The Loan Agreement
expires March 31, 2008, subject to extension by the parties, with an agreement
from Mr. Howard that he will not request repayment of the principal balance
of
the note until March 31, 2009. Accordingly, the outstanding borrowings related
to the loan payable have been classified as a long term liability in the
Company’s consolidated balance sheet as of December 31, 2007. Outstanding
advances are collateralized by substantially all of the assets of the Company
and bear interest at prime interest rate plus 1% (8.25% at December 31, 2007).
Mr. Howard is entitled to convert outstanding advances made by him under
the
Loan Agreement into shares of the Company's common stock at any time based
on
the closing market price of the Company's common stock at the lesser of the
market price at the time each advance is made or at the time of conversion.
Mr.
Howard has also agreed that while the Loan Agreement exists, not to convert
any
outstanding advances under the Loan Agreement into shares of the Company’s
common stock that would exceed the shares available for issuance, defined
as the
authorized shares of the Company’s common stock less issued and outstanding
common shares less any reserved shares for outstanding convertible preferred
stock, convertible notes, non-employee warrants and non-employee stock options.
At December 31, 2007 and 2006, $2,258,906 was outstanding under the Loan
Agreement and $2,741,094 was available for future borrowings through March
31,
2008.
Convertible
Loans Payable to Related Parties
On
June
19, 2006, the Company and Dr. Lawrence Howard, who 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 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 is payable
on the due date. Principal and accrued and unpaid interest under the Howard
Note
can be converted by the holder into shares of the Company’s common stock at
$1.50 per share. Payment of principal under the Howard Note can be accelerated
by the holder if the Company files for, or is found by a court to be, bankrupt
or insolvent and the Company can prepay the Howard Note prior to the due
date.
Dr. Howard has also agreed that he will not convert any principal amount
or
accrued and unpaid interest outstanding under the Howard Note into shares
of the
Company’s common stock that would exceed the number of shares of the Company’s
common stock then available for issuance defined as the authorized shares
of the
Company’s common stock less issued and outstanding common shares less any
reserved shares for outstanding convertible preferred stock, non-employee
warrants and non-employee stock options.
67
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 Company’s Chief Executive
Officer, entered into a Note Purchase Agreement with respect to the purchase by
Mr. Ferry 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 is payable on the due date. Principal
and
accrued and unpaid interest under the Ferry Note can be converted by the
holder
into shares of the Company’s common stock at $1.50 per share. Payment of
principal under the Ferry Note can be accelerated by the holder if the Company
files for, or is found by a court to be, bankrupt or insolvent and the Company
can prepay the Ferry Note prior to the due date. Mr. Ferry has also agreed
that
he will not convert any principal amount or accrued and unpaid interest
outstanding under the Ferry Note into shares of the Company’s common stock that
would exceed the number of shares of the Company’s common stock then available
for issuance defined as the authorized shares of the Company’s common stock less
issued and outstanding common shares less any reserved shares for outstanding
convertible preferred stock, non-employee warrants and non-employee stock
options.
On
September 12, 14 and 19, 2006 the Company entered into Note Purchase Agreements
with respect to the purchase of a total of $2,300,000 principal amount of
7.25%
Convertible Promissory Notes (the “Notes”) from persons who at the time were
directors, officers and employees of the Company, including the following:
Mr.
Robert Howard (now a former director) (as to $1,350,000), Mr. James Harlan
(as
to $300,000), Mr. Steven Rappaport (as to $300,000), Dr. Elliott Sussman
(as to
$100,000) and Dr. Lawrence Howard (as to $100,000), all of whom are directors
of
the Company, 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 are due two years from the date of issue subject to the
right
of the Company to prepay the Notes and the right of the holders of the Notes
to
accelerate payment of their respective Notes upon the Company filing for
or
being adjudicated bankrupt or insolvent. The holders of the Notes may convert
the principal and accrued and unpaid interest under the Notes into shares
of the
Company’s common stock at a price of $1.70 per share, which conversion price is
subject to adjustment under certain circumstances such as common stock splits,
or combinations or common stock dividends. The Note issued to Mr. Steven
Rappaport on September 19, 2006 in the aggregate principal amount of $300,000
was issued with a conversion price below the market price of $1.80 per share
on
the date of the Note and the Company recorded a discount to Note Payables
of
$17,647 to reflect the beneficial conversion feature. This loan is recorded
on
the balance sheet at its face value net of the discount at December 31, 2007
of
$6,618 at $293,382. The Notes are recorded on the balance sheet as Convertible
loans payable to related parties with a balance of $2,793,382 at December
31,
2007. The Notes are due in fiscal 2008.
68
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(3)
Financing
Arrangements (continued)
Convertible
Loans Payable to Non-Related Parties
On
September 19, 2006 the Company entered into Note Purchase Agreements with
respect to an aggregate of $700,000 principal amount (the “September Notes”)
from two accredited outside investors, pursuant to Note Purchase Agreements
between the Company and each of the investors. The loans are evidenced by
notes
issued by the Company in favor of the non-related parties. The September
Notes
mature two years from the date of issue subject to the right of the Company
to
prepay the September Notes and the right of the holders of the September
Notes
to accelerate payment of their respective notes upon the Company filing for
or
being adjudicated bankrupt or insolvent. The holders of the September Notes
may
convert the principal and accrued and unpaid interest under the September
Notes
into shares of the Company’s common stock at a price of $1.70 per share, which
conversion price is subject to adjustment under certain circumstances such
as
common stock splits, or combinations or common stock dividends. The September
Notes issued on September 19, 2006 in the aggregate principal amount of $700,000
were issued with a conversion price below the market price of $1.80 per share
on
the date of the September Notes and the Company recorded a discount to Note
Payables of $41,177 to reflect the beneficial conversion feature. These loans
are recorded on the balance sheet at their face value net of the discount
at
December 31, 2007 of $15,441 at $684,559. The September Notes are due in
fiscal
2008.
(4)
Accrued
Expenses
Accrued
expenses consist of the following at December 31, 2007 and 2006:
2007
|
2006
|
||||||
Accrued
salary and related expenses
|
$
|
1,868,953
|
$
|
1,335,943
|
|||
Accrued
interest
|
675,835
|
221,050
|
|||||
Accrued
accounting and consulting services
|
240,552
|
346,073
|
|||||
Accrued
warranty expense
|
202,836
|
299,034
|
|||||
Accrued
dividends
|
67,760
|
116,200
|
|||||
Accrued
state taxes
|
62,359
|
110,331
|
|||||
Accrued
legal fees
|
17,664
|
43,469
|
|||||
Other
accrued expenses
|
325,463
|
418,181
|
|||||
$
|
3,461,422
|
$
|
2,890,281
|
(5)
Notes
Payable
To
complete the acquisition of CADx in 2003, the Company executed a secured
promissory note in the amount of $4,500,000 to purchase Qualia’s shares issued
in favor of CADx Canada, which was payable in quarterly installments over
a 3
year period commencing April 2004 at the prime interest rate plus 1%. The
note
was payable in quarterly installments of $375,000 plus accrued interest.
In
January 2007 the Company paid the final installment. At December 31, 2007,
$0
was owed under the note.
69
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(6)
Stockholders’
Equity
(a)
Preferred Stock
7%
Series A Convertible Preferred Stock.
On
December 22, 1999 the Company, pursuant to the authority of the Company's
Board
of Directors, adopted a resolution creating a series of preferred stock
designated as 7.0% Series A Convertible Preferred Stock (the “Series A Preferred
Stock”). The number of shares initially constituting the Series A Preferred
Stock was 10,000, par value $.01 per share, which may be decreased (but not
increased) by the Board of Directors without a vote of stockholders, provided,
however, that such number may not be decreased below the number of then
outstanding shares of Series A Preferred Stock. The holders of the shares
of
Series A Preferred Stock vote together with the common stock as a single
class
on all actions to be voted on by the stockholders of the Company. Each share
of
Series A Preferred Stock entitle the holder thereof to such number of votes
per
share on each such action as shall equal the number of whole shares of common
stock into which each share of Series A Preferred Stock is then convertible.
The
holders are entitled to notice of any stockholder’s meeting in accordance with
the By-Laws of the Company. Each share of Series A Preferred Stock is
convertible into that number of shares of common stock determined by dividing
the aggregate liquidation preference of the number of shares of Series A
Preferred Stock being converted by $1.00 (the “Conversion Rate”). The Conversion
Rate is subject to appropriate adjustment by stock split, dividend or similar
division of the common stock or reverse split or similar combinations of
the
common stock prior to conversion. The Company may at any time after the date
of
issuance, at the option of the Board of Directors, redeem in whole or in
part
the Series A Preferred Stock by paying cash equal to $100 per share together
with any accrued and unpaid dividends (the “Redemption Price”). The Redemption
Price is subject to appropriate adjustment by the Board of Directors of similar
division of shares of Series A Preferred Stock or reverse split or similar
combination of the Series A Preferred Stock. In the event the Company
liquidates, dissolves or winds up, no distribution will made to the holders
of
shares of common stock unless, prior thereto the holders of shares of Series
A
Preferred Stock have received $100 per share (as adjusted for any stock
dividends, combinations or splits) plus all declared or accumulated but unpaid
dividends. The holders of shares of Series A Preferred Stock, in preference
to
the holders of shares of common stock, are entitled to receive cumulative
dividends of $7.00 per annum per share, payable annually, subject to appropriate
adjustment by the Board of Directors of the Company in the event of any stock
split, dividend or similar division of shares of Series A Preferred. Dividends
are payable annually, in arrears, on the last day of December in each year.
In
2005,
1,000 shares of the Company’s 7% Series A Preferred Stock were converted by
unrelated parties into 100,000 shares of the Company’s common stock. In 2007,
the remaining 5,150 shares of its 7% Series A Preferred Stock were converted
by
unrelated parties into 515,000 shares of the Company’s common stock. At December
31, 2007 the Company has no outstanding shares of its 7% Series A Preferred
Stock.
70
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(6)
Stockholders’
Equity (continued)
(a)
Preferred Stock (continued)
7%
Series B Convertible Preferred Stock.
On
October 19, 2000 the Company, pursuant to the authority of the Company's
Board
of Directors, adopted a resolution creating a series of preferred stock
designated as 7.0% Series B Convertible Preferred Stock (the “Series B Preferred
Stock”). The number of shares initially constituting the Series B Preferred
Stock was 2,000, par value $.01 per share, which may be decreased (but not
increased) by the Board of Directors without a vote of stockholders, provided,
however, that such number may not be decreased below the number of then
outstanding shares of Series B Preferred Stock. The holders of the shares
of
Series B Preferred Stock have no voting rights other than is required by
law.
Each share of Series B Preferred Stock is convertible into that number of
shares
of common stock determined by dividing the aggregate liquidation preference
of
the number of shares of Series B Preferred Stock being converted by $2.00
(the
“Conversion Rate”). The Conversion Rate is subject to appropriate adjustment by
stock split, dividend or similar division of the common stock or reverse
split
or similar combinations of the common stock prior to conversion. The Company
may
at any time after the date of issuance, at the option of the Board of Directors,
redeem in whole or in part the Series B Preferred Stock by paying cash equal
to
$1,000 per share together with any accrued and unpaid dividends (the “Redemption
Price”). The Redemption Price is subject to appropriate adjustment by the Board
of Directors of similar division of shares of Series B Preferred Stock or
reverse split or similar combination of the Series B Preferred Stock. In
the
event the Company liquidates, dissolves or winds up, no distribution will
be
made to the holders of shares of common stock unless, prior thereto, the
holders
of shares of Series B Preferred Stock have received $1,000 per share (as
adjusted for any stock dividends, combinations or splits) plus all declared
or
accumulated but unpaid dividends. The holders of shares of Series B Preferred
Stock, in preference to the holders of shares of common stock, are entitled
to
receive cumulative dividends of $70.00 per annum per share, payable annually,
subject to appropriate adjustment by the Board of Directors of the Company
in
the event of any stock split, dividend or similar division of shares of Series
B
Preferred. Dividends are payable annually, in arrears, on the last day of
December in each year.
In
October 2000 the Company sold, in private transactions, a total of 1,400
shares
of its 7% Series B Preferred Stock at $1,000 per share, consisting of 1,350
shares to unrelated parties, and 50 shares to Mr. W. Scott Parr, the Company’s
former Chief Executive Officer, for gross proceeds of $1,400,000. The 1,400
shares of 7% Series B Preferred Stock were issued with a conversion price
below
the Company’s common stock quoted value and as a result accreted dividends of
$996,283 were recorded and included in the net loss per share calculation
for
the year ended December 31, 2000. In 2003, 115 shares of the Company’s Series B
Preferred Stock were converted by unrelated parties into 57,500 shares of
the
Company’s common stock. In March 2005, 61 shares of the Company’s Series B
Preferred Stock were converted by unrelated parties into 30,500 shares of
the
Company’s common stock.
71
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(6)
Stockholders’
Equity (continued)
(a)
Preferred Stock (continued)
In
2006,
79 shares of the Company’s Series B Preferred Stock were converted by a person
who was a director at the time of conversion, into 39,500 shares of the
Company’s common stock. In 2007 the remaining 1,145 shares of the Company’s
Series B Preferred Stock were converted by unrelated parties into 572,500
shares
of the Company’s common stock. At December 31, 2007 the Company has no
outstanding shares of its 7% Series B Preferred Stock.
(b)
Stock Options
The
Company has six 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 Company’s 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 Company's 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 Company's common stock on the date of grant, except for
options granted to 10% stockholders for whom the exercise price shall 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 no 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, 2007
there
are no further options available for grant under this plan.
72
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(6)
Stockholders’
Equity (continued)
(b)
Stock Options (continued)
The
2002 Stock Option Plan, ("The 2002 Plan").
The
2002
Plan was adopted by the Company’s 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 Company's 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 Company's 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 not later
than
ten years after the date of grant, except for 10% holders whose options
expire
no 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, 2007, there were no shares available for issuance under the
2002
Plan.
The
2004 Stock Incentive Plan, ("The 2004 Plan").
The
2004
Plan was adopted by the Company’s stockholders in June 2004. 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 Company's 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 Company's 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 no 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, 2007 there were
2,749
options available for issuance under the 2004 Plan.
The
2005 Stock Incentive Plan, ("The 2005 Plan").
The
2005
Plan was adopted by the Company’s stockholders in June 2005. 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 Company's common stock of which at December 31, 2007, 63,170 shares were
eligible for future grants.
73
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(6)
Stockholders’
Equity (continued)
(b)
Stock Options (continued)
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 Company's 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 no 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.
The
2007 Stock Incentive Plan, ("The 2007 Plan").
The
2007
Plan was adopted by the Company’s stockholders in July 2007. 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 2,250,000 shares of the Company’s common stock to
be available for distribution pursuant to the 2007 Plan, and (ii) the
maximum number of shares of the Company’s 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.
The
2007
Plan provides that it will be administered by the Company’s 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 be 100% (110% in the case of an incentive stock option granted to a
ten
percent stockholder within the meaning of Section 422(b)(6) of the Internal
Revenue Code of 1986) 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
74
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(6)
Stockholders’
Equity (continued)
(b)
Stock Options (continued)
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, 2007 there were 1,225,670 options 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, 2005
|
3,914,511
|
|
$0.80-$5.28
|
$
|
3.04
|
|||||
Granted
|
1,162,500
|
|
$1.06-$3.92
|
$
|
3.54
|
|||||
Exercised
|
(293,476
|
)
|
|
$0.80-$3.49
|
$
|
1.67
|
||||
Forfeited
|
(533,772
|
)
|
|
$1.13-$5.28
|
$
|
4.89
|
||||
Outstanding,
December 31, 2005
|
4,249,763
|
|
$0.80-$5.28
|
$
|
3.04
|
|||||
Granted
|
2,405,000
|
|
$1.45-$3.18
|
$
|
1.80
|
|||||
Exercised
|
(320,086
|
)
|
|
$0.95-$2.07
|
$
|
1.89
|
||||
Forfeited
|
(705,947
|
)
|
|
$1.06-$5.28
|
$
|
3.82
|
||||
Outstanding,
December 31, 2006
|
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
|
(256,581
|
)
|
|
$1.06-$4.88
|
$
|
2.82
|
||||
Outstanding,
December 31, 2007
|
5,644,818
|
|
$0.80-$5.28
|
$
|
2.47
|
Exercisable
at year-end
|
||||||||||
2005
|
4,161,763
|
|
$0.80-$5.28
|
$
|
3.08
|
|||||
2006
|
3,998,230
|
|
$0.80-$5.28
|
$
|
2.23
|
|||||
2007
|
4,023,658
|
|
$0.80-$5.28
|
$
|
2.28
|
Available
for future grants at December 31, 2007 for all plans:
1,291,589
The
weighted-average remaining contractual life of stock options outstanding
for all
plans at December 31, 2007 was 3.6 years.
75
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(6)
Stockholders’
Equity (continued)
(b)
Stock Options (continued)
During
the year ended December 31, 2007 and 2006, the Company recorded $1,242,155
and
$1,334,485, respectively, for
share-based compensation in accordance with SFAS 123R.
The
Company’s stock-based compensation expense included $33,211 and $0 in cost of
revenue, $166,068 and $86,704 in engineering and product development, $162,347
and $245,446 in marketing and sales and $880,529 and $1,002,335 in general
and
administrative expense for the year ended December 31, 2007 and 2006,
respectively. As
of
December 31, 2007 there was $3,021,272
of
total
unrecognized compensation costs related to unvested options. That cost is
expected to be recognized over a weighted average period of 3 years.
The
Company issued 1,133,529 stock options and 375,000 restricted shares in the
year
ended December 31, 2007. The option grants issued during 2007 had a weighted
average exercise price of $3.79. The weighted average fair value of options
granted during the year ended December 31, 2007 was $2.32 and was estimated
on
the grant date using the Black-Scholes option-pricing model with generally
the
following weighted average assumptions: expected volatility of 62.8%, expected
term of 3.5 years, risk-free interest rate of 4.57%, and expected dividend
yield
of 0%. The Company issued 2,405,000 stock options in the year ended December
31,
2006. The options granted during 2006 had a weighted average exercise price
of
$1.80. The weighted average fair value of options granted during the year
ended
December 31, 2006 was $0.94 and was estimated on the grant date using the
Black-Scholes and Lattice option-pricing models with generally the following
weighted average assumptions: expected volatility of 62.5%, expected term
of 3.5
years, risk-free interest rate of 4.78%, and expected dividend yield of
0%.
The
Company’s expected volatility is based on the average of peer group volatility,
which includes the Company’s historical volatility within the peer group. The
average expected life was calculated using the simplified method under SAB
107
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, 2007, 2006 and 2005 was $1,020,940, $5,467,459 and $124,285.
The
aggregate intrinsic value of the options exercisable at December 31, 2007,
2006 and 2005 was $795,206, $3,457,814 and $114,605. The aggregate intrinsic
value of stock options exercised during 2007, 2006 and 2005 was $465,076,
$338,851 and $25,856. The
Company used the market price of $2.02, $2.95 and $1.17 at December 31, 2007,
2006 and 2005 versus the exercise price of each option, respectively.
76
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(6)
Stockholders’
Equity (continued)
(c)
Restricted Stock
On
July
18, 2007, 375,000 shares of the Company’s restricted common stock were granted
to the executive officers of the Company under the 2007 Plan. Each of these
restricted stock awards vest in three equal annual installments with the
first
installment vesting on July 18, 2008.
(d) Stock
Subscription Warrants
The
Company has reserved 1,003,311 shares of common stock issuable upon exercise
of
common stock purchase warrants. At December 31, 2007 there are warrants
outstanding to purchase 1,003,311 of the Company’s common stock that are
exercisable at the following prices:
Warrants
|
Exercise Price
|
Expiration Date
|
|||||
67,200
|
$
|
5.00
|
November
24, 2008
|
||||
936,111
|
$
|
5.50
|
December
15, 2009
|
No
warrants were issued or exercised in 2007, 2006 or 2005.
(7) Income
Taxes
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
Company's federal statutory income tax rate for 2007, 2006 and 2005 was 34%.
The
Company has incurred losses from operations but has not recorded an income
tax
benefit for 2007, 2006 and 2005, as the Company has 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.
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:
77
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(7)
Income
Taxes (continued)
2007
|
2006
|
2005
|
||||||||
Inventory
(Section 263A)
|
$
|
(261,000
|
)
|
$
|
(279,000
|
)
|
$
|
(258,000
|
)
|
|
Inventory
reserves
|
(31,000
|
)
|
(142,000
|
)
|
(150,000
|
)
|
||||
Receivable
reserves
|
(17,000
|
)
|
(30,000
|
)
|
(153,000
|
)
|
||||
Other
accruals
|
(362,000
|
)
|
(435,000
|
)
|
(142,000
|
)
|
||||
Accumulated
depreciation/amortization
|
973,000
|
1,398,000
|
1,718,000
|
|||||||
Stock
options
|
(659,000
|
)
|
(337,000
|
)
|
-
|
|||||
Tax
credits
|
(1,763,000
|
)
|
(1,881,000
|
)
|
(1,993,000
|
)
|
||||
NOL
carryforward
|
(13,688,000
|
)
|
(13,771,000
|
)
|
(13,592,000
|
)
|
||||
Net
deferred tax assets
|
(15,808,000
|
)
|
(15,477,000
|
)
|
(14,570,000
|
)
|
||||
Valuation
allowance
|
$
|
15,808,000
|
$
|
15,477,000
|
$
|
14,570,000
|
||||
|
$ | - |
$
|
-
|
$
|
-
|
As
of
December 31, 2007, the Company has net operating loss carryforwards totaling
approximately $40,260,000 expiring between 2008 and 2027. 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 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 2027 and management believes
approximately $1,763,000 will be available to offset income tax in future
periods.
The
Company adopted FASB Interpretation No. 48, "Accounting for Uncertainty in
Income Taxes—an interpretation of FASB Statement No. 109" ("FIN 48") on January
1, 2007. FIN 48 clarifies the accounting for uncertainty in income taxes
recognized in an enterprise's financial statements in accordance with FASB
Statement No. 109, "Accounting for Income Taxes." FIN 48 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. FIN 48 also provides guidance on derecognition, classification,
interest and penalties, accounting in interim periods, disclosure, and
transition.
78
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(7)
Income
Taxes (continued)
At
the
adoption date and as of December 31, 2007, the Company had no material
unrecognized tax benefits and no adjustments to liabilities or operations
were
required under FIN 48. The Company's 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 year
ended
December 31, 2007. All tax years with net operating losses and credit
carry forwards are subject to examination by the federal and state taxing
authorities. 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, 2007 will significantly change within the next
12
months.
(8)
Segment
Reporting, Geographical Information and Major Customers
(a)
Segment Reporting
The
Company follows SFAS No. 131 “Disclosures About Segments of a Business
Enterprise and Related Information”, 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 Company’s 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
Company's 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 $2,655,000 or 10% of sales
in 2007
as compared to $1,022,000 or 5% of total sales in 2006 and $1,747,000 or
9% of
total sales in 2005.
As
of
December 31, 2007 and 2006 the Company had outstanding receivables of $760,453
and $239,660, respectively, from distributors of its products who are located
outside of the United States.
79
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(8)
Segment
Reporting, Geographical Information and Major Customers
(continued)
(c)
Major Customers
The
Company’s major customer in 2007 was GE Healthcare with sales of $7,609,313 or
29%
of
the Company’s sales, with
an
accounts receivable balance of $1,865,747 due December 31, 2007. During the
year
ended December 31, 2006 the Company had sales of $5,077,091 and $2,462,225,
or
26% and 12% of
sales,
to GE Healthcare and Hologic, Inc., respectively. These
were the Company’s two major customers in 2006 with accounts receivable balances
of $1,150,975
and
$18,920,
respectively, due from these customers at December 31, 2006. For the year
ended
December 31, 2005 the Company’s two major customers were SourceOne Healthcare
and GE Healthcare with sales of $3,725,065 and $2,913,493 or 19% and 15%
of
sales in 2005.
(9)
Commitments
and Contingencies
(a)
Lease Obligations
As
of
December 31, 2006, the Company had three lease obligations related to its
facilities. The Company recently relocated its principal executive offices
and
on November 22, 2006 the Company signed a lease (the “Lease”) for office
space located in Nashua, New Hampshire (the “Premises”). 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 month’s 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 $445,000 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 $90,000 per year through December 2010.
80
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(9)
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.
Rental
expense for all leases for the years ended December 31, 2007, 2006 and 2005
was
$730,062, $553,181 and $528,681, net of sublease income of $135,711, $112,278,
and $41,297, respectively.
Future
minimum rental payments due under these agreements and sublease agreements
as of
December 31, 2007 are as follows:
Fiscal Year
|
Operating
Leases
|
Sublease
Amount
|
Net
Amount
|
|||||||
2008
|
678,789
|
173,465
|
505,324
|
|||||||
2009
|
703,560
|
197,594
|
505,966
|
|||||||
2010
|
701,244
|
200,046
|
501,198
|
|||||||
2011
|
220,320
|
-0-
|
220,320
|
|||||||
$
|
2,303,913
|
$
|
571,105
|
$
|
1,732,808
|
(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 one (1) year 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 CRA’s audit of
CADx Medical’s Canadian federal tax return for the year ended December 31, 2002.
The Company believes that it will not be liable for the re-assessment against
CADx Medical and no accrual was recorded as of December 31, 2007. The Company
responded to the notice outlining its grounds of objection with respect to
the
re-assessment. The CRA responded acknowledging receipt of the correspondence
and
advised that they expect to schedule a review within six
months.
81
iCAD,
INC. AND SUBSIDIARY
Notes
to
Consolidated Financial Statements (continued)
(10) Quarterly
Financial Data (unaudited)
|
Net
sales
|
Gross
profit
|
Net
income (loss)
|
Income (Loss)
per share
available
to common
stockholders
|
|||||||||
2007 | |||||||||||||
First
quarter
|
$
|
6,147,486
|
$
|
4,938,858
|
$
|
(553,937
|
)
|
$
|
(0.02
|
)
|
|||
Second
quarter
|
$
|
6,104,736
|
$
|
4,886,543
|
$
|
(839,611
|
)
|
$
|
(0.02
|
)
|
|||
Third
quarter
|
$
|
6,259,541
|
$
|
5,011,536
|
$
|
(670,045
|
)
|
$
|
(0.02
|
)
|
|||
Fourth
quarter
|
$
|
8,100,649
|
$
|
6,518,371
|
$
|
525,061
|
$
|
0.01
|
|||||
2006
|
|||||||||||||
First
quarter
|
$
|
4,373,650
|
$
|
3,454,771
|
$
|
(1,605,894
|
)
|
$
|
(0.04
|
)
|
|||
Second
quarter
|
$
|
3,869,693
|
$
|
3,032,285
|
$
|
(2,558,299
|
)
|
$
|
(0.07
|
)
|
|||
Third
quarter
|
$
|
5,038,336
|
$
|
3,844,162
|
$
|
(1,094,482
|
)
|
$
|
(0.03
|
)
|
|||
Fourth
quarter
|
$
|
6,439,679
|
$
|
5,099,322
|
$
|
(1,379,283
|
)
|
$
|
(0.04
|
)
|
The
fourth quarter results of fiscal 2006 includes discretionary bonuses of
approximately $482,000 which were determined in the fourth quarter, the adoption
of a Board Compensation plan in the fourth quarter resulting in expense of
$163,000 and a reduction in expense of approximately $291,000 for the change
in
estimate related to accounts receivable reserve due to improved collections
as a
percentage of accounts receivable balance.
82
iCAD,
INC. AND SUBSIDIARY
Schedule
II - Valuation and Qualifying Accounts and Reserves
Description
|
Balance at
Beginning
of Year
|
Additions
Charged to
Expense
|
Deductions
from Reserve
|
Balance
at End
of Year
|
|||||||||
Year
End December 31, 2007:
|
|||||||||||||
Allowance
for Doubtful Accounts
|
$
|
88,347
|
$
|
(32,662
|
)
|
$
|
5,685
|
(1)
|
$
|
50,000
|
|||
Inventory
Reserve
|
$
|
418,662
|
$
|
306,760
|
$
|
633,083
|
(2)
|
$
|
92,339
|
||||
Warranty
Reserve
|
$
|
299,034
|
$
|
281,932
|
|
$
|
378,130
|
$
|
202,836
|
||||
Restructuring
Reserve
|
$
|
9,401
|
$
|
-
|
$
|
9,401
|
$
|
-
|
|||||
Year
End December 31, 2006:
|
|||||||||||||
Allowance
for Doubtful Accounts
|
$
|
450,000
|
$
|
(248,482
|
)
|
$
|
113,171
|
(1)
|
$
|
88,347
|
|||
Inventory
Reserve
|
$
|
400,000
|
$
|
413,227
|
$
|
394,565
|
(2)
|
$
|
418,662
|
||||
Warranty
Reserve
|
$
|
150,000
|
$
|
637,354
|
$
|
488,320
|
$
|
299,034
|
|||||
Restructuring
Reserve
|
$
|
25,505
|
$
|
-
|
$
|
16,104
|
$
|
9,401
|
|||||
Year
End December 31, 2005:
|
|||||||||||||
Allowance
for Doubtful Accounts
|
$
|
450,000
|
$
|
40,338
|
$
|
40,338
|
(1)
|
$
|
450,000
|
||||
Inventory
Reserve
|
$
|
300,000
|
$
|
120,782
|
$
|
20,782
|
(2)
|
$
|
400,000
|
||||
Warranty
Reserve
|
$
|
150,000
|
$
|
295,419
|
$
|
295,419
|
$
|
150,000
|
|||||
Restructuring
Reserve
|
$
|
140,945
|
$
|
-
|
$
|
115,440
|
$
|
25,505
|
(1)
Represents the amount of accounts charged off.
(2)
Represents inventory written off and disposed of.
83