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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2008
Commission File No. 001-11182
BIO-IMAGING TECHNOLOGIES, INC.
(Exact name of Registrant as specified in its Charter)
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Delaware |
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11-2872047 |
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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826 Newtown-Yardley Road, Newtown, Pennsylvania |
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18940-1721 |
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(Address of principal executive offices) |
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(Zip Code) |
(267) 757-3000
(Registrants telephone number,
including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Name of each exchange on which registered |
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Common Stock, $0.00025 par value per share |
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NASDAQ Global Market |
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule
405 of the Securities Act.
Yes: o No: þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or Section 15(d) of the Act.
Yes: o No: þ
Indicate by check mark if 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 requirements for the past 90 days.
Yes: þ No: o
Indicate by check mark if the registrant if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K is not contained herein, and will not be contained, to the best of
registrants knowledge, in definitive proxy or information statements incorporated by reference in
Part III of this Form 10-K or any amendment to this Form 10-K. þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer o |
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Non-accelerated filer o |
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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Indicate by check mark if the registrant is a shell company (as defined in Rule 12b-2 of the
Act).
Yes: o No: þ
The aggregate market value of the voting and non-voting common equity held by non-affiliates
of the Registrant was $85.3 million on June 30, 2008, the last business day of the Registrants
most recently completed second fiscal quarter, based on the average bid and asked prices on that
date.
Indicate the number of shares outstanding of each of the Registrants classes of common
equity, as of February 28, 2009:
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Class |
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Number of Shares |
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Common Stock, $.00025 par value |
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14,341,403 |
The following documents are incorporated by reference into the Annual Report on Form 10-K:
Portions of the Registrants definitive Proxy Statement for its 2009 Annual Meeting of Stockholders
are incorporated by reference into Part III of this Report.
TABLE OF CONTENTS
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Item |
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PART I |
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1. Business |
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1 |
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1A. Risk Factors |
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8 |
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1B. Unresolved Staff Comments |
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17 |
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2. Properties |
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17 |
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3. Legal Proceedings |
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17 |
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4. Submission of Matters to a Vote of Security Holders |
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17 |
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PART II |
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5. Market for Registrants Common Equity, Related Stockholder
Matters and Issuer Purchases of Equity Securities |
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18 |
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6. Selected Financial Data |
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21 |
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7. Managements Discussion and Analysis of Financial |
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Condition and Results of Operations |
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22 |
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7A. Quantitative and Qualitative Disclosures About Market Risk |
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36 |
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8. Financial Statements and Supplementary Data |
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38 |
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9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure |
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67 |
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9A(T). Controls and Procedures |
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67 |
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9B. Other Information |
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68 |
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PART III |
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10. Directors, Executive Officers and Corporate Governance |
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69 |
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11. Executive Compensation |
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69 |
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12. Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters |
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69 |
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13. Certain Relationships and Related Transactions, and
Director Independence |
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70 |
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14. Principal Accounting Fees and Services |
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70 |
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PART IV |
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15. Exhibits, Financial Statement Schedules |
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70 |
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PART I
Item 1. Business.
Overview
Bio-Imaging Technologies, Inc., referred to herein as we, us and our, is a global
clinical trials service organization, providing medical image management and eClinical services,
including electronic data capture and clinical data management solutions, to pharmaceutical,
biotechnology and medical device companies and other organizations, including contract research
organizations (CROs), engaged in clinical trials.
Our medical image management services assist our clients in the design and management of the
medical imaging component of clinical trials. We have developed specialized services and
proprietary software applications that enable independent radiologists and other medical
specialists involved in clinical trials to review medical image data in an entirely digital format
and make highly precise measurements and biostatistical inferences to evaluate the efficacy and
safety of pharmaceuticals, biologics or medical devices. Medical imaging is used for clinical
development of therapeutic modalities for use in oncology, disorders of the musculoskeletal,
central nervous, cardiovascular systems, and in a variety of other disease categories.
Our core laboratory imaging services include the collection, processing, analysis and
regulatory submission of medical images and related clinical data. Medical images are received
from a wide variety of imaging modalities including computerized tomography (CT), magnetic
resonance imaging (MRI), radiography, dual energy x-ray absorptiometry (DXA/DEXA), positron
emission tomography (PET), single photon emission computerized tomography (SPECT), quantitative
coronary angiography (QCA), cardiac MRI and CT, intravascular ultrasound (IVUS), peripheral
quantitative angiography (QVA), central nervous system (CNS) MRI and ultrasound. The resulting data
enables our clients and regulatory reviewers, primarily the U.S. Food and Drug Administration and
comparable European agencies, to evaluate product efficacy and safety.
On March 24, 2008, we completed the acquisition of Phoenix Data Systems, referred to herein as
PDS, a provider of electronic data capture (EDC) services offering a comprehensive array of
eClinical data solutions to the pharmaceutical and biotechnology industries. PDS is engaged in
providing full service EDC, a combination of electronic data capture, interactive voice response,
reporting and data management solutions and is focused on making the process of collecting and
analyzing data from clinical trials faster, easier and more reliable.
Our eClinical services offer a variety of customizable proprietary software solutions that
enhance pharmaceutical and biotech companies ability to process and store clinical data through
the use of customized proprietary software and hosting service. This technology improves data
quality and allows our sponsors to see the results of their clinical trials faster and more
accurately than with conventional paper-based methods.
On January 6, 2009, we sold our CapMed division to MBI Benefits, Inc., an indirectly owned
subsidiary of Metavante Technologies, Inc. This division included the Personal Health Record
(PHR) software and the patent-pending Personal HealthKey technology. The sale of CapMed enables
us to focus on our core clinical trials services business.
We were incorporated in Delaware in 1987 under the name Wise Ventures, Inc. Our name was
changed to Bio-Imaging Technologies, Inc. in 1991. The address of our principal executive offices
is 826 Newtown-Yardley Road, Newtown, Pennsylvania, 18940, and our telephone number is
267-757-3000. Our Internet website is www.bioimaging.com. We make available on our Internet
website all of our public filings with the Securities and Exchange Commission, or SEC. However,
nothing on our Internet website is intended to be incorporated by
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reference into this Form 10-K or any other filing made by us with the SEC. The public may
read or copy any filings that Bio-Imaging, Technologies, Inc. files with the SEC at the SEC Public
Reference Room at 100 F. Street, N.E., Washington, D.C. 20549. The SEC maintains an internet site
that contains reports, proxy, and information statements, and other information regarding issuers
that file electronically with the SEC. The website is http://www.sec.gov. The public can also
obtain information on the operation of the Public Reference Room by calling the SEC at
1-800-SEC-0330.
Business Services
Medical Image Management Services
We are a leading provider of medical imaging management services for clinical development
purposes. Our medical image management services assist our clients in the design and management of
the medical imaging component of clinical trials for all modalities, which includes computerized
tomography (CT), magnetic resonance imaging (MRI), radiography, dual energy x-ray absorptiometry
(DXA/DEXA), positron emission tomography (PET), single photon emission computerized tomography
(SPECT), quantitative coronary angiography (QCA), cardiac MRI and CT, intravascular ultrasound
(IVUS), peripheral quantitative angiography (QVA), central nervous system (CNS) MRI and ultrasound.
Our services include the processing and analysis of medical images and the regulatory submission
of medical images and related quantitative data. Our imaging core laboratory facilities in the
United States and Europe provide centralized image data collection, processing, analysis and
archival services for clinical trials conducted worldwide. The facilities are designed for
efficient and accurate high-volume processing of film and digital image data in a secure
environment that complies with regulatory guidelines for clinical data management.
Medical image data are received by us from clinical trial sites located throughout the world.
We have developed procedures for data tracking and quality control that we believe to be of
significant value to our clients. Our facilities contain specialized hardware and software for the
digitization of films and translation of digital data, enabling data to be standardized, regardless
of its source. We believe our ability to handle most commercially available image file formats is
a valuable technical asset and an important competitive advantage in gaining new business from
large, global, multi-center clinical trials.
We have developed image analysis software to measure key indicators of drug efficacy in
different organs and disease states. The results from image analysis derived in our facilities can
be transmitted electronically to our clients for regulatory submission. In addition, clients can
use our image analysis software to determine patient eligibility for their clinical trials.
Our information management services focus on providing specialized solutions for improving the
quality, speed and flexibility of image data management for clinical trials. We believe that our
computer assisted masked reading systems, (BioReadÔ systems), offer numerous advantages over
conventional film-based medical image reading scenarios, including increased reading speed, greater
standardization of image reading, and reduced error in the capture of reader interpretations.
Using our BioReadÔ systems, independent medical specialists can review medical image
data from clinical trials in a digital format. The BioReadÔ systems display all modalities
of medical image data, regardless of source equipment. In addition, the systems display either
translated digital data or digitized films. Such image reviews are often required during clinical
trials to evaluate patients responses to therapy or to determine if patients qualify for studies.
By using the BioReadÔ systems to read and evaluate image data, medical specialists achieve
greater reading speed than is possible with a manual film-based system and perform evaluations in a
more
objective, reproducible manner.
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We have also developed remote BioReadÔ systems that are located on the premises, either
home or office, of the individual medical specialists who are engaged by the sponsor to perform the
analysis of the medical image data. Historically, the BioReadÔ systems have been utilized to
determine efficacy of the compounds being studied. More recently, clients are requesting us to
provide rapid turn-around reads for inclusion/exclusion criteria. We believe that the remote
BioReadÔ system is the optimal tool for this work because it allows us, at our clients
discretion, to provide the images to an expert in the field to facilitate the review of the images
from the experts office or home.
We provide technical consulting in the evaluation of the sites that may participate in
clinical trials. We also provide consulting services to our client regarding regulatory issues
involved in the design, execution, analysis and submission of medical image data in clinical
trials.
eClinical Services
We offer electronic data capture (EDC) technology and data management services designed to
offer our customers automation of time-consuming, paper-based clinical trial processes and to scale
securely, reliably and cost-effectively for clinical trials involving substantial numbers of
clinical sites and patients worldwide. Using our proprietary software, we can centrally collect
and organize clinical data in electronic format. This technology improves data quality and allows
our sponsors to see the results of their clinical trials faster than conventional paper-based
methods. We design and build electronic case report forms (eCRF) with logic and data validation
checks and programmatic queries for more accurate and reliable data. The eCRF is made available to
each research site participating in the clinical trial via the Internet. The export feature of our
software allows completed data and reports to be transmitted directly to a clinical trial sponsors
in-house database. This process allows research data to be collected quicker and with greater
accuracy than with physical management of paper reports. In addition, our technology allows the
sponsor to have complete and continuous access to their data at all times.
Our products are supported by comprehensive consulting and training services and application
hosting and support capabilities. We offer customer and site support 24 hours per day, seven days
per week via our call center.
We offer an IVR system that is integrated with electronic data capture technology for improved
clinical trial management. Our system is extremely useful for obtaining mutilingual study subject
randomization codes and can initiate call backs to issue reminders (such as patient visits) and
integrate fully with the central database, for a full electronic data collection mechanism.
Target Markets
Our primary target market is comprised of global pharmaceutical, biotechnology and medical
device companies with products currently in the clinical development pipeline.
We focus our marketing on the following stages of clinical development:
Phase I Clinical Trials
Phase I clinical trials are generally conducted over six to twelve months to determine drug
safety, including how drugs should be administered, dose levels and potential side effects of
exposing approximately five to 80 patients to the drug.
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Phase II Clinical Trials
Phase II clinical trials are generally conducted over six months to two years and involve
basic efficacy, safety and dose-range testing in approximately 50 to 400 patients suffering from
the disease or condition under study. Such trials help determine the best effective dose, confirm
that the drug works as expected, and provide initial safety data.
Phase III Clinical Trials
Phase III clinical trials are generally conducted over one to four years and involve efficacy
and safety studies in broader populations of hundreds or thousands of patients and many
investigational sites, such as hospitals and clinics. These trials are sometimes referred to as
pivotal studies for submission to the regulatory agencies. Generally, Phase III studies are
intended to provide additional information on drug safety and efficacy, and the evaluation of the
risk-benefit of the drug and information for the adequate labeling of the product.
Phase IV Post Approval Studies
Phase IV studies are studies conducted after a pharmaceutical drug or device has been approved
for use. These studies are generally conducted over a two to four year period and involve either a
continuation of a Phase III patient population or the recruitment of a new patient population. As
there continues to be pressure to expedite approval of pharmaceuticals and medical devices, there
is an increase in the number of conditional approvals based on the conduct of additional Phase IV
studies.
In addition, our experience spans a wide range of therapeutic areas with a concentration in
the following for our medical image management services:
Cancer Therapeutics
Many pharmaceutical companies are currently developing new therapies for the treatment of
cancer. For solid tumor studies, medical imaging modalities are used to determine the response of
treated and untreated tumors. These medical images are evaluated by medical specialists during the
course of oncology clinical trials to determine the extent of disease and changes in tumor size
over time.
The FDA guidelines aimed at accelerating access to new drugs for the review and approval of
new cancer therapies place greater emphasis on shrinkage of tumors as an early indicator of
anti-tumor efficacy. We believe that these FDA guidelines may have a favorable impact on our
business as pharmaceutical and biotechnology companies may have an increased need for
regulatory-compliant medical imaging services to conduct their oncology clinical trials.
Musculoskeletal Therapeutics
Anti-inflammatory clinical trials, such as those focused on arthritis, include radiologic
evaluation of the bones and joints to determine drug efficacy. We believe that demand among
pharmaceutical companies for our services will increase as new classes of biotechnology-derived
drugs enter and progress through the clinical development pipeline.
Osteoporosis is a disease characterized by diminished bone density, which leads to pathologic
bone fractures in the elderly. The FDA guidance document for developing treatments for this
disease recognized
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DEXA as one of the primary efficacy and safety measurement tools available. Furthermore, all
data needs to be processed by a quality assurance laboratory. This is now standard practice in all
studies using DEXA instruments for assessing therapies for osteoporosis, oncology, obesity, or
muscle wasting diseases.
Central Nervous System and Neurovascular Therapeutics
Many pharmaceutical companies are developing drugs for treatment of neurovascular diseases and
conditions of the central nervous system, referred to as CNS, such as multiple sclerosis,
infectious diseases that target the CNS, stroke and Alzheimers disease. For many of these
diseases, the diagnosis is largely dependent upon imaging, particularly MRI. We believe that the
central nervous system clinical trials business may increase as more of these therapies progress
through the research pipeline.
Cardiovascular Therapeutics
We provide our services to clients developing drugs and medical devices for the diagnosis and
treatment of cardiovascular diseases and conditions that are evaluated with the aid of medical
imaging. We offer various cardiovascular, quantitative, image-analysis services including:
quantitative coronary angiography (QCA), cardiac MRI and CT, ultrasound, intravascular ultrasound
(IVUS) and peripheral quantitative angiography (QVA). We have participated in numerous
multinational trials for leading pharmaceutical, biotechnology and medical device companies
throughout the world. As research continues to advance, our collective knowledge base of the
underlying pathophysiology of cardiovascular disease will grow as well as the need for advanced
imaging technology to be used in cardiovascular trials. For example, CT may be used to identify
coronary calcifications, which are considered to be a predictor of cardiovascular risk. It follows
that clinical trials involving therapeutic interventions targeting coronary calcifications will
require imaging as an endpoint of efficacy.
Diagnostic Imaging Agents
We provide our services to clients developing diagnostic imaging agents that are designed to
diagnose disease conditions more quickly and accurately in their development in order to facilitate
earlier and more accurate treatment.
Intellectual Property
Proprietary intellectual property protection for our computer-imaging programs processes and
expertise is important to our business. We have developed certain technically-derived procedures
and computer software applications that are intended to increase the effectiveness and quality of
our services. We rely upon patents, trademarks, copyrights, trade secrets, know-how and continuing
technological innovation to develop and maintain our competitive position. We have claimed
trademark protection for BioReadÔ and Intelligent ImagingÔ. We hold patents for the
two DEXA phantoms, titled Spine and Variable Composition Phantoms, which we sell to trial sites.
We have registered our Stylized Man Design with the U.S. Patent and Trademark Office. We cannot
assure you that we can limit unauthorized or wrongful disclosures of trade secrets or otherwise
confidential information. In addition, to the extent we rely on trade secrets and know-how to
maintain our competitive technological position, we cannot assure you that others may not develop
independently the same, similar or superior techniques. Although our intellectual property rights
are important to the results of our operations, we believe that other factors, such as our
independence, process knowledge, technical expertise and experience are more important, and that,
overall, these technological capabilities offer significant benefits to our clients.
Government Regulation
It is our view that demand for our software products, services and hosted solutions is largely
a function of
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the regulatory requirements associated with the investigation and approval of drugs, biologics
and medical devices, as well as the monitoring of and reporting on the safety of these products.
The clinical testing of drugs, biologics and medical devices is subject to regulation by the U.S.
Food and Drug Administration, or FDA, and other governmental authorities worldwide. The use of
software and services during the clinical trial process must adhere to the regulations known as
Good Clinical Practices and other various codified FDA regulations, and should adhere to regulatory
guidance such as the Consolidated Guidance for Industry from the International Conference on
Harmonization regarding Good Clinical Practice for Europe, Japan and the United States and other
guidance documents. Our products, services and hosted solutions are developed using our domain
expertise and are designed to allow compliance with applicable rules and regulations, and
conformance with applicable guidance. The foregoing regulations and regulatory guidance are subject
to change at any time. Changes in regulations and regulatory guidance to either more or less
stringent conditions could adversely affect our business and the software products, services and
hosted solutions we make available to our customers. Further, a material violation by us or our
customers of Good Clinical Practices could result in a warning letter from the FDA, the suspension
or termination of clinical trials, investigator disqualification, debarment, the rejection or
withdrawal of a product marketing application, criminal prosecution or civil penalties, any of
which could have a material adverse effect on our business, results of operations or financial
condition.
In addition to the aforementioned regulations and regulatory guidance, the FDA has developed
regulations and regulatory guidance concerning electronic records and electronic signatures. The
regulations, codified as 21 CFR Part 11, are interpreted for clinical trials in a guidance document
titled Computerized Systems Used in Clinical Trials. This regulatory guidance stipulates that
computerized systems used to capture or manage clinical trial data must meet certain standards for
attributability, accuracy, retrievability, traceability, inspectability, validity, security and
dependability. Other guidance documents have been issued that also help in the interpretation of 21
CFR Part 11. We cannot assure you that the design of our software solutions, will continue to allow
customers to maintain conformance with these guidelines as they develop. Any changes in applicable
regulations that are inconsistent with the design of any of our software solutions or which reduce
the overall level of record-keeping or other controls or performances of clinical trials, may have
a material adverse effect on our business and operations. If we fail to offer solutions that allow
our customers to comply with applicable regulations, it could result in the suspension or
termination of on-going clinical trials, the disqualification of data for submission to regulatory
authorities, or the withdrawal of approved marketing applications.
The FDA has established mandatory procedures and safety standards that apply to the clinical
testing, manufacturing and marketing of drugs and medical devices. These procedures and safety
standards include, among other things, the completion of adequate and well-controlled human
clinical trials to establish the safety and efficacy of the drug or device for its recommended
conditions or use. We advise our clients in the execution of clinical trials and other drug and
device development tasks. We do not administer drugs to or utilize medical devices on patients.
The success of our business is dependent upon continued acceptance by the FDA and other
regulatory authorities of the data and analyses generated by our services in connection with the
evaluation of the safety and efficacy of new drugs and devices. The FDA has formal guidelines that
encourage the use of surrogate measures, through submission of digital image data, for evaluation
of drugs to treat life-threatening or debilitating conditions. We cannot assure you that the FDA
or other regulatory authorities will accept the data or analyses generated by us in the future and,
even assuming acceptance, we cannot assure you that the FDA or other regulatory authorities will
require the application of imaging techniques to numbers of patients and over time periods
substantially similar to those required of traditional safety and efficacy techniques.
Changes in the FDAs policy for the evaluation of therapeutic oncology agents may have a
positive impact on the time to market of such therapeutics. According to FDA guidelines, approval
times for new cancer
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therapies can be shortened if evidence of tumor shrinkage is verifiable and demonstrable
through the use of objective measurement techniques. These guidelines place greater reliance on
the use of medical image data to demonstrate objective tumor shrinkage. In addition, the FDA has
implemented guidelines aimed at accelerating other therapeutic categories through the use of
imaging markers as surrogate endpoints for measuring therapeutic effectiveness. We believe the
FDAs initiatives to streamline and accelerate the submission and review process of therapeutic
agents has had a favorable impact on our business.
We believe that our ability to achieve continued and sustainable growth will be materially
dependent upon, among other factors, the continued stringent enforcement of the comprehensive
regulatory framework by various government agencies. Any significant change in these regulatory
requirements or the enforcement thereof, especially relaxation of standards, could adversely affect
our business.
The current European market regulation is more fragmented than in the United States. However,
we believe that our expertise in working with the standards of the FDA provides us with experience
when working with the various European regulatory agencies.
Competition
The market for medical image management, electronic data collection, data management and other
clinical trial services is highly competitive and rapidly evolving. Our imaging services primarily
compete against specialty contract research organizations, or CROs, and to a lesser extent,
universities and teaching hospitals. Our eClinical Services competes with internally developed
solutions, CROs, and independent providers of such services. Certain of these competitors are
owned by or are divisions of larger organizations, some of which have substantially greater
resources than we do. As competition increases, we will look to provide value-added services and
undertake marketing and sales programs to differentiate our services based on our expertise and
experience in specific therapeutic and diagnostic areas, our technical expertise, our regulatory
and clinical development experience, our quality performance and our international capabilities.
Our competitive position also depends upon our ability to attract and retain qualified personnel
and develop and preserve proprietary technology, processes and know-how. Competition in our
industry has resulted in additional pressure being placed on price, service and quality. Although
we believe that we are well positioned against our competitors due to our experience in clinical
trials and regulatory compliance along with our international presence, we cannot assure you that
our competitors or clients will not provide or develop services similar or superior to those
provided by us. This competition could have a material adverse impact on us.
Marketing and Sales
We provide and market our services on an international basis primarily to pharmaceutical,
biotechnology and medical device companies. We sell our products through a direct sales force and
through relationships with CROs. Our direct sales force is operated out of two U.S. field offices
and two European field offices, as well as our operational facilities in Pennsylvania and Leiden,
The Netherlands. In addition, follow-on sales are accomplished by the efforts of sales
professionals, project managers and other consulting services professionals.
Our selling efforts are primarily focused on North America and Western Europe. Our marketing
activities include exhibiting at major trade shows, advertising in trade journals and the
sponsoring of industry associations. As of December 31, 2008, we had 38 employees in sales and
marketing.
Significant Clients
No one client represented more than 10% of our service revenues for the year ended December
31, 2008,
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while for the year ended December 31, 2007, one client, Hoffmann-La Roche, which encompassed
11 projects, accounted for 13.4% of our service revenues. For the year ended December 31, 2006,
one client, Novartis Pharmaceuticals, Inc., which encompassed 14 projects, accounted for 10.9% of
our service revenues. These contracts are terminable by our client at any time and for any reason.
The loss of a significant client, or a reduction in services provided to a significant client,
would have a material adverse effect on our business, financial condition and results of
operations.
Business Segments and Geographic Information
We view our operations and manage our business as one operating segment, clinical trials
services.
Our corporate headquarters and operational facilities are in Pennsylvania, in the United
States. We also have a European facility in Leiden, the Netherlands. We manage our services for
European-based clinical trials from this facility. Our European facility has similar processing and
analysis capabilities as our United States headquarters. We also have a facility in Lyon, France
that provides product development and research activities.
Employees
As of December 31, 2008, we had 474 employees, four of whom were executive officers.
Of our employees, as of December 31, 2008, 38 were engaged in sales and marketing, 387 were
engaged in client-related projects and 49 were engaged in administration and management. A
significant number of our management and professional employees have prior industry experience. We
believe that we have been successful in attracting skilled and experienced personnel; however, it
remains a competitive market for recruiting such personnel. As of February 28, 2009, we have
employment agreements with two of our executive officers. See Item 11. Executive Compensation.
We consider relations with our employees to be good.
Item 1A. Risk Factors.
The more prominent risks and uncertainties inherent in our business are described below.
However, additional risks and uncertainties may also impair our business operations. If any of the
following risks actually occur, our business, financial condition or results of operations may
suffer. Investing in our common stock involves a high degree of risk. Any of the following factors
could harm our business and future results of operations and you could lose all or part of your
investment.
Risks Related to Our Company and Business
We may incur financial losses because contracts may be delayed or terminated or reduced in scope
for reasons beyond our control.
Our clients may terminate or delay their contracts for a variety of reasons, including, but
not limited to:
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unexpected or undesired clinical results; |
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the clients decision to terminate the development of a particular product or to end a
particular study; |
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insufficient patient enrollment in a study; |
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insufficient investigator recruitment; |
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failure to perform our obligations under the contract; or |
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the failure of products to satisfy safety requirements. |
8
In addition, we believe that FDA-regulated companies may proceed with fewer clinical trials or
conduct them without assistance of contract service organizations if they are trying to reduce
costs as a result of cost containment pressures associated with healthcare reform, budgetary limits
or changing priorities. These factors may cause such companies to cancel contracts with contract
service organizations.
We cannot assure you that our clients will continue to use our services or that we will be
able to replace, in a timely or effective manner, departing clients with new clients that generate
comparable revenues. Further, we cannot assure you that our clients will continue to generate
consistent amounts of revenues over time.
The loss, reduction in scope or delay of a large contract or the loss or delay of multiple
contracts could materially adversely affect our business, although our contracts entitle us to
receive all fees earned up to the time of termination.
The current economic downturn may adversely impact our ability to raise capital.
The recent economic downturn and adverse conditions in the national and global markets may
negatively affect our operations in the future. The falling equity markets and adverse credit
markets may make it difficult for us to raise capital or procure credit in the future to fund the
growth of our business, which could have a negative impact on our business and results of
operations and limit our ability to pursue acquisitions.
We depend on a small number of industries and clients for all of our business, and the loss of one
such significant client could cause revenues to drop quickly and unexpectedly.
We depend on research and development expenditures by pharmaceutical, biotechnology and
medical device companies to sustain our business. Our operations could be materially and adversely
affected if:
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our clients businesses experience financial problems or are affected by a general
economic downturn; |
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consolidation in the pharmaceutical, biotechnology or medical device industries leads to
a smaller client base for us; or |
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clients reduce their research and development expenditures. |
No one client represented more than 10% of our service revenues for the year ended December
31, 2008, while for the comparable period last year, one client, Hoffmann-La Roche, which
encompassed 11 projects, represented 13.4% of our service revenues for the year ended December 31,
2007. The loss of business from a significant client or our failure to continue to obtain new
business to replace completed or canceled projects would have a material adverse effect on our
business and revenues.
Our contracted/committed backlog may not be indicative of future results.
Our reported contracted/committed backlog of $92.7 million at December 31, 2008 is based on
anticipated service revenue from uncompleted projects with clients. Backlog is the expected service
revenue that remains to be earned and recognized on signed and verbally agreed to contracts.
Contracts included in backlog are subject to termination by our clients at any time. In the event
that a client cancels a contract, we would be entitled to receive payment for all services
performed up to the cancellation date and subsequent client authorized services related to the
cancellation of the project. The duration of the projects included in our backlog range from less
than three months to seven years. We cannot assure that this backlog will be indicative of future
results. A number of factors may affect backlog, including:
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the variable size and duration of the projects (some are performed over several years); |
9
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the loss or delay of projects; |
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the change in the scope of work during the course of a project; and |
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the cancellation of such contracts by our clients. |
Also, if clients delay projects, the projects will remain in backlog, but will not generate
revenue at the rate originally expected. Accordingly, the historical relationship of backlog to
revenues may not be indicative of future results.
We recently acquired Phoenix Data Systems, Inc. and may engage in future acquisitions, which may be
expensive and time consuming, and from which we may not realize anticipated benefits.
We recently acquired Phoenix Data Systems Inc. (PDS) and may acquire additional businesses,
technologies and products if we determine that these additional businesses, technologies and
products complement our existing business, or otherwise serve our strategic goals. Either as a
result of the acquisition of PDS or future acquisitions undertaken, the process of integrating the
acquired business, technology or product may result in operating difficulties and expenditures, and
may absorb significant management attention that would otherwise be available for ongoing
development of our business. Moreover, we may never realize the anticipated benefits of any such
acquisition. Such acquisitions could result in potentially dilutive issuances of our securities,
the incurrence of debt and contingent liabilities and amortization expenses related to intangible
assets, all of which could adversely affect our results of operations and financial condition.
Loss of key personnel, or failure to attract and retain additional personnel, may cause the success
and growth of our business to suffer.
Future success depends on the personal efforts and abilities of the principal members of our
senior management to provide strategic direction, develop business, manage operations and maintain
a cohesive and stable environment. Specifically, we are dependent upon Mark L. Weinstein, President
and Chief Executive Officer, Ted I. Kaminer, Executive Vice President
of Finance and Administration and Chief Financial Officer,
David A. Pitler, Executive Vice President, Bio-Imaging Services and Peter Benton, Executive Vice
President, eClinical. Although we have employment agreements with Mr. Weinstein, Mr. Kaminer and
Mr. Benton, this does not necessarily mean that they will remain with us. Although we have
executive retention agreements with our officers, we do not have employment agreements with any
other key personnel. Furthermore, our performance also depends on our ability to attract and retain
management and qualified professional and technical operating staff. Competition for these skilled
personnel is intense. The loss of services of any key executive, or inability to continue to
attract and retain qualified staff, could have a material adverse effect on our business, results
of operations and financial condition. We do not maintain any key employee insurance on any of our
executives.
Our revenues, earnings and operating costs are exposed to exchange rate fluctuations.
During fiscal 2008, a portion of our service revenues were denominated in foreign currency.
Our financial statements are denominated in United States dollars. In the event a greater portion
of our service revenues are denominated in a foreign currency, changes in foreign currency exchange
rates could affect our results of operations and financial condition. Fluctuations in foreign
currency exchange rates could materially impact the operating costs of our European facility in
Leiden, the Netherlands, which are primarily Euro denominated. We hedge our foreign currency
exposure when and as appropriate to mitigate the adverse impact of fluctuating exchange rates.
Our investments may be exposed to credit risk.
10
Financial instruments that potentially subject us to significant credit risk consist
principally of cash. As part of our risk management processes, we continuously evaluate the
relative credit standing of all of the financial institutions that service us and monitor actual
exposures versus established limits. We have not sustained credit losses from instruments held at
financial institutions. We maintain cash and cash equivalents, comprised of savings accounts,
short-term certificate of deposits and money market funds with various financial institutions.
These financial institutions are generally highly rated and the company has a policy to limit the
dollar amount of credit exposure with any one institution.
We may be required to record additional significant charges to earnings if our goodwill becomes
impaired.
Under accounting principles generally accepted in the United States, we review our goodwill
for impairment each year as of December 31 and when events or changes in circumstances indicate the
carrying value may not be recoverable. The carrying value of our goodwill may not be recoverable
due to factors such as a decline in stock price and market capitalization, reduced estimates of
future cash flows and slower growth rates in our industry. Estimates of future cash flows are based
on an updated long-term financial outlook of our operations. However, actual performance in the
near-term or long-term could be materially different from these forecasts, which could impact
future estimates. For example, a significant decline in our stock price and/or market
capitalization may result in impairment of our goodwill valuation. We may be required to record a
charge to earnings in our financial statements during a period in which an impairment of our
goodwill is determined to exist, which may negatively impact our results of operations.
Risks Related to Our Industry
Our failure to compete effectively in our industry could cause our revenues to decline.
Significant factors in determining whether we will be able to compete successfully include:
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consultative and clinical trials design capabilities; |
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reputation for on-time quality performance; |
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expertise and experience in specific therapeutic areas; |
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the scope of service offerings; |
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strength in various geographic markets; |
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the price of services; |
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ability to acquire, process, analyze and report data in a time-saving and accurate
manner; |
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ability to manage large-scale clinical trials both domestically and internationally; |
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our size; and |
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the service and product offerings of our competitors. |
If our services are not competitive based on these or other factors, our business, financial
condition and results of operations could be materially harmed.
The biopharmaceutical services industry is highly competitive, and we face numerous
competitors in our business, including hundreds of contract research organizations. If we fail to
compete effectively, we will lose clients, which would cause our business to suffer. We primarily
compete against in-house departments of pharmaceutical companies, full service contract research
organizations, (CROs), small specialty CROs, and to a lesser extent, universities and teaching
hospitals. Some of these competitors have substantially greater capital, technical and other
resources than we do. In addition, certain of our competitors that are smaller specialized
companies may compete effectively against us because of their concentrated size and focus.
11
Changes in outsourcing trends in the pharmaceutical and biotechnology industries could adversely
affect our operating results and growth rate.
Service revenues depend greatly on the expenditures made by the pharmaceutical and
biotechnology industries in research and development. Accordingly, economic factors and industry
trends that affect our clients in these industries also affect our business. For example, the
practice of many companies in these industries has been to hire outside organizations like us to
conduct clinical research projects. This practice has grown significantly in the last decade, and
we have benefited from this trend. However, if this trend were to change and companies in these
industries were to reduce the number of research and development projects they outsource, our
business could be materially adversely affected.
Additionally, numerous governments have undertaken efforts to control growing healthcare costs
through legislation, regulation and voluntary agreements with medical care providers and
pharmaceutical companies. If future regulatory cost containment efforts limit the profits that can
be derived from new drug sales, our clients might reduce their research and development spending,
which could reduce our business.
Consolidation among our customers could cause us to lose customers, decrease the market for our
products and result in a reduction of our revenues.
Our customer base could decline because of industry consolidation, and we may not be able to
expand sales of our products and services to new customers. Consolidation in the pharmaceutical,
biotechnology and medical device industries has accelerated in recent years, and we expect this
trend to continue. As these industries consolidate, competition to provide products and services
to industry participants will become more intense and the importance of establishing relationships
with large industry participants will become greater. These industry participants may try to use
their market power to negotiate price reductions for our products and services. Also, if
consolidation of larger current customers occurs, the combined organization may represent a larger
percentage of business for us and, as a result, we are likely to rely more significantly on the
combined organizations revenues to continue to achieve growth.
The current economic downturn coupled with the current regulatory environment could have a negative
impact on the pharmaceutical, biotechnology and medical device industries.
The recent economic downturn and adverse conditions in the national and global markets may
negatively affect our operations in the future. Our revenues are contingent upon the research and
development expenditures by pharmaceutical, biotechnology and medical device companies. Some
companies in these industries have found it difficult to raise capital in the equity and debt
markets or through traditional credit markets to fund research and development. In addition,
increased regulatory scrutiny from the FDA may have increased the costs of research and development
for these companies. These companies have responded to the general economic downturn and
regulatory environment, by postponing, attenuating or cancelling clinical trials projects, or
portions thereof, which may reduce the need for our services. As a result, our revenues may be
similarly decreased. Furthermore, while our revenues may decrease, our costs may remain relatively
fixed, resulting in decreased earnings.
Failure to comply with existing regulations could result in increased costs to complete clinical
trials.
Our business is subject to numerous governmental regulations, primarily relating to
pharmaceutical product development and the conduct of clinical trials. In particular, we are
subject to 21 CFR Part 11 of the Code of Federal Regulations that provides the criteria for
acceptance by the FDA of electronic records. If we fail to comply with these governmental
regulations, it could result in the termination of ongoing clinical research or the
disqualification of data for submission to regulatory authorities. We also could be barred from
providing clinical
12
trial services in the future or be subjected to fines. Any of these consequences would harm
our reputation, our prospects for future work and our operating results.
Changes in governmental regulation could decrease the need for the services we provide, which would
negatively affect our future business opportunities.
In recent years, the United States Congress and state legislatures have considered various
types of healthcare reform in order to control growing healthcare costs. The United States Congress
and state legislatures may again address healthcare reform in the future. We are unable to predict
what legislative proposals will be adopted in the future, if any. Similar reform movements have
occurred in Europe and Asia.
Implementation of healthcare reform legislation that results in additional costs could limit
the profits that can be made by clients from the development of new products. This could adversely
affect our clients research and development expenditures, which could, in turn, decrease the
business opportunities available to us both in the United States and abroad. In addition, new laws
or regulations may create a risk of liability, increase costs or limit service offerings. We cannot
predict the likelihood of any of these events.
In addition to healthcare reform proposals, the expansion of managed care organizations in the
healthcare market may result in reduced spending on research and development. Managed care
organizations efforts to cut costs by limiting expenditures on pharmaceuticals and medical devices
could result in pharmaceutical, biotechnology and medical device companies spending less on
research and development. If this were to occur, we would have fewer business opportunities and our
revenues could decrease, possibly materially.
Governmental agencies throughout the world, but particularly in the United States, strictly
regulate the drug development/approval process. Our business involves helping pharmaceutical and
biotechnology companies navigate the regulatory drug approval process. Changes in regulation, such
as relaxation in regulatory requirements or the introduction of simplified drug approval procedures
or an increase in regulatory requirements that we may have difficulty satisfying could eliminate or
substantially reduce the need for our services. If these changes in regulations were to occur, our
business, results of operations and financial condition could be materially adversely affected.
These and other changes in regulation could have a material adverse impact on our available
business opportunities.
If governmental agencies do not accept the data and analyses generated by our services, the need
for our services would be eliminated or substantially reduced.
The success of our business is dependent upon continued acceptance by the FDA and other
regulatory authorities of the data and analyses generated by our services in connection with the
evaluation of the safety and efficacy of new drugs and devices. The FDA has formal guidelines that
encourage the use of surrogate measures through submission of digital image data, for evaluation
of drugs to treat life-threatening or debilitating conditions. We cannot assure you that the FDA or
other regulatory authorities will accept the data or analyses generated by us in the future and,
even assuming acceptance, the FDA or other regulatory authorities may not require the application
of imaging techniques to the number of patients and over time periods substantially similar to
those required of traditional safety and efficacy techniques. If the governmental agencies do not
accept data and analyses generated by our services in connection with the evaluation of new drugs
and devices, the need for our services would be eliminated or substantially reduced, and, as a
result, our business, results of operations and financial condition could be materially adversely
affected.
We may be exposed to liability claims as a result of our involvement in clinical trials.
13
We may be exposed to liability claims as a result of our involvement in clinical trials. We
cannot assure you that liability claims will not be asserted against us as a result of work
performed for our clients. We maintain liability insurance coverage in amounts that we believe are
sufficient for the pharmaceutical services industry. Furthermore, we cannot assure you that our
clients will agree to indemnify us, or that we will have sufficient insurance to satisfy any such
liability claims. If a claim is brought against us and the outcome is unfavorable to us, such
outcome could have a material adverse impact on us.
Risks Related to Our Common Stock
Your percentage ownership and voting power and the price of our common stock may decrease as a
result of events that increase the number of our outstanding shares.
As of December 31, 2008, we had the following capital structure (in thousands):
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Common stock outstanding |
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14,341 |
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Common stock issuable upon: |
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Exercise of options which are outstanding |
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1,718 |
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Exercise of options which have not been granted |
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1,133 |
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Total common stock outstanding assuming exercise or conversion of
all of the above |
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17,192 |
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As of December 31, 2008, we had outstanding options to purchase 1,718,173 shares of common
stock at exercise prices ranging from $0.63 to $8.06 per share (exercisable at a weighted average
of $4.58 per share), of which 1,176,843 options were then exercisable. Exercise of our outstanding
options into shares of our common stock may significantly and negatively affect the market price
for our common stock as well as decrease your percentage ownership and voting power. In addition,
we may conduct future offerings of our common stock or other securities with rights to convert the
securities into shares of our common stock. As a result of these and other events, such as future
acquisitions, that increase the number of our outstanding shares, your percentage ownership and
voting power and the price of our common stock may decrease.
Shares of our common stock eligible for public sale may have a negative impact on its market price.
Future sales of shares of our common stock by existing holders of our common stock or by
holders of outstanding options, upon the exercise thereof, could have a negative impact on the
market price of our common stock. As of December 31, 2008, we had 14.3 million shares of our common
stock issued and outstanding, substantially all of which are currently freely tradable. In
addition, the sale of a significant number of shares of our common stock in the public market
following the effectiveness of the registration statement we recently filed to register shares
issued in connection with our acquisition of PDS could harm the market price of our common stock.
As additional shares of common stock become available for resale in the public market pursuant to
the registration statement and releases of lock-up agreements, the market supply of shares of
common stock will increase, which could also decrease its market price.
We are unable to estimate the number of shares that may be sold because this will depend on
the market price for our common stock, the personal circumstances of the sellers and other factors.
Any sale of substantial amounts of our common stock or other securities in the open market may
adversely affect the market price of the securities offered hereby and may adversely affect our
ability to obtain future financing in the capital markets as
well as create a potential market overhang.
14
There are a limited number of stockholders who have significant control over our common stock,
allowing them to have significant influence over the outcome of all matters submitted to our
stockholders for approval, which may conflict with our interests and the interests of our other
stockholders.
Our directors, officers and principal stockholders (stockholders owning 10% or more of our
common stock), including Covance Inc., beneficially owned 23.9% of the outstanding shares of common
stock and stock options that could have been converted to common stock at December 31, 2008, and
such stockholders will have significant influence over the outcome of all matters submitted to our
stockholders for approval, including the election of our directors and other corporate actions. In
addition, such influence by these affiliates could have the effect of discouraging others from
attempting to take us over, thereby increasing the likelihood that the market price of the common
stock will not reflect a premium for control.
Because we do not intend to pay dividends, stockholders will benefit from an investment in our
common stock only if it appreciates in value.
We have never declared or paid any cash dividends on our common stock. We currently intend to
retain our future earnings, if any, to finance further research and development and do not expect
to pay any cash dividends in the foreseeable future. As a result, the success of an investment in
our common stock will depend upon any future appreciation in its value. There is no guarantee that
our common stock will appreciate in value or even maintain the price at which stockholders have
purchased their shares.
Trading in our common stock may be volatile, which may result in substantial declines in its market
price.
The market price of our common stock has experienced historical volatility and might continue
to experience volatility in the future in response to quarter-to-quarter variations in:
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operating results; |
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analysts reports; |
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market conditions in the industry; |
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changes in governmental regulations; and |
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changes in general conditions in the economy or the financial markets. |
The overall market (including the market for our common stock) has also experienced
significant decreases in value in the past. This volatility and potential market decline could
affect the market prices of securities issued by many companies, often for reasons unrelated to
their operating performance, and may adversely affect the price of our common stock. Between
January 1, 2008 and December 31, 2008, our common stock has traded at a low of $2.15 per share and
a high of $8.98 per share. Between January 1, 2009 and February 28, 2009, our common stock has
traded at a low of $2.96 per share and a high of $3.72 per share.
Our common stock began trading on the NASDAQ Global Market, formerly called the NASDAQ
National Market, on December 18, 2003 and has a limited trading market. We cannot assure that an
active trading market will develop or, if developed, will be maintained. As a result, our
stockholders may find it difficult to dispose of shares of our common stock and, as a result, may
suffer a loss of all or a substantial portion of their investment.
Certain provisions of our charter and Delaware law could make a takeover difficult and may prevent
or frustrate attempts by our stockholders to replace or remove our management team.
15
We have an authorized class of 3,000,000 shares of undesignated preferred stock, of which
1,250,000 shares were previously issued and converted to common stock. The remaining 1,750,000
shares may be issued by our board of directors, on such terms and with such rights, preferences and
designation as the board of directors may determine. Issuance of such preferred stock, depending
upon the rights, preferences and designations thereof, may have the effect of delaying, deterring
or preventing a change in control of our company. In addition, we are subject to provisions of
Delaware corporate law which, subject to certain exceptions, will prohibit us from engaging in any
business combination with a person who, together with affiliates and associates, owns 15% or more
of our common stock for a period of three years following the date that the person came to own 15%
or more of our common stock, unless the business combination is approved in a prescribed manner.
These provisions of our certificate of incorporation, and of Delaware law, may have the effect
of delaying, deterring or preventing a change in control of our company, may discourage bids for
our common stock at a premium over market price and may adversely affect the market price, and the
voting and other rights of the holders, of our common stock. In addition, these provisions make it
more difficult to replace or remove our current management team in the event our stockholders
believe this would be in the best interest of our company and our stockholders.
16
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
We lease 58,700 square feet of office space located in Newtown, Pennsylvania. This lease
expires December 2018 and provides for a fixed base rent of $95,350 per month with an annual
inflation increase. We lease 9,300 square feet of additional office space located in Newtown,
Pennsylvania for $8,500 per month in base rent, which expires May 2014. We also lease 34,275 square
feet of office space in King of Prussia, Pennsylvania for $55,884 per month in base rent, which
expires January 31, 2010. In addition, we lease 23,750 square feet of office space in Leiden, the
Netherlands and another 6,265 square feet in Lyon, France. These leases are denominated in the
Euro and expire in April 2013 and May 2017, respectively. The base rent for the Netherlands is
$45,400 per month and Lyons base rent is $12,600, based upon the conversion rate as of December
31, 2008, with an annual inflation increase. We periodically review our office space requirements
and may increase the amount of office space we lease as needed.
Item 3. Legal Proceedings.
In the normal course of business, we may be a party to legal proceedings. We are not
currently a party to any material legal proceedings.
Item 4. Submission of Matters to a Vote of Security Holders.
None.
17
PART II
Item 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Our common stock began trading on the NASDAQ Global Market, formerly called the NASDAQ
National Market, on December 18, 2003 under the symbol BITI. Prior to listing on the NASDAQ
Global Market, our common stock was traded on the American Stock Exchange under the symbol BIT from
February 25, 2003 until December 18, 2003. Our common stock was quoted on the NASD OTC Bulletin
Board under the symbol BITI prior to being listed on the American Stock Exchange.
The following table sets forth the high and low bid quotations for our common stock as
reported on the NASDAQ Global Market for each full quarterly period within the two most recent
fiscal years. Such quotations reflect interdealer prices, without retail mark-up, mark-down or
commission and may not represent actual transactions.
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Common |
Quarter |
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Stock |
Ended |
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High |
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Low |
March 31, 2007
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9.40 |
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5.84 |
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June 30, 2007
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7.45 |
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5.75 |
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September 30, 2007
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8.00 |
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6.03 |
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December 31, 2007
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9.95 |
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6.83 |
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March 31, 2008
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8.98 |
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6.57 |
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June 30, 2008
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8.20 |
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6.18 |
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September 30, 2008
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8.00 |
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6.48 |
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December 31, 2008
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7.58 |
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2.15 |
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As of February 28, 2009, the number of holders of record of our common stock was 90 and the
approximate number of beneficial holders of our common stock was 1,700.
On March 24, 2008, we acquired Phoenix Data Systems Inc. (PDS) to expand our pharmaceutical
services in the area of electronic data capture and other eClinical data solutions to our clients.
Under the terms of the Merger Agreement, the Company acquired all of PDSs outstanding capital
stock. The total consideration paid by the Company, adjusted for a decrease to Tangible Net Worth
of $64,000 in cash as described below, to PDSs stockholders was $23.9 million, comprised of $6.9
million in cash and 2.3 million shares of common stock, par value $0.00025 per share, of the
Company, with an average closing price per share over the last 30 trading days ending and including
March 19, 2008 of $7.42 (Common Stock). The aggregate purchase price was subject to a
post-closing adjustment based on the Tangible Net Worth (as defined in the Merger Agreement) of PDS
on the Closing Date (as defined in the Merger Agreement). Pursuant to the terms of the Merger
Agreement, five percent of the aggregate consideration was held in escrow for the finalization of
the Closing Tangible Net Worth Statement (as defined in the Merger Agreement). On June 13, 2008,
Bio-Imaging and the Stockholders Representative agreed to a decrease of $230,000 to the purchase
price due to the minimum threshold to the Closing Tangible Net Worth Statement not being achieved.
Bio-Imaging received $64,000 in cash back in June 2008 and 22,453 shares of our common stock back
in July 2008 from the purchase price escrow. Additionally, ten percent of the aggregate
consideration is to be held in escrow to cover any potential indemnification claims under the
Merger Agreement for a period ending no later than March 31, 2009. We also incurred approximately
$1.1 million in acquisition costs. At the acquisition date, the stock was recorded at an average
price of $7.04 per
share.
18
On February 6, 2007, we acquired 100% of the outstanding securities of Theralys S.A., a
company headquartered in Lyon, France to expand our therapeutic expertise in the Central Nervous
System and Neurovascular areas. The aggregate purchase price was 2,958,000 Euros ($3,853,000 as
determined by an agreed upon exchange rate), of which 2,375,000 Euros ($3,093,000) was paid in cash
and $760,000 in value was paid with 93,000 shares of our common stock. We also incurred
approximately $615,000 in acquisition costs.
On February 26, 2008, in connection with his employment agreement dated March 1, 2006, we
issued 16,335 shares of restricted stock to our President and Chief Executive Officer, which was
net of 11,165 shares withheld for withholding taxes associated with the issuance of the shares.
We believe that the issuance of the foregoing securities was exempt from registration under
Section 4(2) of the Securities Act of 1933, as amended, as transactions not involving a public
offering. Each of the recipients were sophisticated or accredited investors, acquired the
securities for investment purposes only and not with a view to distribution and had adequate
information about our company.
We have neither paid nor declared dividends on our common stock since our inception and do not
plan to pay dividends on our common stock in the foreseeable future. We expect that any earnings
which we may realize will be retained to finance our growth.
The following table provides information as of December 31, 2008 with respect to the shares of
our Common Stock that may be issued under our existing equity compensation plans.
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Number of |
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Weighted |
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Securities to be |
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Average Exercise |
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Number of Securities |
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Issued Upon |
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Price of |
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Available for Future Issuance |
|
|
Exercise of |
|
Outstanding |
|
Under Equity Compensation |
Plan Category |
|
Outstanding Options |
|
Options |
|
Plans |
Equity compensation
plans that have
been approved by
security holders |
|
|
1,718,000 |
|
|
$ |
4.58 |
|
|
|
1,133,000 |
|
Equity compensation
plans not approved
by security holders |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,718,000 |
|
|
$ |
4.58 |
|
|
|
1,133,000 |
|
19
STOCK PRICE PERFORMANCE GRAPH
Our common stock is listed for trading on the NASDAQ Global Market under the symbol BITI.
The Stock Price Performance Graph set forth below compares the cumulative total stockholder return
on our common stock for the period from December 31, 2003 through December 31, 2008, with the
cumulative total return of the NASDAQ U.S. Stock Index and the NASDAQ Health Services Index over
the same period. The comparison assumes $100 was invested on December 31, 2003 in our common stock,
in the NASDAQ U.S. Stock Index and in the NASDAQ Health Services Index and assumes reinvestment of
dividends, if any.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, |
|
Dec. 31, |
|
Dec. 31, |
|
Dec. 31, |
|
Dec. 31, |
|
Dec. 31, |
|
|
2003 |
|
2004 |
|
2005 |
|
2006 |
|
2007 |
|
2008 |
Bio-Imaging Technologies Inc |
|
|
100.00 |
|
|
|
87.96 |
|
|
|
51.85 |
|
|
|
129.37 |
|
|
|
129.70 |
|
|
|
58.75 |
|
NASDAQ U.S. Stock Index |
|
|
100.00 |
|
|
|
108.83 |
|
|
|
111.14 |
|
|
|
122.11 |
|
|
|
132.43 |
|
|
|
63.87 |
|
Nasdaq Health Services Index |
|
|
100.00 |
|
|
|
126.03 |
|
|
|
173.21 |
|
|
|
172.96 |
|
|
|
226.07 |
|
|
|
165.11 |
|
The foregoing Stock Price Performance Graph and related information shall not be deemed
soliciting material or to be filed with the SEC, nor shall such information be incorporated by
reference into any future filing under the Securities Act of 1933 or Securities Exchange Act of
1934, each as amended, except to the extent that we specifically incorporate it by reference into
such filing.
20
Item 6. Selected Financial Data.
The following table presents selected consolidated financial data. This data is derived from
historical financial information and should be read in conjunction with the Managements
Discussion and Analysis of Financial Condition and Results of Operations and the consolidated
financial statements and related footnotes included in this Form 10-K.
For the years ended,
(in thousands, except per share data and number of employees)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, |
|
Dec. 31, |
|
Dec. 31, |
|
Dec. 31, |
|
Dec. 31, |
|
|
2008 |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
CONTINUING OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
$ |
56,181 |
|
|
$ |
37,543 |
|
|
$ |
31,853 |
|
|
$ |
23,734 |
|
|
$ |
24,958 |
|
Total revenue |
|
|
69,116 |
|
|
|
47,254 |
|
|
|
40,257 |
|
|
|
30,126 |
|
|
|
29,580 |
|
Income (loss) from continuing operations
before interest and taxes |
|
|
8,480 |
|
|
|
4,848 |
|
|
|
2,670 |
|
|
|
(3,226 |
) |
|
|
2,433 |
|
Income from continuing operations, net of taxes |
|
|
5,791 |
|
|
|
3,343 |
|
|
|
1,968 |
|
|
|
(1,881 |
) |
|
|
1,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations |
|
|
0.42 |
|
|
|
0.29 |
|
|
|
0.18 |
|
|
|
(0.17 |
) |
|
|
0.13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations |
|
|
0.40 |
|
|
|
0.26 |
|
|
|
0.16 |
|
|
|
(0.17 |
) |
|
|
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to calculate
earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
13,752 |
|
|
|
11,616 |
|
|
|
11,219 |
|
|
|
11,114 |
|
|
|
10,812 |
|
Diluted |
|
|
14,469 |
|
|
|
12,745 |
|
|
|
12,364 |
|
|
|
11,114 |
|
|
|
12,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL POSITION |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents |
|
$ |
14,265 |
|
|
$ |
17,915 |
|
|
$ |
16,166 |
|
|
$ |
10,554 |
|
|
$ |
9,650 |
|
Working capital |
|
|
7,918 |
|
|
|
9,721 |
|
|
|
10,219 |
|
|
|
8,055 |
|
|
|
13,121 |
|
Total assets |
|
|
69,208 |
|
|
|
43,057 |
|
|
|
34,108 |
|
|
|
28,791 |
|
|
|
28,374 |
|
Long-term debt |
|
|
65 |
|
|
|
|
|
|
|
97 |
|
|
|
551 |
|
|
|
907 |
|
Stockholders equity |
|
|
43,412 |
|
|
|
23,529 |
|
|
|
18,842 |
|
|
|
17,197 |
|
|
|
19,518 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER DATA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
$ |
2,916 |
|
|
$ |
3,928 |
|
|
$ |
2,232 |
|
|
$ |
1,871 |
|
|
$ |
1,849 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
2,266 |
|
|
|
2,335 |
|
|
|
2,035 |
|
|
|
2,312 |
|
|
|
1,760 |
|
Number of employees |
|
|
474 |
|
|
|
337 |
|
|
|
283 |
|
|
|
264 |
|
|
|
269 |
|
21
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Overview
Bio-Imaging Technologies, Inc. is a global clinical trials service organization, providing
medical image management and eClinical services, including electronic data capture and clinical
data management solutions, to pharmaceutical, biotechnology, medical device companies and other
organizations, including contract research organizations (CROs), engaged in clinical trials.
Our medical image management services assist our clients in the design and management of the
medical imaging component of clinical trials. We have developed specialized services and
proprietary software applications that enable independent radiologists and other medical
specialists involved in clinical trials to review medical image data in an entirely digital format
and make highly precise measurements and biostatistical inferences to evaluate the efficacy and
safety of pharmaceuticals, biologics or medical devices. Medical imaging is used for clinical
development of therapeutic modalities for use in oncology, disorders of the musculoskeletal,
central nervous, cardiovascular systems, and in a variety of other disease categories.
Our core laboratory imaging services include the collection, processing, analysis and
regulatory submission of medical images and related clinical data. Medical images are received
from a wide variety of imaging modalities including computerized tomography (CT), magnetic
resonance imaging (MRI), radiography, dual energy x-ray absorptiometry (DXA/DEXA), positron
emission tomography (PET), single photon emission computerized tomography (SPECT), quantitative
coronary angiography (QCA), cardiac MRI and CT, intravascular ultrasound (IVUS), peripheral
quantitative angiography (QVA), central nervous system (CNS) MRI and ultrasound. The resulting data
enables our clients and regulatory reviewers, primarily the U.S. Food and Drug Administration and
comparable European agencies, to evaluate product efficacy and safety.
On March 24, 2008, we completed the acquisition of Phoenix Data Systems, referred to herein as
PDS, a provider of electronic data capture (EDC) services offering a comprehensive array of
eClinical data solutions to the pharmaceutical and biotechnology industries. PDS is engaged in
providing full service EDC, a combination of electronic data capture, interactive voice response,
reporting and data management solutions and is focused on making the process of collecting and
analyzing data from clinical trials faster, easier and more reliable.
Our eClinical services offer a variety of customizable proprietary software solutions that
enhance pharmaceutical and biotech companies ability to process and store clinical data through
the use of customized proprietary software and hosting service. This technology improves data
quality and allows our sponsors to see the results of their clinical trials faster and more
accurately than with conventional paper-based methods.
Our sales cycle, referring to the period from the presentation by us to a potential client to
the engagement of us by such client, has historically ranged from three to 12 months. In addition,
the contracts under which we perform services typically cover a period of three to 60 months and
the volume and type of services performed by us generally vary during the course of a project. We
cannot assure you that our project revenues will be at levels sufficient to maintain profitability.
Our contracted/committed backlog, referred to as backlog, is the expected service revenue that
remains to be earned and recognized on both signed and verbally agreed to contracts. Our backlog
as of December 31, 2008, which includes our medical image management and eClinical services, was
$92.7 million compared to $92.5 million at December 31, 2007. Changes in backlog for the period
reflect the net effect of the acquisition of PDS, new contract signings, addendums, cancellations
expansions, and reductions in scope of existing projects, all of which impacted our backlog at
December 31, 2008.
22
Contracts included in backlog are subject to termination by our clients at any time. In the
event that a contract is cancelled by the client, we would be entitled to receive payment for all
services performed up to the cancellation date. The duration of the projects included in our
backlog range from less than three months to seven years. We believe that our backlog assists our
management as an indicator of our long-term business. However, we do not believe that backlog is a
reliable predictor of near-term results because service revenues may be incurred in a given period
on contracts that were not included in the previous reporting periods backlog and/or contract
cancellations or project delays may occur in a given period on contracts that were included in the
previous reporting periods backlog.
We believe that the market for our services has been adversely impacted by pharmaceutical
companies response to overall economic conditions, resulting in some contract decisions being
delayed and major projects being split into smaller components as part of a revised budgetary
approval process. On a long term basis, we believe that the recognition within the
bio-pharmaceutical industry of the operational efficiency and scalable reliability of using an
independent centralized core laboratory for analysis of medical-imaging data and compliance with
the regulatory demands for the submission of such data will continue to drive demand for our
services. We also believe that rapidly growing recognition of the inherent advantages of eClinical
/ EDC technology to standardize and accelerate reliable data flow from the clinical trial sites to
the clinical trial sponsor will further drive the adoption and growth of our eClinical service
offerings. We believe our eClinical services favorably compares to the traditional process of
manual data collection on paper case report forms that are more susceptible to transcription and
other data entry errors.
CapMed Division
On January 6, 2009, pursuant to the Asset Purchase Agreement by and among the Company and MBI
Benefits, Inc., or the Purchaser, an indirectly owned subsidiary of Metavante Technologies, Inc.,
or Metavante, dated as of January 6, 2009, referred to herein as the Agreement, the Company sold
its CapMed Division, including the divisions Personal Health Record (PHR) software and the
patent-pending Personal HealthKey technology, to Metavante. Under the terms of the Agreement,
Metavante paid the Company an upfront payment of Five Hundred Thousand Dollars ($500,000) in cash
and will make an earn-out payment to the Company based upon a percentage of the gross revenues
recognized by Metavante for contracts entered into with certain prospects set forth on a schedule
during certain time periods in 2009 and 2010. The Company will receive 25% of the gross revenues
recognized by Metavante during any period ending on or prior to December 31, 2010 from the sale
pursuant to any contract the Purchaser enters into with certain prospects during the first six
months of 2009. Additionally, the Company will receive 15% of the gross revenues recognized by
Metavante during any period ending on or prior to December 31, 2010 from the sale pursuant to any
contract the Purchaser enters into with certain prospects during the period commencing on July 1,
2009 and ending on December 31, 2010.
Forward Looking Statements
Certain matters discussed in this Form 10-K are forward-looking statements intended to
qualify for the safe harbors from liability established by the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements may be identified by, among other things, the use of
forward-looking terminology such as believes, expects, may, will, should or anticipates
or the negative thereof or other variations thereon or comparable terminology, or by discussions of
strategy that involve risks and uncertainties. In particular, our statements regarding: our
projected financial results; the demand for our services and technologies; growing recognition for
the use of independent centralized core laboratories; trends toward the outsourcing of imaging
services in clinical trials; realized return from our marketing efforts; increased use of digital
medical images in
23
clinical trials; integration of our acquired companies and businesses; expansion into new
business segments; the success of any potential acquisitions and the integration of current
acquisitions; and the level of our backlog are examples of such forward-looking statements. The
forward-looking statements include risks and uncertainties, including, but not limited to, the
timing of revenues due to the variability in size, scope and duration of projects, estimates made
by management with respect to our critical accounting policies, regulatory delays, clinical study
results which lead to reductions or cancellations of projects, and other factors, including general
economic conditions and regulatory developments, not within our control. The factors discussed in
this Form 10-K and expressed from time to time in our filings with the SEC, as well as the risk
factors set forth in this Form 10-K, could cause actual results and developments to be materially
different from those expressed in or implied by such statements. The forward-looking statements
are made only as of the date of this filing, and we undertake no obligation to publicly update such
forward-looking statements to reflect subsequent events or circumstances.
Critical Accounting Policies, Estimates and Risks
Our discussion and analysis of our financial condition and results of operations are based
upon our Consolidated Financial Statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. The preparation of financial statements in
accordance with generally accepted accounting principles in the United States requires management
to make estimates and assumptions that affect the reported amounts of assets and liabilities,
including the recoverability of tangible and intangible assets, disclosure of contingent assets and
liabilities as of the date of the financial statements and the reported amounts of revenues and
expenses during the reported period.
On an on-going basis, we evaluate our estimates. The most significant estimates relate to the
recognition of revenue and profits based on the proportional performance method of accounting for
fixed service contracts and income taxes.
We believe the following critical accounting policies affect our more significant judgments
and estimates used in the preparation of our Consolidated Financial Statements:
Revenue. Service revenues are recognized over the contractual term of the Companys customer
contracts using the proportional performance method. Service revenues are first recognized when
the Company has a signed contract from a customer which: (i) contain fixed or determinable fees;
(ii) collectability of such fees is reasonably assured; and (iii) services are performed. Any
change to recognized service revenue as a result of revisions to estimated total hours are
recognized in the period the estimate changes.
The Company enters into contracts that contain fixed or determinable fees. The fees in the
contracts are based on the scope of work we are contracted to perform; there are unitized fees per
service and fixed fees with a total estimated for the contract based upon the estimated unitized
service expected to be performed, as well as the service to be delivered under the fixed fee
component of the contract. The units are estimated based on the information provided by the
customer, and the Company bills the customer for actual units completed in accordance with the
terms of the contract. In the event that a contract is cancelled by the client, we would be
entitled to receive payment for all services performed up to the cancellation date.
The Company, at the request of its clients, directly contract with and pay independent
radiologists, referred to as Readers, who review the clients imaging data as part of the clinical
trial. The costs of the Readers and other out-of-pocket expenses are reimbursed to the Company and
recognized gross as reimbursement revenues pursuant to EITF 99-19 Reporting Revenue Gross as a
Principal versus Net as an Agent.
Property and Equipment, Net. Property and equipment are recorded at cost less accumulated
24
depreciation. Expenditures for major additions and improvements are capitalized, while minor
replacements, maintenance, and repairs are charged to expense as incurred. When property is retired
or otherwise disposed of, the cost and accumulated depreciation are removed from the accounts and
any resulting gain or loss is reflected in Other Expenses (Income), Net in the Consolidated Income
Statements. Depreciation is provided over the estimated useful lives of the assets involved using
the straight-line method. Leasehold improvements are amortized over the estimated useful life of
the asset or the respective lease term used in determining lease classification, whichever is
shorter. The estimated useful lives are: five to forty years for buildings and improvements and
three to ten years for furniture, fixtures, and equipment.
Goodwill and Other Intangible Assets, Net. We account for acquisitions using the purchase
method of accounting. Goodwill consists of the cost of acquired businesses in excess of the fair
value of the net assets acquired. Additionally, other intangible assets are separately recognized
if the benefit of the intangible asset is obtained through contractual or other legal rights, or if
the intangible asset can be sold, transferred, licensed, rented, or exchanged, regardless of our
intent to do so. Goodwill is tested for impairment annually at December 31 or more frequently when
events or circumstances indicate that impairment may have occurred. The goodwill test includes
determining the fair value of our single reporting unit and comparing it to the carrying value of
the net assets allocated to the reporting unit. No goodwill impairment charges resulted from the
required goodwill impairment tests.
Capitalized Software Development. We capitalize development costs for a software project once
the preliminary project stage is completed, we have committed to fund the project and it is
probable that the project will be completed and the software will be used to perform the function
intended. We cease capitalization at such time as the computer software project is substantially
complete and ready for its intended use. The determination that a software project is eligible for
capitalization and the ongoing assessment of recoverability of capitalized software development
costs require considerable judgment by us with respect to certain external factors including, but
not limited to, anticipated future revenue, estimated economic life and changes in software and
hardware technologies.
Income Taxes. We evaluate the need to record a valuation allowance to reduce our deferred tax
assets to an amount that is more likely than not to be realized. In assessing the need for the
valuation allowance, we consider our future taxable income and on-going prudent and feasible tax
planning strategies. In the event that we were to determine that, in the future, we would be able
to realize our deferred tax assets in excess of its net recorded amount, an adjustment to the
deferred tax asset would be made, thereby increasing net income in the period such determination
was made. Likewise, should we determine that it is more likely than not that we will be unable to
realize all or part of our net deferred tax asset in the future, an adjustment to the deferred tax
asset would be charged, thereby decreasing net income in the period such determination was made.
We recognize contingent liabilities for any tax related exposures when those exposures are more
likely than not to occur.
Stock-based compensation costs. Effective January 1, 2006, we account for stock-based
compensation costs in accordance with SFAS 123R, which requires the measurement and recognition of
compensation expense for all stock-based payment awards made to our employees and directors. Under
the fair value recognition provisions of SFAS 123R, stock-based compensation cost is measured at
the grant date based on the value of the award and is recognized as expense over the vesting
period. Determining the fair value of the stock-based awards at the grant date requires
considerable judgment. In addition, judgment is also required in estimating the amount of
stock-based awards that are expected to be forfeited. If the actual experience differs
significantly from the assumptions used to compute our stock-based compensation cost, or if
different assumptions had been used, we may have recorded too much or too little stock-based
compensation cost.
Foreign Currency Risks
25
Our financial statements are denominated in U.S. dollars. Fluctuations in foreign currency
exchange rates could materially increase the operating costs of our facilities in the Netherlands
and France, which are Euro denominated. A ten percent increase or decrease in the Euro to U.S.
dollar spot exchange rate would result in a change of $279,000 and $546,000 to our net asset
position, at December 31, 2008 and December 31, 2007, respectively. In addition, certain of our
contracts are denominated in foreign currency. We believe that any adverse fluctuation in the
foreign currency markets relating to these costs will not result in any material adverse effect on
our financial condition or results of operations. In the event we derive a greater portion of our
service revenues from international operations, factors associated with international operations,
including changes in foreign currency exchange rates, could affect our results of operations and
financial condition.
Our foreign currency financial assets and liabilities primarily consist of cash, trade
receivables, prepaid expenses, fixed assets, trade payables and accrued expenses. We were in a net
asset position at December 31, 2008 and December 31, 2007. An increase in the exchange rate would
result in less net assets when converted to U.S. dollars. Conversely, if we were in a net
liability position, a decrease in the exchange rate would result in more net liabilities when
converted to U.S. dollars.
We hedge our foreign currency exposure when and as appropriate to mitigate the adverse impact
of fluctuating exchange rates. As of December 31, 2008, there are no outstanding derivative
positions.
26
Results of Operations
Year Ended December 31, 2008 Compared with Year Ended December 31, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
(in thousands) |
|
2008 |
|
|
Revenue |
|
|
2007 |
|
|
Revenue |
|
|
$ Change |
|
|
% Change |
|
Service revenues |
|
$ |
56,181 |
|
|
|
81.3 |
% |
|
$ |
37,543 |
|
|
|
79.4 |
% |
|
$ |
18,638 |
|
|
|
49.6 |
% |
Reimbursement revenues |
|
|
12,935 |
|
|
|
18.7 |
% |
|
|
9,711 |
|
|
|
20.6 |
% |
|
|
3,224 |
|
|
|
33.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
69,116 |
|
|
|
100.0 |
% |
|
|
47,254 |
|
|
|
100.0 |
% |
|
|
21,862 |
|
|
|
46.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service
revenues |
|
|
32,446 |
|
|
|
46.9 |
% |
|
|
21,900 |
|
|
|
46.3 |
% |
|
|
10,546 |
|
|
|
48.2 |
% |
Cost of
reimbursement
revenues |
|
|
12,935 |
|
|
|
18.7 |
% |
|
|
9,711 |
|
|
|
20.6 |
% |
|
|
3,224 |
|
|
|
33.2 |
% |
Sales and marketing
expenses |
|
|
7,860 |
|
|
|
11.4 |
% |
|
|
5,005 |
|
|
|
10.6 |
% |
|
|
2,855 |
|
|
|
57.0 |
% |
General and
administrative
expenses |
|
|
7,015 |
|
|
|
10.1 |
% |
|
|
5,734 |
|
|
|
12.1 |
% |
|
|
1,281 |
|
|
|
22.3 |
% |
Amortization of
intangible assets
related to
acquisitions |
|
|
380 |
|
|
|
0.6 |
% |
|
|
56 |
|
|
|
0.1 |
% |
|
|
324 |
|
|
|
578.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
60,636 |
|
|
|
87.7 |
% |
|
|
42,406 |
|
|
|
89.7 |
% |
|
|
18,230 |
|
|
|
43.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing
operations before
interest and taxes |
|
|
8,480 |
|
|
|
12.3 |
% |
|
|
4,848 |
|
|
|
10.3 |
% |
|
|
3,632 |
|
|
|
74.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
429 |
|
|
|
0.6 |
% |
|
|
655 |
|
|
|
1.4 |
% |
|
|
(226 |
) |
|
|
(34.5 |
)% |
Interest expense |
|
|
(7 |
) |
|
|
0.0 |
% |
|
|
(11 |
) |
|
|
0.0 |
% |
|
|
4 |
|
|
|
(36.4 |
)% |
Income tax provision |
|
|
(3,111 |
) |
|
|
(4.5 |
)% |
|
|
(2,148 |
) |
|
|
(4.6 |
)% |
|
|
(963 |
) |
|
|
44.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing
operations, net of
taxes |
|
$ |
5,791 |
|
|
|
8.4 |
% |
|
$ |
3,344 |
|
|
|
7.1 |
% |
|
$ |
2,447 |
|
|
|
73.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued
operations, net of
taxes |
|
|
(3,001 |
) |
|
|
(4.3 |
)% |
|
|
(1,011 |
) |
|
|
(2.1 |
)% |
|
|
(1,990 |
) |
|
|
196.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,790 |
|
|
|
4.1 |
% |
|
$ |
2,333 |
|
|
|
5.0 |
% |
|
$ |
457 |
|
|
|
19.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Consolidated Statements of Income for all periods presented were reclassified to reflect
the CapMed division in discontinued operations.
The Consolidated Statement of Income for fiscal 2008 excludes the financial results of PDS
from the
27
acquisition date of March 24, 2008 through March 31, 2008 due to immateriality of PDSs
results of operations for that period.
Service revenues were $56.2 million for fiscal 2008 and $37.5 million for fiscal 2007, an
increase of $18.6 million, or 49.6%. The increase in fiscal 2008 service revenues of $18.6
million, included $12.5 million in service revenue from PDS from the date of acquisition through
December 31, 2008. The additional increase in service revenues of $6.1 million, a 16.3% increase
in non-PDS revenues resulted from an increase in work performed from our backlog. In fiscal 2008,
no one client accounted for more than 10% of our service revenues, while in fiscal 2007 one client,
Hoffmann-La Roche, with 11 projects, represented 13.4% of our service revenues.
Reimbursement revenues and cost of reimbursement revenues was $12.9 million for fiscal 2008
and $9.7 million for fiscal 2007, an increase of $3.2 million, or 33.2%. Reimbursement revenues
and cost of reimbursement revenues consist of payments received from the customer for reimbursable
costs. Reimbursement revenues and cost of reimbursement revenues fluctuate significantly over the
course of any given project and quarter to quarter variations are a reflection of this project
timing. Therefore, our management believes that reimbursement revenues and cost of reimbursement
revenues are not a significant indicator of our overall performance trends. At the request of our
clients, we may directly pay the independent radiologists who review our clients imaging data. In
such cases, per contractual arrangement, these costs are billed to our clients and are included in
reimbursement revenues and cost of reimbursement revenues.
Cost of service revenues was $32.4 million for fiscal 2008 and $21.9 million for fiscal 2007,
an increase of $10.5 million, or 48.2%. Cost of service revenues for fiscal 2008 and 2007 was
comprised of professional salaries and benefits and allocated overhead. The increase in cost of
service revenues is primarily due to the addition of salaries and other labor related costs of $7.8
million, a 35.6% increase related to the operations of PDS. The remaining increase of $2.7 million
is attributable to the increase in costs of our European facilities, and an increase in operational
personnel to support the increased service revenue. The cost of revenues as a percentage of total
revenues also fluctuates due to work-flow variations in the utilization of staff and the mix of
services provided by us in any given period. We expect that our cost of revenues will continue to
increase in fiscal 2009 as we expand our presence in the eClinical market.
Sales and marketing expenses were $7.9 million for fiscal 2008 and $5.0 million for fiscal
2007, an increase of $2.9 million, or 57.0%. Sales and marketing expenses in fiscal 2008 and 2007
were comprised of direct sales and marketing costs, salaries and benefits and allocated overhead.
The increase is primarily due to the addition of sales personnel from the PDS acquisition along
with increased marketing and tradeshow attendance. We expect that sales and marketing expenses
will increase in fiscal 2009 as we continue to expand our market presence in the United States and
Europe.
General and administrative expenses were $7.0 million for fiscal 2008 and $5.7 million for
fiscal 2007, an increase of $1.3 million, or 22.3%. General and administrative expenses in fiscal
2008 and 2007 consisted primarily of salaries and benefits, allocated overhead, professional and
consulting services and corporate insurance. The increase is primarily due to the addition of
personnel and other professional services related to the administration of PDS. We expect that our
general and administrative expenses will increase in 2009 due to increased professional fees
associated with being a publicly traded company and general corporate matters.
Net interest income was $422,000 for fiscal 2008 and net interest income was $644,000 for
fiscal 2007, a decrease of $222,000, or 34.5%. This decrease is primarily due to a lower
investable cash balances and lower interest rates on short term investments. Net interest income and expense for 2008 and 2007
is comprised of
28
interest income earned on our cash balance and interest expense incurred on
equipment lease obligations. We expect interest income to decline in 2009 due to the reduction in
cash balance as a result of the cash used during the first quarter 2008 for the acquisition of PDS
and the decline in interest rates for short-term investments.
Our income tax provision for fiscal 2008 was $3.1 million and $2.1 million for fiscal 2007.
Our effective tax rate from continuing operations is 34.9% for fiscal 2008 and 39.1% for fiscal
2007. The lower effective tax rate in fiscal 2008 was due to the mix of pre-tax income in the U.S.
and in the Netherlands, which has a lower corporate income tax rate than the U.S., and the changes
affecting state tax rates.
29
Results of Operations
Year Ended December 31, 2007 Compared with Year Ended December 31, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
(in thousands) |
|
2007 |
|
|
Revenue |
|
|
2006 |
|
|
Revenue |
|
|
$ Change |
|
|
% Change |
|
Service revenues |
|
$ |
37,543 |
|
|
|
79.4 |
% |
|
$ |
31,853 |
|
|
|
79.1 |
% |
|
$ |
5,690 |
|
|
|
17.9 |
% |
Reimbursement
revenues |
|
|
9,711 |
|
|
|
20.6 |
% |
|
|
8,404 |
|
|
|
20.9 |
% |
|
|
1,307 |
|
|
|
15.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
47,254 |
|
|
|
100.0 |
% |
|
|
40,257 |
|
|
|
100.0 |
% |
|
|
6,997 |
|
|
|
17.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service
revenues |
|
|
21,900 |
|
|
|
46.3 |
% |
|
|
19,629 |
|
|
|
48.9 |
% |
|
|
2,271 |
|
|
|
11.6 |
% |
Cost of
reimbursement
revenues |
|
|
9,711 |
|
|
|
20.6 |
% |
|
|
8,404 |
|
|
|
20.9 |
% |
|
|
1,307 |
|
|
|
15.6 |
% |
Sales and
marketing
expenses |
|
|
5,005 |
|
|
|
10.6 |
% |
|
|
4,286 |
|
|
|
10.6 |
% |
|
|
719 |
|
|
|
16.8 |
% |
General and
administrative
expenses |
|
|
5,734 |
|
|
|
12.1 |
% |
|
|
5,131 |
|
|
|
12.7 |
% |
|
|
603 |
|
|
|
11.8 |
% |
Amortization of
intangible
assets related
to acquisitions |
|
|
56 |
|
|
|
0.1 |
% |
|
|
137 |
|
|
|
0.3 |
% |
|
|
(81 |
) |
|
|
(59.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and
expenses |
|
|
42,406 |
|
|
|
89.7 |
% |
|
|
37,587 |
|
|
|
93.4 |
% |
|
|
4,819 |
|
|
|
12.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from
continuing
operations before
interest and taxes |
|
|
4,848 |
|
|
|
10.3 |
% |
|
|
2,670 |
|
|
|
6.6 |
% |
|
|
2,178 |
|
|
|
81.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
655 |
|
|
|
1.4 |
% |
|
|
560 |
|
|
|
1.4 |
% |
|
|
95 |
|
|
|
17.0 |
% |
Interest expense |
|
|
(11 |
) |
|
|
0.0 |
% |
|
|
(56 |
) |
|
|
(0.1 |
)% |
|
|
45 |
|
|
|
(80.4 |
)% |
Income tax provision |
|
|
(2,148 |
) |
|
|
(4.6 |
)% |
|
|
(1,206 |
) |
|
|
(3.0 |
)% |
|
|
(942 |
) |
|
|
78.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from
continuing
operations, net of
taxes |
|
|
3,344 |
|
|
|
7.1 |
% |
|
|
1,968 |
|
|
|
4.9 |
% |
|
|
1,376 |
|
|
|
69.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
discontinued
operations, net of
taxes |
|
|
(1,011 |
) |
|
|
(2.1 |
)% |
|
|
(964 |
) |
|
|
(2.4 |
)% |
|
|
(47 |
) |
|
|
4.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,333 |
|
|
|
5.0 |
% |
|
$ |
1,004 |
|
|
|
2.5 |
% |
|
$ |
1,329 |
|
|
|
132.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Consolidated Statements of Income for all periods presented were reclassified to reflect
the CapMed division in discontinued operations.
30
Service revenues were $37.5 million for fiscal 2007 and $31.9 million for fiscal 2006, an
increase of $5.7 million, or 17.9%. The change in service revenue is due to the increase in
contract signings and work performed in 2007 as compared to 2006. Our primary scope of work in
both periods included medical-imaging core laboratory services and image-based information
management services. Our backlog at December 31, 2007 increased to $92.5 million from $75.2
million at December 31, 2006, an increase of 23.0%. Contracts with Hoffmann-La Roche, which
encompassed 11 projects, represented 13.4% of our service revenues for the year ended December 31,
2007, while one client, Novartis Pharmaceutical, Inc., which encompassed 14 projects, represented
10.9% of our service revenues for the year ended December 31, 2006.
Reimbursement revenues and cost of reimbursement revenues was $9.7 million for fiscal 2007 and
$8.4 million for fiscal 2006, an increase of $1.3 million, or 15.6%. Reimbursement revenues and
cost of reimbursement revenues consist of payments received from the customer for reimbursable
costs. Reimbursement revenues and cost of reimbursement revenues fluctuate significantly over the
course of any given project and quarter to quarter variations are a reflection of this project
timing. Therefore, our management believes that reimbursement revenues and cost of reimbursement
revenues are not a significant indicator of our overall performance trends. At the request of our
clients, we may directly pay the independent radiologists who review our clients imaging data. In
such cases, per contractual arrangement, these costs are billed to our clients and are included in
reimbursement revenues and cost of reimbursement revenues.
Cost of service revenues was $21.9 million for fiscal 2007 and $19.6 million for fiscal 2006,
an increase of $2.3 million, or 11.6%. Cost of service revenues for fiscal 2007 and 2006 was
comprised of professional salaries and benefits and allocated overhead. The increase in cost of
service revenues is primarily due to the addition of operating costs from Theralys S.A.
Sales and marketing expenses were $5.0 million for fiscal 2007 and $4.3 million for fiscal
2006, an increase of $719,000, or 16.8%. Sales and marketing expenses in fiscal 2007 and 2006 were
comprised of direct sales and marketing costs, salaries and benefits and allocated overhead. The
increase is primarily due to an increase in the Companys tradeshow attendance and marketing
expenditures.
General and administrative expenses were $5.7 million for fiscal 2007 and $5.1 million for
fiscal 2006, an increase of $603,000, or 11.8%. General and administrative expenses in fiscal 2007
and 2006 consisted primarily of salaries and benefits, depreciation and amortization, professional
and consulting services, office rent and corporate insurance. The increase is primarily due to an
increase in professional and consulting services.
Net interest income was $644,000 for fiscal 2007 and net interest income was $504,000 for
fiscal 2006, an increase of $140,000, or 27.8%. This increase is primarily due to a higher
investable cash balances and higher interest rates on short term investments. Also, interest
expense has decreased as our capital leases are maturing. Net interest income and expense for 2007
and 2006 is comprised of interest income earned on our cash balance and interest expense incurred
on equipment lease obligations.
Our income tax provision from continuing operations for fiscal 2007 was $2.1 million and $1.2
million for fiscal 2006. Our effective tax rate is 39.1% for fiscal 2007 and 37.3% for fiscal
2006. The increase in the
effective tax rate is due to the mix of pre-tax income in the U.S. versus the Netherlands and
France, which have lower corporate income tax rates.
31
Quarterly Results
The following is a summary of unaudited quarterly results of operations for the years ended
December 31, 2008 and 2007. This quarterly financial data should be read in conjunction with the
audited consolidated financial statements included herein.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended |
|
|
Dec. 31, |
|
Sept. 30, |
|
June 30, |
|
Mar. 31, |
|
Dec. 31, |
|
Sept. 30, |
|
June 30, |
|
Mar. 31, |
(in thousands except per share data) |
|
2008 |
|
2008 |
|
2008 |
|
2008 |
|
2007 |
|
2007 |
|
2007 |
|
2007 |
Service revenues |
|
|
14,956 |
|
|
|
15,093 |
|
|
|
15,109 |
|
|
|
11,023 |
|
|
$ |
10,109 |
|
|
$ |
9,500 |
|
|
$ |
9,257 |
|
|
$ |
8,677 |
|
Reimbursement revenues |
|
|
2,737 |
|
|
|
3,048 |
|
|
|
4,073 |
|
|
|
3,077 |
|
|
|
2,323 |
|
|
|
2,893 |
|
|
|
2,230 |
|
|
|
2,265 |
|
Total revenues |
|
|
17,693 |
|
|
|
18,141 |
|
|
|
19,182 |
|
|
|
14,100 |
|
|
|
12,432 |
|
|
|
12,393 |
|
|
|
11,487 |
|
|
|
10,942 |
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
8,995 |
|
|
|
8,513 |
|
|
|
8,595 |
|
|
|
6,343 |
|
|
|
5,794 |
|
|
|
5,380 |
|
|
|
5,463 |
|
|
|
5,263 |
|
Cost of reimbursement revenues |
|
|
2,737 |
|
|
|
3,048 |
|
|
|
4,073 |
|
|
|
3,077 |
|
|
|
2,323 |
|
|
|
2,893 |
|
|
|
2,230 |
|
|
|
2,265 |
|
Sales and marketing expenses |
|
|
2,043 |
|
|
|
2,120 |
|
|
|
2,229 |
|
|
|
1,468 |
|
|
|
1,397 |
|
|
|
1,160 |
|
|
|
1,270 |
|
|
|
1,178 |
|
General and administrative expenses |
|
|
1,614 |
|
|
|
1,962 |
|
|
|
1,900 |
|
|
|
1,539 |
|
|
|
1,495 |
|
|
|
1,415 |
|
|
|
1,448 |
|
|
|
1,376 |
|
Amortization of intangible assets related to acquisitions |
|
|
11 |
|
|
|
212 |
|
|
|
133 |
|
|
|
24 |
|
|
|
11 |
|
|
|
15 |
|
|
|
15 |
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
15,400 |
|
|
|
15,855 |
|
|
|
16,930 |
|
|
|
12,451 |
|
|
|
11,020 |
|
|
|
10,863 |
|
|
|
10,426 |
|
|
|
10,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations
before interest and taxes |
|
|
2,293 |
|
|
|
2,286 |
|
|
|
2,252 |
|
|
|
1,649 |
|
|
|
1,412 |
|
|
|
1,530 |
|
|
|
1,061 |
|
|
|
845 |
|
Interest income |
|
|
77 |
|
|
|
98 |
|
|
|
101 |
|
|
|
153 |
|
|
|
170 |
|
|
|
168 |
|
|
|
156 |
|
|
|
160 |
|
Interest expense |
|
|
(3 |
) |
|
|
(1 |
) |
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
(1 |
) |
|
|
(6 |
) |
|
|
(4 |
) |
Income tax provision |
|
|
(702 |
) |
|
|
(856 |
) |
|
|
(887 |
) |
|
|
(666 |
) |
|
|
(611 |
) |
|
|
(659 |
) |
|
|
(481 |
) |
|
|
(397 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations,
net of taxes |
|
|
1,665 |
|
|
|
1,527 |
|
|
|
1,463 |
|
|
|
1,136 |
|
|
|
971 |
|
|
|
1,038 |
|
|
|
730 |
|
|
|
604 |
|
Loss from discontinued operations |
|
|
(1,836 |
) |
|
|
(451 |
) |
|
|
(402 |
) |
|
|
(312 |
) |
|
|
(174 |
) |
|
|
(391 |
) |
|
|
(236 |
) |
|
|
(210 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
(171 |
) |
|
|
1,076 |
|
|
|
1,061 |
|
|
|
824 |
|
|
$ |
797 |
|
|
$ |
647 |
|
|
$ |
494 |
|
|
$ |
394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
|
0.12 |
|
|
|
0.11 |
|
|
|
0.10 |
|
|
|
0.09 |
|
|
$ |
0.09 |
|
|
$ |
0.09 |
|
|
$ |
0.06 |
|
|
$ |
0.05 |
|
Discontinued operations |
|
|
(0.13 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.02 |
) |
|
|
(0.03 |
) |
|
|
(0.02 |
) |
|
|
(0.02 |
) |
Net Income |
|
|
(0.01 |
) |
|
|
0.08 |
|
|
|
0.07 |
|
|
|
0.06 |
|
|
|
0.07 |
|
|
|
0.06 |
|
|
|
0.04 |
|
|
|
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
|
0.11 |
|
|
|
0.10 |
|
|
|
0.10 |
|
|
|
0.09 |
|
|
$ |
0.07 |
|
|
$ |
0.08 |
|
|
$ |
0.06 |
|
|
$ |
0.05 |
|
Discontinued operations |
|
|
(0.12 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.01 |
) |
|
|
(0.03 |
) |
|
|
(0.02 |
) |
|
|
(0.02 |
) |
Net Income |
|
|
(0.01 |
) |
|
|
0.07 |
|
|
|
0.07 |
|
|
|
0.06 |
|
|
|
0.06 |
|
|
|
0.05 |
|
|
|
0.04 |
|
|
|
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to
calculate earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
14,341 |
|
|
|
14,279 |
|
|
|
14,279 |
|
|
|
12,021 |
|
|
|
11,725 |
|
|
|
11,658 |
|
|
|
11,602 |
|
|
|
11,467 |
|
Diluted |
|
|
14,764 |
|
|
|
15,168 |
|
|
|
15,168 |
|
|
|
12,964 |
|
|
|
12,856 |
|
|
|
12,678 |
|
|
|
12,654 |
|
|
|
12,657 |
|
32
Liquidity and Capital Resources
Our principal liquidity requirements have been and we expect will be, for working capital and
general corporate purposes, including capital expenditures.
Statement of Cash Flow for the year ended December 31, 2008 compared to December 31, 2007
|
|
|
|
|
|
|
|
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
Net cash provided by activities from continuing operations |
|
$ |
9,768 |
|
|
$ |
9,985 |
|
Net cash
used in investing activities from continuing operations |
|
$ |
(10,605 |
) |
|
$ |
(6,082 |
) |
Net cash provided by financing activities from continuing operations |
|
$ |
523 |
|
|
$ |
490 |
|
At December 31, 2008, we had cash and cash equivalents of $14.3 million. Working capital,
defined as current assets minus current liabilities, at December 31, 2008 was $7.9 million as
compared to working capital at December 31, 2007 of $12.4 million.
Net cash provided by continuing operating activities for fiscal 2008 was $9.8 million compared
to net cash provided by operating activities of $10.0 million for fiscal 2007. This amount
remained relatively flat due to the increases and decreases from changes in operating assets and
liabilities.
Cash used by discontinued operations for fiscal 2008 was $3.0 million compared to $1.3 million
for fiscal 2007. This increase of $1.7 million primarily related to an increase in expenses to
market the CapMed product and services.
Net cash used in investing activities consists primarily of our investment in capital and
leasehold improvements from continuing operations of $2.7 million and our cash portion of the
acquisition of Phoenix Data Systems for $7.9 million. We currently anticipate that capital
expenditures for fiscal 2009 will be approximately $4 million. These expenditures primarily
represent additional upgrades in our networking, data storage and core laboratory capabilities for
both the United States and European operations as well as capitalization of software costs.
Net cash provided by financing activities is primarily attributable to a tax benefit related
to stock options of $290,000 and proceeds from stock option exercises of $386,000 offset by
payments on capital leases of $153,000.
The following table lists our cash contractual obligations as of December 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period |
(in thousands) |
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
More than |
Contractual obligations |
|
Total |
|
year |
|
1-3 years |
|
3-5 years |
|
5 years |
Capital lease obligations |
|
|
120 |
|
|
|
97 |
|
|
|
23 |
|
|
|
|
|
|
|
|
|
Facility rent operating
leases |
|
|
16,987 |
|
|
|
2,506 |
|
|
|
3,709 |
|
|
|
3,527 |
|
|
|
7,245 |
|
Employment agreements |
|
|
919 |
|
|
|
835 |
|
|
|
84 |
|
|
|
|
|
|
|
|
|
Total contractual cash
obligations |
|
$ |
18,026 |
|
|
$ |
3,438 |
|
|
$ |
3,816 |
|
|
$ |
3,527 |
|
|
$ |
7,245 |
|
We have neither paid nor declared dividends on our common stock since our inception and do not
plan to
33
pay dividends on our common stock in the foreseeable future.
We have not entered into any off-balance sheet transactions, arrangements or other
relationships with unconsolidated entities or other persons.
We anticipate that our existing capital resources together with cash flow from operations will
be sufficient to meet our foreseeable cash needs. However, we cannot assure you that our operating
results will continue to achieve profitability on an annual basis in the future. The inherent
operational risks associated with the following factors may have a material adverse affect on our
future liquidity:
|
|
|
our ability to gain new client contracts; |
|
|
|
|
project cancellations; |
|
|
|
|
the variability of the timing of payments on existing client contracts; and |
|
|
|
|
other changes in our operating assets and liabilities. |
We may seek to raise additional capital from equity or debt sources in order to take advantage
of opportunities such as more rapid expansion, acquisitions or the development of new services. We
cannot assure you that additional financing will be available, if at all, on terms acceptable to
us.
Our fiscal year 2009 operating plan contains assumptions regarding revenue and expenses. The
achievement of our operating plan depends heavily on the timing of work performed by us on existing
projects and our ability to gain and perform work on new projects. Project cancellations or delays
in the timing of work performed by us on existing projects or our inability to gain and perform
work on new projects could have an adverse impact on our ability to execute our operating plan and
maintain adequate cash flow. In the event actual results do not meet the operating plan, our
management believes it could execute contingency plans to mitigate these effects. Considering the
cash on hand and based on the achievement of the operating plan and managements actions taken to
date, management believes it has the ability to continue to generate sufficient cash to satisfy our
operating requirements in the normal course of business for at least the next twelve months and the
foreseeable future.
34
Recently Issued Accounting Statements
On October 29, 2008 the FASB issued FSP FAS 157-3, Determining the Fair Value of a Financial
Asset When the Market for That Asset Is Not Active (FSP FAS 157-3) which clarifies the application
of SFAS 157 in a market that is not active and provides an example to illustrate key considerations
in determining the fair value of a financial asset when the market for that financial asset is not
active. The adoption of FSP FAS 157-3 had no impact on the Financial Statements.
In April 2008, the FASB issued FSP No. FAS 142-3, Determination of the Useful Life of
Intangible Assets (FSP FAS 142-3). FSP FAS 142-3 amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of a recognized
intangible asset under FASB Statement No. 142, Goodwill and Other Intangible Assets (SFAS 142),
in order to improve the consistency between the useful life of a recognized intangible asset under
SFAS 142 and the period of expected cash flows used to measure the fair value of the asset under
SFAS 141(R) and other GAAP. FSP FAS 142-3 becomes effective for Bio-Imaging on January 1, 2009.
Management has concluded that the adoption of FSP FAS 142-3 will not have a material impact on the
Financial Statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activitiesan amendment of FASB Statement No. 133 (SFAS 161). SFAS 161 requires enhanced
disclosures about an entitys derivative and hedging activities, including (i) how and why an
entity uses derivative instruments, (ii) how derivative instruments and related hedged items are
accounted for under SFAS 133 and (iii) how derivative instruments and related hedged items affect
an entitys financial position, financial performance and cash flows. This standard becomes
effective for Bio-Imaging Technologies, Inc. on January 1, 2009. Earlier adoption of SFAS 161 and,
separately, comparative disclosures for earlier periods at initial adoption are encouraged. As SFAS
161 only requires enhanced disclosures, this standard will have no impact on the Financial
Statements.
On January 1, 2008, we elected not to adopt the FASB issued SFAS No. 159, Fair Value Option
for Financial Assets and Financial Liabilities (SFAS 159), which permits companies to use fair
value for reporting purposes under GAAP.
In December 2007, the FASB issued SFAS No. 141R, Business Combinations (Revised 2007) (SFAS
141R), which addresses ways to improve the relevance, representational faithfulness and
comparability of the information that a reporting entity provides in its financial reports about a
business combination. This statement applies prospectively to business combinations for which the
acquisition date is on or after fiscal years beginning December 15, 2008. Retrospective application
is not permitted. The Company is currently evaluating SFAS 141R and the related impact on our
financial position and results of operations.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statementsan amendment of ARB No. 51 (SFAS 160). SFAS 160 amends Accounting Research
Bulletin No. 51, Consolidated Financial Statements, to establish accounting and reporting
standards for the noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. This standard defines a noncontrolling interest, sometimes called a minority interest,
as the portion of equity in a subsidiary not attributable, directly or indirectly, to a parent.
SFAS 160 requires, among other items, that a noncontrolling interest be included in the
consolidated statement of financial position within equity separate from the parents equity;
consolidated net income to be reported at amounts inclusive of both the parents and noncontrolling
interests shares and, separately, the amounts of consolidated net income attributable to the
parent and noncontrolling interest all on the consolidated statement of income; and if a subsidiary
is deconsolidated, any
35
retained noncontrolling equity investment in the former
subsidiary be measured at fair value and a gain or loss be recognized in net income based on
such fair value. SFAS 160 becomes effective for Bio-Imaging Technologies, Inc. on January 1, 2009.
Management is currently evaluating the potential impact of SFAS 160 on the Financial Statements.
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 in GAAP, and expands
disclosures about fair value measurements. The provisions of this standard apply to other
accounting pronouncements that require or permit fair value measurements. SFAS 157, as it relates
to financial assets and financial liabilities, became effective for Bio-Imaging Technologies, Inc.
on January 1, 2008. On February 12, 2008, the FASB issued FSP No. FAS 157-2, Effective Date of
FASB Statement No. 157, which delays the effective date of SFAS 157 for all nonfinancial assets
and nonfinancial liabilities, except those that are recognized or disclosed at fair value in the
financial statements on at least an annual basis, until January 1, 2009 for calendar year-end
entities. Upon adoption, the provisions of SFAS 157 are to be applied prospectively with limited
exceptions. We have determined that the adoption of SFAS 157, as it relates to financial assets and
financial liabilities did not have an impact on the Consolidated Financial Statements. We are
currently evaluating the potential impact of SFAS 157, as it relates to nonfinancial assets and
nonfinancial liabilities, on the Consolidated Financial Statements as we have elected the deferral
of FAS 157-2.
Existing Contracts
As of December 31, 2008, we had entered into agreements with 101 companies, encompassing 279
projects, to provide services in the aggregate amount of $175.4 million through January 2014, of
which services valued at $92.7 million remain to be completed. Such contracts are subject to
termination by us or our clients at any time or for any reason. In addition, clients clinical
trials or other projects are subject to timing and scope changes. Therefore, total service revenue
generated by us during the life of these contracts may be less than initial contract values.
Item 7a. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
We invest in high-quality financial instruments, comprised of savings accounts, certificate of
deposits and money market funds. Due to the short-term nature of our investments, we do not
believe that we have any material exposure to interest rate risk arising from our investments.
Foreign Currency Risk
During the year ended December 31, 2008, we have not purchased any additional such Euro call
options, because our foreign currency needs are generally being met by the cash flow generated by
Euro denominated contracts. As of December 31, 2008, there are no outstanding derivative
positions.
In accordance with our current foreign exchange rate risk management policy, since inception,
we have purchased twenty monthly Euro call options. Nineteen monthly call options were in the
amount of 250,000 Euros each, and one call option was for 200,000 Euros for anticipated additional
costs in May, 2006. The first expiration was on July 27, 2005, and the last expiration was in March
2007 with a strike price ranging from $1.26 to $1.27. These options were intended to hedge against
the exposure to variability in our cash flows resulting from the Euro denominated costs for our
Netherlands subsidiary. We paid a total premium of $132,000 for the options.
36
During the twelve months ended December 31, 2007, we exercised the remaining two options and a
gain of $10,000 was recognized in the Consolidated Statement of Income on the exercised options.
During the twelve months ended December 31, 2006, we exercised seven options and a loss of $11,000
was recognized in the Consolidated Statement of Income.
Under our current foreign exchange rate risk management policy, and upon expiration or
ineffectiveness of the derivative, we will record a gain or loss from the derivative that is
deferred in stockholders equity to cost of revenues and general and administrative expenses in the
Consolidated Statement of Income based on the nature of the underlying cash flow hedged.
See Managements Discussion and Analysis of Financial Condition and Results of Operations -
Foreign Currency Risks for a more detailed discussion of our foreign currency risks and exposures.
37
Item 8. Financial Statements and Supplementary Data.
|
|
|
|
|
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS |
|
PAGE |
|
|
|
|
39 |
|
|
|
|
|
|
|
|
|
40 |
|
|
|
|
|
|
|
|
|
41 |
|
|
|
|
|
|
|
|
|
42 |
|
|
|
|
|
|
|
|
|
43 |
|
|
|
|
|
|
|
|
|
45 |
|
38
Report of Independent Registered Public Accounting Firm
To the Board of Directors
And Stockholders of
Bio-Imaging Technologies, Inc.:
In our opinion, the accompanying consolidated balance sheets and the related consolidated
statements of income, comprehensive income, stockholders equity and cash flows, present fairly, in
all material respects, the financial position of Bio-Imaging Technologies, Inc. and its
subsidiaries at December 31, 2008 and 2007, and the results of their operations and their cash
flows for each of the three years in the period ended December 31, 2008 in conformity with
accounting principles generally accepted in the United States of America. These financial
statements are the responsibility of the Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits. We conducted our audits of these
statements in accordance with the standards of the Public Company Accounting Oversight Board
(United States). Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement. An audit
includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements, assessing the accounting principles used and significant estimates made by
management, and evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
PricewaterhouseCoopers LLP
Philadelphia, PA
March 5, 2009
39
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,265 |
|
|
$ |
17,915 |
|
Accounts receivable, net of allowance for doubtful
accounts of $11 and $29, respectively |
|
|
11,982 |
|
|
|
5,881 |
|
Prepaid expenses and other current assets |
|
|
2,315 |
|
|
|
1,235 |
|
Assets held for sale |
|
|
500 |
|
|
|
2,703 |
|
Deferred income taxes |
|
|
3,084 |
|
|
|
2,930 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
32,146 |
|
|
|
30,664 |
|
Property and equipment, net |
|
|
7,022 |
|
|
|
5,420 |
|
Intangibles, net |
|
|
2,058 |
|
|
|
307 |
|
Goodwill |
|
|
27,391 |
|
|
|
6,025 |
|
Other assets |
|
|
591 |
|
|
|
641 |
|
|
|
|
|
|
|
|
|
Total Assets |
|
$ |
69,208 |
|
|
$ |
43,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,832 |
|
|
$ |
1,864 |
|
Accrued expenses and other current liabilities |
|
|
5,236 |
|
|
|
4,616 |
|
Deferred revenue |
|
|
15,106 |
|
|
|
11,664 |
|
Current maturities of capital lease obligations |
|
|
54 |
|
|
|
97 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
24,228 |
|
|
|
18,241 |
|
Long-term capital lease obligations |
|
|
65 |
|
|
|
|
|
Deferred income tax |
|
|
927 |
|
|
|
691 |
|
Other liability |
|
|
576 |
|
|
|
597 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
25,796 |
|
|
|
19,529 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock- $.00025 par value; authorized
3,000,000 shares, 0 issued and outstanding at
December 31, 2008 and 2007 |
|
|
|
|
|
|
|
|
Common stock $.00025 par value; authorized
18,000,000 shares, issued and outstanding 14,341,403
and 11,765,483 shares at December 31, 2008 and 2007,
respectively |
|
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
42,270 |
|
|
|
25,084 |
|
Retained earnings (accumulated deficit) |
|
|
1,080 |
|
|
|
(1,710 |
) |
Accumulated other comprehensive income |
|
|
58 |
|
|
|
151 |
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
43,412 |
|
|
|
23,528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
69,208 |
|
|
$ |
43,057 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these statements.
40
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands except per share data) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenues |
|
$ |
56,181 |
|
|
$ |
37,543 |
|
|
$ |
31,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement revenues |
|
|
12,935 |
|
|
|
9,711 |
|
|
|
8,404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
69,116 |
|
|
|
47,254 |
|
|
|
40,257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
32,446 |
|
|
|
21,900 |
|
|
|
19,629 |
|
Cost of reimbursement revenues |
|
|
12,935 |
|
|
|
9,711 |
|
|
|
8,404 |
|
Sales and marketing expenses |
|
|
7,860 |
|
|
|
5,005 |
|
|
|
4,286 |
|
General and administrative expenses |
|
|
7,015 |
|
|
|
5,734 |
|
|
|
5,131 |
|
Amortization of intangible assets related to acquisitions |
|
|
380 |
|
|
|
56 |
|
|
|
137 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
60,636 |
|
|
|
42,406 |
|
|
|
37,587 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before interest and taxes |
|
|
8,480 |
|
|
|
4,848 |
|
|
|
2,670 |
|
Interest income |
|
|
429 |
|
|
|
654 |
|
|
|
560 |
|
Interest expense |
|
|
(7 |
) |
|
|
(11 |
) |
|
|
(56 |
) |
Income tax provision |
|
|
(3,111 |
) |
|
|
(2,148 |
) |
|
|
(1,206 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations, net of taxes |
|
$ |
5,791 |
|
|
$ |
3,343 |
|
|
$ |
1,968 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations, net of taxes |
|
|
(3,001 |
) |
|
|
(1,011 |
) |
|
|
(964 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,790 |
|
|
$ |
2,332 |
|
|
$ |
1,004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.42 |
|
|
$ |
0.29 |
|
|
$ |
0.18 |
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
$ |
(0.22 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
Net Income |
|
$ |
0.20 |
|
|
$ |
0.20 |
|
|
$ |
0.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.40 |
|
|
$ |
0.26 |
|
|
$ |
0.16 |
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
$ |
(0.21 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
|
Net Income |
|
$ |
0.19 |
|
|
$ |
0.18 |
|
|
$ |
0.08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to calculate earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
13,752 |
|
|
|
11,616 |
|
|
|
11,219 |
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
14,469 |
|
|
|
12,745 |
|
|
|
12,364 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these statements.
41
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Compre- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
(Deficit) |
|
|
hensive |
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Retained |
|
|
Gain |
|
|
Stockholders |
|
(in thousands) |
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Earnings |
|
|
(Loss) |
|
|
Equity |
|
Balance at December 31, 2005 |
|
|
11,168 |
|
|
$ |
3 |
|
|
$ |
22,302 |
|
|
$ |
(5,047 |
) |
|
$ |
(62 |
) |
|
$ |
17,196 |
|
Stock options exercised |
|
|
127 |
|
|
|
|
|
|
|
153 |
|
|
|
|
|
|
|
|
|
|
|
153 |
|
Restricted shares issued |
|
|
15 |
|
|
|
|
|
|
|
(5 |
) |
|
|
|
|
|
|
|
|
|
|
(5 |
) |
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
363 |
|
|
|
|
|
|
|
|
|
|
|
363 |
|
Tax benefit on exercise of
stock options |
|
|
|
|
|
|
|
|
|
|
51 |
|
|
|
|
|
|
|
|
|
|
|
51 |
|
Net unrealized gain on
derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
79 |
|
|
|
79 |
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,004 |
|
|
|
|
|
|
|
1,004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
11,310 |
|
|
$ |
3 |
|
|
$ |
22,864 |
|
|
$ |
(4,043 |
) |
|
$ |
17 |
|
|
$ |
18,841 |
|
Stock options exercised |
|
|
341 |
|
|
|
|
|
|
|
301 |
|
|
|
|
|
|
|
|
|
|
|
301 |
|
Restricted shares issued |
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued for acquisitions |
|
|
99 |
|
|
|
|
|
|
|
802 |
|
|
|
|
|
|
|
|
|
|
|
802 |
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
474 |
|
|
|
|
|
|
|
|
|
|
|
474 |
|
Tax benefit on exercise of
stock options |
|
|
|
|
|
|
|
|
|
|
643 |
|
|
|
|
|
|
|
|
|
|
|
643 |
|
Net unrealized loss on
derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17 |
) |
|
|
(17 |
) |
Equity adjustment from
foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
151 |
|
|
|
151 |
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,333 |
|
|
|
|
|
|
|
2,333 |
|
|
|
|
Balance at December 31, 2007 |
|
|
11,765 |
|
|
$ |
3 |
|
|
$ |
25,084 |
|
|
$ |
(1,710 |
) |
|
$ |
151 |
|
|
$ |
23,528 |
|
Stock options exercised |
|
|
290 |
|
|
|
|
|
|
|
387 |
|
|
|
|
|
|
|
|
|
|
|
387 |
|
Restricted shares issued |
|
|
21 |
|
|
|
|
|
|
|
(86 |
) |
|
|
|
|
|
|
|
|
|
|
(86 |
) |
Stock issued for acquisitions |
|
|
2,265 |
|
|
|
1 |
|
|
|
15,946 |
|
|
|
|
|
|
|
|
|
|
|
15,947 |
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
649 |
|
|
|
|
|
|
|
|
|
|
|
649 |
|
Tax benefit on exercise of
stock options |
|
|
|
|
|
|
|
|
|
|
290 |
|
|
|
|
|
|
|
|
|
|
|
290 |
|
Equity adjustment from
foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(93 |
) |
|
|
(93 |
) |
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,790 |
|
|
|
|
|
|
|
2,790 |
|
|
|
|
Balance at December 31, 2008 |
|
|
14,341 |
|
|
$ |
4 |
|
|
$ |
42,270 |
|
|
$ |
1,080 |
|
|
$ |
58 |
|
|
$ |
43,412 |
|
Statement of comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Net income |
|
$ |
2,790 |
|
|
$ |
2,333 |
|
|
$ |
1,004 |
|
Net unrealized income (loss) on derivative instruments |
|
|
|
|
|
|
(17 |
) |
|
|
79 |
|
Equity adjustment from foreign currency translation |
|
|
(93 |
) |
|
|
151 |
|
|
|
|
|
|
|
|
Total comprehensive income |
|
$ |
2,697 |
|
|
$ |
2,467 |
|
|
$ |
1,083 |
|
The
accompanying notes are an integral part of these statements.
42
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,790 |
|
|
$ |
2,332 |
|
|
$ |
1,004 |
|
Adjustments to reconcile net income to net cash provided by
Operating activities, net of acquisition: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
2,266 |
|
|
|
2,335 |
|
|
|
2,035 |
|
Provision for deferred income taxes |
|
|
(311 |
) |
|
|
286 |
|
|
|
24 |
|
Sales leaseback deferred gains |
|
|
|
|
|
|
|
|
|
|
|
|
Bad debt provision |
|
|
(6 |
) |
|
|
15 |
|
|
|
16 |
|
Stock based compensation expense |
|
|
563 |
|
|
|
474 |
|
|
|
358 |
|
(Gain) Loss on foreign currency options |
|
|
|
|
|
|
(10 |
) |
|
|
82 |
|
Loss from discontinued operations |
|
|
3,001 |
|
|
|
1,011 |
|
|
|
964 |
|
Changes in operating assets and liabilities, net of acquisitions: |
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in accounts receivable |
|
|
(1,339 |
) |
|
|
(145 |
) |
|
|
1,051 |
|
Increase in prepaid expenses and other current assets |
|
|
(830 |
) |
|
|
(77 |
) |
|
|
(234 |
) |
Decrease (increase) in other assets |
|
|
93 |
|
|
|
(53 |
) |
|
|
(93 |
) |
Increase (decrease) in accounts payable |
|
|
1,599 |
|
|
|
78 |
|
|
|
(271 |
) |
Increase in accrued expenses and other current liabilities |
|
|
353 |
|
|
|
1,334 |
|
|
|
1,359 |
|
(Decrease) increase in deferred revenue |
|
|
(850 |
) |
|
|
2,073 |
|
|
|
3,196 |
|
(Decrease) increase in other liabilities |
|
|
(3 |
) |
|
|
23 |
|
|
|
2 |
|
Decrease in net assets held for sale |
|
|
2,442 |
|
|
|
309 |
|
|
|
257 |
|
|
|
|
|
|
|
|
|
|
|
Cash provided by activities from continuing operations |
|
|
9,768 |
|
|
|
9,985 |
|
|
|
9,750 |
|
Cash used by discontinued operations |
|
|
(2,974 |
) |
|
|
(1,319 |
) |
|
|
(1,221 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
6,794 |
|
|
|
8,666 |
|
|
|
8,529 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows used in investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(2,677 |
) |
|
|
(2,575 |
) |
|
|
(1,310 |
) |
Net cash paid for acquisition |
|
|
(7,928 |
) |
|
|
(3,507 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities from continuing operations |
|
|
(10,605 |
) |
|
|
(6,082 |
) |
|
|
(1,310 |
) |
Purchase of plant, property and equipment for discontinued operations |
|
|
(239 |
) |
|
|
(1,353 |
) |
|
|
(922 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(10,844 |
) |
|
|
(7,435 |
) |
|
|
(2,232 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Payments under equipment lease obligations |
|
|
(153 |
) |
|
|
(454 |
) |
|
|
(875 |
) |
Premiums paid for foreign currency options |
|
|
|
|
|
|
|
|
|
|
(14 |
) |
Proceeds from exercise of stock options |
|
|
386 |
|
|
|
301 |
|
|
|
153 |
|
Excess tax benefit related to stock options |
|
|
290 |
|
|
|
643 |
|
|
|
51 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities from continuing
operations |
|
|
523 |
|
|
|
490 |
|
|
|
(685 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
(123 |
) |
|
|
28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(3,650 |
) |
|
|
1,749 |
|
|
|
5,612 |
|
Cash and cash equivalents at beginning of period |
|
|
17,915 |
|
|
|
16,166 |
|
|
|
10,554 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
14,265 |
|
|
$ |
17,915 |
|
|
$ |
16,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
11 |
|
|
$ |
12 |
|
|
$ |
56 |
|
Cash paid during the period for income taxes |
|
$ |
1,970 |
|
|
$ |
604 |
|
|
$ |
98 |
|
The accompanying notes are an integral part of these statements.
43
Supplemental cash flow disclosure
Schedule of non cash investing and financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
(in thousands) |
|
2008 |
|
2007 |
|
2006 |
Increase in property, plant
and equipment acquisitions
in accounts payable |
|
$ |
7 |
|
|
$ |
11 |
|
|
$ |
311 |
|
Acquired business
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
(in thousands) |
|
2008 |
|
2007 |
|
2006 |
Accounts receivable |
|
$ |
4,926 |
|
|
$ |
228 |
|
|
|
|
|
Property and equipment |
|
|
721 |
|
|
|
185 |
|
|
|
|
|
Other assets |
|
|
295 |
|
|
|
53 |
|
|
|
|
|
Intangible assets and goodwill |
|
|
23,874 |
|
|
|
4,590 |
|
|
|
|
|
Current liabilities assumed |
|
|
(1,061 |
) |
|
|
(377 |
) |
|
|
|
|
Other liabilities assumed |
|
|
(4,880 |
) |
|
|
(412 |
) |
|
|
|
|
Common stock issued |
|
|
(15,947 |
) |
|
|
(760 |
) |
|
|
|
|
|
|
|
Cash paid for acquired
business, net of cash
acquired of $418,000 and
$201,000, respectively |
|
$ |
7,928 |
|
|
$ |
3,507 |
|
|
|
|
|
The accompanying notes are an integral part of these statements.
44
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT (Continued)
1. Organization and Summary of Significant Accounting Policies
Description of Business
Bio-Imaging Technologies, Inc. and Subsidiaries (Bio-Imaging or the Company) is a global
clinical trials service organization, providing medical image management and eClinical services,
including electronic data capture and clinical data management solutions, to pharmaceutical,
biotechnology and medical device companies and other organizations, including contract research
organizations (CROs), engaged in clinical trials.
Our medical image management services assist our clients in the design and management of the
medical imaging component of clinical trials. We have developed specialized services and
proprietary software applications that enable independent radiologists and other medical
specialists involved in clinical trials to review medical image data in an entirely digital format
and make highly precise measurements and biostatistical inferences to evaluate the efficacy and
safety of pharmaceuticals, biologics or medical devices. Medical imaging is used for clinical
development of therapeutic modalities for use in oncology, disorders of the musculoskeletal,
central nervous, cardiovascular systems, and in a variety of other disease categories.
Our core laboratory imaging services include the collection, processing, analysis and
regulatory submission of medical images and related clinical data. Medical images are received
from a wide variety of imaging modalities including computerized tomography (CT), magnetic
resonance imaging (MRI), radiography, dual energy x-ray absorptiometry (DXA/DEXA), positron
emission tomography (PET), single photon emission computerized tomography (SPECT), quantitative
coronary angiography (QCA), cardiac MRI and CT, intravascular ultrasound (IVUS), peripheral
quantitative angiography (QVA), central nervous system (CNS) MRI and ultrasound. The resulting data
enables our clients and regulatory reviewers, primarily the U.S. Food and Drug Administration and
comparable European agencies, to evaluate product efficacy and safety.
On March 24, 2008, we completed the acquisition of Phoenix Data Systems, referred to herein as
PDS, a provider of electronic data capture (EDC) services offering a comprehensive array of
eClinical data solutions to the pharmaceutical and biotechnology industries. PDS is engaged in
providing full service EDC, a combination of electronic data capture, interactive voice response,
reporting and data management solutions and is focused on making the process of collecting and
analyzing data from clinical trials faster, easier and more reliable.
Our eClinical services offer a variety of customizable proprietary software solutions that
enhance pharmaceutical and biotech companies ability to process and store clinical data through
the use of customized proprietary software and hosting service. This technology improves data
quality and allows our sponsors to see the results of their clinical trials faster and more
accurately than with conventional paper-based methods. Through the acquisition of PDS, we
established our eClinical services offering.
On January 6, 2009, we sold our CapMed division to MBI Benefits, Inc., an indirectly owned
subsidiary of Metavante Technologies, Inc. This division included the Personal Health Record
(PHR) software and the patent-pending Personal HealthKey technology. The sale of CapMed enables
us to focus on our core clinical trial services business.
45
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries, Oxford Bio-Imaging Research, Inc. and Bio-Imaging Technologies Holding
B.V. The results of companies acquired during the year are included in the consolidated financial
statements from the effective date of the acquisition. All intercompany transactions and balances
have been eliminated in consolidation.
Basis of Presentation
The financial information for all prior periods presented have been reclassified to reflect
assets held for sale and discontinued operations related to the CapMed division. See Note 3 for
additional information.
Foreign Currency Translation
Assets and liabilities of non-U.S. subsidiaries are translated into U.S. dollars at fiscal
year-end exchange rates. Income and expense items are translated at average exchange rates
prevailing during the fiscal year. The resulting translation adjustments are recorded as a
component of shareholders equity. Gains and losses from foreign currency transactions are
included in net income.
Functional Currency
Historically, the functional currency for our Netherlands operations was the US Dollar based
on an initial evaluation, as well as periodic evaluations of economic factors, as set forth in SFAS
52.
We periodically evaluated the economic facts and circumstances that led to the initial
conclusion that the functional currency of the Netherlands operation was the US Dollar for any
significant changes that might indicate that the functional currency of the Netherlands operation
had changed. Based on our evaluation performed in connection with the commencement of our quarter
ended September 30, 2007, we concluded that, effective July 1, 2007, the functional currency of our
Netherlands operation is the Euro. The primary economic factor change was the increase in the
sales price and market indicator of significantly more contracts in EUROs as well as the cash flow
and financing indicator of US Dollar to Euro in our Netherlands operation.
The equity adjustment from foreign currency translation was ($93,000) and $151,000 at December
31, 2008 and 2007, respectively.
The functional currency for our French operations is the Euro based on our initial and
periodic evaluations of economic factors as set forth in SFAS 52.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States 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.
Fair Value of Financial Instruments
The carrying values of the Companys financial instruments, which include cash equivalents,
46
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
accounts receivable, accounts payable and other accrued expenses approximate their fair values due
to their short maturities. Based on borrowing rates currently available to the Company for loans
with similar
terms, the carrying value of capital lease obligations approximate fair value.
Cash and Cash Equivalents
The Company maintains cash in excess of FDIC insurance limits in certain financial
institutions. The Company considers cash equivalents to be highly liquid investments with a
maturity at the time of purchase of three months or less.
The Company has a standby letter of credit which approximated $166,000 at December 31, 2008
and 2007. This letter of credit represents an irrevocable guarantee to fulfill the office
facilities operating lease obligation.
Revenue Recognition
Service revenues are recognized over the contractual term of the Companys customer contracts
using the proportional performance method. Service revenues are first recognized when the Company
has a signed contract from a customer which: (i) contains fixed or determinable fees; (ii)
collectability of such fees is reasonably assured; and (iii) the services were performed. Any
change to recognized service revenue as a result of revisions to estimated total hours are
recognized in the period the estimate changes.
The Company enters into contracts that contain fixed or determinable fees. The fees in the
contracts are based on the scope of work we are contracted to perform; there are unitized fees per
service and fixed fees with a total estimated for the contract based upon the estimated unitized
service expected to be performed, as well as the service to be delivered under the fixed fee
component of the contract. The units are estimated based on the information provided by the
customer, and the Company bills the customer for actual units completed in accordance with the
terms of the contract. In the event that a contract is cancelled by the client, we would be
entitled to receive payment for all services performed up to the cancellation date.
The Companys revenue recognition policy entails a number of estimates including an estimate
of the total hours that are expected to be incurred on a project, which is used as the basis for
determining the portion of the Companys revenue to be recognized for each period. The revenue
recognized in any period might have been materially affected if different assumptions or conditions
prevailed. The timing of the Companys recognition of revenue would be revised if there were
changes in the total estimated hours (other than scope changes in a project which typically result
in a revision to the contract). The Company reviews its total estimated hours monthly. Provisions
for losses expected to be incurred on contracts are recognized in full in the period in which it is
determined that a loss will result from performance of the contractual arrangement.
Unbilled services represent revenue recognized which pursuant to contractual terms have not
yet been billed to the client. In general, amounts become billable pursuant to contractual
milestones or in accordance with predetermined payment schedules. Unbilled services are generally
billable within one year from the respective balance sheet date and are usually billed within the
next quarter from any balance sheet. Deferred revenue is recorded for cash received from clients
for services that have not yet been earned at the respective balance sheet date.
47
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS-(Continued)
The Company, at the request of its clients, directly contract with and pay independent
radiologists, referred to as Readers, who review the clients imaging data as part of the clinical
trial. The costs of the
Readers and other out-of-pocket expenses are reimbursed to the Company and recognized gross as
reimbursement revenues pursuant to EITF 99-19 Reporting Revenue Gross as a Principal versus Net as
an Agent.
Allowance For Doubtful Accounts
The Company maintains allowances for doubtful accounts on a specific identification method for
estimated losses resulting from the inability of its customers to make required payments. If the
financial condition of its customers were to deteriorate, resulting in an impairment of the
customers ability to make payments, additional allowances may be required. The Company does not
have any off-balance-sheet credit exposure related to its customers and the trade accounts
receivable does not bear interest.
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Billed trade accounts receivable |
|
$ |
10,091 |
|
|
$ |
5,090 |
|
Unbilled trade accounts receivable |
|
|
1,863 |
|
|
|
746 |
|
Other |
|
|
28 |
|
|
|
45 |
|
Total receivables |
|
$ |
11,982 |
|
|
$ |
5,881 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance Rollforward: |
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
$ |
14 |
|
|
|
|
|
Additions |
|
|
29 |
|
|
|
|
|
Write offs (net of recoveries) |
|
|
(14 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
29 |
|
|
|
|
|
Additions |
|
|
6 |
|
|
|
|
|
Write offs (net of recoveries) |
|
|
(24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and Equipment
Property and equipment is recorded at historical cost and depreciated over the estimated
useful lives of the respective assets. Amortization of leasehold improvements is provided for over
the lesser of the related lease term, or the useful lives of the related assets. The cost and
related accumulated depreciation of assets fully depreciated, sold, retired or otherwise disposed
of are removed from the respective accounts and any resulting gains or losses are included in the
statements of income.
Management annually evaluates the net realizable value of long-lived assets, including property and
equipment, relying on a number of factors including operating results, business plans, economic
projections and anticipated future cash flows. If these factors indicate that the carrying value of
a long lived asset exceeds the net realizable value, the Company will record an impairment and
reduce the carrying value of the asset to the net realizable value.
Capitalized Software Development
The Company capitalizes development costs for a software project once the preliminary project
stage is completed, management commits to funding the project and it is probable that the project
will be
48
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
completed and the software will be used to perform the function intended. The Company
ceases capitalization at such time as the computer software project is substantially complete and
ready for its intended use. The determination that a software project is eligible for
capitalization and the ongoing
assessment of recoverability of capitalized software development costs require considerable
judgment by management with respect to certain external factors, including, but not limited to,
anticipated future revenue, estimated economic life and changes in software and hardware
technologies. The Company capitalized software development costs of $897,000 and $1.7 million for
the year ended December 31, 2008, and 2007 respectively. Amortization expense related to
capitalized computer software costs amounted to $582,000, $445,000 and $357,000 at December 31,
2008, 2007, and 2006 respectively. Capitalized software development costs are included as a
component of property and equipment.
Goodwill and Other Intangible Assets
Goodwill and indefinite-lived intangible assets are tested for impairment at least annually;
however, these tests are performed more frequently when events or changes in circumstances indicate
the carrying value may not be recoverable. The companys fair value methodology is based on quoted
market prices, if available. If quoted market prices are not available, an estimate of fair market
value is made based on prices of similar assets or other valuation methodologies including present
value techniques. Definite-lived intangible assets, such as purchased and licensed technology,
patents and customer lists are amortized over their estimated useful lives, generally for periods
ranging from 2 to 7 years. The Company continually evaluates the reasonableness of the useful lives
of these assets.
Income Taxes
The Company accounts for income taxes under the provisions of SFAS No. 109, Accounting for
Income Taxes, which utilizes the liability method. Deferred taxes are determined based on the
estimated future tax effects of differences between the financial statement and tax bases of assets
and liabilities at currently enacted tax laws and rates. A valuation allowance is provided against
the carrying value of deferred tax assets when management believes it is more likely than not that
the deferred tax assets will not be realized. The Company recognizes contingent liabilities for
any tax related exposures when those exposures are more likely than not to occur.
Earnings Per Share
SFAS No. 128 Earnings per Share requires the presentation of basic earnings per share and
diluted earnings per share. Basic earnings per common share are calculated by dividing the net
income available to Common Stockholders by the weighted average number of shares of Common Stock
outstanding during the period. Diluted earnings per common share is calculated by dividing net
income by the weighted average number of shares of Common Stock outstanding, adjusted for the
effect of potentially dilutive securities using the treasury stock method.
The computation of basic earnings per common share and diluted earnings per common share is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands except per share data) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Net income diluted and basic |
|
$ |
2,790 |
|
|
$ |
2,333 |
|
|
$ |
1,004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator basic: |
|
|
|
|
|
|
|
|
|
|
|
|
49
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands except per share data) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Weighted average number of common
shares |
|
|
13,752 |
|
|
|
11,616 |
|
|
|
11,219 |
|
|
|
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.20 |
|
|
$ |
0.20 |
|
|
$ |
0.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares |
|
|
13,752 |
|
|
|
11,616 |
|
|
|
11,219 |
|
Common share equivalents of
outstanding stock options |
|
|
648 |
|
|
|
1,023 |
|
|
|
968 |
|
Common share equivalents of
unrecognized compensation expense |
|
|
69 |
|
|
|
106 |
|
|
|
177 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of dilutive
common equivalent shares |
|
|
14,469 |
|
|
|
12,745 |
|
|
|
12,364 |
|
|
|
|
|
|
|
|
|
|
|
Diluted income per common share |
|
$ |
0.19 |
|
|
$ |
0.18 |
|
|
$ |
0.08 |
|
|
|
|
|
|
|
|
|
|
|
We excluded options to purchase 719,000, 140,000 and 412,000 shares of our common stock for
the twelve months ended December 31, 2008, 2007 and 2006, respectively, since they were
out-of-the-money and antidilutive.
Derivatives
The Company uses derivative financial instruments to reduce the risk caused by interest rate
fluctuations. The derivative instruments are not held for trading purposes. Derivatives are
accounted for in accordance with FAS No. 133, Accounting for Derivative Instruments and Hedging
Activities. The Company recognizes derivative instruments as either assets or liabilities in the
balance sheet and measures them at fair value. If designated as a cash flow hedge, the
corresponding changes in fair value are recorded in stockholders equity (as a component of
comprehensive income/expense).
Recently Issued Accounting Statements
On October 29, 2008, the FASB issued FSP FAS 157-3, Determining the Fair Value of a Financial
Asset When the Market for That Asset Is Not Active (FSP FAS 157-3), which clarifies the
application of SFAS 157 in a market that is not active and provides an example to illustrate key
considerations in determining the fair value of a financial asset when the market for that
financial asset is not active. The adoption of FSP FAS 157-3 had no impact on the Financial
Statements.
In April 2008, the FASB issued FSP No. FAS 142-3, Determination of the Useful Life of
Intangible Assets (FSP FAS 142-3). FSP FAS 142-3 amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of a recognized
intangible asset under FASB Statement No. 142, Goodwill and Other Intangible Assets (SFAS 142),
in order to improve the consistency between the useful life of a recognized intangible asset under
SFAS 142 and the period of expected cash flows used to measure the fair value of the asset under
SFAS 141(R) and other GAAP. FSP FAS 142-3 becomes effective for Bio-Imaging on January 1, 2009.
Management has concluded that the adoption of FSP FAS 142-3 will not have a material impact on the
Financial Statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activitiesan amendment of FASB Statement No. 133 (SFAS 161). SFAS 161 requires enhanced
disclosures about an entitys derivative and hedging activities, including (i) how and why an
entity uses derivative instruments, (ii) how derivative instruments and related hedged items are
accounted
50
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
for under SFAS 133, and (iii) how derivative instruments and related hedged items affect
an entitys financial position, financial performance and cash flows. This standard becomes
effective for Bio-Imaging Technologies, Inc. on January 1, 2009. Earlier adoption of SFAS 161 and,
separately, comparative disclosures for earlier periods at initial adoption are encouraged. As SFAS
161 only requires enhanced
disclosures, this standard will have no impact on the Financial Statements.
On January 1, 2008, we elected not to adopt the FASB issued SFAS No. 159, Fair Value Option
for Financial Assets and Financial Liabilities (SFAS 159) which permits companies to use fair
value for reporting purposes under GAAP.
In December 2007, the FASB issued SFAS No. 141R, Business Combinations (Revised 2007) (SFAS
141R), which addresses ways to improve the relevance, representational faithfulness and
comparability of the information that a reporting entity provides in its financial reports about a
business combination. This statement applies prospectively to business combinations for which the
acquisition date is on or after fiscal years beginning December 15, 2008. Retrospective application
is not permitted. The Company is currently evaluating SFAS 141R and the related impact on our
financial position and results of operations.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statementsan amendment of ARB No. 51 (SFAS 160). SFAS 160 amends Accounting Research
Bulletin No. 51, Consolidated Financial Statements, to establish accounting and reporting
standards for the noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. This standard defines a noncontrolling interest, sometimes called a minority interest,
as the portion of equity in a subsidiary not attributable, directly or indirectly, to a parent.
SFAS 160 requires, among other items, that a noncontrolling interest be included in the
consolidated statement of financial position within equity separate from the parents equity;
consolidated net income to be reported at amounts inclusive of both the parents and noncontrolling
interests shares and, separately, the amounts of consolidated net income attributable to the
parent and noncontrolling interest all on the consolidated statement of income; and, if a
subsidiary is deconsolidated, any retained noncontrolling equity investment in the former
subsidiary be measured at fair value and a gain or loss be recognized in net income based on such
fair value. SFAS 160 becomes effective for Bio-Imaging Technologies, Inc. on January 1, 2009.
Management is currently evaluating the potential impact of SFAS 160 on the Financial Statements.
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 in GAAP, and expands
disclosures about fair value measurements. The provisions of this standard apply to other
accounting pronouncements that require or permit fair value measurements. SFAS 157, as it relates
to financial assets and financial liabilities, became effective for Bio-Imaging Technologies, Inc.
on January 1, 2008. On February 12, 2008, the FASB issued FSP No. FAS 157-2, Effective Date of
FASB Statement No. 157, which delays the effective date of SFAS 157 for all nonfinancial assets
and nonfinancial liabilities, except those that are recognized or disclosed at fair value in the
financial statements on at least an annual basis, until January 1, 2009 for calendar year-end
entities. Upon adoption, the provisions of SFAS 157 are to be applied prospectively with limited
exceptions. We have determined that the adoption of SFAS 157, as it relates to financial assets and
financial liabilities did not have an impact on the Consolidated Financial Statements. We are
currently evaluating the potential impact of SFAS 157, as it relates to nonfinancial
51
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
assets and
nonfinancial liabilities, on the Consolidated Financial Statements as we have elected the deferral
of FAS 157-2.
2. Acquisitions
On March 24, 2008, Bio-Imaging acquired Phoenix Data Systems, Inc. (PDS) to expand our
pharmaceutical services in the area of electronic data capture and other eClinical data solutions
to our
clients, (the Acquisition). The Acquisition was made pursuant to an Agreement and Plan of Merger
(the Merger Agreement), dated March 24, 2008, by and among the Company, Bio-Imaging Acquisition
Corporation, a Pennsylvania corporation and wholly-owned subsidiary of the Company (Merger Sub),
and PDS and its Stockholders Representative. Pursuant to the terms of the Merger Agreement, PDS
merged with and into Merger Sub. Following the consummation of the Acquisition, PDS ceased to
exist and Merger Sub became a wholly-owned subsidiary of the Company. In connection with the
Acquisition, the Company also entered into employment agreements with members of the senior
management team of PDS. However, none of these individuals are executive officers of the Company.
Under the terms of the Merger Agreement, the Company acquired all of PDSs outstanding capital
stock. The total consideration paid by the Company to the PDSs stockholders was $23.9 million,
comprised of $6.9 million in cash and 2.3 million shares of common stock, par value $0.00025 per
share, of the Company, with an average closing price per share over the last 30 trading days ending
and including March 19, 2008 of $7.42 (Common Stock). The aggregate purchase price was subject
to a post-closing adjustment based on the Tangible Net Worth (as defined in the Merger Agreement)
of PDS on the Closing Date (as defined in the Merger Agreement). Pursuant to the terms of the
Merger Agreement, five percent of the aggregate consideration was held in escrow for the
finalization of the Closing Tangible Net Worth Statement (as defined in the Merger Agreement). On
June 13, 2008, Bio-Imaging and the Stockholders Representative agreed to a decrease of $230,000 to
the purchase price due to the minimum threshold to the Closing Tangible Net Worth Statement not
being achieved. Bio-Imaging received $64,000 in cash back in June 2008 and 22,453 shares of our
common stock back in July 2008 from the purchase price escrow. Additionally, ten percent of the
aggregate consideration is to be held in escrow to cover any potential indemnification claims under
the Merger Agreement for a period ending no later than March 31, 2009. We also incurred
approximately $1.1 million in acquisition costs. At the Acquisition date, the stock was recorded
at an average price of $7.04 per share.
In connection with the Acquisition, the stockholders of PDS entered into various agreements.
The stockholders of PDS executed stockholders agreements, whereby each stockholder agreed, among
other things, to approve the Acquisition and not to compete in the business area occupied by PDS at
the time of the Acquisition for a reasonable period of time. All stockholders executed lockup
agreements, whereby all stockholders agreed not to directly or indirectly sell, or otherwise
dispose of any shares of the Companys Common Stock received pursuant to the Merger Agreement for a
period of 180 days after the Closing Date (the Initial Lockup Period Date), and certain
additional stockholders agreed not to directly or indirectly offer, sell, contract to sell, pledge,
grant any option to purchase, make any short sale or otherwise dispose of 67% of the shares of the
Companys Common Stock received pursuant to the Merger Agreement for a period beginning on the
Initial Lockup Period Date and continuing to and including the date of the first anniversary of the
Closing Date.
The following table summarizes the final allocation of the total cost of the PDS acquisition
to the assets acquired and the liabilities assumed.
52
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
|
|
|
|
|
(in thousands) |
|
|
|
|
Net Working Capital |
|
$ |
701 |
|
Fixed Assets |
|
|
721 |
|
Other Assets |
|
|
46 |
|
Other Liabilities |
|
|
(175 |
) |
Deferred Tax Liability |
|
|
(854 |
) |
Software |
|
|
552 |
|
Trademark |
|
|
48 |
|
Customer Backlog |
|
|
730 |
|
Customer Relationships |
|
|
665 |
|
Non-Compete Agreements |
|
|
138 |
|
Goodwill, including Workforce |
|
|
21,366 |
|
|
|
|
|
Total Purchase Price |
|
$ |
23,938 |
|
|
|
|
|
The results of operations of PDS from the acquisition date, March 24, 2008 to March 31, 2008
were immaterial; therefore, the Company did not include the results of operations for those eight
days in the Consolidated Statement of Income for the twelve months ended December 31, 2008.
Pro Forma Results. The following schedule includes consolidated statements of income data for
the unaudited pro forma results for the twelve months ended December 31, 2008 and 2007 as if the
Acquisition had occurred as of the beginning of each of the periods presented after giving effect
to certain adjustments. The pro forma results for the twelve months ended December, 31, 2008
include $789,000 of acquisition costs incurred by PDS. The unaudited pro forma information is
provided for illustrative purposes only and is not indicative of the results of operations or
financial condition that would have been achieved if the acquisition would have taken place at the
beginning of each of the periods presented and should not be taken as indicative of our future
consolidated results of operations or financial condition. Pro forma adjustments are tax-effected
at our effective tax rate.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended |
|
|
December 31, 2008, |
(in thousands except per share data) |
|
2008 |
|
2007 |
|
2006 |
|
Total revenue |
|
$ |
73,566 |
|
|
$ |
59,324 |
|
|
$ |
47,424 |
|
Income from continuing operations before
interest and taxes |
|
|
7,783 |
|
|
|
5,523 |
|
|
|
1,429 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations, net of taxes |
|
|
5,300 |
|
|
|
3,723 |
|
|
|
1,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.38 |
|
|
$ |
0.27 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.35 |
|
|
$ |
0.25 |
|
|
$ |
0.03 |
|
53
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
On February 6, 2007, we acquired 100% of the outstanding securities of Theralys S.A., a
company headquartered in Lyon, France to expand our therapeutic expertise in the Central Nervous
System and Neurovascular areas. The aggregate purchase price was 2,958,000 Euros ($3,853,000 as
determined by an agreed upon exchange rate), of which 2,375,000 Euros ($3,093,000) was paid in cash
and $760,000 in value was paid with 93,000 shares of our common stock. We also incurred
approximately $615,000 in acquisition costs. The purchase of the business was accounted for under
the purchase method of accounting. The result of operations of Theralys were included in our financial statements at the
acquisition date in our pharmaceutical contract services business segment. The assets acquired
primarily consisted of $4,153,000 goodwill, $291,000 software, $52,000 customer relationship and
$36,000 non-compete. The pro forma impact of the Theralys acquisition on 2007 results was
immaterial.
3. Discontinued Operations and Assets Held for Sale
In the fourth quarter of 2008 the Company sold its interest in its CapMed business.
Therefore, the financial statements for the years ended December 31, 2008, 2007 and 2006 have been
presented as discontinued operations in the consolidated financial statements. Our exit of the
Capmed business resulted, in part, from our strategy to exit non-strategic businesses. Results of
the CapMed business are reported as discontinued operations for all periods presented.
The following amounts related to the CapMed operations were derived from historical financial
information and have been segregated from continuing operations and reported in discontinued
operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Service revenues |
|
$ |
321 |
|
|
$ |
653 |
|
|
$ |
262 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(2,323 |
) |
|
|
(1,659 |
) |
|
|
(1,555 |
) |
Loss from impairment |
|
|
(2,726 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pretax loss |
|
|
(5,049 |
) |
|
|
(1,659 |
) |
|
|
(1,555 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit from income taxes |
|
|
2,048 |
|
|
|
648 |
|
|
|
591 |
|
|
|
|
|
|
|
|
|
|
|
Net loss from discontinued operations |
|
|
(3,001 |
) |
|
|
(1,011 |
) |
|
|
(964 |
) |
|
|
|
|
|
|
|
|
|
|
In 2008, the Company sold its interest in the CapMed division. The sale generated total gross
proceeds of $500,000 and a pretax loss of $5,049,000 ($3,001,000 , net of income taxes), which was
recognized in the fourth quarter of 2008.
The following is a summary of the assets and liabilities of the CapMed discontinued operations
as of December 31, 2008. The amounts presented below were derived from historical financial
information and adjusted to exclude intercompany receivables and payables between CapMed
discontinued operations and the Company (in thousands):
|
|
|
|
|
Current Assets |
|
|
27 |
|
Fixed Assets |
|
|
1,257 |
|
|
|
|
|
Net Assets and Liabilities |
|
$ |
1,284 |
|
|
|
|
|
54
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
On January 6, 2009, pursuant to the Asset Purchase Agreement by and among the Company and MBI
Benefits, Inc. (the Purchaser), an indirectly owned subsidiary of Metavante Technologies, Inc.
(Metavante), dated as of January 6, 2009 (the Agreement), the Company sold its CapMed Division,
including the divisions Personal Health Record (PHR) software and the patent-pending Personal
HealthKey technology, to Metavante. Under the terms of the Agreement, Metavante paid the Company
an upfront payment of Five Hundred Thousand Dollars ($500,000) in cash and will make an earn-out
payment to the Company based upon a percentage of the gross revenues recognized by Metavante
for contracts entered into with certain prospects set forth on a schedule during certain time
periods in 2009 and 2010. The Company will receive 25% of the gross revenues recognized by
Metavante during any period ending on or prior to December 31, 2010 from the sale pursuant to any
contract the Purchaser enters into with certain prospects during the first six months of 2009.
Additionally, the Company will receive 15% of the gross revenues recognized by Metavante during any
period ending on or prior to December 31, 2010 from the sale pursuant to any contract the Purchaser
enters into with certain prospects during the period commencing on July 1, 2009 and ending on
December 31, 2010.
As a result of the sale, the results of the CapMed operations, which had previously been
presented as a separate reporting segment, are included in discontinued operations in the Companys
consolidated statements of operations. In addition, any assets and liabilities related to these
discontinued operations are presented separately on the consolidated balance sheets, and any cash
flows related to these discontinued operations are presented separately in the consolidated
statements of cash flows. All prior period information has been reclassified to be consistent with
the current period presentation.
4. Property and Equipment
Property and equipment, at cost, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
Estimated |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
Useful Life |
|
Equipment |
|
$ |
8,692 |
|
|
$ |
6,963 |
|
|
5 years |
Equipment under capital leases |
|
|
4,332 |
|
|
|
4,332 |
|
|
5 years |
Furniture and fixtures |
|
|
1,582 |
|
|
|
880 |
|
|
7 years |
Leasehold improvements |
|
|
1,336 |
|
|
|
1,175 |
|
|
5 years |
Computer software costs |
|
|
5,038 |
|
|
|
4,142 |
|
|
5 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,980 |
|
|
|
17,492 |
|
|
|
|
|
Less: Accumulated depreciation
and amortization |
|
|
(13,958 |
) |
|
|
(12,072 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
7,022 |
|
|
$ |
5,420 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated depreciation related to equipment acquired under capital leases amounted to $4.1
million and $3.6 million at December 31, 2008 and 2007, respectively. Accumulated amortization
related to capitalized computer software costs amounted to $2.5 million and $1.9 million at
December 31, 2008 and 2007,, respectively. Depreciation expense for the year ended December 31,
2008 and 2007 were $2.1 million and $2.1 million, respectively.
55
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
5. Intangible Assets
Included in other assets, the following is the acquired intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
Estimated |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
Useful Life |
|
Amortized intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Technology |
|
$ |
843 |
|
|
$ |
291 |
|
|
5 years |
Trademarks |
|
|
48 |
|
|
|
|
|
|
5 years |
Customer backlog |
|
|
1,613 |
|
|
|
218 |
|
|
3-7 years |
Non-competition agreement |
|
|
349 |
|
|
|
211 |
|
|
2-3 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,853 |
|
|
|
720 |
|
|
|
|
|
Accumulated amortization |
|
|
(795 |
) |
|
|
(413 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,058 |
|
|
$ |
307 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
$ |
27,391 |
|
|
$ |
6,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The goodwill relates to the Companys Pharmaceutical Services Segment. The Company has
evaluated the goodwill and has determined that there is no impairment of the values at December 31,
2008. Amortization expense of intangible assets for the year ended December 31, 2008, 2007 and
2006 were $382,000, $283,000 and $293,000, respectively.
Future amortization of the intangible assets is as follows:
|
|
|
|
|
|
|
Year Ending |
|
(in thousands) |
|
December 31, 2008 |
|
2009 |
|
$ |
456 |
|
2010 |
|
|
423 |
|
2011 |
|
|
379 |
|
2012 |
|
|
324 |
|
2013 |
|
|
227 |
|
Thereafter |
|
|
249 |
|
|
|
|
|
|
|
$ |
2,058 |
|
|
|
|
|
The following table details the changes in the carrying amount of goodwill:
|
|
|
|
|
|
|
|
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Balance at the beginning of year |
|
$ |
6,025 |
|
|
$ |
1,874 |
|
Acquisition of businesses |
|
|
21,366 |
|
|
|
4,151 |
|
|
|
|
|
|
|
|
Balance at end of year |
|
$ |
27,391 |
|
|
$ |
6,025 |
|
|
|
|
|
|
|
|
56
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
6. Accrued Expenses
Accrued expenses and other current liabilities at December 31, 2008 and 2007 consist of the
following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Accrued compensation |
|
$ |
3,351 |
|
|
$ |
2,616 |
|
Accrued consulting fees |
|
|
88 |
|
|
|
45 |
|
Accrued income taxes |
|
|
|
|
|
|
314 |
|
Accrued other |
|
|
1,797 |
|
|
|
1,641 |
|
|
|
|
|
|
|
|
|
|
$ |
5,236 |
|
|
$ |
4,616 |
|
|
|
|
|
|
|
|
7. Capital Lease Obligations
Capital lease obligations consist of equipment lease obligations at December 31, 2008 and
2007. The equipment lease obligations are payable in monthly installments ranging from $2,000 to
$3,000 for 2008 and from $4,000 to $16,000 for 2007. Interest rates range from 7.71% to 8.71%
through November 2012, and are collateralized by the related equipment.
In November 2007, PDS entered into a $111,000 transaction whereby they leased office
furniture. The resulting lease is being accounted for as a capital lease. The lease term is for 5
years with an interest rate of 7.71%.
In November 2006, PDS entered into a $78,000 transaction whereby they leased computer hardware
and software. The resulting lease is being accounted for as a capital lease. The lease term is
for 2.5 years with an interest rate of 8.71%.
In November 2004, PDS entered into a $95,000 transaction whereby they leased office
furniture. The resulting lease is being accounted for as a capital lease. The lease term is for 5
years with an interest rate of 7.90%.
The following is a schedule, by year, of the future minimum payments under capital leases,
together with the present value of the net minimum payments as of December 31, 2008:
|
|
|
|
|
(in thousands) |
|
2009 |
|
$ |
61 |
|
2010 |
|
|
29 |
|
2011 |
|
|
28 |
|
2012 |
|
|
26 |
|
2013 and thereafter |
|
|
|
|
|
|
|
|
Total minimum capital lease payments |
|
|
144 |
|
Less amount representing interest |
|
|
(25 |
) |
|
|
|
|
Total present value of minimum payment |
|
$ |
119 |
|
Less current portion of such obligations |
|
|
(54 |
) |
|
|
|
|
Long-term capital lease obligations |
|
|
65 |
|
|
|
|
|
8. Stock Based Compensation
Effective January 1, 2006, we adopted the provisions of Statement of Financial Accounting
Standards No. 123R, Share-Based Payment (SFAS 123R), which establishes the financial accounting
57
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
and
reporting standards for stock-based compensation plans. SFAS 123R requires the measurement and
recognition of compensation expense for all stock-based awards made to employees and directors.
The stock-based compensation cost is measured at the grant date, based on the calculated fair value
of the award, and is recognized as an expense on a straight-line basis over the requisite service
period of the entire award. This period is generally the vesting period of the corresponding
award. We have adopted the forfeiture rate on stock option grants issued after January 1, 2006 and
the application of the forfeiture rate on unvested stock options at January 1, 2006 was immaterial
to our financial statement.
At December 31, 2008, the Company has one stock-based employee compensation plan. The
compensation cost that has been recorded to income under the plan for the year ended December 31,
2008 was $649,000, of which $315,000 is a result of the expensing of stock options pursuant to FAS
123R, $240,000 is a result of expensing restricted stock units issued to our Board of Directors and
$94,000 is a result of expensing a potential stock award to our President and Chief Executive
Officer.
The following table presents the total stock-based compensation expense resulting from stock
options and restricted stock unit awards:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year |
|
|
For the year |
|
|
For the year |
|
|
|
ended |
|
|
ended |
|
|
ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Cost of revenues |
|
$ |
386 |
|
|
$ |
335 |
|
|
$ |
255 |
|
General and administrative |
|
|
83 |
|
|
|
66 |
|
|
|
50 |
|
Sales and marketing |
|
|
94 |
|
|
|
73 |
|
|
|
52 |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
expense before income
taxes |
|
$ |
563 |
|
|
$ |
474 |
|
|
$ |
357 |
|
|
|
|
|
|
|
|
|
|
|
The fair value of each option granted is estimated on the date of grant using the
Black-Scholes option pricing model with the following weighted average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
2007 |
|
2006 |
Risk-free interest rate (range) |
|
|
2.29-2.63 |
% |
|
|
4.13-4.48 |
% |
|
|
4.61-4.94 |
% |
Dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected volatility |
|
|
55.00-56.00 |
% |
|
|
56.00 |
% |
|
|
58.00 |
% |
Expected term (in years) |
|
|
4.00-5.00 |
|
|
|
4.00-5.00 |
|
|
|
4.00 |
|
Expected Volatility. Expected volatility is calculated on a weekly basis over the expected term of
the option using the companys common stock close price.
Expected Term. The expected term is based on historical observations of employee exercise patterns
during our history.
Risk-Free Interest Rate. The interest rate used in valuing awards is based on the yield at the time
of grant of a U.S. Treasury security with an equivalent remaining term.
58
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Dividend Yield. The Company has never paid cash dividends, and does not currently intend to pay
cash dividends, and thus has assumed a 0% dividend yield.
Pre-Vesting Forfeitures. Estimates of pre-vesting option forfeitures are based on our experience.
We used a 10% forfeiture rate assumption. We will adjust our estimate of forfeitures over the
requisite service period based on the extent to which actual forfeitures differ, or are expected to
differ, from such estimates.
Stock Options
Fiscal 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
|
(in thousands) |
|
|
|
|
|
Exercise |
|
Contractual |
|
Aggregate |
Stock Options |
|
Shares |
|
Price |
|
Term |
|
Intrinsic Value |
Outstanding at
December 31, 2006 |
|
|
1,871 |
|
|
$ |
2.61 |
|
|
|
4.78 |
|
|
$ |
10,193 |
|
Granted |
|
|
148 |
|
|
|
8.02 |
|
|
|
6.02 |
|
|
|
9 |
|
Exercised |
|
|
(342 |
) |
|
|
1.43 |
|
|
|
|
|
|
|
489 |
|
Forfeited or expired |
|
|
(49 |
) |
|
|
3.89 |
|
|
|
|
|
|
|
190 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at
December 31 ,2007 |
|
|
1,628 |
|
|
|
3.31 |
|
|
|
4.37 |
|
|
|
7,763 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested at
December 31, 2007 |
|
|
228 |
|
|
|
6.54 |
|
|
|
5.82 |
|
|
|
350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at
December 31, 2007 |
|
|
1,400 |
|
|
|
2.79 |
|
|
|
4.13 |
|
|
|
7,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
|
(in thousands) |
|
|
|
|
|
Exercise |
|
Contractual |
|
Aggregate |
Stock Options |
|
Shares |
|
Price |
|
Term |
|
Intrinsic Value |
Outstanding at
December 31, 2007 |
|
|
1,628 |
|
|
|
3.31 |
|
|
|
4.37 |
|
|
|
7,763 |
|
Granted |
|
|
395 |
|
|
|
7.53 |
|
|
|
6.37 |
|
|
|
(1,529 |
) |
Exercised |
|
|
(290 |
) |
|
|
1.64 |
|
|
|
|
|
|
|
473 |
|
Forfeited or Expired |
|
|
(15 |
) |
|
|
1.80 |
|
|
|
|
|
|
|
27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at
December 31, 2008 |
|
|
1,718 |
|
|
|
4.58 |
|
|
|
4.39 |
|
|
|
(1,574 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested at
December 31, 2008 |
|
|
541 |
|
|
|
7.23 |
|
|
|
5.94 |
|
|
|
(1,934 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at
December 31, 2008 |
|
|
1,177 |
|
|
|
3.35 |
|
|
|
3.67 |
|
|
|
360 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
The weighted-average grant date fair value of options granted for the years ended December 31,
2008, 2007 and 2006 was $7.53, $8.02 and $4.06, respectively. Cash received from option exercises
for the years ended 2008, 2007 and 2006 was $386,000, $301,000, and $153,000, respectively.
As of December 31, 2008, there was $1.5 million of total unrecognized compensation cost
related to nonvested stock options. That cost is expected to be recognized over a period of 4.25
years.
During 2002, the Companys Board of Directors and stockholders approved the adoption of the
Bio-Imaging Technologies, Inc. Stock Incentive Plan (the Plan) and authorized the issuance of
950,000 shares of the Companys common stock under the plan. In May 2005, the Companys Board of
Directors and stockholders approved an amendment to the Plan and authorized the issuance of an
additional 750,000 shares of the Companys common stock under the plan. In May 2008, the Companys
Board of Directors and stockholders approved an amendment to the Plan and authorized the issuance
of an additional 1,000,000 shares of the Companys common stock under the plan.
Each option is exercisable into one share of common stock. Options granted pursuant to the
plan may be qualified incentive stock options, as defined in the Internal Revenue Code, or
nonqualified options. The exercise price of qualified incentive stock options may not be less than
the fair market value of the Companys Common Stock at the date of grant. The term of such stock
options granted under the plan shall not exceed ten years and the vesting schedule of such stock
option grants varies from immediate vesting on date of grant to vesting over a period of up to five
years.
The following table summarizes the transactions pursuant to the Companys stock option plan
for the three years ended December 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number of Shares |
|
Option Grant Date Fair |
(in thousands) |
|
Underlying Options |
|
Value |
Non-vested at December 31, 2005 |
|
|
78 |
|
|
$ |
2.83 |
|
Granted |
|
|
198 |
|
|
$ |
3.53 |
|
Vested |
|
|
(96 |
) |
|
$ |
3.04 |
|
Non-vested at December 31, 2006 |
|
|
180 |
|
|
$ |
3.49 |
|
Granted |
|
|
148 |
|
|
$ |
6.71 |
|
Vested |
|
|
(100 |
) |
|
$ |
3.73 |
|
Non-vested at December 31, 2007 |
|
|
228 |
|
|
$ |
5.47 |
|
Granted |
|
|
395 |
|
|
$ |
6.70 |
|
Vested |
|
|
(82 |
) |
|
$ |
5.66 |
|
Non-vested at December 31, 2008 |
|
|
541 |
|
|
$ |
6.34 |
|
1.7 million, 1.6 million and 1.7 million options are exercisable at December 31, 2008, 2007
and 2006, respectively, at a weighted average exercise price of $4.58, $3.31 and $2.46,
respectively.
The intrinsic value of stock options exercised for the years ended December 31, 2008, 2007 and
60
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
2006 respectively, were $586,000, $2.3 million and $471,000.
At December 31, 2008, by range of exercise prices, the number of shares represented by
outstanding options with their weighted average exercise price and weighted average remaining
contractual life, in years, and the number of shares represented by exercisable options with their
weighted average exercise price are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
Options Exercisable |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
Number |
|
Average |
|
Weighted |
|
Number |
|
Average |
|
Weighted |
Range of |
|
Outstanding |
|
Remaining |
|
Average |
|
Exercisable |
|
Remaining |
|
Average |
Exercise |
|
(in |
|
Contractual |
|
Exercise |
|
(in |
|
Contractual |
|
Exercise |
Prices |
|
thousands) |
|
Life |
|
Price |
|
thousands) |
|
Life |
|
Price |
|
$0.63-$0.88 |
|
|
306 |
|
|
1.45 years |
|
$ |
0.73 |
|
|
|
306 |
|
|
1.45 years |
|
$ |
0.73 |
|
$1.00-$1.16 |
|
|
144 |
|
|
2.92 years |
|
$ |
1.11 |
|
|
|
144 |
|
|
2.92 years |
|
$ |
1.11 |
|
$1.28-$2.80 |
|
|
109 |
|
|
2.95 years |
|
$ |
2.20 |
|
|
|
109 |
|
|
2.95 years |
|
$ |
2.20 |
|
$3.05-$5.10 |
|
|
440 |
|
|
4.93 years |
|
$ |
4.20 |
|
|
|
383 |
|
|
5.04 years |
|
$ |
4.23 |
|
$6.97-$8.06 |
|
|
719 |
|
|
5.82 years |
|
$ |
7.50 |
|
|
|
235 |
|
|
5.13 years |
|
$ |
7.25 |
|
|
|
|
$0.63-$8.06 |
|
|
1,718 |
|
|
4.39 years |
|
$ |
4.58 |
|
|
|
1,177 |
|
|
3.67 years |
|
$ |
3.35 |
|
|
|
|
Restricted Stock Units: On March 1, 2006, we entered into an employment agreement with our
President and Chief Executive Officer that expires on February 28, 2009. This agreement amended
and restated the prior agreement that originally expired January 31, 2007 and extended the term of
service through February 28, 2009. Pursuant to this employment agreement, our President and Chief
Executive Officer can potentially receive up to 25,000 restricted shares of the companys common
stock for fiscal 2008. Based on managements assumptions, we recognized the related proportionate
expense of $84,000 for 25,000 shares of these restricted stock units for fiscal 2008 based on a
fair value of $3.66 at December 31, 2008. These restricted shares are service and
performance-based and the value is determined by its fair value (as if underlying shares were
vested and issued). On March 4, 2009, we entered into an employment agreement with our President
and Chief Executive Officer effective March 1, 2009 and expires February 28, 2012.
9. Commitments
The Company has entered into non-cancelable operating leases for office facilities which
expire through November 2018.
Future minimum aggregate rental payments on the noncancelable portion of the lease are as
follows:
61
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
|
|
|
|
|
|
|
Year Ending |
|
(in thousands) |
|
December 31, 2008 |
|
2009 |
|
$ |
2,506 |
|
2010 |
|
|
1,874 |
|
2011 |
|
|
1,835 |
|
2012 |
|
|
1,873 |
|
2013 |
|
|
1,654 |
|
Thereafter |
|
|
7,245 |
|
|
|
|
|
|
|
$ |
16,987 |
|
|
|
|
|
Rent expense charged to operations for the year ended December 31, 2008, 2007 and 2006 was
$2.2 million, $1.8 million and $1.6 million, respectively.
On March 4, 2009, the Company entered into an employment agreement with its President and
Chief Executive Officer effective March 1, 2009 and expires on February 28, 2012. In addition, the
Company has employment agreements with its Chief Financial Officer and the President of eClinical
division. The Chief Financial Officers agreement expires February 5, 2010 and is renewable on an
annual basis. The President of eClinical divisions agreement expires September 30, 2009 and is
renewable on an annual basis. The aggregate amount due from January 1, 2009 through the expiration
under these agreements was $919,000. At December 31, 2008, the Company has recorded compensation
of $84,000,
which we believe will be paid in stock, to its President and Chief Executive Officer pursuant
to his employment agreement.
10. Employee Benefit Plan
The Company sponsors the Bio-Imaging Technologies, Inc. Employees Savings Plan (the 401(k)
Plan), a defined contribution plan with a cash or deferred arrangement. Under the terms of the
401(k) Plan, eligible employees may elect to reduce their annual compensation up to the annual
limit prescribed by the Internal Revenue Service. The Company may make discretionary matching
contributions in cash, subject to plan limits. The Company made contributions of $235,000,
$158,000 and $54,000 for the year ended December 31, 2008, 2007 and 2006, respectively.
11. Major Customers
No one client represented more than 10% of our service revenues for the year ended December
31, 2008, while for the year ended December 31, 2007, one client, Hoffmann-La Roche, which
encompassed 11 projects, accounted for 13.4%. For the year ended December 31, 2006, one client,
Novartis Pharmaceuticals, Inc., which encompassed 14 projects, accounted for 10.9% or more of our
service revenues.
12. Income Taxes
The income tax provision from continuing operations consist of the following:
62
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
2,027 |
|
|
$ |
546 |
|
|
$ |
121 |
|
State and local |
|
|
136 |
|
|
|
504 |
|
|
|
207 |
|
Foreign |
|
|
167 |
|
|
|
164 |
|
|
|
211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,330 |
|
|
$ |
1,214 |
|
|
$ |
539 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
730 |
|
|
|
458 |
|
|
|
269 |
|
State and local |
|
|
42 |
|
|
|
(172 |
) |
|
|
(129 |
) |
Foreign |
|
|
|
|
|
|
|
|
|
|
(64 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
772 |
|
|
|
286 |
|
|
|
76 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision from
continuing operations |
|
$ |
3,102 |
|
|
$ |
1,500 |
|
|
$ |
615 |
|
|
|
|
|
|
|
|
|
|
|
The Companys reconciliation of the expected federal provision rate to the effective income
tax rate from continuing operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
2008 |
|
2007 |
|
2006 |
Tax provision at statutory rate |
|
|
34.0 |
% |
|
|
34.0 |
% |
|
|
34.0 |
% |
State and local income taxes, net of federal benefit |
|
|
2.8 |
% |
|
|
5.7 |
% |
|
|
4.4 |
% |
Permanent differences |
|
|
0.4 |
% |
|
|
0.6 |
% |
|
|
1.6 |
% |
Foreign rate difference |
|
|
(0.5 |
)% |
|
|
(1.0 |
)% |
|
|
(1.1 |
)% |
Other |
|
|
(1.9 |
)% |
|
|
(0.2 |
)% |
|
|
(1.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective income tax rate from continuing
operations |
|
|
34.8 |
% |
|
|
39.1 |
% |
|
|
37.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys domestic and foreign income before income tax from continuing operations is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Domestic income before income tax |
|
$ |
8,290 |
|
|
$ |
4,891 |
|
|
$ |
2,743 |
|
Foreign income before income tax |
|
|
612 |
|
|
|
600 |
|
|
|
431 |
|
|
|
|
|
|
|
|
|
|
|
Total income before income tax
from continuing operations |
|
$ |
8,902 |
|
|
$ |
5,491 |
|
|
$ |
3,174 |
|
|
|
|
|
|
|
|
|
|
|
The components of net deferred tax assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Accrued expenses |
|
$ |
47 |
|
|
$ |
33 |
|
Allowance for doubtful accounts |
|
|
4 |
|
|
|
12 |
|
Deferred revenue |
|
|
3,212 |
|
|
|
2,996 |
|
Net operating loss carryforwards |
|
|
580 |
|
|
|
375 |
|
63
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Restricted stock |
|
|
183 |
|
|
|
130 |
|
Stock options |
|
|
254 |
|
|
|
130 |
|
Amortization of acquisition costs |
|
|
|
|
|
|
17 |
|
Impairment of assets |
|
|
723 |
|
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
5,003 |
|
|
|
3,693 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Excess of tax over book depreciation |
|
|
(1,653 |
) |
|
|
(676 |
) |
Amortization of acquisition costs |
|
|
(479 |
) |
|
|
|
|
Prepaid expenses |
|
|
(340 |
) |
|
|
(370 |
) |
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
|
(2,472 |
) |
|
|
(1,046 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance |
|
|
(374 |
) |
|
|
(408 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
2,157 |
|
|
$ |
2,239 |
|
|
|
|
|
|
|
|
The Company records a valuation allowance to reduce its deferred tax assets to an amount that
is
more likely than not to be realized. In assessing the need for the valuation allowance, the
Company considers future taxable income and on-going prudent and feasible tax planning strategies.
In the event that the Company was to determine that, in the future, they would be able to realize
the deferred tax assets in excess of its net recorded amount, an adjustment to the deferred tax
asset would be made, thereby increasing net income in the period such determination was made.
Likewise, should the Company determine that it is more likely than not that it will be unable to
realize all or part of the net deferred tax asset in the future, an adjustment to the deferred tax
asset would be charged, thereby decreasing net income in the period such determination was made.
The Company has accumulated tax losses, which include allowable deductions related to
exercised employee stock options, generating federal and state net operating loss (NOL) credit
carryforwards of $1.3 million as of December 31, 2008 and $1.1 million as of December 31, 2007.
Under limitations imposed by Internal Revenue Code Section 382, certain potential changes in
ownership of the Company, which may be outside the Companys knowledge or control, may restrict
future utilization of these carryforwards. Due to such ownership changes that have occurred in
prior years, the Company has estimated that $1.1 million of the current federal net operating loss
will likely expire unused, in the years 2009 through 2022, due to Internal Revenue Code Section 382
limitations. GAAP requires that the Company establish a valuation allowance for any portion of its
deferred tax assets for which management believes that it is more likely than not the Company will
be unable to utilize the asset to offset future taxes. The Company will continue to evaluate the
potential use of its deferred tax assets and the need for a valuation allowance by considering
future taxable income and on-going prudent and feasible tax planning strategies. Subsequent
revisions to the estimated realizable value of the deferred tax assets could cause the provision
for income taxes to vary significantly from period to period, although the cash tax payments would
remain unaffected until the NOL credit carryforward is fully utilized or has expired. Our deferred
tax assets are primarily comprised of the temporary book to tax differences related to deferred
revenue.
The Company recognizes contingent liabilities for any tax related exposures when those
exposures are more likely than not to occur.
64
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
The tax benefit of the stock option deductions have been recorded to additional paid-in
capital in the amount of $290,000 and $643,000 for the year ended December 31, 2008 and 2007,
respectively.
The Company has not provided for U.S. federal income and foreign withholding taxes on
approximately $2.6 million of undistributed earnings from its non-U.S. operations as of December
31, 2008 because such earnings are intended to be reinvested indefinitely outside of the United
States.
On January 1, 2007, we adopted FASB Interpretation No. 48 Accounting for Uncertainty in
Income Taxes (FIN 48). FIN 48 prescribes a recognition threshold that a tax position is required
to meet before being recognized in the financial statements.
Historically, our tax provision for financial statement purposes and the actual tax returns
have been prepared using consistent methodologies. There were no material unrecognized tax
benefits as of December 31, 2006. Accordingly, the adoption did not have a material impact on the
financial statements.
We do not expect the unrecognized tax benefit to materially change during the next 12 months.
Any interest and penalties incurred on settlements of outstanding tax positions would be recorded
as a component of tax expense. We file our tax returns as prescribed by the tax laws of the
jurisdictions in which we operate. Our federal tax returns for years 2005, 2006 and 2007 are
subject to examination. Our state taxes for years 2000 through 2007 are subject to examination.
Our foreign taxes for years 2002 through 2006 are subject to examination by the respective
authorities.
13. Derivatives
We have not entered into any derivatives or other hedging instruments during the twelve months
ended December 31, 2008. As of December 31, 2008, there are no outstanding derivative positions.
For instruments that are associated with the hedge of cash flows, hedge effectiveness criteria also
require that it be probable that the underlying transaction will occur. Instruments that meet
established accounting criteria are formally designated as hedges at the inception of the contract.
These criteria demonstrate that the derivative is expected to be highly effective at offsetting
changes in fair value or cash flows of the underlying exposure both at inception of the hedging
relationship and on an ongoing basis. The assessment for effectiveness is formally documented at
hedge inception and reviewed at least quarterly throughout the designated hedge period.
In accordance with our current foreign exchange rate risk management policy, since inception,
we have purchased twenty monthly Euro call options. Nineteen monthly call options are in the
amount of 250,000 Euros each and one call option is for 200,000 Euros for anticipated additional
costs in May, 2006. The first expiration was on July 27, 2005 and the last expiration was in March
2007 with a strike price ranging from $1.26 to $1.27. These options were to hedge against the
exposure to variability in our cash flows due to the Euro denominated costs for our Netherlands
subsidiary. We paid a total premium of $132,000 for the options and at December 31, 2006 had
recorded an Accumulated Other Comprehensive Gain of $17,000 in the stockholders equity section of
the Balance Sheet due to changes in the value of this derivative.
During the twelve months ended December 31, 2007, we exercised two options. A gain of $10,000
was recognized in the Consolidated Statement of Operations during fiscal 2007.
65
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Under our current foreign exchange rate risk management policy, and upon expiration or
ineffectiveness of the derivative, we will record a gain or loss from the derivative that is
deferred in stockholders equity to cost of revenues and general and administrative expenses in the
Consolidated Statement of Operations based on the nature of the underlying cash flow hedged.
14. Foreign Operations
Foreign customers accounted for 28% and 43% of service revenues for the year ended December
31, 2008 and 2007, respectively.
The Company maintains offices in Newtown and King of Prussia, Pennsylvania, Leiden, the
Netherlands and Lyon, France. Net fixed assets located in Newtown, Pennsylvania were $4.4 million
and $6.3 million at December 31, 2008 and 2007, respectively. Net fixed assets located in King of
Prussia, Pennsylvania were $1.1 million and $0 at December 31, 2008 and 2007, respectively. Net
fixed assets
located in Leiden, the Netherlands, were $1.3 million and $1.3 million at December 31, 2008
and 2007, respectively. Net fixed assets located in Lyon, France were $722,000 and $365,000 at
December 31, 2008 and 2007, respectively.
15. Related Party Transactions
At December 31, 2008, Covance, Inc. owned 16% of the Companys outstanding Common Shares. The
Company and Covance, Inc. have entered into various services agreements, for Covances clients that
sponsor clinical trials, in the ordinary course of business. The Companys service revenues from
Covance, Inc. include $1.7 million, $1.2 million and $821,000 for the year ended December 31, 2008,
2007 and 2006, respectively. At December 31, 2008 and 2007, the amounts due from Covance, Inc.
were $122,000 and $3,000, respectively as reported in accounts receivable.
66
|
|
|
Item 9. |
|
Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure. |
None.
Item 9A(T). Controls and Procedures.
Evaluation of Disclosure Controls and Procedures. We evaluated, under the supervision and with the
participation of the Chief Executive Officer and Chief Financial Officer, the effectiveness of the
design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) under the Securities and Exchange Act of 1934 (Exchange Act), as amended) as of
December 31, 2008, the end of the period covered by this report on Form 10-K. Based on this
evaluation, our President and Chief Executive Officer (principal executive officer) and our Chief
Financial Officer (principal accounting and financial officer) have concluded that our disclosure
controls and procedures were effective at December 31, 2008. Disclosure controls and procedures
are designed to ensure that information required to be disclosed by us in the reports that we file
or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the
time periods specified in the SECs rules and forms, and were operating in an effective manner for
the period covered by this report, and (ii) is accumulated and communicated to management,
including the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely
decisions regarding required disclosures.
Managements Report on Internal Control Over Financial Reporting. Our management is responsible
for establishing and maintaining adequate internal control over financial reporting. Internal
control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the
Exchange Act and is a process designed by, or under the supervision of, our principal executive and
principal financial officers and effected by our board of directors, management and other
personnel, 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, and includes those policies and procedures that pertain to the maintenance
of records that in reasonable detail accurately and fairly reflect the transactions and
dispositions of our assets;
|
|
|
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 our management and directors; and |
|
|
|
|
Provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use or disposition of the companys assets that could have a material effect
on the financial statements. |
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. 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.
Our management assessed the effectiveness of the companys internal control over financial
reporting as of December 31, 2008. In making this assessment, the companys management used the
criteria set
67
forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO)
in Internal Control-Integrated Framework.
Based on its evaluation, our management has concluded that, as of December 31, 2008, our
internal control over financial reporting was effective.
This annual report does not include an attestation report of the companys registered public
accounting firm regarding internal control over financial reporting. Managements report was not
subject to attestation by the companys registered public accounting firm pursuant to temporary
rules of the Securities and Exchange Commission that permit the company to provide only
managements report in this annual report.
Changes in internal control over financial reporting There was no change in our internal controls
over financial reporting that occurred during the year ended December 31, 2008 that has materially
affected, or is reasonably likely to materially affect, our internal controls over financial
reporting.
Item 9B. Other Information.
None.
68
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
On March 3, 2009, our Board of Directors elected Peter Benton,
a current employee of the Company, as the new Executive Vice President,
President eClinical, an executive officer of the Company. The Board of Directors also changed the title of Ted
I. Kaminer from Senior Vice President and Chief Financial Officer to
Executive Vice President of Finance and Administration and
Chief Financial Officer, and David A. Pitler from Senior Vice President, Operations to Executive
Vice President, President Bio-Imaging Services. Colin G. Miller,
Senior Vice President, Medical
Affairs will no longer be an executive officer of the Company.
The information relating to our directors, nominees for election as directors and executive
officers under the headings Election of Directors and Executive Officers in our definitive
proxy statement for the 2009 Annual Meeting of Stockholders is incorporated herein by reference to
such proxy statement.
We have adopted a written code of business conduct and ethics that applies to our principal
executive officer and principal financial and accounting officer, or persons performing similar
functions. We intend to disclose any amendments to, or waivers from, our code of business conduct
and ethics that are required to be publicly disclosed pursuant to rules of the SEC and the NASDAQ
Global Market by filing such amendment or waiver with the SEC.
Item 11. Executive Compensation.
On March 4, 2009, our Board of Directors approved the employment agreement to be entered into
with Mark Weinstein, President and Chief Executive Officer of the Company. This agreement
is for a three year term, beginning as of March 1, 2009 and ending on February 28, 2012. The terms
and conditions of the employment agreement are: (i) an annual base salary of $370,000 in addition
to certain benefits and perquisites; (ii) cash bonuses in amounts
that are to be determined by the Compensation Committee of the Board
of Directors in accordance with the Companys management
incentive policy; (iii) the grant of a restricted stock award
covering 40,000 shares of our common stock to vest over a three-year
period, and thereafter, equity incentive
compensation awards from the Companys incentive compensation plans on a basis commensurate with
his position and responsibility is the sole discretion of the
Compensation Committee; (iv) a car allowance not to exceed $750.00 per month;
and (v) continuation of
annual salary payments for a period of 180 days after the termination date in the event that Mr.
Weinstein is terminated from employment with the Company for reasons other than cause, death or
disability.
The discussion under the heading Executive Compensation in our definitive proxy statement
for the 2009 Annual Meeting of Stockholders is incorporated herein by reference to such proxy
statement.
|
|
|
Item 12. |
|
Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters. |
The discussion under the heading Security Ownership of Certain Beneficial Owners and
Management in our definitive proxy statement for the 2009 Annual Meeting of Stockholders is
incorporated herein by reference to such proxy statement.
69
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The discussion under the headings Certain Relationships and Related Transactions and
Election of Directors in our definitive proxy statement for the 2009 Annual Meeting of
Stockholders is incorporated herein by reference to such proxy statement.
Item 14. Principal Accounting Fees and Services.
The discussion under the heading Independent Registered Public Accounting Firm Fees and Other
Matters in our definitive proxy statement for the 2009 Annual Meeting of Stockholders is
incorporated herein by reference to such proxy statement.
Item 15. Exhibits, Financial Statement Schedules.
(a)(1) Financial Statements. The financial statements filed as part of this report are listed
on the Index to the Consolidated Financial Statements.
(a)(2) Financial Statement Schedules. Schedules are omitted because they are not applicable
or the required information is shown in the consolidated financial statements or notes thereto.
(a)(3) Exhibits. Reference is made to the Exhibit Index. The exhibits are included, or
incorporated by reference, in the Annual Report on Form 10-K and are numbered in accordance with
Item 601 of Regulation S-K.
70
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 this 5th day of March, 2009.
|
|
|
|
|
|
BIO-IMAGING TECHNOLOGIES, INC. |
|
|
By: |
/s/ Mark L. Weinstein |
|
|
|
Mark L. Weinstein, President and Chief Executive |
|
|
|
Officer |
|
71
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/ Mark L. Weinstein
Mark L. Weinstein |
|
President and Chief
Executive Officer and Director
(principal executive officer) |
|
March 5, 2009 |
|
|
|
|
|
/s/ Ted I. Kaminer
Ted I. Kaminer |
|
Executive Vice President of Finance
and
Administration and Chief Financial Officer
(principal financial and
accounting officer) |
|
March 5,
2009 |
|
|
|
|
|
/s/ Jeffrey H. Berg, Ph.D.
Jeffrey H. Berg, Ph.D. |
|
Director |
|
March 5, 2009 |
|
|
|
|
|
/s/ Richard F. Cimino
Richard F. Cimino |
|
Director |
|
March 5, 2009 |
|
|
|
|
|
/s/ E. Martin Davidoff, CPA, Esq.
E. Martin Davidoff, CPA, Esq. |
|
Director |
|
March 5, 2009 |
|
|
|
|
|
/s/ David E. Nowicki, D.M.D.
David E. Nowicki, D.M.D. |
|
Chairman of the Board
and Director |
|
March 5,
2009 |
|
|
|
|
|
/s/ Adeoye Y. Olukotun
Adeoye Y. Olukotun, M.D., M.P.H., |
|
Director |
|
March 5, 2009 |
F.A.C.C., FAHA |
|
|
|
|
|
|
|
|
|
/s/ David Stack
David Stack |
|
Director |
|
March 5, 2009 |
|
|
|
|
|
/s/ James A. Taylor, Ph.D.
James A. Taylor, Ph.D. |
|
Director |
|
March 5, 2009 |
72
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
No. |
|
Description of Exhibit |
2.1
|
|
Asset Purchase Agreement, dated October 25, 2001, by and between
Bio-Imaging Technologies, Inc. and Quintiles, Inc. Incorporated
by reference to Exhibit 2.1 of our Current Report on Form 8-K
dated October 25, 2001. |
|
|
|
2.2
|
|
Agreement and Plan of Merger, dated March 24, 2008, by and among
Bio-Imaging Technologies, Inc., Bio-Imaging Acquisition
Corporation and Phoenix Data Systems, Inc. and James G.
Fitzgerald, as Stockholders Representative. Incorporated by
reference to Exhibit 2.2 of our Current Report on Form 8-K/A,
dated March 24, 2008. |
|
|
|
2.3
|
|
Asset Purchase Agreement, dated January 6, 2009, by and between
Bio-Imaging Technologies, Inc. and MBI Benefits, Inc.** |
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Bio-Imaging Technologies,
Inc. Incorporated by reference to Exhibit 3.1 of our Registration
Statement on Form S-1 (File Number 33-47471), which became
effective on June 18, 1992. Amendments incorporated by reference
to Exhibit 3.1 of our Annual Report on Form 10-K for the year
ended September 30, 1993 and to Exhibit 3.1 of our Quarterly
Report on Form 10-QSB for the quarter ended March 31, 1995. |
|
|
|
3.2
|
|
Amended and Restated By-Laws of Bio-Imaging Technologies, Inc.
Incorporated by reference to Exhibit 3.1 of our Quarterly Report
on Form 10-QSB for the quarter ended June 30, 2001. |
|
|
|
4.1
|
|
Specimen Common Stock Certificate. Incorporated by reference to
Exhibit 4.1 of our Registration Statement on Form S-1 (File Number
33-47471), which became effective on June 18, 1992. |
|
|
|
4.2
|
|
Registration Agreement, dated October 13, 1994, between
Bio-Imaging Technologies, Inc. and Corning Pharmaceuticals
Services Inc., now Covance Inc. Incorporated by reference to
Exhibit 4.1 of our Current Report on Form 8-K, dated October 13,
1994. |
|
|
|
4.3
|
|
Registration Rights Agreement, dated as of October 25, 2001, by
and between Bio-Imaging Technologies, Inc. and Quintiles, Inc.
Incorporated by reference to Exhibit 2 of our Current Report on
Form 8-K/A, dated October 25, 2001. |
|
|
|
10.1*
|
|
2002 Stock Incentive Plan, adopted by the stockholders of
Bio-Imaging Technologies, Inc. on February 27, 2002, as amended
and restated on April 14, 2005. Incorporated by reference to
Exhibit 99.1 of our Registration Statement on Form S-8, dated
December 21, 2006. |
|
|
|
10.2*
|
|
401(k) Plan. Incorporated by reference to Exhibit 10.7 of our
Registration Statement on Form S-1 (File Number 33-47471), which
became effective on June 18, 1992. |
|
|
|
10.3
|
|
Form of Employees Invention Assignment, Confidential Information
and Non-Competition Agreement. Incorporated by reference to
Exhibit 10.9 of our Annual Report on Form 10-K for the fiscal year
ended September 30, 1992. |
|
|
|
10.4
|
|
Stock Purchase Agreement, dated October 13, 1994, by and between
Bio-Imaging Technologies, Inc. and Covance Inc. Incorporated by
reference to Exhibit 10.2 of our Current Report on Form 8-K dated
October 13, 1994. |
|
|
|
10.5*
|
|
Invention Assignment and Confidential Information Agreement, dated
January 20, 2000, by and between Bio-Imaging Technologies, Inc.
and Mark L. Weinstein. Incorporated by reference to Exhibit 10.1
of our Quarterly Report on Form 10-QSB for the quarter ended
December 31, 1999. |
73
|
|
|
Exhibit |
|
|
No. |
|
Description of Exhibit |
10.6*
|
|
Employment Agreement, dated March 4, 2009, by and between
Bio-Imaging Technologies, Inc. and Mark L. Weinstein. |
|
|
|
10.7
|
|
Agreement of Lease by and between 826 Newtown Associates, L.P. and
Bio-Imaging Technologies, Inc., dated December 1, 2008, such lease
superseding and rendering null and void all previous leases
related to the Premises at 826 and 828 Newtown-Yardley Road,
Newtown, Pennsylvania. |
|
|
|
10.8
|
|
Office Space Lease, dated September 22, 1999, by and between
Yardley Road Associates, L.P. and Bio-Imaging Technologies, Inc.
Incorporated by reference to Exhibit 10.9 of our Annual Report on
Form 10-KSB for the fiscal year ended September 30, 1999. |
|
|
|
10.9
|
|
Office Space Lease, dated September 11, 2000, by and between
Angelo Investment Company and Bio-Imaging Technologies, Inc.
Incorporated by reference to Exhibit 10.11 of our Annual Report on
Form 10-KSB for the fiscal year ended September 30, 2000. |
|
|
|
10.10*
|
|
Employment Agreement, dated February 6, 2003, by and between
Bio-Imaging Technologies, Inc. and Ted I. Kaminer. Incorporated
by reference to Exhibit 10.1 of our Quarterly Report on Form
10-QSB/A for the quarter ended March 31, 2003. |
|
|
|
10.11
|
|
Securities Purchase Agreement, dated September 15, 2003, by and
between Bio-Imaging Technologies, Inc. and certain institutional
investors. Incorporated by reference to Exhibit 10.1 of our
Current Report on Form 8-K dated September 15, 2003. |
|
|
|
10.12
|
|
Registration Rights Agreement, dated September 15, 2003, by and
between Bio-Imaging Technologies, Inc. and certain institutional
investors. Incorporated by reference to Exhibit 10.2 of our
Current Report on Form 8-K, dated September 15, 2003. |
|
|
|
10.13*
|
|
Form of Amended Executive Retention Agreement by and between
Bio-Imaging Technologies, Inc. and certain executive officers.
Incorporated by reference to Exhibit 10.1 of our Quarterly Report
on Form 10-Q for the quarter ended March 31, 2006. |
|
|
|
10.14
|
|
Asset Purchase Agreement, dated November 20, 2003, by and between
Bio-Imaging Technologies, Inc. and CapMed, Inc. Incorporated by
reference to Exhibit 10.16 of our Annual Report on Form 10-K for
the fiscal year ended December 31, 2005. |
|
|
|
10.15
|
|
Stock Purchase Agreement, dated December 10, 2004, by and between
Bio-Imaging Technologies, Inc. and Heart Core B.V. Incorporated
by reference to Exhibit 10.17 of our Annual Report on Form 10-K
for the fiscal year ended December 31, 2005. |
|
|
|
10.16
|
|
Fourth Modification of Office Space Lease by and between 826
Newtown Associates, LP and Bio-Imaging Technologies, Inc., dated
September 29, 2004. Incorporated by reference to Exhibit 10.18 of
our Annual Report on Form 10-K for the fiscal year ended December
31, 2005. |
|
|
|
10.17
|
|
Stock Purchase Agreement, dated February 6, 2007, by and between
Bio-Imaging Technologies, Inc. and Theralys, S.A. Incorporated by
reference to Exhibit 10.17 of our Annual Report on Form 10-K for
the fiscal year ended December 31, 2006. |
|
|
|
10.18
|
|
Development and Supply Agreement, dated June 20, 2005 by and
between CapMed, a division of Bio-Imaging Technologies, Inc. and
Medic Alert Foundation United States, Inc. (Portions of this
exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission on August 15, 2005).
Incorporated by reference to Exhibit 10.2 of our Quarterly Report
on Form 10-Q for the quarter ended June 30, 2005. |
|
|
|
21
|
|
List of Subsidiaries of Registrant. Incorporated by reference to
Exhibit 21.1 of our Annual Report on Form 10-KSB for the fiscal
year ended September 30, 1997. |
|
|
|
23.1
|
|
Consent of PricewaterhouseCoopers LLP. |
|
|
|
31.1
|
|
Certification of principal executive officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
74
|
|
|
Exhibit |
|
|
No. |
|
Description of Exhibit |
31.2
|
|
Certification of principal financial and accounting officer
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification of principal executive officer pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350. |
|
|
|
32.2
|
|
Certification of principal financial and accounting officer
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18
U.S.C. 1350. |
|
|
|
* |
|
A management contract or compensatory plan or arrangement required to be filed as an exhibit
pursuant to Item 13(a) of Form 10-K. |
|
** |
|
Schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The
Company undertakes to furnish supplementally copies of any of the omitted schedules and
exhibits upon request by the Securities and Exchange Commission. |
|
|
|
Included herewith. |
75