e10vk
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, 2009
Commission File No. 001-11182
BIOCLINICA, INC.
(Exact name of Registrant as specified in its Charter)
|
|
|
Delaware
|
|
11-2872047 |
|
|
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer Identification No.) |
|
|
|
826 Newtown-Yardley Road, Newtown, Pennsylvania
|
|
18940-1721 |
|
|
|
(Address of principal executive offices)
|
|
(Zip Code) |
(267) 757-3000
(Registrants telephone number,
including area code)
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
Title of each class |
|
Name of each exchange on which registered |
Common Stock, $0.00025 par value per share
|
|
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 whether the registrant has submitted electronically and posted on its
corporate Website; if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulate S-T during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes: o No: o
* The registrant has not yet been phased into the interactive data requirement
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K is not contained herein, and will not be contained, to the best of registrants knowledge, in
definitive proxy or information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. þ
Indicate by check mark if the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See definition of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act (check one):
|
|
|
|
|
|
|
Large accelerated filer o
|
|
Accelerated filer o
|
|
Non-accelerated filer o
(do not check if a smaller reporting company)
|
|
Smaller reporting company þ |
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 $41.3 million on June 30, 2009, 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 March 15, 2010:
|
|
|
Class
|
|
Number of Shares |
Common Stock, $.00025 par value
|
|
14,524,102 |
The following documents are incorporated by reference into the Annual Report on Form 10-K:
Portions of the Registrants definitive Proxy Statement for its 2010 Annual Meeting of Stockholders
are incorporated by reference into Part III of this Report.
TABLE OF CONTENTS
|
|
|
|
|
Item |
|
Page |
|
PART I 1. Business |
|
|
1 |
|
1A. Risk Factors |
|
|
9 |
|
1B. Unresolved Staff Comments |
|
|
18 |
|
2. Properties |
|
|
18 |
|
3. Legal Proceedings |
|
|
18 |
|
4. RESERVED |
|
|
18 |
|
|
|
|
|
|
PART II 5. Market for Registrants Common Equity, Related Stockholder
Matters and Issuer Purchases of Equity Securities |
|
|
19 |
|
6. Selected Financial Data |
|
|
22 |
|
7. Managements Discussion and Analysis of Financial
Condition and Results of Operations |
|
|
23 |
|
7A. Quantitative and Qualitative Disclosures About Market Risk |
|
|
38 |
|
8. Financial Statements and Supplementary Data |
|
|
39 |
|
9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure |
|
|
71 |
|
9A(T). Controls and Procedures |
|
|
71 |
|
9B. Other Information |
|
|
72 |
|
|
|
|
|
|
PART III 10. Directors, Executive Officers and Corporate Governance |
|
|
73 |
|
11. Executive Compensation |
|
|
73 |
|
12. Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters |
|
|
73 |
|
13. Certain Relationships and Related Transactions, and
Director Independence |
|
|
73 |
|
14. Principal Accounting Fees and Services |
|
|
73 |
|
|
|
|
|
|
PART IV 15. Exhibits, Financial Statement Schedules |
|
|
73 |
|
i
PART I
Item 1. Business.
Overview
On July 8, 2009, our shareholders approved an amendment to our Certificate of Incorporation,
as amended, to change our name from Bio-Imaging Technologies, Inc. to BioClinica, Inc.
BioClinicaTM, Inc., referred to herein as we, us and our, provides integrated
clinical research services including imaging core lab and eClinical technologies and services to
pharmaceutical, biotechnology, and medical device companies, and other organizations such as
contract research organizations (CROs), engaged in global clinical studies. Our products and
services include: medical image management, electronic data capture, clinical data management,
interactive voice and web response, clinical trial supply forecasting tools, and electronic image
transport and archive solutions. By supplying enterprise-class software and hosted solutions
accompanied by expert services to fully utilize these tools, we believe that our offerings provide
our clients, large and small, improved speed and efficiency in the execution of clinical studies,
with reduced clinical and business risk.
Our services support clinical stage research and development (R&D) functions for our clients,
and specifically, the collection, cleaning, and reporting of data related to their clinical trials.
For large pharmaceutical and biotechnology companies, outsourcing these services to BioClinica is
a cost effective alternative to the fixed cost model associated with internal drug development.
Moreover, these large companies can benefit from BioClinicas technical resource pool, broad
therapeutic expertise, and global infrastructure to support simultaneous multi-country clinical
trials. For smaller companies, BioClinica provides the focused expertise and the manpower that they
simply may not have in-house to pursue the resource-intensive clinical stages of drug development.
Our vision is to build critical mass in the complementary disciplines of clinical research
related to data collection and processing especially those which can benefit from our
information technology products and support services and to integrate them in ways that yield
efficiency and value for our clients. Our goal is to provide demonstrable benefits to sponsor
clients through this strategy, that is, faster and less expensive drug development. We believe that
the outsourcing of these services should continue to increase in the future because of increased
pressure on clients, including factors such as: the need to more tightly manage costs, capacity
limitations, reductions in marketing exclusivity periods, the desire to reduce development time,
increased globalization of clinical trials, productivity challenges, imminent patent expirations,
and more stringent regulation. We believe these trends will continue to create opportunities for
companies like BioClinica that are focused on improving the efficiency of drug and medical device
development.
Our Business
We view our operations and manage our business as one operating segment. Our extensive
customer base includes 19 of the top 20 global pharmaceutical companies measured by revenue and
many small and middle-market life sciences companies, as well as CROs. Our product offerings fall
into two general product and service categories: eClinical and Imaging Core Laboratory solutions.
BioClinicas eClinical solutions enhance pharmaceutical and biotech companies ability to
collect, clean (i.e., verify and ensure accuracy), process, and store the vast quantities of data
generated in clinical trials.
1
Through the use of our proprietary software and associated services,
our customers see the results of their clinical trials sooner and more accurately than through
alternate methods. We believe our forecasting, simulation, and reporting tools improve our
clients ability to manage their clinical trials and significantly reduce cost and risk inherent in
clinical development.
Like our eClinical solutions, BioClinicas Imaging Core Laboratory services also support the
collection and processing of clinical data, but specifically those related to medical images. The
large size of digital image files requires rigorous processes to manage this data. We have
developed proprietary expert software applications and services to make image collection both
accurate and efficient. BioClinicas Imaging Core Laboratory services also assist clients with the
design and management of the medical imaging component of clinical trials, and with the analysis
and regulatory submission. Our systems enable us to contract with the foremost independent
radiologists and other medical specialists who are 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.
The resulting data enables our clients and regulatory reviewers, primarily the U.S. Food and Drug
Administration (FDA) and comparable European agencies, to evaluate product efficacy and safety.
Acquisitions have been, and may continue to be, an important component of BioClinicas growth
strategy. On September 16, 2009, BioClinica acquired Tourtellotte Solutions, Inc., a private
Massachusetts software firm. Tourtellotte Solutions supply chain simulation software added a new
enterprise-class offering to our eClinical product line, and we believe that their interactive
voice (IVR)/interactive web (IWR) technology developments will greatly advance BioClinicas
capabilities in this area.
On August 27, 2009, we acquired the CardioNow unit of Agfa HealthCare. With this addition,
BioClinica now offers electronic transport solutions to facilitate the blinding, sharing, tracking,
and archiving of medical images for multi-center clinical trials as part of its suite of imaging
services. Imaging tracking information can also be integrated with BioClinica eClinical data to
further simplify and enhance the clinical trial process for life science companies.
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 and was changed to BioClinica, Inc. in 2009. We
changed the company name to BioClinica, Inc. in 2009 to better reflect our expanded products and
services. 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 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 BioClinica, 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.
2
Target Markets
Our primary target market is comprised of pharmaceutical, biotechnology, and medical device
companies with products in any stage of clinical development (Phase I, Phase II, Phase III, or
Phase IV). Though our experience spans a wide range of therapeutic areas, we also target the
largest areas of clinical research with customized products and services to support the precise
requirements of these projects. Our therapeutic areas of expertise include: oncology,
musculoskeletal conditions, and cardiology, plus central nervous system, neurovascular, and
metabolic diseases.
Our Solutions and Services
The processes and technology incorporated into our offerings are designed to provide clients
with the ease of use and scalability to handle large global trials as well as the flexibility,
speed, and efficiency necessary to support smaller or early phase trials. The conduct of clinical
trials for new drugs, biological products, and medical devices is regulated by the FDA and other
regulatory bodies. Our products and services are designed to help our clients to operate in a
manner that is compliant with applicable regulations and follows applicable regulatory guidance.
eClinical Services
Our eClinical product line is comprised of four primary product and service offerings:
|
|
|
BioClinicaTM Express electronic data capture (EDC); |
|
|
|
|
BioClinicaTM Express clinical data management; |
|
|
|
|
BioClinicaTM Optimizer clinical supply forecasting and optimization; and |
|
|
|
|
BioClinicaTM interactive response technologies (IVR/IWR). |
Electronic Data Capture
BioClinica Express is an electronic data capture (EDC) technology platform that automates
expensive, time-consuming, paper-based clinical trial processes and scales securely, reliably, and
cost-effectively for global clinical trials involving large numbers of clinical sites and patients.
The Express system integrates EDC functionality with clinical data management system features into
a single solution that replaces traditional paper-based methods. Using our proprietary software,
clients collect, clean, and manage their clinical data completely in electronic format. This
technology-enabled process improves data quality and allows our sponsors to see the results of
their clinical trials faster than conventional paper-based methods. Electronic versions of case
report forms (eCRFs) are made available to each research site participating in the clinical trial
via the Internet. The Express system also allows the import and integration of clinical data from
other sources during the course of the trial to help to reduce the imprecision and inefficiencies
of waiting until the end of the trial to get a full and accurate analysis of the efficacy and
safety of the investigational compound.
We also offer modules and add-on products and services for the Express Platform, which
include:
|
|
|
The Express AutoEncoder to automatically or manually code clinical drug names and
indications, adverse event terms, and patient medical histories; |
|
|
|
|
Direct integration with BioClinica IVR/IWR to enable randomization and drug supply
tracking through either a computer or the telephone with the same clinical study; |
|
|
|
|
The BioClinica Reportal, which enables clinical trial sponsors to securely publish and
share relevant clinical trial-related data for use by clinical investigators through a
standard Web-browser; and |
3
|
|
|
Access to Clinical Data Acquisition Standards Harmonization (CDASH) and Clinical Data
Interchange Standards Consortium (CDISC)-based forms libraries to assist clients with the
rapid adoption and utilization of complex data formatting standards for regulatory
submission. |
Data Management
BioClinicas data management services support the accurate collection, verification, and
analysis of clinical data. The data management team designs eCRFs and data management plans to
ensure that data are collected in compliance with both the study protocol and applicable regulatory
requirements. Prior to data lock, BioClinica personnel screen the data to detect errors, omissions,
and other deficiencies in completed eCRFs. Data management personnel review, code, reconcile
serious adverse events, and assist with the resolution of any data-related problems. Clients can
utilize these services to augment their organization for an entire trial or to manage unexpected
resource situations. Other clients choose to completely outsource the data management function in
lieu of direct staff.
Clinical Supply Forecasting and Optimization
BioClinica Optimizer is a product that allows biopharmaceutical companies to simulate and
optimize their clinical supply chain. Optimizer allows clients to design unlimited supply chain
scenarios and vary relevant study parameters from a global level down to a site level. Simulated
results can be analyzed and modified to create the ideal clinical supply chain. Simulation is a
process that replicates a real-world system or environment in order to predict actual behavior.
Simulating study scenarios can help identify and mitigate supply crisis, study delays, and
unnecessary overages. Optimization helps define the minimum thresholds for site stock and local
country depots using specific shipping lead times. Finding the maximum unpredictable demand over
time allows users to change their minimum stock levels as the study progresses, e.g. dropping off
as enrollment or other unpredictable events become complete. BioClinica offers Optimizer both
through software licensing and as an outsourced service to make these benefits accessible to
organizations of any size.
IVR/IWR Interactive Response Solutions
Interactive Voice Response (IVR) solutions, systems that use the telephone to interact with
databases, have been used in clinical trials for many years for basic data capture. BioClinica has
significantly expanded the capabilities of our IVR offering with the introduction of BioClinica IVR
the first IVR created from inception as an eClinical module tightly integrated with EDC
technology for improved clinical trial management. Our system is extremely useful for obtaining
multi-lingual 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.
Process knowledge and expertise in IVR/IWR, simulation and forecasting, and clinical supplies
combined with other innovations, has led to the development of Trident, a next-generation
interactive voice/interactive web response system that will be released in 2010. It is
parameter-driven, built specifically for the web, and is able to support rapid, flexible
customization that supplies greater control over cost and data than legacy clinical IVR systems.
Imaging Core Laboratory Services
BioClinica provides a broad array of medical imaging management services to support clinical
development. Medical image data are received by us from clinical trial sites located throughout the
world. We have developed systems and procedures for data tracking and quality control that we
believe to be of significant
4
value to our clients. Our facilities in the U.S. and Europe 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 also 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 system (BioRead) offers 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 BioRead system, independent medical specialists can review medical image data from
clinical trials in a digital format. The BioRead system displays 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
BioRead system to read and evaluate image data, medical specialists achieve greater reading speed
than is possible with a manual film-based system and can perform evaluations in a more objective,
reproducible manner.
We have also developed remote BioRead systems that are located on the premises of the
individual medical specialists who are engaged by the sponsor to perform the analysis of the
medical image data. Historically, the BioRead systems have been utilized to determine efficacy of
the compounds being studied.
BioClinica assists 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.
The acquisition of CardioNow resulted in an opportunity for two new product offerings for
BioClinica. CardioNow has developed a web-based system for the secure transmission of medical
cardiac images. The software was specifically developed for and marketed to the invasive cardiology
departments of hospitals within the United States. BioClinica will integrate and enhance the
current CardioNow software and service to offer our clients a streamlined electronic transport
solution to facilitate the blinding, sharing, tracking and archiving of medical images for
multi-center clinical trials as part of our suite of imaging services. Most clinical studies use
courier services to transport large medical image files a process that can be slow, cumbersome,
and prone to error. BioClinica WebSend will provide investigator sites with a simple tool to
complete transmittal forms with full validation of protocol-specific requirements and send large
image studies directly to BioClinica in minutes via an Internet connection. BioClinica WebView will
extend WebSend functionality to facilitate electronic sharing, tracking, analysis, and archiving of
medical images for single or multi-center clinical trials with imaging endpoints.
Clients are increasingly using imaging criteria for inclusion/exclusion criteria. This use
requires extremely rapid turn-around reads. We believe that the combination of WebSend and BioRead
offers 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
5
facilitate the review of the images from the experts
office or home, with the utmost possible speed in transport. Imaging information can also be
integrated with BioClinica Express EDC to further simplify and enhance the clinical trial process
and improve the visibility of clinical data for life science companies.
Services
Our products are supported by comprehensive consulting, training services, and application
hosting and support capabilities to support clinical trials on a global scale. In addition to our
U.S. headquarters, we have offices with service personnel in the Netherlands, France, India, China,
and the United Kingdom.
Application Hosting Services. Other than our internal Imaging Core Lab systems, our software
products are available to customers through software licensing arrangements and as hosted
application solutions with technical and training support services.
Consulting Services. We provide technical consulting in the evaluation of the sites that may
participate in clinical trials. We also provide consulting services to our clients regarding
regulatory issues involved in the design, execution, analysis, and submission of medical image data
in clinical trials. BioClinica provides expertise through our deep roster of collaborative
consultants, which includes board-certified radiologists, oncologists, rheumatologists,
cardiologists, and other therapeutic specialists to ensure the highest quality independent review,
as well as eClinical design and deployment expertise.
Customer Support. Our multi-lingual customer and site technical support is available 24 hours
per day, seven days per week, via our call center. Customer support also includes training and
software maintenance. Support services are bundled within our software licenses and outsourced
service offerings.
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 BioClinicaÔ 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 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
6
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 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
7
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 compete 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, 2009, we had 29 employees in sales and
marketing.
Significant Clients
No one client represented more than 10% of our service revenues for the years ended December
31, 2009 or December 31, 2008, 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. Contracts are
terminable by our clients 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.
8
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 the Leiden 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. In January 2010, we
incorporated BioClinica Private Limited in Bhubaneshwar, India to provide information technology
support services.
Employees
As of December 31, 2009, we had 479 employees, four of whom were executive officers.
Of our employees, as of December 31, 2009, 29 were engaged in sales and marketing, 406 were
engaged in client-related projects and 44 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, 2010, we have
employment agreements with three 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:
|
|
|
unexpected or undesired clinical results; |
|
|
|
|
the clients decision to terminate the development of a particular product or to end a
particular study; |
|
|
|
|
insufficient patient enrollment in a study; |
|
|
|
|
insufficient investigator recruitment; |
|
|
|
|
failure to perform our obligations under the contract; or |
|
|
|
|
the failure of products to satisfy safety requirements. |
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.
9
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 recent 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 fallen 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:
|
|
|
our clients businesses experience financial problems or are affected by a general
economic downturn; |
|
|
|
|
consolidation in the pharmaceutical, biotechnology or medical device industries leads to
a smaller client base for us; or |
|
|
|
|
clients reduce their research and development expenditures. |
No one client represented more than 10% of our service revenues for the years ended December
31, 2009 or December 31, 2008, while for the comparable period of 2007, one client, Hoffmann-La
Roche, which encompassed 11 projects, represented 13.4% of our service revenues. 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 $98.7 million at December 31, 2009 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:
|
|
|
the variable size and duration of the projects (some are performed over several years); |
|
|
|
|
the loss or delay of projects; |
|
|
|
|
the change in the scope of work during the course of a project; and |
|
|
|
|
the cancellation of such contracts by our clients. |
10
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 made two acquisitions in the third quarter of 2009 and may engage in future acquisitions, which
may be expensive and time consuming, and from which we may not realize anticipated benefits.
We acquired the CardioNow unit from AGFA Healthcare and substantially all of the assets of
Tourtellotte Solutions, Inc. in the third quarter of 2009 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 recent acquisitions 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, President BioImaging
Services, and Peter Benton, Executive Vice President, 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 2009, 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.
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
11
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.
We may be unable to adequately protect, and we may incur significant costs in defending, our
intellectual property and other proprietary rights.
Our success depends on our ability to protect our intellectual property and other proprietary
rights. We rely upon a combination of trademark, trade secret, copyright, patent and unfair
competition laws, as well as license agreements and other contractual provisions, to protect our
intellectual property and other proprietary rights. In addition, we attempt to protect our
intellectual property and proprietary information by requiring certain of our employees and
consultants to enter into confidentiality, non-competition and assignment of inventions agreements.
To the extent that our intellectual property and other proprietary rights are not adequately
protected, third parties might gain access to our proprietary information, develop and market
products or services similar to ours, or use trademarks similar to ours, each of which could
materially harm our business. Existing U.S. federal and state intellectual property laws offer only
limited protection. Moreover, the laws of other countries in which we market our software products,
services and hosted solutions may afford little or no effective protection of our intellectual
property. If we resort to legal proceedings to enforce our intellectual property rights or to
determine the validity and scope of the intellectual property or other proprietary rights of
others, the proceedings could be burdensome and expensive, even if we were to prevail. The failure
to adequately protect our intellectual property and other proprietary rights may have a material
adverse effect on our business, results of operations or financial condition.
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:
|
|
|
consultative and clinical trials design capabilities; |
|
|
|
|
reputation for on-time quality performance; |
|
|
|
|
expertise and experience in specific therapeutic areas; |
|
|
|
|
the scope of service offerings; |
|
|
|
|
strength in various geographic markets; |
|
|
|
|
the price of services; |
|
|
|
|
ability to acquire, process, analyze and report data in a time-saving and accurate
manner; |
|
|
|
|
ability to manage large-scale clinical trials both domestically and internationally; |
|
|
|
|
our size; and |
|
|
|
|
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.
12
The biopharmaceutical services industry is highly competitive, and we face numerous
competitors in our business, including hundreds of CROs. 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 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.
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 recent 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 recent 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.
13
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 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
14
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.
Our software products and hosted solutions are at varying stages of market acceptance and the
failure of any of our products to achieve or maintain wide acceptance would harm our operating
results.
We began offering our electronic data capture software solution for clinical trials in March
2008. Continued use of our current electronic data capture software products, and broad and timely
acceptance of newly-introduced electronic data capture software products, as well as integrated
solutions combining one or more of our software products, is critical to our future success and is
subject to a number of significant risks, some of which are outside our control. These risks
include:
|
|
|
our customers and prospective customers desire for and acceptance of our electronic data
capture, clinical data management, drug safety and interactive response technology
solutions; |
|
|
|
|
our ability to meet product development and release schedules; |
|
|
|
|
our software products and hosted solutions ability to support large numbers of users and
manage vast amounts of data; |
|
|
|
|
our ability to significantly expand our internal resources and increase our capital and
operating expenses to support the anticipated growth and continued integration of our
software products, services and hosted solutions; and |
|
|
|
|
our customers ability to use our software products and hosted solutions, train their
employees and successfully deploy our technology in their clinical trial and safety
evaluation and monitoring activities. |
Our failure to address, mitigate or manage these risks would seriously harm our business,
particularly if the failure of any or all of our software products or hosted solutions to achieve
market acceptance negatively affects our sales of our other products and services.
We may be exposed to liability claims as a result of our involvement in clinical trials.
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.
15
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, 2009, we had the following capital structure (in thousands):
|
|
|
|
|
Common stock outstanding |
|
|
14,394 |
|
|
|
|
|
|
Common stock issuable upon: |
|
|
|
|
Exercise of options which are outstanding |
|
|
1,865 |
|
Available shares in the stock incentive plan which
have not yet been granted |
|
|
753 |
|
Restricted stock units outstanding |
|
|
173 |
|
|
|
|
|
|
Total common stock outstanding assuming exercise or conversion of
all of the above |
|
|
17,185 |
|
As of December 31, 2009, we had outstanding options to purchase 1,865,235 shares of common
stock at exercise prices ranging from $0.66 to $8.06 per share (exercisable at a weighted average
of $4.29 per share), of which 1,303,432 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, 2009, we had 14.4 million shares of our common
stock issued and outstanding, all of which are currently freely tradable. As part of the
acquisition of substantially all of the assets of Tourtellotte Solutions, we also agreed to issue
350,000 shares of our common stock to Tourtellotte Solutions based upon achieving certain
milestones, which include certain product development and revenue targets. At December 31, 2009,
we believe these milestones will be achieved in 2010, see Note 2 to our Consolidated Financial
Statements for additional information.
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 our securities and may adversely affect our ability to obtain
future financing in the capital markets as well as create a potential market overhang.
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
16
stock), including Covance Inc., beneficially owned 25% of the outstanding shares of common
stock, restricted stock units and stock options that could have been converted to common stock at
December 31, 2009, 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:
|
|
|
operating results; |
|
|
|
|
analysts reports; |
|
|
|
|
market conditions in the industry; |
|
|
|
|
changes in governmental regulations; and |
|
|
|
|
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, 2009 and December 31, 2009, our common stock has traded at a low of $2.75 per share and
a high of $4.75 per share. Between January 1, 2010 and February 28, 2010, our common stock has
traded at a low of $4.15 per share and a high of $5.93 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 you 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.
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
17
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.
In July 2009, our board of directors also adopted a stockholder rights plan, similar to plans
adopted by many other publicly-traded companies. The stockholder rights plan is intended to
protect stockholders against unsolicited attempts to acquire control of us that do not offer a fair
price to our stockholders as determined by our board of directors.
These provisions of our certificate of incorporation, stockholder rights plan 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.
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 36,143 square
feet of office space in Audubon, Pennsylvania for $59,444 per month in base rent, which expires
January 18, 2019. 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
$46,200 per month and the base rent for Lyon is $12,900, based upon the conversion rate as of
December 31, 2009, 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. RESERVED
18
PART II
|
|
|
Item 5. |
|
Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities. |
On July 8, 2009, our shareholders approved an amendment to our Certificate of
Incorporation, as amended, to change our name from Bio-Imaging Technologies, Inc. to BioClinica,
Inc. and to change our stock symbol from BITI to BIOC. Our common stock began trading on the
NASDAQ Global Market, formerly called the NASDAQ National Market, on December 18, 2003 under the
symbol BITI and now trades under the symbol BIOC. 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.
|
|
|
|
|
|
|
|
|
|
|
Common |
|
Quarter |
|
Stock |
|
Ended |
|
High |
|
|
Low |
|
March 31, 2008 |
|
|
8.95 |
|
|
|
6.57 |
|
June 30, 2008 |
|
|
8.15 |
|
|
|
6.18 |
|
September 30, 2008 |
|
|
7.99 |
|
|
|
6.48 |
|
December 31, 2008 |
|
|
7.53 |
|
|
|
2.15 |
|
|
March 31, 2009 |
|
|
3.71 |
|
|
|
2.63 |
|
June 30, 2009 |
|
|
4.24 |
|
|
|
3.02 |
|
September 30, 2009 |
|
|
4.07 |
|
|
|
3.20 |
|
December 31, 2009 |
|
|
4.75 |
|
|
|
3.25 |
|
As of February 28, 2010, the number of holders of record of our common stock was 77 and the
approximate number of beneficial holders, investors who hold our shares through brokers, of our
common stock was 1,600.
On September 15, 2009, BioClinica acquired substantially all of the assets of Tourtellotte
Solutions, Inc., or Tourtellotte. Tourtellotte provided software applications and consulting
services which support clinical trials in the pharmaceutical industry. The purchase price for
Tourtellotte was $2.1 million in cash. Pursuant to the acquisition agreement, we agreed to pay up
to an additional $3.2 million in cash and 350,000 shares of our common stock based upon achieving
certain milestones, which include certain product development and revenue targets. At the
acquisition date, the stock was recorded at an average price of $3.67 per share.
We believe that the issuances 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.
19
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, 2009 with respect to the shares of
our Common Stock that may be issued under our existing equity compensation plans.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Weighted |
|
|
|
|
|
|
Securities to be |
|
|
Average Exercise |
|
|
Number of Securities |
|
|
|
Issued Upon |
|
|
Price of |
|
|
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 |
|
|
1,865,000 |
|
|
$ |
4.29 |
|
|
|
1,303,000 |
|
Equity compensation
plans not approved
by security holders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,865,000 |
|
|
$ |
4.29 |
|
|
|
1,303,000 |
|
|
|
|
|
|
|
|
|
|
|
20
STOCK PRICE PERFORMANCE GRAPH
Our common stock is listed for trading on the NASDAQ Global Market under the symbol BIOC.
The Stock Price Performance Graph set forth below compares the cumulative total stockholder return
on the common stock for the period from December 31, 2004 through December 31, 2009, 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, 2004 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, 2004 |
|
|
Dec. 31, 2005 |
|
|
Dec. 31, 2006 |
|
|
Dec. 31, 2007 |
|
|
Dec. 31, 2008 |
|
|
Dec. 31, 2009 |
|
BioClinica, Inc. |
|
|
100.00 |
|
|
|
58.94 |
|
|
|
147.08 |
|
|
|
147.45 |
|
|
|
66.79 |
|
|
|
77.19 |
|
NASDAQ U.S. Stock Index |
|
|
100.00 |
|
|
|
102.13 |
|
|
|
112.21 |
|
|
|
121.69 |
|
|
|
58.69 |
|
|
|
84.30 |
|
Nasdaq Health Services Index |
|
|
100.00 |
|
|
|
137.44 |
|
|
|
137.24 |
|
|
|
179.38 |
|
|
|
131.01 |
|
|
|
173.20 |
|
Source: CRSP NASDAQ Monthly Historical Industry Indexes. Copyright© NASDAQ. All rights
reserved
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.
21
|
|
|
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 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, |
|
|
2009 |
|
2008 |
|
2007 |
|
2006 |
|
2005 |
CONTINUING OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
$ |
57,393 |
|
|
$ |
56,181 |
|
|
$ |
37,543 |
|
|
$ |
31,853 |
|
|
$ |
23,734 |
|
Total revenue |
|
|
72,723 |
|
|
|
69,116 |
|
|
|
47,254 |
|
|
|
40,257 |
|
|
|
30,126 |
|
Income (loss) from continuing operations before interest and taxes |
|
|
4,688 |
|
|
|
8,480 |
|
|
|
4,848 |
|
|
|
2,670 |
|
|
|
(3,226 |
) |
Income (loss) from continuing operations, net of taxes |
|
|
2,959 |
|
|
|
5,791 |
|
|
|
3,343 |
|
|
|
1,968 |
|
|
|
(1,881 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations |
|
|
0.21 |
|
|
|
0.42 |
|
|
|
0.29 |
|
|
|
0.18 |
|
|
|
(0.17 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations |
|
|
0.20 |
|
|
|
0.40 |
|
|
|
0.26 |
|
|
|
0.16 |
|
|
|
(0.17 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to calculate earnings (loss) per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
14,354 |
|
|
|
13,752 |
|
|
|
11,616 |
|
|
|
11,219 |
|
|
|
11,114 |
|
Diluted |
|
|
15,100 |
|
|
|
14,469 |
|
|
|
12,745 |
|
|
|
12,364 |
|
|
|
11,114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL POSITION |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents |
|
$ |
14,570 |
|
|
$ |
14,265 |
|
|
$ |
17,915 |
|
|
$ |
16,166 |
|
|
$ |
10,554 |
|
Working capital |
|
|
7,302 |
|
|
|
7,918 |
|
|
|
9,721 |
|
|
|
10,219 |
|
|
|
8,055 |
|
Total assets |
|
|
75,337 |
|
|
|
69,208 |
|
|
|
43,057 |
|
|
|
34,108 |
|
|
|
28,791 |
|
Other liabilities |
|
|
2,162 |
|
|
|
641 |
|
|
|
597 |
|
|
|
305 |
|
|
|
757 |
|
Stockholders equity |
|
|
48,535 |
|
|
|
43,412 |
|
|
|
23,529 |
|
|
|
18,842 |
|
|
|
17,197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER DATA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
$ |
4,258 |
|
|
$ |
2,916 |
|
|
$ |
3,928 |
|
|
$ |
2,232 |
|
|
$ |
1,871 |
|
|
Depreciation and amortization |
|
|
2,713 |
|
|
|
2,266 |
|
|
|
2,335 |
|
|
|
2,035 |
|
|
|
2,312 |
|
Number of employees |
|
|
479 |
|
|
|
474 |
|
|
|
337 |
|
|
|
283 |
|
|
|
264 |
|
22
|
|
|
Item 7. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations. |
Overview
On July 8, 2009, our shareholders approved an amendment to our Certificate of Incorporation,
as amended, to change our name from Bio-Imaging Technologies, Inc. to BioClinica, Inc.
BioClinica, provides integrated clinical research services including imaging core lab and
eClinical technologies and services to pharmaceutical, biotechnology, and medical device companies,
and other organizations such as contract research organizations (CROs), engaged in global clinical
studies. Our products and services include: medical image management, electronic data capture,
clinical data management, interactive voice and web response, clinical trial supply forecasting
tools, and electronic image transport and archive solutions. By supplying enterprise-class software
and hosted solutions accompanied by expert services to fully utilize these tools, we believe that
our offerings provide our clients, large and small, improved speed and efficiency in the execution
of clinical studies, with reduced clinical and business risk.
Market For Our Services
We believe that the short-term 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
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 compare to the traditional process of
manual data collection on paper case report forms that are more susceptible to transcription and
other data entry errors. Our rebranding to BioClinica continues to be well received, re-energizing
our marketplace reputation for offering what we believe to be best in class solutions for imaging
and eClinical services for clinical trials.
Sales and Backlog
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 3 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, 2009, which includes our medical image management and eClinical services, was
$98.7 million compared to $92.7 million at December 31, 2008 and $92.5 million at December 31,
2007. Changes in backlog for the period reflect the net effect of new contract signings,
addendums, cancellations expansions, and reductions in scope of existing projects, all of which
impacted our backlog at December 31, 2009.
23
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 do not believe that backlog is a
reliable predictor of future 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.
Acquisitions and Dispositions
During the third quarter of 2009, the Company acquired two companies that expand the range of
products and services the Company offers in the clinical trials services sector.
On September 15, 2009, BioClinica acquired substantially all of the assets of Tourtellotte
Solutions, Inc., or Tourtellotte. Tourtellotte provided software applications and consulting
services which support clinical trials in the pharmaceutical industry. The purchase price for
Tourtellotte was $2.1 million in cash. Pursuant to the acquisition agreement, we agreed to pay up
to an additional $3.2 million in cash and 350,000 shares of our common stock based upon achieving
certain milestones, which include certain product development and revenue targets, hereinafter
referred to as the earn-out. The fair value of the cash earn-out of $2.8 million has been
recorded as a liability and the fair value of the 350,000 shares of $1.3 million has been
classified separately within stockholders equity as contingent consideration for a total purchase
price of $6.2 million as of December 31, 2009. We used cash from operations to fund the cash
purchase price for Tourtellotte. The financial results of Tourtellotte for the fiscal year are
included in the consolidated statement of income for the period ended December 31, 2009.
On August 27, 2009, BioClinica acquired the CardioNow unit of Agfa Healthcare, or CardioNow.
CardioNow has developed a web-based system for the secure transmission of medical cardiac images.
The software was specifically developed for and marketed to the invasive cardiology departments of
hospitals within the United States. BioClinica will integrate and enhance the current CardioNow
software and service to offer our clients a streamlined electronic transport solution to facilitate
the blinding, sharing, tracking and archiving of medical images for multi-center clinical trials as
part of our suite of imaging services. The purchase price for CardioNow consisted of cash
consideration paid to Agfa Healthcare of $1 million. We paid the purchase price for CardioNow with
cash from operations. The financial results of CardioNow for the fiscal year are included in the
consolidated statement of income for the period ended December 31, 2009.
On January 6, 2009, pursuant to the asset aurchase agreement by and among BioClinica and MBI
Benefits, Inc., or MBI, an indirectly owned subsidiary of Metavante Technologies, Inc., or
Metavante, dated as of January 6, 2009, we sold our 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 us an upfront payment of Five Hundred
Thousand Dollars ($500,000) in cash and will make an earn-out payment to us 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. We 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 MBI enters into with certain prospects during the first
six months of 2009. Additionally, we 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 MBI enters into with certain prospects during the period commencing on July 1, 2009 and
ending on December 31, 2010. At December 31, 2009, we have not received any earn-out payments from
Metavante.
24
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, 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 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, accounting for acquisitions, capitalization of software development costs,
income taxes and fair value accounting for stock based compensation.
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 our customer contracts
using the proportional performance method. Service revenues are first recognized when we have 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.
We enter 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
25
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 we bill 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.
We, at the request of our 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 us and recognized gross as
reimbursement revenues
Goodwill and Other Intangible Assets, Net. Goodwill is not amortized; instead, it is tested
for impairment annually (at December 31st) or more frequently if indicators of
impairment exist or if a decision is made to sell a business. A significant amount of judgment is
involved in determining if an indicator of impairment has occurred. Such indicators may include a
decline in expected cash flows, a significant adverse change in legal factors or in the business
climate, unanticipated competition, or slower growth rates, among others. It is important to note
that fair values that could be realized in an actual transaction may differ from those used to
evaluate the impairment of goodwill.
Goodwill is allocated among and evaluated for impairment at the reporting level unit, which is
defined as an operating segment or one level below an operating segment. BioClinica has one
operating segment, clinical trial services, which is a single reporting unit.
We use a discounted cash flow model to estimate the current fair value of the reporting unit
when testing for impairment, as management believes forecasted cash flows are the best indicator of
such fair value. A number of significant assumptions and estimates are involved in the application
of the discounted cash flow model to forecast operating cash flows, including revenue growth rate,
operating profit margins, discount rate, tax rates, capital spending, and working capital changes.
We consider market participant assumptions in estimating fair value of the reporting unit. Revenue
growth rate and operating profit assumptions are consistent with those utilized in our operating
plan and long-term financial planning process. Management judgment is required in the
determination of each assumption utilized in the valuation model, and actual results could differ
from the estimates. At December 31, 2009, we conducted the required annual test of impairment. In
2009, the estimated fair values of the clinical trial services reporting unit was in excess of its
carrying values, resulting in no impairment.
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
26
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. We account for stock-based compensation costs in accordance
with FASB ASC 718 Compensation Stock Compensation, 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 of this guidance, 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
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 $215,000 and $279,000 to our net asset
position, at December 31, 2009 and December 31, 2008, 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, 2009 and December 31, 2008. 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, 2009, there are no outstanding derivative
positions.
27
Results of Operations
Year Ended December 31, 2009 Compared with Year Ended December 31, 2008.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Total |
|
|
$ |
|
|
% |
|
(in thousands) |
|
2009 |
|
|
Revenue |
|
|
2008 |
|
|
Revenue |
|
|
Change |
|
|
Change |
|
Service revenues |
|
$ |
57,393 |
|
|
|
78.9 |
% |
|
$ |
56,181 |
|
|
|
81.3 |
% |
|
$ |
1,212 |
|
|
|
2.2 |
% |
Reimbursement revenues |
|
|
15,330 |
|
|
|
21.1 |
% |
|
|
12,935 |
|
|
|
18.7 |
% |
|
|
2,395 |
|
|
|
18.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
72,723 |
|
|
|
100.0 |
% |
|
|
69,116 |
|
|
|
100.0 |
% |
|
|
3,607 |
|
|
|
5.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
35,630 |
|
|
|
49.0 |
% |
|
|
32,446 |
|
|
|
46.9 |
% |
|
|
3,184 |
|
|
|
9.8 |
% |
Cost of reimbursement revenues |
|
|
15,330 |
|
|
|
21.1 |
% |
|
|
12,935 |
|
|
|
18.7 |
% |
|
|
2,395 |
|
|
|
18.5 |
% |
Sales and marketing expenses |
|
|
8,052 |
|
|
|
11.1 |
% |
|
|
7,860 |
|
|
|
11.4 |
% |
|
|
192 |
|
|
|
2.4 |
% |
General and administrative expenses |
|
|
7,414 |
|
|
|
10.2 |
% |
|
|
7,015 |
|
|
|
10.1 |
% |
|
|
399 |
|
|
|
5.7 |
% |
Amortization of intangible assets
related to acquisitions |
|
|
489 |
|
|
|
0.7 |
% |
|
|
380 |
|
|
|
0.6 |
% |
|
|
109 |
|
|
|
28.7 |
% |
Restructuring charges |
|
|
466 |
|
|
|
0.6 |
% |
|
|
|
|
|
|
0.0 |
% |
|
|
466 |
|
|
|
|
|
Merger and acquisition related costs |
|
|
654 |
|
|
|
0.9 |
% |
|
|
|
|
|
|
0.0 |
% |
|
|
654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
68,035 |
|
|
|
93.6 |
% |
|
|
60,636 |
|
|
|
87.7 |
% |
|
|
7,399 |
|
|
|
12.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations
before interest and taxes |
|
|
4,688 |
|
|
|
6.4 |
% |
|
|
8,480 |
|
|
|
12.3 |
% |
|
|
(3,792 |
) |
|
|
(44.7 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
41 |
|
|
|
0.1 |
% |
|
|
429 |
|
|
|
0.6 |
% |
|
|
(388 |
) |
|
|
(90.4 |
%) |
Interest expense |
|
|
(13 |
) |
|
|
0.0 |
% |
|
|
(7 |
) |
|
|
0.0 |
% |
|
|
(6 |
) |
|
|
85.7 |
% |
Income tax provision |
|
|
(1,757 |
) |
|
|
(2.4 |
%) |
|
|
(3,111 |
) |
|
|
(4.5 |
)% |
|
|
1,354 |
|
|
|
(43.5 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
from continuing operations, net of taxes |
|
$ |
2,959 |
|
|
|
4.1 |
% |
|
$ |
5,791 |
|
|
|
8.4 |
% |
|
$ |
(2,832 |
) |
|
|
(48.9 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations, net
of taxes |
|
|
|
|
|
|
0.0 |
% |
|
|
(3,001 |
) |
|
|
(4.3 |
)% |
|
|
3,001 |
|
|
|
(100 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,959 |
|
|
|
4.1 |
% |
|
$ |
2,790 |
|
|
|
4.1 |
% |
|
$ |
169 |
|
|
|
6.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Consolidated Statements of Income for all periods presented reflect the CapMed
division in discontinued operations.
The results of operations of CardioNow and Tourtellotte are included in the Consolidated
Statements of Income for the period ended December 31, 2009 from the respective acquisition dates.
The results of operations for the year ended December 31, 2008 excludes the results of PDS from
January 1, 2008 through March 31, 2008 (PDS was acquired on March 24, 2008 and we did not include
the eight days from March 24, 2008 through March 31, 2008 due to immateriality).
Service revenues were $57.4 million for fiscal 2009 and $56.2 million for fiscal 2008, an
increase of $1.2
28
million, or 2.2%. The increase in our service revenues was due to a full year of PDS service
revenue for fiscal 2009 versus only nine months of PDS service revenue for fiscal 2008 offset by an
overall decrease in service revenues for fiscal 2009. Our service revenues have been impacted due
to the pharmaceutical companies response to overall economic conditions, resulting in
re-evaluation of drug programs and some contract decisions being delayed. We believe as worldwide
demand for new drugs grow, our customers will continue to conduct more clinical trials in pursuit
of regulatory approval in countries around the world and clinical trials service organizations,
such as ours, with an established global presence, depth of services and expertise, will continue
to benefit.
Reimbursement revenues and cost of reimbursement revenues was $15.3 million for fiscal 2009
and $12.9 million for fiscal 2008, an increase of $2.4 million, or 18.5%. 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 $35.6 million for fiscal 2009 and $32.4 million for fiscal 2008,
an increase of $3.2 million, or 9.8%. The increase in cost of service revenues is primarily due to
a full year of PDS costs in 2009 versus nine months of PDS costs in 2008 and the addition of
personnel from the Tourtellotte acquisition in the third quarter of 2009. The cost of service
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 service revenues will increase in 2010 due to the addition of personnel from
Tourtellotte from the acquisition on September 15, 2009 offset by the savings of $1.6 million from
the restructuring in Q2 2009.
Sales and marketing expenses were $8.1 million for fiscal 2009 and $7.9 million for fiscal
2008, an increase of $192,000 or 2.4%. The increase is primarily due to a full year of sales
personnel from the PDS acquisition offset by less marketing costs and tradeshow attendance. We
expect that sales and marketing expenses will remain relatively flat in fiscal 2010.
General and administrative expenses were $7.4 million for fiscal 2009 and $7.0 million for
fiscal 2008, an increase of $400,000, or 5.7%. General and administrative expenses in fiscal 2009
and 2008 consisted primarily of salaries and benefits, allocated overhead, professional and
consulting services and corporate insurance. This increase is primarily due to a full year of
finance and administrative personnel from the PDS acquisition offset by less professional and
consulting service fees. In the second quarter of 2009, as a result of a potential acquisition
which was terminated, we incurred $734,000 of acquisition related costs and received $750,000,
comprised of a $500,000 break-up fee and $250,000 expense reimbursement, from the target company,
resulting in a $16,000 gain on the transaction. We expect that our general and administrative
expenses will remain relatively flat for fiscal 2010.
Amortization of intangible assets related to acquisitions for fiscal 2009 and 2008 were
$489,000 and $380,000, respectively, an increase of $109,000, or 28.7%. Amortization of intangible
assets related to acquisitions consisted primarily of amortization of customer backlog, customer
relationships, software and non-compete intangibles acquired from the acquisitions of PDS, Tourtellotte and Theralys. The
increase is primarily
29
due to the addition of Tourtellotte. We expect that the amortization of
intangible assets related to acquisitions may increase as we look to continue to expand our
pharmaceutical contract services through potential acquisitions.
In the second quarter of 2009, in order to streamline the operations and reduce costs,
management decided to eliminate certain positions and consolidate redundant departments. This
resulted in restructuring charges of $466,000 consisting of $439,000 in employee severance and
$27,000 in other close down costs. We have paid the $466,000 in the third and fourth quarters of
2009 and nothing is left to be paid from the restructuring at December 31, 2009. We expect to
realize annual savings of $1.6 million from the restructuring.
Merger and acquisition related costs of $654,000 for fiscal 2009 include expenses of $560,000
consisting of costs resulting directly from merger and acquisition activities for the Tourtellotte
and CardioNow acquisitions such as legal, accounting and investment banking fees and other due
diligence and integration costs. Also included in this cost is $94,000 of earn-out accretion from
the Tourtellotte acquisition due to the difference in the fair value from the purchase price
recorded at the date of acquisition to December 31, 2009. On January 1, 2009, we adopted FASB ASC
805 which requires acquisition-related costs to be expensed in the period in which the costs are
incurred and the services are received instead of including such costs as part of the acquisition
price.
Net interest income was $28,000 for fiscal 2009 and net interest income was $422,000 for
fiscal 2008, a decrease of $394,000, or 93.4%. Net interest income and expense for fiscal 2009 and
2008 is comprised of interest income earned on our cash balance and interest expense incurred on
equipment lease obligations. The decrease was due to a decline in market interest rates for
short-term cash investments; we expect this trend to continue throughout 2010.
Our income tax provision for fiscal 2009 was $1.8 million and $3.1 million for fiscal 2008.
Our effective tax rate from continuing operations was 37% for fiscal 2009 and 35% for fiscal 2008.
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.
30
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 |
% |
|
|
654 |
|
|
|
1.4 |
% |
|
|
(225 |
) |
|
|
(34.4 |
)% |
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 |
% |
|
$ |
3,343 |
|
|
|
7.1 |
% |
|
$ |
2,448 |
|
|
|
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 |
% |
|
$ |
2,332 |
|
|
|
5.0 |
% |
|
$ |
458 |
|
|
|
19.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Consolidated Statements of Income for all periods presented reflect the CapMed
division in discontinued operations.
The Consolidated Statement of Income for fiscal 2008 excludes the financial results of PDS
from the 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
31
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 were
comprised of professional salaries and benefits and allocated overhead. The increase in cost of
service revenues was 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 was 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.
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 was primarily due to the addition of sales personnel from the PDS acquisition along
with increased marketing and tradeshow attendance.
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 was primarily due to the addition of
personnel and other professional services related to the administration of PDS.
Net interest income was $422,000 for fiscal 2008 and net interest income was $643,000 for
fiscal 2007, a decrease of $221,000, or 34.4%. 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 interest income earned on our cash balance and
interest expense incurred on equipment lease obligations.
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 was 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.
32
Quarterly Results
The following is a summary of unaudited quarterly results of operations for the years ended
December 31, 2009 and 2008. 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) |
|
2009 |
|
|
2009 |
|
|
2009 |
|
|
2009 |
|
|
2008 |
|
|
2008 |
|
|
2008 |
|
|
2008 |
|
Service revenues |
|
|
14,851 |
|
|
|
14,146 |
|
|
|
13,921 |
|
|
|
14,475 |
|
|
|
14,956 |
|
|
|
15,093 |
|
|
|
15,109 |
|
|
|
11,023 |
|
Reimbursement revenues |
|
|
5,366 |
|
|
|
4,227 |
|
|
|
3,142 |
|
|
|
2,595 |
|
|
|
2,737 |
|
|
|
3,048 |
|
|
|
4,073 |
|
|
|
3,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
20,217 |
|
|
|
18,373 |
|
|
|
17,063 |
|
|
|
17,070 |
|
|
|
17,693 |
|
|
|
18,141 |
|
|
|
19,182 |
|
|
|
14,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
9,024 |
|
|
|
8,937 |
|
|
|
8,608 |
|
|
|
9,061 |
|
|
|
8,995 |
|
|
|
8,513 |
|
|
|
8,595 |
|
|
|
6,343 |
|
Cost of reimbursement revenues |
|
|
5,366 |
|
|
|
4,227 |
|
|
|
3,142 |
|
|
|
2,595 |
|
|
|
2,737 |
|
|
|
3,048 |
|
|
|
4,073 |
|
|
|
3,077 |
|
Sales and marketing expenses |
|
|
2,113 |
|
|
|
1,617 |
|
|
|
2,166 |
|
|
|
2,156 |
|
|
|
2,043 |
|
|
|
2,120 |
|
|
|
2,229 |
|
|
|
1,468 |
|
General and administrative expenses |
|
|
1,871 |
|
|
|
1,759 |
|
|
|
1,867 |
|
|
|
1,917 |
|
|
|
1,614 |
|
|
|
1,962 |
|
|
|
1,900 |
|
|
|
1,539 |
|
Amortization of intangible assets
related to acquisitions |
|
|
145 |
|
|
|
112 |
|
|
|
112 |
|
|
|
119 |
|
|
|
11 |
|
|
|
212 |
|
|
|
133 |
|
|
|
24 |
|
Restructuring charges |
|
|
|
|
|
|
|
|
|
|
466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mergers and acquisitions expense |
|
|
94 |
|
|
|
560 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
18,613 |
|
|
|
17,212 |
|
|
|
16,361 |
|
|
|
15,848 |
|
|
|
15,400 |
|
|
|
15,855 |
|
|
|
16,930 |
|
|
|
12,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations
before interest and taxes |
|
|
1,604 |
|
|
|
1,161 |
|
|
|
702 |
|
|
|
1,222 |
|
|
|
2,293 |
|
|
|
2,286 |
|
|
|
2,252 |
|
|
|
1,649 |
|
Interest income |
|
|
4 |
|
|
|
5 |
|
|
|
10 |
|
|
|
22 |
|
|
|
77 |
|
|
|
98 |
|
|
|
101 |
|
|
|
153 |
|
Interest expense |
|
|
(7 |
) |
|
|
(1 |
) |
|
|
(3 |
) |
|
|
(2 |
) |
|
|
(3 |
) |
|
|
(1 |
) |
|
|
(3 |
) |
|
|
|
|
Income tax provision |
|
|
(658 |
) |
|
|
(463 |
) |
|
|
(180 |
) |
|
|
(456 |
) |
|
|
(702 |
) |
|
|
(856 |
) |
|
|
(887 |
) |
|
|
(666 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations,
net of taxes |
|
|
943 |
|
|
|
702 |
|
|
|
529 |
|
|
|
786 |
|
|
|
1,665 |
|
|
|
1,527 |
|
|
|
1,463 |
|
|
|
1,136 |
|
Loss from discontinued
operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,836 |
) |
|
|
(451 |
) |
|
|
(402 |
) |
|
|
(312 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
943 |
|
|
|
702 |
|
|
|
529 |
|
|
|
786 |
|
|
|
(171 |
) |
|
|
1,076 |
|
|
|
1,061 |
|
|
|
824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
|
0.07 |
|
|
|
0.05 |
|
|
|
0.04 |
|
|
|
0.05 |
|
|
|
0.12 |
|
|
|
0.11 |
|
|
|
0.10 |
|
|
|
0.09 |
|
Discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.13 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
Net Income |
|
|
0.07 |
|
|
|
0.05 |
|
|
|
0.04 |
|
|
|
0.05 |
|
|
|
(0.01 |
) |
|
|
0.08 |
|
|
|
0.07 |
|
|
|
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
|
0.06 |
|
|
|
0.05 |
|
|
|
0.04 |
|
|
|
0.05 |
|
|
|
0.11 |
|
|
|
0.10 |
|
|
|
0.10 |
|
|
|
0.09 |
|
Discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.12 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
Net Income |
|
|
0.06 |
|
|
|
0.05 |
|
|
|
0.04 |
|
|
|
0.05 |
|
|
|
(0.01 |
) |
|
|
0.07 |
|
|
|
0.07 |
|
|
|
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to
calculate earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
14,358 |
|
|
|
14,367 |
|
|
|
14,356 |
|
|
|
14,341 |
|
|
|
14,341 |
|
|
|
14,279 |
|
|
|
14,279 |
|
|
|
12,021 |
|
Diluted |
|
|
15,158 |
|
|
|
15,146 |
|
|
|
15,118 |
|
|
|
15,085 |
|
|
|
14,764 |
|
|
|
15,168 |
|
|
|
15,168 |
|
|
|
12,964 |
|
33
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, 2009 compared to December 31, 2008
|
|
|
|
|
|
|
|
|
(in thousands) |
|
2009 |
|
|
2008 |
|
|
|
|
Net cash provided by activities from continuing operations |
|
$ |
7,552 |
|
|
$ |
9,768 |
|
Net cash used in investing activities from continuing
operations |
|
$ |
(7,713 |
) |
|
$ |
(10,605 |
) |
Net cash (used in) provided by financing activities from
continuing operations |
|
$ |
(43 |
) |
|
$ |
523 |
|
At December 31, 2009, we had cash and cash equivalents of $14.6 million. Working capital,
defined as current assets minus current liabilities, at December 31, 2009 was $7.3 million as
compared to working capital at December 31, 2008 of $7.9 million.
Net cash provided by continuing operating activities for fiscal 2009 was $7.6 million compared
to net cash provided by operating activities of $9.8 million for
fiscal 2008. The primary drivers
of the change in cash provided by continuing operations is the decrease in accounts receivable and
decrease in accrued expenses.
Net cash used in investing activities consists primarily of our investment in capital and
leasehold improvements from continuing operations of $4.3 million and cash paid for the acquisition
of Tourtellotte Solutions and CardioNow for $3.1 million. We currently anticipate that capital
expenditures for fiscal 2010 will be approximately $4.5 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 (used in) financing activities is primarily attributable to a tax benefit
related to stock options of $44,000 and proceeds from stock option exercises of $31,000 offset by
payments on capital leases of $118,000.
The following table lists our cash contractual obligations as of December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period |
|
(in thousands) |
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More than |
|
Contractual obligations |
|
Total |
|
|
1 year |
|
|
1-3 years |
|
|
3-5 years |
|
|
5 years |
|
Facility rent operating
leases |
|
|
20,822 |
|
|
|
1,874 |
|
|
|
4,761 |
|
|
|
4,864 |
|
|
|
9,323 |
|
Employment agreements |
|
|
1,289 |
|
|
|
225 |
|
|
|
1,064 |
|
|
|
|
|
|
|
|
|
Earn-outs for
Tourtellotte
acquisition |
|
|
3,258 |
|
|
|
1,258 |
|
|
|
2,000 |
|
|
|
|
|
|
|
|
|
Total contractual cash
obligations |
|
$ |
25,369 |
|
|
$ |
3,357 |
|
|
$ |
7,825 |
|
|
$ |
4,864 |
|
|
$ |
9,323 |
|
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 have not entered into any off-balance sheet transactions, arrangements or other
relationships with
34
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; |
|
|
|
|
acquisition expenses; 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 2010 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.
35
Recently Issued Accounting Statements
On September 30, 2009, BioClinica adopted FASB ASC 105, Generally Accepted Accounting
Principles, (FASB ASC 105). FASB ASC 105 establishes the FASB Accounting Standards Codification
(Codification) as the source of authoritative accounting principles recognized by the FASB to be
applied by nongovernmental entities in the preparation of financial statements in conformity with
GAAP. Rules and interpretive releases of the Securities and Exchange Commission (SEC) under
authority of federal securities laws are also sources of authoritative GAAP for SEC registrants.
The FASB will no longer issue new standards in the form of Statements, FASB Staff Positions, or
Emerging Issues Task Force Abstracts; instead the FASB will issue Accounting Standards Updates.
Accounting Standards Updates will not be authoritative in their own right as they will only serve
to update the Codification. FASB ASC 105 and the Codification itself do not change GAAP. Other than
the manner in which new accounting guidance is referenced, the adoption of FASB ASC 105 had no
impact on the Financial Statements.
In May 2009, the FASB issued guidance regarding subsequent events, which was subsequently
updated in February 2010. This guidance established general standards of accounting for and
disclosure of events that occur after the balance sheet date but before financial statements are
issued or are available to be issued. In particular, this guidance set forth the period after the
balance sheet date during which management of a reporting entity should evaluate events or
transactions that may occur for potential recognition or disclosure in the financial statements,
the circumstances under which an entity should recognize events or transactions occurring after the
balance sheet date in its financial statements, and the disclosures that an entity should make
about events or transactions that occurred after the balance sheet date. This guidance was
effective for financial statements issued for fiscal years and interim periods ending after June
15, 2009, and was therefore adopted by us for the second quarter 2009 reporting. The adoption did
not have a significant impact on the subsequent events that we report, either through recognition
or disclosure, in the consolidated financial statements. In February 2010, the FASB amended its
guidance on subsequent events to remove the requirement to disclose the date through which an
entity has evaluated subsequent events, alleviating conflicts with current SEC guidance. This
amendment was effective immediately and we therefore removed the disclosure in this Annual Report.
On June 30, 2009, BioClinica adopted FASB ASC 270, Interim Reporting (FASB ASC 270), issued by
the FASB to fair value disclosures of financial instruments. FASB ASC 270 requires a publicly
traded company to include disclosures about the fair value of its financial instruments whenever it
issues summarized financial information for interim reporting periods. Such disclosures include the
fair value of all financial instruments, for which it is practicable to estimate that value,
whether recognized or not recognized in the statement of financial position; the related carrying
amount of these financial instruments; and the method(s) and significant assumptions used to
estimate the fair value. Other than the required disclosures, the adoption of FASB ASC 270 had no
impact on the Financial Statements.
On January 1, 2009, BioClinica adopted FASB ASC 820, Fair Value Measurements and
Disclosures,(FASB ASC 820), issued by the FASB to fair value accounting and reporting as it relates
to nonfinancial assets and nonfinancial liabilities that are not recognized or disclosed at fair
value in the financial statements on at least an annual basis. FASB ASC 820 defines fair value,
establishes a framework for measuring fair value in GAAP, and expands disclosures about fair value
measurements. This guidance applies to other GAAP that require or permit fair value measurements
and is to be applied prospectively with limited exceptions. The adoption of FASB ASC 820, as it
relates to nonfinancial assets and nonfinancial liabilities, had no impact on the Financial
Statements.
On January 1, 2009, BioClinica adopted FASB ASC 805, Business Combinations (FASB ASC 805),
issued by the FASB to accounting for business combinations. While retaining the fundamental
requirements of
36
accounting for business combinations, including that the purchase method be used
for all business combinations and for an acquirer to be identified for each business combination, FASB ASC 805 defines the
acquirer as the entity that obtains control of one or more businesses in the business combination
and establishes the acquisition date as the date that the acquirer achieves control instead of the
date that the consideration is transferred. These changes require an acquirer in a business
combination, including business combinations achieved in stages (step acquisition), to recognize
the assets acquired, liabilities assumed, and any noncontrolling interest in the acquiree at the
acquisition date, measured at their fair values as of that date, with limited exceptions. This
guidance also applies to all assets acquired and liabilities assumed in a business combination that
arise from certain contingencies and requires (i) an acquirer to recognize at fair value, at the
acquisition date, an asset acquired or liability assumed in a business combination that arises from
a contingency if the acquisition-date fair value of that asset or liability can be determined
during the measurement period otherwise the asset or liability should be recognized at the
acquisition date if certain defined criteria are met; (ii) contingent consideration arrangements of
an acquiree assumed by the acquirer in a business combination be recognized initially at fair
value; (iii) subsequent measurements of assets and liabilities arising from contingencies be based
on a systematic and rational method depending on their nature and contingent consideration
arrangements be measured subsequently; and (iv) disclosures of the amounts and measurement basis of
such assets and liabilities and the nature of the contingencies. Additionally, FASB ASC 805
requires acquisition-related costs to be expensed in the period in which the costs are incurred and
the services are received instead of including such costs as part of the acquisition price. The
adoption of FASB ASC 805 resulted in a charge of $560,000 ($333,000 after-tax) in mergers and
acquisitions related expenses on the accompanying Consolidated Statements of Income for
acquisitions completed in the third quarter of 2009. These provisions were applied to the
acquisitions completed in the fourth quarter, refer to Note 2 of our Consolidated Financial
Statements.
On January 1, 2009, BioClinica adopted changes to FASB ASC 350, Intangibles Goodwill and
Other (FASB ASC 350), issued by the FASB to accounting for intangible assets. The changes to FASB
ASC 350 amends the factors that should be considered in developing renewal or extension assumptions
used to determine the useful life of a recognized intangible asset in order to improve the
consistency between the useful life of a recognized intangible asset outside of a business
combination and the period of expected cash flows used to measure the fair value of an intangible
asset in a business combination. The adoption of FASB ASC 350 had no impact on the Financial
Statements.
In October 2009, the FASB issued guidance on revenue recognition that will become effective
for us beginning January 1, 2011, with earlier adoption permitted. Under the new guidance on
arrangements that include software elements, tangible products that have software components that
are essential to the functionality of the tangible product will no longer be within the scope of
the software revenue recognition guidance, and software-enabled products will now be subject to
other relevant revenue recognition guidance. Additionally, the FASB issued guidance on revenue
arrangements with multiple deliverables that are outside the scope of the software revenue
recognition guidance. Under the new guidance, when vendor specific objective evidence or third
party evidence for deliverables in an arrangement cannot be determined, a best estimate of the
selling price is required to separate deliverables and allocate arrangement consideration using the
relative selling price method. The new guidance includes new disclosure requirements on how the
application of the relative selling price method affects the timing and amount of revenue
recognition. Management believes the adoption of this new guidance will not have a material impact
on our financial statements.
Existing Contracts
As of December 31, 2009, we had entered into agreements to provide services with a remaining
value of $98.7 million. 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.
37
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
In accordance with our foreign exchange rate risk management policy, we had purchased monthly
Euro call options in prior years. These options were intended to hedge against the exposure to
variability in our cash flows resulting from the Euro denominated costs for our Netherlands and
France subsidiaries. During the twelve months ended December 31, 2009 and 2008, we have not
purchased any Euro call options, because our foreign currency needs are generally being met by the
cash flow generated by Euro denominated contracts. The last Euro call option expired March 31,
2007, and we have not entered into any new Euro call options since that time. As of December 31,
2009, there were no outstanding derivative positions.
Under our current foreign exchange rate risk management policy, and upon expiration or
ineffectiveness of any derivatives, we will record a gain or loss from such derivatives that are
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.
38
Item 8. Financial Statements and Supplementary Data.
|
|
|
|
|
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS |
|
PAGE |
|
Report of Independent Registered Public Accounting Firm |
|
|
40 |
|
Consolidated Balance Sheets as of December 31, 2009 and 2008 |
|
|
41 |
|
Consolidated Statements of Income for the year ended December 31, 2009, 2008 and 2007 |
|
|
42 |
|
Consolidated Statements of Stockholders Equity for the year ended
December 31, 2009, 2008 and 2007 |
|
|
43 |
|
Consolidated Statements of Cash Flows for the year ended December 31, 2009, 2008 and 2007 |
|
|
44 |
|
Notes to Consolidated Financial Statements |
|
|
46 |
|
39
Report of Independent Registered Public Accounting Firm
To the Board of Directors
And Shareholders of
BioClinica, 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 BioClinica, Inc. and its subsidiaries at
December 31, 2009 and 2008, and the results of their operations and their cash flows for each of
the three years in the period ended December 31, 2009 in conformity with accounting principles
generally accepted in the United States of America. 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 audits to obtain reasonable assurance about
whether the financial statements are free of material misstatement. Our audits of the financial
statements included 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.
As discussed in Note 2 to the consolidated financial statements, the Company changed the manner in
which it accounts for business combinations in 2009.
PricewaterhouseCoopers LLP
Philadelphia, PA
March 30, 2010
40
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
(in thousands) |
|
2009 |
|
|
2008 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,570 |
|
|
$ |
14,265 |
|
Accounts receivable, net of allowance for doubtful accounts of $9 and $11, respectively |
|
|
10,966 |
|
|
|
11,982 |
|
Prepaid expenses and other current assets |
|
|
1,869 |
|
|
|
2,315 |
|
Assets held for sale |
|
|
|
|
|
|
500 |
|
Deferred income taxes |
|
|
3,370 |
|
|
|
3,084 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
30,775 |
|
|
|
32,146 |
|
Property and equipment, net |
|
|
9,040 |
|
|
|
7,022 |
|
Intangibles, net |
|
|
1,969 |
|
|
|
2,058 |
|
Goodwill |
|
|
32,933 |
|
|
|
27,391 |
|
Other assets |
|
|
620 |
|
|
|
591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets |
|
$ |
75,337 |
|
|
$ |
69,208 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,899 |
|
|
$ |
3,832 |
|
Accrued expenses and other current liabilities |
|
|
4,134 |
|
|
|
5,236 |
|
Deferred revenue |
|
|
14,256 |
|
|
|
15,106 |
|
Current maturities of capital lease obligations |
|
|
|
|
|
|
54 |
|
Current liability for acquisition earn-out |
|
|
1,184 |
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
23,473 |
|
|
|
24,228 |
|
Long-term capital lease obligations |
|
|
|
|
|
|
65 |
|
Long-term liability for acquisition earn-out |
|
|
1,657 |
|
|
|
|
|
Deferred income tax |
|
|
1,167 |
|
|
|
927 |
|
Other liability |
|
|
505 |
|
|
|
576 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
26,802 |
|
|
|
25,796 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock- $.00025 par value; authorized 3,000,000 shares,
0 issued and outstanding at December 31, 2009 and 2008 |
|
|
|
|
|
|
|
|
Common stock $.00025 par value; authorized 36,000,000 shares, issued and outstanding 14,394,374 shares at December 31, 2009
and authorized 18,000,000 shares, issued and outstanding 14,341,403 shares at December 31, 2008 |
|
|
4 |
|
|
|
4 |
|
Common stock consideration for earn-out |
|
|
1,309 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
43,104 |
|
|
|
42,270 |
|
Retained earnings |
|
|
4,039 |
|
|
|
1,080 |
|
Accumulated other comprehensive income |
|
|
79 |
|
|
|
58 |
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
48,535 |
|
|
|
43,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
75,337 |
|
|
$ |
69,208 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these statements.
41
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands except per share data) |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Service revenues |
|
$ |
57,393 |
|
|
$ |
56,181 |
|
|
$ |
37,543 |
|
Reimbursement revenues |
|
|
15,330 |
|
|
|
12,935 |
|
|
|
9,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
72,723 |
|
|
|
69,116 |
|
|
|
47,254 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
35,630 |
|
|
|
32,446 |
|
|
|
21,900 |
|
Cost of reimbursement revenues |
|
|
15,330 |
|
|
|
12,935 |
|
|
|
9,711 |
|
Sales and marketing expenses |
|
|
8,052 |
|
|
|
7,860 |
|
|
|
5,005 |
|
General and administrative expenses |
|
|
7,414 |
|
|
|
7,015 |
|
|
|
5,734 |
|
Amortization of intangible assets related to acquisitions |
|
|
489 |
|
|
|
380 |
|
|
|
56 |
|
Restructuring charges |
|
|
466 |
|
|
|
|
|
|
|
|
|
Mergers and acquisitions related costs |
|
|
654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
68,035 |
|
|
|
60,636 |
|
|
|
42,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before interest and taxes |
|
|
4,688 |
|
|
|
8,480 |
|
|
|
4,848 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
41 |
|
|
|
429 |
|
|
|
654 |
|
Interest expense |
|
|
(13 |
) |
|
|
(7 |
) |
|
|
(11 |
) |
Income tax provision |
|
|
(1,757 |
) |
|
|
(3,111 |
) |
|
|
(2,148 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations, net of taxes |
|
$ |
2,959 |
|
|
$ |
5,791 |
|
|
$ |
3,343 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations, net of taxes |
|
|
|
|
|
|
(3,001 |
) |
|
|
(1,011 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,959 |
|
|
$ |
2,790 |
|
|
$ |
2,332 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.21 |
|
|
$ |
0.42 |
|
|
$ |
0.29 |
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
|
|
|
|
$ |
(0.22 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
Net Income |
|
$ |
0.21 |
|
|
$ |
0.20 |
|
|
$ |
0.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.20 |
|
|
$ |
0.40 |
|
|
$ |
0.26 |
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
|
|
|
|
$ |
(0.21 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
|
Net Income |
|
$ |
0.20 |
|
|
$ |
0.19 |
|
|
$ |
0.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to calculate earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
14,354 |
|
|
|
13,752 |
|
|
|
11,616 |
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
15,100 |
|
|
|
14,469 |
|
|
|
12,745 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these statements.
42
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
Common Stock |
|
Accumulated |
|
Comprehensive |
|
|
|
|
Common Stock |
|
Paid-in |
|
Consideration for |
|
(Deficit) Retained |
|
Gain |
|
Stockholders |
(in thousands) |
|
Shares |
|
Amount |
|
Capital |
|
Earn-out |
|
Earnings |
|
(Loss) |
|
Equity |
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 |
|
Stock options exercised |
|
|
38 |
|
|
|
|
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 |
|
Restricted shares issued |
|
|
15 |
|
|
|
|
|
|
|
(31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31 |
) |
Stock consideration for acquisitions |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,309 |
|
|
|
|
|
|
|
|
|
|
|
1,309 |
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
790 |
|
Tax benefit on exercise of stock options |
|
|
|
|
|
|
|
|
|
|
44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
44 |
|
Equity adjustment from foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21 |
|
|
|
21 |
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,959 |
|
|
|
|
|
|
|
2,959 |
|
|
|
|
Balance at December 31, 2009 |
|
|
14,394 |
|
|
$ |
4 |
|
|
$ |
43,104 |
|
|
$ |
1,309 |
|
|
$ |
4,039 |
|
|
$ |
79 |
|
|
$ |
48,535 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statements of comprehensive income |
|
For the year ended December 31, |
(in thousands) |
|
2009 |
|
2008 |
|
2007 |
Net income |
|
$ |
2,959 |
|
|
$ |
2,790 |
|
|
$ |
2,333 |
|
Net unrealized income (loss) on derivative instruments, net of tax |
|
|
|
|
|
|
|
|
|
|
(17 |
) |
Equity adjustment from foreign currency translation |
|
|
21 |
|
|
|
(93 |
) |
|
|
151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
$ |
2,980 |
|
|
$ |
2,697 |
|
|
$ |
2,467 |
|
The accompanying notes are an integral part of these statements.
43
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,959 |
|
|
$ |
2,790 |
|
|
$ |
2,332 |
|
Adjustments to reconcile net income to net cash provided by
Operating activities, net of acquisition: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
2,711 |
|
|
|
2,266 |
|
|
|
2,335 |
|
(Benefit) provision for deferred income taxes |
|
|
336 |
|
|
|
(311 |
) |
|
|
286 |
|
Accretion of acquisition earn-out |
|
|
94 |
|
|
|
|
|
|
|
|
|
Bad debt provision (recovery) |
|
|
93 |
|
|
|
(6 |
) |
|
|
15 |
|
Stock based compensation expense |
|
|
760 |
|
|
|
563 |
|
|
|
474 |
|
Gain on foreign currency options |
|
|
|
|
|
|
|
|
|
|
(10 |
) |
Loss from discontinued operations |
|
|
|
|
|
|
3,001 |
|
|
|
1,011 |
|
Changes in operating assets and liabilities, net of acquisitions: |
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in accounts receivable |
|
|
1,802 |
|
|
|
(1,339 |
) |
|
|
(145 |
) |
Decrease (increase) in prepaid expenses and other current assets |
|
|
447 |
|
|
|
(830 |
) |
|
|
(77 |
) |
(Increase) decrease in other assets |
|
|
(30 |
) |
|
|
93 |
|
|
|
(53 |
) |
Increase in accounts payable |
|
|
403 |
|
|
|
1,599 |
|
|
|
78 |
|
(Decrease) increase in accrued expenses and other current liabilities |
|
|
(1,100 |
) |
|
|
353 |
|
|
|
1,334 |
|
(Decrease) increase in deferred revenue |
|
|
(852 |
) |
|
|
(850 |
) |
|
|
2,073 |
|
(Decrease) increase in other liabilities |
|
|
(71 |
) |
|
|
(3 |
) |
|
|
23 |
|
Increase in net assets held for sale |
|
|
|
|
|
|
2,442 |
|
|
|
309 |
|
|
|
|
|
|
|
|
|
|
|
Cash provided by activities from continuing operations |
|
|
7,552 |
|
|
|
9,768 |
|
|
|
9,985 |
|
Cash used by discontinued operations |
|
|
|
|
|
|
(2,974 |
) |
|
|
(1,319 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
7,552 |
|
|
|
6,794 |
|
|
|
8,666 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows used in investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(4,569 |
) |
|
|
(2,677 |
) |
|
|
(2,575 |
) |
Net cash paid for acquisition |
|
|
(3,144 |
) |
|
|
(7,928 |
) |
|
|
(3,507 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities from continuing operations |
|
|
(7,713 |
) |
|
|
(10,605 |
) |
|
|
(6,082 |
) |
Purchase of plant, property and equipment for discontinued operations |
|
|
|
|
|
|
(239 |
) |
|
|
(1,353 |
) |
Net cash received for sale of assets of discontinued operations |
|
|
500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(7,213 |
) |
|
|
(10,844 |
) |
|
|
(7,435 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Payments under equipment lease obligations |
|
|
(118 |
) |
|
|
(153 |
) |
|
|
(454 |
) |
Proceeds from exercise of stock options |
|
|
31 |
|
|
|
386 |
|
|
|
301 |
|
Excess tax benefit related to stock options |
|
|
44 |
|
|
|
290 |
|
|
|
643 |
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities from continuing operations |
|
|
(43 |
) |
|
|
523 |
|
|
|
490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
9 |
|
|
|
(123 |
) |
|
|
28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
305 |
|
|
|
(3,650 |
) |
|
|
1,749 |
|
Cash and cash equivalents at beginning of period |
|
|
14,265 |
|
|
|
17,915 |
|
|
|
16,166 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
14,570 |
|
|
$ |
14,265 |
|
|
$ |
17,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
11 |
|
|
$ |
11 |
|
|
$ |
12 |
|
Cash paid during the period for income taxes |
|
$ |
1,226 |
|
|
$ |
1,970 |
|
|
$ |
604 |
|
The accompanying notes are an integral part of these statements.
44
Supplemental cash flow disclosure
Schedule of non cash investing and financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
(in thousands) |
|
2009 |
|
2008 |
|
2007 |
Increase in property, plant and equipment acquisitions in accounts payable |
|
$ |
334 |
|
|
$ |
7 |
|
|
$ |
11 |
|
Value of contingent stock and cash to be used for earn-out provisions related to acquired business |
|
$ |
4,150 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired business |
|
For the year ended December 31, |
(in thousands) |
|
2009 |
|
2008 |
|
2007 |
Accounts receivable |
|
$ |
934 |
|
|
$ |
4,926 |
|
|
$ |
228 |
|
Property and equipment |
|
|
|
|
|
|
721 |
|
|
|
185 |
|
Other assets |
|
|
55 |
|
|
|
295 |
|
|
|
53 |
|
Intangible assets and goodwill |
|
|
2,248 |
|
|
|
23,874 |
|
|
|
4,590 |
|
Current liabilities assumed |
|
|
(93 |
) |
|
|
(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 $0, $418,000 and $201,000, respectively |
|
$ |
3,144 |
|
|
$ |
7,928 |
|
|
$ |
3,507 |
|
The accompanying notes are an integral part of these statements.
45
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
1. Organization and Summary of Significant Accounting Policies
Description of Business
On July 8, 2009, our shareholders approved an amendment to our Certificate of Incorporation,
as amended, to change our name from Bio-Imaging Technologies, Inc. to BioClinica, Inc.
BioClinica, provides integrated clinical research services including imaging core lab and
eClinical technologies and services to pharmaceutical, biotechnology, and medical device companies,
and other organizations such as contract research organizations (CROs), engaged in global clinical
studies. Our products and services include: medical image management, electronic data capture,
clinical data management, interactive voice and web response, clinical trial supply forecasting
tools, and electronic image transport and archive solutions. By supplying enterprise-class software
and hosted solutions accompanied by expert services to fully utilize these tools, we believe that
our offerings provide our clients, large and small, improved speed and efficiency in the execution
of clinical studies, with reduced clinical and business risk.
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.
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 BioClinica 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.
Our results for fiscal 2009 include reductions to net income of $42,000 as a result of
additional income tax provision recorded in the fourth quarter of fiscal 2009 that should have been
recorded as a reduction of net income in fiscal 2008. An additional out-of-period adjustment was
recorded in the fourth quarter of fiscal 2009 that decreased goodwill and increased our deferred
tax asset by $363,000, related to recording a net operating loss carryforward that should have been
recorded in the first quarter of fiscal 2008. We have determined that the impact of these adjustments recorded in the fourth quarter of fiscal 2009 were immaterial to our results of operations
in all applicable prior interim and annual periods. As a result, we
have not restated any prior period amounts.
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
46
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
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 FASB
ASC 830 Foreign Currency Matters.
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 $21,000 and $(93,000) at December
31, 2009 and 2008, 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 FASB ASC 830 Foreign Currency Matters.
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,
accounts receivable, accounts payable and other accrued expenses approximate their fair values due
to their short maturities. The earn-out liability from the Tourtellotte acquisition is recorded at
fair value, see Note 2 for additional information.
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 an
original maturity of three months or less.
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
47
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
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.
The Company, at the request of its clients, directly contracts with and pays 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.
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 do not bear interest.
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
(in thousands) |
|
2009 |
|
|
2008 |
|
Billed trade accounts receivable |
|
|
10,164 |
|
|
$ |
10,091 |
|
Unbilled trade accounts receivable |
|
|
747 |
|
|
|
1,863 |
|
Other |
|
|
55 |
|
|
|
28 |
|
|
|
|
|
|
|
|
Total receivables |
|
|
10,966 |
|
|
$ |
11,982 |
|
|
|
|
|
|
|
|
48
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
|
|
|
|
|
Allowance Rollforward: |
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
29 |
|
Additions |
|
|
6 |
|
Write offs (net of recoveries) |
|
|
(24 |
) |
|
|
|
|
Balance at December 31, 2008 |
|
$ |
11 |
|
Additions |
|
|
93 |
|
Write offs (net of recoveries) |
|
|
(95 |
) |
|
|
|
|
Balance at December 31, 2009 |
|
$ |
9 |
|
|
|
|
|
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.
Property and equipment are reviewed for impairment whenever events or changes in circumstances
indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets
is determined by comparing the estimated undiscounted cash flows of the operations related to the
assets to their carrying amount An impairment loss would be recognized when the carrying amount of
the assets exceeds the estimated undiscounted net cash flows. The amount of the impairment loss to
be recorded is calculated as the excess of the carrying value of the assets over their fair value,
with fair value determined using the best information available, which generally is a discounted
cash flow model. The estimated undiscounted net cash flows require significant management
judgments.
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 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
$1,806,000, $897,000 and $1,7000,000 for the year ended December 31, 2009, 2008 and 2007
respectively. Amortization expense related to capitalized computer software costs amounted to
$423,000, $582,000 and $445,000 at December 31, 2009, 2008 and 2007 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.
49
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
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 FASB ASC 740 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
FASB ASC 260 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) |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Net income diluted and basic |
|
|
2,959 |
|
|
$ |
2,790 |
|
|
$ |
2,332 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator basic: |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares |
|
|
14,354 |
|
|
|
13,752 |
|
|
|
11,616 |
|
|
|
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.21 |
|
|
$ |
0.20 |
|
|
$ |
0.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares |
|
|
14,354 |
|
|
|
13,752 |
|
|
|
11,616 |
|
Common share equivalents of
outstanding stock options |
|
|
403 |
|
|
|
648 |
|
|
|
1,023 |
|
Common share equivalents of
unrecognized compensation expense |
|
|
343 |
|
|
|
69 |
|
|
|
106 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
dilutive common equivalent shares |
|
|
15,100 |
|
|
|
14,469 |
|
|
|
12,745 |
|
|
|
|
|
|
|
|
|
|
|
Diluted income per common share |
|
$ |
0.20 |
|
|
$ |
0.19 |
|
|
$ |
0.18 |
|
|
|
|
|
|
|
|
|
|
|
We excluded options to purchase 656,000, 719,000 and 140,000 shares of our common stock for
the twelve months ended December 31, 2009, 2008 and 2007, respectively, since they were out-of-the-money and antidilutive.
50
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
Recently Issued Accounting Statements
On September 30, 2009, BioClinica adopted FASB ASC 105, Generally Accepted Accounting
Principles, (FASB ASC 105). FASB ASC 105 establishes the FASB Accounting Standards Codification
(Codification) as the source of authoritative accounting principles recognized by the FASB to be
applied by nongovernmental entities in the preparation of financial statements in conformity with
GAAP. Rules and interpretive releases of the Securities and Exchange Commission (SEC) under
authority of federal securities laws are also sources of authoritative GAAP for SEC registrants.
The FASB will no longer issue new standards in the form of Statements, FASB Staff Positions, or
Emerging Issues Task Force Abstracts; instead the FASB will issue Accounting Standards Updates.
Accounting Standards Updates will not be authoritative in their own right as they will only serve
to update the Codification. FASB ASC 105 and the Codification itself do not change GAAP. Other than
the manner in which new accounting guidance is referenced, the adoption of FASB ASC 105 had no
impact on the Financial Statements.
In May 2009, the FASB issued guidance regarding subsequent events, which was subsequently
updated in February 2010. This guidance established general standards of accounting for and
disclosure of events that occur after the balance sheet date but before financial statements are
issued or are available to be issued. In particular, this guidance set forth the period after the
balance sheet date during which management of a reporting entity should evaluate events or
transactions that may occur for potential recognition or disclosure in the financial statements,
the circumstances under which an entity should recognize events or transactions occurring after the
balance sheet date in its financial statements, and the disclosures that an entity should make
about events or transactions that occurred after the balance sheet date. This guidance was
effective for financial statements issued for fiscal years and interim periods ending after June
15, 2009, and was therefore adopted by us for the second quarter 2009 reporting. The adoption did
not have a significant impact on the subsequent events that we report, either through recognition
or disclosure, in the consolidated financial statements. In February 2010, the FASB amended its
guidance on subsequent events to remove the requirement to disclose the date through which an
entity has evaluated subsequent events, alleviating conflicts with current SEC guidance. This
amendment was effective immediately and we therefore removed the disclosure in this Annual Report.
On June 30, 2009, BioClinica adopted FASB ASC 270, Interim Reporting (FASB ASC 270), issued by
the FASB to fair value disclosures of financial instruments. FASB ASC 270 requires a publicly
traded company to include disclosures about the fair value of its financial instruments whenever it
issues summarized financial information for interim reporting periods. Such disclosures include the
fair value of all financial instruments, for which it is practicable to estimate that value,
whether recognized or not recognized in the statement of financial position; the related carrying
amount of these financial instruments; and the method(s) and significant assumptions used to
estimate the fair value. Other than the required disclosures, the adoption of FASB ASC 270 had no
impact on the Financial Statements.
On January 1, 2009, BioClinica adopted FASB ASC 820, Fair Value Measurements and
Disclosures,(FASB ASC 820), issued by the FASB to fair value accounting and reporting as it relates
to nonfinancial assets and nonfinancial liabilities that are not recognized or disclosed at fair
value in the financial statements on at least an annual basis. FASB ASC 820 defines fair value,
establishes a framework for measuring fair value in GAAP, and expands disclosures about fair value
measurements. This guidance applies to other GAAP that require or permit fair value measurements
and is to be applied
51
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
prospectively with limited exceptions. The adoption of FASB ASC 820, as it relates to
nonfinancial assets and nonfinancial liabilities, had no impact on the Financial Statements.
On January 1, 2009, BioClinica adopted FASB ASC 805, Business Combinations (FASB ASC 805),
issued by the FASB to accounting for business combinations. While retaining the fundamental
requirements of accounting for business combinations, including that the purchase method be used
for all business combinations and for an acquirer to be identified for each business combination,
FASB ASC 805 defines the acquirer as the entity that obtains control of one or more businesses in
the business combination and establishes the acquisition date as the date that the acquirer
achieves control instead of the date that the consideration is transferred. These changes require
an acquirer in a business combination, including business combinations achieved in stages (step
acquisition), to recognize the assets acquired, liabilities assumed, and any noncontrolling
interest in the acquiree at the acquisition date, measured at their fair values as of that date,
with limited exceptions. This guidance also applies to all assets acquired and liabilities assumed
in a business combination that arise from certain contingencies and requires (i) an acquirer to
recognize at fair value, at the acquisition date, an asset acquired or liability assumed in a
business combination that arises from a contingency if the acquisition-date fair value of that
asset or liability can be determined during the measurement period otherwise the asset or liability
should be recognized at the acquisition date if certain defined criteria are met; (ii) contingent
consideration arrangements of an acquiree assumed by the acquirer in a business combination be
recognized initially at fair value; (iii) subsequent measurements of assets and liabilities arising
from contingencies be based on a systematic and rational method depending on their nature and
contingent consideration arrangements be measured subsequently; and (iv) disclosures of the amounts
and measurement basis of such assets and liabilities and the nature of the contingencies.
Additionally, FASB ASC 805 requires acquisition-related costs to be expensed in the period in which
the costs are incurred and the services are received instead of including such costs as part of the
acquisition price. The adoption of FASB ASC 805 resulted in a charge of $560,000 ($333,000
after-tax) in mergers and acquisitions related expenses on the accompanying Consolidated Statements
of Income for acquisitions completed in the third quarter of 2009. These provisions were applied
to the acquisitions completed in the fourth quarter, refer to Note 2 of our Consolidated Financial
Statements.
On January 1, 2009, BioClinica adopted changes to FASB ASC 350, Intangibles Goodwill and
Other (FASB ASC 350), issued by the FASB to accounting for intangible assets. The changes to FASB
ASC 350 amends the factors that should be considered in developing renewal or extension assumptions
used to determine the useful life of a recognized intangible asset in order to improve the
consistency between the useful life of a recognized intangible asset outside of a business
combination and the period of expected cash flows used to measure the fair value of an intangible
asset in a business combination. The adoption of FASB ASC 350 had no impact on the Financial
Statements.
In October 2009, the FASB issued guidance on revenue recognition that will become effective
for us beginning January 1, 2011, with earlier adoption permitted. Under the new guidance on
arrangements that include software elements, tangible products that have software components that
are essential to the functionality of the tangible product will no longer be within the scope of
the software revenue recognition guidance, and software-enabled products will now be subject to
other relevant revenue recognition guidance. Additionally, the FASB issued guidance on revenue
arrangements with multiple deliverables that are outside the scope of the software revenue
recognition guidance. Under the new guidance, when vendor specific objective evidence or third
party evidence for deliverables in an
52
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
arrangement cannot be determined, a best estimate of the
selling price is required to separate deliverables
and allocate arrangement consideration using the relative selling price method. The new
guidance includes new disclosure requirements on how the application of the relative selling price
method affects the timing and amount of revenue recognition. Management believes the adoption of
this new guidance will not have a material impact on our financial statements.
2. Acquisitions
2009 Acquisitions:
On August 27, 2009, BioClinica acquired the CardioNow unit of Agfa Healthcare (CardioNow).
CardioNow has developed a web-based system for the secure transmission of medical cardiac images.
The software was specifically developed for and marketed to the invasive cardiology departments of
hospitals within the United States. BioClinica will integrate and enhance the current CardioNow
software and service to offer our clients a streamlined electronic transport solution to facilitate
the blinding, sharing, tracking and archiving of medical images for multi-center clinical trials as
part of our suite of imaging services. The purchase price for CardioNow consisted of cash
consideration paid to Agfa Healthcare of $1 million. The Company paid the purchase price for
CardioNow with cash from operations. The financial results of CardioNow for the fiscal year are
included in the consolidated statement of income for the period ended December 31, 2009 since the
date of acquisition. The pro forma impact of the CardioNow acquisition on 2009 results was
immaterial.
On September 15, 2009, BioClinica acquired substantially all of the assets of Tourtellotte
Solutions, Inc. (Tourtellotte). Tourtellotte provides software applications and consulting
services which support clinical trials in the pharmaceutical industry. The purchase price for
Tourtellotte was $2.1 million in cash. Pursuant to the acquisition agreement, the Company agreed to
pay up to an additional $3.2 million in cash and 350,000 shares of our common stock based upon
achieving certain milestones, which include certain product development and revenue targets. (the
earn-out). The fair value of the cash earn-out of $2.8 million has been recorded as a liability
and the fair value of the 350,000 shares of $1.3 million has been classified separately within
stockholders equity as contingent consideration for a total purchase price of $6.2 million as of
December 31, 2009. The Company used cash from operations to fund the cash purchase price for
Tourtellotte. The financial results of Tourtellotte from the acquisition date are included in the
consolidated statement of income for the period ended December 31, 2009.
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, 2009 and 2008 as if the
Tourtellotte acquisition had occurred as of the beginning of each of the periods presented after
giving effect to certain adjustments. 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 Tourtellotte 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.
53
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended |
(in thousands except per share data) |
|
2009 |
|
2008 |
Total revenue |
|
$ |
76,823 |
|
|
$ |
72,979 |
|
Income from continuing operations before interest and taxes |
|
|
5,003 |
|
|
|
8,270 |
|
Income from continuing operations, net of taxes |
|
|
3,156 |
|
|
|
5,654 |
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.22 |
|
|
$ |
0.41 |
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.21 |
|
|
$ |
0.39 |
|
In connection with the acquisitions of CardioNow and Tourtellotte, the Company performed an
evaluation of the guidance included in FASB ASC 280, Segment Reporting (FASB ASC 280) and FASB
ASC 350, Intangibles Goodwill and Other (FASB ASC 350). Based on that evaluation, the Company
included CardioNow and Tourtellotte as part of its clinical trials services reportable segment.
In accordance with FASB ASC 805, the Company expensed all costs related to the acquisitions.
The total costs related to the acquisitions were $560,000 and included in mergers and acquisition
related costs on the consolidated statement of income.
The following table summarizes the consideration transferred to acquire CardioNow and
Tourtolette at the respective acquisition dates:
|
|
|
|
|
|
|
|
|
|
|
CardioNow |
|
|
Tourtellotte |
|
Cash |
|
$ |
1,000 |
|
|
$ |
2,144 |
|
Estimated earnout payments: |
|
|
|
|
|
|
|
|
Contingent consideration to be settled in cash |
|
|
|
|
|
|
2,656 |
|
Contingent consideration to be settled in stock |
|
|
|
|
|
|
1,300 |
|
Working capital adjustment |
|
|
|
|
|
|
94 |
|
|
|
|
|
|
|
|
Total purchase price |
|
$ |
1,000 |
|
|
$ |
6,194 |
|
|
|
|
|
|
|
|
54
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
The following table summarizes the amounts of identified assets acquired and liabilities assumed
from CardioNow and Tourtellotte at the respective acquisition date fair value:
|
|
|
|
|
|
|
|
|
|
|
CardioNow |
|
|
Tourtellotte |
|
Accounts Receivable |
|
|
|
|
|
$ |
934 |
|
Other Assets |
|
|
|
|
|
|
55 |
|
Other Liabilities |
|
|
|
|
|
|
(93 |
) |
Customer Relationships |
|
|
|
|
|
|
393 |
|
Goodwill, including Workforce |
|
$ |
1,000 |
|
|
|
4,905 |
|
|
|
|
|
|
|
|
Total Fair Value of Purchase Price |
|
$ |
1,000 |
|
|
$ |
6,194 |
|
|
|
|
|
|
|
|
Accounts receivable, other assets and other liabilities were stated at their historical
carrying values, which approximate fair value given the short-term nature of these assets and
liabilities.
The cash contingent consideration expected to be paid within one year from December 31, 2009
of $1,184,000 was classified as a short-term liability and the remaining cash contingent
consideration of $1,657,000 was classified as a long-term liability on the financial statements.
The contingent consideration expected to be paid in stock of $1,309,000 is recorded in the equity
section of the financial statements. The difference between the fair value of the cash contingent
consideration at date of acquisition and the expected payment will be recorded as an expense in the
financial statements at the end of each reporting period. In fiscal 2009, the Company recorded
$94,000 of accretion expense in mergers and acquisition related costs on the income statement for
this difference.
In accordance with FASB ASC 820, Fair Value Measurements (FASB ASC 820) the Company
determined that the non-financial assets and liabilities summarized above are derived from
significant unobservable inputs (Level 3 inputs) determined by management based on various market
and income analyses and recent asset appraisals. The goodwill recorded in connection with these
acquisitions will be deductible for tax purposes over 15 years.
The results of operations of CardioNow and Tourtellotte are included in our financial
statements from the respective acquisition dates.
2008 Acquisition:
On March 24, 2008, BioClinica 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 PDS Merger Agreement), dated March 24, 2008, by and among the Company, BioClinica
Acquisition Corporation, a Pennsylvania corporation and wholly-owned subsidiary of the Company
(PDS Merger Sub), and PDS and its Stockholders Representative.
Under the terms of the PDS Merger Agreement, the Company acquired all of PDSs outstanding
capital stock. The total consideration paid by the Company to the PDS 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
55
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
including March 19, 2008 of $7.42. The aggregate purchase price was
subject to a post-closing
adjustment based on the Tangible Net Worth (as defined in the PDS Merger Agreement) of PDS on
the Closing Date (as defined in the PDS Merger Agreement). Pursuant to the terms of the PDS 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 PDS Merger Agreement). On June 13,
2008, BioClinica 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. BioClinica 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 was to be held in escrow to cover any potential indemnification claims under the PDS
Merger Agreement for a period ending no later than March 31, 2009. There were no indemnification
claims and this amount was paid to the stockholders in April 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 PDS 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 PDS 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 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.
The following table summarizes the final allocation of the total cost of the PDS Acquisition
to the assets acquired and the liabilities assumed.
|
|
|
|
|
(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
56
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT(Continued)
were immaterial; therefore, the Company did not include the results of operations for those eight
days in the Consolidated Statement of Income for the 12 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 |
(in thousands except per share data) |
|
2008 |
|
2007 |
|
Total revenue |
|
$ |
73,566 |
|
|
$ |
59,324 |
|
Income from continuing operations before interest and taxes |
|
|
7,783 |
|
|
|
5,523 |
|
Income from continuing operations, net of taxes |
|
|
5,300 |
|
|
|
3,723 |
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.38 |
|
|
$ |
0.27 |
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.35 |
|
|
$ |
0.25 |
|
2007 Acquisition:
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 clinical trials 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.
57
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Other:
In the second quarter of 2009, as a result of a potential acquisition which was terminated, we
incurred $734,000 of acquisition related costs and received $750,000, comprised of a $500,000
break-up fee and $250,000 expense reimbursement, from the target company, resulting in a $16,000
gain on the transaction.
3. Discontinued Operations and Assets Held for Sale
In the fourth quarter of 2008 the Company classified its interest in its CapMed business as
held for sale. Therefore, the financial statements for the years ended December 31, 2008 and 2007
have been presented as discontinued operations in the consolidated financial statements. 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.
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 |
|
Service revenues |
|
$ |
321 |
|
|
$ |
653 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(2,323 |
) |
|
|
(1,659 |
) |
Loss from impairment |
|
|
(2,726 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pretax loss |
|
|
(5,049 |
) |
|
|
(1,659 |
) |
Benefit from income taxes |
|
|
2,048 |
|
|
|
648 |
|
|
|
|
|
|
|
|
Net loss from discontinued operations |
|
|
(3,001 |
) |
|
|
(1,011 |
) |
|
|
|
|
|
|
|
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 |
|
|
|
|
|
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,
58
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
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. At December 31, 2009, the Company has not received any
earn-out payments from Metavante.
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) |
|
2009 |
|
|
2008 |
|
|
Useful Life |
|
Equipment |
|
|
9,796 |
|
|
$ |
8,692 |
|
|
5 years |
Equipment under capital leases |
|
|
4,332 |
|
|
|
4,332 |
|
|
5 years |
Furniture and fixtures |
|
|
2,115 |
|
|
|
1,582 |
|
|
7 years |
Leasehold improvements |
|
|
1,913 |
|
|
|
1,336 |
|
|
5 years |
Computer software costs |
|
|
7,065 |
|
|
|
5,038 |
|
|
5 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,221 |
|
|
|
20,980 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: Accumulated depreciation and
amortization |
|
|
(16,181 |
) |
|
|
(13,958 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
9,040 |
|
|
$ |
7,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated depreciation related to equipment acquired under capital leases amounted to $4.3
million and $4.1 million at December 31, 2009 and 2008, respectively. Accumulated amortization
related to capitalized computer software costs amounted to $3.2 million and $2.5 million at
December 31, 2009 and 2008, respectively. Depreciation expense for the year ended December 31,
2009 and 2008 were $2.2 million and $2.1 million, respectively.
59
BIOCLINICA, 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) |
|
2009 |
|
|
2008 |
|
|
Useful Life |
|
Amortizable intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Technology |
|
$ |
843 |
|
|
$ |
843 |
|
|
5 years |
Trademarks |
|
|
48 |
|
|
|
48 |
|
|
5 years |
Customer backlog |
|
|
2,012 |
|
|
|
1,613 |
|
|
3-7 years |
Non-competition agreement |
|
|
349 |
|
|
|
349 |
|
|
2-3 years |
|
|
$ |
3,252 |
|
|
|
2,853 |
|
|
|
|
|
Accumulated amortization |
|
|
(1,283 |
) |
|
|
(795 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,969 |
|
|
$ |
2,058 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
$ |
33,296 |
|
|
$ |
27,391 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The goodwill relates to the Companys clinical trials services segment. The Company has
evaluated the goodwill and has determined that there is no impairment of the values at December 31,
2009. Amortization expense of intangible assets for the year ended December 31, 2009, 2008 and
2007 were $489,000, $382,000 and $283,000, respectively.
Future amortization of the intangible assets is as follows:
|
|
|
|
|
|
|
Year Ending |
|
(in thousands) |
|
December 31, 2009 |
|
2010 |
|
$ |
556 |
|
2011 |
|
|
513 |
|
2012 |
|
|
424 |
|
2013 |
|
|
227 |
|
2014 |
|
|
199 |
|
Thereafter |
|
|
50 |
|
|
|
|
|
|
|
$ |
1,969 |
|
|
|
|
|
The following table details the changes in the carrying amount of goodwill:
|
|
|
|
|
|
|
|
|
(in thousands) |
|
2009 |
|
|
2008 |
|
Balance at the beginning of year |
|
$ |
27,391 |
|
|
$ |
6,025 |
|
Acquisition of businesses |
|
|
5,905 |
|
|
|
21,366 |
|
Changes to goodwill due to tax contingencies |
|
|
(363 |
) |
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year |
|
$ |
32,933 |
|
|
$ |
27,391 |
|
|
|
|
|
|
|
|
60
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
6. Accrued Expenses
Accrued expenses and other current liabilities at December 31, 2009 and 2008 consist of the
following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
(in thousands) |
|
2009 |
|
|
2008 |
|
Accrued compensation |
|
|
2,797 |
|
|
$ |
3,351 |
|
Accrued consulting fees |
|
|
255 |
|
|
|
88 |
|
Accrued other |
|
|
1,082 |
|
|
|
1,797 |
|
|
|
|
|
|
|
|
|
|
|
4,134 |
|
|
$ |
5,236 |
|
|
|
|
|
|
|
|
7. Capital Lease Obligations
Capital lease obligations at December 31, 2008 consisted of equipment lease obligations. The
equipment lease obligations were payable in monthly installments ranging from $2,000 to $3,000.
Interest rates ranged from 7.71% to 8.71%, and were collateralized by the related equipment. In
December 2009, the Company paid the balance of the outstanding equipment lease obligations. There
are no capital lease obligations outstanding at December 31, 2009.
8. Stock Based Compensation
We account for stock based compensation plans under the provisions of FASB ASC 718
Compensation Stock Compensation (FASB ASC 718), which 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, 2009, 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,
2009 was $790,000, of which $479,000 is a result of the expensing of stock options pursuant to FASB
ASC 718, $285,000 is a result of expensing restricted stock units issued to our Board of Directors
and $26,000 is a result of expensing a potential stock award to our President and Chief Executive
Officer. For the year ended December 31, 2008, the compensation cost that has been recorded to
income under the plan was $649,000, of which $315,000 is a result of expensing stock options
pursuant to FASB ASC 718, $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.
61
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
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) |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Cost of revenues |
|
$ |
598 |
|
|
$ |
386 |
|
|
$ |
335 |
|
General and administrative |
|
|
81 |
|
|
|
94 |
|
|
|
66 |
|
Sales and marketing |
|
|
81 |
|
|
|
83 |
|
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
expense before income
taxes |
|
$ |
760 |
|
|
$ |
563 |
|
|
$ |
474 |
|
|
|
|
|
|
|
|
|
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Risk-free interest rate (range) |
|
|
2.06-2.33 |
% |
|
|
2.29-2.63 |
% |
|
|
4.13-4.48 |
% |
Dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected volatility |
|
|
61.00 |
% |
|
|
55.00-56.00 |
% |
|
|
56.00 |
% |
Expected term (in years) |
|
|
5.00 |
|
|
|
4.00-5.00 |
|
|
|
4.00-5.00 |
|
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.
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.
62
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Stock Options
Fiscal 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
|
|
(in thousands) |
|
|
|
|
|
Exercise |
|
|
Contractual |
|
|
Aggregate |
|
stock options |
|
Shares |
|
|
Price |
|
|
Term |
|
|
Intrinsic Value |
|
Outstanding at
December 31, 2008 |
|
|
1,718 |
|
|
$ |
4.58 |
|
|
|
4.39 |
|
|
$ |
1,467 |
|
Granted |
|
|
298 |
|
|
|
3.06 |
|
|
|
6.16 |
|
|
|
349 |
|
Exercised |
|
|
(38 |
) |
|
|
0.81 |
|
|
|
|
|
|
|
130 |
|
Forfeited or expired |
|
|
(112 |
) |
|
|
6.62 |
|
|
|
|
|
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at
December 31 ,2009 |
|
|
1,866 |
|
|
$ |
4.29 |
|
|
|
3.83 |
|
|
$ |
2,062 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested at
December 31, 2009 |
|
|
562 |
|
|
|
5.56 |
|
|
|
5.48 |
|
|
|
277 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at
December 31, 2009 |
|
|
1,304 |
|
|
$ |
3.74 |
|
|
|
3.11 |
|
|
$ |
1,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
0 |
|
Exercised |
|
|
(290 |
) |
|
|
1.64 |
|
|
|
|
|
|
|
645 |
|
Forfeited or Expired |
|
|
(15 |
) |
|
|
1.80 |
|
|
|
|
|
|
|
27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at
December 31, 2008 |
|
|
1,718 |
|
|
$ |
4.58 |
|
|
|
4.39 |
|
|
$ |
1,467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested at
December 31, 2008 |
|
|
541 |
|
|
|
7.23 |
|
|
|
5.94 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at
December 31, 2008 |
|
|
1,177 |
|
|
$ |
3.35 |
|
|
|
3.67 |
|
|
$ |
1,467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant date fair value of options granted for the years ended December 31,
2009, 2008 and 2007 was $3.06, $7.53 and $8.02, respectively. Cash received from option exercises
for the years ended 2009, 2008 and 2007 was $31,000, $386,000, and $301,000, respectively.
63
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
As of December 31, 2009, 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
BioClinica, 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. At December 31, 2009 we have
753,000 available shares to be issued from the Plan. On January 20, 2010, the Companys Board of
Directors approved an amendment to the Plan to reflect the Companys name change and to provide an
exemption to the yearly grant limitation for new hires.
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 Plan for the three years ended
December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
Number of Shares |
|
|
Option Grant Date Fair |
|
(in thousands) |
|
Underlying Options |
|
|
Value |
|
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 |
|
Granted |
|
|
298 |
|
|
$ |
2.72 |
|
Vested |
|
|
(277 |
) |
|
$ |
4.03 |
|
Non-vested at December 31, 2009 |
|
|
562 |
|
|
$ |
5.56 |
|
1.3 million, 1.2 million and 1.6 million options are exercisable at December 31, 2009, 2008
and 2007, respectively, at a weighted average exercise price of $3.74, $3.35 and $2.79,
respectively.
The intrinsic value of stock options exercised for the years ended December 31, 2009, 2008 and
2007 respectively, were $130,000, $586,000 and $2.3 million.
64
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
At December 31, 2009, 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 |
|
Range of Exercise Prices |
|
Number Outstanding (in thousands) |
|
|
|
Weighted Average Remaining Contractual Life |
|
Weighted Average Exercise Price |
|
|
Number Exerciable (in thousands) |
|
|
|
Weighted Average Remaining Contractual Life |
|
Weighted Average Exercise Price |
|
|
$0.66-$0.88 |
|
|
272 |
|
|
0.53 years |
|
$ |
0.74 |
|
|
|
272 |
|
|
0.53 years |
|
$ |
0.74 |
|
$1.00-$1.16 |
|
|
140 |
|
|
1.92 years |
|
$ |
1.11 |
|
|
|
140 |
|
|
1.92 years |
|
$ |
1.11 |
|
$1.28-$2.80 |
|
|
107 |
|
|
1.93 years |
|
$ |
2.19 |
|
|
|
107 |
|
|
1.93 years |
|
$ |
2.19 |
|
$3.05-$5.10 |
|
|
719 |
|
|
4.84 years |
|
$ |
3.74 |
|
|
|
461 |
|
|
4.28 years |
|
$ |
4.07 |
|
$6.97-$8.06 |
|
|
628 |
|
|
4.84 years |
|
$ |
7.51 |
|
|
|
324 |
|
|
4.53 years |
|
$ |
7.42 |
|
|
|
|
|
|
$0.63-$8.06 |
|
|
1,866 |
|
|
3.83 years |
|
$ |
4.29 |
|
|
|
1,304 |
|
|
3.11 years |
|
$ |
3.74 |
|
|
|
|
|
|
Restricted Stock Units: On March 4, 2009, we entered into an employment agreement with our
President and Chief Executive Officer effective March 1, 2009 and expiring February 28, 2012.
Pursuant to this employment agreement we granted him 40,000 restricted stock units that vests over
three years and the underlying common stock will be issued, after the vesting period, and the
earlier of: cessation of service; change in control; or seven years. Based on a fair value of
$3.09 at March 4, 2009 we recorded stock compensation expense of $34,000 for the twelve months
ended December 31, 2009.
On July 8, 2009 we granted to our Board of Directors 60,000 restricted stock units that vests
monthly until May 2010 and the underlying common stock will be issued, after the vesting period,
and the earlier of: cessation of service; change in control; or seven years. Based on a fair value
of $3.62 at July 8, 2009 we recorded stock compensation expense of $118,000 for the twelve months
ended December 31, 2009.
9. Commitments
The Company has entered into non-cancelable operating leases for office facilities which
expire through November 2018.
65
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Future minimum aggregate rental payments on the noncancelable portion of the lease are as follows:
|
|
|
|
|
|
|
Year Ending |
|
(in thousands) |
|
December 31, 2009 |
|
2010 |
|
$ |
1,874 |
|
2011 |
|
$ |
2,179 |
|
2012 |
|
$ |
2,583 |
|
2013 |
|
$ |
2,503 |
|
2014 |
|
$ |
2,361 |
|
Thereafter |
|
$ |
9,322 |
|
|
|
|
|
|
|
$ |
20,822 |
|
|
|
|
|
Rent expense charged to operations for the year ended December 31, 2009, 2008 and 2007 was $3.3 million, $2.2 million and $1.8 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 24, 2011 and is renewable on an annual basis. The President of eClinical divisions agreement expires
September 30, 2010 and is renewable on an annual basis. The aggregate amount due from January 1, 2010 through the expiration under these agreements was $1.3 million.
10. Employee Benefit Plan
The Company sponsors the BioClinica, 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 $283,000, $235,000 and $158,000 for the
year ended December 31, 2009, 2008 and 2007, respectively.
11. Major Customers
No one client represented more than 10% of our service revenues for the year ended December 31, 2009 or 2008, while for the year ended December 31, 2007, one client,
Hoffmann-La Roche, which encompassed 11 projects, accounted for 13.4%.
66
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
12. Income Taxes
The income tax provision from continuing operations consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
1,040 |
|
|
$ |
2,027 |
|
|
$ |
546 |
|
State and local |
|
|
356 |
|
|
|
136 |
|
|
|
504 |
|
Foreign |
|
|
25 |
|
|
|
167 |
|
|
|
164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,421 |
|
|
$ |
2,330 |
|
|
$ |
1,214 |
|
|
|
|
|
|
|
|
|
|
|
Deferred: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
317 |
|
|
|
730 |
|
|
|
458 |
|
State and local |
|
|
(172 |
) |
|
|
42 |
|
|
|
(172 |
) |
Foreign |
|
|
191 |
|
|
|
|
|
|
|
|
|
|
|
|
336 |
|
|
|
772 |
|
|
|
286 |
|
|
|
|
|
|
|
|
|
|
|
Income tax provision from
continuing operations |
|
$ |
1,757 |
|
|
$ |
3,102 |
|
|
$ |
1,500 |
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Tax provision at statutory rate |
|
|
34.0 |
% |
|
|
34.0 |
% |
|
|
34.0 |
% |
State and local income taxes, net of federal benefit |
|
|
4.1 |
% |
|
|
2.8 |
% |
|
|
5.7 |
% |
Permanent differences |
|
|
0.6 |
% |
|
|
0.4 |
% |
|
|
0.6 |
% |
Foreign rate difference |
|
|
(0.9 |
)% |
|
|
(0.5 |
)% |
|
|
(1.0 |
)% |
Other |
|
|
(0.5 |
)% |
|
|
(1.9 |
)% |
|
|
(0.2 |
)% |
|
|
|
|
|
|
|
|
|
|
Effective income tax rate from continuing
operations |
|
|
37.3 |
% |
|
|
34.8 |
% |
|
|
39.1 |
% |
|
|
|
|
|
|
|
|
|
|
The Companys domestic and foreign income before income tax from continuing operations is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Domestic income before income tax |
|
$ |
4,080 |
|
|
$ |
8,290 |
|
|
$ |
4,891 |
|
Foreign income before income tax. |
|
|
636 |
|
|
|
612 |
|
|
|
600 |
|
|
|
|
|
|
|
|
|
|
|
Total income before income tax from continuing operations |
|
$ |
4,716 |
|
|
$ |
8,902 |
|
|
$ |
5,491 |
|
|
|
|
|
|
|
|
|
|
|
67
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
The components of net deferred tax assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2009 |
|
|
2008 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Accrued expenses |
|
$ |
104 |
|
|
$ |
47 |
|
Allowance for doubtful accounts |
|
|
4 |
|
|
|
4 |
|
Deferred revenue |
|
|
2,952 |
|
|
|
3,212 |
|
Net operating loss carryforwards |
|
|
317 |
|
|
|
580 |
|
Restricted stock |
|
|
279 |
|
|
|
183 |
|
Stock options |
|
|
429 |
|
|
|
254 |
|
Amortization of acquisition costs |
|
|
|
|
|
|
|
|
Impairment of assets |
|
|
|
|
|
|
723 |
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
4,085 |
|
|
$ |
5,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Excess of tax over book depreciation |
|
|
(1,126 |
) |
|
|
(1,653 |
) |
Amortization of acquisition costs |
|
|
(358 |
) |
|
|
(479 |
) |
Prepaid expenses |
|
|
(398 |
) |
|
|
(340 |
) |
|
|
|
|
|
|
|
Total deferred tax liabilities. |
|
|
(1,882 |
) |
|
|
(2,472 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance |
|
|
|
|
|
|
(374 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
2,203 |
|
|
$ |
2,157 |
|
|
|
|
|
|
|
|
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.
As of December 31, 2008 the Company had $1.3 million in accumulated tax losses in the United
States, which included allowable deductions related to exercised employee stock options, generating
federal and state net operating loss (NOL) credit carryforwards. 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
estimated that $1.1 million of the federal net operating loss would likely expire unused, in the
years 2010 through 2022, due to Internal Revenue Code Section 382 limitations. The Company has
foreign NOL carryforwards from its French subsidiary of $575,000 as of December 31, 2009 and
$717,000 as of December 31, 2008. GAAP requires that the Company establish a valuation allowance
for any portion of its deferred tax assets for which
68
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
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 tax benefit of the stock option deductions have been recorded to additional paid-in
capital in the amount of $44,000 and $290,000 for the year ended December 31, 2009 and 2008,
respectively.
The Company recognizes contingent liabilities for any tax related exposures when those
exposures are more likely than not to occur.
The Company has not provided for U.S. federal income and foreign withholding taxes on
approximately $1.8 million of undistributed earnings from its non-U.S. operations as of December
31, 2009 because such earnings are intended to be reinvested indefinitely outside of the United
States.
On January 1, 2007, we adopted FASB ASC 740 Income Taxes (FASB ASC 740). FASB ASC 740
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
through 2008 are subject to examination. We are currently under a routine IRS examination of our
2007 tax return year. Our state taxes for years 2000 through 2008 are subject to examination. Our
foreign taxes for years 2002 through 2008 are subject to examination by the respective authorities.
13. Foreign Operations
Foreign customers accounted for 29% and 28% of service revenues for the year ended December
31, 2009 and 2008, respectively.
The Company maintains offices in Newtown and Audobon, Pennsylvania, Leiden, the Netherlands
and Lyon, France. Net fixed assets located in Newtown, Pennsylvania were $2.7 million and $4.4
million at December 31, 2009 and 2008, respectively. Net fixed assets located in King of Prussia,
Pennsylvania were $1.8 million and $1.1 million at December 31, 2009 and 2008, respectively. Net
fixed assets located in Leiden, the Netherlands, were $1.2 million and $1.3 million at December 31,
2009 and 2008, respectively. Net fixed assets located in Lyon, France were $714,000 and $722,000
at December 31, 2009 and 2008, respectively.
69
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
14. Related Party Transactions
At December 31, 2009, Covance, Inc. owned 16.4% 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 $446,000, $1.7 million and $1.2 million for the year ended December 31,
2009, 2008 and 2007, respectively. At December 31, 2009 and 2008, the amounts due from Covance,
Inc. were $82,000 and $122,000, respectively as reported in accounts receivable.
15. Subsequent Events
On March 25, 2010, the Company acquired substantially all of the assets of privately held
TranSenda International, LLC (TranSenda). Headquartered in Bellevue, WA, TranSenda is a provider
of clinical trial management software (CTMS) solutions. TranSendas suite of web-based,
Office-Smart CTMS solutions create efficiencies for trial operations through interoperability with
Microsoft Office tools. With this acquisition, BioClinica enhances its ability to serve customers
throughout the clinical research process with technologies that include improved efficiencies by
reducing study durations and costs through integrated operational management. The Acquisition was
made pursuant to an Asset Purchase Agreement, dated March 25, 2010, by and between the Company and
TranSenda (the Purchase Agreement). Pursuant to the terms of the Purchase Agreement, the Company
purchased and acquired from TranSenda all right, title and interest of TranSenda in and to the
Purchased Assets (as defined in the Purchase Agreement) and assumed the Assumed Liabilities (as
defined in the Purchase Agreement) of TranSenda.
As consideration for the Purchased Assets and Assumed Liabilities, the Company paid Five
Hundred Seventy-Seven Thousand Nine Hundred Sixty (577,960) shares of common stock, par value
$0.00025 per share, of the Company, valued at a volume weighted average price per share equal to
$4.325560, and subject to a post-closing adjustment based on the Final Closing Net Working Capital
(as defined in the Purchase Agreement). Pursuant to the terms of the Purchase Agreement, fifteen
percent (15%) of the aggregate consideration is to be held in escrow to cover any potential
indemnification claims under the Purchase Agreement for a period of twelve (12) months following
the Closing Date (as defined in the Purchase Agreement). As part of the Purchase Agreement,
TranSenda 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 any shares of the Companys common
stock received pursuant to the Purchase Agreement for a period beginning on the date the Purchase
Agreement was executed and continuing to and including the date twelve (12) months after such date.
70
|
|
|
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, 2009, 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, 2009. 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.
71
Our management assessed the effectiveness of the companys internal control over financial
reporting as of December 31, 2009. In making this assessment, the companys management used the
criteria set 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, 2009, 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, 2009 that has materially
affected, or is reasonably likely to materially affect, our internal controls over financial
reporting.
|
|
|
Item 9B. |
|
Other Information. |
None.
72
PART III
|
|
|
Item 10. |
|
Directors, Executive Officers and Corporate Governance. |
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 2010 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. |
The discussion under the heading Executive Compensation in our definitive proxy statement
for the 2010 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 2010 Annual Meeting of Stockholders is
incorporated herein by reference to such proxy statement.
|
|
|
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 2010 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 2010 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
73
incorporated by reference, in the Annual Report on Form 10-K and are numbered in accordance with
Item 601 of Regulation S-K.
74
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 30th day of March, 2010.
|
|
|
|
|
|
BIOCLINICA, INC.
|
|
|
By: |
/s/ Mark L. Weinstein
|
|
|
|
Mark L. Weinstein, President and
Chief Executive Officer |
|
75
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 30, 2010 |
|
|
|
|
|
/s/ Ted I. Kaminer
Ted I. Kaminer
|
|
Executive Vice President of
Finance
and
Administration and
Chief Financial Officer
(principal financial and
accounting officer)
|
|
March 30, 2010 |
|
|
|
|
|
/s/ Jeffrey H. Berg, Ph.D.
Jeffrey H. Berg, Ph.D.
|
|
Director
|
|
March 30, 2010 |
|
|
|
|
|
/s/ Richard F. Cimino
Richard F. Cimino
|
|
Director
|
|
March 30, 2010 |
|
|
|
|
|
/s/ E. Martin Davidoff, CPA, Esq.
E. Martin Davidoff, CPA, Esq.
|
|
Director
|
|
March 30, 2010 |
|
|
|
|
|
/s/ David E. Nowicki, D.M.D.
David E. Nowicki, D.M.D.
|
|
Chairman of the Board
and Director
|
|
March 30, 2010 |
|
|
|
|
|
/s/ Adeoye Y. Olukotun
Adeoye Y. Olukotun, M.D., M.P.H.,
F.A.C.C., FAHA
|
|
Director
|
|
March 30, 2010 |
|
|
|
|
|
/s/ David Stack
David Stack
|
|
Director
|
|
March 30, 2010 |
|
|
|
|
|
/s/ James A. Taylor, Ph.D.
James A. Taylor, Ph.D.
|
|
Director
|
|
March 30, 2010 |
76
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
No. |
|
Description of Exhibit |
2.1
|
|
Asset Purchase Agreement, dated as of September 15, 2009, by and
among BioClinica, Inc., BioClinica Acquisition, Inc., and
Tourtellotte Solutions, Inc. Incorporated by reference to Exhibit
10.1 of our Current Report on Form 8-K, dated September 18, 2009. |
|
|
|
2.2**
|
|
Asset Purchase Agreement, dated January 6, 2009, by and between
Bio-Imaging Technologies, Inc. and MBI Benefits, Inc.
Incorporated by reference to Exhibit 2.3 of our Annual Report on
Form 10-K for the year ended December 31, 2008. |
|
|
|
2.3
|
|
Asset Purchase Agreement, dated March 25, 2010, by and between
BioClinica, Inc. and TranSenda International LLC. Incorporated by
reference to Exhibit 2.1 of our Current Report on Form 8-K, dated
March 26, 2010. |
|
|
|
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, Exhibit 3.1 of our Quarterly Report on
Form 10-QSB for the quarter ended March 31, 1995 and Exhibit 3.1
of our Current Report on Form 8-K, dated July 8, 2009. |
|
|
|
3.2
|
|
Amended and Restated Bylaws of BioClinica, Inc. Incorporated by
reference to Exhibit 3.1 of our Current Report on Form 8-K, dated
November 23, 2009. |
|
|
|
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
|
|
Rights Agreement, dated as of July 20, 2009, between BioClinica,
Inc. and Computershare Trust Company, N.A. Incorporated by
reference to Exhibit 4.1 of our Current Report on form 8-K, dated
July 20, 2009. |
|
|
|
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, as amended and restated on May 14,
2008, as amended and restated on January 20, 2010. |
|
|
|
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. |
77
|
|
|
Exhibit |
|
|
No. |
|
Description of Exhibit |
10.6*
|
|
Employment Agreement, dated March 4, 2009, by and between
Bio-Imaging Technologies, Inc. and Mark L. Weinstein.
Incorporated by reference to Exhibit 10.6 of our Annual Report on
Form 10-K for fiscal year ended December 31, 2008. |
|
|
|
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. Incorporated by reference to Exhibit 10.7
of our Annual Report on Form 10K for fiscal year ended December
31, 2008. |
|
|
|
10.8*
|
|
Amended and Restated Employment Agreement, dated February 24,
2010, by and between BioClinica, Inc. and Ted I. Kaminer. |
|
|
|
10.9*
|
|
Form of Amended and Restated Executive Retention Agreement by and
between BioClinica, Inc. and certain executive officers. |
|
|
|
10.10*
|
|
Employment Agreement, dated September 19, 2008, by and between
Bio-Imaging Technologies, Inc. and Peter Benton. Incorporated by
reference to Exhibit 10.1 of our Quarterly Report on Form 10-Q for
the quarter ended June 30, 2009. |
|
|
|
21
|
|
List of Subsidiaries of Registrant. |
|
|
|
23.1
|
|
Consent of PricewaterhouseCoopers LLP. |
|
|
|
31.1
|
|
Certification of principal executive officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
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. |
78