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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF |
THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2010
Commission File No. 001-11182
BIOCLINICA, INC.
(Exact name of Registrant as specified in its
Charter)
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Delaware
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11-2872047 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer Identification No.) |
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826 Newtown-Yardley Road, Newtown, Pennsylvania
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18940-1721 |
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(Address of principal executive offices)
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(Zip Code) |
(267) 757-3000
(Registrants telephone number,
including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Name of each exchange on which registered |
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Common Stock, $0.00025 par value per share
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NASDAQ Global Market |
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.
Yes: o No: þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or Section 15(d) of the Act.
Yes: o No: þ
Indicate by check mark if the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes: þ No: o
Indicate by check mark 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 Regulation S-T during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). *
Yes: o No: o
* 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):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
(do not check if a smaller reporting company)
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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 $50.1 million on June 30, 2010, the last business day of the registrants
most recently completed second fiscal quarter, based on the close price on that date.
Indicate the number of shares outstanding of each of the registrants classes of common
equity, as of January 31, 2011:
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Class
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Number of Shares |
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Common Stock, $.00025 par value
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15,649,164 |
The following documents are incorporated by reference into the Annual Report on Form 10-K:
Portions of the Registrants definitive Proxy Statement for its 2011 Annual Meeting of Stockholders
are incorporated by reference into Part III of this Report.
TABLE OF CONTENTS
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Item |
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Page |
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PART I |
1. Business |
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1 |
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1A. Risk Factors |
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10 |
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1B. Unresolved Staff Comments |
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20 |
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2. Properties |
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20 |
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3. Legal Proceedings |
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20 |
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4. REMOVED AND RESERVED |
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20 |
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PART II |
5. Market for Registrants Common Equity, Related Stockholder
Matters and Issuer Purchases of Equity Securities |
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21 |
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6. Selected Financial Data |
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24 |
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7. Managements Discussion and Analysis of Financial
Condition and Results of Operations |
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25 |
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7A. Quantitative and Qualitative Disclosures About Market Risk |
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39 |
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8. Financial Statements and Supplementary Data |
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40 |
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9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure |
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75 |
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9A. Controls and Procedures |
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75 |
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9B. Other Information |
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76 |
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PART III |
10. Directors, Executive Officers and Corporate Governance |
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77 |
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11. Executive Compensation |
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77 |
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12. Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters |
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77 |
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13. Certain Relationships and Related Transactions, and
Director Independence |
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77 |
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14. Principal Accounting Fees and Services |
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77 |
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PART IV |
15. Exhibits, Financial Statement Schedules |
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77 |
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PART I
Item 1. Business.
Overview
BioClinica®, Inc., referred to herein as BioClinica, we, us and our,
provides integrated clinical research technology solutions to pharmaceutical, biotechnology, and
medical device companies, and other organizations such as contract research organizations, or 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, clinical trial management systems, 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 solutions support clinical stage research and development, or 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, more reliable, 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 all of the top 20 global pharmaceutical companies measured by revenue and
many small and middle-market life sciences companies, as well as CROs.
BioClinicas clinical trial 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. 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. Our Medical Imaging Solutions 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
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image collection both accurate and efficient. BioClinicas Medical Imaging Solutions 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, or the 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 March 25, 2010, we acquired substantially all of the assets of privately held TranSenda
International, LLC, or TranSenda. TranSenda was a provider of clinical trial management software,
or CTMS, solutions. TranSendas suite of web-based, Office-Smart CTMS solutions creates
efficiencies for trial operations through interoperability with Microsoft Office tools. With this
acquisition, we enhanced our 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.
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 product line, and we believe that their interactive voice, or IVR,
interactive web, or 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 other clinical trial 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, or
PHR, software and the patent-pending Personal HealthKey technology. The sale of CapMed enables us
to focus on our core clinical trials solutions 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.bioclinica.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.
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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.
Medical Imaging Solutions
BioClinica provides a broad array of medical imaging management solutions 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 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 utilizing our
BioReadTM system 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
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trials for all modalities, which includes computerized tomography, or CT, magnetic resonance
imaging, or MRI, radiography, dual energy x-ray absorptiometry, or DXA/DEXA, positron emission
tomography, or PET, single photon emission computerized tomography, or SPECT, quantitative coronary
angiography, or QCA, cardiac MRI and CT, intravascular ultrasound, or IVUS, peripheral quantitative
angiography, or QVA, central nervous system, or CNS, MRI, and ultrasound. We offer our clients
therapeutic expertise in areas including oncology, musculoskeletal conditions, and cardiology, plus
central nervous system, neurovascular, and metabolic diseases
BioClinica WebSend and BioClinica WebView provide our clients with 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 provides 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
extends 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 facilitate the review of the images from the experts
remote location , with the utmost possible speed in transport. Imaging information can also be
integrated with BioClinica Express electronic data capture, or EDC, to further simplify and enhance
the clinical trial process and improve the visibility of clinical data for life science companies.
Electronic Data Capture
BioClinica ExpressTM EDC is an 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, or 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.
IVR/IWR Interactive Response Solutions
BioClinica Trident IWRTM is a next-generation interactive voice response IVR/IWR
system that was 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. Process knowledge and expertise in IVR/IWR, simulation and
forecasting, and clinical supplies combined with other innovations, has led to the development of
Trident IWR.
Trident IWRs unique interface provides clinical operations personnel with an intuitive way to
directly set up, monitor, and maintain randomization and supplies for their clinical trials, in
a fraction of the time previously required. Trident IWR delivers rapid study setup with no
programming, while supporting multiple concurrent studies. Trident IWR eliminates the need to
design and create a new database for each new trial, and it provides custom data reporting and
metrics. Trident IWR also offers an innovative integration with BioClinica Optimizer that
unifies planning and execution systematically, extending clients precision and control over
these complex processes.
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Clinical Supply Forecasting and Optimization
BioClinica OptimizerTM clinical supply forecasting and optimization is a product
that allows biopharmaceutical companies to simulate, forecast, 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. Optimizer
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.
Clinical Trial Management Systems, or CTMS
BioClinica CTMS is an application that helps sponsors and CROs better manage business and
operational processes for clinical trials by capturing and manipulating the trial data
electronically. BioClinica CTMS includes: applications to manage data related to clinical sites,
personnel, subjects, and clinical supplies; scheduling, tracking, and monitoring performance; site
payments; study document management; vendors; and more.
BioClinica Office-Smart Clinical Trial Manager, or Office-Smart CTMS, leverages
Microsoft® SharePoint and BioClinica technologies to provide superior team
collaboration, connectivity, and efficiency in a multi-site environment; it is the only CTMS
capable of fully utilizing the Microsoft Office environment. BioClinica CTMS interfaces with a
variety of systems, such as EDC and IVR/IWR systems, to fully integrate all clinical operational
data. The CTMS product line also includes the BioClinica Clinical Payment Manager. Most financial
systems do not have the functions or the flexibility needed to efficiently track payments specific
to clinical trials; and manual payment calculation can involve extensive sorting through trial
activity and contractsa process that takes time, limits visibility and is often prone to error.
This results in one of the leading complaints of investigatorsa lack of timely and accurate
payments. Offered as both a stand-alone system or fully integrated with BioClinica CTMS, Clinical
Payment Manager also works with Microsoft Office software to further maximize efficiency.
Data Management
BioClinica Express clinical 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.
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Additional 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 and India.
Application Hosting Services. Other than our internal medical imaging 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 clinical trial 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 BioClinica. We hold patents for the two DEXA phantoms, titled Spine and
Variable Composition Phantoms, which we sell to trial sites. 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 FDA and other governmental authorities worldwide. The use of software and services during the
clinical trial process must adhere to the regulations known as Good Clinical Practices and other
various codified FDA regulations, and should adhere to regulatory guidance such as the Consolidated
Guidance for Industry from the International Conference on Harmonization regarding Good Clinical
Practice for Europe, Japan and the United States and other guidance documents. Our products,
services and hosted solutions are developed using our domain expertise and are designed to allow
compliance with applicable rules and regulations and conformance with applicable guidance. The
foregoing regulations and regulatory guidance are subject to change at any time. Changes in
regulations and regulatory guidance to either more or less stringent conditions could adversely
affect our business and the software products, services and
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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 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.
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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 clinical research
technology solutions compete against specialty CROs, and to a lesser extent, universities and
teaching hospitals. Certain of our technology solutions compete with internally developed
solutions, general 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 three 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.
Significant Clients
Contracts with one client, Pfizer, Inc., which encompassed 22 projects, represented 20% of our
service revenues for the years ended December 31, 2010. No one client represented more than 10% of
our service revenues for the year ended December 31, 2009, or December 31, 2008. 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.
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
8
States headquarters. We also have a facility in
Lyon, France that provides product development and research activities. We have an office in
Bhubaneshwar, India to provide information technology support services.
Employees
As of December 31, 2010, we had 475 employees, four of whom were executive officers.
Of our employees, as of December 31, 2010, 30 were engaged in sales and marketing, 395 were
engaged in client-related projects, and 46 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, 2011, we have
employment agreements with three of our executive officers. See Item 11. Executive
Compensation. We consider relations with our employees to be good.
9
Item 1A. Risk Factors.
The more prominent risks and uncertainties inherent in our business are described below.
However, additional risks and uncertainties may also impair our business operations. If any of the
following risks actually occur, our business, financial condition or results of operations may
suffer. Investing in our common stock involves a high degree of risk. Any of the following factors
could harm our business and future results of operations, and you could lose all or part of your
investment.
Risks Related to Our Company and Business
We may incur financial losses because contracts may be delayed or terminated or reduced in scope
for reasons beyond our control.
Our clients may terminate or delay their contracts for a variety of reasons, including, but
not limited to:
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unexpected or undesired clinical results; |
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the clients decision to terminate the development of a particular product or to end a
particular study; |
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insufficient patient enrollment in a study; |
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insufficient investigator recruitment; |
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failure to perform our obligations under the contract; or |
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the failure of products to satisfy safety requirements. |
In addition, we believe that FDA-regulated companies may proceed with fewer clinical trials or
conduct them without assistance of contract service organizations if they are trying to reduce
costs as a result of cost containment pressures associated with healthcare reform, budgetary limits
or changing priorities. These factors may cause such companies to cancel contracts with contract
service organizations.
We cannot assure you that our clients will continue to use our services or that we will be
able to replace, in a timely or effective manner, departing clients with new clients that generate
comparable revenues. Further, we cannot assure you that our clients will continue to generate
consistent amounts of revenues over time.
The loss, reduction in scope or delay of a large contract or the loss or delay of multiple
contracts could materially adversely affect our business.
The recent economic downturn may adversely impact our ability to grow our business.
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:
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our clients businesses experience financial problems or are affected by a general
economic downturn; |
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consolidation in the pharmaceutical, biotechnology or medical device industries leads to
a smaller client base for us; or |
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clients reduce their research and development expenditures. |
Contracts with one client, Pfizer, Inc., which encompassed 22 projects, represented 20% of our
service revenues for the year ended December 31, 2010. No one client represented more than 10% of
our service revenues for the years ended December 31, 2009, or December 31, 2008. 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 $110.7 million at December 31, 2010 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 you that this backlog will be indicative of
future results. A number of factors may affect backlog, including:
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the variable size and duration of the projects (some are performed over several years); |
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the loss or delay of projects; |
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the change in the scope of work during the course of a project; and |
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the cancellation of such contracts by our clients. |
Also, if clients delay projects, the projects will remain in backlog, but will not generate
revenue at the rate originally expected. Accordingly, the historical relationship of backlog to
revenues may not be indicative of future results.
We made one acquisition in the first quarter 2010, 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.
On March 25, 2010, we acquired substantially all of the assets of privately held TranSenda
International, LLC, headquartered in Bellevue, WA. In the third quarter of 2009, we acquired the
CardioNow unit from AGFA Healthcare and substantially all of the assets of Tourtellotte Solutions,
Inc. 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.
11
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 of Bioimaging
Solutions, and Peter Benton, Executive Vice President, President of eClinical Solutions. 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 2010, 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 facilities in
Leiden, the Netherlands and Lyon, France, 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 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 or in defending claims that we are infringing
upon the intellectual property rights of others.
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,
12
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 are involved in legal proceedings to
enforce our intellectual property rights, to determine the validity and scope of the intellectual
property or other proprietary rights of others or to defend against claims of infringement by third
parties, the proceedings could be burdensome and expensive, even if we were to prevail. Any
potential infringement actions brought against us could require us to stop using the product or
service which incorporates such third party intellectual property, obtain a license to use such
third party intellectual property (which could be costly or unavailable) or redesign our products
or services that incorporate such third party intellectual property (which could be time consuming
and costly and affect the market acceptance of such product or service). The failure to adequately
protect our intellectual property and other proprietary rights or acknowledge third party
intellectual property 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:
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consultative and clinical trials design capabilities; |
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reputation for on-time quality performance; |
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expertise and experience in specific therapeutic areas; |
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the scope of service offerings; |
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strength in various geographic markets; |
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the price of services; |
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ability to acquire, process, analyze and report data in a time-saving and accurate
manner; |
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ability to manage large-scale clinical trials both domestically and internationally; |
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our size; |
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the service and product offerings of our competitors; and |
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our ability to upgrade our products, services and hosted solutions so such offerings are
not deemed obsolete in comparison to the service and product offerings of our competitors. |
If our services are not competitive based on these or other factors, our business, financial
condition and results of operations could be materially harmed.
The biopharmaceutical services industry is highly competitive, and we face numerous
competitors in our business, including hundreds of 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.
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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.
We may not be able to effectively manage our international operations.
We maintain facilities in France, the Netherlands and India, and we may continue to expand our
international operations in the future. There are significant risks associated with the
establishment of foreign operations, including, but not limited to: geopolitical risks, foreign
currency exchange rates and the impact of shifts in the U.S. and local economies on those rates,
compliance with local laws and regulations, the protection of our intellectual property and that of
our customers, the ability to integrate our corporate culture with local customs and cultures, and
the ability to effectively and efficiently supply our international facilities with the required
equipment and materials. If we are unable to effectively manage these risks, these locations may
not produce the revenues, earnings, or strategic benefits that we anticipate which could have a
material adverse affect on 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
14
may reduce the need for our services. As a result, our revenues may be similarly decreased.
Furthermore, while our revenues may decrease, our costs may remain relatively fixed, resulting in
decreased earnings.
Failure
to comply with existing regulations could result in increased costs to complete clinical
trials.
Our business is subject to numerous governmental regulations, primarily relating to
pharmaceutical product development and the conduct of clinical trials. In particular, we are
subject to 21 CFR Part 11 of the Code of Federal Regulations that provides the criteria for
acceptance by the FDA of electronic records. If we fail to comply with these governmental
regulations, it could result in the termination of ongoing clinical research or the
disqualification of data for submission to regulatory authorities. We also could be barred from
providing clinical 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.
We may be affected by health care reform.
In March 2010, the United States Congress enacted health care reform legislation intended over
time to expand health insurance coverage and impose health industry cost containment measures.
This legislation may significantly impact the pharmaceutical and biotechnology industries. In
addition, the U.S. Congress, various state legislatures and European and Asian governments may
consider various types of health care reform in order to control growing health care costs. We are
presently uncertain as to the effects of the recently enacted legislation on our business and are
unable to predict what legislative proposals will be adopted in the future, if any.
Implementation of health care reform legislation may have certain benefits but also may
contain costs that could limit the profits that can be made from the development of new drugs. This
could adversely affect research and development expenditures by pharmaceutical and biotechnology
companies, 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 our costs or limit our service offerings.
In addition to healthcare reform legislation, 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.
Changes in governmental regulation could decrease the need for the services we provide, which would
negatively affect our future business opportunities.
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.
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The success of our business is dependent upon continued acceptance by the FDA and other
regulatory authorities of the data and analyses generated by our services in connection with the
evaluation of the safety and efficacy of new drugs and devices. The FDA has formal guidelines that
encourage the use of surrogate measures through submission of digital image data, for evaluation
of drugs to treat life-threatening or debilitating conditions. We cannot assure you that the FDA or
other regulatory authorities will accept the data or analyses generated by us in the future and,
even assuming acceptance, the FDA or other regulatory authorities may not require the application
of imaging techniques to the number of patients and over time periods substantially similar to
those required of traditional safety and efficacy techniques. If the governmental agencies do not
accept data and analyses generated by our services in connection with the evaluation of new drugs
and devices, the need for our services would be eliminated or substantially reduced, and, as a
result, our business, results of operations and financial condition could be materially adversely
affected.
In the course of conducting our business, we possess or could be deemed to possess personal medical
information in connection with the conduct of clinical trials. If we fail to keep this information
properly protected we could be subject to significant liability.
Our software solutions are used to collect, manage and report information in connection with
the conduct of clinical trial and safety evaluation and monitoring activities. This information is
or could be considered to be personal medical information of the clinical trial participants or
patients. Regulation of the use and disclosure of personal medical information is complex and
growing. Increased focus on individuals rights to confidentiality of their personal information,
including personal medical information, could lead to an increase of existing and future
legislative or regulatory initiatives giving direct legal remedies to individuals, including rights
to damages, against entities deemed responsible for not adequately securing such personal
information. In addition, courts may look to regulatory standards in identifying or applying a
common law theory of liability, whether or not that law affords a private right of action. Since we
receive and process personal information of clinical trial participants and patients from customers
utilizing our hosted solutions, there is a risk that we could be liable if there were a breach of
any obligation to a protected person under contract, standard of practice or regulatory
requirement. If we fail to properly protect this personal information that is in our possession or
deemed to be in our possession, we could be subjected to significant liability.
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;
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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.
In the event we are unable to satisfy regulatory requirements relating to internal control over
financial reporting, or if these internal controls are not effective, our business and financial
results may suffer.
Effective internal controls are necessary for us to provide reasonable assurance with respect
to our financial reports and to effectively prevent fraud. If we cannot provide reasonable
assurance with respect to our financial reports and effectively prevent fraud, our brand and
operating results could be harmed. Pursuant to the Sarbanes-Oxley Act of 2002, we are required to
furnish a report by management on internal control over financial reporting, including managements
assessment of the effectiveness of such control. Internal control over financial reporting may not
prevent or detect misstatements because of its inherent limitations, including the possibility of
human error, the circumvention or overriding of controls, or fraud. Therefore, even effective
internal controls can provide only reasonable assurance with respect to the preparation and fair
presentation of financial statements. In addition, projections of any evaluation of the
effectiveness of internal control over financial reporting to future periods are subject to the
risk that the control may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate. If we fail to maintain the adequacy of
our internal controls, including any failure to implement required new or improved controls, or if
we experience difficulties in their implementation, our business and operating results could be
harmed, we could fail to meet our reporting obligations, and there could also be a material adverse
effect on our stock price.
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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, 2010, we had the following capital structure (in thousands):
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Common stock outstanding |
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15,632 |
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Common stock issuable upon: |
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Exercise of options which are outstanding |
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1,717 |
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Exercise of options which have not been granted |
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1,150 |
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Restricted stock units outstanding |
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340 |
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Total common stock outstanding assuming exercise or conversion of
all of the above |
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18,839 |
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As of December 31, 2010, we had outstanding options to purchase 1.7 million shares of common
stock at exercise prices ranging from $0.72 to $8.06 per share (exercisable at a weighted average
of $4.83 per share), of which 1.2 million 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, 2010, we had 15.6 million shares of our common
stock issued and outstanding, substantially all of which are currently freely tradable. As
additional shares of common stock become available for resale in the public market pursuant to
registration statements and releases of lock-up agreements, the market supply of shares of common
stock will increase, which could also decrease its market price.
We are unable to estimate the number of shares that may be sold because this will depend on
the market price for our common stock, the personal circumstances of the sellers and other factors.
Any sale of substantial amounts of our common stock or other securities in the open market may
adversely affect the market price of 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 stock), including Covance Inc., beneficially owned 23% of the outstanding shares of common
stock and stock options that could have been converted to common stock at December 31, 2010, and
such stockholders will have significant influence over the outcome of all matters submitted to our stockholders for
approval, including the
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election of our directors and other corporate actions. In addition, such
influence by these affiliates could have the effect of discouraging others from attempting to take
us over, thereby increasing the likelihood that the market price of the common stock will not
reflect a premium for control.
Because we do not intend to pay dividends, stockholders will benefit from an investment in our
common stock only if it appreciates in value.
We have never declared or paid any cash dividends on our common stock. We currently intend to
retain our future earnings, if any, to finance further research and development and do not expect
to pay any cash dividends in the foreseeable future. As a result, the success of an investment in
our common stock will depend upon any future appreciation in its value. There is no guarantee that
our common stock will appreciate in value or even maintain the price at which stockholders have
purchased their shares.
Trading in our common stock may be volatile, which may result in substantial declines in its market
price.
The market price of our common stock has experienced historical volatility and might continue
to experience volatility in the future in response to quarter-to-quarter variations in:
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operating results; |
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analysts reports; |
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market conditions in the industry; |
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changes in governmental regulations; and |
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changes in general conditions in the economy or the financial markets. |
The overall market (including the market for our common stock) has also experienced
significant decreases in value in the past. This volatility and potential market decline could
affect the market prices of securities issued by many companies, often for reasons unrelated to
their operating performance, and may adversely affect the price of our common stock. Between
January 1, 2010 and December 31, 2010, our common stock has traded at a low of $3.13 per share and
a high of $5.93 per share. Between January 1, 2011 and February 18, 2011, our common stock has
traded at a low of $4.20 per share and a high of $4.95 per share.
Our common stock began trading on the NASDAQ Global Market, formerly called the NASDAQ
National Market, on December 18, 2003 and has a limited trading market. We cannot assure that an
active trading market will develop or, if developed, will be maintained. As a result, our
stockholders may find it difficult to dispose of shares of our common stock and, as a result, may
suffer a loss of all or a substantial portion of their investment.
Certain provisions of our charter and Delaware law could make a takeover difficult and may prevent
or frustrate attempts by our stockholders to replace or remove our management team.
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 and 36,000 shares designated
as Series A Junior Participating Preferred Stock under our stockholder rights plan as previously
disclosed. The remaining 1,714,000 shares may be issued by our board of directors, on such terms
and with such rights, preferences and designation as the board of directors may determine. Issuance
of such preferred stock, depending upon the rights, preferences and designations thereof, may have
the effect of delaying, deterring or preventing a change in control of our company. In addition, we
are subject to provisions of Delaware corporate law which, subject to certain exceptions, will
prohibit us from engaging in any business combination with a person who, together with
affiliates and associates, owns 15% or more of our common stock for a period of three years
following the date that the person came to own 15% or more of our common stock, unless the business
combination is approved in a
19
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, stockholders 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 November 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 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, 2010, 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. REMOVED AND RESERVED
20
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 sales prices 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.
|
|
|
|
|
|
|
|
|
Quarter |
|
Common |
Ended |
|
Stock |
|
|
High |
|
Low |
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 |
|
|
|
|
|
|
|
|
|
|
March 31, 2010
|
|
|
5.93 |
|
|
|
4.08 |
|
June 30, 2010
|
|
|
5.46 |
|
|
|
3.95 |
|
September 30, 2010
|
|
|
4.46 |
|
|
|
3.13 |
|
December 31, 2010
|
|
|
4.77 |
|
|
|
3.50 |
|
As of January 31, 2011, the number of holders of record of our common stock was 74 and the
approximate number of beneficial holders, investors who hold our shares through brokers, of our
common stock was 1,700.
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. In December, 2010,
the first milestone was achieved and we issued 350,000 shares of our common stock to the seller of
Tourtellotte along with $1.2 million in cash.
On March 25, 2010, the Company acquired substantially all of the assets of TranSenda
International, LLC, or TranSenda. TranSenda provided clinical trial management software, or CTMS,
solutions. We issued 577,960 shares of our common stock, valued at a volume weighted average price
per share equal to $4.325560, as the purchase price consideration.
21
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.
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, 2010 with respect to the shares of
our common stock that may be issued under our existing equity compensation plans.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Weighted |
|
|
Number of Securities |
|
|
|
Securities to be |
|
|
Average Exercise |
|
|
Available for Future |
|
|
|
Issued Upon |
|
|
Price of |
|
|
Issuance |
|
|
|
Exercise of |
|
|
Outstanding |
|
|
Under Equity Compensation |
|
Plan Category |
|
Outstanding Options |
|
|
Options |
|
|
Plans |
|
Equity compensation
plans that have
been approved by
security holders |
|
|
1,717,189 |
|
|
$ |
4.83 |
|
|
|
1,149,787 |
|
Equity compensation
plans not approved
by security holders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,717,189 |
|
|
$ |
4.83 |
|
|
|
1,149,787 |
|
|
|
|
|
|
|
|
|
|
|
The following table provides information relating to our repurchase of common stock for the
fourth quarter of 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approximate Dollar |
|
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
|
Value of Shares |
|
|
|
|
|
|
|
|
|
|
|
Shares Purchased as |
|
|
that May Yet Be |
|
|
|
Total Number of |
|
|
Average Price Paid |
|
|
Part of Publicly |
|
|
Purchased Under the |
|
|
|
Shares Purchased |
|
|
per Share |
|
|
Announced Program |
|
|
Program (1) |
|
December 17, 2010 |
|
|
3,400 |
|
|
$ |
4.62 |
|
|
|
3,400 |
|
|
$ |
1,984,177 |
|
|
|
|
(1) |
|
On December 17, 2010, our Board of Directors authorized $2 million in funds for use
in our common stock repurchase program over the following 18 months. Repurchase under the
program may be made through open market purchases or privately negotiated transactions in
accordance with applicable federal securities laws, including Rule 10b-18. The timing of
the repurchases and the exact number of shares of common stock to be purchased will be
determined by the discretion of our management, and will depend upon market conditions and
other factors. The program will be funded using our cash on hand and cash generated from
operations. The program may be extended, suspended or discontinued at any time. |
22
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, 2005 through December 31, 2010, 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, 2005 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, 2005 |
|
|
Dec. 31, 2006 |
|
|
Dec. 31, 2007 |
|
|
Dec. 31, 2008 |
|
|
Dec. 31, 2009 |
|
|
Dec. 31, 2010 |
|
BioClinica, Inc. |
|
|
100.00 |
|
|
|
249.54 |
|
|
|
250.15 |
|
|
|
113.31 |
|
|
|
130.96 |
|
|
|
138.08 |
|
NASDAQ U.S. Stock Index |
|
|
100.00 |
|
|
|
109.88 |
|
|
|
119.16 |
|
|
|
57.47 |
|
|
|
82.54 |
|
|
|
97.98 |
|
Nasdaq Health Services Index |
|
|
100.00 |
|
|
|
99.86 |
|
|
|
130.52 |
|
|
|
95.32 |
|
|
|
126.02 |
|
|
|
151.92 |
|
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.
23
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, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
CONTINUING OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
$ |
62,714 |
|
|
$ |
57,393 |
|
|
$ |
56,181 |
|
|
$ |
37,543 |
|
|
$ |
31,853 |
|
Total revenue |
|
|
75,188 |
|
|
|
72,723 |
|
|
|
69,116 |
|
|
|
47,254 |
|
|
|
40,257 |
|
Income from continuing operations before interest and taxes |
|
|
4,318 |
|
|
|
4,688 |
|
|
|
8,480 |
|
|
|
4,848 |
|
|
|
2,670 |
|
Income from continuing operations, net of taxes |
|
|
2,753 |
|
|
|
2,959 |
|
|
|
5,791 |
|
|
|
3,343 |
|
|
|
1,968 |
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
|
0.18 |
|
|
|
0.21 |
|
|
|
0.42 |
|
|
|
0.29 |
|
|
|
0.18 |
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
|
0.17 |
|
|
|
0.20 |
|
|
|
0.40 |
|
|
|
0.26 |
|
|
|
0.16 |
|
Weighted average shares used to calculate earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
15,035 |
|
|
|
14,354 |
|
|
|
13,752 |
|
|
|
11,616 |
|
|
|
11,219 |
|
Diluted |
|
|
15,874 |
|
|
|
15,100 |
|
|
|
14,469 |
|
|
|
12,745 |
|
|
|
12,364 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL POSITION |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents |
|
$ |
10,443 |
|
|
$ |
14,570 |
|
|
$ |
14,265 |
|
|
$ |
17,915 |
|
|
$ |
16,166 |
|
Working capital |
|
|
8,606 |
|
|
|
7,302 |
|
|
|
7,918 |
|
|
|
9,721 |
|
|
|
10,219 |
|
Total assets |
|
|
80,029 |
|
|
|
75,337 |
|
|
|
69,208 |
|
|
|
43,057 |
|
|
|
34,108 |
|
Other liabilities |
|
|
2,766 |
|
|
|
2,162 |
|
|
|
641 |
|
|
|
597 |
|
|
|
305 |
|
Stockholders equity |
|
|
54,879 |
|
|
|
48,535 |
|
|
|
43,412 |
|
|
|
23,529 |
|
|
|
18,842 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER DATA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment and capitalized software
development costs |
|
$ |
7,193 |
|
|
$ |
4,258 |
|
|
$ |
2916 |
|
|
$ |
3,928 |
|
|
$ |
2,232 |
|
Depreciation and amortization |
|
|
3,452 |
|
|
|
2,713 |
|
|
|
2,266 |
|
|
|
2,335 |
|
|
|
2,035 |
|
Number of employees |
|
|
475 |
|
|
|
479 |
|
|
|
474 |
|
|
|
337 |
|
|
|
283 |
|
24
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Overview
BioClinica provides integrated clinical research technology solutions to pharmaceutical,
biotechnology, medical device companies and other organizations such as CROs, engaged in global
clinical studies. Our products and services include: medical image management, electronic image
transport and archive solutions, electronic data capture, clinical data management, interactive
voice and web response, clinical trial supply forecasting tools, and clinical trial management
software 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
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.
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 three to 60 months and
the volume and type of services performed by us generally vary during the course of a project. We
cannot assure you that our project revenues will be at levels sufficient to maintain profitability.
Our contracted/committed backlog, referred to as backlog, is the expected service revenue that
remains to be earned and recognized on both signed and verbally agreed to contracts. Our backlog
as of December 31, 2010 was $110.7 million, compared to $98.7 million at December 31, 2009 and
$92.7 million at December 31, 2008. 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, 2010.
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.
25
Acquisitions and Dispositions
On March 25, 2010, we acquired substantially all of the assets of privately held TranSenda
International, LLC, or TranSenda. Headquartered in Bellevue, WA, TranSenda was a provider of CTMS
solutions. TranSendas suite of web-based, Office-Smart CTMS solutions create efficiencies for
trial operations through interoperability with Microsoft Office tools. The CTMS solutions enable
our clients to have their applications work together instead of being locked into a single suite
vendor and serves as the foundation for operational data interchange among different software
applications. This facilitates easier access to data with a consistent user interface and reduces
training costs. With this acquisition, we enhanced our 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 BioClinica and TranSenda, or
the Purchase Agreement. Pursuant to the terms of the Purchase Agreement, we 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, we paid 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, 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 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 BioClinicas 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 12 months after such date. We
recorded the fair value of the acquisition of $2,468,000 based on our market value of $4.27 on
March 25, 2010, the date of acquisition.
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. In December 2010, pursuant to obtaining certain milestones, we paid
to the sellers of Tourtellotte, $1.2 million in cash and 350,000 shares of our common stock. At
December 31, 2010, the fair value of the remaining cash earn-out of $1.9 million has been recorded
as a liability. We used cash from operations to fund the cash purchase price for Tourtellotte.
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.
26
On January 6, 2009, pursuant to the asset purchase 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 PHR
software and the patent-pending Personal HealthKey technology, to Metavante. Under the terms of
the agreement, Metavante paid us an upfront payment of $500,000 in cash and we were entitled to
earn-out payments 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 were entitled to 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
were entitled to 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, 2010, we did not receive any earn-out payments from Metavante and due to the
expiration of the earn-out period we do not expect to receive any earn-out payments in the future.
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 medical image review services; 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
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.
27
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 service 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 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.
We also enter into software license contracts that permit the customer to use our software
products at its site. Generally, these contracts are multiple-element arrangements since they
usually provide for professional services and ongoing software maintenance. In these instances,
license fees are recognized upon the signing of the contract and delivery of the software if the
license fee is fixed or determinable, collection is probable, and there is sufficient vendor
specific evidence of the fair value of each undelivered element. Revenue for the software
maintenance is recognized over the duration of the maintenance period.
When contracts include both professional services and software and require a significant
amount of program modification or customization, installation, systems integration or related
services, the professional services and license revenue is recorded based upon the estimated
percentage of completion, measured in the manner described above. Changes in the estimated costs or
hours to complete the contract and losses, if any, are reflected in the period during which the
change or loss becomes known.
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.
28
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, 2010, we conducted the required annual test of impairment. In
2010, 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 an internal use
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.
Software development costs related to products that will be sold, leased or marketed to be
operated by customers on their equipment and premises are expensed as incurred and consist
primarily of design and development costs of new products and significant enhancements to existing
products incurred before the establishment of technological feasibility. Recoverable costs incurred
subsequent to technological feasibility of new products and enhancements to existing products as
well as costs associated with purchased software and software obtained through business
acquisitions are capitalized and amortized over the estimated useful lives of the related products,
generally five to ten years (average life is five years), using the straight-line method or the
ratio of current revenue to current and anticipated revenue from such software, whichever provides
the greater amortization.
Income Taxes. We evaluate the need to record a valuation allowance to reduce our deferred tax
assets to an amount that is more likely than not to be realized. In assessing the need for the
valuation allowance, we consider our future taxable income and on-going prudent and feasible tax
planning strategies. In the event that we were to determine that, in the future, we would be able
to realize our deferred tax assets in excess of its net recorded amount, an adjustment to the
deferred tax asset would be made, thereby increasing net income in the period such determination
was made. Likewise, should we determine that it is more likely than not that we will be unable to
realize all or part of our net deferred tax asset in the future, an adjustment to the deferred tax
asset would be charged, thereby decreasing net income in the period such determination was made.
We recognize contingent liabilities for any tax related exposures when those exposures are more
likely than not to occur.
Stock-based compensation costs. 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
29
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 $200,000 and $215,000 to our net asset
position, at December 31, 2010 and December 31, 2009, 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, 2010 and December 31, 2009. 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, 2010 and 2009, there are no outstanding
derivative positions.
30
Results of Operations
Year Ended December 31, 2010 Compared with Year Ended December 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Total |
|
|
$ |
|
|
% |
|
(in thousands) |
|
2010 |
|
|
Revenue |
|
|
2009 |
|
|
Revenue |
|
|
Change |
|
|
Change |
|
Service revenues |
|
$ |
62,714 |
|
|
|
83.4 |
% |
|
$ |
57,393 |
|
|
|
78.9 |
% |
|
$ |
5,321 |
|
|
|
9.3 |
% |
Reimbursement revenues |
|
|
12,474 |
|
|
|
16.6 |
% |
|
|
15,330 |
|
|
|
21.1 |
% |
|
|
(2,856 |
) |
|
|
(18.6 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
75,188 |
|
|
|
100.0 |
% |
|
|
72,723 |
|
|
|
100.0 |
% |
|
|
2,465 |
|
|
|
3.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
39,559 |
|
|
|
52.6 |
% |
|
|
35,630 |
|
|
|
49.0 |
% |
|
|
3,929 |
|
|
|
11.0 |
% |
Cost of reimbursement revenues |
|
|
12,474 |
|
|
|
16.6 |
% |
|
|
15,330 |
|
|
|
21.1 |
% |
|
|
(2,856 |
) |
|
|
(18.6 |
%) |
Sales and marketing expenses |
|
|
9,004 |
|
|
|
12.0 |
% |
|
|
8,052 |
|
|
|
11.1 |
% |
|
|
952 |
|
|
|
11.8 |
% |
General and administrative expenses |
|
|
8,446 |
|
|
|
11.2 |
% |
|
|
7,414 |
|
|
|
10.2 |
% |
|
|
1,032 |
|
|
|
13.9 |
% |
Amortization of intangible assets related
to acquisitions |
|
|
638 |
|
|
|
0.8 |
% |
|
|
489 |
|
|
|
0.7 |
% |
|
|
149 |
|
|
|
30.5 |
% |
Restructuring charges |
|
|
|
|
|
|
0.0 |
% |
|
|
466 |
|
|
|
0.6 |
% |
|
|
(466 |
) |
|
|
(100 |
%) |
Merger and acquisition related costs |
|
|
749 |
|
|
|
1.0 |
% |
|
|
654 |
|
|
|
0.9 |
% |
|
|
95 |
|
|
|
14.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
70,870 |
|
|
|
94.3 |
% |
|
|
68,035 |
|
|
|
93.6 |
% |
|
|
2,835 |
|
|
|
4.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
4,318 |
|
|
|
5.7 |
% |
|
|
4,688 |
|
|
|
6.4 |
% |
|
|
(370 |
) |
|
|
(7.9 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
23 |
|
|
|
0.0 |
% |
|
|
41 |
|
|
|
0.1 |
% |
|
|
(18 |
) |
|
|
(43.9 |
%) |
Interest expense |
|
|
(12 |
) |
|
|
0.0 |
% |
|
|
(13 |
) |
|
|
0.0 |
% |
|
|
1 |
|
|
|
(7.7 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income tax |
|
|
4,329 |
|
|
|
5.8 |
% |
|
|
4,716 |
|
|
|
6.5 |
% |
|
|
(387 |
) |
|
|
(8.2 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
(1,576 |
) |
|
|
(2.1 |
%) |
|
|
(1,757 |
) |
|
|
(2.4 |
%) |
|
|
181 |
|
|
|
(10.3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income |
|
$ |
2,753 |
|
|
|
3.7 |
% |
|
$ |
2,959 |
|
|
|
4.1 |
% |
|
$ |
(206 |
) |
|
|
(7.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Consolidated Statement of Income for the twelve months ended December 31, 2010
excludes the financial results of TranSenda from the acquisition date of March 25, 2010 through
March 31, 2010 due to immateriality of TranSendas results of operations for that period.
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.
Service revenues were $62.7 million for fiscal 2010 and $57.4 million for fiscal 2009, an
increase of $5.3 million, or 9.3%. The increase in service revenues was due to an increase in work
performed on the increased backlog from the prior year. Pfizer, Inc., encompassing 22 projects,
represented 20% of our service revenue for fiscal 2010. No one client accounted for more than 10%
of service revenues for fiscal 2009.
31
Reimbursement revenues and cost of reimbursement revenues was $12.5 million for fiscal 2010
and $15.3 million for fiscal 2009, a decrease of $2.8 million, or 18.6%. Reimbursement revenues
and cost of reimbursement revenues consist of payments received from the customer for reimbursable
costs. Reimbursement revenues and cost of reimbursement revenues fluctuate significantly over the
course of any given project, and quarter to quarter variations are a reflection of this project
timing. Therefore, our management believes that reimbursement revenues and cost of reimbursement
revenues are not a significant indicator of our overall performance trends. At the request of our
clients, we may directly pay the independent radiologists who review our clients imaging data. In
such cases, per contractual arrangement, these costs are billed to our clients and are included in
reimbursement revenues and cost of reimbursement revenues.
Cost of service revenues was $39.6 million for fiscal 2010 and $35.6 million for fiscal 2009,
an increase of $3.9 million, or 11.0%. Cost of service revenues for fiscal 2010 and fiscal 2009
were comprised of professional salaries and benefits and allocated overhead. The increase is due
to additional personnel from the Tourtellotte and TranSenda acquisitions. The cost of revenues as
a percentage of total revenues also fluctuates due to work-flow variations in the utilization of
staff and the mix of services provided by us in any given period. We expect that our cost of
service revenues will increase in fiscal 2011 to service our newly released products.
Sales and marketing expenses were $9.0 million for fiscal 2010 and $8.1 million for fiscal
2009, an increase of $952,000 or 11.8%. Sales and marketing expenses for fiscal 2010 and fiscal
2009 were comprised of direct sales and marketing costs, salaries and benefits and allocated
overhead. The increase is primarily due to additional personnel to increase our marketing and
sales presence in the United States and Europe. We expect that our sales and marketing expenses
will increase in fiscal 2011.
General and administrative expenses were $8.4 million for fiscal 2010 and $7.4 million for
fiscal 2009, an increase of $1.0 million or 13.9%. General and administrative expenses for fiscal
2010 and fiscal 2009 consisted primarily of salaries and benefits, allocated overhead, professional
and consulting services and corporate insurance. The increase is due to the inclusion of costs from
the acquisition of TranSenda and increased professional fees. We expect that our general and
administrative expenses will increase in fiscal 2011.
Amortization of intangible assets related to acquisitions was $638,000 for fiscal 2010 and
$489,000 for fiscal 2009, an increase of $149,000, or 30.5%. 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, TranSenda and Theralys. The increase is primarily due to the acquisition of
Tourtellotte and TranSenda. We expect that the amortization of intangible assets related to
acquisitions will remain relatively flat in fiscal 2011.
Restructuring costs were $0 for fiscal 2010 and $466,000 for fiscal 2009. In the second
quarter of fiscal 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 fiscal 2009 and
nothing is left to be paid from the restructuring at December 31, 2010. We do not expect any
additional costs from the fiscal 2009 restructuring plan.
32
Merger and acquisition related costs were $749,000 for fiscal 2010 and $654,000 for fiscal
2009, an increase of $95,000, or 14.5%. Fiscal 2010 includes expenses of $447,000 resulting
directly from merger and
acquisition activities for the TranSenda acquisition such as legal, accounting and other due
diligence and integration costs. Also included in this cost is $302,000 of accretion related to
the change in fiscal 2010 in the fair value of the earn-out payments associated with the
Tourtellotte acquisition. Fiscal 2009 includes 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 accretion related to the change in the fair value
of earn-out payments associated with the Tourtellotte acquisition from the purchase price recorded
at the date of acquisition to December 31, 2009.
Net interest income was $11,000 for fiscal 2010 and $28,000 for fiscal 2009, a decrease of
$17,000, or 60.7%. Net interest income is comprised of interest income earned on our cash balance
and interest expense incurred on equipment lease obligations. The decrease is due to lower average
daily cash balances and lower interest rates earned on deposits.
Our income tax provision was $1.6 million for fiscal 2010 and $1.8 million for fiscal 2009.
Our effective tax rate from continuing operations was 36% for fiscal 2010 and 37% for fiscal 2009.
The lower effective tax rate in fiscal 2010 was due to the application of the R&D tax credit.
33
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 |
|
|
|
96.6 |
% |
|
|
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 |
|
|
|
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.
34
Service revenues were $57.4 million for fiscal 2009 and $56.2 million for fiscal 2008, an
increase of $1.2 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 fiscal 2008 and the addition of
personnel from the Tourtellotte acquisition in the third quarter of fiscal 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.
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.
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 fiscal 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.
Amortization of intangible assets related to acquisitions were $489,000 for fiscal 2009 and
$380,000 for fiscal 2008, 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
due to the addition of Tourtellotte.
35
In the second quarter of fiscal 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
fiscal 2009 and nothing is left to be paid from the restructuring at December 31, 2009.
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 accretion related to the
change in the fair value of earn-out payments associated with the Tourtellotte acquisition 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 $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.
Our income tax provision was $1.8 million for fiscal 2009 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.
36
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, 2010 compared to December 31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
Net cash provided by activities from
continuing operations |
|
$ |
3,992 |
|
|
$ |
7,552 |
|
|
$ |
9,768 |
|
Net cash used in investing
activities from continuing
operations |
|
$ |
(8,450 |
) |
|
$ |
(7,713 |
) |
|
$ |
(10,844 |
) |
Net cash provided by (used in)
financing activities from continuing
operations |
|
$ |
348 |
|
|
$ |
(43 |
) |
|
$ |
523 |
|
At December 31, 2010, we had cash and cash equivalents of $10.4 million. Working capital,
defined as current assets minus current liabilities, at December 31, 2010 was $8.6 million as
compared to working capital at December 31, 2009 of $7.3 million.
Net cash provided by continuing operating activities was $4.0 million for fiscal 2010 compared
to net cash provided by operating activities of $7.6 million for fiscal 2009. The primary drivers
of the change in cash provided by continuing operations is the increase in accounts receivable and
decrease in accounts payable.
Net cash used in investing activities was $8.5 million for fiscal 2010 and $7.7 million for
fiscal 2009. This increase was primarily due to increased capitalized software development costs
in fiscal 2010. Net cash used in investing activities consists primarily of our investment in
capitalized software development costs and property and equipment from continuing operations of
$7.2 million and cash paid for the acquisition earn-out of Tourtellotte of $1.3 million. We
currently anticipate that capital expenditures for fiscal 2011 will be approximately $6.0 million.
These expenditures primarily represent additional upgrades in our networking, data storage and data
center infrastructure as well as capitalization of software costs.
Net cash provided by financing activities was $348,000 for fiscal 2010 compared to net cash
used in financing activities of $43,000 for fiscal 2009. Net cash provided by (used in) financing
activities is primarily attributable to a sale/leaseback transaction of $195,000 and tax benefit
related to stock options of $46,000.
The following table lists our cash contractual obligations as of December 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period |
|
(in thousands) |
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
|
Contractual obligations |
|
Total |
|
|
year |
|
|
1-3 years |
|
|
3-5 years |
|
|
More than 5 years |
|
Facility rent operating
leases |
|
|
20,538 |
|
|
|
2,613 |
|
|
|
5,736 |
|
|
|
5,017 |
|
|
|
7,172 |
|
Employment agreements |
|
|
919 |
|
|
|
835 |
|
|
|
84 |
|
|
|
|
|
|
|
|
|
Earn-outs for
Tourtellotte
acquisition |
|
|
2,000 |
|
|
|
2,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease |
|
|
878 |
|
|
|
168 |
|
|
|
353 |
|
|
|
357 |
|
|
|
|
|
Total contractual cash
obligations |
|
$ |
24,335 |
|
|
$ |
5,616 |
|
|
$ |
6,173 |
|
|
$ |
5,374 |
|
|
$ |
7,172 |
|
37
On May 5, 2010, we entered into an unsecured, committed line of credit with PNC Bank, expiring
May 5, 2012. Under the credit agreement, we have the ability to borrow $7.5 million at interest
rates equal to LIBOR plus 1.75%. In addition, we pay a fee of 0.25% per annum on the loan
commitment regardless of usage. The credit agreement requires our compliance with certain
covenants, including maintaining a minimum stockholders equity of $35 million. As of December 31,
2010, we had no borrowings under this line of credit, and we were compliant with the covenants.
Capital lease obligations consist of one equipment lease obligation at December 31, 2010. In
December 2010, we entered into a capital lease with a bank totaling $892,000, which included a
$194,000 sale-leaseback transaction that we entered into with the same bank in September 2010 and
$698,000 of equipment lease obligation, the lease term is 5 years with an interest rate of 3.87%.
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 unconsolidated entities or other persons that are likely to affect liquidity or
the availability of or requirements for capital resources.
We anticipate that our existing capital resources together with cash flow from operations will
be sufficient to meet our cash needs for the next 12 months. However, we cannot assure you that
our operating results will maintain profitability on an annual basis in the future. The inherent
operational risks associated with the following factors may have a material adverse affect on our
future liquidity:
|
|
|
our ability to gain new client contracts; |
|
|
|
|
project cancellations; |
|
|
|
|
the variability of the timing of payments on existing client contracts; and |
|
|
|
|
other changes in our operating assets and liabilities. |
We may seek to raise additional capital from equity or debt sources in order to take advantage
of unanticipated opportunities, such as more rapid expansion, acquisitions of complementary
businesses or the development of new services. We cannot assure you that additional financing will
be available, if at all, on terms acceptable to us.
38
Recently Issued Accounting Statements
In October 2009, the FASB issued guidance on revenue recognition that will become effective
for us beginning January 1, 2011. 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.
In December 2010, the FASB issued ASU 2010-29, Business Combinations (ASC Topic 805) -
Disclosure of Supplementary Pro Forma Information for Business Combinations. This amendment
expands the supplemental pro forma disclosures required. This amendment is effective prospectively
for business combinations for which the acquisition date is on or after the beginning of the first
annual reporting period beginning on or after December 15, 2010, with earlier adoption permitted.
As the adoption of ASU 2010-29 only requires enhanced disclosures, this standard will have no
impact on our financial statements.
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 12 months ended December 31, 2010 and 2009, 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. As of December 31, 2010, 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.
39
Item 8. Financial Statements and Supplementary Data.
|
|
|
|
|
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS |
|
PAGE |
|
Report of Independent Registered Public Accounting Firm |
|
|
41 |
|
|
|
|
|
|
Consolidated Balance Sheets as of December 31, 2010 and 2009 |
|
|
42 |
|
|
|
|
|
|
Consolidated Statements of Income for the year ended December 31, 2010, 2009 and 2008 |
|
|
43 |
|
|
|
|
|
|
Consolidated Statements of Stockholders Equity for the year ended
December 31, 2010, 2009 and 2008 |
|
|
44 |
|
|
|
|
|
|
Consolidated Statements of Cash Flows for the year ended December 31, 2010, 2009 and 2008 |
|
|
45 |
|
|
|
|
|
|
Notes to Consolidated Financial Statements |
|
|
47 |
|
|
|
|
|
|
Quarterly Financial Results (Unaudited) |
|
|
74 |
|
40
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, 2010 and 2009, and the results of their operations and their cash flows for each of
the three years in the period ended December 31, 2010 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 audit 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. An audit includes examining, on a test
basis, evidence supporting the amounts and disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by management, and evaluating the overall
financial statement presentation. We believe that our audits provide a reasonable basis for our
opinion.
As discussed in Note 2 to the consolidated financial statements, the Company changed the manner in
which it accounts for business combinations in 2009.
/s/ PricewaterhouseCoopers LLP
Philadelphia, PA
February 28, 2011
41
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
ASSETS |
|
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
10,443 |
|
|
$ |
14,570 |
|
Accounts receivable, net of allowance for doubtful accounts of
$15 and $9, respectively |
|
|
11,866 |
|
|
|
10,966 |
|
Prepaid expenses and other current assets |
|
|
2,501 |
|
|
|
1,869 |
|
Deferred income taxes |
|
|
3,625 |
|
|
|
3,370 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
28,435 |
|
|
|
30,775 |
|
Property and equipment, net |
|
|
14,029 |
|
|
|
9,040 |
|
Intangibles, net |
|
|
2,430 |
|
|
|
1,969 |
|
Goodwill |
|
|
34,302 |
|
|
|
32,933 |
|
Deferred income taxes |
|
|
128 |
|
|
|
|
|
Other assets |
|
|
705 |
|
|
|
620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets |
|
$ |
80,029 |
|
|
$ |
75,337 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,983 |
|
|
$ |
3,899 |
|
Accrued expenses and other current liabilities |
|
|
4,283 |
|
|
|
4,134 |
|
Deferred revenue |
|
|
13,395 |
|
|
|
14,256 |
|
Current maturities of capital lease obligations |
|
|
168 |
|
|
|
|
|
Current liability for acquisition earn-out |
|
|
|
|
|
|
1,184 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
19,829 |
|
|
|
23,473 |
|
Long-term capital lease obligations |
|
|
710 |
|
|
|
|
|
Long-term liability for acquisition earn-out |
|
|
1,886 |
|
|
|
1,657 |
|
Deferred income taxes |
|
|
1,845 |
|
|
|
1,167 |
|
Other liability |
|
|
880 |
|
|
|
505 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
25,150 |
|
|
|
26,802 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies (see Note 9) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock- $.00025 par value; authorized 3,000,000 shares,
0 issued and outstanding at December 31, 2010 and 2009 |
|
|
|
|
|
|
|
|
Common stock $.00025 par value; authorized 36,000,000
shares, issued and outstanding 15,631,664 shares at December 31, 2010
and authorized 36,000,000 shares, issued and outstanding 14,394,374
shares at December 31, 2009 |
|
|
4 |
|
|
|
4 |
|
Treasury stock at cost; shares held: 3,400 at December 31, 2010 and 0 at
December 31, 2009 |
|
|
(16 |
) |
|
|
|
|
Common stock consideration for earn-out |
|
|
|
|
|
|
1,309 |
|
Additional paid-in capital |
|
|
48,074 |
|
|
|
43,104 |
|
Retained earnings |
|
|
6,792 |
|
|
|
4,039 |
|
Accumulated other comprehensive income |
|
|
25 |
|
|
|
79 |
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
54,879 |
|
|
|
48,535 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
80,029 |
|
|
$ |
75,337 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these statements.
42
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
(in thousands except per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
Service revenues |
|
$ |
62,714 |
|
|
$ |
57,393 |
|
|
$ |
56,181 |
|
Reimbursement revenues |
|
|
12,474 |
|
|
|
15,330 |
|
|
|
12,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
75,188 |
|
|
|
72,723 |
|
|
|
69,116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
39,559 |
|
|
|
35,630 |
|
|
|
32,446 |
|
Cost of reimbursement revenues |
|
|
12,474 |
|
|
|
15,330 |
|
|
|
12,935 |
|
Sales and marketing expenses |
|
|
9,004 |
|
|
|
8,052 |
|
|
|
7,860 |
|
General and administrative expenses |
|
|
8,446 |
|
|
|
7,414 |
|
|
|
7,015 |
|
Amortization of intangible assets related to acquisitions |
|
|
638 |
|
|
|
489 |
|
|
|
380 |
|
Restructuring charges |
|
|
|
|
|
|
466 |
|
|
|
|
|
Mergers and acquisitions related costs |
|
|
749 |
|
|
|
654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
70,870 |
|
|
|
68,035 |
|
|
|
60,636 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
4,318 |
|
|
|
4,688 |
|
|
|
8,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
23 |
|
|
|
41 |
|
|
|
429 |
|
Interest expense |
|
|
(12 |
) |
|
|
(13 |
) |
|
|
(7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
4,329 |
|
|
|
4,716 |
|
|
|
8,902 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
(1,576 |
) |
|
|
(1,757 |
) |
|
|
(3,111 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
2,753 |
|
|
$ |
2,959 |
|
|
$ |
5,791 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations, net of taxes |
|
|
|
|
|
|
|
|
|
|
(3,001 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,753 |
|
|
$ |
2,959 |
|
|
$ |
2,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.18 |
|
|
$ |
0.21 |
|
|
$ |
0.42 |
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
|
|
|
|
|
|
|
|
$ |
(0.22 |
) |
|
|
|
|
|
|
|
|
|
|
Net Income |
|
$ |
0.18 |
|
|
$ |
0.21 |
|
|
$ |
0.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
0.17 |
|
|
$ |
0.20 |
|
|
$ |
0.40 |
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
|
|
|
|
|
|
|
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
Net Income |
|
$ |
0.17 |
|
|
$ |
0.20 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to calculate earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
15,035 |
|
|
|
14,354 |
|
|
|
13,752 |
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
15,874 |
|
|
|
15,100 |
|
|
|
14,469 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these statements.
43
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Common Stock |
|
|
Accumulated |
|
|
Comprehensive |
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Treasury |
|
|
Consideration for |
|
|
(Deficit) Retained |
|
|
Gain |
|
|
Stockholders |
|
(in thousands) |
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Stock |
|
|
Earnout |
|
|
Earnings |
|
|
(Loss) |
|
|
Equity |
|
|
|
|
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 |
|
Stock options exercised |
|
|
262 |
|
|
|
|
|
|
|
122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
122 |
|
Restricted shares issued |
|
|
48 |
|
|
|
|
|
|
|
(55 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(55 |
) |
Stock consideration for
acquisitions |
|
|
350 |
|
|
|
|
|
|
|
1,309 |
|
|
|
|
|
|
|
(1,309 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued for acquisitions |
|
|
578 |
|
|
|
|
|
|
|
2,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,468 |
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
1,080 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,080 |
|
Purchase of treasury stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16 |
) |
Tax benefit on exercise of
stock options |
|
|
|
|
|
|
|
|
|
|
46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46 |
|
Equity adjustment from
foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(54 |
) |
|
|
(54 |
) |
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,753 |
|
|
|
|
|
|
|
2,753 |
|
|
|
|
Balance at December 31, 2010 |
|
|
15,632 |
|
|
$ |
4 |
|
|
$ |
48,074 |
|
|
$ |
(16 |
) |
|
|
|
|
|
$ |
6,792 |
|
|
$ |
25 |
|
|
$ |
54,879 |
|
Statements of comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Net income |
|
$ |
2,753 |
|
|
$ |
2,959 |
|
|
$ |
2,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity adjustment from foreign currency translation |
|
|
(54 |
) |
|
|
21 |
|
|
|
(93 |
) |
|
|
|
Total comprehensive income |
|
$ |
2,699 |
|
|
$ |
2,980 |
|
|
$ |
2,697 |
|
The accompanying notes are an integral part of these statements.
44
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,753 |
|
|
$ |
2,959 |
|
|
$ |
2,790 |
|
Adjustments to reconcile net income to net cash provided by
operating activities, net of acquisition: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
3,452 |
|
|
|
2,711 |
|
|
|
2,266 |
|
(Benefit) provision for deferred income taxes |
|
|
295 |
|
|
|
336 |
|
|
|
(311 |
) |
Accretion of acquisition earn-out |
|
|
302 |
|
|
|
94 |
|
|
|
|
|
Bad debt provision (recovery) |
|
|
15 |
|
|
|
93 |
|
|
|
(6 |
) |
Stock based compensation expense |
|
|
1,080 |
|
|
|
760 |
|
|
|
563 |
|
Loss from discontinued operations |
|
|
|
|
|
|
|
|
|
|
3,001 |
|
Changes in operating assets and liabilities, net of acquisitions: |
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in accounts receivable |
|
|
(605 |
) |
|
|
1,802 |
|
|
|
(1,339 |
) |
(Increase) decrease in prepaid expenses and other current assets |
|
|
(667 |
) |
|
|
447 |
|
|
|
(830 |
) |
(Increase) decrease in other assets |
|
|
(67 |
) |
|
|
(30 |
) |
|
|
93 |
|
(Decrease) increase in accounts payable |
|
|
(1,848 |
) |
|
|
403 |
|
|
|
1,599 |
|
(Decrease)
increase in accrued expenses and other current liabilities |
|
|
(251 |
) |
|
|
(1,100 |
) |
|
|
353 |
|
Decrease in deferred revenue |
|
|
(855 |
) |
|
|
(852 |
) |
|
|
(850 |
) |
Increase (decrease) in other liabilities |
|
|
388 |
|
|
|
(71 |
) |
|
|
(3 |
) |
Increase in net assets held for sale |
|
|
|
|
|
|
|
|
|
|
2,442 |
|
|
|
|
|
|
|
|
|
|
|
Cash provided by activities from continuing operations |
|
|
3,992 |
|
|
|
7,552 |
|
|
|
9,768 |
|
Cash used by discontinued operations |
|
|
|
|
|
|
|
|
|
|
(2,974 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
3,992 |
|
|
|
7,552 |
|
|
|
6,794 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows used in investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(2,916 |
) |
|
|
(2,763 |
) |
|
|
(1,780 |
) |
Capitalized software development costs |
|
|
(4,277 |
) |
|
|
(1,806 |
) |
|
|
(897 |
) |
Net cash paid for acquisition |
|
|
|
|
|
|
(3,144 |
) |
|
|
(7,928 |
) |
Net cash paid for acquisition earn-out |
|
|
(1,257 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities from continuing operations |
|
|
(8,450 |
) |
|
|
(7,713 |
) |
|
|
(10,605 |
) |
Purchase of plant, property and equipment for discontinued operations |
|
|
|
|
|
|
|
|
|
|
(239 |
) |
Net cash received for sale of assets of discontinued operations |
|
|
|
|
|
|
500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(8,450 |
) |
|
|
(7,213 |
) |
|
|
(10,844 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Payments under equipment lease obligations |
|
|
|
|
|
|
(118 |
) |
|
|
(153 |
) |
Proceeds from sale/leaseback |
|
|
195 |
|
|
|
|
|
|
|
|
|
Purchase of treasury stock |
|
|
(15 |
) |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
122 |
|
|
|
31 |
|
|
|
386 |
|
Excess tax benefit related to stock options |
|
|
46 |
|
|
|
44 |
|
|
|
290 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities from continuing
operations |
|
|
348 |
|
|
|
(43 |
) |
|
|
523 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
(17 |
) |
|
|
9 |
|
|
|
(123 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(4,127 |
) |
|
|
305 |
|
|
|
(3,650 |
) |
Cash and cash equivalents at beginning of period |
|
|
14,570 |
|
|
|
14,265 |
|
|
|
17,915 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
10,443 |
|
|
$ |
14,570 |
|
|
$ |
14,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
3 |
|
|
$ |
11 |
|
|
$ |
11 |
|
Cash paid during the period for income taxes |
|
$ |
1,775 |
|
|
$ |
1,226 |
|
|
$ |
1,970 |
|
The accompanying notes are an integral part of these statements.
45
Supplemental cash flow disclosure
Schedule of non cash investing and financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
Increase in property, plant and equipment
acquisitions in accounts payable |
|
$ |
20 |
|
|
$ |
334 |
|
|
$ |
7 |
|
Value of contingent stock and cash to be used for
earn-out provisions related to acquired business |
|
|
|
|
|
$ |
4,150 |
|
|
|
|
|
Equipment purchases under capital lease obligations |
|
$ |
892 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired business |
|
For the year ended December 31, |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Accounts receivable |
|
$ |
309 |
|
|
$ |
934 |
|
|
$ |
4,926 |
|
Property and equipment |
|
|
91 |
|
|
|
|
|
|
|
721 |
|
Other assets |
|
|
58 |
|
|
|
55 |
|
|
|
295 |
|
Intangible assets and goodwill |
|
|
2,469 |
|
|
|
2,248 |
|
|
|
23,874 |
|
Current liabilities assumed |
|
|
(459 |
) |
|
|
(93 |
) |
|
|
(1,061 |
) |
Other liabilities assumed |
|
|
|
|
|
|
|
|
|
|
(4,880 |
) |
Common stock issued |
|
|
(2,468 |
) |
|
|
|
|
|
|
(15,947 |
) |
|
|
|
Cash paid for acquired business, net of cash
acquired of $0, $0 and $418,000, respectively |
|
$ |
|
|
|
$ |
3,144 |
|
|
$ |
7,928 |
|
The accompanying notes are an integral part of these statements.
46
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENT (Continued)
1. Organization and Summary of Significant Accounting Policies
Description of Business
BioClinica provides integrated clinical research technology solutions to pharmaceutical,
biotechnology, 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 image transport and archive solutions, electronic data
capture, clinical data management, interactive voice and web response, clinical trial supply
forecasting tools, and clinical trial management software 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 solutions 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., BioClinica Holding B.V. and
BioClinica Private Limited. All intercompany transactions and balances have been eliminated in
consolidation.
Basis of Presentation
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.
47
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Foreign Currency Translation
Assets and liabilities of non-U.S. subsidiaries are translated into U.S. dollars at fiscal
year-end exchange rates. Income and expense items are translated at average exchange rates
prevailing during the fiscal year. The resulting translation adjustments are recorded as a
component of shareholders equity. Gains and losses from foreign currency transactions are
included in net income.
Functional Currency
The functional currency of each of the Companys foreign operations is the local currency of
the country in which the operation is located. All assets and liabilities are translated into U.S.
dollars using exchange rates in effect at the balance sheet date. Revenue and expenses are
translated using average exchange rates during the period. Increases and decreases in net assets
resulting from foreign currency translation are reflected in stockholders equity as a component of
accumulated other comprehensive income (loss).
The equity adjustment from foreign currency translation was $54,000 and $21,000 at December
31, 2010 and 2009, respectively.
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 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
48
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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 for service contracts 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.
The Company also enters into software license contracts that permit the customer to use
software products at its site. Generally, these contracts are multiple-element arrangements since
they usually provide for professional services and ongoing software maintenance. In these
instances, license fees are recognized upon the signing of the contract and delivery of the
software if the license fee is fixed or determinable, collection is probable, and there is
sufficient vendor specific evidence of the fair value of each undelivered element. Revenue for the
software maintenance is recognized over the duration of the maintenance period.
When contracts include both professional services and software and require a significant
amount of program modification or customization, installation, systems integration or related
services, the professional services and license revenue is recorded based upon the estimated
percentage of completion, measured in the manner described above. Changes in the estimated costs or
hours to complete the contract and losses, if any, are reflected in the period during which the
change or loss becomes known.
49
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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) |
|
2010 |
|
|
2009 |
|
Billed trade accounts receivable |
|
|
11,085 |
|
|
|
10,164 |
|
Unbilled trade accounts receivable |
|
|
782 |
|
|
|
747 |
|
Other |
|
|
16 |
|
|
|
55 |
|
|
|
|
|
|
|
|
Total receivables |
|
|
11,883 |
|
|
|
10,966 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance Rollforward: |
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
11 |
|
|
|
|
|
Additions |
|
|
93 |
|
|
|
|
|
Write offs (net of recoveries) |
|
|
(95 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
$ |
9 |
|
|
|
|
|
Additions |
|
|
15 |
|
|
|
|
|
Write offs (net of recoveries) |
|
|
(9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2010 |
|
$ |
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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 an internal use 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
50
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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.
Software development costs related to products that will be sold, leased or marketed to be
operated by customers on their equipment and premises, are expensed as incurred and consist
primarily of design and development costs of new products and significant enhancements to existing
products incurred before the establishment of technological feasibility. Recoverable costs incurred
subsequent to technological feasibility of new products and enhancements to existing products as
well as costs associated with purchased software and software obtained through business
acquisitions are capitalized and amortized over the estimated useful lives of the related products,
generally five to ten years (average life is five years), using the straight-line method or the
ratio of current revenue to current and anticipated revenue from such software, whichever provides
the greater amortization.
The Company capitalized software development costs of $4,277,000, $1,806,000 and $897,000 for
the years ended December 31, 2010, 2009 and 2008 respectively. Amortization expense related to
capitalized computer software costs amounted to $663,000, $423,000 and $582,000 at December 31,
2010, 2009 and 2008, 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 December
31st of each year; however, these tests are performed more frequently when events or
changes in circumstances indicate the carrying value may not be recoverable. The Companys fair
value methodology is based on quoted market prices, if available. If quoted market prices are not
available, an estimate of fair market value is made based on prices of similar assets or other
valuation methodologies including present value techniques. Definite-lived intangible assets, such
as purchased and licensed technology, patents and customer lists are amortized over their estimated
useful lives, generally for periods ranging from two to seven years. The Company continually
evaluates the reasonableness of the useful lives of these assets.
Treasury Stock
Shares of common stock repurchased by the Company are recorded at cost as treasury stock and
result in a reduction of shareholders equity in the consolidated balance sheets.
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.
51
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands except per share data) |
|
For the year ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
Net income diluted and basic |
|
|
2,753 |
|
|
|
2,959 |
|
|
$ |
2,790 |
|
|
|
|
|
|
|
|
|
|
|
|
Denominator basic: |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares |
|
|
15,035 |
|
|
|
14,354 |
|
|
|
13,752 |
|
|
|
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.18 |
|
|
$ |
0.21 |
|
|
$ |
0.20 |
|
|
|
|
|
|
|
|
|
|
|
|
Denominator diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares |
|
|
15,035 |
|
|
|
14,354 |
|
|
|
13,752 |
|
Common share equivalents of
outstanding stock options |
|
|
288 |
|
|
|
403 |
|
|
|
648 |
|
Common share equivalents of
unrecognized compensation expense |
|
|
551 |
|
|
|
343 |
|
|
|
69 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
dilutive common equivalent shares |
|
|
15,874 |
|
|
|
15,100 |
|
|
|
14,469 |
|
|
|
|
|
|
|
|
|
|
|
Diluted income per common share |
|
$ |
0.17 |
|
|
$ |
0.20 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
|
|
|
We excluded options to purchase 655,000, 656,000 and 719,000 shares of our common stock for
the 12 months ended December 31, 2010, 2009 and 2008, respectively, since they were
out-of-the-money and antidilutive.
Recently Issued Accounting 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
application of the relative selling price method affects
52
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
the timing and amount of revenue recognition. Management believes the adoption of this new
guidance will not have a material impact on the Companys financial statements.
In December 2010, the FASB issued ASU 2010-29, Business Combinations (ASC Topic 805) -
Disclosure of Supplementary Pro Forma Information for Business Combinations. This amendment
expands the supplemental pro forma disclosures required. This amendment is effective
prospectively for business combinations for which the acquisition date is on or after the beginning
of the first annual reporting period beginning on or after December 15, 2010, with earlier adoption
permitted. As the adoption of ASU 2010-29 only requires enhanced disclosures, this standard will
have no impact on the Companys financial statements.
2. Acquisitions
2010 Acquisition
On March 25, 2010, the Company acquired substantially all of the assets of privately held
TranSenda International, LLC (TranSenda). Headquartered in Bellevue, WA, TranSenda was a provider
of clinical trial management software (CTMS) solutions. TranSendas suite of web-based,
Office-Smart CTMS solutions creates efficiencies for trial operations through interoperability with
Microsoft Office tools. With this acquisition, BioClinica enhanced 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 rights, 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 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, 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 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 12 months after such date. The
Company recorded the fair value of the acquisition of $2,468,000 based on the Companys market
value of $4.27 for the stock consideration on March 25, 2010, the date of acquisition.
Pro Forma Results. The following schedule includes consolidated statements of income data for
the unaudited pro forma results for the period ended December 31, 2010 and 2009 as if the TranSenda
acquisition had occurred as of the beginning of the periods presented after giving effect to
certain adjustments. The unaudited pro forma information is provided for illustrative purposes
only and is not
53
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
indicative of the results of operations or financial condition that would have been
achieved if the TranSenda acquisition would have taken place at the beginning 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.
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
Twelve Months Ended |
|
(in thousands except per share data) |
|
2010 |
|
|
2009 |
|
|
Total revenue |
|
$ |
75,419 |
|
|
$ |
73,554 |
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
3,645 |
|
|
|
1,681 |
|
|
|
|
|
|
|
|
|
|
Net Income |
|
|
2,325 |
|
|
|
1,142 |
|
|
|
|
|
|
|
|
|
|
Basic earnings per share |
|
$ |
0.15 |
|
|
$ |
0.08 |
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share |
|
$ |
0.15 |
|
|
$ |
0.08 |
|
In connection with the acquisition of TranSenda, 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 TranSenda as
part of its clinical trials services reportable segment.
In accordance with FASB ASC 805, Business Combinations, the Company expensed all costs related
to the acquisition. The total costs incurred to date related to the acquisition were $447,000 for
the period ended December 31, 2010 and are included in mergers and acquisition related costs on the
consolidated statement of income for fiscal 2010.
The following table summarizes the amounts of identified assets acquired and liabilities
assumed from TranSenda at the acquisition date fair value:
|
|
|
|
|
|
|
TranSenda |
|
Accounts Receivable |
|
$ |
309 |
|
Property and Equipment |
|
|
91 |
|
Other Assets |
|
|
58 |
|
Other Liabilities |
|
|
(459 |
) |
Customer Relationships |
|
|
100 |
|
Technology |
|
|
1,000 |
|
Goodwill, including Workforce |
|
|
1,369 |
|
|
|
|
|
Total Fair Value of Purchase Price |
|
$ |
2,468 |
|
|
|
|
|
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 goodwill is attributable to the workforce of the acquired business and synergies
expected to arise after the acquisition of the business.
54
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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 Consolidated Statement of Income for period ended December 31, 2010 excludes the financial
results of TranSenda from the acquisition date of March 25, 2010 through March 31, 2010 due to
immateriality of TranSendas results of operations for that period. TranSendas results of
operations are included in the Consolidated Statement of Income beginning April 1, 2010.
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 are included in the
consolidated statement of income from 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 are included in the consolidated statement of
income from the acquisition date.
Pro Forma Results. The following schedule includes consolidated statements of income data for
the unaudited pro forma results for the 12 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
55
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
condition. Pro forma adjustments are tax-effected at our effective tax rate.
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
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 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 are 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 |
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
56
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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 remaining cash contingent consideration expected to be paid in the fair value amount of
$1,886,000 was classified as a long-term liability on the financial statements at December 31,
2010. 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. The Company recorded $302,000 in fiscal 2010 and $94,000 in
fiscal 2009 of accretion expense in mergers and acquisition related costs on the income statement
for this difference. In December 2010, the Company paid the first acquisition earn-out of
$1,257,000 in cash and the issuance of 350,000 shares of the Companys Common Stock.
In accordance with FASB ASC 820, the Company determined that the non-financial assets and
liabilities summarized above are derived from 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 following table represents changes in assets and liabilities measured at fair value using
Level 3 inputs:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value at |
|
|
Earn out |
|
|
Payment on |
|
|
Fair value at |
|
|
|
September 15, 2009 |
|
|
accretion |
|
|
earn-out 1 |
|
|
December 31, 2010 |
|
Cash contingent
consideration |
|
$ |
2,747,000 |
|
|
$ |
396,000 |
|
|
|
($1,257,000 |
) |
|
$ |
1,886,000 |
|
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 clinical research
technology solutions to our clients (the Acquisition). The Acquisition was made pursuant to an
Agreement and
57
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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 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.
58
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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 of March 24, 2008 to March 31, 2008
were immaterial; therefore, the Company did not include the results of operations for those eight
days in the Consolidated Statement of Income for the 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 12 months ended December 31, 2008 as if the Acquisition had
occurred as of the beginning of the period presented after giving effect to certain adjustments.
The pro forma results for the 12 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.
59
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
Twelve Months Ended |
|
(in thousands except per share data) |
|
2008 |
|
Total revenue |
|
$ |
73,566 |
|
Income from continuing operations before interest and
taxes |
|
|
7,783 |
|
Income from continuing operations, net of taxes |
|
|
5,300 |
|
Basic earnings per share: |
|
|
|
|
Income from continuing operations |
|
$ |
0.38 |
|
Diluted earnings per share: |
|
|
|
|
Income from continuing operations |
|
$ |
0.35 |
|
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 that is recorded as a reduction to general and administrative expenses.
3. Discontinued Operations
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 year ended December 31, 2008 and prior
periods have been presented with CapMed operations 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.
60
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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 |
|
Service revenues |
|
$ |
321 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(2,323 |
) |
Loss from impairment |
|
|
(2,726 |
) |
|
|
|
|
|
|
|
|
|
Pretax loss |
|
|
(5,049 |
) |
Benefit from income taxes |
|
|
2,048 |
|
|
|
|
|
Net loss from discontinued operations |
|
|
(3,001 |
) |
|
|
|
|
On January 6, 2009, pursuant to the Asset Purchase Agreement by and among the Company and MBI
Benefits, Inc. (the Purchaser), an indirectly owned subsidiary of Metavante Technologies, Inc.
(Metavante), dated as of January 6, 2009 (the Agreement), the Company sold its CapMed Division,
including the divisions Personal Health Record (PHR) software and the patent-pending Personal
HealthKey technology, to Metavante. Under the terms of the Agreement, Metavante paid the Company
an upfront payment of $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 was
entitled to 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 was entitled to
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, 2010, the Company has not received any earn-out payments from Metavante and due to the
expiration of the earn-out period we do not expect to receive any earn-out payments in the future.
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. 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.
61
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. Property and Equipment
Property and equipment, at cost, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
Estimated |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
Useful Life |
|
Equipment |
|
|
10,978 |
|
|
|
9,796 |
|
|
5 years |
Equipment under capital leases |
|
|
5,224 |
|
|
|
4,332 |
|
|
5 years |
Furniture and fixtures |
|
|
2,504 |
|
|
|
2,115 |
|
|
7 years |
Leasehold improvements |
|
|
2,177 |
|
|
|
1,913 |
|
|
5 years |
Computer software costs |
|
|
11,698 |
|
|
|
7,065 |
|
|
5 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32,581 |
|
|
|
25,221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: Accumulated depreciation and
amortization |
|
|
(18,552 |
) |
|
|
(16,181 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
14,029 |
|
|
|
9,040 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated depreciation related to equipment acquired under capital leases amounted to $4.3
million and $4.3 million at December 31, 2010 and 2009, respectively. Accumulated amortization
related to capitalized computer software costs amounted to $4.0 million and $3.2 million at
December 31, 2010 and 2009, respectively. Depreciation expense for the years ended December 31,
2010, 2009 and 2008 were $2.4 million, $2.2 million and $1.9 million, respectively.
5. Intangible Assets
Included in other assets, the following is the acquired intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
Estimated |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
Useful Life |
|
Amortizable intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Technology |
|
$ |
1,843 |
|
|
$ |
843 |
|
|
5-10 years |
Trademarks |
|
|
48 |
|
|
|
48 |
|
|
5 years |
Customer backlog |
|
|
2,112 |
|
|
|
2,012 |
|
|
3-7 years |
Non-competition agreement |
|
|
349 |
|
|
|
349 |
|
|
2-3 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,352 |
|
|
$ |
3,252 |
|
|
|
|
|
Accumulated amortization |
|
|
(1,922 |
) |
|
|
(1,283 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,430 |
|
|
$ |
1,969 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
$ |
34,302 |
|
|
$ |
32,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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,
2010 and 2009. Amortization expense of intangible assets for the years ended December 31, 2010,
2009 and 2008 were $639,000, $489,000 and $382,000, respectively.
62
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Future amortization of the intangible assets is as follows:
|
|
|
|
|
(in thousands) |
|
Year Ending December 31 |
|
2011 |
|
$ |
623 |
|
2012 |
|
|
534 |
|
2013 |
|
|
337 |
|
2014 |
|
|
309 |
|
2015 |
|
|
160 |
|
Thereafter |
|
|
467 |
|
|
|
|
|
|
|
$ |
2,430 |
|
|
|
|
|
The following table details the changes in the carrying amount of goodwill:
|
|
|
|
|
|
|
|
|
(in thousands) |
|
2010 |
|
|
2009 |
|
Balance at the beginning of year |
|
$ |
32,933 |
|
|
$ |
27,391 |
|
Acquisition of businesses |
|
|
1,369 |
|
|
|
5,905 |
|
Changes to goodwill due to tax contingencies |
|
|
|
|
|
|
(363 |
) |
|
|
|
|
|
|
|
Balance at end of year |
|
$ |
34,302 |
|
|
$ |
32,933 |
|
|
|
|
|
|
|
|
6. Accrued Expenses
Accrued expenses and other current liabilities at December 31, 2010 and 2009 consist of the
following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
Accrued compensation |
|
|
2,585 |
|
|
|
2,797 |
|
Accrued consulting fees |
|
|
241 |
|
|
|
255 |
|
Accrued other |
|
|
1,457 |
|
|
|
1,082 |
|
|
|
|
|
|
|
|
|
|
|
4,283 |
|
|
|
4,134 |
|
|
|
|
|
|
|
|
7. Capital Lease Obligations
Capital lease obligations consist of one equipment lease obligation at December 31, 2010. In
December 2010, the Company entered into a capital lease with a bank totaling $892,000, which
included a $194,000 sale-leaseback transaction that the Company entered into with the same bank in
September 2010 and $698,000 of equipment lease obligation, the lease term is 5 years with an
interest rate of 3.87%.The equipment lease obligations are payable in monthly installments of
$16,318.
8. Stock Based Compensation
The Company accounts for stock based compensation plans under the provisions of FASB ASC 718
Compensation Stock Compensation (FASB ASC 718), which requires the measurement and
63
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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, 2010, 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,
2010 was $1,080,000, of which $553,000 is a result of the expensing of stock options pursuant to
FASB ASC 718, $311,000 is a result of expensing restricted stock units issued to our Board of
Directors, $95,000 is a result of expensing restricted stock units issued to our President and
Chief Executive Officer and $121,000 is a result of expensing restricted stock units issued to our
executive officers. For the year ended December 31, 2009, the compensation cost that has been
recorded to income under the plan was $760,000, of which $479,000 is a result of expensing stock
options pursuant to FASB ASC 718, $285,000 is a result of expensing restricted stock units issued
to our Board of Directors and ($4,000) is a result of expensing restricted stock units issued to
our President and Chief Executive Officer.
The following table presents the total stock-based compensation expense resulting from stock
options and restricted stock unit awards:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended |
|
|
For the year ended |
|
|
For the year ended |
|
(in thousands) |
|
December 31, 2010 |
|
|
December 31, 2009 |
|
|
December 31, 2008 |
|
Cost of revenues |
|
$ |
750 |
|
|
$ |
598 |
|
|
$ |
386 |
|
Sales and marketing |
|
|
171 |
|
|
|
81 |
|
|
|
83 |
|
General and administrative |
|
|
159 |
|
|
|
81 |
|
|
|
94 |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
expense before income
taxes |
|
$ |
1,080 |
|
|
$ |
760 |
|
|
$ |
563 |
|
|
|
|
|
|
|
|
|
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
Risk-free interest rate (range) |
|
|
1.59-2.44 |
% |
|
|
2.06-2.33 |
% |
|
|
2.29-2.63 |
% |
Dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected volatility |
|
|
52.00-53.00 |
% |
|
|
61.00 |
% |
|
|
55.00-56.00 |
% |
Expected term (in years) |
|
|
5.00 |
|
|
|
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.
64
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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.
Stock Options
Fiscal 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
(in thousands) |
|
|
|
|
|
Weighted Average |
|
|
Remaining |
|
|
Aggregate Intrinsic |
|
Stock Options |
|
Shares |
|
|
Exercise Price |
|
|
Contractual Term |
|
|
Value |
|
Outstanding at
December 31, 2009 |
|
|
1,866 |
|
|
$ |
4.29 |
|
|
|
3.83 |
|
|
$ |
2,062 |
|
Granted |
|
|
216 |
|
|
|
4.29 |
|
|
|
6.80 |
|
|
|
37 |
|
Exercised |
|
|
(309 |
) |
|
|
0.96 |
|
|
|
|
|
|
|
1,081 |
|
Forfeited or expired |
|
|
(56 |
) |
|
|
5.97 |
|
|
|
|
|
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at
December 31, 2010 |
|
|
1,717 |
|
|
$ |
4.83 |
|
|
|
3.78 |
|
|
$ |
1,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested at
December 31, 2010 |
|
|
516 |
|
|
|
5.08 |
|
|
|
5.15 |
|
|
|
250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at
December 31, 2010 |
|
|
1,201 |
|
|
$ |
4.72 |
|
|
|
3.19 |
|
|
$ |
996 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Fiscal 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
(in thousands) |
|
|
|
|
|
Weighted Average |
|
|
Remaining |
|
|
Aggregate Intrinsic |
|
Stock Options |
|
Shares |
|
|
Exercise Price |
|
|
Contractual Term |
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant date fair value of options granted for the years ended December 31,
2010, 2009 and 2008 was $4.29, $3.06 and $7.53, respectively. Cash received from option exercises
for the years ended 2010, 2009 and 2008 was $122,000, $31,000, and $386,000, respectively.
As of December 31, 2010, there was $1.3 million of total unrecognized compensation cost
related to nonvested stock options. That cost is expected to be recognized over a period of 4.67
years.
In May 2010, the Companys Board of Directors and stockholders approved the adoption of the
BioClinica, Inc. 2010 Stock Incentive Plan (the Plan) and authorized the issuance of 1,121,616
shares of the Companys common stock under the Plan and up to 250,000 shares of any options or
restricted stock units awards outstanding under the previous plan at May 12, 2010, the effective
date of the Plan, that are subsequently forfeited or cancelled or otherwise expire or terminate
unexercised, may add to the share reserve. At December 31, 2010, we have 1,149,787 available
shares to be issued from the Plan.
Each option is exercisable into one share of common stock. Options granted pursuant to the
Plan may be qualified incentive stock options, as defined in the Internal Revenue Code, or
nonqualified options. The exercise price of qualified incentive stock options may not be less than
the fair market value of the Companys Common Stock at the date of grant. The term of such stock
options granted under the Plan shall not exceed 10 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.
66
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
The following table summarizes the stock option transactions pursuant to the Plan for the
three years ended December 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
Number of Shares |
|
|
Option Grant Date |
|
(in thousands) |
|
Underlying Options |
|
|
Fair Value |
|
Non-vested at December 31, 2007 |
|
|
228 |
|
|
$ |
5.47 |
|
Granted |
|
|
395 |
|
|
$ |
7.53 |
|
Vested |
|
|
(82 |
) |
|
$ |
3.78 |
|
Non-vested at December 31, 2008 |
|
|
541 |
|
|
$ |
7.23 |
|
Granted |
|
|
298 |
|
|
$ |
3.06 |
|
Vested |
|
|
(277 |
) |
|
$ |
6.13 |
|
Non-vested at December 31, 2009 |
|
|
562 |
|
|
$ |
5.56 |
|
Granted |
|
|
216 |
|
|
$ |
4.29 |
|
Vested |
|
|
(262 |
) |
|
$ |
5.46 |
|
Non-vested at December 31, 2010 |
|
|
516 |
|
|
$ |
5.08 |
|
1.2 million, 1.3 million and 1.2 million options are exercisable at December 31, 2010, 2009
and 2008, respectively, at a weighted average exercise price of $4.72, $3.74 and $3.35,
respectively.
The intrinsic value of stock options exercised for the years ended December 31, 2010, 2009 and
2008, respectively, were $1.1 million, $130,000 and $586,000, respectively.
At December 31, 2010, by range of exercise prices, the number of shares represented by
outstanding options with their weighted average exercise price and weighted average remaining
contractual life, in years, and the number of shares represented by exercisable options with their
weighted average exercise price are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Options Exercisable |
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
Number |
|
|
Weighted Average |
|
|
|
|
Range of Exercise |
|
Number Outstanding |
|
|
Remaining |
|
|
Weighted Average |
|
|
Exercisable(in |
|
|
Remaining |
|
|
Weighted Average |
|
Prices |
|
(in thousands) |
|
|
Contractual Life |
|
|
Exercise Price |
|
|
thousands) |
|
|
Contractual Life |
|
|
Exercise Price |
|
|
$0.66-$0.88 |
|
|
38 |
|
|
0.75 years |
|
$ |
0.77 |
|
|
|
38 |
|
|
0.50 years |
|
$ |
0.77 |
|
$1.00-$1.16 |
|
|
120 |
|
|
0.88 years |
|
$ |
1.10 |
|
|
|
120 |
|
|
0.88 years |
|
$ |
1.10 |
|
$1.28-$2.80 |
|
|
61 |
|
|
2.10 years |
|
$ |
2.80 |
|
|
|
61 |
|
|
2.10 years |
|
$ |
2.80 |
|
$3.04-$5.10 |
|
|
910 |
|
|
4.38 years |
|
$ |
3.88 |
|
|
|
574 |
|
|
3.63 years |
|
$ |
3.97 |
|
$6.97-$8.06 |
|
|
588 |
|
|
3.82 years |
|
$ |
7.54 |
|
|
|
408 |
|
|
3.66 years |
|
$ |
7.50 |
|
|
|
|
$0.63-$8.06 |
|
|
1,717 |
|
|
3.78 years |
|
$ |
4.83 |
|
|
|
1,201 |
|
|
3.19 years |
|
$ |
4.72 |
|
|
|
|
67
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Restricted Stock Units:
The following table summarizes the restricted stock unit transactions pursuant to the Plan for
the three years ended December 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
Weighted Average |
|
|
Restricted Stock |
|
Grant Date Fair |
(in thousands) |
|
Units |
|
Value |
Balance at December 31, 2007 |
|
|
25,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
47,500 |
|
|
$ |
7.33 |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
72,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
100,000 |
|
|
$ |
3.41 |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
172,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
232,500 |
|
|
$ |
4.51 |
|
|
|
|
|
|
|
|
|
|
Issued to Common Stock (1) |
|
|
(60,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled |
|
|
(5,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2010 |
|
|
340,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
48,000 shares of common stock were issued to the employees, 12,000 shares were
withheld for taxes. |
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 vest 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.
On July 8, 2009, we granted to our Board of Directors 60,000 restricted stock units that vest
monthly until May 2010 and the underlying common stock will be issued upon cessation of service.
On February 10, 2010, we granted to our President and CEO 40,000 restricted stock units that
vest quarterly over three years and the underlying common stock will be issued each quarter.
On February 10, 2010, we granted to our executive officers a total of 120,000 restricted stock
units, 40,000 restricted stock units to each executive officer, that vest quarterly over four years
and the underlying common stock will be issued each quarter.
On May 12, 2010, we granted to our Board of Directors 60,000 restricted stock units that vest
monthly until May 2011 and the underlying common stock will be issued upon cessation of service.
On November 17, 2010, we granted to a new Board of Director member 12,500 restricted stock
units that vest monthly until May 2011 and the underlying common stock will be issued, after the
vesting period, and upon cessation of service..
68
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
9. Commitments
The Company has entered into non-cancelable operating leases for office facilities which
expire through November 2018.
Future minimum aggregate rental payments on the non-cancelable portion of the leases are as
follows:
|
|
|
|
|
|
|
Year Ending |
|
(in thousands) |
|
December 31, 2010 |
|
2011 |
|
|
2,613 |
|
2012 |
|
|
2,964 |
|
2013 |
|
|
2,772 |
|
2014 |
|
|
2,550 |
|
2015 |
|
|
2,467 |
|
Thereafter |
|
|
7,172 |
|
|
|
|
|
|
|
$ |
20,538 |
|
|
|
|
|
Rent expense charged to operations for the years ended December 31, 2010, 2009 and 2008 was
$3.6 million, $3.3 million and $2.2 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
Solutions. The Chief Financial Officers agreement expires January 31, 2012 and is renewable on an
annual basis. The President of eClinical Solutions agreement expires September 30, 2011 and is
renewable on an annual basis. The aggregate amount due from January 1, 2011 through the expiration
under these agreements was $919,000.
On May 5, 2010, we entered into an unsecured, committed line of credit with PNC Bank, expiring
May 5, 2012. Under the credit agreement, we have the ability to borrow $7.5 million at interest
rates equal to LIBOR plus 1.75%. In addition, we pay a fee of 0.25% per annum on the loan
commitment regardless of usage. The credit agreement requires our compliance with certain
covenants, including maintaining a minimum stockholders equity of $35 million. As of December 31,
2010, we had no borrowings under this line of credit, and we were compliant with the covenants.
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 $317,000, $283,000 and $235,000
for the years ended December 31, 2010, 2009 and 2008, respectively.
69
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
11. Major Customers
Contracts with one client, Pfizer Inc., which encompassed 22 projects, represented 20% of our
service revenues for the year ended December 31, 2010. No one client represented more than 10% of
our service revenues for the years ended December 31, 2009, or December 31, 2008.
12. Income Taxes
The income tax provision from continuing operations consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
661 |
|
|
$ |
1,040 |
|
|
$ |
2,036 |
|
State and local |
|
|
363 |
|
|
|
356 |
|
|
|
136 |
|
Foreign |
|
|
130 |
|
|
|
25 |
|
|
|
167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,154 |
|
|
|
1,421 |
|
|
$ |
2,339 |
|
|
|
|
|
|
|
|
|
|
|
Deferred: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
325 |
|
|
|
317 |
|
|
|
730 |
|
State and local |
|
|
33 |
|
|
|
(172 |
) |
|
|
42 |
|
Foreign |
|
|
64 |
|
|
|
191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
422 |
|
|
|
336 |
|
|
|
772 |
|
|
|
|
|
|
|
|
|
|
|
Income tax provision from
continuing operations |
|
$ |
1,576 |
|
|
$ |
1,757 |
|
|
$ |
3,111 |
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
Tax provision at statutory rate |
|
|
34.0 |
% |
|
|
34.0 |
% |
|
|
34.0 |
% |
State and local income taxes, net of federal benefit |
|
|
6.3 |
% |
|
|
4.1 |
% |
|
|
2.8 |
% |
Permanent differences |
|
|
1.0 |
% |
|
|
0.6 |
% |
|
|
0.4 |
% |
Foreign rate difference |
|
|
(0.9 |
)% |
|
|
(0.9 |
)% |
|
|
(0.5 |
)% |
Federal credit for increasing research activities |
|
|
(5.4 |
)% |
|
|
|
|
|
|
|
|
Other |
|
|
1.4 |
% |
|
|
(0.5 |
)% |
|
|
(1.9 |
)% |
|
|
|
|
|
|
|
|
|
|
Effective income tax rate from continuing
operations |
|
|
36.4 |
% |
|
|
37.3 |
% |
|
|
34.8 |
% |
|
|
|
|
|
|
|
|
|
|
70
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
The Companys domestic and foreign income before income tax from continuing operations is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Domestic income before income tax |
|
$ |
3,722 |
|
|
$ |
4,080 |
|
|
$ |
8,290 |
|
Foreign income before income tax. |
|
|
607 |
|
|
|
636 |
|
|
|
612 |
|
|
|
|
|
|
|
|
|
|
|
Total income
before income tax from continuing operations |
|
$ |
4,329 |
|
|
$ |
4,716 |
|
|
$ |
8,902 |
|
|
|
|
|
|
|
|
|
|
|
The components of net deferred tax assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Accrued expenses |
|
$ |
83 |
|
|
$ |
104 |
|
Allowance for doubtful accounts |
|
|
6 |
|
|
|
4 |
|
Deferred revenue |
|
|
3,220 |
|
|
|
2,952 |
|
Net operating loss carryforwards |
|
|
130 |
|
|
|
317 |
|
Restricted stock |
|
|
415 |
|
|
|
279 |
|
Stock options |
|
|
574 |
|
|
|
429 |
|
Amortization of acquisition costs |
|
|
665 |
|
|
|
|
|
State tax depreciation |
|
|
284 |
|
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
5,377 |
|
|
|
4,085 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Excess of tax over book depreciation |
|
|
(2,511 |
) |
|
|
(1,126 |
) |
Amortization of acquisition costs |
|
|
(543 |
) |
|
|
(358 |
) |
Prepaid expenses |
|
|
(399 |
) |
|
|
(398 |
) |
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
|
(3,453 |
) |
|
|
(1,882 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance |
|
|
(16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
1,908 |
|
|
$ |
2,203 |
|
|
|
|
|
|
|
|
The Company has foreign NOL carryforwards from its French subsidiary of $343,000 as of
December 31, 2010, $575,000 as of December 31, 2009 and $717,000 as of December 31, 2008. The NOL
carryforwards from the Companys French subsidiary does not have an expiration date and can be
carried forward indefinitely. 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. The Company recorded a $16,000 valuation allowance related to separate
company NOL carryforwards not expected to be realized. In the event that the Company was to
determine that, in the future, they
71
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
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. 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 $46,000 and $44,000 for the years ended December 31, 2010 and 2009,
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 $2.2 million of undistributed earnings from its non-U.S. operations as of December
31, 2010 because such earnings are intended to be reinvested indefinitely outside of the United
States.
The Company applies FASB ASC 740 Income Taxes FASB ASC 740 which prescribes a recognition
threshold that a tax position is required to meet before being recognized in the financial
statements.
A reconciliation of the beginning and ending balances of the total amounts of gross
unrecognized tax benefits is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Balance at the beginning of the period |
|
|
|
|
|
|
|
|
|
|
|
|
Additions
based on tax positions related to the current year |
|
$ |
57 |
|
|
|
|
|
|
|
|
|
Additions for tax positions of prior years |
|
|
|
|
|
|
|
|
|
|
|
|
Reductions for tax positions of prior years |
|
|
|
|
|
|
|
|
|
|
|
|
Settlements |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year |
|
$ |
57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total amount of net unrecognized tax benefits that, if recognized, would impact the
Companys effective tax rate were $57 and $0 at December 31, 2010 and 2009, respectively. The
Company accrues interest and penalties related to unrecognized tax benefits in income tax expense
in the Consolidated Statements of Income. During the years ended December 31, 2010 and 2009, the
Company recognized a benefit of $1 and $0 in interest and penalties. The Company had $1 and $0 for
the payment of interest and penalties accrued at December 31, 2010 and 2009, respectively.
We file our tax returns as prescribed by the tax laws of the jurisdictions in which we
operate. Our federal tax returns for years 2009 through 2010 are subject to examination. 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.
72
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
13. Foreign Operations
The Companys service revenue by customer location is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
2008 |
|
United States |
|
$ |
49,204 |
|
|
$ |
41,404 |
|
|
$ |
39,933 |
|
United Kingdom |
|
|
3,390 |
|
|
|
2,732 |
|
|
|
4,258 |
|
Continental Europe |
|
|
8,219 |
|
|
|
10,892 |
|
|
|
10,360 |
|
Canada |
|
|
519 |
|
|
|
817 |
|
|
|
672 |
|
Asia/Pacific |
|
|
1,297 |
|
|
|
1,399 |
|
|
|
868 |
|
Other |
|
|
85 |
|
|
|
149 |
|
|
|
90 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
62,714 |
|
|
$ |
57,393 |
|
|
$ |
56,181 |
|
|
|
|
|
|
|
|
|
|
|
The Company maintains principal offices in Newtown and Audubon, Pennsylvania, Leiden, the
Netherlands and Lyon, France. Net fixed assets located in Newtown, Pennsylvania were $2.8 million
and $2.7 million at December 31, 2010 and 2009, respectively. Net fixed assets located in King of
Prussia, Pennsylvania were $3.6 million and $1.8 million at December 31, 2010 and 2009,
respectively. Net fixed assets located in Leiden, the Netherlands, were $875,000 and $1.2 million
at December 31, 2010 and 2009, respectively. Net fixed assets located in Lyon, France were
$722,000 and $714,000 at December 31, 2010 and 2009, respectively.
14. Related Party Transactions
At December 31, 2010, Covance, Inc. owned 15.1% 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 $666,000, $446,000 and $1.7 million for the years ended December 31,
2010, 2009 and 2008, respectively. At December 31, 2010 and 2009, the amounts due from Covance,
Inc. were $157,000 and $82,000, respectively as reported in accounts receivable.
15. Subsequent Event
In January 2011, due to the launch of certain technology that further enhances the quality of
the Companys services and efficiencies gained by better utilizing resources across the Companys
U.S. and European operations, the Company decided to eliminate certain duplicate functions and
expects to take a total restructuring charge, primarily comprised of severance and facility
restructuring costs, of $1.6 million. Approximately half of this restructuring charge is expected
to be incurred in the first quarter of 2011 and the other half to be incurred during the second and
third quarters of 2011.
73
Quarterly Financial Results
The following is a summary of unaudited quarterly results of operations for the years ended
December 31, 2010 and 2009. This quarterly financial data should be read in conjunction with the
audited consolidated financial statements included herein. We have revised certain of the
quarterly information below to appropriately reflect the following adjustments in the correct
interim periods. Such adjustments had no impact to the reported annual results. We identified and
corrected clerical billing errors in the quarter ending June 30, 2010 that overstated service
revenue and income from operations by $155,000 ($94,000 net of tax) and understated the quarter
ending September 30, 2010 service revenue and income from operations by $155,000 ($94,000 net of
tax). We determined that these adjustments were not material to our consolidated financial
statements for any of the quarterly periods affected; therefore, no revisions have been made to the
fiscal 2010 quarterly financial statements included in our previously filed Form 10-Qs for this
matter.
Quarter Ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, |
|
|
Sept. 30, |
|
|
June 30, |
|
|
Mar. 31, |
|
|
Dec. 31, |
|
|
Sept. 30, |
|
|
June 30, |
|
|
Mar. 31, |
|
(in thousands except per share data) |
|
2010 |
|
|
2010 |
|
|
2010 |
|
|
2010 |
|
|
2009 |
|
|
2009 |
|
|
2009 |
|
|
2009 |
|
Service revenues |
|
|
16,466 |
|
|
|
15,969 |
|
|
|
15,533 |
|
|
|
14,746 |
|
|
|
14,851 |
|
|
|
14,146 |
|
|
|
13,921 |
|
|
|
14,475 |
|
Reimbursement revenues |
|
|
3,061 |
|
|
|
2,352 |
|
|
|
3,703 |
|
|
|
3,358 |
|
|
|
5,366 |
|
|
|
4,227 |
|
|
|
3,142 |
|
|
|
2,595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
19,527 |
|
|
|
18,321 |
|
|
|
19,236 |
|
|
|
18,104 |
|
|
|
20,217 |
|
|
|
18,373 |
|
|
|
17,063 |
|
|
|
17,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
10,450 |
|
|
|
10,212 |
|
|
|
9,946 |
|
|
|
8,951 |
|
|
|
9,024 |
|
|
|
8,937 |
|
|
|
8,608 |
|
|
|
9,061 |
|
Cost of reimbursement revenues |
|
|
3,061 |
|
|
|
2,352 |
|
|
|
3,703 |
|
|
|
3,358 |
|
|
|
5,366 |
|
|
|
4,227 |
|
|
|
3,142 |
|
|
|
2,595 |
|
Sales and marketing expenses |
|
|
2,139 |
|
|
|
2,090 |
|
|
|
2,565 |
|
|
|
2,210 |
|
|
|
2,113 |
|
|
|
1,617 |
|
|
|
2,166 |
|
|
|
2,156 |
|
General and administrative expenses |
|
|
2,389 |
|
|
|
2,069 |
|
|
|
1,916 |
|
|
|
2,072 |
|
|
|
1,871 |
|
|
|
1,759 |
|
|
|
1,867 |
|
|
|
1,917 |
|
Amortization of intangible assets
related to acquisitions |
|
|
165 |
|
|
|
194 |
|
|
|
138 |
|
|
|
141 |
|
|
|
145 |
|
|
|
112 |
|
|
|
112 |
|
|
|
119 |
|
Restructuring charges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
466 |
|
|
|
|
|
Mergers and acquisitions expense |
|
|
114 |
|
|
|
119 |
|
|
|
311 |
|
|
|
205 |
|
|
|
94 |
|
|
|
560 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
18,318 |
|
|
|
17,036 |
|
|
|
18,579 |
|
|
|
16,937 |
|
|
|
18,613 |
|
|
|
17,212 |
|
|
|
16,361 |
|
|
|
15,848 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
1,209 |
|
|
|
1,285 |
|
|
|
657 |
|
|
|
1,167 |
|
|
|
1,604 |
|
|
|
1,161 |
|
|
|
702 |
|
|
|
1,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
5 |
|
|
|
10 |
|
|
|
2 |
|
|
|
6 |
|
|
|
4 |
|
|
|
5 |
|
|
|
10 |
|
|
|
22 |
|
Interest expense |
|
|
(5 |
) |
|
|
(0 |
) |
|
|
(4 |
) |
|
|
(3 |
) |
|
|
(7 |
) |
|
|
(1 |
) |
|
|
(3 |
) |
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before tax |
|
|
1,209 |
|
|
|
1,295 |
|
|
|
655 |
|
|
|
1,170 |
|
|
|
1,601 |
|
|
|
1,165 |
|
|
|
709 |
|
|
|
1,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
(378 |
) |
|
|
(487 |
) |
|
|
(252 |
) |
|
|
(459 |
) |
|
|
(658 |
) |
|
|
(463 |
) |
|
|
(180 |
) |
|
|
(456 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
831 |
|
|
|
808 |
|
|
|
403 |
|
|
|
711 |
|
|
|
943 |
|
|
|
702 |
|
|
|
529 |
|
|
|
786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income |
|
|
0.05 |
|
|
|
0.05 |
|
|
|
0.03 |
|
|
|
0.05 |
|
|
|
0.07 |
|
|
|
0.05 |
|
|
|
0.04 |
|
|
|
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income |
|
|
0.05 |
|
|
|
0.05 |
|
|
|
0.03 |
|
|
|
0.05 |
|
|
|
0.06 |
|
|
|
0.05 |
|
|
|
0.04 |
|
|
|
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to
calculate earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
15,246 |
|
|
|
15,174 |
|
|
|
15,115 |
|
|
|
14,545 |
|
|
|
14,358 |
|
|
|
14,367 |
|
|
|
14,356 |
|
|
|
14,341 |
|
Diluted |
|
|
15,981 |
|
|
|
15,796 |
|
|
|
16,065 |
|
|
|
15,382 |
|
|
|
15,158 |
|
|
|
15,146 |
|
|
|
15,118 |
|
|
|
15,085 |
|
74
|
|
|
Item 9. |
|
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. |
None.
|
|
|
Item 9A. |
|
Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures. 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, 2010, 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, 2010. 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.
75
Our management assessed the effectiveness of the companys internal control over financial
reporting as of December 31, 2010. 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, 2010, our
internal control over financial reporting was effective.
This annual report does not include an attestation report of our independent registered public
accounting firm regarding internal control over financial reporting. Managements report was not
subject to the attestation by our independent registered public accounting firm because smaller
reporting companies are exempt from this requirement.
Changes in internal control over financial reporting There was no change in our internal controls
over financial reporting that occurred during the fourth quarter of 2010 that has materially
affected, or is reasonably likely to materially affect, our internal controls over financial
reporting.
|
|
|
Item 9B. |
|
Other Information. |
None.
76
PART III
|
|
|
Item 10. |
|
Directors, Executive Officers and Corporate Governance. |
The information required by this item is set forth in our definitive proxy statement for the
2011 Annual Meeting of Stockholders and 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 information required by this item is set forth in our definitive proxy statement for the
2011 Annual Meeting of Stockholders and is incorporated herein by reference to such proxy
statement.
|
|
|
Item 12. |
|
Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters. |
The information required by this item is set forth in our definitive proxy statement for the
2011 Annual Meeting of Stockholders and is incorporated herein by reference to such proxy
statement.
|
|
|
Item 13. |
|
Certain Relationships and Related Transactions, and Director Independence. |
The information required by this item is set forth in our definitive proxy statement for the
2011 Annual Meeting of Stockholders and is incorporated herein by reference to such proxy
statement.
|
|
|
Item 14. |
|
Principal Accounting Fees and Services. |
The information required by this item is set forth in our definitive proxy statement for the
2011 Annual Meeting of Stockholders and is incorporated herein by reference to such proxy
statement.
|
|
|
Item 15. |
|
Exhibits, Financial Statement Schedules. |
(a)(1) Financial Statements. The financial statements filed as part of this report are listed
on the Index to the Consolidated Financial Statements.
(a)(2) Financial Statement Schedules. Schedules are omitted because they are not applicable
or the required information is shown in the consolidated financial statements or notes thereto.
(a)(3) Exhibits. Reference is made to the Exhibit Index. The exhibits are included, or
incorporated by reference, in the Annual Report on Form 10-K and are numbered in accordance with
Item 601 of Regulation S-K.
77
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 28th day of February, 2011.
|
|
|
|
|
|
BIOCLINICA, INC.
|
|
|
By: |
/s/ Mark L. Weinstein
|
|
|
|
Mark L. Weinstein, President and Chief Executive Officer |
|
78
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)
|
|
February 28, 2011 |
|
|
|
|
|
/s/ Ted I. Kaminer
Ted I. Kaminer
|
|
Executive Vice President of
Finance and Administration and
Chief Financial Officer
(principal financial and accounting officer)
|
|
February 28, 2011 |
|
|
|
|
|
/s/ Jeffrey H. Berg, Ph.D.
Jeffrey H. Berg, Ph.D.
|
|
Director
|
|
February 28, 2011 |
|
|
|
|
|
/s/ Richard F. Cimino
Richard F. Cimino
|
|
Director
|
|
February 28, 2011 |
|
|
|
|
|
/s/ E. Martin Davidoff, CPA, Esq.
E. Martin Davidoff, CPA, Esq.
|
|
Director
|
|
February 28, 2011 |
|
|
|
|
|
/s/ James Lovett, Esq.
James Lovett, Esq.
|
|
Director
|
|
February 28, 2011 |
|
|
|
|
|
/s/ David E. Nowicki, D.M.D.
David E. Nowicki, D.M.D.
|
|
Chairman of the Board and Director
|
|
February 28, 2011 |
|
|
|
|
|
/s/ Wallace P. Parker
Wallace P. Parker
|
|
Director
|
|
February 28, 2011 |
|
|
|
|
|
/s/ Adeoye Y. Olukotun
Adeoye Y. Olukotun, M.D., M.P.H.,
F.A.C.C., FAHA
|
|
Director
|
|
February 28, 2011 |
|
|
|
|
|
/s/ James A. Taylor, Ph.D.
James A. Taylor, Ph.D.
|
|
Director
|
|
February 28, 2011 |
79
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. |
|
|
|
4.4
|
|
Registration Rights Agreement, dated March 25, 2010, between
BioClinica, Inc. and TranSenda International LLC and each common
member of TranSenda International, LLC. Incorporated by reference
to Exhibit 4.1 of our Current Report on Form 8-K, dated March 26,
2010. |
|
|
|
4.5
|
|
Committed Line of Credit Note dated May 5, 2010, by and between
BioClinica, Inc. and Oxford Bio-Imaging Research, Inc. and PNC
Bank, National Association. Incorporated by reference to Exhibit
4.1 of our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2010. |
|
|
|
10.1*
|
|
2010 Stock Incentive Plan, adopted by the stockholders of
BioClinica, Inc. on May 10, 2010. Incorporated by reference to
Exhibit 10.1 of our Quarterly Report on Form 10-Q for the quarter
ended June 30, 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. |
80
|
|
|
Exhibit |
|
|
No. |
|
Description of Exhibit |
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. |
|
|
|
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 10-K 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.
Incorporated by reference to Exhibit 10.8 of our Annual Report on
Form 10-K for fiscal year ended December 31, 2009. |
|
|
|
10.9*
|
|
Form of Amended and Restated Executive Retention Agreement by and
between BioClinica, Inc. and certain executive officers.
Incorporated by reference to Exhibit 10.9 of our Annual Report on
Form 10-K for fiscal year ended December 31, 2009. |
|
|
|
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. |
|
|
|
10.11
|
|
Loan Agreement dated May 5, 2010, by and between BioClinica, Inc.
and Oxford Bio-Imaging Research, Inc. and PNC Bank, National
Association. Incorporated by reference to Exhibit 10.1 of our
Quarterly Report on Form 10-Q for the quarter ended March 31,
2010. |
|
|
|
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 15(b) 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. |
81