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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K
FOR
ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR
15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
[X]
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE
ACT
OF 1934
For the
fiscal year ended December 31, 2004
OR
[_]
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE
ACT OF 1934 For the transition period from _____________to
_____________
Commission
file number: 0-30318
VENTIV
HEALTH, INC.
(Exact
Name of Registrant as Specified in its Charter)
|
Delaware
(State
or Other Jurisdiction No. of Incorporation or
Organization) |
52-2181734
(I.R.S.
Employer Identification No.) |
200
Cottontail Lane Vantage Court North; Somerset, New Jersey 08873
(Address
of Principal Executive Offices) (Zip Code)
Registrant’s
telephone number, including area code: (800) 416-0555
Securities
registered pursuant to Section 12(g) of the Act:
Securities
registered pursuant to Section 12(g) of the Act: Common
Stock
(Title
of Class)
Indicate
by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes [X] No [_]
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant's knowledge, in definitive proxy or information statement
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. [X]
Indicate
by check mark whether the registrant is an accelerated filer (as defined in
Exchange Act Rule 12b-2). Yes [X] No [ ]
Based on
the closing sale price on the Nasdaq National Market as of the last business day
of the registrant’s most recently completed second fiscal quarter, the aggregate
market value of the voting stock held by nonaffiliates of the registrant was
approximately $287,600,993. For the purposes of this calculation, shares owned
by officers, directors and 10% shareholders known to the registrant have been
deemed to be owned by affiliates. This determination of affiliate status is not
a determination for other purposes.
As of
February 28, 2005, there were 26,129,138 outstanding shares of the registrant's
common stock.
DOCUMENTS
INCORPORATED BY REFERENCE
Certain
portions of the Registrant's Definitive Proxy Statement to be filed with the
Commission for use in connection with the 2005 Annual Meeting of Stockholders
are incorporated by reference into Part III of this Form 10-K.
TABLE
OF CONTENTS
|
Item |
Description |
Page |
|
PART
I |
|
1 |
Business |
2 |
|
2 |
Properties |
9 |
|
3 |
Legal
Proceedings |
9 |
|
4 |
Submission
of Matters to a Vote of Securities Holders |
9 |
| |
|
PART
II |
|
5 |
Market
for the Registrant’s Common Stock and Related Stockholder
Matters |
10 |
|
6 |
Selected
Financial Data |
11 |
|
7 |
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations |
12 |
|
7A |
Quantitative
and Qualitative Disclosures About Market Risk |
27 |
|
8 |
Financial
Statements and Supplementary Data |
28 |
|
9 |
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures |
52 |
|
9A |
Controls
and Procedures |
52 |
|
9B |
Other
Information |
52 |
| |
|
PART
III |
|
10 |
Directors
and Executive Officers of the Registrant |
53 |
|
11 |
Executive
Compensation |
53 |
|
12 |
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters |
53 |
|
13 |
Certain
Relationships and Related Transactions |
53 |
|
14 |
Principal
Accounting Fees and Services |
53 |
| |
|
PART
IV |
|
15 |
Exhibits,
Financial Statement Schedules, and Reports on Form 8-K |
54 |
CAUTIONARY
STATEMENT
All
statements included or incorporated by reference in this Annual Report on Form
10-K (the “Report”), other than statements or characterizations of historical
fact, are forward-looking statements. Examples of forward-looking statements
include, but are not limited to, statements concerning future revenues,
operating expenses, capital requirements, growth rates, cash flows, operational
performance, sources and uses of funds and acquisitions, our accounting
estimates, assumptions and judgments, the competitive nature of and anticipated
growth in our markets, the need for additional capital, changes in the
pharmaceutical and life sciences industries, uncertainty related to the
continued growth of outsourcing in those industries, changes in the competitive
climate in which we operate, our ability to maintain large client contracts or
enter into new contracts, uncertainties related to future incentive payments and
earnings generated through revenue sharing arrangements and the emergence of
future opportunities and other factors. These forward-looking statements are
based on our current expectations, estimates and projections about our industry,
management’s beliefs, and certain assumptions made by us. Forward-looking
statements can often be identified by words such as “anticipates,” “expects,”
“intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,”
“should,” “would,” “potential,” “continue,” “assuming,” similar expressions and
variations or negatives of these words. In addition, any statements that refer
to expectations, projections or other characterizations of future events or
circumstances, including any underlying assumptions, are forward-looking
statements. These statements are not guarantees of future performance and are
subject to risks, uncertainties and assumptions that are difficult to predict.
Therefore, our actual results could differ materially and adversely from those
expressed in any forward-looking statements as a result of various factors, some
of which are listed under the section “Risks Related to Our Business” in Item 7
of this Report.
The
forward-looking statements contained in this Report speak only as of the date
hereof and are based upon information available to us at this time. Such
information is subject to change, and we will not necessarily inform you of such
changes. Except as required by applicable laws or regulations, we undertake no
obligation to revise or update any forward-looking statements for any
reason.
Item
1.
Business.
Overview
Ventiv
Health Inc. and subsidiaries (collectively “Ventiv”) is a diversified
pharmaceutical services company spanning late-stage clinical through
commercialization services, with leading market positions in outsourced sales
teams, clinical staffing, compliance, patient assistance and analytical
planning. We provide these services to the world's largest pharmaceutical
organizations as well as to emerging and specialty pharmaceutical and life
sciences organizations. Over almost three decades, our businesses have provided
excellence in customized solutions and helped our clients achieve their business
objectives.
We make
available on our website, located at www.ventiv.com, the following filings as
soon as reasonably practicable after they are electronically filed with or
furnished to the United States Securities and Exchange Commission (“SEC”): our
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and any amendments to those reports filed or furnished pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of 1934. All such filings
are available free of charge. Information found on our website should not be
considered part of this annual report on Form 10-K.
Services
We offer
a broad range of integrated and stand alone services, in a context of
consultative partnership that identifies strategic goals and applies targeted,
tailored solutions. These programs include:
| · |
sales
and marketing teams; |
| · |
planning
and analytics; |
| · |
sample
accountability and patient assistance; |
| · |
marketing
support services; |
| · |
professional
development and training; |
| · |
data
collection and management; and |
Our
organization and service offerings reflect the changing needs of our clients as
their new products move through late-stage development and regulatory approval
process and through commercialization. As a potential drug or device advances
through the clinical trial process, a number of key professionals are needed
within the clients’ clinical organization, including statisticians, data
managers, statistical programmers and clinical research associates, to support
the creation of the New Drug Applications (“NDA”). As the drug advances beyond
clinical trials towards commercialization, our clients must plan and design a
focused launch campaign to maximize product profitability upon regulatory
approval of their product, decide upon the optimal promotional approach, and
upon launch, support the product(s) with the appropriate product detailing and
other promotional resources. In addition, there are a number of regulatory and
compliance requirements that clients must adhere to. All along this lifecycle,
Ventiv offers a range of services that support client needs, from late-stage
clinical, through marketing and sales, and into compliance.
Ventiv's
Business Units
We
currently serve our clients primarily through three business units, which
correspond to our reporting segments for 2004:
| · |
Ventiv
Commercial Services,
formerly known as Ventiv Pharma Services and previous to that as Ventiv
Health Sales and Marketing, which includes our outsourced sales and
marketing teams, compliance and patient assistance businesses, marketing
support services, professional development and training, and recruitment
of sales representatives in the commercial services
area; |
| · |
Ventiv
Analytic Services,
comprising Health Products Research ("HPR"), which provides planning and
analytics services; and |
|
· |
Ventiv
Clinical Services,
which consists of the newly acquired businesses of Smith Hanley
Associates, Smith Hanley Consulting Group and MedFocus (collectively
“Smith Hanley”) and HHI Clinical & Statistical Research Services
(“HHI”). This segment provides services related to recruitment, clinical
staffing, and data collection and
management. |
Our clients may
choose either to work with us across our full spectrum of services or narrowly
focus their service needs within one of these units. Given the nature of the
services provided by each business unit in relation to marketing needs
throughout a product's life cycle, ample opportunities exist for cross-selling
to current clients. Many of our larger clients utilize the services of all three
units.
Our
strategic goal is to provide the pharmaceutical and life sciences industries
with value-added clinical, marketing, sales and compliance services that will
enable our clients to achieve accelerated development and superior product sales
through higher market penetration. Our business units possess significant
combined experience, as each has developed and conducted successful clinical
and/or commercialization programs for hundreds of individual pharmaceutical and
life science products. Our expertise spans most therapeutic categories,
including the significant markets of cardiology, anti-infectives, oncology,
gastroenterology, respiratory, allergy, dermatology, and neurology. Our core
competencies and track record of proven success enable us to establish strong
relationships with our clients' senior personnel, which greatly contributes to
client retention.
During
2004 we modified our segment reporting to take into account the integration of
operations from our acquisition transactions. Ventiv Commercial Services,
formerly known as Ventiv Pharma Services and prior to that as Ventiv Health
Sales and Marketing, includes the compliance and patient assistance operations
we acquired during 2004 in the Franklin transaction described below. Ventiv
Analytic Services continues to comprise HPR’s planning and analytics services
business. Ventiv Clinical Services includes our newly acquired Smith Hanley and
HHI businesses. See Part II - Item 8 - Notes to Consolidated Financial
Statements - Note 18 Segment Information , for a further description.
The
following is a detailed description of our individual business
units:
Ventiv
Commercial Services
Ventiv
Commercial Services encompasses three offerings:
Ventiv
Pharma Teams
The
Ventiv Pharma Teams group within Ventiv Commercial Services is organized to
plan, implement and execute outsourced product commercialization programs for
prescription pharmaceutical and other life sciences products. Ventiv Commercial
Services maintains and operates systems, facilities, and support services
necessary to recruit, train and deploy a customized, full-service, targeted
sales force. Currently, Ventiv Pharma Teams operates one of the largest
pharmaceutical outsourced sales organizations in the U.S., with approximately
2,500 sales representatives as of December 31, 2004.
Life
sciences companies, particularly pharmaceutical manufacturers, have
traditionally relied upon product detailing as the primary means of influencing
prescription writing patterns and promoting their products. Product detailing
consists of a one-on-one meeting in a physician's office where a sales
representative reviews the medical profile of a product's Food and Drug
Administration (“FDA”) approved indications. Information provided by the sales
representative includes the product's role in treatment, efficacy, potential
side-effects, dosage, danger of contra-indications with other drugs, cost and
any other appropriate information. In addition to engaging in an educational
dialogue with the medical professional, the sales representative will provide
free product samples as a supplement to the sales effort. This affords the
prescription writer and his or her patients first-hand exposure to the medical
product and creates a sense of familiarity and comfort with the product. In
order to engage in an effective dialogue, the salesperson must be well educated
and highly trained. Recruiting qualified personnel and providing client and
product specific training are both core competencies of Ventiv Commercial
Services.
Providing
clients with high quality sales people requires effective recruiting and
training. To accomplish a coordinated recruiting effort, we maintain a national
recruitment office that locates and hires potential sales representatives. Our
in-house human resources team adheres to selective hiring criteria and conducts
detailed evaluations to ensure high quality of representation for our clients.
Ventiv Commercial Services’ recruiters maintain a fully automated database of
qualified candidates for immediate hiring opportunities, and our website home
page offers an online application for employment. We offer these recruitment
services to clients as part of an integrated sales force recruitment, training
and management program, or on a stand alone basis. Ventiv Pharma Teams hires a
mix of full-time and flex-time representatives in order to accommodate the
detailing level required by clients and maximize cost
efficiency.
We also
emphasize the training of our personnel, and believe we have made significant
investments in this area. Ventiv Commercial Services' Professional Development
Group has one of the largest dedicated training facilities of its type in the
United States. Our goal is to ensure that sales representatives are
knowledgeable and operate professionally, effectively, and efficiently.
Topics
such as sample accountability, negotiation tactics, personal writing skills,
integrity selling, time and territory management, team productivity, and
pharma-manager leadership are covered extensively in order to prepare the
representatives for their contact with medical professionals. Ventiv Commercial
Services' trainers are top professionals in their field and rely upon
proprietary information regarding physician prescribing behavior and industry
best practices. As the trainees are from both Ventiv Commercial Services' sales
force and our clients' sales forces, the training and development services are
essential to maintaining and building our relationships with the pharmaceutical
companies. These strengths are widely recognized as differentiating factors,
which distinguish Ventiv Commercial Services from its competitors and benefit
the overall outsourced sales effort. Ventiv Commercial Services also offers
these training services to clients as part of an integrated package or on a
stand alone basis.
We are
committed to providing our clients with customized cost-effective sales support.
This is reflected in the variety of options clients have to choose from,
including the type of sales force, the specialties of the sales force (oncology,
cardiology, etc.), the methodology employed to target decision makers in the
medical community and the type of analysis to be conducted based on the
information the sales force collects. We work closely with our clients in all
aspects of our service offering to ensure maximum impact of the product's
promotional effort.
Consistent
with standard practices in the pharmaceutical industry, Ventiv Commercial
Services collects and analyzes sales force level data necessary to make
marketing resource allocation decisions. Sales representatives are equipped with
an industry-leading palm-top and laptop sales force automation system developed
for Ventiv Commercial Services. This system enables our sales representatives to
rapidly collect sales call and physician profiling information while in the
field, which is compiled daily in a central data storage server. Our information
processing system allows sales management teams to analyze data regularly,
compare the results with targeted initiatives and historical data, and make
necessary adjustments to the sales strategy. Ventiv Commercial Services also
offers this sales force automation system on a stand alone basis to
clients.
Franklin
During
2004, we acquired the businesses of Franklin Group, Inc. and Lincoln Ltd., Inc.
(together, “Franklin”). Franklin specializes primarily in conducting patient
assistance programs and pharmaceutical compliance services.
Franklin
expands Ventiv’s portfolio by offering Patient Assistance Programs and
Reimbursement Counseling. As one of the industry pioneers in Patient Assistance
Programs (“PAPs”), Franklin has firmly established a leadership position in
providing reliable and innovative programs in patient assistance, institutional
PAPs, reimbursement counseling, web-based programs, missions programs and
proactive fulfillment.
Franklin
also provides to clients and to internal Ventiv Pharma Teams independent
oversight of Prescription Drug Marketing Act (“PDMA”) and Office of Inspector
General compliance. Franklin’s expertise in PDMA compliance issues is nationally
recognized and Franklin further strengthens that position by serving as a
liaison for the pharmaceutical industry and consultant to the FDA and enjoying
an ongoing working relationship with the Department of Justice. In addition,
Franklin provides a number of processes, systems and services to help clients
comply with federal and state regulations specific to sample accountability,
including:
• PDMA
Consultative Services - Franklin can perform a “Whole Systems” assessment of a
client’s sample accountability system, processes, documents and third party
vendors, and then provide recommendations for any necessary corrective action.
• Sample
Accountability Services - Franklin offers an auditing field force of medical
professionals with a pharmaceutical orientation. This experienced group
understands the difference in packaging configurations, and is fully trained in
PDMA compliance to provide accurate physical inventories.
• PDMA
Compliance Software Solutions - Franklin licenses software solutions that define
significant loss and reconciliation thresholds; allows for the on-line or CD
administration of PDMA and other compliance based training and certification;
and provides a state-of-the-art “proactive” sample accountability database
management security solution that detects sample diversion or other aberrant
behavior through established thresholds.
Promotech
Ventiv
Commercial Services addresses clients’ product life-cycle marketing needs with
non-personal promotional programs through its Promotech Research Associates
(“Promotech”) division. Promotech provides assembly, mailing, fulfillment,
pharmacy, teleservices and eServices from its newly expanded Colorado facility
with over 62,000 square feet that includes an environmentally controlled, FDA
and Drug Enforcement Agency (“DEA”) Certified and PDMA compliant warehouse,
office space and a 64-station call center. Clients rely on us for sample and
literature shipments to sales representatives; physicians and
patients/consumers; field force sample reconciliation; audit and compliance
management; comprehensive fulfillment including tradeshows, physician requests,
and trade advertising; and fulfillment of prescription products as dictated by
patient assistant programs. By utilizing its core marketing and sales resources
(fulfillment, teleservices, direct mail, and incentive programs), Promotech is
able to offer a combination of customized solutions to meet a client’s objective
when a single service will not suffice. One such seamless client offering would
be a coordinated sample delivery with sales calls on physicians as well as
rebate program administration.
Ventiv
Analytic Services
Ventiv
Analytic Services includes HPR, a leader in the development and implementation
of advanced data analysis and research technologies to support client decision
making within pharmaceutical and biotechnology companies. HPR combines leading
edge technology with advanced statistical techniques and empirical research to
deliver strategic and tactical solutions that help pharmaceutical executives
maximize their return on investment (“ROI”) for promotional resources. Clients
rely heavily on HPR’s diversified staff of professionals with experience in
pharmaceutical sales and marketing, quantitative sciences and customer support
to deliver solutions that are grounded in industry expertise and coupled with
technical sophistication.
HPR’s
complete range of services includes:
| · |
Market
Segmentation:
HPR’s segmentation solution suite is a critical first step designed to
enhance the accuracy of the promotion response analytics and optimization
processes. HPR conducts segmentation analyses across a broad array of
industry customers using both proprietary and secondary data sources. This
analysis enables the construction of a concise view of the multiple
variables driving the marketplace. |
| · |
Promotion
Analytics:
By developing a relationship between promotion activity and effect in the
marketplace, HPR offers a number of analyses to help clients assess ROI
across all promotion channels and strategies. MarketVantage, a proprietary
analysis tool, gives clients the unique ability to view the performance of
various promotional activity for their brands - and also for competing
brands. HPR’s family of Promotion Response Models (PROMSM)
measure response to different promotional channels, including detailing,
sampling, medical education and direct-to-consumer communications. Through
a series of offerings with their Direct to Consumer ROI Modeling, HPR has
emerged as the leader in Direct to Consumer ROI analysis in the
pharmaceutical industry. In addition, HPR has developed a significant body
of work in empirically based forecasting and independent forecast
development. Recently launched PC-based simulators that allow clients to
produce their own forecasts now supplement these
offerings. |
| · |
Market
Research:
HPR utilizes a wide range of tools to conduct primary and secondary
research, syndicated studies, market tracking and custom research audits.
The HPR team has proven expertise in developing proprietary, customized
market research approaches that measure attitudes and behaviors of diverse
audiences. Core to HPR’s syndicated service offering is the Metropolitan
Area Promotional Audit (“MPA”) — a service that studies thousands of
physicians and tracks pharmaceutical promotional activity city by city.
This intelligence, previously available only on a national basis,
addresses the differential share of voice metrics, impact and
effectiveness of rep-driven promotion efforts. Rapid Recall™ is a
customized service that enables clients to capture independent customer
feedback within a 72-hour window post contact. With this tool, HPR
provides its clients with feedback on their performance compared to their
competitors in such key areas as message delivery, message impact, and
areas for change. HPR has also emerged as a leader in the identification
of local peer influence networks. HPR’s Influence Mapping research is able
to identify the informal network used by physicians within specific
therapeutic areas to determine which local physicians are informally
influencing prescribing behavior of other key physicians at the territory
level. HPR has worked with clients to conduct these efforts on close to
100 brands. |
| · |
Strategic
Planning:
HPR’s strategic consulting service responds to a broad series of questions
clients must address for successful brand management. HPR works with
clients to develop resource solutions that optimize ROI for the future
market environment. HPR’s resource allocation models determine the
resource needs for single-product and portfolio promotion activity across
the various promotion channels, allowing clients to determine optimal
investment levels for promotion and expected portfolio return. HPR’s
UniBrandSM
model develops the optimal sales and marketing solution for a single
brand. Known as RAMSM,
HPR’s portfolio model is used by clients to determine the optimal sales
force size and structure, optimum number of details across brands, return
on investment across promotion channel and the future impact of
marketplace events on promotion activity. |
| · |
Tactical
Planning:
HPR’s tactical planning provides pharmaceutical companies the tactics
needed to successfully execute their strategic plan, uniquely integrating
the optimal detailing, sampling and promotional spending levels across
Ventiv’s portfolio with an execution plan at the representative level. HPR
utilizes several proprietary tools to assist its client’s tactical
planning and execution, including: |
| o |
Call
Planning System (“CAPS”), which allocates the number of sales, calls, by
physician, for every sales representative and the detailing priorities of
each call. CAPS also supports changes in the portfolio focus on short
notice, thereby enabling clients to respond quickly to internal and
external developments. |
| o |
PharmAlign™,
a proprietary territory design software system that provides sales force
deployment options for a territory, district, region or
nation. |
| o |
Field
Manager and Field Manager HQ, a system used by District Managers and/or
Headquarters to support analysis of rep and district manager performance
at a geographic level. |
When
coupled together, these tools provide the capability for HPR’s clients to ensure
that they are continually improving the effectiveness of deployed sales force
resources.
Ventiv
Clinical Services
The
companies making up our Ventiv Clinical Services unit include Smith Hanley and
HHI, leading providers of clinical staffing and data management services. We
acquired these companies in two transactions during 2004. Through these
acquisitions, we broadened our capabilities into the clinical arena, and
established Ventiv Clinical Services. Ventiv Clinical Services has successfully
met the staffing and recruiting needs of more than 65 pharmaceutical and
biotechnology clients, including 14 of the top 20 global pharmaceutical
companies, as well as performed data management and analytical services for over
150 clinical trials. These accomplishments are driven by four
divisions:
• Smith
Hanley Associates, which provides executive placement services;
• Smith
Hanley Consulting Group (“SHCG”), which provides outsourced contract staffing
and recruiting services for pharmaceutical clinical research
trials;
•
MedFocus, which provides outsourced contract staffing and recruiting services
for pharmaceutical clinical research trials and is based in Chicago, Illinois;
and
• HHI
Clinical & Statistical Research Services (“HHI”), a clinical service
provider that manages statistical analysis and data management functions.
Through
its pool of experienced clinical staff and staff augmentation capabilities, SHCG
and MedFocus give pharmaceutical companies and start-up biotechnology firms the
flexibility to manage and execute clinical trials internally without the expense
of hiring and training all of their own staff. Clients obtain qualified
personnel for immediate deployment on a project and are better able to execute
project management as there is no need for the recruiting, hiring, training and
managing process essential with internal employees. Clients also get an
opportunity to understand their work flow, and determine what the most
cost-effective employee mix will be as they continue to move
forward.
Currently,
SHCG and MedFocus provide clients with contract services for such mission
critical positions as SAS™ programmers, data managers, statisticians, monitors
and clinical research associates, study & project managers, clinical trials
coordinators, safety/regulatory staff, medical writers, scientific and
laboratory staff and other clinical positions. They draw from a database of over
30,000 candidates, which they are continually expanding with new recruiting
efforts through search engines, job fairs, conferences, and referral
bonuses.
The HHI
division complements SHCG and MedFocus’s contract service pool with a
statistically-knowledgeable physician and medically-knowledgeable statisticians
to deliver well-organized research used in clinical trial and clinical program
design, data management, data analysis, double key data entry and validation,
reporting and Standard Operating Procedures writing. This bi-disciplinary
expertise enables HHI to set up, manage and present data to help pharmaceutical
clients move from the preclinical stage through the drug approval process and
post-commercialization oversight as painlessly as possible.
Smith
Hanley Associates offers customized executive placement services to the
pharmaceutical industry as well as clients in the financial services, consumer
products, consulting and insurance industries.
Competitive
Advantages
Our
strategic goal is to provide the pharmaceutical and life sciences industries
with value-added clinical, marketing, sales and compliance services that will
enable our clients to achieve accelerated development, superior product sales
through higher market penetration and appropriate regulatory compliance. Our
business units possess significant combined experience, as each has developed
and conducted successful clinical and/or commercialization programs for hundreds
of individual pharmaceutical and life science products. Our expertise spans most
therapeutic categories, including the significant markets of cardiology,
anti-infectives, oncology, gastroenterological, respiratory, allergy,
dermatology and neurology. Our core competencies and track record of proven
success enable us to establish strong relationships with our clients' senior
personnel, which greatly contributes to client retention.
Comprehensive
Service Offering: We offer
a broad range of services, from strategic and tactical planning and analytics to
the recruiting, training, deployment and management of sales forces and
development of sales and marketing strategies. During 2004, we significantly
broadened our service offerings through complementary service extensions and
strategic acquisitions in the areas of compliance and clinical staffing. This
development positions us to better meet the varied needs of our existing and
prospective pharmaceutical and biotechnology clients. While our offerings are
broad relative to some of our direct competitors, we do also face select
competitors who have also assembled a relatively broad service
offering.
Leading
Position Across Our Offerings: We are
one of the largest providers of pharmaceutical outsourced sales services in the
United States and we are also a significant provider of strategic and tactical
sales and marketing planning in the U.S. We detail to a large number of
physicians, nurses, pharmacists and formularies—approximately 3.6 million calls
were made in 2004 alone. These targets are regularly contacted by our
representatives. Given the preference by many of our clients to work with
organizations possessing strong reputations and a strong track record, our
large-scale presence in our markets, which is underpinned by our experience,
speed, capabilities, and technology, provides significant advantages in
continuing to win new business. We are
also a recognized leader in clinical trials staffing, providing services to a
wide range of pharmaceutical, biotechnology and medical device companies, as
well as to their outsourced service providers to those sectors. Ventiv Clinical
Services has emerged as a leading provider of clinical trials-related SAS
programmers, statisticians, data management and monitoring personnel to the
major pharmaceutical and biotechnology companies. In selecting a vendor to work
with, many pharmaceutical companies prefer to work with a handful of larger,
more reputable organizations, and given our long history and strong brand name
in the business, large database of potential clinical staff and reputation for
quality and flexibility, we have significant advantages in continuing to win new
business.
Broad
and Diversified Client Base: In
addition to serving many of the largest pharmaceutical companies, we also serve
a large number of mid-size and smaller biotech and life sciences companies. As
each of these companies uses our services, our relationship is expanded and the
opportunity to cross-sell products increases. Our client base of over 65
pharmaceutical and biotechnology clients is broad and diversified, and with many
of these clients we have maintained long-term, non-exclusive relationships that
do help us in continuing to win new business.
Proprietary
Technologies and Data: We
maintain and operate a number of proprietary software programs and systems for
marketing development and data gathering. To conduct strategic studies, HPR
employs a series of programs, which were designed in-house and utilize data,
which is gathered and processed by HPR's clients and, on certain engagements,
Ventiv Commercial Services to conduct proprietary market research. Also, we have
made a considerable investment in technology and have developed and deployed
cutting-edge sales force automation tools to increase our efficiency. Such data
collection is important for the management of a sales and marketing campaign for
pharmaceutical products throughout their life cycle, especially during the
product launch phase.
Experienced
Management Team: Our
management team includes executives with substantial expertise in pharmaceutical
and health care services, as well as substantial background within
pharmaceutical companies themselves, including managing pharmaceutical sales
forces and establishing sales and marketing strategies. The team also has
extensive experience in the areas of outsourced staffing, permanent placement
and executive search services. We believe our mix of senior management with
pharmaceutical services experience, entrepreneurial talent and strategic
perspective is unique in the industry.
Our
overall focus is on offering the best combination of high-quality, flexible and
cost-effective services to our clients, versus our competitors and versus other
alternatives available to our clients for addressing their clinical, sales,
marketing and compliance needs. We continue to enhance our capabilities, deepen
our client relationships and offer more fully-integrated solutions. Because of
our high level of quality service, many of our pharmaceutical clients have
rewarded us with contract extensions and additional new business.
Clients
We
provide our services to leading pharmaceutical, biotechnology, medical device
and diagnostics companies. During 2004, approximately 70% of our revenues were
derived from our ten largest clients. Our ten largest clients during 2004,
listed alphabetically, were as follows: ALTANA Pharma (“ALTANA”), Bayer
Corporation (“Bayer”), Bristol-Myers Squibb Company (“BMS”), Fournier
Pharmaceuticals, Ltd., Johnson and Johnson (“J&J”), Noven Pharmaceuticals,
Inc., Sanofi-Aventis Group, Synthon Pharmaceuticals, Ltd. (“Synthon”),
Upsher-Smith Laboratories, Inc. and Watson Pharmaceuticals, Inc. (“Watson”). Two
clients accounted for approximately 16% and 14%, respectively, of our total
revenue for the year ended December 31, 2004. Two clients accounted for 23%, and
18%, respectively, of our revenues during 2003. No other clients accounted for
more than 10% of revenue in 2004 or 2003.
We
consider our close relationships with leading pharmaceutical manufacturers to be
an important competitive advantage, providing us with a source for recurring
revenues as well as sales growth opportunities as our clients launch new
products and as we develop new offerings. Our services are typically sold to
similar target groups within the client organization, typically their clinical
or their marketing and sales departments. This provides the basis for continuous
interaction and feedback, allowing us to continuously improve our services and
identify new business opportunities, a process augmented by the longevity of
many of our client relationships. We have developed sustained relationships with
large, mid-tier and emerging pharmaceutical clients that provide us with
recurring revenue streams and cross-selling opportunities. Our ability to
perform services and add value at every part of the product life cycle enhances
our ability to develop new business opportunities and form long-lasting
relationships with clients.
Our
relationships with a client's clinical or marketing and sales organizations also
benefit from high switching costs, as retaining another sales force and
redesigning a marketing program creates substantial additional expense and
causes losses in time and productivity for our clients. In addition, successful
marketing and sales outsourcers have established their reputations due to
sophisticated performance evaluation capabilities, and clients are unlikely to
use vendors without widely recognized expertise.
We
provide services to many of our most significant clients under contracts that
our clients may cancel, typically on 30 to 120 days notice. In addition, many of
the Ventiv Pharma Team contracts provide our clients with the opportunity to
internalize the sales forces ("sales force conversion") under contract, with
sufficient notice. Although Ventiv Pharma Teams has been successful in a number
of cases in negotiating longer-term commitments and an initial non-cancelable
contract period, we cannot be assured that clients will renew relationships
beyond the expiration date of existing contracts.
Competition
Our
competitors include outsourced sales organizations as well as contract research
organizations that also offer healthcare marketing services. Additionally, drug
distribution companies have indicated a desire to enter this lucrative market by
leveraging their knowledge base and effecting strategic acquisitions. Each of
our operating groups faces distinct competitors in the individual markets in
which the group operates.
Ventiv
Commercial Services: A small
number of providers comprise the market for outsourced sales teams, although the
majority of sales teams are managed internally. We believe that Ventiv, Innovex
(Quintiles) and Professional Detailing, Inc. combined account for the majority
of the U.S. outsourced sales team market share. The rest of the industry is
fragmented, with a number of small providers attempting to develop niche
services. One or more of our large competitors in the outsourced sales team
market could become significant competitors with regard to the other services we
offer by either developing additional capabilities or acquiring smaller
companies.
Ventiv
Analytic Services: HPR’s
largest competitor in the strategic and tactical planning marketplace is ZS
Associates, which provides a range of market segmentation, promotion planning
and resource allocation services comparable to HPR’s service offerings. In the
market research marketplace, HPR competes against a variety of large and small
companies, which provide primary and secondary market research on a contract
basis.
Ventiv
Clinical Services: The
specialty staffing services industry is very competitive and fragmented with
relatively few barriers to entry. Although several large nationwide temporary
staffing companies compete with us, we are one of the only national firms that
specializes exclusively in professional clinical trials research personnel.
Ventiv Clinical Services’ primary competitors include ClinForce (a division of
Cross Country), Managed Clinical Solutions (a division of ICON), ASG, Advanced
Clinical Services and Kforce. Primary competitors in the permanent placement
area include Korn Ferry, Reynolds and Reynolds, Heidrick and Struggles as wells
as numerous smaller specialty permanent placement groups.
Seasonality
Although
our business is subject to variability as a result of the ongoing startup and
completion of contracts, periodic receipt of incentive fees and the ramp up of
product revenues in certain contracts, our business is not generally subject to
seasonal variation.
Employees
At
December 31, 2004, we employed approximately 4,000 people in continuing
operations, including approximately 2,700 sales representatives and managers.
Our part-time sales force employees account for approximately four percent of
our total field workforce. We believe that our relations with our employees are
satisfactory.
Many
aspects of our business are very labor intensive and the turnover rate of
employees in our industry, and in corresponding segments of the pharmaceutical
industry, is generally high, particularly with respect to sales force employees.
We believe our turnover rate is comparable to that of other outsourced service
organizations and internal pharmaceutical sales and marketing departments. An
increase in the turnover rate among our employees would increase our recruiting
and training costs and decrease our operating efficiencies and productivity. Our
operations typically require specially trained persons, such as those employees
in the pharmaceutical detailing business. Growth in our business will require us
to recruit and train qualified personnel at an accelerated rate from time to
time. The labor markets for quality personnel are competitive, and we cannot
assure you that we will be able to continue to hire, train and retain a
sufficient labor force of qualified persons.
Government
Regulation
Several
of the industries in which our clients operate are subject to varying degrees of
governmental regulation, particularly the pharmaceutical and healthcare
industries. Generally, compliance with these regulations is the responsibility
of our clients. However, we could be subject to a variety of enforcement or
private actions for our failure or the failure of our clients to comply with
such regulations.
In
connection with the handling and distribution of pharmaceutical products
samples, we are subject to the Prescription Drug Marketing Act of 1987 and other
applicable federal, state and local laws and regulations. These laws and
regulations regulate the distribution of drug samples by mandating storage,
handling, solicitation and record-keeping requirements for drug samples and by
banning the purchase or sale of drug samples.
Some of
our physician education services are subject to a variety of federal and state
regulations relating to both the education of medical professionals and the
marketing and sale of pharmaceuticals. In addition, certain ethical guidelines
promulgated by the American Medical Association ("AMA") govern the receipt by
physicians of gifts in connection with the marketing of healthcare products.
These guidelines govern the honoraria and other items of value that AMA
physicians may receive, directly or indirectly, from pharmaceutical companies.
Any changes in such regulations or their application could have a material
adverse effect on Ventiv. Failure to comply with these requirements could result
in the imposition of fines, loss of licenses and other penalties and could have
a material adverse effect on Ventiv.
From time
to time, state and federal legislation is proposed with regard to the use of
proprietary databases of consumer and health groups. The uncertainty of the
regulatory environment is increased by the fact that we generate and receive
data from many sources. As a result, there are many ways government might
attempt to regulate our use of this data. Any such restriction could have a
material adverse effect on Ventiv.
Non-U.S.
Operations
We have
no operations outside the United States and do not derive any material revenues
from non-U.S. sources.
Item
2. Properties.
As of
December 31, 2004, we leased 18 facilities totaling 330,603 square feet,
including our principal executive offices located in Somerset, New Jersey. Six
facilities totaling 189,345 square feet are leased by the Ventiv Commercial
Services segment, seven facilities totaling 53,464 square feet are leased by the
Ventiv Clinical Services segment, three facilities with 29,631 square feet is
leased by the Ventiv Analytic Services segment and two facilities with
approximately 58,163 square feet is leased by the Other (corporate) segment.
These leases expire at varying dates through 2013. Leased facilities increased
during 2004 due to the completion of several business acquisitions. We believe
that our facilities are adequate for our present and reasonably anticipated
business requirements.
Item
3. Legal
Proceedings.
We are
subject to lawsuits, investigations and claims arising out of the conduct of our
business, including those related to commercial transactions, contracts,
government regulation and employment matters. Certain claims, suits and
complaints have been filed or are pending against us. In the opinion of
management and based on the advice of legal counsel, all matters are believed to
be without merit or are of such kind, or involve such amounts, as would not have
a material effect on our consolidated financial position or consolidated results
of operations if disposed of unfavorably.
Item
4. Submission
of Matters to a Vote of Securities Holders.
No
matters were submitted to a vote of security holders during the fourth quarter
of the year ended December 31, 2004.
PART
II