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U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 10-KSB
(Mark One)
[X] Annual report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934
For the fiscal year ended December 31, 1998
[ ] Transition report under Section 13 or 15(d) of the Securities Exchange Act
of 1934
Commission File No. 0-21721
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CLINICOR, INC.
(Name of Small Business Issuer in Its Charter)
Nevada 88-0309093
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
1717 West Sixth Street, Suite 400, Austin, Texas 78703
(Address of Principal Executive Offices) (Zip Code)
(512) 344-3300
(Issuer's Telephone Number, Including Area Code)
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Securities registered under Section 12(b) of the Exchange Act: None
Securities registered under Section 12(g) of the Exchange Act:
Common Stock, $.001 par value
(Title of Class)
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Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 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
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Check if no disclosure of delinquent filers in response to Item 405 of
Regulation S-B is contained in this form, and no disclosure will be contained,
to the best of Registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-KSB or any
amendment to this Form 10-KSB. [ ]
Issuer's gross revenue for fiscal year ended December 31, 1998: $11,553,901.
As of March 22, 1999, the aggregate market value of the common stock held by
non-affiliates of the Registrant, computed by reference to the last quoted price
at which such stock was sold on such date as reported on the Over-the-Counter
Bulletin Board was $2,943,658.
As of March 22, 1999, 4,169,734 shares of the Issuer's Common Stock were
outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Proxy Statement for the Registrant's 1998 Annual Meeting of
Shareholders are incorporated by reference into Part III (Items 9, 10, 11 and
12) hereof.
Transitional Small Business Disclosure Format (check one): Yes No X
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TABLE OF CONTENTS
Page
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PART I
Item 1. Description of Business.......................................... 3
Item 2. Description of Property.......................................... 13
Item 3. Legal Proceedings................................................ 13
Item 4. Submission of Matters to a Vote of Security Holders.............. 13
PART II
Item 5. Market For Common Equity and Related Shareholder Matters......... 13
Item 6. Management's Discussion and Analysis or Plan of Operation........ 14
Item 7. Financial Statements............................................. 19
Item 8. Changes in and Disagreements With Accountants on Accounting
and Financial Disclosure......................................... 19
PART III
Item 9. Directors, Executive Officers, Promoters and Control Persons;
Compliance With Section 16(a) of the Exchange Act................ 19
Item 10. Executive Compensation........................................... 19
Item 11. Security Ownership of Certain Beneficial Owners and Management... 20
Item 12. Certain Relationships and Related Transactions................... 20
Item 13. Exhibits List and Reports on Form 8-K............................ 20
Signatures....................................................... 24
Audited Financial Statements.....................................F-1
2
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PART I
Item 1. Description of Business
General
Clinicor, Inc. (together with its predecessor, described below, "Clinicor"
or the "Company") is a fully-integrated contract research organization ("CRO")
serving the pharmaceutical, biotechnology and medical device industries. The
Company designs, manages and monitors clinical trials in North America and
Europe and provides integrated clinical and product development services,
including patient recruitment, data management, biostatistical analysis,
regulatory affairs, quality assurance and other consultation services for its
clients. The Company generates substantially all of its revenue from services
related to the clinical testing of new pharmaceutical, biotechnology and medical
device products.
The Company, a Nevada corporation, was formed in December 1993. A
predecessor company, also named Clinicor, Inc. (the "Predecessor Company"), was
formed as a Texas corporation in September 1992 and merged into the Nevada
corporation in February 1995. References herein to "Clinicor" or the "Company"
denote the existing Nevada corporation and the Predecessor Company.
The Company performs and manages clinical trials in North America from its
corporate headquarters in Austin, Texas. The Company also maintains a regional
sales office in Bridgewater, New Jersey. The Company's European operations are
headquartered in offices in Windsor, England.
The Company's principal executive offices are located at 1717 West 6th
Street, Suite 400, Austin, Texas 78703, and its telephone number is (512) 344-
3300.
Business
The Company designs, manages and monitors clinical trials in North America
and Europe and provides clinical and product development services, including
patient recruitment, data management, biostatistical analysis, regulatory
affairs, quality assurance and other consultation services for its clients. The
Company provides centralized patient recruitment services on a nationwide basis
using its patient recruiting department and computer database system located in
Austin, Texas. In the CRO industry, this service is typically an ancillary one,
offered outside of the standard CRO services model by investigative sites or
site management organizations ("SMOs"). Clinicor is one of a small number of
CROs that has integrated this service into its services model.
New Product Development
Before a new pharmaceutical, biotechnology, medical device or diagnostic
product may be marketed, it generally must undergo extensive testing and
regulatory review to determine that it is safe and effective. This development
process consists of two stages, pre-clinical and clinical. In the pre-clinical
stage, the sponsor of the new product conducts laboratory analyses and animal
tests, generally over a one to three year period, to determine the basic
biological activity and clinical processes and safety of the product. Upon
successful completion of the pre-clinical phase, the product undergoes a series
of clinical tests in humans, including healthy volunteers as well as patients
with the targeted disease or condition. These tests are generally longer in
duration, at times averaging from two to six years. In the United States, pre-
clinical and clinical testing must comply with the requirements of Good Clinical
Practices ("GCP") and other standards promulgated by the Food and Drug
Administration ("FDA") and other federal and state governmental authorities.
GCP stipulates procedures which are designed to ensure the quality and integrity
of data obtained from clinical testing and to protect the rights and safety of
clinical subjects.
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In the United States, a sponsor must file an Investigational New Drug
Application ("IND"), an Investigational Device Exemption ("IDE") or other filing
with the FDA before the commencement of human testing of an investigational
product. The filing includes pre-clinical testing results and sets forth the
sponsor's plans for conducting human clinical trials. The design of these plans,
also referred to as study protocols, is critical to the success of the
development effort because the protocol must correctly anticipate the data and
results that the FDA will require before approving the product.
Human trials usually start on a small scale to assess safety and then expand
to larger trials to test for both safety and efficacy. Trials are usually
grouped into four phases, with multiple trials generally conducted within each
phase. Trials may be performed at single or multiple sites.
Phase I. Phase I trials are usually conducted on healthy volunteers,
typically 20 to 80 persons, to develop basic safety data relating to toxicity,
metabolism, absorption and other pharmacological actions.
Phase II. Phase II trials are conducted on a relatively small number of
subjects, typically 100 to 200 patients, who suffer from the product's targeted
disease or condition. Phase II trials offer the first evidence of clinical
efficacy, as well as additional safety data.
Phase III. Phase III trials are typically conducted on a larger
population of several hundred to several thousand patients who suffer from the
targeted disease or condition. Phase III trials are designed to measure safety
and efficacy on a large scale as well as side effects. Before granting an
approval to market, the FDA generally requires completion of two pivotal, multi-
site Phase III trials to demonstrate and confirm safety and efficacy.
Phase IV. As a condition of granting marketing approval, the FDA may
require that a sponsor continue to conduct additional clinical trials, known as
Phase IV post-submission trials, to monitor long-term risks and benefits, study
different dosage levels, or evaluate different safety and efficacy parameters in
target patient populations. In addition, Phase IV trials may be necessary to
support a sponsor's promotional claims, expanded indications or comparative
trials.
Clinical trials often represent the most expensive and time-consuming part
of the overall development process. The information generated during these
trials is critical for gaining marketing approval from the FDA or other
regulatory agencies. After the completion of Phase III trials, the sponsor of a
new product must submit a New Drug Application ("NDA") or other approval to
market application to the FDA. This application is a comprehensive filing that
includes, among other things, the results of all pre-clinical and clinical
studies, information about the product's composition, and the sponsor's plans
for formulating, producing, packaging and labelling the product.
A clinical trial is a scientific experiment to test the efficacy and safety
of an investigational product in accordance with a detailed plan as documented
in the protocol. The investigational product is administered to patients who
meet specific inclusion/exclusion criteria. Typically, the investigational
product is compared to another approved product and/or a placebo. Usually,
neither the patient nor the physician investigator knows which patients receive
which substance, although that information is readily available if needed. The
protocol will specify when, how often and how much of the study product a
patient will receive, how often they will be examined by the investigator during
the study (i.e., the number and frequency of patient visits) and what
measurements and assessments will be made and recorded at each patient visit.
The resulting data is recorded in source documents and transcribed into Case
Report Forms ("CRFs"). The recorded data is monitored to verify its accuracy
and consistency with source documents. The data from the CRFs is entered into a
computer database for biostatistical analysis.
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Services
The Company's services include clinical trials management, patient
recruitment, clinical data management, biostatistical analysis, regulatory
affairs, quality assurance and other consultation services. The Company will
provide these services separately or as an integrated package. Services from
each of these categories can be utilized for the development and preparation of
a variety of regulatory filings.
Clinical Trials Management Services. The Company offers complete services
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for the design, placement, performance, patient recruitment, monitoring and
management of clinical trial programs. The Company has performed services in
connection with trials in many therapeutic areas. The Company has the ability to
examine a product's existing pre-clinical and clinical data for the purpose of
designing protocols for clinical trials in order to demonstrate the product's
safety and efficacy in the treatment of the targeted disease.
The Company manages every aspect of trials in Phases I through IV, including
design of operations manuals, identification and recruitment of trial
investigators, initiation of sites, recruitment of patients, site monitoring
visits to determine compliance with protocol procedures, adherence to GCP and
proper collection of data, data management, biostatistical analysis,
interpretation of trial results and report preparation. The Company's current
projects involve Phase I, II, III and IV clinical trials. The Company does not
own or maintain a Phase I facility for the confinement of study subjects.
The Company assists clients with one or more of the following steps of
clinical trials:
. Study Protocol. The protocol defines the disease and treatment the
study seeks to examine and the statistical tests that will be conducted.
Accordingly, the protocol defines: (i) the targeted patient population; (ii) the
frequency and type of laboratory and clinical measures that are to be recorded
and analyzed; (iii) the number of patients required to produce a statistically
significant result; (iv) the period of time over which the measurements must be
recorded; and (v) the frequency and dosage of drug or other product
administration.
. Case Report Forms. Once the study protocol has been finalized, special
forms for recording study-specific data must be developed. These forms are
called CRFs. Study data are transcribed onto CRFs from original source
documents. The CRF for one patient in a given study may consist of as many as
100 pages or more.
. Site and Investigator Recruitment. The drug or other product is
administered to patients by investigators at hospitals, academic centers,
clinics or other locations, referred to as sites. Potential investigators may
be identified by the sponsor or the CRO. The investigators are then solicited
to participate in the study. Generally, the Company locates properly qualified
investigators who contract directly with the Company.
. Patient Recruitment and Enrollment. One of the Company's main
competitive strengths is its ability to quickly and efficiently recruit patients
using mass marketing techniques and a centralized patient management system.
The clinical trial's success depends upon the rapid recruitment of patients that
meet all of the trial criteria. Patients are prescreened for eligibility by
personnel using an on-line computer scheduling and database system which
captures relevant data for each patient. Prospective patients are required to
review information about the study drug or other product and possible side
effects and sign an informed consent to record their knowledge and acceptance of
potential risks. Patients also undergo a medical examination performed by the
investigator to determine whether they meet the requirements of the study
protocol. Patients then receive the study drug or other product and are
examined by the investigator as specified by the study protocol.
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. Study Monitoring and Data Collection. As patients are examined and
tests are conducted in accordance with the study protocol, patient information
is recorded in the patient chart. Data is then transcribed to CRFs. CRAs visit
sites regularly to ensure that regulatory requirements are being met and the
protocol is followed. The CRFs are reviewed for accuracy and consistency with
the underlying source documents. The completed CRFs are retrieved and are
entered into an electronic database.
. QA/QC. The Company can provide quality assurance and control audit
services to its sponsors. These services involve auditing all aspects of the
preclinical and clinical trial process for regulatory compliance with FDA rules,
regulations and guidelines.
. Medical Writing. The results of biostatistical analysis of data
collected during the trial, together with other clinical data, are included in a
final report generated for inclusion in regulatory documents.
. Medical Affairs. Throughout the course of a clinical trial, the Company
may provide various medical and research services, including medical monitoring
of clinical trials, interpretation of clinical trial results, and preparation of
clinical study reports.
Clinical Data Management and Biostatistical Services. The Company's data
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management professionals assist in the design of protocols and CRFs, as well as
training manuals and training sessions for investigational staff, to ensure that
data are collected in an organized and consistent format. Databases are
designed according to the analytical specifications of the project and the
particular needs of the client. Prior to data entry, the Company's personnel
screen CRFs for errors, omissions and other deficiencies. The Company provides
clients with data abstraction, data review and coding, data entry, database
verification and editing, and problem data resolution.
The Company's biostatistics professionals provide biostatistical consulting
and plans, database design, data analysis, biostatistical reporting, and
assistance in all phases of drug development. These professionals develop and
review protocols, design appropriate analysis plans and design report formats to
address the objectives of the study protocol as well as the client's individual
objectives. Working with the programming staff, biostatisticians perform
appropriate analyses and produce tables, graphs, listings and other applicable
displays of results according to the analysis plan. Biostatisticians assist
clients before panel hearings at the FDA.
These services are utilized by clients to process data that have previously
been collected by either the client itself or the Company as part of a distinct
phase in the drug development process. The Company believes that its data
management and biostatistical services capabilities can be utilized by a client
more effectively when packaged as part of its total clinical trials management
services. This permits a faster and less costly clinical trial process, because
the data is collected and analyzed more rapidly. The Company emphasizes this
data management and biostatistical integration as a "turn-key" approach in its
marketing efforts.
Product Registration Services. The Company provides comprehensive product
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registration services in the United States and Europe. The Company provides
regulatory strategy formulation, document preparation, and Good Manufacturing
Practice consultation. The Company also acts as liaison with the FDA and other
regulatory agencies. Although these services have not generated material
revenue to date, the Company offers them in order to provide a full range of
services for its clients.
The Company works closely with clients to devise regulatory strategies and
comprehensive product development programs. The Company's scientific and
regulatory affairs experts review existing published literature, assess the
scientific background of a product, assess the competitive and regulatory
environment, identify deficiencies and define the steps necessary to obtain
registration in the most expeditious manner.
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Through this service, the Company helps its clients determine the feasibility of
developing a particular product or product line.
The Company's scientific and regulatory affairs professionals have
experience in the analysis, preparation and submission of regulatory documents
covering a wide range of products, including drugs and over-the-counter
products. The Company also offers the preparation of regulatory documentation
for submission to regulatory authorities.
Information Systems
The Company is committed to investing in information technology designed to
expedite the flow of information to its employees and clients in order to
improve the high quality of its clinical study services and to manage its
internal resources. During 1998, the Company installed an Oracle database
platform on a Unix server with Oracle-based applications encompassing critical
aspects of its business, such as patient recruitment, clinical trial management,
data management, time information management and financial applications. The
Oracle platform is web-enabled which will allow the Company to gather clinical
study information through web applications and deliver information to clinical
staff and clients through web-based products. The Company believes that it is
one of a few CROs that has standardized its information technology systems on a
single database platform. The Company feels that its Oracle platform
initiatives will help the organization scale up as needed to handle the demands
of a multi-office, multi-country, multi-currency environment.
The Company's information technology group is responsible for technology
procurement, user support, applications development, and management of the
computer network. The Company's information systems are designed to work in
support of the Company's standard operating procedures. The Company's
information technology systems are designed to be open and flexible to support
its internal and client demand both currently and in the future.
Marketing and Business Development
The marketing strategy of Clinicor consists of differentiating and
positioning Clinicor in the U.S. and European markets, and promoting its CRO
services to the pharmaceutical, biotechnology and medical device markets. The
Company seeks to maintain and expand upon its excellent sponsor service
reputation among its core and loyal client base. A launch strategy will be
implemented for the introduction of a new image as well as a new service
offering, CorDat@. Clinicor will create a brand identification strategy with
the launch of CorDat@, an integrated enterprise application solution. CorDat@
pulls together study management, patient recruitment, clinical data management
and financial applications through a web-enabled tool. Seasonality strategies
will be used for advertising. Service and pricing strategies will be introduced
to expand Clinicor's services and to establish various premier service
offerings. The primary promotional emphasis will be on media communications
through industry journals, magazines and internet tools, with secondary emphasis
on direct mail and public relations efforts.
The marketing strategy emphasizes a sales plan to target accounts to
penetrate various markets as well as entrench some niche/specialty areas such as
patient recruitment. Clinicor's strategic objective is to provide comprehensive
CRO services and to promote long-term relationships with its key existing
sponsors and as well as new sponsors.
Clients
The Company has performed or is currently performing studies for 44
different clients, including eight of the 25 largest pharmaceutical companies
with the largest new drug pipelines in the world. All of
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the Company's foreign-based clients have operations in the United States. The
Company's revenues have historically been derived primarily from services
performed in the United States.
The Company derives a significant portion of its revenue from a relatively
limited number of projects or clients. Concentrations of business in the CRO
industry are typical, and the Company is likely to experience such
concentrations in 1999 and future years. In 1998, four clients each accounted
for more than 10% of the Company's total revenue, or 36%, 13%, 12% and 10%,
respectively. In 1997, three clients each accounted for more than 10% of the
Company's total revenue, or 11%, 24%, and 22%, respectively. The Company's
total revenues for 1998 and 1997 were provided from 28 and 21 separate clients,
respectively.
Competition
The Company primarily competes against other full service CROs, and, to a
lesser extent, SMOs and academic centers. Some of these competitors have
substantially greater capital, technical and other resources than the Company.
CROs generally compete on the basis of previous experience, medical and
scientific expertise in specific therapeutic areas, quality of contract
research, ability to organize and manage large-scale trials on a global basis,
ability to manage large, complex medical databases, ability to provide
biostatistical analysis and regulatory services, ability to respond rapidly to
requests for proposals, ability to recruit investigators, ability to rapidly
recruit patients, ability to integrate information technology with systems to
improve the efficiency of contract research, financial viability and price. The
Company believes that it competes favorably in these areas, except that it does
not have a significant international presence necessary to perform large scale
global trials.
The CRO industry is highly fragmented, with participants ranging from
several hundred small, limited-service providers to several large, full-service
CROs with global operations. Some of the largest CROs are Quintiles
Transnational Corporation, Covance, Inc., Parexel International Corporation and
PPD Pharmaco, Inc. The trend toward consolidation in the CRO and pharmaceutical
industries has resulted in heightened competition among the larger CROs for
clients and acquisition candidates.
Intellectual Property
The Company has registered CLINICOR x (R) as a service mark with the United
States Patent and Trademark Office.
Employees
At December 31, 1998, the Company had approximately 76 full-time employees.
Government Regulation
The clinical investigation of new pharmaceutical, biotechnology and medical
device products is highly regulated by governmental agencies. The purpose of
these regulations is to ensure that only those products which have been proven
to be safe and effective are made available to the public. The FDA has set
forth regulations and guidelines that pertain to applications to initiate trials
of products, approval and conduct of studies, report and record retention,
informed consent, applications for the approval of new products, and post-
marketing requirements. Pursuant to these regulations, CROs that assume
obligations of a drug sponsor are required to comply with applicable regulations
and are subject to regulatory action for failure to comply with such
regulations. In the United States, the historical trend has been in the
direction of increased regulation by the FDA, although the FDA in the last four
years has made some modifications to expedite certain processes and recent
legislative initiatives have been proposed to accelerate that trend.
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The services provided by the Company are ultimately subject to FDA
regulation in the United States and comparable agencies in other countries,
although the level of applicable regulation in other countries can be less
comprehensive than regulation present in the United States. The Company is
obligated to comply with FDA regulations governing such activities as selecting
qualified investigators, obtaining required forms from investigators, recruiting
patients, verifying that patient informed consent is obtained, monitoring the
validity and accuracy of data, verifying drug/device accountability, and
instructing investigators to maintain records and reports. The Company must
also maintain records for each study for specified periods for inspection by the
study sponsor and the FDA. The FDA has the authority to audit the Company's
compliance with Federal regulations and guidelines, and if such audits document
that the Company has failed to adequately comply, it could have a material
adverse effect on the Company. In addition, the Company's failure to comply
with applicable regulations could possibly result in termination of ongoing
research or the disqualification of data, either of which could have a material
adverse effect on the Company, including, without limitation, damage to the
Company's reputation.
Risk Factors
Portions of this report contain certain "forward-looking" statements within
the meaning of the federal securities laws. In addition, the Company and its
representatives may from time to time make oral and other written forward-
looking statements. The Company notes that a variety of factors could cause the
Company's actual results and experience to differ materially from the
anticipated results expressed in the Company's forward-looking statements. The
risks and uncertainties that may affect the operations, performance, development
and results of the Company's business include the factors set forth below.
Operating History; Unprofitability. The Company was organized in September
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1992. As of December 31, 1998 the Company had an accumulated deficit of
$8,017,086 and had reported net losses since its organization, including net
losses of $1,966,196, $2,340,535 and $1,941,202 for the years ended December 31,
1996, 1997 and 1998, respectively. There can be no assurance that the Company
will be able to operate profitably in the future. See the discussion in the
remainder of this Item 1, below.
Loss or Delay of Clinical Research Contracts. Clients of the Company
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generally have the right to terminate a clinical research contract upon 60 to 90
days notice, potentially causing periods of excess capacity and reductions in
service revenue and net income. Contracts may be terminated for various
reasons, including unexpected or undesired results, inadequate patient
enrollment or investigator recruitment, production problems resulting in
shortages of the drug, adverse patient reactions to the drug, or the client's
decision to de-emphasize a particular trial. Clinical trials may often be
delayed for similar reasons. The loss or delay of a large contract or the
simultaneous loss or delay of multiple contracts could result in unplanned
periods of excess capacity, thereby materially and adversely affecting the
Company's backlog, revenue and profitability. In most instances, if a contract
is terminated, the Company is entitled to receive revenue earned to date.
However, in the case of fixed-price contracts, the Company bears the risk of
cost overruns. See "Description of Business--Clients" and the discussion in the
remainder of this Item 1, below.
Dependence on Certain Industries and Clients. The Company provides services
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primarily to the pharmaceutical, medical device and biotechnology industries.
Accordingly, the Company's service revenue is substantially dependent on these
industries' expenditures on research and development. Although these
expenditures are large, the number of potential CRO clients is relatively
limited, and concentrations of business in the CRO industry are not uncommon.
In fiscal 1998, the Company's top four clients accounted for 71% of the
Company's revenue. In fiscal 1997, the Company's top three clients accounted
for 57% of the Company's revenue. The Company is likely to continue to derive a
substantial portion of its revenue from a relatively limited number of major
projects or clients. The loss of business from a significant client could have
a material adverse effect on the Company. Additionally, the Company's operations
could be materially and adversely affected by, among other factors, any economic
downturn
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in the pharmaceutical, medical device or biotechnology industries, any decrease
in their research and development expenditures, or a change in the governmental
regulations pursuant to which these industries operate. Furthermore, management
believes that the Company has benefited to date from the increasing tendency of
pharmaceutical, medical device and biotechnology companies to outsource the
performance and analysis of clinical research projects to independent outside
organizations. A reversal or slowing of this trend could have a material adverse
effect on the Company. See "Description of Business--Clients."
Impact of Government Regulation; Compliance with Regulatory Standards. The
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market for the Company's services depends upon the comprehensive government
regulation of the drug development process. In the United States, the
historical trend has been in the direction of continued or increased regulation
by the FDA and other governmental agencies, although the FDA recently announced
regulatory changes intended to streamline the approval process for biotechnology
products by applying the same standards as are in effect for conventional drugs.
Changes in regulation, including a relaxation in regulatory requirements or the
introduction of simplified drug approval procedures, could materially and
adversely affect the demand for the services offered by the Company. In
addition, failure on the part of the Company to comply with applicable
regulations could result in the termination of ongoing research or the
disqualification of data, either of which could have a material and adverse
affect on the Company, including damage to the Company's reputation in the CRO
industry. See "Description of Business--Government Regulation."
Competition; Industry Consolidation. The CRO industry is not capital
-----------------------------------
intensive and the financial costs of entry into this industry are relatively
low. However, barriers to entry for full-service CROs are significant. The
industry, therefore, is highly fragmented with many small, niche providers in
addition to several medium-sized CROs and a few large, full-service CROs with
global operations. Clinicor competes primarily against other CROs, SMOs, and
academic centers, many of which have substantially greater financial and other
resources than the Company. CROs generally compete on the basis of previous
experience, medical and scientific expertise in specific therapeutic areas, the
quality of contract research, the ability to organize and manage large-scale
trials on a global basis, the ability to manage large and complex medical
databases, the ability to provide biostatistical analysis and regulatory
services, the ability to recruit investigators, the ability to respond rapidly
to requests for proposals, the ability to integrate information technology with
systems to improve the efficiency of contract research, an international
presence with strategically located facilities, financial viability and price.
There can be no assurance that the Company will be able to compete favorably in
these areas. Competitive pressures have resulted in an increasing
consolidation of the CRO industry, which is likely to result in heightened
competition among the larger CROs for both clients and acquisition candidates.
In addition, consolidation within the CRO and pharmaceutical industries as well
as a trend by pharmaceutical companies to outsource among fewer CROs, to build
their own in-house clinical staffs, and to develop preferred provider
relationships has led to heightened competition for CRO contracts. Increased
competition may lead to price and other forms of competition that may materially
and adversely affect the Company's business. See "Description of Business--
Competition."
Fluctuation in Quarterly Operating Results; Potential Volatility of Stock
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Price. The Company's quarterly operating results have fluctuated as a result of
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factors such as client delays in implementing particular clinical trials and the
costs associated with start-up operations. Because a high percentage of the
Company's operating costs are relatively fixed while revenue recognition is
subject to fluctuation, minor variations in the timing of contracts or the
progress of clinical trials may cause significant variations in quarterly
operating results. Results of one quarter are not necessarily indicative of
results for future quarters. In addition, the market price of the Company's
Common Stock could be subject to wide fluctuations in response to quarter-to-
quarter variations in operating results, changes in earnings estimates by
analysts, market conditions in the industry, prospects of health care reform,
changes in government regulation and general economic conditions. In addition,
the stock market has from time to time experienced significant price and volume
fluctuations that have been unrelated to the operating performance
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of particular companies. These market fluctuations may adversely affect the
market price of the Company's Common Stock. Investors in the Company's Common
Stock must be willing to bear the risk of such fluctuations in earnings and
stock price.
Potential Liability from Operations. Clinical trials involve the testing of
-----------------------------------
approved and experimental drugs on human volunteers pursuant to study protocols.
Such testing involves a risk of liability for personal injury or death to
participants due to, among other reasons, possible unforeseen adverse reactions
or side effects. The Company may be subject to claims in the event of personal
injury or death of persons participating in clinical trials. The Company does
not provide health care services directly to patients. Additionally, the
Company, on behalf of its clients, contracts with physicians who render
professional services, including the administration of the substance being
tested, to trial participants. As a result, the Company may be subject to
claims arising from professional malpractice of such physicians.
The Company believes that the risk of liability to patients in clinical
trials is mitigated by various regulatory requirements, including the role of
institutional review boards ("IRBs") and the need to obtain each patient's
informed consent. The FDA requires each human clinical trial to be reviewed and
approved by the IRB at each study site. An IRB is an independent committee that
includes both medical and non-medical personnel and is obligated to protect the
interests of patients enrolled in the trial. The IRB monitors the protocol and
measures designed to protect patients, such as the requirement to obtain
informed consent.
The Company attempts to manage its liability risk through contractual
indemnification provisions with clients and its physician investigators. The
contractual indemnifications generally do not protect the Company against
certain of its own actions such as negligence. The contractual arrangements are
subject to negotiation with clients, and the terms and scope of such
indemnification vary from client to client and from trial to trial. Although
most of the Company's clients are large, well-capitalized companies, the
financial performance of these indemnities is not secured. Therefore, the
Company bears the risk that the indemnifying party may not have the financial
ability to fulfill its indemnification obligations. The financial position of
the Company could be materially and adversely affected if it were required to
pay damages or incur defense costs in connection with an uninsured or
inadequately insured claim that is beyond the scope of an indemnity provision or
where the indemnifying party does not fulfill its indemnification obligations.
The Company currently maintains an errors and omissions professional
liability insurance policy. There can be no assurance that this insurance
coverage will be adequate or that insurance coverage will continue to be
available on terms acceptable to the Company. The Company has not experienced
any claims to date arising out of any clinical trial managed or monitored by it.
Potential Adverse Impact of Health Care Reform. In the last several years,
----------------------------------------------
several comprehensive health care reform proposals have been introduced in the
U.S. Congress. The intent of the proposals was, generally, to expand health
care coverage for the uninsured and control growing health care costs. While
none of the proposals were adopted, health care reform may again be addressed by
the U.S. Congress. Implementation of government health care reform may adversely
affect research and development expenditures by pharmaceutical and biotechnology
companies, resulting in a decrease of the business opportunities available to
the Company. See "Description of Business--Clients." Management is unable to
predict the likelihood of health care reform proposals being enacted into law or
the effect such law would have on the Company.
Dependence on Personnel. The Company relies on a number of key executives,
-----------------------
including Robert S. Sammis, its President, upon whom the Company maintains key
man life insurance, James W. Clark, Jr., its Vice President of Finance,
Secretary, Treasurer and Chief Financial Officer, Rosina Maar, M.D., its Vice
President of Operations and Chief Operating Officer, and Susan Krivacic, its
Senior Vice President of Marketing and Business Development. The loss of the
services of any of the Company's key executives
11
<PAGE>
could have a material adverse effect on the Company. The Company's performance
also depends on its ability to attract and retain qualified professional,
scientific and technical operating staff. See "Description of Business--
Services." The level of competition among employers for skilled technical and
scientific personnel, particularly those with M.D., Ph.D. or equivalent degrees
and with significant years of experience in the CRO industry, is high. There can
be no assurance the Company will be able to continue to attract and retain
sufficient numbers of qualified personnel.
Management of Business Expansion; Need for Improved Systems; Expansion of
-------------------------------------------------------------------------
Foreign Operations. Since the Company was organized, its business and operations
- ------------------
have experienced substantial expansion. The Company believes that such expansion
places a strain on operational, human and financial resources. In order to
manage such expansion, the Company must continue to improve on its operating,
administrative and information systems, accurately predict its future personnel
and resource needs to meet client contract commitments, track the progress of
ongoing client projects and attract and retain qualified management,
professional, scientific and technical operating personnel. Expansion of
foreign operations also may involve the additional risks of adjusting to
differences in foreign business practices, hiring and retaining qualified
personnel, and overcoming language and cultural barriers. Failure of the
Company to meet the demands of and to manage expansion of its business and
operations could have a material adverse effect on the Company's business.
Risks Associated with Future Acquisitions. The Company has not made any
-----------------------------------------
acquisitions to date but intends to review acquisition opportunities in 1999.
If the Company were to make one or more acquisitions, these acquisitions would
involve numerous risks, such as the difficulties and expenses that would be
incurred in connection with the acquisition and the subsequent assimilation of
the operations and services of the acquired companies and the diversion of
management's attention from other business concerns.
Uncertainty of Year 2000 Compliance. The Year 2000 issue is the result of
-----------------------------------
date-sensitive devices, systems and computer programs that use a two-digit
rather than a four-digit recognition system to define an applicable year. The
Company has changed its information systems relating to clinical operations,
data management and financial operations to software applications on an Oracle
database which the Company believes to be Year 2000 compliant. The Company is
continuing to review and test all of its internal systems to ensure that these
systems will be fully capable of handling the Year 2000 issue. Notwithstanding
the Company's internal Year 2000 program, the Company also faces external risks
related to the Year 2000 issue that are beyond the Company's control. The
Company is in the process of contacting sponsors concerning the state of their
Year 2000 readiness. Until that effort is complete, the Company cannot be
assured that sponsors' systems will be Year 2000 compliant on time. The
possibility of Year 2000 noncompliance by governmental agencies and other third
parties creates additional risks for the Company. These risks include the
possibility that infrastructural systems, such as utilities and
telecommunications and transportation systems, could experience failures. Given
the uncertainties, there can be no assurance that the failure by a sponsor or
other third party to achieve Year 2000 compliance may not have a material
adverse effect on the Company's operations or financial condition.
Preferred Stock Provisions. The Company's organizational documents
--------------------------
authorize its Board of Directors to issue shares of new series of Preferred
Stock without the approval of holders of its Common Stock. The issuance of
additional series of Preferred Stock could grant preferential rights with
respect to the Company's earnings and assets to the holders of such Preferred
Stock and could otherwise adversely affect the rights and powers, including
voting rights, of other shareholders. Moreover, the issuance of Preferred Stock
could make it more difficult for a third party to acquire, or could discourage a
third party from acquiring, other securities of the Company. Accordingly, these
Preferred Stock provisions could limit the price that investors would be willing
to pay for the Company's Common Stock.
12
<PAGE>
Item 2. Description of Property
The Company leases approximately 21,634 square feet in Austin, Texas. The
Company believes it will not encounter any unusual difficulty obtaining
additional leased office space at acceptable terms and rates if required for
future expansion. The Company also has short term leases of office space in
Bridgewater, New Jersey and Windsor, England.
Item 3. Legal Proceedings
None
Item 4. Submission of Matters to a Vote of Security Holders
None
PART II
Item 5. Market For Common Equity and Related Shareholder Matters
The Company's Common Stock has, since March 1995, traded on the Over-the-
Counter Bulletin Board ("OTCBB"). Set forth below for the fiscal quarters
indicated are the range of high and low bids of the Common Stock on the OTCBB:
<TABLE>
<CAPTION>
1997 1998
---- ----
High Low High Low
------ ------ ------ -----
<S> <C> <C> <C> <C>
First Quarter 8-3/8 4 4-7/8 3-1/8
Second Quarter 6-5/16 3-3/4 3-3/8 1-1/4
Third Quarter 5-3/4 3-1/16 1-7/8 9/16
Fourth Quarter 4-7/8 3-7/8 1-7/16 5/16
</TABLE>
The foregoing quotations, which were obtained from Prophet Information Services,
Inc., reflect inter-dealer prices, without retail mark-up, mark-down or
commission, and may not represent actual transactions.
As of March 22, 1999, there were 45 shareholders of record of the Company's
Common Stock.
The Company has never paid dividends on its Common Stock and does not
anticipate that it will do so in the foreseeable future. The Company is
prohibited from paying dividends on its Common Stock without the consent of the
holders of the Company's Preferred Stock.
The Company has made the following sales of its Common Stock and Preferred
Stock during the fiscal year ended December 31, 1998. None of the sales have
involved the use of underwriters.
13
<PAGE>
<TABLE>
<CAPTION>
Amount of
Date of Sale Class of Securities Total
or Issuance Securities (Shares) Purchasers Consideration
- ------------------ ----------------- ----------- ------------- -------------
<S> <C> <C> <C> <C>
1. February 1998 Common 50,000 2 individuals $ 5,000.00
2. May 1998 Common 33,334 1 individual $36,667.40
3. June 1998 Class A Preferred 157 4 entities dividend
4. December 1998 Class A Preferred 166 4 entities dividend
</TABLE>
The sales pursuant to items 1 and 2 above were made upon exercise of options
under the Company's Amended and Restated 1995 Director, Employee and Consultant
Stock Option Plan and were made in reliance upon Regulation 701 promulgated
under the Securities Act of 1933.
The issuances described in items 3 and 4 above were scheduled dividends on
the Company's outstanding shares of Class A Convertible Preferred Stock. The
Class A Convertible Preferred Stock terms provide for semi-annual dividends,
which are payable in kind at the rate of 8% per annum. The Company does not
believe that payment of these dividends constitutes a separate sale and believes
that, to the extent the issuance may be deemed to be a sale, it is exempt
pursuant to Section 4(2) of the Securities Act of 1933 and Rule 506 thereunder.
Certificates representing securities issued in payment of the dividends bore
restrictive legends. For a description of the terms of the Class A Convertible
Preferred Stock, see Note 8 of Notes to Financial Statements.
Item 6. Management's Discussion and Analysis or Plan of Operation
Overview
The Company is a fully integrated contract research organization ("CRO")
serving the pharmaceutical, biotechnology and medical device industries
("sponsors"). The Company designs, manages and monitors clinical trials in
North America and Europe and provides integrated clinical and product
development services, including patient recruitment, data management,
biostatistical analysis, regulatory affairs, quality assurance and other
consultation services for its sponsors. The Company generates substantially all
of its revenue from services related to the clinical testing of new
pharmaceutical, biotechnology and medical device products.
The Company's contracts for services generally vary from a few months to
several years in duration. A portion of the contract fee is typically required
to be paid when the contract is initiated, with the balance payable in
installments over the contract's duration. The installment payments are based
on performance or the achievement of milestones, relating payment to previously
negotiated events such as patient enrollment, patient completion or delivery of
databases, or periodic, based on personnel fees and actual expenses, typically
billed on a monthly basis.
In accordance with the terms of the Company's contracts, sponsors may
terminate or delay the performance of a contract, potentially causing the
Company to experience periods of excess capacity and reductions in service
revenue and net income. Trials may be terminated or delayed for a variety of
reasons, including unexpected or undesired results, production problems
resulting in shortages of the product or delays in supplying the product,
adverse patient reaction to the product, or the sponsor's decision to de-
emphasize a particular trial. If a trial is terminated, the contract generally
provides for a short continuation or wind-down period, as the Company manages
required investigator obligations through the termination date. The Company is
typically entitled to all amounts owed for work performed through the notice of
termination and all costs associated with termination of the study. In
addition, contracts may require the payment of a separate early termination fee,
the amount of which usually declines as the trial progresses.
14
<PAGE>
Revenue from contracts is recognized as work is performed. Some contracts
contain a fixed price per patient plus either fixed or variable fees for
additional service components such as monitoring, project management,
advertising, travel, data management, consulting and report writing. Other
contracts are time and materials based. Payments received on contracts in
excess of amounts earned are recorded as deferred revenue.
The Company's gross revenue backlog consists of anticipated service revenue
from clinical trials and other services that have not been completed and that
generally specify completion dates within 24 months. To qualify as "backlog"
anticipated projects must be represented by contracts or letter agreements or
must be projects for which the Company has commenced a significant level of
effort based upon sponsor commitment and approval of a written budget. Once
work commences, service revenue is recognized over the life of the contract. The
Company's gross revenue backlog was approximately $7.5 million at December 31,
1998 and approximately $14.0 million at December 31, 1997. The decline in gross
revenue backlog reflects the impact of cancellations of certain clinical
studies, representing approximately $5.5 million in gross revenues, because the
Sponsor's drug did not meet their performance expectations. The Company
believes that its backlog at any given date is not necessarily a meaningful
predictor of future results, and no assurances can be given that the Company
will fully realize all of its backlog as service revenue.
Reimbursable costs can include patient stipends and investigator grants,
Institutional Review Board fees, laboratory fees, medical supplies, patient
recruitment advertising, travel and consulting fees. Reimbursable costs that
are paid to the Company directly by the client, and for which the Company does
not bear the risk of economic loss, are deducted from gross service revenue in
accordance with CRO industry practice.
Direct costs include project personnel costs and related allocated overhead
costs such as rent, supplies, postage, express delivery and telecommunications,
as well as study-related costs not reimbursed by clients. Selling, general and
administrative expenses consist primarily of compensation and benefits for
marketing and administrative personnel, professional services, facility costs,
and other allocated overhead items.
Results of Operations
Year ended December 31, 1998 compared to the year ended December 31, 1997
- -------------------------------------------------------------------------
The following table sets forth, for the periods indicated, certain items
included in the Company's audited statements of operations for the years ended
December 31, 1998 and 1997, and the percentage of net service revenue for each
item. Any results or trends illustrated in the following table may not be
indicative of future results or trends.
15
<PAGE>
<TABLE>
<CAPTION>
For the year ended December 31,
-------------------------------
1998 1997
---- ----
<S> <C> <C> <C> <C>
Gross revenue $11,553,901 $10,856,562
Reimbursable costs 4,235,221 3,790,416
----------- -----------
Net service revenue 7,318,680 100.0% 7,066,146 100.0%
Operating costs and expenses:
Direct costs 5,584,810 76.3% 5,052,698 71.5%
Selling, general and administrative 3,255,331 44.4% 3,549,622 50.2%
Depreciation and amortization 435,846 6.0% 474,464 6.7%
----------- -----------
Total operating costs and expenses 9,275,987 126.7% 9,076,784 128.4%
----------- -----------
Loss from operations (1,957,307) -26.7% (2,010,638) -28.4%
Net interest income (expense) 16,105 0.2% (329,897) -4.7%
----------- -----------
Net loss $(1,941,202) -26.5% $(2,340,535) -33.1%
=========== ===========
</TABLE>
Net service revenue increased approximately $253,000, or 4%. The increase
is primarily attributable to an increase in the volume and size of clinical
trials.
Direct costs increased approximately $532,000, or 11%. Most of the increase
in direct costs is due to additions of full-time study, patient and data
management staff and related overhead. As a percentage of net service revenues,
direct costs were approximately 76% for 1998 and 71% for 1997. Staffing levels
were increased in 1997 and early 1998 in anticipation of certain sponsor
programs which were cancelled in June 1998. Staffing levels were reduced in the
fourth quarter of 1998 to match existing levels of current contract revenues.
Selling, general and administrative expenses decreased approximately
$294,000 or 8%, primarily due to modest staffing reductions and cost containment
measures which were implemented in 1998. During 1998, a noncash charge of
approximately $22,000 for compensation expense was recorded related to certain
performance-based stock options, as compared to $158,000 in 1997. Selling,
general and administrative expenses were approximately 44% of net service
revenue for 1998, as compared to 50% for 1997. The improvement in the
percentage of selling, general and administrative expenses to net service
revenues is primarily the result of the decrease in these expenses in 1998.
Depreciation and amortization expenses decreased approximately $39,000 or
8%. Depreciation expense decreased to 6.0% of net service revenues in 1998 as
compared to 6.7% in 1997.
Interest income increased by approximately $107,000 during 1998. This is
primarily attributable to the increase in funds available for investment
resulting from the sale of preferred stock in late 1997. Interest expense
decreased by approximately $239,000. This decrease is due to higher interest
costs incurred in 1997 related to loan issuance costs and the valuation of
warrants issued on a 1997 term loan.
The Company recorded no income tax benefit as a result of the net operating
losses for the years ended December 31, 1998 and 1997, due to the uncertainty
that the loss carryforwards will be utilized.
Liquidity and Capital Resources
Since its inception, the Company has financed its operations and internal
growth with proceeds from private placements of equity securities, advances from
shareholders and borrowing arrangements under capital
16
<PAGE>
leases and lines of credit. Investing activities have consisted of capital
expenditures, primarily for leasehold improvements, information systems,
furniture and office equipment.
Typically, cash flows from contracts include a payment at the time a
contract commences and the balance in installments over the contract's duration,
in some cases on a milestone completion basis. Consequently, cash receipts do
not necessarily correspond to costs incurred and revenue recognized on
contracts. The Company's cash flow is influenced by changes in levels of
accounts receivable, net of amounts billed representing unearned revenue.
Accounts receivable decreased to approximately $2,270,000 at December 31, 1998
from approximately $2,470,000 at December 31, 1997. The decrease of
approximately $200,000 is a result of the timing of payments by sponsors.
Deferred or unearned revenue decreased by approximately $64,000 during 1998.
Cash collections from clinical study contracts for 1998 totaled approximately
$11,240,000 as compared with $10,860,000 for 1997.
Net cash flow used in operating activities was approximately $1,372,000 for
1998, as compared to approximately $1,577,000 in 1997. The improvement of
approximately $205,000 is primarily the result of the increase of accounts
payable in 1998. The 1998 operating losses were primarily the result of excess
capacity of clinical staffing due to the cancellation of certain clinical trials
during 1998. The contract cancellations adversely impacted 1998 earnings and
contract backlog levels. Expected growth in contract backlog did not occur in
1998. As a result, the operating losses did not improve in 1998. Management
intends to control future staff expansion and overhead cost increases until the
growth of net service revenues absorbs the current level of excess capacity.
Net cash decreased by approximately $1,590,000 during 1998. This decrease
is primarily due to continued operating losses and the payment of preferred
stock dividends on the Class B preferred stock.
Investing activities are attributable to purchases of property and equipment
and were approximately $40,000 in 1998 as compared to approximately $229,000 in
1997. In addition, the Company utilized operating and capital leases in 1998
to provide approximately $636,000 of property and equipment additions as
compared to $400,000 in 1997. During 1998, the Company installed an Oracle
database and three separate Oracle software applications on a Unix network
server to support project management, patient recruitment, data management and
accounting departments. The Oracle database and application platforms are
expected to improve operational efficiency, customer communication of clinical
study data, and support future growth.
Financing activities consist of net borrowings under the Company's $2.5
million revolving working capital line of credit. At December 31, 1998, there
was approximately $417,000 in outstanding borrowings. Availability under the
line of credit is primarily based upon 85% of billed accounts receivable, less
current borrowings. Accordingly, at December 31, 1998 there was $2,083,000 of
remaining availability under the line of credit. Pursuant to its Class B
preferred stock agreement, the Company paid approximately $562,000 in dividends
during the twelve months ended December 31, 1998.
Management believes that its existing capital resources, together with cash
flows from operations and borrowing capacity under its working capital line of
credit, will be sufficient to fund its operations in 1999. Should anticipated
growth in contract backlog levels and net service revenue not occur as expected
during the remainder of 1999, the Company will be required to seek additional
external financing in early 2000. Such external financing might be in the form
of public or private issuances of equity or debt securities or bank financing.
In addition, the Company may in the future acquire businesses to expand its
contract backlog and to enhance its therapeutic expertise. Any such acquisition
would also require additional external financing. There can be no assurance that
any required financing will be available on terms acceptable to the Company.
Year 2000
Information systems are an integral part of the services the Company
provides. Since many computer and software systems were designed to handle
dates with just two digits to represent the year applicable to a
17
<PAGE>
transaction, these systems may not operate properly when the last two digits of
the year become "00". For example, on January 1, 2000, these systems may
interpret "00" as the year 1900 not 2000. If the computer equipment and software
used in the operation of the Company do not correctly recognize date information
when the year changes to 2000, there could be an adverse impact on the Company's
operations.
The Company began its assessment of the Year 2000 issue from an internal
perspective in late 1997. The Company decided to change its information
technology ("IT") systems, including those relating to clinical operations, data
management operations and financial operations, to Year 2000 compliant software
applications on an Oracle database platform in the first quarter of 1998. These
new systems were implemented to improve management's control of the organization
and increase operating efficiency. The installation of these software systems
was substantially completed by December 31, 1998, and they are currently in
production. One of the software applications will require a minor upgrade to a
new version release in order to be certified by Oracle to be Year 2000
compliant. This upgrade is expected to be completed by June 30, 1999. The
Company estimates that it has spent approximately $750,000 on its hardware and
software systems to accommodate the Oracle database and related software
applications. These expenditures were financed through operating and capital
leases.
The Company has also reviewed and tested its non-IT systems such as fax
machines and telephone systems without experiencing any material failures. The
Company intends to perform an integrated systems test in the third quarter to
assure itself that all IT and non-IT systems will be fully capable of handling
the Year 2000 issue.
The Company is in the process of contacting its principal clients concerning
the state of their Year 2000 readiness. Until that effort is completed, the
Company cannot be assured that those other systems will be Year 2000 compliant
on time and is unable to estimate the impact of such a failure.
The Company believes that its most likely worst case Year 2000 scenarios
would relate to problems with the systems of unrelated third parties rather than
the Company's internal systems or those of its clients. It is clear that the
Company has the least ability to assess and remediate the Year 2000 problems of
third parties. The Company believes the risks are greatest with infrastructure
(e.g. electricity supply and water service), telecommunications and
transportation systems.
The Company is not in a position to identify or to avoid all possible
scenarios; however, the Company is currently assessing scenarios. This
contingency planning will continue through 1999 as the Company learns more about
the preparations and vulnerabilities of third parties regarding Year 2000
issues. Due to the large number of variables involved, the Company cannot
provide an estimate of the damage it might suffer if any of these scenarios were
to occur.
As we get closer to December 31, 1999, certain of the Company's customers
may decide to delay starting or awarding new clinical trials as a part of a
general restriction of awarding new clinical trials. Should any of the
Company's customers adopt such a strategy, this would have a material adverse
impact of the Company's future operating results.
Based on currently available information, management does not believe that
the Year 2000 issues discussed above related to internal systems will have a
material adverse impact on the Company's financial condition or overall trends
in results of operations; however, it is uncertain to what extent the Company
may be affected by such matters. In addition, there can be no assurance that
the failure to ensure Year 2000 capability by a customer or other third party
would not have a material adverse effect on the Company's financial condition or
overall trends in results of operations.
Information About Forward-Looking Statements
Certain statements made in Management's Discussion and Analysis or Plan of
Operation may constitute "forward-looking" statements within the meaning of the
federal securities laws. The Company notes that a
18
<PAGE>
variety of factors could cause the Company's actual results and experience to
differ materially from the anticipated results expressed in the Company's
forward-looking statements. The risks and uncertainties that may affect the
operations, performance, development and results of the Company's business
include the "Risk Factors" discussed in Item 1 above.
Item 7. Financial Statements
Index to Financial Statements:
Page
----
Report of PricewaterhouseCoopers LLP, Independent Accountants F-1
Balance Sheet - December 31, 1998 and 1997 F-2
Statement of Operations - Years ended December 31, 1998 and 1997 F-3
Statement of Shareholders' Equity - December 31, 1998 and 1997 F-4
Statement of Cash Flows - Years ended December 31, 1998 and 1997 F-5
Notes to Financial Statements F-6 - F-17
Item 8. Changes in and Disagreements With Accountants on Accounting and
Financial Disclosure
None
PART III
The Company plans to file with the Securities and Exchange Commission a
definitive proxy statement for its 1999 Annual Meeting of Shareholders (the
"Proxy Statement") not later than April 30, 1999, and certain information
included therein is incorporated herein by reference.
Item 9. Directors, Executive Officers, Promoters and Control Persons; Compliance
With Section 16(a) of the Exchange Act
The information regarding the Company's directors and executive officers
required by this Item is incorporated by reference to the sections in the
Company's Proxy Statement entitled "Election of Directors" and "Management."
The information regarding compliance with Section 16(a) of the Securities
Exchange Act of 1934 by the directors, executive officers and beneficial owners
of more than ten percent of the Common Stock of the Company required by this
Item is incorporated by reference to the section in the Company's Proxy
Statement entitled "Compliance Under Section 16(a) of the Securities Exchange
Act of 1934."
Item 10. Executive Compensation
The information regarding compensation of directors and executive officers
of the Company required by this Item is incorporated by reference to the section
in the Company's Proxy Statement entitled "Executive Compensation."
19
<PAGE>
Item 11. Security Ownership of Certain Beneficial Owners and Management
The information regarding security ownership of certain beneficial owners
and management required by this Item is incorporated herein by reference to the
section in the Company's Proxy Statement entitled "Ownership of Common Stock and
Preferred Stock."
Item 12. Certain Relationships and Related Transactions
The information regarding certain relationships and related transactions
required by this Item is incorporated by reference to the section in the
Company's Proxy Statement entitled "Certain Transactions."
Item 13. Exhibits List and Reports on Form 8-K
(a) Exhibits.
2 Not applicable
3(a) Articles of Incorporation, as previously amended (incorporated
herein by reference to Exhibit 3(a) filed with the Registration
Statement on Form 10-SB, as amended, declared effective January
13, 1997, Exhibit 3(a) to the registrant's Annual Report on Form
10-KSB as filed with the Securities and Exchange Commission on
March 30, 1998 and Exhibit 3(a) to the registrant's Quarterly
Report on Form 10-QSB as filed with the Securities and Exchange
Commission on August 13, 1998)
3(b) Amended and Restated Bylaws, as amended (incorporated herein by
reference to Exhibit 3(b) filed with the Registration Statement
on Form 10-SB, as amended, declared effective January 13, 1997
and Exhibit 3(a) to the registrant's Quarterly Report on Form 10-
QSB as filed with the Securities and Exchange Commission on
August 13, 1997)
4(a) Stock Purchase Agreement dated as of July 15, 1996 between the
registrant and Oracle Partners, L.P., Quasar International
Partners, C.V., Oracle Institutional Partners, L.P. and GSAM
Oracle Fund, Inc. (incorporated herein by reference to Exhibit
4(a) filed with the Registration Statement on Form 10-SB, as
amended, declared effective January 13, 1997)
4(b) Articles of Incorporation of the registrant, as amended,
incorporated herein by reference to Exhibit 3(a)
4(c) Amended and Restated Bylaws of the registrant, as amended,
incorporated herein by reference to Exhibit 3(b)
4(d) Terms of Warrants issued by the registrant (incorporated herein
by reference to Exhibit 4(d) filed with the Registration
Statement on Form 10-SB, as amended, declared effective January
13, 1997)
4(e) Sales Agent Warrant dated May 20, 1996 issued to SJ Capital, Inc.
(incorporated herein by reference to Exhibit 4(f) filed with the
Registration Statement on Form 10-SB, as amended, declared
effective January 13, 1997)
4(f) Warrant to purchase shares of the registrant's common stock
issued to Oracle Partners, L.P. on July 1, 1997 (incorporated
herein by reference to Exhibit 4(a) to the registrant's
20
<PAGE>
Quarterly Report on Form 10-QSB as filed with the Securities and
Exchange Commission on August 13, 1997)
4(g) Preferred Stock Purchase Agreement dated November 7, 1997 between
the registrant and Sirrom Capital Corporation d/b/a Tandem
Capital (incorporated herein by reference to Exhibit 4(a) to the
registrant's Quarterly Report on Form 10-QSB as filed with the
Securities and Exchange Commission on November 14, 1997)
4(h) Registration Rights Agreement dated as of November 25, 1997
between the registrant and Sirrom Capital Corporation d/b/a
Tandem Capital (incorporated herein by reference to Exhibit
4(h)filed with the registrant's Annual Report on Form 10-KSB as
filed with the Securities and Exchange Commission on March 30,
1998)
4(i) Amended and Restated Registration Rights Agreement dated as of
November 25, 1997 between the registrant, Oracle Partners, L.P.,
Quasar International Partners, C.V., Oracle Institutional
Partners, L.P. and GSAM Oracle Fund, Inc. (incorporated herein by
reference to Exhibit 4(i) filed with the registrant's Annual
Report on Form 10-KSB as filed with the Securities and Exchange
Commission on March 30, 1998)
4(j) Lock-Up Agreement dated as of November 25, 1997 between the
registrant, O'Donnell Family Limited Partnership, Messrs. Robert
S. Sammis and Thomas P. O'Donnell, Oracle Partners, L.P., Quasar
International Partners, C.V., Oracle Institutional Partners,
L.P., GSAM Oracle Fund, Inc. and Sirrom Capital Corporation d/b/a
Tandem Capital (incorporated herein by reference to Exhibit
4(j)filed with the registrant's Annual Report on Form 10-KSB as
filed with the Securities and Exchange Commission on March 30,
1998)
4(k) Warrant to purchase shares of the registrant's common stock
issued to The Robinson-Humphrey Company, LLC on November 25, 1997
(incorporated herein by reference to Exhibit 4(k) filed with the
registrant's Annual Report on Form 10-KSB as filed with the
Securities and Exchange Commission on March 30, 1998)
9 Not applicable
10(a) Voting and Pre-Merger Agreement dated February 14, 1995 among the
registrant, Thomas P. O'Donnell, Robert S. Sammis and Steven J.
Dell, M.D. (incorporated herein by reference to Exhibit 10(a)
filed with the Registration Statement on Form 10-SB, as amended,
declared effective January 13, 1997)
10(b) Voting and Pre-Merger Agreement dated February 14, 1995 among the
registrant, Thomas P. O'Donnell, Robert S. Sammis and William M.
Ramsdell, M.D. (incorporated herein by reference to Exhibit 10(b)
filed with the Registration Statement on Form 10-SB, as amended,
declared effective January 13, 1997)
10(c) Voting and Pre-Merger Agreement dated February 14, 1995 among the
registrant, Thomas P. O'Donnell, Robert S. Sammis and David
Shulman, M.D. (incorporated herein by reference to Exhibit 10(c)
filed with the Registration Statement on Form 10-SB, as amended,
declared effective January 13, 1997)
10(d) Sales Agent Agreement effective September 15, 1995 between the
registrant and SJ Capital, Inc. (incorporated herein by reference
to Exhibit 10(d) filed with the Registration Statement on Form
10-SB, as amended, declared effective January 13, 1997)
21
<PAGE>
10(e) Option Agreement dated March 5, 1996 between the registrant and
Randolph J. Haag (incorporated herein by reference to Exhibit
10(j) filed with the Registration Statement on Form 10-SB, as
amended, declared effective January 13, 1997)
10(f) Stock Option Agreement dated February 27, 1995 between the
registrant and Robert S. Sammis (incorporated herein by reference
to Exhibit 10(m) filed with the Registration Statement on Form
10-SB, as amended, declared effective January 13, 1997)
10(g) Employment Agreement dated July 15, 1996 between the registrant
and Robert S. Sammis (incorporated herein by reference to Exhibit
10(o) filed with the Registration Statement on Form 10-SB, as
amended, declared effective January 13, 1997)
10(h) Unsecured Note dated October 1, 1995 executed by the registrant
and payable to Robert Sammis (incorporated herein by reference to
Exhibit 10(q) filed with the Registration Statement on Form 10-
SB, as amended, declared effective January 13, 1997)
10(i) Letter Agreement dated August 21, 1996 between the registrant and
Zola P. Horovitz (incorporated herein by reference to Exhibit
10(s) filed with the Registration Statement on Form 10-SB, as
amended, declared effective January 13, 1997)
10(j) Lease dated October 23, 1996 between the registrant and Lake
Austin Commons, Ltd. (incorporated herein by reference to Exhibit
10(t) filed with the Registration Statement on Form 10-SB, as
amended, declared effective January 13, 1997)
10(k) First Amendment to Office Lease Agreement dated November 21, 1996
between the registrant and Lake Austin Commons, Ltd.
(incorporated herein by reference to Exhibit 10(u) to the
registrant's Annual Report on Form 10-KSB as filed with the
Securities and Exchange Commission on April 15, 1997)
10(l) Agreement Regarding Option Grant effective January 1, 1997
between the registrant and Robert S. Sammis (incorporated herein
by reference to Exhibit 10(x) to the registrant's Annual Report
on Form 10-KSB as filed with the Securities and Exchange
Commission on April 15, 1997)
10(m) Stock Option Agreement dated May 12, 1997 between the registrant
and James W. Clark, Jr. (incorporated herein by reference to
Exhibit 10(a) to the registrant's Quarterly Report on Form 10-QSB
as filed with the Securities and Exchange Commission on August
13, 1997)
10(n) Employment Agreement effective June 1, 1997 between the
registrant and James W. Clark, Jr. (incorporated herein by
reference to Exhibit 10(a) to the registrant's Quarterly Report
on Form 10-QSB as filed with the Securities and Exchange
Commission on November 14, 1997)
10(o) Loan and Security Agreement effective December 19, 1997 between
the registrant and NationsCredit Commercial Corporation, through
its NationsCredit Commercial Funding Division (incorporated
herein by reference to Exhibit 10(o) filed with the registrant's
Annual Report on Form 10-KSB as filed with the Securities and
Exchange Commission on March 30, 1998)
10(p) Employment Agreement effective March 17, 1998 between the
registrant and Susan Krivacic (incorporated herein by reference
to Exhibit 10(o) filed with the registrant's Annual Report on
Form 10-KSB as filed with the Securities and Exchange Commission
on March 30, 1998)
22
<PAGE>
10(q) Amended and Restated 1995 Director, Employee and Consultant Stock
Option Plan (incorporated herein by reference to Exhibit 10(q)
filed with the registrant's Annual Report on Form 10-KSB as filed
with the Securities and Exchange Commission on March 30, 1998)
11 Not applicable
13 Not applicable
16 Letter on Change in Certifying Accountant (incorporated herein by
reference to Exhibit 16 filed with the Registration Statement on
Form 10-SB, as amended, declared effective January 13, 1997)
18 Not applicable
21 Not applicable
22 Not applicable
23 Not applicable
24 Not applicable
27 Financial Data Schedule
99 Not applicable
(b) Reports on Form 8-K.
No reports on Form 8-K were filed during the last quarter of the fiscal year
covered by this report.
23
<PAGE>
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
CLINICOR, INC.
Date March 30, 1998 By /s/ Robert S. Sammis
------------------------------- --------------------------------------
Robert S. Sammis
President, Principal Executive Officer
In accordance with the Exchange Act, this report has been signed below by
the following persons on behalf of the registrant and in the capacities and on
the dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ Robert S. Sammis President, Principal Executive March 30, 1999
- --------------------------------- Officer, Director
(Robert S. Sammis)
/s/ James W. Clark, Jr. Vice President of Finance, March 30, 1999
- --------------------------------- Principal Financial Officer,
(James W. Clark, Jr.) Secretary, Treasurer, Director
/s/ Rosina Maar, M.D. Vice President of Operations, March 30, 1999
- --------------------------------- Director
(Rosina Maar, M.D..)
/s/ Joel D. Liffmann Director March 30, 1999
- ---------------------------------
(Joel D. Liffmann)
/s/ Zola P. Horovitz, Ph.D. Director March 30, 1999
- ---------------------------------
(Zola P. Horovitz, Ph.D.)
</TABLE>
24
<PAGE>
Report of Independent Accountants
To the Board of Directors and
Shareholders of Clinicor, Inc.
In our opinion, the accompanying balance sheets and the related statements of
operations, of shareholders' equity and of cash flows present fairly, in all
material respects, the financial position of Clinicor, Inc. at December 31, 1998
and 1997, and the results of its operations and its cash flows for the years
then ended in conformity with generally accepted accounting principles. These
financial statements are the responsibility of the Company's management; our
responsibility is to express an opinion on these financial statements based on
our audits. We conducted our audits of these statements in accordance with
generally accepted auditing standards which require that we plan and perform the
audit to obtain reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements,
assessing the accounting principles used and significant estimates made by
management, and evaluating the overall financial statement presentation. We
believe that our audits provide a reasonable basis for the opinion expressed
above.
PricewaterhouseCoopers LLP
Austin, Texas
March 23, 1999
F-1
<PAGE>
<TABLE>
<CAPTION>
Clinicor, Inc.
Balance Sheet
===================================================================================================================================
December 31, December 31,
1998 1997
---------------- ----------------
<S> <C> <C>
Assets
Current assets:
Cash and cash equivalents $ 1,665,672 $ 3,255,182
Accounts receivable, net 2,272,376 2,472,928
Prepaid and other current assets 352,337 129,823
----------------- ----------------
Total current assets 4,290,385 5,857,933
Property and equipment, net 1,097,441 1,029,122
Other assets, net 1,717 -
----------------- ----------------
Total assets $ 5,389,543 $ 6,887,055
================= ================
Liabilities and shareholders' equity
Current liabilities:
Current portion of obligations under capital leases $ 307,796 $ 45,929
Accounts payable and accrued liabilities 1,414,636 1,052,957
Line of credit 416,624 -
Deferred revenue 989,540 1,053,150
----------------- ----------------
Total current liabilities 3,128,596 2,152,036
Obligations under capital leases, less current portion 324,376 68,173
----------------- ----------------
Total liabilities 3,452,972 2,220,209
Shareholders' equity:
Class A convertible preferred stock, no par value,
5,181 shares authorized 4,253 and 3,930 shares issued
and outstanding, respectively , at liquidation value 4,253,000 3,930,000
Class B convertible preferred stock, no par value,
50,000 shares authorized, issued
and outstanding, at liquidation value 5,000,000 5,000,000
Common stock, $0.001 par value, 75,000,000 shares
authorized, 4,169,734 and 4,086,400 shares issued
and outstanding, respectively 4,170 4,086
Additional paid-in capital 718,683 1,875,536
Deferred compensation (22,196) (66,892)
Accumulated deficit (8,017,086) (6,075,884)
----------------- ----------------
Total shareholders' equity 1,936,571 4,666,846
----------------- ----------------
Total liabilities and shareholders' equity $ 5,389,543 $ 6,887,055
================= ================
</TABLE>
The accompanying notes are an integral part of these financial statements.
F-2
<PAGE>
<TABLE>
<CAPTION>
Clinicor, Inc.
Statement of Operations
==================================================================================================================================
Years Ended December 31,
-----------------------------
1998 1997
------------------- --------------------
<S> <C> <C>
Service revenue:
Gross revenue $ 11,553,901 $ 10,856,562
Reimbursable costs 4,235,221 3,790,416
------------------- --------------------
Net service revenue 7,318,680 7,066,146
Operating costs and expenses:
Direct costs 5,584,810 5,052,698
Selling, general and administrative 3,255,331 3,549,622
Depreciation and amortization 435,846 474,464
------------------- --------------------
Total operating costs and expenses 9,275,987 9,076,784
------------------- --------------------
Loss from operations (1,957,307) (2,010,638)
Other income and expenses:
Interest income 144,619 37,274
Interest expense (128,514) (367,171)
------------------- --------------------
Other income and expenses 16,105 (329,897)
------------------- --------------------
Net loss $ (1,941,202) $ (2,340,535)
=================== ====================
Net loss $ (1,941,202) $ (2,340,535)
Preferred stock dividends and conversion discount (923,437) (2,027,880)
------------------- ------------------
Net loss applicable to common stock $ (2,864,639) $ (4,368,415)
=================== ====================
Basic/diluted earnings (loss) per share $ (0.69) $ (1.07)
=================== ====================
Weighted average common shares
outstanding 4,150,761 4,086,400
=================== ====================
</TABLE>
The accompanying notes are an integral part of these financial statements.
F-3
<PAGE>
<TABLE>
<CAPTION>
Clinicor, Inc.
Statement of Shareholders' Equity
==================================================================================================================================
Class A Class B Additional
Convertible Convertible Common Common Paid-In
Preferred Preferred Shares Stock Capital
------------ ----------- ---------- ----------- --------------
<S> <C> <C> <C> <C> <C>
Balance at December 31, 1996 $ 3,631,000 $ - 4,086,400 $ 4,086 $ 2,418,915
Convertible preferred stock issued on
November 25,1997, 50,000 shares, net - 5,000,000 - - (362,868)
Amortization of deferred compensation - - - - -
Warrants issued in connection with debt obtained - - - - 180,000
Net loss - - - - -
Cash dividends on preferred stock - - - - (61,511)
Stock dividends on preferred stock 299,000 - - - (299,000)
----------------- ----------- ---------- ----------- --------------
Balance at December 31, 1997 3,930,000 5,000,000 4,086,400 4,086 1,875,536
Common stock issued - - 83,334 84 41,584
Amortization of deferred compensation - - - - -
Net loss - - - - -
Cash dividends on preferred stock - - - - (600,000)
Stock dividends on preferred stock 323,000 - - - (323,437)
Stock option compensation adjustment (see note 7) - - - - (275,000)
----------------- ------------ ---------- ----------- --------------
Balance at December 31, 1998 $ 4,253,000 $ 5,000,000 4,169,734 $ 4,170 $ 718,683
================= ============ ========== =========== ==============
<CAPTION>
Deferred Accumulated
Compensation Deficit Total
----------------- ------------ -----------
<S> <C> <C> <C>
Balance at December 31, 1996 $ (224,800) $ (3,735,349) $ 2,093,852
Convertible preferred stock issued on
November 25,1997, 50,000 shares, net - - 4,637,132
Amortization of deferred compensation 157,908 - 157,908
Warrants issued in connection with debt obtained - - 180,000
Net loss - (2,340,535) (2,340,535)
Cash dividends on preferred stock - - (61,511)
Stock dividends on preferred stock - - -
----------------- ------------ -----------
Balance at December 31, 1997 66,802 (6,075,884) 4,666,846
Common stock issued - - 41,668
Amortization of deferred compensation 22,196 - 22,196
Net loss - (1,941,202) (1,941,202)
Cash dividends on preferred stock - - (600,000)
Stock dividends on preferred stock - - (437)
Stock option compensation adjustment (see note 7) 22,500 - (252,500)
----------------- ------------ -----------
Balance at December 31, 1998 $ (22,196) $ (8,017,086) $ 1,936,571
================= ============ ===========
</TABLE>
The accompanying notes are an integral part of these financial statements.
F-4
<PAGE>
<TABLE>
<CAPTION>
Clinicor, Inc.
Statement of Cash Flows
====================================================================================================================
Years Ended December 31,
---------------------------------------
1998 1997
---------------- -------------------
<S> <C> <C>
Operating activities:
Net loss $ (1,941,202) $ (2,340,535)
Adjustments to reconcile net loss to net cash used in operating
activities:
Depreciation and amortization 435,846 474,464
Stock option compensation (benefit) expense (230,309) 157,908
Accretion of debt discount - 180,000
Allowance for doubtful accounts - 20,000
Net changes in assets and liabilities:
Accounts receivable 200,553 (1,003,373)
Prepaid expenses and other assets (96,558) 14,169
Accounts payable and accrued liabilities 322,909 (97,503)
Deferred revenue (63,610) 1,018,150
--------------------- ----------------
Net cash used in operating activities (1,372,371) (1,576,720)
--------------------- ----------------
Investing activities:
Purchases of property and equipment (39,592) (228,718)
--------------------- ----------------
Financing activities:
Payments on capital leases (74,172) (29,486)
Repayments of shareholder loans - (181,000)
Proceeds from term loan - 1,000,000
Repayment of term loan - (1,000,000)
Net proceeds from issuing common stock 41,668 -
Net proceeds from issuing preferred stock - 4,637,132
Preferred dividends paid (561,667) -
Borrowings (repayments) under line of credit 416,624 (850,000)
Restricted cash securing line of credit - 1,009,840
--------------------- ----------------
Net cash provided by (used in) financing activities (177,547) 4,586,486
--------------------- ----------------
Net increase (decrease) in cash and cash equivalents (1,589,510) 2,781,048
Cash and cash equivalents at beginning of year 3,255,182 474,134
--------------------- ----------------
Cash and cash equivalents at end of year $ 1,665,672 $ 3,255,182
===================== ================
Supplemental cash flow disclosures:
Interest paid $ 128,514 $ 206,388
===================== ================
Non-cash financing activities:
Preferred stock dividends and conversion discount $ 323,000 $ 1,965,667
===================== ================
Capital lease obligations $ 592,240 $ 115,808
===================== ================
</TABLE>
The accompanying notes are an integral part of these financial statements.
F-5
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
Note l Organization and Summary of Significant Accounting Policies
- -------------------------------------------------------------------
Description of Business
Clinicor, Inc. ("Clinicor" or the "Company") is a contract research organization
serving companies in the pharmaceutical, biotechnology and medical device
industries. Clinicor manages, monitors and performs clinical trials which are
studies of investigational drugs and medical devices performed with human
patients to support sponsors' applications to the Food and Drug Administration
and other governmental authorities. The Company operates in one business
segment.
Use of Estimates
The preparation of financial statements in conformity with generally accepted
accounting principles 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.
Cash and Cash Equivalents
Cash and cash equivalents consist primarily of funds invested in short-term
interest bearing accounts. The Company considers all highly liquid investments
purchased with initial maturities of three months or less to be cash
equivalents.
Concentration of Credit Risk
Financial investments which potentially expose the Company to concentrations of
credit risk, as defined by Statement of Financial Accounting Standards No. 105,
consist primarily of trade accounts receivable.
The majority of the Company's customer base consists of large pharmaceutical and
biotechnology companies. Although the Company is directly affected by the well
being of the pharmaceutical industry, management does not believe significant
credit risks existed at December 31, 1998.
Property and Equipment
Property and equipment is stated at cost, net of accumulated depreciation and
amortization. Depreciation is calculated on the straight-line method over the
estimated useful lives of the assets ranging from three to five years. Repair
and maintenance costs are charged to expense as incurred.
F-6
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
Revenue Recognition
Fixed price contract revenue is recognized using the percentage of completion
method based upon the ratio of services provided to date compared to total
services to be provided under each contract. Revenue from other contracts is
recognized as the services are provided. Losses on contracts, if any, are
accrued when they become probable.
Study contracts generally provide for payments based upon the achievement of
defined benchmarks. Deferred revenue represents amounts invoiced prior to
rendering the related services, while unbilled revenue represents the billing
value of services rendered prior to being invoiced. Substantially all the
deferred revenue and unbilled revenue will be earned and billed, respectively,
within one year.
Direct Costs
Direct costs are direct expenses of performing studies, including compensation
and related benefits for project personnel, investigator fees, patient stipends,
laboratories, advertising, labor, other clinical costs, and allocated overhead
expenses.
Income Taxes
The Company accounts for income taxes in accordance with Statement of Financial
Accounting Standards No. 109, "Accounting for Income Taxes" ("SFAS 109") under
which deferred tax assets and liabilities are provided on differences between
carrying value for financial reporting purposes and tax bases of assets and
liabilities using the enacted tax rates. A valuation allowance is recognized,
if on the weight of available evidence, it is more likely than not that some
portion or all of the deferred tax asset will not be realized.
Fair Value of Financial Instruments
The carrying amounts of the Company's financial instruments, including cash and
cash equivalents and trade accounts receivable and payable and debt approximate
fair values.
Comparative Information
Certain amounts related to the prior year have been reclassified to conform to
the current year presentation.
F-7
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
Note 2 Accounts Receivable
- ---------------------------
Accounts receivable consisted of the following at December 31:
1998 1997
----------- -----------
Billed $ 1,276,671 $ 1,259,614
Unbilled 1,015,705 1,233,314
Allowance for
doubtful accounts (20,000) (20,000)
----------- -----------
$ 2,272,376 $ 2,472,928
=========== ===========
Note 3 Property and Equipment
- ------------------------------
Property and equipment consisted of the following at December 31:
1998 1997
---------- ----------
Computer systems $1,017,481 $ 720,509
Leasehold improvements 421,596 416,511
Office equipment 436,053 512,171
Medical equipment 28,261 57,987
---------- ----------
1,903,391 1,707,178
Less accumulated
depreciation and
amortization 805,950 678,056
---------- ----------
$1,097,441 $1,029,122
========== ==========
Depreciation expense was $435,846 and $444,726 for the years ended December 31,
1998 and 1997, respectively.
Included in the December 31, 1998 and 1997 balances of equipment are $627,500
and $163,000, respectively, of assets acquired under capital leases.
Accumulated depreciation of these assets was $115,500 and $69,000 at December
31, 1998 and 1997, respectively, and depreciation expense was $46,500 and
$46,790 respectively, for the years ended December 31, 1998 and 1997.
F-8
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
Note 4 Accounts Payable and Accrued Liabilities
- ------------------------------------------------
Accounts payable and accrued liabilities consisted of the following at December
31:
1998 1997
---------- ----------
Accounts payable trade $1,111,371 $ 537,204
Accrued investigators 77,872 293,877
Dividends payable 100,725 61,955
Accrued other 124,668 159,921
---------- ----------
$1,414,636 $1,052,957
========== ==========
Note 5 Line of Credit
- ----------------------
On July 1, 1997, the Company entered into a six-month term loan with its Class A
Preferred Shareholder. The loan terms required the payment of interest at 10%.
In connection with negotiating the loan, the Company issued a warrant to
purchase 200,000 shares of Clinicor's common stock at $5.50 per share. The
warrant exercise price was adjusted to $5.06 per share and the shares
purchasable were adjusted to 217,391 in connection with the issuance of the
Class B Preferred Stock (Note 7). The warrants are immediately exercisable and
expire five years from the date of issuance. The Company valued the warrant at
$180,000 and reflected such amount as a discount to the related debt. The
discount was amortized using the effective interest method over the six month
term of the related debt. Total interest expense recognized in 1997 related to
this loan was approximately $314,750. The loan was repaid on November 25, 1997.
On December 30, 1997, the Company entered into a $2.5 million secured revolving
credit facility with a national banking institution which expires on December
19, 2001. Availability under the line of credit is primarily based upon 85% of
billed accounts receivable, less current borrowings, and remaining availability
approximated $2,083,400 at December 31, 1998. The line of credit is repaid with
the proceeds from collections of accounts receivable; therefore, the line of
credit is classified as a current liability. The interest rate at December 31,
1998 on this credit facility was 10.00%. Interest expense for this credit
facility was $110,300 and $0 for the years ended December 31, 1998 and 1997,
respectively.
Note 6 Commitments and Contingencies
- -------------------------------------
The Company leases office space, computers and other equipment under non-
cancelable operating and capital lease agreements. These leases have expiration
dates ranging from 1999 through 2002. Rent expense under operating leases
totaled $439,500 and $423,000 for the years ended December 31, 1998 and 1997,
respectively.
F-9
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
Future minimum lease payments under all leases as of December 31, 1998 are as
follows:
Capital Operating
Leases Leases
-------- ----------
1999 $351,217 $ 633,523
2000 315,562 531,442
2001 30,137 420,692
2002 and thereafter - -
-------- ----------
Total minimum lease payments $696,916 $1,585,657
==========
Less amounts representing interest (64,744)
--------
Present value of net minimum
lease payments 632,172
Less current portion of capital
lease obligations 307,796
--------
$324,376
========
Note 7 - Capital Stock
- ----------------------
Class A Preferred Stock
On July 15, 1996, the Company issued to Oracle Partners, L.P. and certain
affiliates 3,500 shares of convertible Class A preferred stock, no par value
(the "Class A Preferred Stock"), for total consideration of $3,500,000, which
provided the Company net proceeds of $3,180,177 after deducting offering costs
of $319,823. Included in these offering costs was $125,000 of expense to cancel
certain preemptive rights held by three shareholders. The Class A Preferred
Stock carries a liquidation preference of $1,000 per share. The Class A
Preferred Stock provides for annual cumulative dividends, which for a five-year
period following issuance are payable in kind and which accrue at the rate of 8%
per annum. On the fifth anniversary of the date of issuance, the dividend rate
increases to 10% per annum, and the rate thereafter increases by an additional
2% on each successive anniversary date. Dividends accruing after the fifth
anniversary date are payable in cash. Through 1998, the Company issued Class A
Preferred Stock dividends of 753 shares.
The Class A Preferred Stock is redeemable at the option of the Company at any
time after July 15, 1998; there is no mandatory redemption. The Class A
Preferred Stock is convertible into that number of shares of common stock of the
Company as is equal to the liquidation preference of the Class A Preferred Stock
being converted, divided by a "conversion value", which is initially $1.50 and
which is subject to adjustment if certain events occur. No such events had
occurred as of December 31, 1998.
F-10
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
Class B Preferred Stock
On November 25, 1997, the Company issued to Tandem Capital, a division of Sirrom
Capital Corporation, 50,000 shares of Class B Convertible Preferred Stock, no
par value ("Class B Preferred Stock"), for total consideration of $5,000,000,
which provided the Company net proceeds of $4,637,132 after deducting offering
costs of $362,868. The Class B Preferred Stock carries a liquidation preference
of $100 per share. The Class B Preferred Stock provides for annual cumulative
dividends of $12 per share payable quarterly. The annual dividend rate of $12
per share will be increased by $2 per share beginning on the fifth anniversary
of the issuance and subsequently every six months thereafter.
The Class B Preferred Stock cannot be redeemed during the first year of issuance
unless the Company has first offered to redeem all the Class A Preferred Stock.
After the first year and prior to the fifth anniversary of the original issue
date, the Company may redeem the Class B Preferred Stock, as long as the average
bid price of common stock exceeds $6.00 per share for each of the immediately
preceding 20 consecutive trading days.
The Class B Preferred Stock is convertible at any time into that number of
shares of common stock of the Company as is equal to the liquidation preference
divided by the conversion price which is initially set at $3.00 per share The
conversion price was reduced to $2.75 per share as of December 31, 1998,
pursuant to the agreement. The conversion price is subject to future
adjustments if certain events occur.
The original $3.00 conversion price represented a discount from the market price
of Clinicor common stock at the date of issuance of the Class B Preferred Stock.
As a result, $1,666,667 of the proceeds, representing the conversion discount,
was allocated to additional paid in capital. The carrying amount of the Class B
Preferred Stock was accreted to redemption value during 1997 as a charge to paid
in capital equity. The conversion discount is reflected as a reduction of
income available to common shareholders in the 1997 earnings per share
calculation (Note 9).
The holders of the Class A and B Preferred Stock have various additional rights,
including registration rights, pursuant to the Company's Articles of
Incorporation, as amended, and pursuant to various agreements entered into with
the holders of the Class A and B Preferred Stock.
During 1998, the Company paid approximately $562,000 in dividends to Class B
Preferred stockholders.
Stock Option Plan
In December 1994, the Company and the shareholders approved the 1995 Directors,
Employees and Consultants Stock Option Plan (the "Option Plan"), which provides
for the grant of both incentive and non-qualified stock options to directors,
employees and certain other persons affiliated with the Company. The stock
options granted under the Option Plan are generally granted at the fair value of
the common stock on the date of the grant. The terms of each option (including
duration of the options, which is typically 5 to 10 years, and provisions as to
vesting) are determined by the Board of Directors at the time of grant and are
set forth in an option agreement between the Company and the optionee. At
December 31, 1998 and 1997, the Company had reserved 2,000,000 shares of common
stock under the Option Plan.
The Company has adopted the disclosure only provision of Statement of Financial
Accounting Standards No. 123 "Accounting for Stock-Based Compensation" and has
elected to continue to apply Accounting Principles Board No. 25 "Accounting for
Stock Issued to Employees" and related interpretations in accounting for the
Option Plan. Accordingly, no compensation expense has been recognized for
option grants made at fair value and containing fixed vesting terms. The
Company has recorded deferred compensation equal to the fair value of fixed
option grants made to individuals other than employees and directors and fixed
option grants to employees made below fair value, as well as performance based
stock
F-11
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
option grants. Amortization of deferred compensation, which is being charged
against income over the vesting period of the options, totaled $22,196 and
$157,900 in 1998 and 1997, respectively.
During 1998, the Company reversed previously recognized compensation expense of
$252,000 resulting from employees' forfeiture of unvested stock options.
Of the 1,079,620 options outstanding at December 31, 1998, 112,720 have
performance based vesting provisions which allow these options to vest anytime
after January 1, 1999, if for any previous twelve-month period the Company
achieves revenues of $18 million or pre-tax earnings of $3 million. In early
1997, the vesting provisions of these options were modified such that all
options not previously vested will vest on February 27, 2000.
Had compensation cost of all stock option grants been determined based on their
fair value at the grant date consistent with the method prescribed by SFAS No.
123, the Company's pro forma net loss and loss per share would have been as
follows:
For the Year Ended For the Year Ended
December 31, 1998 December 31, 1997
------------------ ------------------
Net loss applicable As reported $ (2,864,639) $ (4,368,415)
to common stock Pro forma $ (3,939,392) $ (4,739,726)
Net loss applicable
to common stock As reported $ (0.69) $ (1.07)
per share Pro forma $ (0.95) $ (1.16)
The fair value of each option grant is estimated on the date of grant using the
Black-Scholes option pricing model with the following weighted average
assumptions used for grants in 1998 and 1997, respectively; dividend yield of
zero for both years; expected volatility of 70% and 55%; risk-free interest rate
of 5.75% and 6.1%; and respective estimated lives of 5 years.
On May 18, 1998, the Board of Directors approved a proposal to reprice
outstanding employee stock options with exercise prices in excess of the fair
market value, except those shares held by outside directors of the Company. A
total of 787,500 options with an average exercise price of $4.43 were repriced
at $2.75 per share. At the time of the repricing, the fair market value of the
Company's stock was $2.00 per share.
F-12
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
The following table summarizes the status of option grants outstanding at
December 31:
1998 1997
------------------- ---------------------
Weighted Weighted
Average Average
Exercise Exercise
Shares Price Shares Price
-------------------- --------------------
Outstanding, beginning of year 1,188,220 $ 3.25 487,720 $ 1.05
Granted 288,500 $ 2.69 710,500 $ 4.73
Exercised (83,334) $ .50 - -
Canceled (313,766) $ 2.32 (10,000) 1.50
--------- ---------
Outstanding, end of year 1,079,620 $ 2.43 1,188,220 $ 3.25
========= =========
Options exercisable at
year end 422,620 $ 1.93 265,168 $ 1.25
Weighted-average fair value of
options granted during year $ 1.24 $ 2.66
The following table summarizes information about stock options outstanding at
December 31, 1998:
Options Outstanding Options Exercisable
----------------------------------------------------------------
Weighted-
Average
Remaining
Range of Contractual Weighted- Weighted-
Exercise Prices Number Life Average Price Number Average Price
----------------------------------------------------------------
$1.00 to $2.00 252,720 1.82 $ 1.23 252,720 $ 1.23
$2.75 799,400 5.92 $ 2.75 142,400 $ 2.75
$4.00 10,000 3.48 $ 4.00 10,000 $ 4.00
$4.25 17,500 3.36 $ 4.25 17,500 $ 4.25
--------- --------
1,079,620 422,620
========= ========
F-13
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
Common Stock Warrants
As discussed in Note 5, the Company issued a warrant in 1997 to purchase a total
of 200,000 shares of Clinicor common stock in conjunction with obtaining a term
loan. The warrant has been subsequently adjusted to 217,391 shares with an
exercise price of $5.06 per share. In addition, the Company issued a warrant in
1997 to purchase a total of 100,000 shares of Clinicor common stock at $5.50 per
share for professional services in connection with the Class B Preferred Stock
offering.
Note 8 - Income Taxes
- ---------------------
The tax expense (benefit) is composed of the following:
<TABLE>
<CAPTION>
For the Year For the Year
Ended Ended
December 31, December 31,
1998 1997
---------------------- -----------------------
<S> <C> <C>
Current $ - $ -
Deferred (766,822) (718,428)
Change in valuation allowance 766,822 718,428
--------------------- ----------------------
Income tax expense (benefit) $ - $ -
===================== ======================
</TABLE>
The difference between the tax expense (benefit) derived by applying the Federal
statutory income tax rate to the Company's net losses and the expense (benefit)
recognized is as follows:
<TABLE>
<CAPTION>
For the Year For the Year
Ended Ended
December 31, December 31,
1998 1997
---------------------- --------------------
<S> <C> <C>
Benefit derived by applying the Federal statutory $(660,009) $(795,782)
income rate to net losses before income taxes
Permanent differences and other (106,813) 77,354
Change in valuation allowance 766,822 718,428
--------------------- -------------------
Income tax expense (benefit) $ - $ -
===================== ===================
</TABLE>
The components of the deferred taxes are:
<TABLE>
<CAPTION>
For the Year For the Year
Ended Ended
December 31, December 31,
1998 1997
--------------------- ---------------------
<S> <C> <C>
Deferred tax assets:
Net operating loss carryforwards $ 2,280,140 $ 1,617,590
Fixed Assets 35,463 (32,145)
Accrued Wages 29,750
Other 19,256 12,342
Valuation allowance (2,364,609) (1,597,787)
--------------------- ---------------------
Deferred tax asset (liability) $ - $ -
===================== =====================
</TABLE>
F-14
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
The Company's net operating loss carryforward totaling $6,706,000 at December
31, 1998 expires in varying amounts through 2013. Under section 382 of the
Internal Revenue Code, changes in ownership exceeding certain levels can result
in an annual limitation on losses and tax credit carryforwards. Such limitation
may limit the Company's ability to fully utilize its carryforwards prior to
expiration.
Note 9 - Earnings per Share
- ---------------------------
Basic EPS is computed by dividing net income (loss) applicable to common
stockholders by the weighted average number of common shares outstanding during
each period. Diluted EPS is computed by dividing net income (loss) applicable
to common stockholders by the weighted average number of common shares and
common share equivalents outstanding (if dilutive), during each period. The
number of common share equivalents outstanding is computed using the treasury
stock method.
The following is a reconciliation of the basic per share computations:
For the year ended December 31,
-------------------------------
1998 1997
------------------------------
Loss from continuing operations $ (1,941,202) $ (2,340,535)
Less-Preferred stock dividends-Class A Preferred (323,437) (299,702)
Preferred stock dividends-Class B Preferred (600,000) (61,511)
Accretion of discount on Class B Preferred - (1,666,667)
------------- -------------
Loss applicable to common shareholders $ (2,864,639) $ (4,368,415)
============= =============
Shares used in computing basic earnings
per share 4,150,761 4,086,400
Loss per share
Basic/Diluted $ (0.69) $ (1.07)
============= ===-=========
At December 31, 1998, potentially dilutive securities, which are excluded from
the EPS computation as they would have an anti-dilutive effect, consisted of
stock options convertible into 1,079,620 shares of common stock; Series A
convertible preferred stock convertible into 2,835,333 shares of common stock;
Series B convertible preferred stock convertible into 1,818,182 shares of common
stock; and warrants convertible into 776,111 shares of common stock.
F-15
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
Note 10 Segment Information and Significant Clients
- ----------------------------------------------------
In June 1997, the FASB issued SFAS No. 131, "Disclosure about Segments of an
Enterprise and Related Information," which the Company adopted in the first
quarter of 1998. The statement supercedes SFAS No. 14 "Financial Reporting for
Segments of a Business Enterprise," replacing the "industry segment" approach
with the "management" approach. The management approach designates the internal
organization that is used by management for making operating decisions and
assessing performance as the source of the Company's reportable segments. It
also requires disclosures about products and services, geographic areas and
major customers.
Management has chosen to organize the Company by geographic areas, and as a
result has determined that it has one reportable segment. All selling and
administrative expenses, interest income, interest expense, depreciation and
amortization are recorded in the United States. In addition, all identifiable
assets are located in the United States.
During the years ended December 31, 1998 and 1997, the Company's international
revenues were primarily attributable to one client. Following are the Company's
international sales by geographic area (in thousands):
For the Year Ended
December 31,
------------------------
1998 1997
--------- ---------
Net service revenue:
United States $6,601 90% $6,576 93%
United Kingdom 718 10% 490 7%
------ ------
$7,319 100% $7,066 100%
====== ======
The Company has had up to four clients who each accounted for more than 10% of
the Company's revenues in a given year as follows:
1998 1997
------------------------
Client A 4.9% 11.0%
Client B 35.9% 24.0%
Client C 12.8% 4.0%
Client D 12.3% 8.0%
Client E 0.5% 22.0%
Client F 10.0% 6.0%
Additionally, at December 31, 1998 and 1997, certain clients had accounts
receivable and unbilled revenue balances with the Company which represented the
following amounts of total net accounts receivable and unbilled revenues:
1998 1997
------------------------
Client A 33.0% 18.0%
Client B 25.0% -
Client C 9.0% 18.0%
Client D 6.0% 10.0%
Client E - 11.0%
F-16
<PAGE>
Clinicor, Inc.
Notes to Financial Statements
================================================================================
Note 11- Employee Benefit Plans
- -------------------------------
Employee 401(K) Plan
The Company's 401(k) Savings and Retirement Plan, effective January 1, 1996, is
a defined contribution retirement plan as described in Section 401(k) of the
Internal Revenue Code (the "401(k) Plan"). The 401(k) Plan is intended to be
qualified under Section 401 (a) of the Code. All full time employees of the
Company are eligible to participate in the 401(k) Plan after approximately 90
days of employment. The 401(k) Plan provides that each participant make
elective contributions up to 15% of his or her compensation, subject to
statutory limits. The Company amended its plan, effective May 1, 1998, to
provide for employee matching contributions of 20% of the first 5% of
participating employee contributions. The Company made matching contributions
of $19,900 and $0 for 1998 and 1997, respectively.
Employee Stock Purchase Plan
In November 1998, the Company established an employee stock purchase plan. The
employees may make elective payroll deductions for the purchase of the Company's
stock. The Company disburses these payroll deductions once per month to a
brokerage firm which purchases the Company stock in the stock market. The
Company pays all brokerage commissions.
F-17
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM CLINICOR,
INC. FINANCIAL STATEMENTS AS OF DECEMBER 31, 1998, AND FOR THE 3- AND 12-MONTH
PERIODS ENDED DECEMBER 31, 1998, AND THE ACCOMPANYING NOTES AND IS QUALIFIED IN
ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<S> <C> <C>
<PERIOD-TYPE> 3-MOS 12-MOS
<FISCAL-YEAR-END> DEC-31-1998 DEC-31-1998
<PERIOD-START> SEP-01-1998 JAN-01-1998
<PERIOD-END> DEC-31-1998 DEC-31-1998
<CASH> 1,665,672 1,665,672
<SECURITIES> 0 0
<RECEIVABLES> 2,272,376 2,272,376
<ALLOWANCES> 20,000 20,000
<INVENTORY> 0 0
<CURRENT-ASSETS> 4,292,102 4,292,102
<PP&E> 1,903,391 1,903,391
<DEPRECIATION> 805,950 805,950
<TOTAL-ASSETS> 5,389,543 5,389,543
<CURRENT-LIABILITIES> 3,128,596 3,128,596
<BONDS> 324,376<F1> 324,376<F1>
0 0
9,253,000 9,253,000
<COMMON> 4,170 4,170
<OTHER-SE> 1,927,318 1,927,318
<TOTAL-LIABILITY-AND-EQUITY> 5,389,543 5,389,543
<SALES> 2,988,448 11,553,901
<TOTAL-REVENUES> 2,988,448 11,553,901
<CGS> 1,106,322 5,584,810
<TOTAL-COSTS> 2,027,509 9,275,987
<OTHER-EXPENSES> 0 0
<LOSS-PROVISION> 0 0
<INTEREST-EXPENSE> 21,925<F2> (16,105)<F2>
<INCOME-PRETAX> (550,803) (1,941,202)
<INCOME-TAX> 0 0
<INCOME-CONTINUING> (550,803) (1,941,202)
<DISCONTINUED> 0 0
<EXTRAORDINARY> 0 0
<CHANGES> 0 0
<NET-INCOME> (550,803) (1,941,202)
<EPS-PRIMARY> (0.19) (0.69)
<EPS-DILUTED> (0.19) (0.69)
<FN>
<F1>Consists of capitalized lease obligations, excluding current portions.
<F2>Net interest expense is net of interest revenue.
</FN>
</TABLE>
