-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WReGjvhnlLEsFqLlRISa1z1Jb+Vl8roaBKB30kw7Yvg7F/WRvz2oFTWDQlA4sl7y ztQosKp/p7x9vJTs4Ms55w== 0000950144-97-002958.txt : 19970327 0000950144-97-002958.hdr.sgml : 19970327 ACCESSION NUMBER: 0000950144-97-002958 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 19961231 FILED AS OF DATE: 19970326 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: PHARMACEUTICAL PRODUCT DEVELOPMENT INC CENTRAL INDEX KEY: 0001003124 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 561640186 STATE OF INCORPORATION: NC FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27570 FILM NUMBER: 97564119 BUSINESS ADDRESS: STREET 1: 3151 17TH STREET EXTENSION CITY: WILMINGTON STATE: NC ZIP: 28401 BUSINESS PHONE: 9102510081 10-K 1 PHARMACEUTICAL PRODUCT DEVELOPMENT INC 12/31/96 1 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (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, 1996 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number 0-27570 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. (Exact name of registrant as specified in its charter) North Carolina 56-1640186 (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) 3151 Seventeenth Street Extension Wilmington, North Carolina 28412 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (910) 251-0081 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, par value $0.10 per share (Title of class) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No ----- ----- Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10-K. [ ] The aggregate market value of the voting stock held by non-affiliates of the registrant was $448,370,794 as of March 10, 1997, based upon the closing price of the Common Stock on that date on the NASDAQ National Market System. Shares of Common Stock held by each executive officer and director and by each person who owns 10% or more of the outstanding Common Stock have been excluded in that such persons may be deemed to be affiliates. This determination of affiliate status may not be conclusive for other purposes. The number of shares outstanding of the registrant's class of Common Stock, par value $0.10 per share, was 22,185,842 as of March 10, 1997. DOCUMENTS INCORPORATED BY REFERENCE The Company's definitive Proxy Statement for its 1997 Annual Meeting of Stockholders (certain parts as indicated herein Part III). 2 PART I Statements in this Annual Report on Form 10-K that are not descriptions of historical facts are forward-looking statements that are subject to risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth herein and in the Company's other SEC filings, and including, in particular, risks relating to government regulation, dependence on certain industries, fixed price nature of contracts, dependence on personnel, management of growth and competition. ITEM 1. BUSINESS. Company Overview Pharmaceutical Product Development, Inc. ("PPD" or "the Company") provides a broad range of research and consulting services in the life and environmental sciences. The Company's life sciences subsidiaries include PPD Pharmaco, Inc. and Clinix International Inc. PPD Pharmaco is a leading contract research organization ("CRO") providing integrated product development services on a global basis to complement the research and development activities of companies in the pharmaceutical and biotechnology industries. Through its environmental sciences subsidiary, APBI Environmental Sciences Group, Inc., operating under the trade name ENVIRON, the Company provides assessment and management of chemical and environmental health risk. In September 1996, a wholly-owned subsidiary of the Company was merged with and into Applied Bioscience International Inc. ("APBI") pursuant to which APBI became a wholly-owned subsidiary of the Company. Subsequent to the merger, the Company believes it is the third largest CRO in the world. The Company's CRO operations (formerly doing business as Pharmaceutical Product Development, Inc., or PPD) and APBI's CRO business (formerly doing business as Pharmaco International) have been integrated and now operate under the trade name PPD Pharmaco. Life Sciences Group The Company's Life Sciences Group provides services through PPD Pharmaco, Inc. and its wholly-owned European, South American and South African subsidiaries (collectively "PPD Pharmaco"), and through Clinix International Inc. ("Clinix"), which currently operates through one division using the trade name Chicago Center for Clinical Research ("CCCR"). PPD Pharmaco offers its clients high quality, value-added services designed to reduce drug development time. Reduced development time allows the client to get its products into the market faster and to maximize the period of marketing exclusivity and the economic return for such products. In addition, PPD Pharmaco's integrated services offer its clients a variable cost alternative to the fixed costs associated with internal drug development. PPD Pharmaco's professional CRO services include Phase I clinical testing, laboratory services, Phase II-IV clinical trial management, clinical data management and biostatistical analysis, treatment Investigational New Drug Applications, medical writing and regulatory services, and healthcare economics and outcomes research. The Company believes that it is one of a few CROs in the world capable of providing such a broad range of clinical development services. Clinix was established in 1995 as a wholly-owned subsidiary of APBI. In August 1995, Clinix acquired the business and substantially all of the assets of CCCR, a nationally recognized organization which conducts clinical trials in the pharmaceutical and food and nutrition industries. The Company believes the acquisition of CCCR is of strategic importance in enhancing and expanding the range of clinical development services offered. In addition to the acquisition of APBI, the Company furthered its expansion outside of the U.S. in 1996 through the acquisition of Trilife Gesellschaft Fur Medizinische Entwicklung Verwaltungs GmbH ("Trilife") in Germany, Medisys S.L. ("Medisys") in Spain and Q&Q Suporte A Pesquisa Clinica Ltda. ("Q&Q") in Brazil. The consideration for Trilife consisted of approximately $567,000 paid at closing. In addition, the Company may pay up to an additional $135,000 as additional purchase price, dependent upon the performance of Trilife for a certain period after the acquisition. The consideration for Medisys consisted of $400,000 paid at closing, plus an additional $300,000 due on each of the first and second anniversaries of the acquisition. The consideration for Q&Q consisted of $500,000 paid at closing, plus an additional $100,000 due on each of the first three anniversaries of the acquisition. In 1996, the Company also acquired Data Acquisition and Research (DAR) Limited ("DAR"), located in Scotland, which allowed it to expand its biostatistics and data analysis capabilities in Europe. The consideration for DAR consisted of cash paid at closing of $992,000, plus an additional $348,000 to be paid in 10 installments between June 1997 and December 2001. Subsequent to year end, the 1 3 Company acquired Belmont Research, Inc. ("Belmont") in a transaction to be accounted for as a pooling of interests. Belmont provides software development and system integration services to the pharmaceutical industry. The consideration for Belmont consisted of 502,384 shares of the Company's common stock plus the issuance of approximately 115,000 options to acquire shares of the Company's common stock. In November 1995, APBI sold its toxicology laboratories, located in New Jersey and Suffolk, England, to Huntingdon International Holdings plc ("Huntingdon"). The Company received as consideration net cash proceeds of $32.5 million and Huntingdon's Phase I clinical center located in Leicester, England, at an agreed-upon value of $4.5 million. Environmental Sciences Group ENVIRON. The Company's Environmental Sciences Group provides services through APBI Environmental Sciences Group, Inc., operating under the trade name ENVIRON. ENVIRON is a multidisciplinary environmental and health sciences consulting firm that provides a broad range of services relating to the presence of hazardous substances in the environment, in drugs and medical devices, in consumer products and in the workplace. Services provided by ENVIRON are concentrated in the assessment and management of chemical risk and are characterized by engagements supporting private sector clients with complex, potentially high-liability concerns. For the first time, the Company expanded its environmental services business outside the U.S. with the acquisition of Environmental Assessment Group Limited ("EAG"), located in the United Kingdom, in September 1996. The consideration for EAG consisted of $1.9 million cash, a note for approximately $350,000 and the potential to earn up to an additional $500,000, depending upon the profits of EAG during the two years after the acquisition. Subsequent to year end, the Company furthered its expansion in its Environmental Sciences Group through the acquisition of Technical Assessment Systems, Inc. ("TAS") in January 1997. The consideration for TAS consisted of cash of $490,000, a note for $300,000 and the potential to pay an additional amount depending upon TAS' profitability for a certain period after the acquisition. Industry Overview Life Sciences Group The CRO industry provides independent product development services to the pharmaceutical and biotechnology industries. In general, CROs derive substantially all of their revenue from the research and development expenditures of pharmaceutical and biotechnology companies. The CRO industry has evolved from providing limited clinical services in the 1970s to a full-service industry today that encompasses the clinical research process (including pre-clinical evaluations), study design, clinical trial management, data collection and biostatistical analysis and product registration support. All of these services are provided in accordance with applicable government regulations covering clinical trials and the drug approval process in the jurisdictions where the services are provided, including the regulations of the Food and Drug Administration ("FDA") in the United States and the European Medicines Evaluation Agency ("EMEA"). The healthcare industry is subject to changing political, economic and regulatory influences that may affect the pharmaceutical and biotechnology industries. Implementation of government healthcare reform may adversely affect research and development expenditures by pharmaceutical and biotechnology companies which could decrease the business opportunities available to the Company. The Company is unable to predict the likelihood of such or similar legislation being enacted into law or the effects such legislation would have on the Company. As a general matter, the clinical CRO industry is not capital intensive and the financial costs of entry into the industry are relatively low. The CRO industry is highly fragmented, with several hundred small, limited-service providers, several medium-sized CROs and a few full-services CROs with international capabilities. Although there are few barriers to entry for small, limited-service providers, the Company believes that there are significant barriers to becoming a full-service CRO with international capabilities. Some of these barriers include the cost and experience necessary to develop broad therapeutic expertise, the ability to manage large, complex clinical trials, the experience to prepare regulatory submissions and the infrastructure and experience to respond to the international needs of clients. Environmental Sciences Group The environmental industry has long been dependent upon governmental programs and regulations developed in response to concerns regarding the safety of chemicals in the air, water, food, consumer products and land. Historically, much of the growth experienced by environmental firms has come from assisting private sector clients respond to the regulatory systems that have been put into place at both the federal and state levels. In addition, litigation support on 2 4 behalf of private sector clients involved in disputes with government agencies or other private parties has been a significant source of market opportunity and revenue. For the next several years, the Company believes that the environmental industry will find continued, but more limited, opportunities to grow. Opportunities to provide litigation support are expected to increase. However, the extent to which new or existing regulations provide a growing base of business will depend largely on how the differences between the views of the current and new Congressional Class of 1997 and the President are resolved. In addition, after many years of dealing with problems created in the past, general industry, especially the manufacturing, industrial and chemical concerns, is now able to turn its attention to current operations and prevention of future environmental issues. The industry's proactive approach will create new and expanding opportunities for the environmental industry. For example, leaders in industry are already developing programs to incorporate safety, health and environmental considerations into their product and process design. A growing area for the environmental industry to provide services is in assisting companies to incorporate environmental and public health concerns into plans for effective corporate strategic growth. The Company believes that international opportunities for environmental industry growth will continue to expand as the world moves toward a global economy. Companies seeking to enter the world economy will need assistance in developing environmental management systems and in monitoring these programs for compliance with international standards. In addition, as world markets become more developed, opportunities will increase for the environmental industry to assist private firms in merger and acquisition planning and in general evaluation and management of environmental and public health risks. The Company believes that its acquisition of EAG will allow it to better pursue these opportunities. The Drug Development Process Before a new drug is marketed, the drug must undergo extensive testing and regulatory review in order to determine that it is safe and effective. The development process consists of two stages: pre-clinical and clinical. The first stage is the pre-clinical research, in which the new drug is tested in vitro (test tube) and in animals, generally over a one-to three-year period, in order to determine the basic biological activity and safety of the drug. The Company does not provide animal-based services in this stage of development. If the drug is perceived to be safe for human testing, the drug then undergoes a series of clinical tests in humans. During the clinical stage, one of the most time-consuming and expensive parts of the drug development process, the drug undergoes a series of tests in humans, including healthy volunteers and patients with the targeted disease or condition. Prior to commencing human clinical trials in the United States, the sponsor must file an Investigational New Drug ("IND") application with the FDA. In order to receive IND status, the sponsor of the new drug must provide available manufacturing data, pre-clinical data, information about any use of the drug in humans in other countries or in the United States for other purposes and a detailed plan for the conduct of the proposed clinical trials. The design of these trials, also referred to as the study protocols, is essential to the success of the drug development effort, because the protocols must correctly anticipate the nature of the data to be generated and results that the FDA will require before approving the drug. In the absence of any FDA comments within 30 days after the IND filing, human clinical trials may begin. Although there is no statutory definition of the structure or design of clinical trials, human trials usually start on a small scale to assess safety and then expand to larger trials to test efficacy. These trials are usually grouped into the following three phases, with multiple trials generally conducted within each phase: - Phase I. Phase I trials involve testing the drug on a limited number of healthy individuals, typically 20 to 80 persons, to determine the drug's basic safety data relating to tolerance, absorption, metabolism and excretion as well as other pharmacological indications and actions. This phase lasts an average of six months to one year. - Phase II. Phase II trials involve testing a small number of volunteer patients, typically 100 to 200 persons who suffer from the targeted disease or condition, to determine the drug's effectiveness and dose response relationship. This phase lasts an average of one to two years. - Phase III. Phase III trials involve testing large numbers of patients, typically several hundred to several thousand persons, to verify efficacy on a large scale, as well as long-term safety. These trials involve numerous sites and generally last two to three years. 3 5 After the successful completion of all three clinical phases, the sponsor of a new drug in the United States submits a New Drug Application ("NDA") to the FDA requesting that the product be approved for marketing. The NDA is a comprehensive, multi-volume filing that includes, among other things, the results of all pre-clinical and clinical studies, information about the drug's composition and the sponsor's plans for producing, packaging and labeling the drug. In addition, while the FDA does not use price as a criterion for approving a new drug, advisory panels of scientists that help the FDA evaluate new types of therapies have started taking cost into consideration. The FDA's review of an NDA can last from a few months, for drugs related to life-threatening circumstances, to many years, with the average review lasting two and one-half years. Drugs that successfully complete this review may be marketed in the United States, subject to the conditions imposed by the FDA. As a condition to its approval of a drug, the FDA may require that the sponsor conduct additional clinical trials following receipt of NDA approval to monitor long-term risks and benefits, study different dosage levels or evaluate different safety and efficacy parameters in target patient populations. In recent years, the FDA has increased its reliance on these trials, known as Phase IV trials, which allow new drugs that show early promise to reach patients without the delay associated with the conventional review process. Phase IV trials usually involve thousands of patients. Regulatory Environment The market for the services offered by both the Company's CRO operations and ENVIRON has developed as a result of significant laws and regulations governing the development and testing of certain drugs and hazardous substances and the impact of hazardous substances on the environment. Many countries require safety testing prior to obtaining governmental approval to market various substances, including pharmaceutical products, industrial chemicals and agrochemicals. The most significant laws and regulations concern the safety of pharmaceutical products. The results of clinical tests conducted upon pharmaceutical products must be submitted to appropriate government agencies, such as the FDA in the U.S., the EMEA and national regulatory agencies in Europe and the Ministry of Health and Welfare in Japan, as part of the relevant pre-market approval process in individual countries. Manufacturers of industrial chemicals and agrochemicals must also comply with toxicological testing requirements in connection with the pre-market approval process. In recent years, heightened concern over the presence of potentially toxic substances in the environment has focused attention on the need to evaluate the effects of existing and new chemical substances. As a result, regulations have been enacted in many jurisdictions expanding the regulatory process for industrial chemical and agrochemical products, including the Toxic Substances Control Act ("TSCA") and the Federal Insecticide, Fungicide & Rodenticide Act in the United States ("FIFRA"), and the council Directive 91/414/EEC in Europe. The management and remediation of hazardous substances in the environment are also subject to extensive federal legislation in the U.S., including the Comprehensive Environmental Response, Compensation and Liability Act of 1980 ("CERCLA", commonly known as the "Superfund" legislation) and the Superfund Amendment and Reauthorization Act of 1986 ("SARA"), which address problems involving the remediation of past waste disposal practices; the Resource Conservation and Recovery Act of 1976 ("RCRA") and the Hazardous Solid Waste Amendments of 1984, which regulate the management of newly created wastes; the Safe Drinking Water Act of 1974; the Clean Water Act; the Occupational Safety and Health Act ("OSHA") and the 1990 Clean Air Act Amendments. In addition, state authorities have enacted significant environmental legislation, including California's Safe Drinking Water and Toxic Enforcement Act of 1986 and New Jersey's Industrial Site Recovery Act. Trends Affecting the CRO Industry In 1996, worldwide expenditures on research and development by pharmaceutical and biotechnology companies are estimated to have been $30 billion, of which the Company estimates $10-15 billion was spent on drug development activities of the type offered by the CRO industry. The Company believes that approximately $2.7 billion of such spending was outsourced to CROs. The Company believes that the outsourcing of drug development activities by pharmaceutical and biotechnology companies has been increasing and will continue to increase for the following reasons: Cost Containment Pressures Market forces and governmental initiatives have placed significant pressure on pharmaceutical and biotechnology companies to reduce drug prices. Pressures on profit margins have arisen from increased competition as a result of patent expiration, market acceptance of generic drugs and governmental and private efforts to reduce healthcare 4 6 costs. In addition, private managed care organizations are beginning to limit the selection of drugs from which affiliated physicians may prescribe, thereby further increasing competition among pharmaceutical and biotechnology companies. The Company believes that the pharmaceutical industry is responding to these pressures by downsizing operations, decentralizing the internal research and development process and converting the fixed costs of maintaining a research and development infrastructure to variable costs by outsourcing drug development activities to CROs. The downsizing of research and development activities also creates demand for CROs as internal development bottlenecks arise when a large number of compounds emerge from the research process and need to be pushed through the development pipeline. In addition, increased pressure to differentiate products and to generate support for product pricing serves as the foundation for growth in the area of healthcare economics, both with respect to drugs under development and to products already on the market. Revenue Enhancement Through Faster Drug Development Pharmaceutical and biotechnology companies face increased pressure to bring innovative, patent-protected medicines to market in the shortest possible time, while following good science practices and adhering to government regulations. Pharmaceutical and biotechnology companies are attempting to increase the speed of new product development, and thereby maximize the period of marketing exclusivity and economic returns for their products, by outsourcing development activities to CROs. The Company believes that CROs, by providing specialized development services, are often able to perform the needed services with a higher level of expertise or specialization, and more quickly, than a pharmaceutical or biotechnology company could perform such services internally. In addition, some pharmaceutical and biotechnology companies are beginning to contract with large full-service CROs to conduct all phases of clinical trials for new product programs lasting several years, rather than separately contracting specific phases of drug development to several different CROs, an approach which the Company believes may result in shorter overall development times. Biotechnology Industry Growth The United States biotechnology industry has grown rapidly over the last ten years and is developing significant numbers of new drug candidates that will require regulatory approval. Many of these new drug candidates are now moving into clinical development and many biotechnology companies do not have the necessary staff, expertise or financial resources to conduct clinical trials on their own. Accordingly, many of these companies have chosen to outsource the product development process rather than expend significant time and resources to develop an internal clinical development capability. Further, PPD Pharmaco's experience suggests that biotechnology companies are increasingly turning to CROs for their sophisticated regulatory expertise to provide assistance in the generation of the ideal development plan. Moreover, the biotechnology industry is expanding into and within Europe, providing growth opportunities for CROs with international capabilities. Need for International Support Pharmaceutical and biotechnology companies are attempting simultaneous filings of registration packages in several major jurisdictions rather than following the past practice of sequential filings. The studies to support such registration packages may include a combination of multinational and domestic trials. Pharmaceutical and biotechnology companies may turn to CROs for assistance with such trials, as well as collecting, analyzing, integrating and reporting the data. The Company believes that CROs with an international presence and management experience in the simultaneous filing of multiple applications may benefit from these trends. Consolidation in the CRO Industry As a result of competitive pressures, the CRO industry is consolidating. Mergers and acquisitions, including the Company's merger with APBI, have resulted in the emergence of several large, full-service CROs that have the capital, technical and financial resources to conduct all phases of clinical trials on behalf of pharmaceutical and biotechnology companies. As pharmaceutical and biotechnology companies increasingly outsource development, they may turn to larger CROs that provide a broad range of clinical services, while at the same time they may also limit the number of CROs they choose to provide such services. The Company believes that this trend will further concentrate market share among larger CROs with a track record of speed, flexibility, responsiveness and overall development experience and expertise. Company Strategy The Company's fundamental strategy is to distinguish its services on the basis of superior performance. The Company strives to deliver to its clients efficient and innovative services that accelerate the rate of new product development. The Company intends to expand the depth and breadth of its services by (i) capitalizing on its managerial 5 7 and operational strengths, (ii) focusing on hiring and training its staff, (iii) focusing on its strategic marketing initiatives, (iv) developing its services in healthcare economics and communications consulting, (v) pursuing strategic acquisitions, (vi) expanding geographically and (vii) pursuing opportunities provided by technological advances. Management and Operational Strength The Company is guided by senior management who have spent much of their careers as development experts within major pharmaceutical companies and who have a record of success before the United States FDA and the EMEA in Europe. PPD Pharmaco concentrates on its core operational strengths in all phases of clinical studies and other critical path studies such as treatment Investigational New Drug Applications. Timely performance is based on parallel drug development processes and leveraging the knowledge and experience of management and investigators. Basic medical, scientific and regulatory services continue to be integrated with, and streamlined through, advances in various areas of technology, all directed toward a reduction in overall development times. PPD Pharmaco emphasizes efficiencies in each phase of clinical trials, data acquisition, data management and analysis, report writing and report filing, in order to reduce the time and cost of obtaining regulatory approval for its clients' products. As a means of differentiating itself from its competitors, PPD Pharmaco emphasizes therapeutic area specialization, in particular in the areas of virology/AIDS/infectious diseases, gastroenterology/metabolic diseases, cardiovascular diseases, critical care, pulmonary/allergy, central nervous systems, dermatology, food and nutrition, oncology, rheumatology and women's health. Hiring and Training The Company believes that its success is based on the quality and dedication of its employees. The Company strives to hire the best available people in terms of ability, attitude, experience and fit with the Company's performance philosophy. New employees are trained extensively, and the Company believes that it is an industry leader in the thoroughness of its training programs. In addition, employees are encouraged to continually upgrade and broaden their skills through internal and external training. As new technologies develop, employees are equipped with and trained to make use of such technological innovations. Strategic Marketing PPD Pharmaco focuses its marketing and sales efforts with an emphasis on high volume clients with needs in the service segments and therapeutic areas in which the Company specializes. Direct salespeople concentrate on a group of assigned clients, marketing across service segments. PPD Pharmaco's business development personnel consult with potential clients early in the bidding stage in order to determine their needs. The business development personnel and PPD Pharmaco's project managers then invest significant time to determine the optimal way to design and carry out the potential client's proposal. PPD Pharmaco's recommendations to the potential client with respect to study design and implementation are an integral part of PPD Pharmaco's bids and an important aspect of the integrated services that PPD Pharmaco offers to its clients. PPD Pharmaco believes that its extensive preliminary efforts relating to the evaluation of a potential client's proposed clinical protocol and implementation plan allows accelerated commencement of the clinical trial after the contract has been awarded to PPD Pharmaco. ENVIRON conducts separate marketing activities at each of its office locations, and believes that its regional presence enables its professionals to gain a greater knowledge of regional environmental issues, a better understanding of regional laws and regulations and a more constructive working relationship with regional governmental agency personnel. Because of the technical nature of ENVIRON's business, most marketing activities at each of ENVIRON's operating divisions are conducted by technical and scientific personnel, with initial contacts frequently followed up by personal visits to clients' offices. The Company sponsors and encourages the participation by its personnel in a variety of scientific endeavors, including the presentation of papers by its professional staff at meetings of professional societies and major conferences and the publication of scientific articles in respected journals. The Company believes such activities enhance its reputation for professional excellence. The Company's core marketing efforts are complemented by advertising in trade journals and by exhibits at scientific conferences. Healthcare Economics and Outcomes Research The healthcare market in the United States is evolving from a fragmented system of individual providers with little incentive to control costs to a managed care system in which large organizations attempt to lower the cost of healthcare through a number of means. The Company believes that such market dynamics support the need for healthcare economics analysis and outcomes research. PPD Pharmaco offers programs integrating such analysis in clinical 6 8 development programs to support regulatory approval, as well as pricing, marketing and reimbursement strategies. While PPD Pharmaco's current focus in this area is on its traditional client base within the pharmaceutical and biotechnology industries, both with respect to drugs under development and products already on the market, PPD Pharmaco expects to extend such services to payers and providers as well. Acquisitions The Company will continue to actively seek strategic acquisitions, both within and outside current CRO service segments. Acquisition candidates must provide opportunities for innovation, synergy and growth. The Company's criteria for acquisitions may include complementary client lists, ability to increase market share within and across clients, complementary therapeutic area and service segment strengths, strategic geographic capabilities or particular process expertise. Acquisitions involve numerous risks, including difficulties in the assimilation of the operations and services of the acquired companies, the expenses incurred in connection with the acquisition and subsequent assimilation of operations and products, the diversion of management's attention from other business concerns and the potential loss of key employees of the acquired company. If the Company consummates any acquisitions in the future, there can be no assurance that such acquisitions will be successfully integrated into the Company's operations. The Company's merger with APBI allowed the Company to become one of the few full-service, multi-national CROs, capable of monitoring clinical trials involving hundreds of investigative sites, conducted simultaneously in North America and Europe. Geographical Expansion In addition to the merger with APBI, the Company's recent acquisitions in Germany, Spain, Brazil, Scotland and England reflect its commitment to strategic geographic expansion. Outside the United States, PPD Pharmaco currently has operations in many locations in Europe, along with Australia, Brazil, Canada and South Africa. PPD Pharmaco has identified certain strategic areas of promise where CROs currently have limited or no presence and intends to selectively pursue these and other strategic opportunities internationally. With its recent acquisition of EAG in the United Kingdom, the Company's Environmental Sciences Group has expanded outside the U.S. for the first time. ENVIRON will continue to pursue other strategic opportunities, both within the U.S. and internationally. Technological Advances PPD Pharmaco believes that optimizing the use of information technology in conjunction with drug development experience can accelerate the drug development process and yield valuable marketing information. PPD Pharmaco has experience in the use of information technology in clinical trial management and offers or is developing a wide range of technology-based services, including initial market research and study design, remote monitoring and data acquisition, ongoing study management, outcomes research, patient and disease management and the filing of Computer Assisted New Drug Applications and Product License Applications. The Company believes that the use of third-party systems and selected internally developed software allows it to offer its clients the best available technology for expediting the drug development process. Services Offered Life Sciences Group PPD Pharmaco has designed its various services to be flexible and integrated in order to assist its clients in optimizing their research and development spending through the clinical stages of the drug development process. PPD Pharmaco provides Phase I clinical testing, laboratory services, Phase II-IV clinical trial management, clinical data management and biostatistical analysis, treatment Investigational New Drug Applications, medical writing and regulatory services and healthcare economics and outcomes research for its clients. PPD Pharmaco's services can be provided individually or as an integrated package of services to meet its client's needs. Through the CCCR division of Clinix, the Life Sciences Group participates in and conducts clinical trials in the pharmaceutical and food and nutrition industries. During 1996, $152.3 million, or 77.0%, of the Company's net revenue was generated by the Life Sciences Group. Phase I Clinical Testing After an Investigational New Drug Application has been filed with the FDA, human testing of a new drug can begin. The drug is typically first administered to healthy volunteers to determine the drug's basic safety data based on 7 9 tolerance, absorption, metabolism, excretion and other pharmacological actions. Later, special studies are conducted in volunteers and special patient populations to further define the drug's overall pharmacological profile. PPD Pharmaco is the largest Phase I provider, with clinical testing services conducted in its 200-bed unit in Austin, Texas, its 66-bed unit located near Research Triangle Park, North Carolina and its 52-bed unit in Leicester, England. The Phase I's professional nursing staff administers general Phase I safety tests, special population studies and bioavailability and bioequivalence testing. Special population studies may involve the elderly, women or patients with specific diagnoses such as renal failure or asymptomatic HIV disease. The Company's clinical research studies rely upon the ready accessibility and willing participation of volunteer subjects. These subjects generally include volunteers from the communities in which the studies are conducted, including the Phase I centers in Austin, Texas; Raleigh, North Carolina and Leicester, England; which have provided a substantial pool of potential subjects for research studies. The Company's business could be adversely affected if the Company were unable to attract suitable and willing volunteers. Bioavailability and bioequivalence testing, generally conducted each time the dosage, form or formulation of the drug is modified, involves administration of the test compounds and obtaining biological fluids sequentially over time to measure absorption, distribution, metabolization and excretion of the drug. PPD Pharmaco attempts to manage its Phase I services to maximize scheduling flexibility and efficiency. The services also can be smoothly and quickly integrated with PPD Pharmaco's other service segments such as laboratory, pharmacokinetic and biostatistical services. PPD Pharmaco is one of the few full-service CROs offering Phase I clinical testing in the United States and Europe. Laboratory Services PPD Pharmaco provides bioanalytical and product analysis services through its laboratories in Richmond, Virginia, and Madison, Wisconsin. Biological fluid samples from clinical studies, such as those conducted by PPD Pharmaco's Phase I units, must be transported to a laboratory such as PPD Pharmaco's to be analyzed for drug and metabolite content and concentration. PPD Pharmaco currently has approximately 275 non-proprietary validated assays available for its clients' use in conducting laboratory analyses, thereby qualifying PPD Pharmaco for a wide range of assignments. PPD Pharmaco's laboratories also process fluid samples for pre-clinical studies. Product analysis services include dissolution and stability studies which are necessary to characterize a dosage form's release patterns and stability under various environmental conditions in the intended package for marketing. These studies must be carried out over the commercial life of products, beginning at the clinical trial stage. New formulations require the same set of studies as the original dosage form. Comprehensive measurement services include Gas Chromatography/Mass Spectrometry, Liquid Chromatography/Mass Spectrometry, High Performance Liquid Chromatography, Gas Chromatography, Radioimmunoassay and Enzyme Linked Immunosorbent Assay. Support services include HIV positive sample handling, sample/data management for kinetic studies from multi-center trials and sample/data archiving. PPD Pharmaco is one of a few full-service CROs able to offer its clients the advantages of both bioanalytical and product analysis and Phase I clinical testing. Phase II-IV Clinical Trial Management The core of PPD Pharmaco's business is a comprehensive package of services for the conduct of Phase II-IV clinical trials, which, in concert with its other analytical and Phase I testing services, allows PPD Pharmaco to offer its clients an integrated package of clinical management services. The Company has significant clinical trials experience in the areas of: 8 10 AIDS Primary disease and treatment/prophylaxis of opportunistic infections Analgesia Acute and chronic pain modeling Biotechnology Growth hormone, multiple sclerosis, sepsis, wound healing Cardiovascular disease Congestive heart failure, hypertension, global survival trials Central nervous system Schizophrenia, depression, anxiety, disease obsessive-compulsive disorders, panic disorders Critical care Acute Respiratory Distress Syndrome, disseminated fungal diseases, sepsis Dermatology Wound healing, acne, hair loss Food and Nutrition Fat substitutes, beta carotene, oligofructose, fibers Gastroenterology Duodenal ulcer, gastric ulcer, gastro-esophageal reflux disease, H. pylori, nonsteroidal anti-inflammatory drug-induced ulcers Infectious disease Acute and critical Metabolic disease Diabetes, hormone replacement therapy Oncology Ovarian, lung cancer Pulmonary/Allergy Asthma, allergic rhinitis, community acquired pneumonia Rheumatology Rheumatoid and osteoarthritis Virology AIDS, herpes simplex, chronic hepatitis B, chronic hepatitis C Women's health Hormone replacement, oral contraception Clients' needs are served by conducting clinical trials through a dedicated project team. A project manager supervises all aspects of the conduct of the clinical trial, while PPD Pharmaco's clinical research associates are in the field, monitoring the trial at the various investigational sites where it is being conducted. Within this project-oriented structure, PPD Pharmaco can manage every aspect of the clinical trials in Phases II through IV of the drug development process, including protocol development, case report form ("CRF") design, feasibility studies, investigator selection, recruitment and training, site initiation and monitoring, accelerated patient enrollment, development of training materials for investigators and training of clients' staff. PPD Pharmaco monitors its clinical trials in strict adherence to government regulations. PPD Pharmaco has adopted standard operating procedures which are intended to satisfy regulatory requirements and serve as a tool for controlling and enhancing the quality of its clinical trials. PPD Pharmaco's procedures are written in accordance with the regulations and guidelines appropriate to the region where they will be used, thus ensuring compliance with Good Clinical Practice ("GCP") requirements. In North America, FDA regulations and guidelines serve as a basis for PPD Pharmaco's procedures. The European Community has agreed to conduct all studies in accordance with the International Conference on Harmonization ("ICH")'s recommendations which set global clinical study standards based on GCP. ICH guidelines have superseded the European Community Note for Guidance, "Good Clinical Practice for Trials on Medicinal Products in the European Community." The FDA is expected to adopt the ICH's standards. Data generated during clinical trials are compiled, analyzed, interpreted and submitted in report form to the FDA or other relevant regulatory agencies for purposes of obtaining regulatory approval. PPD Pharmaco provides its clients with one or more of the following core Phase II-IV clinical trials management services using parallel processing to accelerate the development process: Study Design. PPD Pharmaco serves its clients in the critical area of study design by applying its wide development experience in the preparation of the study protocols and CRFs. The study protocol defines the medical issues to be examined in evaluating the safety and efficacy of the drug under study, the number of patients required to produce statistically valid results, the clinical tests to be performed in the study, the time period over which the study will be conducted, the frequency and dosage of drug administration and the exact inclusion and exclusion criteria to be met for the patients enrolled in the study. The success of the study depends not only on the ability of the protocol to correctly predict requirements of regulatory authorities, but also on the ability of the protocol to fit coherently with the other aspects of the development process and the ultimate marketing strategy for the drug. This includes healthcare economic components to support rational pricing and positioning. 9 11 Once the study protocol has been finalized, CRFs must be developed to record the desired information to be obtained from the clinical studies. The various other disciplines involved in the drug development process, including data management, must work closely with the clinical trial management project team to assure that the right data are acquired in a form which is most efficient for subsequent data entry, management and reporting. Proper CRF design is critical to allowing investigators and field monitors to conduct their respective jobs quickly, accurately and effectively. Investigator Recruitment. During the clinical trials, administration of the drug to patients is supervised by physicians, also referred to as investigators, at hospitals, clinics or other locations, also referred to as investigational sites. The Life Sciences Group solicits the participation in the study of investigators who contract directly with either PPD Pharmaco, CCCR or its client. The successful rapid identification and recruitment of investigators who have the appropriate expertise and an adequate base of patients who satisfy the requirements of the study protocol are critical to the timely completion of the trial. PPD Pharmaco maintains and constantly expands and refines its computerized database of approximately 16,000 investigators. Information regarding PPD Pharmaco's experience with these investigators, including factors relevant to rapid study initiation, are contained in the database. This information allows project managers to choose the appropriate investigators for a particular study in an efficient manner. Study Monitoring. PPD Pharmaco provides study monitoring services which include investigational site initiation, patient enrollment assistance and data collection through subsequent site visits. These visits also serve to assure that data are gathered according to GCP, according to the requirements of the client and applicable regulatory authorities and as specified in the study protocol. Project management and field monitoring services are the operational heart of Phase II and III clinical studies. In most instances a project will meet, exceed or fail to meet expected timeliness for completion based on meeting deadlines during the first few months of study initiation. Therefore, PPD Pharmaco focuses at an early stage on identifying and quickly completing the critical rate-limiting steps of screening and selecting investigators, processing pre-study regulatory paperwork, obtaining investigative review board approvals and scheduling investigational site initiation visits. Drugs under study cannot be released to the investigational sites, and thus the study cannot begin, until these activities have been completed. Following study initiation, PPD Pharmaco utilizes all appropriate methods of accelerating patient recruitment. This may involve PPD Pharmaco's integrated systems of telephone recruitment, telefaxing and media advertising. As with Phase I clinical trials, patient recruitment is critical to the Company's success. Patient data must be obtained from the field efficiently, quickly and accurately to speed subsequent data entry, management and analysis and report writing. PPD Pharmaco acquires data via visits by its field monitors to investigative sites and by electronic means. Field monitors are equipped with laptop computers for the purpose of data collection. PPD Pharmaco has monitored many clinical trials, including a number of very large studies. For example, PPD Pharmaco is in its second five-year contract with the National Institutes of Health ("NIH") to monitor investigational sites for AIDS treatment related trials sponsored by the NIH. This project involves approximately 200 investigational sites and total enrollment of approximately 58,000 patients. Clinical Data Management and Biostatistical Analysis PPD Pharmaco's data management and biostatistical analysis operations are managed by professionals with extensive pharmaceutical and biotechnology industry experience in the design and construction of local and multinational clinical trial databases. PPD Pharmaco provides clients with assistance in such areas as study design, sample size determination, CRF design and production, fax based monitoring, database design and construction, New Drug Application preparation and production, including electronic submission to the FDA, known as Computer Assisted New Drug Applications and FDA presentations and defense. Data management and biostatistical analysis services are offered as discrete products and as part of an integrated drug development program. During the design of development plans and protocols, PPD Pharmaco offers consulting services relating to, and the determination of, sample size parameters for patient enrollment, development of data analysis plans and randomization schemes. During the conduct of clinical trials, PPD Pharmaco assists in the rapid acquisition of clean and accurate data. Following completion of the clinical trials, PPD Pharmaco assists in report preparation and FDA presentations. PPD Pharmaco's biostatisticians may participate with clients in meetings with the FDA to present and 10 12 defend biostatistical analyses prepared by PPD Pharmaco. PPD Pharmaco has expertise in electronically capturing and integrating geographically diverse data. PPD Pharmaco employs SAS, Clintrace, Oracle and BBN Clintrial software, as specified by clients, combined with customized programs developed by PPD Pharmaco. Drug development time is reduced by performing data management and biostatistical analysis activities in parallel with other drug development activities where possible. For example, data management personnel work with clinical program managers and field monitors to continuously enter data, program output tables and listings and validate the database so that there is a rapid progression from data lock, to database freeze, to final tables and listing preparation and to biostatistical analyses. Similarly, there is a close working relationship with medical writing and regulatory services personnel. Treatment Investigational New Drug Application A treatment Investigational New Drug ("IND") Application is an application by a pharmaceutical or biotechnology sponsor and the associated procedure to allow patients to receive treatment with an investigational new drug for a serious or immediate life-threatening disease, such as AIDS or multiple sclerosis, for which no comparable or satisfactory therapy is available. This treatment is provided during the clinical trial phase of development, but outside the controlled clinical trial. For promising new drugs, the treatment IND application has the advantage of getting the new drug into an expanded patient base early, as well as allowing earlier publicity about the potential success of the drug. PPD Pharmaco's involvement in a treatment IND application may range from monitoring the treatment to an integrated service project involving full investigational site management, data management and biostatistical analysis and report writing. Medical Writing and Regulatory Services PPD Pharmaco provides report writing and regulatory services to its clients in a manner designed to complement parallel development processes to reduce overall development time. Strategic plan and protocol design services provided at the beginning of a project, combined with clear, concise data presentation, analysis and discussion at the completion of the project assist the client in obtaining regulatory approvals. These services are fully integrated with PPD Pharmaco's other services to assure maximum speed consistent with good service and regulatory compliance. PPD Pharmaco maintains a large internal compliance and quality assurance department to provide in-process monitoring of GCP performance. PPD Pharmaco also offers these services to clients to assess their own trials, whether conducted by the client or another CRO. Healthcare Economics and Outcomes Research PPD Pharmaco is developing a number of services in the healthcare economics area to be offered to pharmaceutical and biotechnology companies as well as managed care payers and providers. These services include prospective and retrospective clinicoeconomics analysis, quality of life and drug therapy evaluation, large sample market research, clinical hypothesis testing for product marketing, enhanced patient, investigator and managed care plan recruiting, managed care consulting, patient therapeutic support systems and disease management consulting. Environmental Sciences Group APBI Environmental Sciences Group currently provides health and environmental sciences and engineering consulting services through its ENVIRON division. During 1996, the Environmental Sciences Group generated 23.0% of the Company's net revenue. ENVIRON is a leading provider of multidisciplinary consulting services in the chemical risk assessment and risk management field. ENVIRON provides services primarily to private sector clients facing potentially high liability as a result of the presence of hazardous substances in the environment, in drugs and medical devices, in consumer products and in the workplace. ENVIRON's engagements typically involve providing creative, multidisciplinary solutions to complex problems. ENVIRON provides services primarily in two areas: (1) health sciences and (2) environmental sciences and engineering. ENVIRON's health sciences staff includes professionals trained in toxicology, epidemiology, chemistry, biochemistry, microbiology, industrial hygiene, risk assessment and allied fields. Its environmental sciences and engineering staff includes professionals trained in hydrogeology; geology; environmental chemistry; environmental, chemical and civil engineering and ecotoxicology, ecology and natural resources. Approximately 43% of ENVIRON's employees have advanced degrees at the master's level or above. Of those with advanced degrees, approximately 35% have attained their Ph.D. 11 13 ENVIRON offers services in the following areas: Chemical Risk Assessment and Risk Management ENVIRON assesses the potential risk of injury to human health and the environment associated with industrial chemicals during all stages of manufacturing use and disposal. It also provides assistance in determining exposures and the potential health impact of chemicals present in food, consumer products, pharmaceuticals, medical devices and the workplace. The chemical risk assessment services provided by ENVIRON typically involve two components. ENVIRON analyzes toxicological and biological data to assess the inherent hazard or toxicological properties of industrial chemicals and other substances. In addition, ENVIRON assesses the physical-chemical properties of industrial chemicals and other substances in the media in which they are found to evaluate the fate and transport of such substances in the environment and the potential for exposure. The assessments performed by ENVIRON are generally used to evaluate the potential for public health risk and ecological damage. ENVIRON also assists clients in developing workplace standards for industrial chemicals and prepares assessments of risks resulting from occupational exposure. In addition, ENVIRON conducts audits to determine compliance with specific laws regulating chemical releases into air, water and other environmental media and to obtain permits for manufacturing or processing facilities. ENVIRON provides such services in a variety of project areas, including complex hazardous waste sites, current and former industrial manufacturing facilities, leaking underground storage tanks, municipal and hazardous waste disposal facilities, incinerators, abandoned mine sites, pesticide-contaminated agricultural land and large-scale spills and releases. In performing assessments, ENVIRON also analyzes the potential for exposure at the project site and the surrounding environment. Environmental Liability Assessments ENVIRON performs environmental liability assessments of industrial properties, commercial and residential developments, undeveloped parcels of land and hazardous waste sites to identify practices that could result in significant exposure or liability. These services include environmental audits to determine compliance with current and anticipated federal, state and local regulations and to estimate the present value of environmental liabilities. Such assessments have been performed across a broad range of industries, including iron and steel; pulp and paper; mining, oil and gas; textiles, lumber and wood; plastics, leather and electronics. Site Investigation and Remediation ENVIRON assists clients in determining the nature and extent of contamination at industrial and hazardous waste sites through the collection and analysis of soil, water and sediment samples. ENVIRON's services in this area also include the evaluation and analysis of the cost-effectiveness of various alternative remediation strategies designed to protect human health and the environment. ENVIRON also designs the selected remedial strategy, hires subcontractors as appropriate and provides oversight of the implementation of the strategy. Such services are often provided in connection with the negotiation and resolution of disputes that relate to the apportionment of liability arising under various federal, state and local statutes, or private contracts. Litigation Support ENVIRON provides expert technical assistance and strategic support to clients who are or who anticipate becoming involved in litigation relating to environmental, occupational and product safety issues. These services cut across substantially all of its practice areas. Services provided in this area include reviewing environmental data and waste handling records, allocating liability among multiple site owners, developing information on state-of-the-art waste disposal practices, determining the timing of contaminant release events, evaluating sampling programs and remedial measures developed for contaminated sites, reviewing toxicological and epidemiological data associated with the use of consumer products and establishing relationships between exposure and disease or injury. ENVIRON's senior staff members have extensive experience providing expert testimony in the areas of toxicology, risk assessment and contaminant releases. Product Safety Regulation ENVIRON provides strategic scientific support and regulatory affairs guidance in the pre-market approval process for and subsequent use of various products, including drugs and pharmaceuticals, medical devices, food additives, consumer products, agricultural chemicals and biotechnology products. 12 14 Air Quality ENVIRON offers a full spectrum of air quality services, including: air emissions and dispersion modeling from industrial facilities and hazardous waste sites, including siting studies and air toxics impact evaluations; air pollution compliance assistance, including compliance auditing, regulatory analysis and obtaining local and state permits, as well as federal Title V operating permits; ambient and indoor monitoring program design and implementation; process engineering; emergency release modeling and off-site consequence analysis; analysis of the potential regional air quality impacts of alternative control strategies, including advanced vehicles, alternative and reformulated fuels and other mobile and stationary source control measures and leak detection and repair services, including monitoring equipment recommendations, software/data base management system design, program management consulting and field services. Other Environmental Services ENVIRON also provides a variety of other services that complement its primary service areas. Such services include facility siting and permitting, water quality assessments, waste management, emergency planning and development and integration of environmental management systems. Although such other services have historically represented a relatively small percentage of ENVIRON's net revenue, the Company believes that it will have opportunities to expand its business in these areas in the future. Clients and Marketing The Company's Life Sciences Group provides development services to pharmaceutical and biotechnology companies. For the year ended December 31, 1996, approximately 83% of the Company's Life Sciences Group's net revenue was attributable to clinical services and 17% to laboratory services. For the year ended December 31, 1996, net revenue of the Life Sciences Group was derived approximately as follows: Percentage of Source Net Revenue ------ ----------- Pharmaceutical 80.8% Biotechnology 11.2 Government (NIH) 1.4 Other 6.6 The Company has provided services to 24 of the top 25 pharmaceutical companies in the world as ranked by 1995 research and development spending. The Company provides services to the pharmaceutical and biotechnology industries and its revenue is highly dependent on expenditures on research and development by clients in these industries. Accordingly, the Company's operations could be materially and adversely affected by general economic downturns in these industries, the current trend toward consolidation in these industries or other factors resulting in a decrease in research and development expenditures. Furthermore, the Company has benefited to date from the increasing tendency of pharmaceutical and biotechnology companies to outsource large clinical research projects. Should this trend be reversed, the revenue of the Company could be materially and adversely affected. The Company believes that concentration of business among certain large customers is not uncommon in the CRO industry. The Company has experienced such concentration in the past and may experience such concentration in the future. However, during 1995 and 1996, no single client contributed more than 10% of the Company's total net revenue. In 1996, the Company's ten largest clients accounted for approximately 33% of the Company's total net revenue and approximately 44% of the Company's total 1996 net revenue was derived from clients located outside the U.S., in particular in Europe and Japan. ENVIRON's clients come from a wide variety of industrial companies. A significant portion of these engagements is initiated by lawyers whose clients are engaged in merger, acquisition or real estate transactions, or who become involved in or anticipate becoming involved in litigation. ENVIRON also provides services to investment banks, lenders, insurance firms, trade associations, and to a lesser extent, state and local government agencies. Contractual Arrangements Many of PPD Pharmaco's contracts are fixed price, with some variable components, and range in duration from a few months to several years. In other contracts, PPD Pharmaco is paid based on applying agreed upon hourly rates to hours worked. Generally, for multi-year contracts involving clinical trials, a portion of the contract fee is paid at the time the trial is initiated, with the balance of the contract fee payable in installments over the trial duration. The installment payments are typically performance-based, relating payment to previously negotiated events, such as investigator recruitment, patient enrollment or delivery of databases. For contracts which are fixed price, PPD Pharmaco bears the risk 13 15 of cost overruns, but benefits if costs are lower than anticipated. Under-pricing of contracts or significant cost overruns could have a material adverse effect on the Company. Most of PPD Pharmaco's contracts for the provision of its services, including contracts with government agencies, are terminable by the client upon 30- to 90-days' notice under certain circumstances, including the client's unilateral decision to terminate the development of the product or end the study. Contracts may be terminated for a variety of reasons, including the failure of a product to satisfy safety requirements, unexpected or undesired results of the product, the client's decision to forego a particular study or insufficient patient enrollment or investigator recruitment. Although the contracts typically require payment of certain fees for winding down the study and, in some cases, a termination fee, the loss of a large contract or the loss of multiple contracts could materially and adversely affect the Company. Backlog Backlog consists of anticipated net revenue from letters of intent and contracts that have not been completed. Net revenue is defined as professional fee income (gross revenue) less reimbursed costs consisting principally of investigator fees and travel. Once contracted work begins, net revenue is recognized over the life of the contract. In certain cases, PPD Pharmaco begins work for a client before a contract is signed. Backlog does not include anticipated net revenue for which PPD Pharmaco has begun work but for which PPD Pharmaco does not have a letter of intent or signed contract, or fee for service contracts with no specified amount. The order backlog of the Life Sciences Group for the services described above under written agreements, including signed letters of intent, was $156.5 million in net revenue at December 31, 1996, compared to $142.5 million in net revenue at December 31, 1995. PPD Pharmaco believes that its backlog as of any date is not necessarily a meaningful predicator of future results, because backlog can be affected by a number of factors, including variable size and duration of contracts, many of which are performed over several years. Additionally, contracts generally are subject to early termination by the client or delay by regulatory authorities for many reasons, including unexpected test results. Moreover, the scope of a contract can change during the course of a study. There can be no assurances that PPD Pharmaco will be able to fully realize all of its backlog as net revenue. ENVIRON's net revenue is not represented by an order backlog, as ENVIRON's engagements are generally of an indefinite duration in which services are performed on a time-and-expenses basis. Clients are billed at fixed hourly rates for each staff member involved in an assignment, rather than on a project basis. Competition The CRO industry consists of several hundred small, limited-service providers, several medium-sized CROs and a few full-service global drug development companies. The CRO industry is consolidating and, in recent years, several large, full-service competitors have emerged. This trend of industry consolidation will likely result in greater competition among the larger CROs for clients and acquisition candidates. PPD Pharmaco's competitors include ClinTrials Research Inc., Covance, Inc. (formerly Corning Pharmaceutical Services, Inc.), IBAH, Inc., Parexel International Corporation and Quintiles Transnational Corporation. PPD Pharmaco also competes against certain medium-sized companies. Additionally, PPD Pharmaco competes against the in-house research and development departments of pharmaceutical and biotechnology companies, as well as universities and teaching hospitals. In addition, there are few barriers to entry for small, limited-service entities considering entering the CRO industry. These entities may compete against larger CROs for clients. Furthermore, the CRO industry has attracted the attention of the investment community, which could lead to increased competition by increasing the availability of financial resources for CROs. Increased competition may lead to price and other forms of competition that may adversely affect PPD Pharmaco's operating results. CROs compete on the basis of several things, including reputation for on-time quality performance, expertise and experience in specific therapeutic areas, scope of service offerings, strengths in various geographic markets, technological expertise and systems, ability to acquire, process, analyze and report data in a time-saving accurate manner, ability to manage large-scale clinical trials both domestically and internationally, expertise and experience in healthcare economics and communication. The Company believes that it competes favorably in these areas. CCCR is among the largest private clinical investigational sites, capable of conducting over 70 trials simultaneously. CCCR's major competitors are other large investigator sites, including reSearch for Health Inc. and Collaborative Clinical Research, Inc. ENVIRON competes with many firms, ranging from small local firms to large national firms. ENVIRON competes principally on the basis of reputation, scientific and technical expertise, experience and qualifications of professional staff, quality of services, ability to handle complex problems and its risk assessment orientation. A large percentage of ENVIRON's business is generated by existing or former clients. ENVIRON believes that pricing is 14 16 generally not the primary factor in attracting the types of engagements on which it focuses, which typically involve providing creative, multidisciplinary solutions and significant value-added services. Potential Liability and Insurance Clinical research services involve the testing of new drugs on human volunteers pursuant to a study protocol. Such testing exposes the Company to the risk of liability for personal injury or death to patients resulting from, among other things, possible unforeseen adverse side effects or improper administration of the new drug. Many of these patients are already seriously ill and are at risk of further illness or death. The Company attempts to manage its risk of liability for personal injury or death to patients from administration of products under study through measures such as contractual indemnification provisions with clients and through insurance maintained by clients. 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 PPD Pharmaco'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 Company could be materially and adversely affected if it were required to pay damages or incur defense costs in connection with a claim that is beyond the scope of an indemnity provision or beyond the scope or level of insurance coverage maintained by the client or where the indemnifying party does not fulfill its indemnification obligations. Until September 25, 1996, the Company did not maintain liability insurance with respect to these risks. The Company currently maintains liability insurance coverage of up to $5.0 million per claim, with an annual aggregate policy limit of $5.0 million. However, there can be no assurance that liability claims will not exceed the limits of such coverage or that such insurance will continue to be available on commercially reasonable terms or at all. Consequently, a product liability claim or other claim with respect to uninsured liabilities or in excess of insured liabilities could have a material adverse effect on the Company. Government Regulation The laboratory services performed by PPD Pharmaco are subject to various regulatory requirements designed to ensure the quality and integrity of the testing process. The industry standards for conducting laboratory testing are embodied in the regulations for Good Laboratory Practice ("GLP") and Good Manufacturing Practice ("GMP"). GLP and GMP have been adopted by the FDA, by the Department of Health in the United Kingdom and by similar regulatory authorities in other parts of the world. GLP and GMP stipulate requirements for facilities, equipment and professional staff. The regulations require standardization procedures for studies, for recording and reporting data and for retaining appropriate records. To help ensure compliance, PPD Pharmaco has established quality assurance controls at its laboratory facilities which monitor ongoing compliance with GLP and GMP regulations by auditing test data and conducting regular inspections of testing procedures. The industry standard for the conduct of clinical research and development studies is embodied in the ICH regulations for GCP. Although GCP has not been formally adopted by the FDA nor, with certain exceptions, by similar regulatory authorities in other countries, certain provisions of GCP have been included in FDA regulations. As a matter of practice, the FDA and many other regulatory authorities require that test results submitted to such authorities be based on studies conducted in accordance with GCP. These regulations include (i) complying with FDA regulations governing the selection of qualified investigators, (ii) obtaining specific written commitments from the investigators, (iii) verifying that patient informed consent is obtained, (iv) monitoring the validity and accuracy of data, (v) verifying drug or device accountability and (vi) instructing investigators to maintain records and reports. PPD Pharmaco must also maintain reports for each study for specified periods for inspection by the study sponsor and the FDA during audits. Noncompliance with GCP can result in the disqualification of data collected during the clinical trial. PPD Pharmaco's standard operating procedures are written in accordance with regulations and guidelines appropriate to the region where they will be used. Within Europe, all work is carried out in accordance with the ICH's guidelines which superseded the European Community Note for Guidance "Good Clinical Practice for Trials on Medicinal Products in the European Community." In addition, FDA regulations and guidelines serve as a basis for PPD Pharmaco's North American standard operating procedures. From an international perspective when applicable, PPD Pharmaco has implemented common standard operating procedures across regions to assure consistency whenever it is feasible and appropriate to do so. PPD Pharmaco's business depends on the continued strict government regulation of the drug development process, especially in the United States. 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. 15 17 The failure on the part of PPD Pharmaco to comply with applicable regulations could result in the termination of ongoing research or the disqualification of data for submission to regulatory authorities. Furthermore, the issuance of a notice of finding by the FDA to either PPD Pharmaco or its clients based upon a material violation by the Company of GCP, GLP or GMP requirements could materially and adversely affect the Company. The consulting services provided by ENVIRON are not significantly regulated by any governmental authority at this time. However, ENVIRON's environmental risk management services derive in large part from the significant federal and state environmental legislation that has been enacted in the past decade. Recently, the environmental industry has experienced a slowdown in the enforcement of such government regulation at the federal and state level based upon a number of factors, including available funding. Although the Company believes that the environmental industry will find continued but more limited opportunities to grow if the trend towards decreased actual enforcement of such regulations continues, the business of ENVIRON could be adversely affected. Intellectual Property PPD Pharmaco has developed certain computer software and technically derived procedures intended to maximize the quality and efficiency of its services. Although the Company does not believe that its intellectual property rights are as important to its results of operations as are such factors as the technical expertise, knowledge, ability and experience of the Company's professionals, the Company believes that its technological capabilities provide significant benefits to its clients. Employees At December 31, 1996, the Company had approximately 2,264 full-time equivalent employees, of whom 1,869 were employed in the Life Sciences Group, 375 were employed in the Environmental Sciences Group and the remainder were in the Company's corporate headquarters. Of the Company's employees, approximately 99 hold Ph.D., M.D., Pharm.D. or D.V.M. degrees and approximately 250 hold other masters or postgraduate degrees. None of the Company's employees is represented by a labor union or is subject to a collective bargaining agreement. The Company has never had a work stoppage and believes that its relations with its employees are good. The Company's performance depends on its ability to attract and retain qualified professional, scientific and technical staff. The level of competition among employers for such skilled personnel is high. The Company believes that its employee benefit plans enhance employee morale, professional commitment and work productivity and provide an incentive for employees to remain with the Company. The Company, like many of its competitors, also relies on a number of key executives. The loss of services of any of the Company's key executives could have a material and adverse effect on the Company. While the Company has not experienced any significant problems in attracting or retaining qualified staff, there can be no assurance that the Company will be able to avoid such problems in the future. Foreign and Domestic Operations Set forth in Note 18 of Notes to Consolidated Financial Statements for each of fiscal years 1996, 1995 and 1994 are the Company's revenue, operating profit or loss and assets attributable to each geographic area in which the Company operates. ITEM 2. PROPERTIES The Company's principal executive offices are located in Wilmington, North Carolina. In March 1996, the Company entered into a new 10-year build-to-suit lease for approximately 70,000 square feet in Wilmington, which it occupied in November 1996. The Company owns and operates a 52-bed Phase I facility in Leicester, England. The facility, which was acquired by the Company in November 1995, is a modern, state-of-the-art building. The Company also owns a building in Kerswell, Scotland, which it acquired when it purchased DAR in December 1996. All other facilities are leased. The Company's operations occupy approximately 635,000 square feet of space worldwide, including over 70,000 square feet of space located outside of the U.S. The Company believes that its facilities have adequate capacity to handle significant additional business growth. The locations of the Company's operating facilities as of December 31, 1996, were as follows: 16 18 Life Sciences Group - ------------------- Wilmington, North Carolina Kerswell, Scotland Austin, Texas (1) Sao Paolo, Brazil Raleigh, North Carolina Brussels, Belgium Triangle Township, North Carolina Prague, Czech Republic Richmond, Virginia Paris, France Madison, Wisconsin Karlsruhe, Germany Chicago, Illinois Nuremberg, Germany Columbia, Maryland Warsaw, Poland Cambridge, England Johannesburg, South Africa Chelmsford, England Barcelona, Spain Leicester, England Madrid, Spain Southampton, England Stockholm, Sweden Environmental Sciences Group - ---------------------------- Arlington, Virginia (2) Houston, Texas Princeton, New Jersey London, England Emeryville, California Liverpool, England Irvine, California Edinburgh, Scotland Novato, California - -------------- (1) In November 1995, the Company entered into a sale-leaseback transaction related to its Austin, Texas, facilities. See Note 10 of Notes to Consolidated Financial Statements. (2) ENVIRON has an option to lease additional space in this building in 1998. ITEM 3. LEGAL PROCEEDINGS. In the normal course of business, the Company is a party to various claims and legal proceedings. Although the ultimate outcome of these matters is presently not determined, management of the Company, after consultation with legal counsel, does not believe that the resolution of these matters will have a material effect upon the Company's financial condition or results of operations. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS. No matter was submitted to a vote of security holders during the fourth quarter of the fiscal year ended December 31, 1996. 17 19 EXECUTIVE OFFICERS The executive officers of the Company as of December 31, 1996, were as follows:
Name Age Position ---- --- -------- Fredric N. Eshelman, Pharm.D. 48 Vice Chairman and Chief Executive Officer Thomas D'Alonzo 53 President and Chief Operating Officer Rudy C. Howard 39 Chief Financial Officer, Vice President of Finance, Treasurer and Secretary Joshua S. Baker 41 Senior Vice President, Operations, PPD Pharmaco, Inc. Joseph H. Highland 52 Chief Executive Officer, APBI Environmental Sciences Group, Inc. Fred B. Davenport, Jr. 45 General Counsel
Fredric N. Eshelman, Pharm.D. has served as Chief Executive Officer and as a director of the Company since July 1990. Dr. Eshelman founded the Company in 1989. Prior to rejoining the Company in 1990, Dr. Eshelman served as Senior Vice President, Development and as a director of Glaxo Inc., a subsidiary of Glaxo Holdings plc. Thomas D'Alonzo is President and Chief Operating Officer of the Company and of its contract research organization subsidiary, PPD Pharmaco, Inc. Mr. D'Alonzo served as General Counsel of Adria Laboratories, a pharmaceutical company, from 1977 to 1983 and was employed from 1983 to 1993, in various capacities, including as President, by Glaxo Inc., a subsidiary of Glaxo Holdings plc. Mr. D'Alonzo was President of GenVec, Inc., a gene therapy biotechnology company, from 1993 until his employment by the Company in October 1996. Rudy C. Howard is Chief Financial Officer, Vice President Finance and Treasurer of the Company. Prior to joining the Company in October 1995, Mr. Howard worked with Coopers & Lybrand L.L.P., an accounting firm, since 1990 and had been a Partner at Coopers & Lybrand L.L.P. since 1993. Joshua S. Baker, Ph.D. is Senior Vice President, Operations of PPD Pharmaco, Inc., the Company's contract research organization subsidiary. Prior to holding this position, Dr. Baker served as Vice President, Biostatistics and Data Management of the Company. Prior to joining the Company in May 1994, Dr. Baker served as Director of Biostatistics of Glaxo Research Institute, the research and development division of Glaxo Inc., a position he had held since September 1987. Joseph H. Highland co-founded ENVIRON in 1982. He is currently the Chief Executive Officer of ENVIRON and has served as such since February 1992. Dr. Highland also served as a director of APBI from 1990 to 1995. Dr. Highland, who holds a Ph.D. in Biochemistry from the University of Minnesota's School of Medicine, served as co-director for the Hazardous Waste Research Program at Princeton University before joining ENVIRON. Fred B. Davenport, Jr. is General Counsel, Vice President Legal Affairs and Secretary of the Company. Prior to his employment by the Company in December 1996, Mr. Davenport was a Partner in the Wilmington, North Carolina law firm of Murchison, Taylor, Kendrick and Gibson, L.L.P., which he joined in 1977. Mr. Davenport was also a member of the faculty of the University of North Carolina at Wilmington's Cameron School of Business Administration from 1982 to 1991. 18 20 PART II ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS. The Common Stock of the Company, par value $0.10 per share (the "Common Stock"), is traded under the symbol "PPDI" in the over-the-counter market and is quoted on the National Market System of the National Association of Securities Dealers Automated Quotation System ("NASDAQ"). The following table sets forth the high and low prices for shares of the Common Stock subsequent to the Company's initial public offering, as reported by the National Association of Securities Dealers, Inc.
1996 --------------------- High Low ---- --- First Quarter (1) $37.25 $22.75 Second Quarter 47.75 33.25 Third Quarter 34.50 26.50 Fourth Quarter 27.50 14.50
- ---------- (1) From January 23, 1996, the effective date of PPD's initial public offering As of March 10, 1997, there were approximately 3,371 record holders of the Company's Common Stock. Since its conversion from an S corporation, the Company has not paid any cash dividends on its Common Stock. The Company has no present plans to pay cash dividends to its stockholders and, for the foreseeable future, intends to retain all of its earnings for use in its business. The declaration of any future dividends by the Company is within the discretion of its Board of Directors and is dependent upon the earnings, financial condition and capital requirements of the Company, as well as any other factors deemed relevant by the Board of Directors. ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA. The selected consolidated financial data presented below for the year ended December 31, 1996, have been derived from the audited consolidated financial statements of the Company, which have been audited by Coopers & Lybrand L.L.P., independent public accountants. The data presented below should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and with the Company's consolidated financial statements and related notes thereto included elsewhere in this Report. On September 26, 1996, a wholly owned subsidiary of the Company was merged with and into APBI, pursuant to which APBI became a wholly owned subsidiary of the Company. The transaction was accounted for as a pooling of interests. The Company's financial results for each of the years ended December 31, 1992 through December 31, 1995 have been restated to reflect the transaction as if it had occurred at the beginning of the periods being presented. The financial results of PPD for each of the years ended December 31, 1992 through December 31, 1995 have been audited by Coopers & Lybrand L.L.P., independent public accountants. The financial results of APBI for each of the years ended December 31, 1992 through December 31, 1995 have been audited by Arthur Andersen LLP, independent public accountants. The combination of the selected consolidated financial data for each of the years ended December 31, 1992 through December 31, 1995, after restatement for the pooling of interests, has been audited by Coopers & Lybrand L.L.P., independent public accountants. The Company's consolidated financial data reflects certain of its former Environmental Sciences Group divisions as discontinued operations. See Note 4 of Notes to Consolidated Financial Statements. 19 21
Year Ended December 31, --------------------------------------------------------------------------------- 1996 (4) 1995 (4) 1994 1993 1992 (4) ----------- ----------- ---------- ----------- ----------- (in thousands, except per share data) Consolidated Statement of Operations Data: Net revenue (8) $ 197,796 $ 209,778 $ 192,105 $ 165,815 $ 162,330 --------- --------- --------- --------- --------- Operating expenses 182,859 200,022 181,120 169,014 135,984 Loss on sale of business, special charges, restructuring costs and merger costs 16,114 24,290 -- 9,365 7,623 --------- --------- --------- --------- --------- 198,973 224,312 181,120 178,379 143,607 --------- --------- --------- --------- --------- Income (loss) from operations (1,177) (14,534) 10,985 (12,564) 18,723 Other income (expense), net 1,804 (2,616) (2,728) (1,183) (3,622) --------- --------- --------- --------- --------- Income (loss) from continuing operations before provision for income taxes 627 (17,150) 8,257 (13,747) 15,101 --------- --------- --------- --------- Provision for income taxes 4,134 --------- Net loss (7) (3,507) --------- Weighted average number of shares outstanding 21,168 --------- Net loss per share $ (0.17) --------- Pro Forma Data (1): Income (loss) from continuing operations before provision for income taxes (17,150) 8,257 (13,747) 15,101 Pro forma income tax expense (benefit) (14,359) 3,371 (2,001) 6,936 --------- --------- --------- --------- Pro forma net income (loss) from continuing operations (3)(5)(6) (2,791) 4,886 (11,746) 8,165 Discontinued operations (1,716) (12,873) (12,133) (521) Extraordinary loss from early extinguishment of debt (897) -- -- -- --------- --------- --------- --------- Pro forma net income (loss) $ (5,404) $ (7,987) $ (23,879) $ 7,644 --------- --------- --------- --------- Pro forma weighted average number of shares outstanding (2) 18,815 18,671 18,409 18,919 --------- --------- --------- --------- Pro forma net income (loss) per share: Continuing $ (0.15) $ 0.26 $ (0.64) $ 0.43 Discontinued (0.09) (0.69) (0.66) (0.03) Extraordinary (0.05) -- -- -- --------- --------- --------- --------- Net income (loss) $ (0.29) $ (0.43) $ (1.30) $ 0.40 ========= ========= ========= =========
As of December 31, --------------------------------------------------------------------------------- 1996 (4) 1995 (4) 1994 1993 1992 (3)(4) ----------- ----------- ---------- ----------- ----------- (in thousands) Consolidated Balance Sheet Data: Cash and cash equivalents $ 21,838 $ 13,565 $ 9,804 $ 14,854 $ 15,700 Marketable securities 14,210 242 203 -- -- Working capital 66,603 37,320 27,795 (565) 37,320 Total assets 181,457 142,661 202,773 195,492 198,801 Long-term debt 1,428 3,471 47,620 15,411 15,137 Long-term debt including current portion 5,649 5,672 51,170 19,943 15,888 Shareholders' equity 115,306 77,300 74,198 79,065 112,294
- ---------- (1) Following termination of its status as an S corporation prior to completion of its initial public offering in January 1996, PPD became subject to federal and state income taxes. The pro forma data reflect the application of corporate income taxes to PPD's net income at the statutory combined federal and state tax rate as if the termination of PPD's S corporation status had occurred on January 1, 1992. (2) Pro forma weighted average shares outstanding assumes the occurrence of events pursuant to PPD's initial public offering and the issuance of sufficient shares at $18.00 per share to provide net proceeds, after aggregate offering expenses and underwriting discounts, to repay the $5.5 million debt incurred by PPD in making the final S corporation distribution. 20 22 (3) The pro forma income from continuing operations for 1992 was affected by (i) a charge against operating income of $7,623,000 in connection with the restructuring of APBI's business following the acquisition of Pharmaco, (ii) the incurrence of $4,296,000 of merger costs in connection with the acquisition of Pharmaco, (iii) a gain of $338,000 constituting a discount for early payment of a mortgage, (iv) the acquisition of certain assets of EDI in July 1992, which was accounted for as a purchase transaction and (v) an increase in APBI's effective tax rate as a result of the fact that certain merger costs incurred in connection with the acquisition of Pharmaco were not deductible for tax purposes. (4) The acquisitions of Trilife, Medisys, Q&Q, DAR and EAG in 1996; Gabbay and CCCR in 1995 and the acquisition by ETC of certain assets of Southeastern Capital Corporation in June 1992 were accounted for as purchase transactions. (5) The pro forma loss from continuing operations for 1993 was affected by (i) a charge against operating income of $9,365,000 in connection with restructuring APBI's former toxicology services division and planned improvements in APBI's corporate management information systems and (ii) an increase in reserves for accounts receivable of $5,857,000. (6) The pro forma loss from continuing operations for 1995 was affected by (i) the sale of APBI's toxicology business which resulted in a pre-tax loss of $19,308,000 charged against operating income, (ii) a special charge against operating income of $4,982,000 primarily related to the impairment of APBI's available for sale investment (see Note 1 of Notes to Consolidated Financial Statements) and (iii) an increase in APBI's tax benefit as a result of the reversal of certain tax liabilities recorded in prior years for which APBI will not be liable for payment. See Note 3 of Notes to Consolidated Financial Statements and "Management's Discussion and Analysis of Financial Condition and Results of Operations." (7) The net loss for 1996 was affected by the incurrence of $16,114,000 of merger costs in connection with the acquisition of APBI. After associated tax benefits, the impact on net income of such merger costs was $13,568,000. (8) Net of subcontractor costs. ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Statements in this Management's Discussion and Analysis that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 reflecting management's current view with respect to certain future events and financial performance that are subject to risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth herein and in the Company's other SEC filings, and including, in particular, risks relating to government regulation; dependence on certain industries; fixed price nature of contracts; the commencement, completion or cancellation of large contracts; progress of ongoing contracts; potential liability associated with the Company's lines of business; dependence on personnel; management of growth and competition. Since a large percentage of the Company's operating costs are relatively fixed, variations in the timing and progress of large contracts can materially affect results. GENERAL During 1996, the Company reported a net loss of $3.5 million, or $0.17 per share, compared to a pro forma net loss of $5.4 million, or $0.29 per share, during 1995. The Company's loss in 1996 is attributable to the $16.1 million of costs recorded that were associated with the Company's acquisition of APBI. Excluding merger costs, the Company's net income of $10.1 million, or $0.48 per share, was 102.6% higher than pro forma net income (before the impact of 1995 special charges and excluding the Company's former toxicology operations) last year of $5.0 million. In September 1996, a wholly-owned subsidiary of the Company was merged with and into APBI in a pooling-of-interests transaction. As a result, APBI became a wholly-owned subsidiary of the Company. Under the terms of the merger agreement, APBI stockholders received 0.4054 of a share of the Company's Common Stock for each APBI share, which resulted in the Company issuing 12,063,860 shares of its Common Stock in exchange for all of the outstanding shares of Common Stock of APBI. The Company's financial results have been restated to reflect the transaction as if it had occurred at the beginning of the periods presented. RESULTS OF OPERATIONS The following tables set forth, for the periods indicated, amounts for certain items in the Company's consolidated financial statements expressed as a percentage of net revenue from continuing operations and the percentage changes in dollar amounts of certain items compared with the prior period: 21 23 PERCENTAGE OF NET REVENUE FROM CONTINUING OPERATIONS
For the Year Ended December 31, 1996 1995 1994 ----------------------- ----------------------- ------------------------- Amount % Amount % Amount % ------ --- ------ --- ------ --- (dollars in thousands) Net revenue (4): Life sciences $ 152,304 77.0% $ 160,495 76.5% $ 146,342 76.2% Environmental sciences 45,492 23.0 49,283 23.5 45,763 23.8 --------- ----- --------- ----- --------- ----- 197,796 100.0 209,778 100.0 192,105 100.0 Direct costs: Life sciences 79,108 90,315 86,647 Environmental sciences 31,744 32,442 28,670 --------- --------- --------- 110,852 56.0 122,757 58.5 115,317 60.0 Selling, general, and administrative expenses 61,571 31.1 64,014 30.5 55,428 28.9 Depreciation and amortization 10,436 5.3 13,251 6.3 10,375 5.4 Loss on sale of business -- -- 19,308 9.2 -- -- Merger costs and special charges 16,114 8.1 4,982 2.4 -- -- --------- ----- --------- ----- --------- ----- Operating income (loss) (2)(3) (1,177) (0.6) (14,534) (6.9) 10,985 5.7 --------- ----- --------- ----- --------- ----- Net loss $ (3,507) (1.8)% --------- ----- Pro forma income (loss) from (1): Continuing operations (2,791) (1.3) 4,886 2.5 Discontinued operations (1,716) (0.8) (12,873) (6.7) Extraordinary loss (897) (0.4) -- -- --------- ----- --------- ----- Pro forma net loss $ (5,404) (2.6)% $ (7,987) (4.2)% --------- ----- --------- -----
Percentage of Increase (Decrease) For the Year Ended December 31, ----------------------------------- 1996 vs. 1995 (5) 1995 vs. 1994 ----------------- ------------- Net revenue (4): Life sciences (5.1)% 9.7% Environmental sciences (7.7) 7.7 Direct costs: Life sciences (12.4) 4.2 Environmental sciences (2.2) 13.2 Selling, general and administrative expenses (3.8) 15.5 Depreciation and amortization (21.2) 27.7 Operating income (loss) (6) N/A N/A
(1) Following termination of its status as an S corporation prior to completion of its initial public offering in January 1996, PPD became subject to federal and state income taxes. The pro forma data reflect the application of corporate income taxes to PPD's net income at the statutory combined federal and state tax rate as if the termination of PPD's S corporation status had occurred on January 1, 1994. (2) The operating loss for 1995 was affected by (i) the sale of APBI's toxicology operations which resulted in a pre-tax loss of $19,308,000 and (ii) a special charge against operating income of $4,982,000 primarily related to the impairment of APBI's available for sale investment. See Note 1 of Notes to Consolidated Financial Statements. (3) The operating loss for 1996 was affected by the incurrence of $16,114,000 of merger costs in connection with the acquisition of APBI. (4) Net of subcontractor costs. (5) The results from 1995 include the activity of APBI's toxicology operations which were sold in November 1995. See Note 3 of Notes to Consolidated Financial Statements. (6) N/A - Change not meaningful. 22 24 Below is a comparison of 1996 and 1995 operating statements which reflects only on-going operations and excludes 1996 merger costs and 1995 non-recurring charges. STATEMENT OF OPERATIONS DATA EXCLUDES APBI/PPDI MERGER COSTS IN 1996 AND SPECIAL CHARGES, TOXICOLOGY OPERATIONS (SOLD 11/95), DISCONTINUED OPERATIONS AND EXTRAORDINARY LOSS IN 1995 (IN THOUSANDS, EXCEPT PER SHARE DATA)
YEAR ENDED PERCENTAGE CHANGE DECEMBER 31, ----------------- 1996 1995 ---- ---- Net revenue: Life sciences $152,304 $122,049 24.8% Environmental sciences 45,492 49,283 (7.7) -------- -------- Total net revenue 197,796 171,332 15.4 Direct costs: Life sciences 79,108 62,839 25.9 Environmental sciences 31,744 32,442 2.1 -------- -------- Total direct costs 110,852 95,281 16.3 -------- -------- Gross margin 86,944 76,051 14.3 Selling, general and administrative expenses 61,571 56,391 9.2 Depreciation and amortization 10,436 8,768 19.0 -------- -------- Income from operations 14,937 10,892 37.1 Other income (expense), net 1,804 (2,616) N/A -------- -------- Income before taxes 16,741 8,276 102.3 Income tax provision 6,680 3,310 101.8 -------- -------- Net income $ 10,061 $ 4,966 102.6% ======== ======== ======= Net income per share $ 0.48 $ 0.26 ======== ======== Weighted average number of common shares outstanding 21,168 18,815 ======== ========
YEAR ENDED DECEMBER 31, 1996 VERSUS YEAR ENDED DECEMBER 31, 1995 Net revenue decreased $12.0 million, or 5.7%, to $197.8 million in 1996 from $209.8 million last year. PPD Pharmaco's operations account for 77.0% of the Company's net revenue for 1996. PPD Pharmaco generated net revenue of $152.3 million, down $8.2 million, or 5.1%, from last year. After elimination of the net revenue from APBI's former toxicology operations, which were sold in November 1995 ($38.4 million in 1995), net revenue increased 15.4% as compared to 1995. Results of operations which exclude the results of the divested businesses are considered the results of the Company's ongoing operations. Net revenue for the year ended December 31, 1996, from the ongoing PPD Pharmaco operations of $152.3 million reflects an increase of $30.2 million, or 24.8%, from 1995. The growth in ongoing PPD Pharmaco operations was 23 25 due in part to an increase in the size, scope and number of contracts in the North America clinical development and biostatistics business. The acquisitions of CCCR and the Phase I facility in Leicester, England, both completed in the second half of 1995, contributed net revenue of $10.8 million for the year, representing an increase over 1995 of $8.5 million. Net revenue from ENVIRON, the Company's environmental consulting organization, representing 23.0% of the Company's net revenue for 1996, was $45.4 million, compared with $49.3 million in 1995, a decrease of 7.7%, or $3.8 million. The Company believes that the decrease in net revenue at ENVIRON, the Company's environmental consulting business and the sole ongoing operation in the Environmental Sciences Group, is due principally to an overall weakness in the environmental services market. Total direct costs decreased 9.7% to $110.9 million from $122.8 million last year and declined as a percentage of net revenue to 56.0% from 58.5% last year. PPD Pharmaco direct costs decreased as a percentage of related net revenue to 51.9% from 56.3%. The decrease in direct costs is principally due to the divestiture of APBI's toxicology business in the fourth quarter of 1995. During 1995, the worldwide toxicology business reported direct costs of $27.5 million, or 71.5%, of related net revenue. ENVIRON's direct costs as a percentage of related net revenue increased to 69.8% from 65.8% last year. The increase in direct costs as a percentage of related net revenue is attributable to lower consultant utilization. ENVIRON's 1996 consultant utilization of 71.0% was 5.0 percentage points below the 76.0% utilization during the prior year. Selling, general and administrative ("SG&A") expenses decreased 3.8% to $61.6 million from $64.0 million in 1995. As a percentage of net revenue, SG&A expenses increased to 31.1% from 30.5% last year. After factoring out the SG&A expenses associated with the divested toxicology business last year ($7.6 million), consolidated SG&A expenses increased approximately 9.2%, or $5.2 million, for this year as compared to 1995. SG&A expenses from CCCR and the Leicester Phase I laboratory comprise $2.0 million of the increase, and the Company has incurred incremental rent expense of $1.2 million associated with the sale-leaseback of its real estate in Austin, Texas (this increase is partially offset by lower interest expense). The remaining increase of $2.0 million is primarily attributable to the investment in the Company's business development and marketing organization and in the area of information technology, as well as higher litigation costs incurred associated with ENVIRON's air quality practice. As a percentage of ongoing net revenue, SG&A expenses decreased to 31.1% from 32.9% last year. Total depreciation and amortization expense of $10.4 million was $2.8 million, or 21.2%, lower than last year. After adjusting out the depreciation for the divested toxicology business ($4.5 million), total depreciation and amortization increased $1.7 million, or 19.0%, versus last year. The increase was related to the Company's growth as well as the ongoing capital investment in the Company's base business. The Company recorded one-time merger costs of $16.9 million in the third quarter of 1996. These costs are primarily current and future cash expenses, such as investment banking fees and legal and accounting fees, as well as severance provisions as a result of the integration of the administrative functions of PPD and APBI. During the fourth quarter, approximately $0.8 million of these costs were reversed, primarily relating to severance costs that were avoided and reductions in net losses on leases for duplicate facilities. APBI recorded a charge of $19.3 million in 1995 relating to the book loss on the sale of the toxicology business in the fourth quarter of last year. Of that amount, $17.0 million represents a non-cash write off of the net assets of the divested businesses in excess of the proceeds received from Huntingdon. The remaining $2.3 million charge recorded consists of $1.2 million of transaction costs, $1.3 million of severance costs and relocation costs associated with moving the European headquarters from Suffolk, England, to Cambridge, England, and $0.6 million to be incurred in connection with changing the name of Pharmaco to Pharmaco International Inc., net of a $0.8 million gain recorded as a result of the settlement of the Company's defined benefit pension plan. APBI also recorded special charges of $5.0 million in the fourth quarter of 1995. Included in this charge was a $3.4 million non-cash expense to write down to market APBI's EnSys investment and the write-off of other nonproductive assets. In addition, APBI recorded severance charges totaling $1.2 million relating to the downsizing of its corporate overhead structure. The remaining $0.4 million relates primarily to accrued lease loss reserves related to under-utilization of the Richmond laboratory facility. 24 26 Operating income improved $13.3 million to an operating loss of $1.2 million for the year ended December 31, 1996, as compared to an operating loss of $14.5 million for the year 1995. As a percentage of net revenue, the yearly operating loss of 0.6% represents a dramatic improvement from the operating loss of 6.9% of net revenue last year. Other income (expense) improved by $4.4 million, increasing to $1.8 million in income for the year as compared to $2.6 million in expense last year. The favorable change is attributable to funds received in connection with the PPD initial public offering and the significant change in the Company's debt structure this year versus last year. See "Liquidity and Capital Resources." The net loss of $3.5 million represents an improvement of $1.9 million. The net loss per share of $0.17 compares to pro forma net loss per share of $0.29 last year. Excluding the results of the divested businesses and the impact of the merger costs and special charges on both years, the Company's net income of $10.1 million is 102.6% higher than last year's pro forma net income of $5.0 million. On an equivalent earnings-per-share basis the net income per share of $0.48 compares to $0.26 for the same period last year computed on 2.4 million less shares outstanding. YEAR ENDED DECEMBER 31, 1995 VERSUS YEAR ENDED DECEMBER 31, 1994 Net revenue for 1995 increased $17.7 million, or 9.2%, to $209.8 million in 1995 from $192.1 million in 1994. The Company's CRO divisions generated 76.5% of the Company's net revenue in the year, which equated to net revenue of $160.5 million, up $14.2 million, or 9.7%, from the previous year. Net revenue from ENVIRON, representing 23.5% of the Company's net revenue in 1995, was $49.3 million, compared with $45.8 million in 1994, an increase of 7.7%, or $3.5 million. After elimination of the net revenue from APBI's former toxicology operations ($38.4 million for 1995 and $46.4 million in 1994), in 1995 net revenue increased 17.6% as compared to 1994. For the year ended December 31, 1995, net revenue from PPD Pharmaco was $160.5 million, an increase of 9.7% from 1994. The growth in this business unit was due in part to an increase in the size, scope and number of contracts in the North America clinical development and biostatistics business. The acquisitions of CCCR and the Phase I facility in Leicester, England, both completed in the second half of 1995, contributed net revenue of $2.3 million for the last half of 1995. Total direct costs increased 6.5% in 1995 to $122.8 million from $115.3 million in 1994 but decreased as a percentage of net revenue to 58.5% from 60.0%. In PPD Pharmaco, direct costs decreased as a percentage of related net revenue to 56.3% from 59.2%. The decrease in direct costs was principally due to the divestiture of APBI's toxicology business in the fourth quarter of 1995. During 1995, the toxicology business reported direct costs of $27.5 million, or 71.5% of related net revenue, as compared to $33.3 million, or 71.8% of related net revenue, in 1994. ENVIRON's direct costs as a percentage of related net revenue increased to 65.8% from 62.6% in the prior year. The increase in direct costs as a percentage of related net revenue was primarily attributable to the start-up of the new Marin County office in California. 1995's SG&A expenses increased 15.5% to $64.0 million from $55.4 million in 1994. As a percentage of net revenue, SG&A expenses increased to 30.5% from 28.9% the preceding year. Incremental SG&A expenses from CCCR and the Leicester Phase I laboratory comprised $0.9 million of the increase. The remaining increase of $7.7 million was primarily attributable to increases in business development expenses in Austin and Wilmington, administrative staffing at the executive and middle-management levels and the number of employees in finance, human resources and other administrative areas, reflecting the continued growth of the Company. Total depreciation and amortization expense of $13.3 million was $2.9 million, or 27.7%, higher than in the previous year. After adjusting out the depreciation for the divested toxicology business ($4.5 million in 1995 and $3.3 million in 1994), total depreciation and amortization increased $1.7 million, or 23.6%, versus in 1994. The increase was related to the significant increases in the Company's operations and amortization of goodwill related to acquisitions. The operating loss of $14.5 million in 1995, 6.9% of net revenue, was adversely impacted by a $24.3 million charge relating to the book loss on the sale of the toxicology business ($19.3 million) in the fourth quarter and other 25 27 special charges ($5.0 million). Included in this charge was a $3.4 million non-cash expense to write down to market the Company's EnSys investment and the write-off of other non-productive assets. In addition, the Company recorded severance charges totaling $1.2 million relating to the downsizing of its corporate overhead structure. The remaining $0.4 million relates primarily to accrued lease loss reserves related to underutilization of the Richmond laboratory facility. After adjusting for the one-time charges in 1995, operating income of $9.8 million, 4.7% of net revenue, was $1.2 million less than the comparable operating income of $11.0 million, 5.7% of net revenue, in 1994. The pro forma net loss in 1995 of $5.4 million represents a favorable change of $2.6 million as compared to 1994's pro forma net loss. The 1995 pro forma net loss per share of $0.29 compares to pro forma net loss per share of $0.43 in 1994. LIQUIDITY AND CAPITAL RESOURCES As of December 31, 1996, the Company had $21.8 million of cash and cash equivalents on hand and $14.2 million invested in marketable securities. The Company has historically funded its operations and growth, including acquisitions, with cash flow from operations and borrowings. In January 1996, PPD completed an initial public offering of its common stock. Proceeds of the offering, after expenses, were approximately $37.2 million and a portion thereof was used to repay a $5.5 million loan. For the year ended December 31, 1996, the Company experienced a net increase in cash from operating activities of $0.3 million. Capital expenditures totaled $11.2 million. Net proceeds from the Company's initial public offering, combined with proceeds from stock option exercises, totaled $42.9 million. The Company used $5.9 million in cash to pay dividends declared in connection with the Company's revocation of its S corporation election, effective January 1, 1996, and used $13.8 million of cash to increase its holdings of marketable securities. In February 1996, the Company renegotiated a new credit facility with Wachovia Bank of North Carolina, N.A. The new facility consists of a $10.0 million line of credit with an additional discretionary line of credit for $20 million. Terms on the $10.0 million line are for one year, with interest at LIBOR plus 120 basis points, or the Bank's Prime rate, at the Company's option, with interest payable quarterly. Indebtedness under the line is unsecured and subject to certain covenants relating to financial ratios and tangible net worth. As of December 31, 1996, the Company owed $3.3 million under this facility. In February 1995, APBI arranged a $3.0 million master-lease agreement to provide a means to lease, rather than acquire, certain equipment for use in the United States without drawing on its principal credit facility. The Company completed a sale-leaseback transaction involving owned real estate in Austin, Texas, in November 1995. Total gross proceeds from the transaction were $12.0 million. The facilities are leased to the Company as a bond-type net lease with all responsibility of operations and maintenance residing with the Company. The initial term of the operating lease is 15 years followed by four five-year renewal options. The future minimum annual rent is $1.3 million with renewals at the then current market value. The net proceeds from the sale-leaseback transaction were used to repay the remaining mortgage balance on the referenced properties and the remaining cash was applied to APBI's revolving line of credit (which has since been terminated). The Company expects to continue expanding its operations through internal growth and strategic acquisitions. The Company expects such activities will be funded from existing cash and marketable securities, cash flow from operations and borrowings under its credit facility. The Company believes that such sources of cash will be sufficient to fund the Company's current operations for the foreseeable future. The Company is currently evaluating a number of acquisition and other growth opportunities which may require additional external financing, and the Company may from time to time seek to obtain funds from public or private issuances of equity or debt securities. EXCHANGE RATE FLUCTUATIONS AND EXCHANGE CONTROLS The vast majority of the Company's contracts are entered into by the Company's United States or United Kingdom subsidiaries. The contracts entered into by the United States subsidiaries are almost always denominated in United States dollars. 26 28 Contracts between the Company's United Kingdom subsidiaries and their clients are generally denominated in pounds sterling. Because substantially all of the United Kingdom subsidiaries' expenses, such as salaries, services, materials and supplies, are paid in pounds sterling, such subsidiaries' earnings are not materially affected by fluctuations in exchange rates. However, the Company's consolidated financial statements are denominated in dollars and, accordingly, changes in the exchange rate between the pound sterling and the dollar will affect the translation of such subsidiaries' financial results into dollars for purposes of reporting the Company's consolidated financial results, and also affect the dollar amounts actually received by the Company from such subsidiaries. Approximately 11.4% of the Company's net revenue was generated by its European, South African and South American clinical development services businesses, primarily in the United Kingdom, Belgium, France and Germany. As a result of the Company's sale of its toxicology operations, the percentage of the Company's revenue recorded in currencies other than United States dollars was significantly lower in 1996 than in 1995. However, because the Company is currently expanding its foreign operations, it is anticipated that the percentage of the Company's net revenue denominated in foreign currencies may increase in the future. There are no exchange controls currently in effect in any country in which the Company's subsidiaries conduct operations on the payment of dividends or otherwise restricting the transfer of funds outside such countries by a company resident in such countries. Although the Company performs services for clients located in a number of foreign jurisdictions, to date, the Company has not experienced any difficulties in receiving funds remitted from foreign countries. However, if any such jurisdictions were to impose or modify existing exchange control restrictions on the remittance of funds to the Company, such restrictions could have an adverse effect on the Company's business. POTENTIAL VOLATILITY OF QUARTERLY OPERATING RESULTS AND STOCK PRICE The Company's quarterly operating results are subject to volatility due to such factors as the commencement, completion or cancellation of large contracts, progress of ongoing contracts, acquisitions, the timing of start-up expenses for new offices, management of growth and changes in the mix of services. Since a large percentage of the Company's operating costs are relatively fixed, variations in the timing and progress of large contracts can materially affect quarterly results. To the extent the Company's international business increases, exchange rate fluctuations may also influence these results. The Company believes that comparisons of its quarterly financial results are not necessarily meaningful and should not be relied upon as an indication of future performance. However, fluctuations in quarterly results or other factors beyond the Company's control, such as changes in earnings estimates by analysts, market conditions in the CRO, environmental, pharmaceutical and biotechnology industries and general economic conditions, could affect the market price of the Common Stock in a manner unrelated to the longer-term operating performance of the Company. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. The information called for by this Item is set forth herein commencing on page F-1. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. None. 27 29 PART III Certain information required by Part III is omitted from this report, because the Registrant will file a definitive proxy statement for its 1997 Annual Meeting of Stockholders (the "Proxy Statement") within 120 days after the end of its fiscal year pursuant to Regulation 14A promulgated under the Securities Exchange Act of 1934, as amended, and the information included therein is incorporated herein by reference to the extent provided below. ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT. The information required by Item 10 of Form 10-K concerning the Registrant's executive officers is set forth under the heading "Executive Officers" located at the end of Part I of this Form 10-K. The other information required by Item 10 of Form 10-K is incorporated by reference to the information under the headings "Proposal No. 1 - Election of Directors" and "Other Information-Section 16(a) Beneficial Ownership Reporting Compliance" in the Proxy Statement. ITEM 11. EXECUTIVE COMPENSATION. The information required by Item 11 of Form 10-K is incorporated by reference to the information under the heading "Proposal No. 1 - Election of Directors - Information Concerning the Board of Directors and Its Committees," "Other Information - Executive Compensation," "--Director Compensation," "--Report of the Compensation Committee on Executive Compensation," "--Compensation Committee Interlocks and Insider Participation," and "--Performance Graph" in the Proxy Statement. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT. The information required by Item 12 of Form 10-K is incorporated by reference to the information under the heading "Other Information - Principal Shareholders" in the Proxy Statement. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS. The information required by Item 13 of Form 10-K is incorporated by reference to the information under the heading "Other Information - Certain Transactions" in the Proxy Statement. 28 30 PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K. (a) Financial Statements and Financial Statement Schedules 1. The consolidated financial statements of the Company and its subsidiaries filed as part of this Report are listed in the attached Index to Consolidated Financial Statements and Financial Statement Schedule. 2. The schedule to the consolidated financial statements of the Company and its subsidiaries filed as part of this Report is listed in the attached Index to Consolidated Financial Statements and Financial Statement Schedule. 3. The exhibits filed as part of this Report are listed in Item 14c below. (b) Reports on Form 8-K The Company filed a Current Report on Form 8-K with the Securities and Exchange Commission on October 10, 1996, relating to the Company's acquisition of Applied Bioscience International Inc. The financial statements required by Item 7 of Form 8-K were incorporated therein by reference to prior Company filings. On November 19, 1996, the Company filed a Current Report on Form 8-K with the Securities and Exchange Commission reporting the Company's results for the month of October 1996. (c) Exhibits Exhibit No. Description ----------- ----------- 2.1** --Plan of Merger to Merge PPD Subsidiary, Inc. with and into Pharmaceutical Product Development Clinical Research Unit, Inc. ("PPD-CRU"). 2.2** --Plan of Merger to Merge PPD-Europe, Inc. ("PPD Europe") with and into the Registrant. 2.3* --Agreement and Plan of Reorganization, dated as of June 20, 1996, among the Registrant, Wilmington Merger Corp. and Applied Bioscience International Inc. 2.4 --Stock and Asset Master Purchase Agreement by and among Huntingdon International Holdings plc, Huntingdon Life Sciences Inc., Applied Bioscience International Inc. and Pharmaco LSR International Inc., dated as of November 1, 1995, incorporated by reference to Exhibit 2 to Applied Bioscience International Inc.'s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 6, 1996. 3.1* --Restated Articles of Incorporation. 3.2 --Amended and Restated Bylaws. 10.1** --Employment Agreement, dated July 1, 1995, by and between the Registrant and Fredric N. Eshelman. 10.2** --Employment Agreement, dated July 1, 1995, by and between the Registrant and Peter J. Wise. 10.3** --Employment Agreement, dated October 1, 1995, by and between the Registrant and Rudy C. Howard. 10.4** --Plan of Merger to Merge PPD Subsidiary, Inc. with and into PPD-CRU (see Exhibit 2.1). 10.5** --Plan of Merger to Merge PPD-Europe with and into the Registrant (see Exhibit 2.2). 10.6** --Agreement for the Sale and Purchase of the Whole of the Issued Share Capital of Gabbay Group Limited, dated August 1, 1995, by and among Dr. Felicity Jane Gabbay, Professor John Gabbay, Leslie Grant Marshall, Mrs. Elizabeth MacKenzie Marshall, the Registrant, PPD-Europe and Gabbay Group Limited. 10.7** --Stock Purchase Agreement, dated May 16, 1994, by and among the Registrant, Wisconsin Analytical and Research Services, Ltd. ("WARS"), Richard Johnson and Richard Charles. 10.8** --Pharmaceutical Product Development, Inc. Equity Compensation Plan, effective as of October 30, 1995. 10.9** --Pharmaceutical Product Development, Inc. Stock Option Plan for Non-Employee Directors, effective as of October 31, 1995. 10.10** --Registration Rights Agreement, dated January 24, 1995, by and among the Registrant and certain of its shareholders. 10.11** --Term Loan Agreement, dated July 14, 1995, among the Registrant, PPD-CRU, Pharmaceutical 29 31 Research Plus, Inc. and Wachovia Bank of North Carolina, N.A. ("Wachovia"). 10.12** --Note and Security Agreement, dated November 15, 1993, made by the Registrant for the benefit of Wachovia, as amended on July 19, 1995. 10.13** --Note and Security Agreement, dated May 16, 1994, made by the Registrant for the benefit of Wachovia, as amended on July 19, 1995. 10.14** --Note and Security Agreement, dated June 28, 1994, made by PPD-CRU for the benefit of Wachovia, as amended on July 19, 1995. 10.15** --General Security Agreement, dated January 29, 1991, made by the Registrant for the benefit of Wachovia Bank and Trust Company, N.A. 10.16** --Note and Security Agreement, dated May 12, 1994, made by PPD-CRU for the benefit of Wachovia. 10.17** --General Security Agreement, dated June 28, 1994, made by PPD-CRU for the benefit of Wachovia. 10.18** --General Security Agreement, dated March 5, 1991, made by PPD-CRU for the benefit of Wachovia Bank and Trust Company, N.A. 10.19** --Loan Agreement, dated August 11, 1995, among Dr. Felicity Jane Gabbay, Professor John Gabbay and Gabbay Limited. 10.20** --Promissory Note, dated August 1, 1995, made by the Registrant and PPD-Europe for the benefit of Felicity Jane Gabbay, John Gabbay, Leslie Grant Marshall and Mrs. E.M. Marshall. 10.21** --Lease, dated August 18, 1995, by and between LOI Building, Inc. and the Registrant. 10.22** --Lease, dated August 18, 1995, by and between LOI Building, Inc. and the Registrant. 10.23** --Sublease Agreement, dated July 6, 1993, by and between United Carolina Bank and the Registrant. 10.24** --Sublease Agreement, dated April 14, 1993, by and between United Carolina Bank and the Company. 10.25** --Lease, dated June 7, 1993, by and between LOI Building, Inc. and the Registrant, as amended on August 18, 1995. 10.26** --Lease, dated May 1, 1994, by and between LOI Building, Inc. and the Registrant, as amended on August 18, 1995. 10.27** --Lease, dated November 1, 1990, by and between LOI Building, Inc. and the Registrant, as previously amended and as amended on August 18, 1995. 10.28** --Lease, dated February 9, 1993, by and between LOI Building, Inc. and the Registrant, as amended on January 23, 1995 and on August 18, 1995. 10.29** --Lease Agreement, dated August 17, 1995, by and between the Registrant and Pinehurst National Development Corporation, as amended on September 29, 1995. 10.30** --Lease, dated March 7, 1994, by and among John C. Bullock, Jr. and Jean H. Bullock and the Registrant, as supplemented by the Letter dated April 20, 1995 between John C. Bullock and the Registrant. 10.31** --Lease Agreement, dated as of August 1, 1991, by and between Connecticut General Life Insurance Company and the Registrant, as amended on January 5, 1993 and on August 18, 1995. 10.32** --Lease Agreement, dated as of February 22, 1995, by and between Perimeter Park West Associates Limited Partnership and the Registrant. 10.33** --Lease, dated October 15, 1995, by and between John T. Talbert, Jr., Gary M. Garlow and John T. Talbert, III, d/b/a Tagata Properties and the Registrant. 10.34** --Assignment and Assumption of Lease, dated May 17, 1994, by and between WARS and PPD-CRU, with respect to a Lease, dated July 1, 1987, by and between The LAB Associates and WARS. 10.35** --Lease, dated January 26, 1994, by and between Michael James Lawton, Jeffrey William Ware, Prudential Nominees Limited and Gabbay Group Limited. 10.36** --Lease on Offices, dated October 19, 1993, by and between Eucro European Contract Research GmbH and Gabbay Group Ltd. 10.37** --Employment Agreement, dated October 18, 1995, by and between the Registrant and Terrence W. Mischler. 10.38** --Lease Agreement, dated as of October 25, 1995, by and between the Registrant and Perimeter Park West Associates Limited Partnership. 10.39** --Lease Agreement, dated as of October 25, 1995, by and between PPD-CRU and Perimeter Park West Associates Limited Partnership. 10.40** --Note and Security Agreement, dated June 1, 1995 made by the Registrant for the benefit of Wachovia. 10.41** --Guaranty Agreement, dated June 10, 1994, made by Ronald B. McNeill for the benefit of Wachovia. 30 32 10.42** --Guaranty Agreement, dated June 10, 1994, made by Ernest Mario for the benefit of Wachovia. 10.43** --Guaranty Agreement, dated June 10, 1994, made by John A. McNeill, Jr. for the benefit of Wachovia. 10.44** --Guaranty Agreement, dated May 12, 1994, made by Ernest Mario for the benefit of Wachovia. 10.45** --Guaranty Agreement, dated May 12, 1994, made by Fred Eshelman for the benefit of Wachovia. 10.46** --Guaranty Agreement, dated May 12, 1994, made by Ronald B. McNeill for the benefit of Wachovia. 10.47** --Guaranty Agreement, dated May 12, 1994, made by Peter J. Wise for the benefit of Wachovia. 10.48** --Guaranty Agreement, dated May 12, 1994, made by John A. McNeill, Jr. for the benefit of Wachovia. 10.49** --First Amendment to Lease Agreement, dated October 25, 1995, with respect to Lease Agreement dated February 22, 1993, by and between the Registrant and Perimeter Park West Associates Limited Partnership. 10.50** --First Amendment to Lease, dated as of September 20, 1995, with respect to Lease dated April 14, 1993, by and between United Carolina Bank and the Registrant. 10.51** --First Amendment to Lease, dated as of September 20, 1995, with respect to Lease dated July 6, 1993, by and between United Carolina Bank and the Registrant. 10.52** --Assignment of Sublease, dated September 21, 1995 with respect to Sublease dated July 6, 1993, by and among United Carolina Bank, the Registrant and Clinical Investigation Review Board. 10.53** --Guaranty Agreement, dated June 10, 1994, made by Fred Eshelman for the benefit of Wachovia. 10.54** --Guaranty Agreement, dated June 10, 1994, made by Peter J. Wise for the benefit of Wachovia. 10.55** --Lease made January 23, 1996 between PPD-CRU and Western Center Properties, Inc. 10.56** --Note dated January 23, 1996, made by the Registrant for the benefit of Wachovia. 10.57* --First Amendment to Registration Rights Agreement. 10.58* --Shareholder Voting Agreement, dated June 7, 1996. 10.59* --First Amendment to Lease Agreement, dated October 25, 1995, between PPD and Perimeter Park West Associates Limited Partnership. 10.60* --First, Second and Third Amendments to Lease Agreement, dated March 25, 1996, between PPD and BBC Family Limited Partnership. 10.61* --Lease Agreement, dated March 25, 1996, between PPD and BBC Family Limited Partnership. 10.62 --Applied Bioscience International Inc. Employee Stock Purchase Program (1988), incorporated by reference to Exhibit 10.1 to Applied Bioscience International Inc.'s Annual Report on Form 10-K for the year ended December 31, 1993. 10.63 --Pharmaco International Limited Retirement Benefits Scheme and Trust Deed, incorporated by reference to Exhibit 10.2 to Applied Bioscience International Inc.'s Registration Statement on Form S-1 (No. 33-11953). 10.64 --Applied Bioscience International Inc. Stock Incentive Program (1990), incorporated by reference to Exhibit 10.34 to Applied Bioscience International Inc.'s Annual Report on Form 10-K for the year ended December 31, 1990. 10.65 --APBI Retirement Savings Plan, incorporated by reference to Exhibit 4 to Applied Bioscience International Inc.'s Registration Statement on Form S-8 (No. 33-56678). 10.66 --Letter Agreement dated September 3, 1993, between Applied Bioscience International Inc. and Stephen L. Waechter, incorporated by reference to Exhibit 10.32 to Applied Bioscience International Inc.'s Amended Annual Report on Form 10-K/A for the year ended December 31, 1994. 10.67 --Letter Agreement dated September 14, 1993, between Applied Bioscience International Inc. and Stephen L. Waechter, incorporated by reference to Exhibit 10.44 to Applied Bioscience International Inc.'s Amended Annual Report on Form 10-K/A for the year ended December 31, 1994. 10.68 --Change of Control Agreement by and between Applied Bioscience International Inc. and Stephen L. Waechter dated as of June 14, 1995, incorporated by reference to Exhibit 10.35 to Applied Bioscience International Inc.'s Quarterly Report on Form 10-Q for the period ended September 30, 1995. 10.69a-69f --Non-statutory Stock Option Agreements by and between Applied Bioscience International Inc. and Grover C. Wrenn dated as of September 19, 1995, incorporated by reference to Exhibits 10.40a-10.40f to Applied Bioscience International Inc.'s Quarterly Report on Form 10-Q for the period ended September 30, 1995. 10.70 --Purchase Agreement by and between ABI (TX) QRS 12-11, Inc. and Applied Bioscience International Inc., incorporated by reference to Exhibit 10.42 to Applied Bioscience 31 33 International Inc.'s Annual Report on Form 10-K for the year ended December 31, 1995. 10.71 --Lease Agreement by and between ABI (TX) QRS 12-11, Inc. and Pharmaco LSR International Inc., incorporated by reference to Exhibit 10.43 to Applied Bioscience International Inc.'s Annual Report on Form 10-K for the year ended December 31, 1995. 10.72 --Employment Agreement by and between Applied Bioscience International Inc. and Carol P. Hanna dated January 2, 1996, incorporated by reference to Exhibit 10.45 to Applied Bioscience International Inc.'s Annual Report on Form 10-K for the year ended December 31, 1995. 10.73 --Change of Control Agreement between Applied Bioscience International Inc. and Stephen L. Waechter, dated as of June 18, 1996, incorporated by reference to Exhibit 10.46 to Applied Bioscience International Inc.'s Amended Quarterly Report on Form 10-Q/A for the period ended June 30, 1996. 10.74 --Change of Control Agreement between Applied Bioscience International Inc. and Carol P. Hanna, dated as of June 18, 1996, incorporated by reference to Exhibit 10.47 to Applied Bioscience International Inc.'s Amended Quarterly Report on Form 10-Q/A for the period ended June 30, 1996. 10.75 --Form of Agreement, dated as of June 20, 1996, by and between Applied Bioscience International Inc. and each of Joseph H. Highland, Robert M. Wenger, Robert H. Harris and Joseph V. Rodricks, incorporated by reference to Exhibit 10.62 to the Registrant's Quarterly Report on Form 10-Q for the period ended September 30, 1996. 10.76 --Agreement, dated as of September 6, 1996, by and between Applied Bioscience International Inc. and John H. Timoney, incorporated by reference to Exhibit 10.63 to the Registrant's Quarterly Report on Form 10-Q for the period ended September 30, 1996. 10.77 --Agreement, dated as of September 25, 1996, by and between Applied Bioscience International Inc. and Kenneth H. Harper, incorporated by reference to Exhibit 10.64 to the Registrant's Quarterly Report on Form 10-Q for the period ended September 30, 1996. 10.78 --Severance Compensation Agreement, dated as of September 25, 1996, by and between Applied Bioscience International Inc. and John D. Bryer, incorporated by reference to Exhibit 10.65 to the Registrant's Quarterly Report on Form 10-Q for the period ended September 30, 1996. 10.79 --Consulting Agreement, dated as of October 1, 1996, by and between Applied Bioscience International Inc., and John D. Bryer, incorporated by reference to Exhibit 10.66 to the Registrant's Quarterly Report on Form 10-Q for the period ended September 30, 1996. 10.80 --Employment Agreement, dated as of October 5, 1996, by and between Pharmaceutical Product Development, Inc., and Thomas D'Alonzo, incorporated by reference to Exhibit 10.67 to the Registrant's Quarterly Report on Form 10-Q for the period ended September 30, 1996. 10.81 --Employment Agreement, dated as of September 26, 1996, by and between Pharmaceutical Product Development, Inc., and Fred B. Davenport, Jr. 10.82 --Employment Agreement, dated as of September 25, 1996, by and between Pharmaceutical Product Development, Inc. and Joshua S. Baker. 10.83a-83f --Substitute Non-Statutory Stock Option Agreements by and between Pharmaceutical Product Development, Inc. and Grover C. Wrenn, dated as of September 26, 1996. 21 --Subsidiaries of the Registrant 23.1 --Consent of Coopers & Lybrand L.L.P. 23.2 --Consent of Arthur Andersen LLP 27 --Financial Data Schedule (for SEC use only) 99 --Report of Arthur Andersen LLP - ------------ * Previously filed. ** Incorporated by reference to the Registrant's Registration Statement on Form S-1, as amended (File No. 33-98996). 32 34 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES INDEX TO CONSOLIDATED FINANCIAL STATEMENTS AND FINANCIAL STATEMENT SCHEDULE Page ---- Report of Independent Accountants F-2 Consolidated Statements of Operations for the Years Ended December 31, 1996, 1995 and 1994 F-3 Consolidated Balance Sheets as of December 31, 1996 and 1995 F-4 Consolidated Statements of Shareholders' Equity for the Years Ended December 31, 1996, 1995 and 1994 F-5 Consolidated Statements of Cash Flows for the Years Ended December 31, 1996, 1995 and 1994 F-6 Notes to Consolidated Financial Statements F-7 Consolidated Financial Statement Schedule Schedule II - Valuation and Qualifying Accounts F-27 F-1 35 REPORT OF INDEPENDENT ACCOUNTANTS The Board of Directors and Shareholders Pharmaceutical Product Development, Inc. and Subsidiaries We have audited the accompanying consolidated balance sheet of Pharmaceutical Product Development, Inc. and its subsidiaries as of December 31, 1996, and the related consolidated statements of operations, shareholders' equity and cash flows for the year then ended. 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 audit. We conducted our audit in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Pharmaceutical Product Development, Inc. and its subsidiaries as of December 31, 1996, and the results of their operations and their cash flows for the year then ended in conformity with generally accepted accounting principles. We previously audited and reported on the combined balance sheet of Pharmaceutical Product Development, Inc., its affiliates and its consolidated subsidiaries as of December 31, 1995 and the related combined statements of operations, shareholders' equity and cash flows for the two years in the period then ended, prior to their restatement for the 1996 pooling of interests. The contribution of Pharmaceutical Product Development, Inc., its affiliates and its consolidated subsidiaries to total assets represented 19 percent of the restated total assets as of December 31, 1995. The contribution of Pharmaceutical Product Development, Inc., its affiliates and its consolidated subsidiaries to net revenue represented 17 percent and 14 percent of the restated total for 1995 and 1994, respectively. The contribution (in thousands) of Pharmaceutical Product Development, Inc., its affiliates and its consolidated subsidiaries represented $2,537 of net income compared to a restated consolidated net loss of $5,404 in 1995 and represented $2,021 of net income compared to a restated consolidated net loss of $7,987 in 1994. Separate financial statements of the other company included in the restated consolidated balance sheet as of December 31, 1995 and in the 1995 and 1994 restated consolidated statements of operations, shareholders' equity and cash flows were audited and reported on separately by other auditors. We also audited the combination of the accompanying consolidated balance sheet as of December 31, 1995 and the consolidated statements of operations, shareholders' equity and cash flows for the two years in the period then ended, after restatement for the 1996 pooling of interests; in our opinion, such consolidated statements have been properly combined on the basis described in Note 2 of notes to consolidated financial statements. /s/COOPERS & LYBRAND L.L.P. Raleigh, North Carolina February 11, 1997 F-2 36 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEARS ENDED DECEMBER 31, 1996, 1995 AND 1994 (IN THOUSANDS, EXCEPT PER SHARE DATA)
1996 1995 1994 --------- --------- --------- Life sciences revenues, net of subcontractor costs of $47,933, $52,066 and $44,864, respectively $ 152,304 $ 160,495 $ 146,342 Environmental sciences revenues, net of subcontractor costs of $4,752, $7,230 and $4,564, respectively 45,492 49,283 45,763 --------- --------- --------- Net revenue 197,796 209,778 192,105 --------- --------- --------- Direct costs - Life sciences 79,108 90,315 86,647 Direct costs - Environmental sciences 31,744 32,442 28,670 Selling, general and administrative expenses 61,571 64,014 55,428 Depreciation and amortization 10,436 13,251 10,375 Loss on sale of business -- 19,308 -- Merger costs and special charges 16,114 4,982 -- --------- --------- --------- 198,973 224,312 181,120 --------- --------- --------- Operating income (loss) (1,177) (14,534) 10,985 Interest: Expense (420) (3,304) (3,190) Income 1,919 263 508 Other income (expense), net 305 425 (46) --------- --------- --------- Income (loss) from continuing operations before provision for income taxes 627 (17,150) 8,257 --------- --------- Provision for income taxes 4,134 --------- Net loss (3,507) --------- Weighted average number of common shares outstanding 21,168 ========= Net loss per common share $ (0.17) ========= Pro Forma Data (Note 1): Income (loss) from continuing operations before provision for income taxes (17,150) 8,257 Pro forma provision (benefit) for income taxes (14,359) 3,371 --------- --------- Pro forma income (loss) from continuing operations (2,791) 4,886 --------- --------- Discontinued operations: Loss from discontinued operations, net of income tax benefit of $128 -- (285) Estimated loss on disposal of discontinued operations, net of income tax benefit of $2,036 and $227, respectively (1,716) (12,588) --------- --------- Loss from discontinued operations (1,716) (12,873) --------- --------- Pro forma net loss before extraordinary item (4,507) (7,987) Extraordinary loss on early extinguishment of debt, net of income tax benefit of $475 (897) -- --------- --------- Pro forma net loss $ (5,404) $ (7,987) ========= ========= Pro forma weighted average number of common shares outstanding 18,815 18,671 ========= ========= Pro forma earnings (loss) per common share: Income (loss) from continuing operations $ (0.15) $ 0.26 Loss from discontinued operations (0.09) (0.69) Extraordinary loss (0.05) -- --------- --------- Pro forma loss per common share $ (0.29) $ (0.43) ========= =========
The accompanying notes are an integral part of these consolidated financial statements. F-3 37 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 1996 AND 1995 (IN THOUSANDS, EXCEPT SHARE DATA)
1996 1995 ---------- -------- ASSETS Current assets Cash and cash equivalents $ 21,838 $ 13,565 Marketable securities 14,210 242 Accounts receivable and unbilled services, net 76,237 70,263 Investigator advances 5,280 2,960 Prepaid expenses and other current assets 5,752 4,414 Deferred tax asset 4,955 4,756 --------- --------- Total current assets 128,272 96,200 Property and equipment, net 31,479 28,782 Goodwill, net 18,397 12,990 Other assets 3,309 4,689 --------- --------- Total assets $ 181,457 $ 142,661 ========= ========= LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities Current maturities of long-term debt $ 4,221 $ 2,201 Accounts payable 7,051 9,080 Payables to investigators 5,429 8,428 Other accrued expenses 26,263 24,289 Unearned income 18,705 14,882 --------- --------- Total current liabilities 61,669 58,880 Long-term debt, less current maturities 1,428 3,471 Deferred rent and other 3,054 3,010 --------- --------- Total liabilities 66,151 65,361 --------- --------- Commitments and contingencies (Notes 10 and 14) Shareholders' equity: Common stock, $0.10 par value, 95,000,000 shares authorized; 21,624,000 and 18,677,000 shares issued and outstanding, respectively 2,163 1,870 Paid-in capital 112,606 65,701 Retained earnings (accumulated deficit) (363) 10,621 Unrealized gain on investments 232 6 Cumulative translation adjustment 668 (425) Unearned compensation -- (473) --------- --------- Total shareholders' equity 115,306 77,300 --------- --------- Total liabilities and shareholders' equity $ 181,457 $ 142,661 ========= =========
The accompanying notes are an integral part of these consolidated financial statements. F-4 38 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY FOR THE YEARS ENDED DECEMBER 31, 1996, 1995 AND 1994 (IN THOUSANDS)
Common Stock Retained ----------------- Earnings Unrealized Cumulative Par Paid-in (Accumulated Gain (Loss) on Translation Unearned Shares Value Capital Deficit) Investments Adjustment Compensation ------ ----- ------- -------- ----------- ---------- ------------ Balance, December 31, 1993, as previously reported 6,913 $ 692 $ 444 $ 1,607 $ (268) Pooling of interests with APBI (Note 2) 11,365 1,137 58,299 22,070 $ (3,567) (1,404) ------ ------- -------- -------- -------- ------- Balance, December 31, 1993, as restated 18,278 1,829 58,743 23,677 (3,567) (1,672) Adjustment to beginning balance for change in accounting method $ 16 Unrealized loss on investments (763) Amortization of unearned compensation 671 Issuance of 26 common shares in connection with an acquisition accounted for under the purchase method 26 2 798 Minority interest of 26 common shares of affiliated company (2) (144) Income tax provision from exercise of stock options and unearned compensation amortization (249) Translation adjustment 2,006 Net loss (6,489) Dividends (1,237) Other 30 5 518 ------ ------- -------- ------- ----- -------- ------- Balance, December 31, 1994 18,334 1,834 59,666 15,951 (747) (1,561) (1,001) Change in unrealized loss on investments 753 Amortization of unearned compensation 539 Transfer of minority interest to affiliated group 2 168 Issuance of 72 common shares 72 7 708 Issuance of 257 common shares in connection with an acquisition accounted for under the purchase method 257 26 5,020 (977) Income tax benefit from exercise of stock options and unearned compensation amortization 53 Sale of business 1,699 Translation adjustments (563) Net loss (3,630) Dividends (723) Other 12 3 86 (11) ------ ------- -------- -------- ----- -------- ------- Balance, December 31, 1995 18,677 1,870 65,701 10,621 6 (425) (473) Public offering, net of cash offering costs 2,300 230 36,952 Shareholder S-Corp distributions 1,595 (7,532) Unrealized gain on investments 226 Issuance of 242 common shares 242 24 622 Stock issued for exercise of 365 options 365 37 5,058 Income tax benefit from exercise of stock options and unearned compensation amortization 1,990 Translation adjustments 1,093 Net loss (3,507) Other 40 2 688 55 473 ------ ------- -------- -------- ----- -------- ------- Balance, December 31, 1996 21,624 $ 2,163 $112,606 $ (363) $ 232 $ 668 $ -- ====== ======= ======== ======== ===== ======== =======
The accompanying notes are an integral part of these consolidated financial statements. F-5 39 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 1996, 1995 AND 1994 (IN THOUSANDS)
1996 1995 1994 -------- -------- -------- Cash flows from operating activities: Net loss $ (3,507) $ (3,630) $ (6,489) Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation and amortization 10,436 13,232 11,961 Deferred income taxes 1,375 (18,204) 3,235 Stock compensation amortization 668 539 671 Loss on sale of toxicology operations -- 16,991 -- Provision for loss on disposal of discontinued operations -- 3,752 12,815 (Gain) loss on disposition of property and equipment 6 (2,741) 113 Gain on sale of investments (8) -- -- Impairment of investment in EnSys -- 2,638 -- Early extinguishment of debt -- 955 -- Change in assets and liabilities: Accounts receivable and unbilled services, net (2,043) 108 (15,126) Prepaid expenses and other current assets (4,317) 2,076 (4,242) Current income taxes 1,354 1,472 5,115 Goodwill and other assets 1,068 (1,968) (4,015) Assets and liabilities of discontinued operations, net -- (1,593) (2,009) Accounts payable and accrued liabilities (6,872) 9,301 (1,961) Unearned income 2,569 (7,011) 1,401 Other (411) 6 (249) -------- -------- -------- Net cash provided by operating activities 318 15,923 1,220 -------- -------- -------- Cash flows from investing activities: Purchases of property and equipment (11,176) (10,117) (16,089) Proceeds from sale of toxicology operations -- 32,500 -- Proceeds from sale of property and equipment 74 14,158 69 Purchase of marketable securities (13,799) (14) (13) Sale of investments 244 -- -- Net cash paid for acquisitions (3,867) (741) (1,881) -------- -------- -------- Net cash (used in) provided by investing activities (28,524) 35,786 (17,914) -------- -------- -------- Cash flows from financing activities: Short-term bank (repayments) borrowings, net -- (1,687) (16,929) Line of credit (repayments) borrowings, net 669 (12,892) 12,973 Proceeds from long-term debt 167 -- 2,771 Principal repayments on long-term debt (2,415) (32,897) (13,224) Other long-term borrowings -- -- 26,903 Cash dividends paid (5,937) (723) (1,237) Proceeds from issuance of common stock 42,902 761 524 -------- -------- -------- Net cash provided by (used in) financing activities 35,386 (47,438) 11,781 -------- -------- -------- Effect of exchange rate changes on cash 1,093 (510) (137) -------- -------- -------- Net increase (decrease) in cash and cash equivalents 8,273 3,761 (5,050) Cash and cash equivalents, beginning of the year 13,565 9,804 14,854 -------- -------- -------- Cash and cash equivalents, end of the year $ 21,838 $ 13,565 $ 9,804 ======== ======== ========
The accompanying notes are an integral part of these consolidated financial statements. F-6 40 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES: NATURE OF BUSINESS Pharmaceutical Product Development, Inc. and its subsidiaries ("PPD"), collectively (the "Company"), provide a broad range of research and consulting services in two business segments: life sciences and environmental sciences. Services provided in the life sciences segment include worldwide clinical research and development of pharmaceutical products and medical devices, biostatistical analysis and analytical laboratory services. Environmental sciences services include assessment and management of chemical and environmental health risk, site investigation and remediation planning and litigation support. Such services are provided through both segments under contract to clients in the pharmaceutical, general chemical, agrochemical, biotechnology and other industries. The environmental sciences segment also markets services to clients in the industrial, manufacturing and oil and gas industries. The Company's life sciences services, which represented 77% of the Company's business in 1996 based on net revenue, are marketed primarily in the United States and Europe. The remaining 23% of the Company's 1996 net revenue was derived from its environmental sciences segment which is primarily domestic. PRINCIPLES OF CONSOLIDATION The accompanying consolidated financial statements include the accounts and operations of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. MERGER COSTS AND SPECIAL CHARGES In connection with the acquisition of Applied Bioscience International Inc. ("APBI"), the Company implemented a reorganization plan under which the Company would eliminate certain positions and close a facility. The Company recorded merger and reorganization costs of $17.0 million in the third quarter of 1996. Included in these costs were transaction costs of $7.1 million, related primarily to investment banking, legal and accounting fees. In addition, the Company recorded $9.9 million in accruals for severance, lease termination and certain other costs. The Company reversed $0.8 million of these accruals in the fourth quarter due to changes in estimates. Of the amounts accrued above, $3.2 million is for severance payments for approximately 40 individuals consisting mainly of administrative personnel. In the fourth quarter of 1996, $1.1 million in severance was paid and charged against the reserve. Approximately $7.5 million of accrued merger and reorganization costs were accrued as of December 31, 1996 and included in Other accrued expenses. (See Note 2.) In the fourth quarter of 1995, the Company recorded special charges of $5.0 million, primarily related to the impairment of certain investments and assets and the decision to reduce costs and improve efficiencies. These charges included approximately $3.4 million associated with the impairment of the Company's available-for-sale investment (see Note 8) and other assets, $1.2 million related primarily to severance costs associated with the Company's efforts to reduce future costs and $0.4 million related to accrued lease losses and other miscellaneous costs. REVENUE RECOGNITION The Company records revenues from fixed-price contracts extending over more than one accounting period on a percentage-of-completion basis. Revenues from time-and-material contracts are recognized as billable rates multiplied by hours delivered, plus pass-through expenses incurred. Pass-through expenses generally include subcontractor costs which consist of investigator fees, travel and certain other contract costs that are reimbursed by the client. Accordingly, such subcontractor costs are deducted in determining net revenues. F-7 41 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 1. SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) If it is determined that a loss will result from the performance of a contract, the entire amount of the estimated loss is charged against income in the period in which the determination is made. Clients generally may terminate a study at any time, which may cause unplanned periods of excess capacity and reduced revenues and earnings. To offset the effects of early terminations, with respect to contracts of significant size the Company attempts to negotiate the payment of an early termination fee. CASH AND CASH EQUIVALENTS Cash and cash equivalents consists of unrestricted cash accounts, including commercial paper, which are not subject to withdrawal restrictions or penalties, and all highly liquid debt instruments with a maturity of three months or less at the date of purchase. Supplemental cash flow information and non-cash investing activities were as follows (in thousands):
YEAR ENDED DECEMBER 31, --------------------------------- 1996 1995 1994 ------ ------- ------- Cash paid (received): Interest $ 326 $ 3,707 $ 3,800 ====== ======= ======= Income taxes, net $1,594 $(2,299) $(6,355) ====== ======= =======
The non-cash assets and liabilities acquired, including the acquisition of Environmental Assessment Group, Ltd.; Data Acquisition and Research (DAR) Limited; Medisys S.L.; Trilife GmbH; and Q&Q Suporte A Pesquisa Clinica Ltda. in 1996 and Gabbay Limited and the Chicago Center for Clinical Research in 1995 (see Note 2) and the Phase I clinical center received as consideration for the sale of the toxicology operations in 1995 (see Note 3) were as follows (in thousands):
YEAR ENDED DECEMBER 31, ----------------------- 1996 1995 ---- ---- Acquisitions: Fair value of assets acquired $4,841 $7,633 Liabilities assumed 5,242 3,416 Non-cash consideration received: Fair value of assets acquired $ -- $5,098 Liabilities assumed -- 598
MARKETABLE SECURITIES The Company records its investment in marketable securities in accordance with Statement of Financial Accounting Standards No. 115, "Accounting for Certain Investments in Debt and Equity Securities." The classification of securities is generally determined at the date of purchase. All marketable securities of the Company have been classified as available for sale and have been reported at fair value with unrealized gains and losses reported as a separate component of shareholders' equity. The Company intends to hold these securities for an indefinite period of time. Gains and losses on sales of investment securities, computed based on specific identification of adjusted cost of each security, are included in other income at the time of the sales. (See Notes 5 and 8.) F-8 42 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 1. SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) INVESTIGATOR PAYMENTS Investigator payments are recognized based upon the status of the work completed as a percentage of the total procedures required under the contract or based on patient enrollment over the term of the contract. Billings and payments are based on predetermined contractual agreements which may differ from the accrual of the expense. Payments made in excess of the accrued expenses are classified as investigator advances and accrued expenses in excess of amounts paid are classified as payables to investigators. Contracted physician costs are included as a reduction to revenues in the consolidated statements of operations. PROPERTY AND EQUIPMENT Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is recorded using the straight-line method, based on estimated useful lives of 20 to 50 years for buildings, five to 12 years for laboratory equipment, three to five years for computers and related equipment, and four to 10 years for furniture and equipment. Leasehold improvements are amortized over the shorter of the respective lives of the leases or the useful lives of the improvements. Property under capital leases is amortized over the life of the lease or the service life, whichever is shorter. The Company evaluates impairment of its property and equipment based on whether it is probable that undiscounted future cash flows from operations are expected to be less than the asset's carrying value. GOODWILL The excess of the purchase price of the businesses acquired over the fair value of net tangible assets and identifiable intangibles at the date of the acquisitions has been assigned to goodwill. Goodwill is being amortized over periods of 15 to 40 years. As of December 31, 1996 and 1995, accumulated amortization was $3,036,000 and $2,014,000 respectively. The amortization charges for each of the three years ended December 31, 1996, 1995 and 1994 were $950,000, $715,000 and $485,000, respectively. The Company evaluates impairment of goodwill based on whether it is probable that undiscounted future cash flows from operations are expected to be less than the asset's carrying value. OTHER ASSETS Other intangible assets, which are included in other assets, are being amortized over periods of three to five years. (See Note 8.) UNBILLED SERVICES AND UNEARNED INCOME In general, prerequisites for billings are established by contractual provisions including predetermined payment schedules, the achievement of contract milestones or submission of appropriate billing detail. Unbilled services arise when services have been rendered but clients have not been billed. Similarly, unearned income represents amounts billed in excess of revenue recognized. INCOME TAXES The financial statements of the Company for periods prior to its initial public offering in January 1996 ("the IPO") do not include a provision for income taxes, because the taxable income or loss of the Company through December 31, 1995 (excluding the results of APBI - see Note 2) was included in the income tax returns of the individual shareholders under the S corporation election. For informational purposes, the statements of operations include a pro forma income tax provision on taxable income for financial reporting purposes, which combines income taxes on PPD's results, excluding APBI, using statutory federal and state rates that would have resulted if the Company had filed corporate tax returns during these periods and APBI's previously reported provision for income taxes. F-9 43 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 1. SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) In January 1996, prior to the effectiveness of the IPO, the Company elected to no longer be treated as an S corporation for tax purposes. Accordingly, the Company is now subject to federal and state income taxes and recognizes deferred taxes in accordance with Statement of Financial Accounting Standards No. 109 ("SFAS No. 109"), "Accounting for Income Taxes." SFAS No. 109 requires companies subject to income taxes to adjust their deferred tax assets and liabilities based on temporary differences between financial statement and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. TRANSLATION OF FOREIGN FINANCIAL STATEMENTS Assets and liabilities of foreign operations, where the functional currency is the local currency, are translated into U.S. dollars at the year-end rate of exchange. Income and expenses are translated at the average rates of exchange prevailing during the year. Gains or losses from translating foreign currency financial statements are accumulated in a separate component of shareholders' equity. Foreign currency transaction gains and losses are included in other income. Funds generated by each subsidiary of the Company are generally reinvested in the country where they are earned. PER SHARE INFORMATION The computation of income (loss) per share information is based on the weighted average number of common shares outstanding during the year. NEW ACCOUNTING PRONOUNCEMENTS In February 1997, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 128 ("SFAS No. 128"), "Earnings Per Share." SFAS No. 128 is designed to improve the earnings per share information provided in financial statements by simplifying the existing computational guidelines, revising the disclosure requirements and increasing comparability of earnings per share data on an international basis. This pronouncement is effective for periods beginning after December 15, 1997, and is not expected to have a material impact on the Company's financial statements. PERVASIVENESS 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. RECLASSIFICATIONS Certain prior year amounts have been reclassified to conform to the 1996 presentation. 2. ACQUISITIONS: POOLING On September 26, 1996, a wholly-owned subsidiary of the Company was merged with and into APBI in a transaction accounted for as a pooling of interests. As a result of the merger, APBI became a wholly-owned subsidiary of the Company. Under the terms of the merger agreement, APBI shareholders received 0.4054 of a share of the Company's common stock for each APBI share. As a result of the merger, the Company issued 12,063,860 shares of its common stock in exchange for all the outstanding shares of common stock of APBI. F-10 44 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 2. ACQUISITIONS (CONTINUED) Holders of options to acquire APBI stock had the choice to receive either shares of Company stock for the value of the options, or substituted options to acquire Company common stock. As a result of the APBI option holders' choices, 202,967 additional shares of Company common stock were issued, and options to purchase 600,513 shares of Company common stock were issued. In accordance with the pooling of interests method of accounting, the consolidated financial statements are based on the assumption that the companies were combined for the full year and financial statements of prior years have been restated to give effect to the combination. Net revenue and net income (loss) as previously reported for 1995 and for the six months ended June 30, 1996, and as restated for the pooling of interests follow (in thousands):
PPD APBI ADJUSTMENT RESTATED --- ---- ---------- -------- Year ended December 31, 1995 Net revenue $38,263 $183,253 $(11,738) $209,778 Pro forma income (loss) from continuing operations 2,537 (5,328) -- (2,791) Loss from discontinued operations and extraordinary items -- (2,613) -- (2,613) ------- -------- -------- -------- Pro forma net income (loss) 2,537 (7,941) -- (5,404) ------- -------- -------- -------- Six months ended June 30, 1996 Net revenue $25,041 $ 77,011 $ (5,506) $ 96,546 Net income 2,126 2,444 -- 4,570
Prior to the merger, APBI reported certain items as direct expenses, while PPD reported those items as a deduction to arrive at net revenue. APBI's results prior to the pooling have been restated to be presented on a basis consistent with PPD's results. The impact of the restatement on APBI's net revenue is presented above in the column labeled "Adjustment." PURCHASES The Company's Life Sciences Group furthered its expansion outside of the U.S. in 1996 through the acquisition of Trilife Gesellschaft Fur Medizinische Entwicklung Verwaltungs GmbH ("Trilife") in Germany, Medisys S.L. ("Medisys") in Spain and Q&Q Suporte A Pesquisa Clinica Ltda. ("Q&Q") in Brazil. The consideration for Trilife consisted of approximately $567,000 paid at closing. In addition, the Company may pay up to $135,000 as additional purchase price, dependent upon the performance of Trilife for a certain period after the acquisition. The consideration for Medisys consisted of $400,000 paid at closing, plus an additional $300,000 due on each of the first and second anniversaries of the acquisition. The consideration for Q&Q consisted of $500,000 paid at closing, plus an additional $100,000 due on each of the first three anniversaries. The Company also acquired Data Acquisition and Research (DAR) Limited ("DAR") in Scotland in 1996, which allowed it to expand its biostatistics and data analysis capabilities in Europe. The consideration for DAR consisted of cash paid at closing of $992,000, plus an additional $348,000 to be paid in 10 installments between June 1997 and December 2001. The Company's Environmental Sciences Group also expanded its operations in 1996 with the acquisition of Environmental Assessment Group Limited ("EAG") in England. The consideration for EAG consisted of $1.9 million cash, a note for approximately $350,000 and the potential to earn up to an additional $500,000 depending on the profits of EAG during the two years after the acquisition. In connection with these acquisitions, the Company recorded $6,278,000 in goodwill. Pro forma information is not presented as the results of operations prior to the dates of the acquisitions are not material individually or collectively to the Company. F-11 45 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 2. ACQUISITIONS (CONTINUED) On August 1, 1995, PPD and PPD-Europe (an S corporation formed in connection with this transaction), completed the acquisition of Gabbay Group Limited for $306,000 in cash and $241,000 in assumed debt. Gabbay Group Limited, a clinical research organization, is located in Southampton, England. The purchase price resulted in goodwill of $444,000. Pro forma information is not presented as the results of operations prior to the date of the acquisition are not material to the Company. On August 18, 1995, the Company, through its subsidiary Clinix International Inc., acquired the business and assets of the Chicago Center for Clinical Research ("CCCR"), a nationally recognized organization conducting clinical trials in pharmaceuticals, food and nutrition. The consideration consisted of 634,188 shares of APBI's common stock valued at $4,043,000, together with the assumption or retirement of substantially all of CCCR's outstanding indebtedness and other related liabilities. As a result of this transaction, the Company recorded $4,517,000 in goodwill. Pro forma information is not presented, as the results of operations prior to the date of acquisition are not material to the Company. 3. SALE OF BUSINESS: On November 21, 1995, the Company sold its toxicology laboratories located in New Jersey and Suffolk, England, to Huntingdon International Holdings plc ("Huntingdon"). In connection with the sale of the New Jersey toxicology laboratory, which operated as a division of PPD Pharmaco (formerly Pharmaco LSR International Inc., "Pharmaco"), a wholly-owned subsidiary of the Company, Huntingdon acquired substantially all of the assets of such laboratory and assumed substantially all related liabilities. In connection with the sale of the toxicology laboratory located in Suffolk, England, Huntingdon acquired all of the capital stock of Pharmaco LSR Ltd., a wholly-owned subsidiary of the Company. The Company received as consideration cash proceeds of $32,500,000, plus an additional $6,000,000 for an equal amount of cash conveyed to Huntingdon as part of the sale. The consideration also included the Company's acquisition of Huntingdon's Phase I clinical center located in Leicester, England, at an agreed upon value of $4,500,000. As a result of the disposition, the Company recorded a pre-tax loss on sale of business of $19,308,000 which is reflected in the accompanying consolidated statement of operations for the year ended December 31, 1995. The loss reflected the net book value of the net assets sold in excess of consideration received of $16,991,000, $1,178,000 of transaction costs, $1,338,000 of severance and relocation costs, and $581,000 of other costs primarily related to the required name change of the remaining business, net of a $780,000 gain recorded as a result of the settlement of the Company's U.K. pension plan. (See Note 13.) The assets and liabilities sold to Huntingdon are not included in the accompanying consolidated balance sheet as of December 31, 1995. The results of operations (excluding the effect of the loss on the sale of the business) for the years ended December 31, 1995 and 1994 included the following for the disposed business (in thousands):
1995 1994 ---- ---- Net revenues $38,446 $46,387 Operating (loss) income (1,136) 2,409
4. DISCONTINUED OPERATIONS: In June 1994, the Company sold Paragon, a division of its wholly owned subsidiary APBI Environmental Sciences Group, Inc., for cash and a note totaling $525,000. The sale resulted in a loss on disposal before income tax benefits of $732,000. In December 1993, the Company adopted a formal plan to sell its environmental testing laboratory division, Environmental Testing and Certification Corp. ("ETC"). Accordingly, in 1993 the Company's results reflected charges necessary to reduce the carrying value of its investment in ETC to its estimated realizable value. F-12 46 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 4. DISCONTINUED OPERATIONS (CONTINUED) Although it was the Company's desire to exit the environmental analytical laboratory business completely, it became apparent during 1994 that the Company would not be able to dispose of its interest in ETC on terms that it deemed attractive, in part because of the ongoing consolidation within the environmental analytical laboratory industry. Based on the Company's belief that a larger network of analytical laboratories could compete more effectively, and that a minority interest in a larger laboratory business might provide a better means to pursue divestiture opportunities, in August 1994, the ETC division of APBI Environmental Sciences Group, including substantially all of its assets and liabilities, was consolidated with the business operations of PACE Inc. (an unrelated analytical laboratory) and Coast-to-Coast Analytical Services, Inc. (another unrelated analytical laboratory). The combined business operations were operated within PACE Incorporated ("PACE"), a newly formed entity. As a result of the combination, the Company, through APBI Environmental Sciences Group, owned preferred and common stock of PACE representing approximately 36% of the weighted average preferred and common stock outstanding. Due to the additional time required to divest ETC and after assessment of the estimated fair value of APBI's investment in PACE, the Company recorded an additional write down of $2,533,000 in the third quarter of 1994. In the fourth quarter of 1994, the Company recorded $9,550,000 in additional writedowns to reduce the carrying value of the investment to its then estimated net realizable value. During the fourth quarter of 1995, PACE sold substantially all of its laboratories in a series of transactions. Net proceeds from such transactions were used to retire PACE's outstanding bank loan and to partially repay certain other secured indebtedness. PACE, which is currently winding up its remaining business operations, does not have sufficient assets to repay its outstanding liabilities. Accordingly, it is anticipated that equity holders will not receive any distributions upon completion of PACE's winding up and dissolution. Effective December 29, 1995, the Company's voting interest was reduced to below 20%, and the Company changed its accounting for the investment from the equity method to the cost method in accordance with Accounting Principles Board Opinion No. 18, "The Equity Method of Accounting for Investments in Common Stock." In the fourth quarter of 1995, the Company wrote off its remaining investment in PACE of approximately $3,600,000, and accrued its estimated exposure for guarantees on leases. PACE, which is currently winding up its remaining business operations, does not have sufficient assets to repay its outstanding liabilities and was involuntarily placed in bankruptcy under Chapter 7 of the Bankruptcy Code during 1996. The Company does not believe that any further charges will be taken with respect to this investment. The operating results of the discontinued operations include net revenues of $12,045,000 for the year ended December 31, 1994. Assets and liabilities of the discontinued operations were as follows as of December 31, 1994 (in thousands): Accounts receivable, net $ 317 Property and equipment, net 1,542 Other assets 12,959 Other liabilities (12,382) -------- Net assets of discontinued operations $ 2,436 ========
5. MARKETABLE SECURITIES: The estimated market value and aggregate cost of current marketable securities were as follows (in thousands):
DECEMBER 31, ------------------------------- 1996 1995 ---- ---- Estimated market value $14,210 $242 Aggregate cost 14,210 236 ------- ---- Gross unrealized gains $ -- $ 6 ======= ====
F-13 47 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 6. ACCOUNTS RECEIVABLE AND UNBILLED SERVICES: Accounts receivable and unbilled services consisted of the following (in thousands):
DECEMBER 31, ---------------------- 1996 1995 ------ ------ Trade: Billed $45,419 $39,257 Unbilled 30,404 33,509 Reserve for doubtful accounts (1,511) (3,319) ------- ------- 74,312 69,447 Officers and employees 363 395 Other 1,562 421 ------- ------- $76,237 $70,263 ======= =======
7. PROPERTY AND EQUIPMENT: Property and equipment, stated at cost, consisted of the following (in thousands):
DECEMBER 31, ---------------------- 1996 1995 ------ ------ Land $ 593 $ 543 Buildings and leasehold improvements 13,049 10,692 Construction in progress 167 230 Furniture and equipment 28,062 23,879 Computer equipment 27,868 22,410 ------- ------- 69,739 57,754 Less- Accumulated depreciation and amortization 38,260 28,972 ------- ------- $31,479 $28,782 ======= =======
The annual depreciation and amortization charges on property and equipment for each of the three years ended December 31, were (in thousands): 1994 $10,453 1995 12,015 1996 9,399
8. OTHER ASSETS: Other assets consisted of the following (in thousands):
DECEMBER 31, ---------------------- 1996 1995 ------ ------ Investment in SDI $1,240 $1,008 Intangible and other assets, net of accumulated amortization of $1,024 and $2,183, respectively 2,069 3,039 Net non-current assets of discontinued operations -- 642 ------ ------ $3,309 $4,689 ====== ======
The annual amortization charges on intangible assets for each of the three years ended December 31, 1996, 1995 and 1994 were $87,000, $602,000 and $700,000, respectively. F-14 48 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 8. OTHER ASSETS (CONTINUED) The Company owns 729,600 shares of Strategic Diagnostics Inc. ("SDI"), formerly EnSys Environmental Products Inc. ("EnSys") common stock. Warrants to acquire up to an additional 866,667 shares of EnSys common stock at $7.50 per share expired in October 1996. The trading price per share was $2.00 and $1.63 as of December 31, 1996 and 1995, respectively. The Company owns approximately 4.4% of the SDI common stock at December 31, 1996. The Company's investment in SDI is carried at its fair value. In 1996, the difference between the fair value and the carrying value of $232,000 is reported as a separate component of shareholders' equity. In 1995, the difference between the fair value and the carrying value of $2,638,000 was reported as a loss in the consolidated statement of operations as the decline was considered other than temporary. 9. OTHER ACCRUED EXPENSES: Other accrued expenses consisted of the following (in thousands):
DECEMBER 31, -------------------------- 1996 1995 ---- ---- Accrued salaries, wages, benefits and related costs $10,976 $11,457 Accrued merger costs 7,513 -- Accrued loss on sale of business -- 2,395 Accrued special charges and restructuring costs -- 2,223 Other 7,774 8,214 ------- ------- $26,263 $24,289 ======= =======
10. LONG-TERM DEBT AND LEASE OBLIGATIONS: Long-term debt consisted of the following (in thousands):
DECEMBER 31, -------------------------- 1996 1995 ---- ---- LIBOR (5.72% at December 31, 1996) plus 1.2% unsecured line of credit due February 19, 1997 $ 3,300 $ -- Prime (8.5% at December 31, 1995) less 0.5% line of credit reducing $520 annually and expiring January 1, 2000 -- 2,210 Equipment leases 689 894 Various notes at interest rates up to 8.5% 1,660 2,568 ------- ------- 5,649 5,672 Less current maturities (4,221) (2,201) ------- ------- $ 1,428 $ 3,471 ======= =======
As of December 31, 1996, the Company had $6,700,000 in unused line of credit borrowings available, as well as an additional $20,000,000 discretionary line of credit. On February 19, 1997, the Company modified the line of credit to mature on May 1, 1997. F-15 49 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 10. LONG-TERM DEBT AND LEASE OBLIGATIONS (CONTINUED) For the years subsequent to December 31, 1996, annual maturities of long-term debt outstanding are (in thousands): 1997 $4,221 1998 1,013 1999 175 2000 161 2001 79 ------ $5,649 ======
OPERATING LEASES The Company is obligated under noncancellable leases expiring at various dates through 2010 relating to its operating facilities and certain equipment. Rental expense for all operating leases, net of sublease income, was $10,334,000, $8,200,000 and $6,034,000 for the years ended December 31, 1996, 1995 and 1994, respectively. The Company completed a sale-leaseback transaction involving owned real estate in Austin, Texas, on November 13, 1995. Total gross proceeds in the transaction were $12,000,000 resulting in a pre-tax gain of approximately $2,100,000. The gain, which has been deferred, is classified as deferred rent and other in the accompanying consolidated balance sheet and is being amortized on a straight-line basis over the fifteen year lease term. The facilities are leased to the Company with all responsibility of operations and maintenance residing with the Company. Certain facility leases entered into in 1992 and prior years provided for concessions by the landlords, including payments for leasehold improvements, moving expenses, and free rent periods. These concessions have been reflected as deferred rent and other in the accompanying consolidated financial statements. The Company is recording rent expense on a straight-line basis for these leases. Future minimum payments for all operating lease obligations for years subsequent to December 31, 1996 are as follows (in thousands): 1997 $12,422 1998 11,362 1999 8,701 2000 6,867 2001 6,146 2002 and thereafter 31,519
11. STOCK PLANS: STOCK INCENTIVE PROGRAM The Company has a stock option plan (the "Plan") under which the Company may grant options to its employees and directors for up to 1,500,000 shares of common stock. Under the Plan, the exercise price of each option equals the market price of the Company's stock on the date of grant and an option's maximum term is ten years. Options are granted upon approval of the Board of Directors and vest over various periods. F-16 50 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 11. STOCK PLANS (CONTINUED) On January 1, 1996, the Company adopted Statement of Financial Accounting Standards No. 123 ("SFAS No. 123"), "Accounting for Stock Based Compensation". As permitted by SFAS No. 123, the Company has chosen to apply Accounting Principles Board Opinion No. 25 ("APB No. 25"), "Accounting for Stock Issued to Employees" and related interpretations in accounting for its Plans. Accordingly, no compensation cost has been recognized for options granted under the Plan. Had compensation cost for the Company's Plan been determined based on the fair value at the grant dates for awards under the Plan consistent with the method of SFAS No. 123, the Company's net loss and net loss per share would have been increased to the pro forma amounts indicated below.
1996 1995 ------------------- -------------------- AS AS REPORTED PRO FORMA REPORTED PRO FORMA -------- --------- -------- --------- Net loss (in thousands) $3,507 $7,670 $5,404 $5,637 Net loss per share $ 0.17 $ 0.36 $ 0.29 $ 0.30
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 1996 and 1995: expected volatility of 49.9%, risk-free interest of 6.25% and expected lives of five years. The weighted average fair value of options granted during 1996 and 1995 was $11.48 and $6.55 per share, respectively. A summary of the status of the Company's Plan as of December 31, 1996, 1995 and 1994, and changes during the years ending on those dates, is presented below:
1996 1995 1994 ------------------------- ------------------------- ------------------------- WEIGHTED WEIGHTED WEIGHTED AVERAGE AVERAGE AVERAGE SHARES EXERCISE PRICE SHARES EXERCISE PRICE SHARES EXERCISE PRICE ------ -------------- ------ -------------- ------ -------------- Outstanding at beginning of year 1,180,809 $16.29 1,240,682 $17.07 1,358,518 $23.07 Granted 1,056,539 22.57 191,837 12.38 347,959 15.64 Exercised (858,800) 15.10 (63,547) 9.82 (25,549) 8.55 Forfeited (137,406) 17.96 (188,163) 19.63 (440,246) 35.05 --------- --------- --------- Outstanding at end of year 1,241,142 $22.28 1,180,809 $16.29 1,240,682 17.07 ========= ====== ========= ====== ========= ====== Options exercisable at year-end 771,069 $19.85 766,895 $17.31 734,217 $17.56 ========= ====== ========= ====== ========= ======
The following table summarizes information about the Plan's stock options at December 31, 1996:
OPTIONS OUTSTANDING OPTIONS EXERCISABLE ---------------------------------------------- ------------------------------ NUMBER WEIGHTED-AVERAGE WEIGHTED NUMBER WEIGHTED RANGE OF OUTSTANDING REMAINING AVERAGE EXERCISABLE AVERAGE EXERCISE PRICES AT 12/31/96 CONTRACTUAL LIFE EXERCISE PRICE AT 12/31/96 EXERCISE PRICE --------------- ----------- ---------------- -------------- ----------- -------------- $10.01-$20.00 530,832 8.2 years $16.12 530,832 $16.12 $20.01-$30.00 611,605 9.6 years $25.44 141,532 $22.72 $30.01-$40.00 87,241 4.8 years $35.20 87,241 $35.20 $40.01-$40.55 11,464 5.1 years $40.55 11,464 $40.55 --------- ------- 1,241,142 771,069 ========= =======
F-17 51 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 11. STOCK PLANS (CONTINUED) OTHER STOCK PROGRAMS On August 15, 1995, APBI granted a total of 60,000 restricted stock units ("RSUs") to two executive officers of APBI. The RSUs vested at the time the average closing price for APBI's common stock equaled or exceeded $10.00 per share for a period of 10 consecutive trading days. The RSUs vested on July 5, 1996. The executives were not required to pay any consideration in exchange for the RSUs. Unearned compensation was amortized to expense over the vesting period of the RSUs. Compensation expense related to these RSUs of $534,000 and $66,000 has been recorded in the accompanying statement of operations for the years ended December 31, 1996 and 1995, respectively. On September 19, 1995, APBI entered into a Separation Agreement with a former senior executive officer of APBI. In connection therewith, APBI canceled the former executive's unexercised options granted under APBI's stock option plan and provided the officer with options granted outside of APBI's plan to purchase up to 147,428 shares of APBI's common stock. Of the options granted, 92,761 were fully vested at the grant date. The remaining options vest at various dates through September 13, 1997, and expire on the earlier of February 11, 2001, or the day immediately following any period of 20 consecutive trading days in which the last sale for shares of the Company's common stock for each of such trading days equaled or exceeded $49.33, as adjusted, per share. The options were granted at the exercise prices established at the original option grant dates and vary from $13.88 to $39.16, as adjusted. At the grant date of the new options, 102,000 of the options were priced below fair market value. Accordingly, in 1995, the Company recorded compensation expense of $112,000 for the difference between the fair market value and the exercise price. These options to acquire shares of APBI stock were converted into options to acquire Company stock, in connection with the merger. The terms and conditions of the options remained the same, except that the number of options and their exercise price were adjusted in accordance with the exchange ratio provided for in the merger agreement. EMPLOYEE STOCK PURCHASE PLAN The Company has an Employee Stock Purchase Plan under which options are granted to employees who elect to purchase shares of common stock at the end of a five- or seven-year savings period. Savings are accumulated through voluntary payroll deductions. The Company contributes a bonus to each participant's savings account equal to nine monthly contributions at the end of the five-year period and 18 monthly contributions at the end of the seven-year period. When the savings period ends, the employee may elect to purchase the shares using the savings balance, including the bonus; purchase some of the shares and receive the savings balance in cash; or receive the savings and bonus in cash. Those employees electing the five-year savings period may also elect to leave the savings in their accounts for another two years and forfeit the option to purchase the shares. The United Kingdom Plan, as approved by the shareholders, was implemented by Pharmaco LSR Ltd. during 1988. Currently, employees of the Company's United Kingdom subsidiary, Pharmaco International Ltd., participate in this plan. The United States Plan has not been implemented. Outstanding options at the time of the merger were converted in accordance with the exchange ratio provided for in the merger agreement. In connection with the sale of the toxicology operations, options equivalent in value to the savings balance in the terminated employees' accounts became immediately exercisable. Options in excess of the savings balance were forfeited. The exercise period for the vested options extended through April 1996. At December 31, 1996, there were 4,225 options outstanding at an average exercise price of $20.33. Of those, 2,425 options were exercisable at December 31, 1996, at an average exercise price of $21.62. F-18 52 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 12. INCOME TAXES: The components of income (loss) before provision for income taxes were as follows (in thousands):
YEAR ENDED DECEMBER 31, ----------------------------------- 1996 1995 1994 ---- ---- ---- Domestic $1,228 $(16,778) $ 7,847 Foreign (601) (372) 410 ------ -------- -------- Income (loss) from continuing operations 627 (17,150) 8,257 Loss from discontinued operations -- (3,752) (13,228) Extraordinary loss -- (1,372) -- ------ -------- -------- Total $ 627 $(22,274) $ (4,971) ====== ======== ========
The components of the provision (benefit) for income taxes were as follows (in thousands):
YEAR ENDED DECEMBER 31, ----------------------------------- 1996 1995 1994 ---- ---- ---- State income taxes: Current $ 330 $ (63) $ (372) Deferred 90 (166) 182 Federal income taxes: Current 2,130 (1,021) (1,922) Deferred 1,285 (4,716) 2,925 Foreign income taxes: Current 299 109 -- Deferred -- (12,788) 705 ------ -------- ------- Provision (benefit) for income taxes $4,134 $(18,645) $ 1,518 ====== PPD's pro forma income tax provision (see Note 1) 1,775 1,498 -------- ------- Pro forma provision (benefit) for income taxes $(16,870) $ 3,016 ======== =======
The income tax provision (benefit) is included in the financial statements as follows (in thousands):
YEAR ENDED DECEMBER 31, ----------------------------------- 1996 1995 1994 ---- ---- ---- Continuing operations $4,134 $(14,359) $3,371 Discontinued operations -- (2,036) (355) Extraordinary loss -- (475) -- ------ -------- ------ Total $4,134 $(16,870) $3,016 ====== ======== ======
The 1996 current federal and state income tax expense primarily relates to costs associated with the acquisition of APBI which are not deductible for federal and state income tax purposes. The 1996 deferred federal and state income tax expense relates to the utilization of net operating losses and tax credits generated in prior years. In 1995, federal and state income tax benefits were recorded which related to the federal and state income tax losses and credits available for carryforward, discontinued operations reserves and restructuring reserves established for financial reporting purposes which were not currently deductible for income tax purposes. In 1994, federal and state deferred income tax expense resulted primarily from utilization of restructuring reserves and discontinued operations reserves established in years prior to 1994 for financial reporting purposes which resulted in 1994 deductions for income tax purposes. F-19 53 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 12. INCOME TAXES (CONTINUED) The 1996 current foreign income tax expense represents the foreign income tax liabilities associated with the Company's foreign operations. In 1995, a foreign deferred income tax benefit was recorded to reflect the reversal of previously recorded foreign deferred income tax expense associated with the United Kingdom ("U.K.") toxicology operations which were sold during 1995. The 1994 foreign income tax expense resulted primarily from temporary differences related to the excess of U.K. capital allowances for tax purposes over financial reporting depreciation. Taxes computed at the statutory federal income tax rate of 34% are reconciled to the provision (benefit) for income taxes as follows (in thousands):
YEAR ENDED DECEMBER 31, ----------------------------------------- 1996 1995 1994 ---- ---- ---- Effective tax rate 660.2% 83.7% (30.5%) ======= ======== ======= United States federal statutory rate $ 213 $ (7,574) $(1,690) Differential on rates applied to foreign earnings (72) 30 (96) State taxes (net of federal benefit) 277 47 51 Write-down of investment in PACE Incorporated and EnSys -- (40) 3,774 Sale of toxicology operations -- (10,370) -- Allowance for limitation of foreign tax losses 299 841 674 Merger costs not deductible for income tax purposes 2,751 -- -- Goodwill and other items not deductible for income tax purposes 435 -- -- Other 231 196 303 Taxes on PPD's subchapter S earnings -- (1,775) (1,498) ------- -------- ------- Provision (benefit) for income taxes $ 4,134 $(18,645) $ 1,518 ======= ======== =======
During 1996, significant costs were incurred related to the acquisition of APBI which were not deductible for income tax purposes. Accordingly, no tax benefit was recorded on these expenses. As a result of the 1995 sale of the Company's toxicology operations, the Company will not be liable for the payment of certain tax liabilities recorded in prior years. These previously recorded liabilities were reversed in 1995. In 1994, a write-down was recorded of the Company's investment in PACE Incorporated. No tax benefit was recorded in connection with this write-down as it was characterized as a write-down giving rise to a capital loss for income tax purposes. Capital losses can only be deducted for income tax purposes to the extent of capital gains incurred during the three prior years and five subsequent years. As the Company's ability to generate capital gains is uncertain, no benefit was recorded. At December 31, 1994, a deferred tax asset was recorded for the future benefit of U.S. loss carryforwards. However, a valuation allowance was established as a reserve against this asset, as the Company only recognized benefits of U.S. losses which could be realized through a net operating loss carryback. Based on projected future profits, at December 31, 1996 and 1995, the Company recognized a deferred tax asset for the future benefit of U.S. loss carryforwards, and the valuation allowance was reduced to zero. F-20 54 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 12. INCOME TAXES (CONTINUED) Components of the net current deferred tax asset were as follows (in thousands):
DECEMBER 31, -------------------- 1996 1995 ---- ---- Future benefit of foreign net operating losses $ 92 -- Provision for business restructuring -- $1,060 Allowance for doubtful accounts 733 314 Accruals 3,263 524 Future benefit of U.S. and state net operating losses 1,051 2,680 Other (184) 178 ------ ------ Net current deferred tax asset $4,955 $4,756 ====== ======
Components of the net long-term deferred tax asset, included in other assets, were as follows (in thousands):
DECEMBER 31, -------------------- 1996 1995 ---- ---- Depreciation and amortization $ (836) $(1,068) Provision for discontinued operations -- 242 Deferred rent 1,228 1,414 Future benefit of U.S. tax credits 391 613 Other 179 290 ------ ------- Net long-term deferred tax asset $ 962 $ 1,491 ====== =======
The cumulative amount of undistributed earnings of foreign subsidiaries for which the Company has not provided U.S. income taxes at December 31, 1996 was $794,000. No provision has been made for the additional taxes that would result from the distribution of earnings of foreign subsidiaries since such earnings have been permanently reinvested in the foreign operations. As of December 31, 1996, the Company had approximately $2,900,000 of net operating losses available for carryforward to future years which will expire in 2010. The Company also had approximately $391,000 of alternative minimum tax credits available for carryforward which never expire. 13. EMPLOYEE SAVINGS AND PENSION PLANS: SAVINGS PLANS Prior to the merger, PPD maintained the PPD 401(k) Retirement Savings Plan (the "PPD 401(k) Plan") under which all U.S. employees of PPD were eligible to participate. PPD matched 50% of an employee's savings up to 5% of pay. Employer matching contributions vested ratably over a period of six years. APBI maintained the Applied Bioscience International Inc. 401(k) Retirement Savings Plan (the "APBI 401(k) Plan"), under which all U.S. employees were eligible to participate from their date of employment. APBI matched 50% of an employee's savings up to 6% of pay. All participants were 100% vested in Company contributions. Effective January 1, 1997, the two 401 (k) plans have been merged into one plan. Under the new plan, the Company will match 50% of an employee's savings up to 6% of pay, and employer matching contributions will vest ratably over a four-year period. Company contributions for all employees for the three years ended December 31, 1996, 1995 and 1994 were $1,483,000, $1,628,000 and $1,309,000, respectively. F-21 55 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 13. EMPLOYEE SAVINGS AND PENSION PLANS (CONTINUED) PENSION PLANS Pension costs and related disclosures are determined under the provisions of Statement of Financial Accounting Standards No. 87, "Employers' Accounting for Pensions" and Statement of Financial Accounting Standards No. 88, "Employers' Accounting for Settlements and Curtailments of Defined Benefit Pension Plans and for Termination Benefits." The Company has a separate contributory defined benefit plan (the "U.K. Plan") for its qualifying United Kingdom employees and directors employed by APBI's U.K. subsidiaries. The benefits for this plan are based primarily on years of service and average pay at retirement. Plan assets consist principally of investments managed in a mixed fund. The sale of the toxicology business discussed in Note 3 resulted in the termination of employment for the majority of United Kingdom employees who participated in the U.K. Plan. The projected settlement gain of $780,000 was reflected as a reduction of the loss on the sale of business in the accompanying consolidated statement of operations for the year ended December 31, 1995. Pension costs for the United Kingdom plan included the following components (in thousands):
YEAR ENDED DECEMBER 31, ------------------------------- 1996 1995 1994 Service cost-benefits earned during the year $ 553 $ 1,311 $ 1,461 Interest cost on projected benefit obligation 394 1,361 1,349 Actual return on plan assets (500) (1,566) 706 Net amortization and deferral (9) (38) (2,315) ----- ------- ------- Net pension cost $ 438 $ 1,068 $ 1,201 ===== ======= =======
The funded status of the defined benefit plan was as follows (in thousands):
DECEMBER 31, ------------------------ 1996 1995 ---- ---- Actuarial present value of benefit obligations: Vested benefit obligation $(5,033) $(4,361) ======= ======= Accumulated benefit obligation $(5,249) $(4,403) ======= ======= Projected benefit obligation $(5,459) $(4,765) Plan assets at fair value 6,497 6,133 ------- ------- Plan assets in excess of projected benefit obligation 1,038 1,368 Remaining unrecognized net asset arising from initial application of SFAS 87 (67) (59) Unrecognized net loss from past experience different from that assumed and effects of changes in assumptions 558 183 ------- ------- Prepaid pension cost $ 1,529 $ 1,492 ======= =======
F-22 56 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 13. EMPLOYEE SAVINGS AND PENSION PLANS (CONTINUED) Assumptions used to determine pension costs and projected benefit obligations were as follows:
1996 1995 ---- ---- Discount rate 8.5% 8.5% Rate of compensation increase 6.5% 5.5% Long-term rate of return on plan assets 8.5% 8.5%
The Company maintains the APBI Environmental Sciences Group, Inc. Pension Plan (the "Pension Plan"), a tax-qualified, defined-contribution money-purchase pension plan, for the benefit of its eligible ENVIRON division employees. ENVIRON is required to make annual contributions to the Pension Plan in an amount equal to the sum of 3.75% of each eligible employee's total compensation, plus 3.75% of the portion of such employee's compensation in excess of the Social Security wage base. Participants vest in 20% of their account balances after two years of service and 20% per year until they are fully vested. The annual pension expense of the Pension Plan for the three years ended December 31, 1996, 1995 and 1994 was $620,000, $645,000 and $633,000, respectively. Effective January 1, 1994, APBI Environmental Sciences Group, Inc. established the ENVIRON Supplemental Executive Retirement Plan. This plan is nonqualified and provides certain key employees defined-contribution benefits that supplement those provided by the Pension Plan. Company contributions to this plan in 1996, 1995 and 1994 were $39,000, $44,000 and $32,000, respectively. 14. COMMITMENTS AND CONTINGENCIES: The Company currently maintains liability insurance on a "claims made" basis for professional acts, errors and omissions. As of December 31, 1996, this insurance policy included a $500,000 self-insurance retention for each of the Company's Life Sciences Group and Environmental Sciences Group. In the normal course of business, the Company is a party to various claims and legal proceedings. Although the ultimate outcome of these matters is presently not determinable, management of the Company, after consultation with legal counsel, does not believe that the resolution of these matters will have a material effect upon the Company's financial condition or results of operations. 15. RELATED PARTY TRANSACTIONS: The Company is related through common ownership with E.M. Associates, Inc. which provides investigative review board services to the Company. The Company had transactions with E.M. Associates, Inc. of $65,900, $102,000 and $191,000 in expenses for the years ended December 31, 1996, 1995 and 1994, respectively. Several of the Company's shareholders collectively own 14.6% of LOI Building, Inc. ("LOI"), which leased operating facilities to the Company through November 1996. Rent paid to LOI for the years ended December 31, 1996, 1995 and 1994, totaled $402,300, $341,000 and $430,000, respectively. One of the members of the Company's Board of Directors (who was a member of APBI's Board of Directors prior to the Company's acquisition of APBI) is Vice Chairman at Lehman Brothers. Lehman Brothers acted as APBI's investment banker for APBI's acquisition by the Company and for APBI's sale of its toxicology laboratories in 1995. For those investment banking services, Lehman Brothers earned $3,058,718 in 1996 and $500,000 in 1995. Until December 1996, PPD-CRU rented a building from Laboratory Associated Business, Ltd. ("LAB"), a company owned by certain employees of the Company. Rent paid to LAB for the years ended December 31, 1996, 1995 and 1994, totaled $230,200, $186,000 and $112,000, respectively. F-23 57 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 15. RELATED PARTY TRANSACTIONS (CONTINUED) The Company paid legal fees in 1996 of approximately $333,000 to a firm which had a partner who became General Counsel of the Company in 1996. At the time he became the Company's General Counsel he disposed of all of his interest in the law firm. The Company paid legal fees of approximately $39,400, $19,640 and $79,300 in the years ended December 31, 1996, 1995 and 1994, respectively, to a firm having a partner who was also a director of APBI until the date of the merger. 16. FAIR VALUE OF FINANCIAL INSTRUMENTS: The following methods and assumptions were used to estimate the fair value of each class of financial instruments for which it is practicable to estimate that value: CURRENT ASSETS AND CURRENT LIABILITIES The carrying amount approximates fair value because of the short maturity of those instruments. INVESTMENT IN SDI The Company's investment in SDI is recorded at $1,240,300 which represents the market price of $1,459,200 as quoted on the National Market System of the National Association of Securities Dealers Automated Quotation System at December 31, 1996, less a discount of $218,900 representing the relatively illiquid nature of the investment. LONG-TERM DEBT The fair value of the Company's long-term debt is estimated based on the quoted market prices for the same or similar issues or on the current rates offered to the Company for debt of the same remaining maturities. Fair value approximates the carrying amount as most debt instruments bear interest based on variable rates. LETTERS OF CREDIT The Company utilizes letters of credit to back certain guarantees and insurance policies. The letters of credit reflect fair value as a condition of their underlying purpose and are subject to fees competitively determined in the market place. 17. BUSINESS SEGMENT DATA: The Company operates in two business segments - life sciences and environmental sciences. Revenues by principal business segment are separately stated in the consolidated financial statements. Merger costs incurred in 1996 of $16.1 million were not allocated to the Company's business segments and are shown separately for purposes of business segment analysis. Loss from operations, depreciation and amortization, identifiable assets and capital expenditures by principal business segment were as follows (in thousands): F-24 58 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 17. BUSINESS SEGMENT DATA (CONTINUED)
DECEMBER 31, ------------------------- 1996 1995 ---- ---- Income (loss) from operations: Life sciences $ 9,580 $ (18,657) Environmental sciences 5,357 4,123 Merger costs (16,114) -- --------- --------- Operating loss $ (1,177) $ (14,534) ========= ========= Depreciation and amortization: Life sciences $ 8,766 $ 11,601 Environmental sciences 1,670 1,650 --------- --------- Total $ 10,436 $ 13,251 ========= ========= Identifiable assets: Life sciences $ 159,394 $ 117,292 Environmental sciences 22,063 25,369 --------- --------- Total $ 181,457 $ 142,661 ========= ========= Capital expenditures: Life sciences $ 9,895 $ 8,853 Environmental sciences 1,281 1,264 --------- --------- Total $ 11,176 $ 10,117 ========= =========
18. OPERATIONS BY GEOGRAPHIC AREA: The following table presents information about the Company's operations by geographic area (in thousands):
DECEMBER 31, -------------------------------------- 1996 1995 1994 ---- ---- ---- Net revenue: United States $175,173 $170,465 $153,991 Europe and other 22,623 39,313 38,114 -------- -------- -------- Total $197,796 $209,778 $192,105 ======== ======== ======== Operating income (loss): United States $ 14,731 $(14,834) $ 8,734 Europe and other 206 300 2,251 Merger costs (16,114) -- -- -------- -------- -------- Operating income (loss) $ (1,177) $(14,534) $ 10,985 ======== ======== ======== Identifiable assets: United States $142,464 $118,310 $133,506 Europe and other 38,993 24,351 69,267 -------- -------- -------- Total $181,457 $142,661 $202,773 ======== ======== ========
F-25 59 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 19. QUARTERLY FINANCIAL DATA (UNAUDITED): (IN THOUSANDS, EXCEPT PER SHARE DATA)
1996 FIRST SECOND THIRD FOURTH TOTAL ---- ----- ------ ----- ------ ----- Net revenue $ 47,075 $ 49,471 $ 49,503 $ 51,747 $ 197,796 Operating income (loss) 3,214 3,713 (13,987) 5,883 (1,177) Net income (loss) 2,147 2,424 (11,957) 3,879 (3,507) Earnings (loss) per common share $ 0.10 $ 0.11 $ (0.56) $ 0.18 $ (0.17) 1995 ---- Net revenue $ 51,772 $ 53,507 $ 53,127 $ 51,372 $ 209,778 Operating income (loss) 2,763 2,762 3,168 (23,227) (14,534) Income (loss) from continuing operations 1,138 1,236 1,455 (6,620) (2,791) Loss from discontinued operations -- -- -- (1,716) (1,716) Extraordinary loss -- -- -- (897) (897) Net income (loss) 1,138 1,236 1,455 (9,233) (5,404) Earnings (loss) per common share: Continuing operations $ 0.06 $ 0.07 $ 0.08 $ (0.35) $ (0.15) Discontinued operations -- -- -- (0.09) (0.09) Extraordinary loss -- -- -- (0.05) (0.05) -------- -------- -------- -------- --------- Total $ 0.06 $ 0.07 $ 0.08 $ (0.49) $ (0.29) ======== ======== ======== ======== =========
20. SUBSEQUENT EVENTS: ACQUISITIONS In February 1997, the Company agreed to acquire Belmont Research, Inc. ("Belmont") in a transaction to be accounted for as a pooling of interests. The consideration for Belmont consisted of 502,384 shares of the Company's common stock plus the issuance of approximately 115,000 options to acquire Company stock. In January 1997, the Company acquired Technical Assessment Systems, Inc. for $490,000 cash, a note for approximately $300,000 and the potential to earn an additional amount depending on their profitability for a certain period after the acquisition. F-26 60 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES SCHEDULE II -- VALUATION AND QUALIFYING ACCOUNTS (IN THOUSANDS)
ADDITIONS CHARGED OTHER BALANCE AT TO CHANGES BALANCE BEGINNING COSTS AND ADD AT END OF DESCRIPTION OF PERIOD EXPENSES DEDUCTIONS (DEDUCT) PERIOD - ----------- --------- -------- ---------- -------- ------ For the year ended December 31, 1996 Reserve for doubtful accounts $3,319 $1,715 $(3,497) $(26) $1,511 ====== ====== ======= ==== ====== For the year ended December 31, 1995 Reserve for doubtful accounts $3,773 $1,689 $(2,113) $(30) $3,319 ====== ====== ======= ==== ====== For the year ended December 31, 1994 Reserve for doubtful accounts $5,421 $2,594 $(4,305) $ 63 $3,773 ====== ====== ======= ==== ======
F-27 61 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. Date: March ___, 1997 By: /s/ Fredric N. Eshelman, Pharm.D. ----------------------------------- Name: Fredric N. Eshelman, Pharm.D. Title: Chief Executive Officer Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. /s/ Fredric N. Eshelman, Pharm.D. Director and Chief Executive Officer March ___, 1997 - --------------------------------- (Principal Executive Officer) Fredric N. Eshelman, Pharm.D. /s/ Rudy C. Howard Chief Financial Officer and Vice March ___, 1997 - --------------------------------- President, Finance and Treasurer Rudy C. Howard (Principal Financial and Accounting Officer) /s/ Ernest Mario, Ph.D. Director March ___, 1997 - --------------------------------- Ernest Mario, Ph.D. /s/ Stuart Bondurant, M.D. Director March ___, 1997 - --------------------------------- Stuart Bondurant, M.D. /s/ Kirby L. Cramer Director March ___, 1997 - --------------------------------- Kirby L. Cramer /s/ Thomas D'Alonzo Director March ___, 1997 - --------------------------------- Thomas D'Alonzo /s/ Frederick Frank Director March ___, 1997 - --------------------------------- Frederick Frank /s/ Frank E. Loy Director March ___, 1997 - --------------------------------- Frank E. Loy /s/ John A. McNeill, Jr. Director March ___, 1997 - --------------------------------- John A. McNeill, Jr.
EX-3.2 2 AMENDED AND RESTATED BYLAWS 1 EXHIBIT 3.2 AMENDED AND RESTATED BYLAWS OF PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. EFFECTIVE AS OF SEPTEMBER 25, 1996 2 TABLE OF CONTENTS ARTICLE I OFFICES 1. Principal Office ........................... 1 2. Registered Office .......................... 1 3. Other Offices .............................. 1 ARTICLE II MEETINGS OF SHAREHOLDERS 1. Place of Meetings .......................... 1 2. Annual Meeting ............................. 1 3. Substitute Annual Meeting .................. 1 4. Special Meetings ........................... 1 5. Notice of Meetings ......................... 2 6. Shareholders List .......................... 3 7. Quorum ..................................... 3 8. Voting of Shares and Voting Groups ......... 3 9. Proxies .................................... 4 10. Inspectors of Election ..................... 4 11. Informal Action by Shareholders ............ 5 12. Shareholder Proposals ...................... 5 ARTICLE III DIRECTORS 1. General Powers ............................. 6 2. Number, Term and Qualification ............. 6 3A. Nominations ................................ 7 3B. Election of Directors ...................... 8 4. Removal .................................... 8 5. Vacancies .................................. 8 6. Chairman ................................... 9 7. Compensation ............................... 9 8. Executive and Other Committees ............. 9 9. Directors Emeritus ......................... 10 ARTICLE IV MEETINGS OF DIRECTORS 1. Regular Meetings ........................... 10 2. Special Meetings ........................... 10 3. Notice of Meetings ......................... 11 4. Quorum ..................................... 11 5. Manner of Acting ........................... 11 6. Informal Action by Directors ............... 12 7. Attendance by Telephone .................... 12 3 ARTICLE V OFFICERS 1. Number ..................................... 12 2. Appointment and Term ....................... 12 3. Removal .................................... 12 4. Compensation ............................... 13 5. Chairman of the Board ...................... 13 6. Chief Executive Officer .................... 13 7. President .................................. 13 8. Vice Presidents ............................ 13 9. Secretary .................................. 13 10. Treasurer .................................. 14 11. Assistant Secretaries and Treasurers ....... 14 12. Controller and Assistant Controllers ....... 14 13. Bonds ...................................... 15 14. Voting Upon Stock .......................... 15 ARTICLE VI CONTRACTS, LOANS AND DEPOSITS 1. Contracts .................................. 15 2. Loans ...................................... 15 3. Checks and Drafts .......................... 15 4. Deposits ................................... 15 ARTICLE VII CERTIFICATES FOR SHARES AND OTHER TRANSFER 1. Certificates for Shares .................... 15 2. Transfer of Shares ......................... 16 3. Transfer Agent and Registrar ............... 16 4. Record Date ................................ 16 5. Lost Certificates .......................... 16 6. Holder of Record ........................... 17 7. Shares held by Nominees .................... 17 8. Acquisition by Corporation of its Own Shares 18 ARTICLE VIII INDEMNIFICATION AND REIMBURSEMENT OF DIRECTORS AND OFFICERS 1. Indemnification for Expenses and Liabilities 18 2. Advance Payment of Expenses ................ 19 3. Insurance .................................. 19 4. Definitions ................................ 19 4 ARTICLE IX GENERAL PROVISIONS 1. Distributions .............................. 19 2. Seal ....................................... 19 3. Fiscal Year ................................ 19 4. Effective Date of Notice ................... 19 5. Corporate Records .......................... 20 6. Bylaw Amendments ........................... 20 7. Amendments to Articles of Incorporation .... 21 8. Stockholder Protection Statutes ............ 21 5 AMENDED AND RESTATED BYLAWS OF PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. ARTICLE I OFFICES 1. Principal Office. The principal office of the Corporation shall be located in New Hanover County, North Carolina, or such other place as is designated by the Board of Directors. 2. Registered Office. The registered office of the Corporation required by law to be maintained in the State of North Carolina may be, but need not be, identical with the principal office. 3. Other Offices. The Corporation may have offices at such other places, either within or without the State of North Carolina, as the Board of Directors may from time to time determine or as the affairs of the Corporation may require. ARTICLE II MEETINGS OF SHAREHOLDERS 1. Place of Meetings. All meetings of shareholders shall be held at the principal office of the Corporation or at such other place, either within or without the State of North Carolina, as shall be designated in the notice of the meeting or agreed upon by the Board of Directors. 2. Annual Meeting. The annual meeting of the shareholders shall be held at the principal office of the Corporation or at such other place, either within or without the State of North Carolina, on such day and at such time during the month of April or May for the purpose of electing Directors of the Corporation and for the transaction of such other business as may be properly brought before the meeting. 3. Substitute Annual Meeting. If the annual meeting shall not be held on the day designated by these Bylaws, a substitute annual meeting may be called in accordance with the provisions of Paragraph 4 of this Article II. A meeting so called shall be designated and treated for all purposes as the annual meeting. 4. Special Meetings. (a) Special meetings of the shareholders, for any purpose or purposes, unless otherwise prescribed by statute, may be called by the President, the Chief Executive Officer, the Chairman of the Board, a majority of the Board of Directors then in office or the holders of not 1 6 less than seventy-five percent (75%) of all the outstanding shares of the Corporation entitled to vote at the meeting. (b) Any person or persons entitled to call a special meeting of shareholders shall do so by delivering written notice to the Secretary stating that a special meeting has been called and certifying to facts establishing that the person or persons delivering the notice are entitled to call a special meeting. Any such written notice delivered by a shareholder or shareholders (acting in such capacity) entitled to call a special meeting of shareholders shall state the purpose or purposes of the proposed meeting and shall state the information which would be required in a notice by the shareholder described in Section 12 of this Article II with respect to the business proposed to be transacted at the special meeting. 5. Notice of Meetings. (a) Written or printed notice stating the time and place of the meeting shall be delivered not less than ten (10) nor more than sixty (60) days before the date thereof, either personally or by telegraph, teletype or other form of wire or wireless communication, or by facsimile transmission, mail or by private carrier, or by any other means permitted by law, by or at the direction of the Board of Directors, the Chairman of the Board, the Chief Executive Officer, the President, the Secretary or other person calling the meeting, to each shareholder of record entitled to vote at such meeting, provided that such notice must be given to all shareholders, including nonvoting shareholders, with respect to any meeting at which a merger, share exchange, sale of assets other than in the regular course of business, or voluntary dissolution is to be considered and in such other instances as required by law. If a new record date for the adjourned meeting is fixed pursuant to Section 4 of Article VII, notice of the adjourned meeting shall be given to persons who are shareholders as of the new record date. If mailed, such notice shall be deemed to be delivered when deposited in the United States mail addressed to the shareholder at his address as it appears on the record of shareholders of the Corporation, with postage thereon prepaid. (b) In the case of an annual or substitute annual meeting, the notice of meeting need not specifically state the business to be transacted thereat unless it is a matter, other than election of Directors, on which the vote of the shareholders is expressly required by the provisions of the North Carolina Business Corporation Act or notice of such purpose is otherwise required by law to be provided. In the case of a special meeting, the notice of meeting shall specifically state the purpose or purposes for which the meeting is called. (c) When a meeting is adjourned for more than one hundred twenty (120) days, or a new record date is or must be fixed as required by law, notice of the adjourned meeting shall be given as in the case of an original meeting. When a meeting is adjourned for one hundred twenty (120) days or less in any one adjournment, it shall not be necessary to give any notice of the new date, time and place of the adjourned meeting or of the business to be transacted thereat other than by announcement at the meeting at which the adjournment is taken. 2 7 (d) A shareholder in a signed writing may waive notice of any meeting before or after the date and time stated in the notice by delivering such waiver to the Corporation for inclusion in the minutes. Attendance by a shareholder at a meeting constitutes a waiver of notice of such meeting, unless at the beginning of the meeting the shareholder objects to holding the meeting or transacting business at the meeting, or objects to considering a matter not within the purpose or purposes described in the meeting notice before a vote is taken on it. 6. Shareholders List. After fixing the record date for a meeting, the Secretary of the Corporation shall prepare an alphabetical list of the shareholders entitled to notice of such meeting or any adjournment thereof, arranged by voting group, class and series, with the address of and number of shares held by each. Such list shall be kept on file at the principal office of the Corporation, or at a place identified in the meeting notice in the city where the meeting will be held, beginning two (2) business days after notice of such meeting is given and continuing through the meeting, and on written demand shall be subject to inspection or copying by any shareholder, or his agent or attorney, at any time during regular business hours. This list shall also be produced and kept open at the time and place of the meeting and shall be subject to inspection by any shareholder, or his agent or attorney, during the entire time of the meeting or any adjournment. 7. Quorum. (a) Unless otherwise provided by law, a majority of the votes entitled to be cast on a matter by a separate voting group shall constitute a quorum of such voting group on that matter at a meeting of shareholders. A separate voting group may only take action on a matter at a meeting if a quorum of those shares are present with respect to that matter. In the absence of a quorum at the opening of any meeting of shareholders, such meeting may be adjourned from time to time by the vote of a majority of the shares voting on the motion to adjourn, but no other business may be transacted until and unless a quorum is present. When a quorum is present at any adjourned meeting, any business may be transacted which might have been transacted at the original meeting. If a quorum is present at the original meeting, a quorum need not be present at an adjourned meeting to transact business. (b) At a meeting at which a quorum is present, a separate voting group may continue to do business until adjournment, notwithstanding the withdrawal of sufficient shareholders to leave less than a quorum of the separate voting group. 8. Voting of Shares and Voting Groups. (a) Except as otherwise provided by the Articles of Incorporation or by law, each outstanding share having voting rights shall be entitled to one vote on each matter submitted to a vote at a meeting of shareholders. All shares entitled to vote and be counted together collectively on a matter as provided by the Articles of Incorporation or by the North Carolina Business Corporation Act shall constitute a single voting group. Additional required voting 3 8 groups shall be determined in accordance with the Articles of Incorporation, the Bylaws and the North Carolina Business Corporation Act. (b) Except in the election of Directors, at a shareholder meeting duly held and at which a quorum is present, action on a matter by a voting group shall be approved if the votes cast within the voting group favoring the action exceed the votes cast opposing the action, unless the vote by a greater number is required by law or by the Articles of Incorporation or Bylaws of the Corporation. For such actions, abstentions shall not be treated as negative votes. Corporate action on such matters shall be taken only when approved by each and every voting group entitled to vote as a separate voting group on such matter as provided by the Articles of Incorporation or Bylaws or by the North Carolina Business Corporation Act. (c) Voting on all matters except the election of Directors shall be by voice vote or by a show of hands unless the Chairman of the meeting directs that voting on such matter shall be by ballot. (d) Absent special circumstances, shares of the Corporation shall not be entitled to vote if they are owned, directly or indirectly, by another corporation in which the Corporation owns, directly or indirectly, a majority of the shares entitled to vote for directors of the second corporation; provided that this provision does not limit the power of the Corporation to vote its own shares held by it in a fiduciary capacity. 9. Proxies. Shares may be voted either in person or by one or more agents authorized by a written proxy executed by the shareholder or by his duly authorized attorney-in-fact. A proxy shall not be valid after the expiration of eleven (11) months from the date of its execution, unless the person executing it specifies therein the length of time for which it is to continue in force, or limits its use to a particular meeting. Any proxy shall be revocable by the shareholder unless the written appointment expressly and conspicuously provides that it is irrevocable and the appointment is coupled with an interest as required by law. The shareholder may revoke the proxy by filing with the Secretary of the Corporation either a written instrument of revocation or a duly executed proxy bearing a later date or by attending the meeting and voting his shares in person. 10. Inspectors of Election. (a) Appointment of Inspectors of Election. In advance of any meeting of shareholders, the Board of Directors may appoint any persons, other than nominees for office, as inspectors of election to act at such meeting or any adjournment thereof. If inspectors of election are not so appointed, the Chairman of any such meeting may appoint inspectors of election at the meeting. The number of inspectors shall be either one or three. In case any person appointed as inspector fails to appear or fails or refuses to act, the vacancy may be filled by appointment by the Board of Directors in advance of the meeting or at the meeting by the person acting as the Chairman. 4 9 (b) Duties of Inspectors. The inspectors of election shall determine the number of shares outstanding and the voting power of each, the shares represented at the meeting, the existence of a quorum, the authenticity, validity and effect of proxies, receive votes, ballots or consents, hear and determine all challenges and questions in any way arising in connection with the right to vote, count and tabulate all votes or consents, determine the result and do such acts as may be proper to conduct the election or vote with fairness to all shareholders. The inspectors of election shall perform their duties impartially, in good faith, to the best of their ability and as expeditiously as is practical. (c) Vote of Inspectors. If there are three or more inspectors of election, the decision, act or certificate of a majority shall be effective in all respects as the decision, act or certificate of all. (d) Report of Inspectors. On request of the Chairman of the meeting, the inspectors shall make a report in writing of any challenge or question or matter determined by them and shall execute a certificate of any fact found by them. Any report or certificate made by them shall be prima facie evidence of the facts stated therein. 11. Informal Action by Shareholders. Any action which is required or permitted to be taken at a meeting of the shareholders may be taken without a meeting if a consent in writing, setting forth the action so taken, shall be signed by all of the persons who would be entitled to vote upon such action at a meeting and filed with the Secretary of the Corporation to be kept in the corporate minute book, whether done before or after the action so taken. Such consent shall have the same force and effect as a unanimous vote of shareholders. Any shareholder may retract his consent until the last shareholder entitled to vote has signed the appropriate written consent and all consents have been delivered to the Secretary of the Corporation. When notice of a proposed action is required to be given to nonvoting shareholders as provided in Section 5(a) of this Article II, the Corporation shall give the nonvoting shareholders notice at least ten (10) days before action is taken in lieu of a meeting by unanimous consent of the voting shareholders. Such notice to nonvoting shareholders shall contain or be accompanied by any material that would have been required to be sent to the nonvoting shareholders in a notice of meeting at which the proposed action would have been submitted to the shareholders for action. 12. Shareholder Proposals. Any shareholder wishing to bring any other business before a meeting of shareholders must provide notice to the Corporation not more than ninety (90) and not less than fifty (50) days before the meeting in writing by registered mail, return receipt requested, of the business to be presented by him at the shareholders' meeting. Any such notice shall set forth the following as to each matter the shareholder proposes to bring before the meeting: (A) a brief description of the business desired to be brought before the meeting and the reasons for conducting such business at the meeting and, if such business includes a proposal to amend the Bylaws of the Corporation, the language of the proposed amendment; (B) the name and address, as they appear on the Corporation's books, of the shareholder proposing such business; (C) the class and number of shares of the Corporation which are beneficially owned by such shareholder; (D) a representation that the shareholder is a holder of record of stock of the 5 10 Corporation entitled to vote at such meeting and intends to appear in person or by proxy at the meeting to propose such business; and (E) any material interest of the shareholder in such business. Notwithstanding the foregoing provisions of this Section, a shareholder shall also comply with all applicable requirements of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder with respect to the matters set forth in this Section. In the absence of such notice to the Corporation meeting the above requirements, a shareholder shall not be entitled to present any business at any meeting of shareholders. Note: The provisions of this Article II, Section 12 have been adopted by the shareholders of the Corporation and may not be amended except by the shareholders in accordance with the provisions of Article IX, Section 6(a) hereof. ARTICLE III DIRECTORS 1. General Powers. All corporate powers shall be exercised by or under the authority of, and the business and affairs of the Corporation shall be managed by, the Board of Directors or by such committees as the Board of Directors may establish pursuant to these Bylaws. 2. Number, Term and Qualification. (a) The number of Directors of the Corporation shall be not less than eight (8) nor more than twelve (12). Such number may not be changed by the Board of Directors, but only, within the minimum and maximum, by the affirmative vote of seventy-five percent (75%) of all eligible votes present in person or in proxy at a meeting of shareholders at which a quorum is present. Such number may not be changed at a meeting of shareholders unless the notice of the meeting states that the purpose, or one of the purposes, of the meeting is to change the number of Directors of the Corporation. Note: The provisions of this Article III, Section 2(a) have been adopted by the shareholders of the Corporation and may not be amended except by the shareholders in accordance with the provisions of Article IX, Section 6(a) hereof. (b) Each Director shall hold office until his death, resignation, retirement, removal, disqualification or his successor is elected and qualifies. Directors need not be residents of the State of North Carolina or shareholders of the Corporation. 3A. Nominations. Nominations for the election of Directors may only be made by the Board of Directors, by the Nominating Committee of the Board of Directors (or, if none, any other committee serving a similar function) or by any shareholder entitled to vote generally in elections of Directors where the shareholder complies with the requirements of this Section. Any shareholder of record entitled to vote generally in elections of Directors may nominate one or more persons for election as Directors at a meeting of shareholders only if written notice of such shareholder's intent to make such nomination or nominations has been given, either by personal 6 11 delivery or by United States certified mail, postage prepaid, to the Secretary of the Corporation (i) with respect to an election to be held at an annual meeting of shareholders, not more than ninety (90) days nor less than fifty (50) days in advance of such meeting and (ii) with respect to an election to be held at a special meeting of shareholders called for the purpose of the election of Directors, not later than the close of business on the tenth business day following the date on which notice of such meeting is first given to shareholders. Each such notice of a shareholder's intent to nominate a Director or Directors at an annual or special meeting shall set forth the following: (A) the name and address, as they appear on the Corporation's books, of the shareholder who intends to make the nomination and the name and residence address of the person or persons to be nominated; (B) the class and number of shares of the Corporation which are beneficially owned by the shareholder; (C) a representation that the shareholder is a holder of record of stock of the Corporation entitled to vote at such meeting and intends to appear in person or by proxy at the meting to nominate the person or persons specified in the notice; (D) a description of all arrangements or understandings between the shareholder and each nominee and any other persons or persons (naming such person or persons) pursuant to which the nomination or nominations are to be made by the shareholder; (E) such other information regarding each nominee proposed by such shareholder as would be required to be disclosed in solicitations of proxies for election of Directors, or as would otherwise be required, in each case pursuant to Regulation 14A under the Securities Exchange Act of 1934, as amended, including any information that would be required to be included in a proxy statement filed pursuant to Regulation 14A had the nominee been nominated by the Board of Directors; and (F) the written consent of each nominee to be named in a proxy statement and to serve as Director of the Corporation if so elected. No person shall be eligible to serve as a Director of the Corporation unless nominated in accordance with the procedures set forth in this Section. If the Chairman of the shareholders meeting shall determine that a nomination was not made in accordance with the procedures described by the Bylaws, he shall so declare to the meeting, and the defective nomination shall be disregarded. Notwithstanding the foregoing provisions of this Section, a shareholder shall also comply with all applicable requirements of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder with respect to the matters set forth in this Section. Note: The provisions of this Article III, Section 3A have been adopted by the shareholders of the Corporation and may not be amended except by the shareholders in accordance with the provisions of Article IX, Section 6(a) hereof. 3B. Election of Directors. Except as provided in Section 5 of this Article III, Directors shall be elected at the annual meeting of shareholders; and those persons who receive the highest number of votes at a meeting at which a quorum is present shall be deemed to have been elected. If any shareholder so demands, election of Directors shall be by ballot. 4. Removal. (a) A Director may be removed from office with cause by the affirmative vote of seventy-five percent (75%) of all eligible votes present at a meeting of shareholders at which a 7 12 quorum is present. A Director may be removed from office without cause by the affirmative vote of seventy-five percent (75%) of all eligible votes present at a meeting of shareholders at which a quorum is present, provided that removal without cause is recommended to the shareholders by the Board of Directors pursuant to a vote of not less than seventy-five percent (75%) of the Directors then in office. If a Director is elected by a separate voting group, only the members of that voting group may participate in the vote to remove him. For purposes of this Section, "cause" is defined as personal dishonesty, incompetence, mental or physical incapacity, breach of fiduciary duty involving personal profit, a failure to perform stated duties, or a violation of any law, rule or regulation (other than a traffic violation or similar routine offense) based on a conviction for such offense or an opinion of counsel to the Corporation that such violation has occurred. The entire Board of Directors may not be removed except pursuant to the removal of individual Directors in accordance with the foregoing provisions. Note: The provisions of this Article III, Section 4(a) are contained in the Articles of Incorporation of the Corporation. These Bylaw provisions have been adopted by the shareholders of the Corporation and may not be amended except by the shareholders in accordance with the provisions of Article IX, Section 6(a) hereof. (b) No Director may be removed at a meeting of the shareholders unless the notice of the meeting states that the purpose, or one of the purposes, of the meeting is to remove that Director. 5. Vacancies. A vacancy occurring in the Board of Directors of the Corporation, including, without limitation, a vacancy created by an increase in the authorized number of Directors or resulting from the shareholders' failure to elect the full authorized number of Directors, may only be filled by the Directors remaining in office, or, if the Directors remaining in office constitute less than a quorum of the Directors, by the affirmative vote of a majority of all remaining Directors or by the sole remaining Director; provided that if any Director was elected by a particular voting group, a vacancy in that position may be filled only by any remaining Director or Directors elected by that voting group, if any, and if there are none, by members of the related voting group. A Director elected to fill a vacancy shall be elected for the unexpired term of his predecessor in office. Note: The provision of this Article III, Section 5 are contained in the Articles of Incorporation of the Corporation. These Bylaw provisions have been adopted by the Shareholders and may not be amended except by the shareholders of the Corporation in accordance with the provisions of Article IX, Section 6(a) hereof. 6. Chairman. There may be a Chairman of the Board of Directors elected by the Directors from their number at any meeting of the Board of Directors. The Chairman shall preside at all meetings of the Board of Directors and of shareholders and perform such other duties as may be directed by the Board of Directors. Until a Chairman of the Board of Directors is elected, the President of the Corporation shall preside at the meetings of the Board of Directors and shareholders. 8 13 7. Compensation. The Board of Directors may provide for the compensation of Directors for their services as such and may provide for the payment of any and all expenses incurred by the Directors in connection with such services. 8. Executive and Other Committees. (a) The Board of Directors, by resolution adopted by seventy-five percent (75%) of the number of Directors then in office, may designate from among its members an Executive Committee and one or more other committees, each consisting of two or more Directors and each of which, to the extent authorized by law or provided in the resolution, shall have and may exercise all of the authority of the Board of Directors, except no such committee shall have authority as to the following matters: (1) authorize distributions; (2) approve or propose to shareholders action that is required to be approved by shareholders under the North Carolina Business Corporation Act or any successor to such statutes; (3) fill vacancies on the Board of Directors or on any of its committees; (4) amend the Articles of Incorporation; (5) adopt, amend or repeal these Bylaws; (6) approve a plan of merger not requiring shareholder approval; (7) authorize or approve reacquisition of shares, except according to a formula or method prescribed by the Board of Directors; or (8) authorize or approve the issuance or sale or contract for sale of shares, or determine the designation and relative rights, preferences and limitations of a class or series of shares, except that the Board of Directors may authorize a committee (or senior executive officer of the Corporation) to do so within limits specifically prescribed by the Board of Directors. (b) Any resolutions adopted or other action taken by any such committee within the scope of the authority delegated to it by the Board of Directors shall be deemed for all purposes to be adopted or taken by the Board of Directors. The designation of any committee and the delegation thereto of authority shall not operate to relieve the Board of Directors, or any member thereof, of any responsibility or liability imposed upon it or him by law. (c) Regular meetings of any such committee may be held without notice at such time and place as such committee may fix from time to time by resolution. Special meetings of any such committee may be called by any member thereof upon not less than one day's notice stating the place, date and hour of such meeting, which notice may be written or oral and if mailed, shall be deemed to be delivered when deposited in the United States mail addressed to any member of the committee at his business address. Any member of any committee may in a signed writing waive notice of any meeting and no notice of any meeting need be given to any member thereof who attends in person. The notice of a meeting of any committee need not state the business proposed to be transacted at the meeting. (d) A majority of the members of any such committee shall constitute a quorum for the transaction of business at any meeting thereof and actions of such committee must be authorized by the affirmative vote of a majority of the members of such committee. 9 14 (e) Any member of any such committee may be removed at any time with or without cause by resolution adopted by the affirmative vote of at least seventy-five percent (75%) of the Directors then in office, and vacancies in the membership of a committee resulting from death, resignation, disqualification, or removal shall be filled by the Board of Directors pursuant to the affirmative vote of a majority of the Directors then in office. Note: The provisions of Sections 8(a) and 8(e) have been adopted by the shareholders of the Corporation and may not be amended except by the shareholders in accordance with the provisions of Article IX, Section 6(a) hereof. (f) Any such committee shall elect a presiding officer from among its members and may fix its own rules of procedure which shall not be inconsistent with these Bylaws. It shall keep regular minutes of its proceedings and report the same to the Board of Directors for its information at the meeting thereof held next after the proceedings shall have been taken. 9. Directors Emeritus. The Board of Directors may, by resolution, duly adopted, appoint Directors Emeritus of the Corporation for outstanding contributions to the Corporation. Such Director Emeritus shall have no right to vote on matters before the Board of Directors or to attend meetings of the Board of Directors. ARTICLE IV MEETINGS OF DIRECTORS 1. Regular Meetings. A regular meeting of the Board of Directors shall be held immediately after, and at the same place as, the annual meeting of shareholders. In addition, the Board of Directors may provide, by resolution, the time and place, either within or without the State of North Carolina, for the holding of additional regular meetings. 2. Special Meetings. Special meetings of the Board of Directors may be called by or at the request of the Chairman of the Board (if one has been duly elected), the Chief Executive Officer, the President or any two Directors. Such meetings may be held either within or without the State of North Carolina. 3. Notice of Meetings. (a) Any regular meetings of the Board of Directors may be held without notice. (b) The person or persons calling a special meeting of the Board of Directors shall, at least two (2) days before the meeting, give notice thereof either personally or by telephone, telegraph, teletype or other form of wire or wireless communication or by facsimile transmission, mail or private carrier or by any other means permitted by law. Such notice need not specify the business to be transacted at, or the purpose of, the meeting that is called. Notice of an adjourned meeting need not be given if the time and place are fixed at the meeting 10 15 adjourning and if the period of adjournment does not exceed ten (10) days in any one adjournment. (c) A Director, in a signed writing, may waive notice of any meeting before or after the date and time stated in the notice. Attendance by a Director at a meeting shall constitute a waiver of notice of such meeting, except where a Director attends a meeting for the express purpose of objecting to the transaction of any business because the meeting is not lawfully called or convened and does not vote for or assent to action taken at the meeting. 4. Quorum. A majority of the Directors in office immediately before the meeting shall constitute a quorum for the transaction of business at any meeting of the Board of Directors. 5. Manner of Acting. (a) Except as otherwise provided in this Section, the act of a majority of the Directors present at a meeting at which a quorum is present shall be the act of the Board of Directors, unless a greater number is required by law, the Articles of Incorporation or a Bylaw adopted by the shareholders. (b) A Director who is present at a meeting of the Board of Directors at which action on any corporate matter is taken shall be presumed to have assented to the action taken unless his contrary vote is recorded or his dissent is otherwise entered in the minutes of the meeting or unless he shall file his written dissent to such action with the person acting as the secretary of the meeting before the adjournment thereof or shall forward such dissent by registered mail to the Secretary of the Corporation immediately after the adjournment of the meeting. Such right of dissent shall not apply to a Director who voted in favor of such action. (c) The vote of a majority of the number of Directors then in office shall be required to adopt a resolution constituting an Executive Committee or other committee of the Board of Directors. The vote of a majority of the Directors then holding office shall be required to adopt, amend or repeal a Bylaw or to adopt a resolution dissolving the Corporation without action by the shareholders in circumstances authorized by law. Vacancies in the Board of Directors may be filled as provided in Section 5 of Article III of these Bylaws. 6. Informal Action by Directors. Action taken by the Directors or members of a committee of the Board of Directors without a meeting is nevertheless Board or committee action if written consent to the action in question is signed by all of the Directors or members of the committee, as the case may be, and filed with the minutes of the proceedings of the Board of Directors or committee, whether done before or after the action so taken. Such action will become effective when the last Director or committee member signs the consent, unless the consent specifies a different date. Such consent will have the same force and effect as a unanimous vote of the Board of Directors or the committee, as the case may be. 11 16 7. Attendance by Telephone. Any one or more Directors or members of a committee may participate in a meeting of the Board of Directors or committee by means of a conference telephone or similar communications device which allows all persons participating in the meeting to hear each other simultaneously, and such participation in the meeting shall be deemed presence in person at such meeting. ARTICLE V OFFICERS 1. Number. The officers of the Corporation shall consist of a Chairman, a Chief Executive Officer, a President, a Secretary, a Treasurer and such Vice Presidents, Assistant Secretaries, Assistant Treasurers and other officers as the Board of Directors may from time to time appoint. Any two or more offices, other than that of President and Secretary, may be held by the same person. In no event, however, may an officer act in more than one capacity where action of two or more officers is required. 2. Appointment and Term. The officers of the Corporation shall be appointed by the Board of Directors pursuant to the affirmative vote of at least seventy-five percent (75%) of the Directors then in office. Such appointment may be made at any regular or special meeting of the Board of Directors. Each officer shall hold office until his death, resignation, retirement, removal, disqualification, or his successor is appointed and qualifies. Note: The provisions of this Article V, Section 2 have been adopted by the shareholders of the Corporation and may not be amended except by the shareholders in accordance with the provisions of Article IX, Section 6(a) hereof. 3. Removal. Any officer or agent appointed by the Board of Directors may be removed by the Board with or without cause pursuant to the affirmative vote of at least seventy-five percent (75%) of the Directors then in office; but such removal shall be without prejudice to the contract rights, if any, of the person so removed. Note: The provisions of this Article V, Section 3 have been adopted by the shareholders of the Corporation and may not be amended except by the shareholders in accordance with the provisions of Article IX, Section 6(a) hereof. 4. Compensation. The compensation of all officers of the Corporation shall be fixed by the Board of Directors. 5. Chairman of the Board. The Chairman of the Board shall, subject to the direction and control of the Board of Directors, provide strategic direction to the Corporation. 6. Chief Executive Officer. The Chief Executive Officer of the Corporation shall, subject to the control of the Board of Directors, supervise and control the policy and general management of the Corporation. The Chief Executive Officer shall have authority to sign all documents, 12 17 instruments and certificates permitted or authorized to be signed by the President pursuant to these Bylaws or as directed by the Board of Directors. 7. President. The President shall be the Chief Operating Officer of the Corporation and, unless the Board of Directors has elected another, the Chief Executive Officer of the Corporation. The President, subject to the control of the Board of Directors, shall oversee the day to day operations of the Corporation in accordance with these Bylaws. He shall, in the absence of the Chairman of the Board of Directors and the Chief Executive Officer, preside at all meetings of the Board of Directors and shareholders. He shall sign, with any other proper officer, certificates for shares of the Corporation and any deeds, mortgages, bonds, contracts, or other instruments which may be lawfully executed on behalf of the Corporation, except where required or permitted by law to be otherwise signed and executed and except where the signing and execution thereof shall be delegated by the Board of Directors to some other officer or agent; and, in general, he shall perform all duties incident to the office of President and such other duties as may be prescribed by the Board of Directors from time to time. 8. Vice Presidents. The Vice Presidents, in the order of their appointment, unless otherwise determined by the Board of Directors, shall, in the absence or disability of the President, perform the duties and exercise the powers of that office and shall have authority to sign, with any other proper officer, certificates for shares of the Corporation and any deeds, mortgages, bonds, contracts, or other instruments which may be lawfully executed on behalf of the Corporation, except where required or permitted by law to be otherwise signed and executed and except where the signing and execution thereof shall be delegated by the Board of Directors to some other officer or agent. In addition, they shall perform such other duties and have such other powers as the President or the Board of Directors shall prescribe. The Board of Directors shall designate one or more Vice Presidents to be responsible for Finance and may designate one or more Vice Presidents to be responsible for certain other functions. 9. Secretary. The Secretary shall keep accurate records of the acts and proceedings of all meetings of shareholders, Directors and committees. He shall give all notices required by law and by these Bylaws. He shall have general charge of the corporate books and records and of the corporate seal, and he shall affix the corporate seal to any lawfully executed instrument requiring it. He shall have general charge of the stock transfer books of the Corporation and shall keep, at the registered or principal office of the Corporation, a record of shareholders showing the name and address of each shareholder and the number and class of the shares held by each. He shall deliver to the Secretary of State of North Carolina for filing annual reports as required under the provisions contained in Section 55-16-22 of the North Carolina Business Corporation Act or any successor to such statute. He shall sign such instruments as may require his signature, and, in general, attest the signature or certify the incumbency or signature of any other officer of the Corporation and shall perform all duties incident to the office of Secretary and such other duties as may be assigned him from time to time by the President or by the Board of Directors. 10. Treasurer. The Treasurer shall have custody of all funds and securities belonging to the Corporation and shall receive, deposit or disburse the same under the direction of the Board 13 18 of Directors. He shall supervise the accounting affairs of the Corporation and keep full and accurate accounts of the finances of the Corporation in books especially provided for that purpose, which may be consolidated or combined statements of the Corporation and one or more of its subsidiaries as appropriate, that include a balance sheet as of the end of the fiscal year, an income statement for that year, and a statement of cash flows for the year unless that information appears elsewhere in the financial statements. If financial statements are prepared for the Corporation on the basis of generally accepted accounting principles, the annual financial statements must also be prepared on that basis. Subject to any contrary requirement of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, and the rules and regulations of any stock exchange upon which the stock of the Corporation is traded, the Corporation shall mail the annual financial statements, or a written notice of their availability, to each shareholder within one hundred eighty (180) days of the close of each fiscal year. The Treasurer shall, in general, perform all duties incident to his office and such other duties as may be assigned to him from time to time by the President or by the Board of Directors. 11. Assistant Secretaries and Treasurers. The Assistant Secretaries and Assistant Treasurers shall, in the absence or disability of the Secretary or the Treasurer, perform the respective duties and exercise the respective powers of those offices, and they shall, in general, perform such other duties as shall be assigned to them by the Secretary or the Treasurer, respectively, or by the President or by the Board of Directors. 12. Controller and Assistant Controllers. The Controller, if one has been appointed, shall, under the supervision of the Treasurer, have charge of the accounting affairs of the Corporation and shall have such other powers and perform such other duties as the Board of Directors shall designate. Each Assistant Controller shall have such powers and perform such duties as may be assigned by the Board of Directors, and the Assistant Controllers shall exercise the powers of the Controller during that officer's absence or inability to act. 13. Bonds. The Board of Directors, by resolution, may require any or all officers, agents and employees of the Corporation to give bond to the Corporation, with sufficient sureties, conditioned on the faithful performance of the duties of their respective offices or positions, and to comply with such other conditions as may from time to time be required by the Board of Directors. 14. Voting Upon Stock. Unless otherwise ordered by the Board of Directors, the President shall have full power and authority on behalf of the Corporation to attend, act and vote at meetings of the shareholders of any Corporation in which this Corporation may hold stock, and at such meetings shall possess and may exercise any and all rights and powers incident to the ownership of such stock and which, as the owner, the Corporation might have possessed and exercised if present. The Board of Directors may by resolution from time to time confer such power and authority upon any other person or persons. 14 19 ARTICLE VI CONTRACTS, LOANS AND DEPOSITS 1. Contracts. The Board of Directors may authorize any officer or officers, or agent or agents, to enter into any contract or execute and deliver any instrument on behalf of the Corporation, and such authority may be general or confined to specific instances. 2. Loans. No loans shall be contracted on behalf of the Corporation and no evidence of indebtedness shall be issued in its name unless authorized by a resolution of the Board of Directors. Such authority may be general or confined to specific instances. 3. Checks and Drafts. All checks, drafts or other orders for the payment of money issued in the name of the Corporation shall be signed by such officer or officers, or agent or agents, of the Corporation and in such manner as shall from time to time be determined by resolution of the Board of Directors. 4. Deposits. All funds of the Corporation not otherwise employed shall be deposited from time to time to the credit of the Corporation in such depository or depositories as the Board of Directors shall direct. ARTICLE VII CERTIFICATES FOR SHARES AND OTHER TRANSFER 1. Certificates for Shares. Shares of the capital stock of the Corporation shall be represented by certificates. Such certificates shall be in such form as required by law and as determined by the Board of Directors and such certificates shall be issued to every shareholder for the fully paid shares owned by him. These certificates shall be signed by the President or any Vice President or a person who has been designated as the Chief Executive Officer of the Corporation and by the Vice President of Finance, the Secretary, Assistant Secretary, Treasurer or Assistant Treasurer and may be sealed with the seal of the Corporation or a facsimile thereof. The signatures of any such officers upon a certificate may be facsimiles or may be engraved or printed. In case any officer who has signed or whose facsimile or other signature has been placed upon such certificate shall have ceased to be such officer before such certificate is issued, it may be issued by the Corporation with the same effect as if he were such officer at the date of its issue. The certificates shall be consecutively numbered or otherwise identified; and the name and address of the persons to whom they are issued, with the number of shares and date of issue, shall be entered on the stock transfer books of the Corporation. 2. Transfer of Shares. Transfer of shares shall be made on the stock transfer books of the Corporation only upon surrender of the certificates for the shares sought to be transferred by the record holder thereof or by his duly authorized agent, transferee or legal representative. All certificates surrendered for transfer shall be cancelled before new certificates for the transferred shares shall be issued. 15 20 3. Transfer Agent and Registrar. The Board of Directors may appoint one or more transfer agents and one or more registrars of transfer and may require all stock certificates to be signed or countersigned by the transfer agent and registered by the registrar of transfers. 4. Record Date. (a) For the purpose of determining shareholders entitled to notice of or to vote at any meeting of shareholders or any adjournment thereof or entitled to receive payment of any dividend or in order to make a determination of shareholders for any other proper purpose, the Board of Directors may fix in advance a date as the record date for any such determination of shareholders, such date in any case not to be more than seventy (70) days before the meeting or action requiring a determination of shareholders. (b) If no record date is fixed by the Board of Directors for the determination of shareholders entitled to notice of or to vote at a meeting of shareholders or of shareholders entitled to receive payment of a dividend, the date on which notice of the meeting is mailed or the date on which the resolution of the Board of Directors declaring such dividend is adopted, as the case may be, shall be the record date for such determination of shareholders. (c) When a determination of shareholders entitled to vote at any meeting of shareholders has been made as provided in this paragraph, such determination shall apply to any adjournment thereof unless the Board of Directors fixes a new record date, which it shall do if the meeting is adjourned to a date more than one hundred twenty (120) days after the date fixed for the original meeting. 5. Lost Certificates. The Board of Directors may authorize the issuance of a new share certificate in place of a certificate claimed to have been lost or destroyed, upon receipt of an affidavit of such fact from the person claiming the loss or destruction. When authorizing such issuance of a new certificate, the Board of Directors may require the claimant to give the Corporation a bond in such sum as it may direct to indemnify the Corporation against loss from any claim with respect to the certificate claimed to have been lost or destroyed; or the Board of Directors may, by resolution reciting that the circumstances justify such action, authorize the issuance of the new certificate without requiring such a bond. 6. Holder of Record. Except as otherwise required by law, the Corporation may treat the person in whose name the shares stand of record on its books as the absolute owner of the shares and the person exclusively entitled to receive notification and distributions, to vote and to otherwise exercise the rights, powers and privileges of ownership of such shares. The Corporation shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares to receive dividends, and to vote as such owner, and to hold liable for calls and assessments a person registered on its books as the owner of shares, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of any 16 21 other person, whether or not it shall have express or other notice thereof, except as otherwise provided by the laws of North Carolina. 7. Shares held by Nominees. (a) The Corporation shall recognize the beneficial owner of shares registered in the name of a nominee as the owner and shareholder of such shares for certain purposes if the nominee in whose name such shares are registered files with the Secretary of the Corporation a written certificate in a form prescribed by the Corporation, signed by the nominee and indicating the following: (1) the name, address and taxpayer identification number of the nominee; (2) the name, address and taxpayer identification number of the beneficial owner; (3) the number and class or series of shares registered in the name of the nominee as to which the beneficial owner shall be recognized as the shareholder; and (4) the purposes for which the beneficial owner shall be recognized as the shareholder. (b) The purposes for which the Corporation shall recognize a beneficial owner as the shareholder may include the following: (1) receiving notice of, voting at and otherwise participating in shareholders' meetings; (2) executing consents with respect to the shares; (3) exercising dissenters' rights under Article 13 of the North Carolina Business Corporation Act; (4) receiving distributions and share dividends with respect to the shares; (5) exercising inspection rights; (6) receiving reports, financial statements, proxy statements and other communications from the Corporation; (7) making any demand upon the Corporation required or permitted by law; and (8) exercising any other rights or receiving any other benefits of a shareholder with respect to the shares. (c) The certificate shall be effective ten (10) business days after its receipt by the Corporation and until it is changed by the nominee, unless the certificate specifies a later effective time or an earlier termination date. (d) If the certificate affects less than all of the shares registered in the name of the nominee, the Corporation may require the shares affected by the certificate to be registered separately on the books of the Corporation and be represented by a share certificate that bears a conspicuous legend stating that there is a nominee certificate in effect with respect to the shares represented by that share certificate. 8. Acquisition by Corporation of its Own Shares. The Corporation may acquire its own shares and shares so acquired shall constitute authorized but unissued shares. Unless otherwise prohibited by the Articles of Incorporation, the Corporation may reissue such shares. If reissue is prohibited, the Articles of Incorporation shall be amended to reduce the number of authorized shares by the number of shares so acquired. Such required amendment may be adopted by the Board of Directors without shareholder action. ARTICLE VIII INDEMNIFICATION AND REIMBURSEMENT 17 22 OF DIRECTORS AND OFFICERS 1. Indemnification for Expenses and Liabilities. (a) Any person who at any time serves or has served: (1) as a director, officer, employee or agent of the Corporation, (2) at the request of the Corporation as a director, officer, partner, trustee, employee or agent of another foreign or domestic corporation, partnership, joint venture, trust, or other enterprise, or (3) at the request of the Corporation as a trustee or administrator under an employee benefit plan, shall have a right to be indemnified by the Corporation to the fullest extent from time to time permitted by law against Liability and Expenses in any Proceeding (including without limitation a Proceeding brought by or on behalf of the Corporation itself) arising out of his status as such or activities in any of the foregoing capacities or results from him being called as a witness at a time when he has not been made a named defendant or respondent to any Proceeding. (b) The Board of Directors of the Corporation shall take all such action as may be necessary and appropriate to authorize the Corporation to pay the indemnification required by this provision, including, without limitation, to the extent needed, making a good faith evaluation of the manner in which the claimant for indemnity acted and of the reasonable amount of indemnity due him. (c) Any person who at any time serves or has served in any of the aforesaid capacities for or on behalf of the Corporation shall be deemed to be doing or to have done so in reliance upon, and as consideration for, the rights provided for herein. Any repeal or modification of these indemnification provisions shall not affect any rights or obligations existing at the time of such repeal or modification. The rights provided for herein shall inure to the benefit of the legal representatives of any such person and shall not be exclusive of any other rights to which such person may be entitled apart from this provision. (d) The rights granted herein shall not be limited by the provisions contained in Sections 55-8-51 through 55-8-56 of the North Carolina Business Corporation Act or any successor to such statutes. 2. Advance Payment of Expenses. The Corporation shall (upon receipt of an undertaking by or on behalf of the Director, officer, employee or agent involved to repay the Expenses described herein unless it shall ultimately be determined that he is entitled to be indemnified by the Corporation against such Expenses) pay Expenses incurred by such Director, officer, employee or agent in defending a Proceeding or appearing as a witness at a time when he has not been named as a defendant or a respondent with respect thereto in advance of the final disposition of such Proceeding. 3. Insurance. The Corporation shall have the power to purchase and maintain insurance on behalf of any person who is or was a Director, officer, employee or agent of the Corporation, or is or was serving at the request of the Corporation as a director, officer, partner, trustee, employee or agent of another domestic or foreign corporation, partnership, joint venture, trust or 18 23 other enterprise or as a trustee or administrator under an employee benefit plan against any liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or not the Corporation would have the power to indemnify him against such liability. 4. Definitions. The following terms as used in this Article shall have the following meanings. "Proceeding" means any threatened, pending or completed action, suit, or proceeding and any appeal therein (and any inquiry or investigation that could lead to such action, suit, or proceeding), whether civil, criminal, administrative, investigative or arbitrative and whether formal or informal. "Expenses" means expenses of every kind, including counsel fees. "Liability" means the obligation to pay a judgment, settlement, penalty, fine (including an excise tax assessed with respect to an employee benefit plan), reasonable expenses incurred with respect to a Proceeding and all reasonable expenses incurred in enforcing the indemnification rights provided herein. "Director," "officer," "employee" and "agent" include the estate or personal representative of a Director, officer, employee or agent. "Corporation" shall include any domestic or foreign predecessor of this Corporation in a merger or other transaction in which the predecessor's existence ceased upon consummation of the transaction. ARTICLE IX GENERAL PROVISIONS 1. Distributions. The Board of Directors may from time to time declare, and the Corporation may pay, distributions and share dividends on its outstanding shares in the manner and upon the terms and conditions provided by law and by its Articles of Incorporation. 2. Seal. The corporate seal shall have the name of the Corporation inscribed thereon and shall be in such form of as may be approved from time to time by the Board of Directors. Such seal may be an impression or stamp and may be used by the officers of the Corporation by causing it, or a facsimile thereof, to be impressed or affixed or in any other manner reproduced. In addition to any form of seal adopted by the Board of Directors, the officers of the Corporation may use as the corporate seal a seal in the form of a circle containing the name of the Corporation and the state of its incorporation (or an abbreviation thereof) on the circumference and the word "Seal" in the center. 3. Fiscal Year. The fiscal year of the Corporation shall be determined by the Board of Directors. 4. Effective Date of Notice. Except as provided in Section 5(a) of Article II, written notice shall be effective at the earliest of the following: (1) when received; (2) five days after its deposit in the United States mail, as evidenced by the postmark, if mailed with postage thereon prepaid and correctly addressed; (3) upon confirmation of receipt by answer back code, if sent by facsimile transmission; (4) upon transmission, if sent by telegraph or teletype; or (5) on the date shown on the return receipt, if sent by registered or certified mail, return receipt requested and the receipt is signed by or on behalf of the addressee. 19 24 5. Corporate Records. Any records maintained by the Corporation in the regular course of its business, including its stock ledger, books of account and minute books, may be kept on or be in the form of punch cards, magnetic tape, photographs, microphotographs or any other information storage device; provided that the records so kept can be converted into clearly legible form within a reasonable time. The Corporation shall so convert any records so kept upon the request of any person entitled to inspect the same. The Corporation shall maintain at its principal office the following records: (1) Articles of Incorporation or Restated Articles of Incorporation and all amendments thereto; (2) Bylaws or Restated Bylaws and all amendments thereto; (3) resolutions by the Board of Directors creating classes or series of shares and affixing rights, preferences or limitations to shares; (4) minutes of all shareholder meetings or action taken without a meeting for the past three years; (5) all written communications to shareholders for the past three years, including financial statements; and (6) the Corporation's most recent annual report filed with the North Carolina Secretary of State. 6. Bylaw Amendments. (a) Except as otherwise provided herein, these Bylaws may be amended or repealed and new Bylaws may be adopted by the affirmative vote of a majority of the Directors present at any regular or special meeting of the Board of Directors at which a quorum is present or by the shareholders at any regular or special meeting of shareholders at which a quorum is present if the votes cast favoring such action exceed the votes cast opposing such action. Notwithstanding the foregoing, any provision hereof adopted, amended or repealed by the shareholders may not be readopted, amended or repealed by the Directors, but only by the affirmative vote of seventy-five percent (75%) of all eligible votes present at a meeting of shareholders at which a quorum is present. Note: The provisions of this Article IX, Section 6(a) have been adopted by the shareholders of the Corporation and may not be amended except by the shareholders in accordance with this provision. (b) The Board of Directors shall have no power to adopt a Bylaw: (1) changing the statutory requirement for a quorum of Directors or action by Directors or changing the statutory requirement for a quorum of shareholders or action by shareholders; (2) providing for the management of the Corporation otherwise than by the Board of Directors or the committees thereof; (3) except as may be otherwise provided in Article III, Section 2 of these Bylaws, increasing or decreasing the fixed number for the size of the Board of Directors or range of Directors, or changing from a fixed number to a range, or vice versa; or (4) classifying and staggering the election of Directors. (c) No Bylaw adopted, amended or repealed by the shareholders may be readopted, amended or repealed by the Board of Directors, except to the extent that the Articles of Incorporation or a Bylaw adopted by the shareholders authorizes the Board of Directors to adopt, amend or repeal that particular Bylaw or the Bylaws generally. 20 25 7. Amendments to Articles of Incorporation. (a) To the extent permitted by law, the Board of Directors may amend the Articles of Incorporation without shareholder approval to (1) delete the initial directors' names and addresses; (2) change the initial registered agent or office in any state in which it is qualified to do business, provided such change is on file with the respective Secretary of State; (3) change each issued and unissued share of an outstanding class into a greater number of whole shares, provided that class is the Corporation's only outstanding share class; (4) change the corporate name by substituting "corporation," "incorporated," "company," "limited" or the abbreviations therefor for a similar word or abbreviation or by adding, deleting or changing a geographic designation in the name; (5) make any other change expressly permitted by the North Carolina Business Corporation Act to be made without shareholder action. (b) All other amendments to the Articles of Incorporation must be approved by the affirmative vote of seventy-five percent (75%) of the votes present at a meeting of shareholders at which a quorum is present, in accordance with Article XII of the Corporation's Articles of Incorporation unless the provisions of North Carolina law otherwise apply in the circumstances specified in Article XII. The notice of any such meeting must state that the purpose, or one of the purposes, of the meeting is to consider the proposed amendment, and the notice must be accompanied by a copy or summary of the amendment or amendments. The Board of Directors must recommend any amendment to the Articles to be considered by shareholders as set forth in, and subject to the terms of, North Carolina General Statutes ss.55-10- 03(a). Note: The provisions of this Article IX, Section 7(b) are contained in the Articles of Incorporation. These Bylaw provisions have been adopted by the by the shareholders and may not be amended except by the shareholders of the Corporation in accordance with the provisions of Article IX, Section 6(a) hereof. 8. Stockholder Protection Statutes. The Corporation elects not to be subject to Article 9 or Article 9A of Chapter 55 of the North Carolina General Statutes known, respectively, as the "Shareholder Protection Act" and the "Control Share Acquisition Act", as such Articles may be amended from time to time. The foregoing Bylaws were adopted by the Board of Directors at a meeting held on October 30, 1995 and were amended at a joint meeting of the shareholders and Board of Directors held on December 4, 1995 and at a meeting of the shareholders held on September 25, 1996. ------------------------------------------ Fred B. Davenport, Jr., Secretary 21 EX-10.81 3 EMPLOYMENT AGREEMENT 9/26/96 PPD/DAVENPORT 1 EXHIBIT 10.81 EMPLOYMENT AGREEMENT THIS AGREEMENT (hereinafter the "Agreement"), made this 26th day of September, 1996, by and between Pharmaceutical Product Development, Inc., a North Carolina corporation (hereinafter "PPD"), and Fred B. Davenport, Jr. (hereinafter "Employee"). W I N E S S E T H: WHEREAS, Employee desires employment upon the terms and conditions herein stated; and WHEREAS, PPD desires to employ Employee upon the terms and conditions herein stated; and WHEREAS, Employee and PPD desire to embody in writing the terms and conditions of such employment in this Agreement. NOW, THEREFORE, in consideration for the mutual promises, covenants and considerations contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledge, the parties hereby agree as follows: 1. Employment. PPD hereby employs Employee and Employee hereby accepts such employment on a full time basis as General Counsel of PPD upon terms and conditions hereinafter set forth. 2. Term. The term of this Agreement shall be for one year, beginning December 1, 1996, and ending November 30, 1997, unless sooner terminated as provided herein. Thereafter, this Agreement shall be automatically renewed for successive one-year terms upon the terms and conditions herein set forth and subject to salary adjustments as provided for in paragraphs 3 and 10 below, unless either party gives notice as herein provided to the other of said party's intent not renew this Agreement not less than 75 days prior to the expiration of the one-year term then in effect. 3. Salary. For all services rendered by Employee under this Agreement, PPD shall pay to Employee an annual salary of $200,000 for the initial one-year term hereof. Salary successive one-year terms shall be agreed upon not less than 90 days before commencement of each one-year term unless such a requirement is waived by the parties. 4. Stock Options. PPD has granted to Employee as of September 26, 1996 (the "Grant Date") options to purchase 55,000 shares of PPD's common stock at a purchase price equal to the NASDAQ market close price on the Grant Date. Said share options have been granted under the terms of PPD's Equity Compensation Plan (the "Plan") and are subject to all of the terms and conditions of the Plan as more specifically evidenced by that certain Stock Award Agreement entered into by the parties as of the Grant Date, which Stock Award Agreement is in a form substantially similar to that generally provided to Plan participants except that (a) none of said share options can be exercised until six months after the Grant Date, (b) 27,500 of said share options cannot be exercised until the earlier of (i) one year after the Grant Date or (ii) subject to item (a) immediately preceding, Employee's termination of employment under any of paragraphs 8(a), 8(c)(i) and 19 hereof, and (c) all of the share options shall be forfeited if Employee is not employed by PPD for any reason before 120 days after the Grant Date. 5. Duties. Employee shall have overall responsibility for and decision making authority necessary to fulfill PPD's legal needs and functions. Employee's duties shall include but not be limited to (a) supervision of PPD's in-house legal staff and (b) retention and supervision of 2 PPD's outside legal counsel, in consultation with PPD's Chief Executive Officer and Board of Directors. Employee also shall participate in policy decisions and strategic planning as a member of PPD's executive management team. Employee shall carry out his duties and responsibilities under the general supervision of the Chief Executive Officer. Employee hereby agrees to undertake such travel as may be required to perform the duties prescribed herein. During the term of this Agreement, Employee shall devote substantially all of his working time, attention and energies to the business of PPD. 6. Working Facilities. PPD shall furnish Employee with office space, equipment, technical, secretarial and clerical assistance and such other facilities, services, support and supplies as may be reasonably needed to perform the duties herein prescribed in an efficient and professional manner. 7. Non-Compete. During the term of this Agreement, Employee hereby agrees that he shall not (a) become an officer, employee, director, agent, representative, member, associate or consultant of or to a corporation, partnership or other business entity or person, (b) directly or indirectly acquire a proprietary interest in a corporation, partnership or other business entity or person, or (c) directly or indirectly own any stock in a corporation (other than a publicly traded corporation of which Employee owns less than five percent (5%) of the outstanding stock) which is engaged in the business of managing clinical research programs for pharmaceutical and medical products or any other business which is developed by PPD during the term of this Agreement anywhere in the United States (whether or not such business is physically located within the United States). The parties agree that the business and operations of PPD are national in scope. For that reason, the parties agree that a geographical limitation on the foregoing covenant is not appropriate. 8. Termination. Notwithstanding any other provision of this Agreement, PPD may terminate Employee's employment hereunder upon the occurrence of any of the following events. a. Death of Employee. b. A determination by the Board of Directors of PPD, acting in good faith but made in the sole discretion of the Board of Directors, that Employee has failed to substantially perform his duties under this Agreement. c. A determination by the Board of Directors of PPD, acting in good faith but made in the sole discretion of the Board of Directors, that Employee (i) has become physically or mentally incapacitated and is unable to perform his duties under this Agreement as a result of such disability, which inability continues for a period of sixty (60) consecutive calendar days, (ii) has breached any of the material terms of this Agreement, (iii) has demonstrated gross negligence or willful misconduct in the execution of his duties, or (iv) has been convicted of a felony. 9. Disclosure of Information: PPD's Property. Employee recognizes and acknowledges that all of PPD's licenses, permits, data, affairs, confidential information, trade secrets, inventions, know how, discoveries, plans, development of work in progress, customer and supplier information, cost information, contractual provisions, employee capabilities, business methods, opportunities and the like (collectively, the "Proprietary Information"), are valuable and unique assets of PPD's business, regardless of whether PPD has obtained patents on patentable devices and techniques or copyrights on any material subject to copyright. Employee covenants and agrees that during the term of this Agreement and thereafter, he will not disclose the Proprietary Information to any other corporation, partnership, business entity or person for any reason (and without regard as to whether same shall have been originated, discovered or developed by Employee); provided, however, that such Proprietary Information which already is in the public domain shall not give rise to a breach hereunder by Employee for his disclosure thereof. 10. Benefits. During the term hereof, Employee shall be entitled to participate in all benefits provided by PPD to its employees generally, including but not limited to health 3 insurance, disability insurance and retirement plans, all of which are currently provided to employees of PPD, subject to the eligibility requirements of any plan(s) establishing same. Employee shall be subject to PPD's policies applicable to other executive employees of PPD with respect to periodic reviews and increases in salary, and shall be considered for and eligible to participate in benefits, if any, provided generally by PPD to its executive employees, including but not limited to issuance of stock options, cash bonuses, etc. Employee shall be entitled to four weeks paid vacation during each one-year term hereof. 11. Expenses. PPD shall pay all expenses of Employee which are directly related to Employee's duties hereunder, including but not limited to professional dues, continuing legal education required by the North Carolina State Bar or appropriate for a general counsel position, required malpractice insurance, if any, and other reasonable expenses routinely incurred in performing his duties hereunder. In addition, PPD shall pay the cost of any malpractice "tail" policy or coverage procured by Employee in connection with his departure from the private practice of law and shall reimburse Employee in the amount of $3,100 for all costs incurred by Employee prior to or after the date of this Agreement in connection with the storage and disposal of office furniture and related office equipment owned by Employee. 12. Remedies. In the event of Employee's actual or threatened breach of the provisions of paragraph 7 and/or 9 of this Agreement, PPD shall be entitled to a temporary restraining order and/or permanent injunction restraining Employee from such breach. Nothing herein shall be construed as preventing PPD from pursuing any other available remedies for such breach or threatened breach, including recovery of damages from Employee and from any corporation, partnership or other business entity or person with which the Employee has entered or attempted to enter into a relationship or to which Employee has disclosed Proprietary Information. 13. Entire Agreement. This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and may not be altered or amended except by agreement in writing signed by the parties. 14. Waiver or Breach. Waiver by either party of a breach of any provision of this Agreement by the other party shall not operate as a waiver of any subsequent breach by the other party. No waiver shall be valid unless in writing and signed by the party against whom the waiver is sought. 15. Severability. If any portion of this Agreement shall be declared invalid by a court of competent jurisdiction, the remaining portion shall continue in full force and effect as if this Agreement has been executed with the invalid portion eliminated and this Agreement shall be so construed. 16. Benefit. This Agreement shall inure to the benefit of and be binding upon PPD, its successors and assigns, and Employee, his heirs, successors, assigns and personal representatives. 17. Applicable Law. This Agreement shall be governed by the laws of the State of North Carolina. 18. Assignment. Neither party hereto may assign said party's rights or obligations hereunder without the prior written consent of the other. 19. Notice. Any notice required or permitted hereunder shall be delivered in person or mailed certified mail, return receipt requested, to either party at PPD's principal office in Wilmington, North Carolina, and shall be deemed received when actually received. Any notice from Employee to PPD shall be addressed to the Chief Executive Officer. 20. Severance. In the event PPD sustains a "Change of Control" such that Employee's position of general counsel is eliminated or Employee's duties are substantially diminished, or if Employee must relocate to retain the position of general counsel, Employee shall have the right to terminate this Agreement immediately and receive as severance pay a sum equal to two years of Employee's W-2 compensation computed using Employee's W-2 4 compensation for the twelve-month period immediately preceding the effective date of Employee's termination of employment hereunder. Said sum shall be paid on the effective date of termination. "Change of Control" as used herein shall mean (a) any merger, sale of assets or other business reorganization after which PPD is not surviving company (other than a reincorporation to change domicile of PPD), or (b) a change of control of nature that would be required to be reported in response to Item 5(e) of schedule 14A of Regulation 14A promulgated under the Securities Exchange Act of 1934, as amended ("Exchange Act"), provided that such a change in control shall be deemed to have occurred if any "person" (as such term is used in Sections 13(d) and 14(d)(2) of the Exchange Act) is or becomes the beneficial owner, directly or indirectly, of securities of PPD representing fifty percent or more of the combined voting power of PPD's then outstanding securities. IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of the date first hereinabove set forth. PPD PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. (CORPORATE SEAL) By: /s/ Fredric N. Eshelman --------------------------------- Title: Chief Executive Officer ATTEST: - ------------------------------- Title: ------------------------ EMPLOYEE /s/ Fred B. Davenport, Jr. (SEAL) ---------------------------------------- Fred B. Davenport WITNESS: /s/ Marla S. Doster - ------------------------------- EX-10.82 4 EMPLOYMENT AGREEMENT 9/25/96 PPD/BAKER 1 EXHIBIT 10.82 NORTH CAROLINA NEW HANOVER COUNTY EMPLOYMENT AGREEMENT THIS EMPLOYMENT AGREEMENT (hereinafter "Agreement") made this 25th day of September, 1996, by and between Pharmaceutical Product Development, Inc., a North Carolina corporation (hereinafter "Corporation") and Joshua S. Baker (hereinafter "Employee"). WITNESSETH: WHEREAS, the Employee desires employment upon the terms and conditions here stated as an employee of the Corporation; WHEREAS, the Corporation desires to employ the Employee upon the terms and conditions here stated; and WHEREAS, the Employee and Corporation desire to embody in writing the terms and conditions of such employment here made and accepted, in this Agreement; NOW THEREFORE, in consideration of the premises, and mutual promises, covenants and considerations hereinafter contained, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows: 1. Employment. The Corporation hereby employs the Employee and the Employee hereby accepts such employment on a full-time basis as Senior Vice President of Operations of the Corporation upon the terms and conditions hereinafter set forth. 2. Term. The term of this Agreement shall begin September 25, 1996 and continue until September 24, 1997 unless sooner terminated as provided herein. Upon the expiration of this Agreement, it shall thereafter be renewable on a year to year basis upon mutual agreement of Corporation and Employee. 3. Compensation. For all services rendered by Employee under this Agreement the Corporation shall pay to Employee $180,000 annually payable in twenty-six (26) biweekly equal installments or other such pay periods established from time to time by the Corporation, pursuant to its standard employment practices. 4. Duties. Employee shall have the day to day responsibilities of general decision making authority regarding all activities of the clinical operations division of the Corporation. The Employee shall carry out his duties under the general supervision of the Chief Operating Officer and the Board of Directors of the Corporation. The Employee hereby agrees to undertake such travel as may be required in the performance of his duties. During the term of this Agreement, Employee shall devote substantially all his working time, attention and energies to the business of the Corporation. 5. Working Facilities. The Corporation shall furnish Employee with the office space, equipment, technical, secretarial and clerical assistance and such other facilities, services and supplies as may be needed to enable him to perform the duties required of him hereunder from time to time in an efficient and professional manner. 2 6. Noncompete. During the term of this Agreement Employee hereby covenants and agrees that he shall not: (1) become an officer, employee, director, agent, representative or consultant of a corporation, or (2) become an employee, agent, consultant, representative, member or associate of a business, firm or partnership, or other entity, or (3) have, directly or indirectly, a proprietary interest in a business, partnership, firm, or other entity, or (4) own, directly or indirectly, any stock in a corporation (other than a publicly traded corporation of which the Employee owns less then 5% of the outstanding stock) which is engaged in the business of managing clinical research programs for pharmaceutical and medical products or otherwise engaged in any business which is developed by the Corporation during the term of this Agreement anywhere in the United States (whether or not such business is physically located within the United States). The parties agree that the business and operations of the Corporation are national in scope. For that reason, the parties agree that a geographical limitation on the foregoing covenant not to compete would not be appropriate. 7. Termination. Notwithstanding any provision of this Agreement to the contrary, the following items shall constitute " just cause" for termination. The employment of Employee pursuant to this Agreement shall be terminated immediately upon (1) death of Employee; (2) a determination by the Board of Directors of the Corporation, acting in good faith, but made in the sole discretion of such Board, that Employee has failed to perform his duties under this Agreement; (3) a determination by the Board of Directors of the Corporation, acting in good faith, but made in the sole discretion of said Board, that Employee (a) has become physically or mentally incapacitated, or is unable to perform his duties under this Agreement as a result of such, continued for a period of sixty consecutive calendar days, (b) has breached any of the material terms of this Agreement, (c) has demonstrated gross negligence or willful misconduct in the execution of his duties, or (d) has been convicted of a Felony. 8. Disclosure of Information; Corporation's Property. The Employee recognizes and acknowledges that all of the Corporation's licenses, permits, data, affairs, confidential information, trade secrets, inventions, know how, discoveries, plans, development work in progress, customer and supplier information, cost information, contractual provisions, employee capabilities, business methods and opportunities and the like (collectively "Proprietary Information"), are valuable, special, and unique assets of the Corporation's business regardless of whether the Corporation has taken all necessary steps to obtain patents on patentable devices and techniques or copyrights on any materials. Therefore the Employee expressly covenants and agrees that he will not during the term of this Agreement and thereafter disclose the Corporation's Proprietary Information to any other persons, form, corporation, association or any other entity for any reason or purpose whatsoever, regardless of whether the same shall or may have been originated, discovered or developed by Employee. 9. Fringe Benefits. During the period of employment, the Employee shall be entitled to all benefits in effect from time to time which the Corporation provides to its employees and for which Employee is eligible. Furthermore, Employee shall be governed by the Corporation's policies applicable to other executive employees of the Corporation with respect to periodic reviews and increases in salary and fringe benefits provided for such executive employees. Fringe benefits shall include participation in the Corporation's cash bonus and stock option plans. 10. Remedies. In the event of the Employee's actual or threatened breach of the provisions of paragraphs 6 and 8 of this Agreement, the Corporation shall be entitled to a temporary restraining order and/or permanent injunction restraining Employee therefrom. Nothing shall be construed as preventing 3 the Corporation from pursuing any other available remedies for such breach or threatened breach, including the recovery of damages from the Employee and from the corporation, business, firm, partnership or other entity with which Employee may have entered into a relationship, or to which Employee may have disclosed information, which is prohibited by this Agreement. 11. Entire Agreement. This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and may not be altered or amended in any respect or to any extent whatsoever except by agreement in writing executed by each of the parties hereto. 12. Waiver of Breach. Waiver by either party of a breach of any provision of this Agreement by the other party shall not operate or be construed as a waiver of any subsequent breach by the other party. No waiver shall be valid unless in writing and signed by the party against whom the waiver is sought. 13. Severability. If any portion of this agreement shall be declared invalid by a court of competent jurisdiction for any reason, the remaining portion shall remain in force and effect as if this Agreement had been executed with the invalid portion eliminated; provided however, that in the event of a declaration of invalidity, the provision declared invalid shall not be invalidated in its entirety but shall remain in effect and force to the extent such provision is valid and enforceable. The parties agree that any provision shall be deemed altered and amended to the extent necessary to effect such validity and enforceability. 14. Benefit. This Agreement shall inure to the benefit of and be binding upon the Corporation, its successors and assigns, and Employee, his heirs, executors, administrators and legal representatives. 15. Applicable Law. This Agreement shall be construed in accordance with, and governed by, the laws of the State of North Carolina. 16. Assignment. The rights and obligations of the Corporation under this Agreement may be assigned by the Corporation to the successors in interest of the Corporation or of that part of the business of the Corporation to which this Agreement applies. This Agreement may not be assigned by Employee, but any amounts owing to Employee upon his death shall inure to the benefit of his heirs, legatees, personal representative, executor or administrator. IN WITNESS WHEREOF, the parties have executed this Agreement and set their hands and seals the date first written above. Pharmaceutical Product Development, Inc. By: /s/ Fredric N. Eshelman ------------------------------------- Fredric N. Eshelman, Chief Executive Officer Attest: /s/ Rudy C. Howard - ------------------------------- Secretary - -------------------- (Corporate Seal) /s/ Joshua S. Baker (SEAL) ---------------------------------------- Joshua S. Baker EX-10.83A 5 SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENTS 1 EXHIBIT 10.83a SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT THIS SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT ("Agreement") entered into as of the 26th day of September, 1996 by and between Pharmaceutical Product Development, Inc., a North Carolina corporation (the "Company") and Grover C. Wrenn (the "Executive"). WITNESSETH: WHEREAS, the Company has agreed, pursuant to the Agreement and Plan of Reorganization by and among the Company, Wilmington Merger Corp., a North Carolina corporation and wholly-owned subsidiary of the Company, and Applied Bioscience International Inc., a Delaware corporation ("APBI") (the "Merger Agreement"), to assume certain of the non-statutory stock options (the "Options") granted to the Executive in connection with the Separation Agreement dated August 25, 1995, entered into by and between the Executive and APBI (the "Separation Agreement"); and WHEREAS, pursuant to the terms of the Merger Agreement, the Executive is entitled to receive substitute options denominated in shares of common stock of the Company, in substitution for and cancellation of the Options, provided that the substitute options shall be subject to the terms and conditions of this agreement and the Pharmaceutical Product Development, Inc. Equity Compensation Plan (the "Plan") except that the number of shares of the Company's common stock and the exercise price of the option are to be adjusted in the manner set forth in the Merger Agreement and the substitute options are to have substantially the same restrictions, terms and conditions as the options for which they were substituted, NOW, THEREFORE, intending to be legally bound hereby, the Company and the Executive do hereby covenant and agree as follows: 1. SUBSTITUTE OPTION. Pursuant to the terms of the Merger Agreement, the Company does hereby issue to the Executive in substitution for the option granted to the Executive on September 19, 1995, by APBI to replace the original option granted to the Executive on June 25, 1993, the right and option to purchase, under the terms and conditions hereinafter set forth, in whole or in part, 15,820 shares of common stock of the Company, par value $.10 per share, which right and option shall not constitute an incentive stock option within the meaning of Section 422(b) of the Internal Revenue Code of 1986, (the "Non-Statutory Stock Option"). The price at which the shares shall be purchased shall be $13.88, which price is the adjusted exercise price of the Non-Statutory Stock Option as determined under the Merger Agreement. 2. TERMS. The Non-Statutory Stock Option herein granted is fully vested and shall expire at 12:00 midnight on the earlier of (a) February 11, 2001, or (b) the day immediately following any period of twenty (20) consecutive trading days in which the last sale for shares of the Company's Common Stock (as adjusted for stock splits, dividends, and similar events) for each of such trading days equaled or exceeded $49.33 per share as quoted on the NASDAQ National Market System. 2 3. EXERCISE. The Executive may exercise the Non-Statutory Stock Option granted hereunder by giving written notice to the Compensation Committee of the Company ("the Committee") at 3151 S. 17th Street Extension, Wilmington, North Carolina 28412. Such notice, a form of which is attached hereto as Exhibit A and incorporated by reference, shall state the number of full shares (no fractional shares may be purchased) to which the election applies. Such notice shall be accompanied by payment in an amount sufficient to purchase the number of shares set forth in the notice at the per share price established by Section 1 hereof. Payment shall be made in cash, or the Committee in its discretion may allow the Executive to use shares of the Company's Common Stock having a fair market value equal to the purchase price (as determined by the Committee), or the Committee may allow the use of a combination of cash and such shares. 4. DEATH. In the event of death of the Executive, the Non-Statutory Stock Option shall be exercisable by the person or persons who acquired the option by bequest or inheritance or by reason of the death of the Executive, or by the executor or administrator of the estate of the deceased Executive at any time before the expiration date of the Non-Statutory Stock Option. 5. NO IMPLIED RIGHTS. Nothing contained in this Agreement, nor the granting of any options hereunder, shall be construed as giving the Executive or any other person any legal or equitable rights against the Company or any subsidiary corporation or any director, officer, employee or agent thereof, except for those rights as are herein provided. 6. NO ASSIGNMENT. Except as otherwise provided herein, the Non-Statutory Stock Option and the rights and privileges conferred hereby may not be transferred, assigned, pledged, hypothecated or encumbered, and shall not be subject to execution, attachment, garnishment or other similar legal processes. Upon any attempt to transfer, assign, pledge, hypothecate or otherwise encumber or dispose of the Non-Statutory Stock Option, the Non-Statutory Stock Option and the rights and privileges conferred hereunder shall immediately become null and void. This option may be exercised during the lifetime of the Executive only by the Executive; provided, however, that if the Executive is declared legally incompetent, the Executive's duly appointed legal representative may exercise the Non-Statutory Stock Option granted hereunder in the manner and to the extent that the Executive is entitled to exercise the option hereunder. 7. INCORPORATION OF THE PLAN. This Agreement incorporates the terms of the Plan, and any modifications or amendments thereto. The Employee acknowledges receipt of a copy of the Plan and agrees to be bound by all the terms and provisions thereof that are not inconsistent with the terms of this Agreement. 8. GOVERNING LAW. This Agreement shall be governed by the law of North Carolina, without reference to the principles of conflicts of law thereof. - 2 - 3 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first above written. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------------------ Its Chief Executive Officer -------------------------------- /s/ Grover C. Wrenn ------------------------------------ Executive - 3 - EX-10.83B 6 SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENTS 1 EXHIBIT 10.83b SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT THIS SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT ("Agreement") entered into as of the 26th day of September, 1996 by and between Pharmaceutical Product Development, Inc., a North Carolina corporation (the "Company") and Grover C. Wrenn (the "Executive"). WITNESSETH: WHEREAS, the Company has agreed, pursuant to the Agreement and Plan of Reorganization by and among the Company, Wilmington Merger Corp., a North Carolina corporation and wholly-owned subsidiary of the Company, and Applied Bioscience International Inc., a Delaware corporation ("APBI") (the "Merger Agreement"), to assume certain of the non-statutory stock options (the "Options") granted to the Executive in connection with the Separation Agreement dated August 25, 1995, entered into by and between the Executive and APBI (the "Separation Agreement"); and WHEREAS, pursuant to the terms of the Merger Agreement, the Executive is entitled to receive substitute options denominated in shares of common stock of the Company, in substitution for and cancellation of the Options, provided that the substitute options shall be subject to the terms and conditions of this agreement and the Pharmaceutical Product Development, Inc. Equity Compensation Plan (the "Plan") except that the number of shares of the Company's common stock and the exercise price of the option are to be adjusted in the manner set forth in the Merger Agreement and the substitute options are to have substantially the same restrictions, terms and conditions as the options for which they were substituted. NOW, THEREFORE, intending to be legally bound hereby, the Company and the Executive do hereby covenant and agree as follows: 1. SUBSTITUTE OPTION. Pursuant to the terms of the Merger Agreement, the Company does hereby issue to the Executive in substitution for the option granted to the Executive on September 19, 1995, by APBI to replace the original option granted to the Executive on December 10, 1991, the right and option to purchase, under the terms and conditions hereinafter set forth, in whole or in part, 3,334 shares of common stock of the Company, par value $.10 per share, which right and option shall not constitute an incentive stock option within the meaning of Section 422(b) of the Internal Revenue Code of 1986, (the "Non-Statutory Stock Option"). The price at which the shares shall be purchased shall be $32.84, which price is the adjusted exercise price of the Non-Statutory Stock Option as determined under the Merger Agreement. 2. TERMS. The Non-Statutory Stock Option herein granted is fully vested and shall expire at 12:00 midnight on the earlier of (a) February 11, 2001, or (b) the day immediately following any period of twenty (20) consecutive trading days in which the last sale for shares of the Company's Common Stock (as adjusted for stock splits, dividends, and similar events) for each of such trading days equaled or exceeded $49.33 per share as quoted on the NASDAQ National Market System. 2 3. EXERCISE. The Executive may exercise the Non-Statutory Stock Option granted hereunder by giving written notice to the Compensation Committee of the Company ("the Committee") at 3151 S. 17th Street Extension, Wilmington, North Carolina 28412. Such notice, a form of which is attached hereto as Exhibit A and incorporated by reference, shall state the number of full shares (no fractional shares may be purchased) to which the election applies. Such notice shall be accompanied by payment in an amount sufficient to purchase the number of shares set forth in the notice at the per share price established by Section 1 hereof. Payment shall be made in cash, or the Committee in its discretion may allow the Executive to use shares of the Company's Common Stock having a fair market value equal to the purchase price (as determined by the Committee), or the Committee may allow the use of a combination of cash and such shares. 4. DEATH. In the event of death of the Executive, the Non-Statutory Stock Option shall be exercisable by the person or persons who acquired the option by bequest or inheritance or by reason of the death of the Executive, or by the executor or administrator of the estate of the deceased Executive at any time before the expiration date of the Non-Statutory Stock Option. 5. NO IMPLIED RIGHTS. Nothing contained in this Agreement, nor the granting of any options hereunder, shall be construed as giving the Executive or any other person any legal or equitable rights against the Company or any subsidiary corporation or any director, officer, employee or agent thereof, except for those rights as are herein provided. 6. NO ASSIGNMENT. Except as otherwise provided herein, the Non-Statutory Stock Option and the rights and privileges conferred hereby may not be transferred, assigned, pledged, hypothecated or encumbered, and shall not be subject to execution, attachment, garnishment or other similar legal processes. Upon any attempt to transfer, assign, pledge, hypothecate or otherwise encumber or dispose of the Non-Statutory Stock Option, the Non-Statutory Stock Option and the rights and privileges conferred hereunder shall immediately become null and void. This option may be exercised during the lifetime of the Executive only by the Executive; provided, however, that if the Executive is declared legally incompetent, the Executive's duly appointed legal representative may exercise the Non-Statutory Stock Option granted hereunder in the manner and to the extent that the Executive is entitled to exercise the option hereunder. 7. INCORPORATION OF THE PLAN. This Agreement incorporates the terms of the Plan, and any modifications or amendments thereto. The Employee acknowledges receipt of a copy of the Plan and agrees to be bound by all the terms and provisions thereof that are not inconsistent with the terms of this Agreement. 8. GOVERNING LAW. This Agreement shall be governed by the law of North Carolina, without reference to the principles of conflicts of law thereof. - 2 - 3 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first above written. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------------------ Its Chief Executive Officer -------------------------------- /s/ Grover C. Wrenn ------------------------------------ Executive - 3 - EX-10.83C 7 SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENTS 1 EXHIBIT 10.83c SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT THIS SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT ("Agreement") entered into as of the 26th day of September, 1996 by and between Pharmaceutical Product Development, Inc., a North Carolina corporation (the "Company") and Grover C. Wrenn (the "Executive"). WITNESSETH: WHEREAS, the Company has agreed, pursuant to the Agreement and Plan of Reorganization by and among the Company, Wilmington Merger Corp., a North Carolina corporation and wholly-owned subsidiary of the Company, and Applied Bioscience International Inc., a Delaware corporation ("APBI") (the "Merger Agreement"), to assume certain of the non-statutory stock options (the "Options") granted to the Executive in connection with the Separation Agreement dated August 25, 1995, entered into by and between the Executive and APBI (the "Separation Agreement"); and WHEREAS, pursuant to the terms of the Merger Agreement, the Executive is entitled to receive substitute options denominated in shares of common stock of the Company, in substitution for and cancellation of the Options, provided that the substitute options shall be subject to the terms and conditions of this agreement and the Pharmaceutical Product Development, Inc. Equity Compensation Plan (the "Plan") except that the number of shares of the Company's common stock and the exercise price of the option are to be adjusted in the manner set forth in the Merger Agreement and the substitute options are to have substantially the same restrictions, terms and conditions as the options for which they were substituted. NOW, THEREFORE, intending to be legally bound hereby, the Company and the Executive do hereby covenant and agree as follows: 1. SUBSTITUTE OPTION. Pursuant to the terms of the Merger Agreement, the Company does hereby issue to the Executive in substitution for the option granted to the Executive on September 19, 1995, by APBI to replace the original option granted to the Executive on December 10, 1991, the right and option to purchase, under the terms and conditions hereinafter set forth, in whole or in part, 6,975 shares of common stock of the Company, par value $.10 per share, which right and option shall not constitute an incentive stock option within the meaning of Section 422(b) of the Internal Revenue Code of 1986, (the "Non-Statutory Stock Option"). The price at which the shares shall be purchased shall be $32.84, which price is the adjusted exercise price of the Non-Statutory Stock Option as determined under the Merger Agreement. 2. TERMS. The Non-Statutory Stock Option herein granted is fully vested and shall expire at 12:00 midnight on the earlier of (a) February 11, 2001, or (b) the day immediately following any period of twenty (20) consecutive trading days in which the last sale for shares of the Company's Common Stock (as adjusted for stock splits, dividends, and similar events) for each of such trading days equaled or exceeded $49.33 per share as quoted on the NASDAQ National Market System. 2 3. EXERCISE. The Executive may exercise the Non-Statutory Stock Option granted hereunder by giving written notice to the Compensation Committee of the Company ("the Committee") at 3151 S. 17th Street Extension, Wilmington, North Carolina 28412. Such notice, a form of which is attached hereto as Exhibit A and incorporated by reference, shall state the number of full shares (no fractional shares may be purchased) to which the election applies. Such notice shall be accompanied by payment in an amount sufficient to purchase the number of shares set forth in the notice at the per share price established by Section 1 hereof. Payment shall be made in cash, or the Committee in its discretion may allow the Executive to use shares of the Company's Common Stock having a fair market value equal to the purchase price (as determined by the Committee), or the Committee may allow the use of a combination of cash and such shares. 4. DEATH. In the event of death of the Executive, the Non-Statutory Stock Option shall be exercisable by the person or persons who acquired the option by bequest or inheritance or by reason of the death of the Executive, or by the executor or administrator of the estate of the deceased Executive at any time before the expiration date of the Non-Statutory Stock Option. 5. NO IMPLIED RIGHTS. Nothing contained in this Agreement, nor the granting of any options hereunder, shall be construed as giving the Executive or any other person any legal or equitable rights against the Company or any subsidiary corporation or any director, officer, employee or agent thereof, except for those rights as are herein provided. 6. NO ASSIGNMENT. Except as otherwise provided herein, the Non-Statutory Stock Option and the rights and privileges conferred hereby may not be transferred, assigned, pledged, hypothecated or encumbered, and shall not be subject to execution, attachment, garnishment or other similar legal processes. Upon any attempt to transfer, assign, pledge, hypothecate or otherwise encumber or dispose of the Non-Statutory Stock Option, the Non-Statutory Stock Option and the rights and privileges conferred hereunder shall immediately become null and void. This option may be exercised during the lifetime of the Executive only by the Executive; provided, however, that if the Executive is declared legally incompetent, the Executive's duly appointed legal representative may exercise the Non-Statutory Stock Option granted hereunder in the manner and to the extent that the Executive is entitled to exercise the option hereunder. 7. INCORPORATION OF THE PLAN. This Agreement incorporates the terms of the Plan, and any modifications or amendments thereto. The Employee acknowledges receipt of a copy of the Plan and agrees to be bound by all the terms and provisions thereof that are not inconsistent with the terms of this Agreement. 8. GOVERNING LAW. This Agreement shall be governed by the law of North Carolina, without reference to the principles of conflicts of law thereof. - 2 - 3 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first above written. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------------------ Its Chief Executive Officer -------------------------------- /s/ Grover C. Wrenn ------------------------------------ Executive - 3 - EX-10.83D 8 SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENTS 1 EXHIBIT 10.83d SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT THIS SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT ("Agreement") entered into as of the 26th day of September, 1996 by and between Pharmaceutical Product Development, Inc., a North Carolina corporation (the "Company") and Grover C. Wrenn (the "Executive"). WITNESSETH: WHEREAS, the Company has agreed, pursuant to the Agreement and Plan of Reorganization by and among the Company, Wilmington Merger Corp., a North Carolina corporation and wholly-owned subsidiary of the Company, and Applied Bioscience International Inc., a Delaware corporation ("APBI") (the "Merger Agreement"), to assume certain of the non-statutory stock options (the "Options") granted to the Executive in connection with the Separation Agreement dated August 25, 1995, entered into by and between the Executive and APBI (the "Separation Agreement"); and WHEREAS, pursuant to the terms of the Merger Agreement, the Executive is entitled to receive substitute options denominated in shares of common stock of the Company, in substitution for and cancellation of the Options, provided that the substitute options shall be subject to the terms and conditions of this agreement and the Pharmaceutical Product Development, Inc. Equity Compensation Plan (the "Plan") except that the number of shares of the Company's common stock and the exercise price of the option are to be adjusted in the manner set forth in the Merger Agreement and the substitute options are to have substantially the same restrictions, terms and conditions as the options for which they were substituted. NOW, THEREFORE, intending to be legally bound hereby, the Company and the Executive do hereby covenant and agree as follows: 1. SUBSTITUTE OPTION. Pursuant to the terms of the Merger Agreement, the Company does hereby issue to the Executive in substitution for the option granted to the Executive on September 19, 1995, by APBI to replace the original option granted to the Executive on June 25, 1993, the right and option to purchase, under the terms and conditions hereinafter set forth, in whole or in part, 5,260 shares of common stock of the Company, par value $.10 per share, which right and option shall not constitute an incentive stock option within the meaning of Section 422(b) of the Internal Revenue Code of 1986, (the "Non-Statutory Stock Option"). The price at which the shares shall be purchased shall be $13.88, which price is the adjusted exercise price of the Non-Statutory Stock Option as determined under the Merger Agreement. 2. TERMS. The Non-Statutory Stock Option herein granted is fully vested and shall expire at 12:00 midnight on the earlier of (a) February 11, 2001, or (b) the day immediately following any period of twenty (20) consecutive trading days in which the last sale for shares of the Company's Common Stock (as adjusted for stock splits, dividends, and similar events) for each of such trading days equaled or exceeded $49.33 per share as quoted on the NASDAQ National Market System. 2 3. EXERCISE. The Executive may exercise the Non-Statutory Stock Option granted hereunder by giving written notice to the Compensation Committee of the Company ("the Committee") at 3151 S. 17th Street Extension, Wilmington, North Carolina 28412. Such notice, a form of which is attached hereto as Exhibit A and incorporated by reference, shall state the number of full shares (no fractional shares may be purchased) to which the election applies. Such notice shall be accompanied by payment in an amount sufficient to purchase the number of shares set forth in the notice at the per share price established by Section 1 hereof. Payment shall be made in cash, or the Committee in its discretion may allow the Executive to use shares of the Company's Common Stock having a fair market value equal to the purchase price (as determined by the Committee), or the Committee may allow the use of a combination of cash and such shares. 4. DEATH. In the event of death of the Executive, the Non-Statutory Stock Option shall be exercisable by the person or persons who acquired the option by bequest or inheritance or by reason of the death of the Executive, or by the executor or administrator of the estate of the deceased Executive at any time before the expiration date of the Non-Statutory Stock Option. 5. NO IMPLIED RIGHTS. Nothing contained in this Agreement, nor the granting of any options hereunder, shall be construed as giving the Executive or any other person any legal or equitable rights against the Company or any subsidiary corporation or any director, officer, employee or agent thereof, except for those rights as are herein provided. 6. NO ASSIGNMENT. Except as otherwise provided herein, the Non-Statutory Stock Option and the rights and privileges conferred hereby may not be transferred, assigned, pledged, hypothecated or encumbered, and shall not be subject to execution, attachment, garnishment or other similar legal processes. Upon any attempt to transfer, assign, pledge, hypothecate or otherwise encumber or dispose of the Non-Statutory Stock Option, the Non-Statutory Stock Option and the rights and privileges conferred hereunder shall immediately become null and void. This option may be exercised during the lifetime of the Executive only by the Executive; provided, however, that if the Executive is declared legally incompetent, the Executive's duly appointed legal representative may exercise the Non-Statutory Stock Option granted hereunder in the manner and to the extent that the Executive is entitled to exercise the option hereunder. 7. INCORPORATION OF THE PLAN. This Agreement incorporates the terms of the Plan, and any modifications or amendments thereto. The Employee acknowledges receipt of a copy of the Plan and agrees to be bound by all the terms and provisions thereof that are not inconsistent with the terms of this Agreement. 8. GOVERNING LAW. This Agreement shall be governed by the law of North Carolina, without reference to the principles of conflicts of law thereof. - 2 - 3 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first above written. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------------------ Its Chief Executive Officer -------------------------------- /s/ Grover C. Wrenn ------------------------------------ Executive - 3 - EX-10.83E 9 SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENTS 1 EXHIBIT 10.83e SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT THIS SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT ("Agreement") entered into as of the 26th day of September, 1996 by and between Pharmaceutical Product Development, Inc., a North Carolina corporation (the "Company") and Grover C. Wrenn (the "Executive"). WITNESSETH: WHEREAS, the Company has agreed, pursuant to the Agreement and Plan of Reorganization by and among the Company, Wilmington Merger Corp., a North Carolina corporation and wholly-owned subsidiary of the Company, and Applied Bioscience International Inc., a Delaware corporation ("APBI") (the "Merger Agreement"), to assume certain of the non-statutory stock options (the "Options") granted to the Executive in connection with the Separation Agreement dated August 25, 1995, entered into by and between the Executive and APBI (the "Separation Agreement"); and WHEREAS, pursuant to the terms of the Merger Agreement, the Executive is entitled to receive substitute options denominated in shares of common stock of the Company, in substitution for and cancellation of the Options, provided that the substitute options shall be subject to the terms and conditions of this agreement and the Pharmaceutical Product Development, Inc. Equity Compensation Plan (the "Plan") except that the number of shares of the Company's common stock and the exercise price of the option are to be adjusted in the manner set forth in the Merger Agreement and the substitute options are to have substantially the same restrictions, terms and conditions as the options for which they were substituted, NOW, THEREFORE, intending to be legally bound hereby, the Company and the Executive do hereby covenant and agree as follows: 1. SUBSTITUTE OPTION. Pursuant to the terms of the Merger Agreement, the Company does hereby issue to the Executive in substitution for the option granted to the Executive on September 19, 1995, by APBI to replace the original option granted to the Executive on June 25, 1993, the right and option to purchase, under the terms and conditions hereinafter set forth, in whole or in part, 15,820 shares of common stock of the Company, par value $.10 per share, which right and option shall not constitute an incentive stock option within the meaning of Section 422(b) of the Internal Revenue Code of 1986, (the "Non-Statutory Stock Option"). The price at which the shares shall be purchased shall be $13.88, which price is the adjusted exercise price of the Non-Statutory Stock Option as determined under the Merger Agreement. 2. TERMS. The Non-Statutory Stock Option herein granted is fully vested and shall expire at 12:00 midnight on the earlier of (a) February 11, 2001, or (b) the day immediately following any period of twenty (20) consecutive trading days in which the last sale for shares of the Company's Common Stock (as adjusted for stock splits, dividends, and similar events) for each of such trading days equaled or exceeded $49.33 per share as quoted on the NASDAQ National Market System. 2 3. EXERCISE. The Executive may exercise the Non-Statutory Stock Option granted hereunder by giving written notice to the Compensation Committee of the Company ("the Committee") at 3151 S. 17th Street Extension, Wilmington, North Carolina 28412. Such notice, a form of which is attached hereto as Exhibit A and incorporated by reference, shall state the number of full shares (no fractional shares may be purchased) to which the election applies. Such notice shall be accompanied by payment in an amount sufficient to purchase the number of shares set forth in the notice at the per share price established by Section 1 hereof. Payment shall be made in cash, or the Committee in its discretion may allow the Executive to use shares of the Company's Common Stock having a fair market value equal to the purchase price (as determined by the Committee), or the Committee may allow the use of a combination of cash and such shares. 4. DEATH. In the event of death of the Executive, the Non-Statutory Stock Option shall be exercisable by the person or persons who acquired the option by bequest or inheritance or by reason of the death of the Executive, or by the executor or administrator of the estate of the deceased Executive at any time before the expiration date of the Non-Statutory Stock Option. 5. NO IMPLIED RIGHTS. Nothing contained in this Agreement, nor the granting of any options hereunder, shall be construed as giving the Executive or any other person any legal or equitable rights against the Company or any subsidiary corporation or any director, officer, employee or agent thereof, except for those rights as are herein provided. 6. NO ASSIGNMENT. Except as otherwise provided herein, the Non-Statutory Stock Option and the rights and privileges conferred hereby may not be transferred, assigned, pledged, hypothecated or encumbered, and shall not be subject to execution, attachment, garnishment or other similar legal processes. Upon any attempt to transfer, assign, pledge, hypothecate or otherwise encumber or dispose of the Non-Statutory Stock Option, the Non-Statutory Stock Option and the rights and privileges conferred hereunder shall immediately become null and void. This option may be exercised during the lifetime of the Executive only by the Executive; provided, however, that if the Executive is declared legally incompetent, the Executive's duly appointed legal representative may exercise the Non-Statutory Stock Option granted hereunder in the manner and to the extent that the Executive is entitled to exercise the option hereunder. 7. INCORPORATION OF THE PLAN. This Agreement incorporates the terms of the Plan, and any modifications or amendments thereto. The Employee acknowledges receipt of a copy of the Plan and agrees to be bound by all the terms and provisions thereof that are not inconsistent with the terms of this Agreement. 8. GOVERNING LAW. This Agreement shall be governed by the law of North Carolina, without reference to the principles of conflicts of law thereof. - 2 - 3 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first above written. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------------------ Its Chief Executive Officer -------------------------------- /s/ Grover C. Wrenn ------------------------------------ Executive - 3 - EX-10.83F 10 SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENTS 1 EXHIBIT 10.83f SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT THIS SUBSTITUTE NON-STATUTORY STOCK OPTION AGREEMENT ("Agreement") entered into as of the 26th day of September, 1996 by and between Pharmaceutical Product Development, Inc., a North Carolina corporation (the "Company") and Grover C. Wrenn (the "Executive"). WITNESSETH: WHEREAS, the Company has agreed, pursuant to the Agreement and Plan of Reorganization by and among the Company, Wilmington Merger Corp., a North Carolina corporation and wholly-owned subsidiary of the Company, and Applied Bioscience International Inc., a Delaware corporation ("APBI") (the "Merger Agreement"), to assume certain of the non-statutory stock options (the "Options") granted to the Executive in connection with the Separation Agreement dated August 25, 1995, entered into by and between the Executive and APBI (the "Separation Agreement"); and WHEREAS, pursuant to the terms of the Merger Agreement, the Executive is entitled to receive substitute options denominated in shares of common stock of the Company, in substitution for and cancellation of the Options, provided that the substitute options shall be subject to the terms and conditions of this agreement and the Pharmaceutical Product Development, Inc. Equity Compensation Plan (the "Plan") except that the number of shares of the Company's common stock and the exercise price of the option are to be adjusted in the manner set forth in the Merger Agreement and the substitute options are to have substantially the same restrictions, terms and conditions as the options for which they were substituted. NOW, THEREFORE, intending to be legally bound hereby, the Company and the Executive do hereby covenant and agree as follows: 1. SUBSTITUTE OPTION. Pursuant to the terms of the Merger Agreement, the Company does hereby issue to the Executive in substitution for the option granted to the Executive on September 19, 1995, by APBI to replace the original option granted to the Executive on September 13, 1994, the right and option to purchase, under the terms and conditions hereinafter set forth, in whole or in part, 20,270 shares of common stock of the Company, par value $.10 per share, which right and option shall not constitute an incentive stock option within the meaning of Section 422(b) of the Internal Revenue Code of 1986, (the "Non-Statutory Stock Option"). The price at which the shares shall be purchased shall be $14.50, which price is the adjusted exercise price of the Non-Statutory Stock Option as determined under the Merger Agreement. 2. TERMS. The Non-Statutory Stock Option herein granted shall expire at 12:00 midnight on the earlier of (a) February 11, 2001, or (b) the day immediately following any period of twenty (20) consecutive trading days in which the last sale for shares of the Company's 2 Common Stock (as adjusted for stock splits, dividends, and similar events) for each of such trading days equaled or exceeded $49.33 per share as quoted on the NASDAQ National Market System. The Executive may at any time exercise this option to acquire 13,513 shares. Thereafter, the Executive may exercise this option in cumulative annual installments of portions of the shares covered by the option, as follows: Date Number of Shares on or after September 13, 1997 6,757 3. EXERCISE. The Executive may exercise the Non-Statutory Stock Option granted hereunder by giving written notice to the Compensation Committee of the Company ("the Committee") at 3151 S. 17th Street Extension, Wilmington, North Carolina 28412. Such notice, a form of which is attached hereto as Exhibit A and incorporated by reference, shall state the number of full shares (no fractional shares may be purchased) to which the election applies. Such notice shall be accompanied by payment in an amount sufficient to purchase the number of shares set forth in the notice at the per share price established by Section 1 hereof. Payment shall be made in cash, or the Committee in its discretion may allow the Executive to use shares of the Company's Common Stock having a fair market value equal to the purchase price (as determined by the Committee), or the Committee may allow the use of a combination of cash and such shares. 4. DEATH. In the event of death of the Executive, the Non-Statutory Stock Option shall be exercisable by the person or persons who acquired the option by bequest or inheritance or by reason of the death of the Executive, or by the executor or administrator of the estate of the deceased Executive at any time before the expiration date of the Non-Statutory Stock Option. 5. NO IMPLIED RIGHTS. Nothing contained in this Agreement, nor the granting of any options hereunder, shall be construed as giving the Executive or any other person any legal or equitable rights against the Company or any subsidiary corporation or any director, officer, employee or agent thereof, except for those rights as are herein provided. 6. NO ASSIGNMENT. Except as otherwise provided herein, the Non-Statutory Stock Option and the rights and privileges conferred hereby may not be transferred, assigned, pledged, hypothecated or encumbered, and shall not be subject to execution, attachment, garnishment or other similar legal processes. Upon any attempt to transfer, assign, pledge, hypothecate or otherwise encumber or dispose of the Non-Statutory Stock Option, the Non-Statutory Stock Option and the rights and privileges conferred hereunder shall immediately become null and void. This option may be exercised during the lifetime of the Executive only by the Executive; provided, however, that if the Executive is declared legally incompetent, the Executive's duly appointed legal representative may exercise the Non-Statutory Stock Option granted hereunder in the manner and to the extent that the Executive is entitled to exercise the option hereunder. 7. INCORPORATION OF THE PLAN. This Agreement incorporates the terms of the Plan, and any modifications or amendments thereto. The Employee acknowledges receipt of a copy of 3 the Plan and agrees to be bound by all the terms and provisions thereof that are not inconsistent with the terms of this Agreement. 8. GOVERNING LAW. This Agreement shall be governed by the law of North Carolina, without reference to the principles of conflicts of law thereof. IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first above written. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------------------ Its Chief Executive Officer -------------------------------- /s/ Grover C. Wrenn ------------------------------------ Executive EX-21 11 SUBSIDIARIES OF THE REGISTRANT 1 EXHIBIT 21 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC., AND SUBSIDIARIES SUBSIDIARIES The subsidiaries of Pharmaceutical Product Development, Inc., as of February 28, 1997, are as follows:
Jurisdiction of Incorporation or Name of Subsidiary Organized in - ------------------------------------------------------------------------ ------------------------------ 1. Applied Bioscience International Inc. Delaware 2. PPD Pharmaco, Inc. (formerly Pharmaco International Inc.) Texas 3. Pharmaco International Holdings Inc. Delaware 4. Pharmaco Investments, Inc. Delaware 5. PPD Pharmaco International SNC (formerly Pharmaco LSR S.A.) France 6. Pharma Contracts Scandinavia AB (formerly PLSR Scandinavia AB) Sweden 7. Pharmaco Research S.L. (formerly Pharmaco LSR S.L.) Spain 8. PPD Do Brazil-Suporte Brazil 9. Q & Q Brazil 10. Pharmaco International Holdings GmbH (formerly PLSR Beteiligungsverwaltungs GmbH) Germany 11. Pharmaco GmbH (formerly Pharmaco LSR GmbH) Germany 12. Pharmaco International Sp. zo.o (formerly PLSR Sp. zo.o.) Poland 13. PI Praha, s.r.o.(formerly PLSR Praha, s.r.o.) Czech Republic 14. Trilife GmbH & Co. KG Germany 15. Safe-Trade 41 (Pty) Ltd. South Africa 16. APBI UK Holdings Ltd. United Kingdom 17. Pharmaco International Ltd. (formerly Pharmaco UK Ltd.) United Kingdom 18. Leicester Clinical Research Centre, Ltd. United Kingdom 19. Environmental Assessment Group, Ltd. United Kingdom 20. ENVIRON International Ltd. United Kingdom 21. Gabbay Group Ltd. United Kingdom 22. Gabbay Assoc. Ltd. United Kingdom 23. Gabbay Ltd. United Kingdom 24. Data Analysis & Research (DAR) Ltd. United Kingdom 25. APBI Investor Relations, Inc. New Jersey 26. Clinix International Inc. Delaware 27. APBI Finance Corporation Delaware 28. APBI Environmental Sciences Group, Inc. Virginia 29. ENVIRON International Investments, Inc. Delaware 30. Paragon Global Services, S.A. Luxembourg 31. PPD Spain, S.L. Spain 32. Medisys, S.L. Spain 33. Cambridge Applied Nutrition Toxicology and Bioscience Limited United Kingdom 34. Clinical Technology Centre (International) Limited United Kingdom 36. Technical Assessment Systems, Inc. Maryland
Subsidiaries 1 and 31 are wholly owned subsidiaries of Pharmaceutical Product Development, Inc. Subsidiaries 2, 16, 25, 26, 27 and 28 are wholly owned subsidiaries of Subsidiary 1. Subsidiaries 3 and 4 are wholly owned subsidiaries of Subsidiary 2. Subsidiary 5 is owned 99% by Subsidiary 3 and 1% by Subsidiary 25. Subsidiaries 6, 7, 8, 10 and 15 are wholly owned subsidiaries of Subsidiary 3. Subsidiary 9 is a wholly owned subsidiary of Subsidiary 8. Subsidiaries 11, 12 and 13 are wholly owned subsidiaries of Subsidiary 10. Subsidiary 14 is owned 95% by Subsidiary 10 and 5% by Subsidiary 11. Subsidiaries 17, 18, 19, 20, 21 and 24 are wholly owned subsidiaries of Subsidiary 16. 2 Subsidiaries 22 and 23 are wholly owned subsidiaries of Subsidiary 21. Subsidiaries 29, 30 and 36 are wholly owned subsidiaries of Subsidiary 28. Subsidiary 32 is a wholly owned subsidiary of Subsidiary 31. Subsidiaries 33, 34 and 35 are wholly owned subsidiaries of Subsidiary 17. Subsidiary 26 does business under the trade name the Chicago Center for Clinical Research. Subsidiary 28 does business under the trade name ENVIRON.
EX-23.1 12 CONSENT OF COOPERS & LYBRAND LLP 1 EXHIBIT 23.1 CONSENT OF INDEPENDENT ACCOUNTANTS We consent to the incorporation by reference in the registration statement of Pharmaceutical Product Development, Inc. on Form S-8 (File No. 333-20925) of our report dated February 11, 1997, on our audit of the financial statements of Pharmaceutical Product Development, Inc. as of December 31, 1996 and for the year then ended, which report is included in this Annual Report on Form 10-K. /s/COOPERS & LYBRAND L.L.P. Raleigh, North Carolina March 25, 1997 EX-23.2 13 CONSENT OF ARTHUR ANDERSEN LLP 1 EXHIBIT 23.2 CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS As independent public accountants, we hereby consent to the incorporation of our report dated February 22, 1996, included in this Form 10K, into the Company's previously filed Registration Statement on Form S-8, File No. 333-20925. /s/ARTHUR ANDERSEN LLP Washington, DC March 25, 1997 EX-27 14 FINANCIAL DATA SCHEDULE
5 This schedule contains summary financial information extracted from the Pharmaceutical Product Development Inc. Consolidated Balance Sheet and Statement of Operations included within this Form 10-K and is qualified in its entirety by reference to such financial statements. 1,000 12-MOS DEC-31-1996 JAN-01-1996 DEC-31-1996 21,838 14,210 77,748 1,511 0 128,272 69,739 38,260 181,457 61,669 0 0 0 2,163 113,143 181,457 0 197,796 0 110,852 88,121 0 420 627 4,134 (3,507) 0 0 0 (3,507) (0.17) (0.17)
EX-99 15 REPORT OF ARTHUR ANDERSEN LLP 1 EXHIBIT 99 Report of Independent Public Accountants To Applied Bioscience International Inc. and Subsidiaries: We have audited the consolidated balance sheet of Applied Bioscience International Inc. (a Delaware corporation) and subsidiaries as of December 31, 1995 and the related consolidated statements of operations, stockholders' equity and cash flows for each of the two years in the period ended December 31, 1995 prior to the restatement (and, therefore, are not presented herein) for the merger accounted for as a pooling of interests transaction as described in Note 2 to the restated financial statements. These consolidated financial statements are the responsibility of the company's management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Applied Bioscience International Inc. and subsidiaries as of December 31, 1995 and the results of their operations and their cash flows for each of the two years in the period ended December 31, 1995, in conformity with generally accepted accounting principles. /s/ARTHUR ANDERSEN LLP Washington, DC February 22, 1996
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