-----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, SWepHwfjMVuwrRb5eAdoXMaFE46rzdLh89E4a9rQBnMnjVYogJPkudZCSRwNofVS 24yj66n2KaIoBTtnX1mhlQ== 0000950168-98-000931.txt : 19980331 0000950168-98-000931.hdr.sgml : 19980331 ACCESSION NUMBER: 0000950168-98-000931 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 23 CONFORMED PERIOD OF REPORT: 19971231 FILED AS OF DATE: 19980330 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: 1231 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: SEC FILE NUMBER: 000-27570 FILM NUMBER: 98577642 BUSINESS ADDRESS: STREET 1: 3151 17TH ST EXTENSION CITY: WILMINGTON STATE: NC ZIP: 28401 BUSINESS PHONE: 9102510081 10-K405 1 PHARMACEUTICAL PRODUCT DEV, INC. 10-K405 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, 1997 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 incorporation (IRS Employer Identification No.) or organization) 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. [ X ] The aggregate market value of the voting stock held by non-affiliates of the registrant was $370,122,685 as of February 27, 1998, 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 23,024,417 as of February 27, 1998. DOCUMENTS INCORPORATED BY REFERENCE The Company's definitive Proxy Statement for its 1998 Annual Meeting of Stockholders (certain parts as indicated herein Part III). 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 development and consulting services in the life, environmental and discovery sciences. The Company's life sciences subsidiaries include PPD Pharmaco, Inc., Belmont Research, Inc. and Intek Labs, Inc. The Company believes that PPD Pharmaco is the fourth largest contract research organization ("CRO") in the world, 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 also provides assessment and management of chemical and environmental health risk. PPD Discovery, Inc., the Company's discovery sciences subsidiary, focuses on the discovery segment of the research and development outsourcing market. LIFE SCIENCES GROUP The Company's Life Sciences Group provides services through (i) PPD Pharmaco, Inc. and its wholly-owned European, South American, South African, Australian and Canadian subsidiaries (collectively "PPD Pharmaco"), (ii) Belmont Research, Inc. ("Belmont"), and (iii) Intek Labs, Inc. ("Intek"). 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, patient recruitment, 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. BELMONT was acquired by the Company in March 1997. Belmont provides software development and system integration services to the pharmaceutical industry. The company's clients include international and domestic pharmaceutical and biotechnology companies, scientific software vendors and government agencies including the FDA. Belmont also develops specialized software products to support different aspects of the pharmaceutical research process, including drug discovery, clinical trials and regulatory review. Current Belmont software products include RESOLVE TM, which manages data queries to investigator sites, and CROSSGRAPHS (R) which is used for exploration and presentation of research data. INTEK was acquired in November 1997. Intek provides molecular genotyping, phenotyping and large-scale genomic DNA purification services through its current Good Laboratory Practice ("cGLP") compliant reference laboratory. Intek furnishes pharmacogenetic services for clinical trials. Intek routinely reports pharmacogenetic profiles within 48 hours enabling genotyping to be performed on clinical trial candidates at enrollment. Intek also provides genotyping and phenotyping for difficult cellular and tissue samples such as liver, hepatocytes and S9 liver fractions. Additional services include IN VITRO studies to correlate therapeutic response with polymorphisms early in drug development, and large-scale genomic DNA purification and archiving services to prepare clinical trial samples for DNA banking and pharmacogenomic research. During 1997, the Life Sciences Group also included Clinix International, Inc., which in August 1995 acquired the business and substantially all of the assets of Chicago Center for Clinical Research ("CCCR"), a nationally recognized organization which conducts clinical trials in the pharmaceutical, food and nutrition industries. The Company sold substantially all of the assets of CCCR in February 1998. 1 ENVIRONMENTAL SCIENCES GROUP ENVIRON, the Company's Environmental Sciences Group, provides environmental services through APBI Environmental Sciences Group, Inc., operating under the trade name ENVIRON. ENVIRON provides a broad range of scientific, technical and strategic management consulting services that address a wide variety of public health and environmental issues related to the presence of chemicals in foods, drugs, medical devices, consumer products, the workplace, and the environment. 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. In 1997, the Company expanded its Environmental Sciences Group through the acquisition of Technical Assessment Systems, Inc. ("TAS"). ENVIRON expanded its geographic reach through a new presence in the Midwest United States and a strategic alliance with Gerling Consulting Group in Cologne, Germany. Geographical expansion is one of ENVIRON's strategic objectives. The firm's opportunity to service existing clients more efficiently and to penetrate local markets is enhanced by offices in critical regions of the U.S. and other parts of the world. DISCOVERY SCIENCES GROUP PPD DISCOVERY, INC. ("PPD DISCOVERY") was established in June 1997. The Company acquired SARCO, Inc. ("SARCO"), a combinational chemistry company. The Company also acquired the GSX System, a functional genomics platform technology. The acquisitions form the basis of the new wholly-owned subsidiary focused on the discovery research segment of the research and development outsourcing market. Industry Overview LIFE SCIENCES GROUP The CRO industry provides independent product development services to the pharmaceutical and biotechnology industries and derive substantially all of their revenue from the research and development expenditures of these 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, 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 United States Food and Drug Administration ("FDA") 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-service 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. Historically, pharmaceutical companies produced much of the software used in the drug discovery, clinical development, and regulatory compliance processes through use of internal programming resources. Now, these companies are also seeking external sources, provided by companies including our Belmont subsidiary, to meet these automation needs both through custom application development and through proprietary packaged software. While many companies have the computer expertise to provide these products and services, detailed knowledge of the pharmaceutical industry drug discovery and development process forms a barrier to entry. ENVIRONMENTAL SCIENCES GROUP The environmental industry historically has grown from assisting private sector clients in responding to the regulatory systems that have been put into place at both the federal and state levels. In addition, litigation support on 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. 2 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. 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. 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 TAS will allow it to better pursue these opportunities. DISCOVERY SCIENCES GROUP Drugs are chemical compounds that interact with biological targets in the body. Discovering and developing new drugs is an extremely expensive and time-consuming process. Recent figures from the Pharmaceutical Research and Manufacturers of America association (PhRMA), a pharmaceutical industry trade group, show that research-based pharmaceutical companies invested approximately $18.9 billion in R&D activities in 1997. On average, these companies allocate over 40 percent of their Research & Development budget to pre-clinical R&D functions. PhRMA estimates that the average cost of bringing a drug to market exceeds $359 million and takes approximately 10-15 years. Pre-clinical R&D functions include biological target identification and validation, screening of chemical compounds to identify lead compounds, chemical optimization of those leads, toxicology and safety testing in animals, and formulation and stability testing for the new experimental drug. SARCO is a chemical technology company that provides chemical compounds to the pharmaceutical, biotechnology, agrochemical, and animal health industries. SARCO's core expertise includes the rapid synthesis of large numbers of chemical compounds for use in the pre-clinical drug discovery and development process as well as the chemical optimization of those compounds found to have beneficial biological activity. GSX identifies targets for drug discovery by the selective inhibition of genes responsible for key steps in a disease process. The system is based on the finding that a gene fragment, when introduced into cells, sometimes specifically inhibits the function of the whole gene from which the fragment was obtained. Effective inhibitory fragments are obtained by breaking the DNA containing the genes of interest into many different random pieces, inserting these fragments into a population of tester cells and identifying the rare individual cells that acquire a selected new property as a consequence of the inhibitory action. Examples of desirable cellular properties that can be selected include increased resistance to a virus or increased sensitivity to a drug. The "winning" DNA fragments are then recovered from the selected cells and analyzed to determine what genes, and thereby targets, they represent. PPD Discovery markets its products and services to those research-based companies looking for outsource research support. The Company believes that this outsource trend will continue over the next decade. 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 provides IND submission preparation and compilation but 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 enters the clinical stage. 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 as well as patients with the targeted disease or condition. The Company does provide full development services for the clinical stage. 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. 3 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: (bullet) 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. (bullet) 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. (bullet) 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. 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 eighteen months. Drugs that successfully complete this review may be marketed in the United States, subject to any 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 chemicals as well as the impact of chemicals 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. 4 Trends Affecting the CRO Industry In 1997, worldwide expenditures on research and development by pharmaceutical and biotechnology companies are estimated to have been $40 billion, of which the Company estimates $15 to $20 billion was spent on drug development activities of the type offered by the CRO industry. The Company believes that approximately $3.5 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 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 therefore 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 Applied Bioscience International Inc. ("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 5 pharmaceutical and biotechnology companies. As pharmaceutical and biotechnology companies increasingly outsource development, they may increasingly 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 these trends 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 to maximize its clients' return on massive R&D investments. 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 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 to enhance discovery and development services, (vi) expanding geographically and (vii) pursuing opportunities provided by technological advances. The Company differentiates itself from competitors by providing a continuum of services, from discovery through aftermarket support. The Company intends to be a leader in integrating pharmacogenomics in drug development. MANAGERIAL 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 bringing drugs to market both nationally and internationally. PPD Pharmaco concentrates on its core operational strengths in all phases of clinical studies and other critical path studies such as treatment INDs. 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 various technological advances, 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, and report writing and 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, cardiopulmonary diseases, central nervous system, oncology, and immunology. 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, experience, attitude 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 programs. As new technologies develop, employees are equipped with and trained to make use of such technological innovations. GLOBAL STRATEGIC MARKETING INITIATIVES PPD Pharmaco focuses its integrated 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 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. Supplemented by centralized PPD corporate level marketing efforts, ENVIRON conducts separate marketing activities at each of its office locations. ENVIRON 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. 6 Discovery services are marketed through centralized PPD corporate marketing efforts to supplement localized marketing by scientists to scientists, with support from appropriate outside consultants. The functional genomics technology (GSX) is marketed primarily to large pharmaceutical companies, while combinatorial chemistry is directed more toward biotechnology and virtual companies. 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 communications efforts are advertising in trade journals, exhibits and participation at scientific conferences, speakers bureaus, direct mail, sales collateral and media relations. 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 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. GEOGRAPHICAL EXPANSION PPD Pharmaco currently has operations in the Americas (United States, Canada, South America), Europe, including eastern Europe, South Africa and the Pacific Rim. 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. ENVIRON's 1997 acquisition of TAS in the United Kingdom and alliance with Gerling Consulting Group in Cologne, Germany expanded their operations outside the U.S. 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 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 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 advanced technology for expediting the drug development process. 7 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. Belmont provides innovative software development and system integration services and creates a data link between discovery and development. Intek provides molecular genotyping, phenotyping and large-scale genomic DNA purification services through a cGLP compliment reference laboratory for discovery and development services. During 1997, $187.2 million, or 79.6%, 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 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. The Company believes that PPD Pharmaco is the industry's 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 Company'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; Research Triangle Park, North Carolina and Leicester, England, which, to date have provided a substantial pool of potential subjects for research studies. However, the Company's business could be adversely affected if the Company were unable to attract suitable and willing volunteers. The Company also provides bioavailability and bioequivalence testing services. This 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 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 Middleton, Wisconsin. PPD Pharmaco's laboratories analyze biological fluid samples from clinical studies, such as those conducted by PPD Pharmaco's Phase I units, for drug and metabolite content and concentration. PPD Pharmaco currently has approximately 318 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, as well as Phase I clinical testing. 8 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, pharmacogenetics, and infomatics 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:
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, obsessive-compulsive disorders, disease panic disorders 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 and lung cancer Pulmonary/Allergy Asthma, allergic rhinitis, community acquired pneumonia, Acute Respiratory Distress Syndrome 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 compliance with government regulations. PPD Pharmaco has adopted global standard operating procedures (SOPs) which are intended to satisfy regulatory requirements and serve as a tool for controlling and enhancing the quality of its clinical trials. All PPD Pharmaco SOPs are in compliance with Good Clinical Practice ("GCP") requirements and the International Conference on Harmonization ("ICH") standards. The FDA is expected to adopt the ICH's guidelines, and, the European Community has agreed to conduct all studies in accordance with the recommendations from ICH, which sets global clinical study standards based on GCP. 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 study protocols and CRFs. A study protocol defines the medical issues to be examined in evaluating the safety and efficacy of a drug, the number of patients required to produce statistically valid results, the clinical tests to be performed, the time period over which the study will be conducted, the frequency and dosage of drug administration, and the exact patient criteria. 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 process includes healthcare economic components to support rational pricing and positioning. 9 Once the study protocol has been finalized, CRFs must be developed to record the 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 data are recorded in a form that is 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 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 recruits investigators who contract directly with either PPD Pharmaco 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 over 20,000 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 many instances, a project's timely completion is 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 250 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. The Company offers data management and biostatistical analysis services are both 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 sample size parameters for patient enrollment, development of data analysis plans and randomization schemes. During 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 defend biostatistical analyses. PPD Pharmaco has expertise in electronically capturing and integrating geographically diverse data. PPD Pharmaco uses SAS, Clintrace, Oracle, BBN Clintrial and other third party software, as specified by clients, combined with customized programs developed by PPD Pharmaco. Drug development time can be 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 10 the database so that there is a rapid progression to final tables, listing preparation and 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 includes a procedure to allow patients to receive a new drug not yet approved treatment 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. The treatment IND application process has the advantage of getting a 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, 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 integrated with PPD Pharmaco's other services to speed the process 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 trials conducted by the client or another CRO. HEALTHCARE ECONOMICS AND OUTCOMES RESEARCH PPD Pharmaco offers a number of services in the healthcare economics area 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, or ENVIRON, currently provides health and environmental sciences and engineering consulting services. During 1997, the Environmental Sciences Group generated 20.3% 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 chemicals 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) life 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; ecotoxicology, ecology and natural resources. Approximately half of ENVIRON's employees have advanced degrees (master's level or above). Of those with advanced degrees, approximately one-third have attained their Ph.D. ENVIRON offers the following services: 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 11 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 governmental 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. 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 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 involve substantially all of its practice areas. Services provided 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 determining 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. AIR QUALITY ENVIRON offers a full spectrum of air quality services, such as: 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 government 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. 12 DISCOVERY SCIENCES GROUP PPD Discovery consists of SARCO, a combinatorial chemistry company, and the GSX System, a functional genomics platform technology for target discovery. GSX is a proprietary whole-cell-based system that facilitates the rapid identification, validation and functional analysis of novel targets. GSX identifies targets for drug discovery by the selective inhibition of genes responsible for key steps in a disease process. The system is based on the finding that a gene fragment, when introduced into cells, sometimes specifically inhibits the function of the whole gene from which the fragment was obtained. Effective inhibitory fragments are obtained by breaking the DNA containing the genes of interest into many different random pieces, inserting these fragments into a population of tester cells and identifying the rare individual cells that acquire a selected new property as a consequence of the inhibitory action. Examples of desirable cellular properties that can be selected include increased resistance to a virus or increased sensitivity to a drug. The "winning" DNA fragments are then recovered from the selected cells and analyzed to determine what genes, and thereby targets, they represent. Activities surrounding the GSX technology are conducted in Research Triangle Park, North Carolina and Menlo Park, California. SARCO is a chemical technology company that provides chemical compounds to the pharmaceutical, biotechnology, agrochemical, and animal health industries. SARCO's core expertise includes the rapid synthesis of large numbers of novel molecules for use in the pre-clinical drug discovery and development process as well as the chemical optimization of those compounds found to have beneficial biological activity. SARCO is located in the Park Research Center, a high-technology campus in Research Triangle Park, North Carolina, USA. SARCO's research facility is fully equipped to perform solid and solution-phase combinatorial chemistry, custom monomer synthesis and solution-phase medicinal chemistry. SARCO maintains full analytical and computational capabilities in support of its combinatorial and medicinal chemistry activities. Products include SARCO base libraries; chemical compounds designed for high throughput biological screening, and SARCO Focus Libraries; custom designed chemical libraries provided exclusively to a client. Services include research collaborations and partnerships with research-based discovery companies. These collaborations and partnerships are typically structured for fixed period of time or around discrete client projects. Clients and Marketing The Company's Life Sciences Group provides services primarily to pharmaceutical and biotechnology companies. For the year ended December 31, 1997, approximately 83% of the Company's Life Sciences Group's net revenue was attributable to clinical services and 17.0% to laboratory services. For the year ended December 31, 1997, net revenue of the Life Sciences Group was derived approximately as follows: Percentage of Source Net Revenue ------ ------------ Pharmaceutical 77.9% Biotechnology 11.1 Government 3.4 Other 7.6 The Company provided services in 1997 to 24 of the top 25 pharmaceutical companies in the world as ranked by 1996 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 1996 and 1997, no single client contributed more than 10% of the Company's total net revenue. In 1997, the Company's ten largest clients accounted for approximately 36.6% of the Company's total net revenue and approximately 28% of the Company's total 1997 net revenue was derived from clients located outside the U.S., in particular in Europe and Japan. 13 ENVIRON's clients come primarily 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 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 pre-established events or milestones, such as investigator recruitment, patient enrollment or database delivery. For fixed-price contracts, PPD Pharmaco bears the risk of cost overruns, but benefits if costs are lower than anticipated. Under-pricing of such 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 single large contract or 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 $205.7 million in net revenue at December 31, 1997, compared to $156.5 million in net revenue at December 31, 1996. 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, a few 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 large competitors include Clintrials Research Inc., Covance, 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, the CRO industry has few barriers to entry. Newer, smaller entities may compete aggressively 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 factors, 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 14 and client communication. Although there can be no assurance that it will continue to do so, the Company believes that it competes favorably in these areas. Belmont's competitors for its packaged software include major vendors of software used in pharmaceutical applications such as Domain Solutions, Oracle, and SAS as well as a variety of smaller, specialized software companies. Competitors for Belmont's application development services include major consulting companies with pharmaceutical industry groups (e.g., Arthur Andersen, EDS, Coopers and Lybrand) and smaller companies with a pharmaceutical industry focus (e.g. DataCeutics, Netforce, ISCG). ENVIRON has many competitors, ranging from small local firms to large national firms and more recently, firms in Europe. 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 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. However, increased competition could result in price and other forms of competition that may adversely affect ENVIRON. The outsource chemistry research industry consists of several dominate providers and numerous smaller niche companies. SARCO faces significant competition from these companies as well as competition from research teams funded internally at the pharmaceutical and biotechnology companies. While the trend to outsource research is increasing, the vast majority of research spending by these companies is for their own internal research personnel. SARCO competes principally on the basis of reputation, scientific and technical expertise, experience and qualifications of professional staff, quality of services, and ability to delivery quality products to the client's specifications. As such, SARCO's ability to attract and retain qualified technical personnel is a key component in its ability to successfully compete in the outsource contract research market. 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 refuse, or 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 or where the indemnifying party does not fulfill its indemnification obligations. Until September 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. 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 yet 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 regulations governing the 15 selection of qualified investigators, (ii) obtaining specific written commitments from the investigators, (iii) verifying that informed consent is obtained from patients, (iv) monitoring the validity and accuracy of data, (v) verifying drug or device accountability, and (vi) instructing investigators to maintain records and reports. For specified periods PPD Pharmaco must also maintain reports for each study for inspection by the study sponsor and governmental authorities during audits. Noncompliance with GCP can result in the disqualification of data collected during the clinical trial. PPD Pharmaco's Global Standard Operating Procedures (SOPs) are written in accordance with the Code of Federal Regulations and in accordance with ICG guidelines agreed upon by US, European and Japanese Governments. This enables our work to be conducted locally, regionally and globally to meet standards which exceed all current regulatory requirements. PPD Pharmaco's business depends on the continued 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. 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 a governmental authority against 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 governmental 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 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 The Company holds certain trademarks through its Belmont subsidiary including CLASSIFY TM, RESOLVE TM, CROSS GRAPHS (R), and TABLE TRANS TM. In addition, the Company holds certain licensing privileges related to the GSX technology. PPD Pharmaco also has developed certain computer software and technically derived procedures intended to maximize the quality and efficiency of its services. In addition to its rights to certain intellectual property, the Company believes that other factors such as the technical expertise, knowledge, ability and experience of the Company's professionals provide significant benefits to its clients. Employees At December 31, 1997, the Company had approximately 2,470 full-time equivalent employees, of whom 1,900 were employed in the Life Sciences Group, 350 were employed in the Environmental Sciences Group, 30 were employed in the Discovery Sciences Group and the remainder were in the Company's corporate headquarters. Of the Company's employees, approximately 120 hold Ph.D., M.D., Pharm.D. or D.V.M. degrees and approximately 350 hold other masters or other 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 to date 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 Note 18 of Notes to Consolidated Financial Statements presents information about the Company's operations by geographic area for each of fiscal years 1997, 1996 and 1995. 16 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. In July 1997, the Company entered into a new ten year build to suit lease for approximately 100,000 square feet in Morrisville, North Carolina which is scheduled for completion in the fall of 1998. The Company owns and operates a 52-bed Phase I facility in Leicester, England. The Company also owns a building in Kerswell, Scotland, which it acquired when it purchased Data Acquisition and Research Limited in December 1996. All other facilities are leased. The Company's operations occupy approximately 781,000 square feet of space worldwide, including over 78,000 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, 1997 were as follows:
LIFE SCIENCES GROUP Corporate Office Europe Wilmington, North Carolina Brussels, Belgium The Americas Cambridge, England Sao Paulo, Brazil Chelmsford, England La Jolla, California Leicester, England San Bruno, California Southampton, England Mississauga, Canada Gentilly, France Chicago, Illinois (2) Karlsruhe, Germany Columbia, Maryland Nuremburg, Germany Cambridge, Massachusetts Milan, Italy Lawrenceville, New Jersey Kersewell, Scotland Morrisville, North Carolina Barcelona, Spain Research Triangle Park, North Carolina Madrid, Spain Austin, Texas (1) Stockholm, Sweden Richmond, Virginia Eastern Europe Middleton, Wisconsin Prague, Czech Republic Pacific Rim Warsaw, Poland Melbourne, Australia Africa Cape Town, South Africa Johannesburg, South Africa ENVIRONMENTAL SCIENCES GROUP The Americas Europe Emeryville, California Liverpool, England Irvine, California London, England Novato, California Malvern, England Princeton, New Jersey Edinburgh, Scotland Arlington, Virginia Houston, Texas DISCOVERY SCIENCES GROUP The Americas Menlo Park, California Research Triangle Park, North Carolina
- ------ (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) With the sale of CCCR in February 1998, the Company no longer operates in Chicago. 17 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 not yet 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, 1997.
EXECUTIVE OFFICERS The executive officers of the Company as of December 31, 1997, were as follows: Name Age Position - -------------------------------- ---- --------------------------------------------------------- Fredric N. Eshelman, Pharm.D. 49 Vice Chairman and Chief Executive Officer Thomas D'Alonzo 54 President and Chief Operating Officer Joseph H. Highland 53 Chief Executive Officer, APBI Environmental Sciences Group, Inc. (ENVIRON) Rudy C. Howard 40 Chief Financial Officer, Vice President - Finance and Treasurer Fred B. Davenport, Jr. 46 General Counsel, Vice President - Legal and Secretary
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's predecessor in 1985. 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. 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. 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. FRED B. DAVENPORT, JR. is General Counsel, Vice President - Legal 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 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, as reported by the National Association of Securities Dealers, Inc. These prices are based on quotations between dealers, which do not reflect retail mark-up, markdown, or commissions. 1997 1996 -------------------------------------------------------- High Low High Low ------------------------------------------------------- Low First Quarter(1) $ 30.00 $ 18.50 $ 37.25 $ 22.75 Second Quarter $ 25.125 $ 16.00 $ 47.25 $ 33.25 Third Quarter $ 24.00 $ 18.50 $ 34.50 $ 26.50 Fourth Quarter $ 22.625 $ 12.25 $ 27.50 $ 14.50 - ----------------------------- (1) From January 23, 1996, the effective date of PPD's initial public offering. As of February 27, 1998, there were approximately 7,667 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 shareholders 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, 1997 have been derived from the 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, 1993 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, 1993 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, 1993 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, 1993 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
Year Ended December 31, --------------------------------------------------------------------------- 1997 (3) 1996 (3) 1995 (3) 1994 1993 ----------- ----------- ---------- ----------- -------- (in thousands, except per share data) Consolidated Statement of Operations Data: Net revenue (7) $ 235,272 $ 197,796 $ 209,778 $ 192,105 $ 165,815 ----------- ----------- ---------- ---------- ----------- Operating expenses 211,390 182,859 200,022 181,120 169,014 Loss on sale of business, special charges, restructuring costs, merger costs, and acquired in-process research and development costs 9,670 16,114 24,290 - 9,365 ----------- ----------- ---------- ---------- ----------- 221,060 198,973 224,312 181,120 178,379 ----------- ----------- ---------- ---------- ----------- Income (loss) from operations 14,212 (1,177) (14,534) 10,985 (12,564) Other income (expense), net 1,464 1,804 (2,616) (2,728) (1,183) ----------- ----------- ---------- ---------- ----------- Income (loss) from continuing operations before provision for income taxes 15,676 627 (17,150) 8,257 (13,747) ----------- ---------- ---------- Provision for income taxes 6,074 4,134 ----------- ----------- Net income (loss) (6) $ 9,602 $ (3,507) =========== ============ Weighted average number of shares outstanding: Basic 22,825 21,168 Dilutive effect of stock options 60 - ----------- ----------- Diluted 22,885 21,168 =========== =========== Net income (loss) per share: Basic $ 0.42 $ (0.17) ================ ======= Diluted $ 0.42 $ (0.17) ================ ======= Pro Forma Data (1): Income (loss) from continuing operations before provision for income taxes (17,150) 8,257 (13,747) Pro forma income tax expense (benefit) (14,359) 3,371 (2,001) ----------- ---------- ------------ Pro forma net income (loss) from continuing operations (4)(5) (2,791) 4,886 (11,746) Discontinued operations (1,716) (12,873) (12,133) Extraordinary loss from early extinguishment of debt (897) - - ------------- ---------- ----------- Pro forma net loss $ (5,404) $ (7,987) $(23,879) ============= ============= ============ Pro forma basic and diluted weighted average number of shares outstanding (2) 18,815 18,671 18,409 ============ ========== =========== Pro forma basic and diluted net income (loss) per share: Continuing $ (0.15) $ 0.26 $ (0.64) Discontinued (0.09) (0.69) (0.66) Extraordinary (0.05) - - ------------ ----------- --------- Net loss $ (0.29) $ (0.43) $ (1.30) ============= ============ =============
As of December 31, ------------------------------------------------------------------------------ 1997 1996 1995 1994 1993 ----------- ----------- ----------- ----------- ---------- (in thousands) Consolidated Balance Sheet Data: Cash and cash equivalents $ 15,879 $ 21,838 $ 13,565 $ 9,804 $ 14,854 Marketable securities 7,994 14,210 242 203 - Working capital 69,950 66,603 37,320 27,795 (565) Total assets 197,047 181,457 142,661 202,773 195,492 Long-term debt 340 1,428 3,471 47,620 15,411 Long-term debt, including current portion 5,246 5,649 5,672 51,170 19,943 Shareholders' equity 127,605 115,306 77,300 74,198 79,065
- ----------------------------------------------- - ------------------------------------------------------------------------------- SELECTED FINANCIAL DATA, EXCLUDING TOXICOLOGY OPERATIONS (SOLD 11/95), LOSS ON SALE OF BUSINESS, SPECIAL CHARGES, RESTRUCTURING CHARGES, MERGER COSTS, ACQUIRED IN-PROCESS RESEARCH AND DEVELOPMENT COSTS, DISCONTINUED OPERATIONS AND EXTRAORDINARY LOSS. 20
Year Ended December 31, 1997(2) 1996(2) 1995(1)(2) 1994(1) 1993(1) ---------- ----------- ----------------- ------- ----------- (in thousands) Consolidated Statement of Operations Data: Net revenue $ 235,272 $ 197,796 $ 171,332 $ 145,718 $ 122,813 Operating expenses 211,390 182,859 160,440 137,142 114,487 ---------------------------------------------------------------------------- Income from operations 23,882 14,937 10,892 8,576 8,326 Other income (expense), net 1,464 1,804 (2,616) (2,728) (1,183) ----------------------------------------------------------------------------- Income from continuing operations before provision for income taxes 25,346 16,741 8,276 5,848 7,143 Pro forma income tax expense(1) 9,894 6,680 3,310 2,339 2,857 ---------------------------------------------------------------------------- Pro forma net income $ 15,452 10,061 4,966 3,509 4,286 ============================================================================ Pro forma weighted average number of basic shares outstanding(2) 22,885 21,319 18,815 18,761 18,409 ============================================================================ Pro forma net income per share $ 0.68 $ 0.47 $ 0.26 $ 0.19 $ 0.23 - -----------------------------------------------============================================================================
(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 reflects 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, 1993. (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. (3) The acquisitions of TAS and GSX System in 1997, Trilife, Medisys, Q&Q, DAR and EAG in 1996, and Gabbay and CCCR in 1995 were accounted for as purchase transactions. The acquisitions of Belmont, SARCO and Intek in 1997 were accounted for as pooling transactions, however, no pro forma information is presented because the results of operations prior to the date of the acquisitions are not material to the Company. (4) 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. (5) 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. (6) 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. (7) Net of subcontractor costs. 21 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 1997, the Company reported net income of $9.6 million, or $0.42 per share, compared to a net loss of $3.5 million, or $0.17 per share, during 1996. Excluding merger and acquisition related costs, the Company's net income of $15.5 million, or $0.68 per share, was 53.6% higher than net income, excluding merger and acquisition costs, last year of $10.1 million, or $0.47 per share. In 1997, the Company moved into a new line of business with the acquisition of SARCO and the GSX System in June. These acquisitions form the basis of the Company's Discovery Sciences Group which focuses on the discovery segment of the research and development outsourcing market. The company acquired SARCO in a transaction accounted for as a pooling-of-interests. The consideration for SARCO consisted of 263,158 shares of the Company's common stock. The Company also acquired the GSX System, a functional genomics platform technology. The GSX System was purchased for approximately $8.7 million in cash. 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. In March 1997, the Company acquired Belmont, a software systems company, in a transaction accounted for as a pooling-of-interests. The consideration for Belmont consisted of 502,384 shares of the Company's common stock. In November 1997, the Company acquired Intek Labs, Inc. ("Intek"), a pharmacogenetics company, in a transaction accounted for as a pooling-of-interests. The consideration for Intek consisted of 399,999 shares of the Company's common stock. 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. 22 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:
PERCENTAGE OF NET REVENUE FROM CONTINUING OPERATIONS For the Year Ended December 31, 1997 1996 1995 ----------------------- ---------------------- ------------- Amount % Amount % Amount % ------- ----- ------- ---- ------ ---- (dollars in thousands) Net revenue (4): Life sciences $ 187,201 79.6% $ 152,304 77.0% $ 160,495 76.5% Environmental sciences 47,785 20.3 45,492 23.0 49,283 23.5 Discovery sciences 286 0.1 - - - - ---------- --------- ------- ------ ---------- ----- 235,272 100.0 197,796 100.0 209,778 100.0 Direct costs: Life sciences 94,909 79,108 90,315 Environmental sciences 33,431 31,744 32,442 Discovery sciences 1,859 - - ---------- ---------- ---------- 130,199 55.3 110,852 56.0 122,757 58.5 Selling, general, and administrative expenses 68,797 29.2 61,571 31.1 64,014 30.5 Depreciation and amortization 12,394 5.3 10,436 5.3 13,251 6.3 Loss on sale of business - - - - 19,308 9.2 Acquired in-process research and development costs 9,112 3.9 - - - - Merger costs and special charges 558 0.2 16,114 8.1 4,982 2.4 ---------- --------- ---------- ---------- ---------- ------ Operating income (loss) (2)(3) 14,212 6.0 (1,177) (0.6) (14,534) (6.9) ---------- --------- ---------- ---------- ----------- ------- Net income (loss) $ 9,602 4.1% $ (3,507) (1.8)% ========== ========= =========== ========== Pro forma loss from (1): Continuing operations (2,791) (1.3) Discontinued operations (1,716) (0.8) Extraordinary loss (897) (0.4) ---------- ------- Pro forma net loss $ (5,404) (2.6)% =========== ========
Percentage Change For the Year Ended December 31, -------------------------------------------------- 1997 vs. 1996 1996 vs. 1995(5) ------------- ---------------- Net revenue (4): Life sciences 22.9% (5.1)% Environmental sciences 5.0 (7.7) Discovery sciences(6) N/A N/A Total net revenue 18.9 (5.7) Direct costs: Life sciences 20.0 (12.4) Environmental sciences 5.3 (2.2) Discovery sciences(6) N/A N/A Selling, general and administrative expenses 11.7 (3.8) Depreciation and amortization 18.8 (21.2)
- -------------------------- (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 reflects 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, 1995. (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 calculable or meaningful. 23 Below is a comparison of 1997 and 1996 operating statements which reflects only on-going operations and excludes 1997 merger and acquisition related charges and 1996 merger costs. STATEMENT OF OPERATIONS DATA EXCLUDES MERGER COSTS AND ACQUIRED IN-PROCESS RESEARCH AND DEVELOPMENT COSTS IN 1997 AND APBI MERGER COSTS IN 1996.
YEAR ENDED DECEMBER 31, 1997 1996 PERCENTAGE CHANGE ---- ---- ------------------ (dollars in thousands) Net revenue: Life sciences $ 187,201 $ 152,304 22.9% Environmental sciences 47,785 45,492 5.0 Discovery sciences 286 - N/A ---------- --------- Total net revenue 235,272 197,796 Direct costs: Life sciences $ 94,909 $ 79,108 20.0 Environmental sciences 33,431 31,744 5.3 Discovery sciences 1,859 - N/A ---------- ---------- Total direct costs 130,199 110,852 ---------- ---------- Gross margin 105,073 86,944 20.9 Selling, general and administrative expenses 68,797 61,571 11.7 Depreciation and amortization 12,394 10,436 18.8 ---------- ---------- Income from operations 23,882 14,937 59.9 Other income (expense), net 1,464 1,804 (18.9) ---------- ---------- Income before taxes 25,346 16,741 51.4 Income tax provision 9,894 6,680 48.1 ---------- ---------- Net income $ 15,452 $ 10,061 53.6% ========== ========== ======= Net income per share: Basic $ 0.68 $ 0.48 ========== ========== Diluted $ 0.68 $ 0.47 ========== ========== Weighted average number of common shares outstanding: Basic 22,825 21,168 ========== ========== Diluted 22,885 21,319 ========== ==========
24 YEAR ENDED DECEMBER 31, 1997 VERSUS YEAR ENDED DECEMBER 31, 1996 Net revenue increased $37.5 million, or 19.0%, to $235.3 million in 1997 from $197.8 million. The Life Sciences Group's operations accounted for 79.6% of the Company's net revenue for 1997. The Life Sciences Group generated net revenue of $187.2 million, up $34.9 million, or 22.9%, from last year. The growth in the Life Sciences Group operations was primarily attributable to an increase in the size, scope and number of contracts in the North America clinical development and biostatistics business. The acquisitions of Belmont and Intek, both completed in 1997, contributed net revenue of $5.7 million for the year. Net revenue from ENVIRON, the Company's Environmental Sciences Group, representing 20.3% of the Company's net revenue for 1997, was $47.8 million, compared with $45.4 million in 1996, an increase of 5.0%, or $2.4 million. The increase in net revenue at ENVIRON was due principally to the 1997 acquisition of TAS and EAG's increase in net revenue, which contributed net revenue of $6.3 million. The decrease in ENVIRON's core business resulted from the completion of a significant contract in early 1997. Total direct costs increased 17.4% to $130.2 million from $110.9 million last year and declined as a percentage of net revenue to 55.3% from 56.0% last year. The Life Sciences Group direct costs decreased as a percentage of related net revenue to 50.7% from 51.9%. This decrease is principally due to higher labor utilization and a focused effort to control costs across all business segments. ENVIRON's direct costs as a percentage of related net revenue increased slightly to 70.0% from 69.8% last year. Selling, general and administrative ("SG&A") expenses increased 11.7% to $68.8 million from $61.6 million in 1996. SG&A expenses from 1997 acquisitions comprise $2.8 million of the increase. The remaining increase of $4.4 million is primarily attributable to the investment in the Company's business development and marketing organization and in the area of information technology. As a percentage of net revenue, SG&A expenses decreased to 29.2% from 31.1% last year, primarily as a result of the increase in net revenue. Total depreciation and amortization expense of $12.4 million was $2.0 million, or 18.8%, higher than last year. The increase was related to the Company's growth as well as the ongoing capital investment in the Company's business. During 1997, the Company recorded one-time merger costs of $0.6 million in connection with the acquisitions of Belmont, SARCO and Intek. These costs are primarily current cash expenses, such as legal and accounting fees related to pooling transactions. During 1996, the Company recorded one-time merger costs of $16.1 million. 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. The Company also recorded acquired in-process research and development costs of $9.1 million in the second quarter of 1997. These costs were charged to operations upon the acquisition of the GSX System. A valuation was performed by an independent consultant to determine the fair value of the acquired in-process research and development. The purchase price in excess of the net assets of the GSX System was allocated to acquired in-process research and development costs and was charged to operations upon the acquisition of the GSX System, as the technology has no alternative future use and the technology has not yet reached technological feasibility. Operating income (loss) improved $15.4 million to an operating income of $14.2 million for the year ended December 31, 1997, as compared to an operating loss of $1.2 million for the year 1996. Excluding merger and acquisition related costs, the Company's operating income of $23.9 million in 1997 was 59.9% higher than operating income (before the impact of merger and acquisition related costs) of $14.9 million in 1996. As a percentage of net revenue, the yearly operating income of 6.0% represents a dramatic improvement from the operating loss of 0.6% of net revenue last year. The net income of $9.6 million in 1997 represents an improvement of $13.1 million over the $3.5 million net loss in 1996. 1997 net income per basic and diluted share of $0.42 compares to net loss per basic and diluted share of $0.17 in 1996. Excluding the impact of the merger costs and acquisition related charges on both years, the Company's 1997 net income of $15.5 million is 53.6% higher than 1996's net income of $10.1 million. This net income per diluted share of $0.68 compares to $0.47 for 1996 computed on 1.6 million more shares outstanding for 1997. 25 YEAR ENDED DECEMBER 31, 1996 VERSUS YEAR ENDED DECEMBER 31, 1995 Net revenue in 1996 decreased $12.0 million, or 5.7%, to $197.8 million in 1996 from $209.8 million in 1995. The Life Sciences Group's operations accounted for 77.0% of the Company's net revenue for 1996. After elimination of the net revenue from APBI's former toxicology operations, which were sold in November 1995 ($38.4 million in 1995), 1996 net revenue increased 15.4% as compared to 1995. Results of operations which exclude the results of the divested businesses (APBI's former toxicology operations) are considered the results of the Company's ongoing operations. Net revenue for the year ended December 31, 1996 from the Life Sciences Group's operations of $152.3 million reflects an increase of $30.2 million, or 24.8%, from 1995. The growth in Life Sciences Group operations 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 $10.8 million in 1996, representing an increase of $8.5 million over 1995. Net revenue from ENVIRON, which represented 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 sole ongoing operation in the Environmental Sciences Group, was 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 and declined as a percentage of net revenue to 56.0% from 58.5% in 1995. Life Sciences Group 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 was 71.0% compared to 76.0% during the prior year. 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% in 1996 from 30.5% in 1995. After factoring out the SG&A expenses associated with the divested toxicology business ($7.6 million in 1995), SG&A expenses increased approximately 9.2%, or $5.2 million, for 1996 as compared to 1995. SG&A expenses from CCCR and the Leicester Phase I laboratory comprised $2.0 million of the increase, and the Company incurred incremental rent expense of $1.2 million associated with the sale-leaseback of its real estate in Austin, Texas (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 in 1996 was $2.8 million, or 21.2%, lower than in 1995. After adjusting out the depreciation for the divested toxicology business ($4.5 million in 1995), total depreciation and amortization increased $1.7 million, or 19.0%, versus 1995. The increase was related to the Company's growth as well as the ongoing capital investment in the Company's 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 of 1996, 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. In the fourth quarter of 1995, APBI recorded a charge of $19.3 million in 1995 relating to the book loss on the sale of the toxicology business. 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. The remaining $2.3 million 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 termination of the Company's defined benefit pension plan. APBI also recorded special charges of $5.0 million in the fourth quarter of 1995, including a $3.4 million non-cash expense to write down to market APBI's EnSys investment and the write-off of other non-productive assets. In addition, APBI recorded severance charges totaling $1.2 million in the quarter 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. 26 Operating loss 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 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 primarily 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 in 1996 represents an improvement of $1.9 million from 1995. The 1996 net loss per basic and diluted share of $0.17 compares to pro forma net loss per basic and diluted share of $0.29 in 1995. 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 was 102.6% higher than 1995's pro forma net income of $5.0 million. This net income per share of $0.47 compares to $0.26 for 1995 computed on 2.4 million more shares outstanding for 1996. LIQUIDITY AND CAPITAL RESOURCES As of December 31, 1997, the Company had $15.9 million of cash and cash equivalents on hand and $8.0 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, 1997, the Company experienced a net increase in cash from operating activities of $11.1 million. For the period, net income of $9.6 million, depreciation and amortization of $12.4 million and the acquired in-process research and development of $9.1 million were offset primarily by the net decrease of $19.1 million in other assets and liabilities (which includes a $24.5 million increase in billed and unbilled receivables), as well as cash disbursements of $7.4 million related to previously accrued merger expenses. For the year ended December 31, 1997, the Company used net cash of $16.8 million in investing activities, as capital expenditures $13.6 million and the $8.1 million net cash paid for acquisitions were only partially offset by $6.3 million in cash provided by net maturities of investments. For the year ended December 31, 1997, the Company's financing activities provided $1.0 million in cash, as net proceeds from stock option exercises of $2.2 million were partially offset by $1.3 million in net repayment of long-term debt and $0.4 million in cash used to pay pre-merger distributions to stockholders of Belmont. 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 holding of marketable securities. In June 1997, the Company obtained a $50.0 million revolving credit facility with First Union National Bank. Interest accrues on amounts borrowed at a floating rate currently equal to LIBOR plus 0.75% per year. Indebtedness under the line is unsecured and subject to certain covenants relating to financial ratios and tangible net worth. The unused portion of the loan is available to provide working capital and for general corporate purposes. As of December 31, 1997, the Company had no amounts outstanding under this facility. In August 1997, the Company negotiated a credit facility for $50.0 million with Wachovia Bank, N.A. Interest accrues on amounts borrowed at a floating rate currently equal to LIBOR plus 0.70% per year. Indebtedness under the line is unsecured and subject to certain covenants relating to financial ratios and tangible net worth. The unused portion of the loan is available to provide working capital and for general corporate purposes. As of December 31, 1997, the Company had $3.3 million outstanding under this facility. 27 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 facilities. The Company believes that such sources of cash will be sufficient to fund the Company's current operations for at least the next 12 months. 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. YEAR 2000 IMPACT The Company has accessed the impact Year 2000 could have on its operations and does not anticipate that the Year 2000 will materially impact the Company's information systems, business, and ability to operate in a well-controlled environment. 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. Contracts between the Company's United Kingdom subsidiaries and their clients are generally denominated in pounds sterling. Substantially all of the United Kingdom subsidiaries' expenses, such as salaries, services, materials and supplies, are paid in pounds sterling. 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. The Company currently participates in only a small number of transactions involving multiple currencies. In most of those situations, contractual provisions either limit or reduce the translation risk. Financial statement translation has not, to date, been material to the Company's balance sheet. The reasons for this are that the majority of international operations are located in the United Kingdom, which traditionally has had a relatively stable currency, and that international operations have not accounted for a significant portion of total operations (less than 15%). It is anticipated that those conditions will persist for at least the following year. There are no material 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. 28 PART III Certain information required by Part III is omitted from this report, because the Registrant will file a definitive proxy statement for its 1998 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. 29 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. None. (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. 10.4** --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). 10.8** --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. 10.31** --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. 10.35** --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. 10.38** --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. 10.49** --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. 10.55** --Lease made January 23, 1996 between PPD-CRU and Western Center Properties, Inc. 10.57* --First Amendment to Registration Rights Agreement. 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. 10.71* --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. 10.73* --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. 30 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. 10.84* --Employment Agreement, dated June 4, 1997, by and between the PPD Discovery, Inc. and Mark E. Furth. 10.85* --Note and Loan Agreement, dated June 25, 1997, made by the PPD Discovery, Inc. for the benefit of First Union National Bank of North Carolina. 10.86* --Pharmaceutical Product Development, Inc. Employee Stock Purchase Plan, dated May 15,1997. 10.87* --Amendment to Employee Stock Purchase Plan, dated June 21, 1997. 10.88* --Amendment to Stock Option Plan for Non-Employee Directors, dated May 15, 1997. 10.89* --Amendment to Equity Compensation Plan, dated May 15, 1997. 10.90* --Employment Agreement, effective July 1, 1997, between Pharmaceutical Product Development, Inc. and Fredric N. Eshelman. 10.91* --Note and Loan Agreement, dated August 7, 1997, between Pharmaceutical Product Development, Inc. and Wachovia Bank, N.A. 10.92* --First Amendment to Loan Agreement dated August 11, 1997, between the Registrant and First Union National Bank. 10.93* --Lease Agreement dated July 9, 1997, between Weeks Realty, Inc. and PPD Pharmaco, Inc. 10.94 --Employment Agreement dated October 1, 1997 between PPD Pharmaco, Inc. and Joshua S. Baker. 10.95 --Employment Agreement dated January 1, 1998 between Pharmaceutical Product Development, Inc. and Rudy C. Howard. 10.96 --Employment Agreement dated January 1, 1998 between PPD Pharmaco, Inc. and Patrick C. O'Connor. 10.97 --Employment Agreement dated January 1, 1998 between PPD Pharmaco, Inc. and Paul S. Covington. 10.98 --Employment Agreement dated January 1, 1998 between PPD Pharmaco, Inc. and Mark A. Sirgo. 10.99 --Amendment to Employment Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and Fred B. Davenport, Jr. 10.100 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and Fredric N. Eshelman. 10.101 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and Thomas D'Alonzo. 10.102 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and Rudy C. Howard. 10.103 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and Fred B. Davenport, Jr. 10.104 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. 31 and Joseph H. Highland. 10.105 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and Joshua S. Baker. 10.106 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and Patrick C. O'Connor. 10.107 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and Paul S. Covington. 10.108 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and Mark A. Sirgo. 10.109 --Severance Agreement dated February 2, 1998 between Pharmaceutical Product Development, Inc. and William Neilson. 10.110 --Amendment to Employee Stock Purchase Plan, dated March 2, 1998. 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 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, 1997, 1996 and 1995 F-3 Consolidated Balance Sheets as of December 31, 1997 and 1996 F-4 Consolidated Statements of Shareholders' Equity for the Years Ended December 31, 1997, 1996 and 1995 F-5 Consolidated Statements of Cash Flows for the Years Ended December 31, 1997, 1996 and 1995 F-6 Notes to Consolidated Financial Statements F-7 Report of Independent Accountants on Supplemental Schedule F-29 Consolidated Financial Statement Schedule Schedule II - Valuation and Qualifying Accounts F-30
F-1 REPORT OF INDEPENDENT ACCOUNTANTS The Board of Directors and Shareholders Pharmaceutical Product Development, Inc. and Subsidiaries We have audited the accompanying consolidated balance sheets of Pharmaceutical Product Development, Inc. and its subsidiaries as of December 31, 1997 and 1996, and the related consolidated statements of operations, shareholders' equity and cash flows for the years 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 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 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, 1997 and 1996, and the results of their operations and their cash flows for the years then ended in conformity with generally accepted accounting principles. We previously audited and reported on the combined statements of operations, shareholders' equity and cash flows of Pharmaceutical Product Development, Inc., its affiliates and its consolidated subsidiaries for the year ended December 31, 1995, prior to their restatement for the 1996 pooling of interests. The contribution of Pharmaceutical Product Development, Inc., its affiliates and its consolidated subsidiaries to net revenue represented 17 percent of the restated total for 1995. 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. Separate financial statements of the other company included in the 1995 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 statements of operations, shareholders' equity and cash flows for the year ended December 31, 1995, 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. COOPERS & LYBRAND L.L.P. Raleigh, North Carolina February 5, 1998, except as to the information presented in Note 20 for which the date is February 27, 1998. F-2 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEARS ENDED DECEMBER 31, 1997, 1996 AND 1995 (IN THOUSANDS, EXCEPT PER SHARE DATA)
1997 1996 1995 ---------- ---------- -------- Life sciences revenues, net of subcontractor costs of $69,094 $47,933 and $52,066, respectively $ 187,201 $ 152,304 $ 160,495 Environmental sciences revenues, net of subcontractor costs of $6,408, $4,752 and $7,230, respectively 47,785 45,492 49,283 Discovery sciences revenues, net of subcontractor costs of $45 in 1997 286 - - ---------- ---------- ---------- Net revenue 235,272 197,796 209,778 ---------- ---------- ---------- Direct costs - Life sciences 94,909 79,108 90,315 Direct costs - Environmental sciences 33,431 31,744 32,442 Direct costs - Discovery sciences 1,859 - - Selling, general and administrative expenses 68,797 61,571 64,014 Depreciation and amortization 12,394 10,436 13,251 Loss on sale of business - - 19,308 Merger costs and special charges 558 16,114 4,982 Acquired in-process research and development costs 9,112 - - ---------- ---------- ---------- 221,060 198,973 224,312 ---------- ---------- ---------- Operating income (loss) 14,212 (1,177) (14,534) Interest: Expense (478) (420) (3,304) Income 1,342 1,919 263 Other income (expense), net 600 305 425 ---------- ---------- ---------- Income (loss) from continuing operations before provision for income taxes 15,676 627 (17,150) ----------- Provision for income taxes 6,074 4,134 ---------- ---------- Net income (loss) $ 9,602 $ (3,507) ========== ========== Weighted average number of common shares outstanding: Basic 22,825 21,168 Dilutive effect of stock options 60 - ---------- ---------- Diluted 22,885 21,168 ========== ========== Net income (loss) per share: Basic $ 0.42 $ (0.17) ========= =========== Diluted $ 0.42 $ (0.17) ========= =========== Pro Forma Data (Note 1): Loss from continuing operations before provision for income taxes (17,150) Pro forma benefit for income taxes (14,359) ----------- Pro forma loss from continuing operations (2,791) Loss from discontinued operations: Estimated loss on disposal of discontinued operations, net of income tax benefit of $2,036 (1,716) ---------- Pro forma net loss before extraordinary item (4,507) Extraordinary loss on early extinguishment of debt, net of income tax benefit of $475 (897) ----------- Pro forma net loss $ (5,404) ========== Pro forma basic and diluted weighted average number of common shares outstanding 18,815 ========== Pro forma basic and diluted loss per common share: Loss from continuing operations $ (0.15) Loss from discontinued operations (0.09) Extraordinary loss (0.05) ----------- Pro forma loss per common share $ (0.29) ===========
The accompanying notes are an integral part of these consolidated financial statements. F-3 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 1997 AND 1996 (IN THOUSANDS, EXCEPT SHARE DATA)
ASSETS 1997 1996 ---------- -------- Current assets Cash and cash equivalents $ 15,879 $ 21,838 Marketable securities 7,994 14,210 Accounts receivable and unbilled services, net 101,554 76,237 Investigator advances 1,870 5,280 Prepaid expenses and other current assets 7,227 5,752 Deferred tax asset 1,973 4,955 ---------- ---------- Total current assets 136,497 128,272 Property and equipment, net 34,902 31,479 Goodwill, net 18,026 18,397 Other assets 7,622 3,309 ---------- ---------- Total assets $ 197,047 $ 181,457 ========== ========== LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities Current maturities of long-term debt $ 4,906 $ 4,221 Accounts payable 6,249 7,051 Payables to investigators 4,138 5,429 Other accrued expenses 23,532 26,263 Unearned income 27,722 18,705 ---------- ---------- Total current liabilities 66,547 61,669 Long-term debt, less current maturities 340 1,428 Deferred rent and other 2,555 3,054 ---------- ---------- Total liabilities 69,442 66,151 ---------- ---------- Commitments and contingencies (Notes 10 and 14) Shareholders' equity Common stock, $0.10 par value, 95,000,000 shares authorized; 22,949,000 and 21,624,000 shares issued and outstanding, respectively 2,295 2,163 Paid-in capital 115,680 112,606 Retained earnings (accumulated deficit) 10,112 (363) Unrealized gain on investments, net 168 232 Cumulative translation adjustment (650) 668 ---------- ---------- Total shareholders' equity 127,605 115,306 ---------- --------- Total liabilities and shareholders' equity $ 197,047 $ 181,457 ========== ===========
The accompanying notes are an integral part of these consolidated financial statements. F-4 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY FOR THE YEARS ENDED DECEMBER 31, 1997, 1996 AND 1995 (IN THOUSANDS)
COMMON RETAINED UNREALIZED COMMON STOCK EARNINGS GAIN (LOSS) CUMULATIVE STOCK PAR PAID-IN (ACCUMULATED ON TRANSLATION UNEARNED SHARES VALUE CAPITAL DEFICIT) INVESTMENTS ADJUSTMENT COMPENSATION ------ ----- ------- -------- ----------- ---------- ------------ 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 - Unrealized loss on investments, net (61) Issuance of 1,165 common shares in connection with acquisitions 1,165 115 89 1,304 Issuance of 142 common shares 142 16 2,199 Income tax benefit from exercise of stock options 510 Translation adjustments (1,318) Net income 9,602 Distribution to shareholders (431) Proceeds of Section 16(b) transaction, net of related tax provision of $155 276 Other 18 1 (3) -------- -------- --------- ----------- ---------- -------- ----------- Balance, December 31, 1997 22,949 $ 2,295 $115,680 $10,112 $ 168 $ (650) $ - ======== ======== ========= =========== ========== ========= ===========
The accompanying notes are an integral part of these consolidated financial statements. F-5 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 1997, 1996 AND 1995 (IN THOUSANDS)
1997 1996 1995 ------------ --------- --------- Cash flows from operating activities: Net income (loss) $ 9,602 $ (3,507) $ (3,630) Adjustments to reconcile net income (loss) to net cash provided by operating activities: Depreciation and amortization 12,394 10,436 13,251 Purchased in-process research and development 9,112 - - Deferred income taxes (910) 1,375 (18,204) Stock compensation amortization - 668 539 Loss on sale of toxicology operations - - 16,991 Provision for loss on disposal of discontinued operations - - 3,752 (Gain) loss on disposition of property and equipment 32 6 (2,741) (Gain) loss on sale of investments 3 (8) - Impairment of investment in EnSys - - 2,638 Early extinguishment of debt - - 955 Change in assets and liabilities: Accounts receivable and unbilled services, net (24,470) (2,043) 108 Prepaid expenses and other current assets 2,073 (4,317) 2,076 Current income taxes 3,406 1,354 1,472 Other assets 842 1,068 (1,968) Assets and liabilities of discontinued operations, net - - (1,593) Accounts payable and accrued liabilities (9,627) (6,872) 9,301 Unearned income 8,740 2,569 (7,011) Other (58) (411) (13) ---------- ----------- ----------- Net cash provided by operating activities 11,139 318 15,923 --------- ---------- ---------- Cash flows from investing activities: Purchases of property and equipment (13,599) (11,176) (10,117) Proceeds from sale of toxicology operations - - 32,500 Proceeds from sale of property and equipment 174 74 14,158 Proceeds (purchase) of marketable securities, net 6,268 (13,799) (14) Sale of investments - 244 - Purchase of investments (1,500) - - Net cash paid for acquisitions (8,121) (3,867) (741) ---------- ---------- ---------- Net cash (used in) provided by investing activities (16,778) (28,524) 35,786 ---------- ---------- ---------- Cash flows from financing activities: Short-term bank (repayments) borrowings, net - - (1,687) Line of credit (repayments) borrowings, net - 669 (12,892) Proceeds from long-term debt 138 167 - Principal repayments on long-term debt (1,355) (2,415) (32,897) Proceeds of Section 16(b) transaction 431 - - Cash dividends paid - (5,937) (723) Distribution to shareholders (431) - - Proceeds from issuance of common stock 2,215 42,902 761 --------- ---------- ---------- Net cash provided by (used in) financing activities 998 35,386 (47,438) --------- ---------- ----------- Effect of exchange rate changes on cash (1,318) 1,093 (510) ---------- ---------- ---------- Net increase (decrease) in cash and cash equivalents (5,959) 8,273 3,761 Cash and cash equivalents, beginning of the year 21,838 13,565 9,804 --------- --------- ---------- Cash and cash equivalents, end of the year $ 15,879 $ 21,838 $ 13,565 ========= ========== ==========
The accompanying notes are an integral part of these consolidated financial statements. F-6 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 three business segments: life sciences, environmental sciences and discovery 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. Discovery sciences services include target identification and validation, compound creation, screening and compound selection. Such services are provided through all three 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 79.6% of the Company's business in 1997 based on net revenue, are marketed primarily in the United States and Europe. The Company's remaining 1997 net revenue was derived from its environmental sciences segment (20.3%) which is primarily domestic and its discovery segment (0.1%) which is entirely 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 During 1997, the Company recorded one-time merger cost of $0.6 million in connection with the acquisitions of Belmont Research, Inc., SARCO, Inc., and Intek Labs, Inc. These costs are primarily current cash expenses, such as legal and accounting fees related to pooling transactions. 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 $16.1 million in 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 $9.0 million in accruals for severance, lease termination and certain other costs. Of the amounts accrued, $3.2 million is for severance payments for approximately 40 individuals consisting mainly of administrative personnel. Approximately $0.1 million and $7.5 million of merger and reorganization costs were accrued as of December 31, 1997 and 1996, respectively, and included in other accrued expenses. 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. ACQUIRED IN-PROCESS RESEARCH AND DEVELOPMENT COSTS The purchase price in excess of the net assets of the GSX System was allocated to acquired in-process research and development costs and was charged to operations upon the acquisition of the GSX System, as the technology has no alternative future use and the technology has not yet reached technological feasibility. F-7 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED): 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. 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 consist 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, ------------------------------- 1997 1996 1995 -------- -------- ------- Cash paid (received): Interest $ 354 $ 326 $ 3,707 ======== ======== ======== Income taxes, net $ 2,583 $ 1,594 $ (2,299) ======== ======== ======== The non-cash assets and liabilities acquired, including the acquisition of Technical Assessment Systems, Inc.; Belmont Research, Inc.; SARCO, Inc.; Intek Labs, Inc.; and the GSX System in 1997 and 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, ------------------------------ 1997 1996 1995 -------- -------- ------- Acquisitions: Fair value of assets acquired $ 2,795 $ 4,841 $ 7,633 Liabilities assumed 3,346 5,242 3,416 Non-cash consideration received: Fair value of assets acquired $ - $ - $ 5,098 Liabilities assumed - - 598 F-8 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED): 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.) 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 is required to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable, in accordance with the provisions of Statement of Financial Accounting Standards No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of" ("SFAS 121"). Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of property, plant and equipment and intangibles in relation to the operating performance and estimates of future discounted cash flows of the underlying business. 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, 1997 and 1996, accumulated amortization was $4,383,000 and $3,036,000, respectively. The amortization charges for each of the three years ended December 31, 1997, 1996 and 1995 were $1,401,000, $950,000 and $715,000, 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.) F-9 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED): 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 1995 statement of operations includes a pro forma income tax provision related to the net loss 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. 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 basic income (loss) per share information is based on the weighted average number of common shares outstanding during the year. The computation of diluted income (loss) per share information is based on the weighted average number of common shares outstanding during the year plus the effects of any common stock equivalents at year end. NEW ACCOUNTING PRONOUNCEMENTS The Company adopted Statement of Financial Accounting Standards No. 128, "Earnings Per Share" ("SFAS No. 128"), on December 31, 1997. SFAS No. 128 requires the Company to change its method of computing, presenting and disclosing earnings per share information. Accordingly, all prior period data presented has been restated to conform to the provisions of SFAS No. 128. The Company will adopt Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive Income" ("SFAS No. 130"), for the year ending December 31, 1998. SFAS No. 130 requires the Company to display an amount representing total comprehensive income for the period in a financial statement which is displayed with the same prominence as other financial statements. Upon adoption, all prior period data presented will be restated to conform to the provisions of SFAS No. 130. The Company does not expect this new pronouncement to have a significant impact on the financial statements. F-10 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED): The Company will adopt Statement of Financial Accounting Standards No. 131, "Disclosures about Segments of an Enterprise and Related Information" ("SFAS No. 131"), for the year ending December 31, 1998. SFAS No. 131 requires the Company to report certain information about operating segments in complete sets of financial statements and in condensed financial statements of interim period issued to shareholders. It also establishes standards for related disclosures about products and services, geographic areas and major customers. The Company does not expect this new pronouncement to have a significant impact on the financial statements. The Company will adopt Statement of Financial Accounting Standards No. 132, "Employers' Disclosures about Pensions and Other Postretirement Benefits" ("SFAS No. 132"), for the year ending December 31, 1998. SFAS No. 132 standardizes the disclosure requirements for pensions and other postretirement benefits to the extent practicable, requires additional information and changes in the benefit obligations and fair values of plan assets that will facilitate financial analysis, and eliminates certain disclosures that are no longer useful. The Company does not expect this new pronouncement to have a significant impact on the financial statements. USE OF ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. RECLASSIFICATIONS Certain prior year amounts have been reclassified to conform to the 1997 presentation. 2. ACQUISITIONS: POOLINGS In March 1997, the Company acquired Belmont Research, Inc. ("Belmont"). The consideration for Belmont consisted of 502,384 shares of the Company's common stock plus options to purchase approximately 115,000 shares of Company common stock. In June 1997, the Company acquired SARCO, Inc. ("SARCO"). The consideration for SARCO consisted of 263,158 shares of the Company's common stock. In November 1997, the Company acquired Intek Labs, Inc. ("Intek"). The consideration for Intek consisted of 399,999 shares of the Company's common stock. All three of these acquisitions were accounted for as pooling of interests transactions. 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. 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. 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. F-11 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 2. ACQUISITIONS (CONTINUED): 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 all of 1996 and the 1995 financial statements 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: In a January 1997 transaction, 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. In connection with the acquisition, the Company recorded $1,070,000 in goodwill. In June 1997, the Company acquired the GSX System, a functional genomics platform technology. The GSX System was purchased for approximately $8.7 million in cash. Liabilities assumed in this transaction were $832,000. 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. 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-12 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 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 results of operations (excluding the effect of the loss on the sale of the business) for the year ended December 31, 1995 included the following for the disposed business (in thousands): 1995 ---- Net revenues $ 38,446 Operating loss (1,136) 4. DISCONTINUED OPERATIONS: During the fourth quarter of 1995, PACE Incorporated ("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. 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." At that time, the Company wrote off its remaining investment in PACE of approximately $3,600,000, and accrued its estimated exposure for guarantees on leases. PACE was involuntarily placed in bankruptcy under Chapter 7 of the Bankruptcy Code during 1996. As a result of a settlement reached with the bankruptcy trustee in December 1997, the Company expects repayment of approximately $300,000 related to funds loaned to PACE and written off in the fourth quarter of 1995. F-13 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 5. MARKETABLE SECURITIES: The estimated market value and aggregate cost of current marketable securities were as follows (in thousands): DECEMBER 31, ---------------------- 1997 1996 --------- --------- Estimated market value $ 7,994 $ 14,210 Aggregate cost 8,000 14,210 --------- --------- Gross unrealized loss $ (6) $ - ========== ========= Marketable securities consist of debt securities issued by the U.S. Treasury in 1997 and 1996. These securities are classified as available-for-sale and reported in the balance sheet at fair value. The U.S. Treasury note held at December 31, 1997 matured February 2, 1998. 6. ACCOUNTS RECEIVABLE AND UNBILLED SERVICES: Accounts receivable and unbilled services consisted of the following (in thousands): DECEMBER 31, ----------------- 1997 1996 ---- ---- Trade: Billed $ 55,257 $ 45,419 Unbilled 46,730 30,404 Reserve for doubtful accounts (1,515) (1,511) ---------- --------- 100,472 74,312 Officers and employees 386 363 Other 696 1,562 --------- --------- $ 101,554 $ 76,237 ========= ========= 7. PROPERTY AND EQUIPMENT: Property and equipment, stated at cost, consisted of the following (in thousands):
DECEMBER 31, ----------------- 1997 1996 ---- ---- Land $ 517 $ 593 Buildings and leasehold improvements 13,291 13,049 Construction in progress and asset deposits 620 167 Furniture and equipment 33,066 28,062 Computer equipment and software 36,466 27,868 --------- --------- 83,960 69,739 Less - Accumulated depreciation and amortization 49,058 38,260 --------- --------- $ 34,902 $ 31,479 ========= =========
The annual depreciation and amortization charges on property and equipment for each of the three years ended December 31, were (in thousands): 1995 $12,015 1996 9,399 1997 10,830 F-14 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 8. OTHER ASSETS: Other assets consisted of the following (in thousands):
DECEMBER 31, ------------------ 1997 1996 -------- ------- Investment in DAS $ 1,500 $ - Investment in SDI 1,161 1,240 Long-term deferred tax asset 3,742 963 Intangible and other assets, net of accumulated amortization of $1,040 and $1,024, respectively 1,219 1,106 -------- ------ $ 7,622 $ 3,309 ======== ========
The annual amortization charges on intangible assets for each of the three years ended December 31, 1997, 1996 and 1995 were $163,000, $87,000 and $602,000, respectively. The Company owns 600,000 shares (approximately 8.0%) of Digital Arts and Sciences ("DAS") Series D preferred stock as of December 31, 1997. The Company's investment in DAS is valued at cost, which approximates fair market value. The Company owns 714,600 and 729,600 shares of Strategic Diagnostics Inc. ("SDI"), formerly EnSys Environmental Products Inc. ("EnSys") common stock as of December 31, 1997 and 1996, respectively. 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 $2.25 and $2.00 as of December 31, 1997 and 1996, respectively. The Company owned approximately 5.5% of the SDI common stock at December 31, 1997. The Company's investment in SDI was carried at its fair value in 1996. However, during 1997 the Company sold options to various other companies which provided them the right to acquire all SDI shares owned by the Company at a price of $1.625 per share. Accordingly, during 1997 the Company reduced the carrying value of this investment to the lower of market or $1.625 per share ($1.625 at December 31, 1997). 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 1997, $174,000 is reported as a separate component of shareholders' equity to represent the difference between option value and the prior year's carrying value. 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, ----------------- 1997 1996 ---- ---- Accrued salaries, wages, benefits and related costs $ 15,626 $ 10,976 Accrued merger costs 117 7,513 Other 7,789 7,774 --------- --------- $ 23,532 $ 26,263 ========= =========
F-15 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 10. LONG-TERM DEBT AND LEASE OBLIGATIONS: Long-term debt consisted of the following (in thousands): DECEMBER 31, -------------------- 1997 1996 -------- ------- LIBOR (5.9% at December 31, 1997) plus 0.70% unsecured line of credit due March 3, 1998 $ 3,300 $ 3,300 Equipment leases 721 689 Various notes at interest rates up to 9.75% 1,225 1,660 -------- -------- 5,246 5,649 Less current maturities (4,906) (4,221) --------- -------- $ 340 $ 1,428 ======== ======== In June 1997, the Company obtained a $50.0 million revolving credit facility with First Union National Bank which accrues interest on amounts borrowed at a floating rate currently equal to the LIBOR Rate plus 0.75% per year. Indebtedness under the line is unsecured and subject to certain covenants relating to financial ratios and tangible net worth. The unused portion of the loan is available to provide working capital and for general corporate purposes. As of December 31, 1997, the Company has no amounts outstanding under this facility. In August 1997, the Company negotiated a new credit facility for $50.0 million with Wachovia Bank, N.A. which accrues interest on amounts borrowed at a floating rate currently equal to the LIBOR Rate plus 0.70% per year. Indebtedness under the line is unsecured and subject to certain covenants relating to financial ratios and tangible net worth. The unused portion of the loan is available to provide working capital and for general corporate purposes. As of December 31, 1997, the Company had $3.3 million outstanding under this facility. For the years subsequent to December 31, 1997, annual maturities of long-term debt outstanding are (in thousands): 1998 $ 4,906 1999 205 2000 81 2001 54 -------- $ 5,246 ======== 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 $13,492,000, $10,334,000 and $8,200,000 for the years ended December 31, 1997, 1996 and 1995, 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 15-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. F-16 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 10. LONG-TERM DEBT AND LEASE OBLIGATIONS (CONTINUED): Future minimum payments for all operating lease obligations for years subsequent to December 31, 1997 are as follows (in thousands): 1998 $ 13,983 1999 11,583 2000 9,577 2001 8,784 2002 8,312 2003 and thereafter 34,004 --------- $ 86,243 ========= 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 2,500,000 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 10 years. Options are granted upon approval of the Board of Directors and vest over various periods. 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 the Plan. 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 income (loss) and basic and diluted net income (loss) per share would have been decreased (increased) to the pro forma amounts indicated below.
1997 1996 1995 ----------------------- ----------------------- ------------------------- AS AS AS REPORTED PRO FORMA REPORTED PRO FORMA REPORTED PRO FORMA -------- --------- -------- --------- -------- --------- Net income (loss) (in thousands) $ 9,602 $ 7,730 $(3,507) $ (7,670) $(5,404) $ (5,637) Basic and diluted net income (loss) per share $ 0.42 $ 0.34 $ (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 1997, 1996 and 1995: expected volatility of 58.7%, 49.9% and 49.9%, respectively, risk-free interest of 6.0%, 6.25% and 6.25%, respectively, and expected lives of five years. The weighted average fair value of options granted during 1997, 1996 and 1995 was $9.48, $11.48 and $6.55 per share, respectively. A summary of the status of the Company's Plan as of December 31, 1997, 1996 and 1995, and changes during the years ending on those dates, is presented below:
1997 1996 1995 ----------------------- ------------------------- -------------------------- WEIGHTED WEIGHTED WEIGHTED AVERAGE AVERAGE AVERAGE SHARES EXERCISE PRICE SHARES EXERCISE PRICE SHARES EXERCISE PRICE ------ -------------- ------ -------------- ------ -------------- Outstanding at beginning of year 1,241,142 $ 22.28 1,180,809 $ 16.29 1,240,682 $ 17.07 Granted 459,740 15.45 1,056,539 22.57 191,837 12.38 Exercised (157,857) 14.74 (858,800) 15.10 (63,547) 9.82 Forfeited (105,959) 24.63 (137,406) 17.96 (188,163) 19.63 --------- -------- -------- Outstanding at end of year 1,437,066 $ 20.71 1,241,142 $ 22.28 1,180,809 $ 16.29 ========= ======= ========= ======== ========= ======= Options exercisable at year-end 799,361 $ 20.77 771,069 $ 19.85 766,895 $ 17.31 ======== ======= ========= ======== ========= =======
F-17 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 11. STOCK PLANS (CONTINUED): The following table summarizes information about the Plan's stock options at December 31, 1997:
OPTIONS OUTSTANDING OPTIONS EXERCISABLE ----------------------------------------------- --------------------------- NUMBER WEIGHTED-AVERAGE WEIGHTED NUMBER WEIGHTED RANGE OF OUTSTANDING REMAINING AVERAGE EXERCISABLE AVERAGE EXERCISE PRICES AT 12/31/97 CONTRACTUAL LIFE EXERCISE PRICE AT 12/31/97 EXERCISE PRICE --------------- ----------- ---------------- -------------- ----------- -------------- $ 1.71-$ 10.00 28,264 5.1 years $ 6.23 25,832 $ 5.93 $ 10.01-$ 20.00 706,296 7.8 years $ 15.65 434,041 $ 16.21 $ 20.01-$ 30.00 622,046 8.7 years $ 25.14 259,028 $ 25.16 $ 30.01-$ 40.00 74,668 3.8 years $ 35.59 74,668 $ 35.59 $ 40.01-$ 40.55 5,792 4.2 years $ 40.55 5,792 $ 40.55 -------- -------- 1,437,066 799,361 ========= ========
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. SAVINGS RELATED STOCK OPTION PLAN The Company has a Savings Related Stock Option 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 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 to accrue the additional bonuses and forfeit the option to purchase the shares. The United Kingdom Plan, as approved by the shareholders, was implemented by Applied Bioscience International Inc. during 1988. Currently, employees of the Company's United Kingdom subsidiary, Pharmaco International Ltd., participate in this plan. Outstanding options at the time of the merger with APBI were converted in accordance with the exchange ratio provided for in the merger agreement. F-18 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 11. STOCK PLANS (CONTINUED): 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 granted in excess of the savings balance were forfeited. The exercise period for the vested options extended through April 1996. At December 31, 1997, there were 1,029 options outstanding at an average exercise price of $13.72. Of those, 667 options were exercisable at December 31, 1997, at an average exercise price of $13.75. These options are included in the table above that summarizes total options outstanding at December 31, 1997. EMPLOYEE STOCK PURCHASE PLAN The Board of Directors has reserved 500,000 shares of the Company's common stock for issuance under the Employee Stock Purchase Plan (the "ESPP"). The plan will have two six-month offering periods (each an "Offering Period") annually, beginning January 1 and July 1, respectively. The first Offering Period under the ESPP began July 1, 1997. Eligible employees can elect to make deductions from 1% to 15% of their compensation during each payroll period of an Offering Period. An eligible employee may also make contributions outside elected payroll deductions, provided that no eligible employee can purchase common stock of the Company under the ESPP in excess of $25,000 in any calendar year. Special limitations apply to eligible employees who own 5% or more of the outstanding common stock of the Company. None of the contributions made by eligible employees to purchase the Company's common stock under the ESPP, whether through elected payroll deductions or outside of elected payroll deductions, are tax deductible to the employees. At the end of an Offering Period, the total payroll deductions and other contributions by an eligible employee for that Offering Period will be used to purchase common stock of the Company at a price equal to 85% of the lesser of (a) the reported closing price of the Company's common stock for the first day of the Offering Period, or (b) the reported closing price of the common stock for the last day of the Offering Period. Employees eligible to participate in the ESPP include employees of the Company and its United States operating subsidiaries, except those employees who customarily work less than 20 hours per week or five months in a year. Since both participation in and contributions to the ESPP are determined by the eligible employee, it is not possible to determine the benefits and amounts that would be received by an eligible participant or group of participants in the future. At December 31, 1997, $991,000 had been contributed to the ESPP. Shares were not issued on December 31, 1997 since the market had to be closed before a purchase price could be determined. On January 2, 1998, 75,508 shares were issued. The compensation costs for the ESPP as determined based on the fair value of the contributions under the ESPP, consistent with the method of SFAS No. 123, was $196,000, and is reflected in the pro forma net income and basic and diluted net income per share for 1997 as disclosed above. The ESPP was amended to limit additional cash contributions to $5,000 for the Offering period commencing January 1, 1998 and eliminate additional cash contributions during the Offering Period commencing July 1, 1998 and thereafter. Stock available for purchase during the Offering Period commencing January 1, 1998, will be limited to a total of 150,000 shares. F-19 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 12. INCOME TAXES: The components of income (loss) before provision for income taxes were as follows (in thousands):
YEAR ENDED DECEMBER 31, -------------------------------- 1997 1996 1995 ------- ---------- ------ Domestic $16,907 $ 1,228 $ (16,778) Foreign (1,231) (601) (372) -------- ---------- ---------- Income (loss) from continuing operations 15,676 627 (17,150) Loss from discontinued operations - - (3,752) Extraordinary loss - - (1,372) ------- ---------- ---------- Total $15,676 $ 627 $ (22,274) ======= ========== =========
The components of the provision (benefit) for income taxes were as follows (in thousands):
YEAR ENDED DECEMBER 31, -------------------------------- 1997 1996 1995 ------- ---------- ------ State income taxes: Current $ 313 $ 330 $ (63) Deferred (97) 90 (166) Federal income taxes: Current 5,305 2,130 (1,021) Deferred 115 1,285 (4,716) Foreign income taxes: Current 438 299 109 Deferred - - (12,788) ------ ---------- --------- Provision (benefit) for income taxes $ 6,074 $ 4,134 (18,645) ======= ========== PPD's pro forma income tax provision (See Note 1) 1,775 -------- Pro forma benefit for income taxes $ (16,870) ==========
The income tax provision (benefit) is included in the financial statements as follows (in thousands): YEAR ENDED DECEMBER 31, ------------------------------------ 1997 1996 1995 ------- ---------- ---------- Continuing operations $ 6,074 $ 4,134 $(14,359) Discontinued operations - - (2,036) Extraordinary loss - - (475) ------- ---------- --------- Total $ 6,074 $ 4,134 $(16,870) ======= ========== ========= F-20 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 12. INCOME TAXES (CONTINUED): 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. The 1997 and 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. Taxes computed at the statutory federal income tax rate are reconciled to the provision (benefit) for income taxes as follows (in thousands):
YEAR ENDED DECEMBER 31, ------------------------------------ 1997 1996 1995 -------- --------- --------- Effective tax rate 38.7% 660.2% 83.7% ======== ========= ========= United States federal statutory rate $ 5,487 $ 213 $ (7,574) Differential on rates applied to foreign earnings - (72) 30 State taxes (net of federal benefit) 237 277 47 Write-down of investment in PACE Incorporated and EnSys - - (40) Sale of toxicology operations - - (10,370) Allowance for limitation of foreign tax losses 533 299 841 Merger costs not deductible for income tax purposes - 2,751 - Goodwill and other items not deductible for income tax purposes 449 435 - Other (371) 231 196 Benefit of federal statutory rate reduction from 35% to 34% (100) - - Deferred taxes set up for S to C conversion on acquisitions (161) - - Taxes on PPD's subchapter S earnings paid by former S shareholders - - (1,775) -------- ---------- --------- Provision (benefit) for income taxes $ 6,074 $ 4,134 $ (18,645) ======== ========== ==========
During 1997, the Company began recording deferred taxes at a 35% federal rate due to expected levels of income in the future. 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. F-21 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 12. INCOME TAXES (CONTINUED): Components of the net current deferred tax asset were as follows (in thousands):
DECEMBER 31, ------------------ 1997 1996 -------- ------- Future benefit of foreign net operating losses $ 96 $ 92 Allowance for doubtful accounts 787 733 Accruals 1,090 3,263 Future benefit of U.S. and state net operating losses - 1,051 Other - (184) -------- --------- Net current deferred tax asset $ 1,973 $ 4,955 ======== ========
Components of the net long-term deferred tax asset, included in other assets, were as follows (in thousands): DECEMBER 31, ---------------- 1997 1996 ---- ---- Depreciation and amortization $ 2,721 $ (836) Deferred rent 1,068 1,228 Future benefit of U.S. tax credits - 391 Other (47) 179 -------- --------- Net long-term deferred tax asset $ 3,742 $ 962 ======= ========= The cumulative amount of undistributed earnings of foreign subsidiaries for which the Company has not provided U.S. income taxes at December 31, 1997 was $805,000. 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. During 1997, the Company utilized all U.S. net operating loss carryforwards and alternative minimum tax credit carryforwards. 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, 1997, 1996 and 1995 were $1,945,000, $1,483,000 and $1,628,000, respectively. F-22 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 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 the Company'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, ---------------------------------- 1997 1996 1995 --------- -------- ------- Service cost-benefits earned during the year $ 738 $ 553 $ 1,311 Interest cost on projected benefit obligation 631 394 1,361 Actual return on plan assets (954) (500) (1,566) Net amortization and deferral (13) (9) (38) -------- -------- -------- Net pension cost $ 402 $ 438 $ 1,068 ======= ======== ======== The funded status of the defined benefit plan was as follows (in thousands):
DECEMBER 31, ---------------------- 1997 1996 --------- --------- Actuarial present value of benefit obligations: Vested benefit obligation $ (8,034) $ (5,033) ========= ========= Accumulated benefit obligation $ (8,214) $ (5,249) ========= ========= Projected benefit obligation $ (8,528) $ (5,459) Plan assets at fair value 10,932 6,497 --------- --------- Plan assets in excess of projected benefit obligation 2,404 1,038 Remaining unrecognized net asset arising from initial application of SFAS 87 (98) (67) Unrecognized net loss from past experience different from that assumed and effects of changes in assumptions (406) 558 ---------- --------- Prepaid pension cost $ 1,900 $ 1,529 ========= =========
Assumptions used to determine pension costs and projected benefit obligations were as follows: 1997 1996 ---- ---- Discount rate 8.5% 8.5% Rate of compensation increase 6.0% 6.5% Long-term rate of return on plan assets 9.5% 8.5% F-23 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 13. EMPLOYEE SAVINGS AND PENSION PLANS (CONTINUED): 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, 1997, 1996 and 1995 was $638,000, $620,000 and $645,000, respectively. As of December 31, 1997 and 1996, accrued pension was $701,000 and $648,000, 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 1997, 1996 and 1995 were $35,000, $39,000 and $44,000, 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, 1997, this coverage included two policies. One policy is for the Life and Discovery Sciences Groups and one is for the Environmental Sciences Group. Both policies included a $500,000 self-insured retention per claim. In July 1997, the Company entered into a new 10 year build-to-suit lease for approximately 100,000 square feet in Morrisville, North Carolina which is scheduled for completion in the fall of 1998. 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 $37,200, $65,900 and $102,000 in expenses for the years ended December 31, 1997, 1996 and 1995, 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 and 1995, totaled $402,300 and $341,000, 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 and $500,000 in 1996 and 1995, respectively. F-24 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 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. 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 DAS The Company's investment in DAS is recorded at $1,500,000 at December 31, 1997. The Company's investment in DAS is valued based on the cost method and does not exceed estimated net realizable value. INVESTMENT IN SDI The Company's investment in SDI is recorded at $1,161,200 and $1,240,300 compared to the market price of $1,607,900 and $1,459,200 as quoted on the National Market System of the National Association of Securities Dealers Automated Quotation System at December 31, 1997 and 1996. In 1997, this investment was not valued at the market price due to the options outstanding at the exercise price of $1.625 for all shares which the Company owns. In 1996, the market price was discounted $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. F-25 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 17. BUSINESS SEGMENT DATA: The Company operates in three business segments - life sciences, environmental sciences and discovery sciences. Revenues by principal business segment are separately stated in the consolidated financial statements. Merger costs and acquired in-process research and development costs incurred in 1997 and 1996 of $9.7 million and $16.1 million, respectively, 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):
DECEMBER 31, --------------------------------------- 1997 1996 1995 ---------- ---------- ---------- Income (loss) from operations: Life sciences $ 19,902 $ 9,580 $ (18,657) Environmental sciences 6,305 5,357 4,123 Discovery sciences (2,325) - - Merger costs and acquired in-process research and development costs (9,670) (16,114) - ----------- ----------- ---------- Operating income (loss) $ 14,212 $ (1,177) $ (14,534) ========== =========== =========== Depreciation and amortization: Life sciences $ 10,651 $ 8,766 $ 11,601 Environmental sciences 1,514 1,670 1,650 Discovery sciences 229 - - ---------- ---------- ---------- Total $ 12,394 $ 10,436 $ 13,251 ========== ========== ========== Identifiable assets: Life sciences $ 165,855 $ 159,394 $ 117,292 Environmental sciences 29,727 22,063 25,369 Discovery sciences 1,465 - - ---------- ---------- ---------- Total $ 197,047 $ 181,457 $ 142,661 ========== ========== ========== Capital expenditures: Life sciences $ 11,589 $ 9,895 $ 8,853 Environmental sciences 1,515 1,281 1,264 Discovery sciences 495 - - ---------- ---------- ---------- Total $ 13,599 $ 11,176 $ 10,117 ========== ========== ==========
F-26 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 18. OPERATIONS BY GEOGRAPHIC AREA: The following table presents information about the Company's operations by geographic area (in thousands):
DECEMBER 31, ------------------------------------ 1997 1996 1995 ---------- ---------- ------- Net revenue: United States $ 204,921 $ 175,173 $ 170,465 U.K. 20,269 15,542 31,141 * Other 10,082 7,081 8,172 ---------- ---------- ---------- Total $ 235,272 $ 197,796 $ 209,778 ========== ========== ========== Operating income (loss): United States $ 24,617 $ 14,731 $ (14,834) U.K. 119 (837) 1,556 * Other (854) 1,043 (1,256) Merger costs and acquired in-process research and development costs (9,670) (16,114) - ----------- ----------- ---------- Operating income (loss) $ 14,212 $ (1,177) $ (14,534) ========== ========== =========== Identifiable assets: United States $ 157,543 $ 142,464 $ 118,310 U.K. 27,063 27,657 12,579 * Other 12,441 11,336 11,772 ---------- ---------- ---------- Total $ 197,047 $ 181,457 $ 142,661 ========== ========== ==========
* Principally consists of revenue from 11 countries, seven of which are located in Europe. 19. QUARTERLY FINANCIAL DATA (UNAUDITED): (IN THOUSANDS, EXCEPT PER SHARE DATA)
1997 FIRST SECOND THIRD FOURTH TOTAL - ------------------------------------- --------- -------- ---------- ---------- --------- Net revenue $ 57,678 $ 60,065 $ 58,325 $ 59,204 $ 235,272 Operating income (loss) 5,266 (2,588) 6,568 4,966 14,212 Net income (loss) 3,343 (1,346) 4,141 3,464 9,602 Net income (loss) per common share: Basic $ 0.15 $ (0.06) $ 0.18 $ 0.15 $ 0.42 Diluted $ 0.15 $ (0.06) $ 0.18 $ 0.15 $ 0.42 1996 - ------------------------------------ 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) Net income (loss) per common share: Basic $ 0.10 $ 0.11 $ (0.56) $ 0.18 $ (0.17) Diluted $ 0.10 $ 0.11 $ (0.56) $ 0.18 $ (0.17)
F-27 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 20. SUBSEQUENT EVENT: On February 27, 1998, the Company, through its subsidiary Clinix International Inc., sold the business and assets of the Chicago Center for Clinical Research ("CCCR"). The selling price was approximately $7.6 million in the form of cash and a promissory note payable over five years. The sale resulted in a gain of approximately $1.0 million which will be included in operations during the first quarter of 1998. As part of the sales agreement, the Company will continue to provide clinical and administrative services over the next several quarters. F-28 REPORT OF INDEPENDENT ACCOUNTANTS ON SUPPLEMENTAL SCHEDULE The Board of Directors and Shareholders Pharmaceutical Product Development, Inc. and Subsidiaries Our report on the consolidated financial statements of Pharmaceutical Product Development, Inc. and its subsidiaries is included on page F-2 of this Form 10-K. In connection with our audits of such financial statements, we have also audited the 1997 and 1996 information included in the related financial statement schedule listed on page F-30 of this Form 10-K. In our opinion, this financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly, in all material respects, the information required to be included therein. COOPERS & LYBRAND L.L.P. Raleigh, North Carolina February 5, 1998 F-29 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, 1997 Reserve for doubtful accounts $ 1,511 $ 647 $ (740) $ 97 $ 1,515 ======= ======== ========== ===== ======== 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 ======= ======== ========= ====== ======== F-30 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 27, 1998 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 27, 1998 ----------------------------------- (Principal Executive Officer) Fredric N. Eshelman, Pharm.D. /s/ Rudy C. Howard Chief Financial Officer, Vice President of March 27, 1998 ----------------------------------- Finance and Treasurer (Principal Financial Rudy C. Howard Officer) /s/ Linda Baddour Chief Accounting Officer and Executive March 27, 1998 --------------------------- Director, Finance (Principal Accounting Linda Baddour Officer) /s/ Ernest Mario, Ph.D. Director March 27, 1998 ------------------------------------ Ernest Mario, Ph.D. /s/ Stuart Bondurant, M.D. Director March 27, 1998 --------------------------- Stuart Bondurant, M.D. /s/ Kirby L. Cramer Director March 27, 1998 ------------------------------------ Kirby L. Cramer /s/ Thomas D'Alonzo Director March 27, 1998 ------------------------------------ Thomas D'Alonzo /s/ Frederick Frank Director March 27, 1998 ------------------------------------ Frederick Frank /s/ Frank E. Loy Director March 27, 1998 ------------------------------------ Frank E. Loy /s/ John A. McNeill, Jr. Director March 27, 1998 ------------------------------------ John A. McNeill, Jr.
S-1
EX-10 2 PPD EXHIBIT 10.94 5 EMPLOYMENT AGREEMENT THIS EMPLOYMENT AGREEMENT (hereinafter the "Agreement"), made this 1st day of October, 1997, by and between PPD Pharmaco, Inc., a Texas corporation with its principal office at 3151 17th Street Extension, Wilmington, North Carolina 28412 (hereinafter "PPD Pharmaco"), and Joshua S. Baker (hereinafter "Employee"). RECITALS: A. Employee desires employment upon the terms and conditions herein stated. B. PPD Pharmaco desires to employ Employee upon the terms and conditions herein stated. C. Employee and PPD Pharmaco desire to embody in writing the terms and conditions of such employment in this Agreement. NOW, THEREFORE, in consideration of the mutual promises, covenants and considerations contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows: 1. Employment. PPD Pharmaco hereby employs Employee and Employee hereby accepts such employment on a full time basis as Senior Vice President - Clinical Operations upon the terms and conditions hereinafter set forth. 2. Term. The term of this Agreement shall be for one year, beginning October 1, 1997, and ending September 30, 1998, 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 paragraph 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 60 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 Pharmaco shall pay to Employee an annual salary of $200,000 for the initial one-year term hereof. 4. Stock Options. Pharmaceutical Product Development, Inc. ("PPD"), the parent company of PPD Pharmaco, has granted to Employee as of the date of this Agreement (the "Grant Date") options to purchase 10,000 shares of PPD's common stock at a purchase price equal to NASDAQ market close price on the Grant Date. Said share options have been granted under the terms of PPD's Equity 2 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) 3,334 of the share options may only be exercised one year after the Grant Date, (b) 3,333 of the share options may only be exercised two years after the Grant Date, (c) the remaining 3,333 share options may only be exercised three years after the Grant Date, and (d) any unvested share options, i.e., share options which cannot be exercised under the terms hereof, shall be forfeited upon Employee's termination of employment with PPD Pharmaco. 5. Duties. Employee shall have overall responsibility for and decision making authority necessary to fulfill the duties of Senior Vice President - Clinical Operations of PPD Pharmaco. Employee shall undertake such travel as 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 Pharmaco. 6. Working Facilities. PPD Pharmaco 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 in any other business which is developed by PPD Pharmaco 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 Pharmaco 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 Pharmaco may terminate Employee's employment hereunder upon the occurrence of any of the following events: a. Death of Employee. b. A determination by the Chief Executive Officer and the President and Chief Operating Officer of PPD, acting in good faith but made in their sole discretion, that Employee has failed to substantially perform his duties under this Agreement. c. A determination by the Chief Executive Officer and the President and Chief Operating Officer of PPD, acting in good faith but made in their sole discretion, 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. As a condition of employment hereunder, Employee will execute as of the date of this Agreement that certain Proprietary and Inventions Agreement attached hereto as Exhibit A and incorporated herein by reference. 10. Benefits. During the term thereof, Employee shall be entitled to participate in all benefits provided by PPD Pharmaco to its employees generally, including but not limited to health insurance, disability insurance and retirement plans, all of which are currently provided to employees of PPD Pharmaco, subject to the eligibility requirements of any plan(s) establishing same. Employee shall be subject to PPD Pharmaco's policies applicable to other executive employees of PPD Pharmaco 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 Pharmaco to its executive employees, including but not limited to issuance of stock options, cash bonuses, etc., to the extent such bonuses, etc., are not otherwise provided for herein in connection with Employee's duties and performance as an executive employee. 11. Expenses. PPD Pharmaco shall pay all reasonable expenses of Employee which are directly related to Employee's duties hereunder in accordance with PPD Pharmaco's policy for reimbursement of employee expenses. 12. Remedies. In the event of Employee's actual or threatened breach of the provisions of paragraph 7 of this Agreement, PPD Pharmaco 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 Pharmaco 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. 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. 3 14. Waiver of 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 Pharmaco, 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, if to PPD Pharmaco at PPD Pharmaco's principal office in Wilmington, North Carolina at the address hereinabove set forth, and if to Employee at PPD Pharmaco's principal office in Morrisville, North Carolina, and shall be deemed received when actually received. Any notice from Employee to PPD Pharmaco shall be addressed to the Chief Executive Officer and to the President and Chief Operating Officer of PPD, with a copy to the General Counsel of PPD. Either party hereto may change the notice address provided for herein upon ten days prior written notice to the other in the manner prescribed for herein. 20. Arbitration. Any dispute, controversy or claim arising out of or relating to this Agreement, including but not limited to any breach, or as to its existence, validity, interpretation, performance or non-performance, breach or damages, including claims in tort, shall be decided by a single neutral arbitrator in Wilmington, North Carolina in binding arbitration pursuant to the commercial Arbitration Rules of the American Arbitration Association then in effect. The parties to any such arbitration shall be limited to the parties to this Agreement or any successor thereof. The arbitration shall be conducted in accordance with the procedural laws of the United States Federal Arbitration Act, as amended. The written decision of the arbitrator shall be final and binding, and may be entered and enforced in any court of competent jurisdiction and each party specifically acknowledges and agrees to waive any right to a jury trial in any such forum. Each party to the arbitration shall pay its fees and expenses, unless otherwise determined by the arbitrator. 4 21. Amendment; Modification. No amendment or modification of this Agreement and no waiver by any party of the breach of any covenant contained herein shall be binding unless executed in writing by the party against whom enforcement of such amendment, modification or waiver is sought. No waiver shall be deemed a continuing waiver or a waiver in respect of any subsequent breach or deferral, either of a similar or different nature, unless expressly so stated in writing. 22. Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original and all of which taken together shall constitute one and the same Agreement. 23. Descriptive Headings: Interpretation. The descriptive headings in this Agreement are inserted for convenience of reference only and are not intended to be part of or to affect the meaning or interpretation of this Agreement. IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of the date first hereinabove set forth. PPD PHARMACO, INC. By: /s/ Thomas W. D'Alonzo ------------------------------ Name: Thomas W. D'Alonzo ------------------------------ Title: President ---------------------------- /s/ Joshua S. Baker ----------------------------(SEAL) Joshua S. Baker 5 EX-10 3 PPD - EXHIBIT 10.95 5 EMPLOYMENT AGREEMENT THIS EMPLOYMENT AGREEMENT (hereinafter the "Agreement"), made this 1st day of January, 1998, by and between Pharmaceutical Product Development, Inc., a North Carolina corporation with its principal office at 3151 17th Street Extension, Wilmington, North Carolina 28412 (hereinafter "PPD"), and Rudy C. Howard (hereinafter "Employee"). RECITALS: A. Employee desires employment upon the terms and conditions herein stated. B. PPD desires to employ Employee upon the terms and conditions herein stated. C. Employee and PPD desire to embody in writing the terms and conditions of such employment in this Agreement. NOW, THEREFORE, in consideration of the mutual promises, covenants and considerations contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows: 1. Employment. PPD hereby employs Employee and Employee hereby accepts such employment on a full time basis as Chief Financial Officer upon the terms and conditions hereinafter set forth. 2. Term. The term of this Agreement shall be for one year, beginning January 1, 1998, and ending December 31, 1998, 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 paragraph 9 below, unless either party gives notice as herein provided to the other of said party's intent not renew this Agreement not less than 60 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 Pharmaco shall pay to Employee an annual salary of $200,000 for the initial one-year term hereof. 4. Duties. Employee shall have overall responsibility for and decision making authority necessary to fulfill the duties of Chief Financial Officer of PPD. Employee shall undertake such travel as 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. 5. 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. 6. 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 in 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. 7. 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 Chief Executive Officer of PPD, acting in good faith but made in his sole discretion, that Employee has failed to substantially perform his duties under this Agreement. c. A determination by the Chief Executive Officer of PPD, acting in good faith but made in his sole discretion, 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. 8. Disclosure of Information. As a condition of employment hereunder, Employee will execute as of the date of this Agreement that certain Proprietary and Inventions Agreement attached hereto as Exhibit A and incorporated herein by reference. 9. Benefits. During the term thereof, Employee shall be entitled to participate in all benefits provided by PPD and its subsidiaries to their employees 2 generally, including but not limited to health insurance, disability insurance and retirement plans, all of which are currently provided to employees of PPD and its subsidiaries, 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., in connection with Employee's duties and performance as an executive employee. 10. Expenses. PPD Pharmaco shall pay all reasonable expenses of Employee which are directly related to Employee's duties hereunder in accordance with PPD's policy for reimbursement of employee expenses. 11. Remedies. In the event of Employee's actual or threatened breach of the provisions of paragraph 6 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. 12. 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. 13. Waiver of 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. 14. 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. 15. 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. 16. Applicable Law. This Agreement shall be governed by the laws of the State of North Carolina. 17. Assignment. Neither party hereto may assign said party's rights or obligations hereunder without the prior written consent of the other. 3 18. Notice. Any notice required or permitted hereunder shall be delivered in person or mailed certified mail, return receipt requested, if to PPD at PPD's principal office in Wilmington, North Carolina at the address hereinabove set forth, and if to Employee 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 of PPD, with a copy to the General Counsel of PPD. Either party hereto may change the notice address provided for herein upon ten days prior written notice to the other in the manner prescribed for herein. 19. Arbitration. Any dispute, controversy or claim arising out of or relating to this Agreement, including but not limited to any breach, or as to its existence, validity, interpretation, performance or non-performance, breach or damages, including claims in tort, shall be decided by a single neutral arbitrator in Wilmington, North Carolina in binding arbitration pursuant to the commercial Arbitration Rules of the American Arbitration Association then in effect. The parties to any such arbitration shall be limited to the parties to this Agreement or any successor thereof. The arbitration shall be conducted in accordance with the procedural laws of the United States Federal Arbitration Act, as amended. The written decision of the arbitrator shall be final and binding, and may be entered and enforced in any court of competent jurisdiction and each party specifically acknowledges and agrees to waive any right to a jury trial in any such forum. Each party to the arbitration shall pay its fees and expenses, unless otherwise determined by the arbitrator. 20. Amendment; Modification. No amendment or modification of this Agreement and no waiver by any party of the breach of any covenant contained herein shall be binding unless executed in writing by the party against whom enforcement of such amendment, modification or waiver is sought. No waiver shall be deemed a continuing waiver or a waiver in respect of any subsequent breach or deferral, either of a similar or different nature, unless expressly so stated in writing. 21. Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original and all of which taken together shall constitute one and the same Agreement. 22. Descriptive Headings: Interpretation. The descriptive headings in this Agreement are inserted for convenience of reference only and are not intended to be part of or to affect the meaning or interpretation of this Agreement. 4 IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman -------------------------------- Name: Fredric N. Eshelman ----------------------------- Title: Chief Executive Officer ----------------------------- /s/ Rudy C. Howard ---------------------------- (SEAL) Rudy C. Howard 5 EX-10 4 PPD- EXHIBIT 10.96 5 EMPLOYMENT AGREEMENT THIS EMPLOYMENT AGREEMENT (hereinafter the "Agreement"), made this 1st day of October, 1997, by and between PPD Pharmaco, Inc., a Texas corporation with its principal office at 3151 17th Street Extension, Wilmington, North Carolina 28412 (hereinafter "PPD Pharmaco"), and Patrick C. O'Connor, MRCP, Ph.D. (hereinafter "Employee"). RECITALS: A. Employee desires employment upon the terms and conditions herein stated. B. PPD Pharmaco desires to employ Employee upon the terms and conditions herein stated. C. Employee and PPD Pharmaco desire to embody in writing the terms and conditions of such employment in this Agreement. NOW, THEREFORE, in consideration of the mutual promises, covenants and considerations contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows: 1. Employment. PPD Pharmaco hereby employs Employee and Employee hereby accepts such employment on a full time basis as Senior Vice President - Regulatory and Product Development upon the terms and conditions hereinafter set forth. 2. Term. The term of this Agreement shall be for one year, beginning January 1, 1998, and ending December 31, 1998, 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 paragraph 9 below, unless either party gives notice as herein provided to the other of said party's intent not renew this Agreement not less than 60 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 Pharmaco shall pay to Employee an annual salary of $224,000 for the initial one-year term hereof. 4. Duties. Employee shall have overall responsibility for and decision making authority necessary to fulfill the duties of Senior Vice President - Regulatory and Product Development of PPD Pharmaco. Employee shall undertake such travel as 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 Pharmaco. 5. Working Facilities. PPD Pharmaco 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. 6. 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 in any other business which is developed by PPD Pharmaco 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 Pharmaco are national in scope. For that reason, the parties agree that a geographical limitation on the foregoing covenant is not appropriate. 7. Termination. Notwithstanding any other provision of this Agreement, PPD Pharmaco may terminate Employee's employment hereunder upon the occurrence of any of the following events: a. Death of Employee. b. A determination by the Chief Executive Officer and the President and Chief Operating Officer of Pharmaceutical Product Development, Inc. ("PPD"), acting in good faith but made in their sole discretion, that Employee has failed to substantially perform his duties under this Agreement. c. A determination by the Chief Executive Officer and the President and Chief Operating Officer of PPD, acting in good faith but made in their sole discretion, 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. 8. Disclosure of Information. As a condition of employment hereunder, Employee will execute as of the date of this Agreement that certain Proprietary and Inventions Agreement attached hereto as Exhibit A and incorporated herein by reference. 2 9. Benefits. During the term thereof, Employee shall be entitled to participate in all benefits provided by PPD Pharmaco to its employees generally, including but not limited to health insurance, disability insurance and retirement plans, all of which are currently provided to employees of PPD Pharmaco, subject to the eligibility requirements of any plan(s) establishing same. Employee shall be subject to PPD Pharmaco's policies applicable to other executive employees of PPD Pharmaco 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 Pharmaco to its executive employees, including but not limited to issuance of stock options, cash bonuses, etc., in connection with Employee's duties and performance as an executive employee. 10. Expenses. PPD Pharmaco shall pay all reasonable expenses of Employee which are directly related to Employee's duties hereunder in accordance with PPD Pharmaco's policy for reimbursement of employee expenses. 11. Remedies. In the event of Employee's actual or threatened breach of the provisions of paragraph 6 of this Agreement, PPD Pharmaco 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 Pharmaco 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. 12. 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. 13. Waiver of 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. 14. 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. 15. Benefit. This Agreement shall inure to the benefit of and be binding upon PPD Pharmaco, its successors and assigns, and Employee, his heirs, successors, assigns and personal representatives. 16. Applicable Law. This Agreement shall be governed by the laws of the State of North Carolina. 3 17. Assignment. Neither party hereto may assign said party's rights or obligations hereunder without the prior written consent of the other. 18. Notice. Any notice required or permitted hereunder shall be delivered in person or mailed certified mail, return receipt requested, if to PPD Pharmaco at PPD Pharmaco's principal office in Wilmington, North Carolina at the address hereinabove set forth, and if to Employee at PPD Pharmaco's principal office in Morrisville, North Carolina, and shall be deemed received when actually received. Any notice from Employee to PPD Pharmaco shall be addressed to the Chief Executive Officer and to the President and Chief Operating Officer of PPD, with a copy to the General Counsel of PPD. Either party hereto may change the notice address provided for herein upon ten days prior written notice to the other in the manner prescribed for herein. 19. Arbitration. Any dispute, controversy or claim arising out of or relating to this Agreement, including but not limited to any breach, or as to its existence, validity, interpretation, performance or non-performance, breach or damages, including claims in tort, shall be decided by a single neutral arbitrator in Wilmington, North Carolina in binding arbitration pursuant to the commercial Arbitration Rules of the American Arbitration Association then in effect. The parties to any such arbitration shall be limited to the parties to this Agreement or any successor thereof. The arbitration shall be conducted in accordance with the procedural laws of the United States Federal Arbitration Act, as amended. The written decision of the arbitrator shall be final and binding, and may be entered and enforced in any court of competent jurisdiction and each party specifically acknowledges and agrees to waive any right to a jury trial in any such forum. Each party to the arbitration shall pay its fees and expenses, unless otherwise determined by the arbitrator. 20. Amendment; Modification. No amendment or modification of this Agreement and no waiver by any party of the breach of any covenant contained herein shall be binding unless executed in writing by the party against whom enforcement of such amendment, modification or waiver is sought. No waiver shall be deemed a continuing waiver or a waiver in respect of any subsequent breach or deferral, either of a similar or different nature, unless expressly so stated in writing. 21. Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original and all of which taken together shall constitute one and the same Agreement. 22. Descriptive Headings: Interpretation. The descriptive headings in this Agreement are inserted for convenience of reference only and are not intended to be part of or to affect the meaning or interpretation of this Agreement. 4 IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of the date first hereinabove set forth. PPD PHARMACO, INC. By: /s/ Fredric N. Eshelman ------------------------------- Name: Fredric N. Eshelman ----------------------------- Title: Chief Executive Officer ----------------------------- /s/ Patrick C. O'Connor, MRCP ------------------------------(SEAL) Patrick C. O'Connor, MRCP, Ph.D. 5 EX-10 5 PPD PHARMACO, INC. EXHIBIT 10.97 EMPLOYMENT AGREEMENT THIS EMPLOYMENT AGREEMENT (hereinafter the "Agreement"), made this 1st day of October, 1997, by and between PPD Pharmaco, Inc., a Texas corporation with its principal office at 3151 17th Street Extension, Wilmington, North Carolina 28412 (hereinafter "PPD Pharmaco"), and Paul S. Covington, M.D. (hereinafter "Employee"). RECITALS: A. Employee desires employment upon the terms and conditions herein stated. B. PPD Pharmaco desires to employ Employee upon the terms and conditions herein stated. C. Employee and PPD Pharmaco desire to embody in writing the terms and conditions of such employment in this Agreement. NOW, THEREFORE, in consideration of the mutual promises, covenants and considerations contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows: 1. Employment. PPD Pharmaco hereby employs Employee and Employee hereby accepts such employment on a full time basis as Senior Vice President - Medical Affairs and Chief Safety Officer upon the terms and conditions hereinafter set forth. 2. Term. The term of this Agreement shall be for one year, beginning January 1, 1998, and ending December 31, 1998, 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 paragraph 9 below, unless either party gives notice as herein provided to the other of said party's intent not renew this Agreement not less than 60 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 Pharmaco shall pay to Employee an annual salary of $200,000 for the initial one-year term hereof. 4. Duties. Employee shall have overall responsibility for and decision making authority necessary to fulfill the duties of Senior Vice President - Medical Affairs and Chief Safety Officer of PPD Pharmaco. Employee shall undertake such travel as 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 Pharmaco. 5. Working Facilities. PPD Pharmaco 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. 6. 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 in any other business which is developed by PPD Pharmaco 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 Pharmaco are national in scope. For that reason, the parties agree that a geographical limitation on the foregoing covenant is not appropriate. 7. Termination. Notwithstanding any other provision of this Agreement, PPD Pharmaco may terminate Employee's employment hereunder upon the occurrence of any of the following events: a. Death of Employee. b. A determination by the Chief Executive Officer and the President and Chief Operating Officer of Pharmaceutical Product Development, Inc. ("PPD"), acting in good faith but made in their sole discretion, that Employee has failed to substantially perform his duties under this Agreement. c. A determination by the Chief Executive Officer and the President and Chief Operating Officer of PPD, acting in good faith but made in their sole discretion, 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. 8. Disclosure of Information. As a condition of employment hereunder, Employee will execute as of the date of this Agreement that certain Proprietary and Inventions Agreement attached hereto as Exhibit A and incorporated herein by reference. 2 9. Benefits. During the term thereof, Employee shall be entitled to participate in all benefits provided by PPD Pharmaco to its employees generally, including but not limited to health insurance, disability insurance and retirement plans, all of which are currently provided to employees of PPD Pharmaco, subject to the eligibility requirements of any plan(s) establishing same. Employee shall be subject to PPD Pharmaco's policies applicable to other executive employees of PPD Pharmaco 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 Pharmaco to its executive employees, including but not limited to issuance of stock options, cash bonuses, etc., in connection with Employee's duties and performance as an executive employee. 10. Expenses. PPD Pharmaco shall pay all reasonable expenses of Employee which are directly related to Employee's duties hereunder in accordance with PPD Pharmaco's policy for reimbursement of employee expenses. 11. Remedies. In the event of Employee's actual or threatened breach of the provisions of paragraph 6 of this Agreement, PPD Pharmaco 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 Pharmaco 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. 12. 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. 13. Waiver of 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. 14. 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. 15. Benefit. This Agreement shall inure to the benefit of and be binding upon PPD Pharmaco, its successors and assigns, and Employee, his heirs, successors, assigns and personal representatives. 16. Applicable Law. This Agreement shall be governed by the laws of the State of North Carolina. 3 17. Assignment. Neither party hereto may assign said party's rights or obligations hereunder without the prior written consent of the other. 18. Notice. Any notice required or permitted hereunder shall be delivered in person or mailed certified mail, return receipt requested, if to PPD Pharmaco at PPD Pharmaco's principal office in Wilmington, North Carolina at the address hereinabove set forth, and if to Employee at PPD Pharmaco's principal office in Wilmington, North Carolina, and shall be deemed received when actually received. Any notice from Employee to PPD Pharmaco shall be addressed to the Chief Executive Officer and to the President and Chief Operating Officer of PPD, with a copy to the General Counsel of PPD. Either party hereto may change the notice address provided for herein upon ten days prior written notice to the other in the manner prescribed for herein. 19. Arbitration. Any dispute, controversy or claim arising out of or relating to this Agreement, including but not limited to any breach, or as to its existence, validity, interpretation, performance or non-performance, breach or damages, including claims in tort, shall be decided by a single neutral arbitrator in Wilmington, North Carolina in binding arbitration pursuant to the commercial Arbitration Rules of the American Arbitration Association then in effect. The parties to any such arbitration shall be limited to the parties to this Agreement or any successor thereof. The arbitration shall be conducted in accordance with the procedural laws of the United States Federal Arbitration Act, as amended. The written decision of the arbitrator shall be final and binding, and may be entered and enforced in any court of competent jurisdiction and each party specifically acknowledges and agrees to waive any right to a jury trial in any such forum. Each party to the arbitration shall pay its fees and expenses, unless otherwise determined by the arbitrator. 20. Amendment; Modification. No amendment or modification of this Agreement and no waiver by any party of the breach of any covenant contained herein shall be binding unless executed in writing by the party against whom enforcement of such amendment, modification or waiver is sought. No waiver shall be deemed a continuing waiver or a waiver in respect of any subsequent breach or deferral, either of a similar or different nature, unless expressly so stated in writing. 21. Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original and all of which taken together shall constitute one and the same Agreement. 22. Descriptive Headings: Interpretation. The descriptive headings in this Agreement are inserted for convenience of reference only and are not intended to be part of or to affect the meaning or interpretation of this Agreement. 4 IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of the date first hereinabove set forth. PPD PHARMACO, INC. By: /s/ Fred Eshelman ----------------------------- Name: Fred Eshelman --------------------------- Title: CEO -------------------------- /s/ Paul S. Covington ---------------------------(SEAL) Paul S. Covington, M.D. EX-10 6 PPD PHARMACO EXHIBIT 10.98 5 EMPLOYMENT AGREEMENT THIS EMPLOYMENT AGREEMENT (hereinafter the "Agreement"), effective this 1st day of January, 1998 by and between PPD Pharmaco, Inc., a Texas corporation with its principal office at 3151 Seventeenth Street Extension, Wilmington, North Carolina 28412 (hereinafter "PPD Pharmaco"), and Mark A. Sirgo (hereinafter "Employee"). RECITALS: A. Employee desires employment upon the terms and conditions herein stated. B. PPD Pharmaco desires to employ Employee upon the terms and conditions herein stated. C. Employee and PPD Pharmaco desire to embody in writing the terms and conditions of such employment in this Agreement. NOW, THEREFORE, in consideration of the mutual promises, covenants and considerations contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows: 1. Employment. PPD Pharmaco hereby employs Employee and Employee hereby accepts such employment on a full time basis as Senior Vice President-Business Development upon the terms and conditions hereinafter set forth. 2. Term. The term of this Agreement shall be for one year, beginning January 1, 1998, and ending December 31, 1998 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 except for (a) salary adjustments as provided for in paragraph 9 below and (b) new bonus plans as provided in paragraph 3 below, unless either party gives notice as herein provided to the other of said party's intent not renew this Agreement not less than 60 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 Pharmaco shall pay Employee an annual base salary of $180,000 for the initial one-year term hereof. In addition, during the initial one-year term of this Agreement Employee shall be entitled to a Quarterly Bonus if the Businesses (as hereinafter defined) attain a certain level of Authorizations for the applicable quarter, as set forth in Appendix I attached. Each Quarterly Bonus to which Employee is entitled shall be paid within thirty (30) days after its determination. A new bonus plan shall be agreed upon by Employee and PPD Pharmaco for each one-year renewal term of this agreement. 4. Duties. Employee shall have overall responsibility for business development of (a) the Company and all of its subsidiaries (except Pharmaco Investments, Inc.), (b) Pharmaco International Ltd. and (c) Leicester Clinical Research Centre Ltd. (collectively, the "Businesses"). Employee's duties shall include but not be limited to supervision of the Businesses' sales and bids and contracts divisions. Employee shall carry out his duties and responsibilities under the general supervision of Chief Operating Officer of Pharmaceutical Product Development, Inc. ("PPD"). Employee shall 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 Pharmaco. 5. Working Facilities. PPD Pharmaco 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, including a car phone, home personal computer, printer and fax machine. 6. 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 in any other business which is developed by PPD Pharmaco 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 Pharmaco are national in scope. For that reason, the parties agree that a geographical limitation on the foregoing covenant is not appropriate. 7. Termination. Notwithstanding any other provision of this Agreement, PPD Pharmaco may terminate Employee's employment hereunder upon the occurrence of any of the following events: a. Death of Employee. b. A determination by the Chief Executive Officer and the President and Chief Operating Officer of PPD, acting in good faith but made in their sole discretion, that Employee has failed to substantially perform his duties under this Agreement. 2 c. A determination by the Chief Executive Officer and the President and Chief Operating Officer of PPD, acting in good faith but made in their sole discretion, 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, including failure to meet Quarterly Targets set forth in Appendix I attached, (iii) has demonstrated gross negligence or willful misconduct in the execution of his duties, or (iv) has been convicted of a felony. 8. Disclosure of Information. As a condition of employment hereunder, Employee will execute as of the date of this Agreement that certain Proprietary and Inventions Agreement attached hereto as Exhibit A and incorporated herein by reference. 9. Benefits. During the term thereof, Employee shall be entitled to participate in all benefits provided by PPD Pharmaco to its employees generally, including but not limited to health insurance, disability insurance and retirement plans, all of which are currently provided to employees of PPD Pharmaco, subject to the eligibility requirements of any plan(s) establishing same. Employee shall be subject to PPD Pharmaco's policies applicable to other executive employees of PPD Pharmaco 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 Pharmaco to its executive employees, including but not limited to issuance of stock options, cash bonuses, etc., to the extent such bonuses, etc., are not otherwise provided for herein in connection with Employee's duties and performance as an executive employee. Employee shall be entitled to six weeks paid vacation during each one-year term hereof. 10. Expenses. PPD Pharmaco shall pay all expenses of Employee which are directly related to Employee's duties hereunder. In addition, PPD Pharmaco will pay for a dining club membership, health club membership and annual professional dues not to exceed $1,500 a year. 11. Remedies. In the event of Employee's actual or threatened breach of the provisions of paragraph 6 of this Agreement, PPD Pharmaco 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 Pharmaco 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. 12. 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. 3 13. Waiver of 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. 14. 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. 15. Benefit. This Agreement shall inure to the benefit of and be binding upon PPD Pharmaco, its successors and assigns, and Employee, his heirs, successors, assigns and personal representatives. 16. Applicable Law. This Agreement shall be governed by the laws of the State of North Carolina. 17. Assignment. Neither party hereto may assign said party's rights or obligations hereunder without the prior written consent of the other. 18. Notice. Any notice required or permitted hereunder shall be delivered in person or mailed certified mail, return receipt requested, if to PPD Pharmaco at PPD Pharmaco's principal office in Wilmington, North Carolina at the address hereinabove set forth, and if to Employee at PPD Pharmaco's principal office in Morrisville, North Carolina, or to his last known home address, and shall be deemed received when actually received. Any notice from Employee to PPD Pharmaco shall be addressed to the Chief Executive Officer and to the President and Chief Operating Officer of PPD, with a copy to the General Counsel of PPD. Either party hereto may change the notice address provided for herein upon ten (10) days prior written notice to the other in the manner prescribed herein. 19. Arbitration. Any dispute, controversy or claim arising out of or relating to this Agreement, including but not limited to any breach of this Agreement, or its existence, validity, interpretation, performance or non-performance, or damages hereunder, including claims in tort, shall be decided by a single neutral arbitrator in Wilmington, North Carolina in binding arbitration pursuant to the commercial Arbitration Rules of the American Arbitration Association then in effect. The parties to any such arbitration shall be limited to the parties to this Agreement or any successor thereof. The arbitration shall be conducted in accordance with the procedural laws of the United States Federal Arbitration Act, as amended. The written decision of the arbitrator shall be final and binding, and may be entered and enforced in any court of competent jurisdiction and each party specifically acknowledges and agrees to waive any right to a jury trial in any such forum. Each party to the arbitration shall pay its fees and expenses, unless otherwise determined by the arbitrator. 4 20. Amendment; Modification. No amendment or modification of this Agreement and no waiver by any party of the breach of any covenant contained herein shall be binding unless executed in writing by party against whom enforcement of such amendment, modification or waiver is sought. 21. Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original and all of which taken together shall constitute one and the same Agreement. 22. Descriptive Headings: Interpretation. The descriptive headings in this Agreement are inserted for convenience of reference only and are not intended to be part of or to affect the meaning or interpretation of this Agreement. IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of the date first hereinabove set forth. PPD PHARMACO, INC. By: /s/ Fred N. Eshelman -------------------------------- Name: Fred N. Eshelman ----------------------------- Title: Chief Executive Officer ---------------------------- /s/ Mark A. Sirgo -----------------------------(SEAL) Mark A. Sirgo APPENDIX I A. Definitions "Authorizations" means that portion of the face amount of all client contracts and amendments thereto, letters of intent and client verbal commitments included in backlog for the Businessess in 1998. Authorizations attained by the Businesses for each quarter shall be determined by PPD's Finance Department, acting in good faith after consultation with appropriate senior representatives of the Company's Global Business Development and Global Operations divisions, but in its sole discretion. "Quarterly Bonus" means the bonus to be paid to Employee based upon the Quarterly Target attained by the Businesses for the applicable quarter. "Quarterly Target" means the level of Authorizations attained by the Businesses for the applicable quarter which entitles Employee to a Quarterly Bonus. B. Quarterly Bonus Schedule 1. Q1 '98 (January 1, 1998-March 31, 1998) Quarterly Target(1) Quarterly Bonus - ------------------- --------------- At least 73,842 but less than 77,945 $ 6,250.00 At least 77,945 but less than 82,047 12,500.00 At least 82,047 but less than 86,149 18,750.00 At least 86,149 but less than 90,252 22,500.00 At least 90,252 but less than 94,354 25,000.00 At least 94,354 but less than 98,456 31,250.00 At least 98,456 but less than 102,559 37,500.00 102,559 or more 43,750.00 2. Q2 '98 (April 1, 1998-June 30, 1998) Quarterly Target(1) Quarterly Bonus - ------------------- --------------- At least 80,332 but less than 84,795 $ 6,250.00 At least 84,795 but less than 89,258 12,500.00 At least 89,258 but less than 93,721 18,750.00 At least 93,721 but less than 98,184 22,500.00 At least 98,184 but less than 102,647 25,000.00 At least 102,647 but less than 107,110 31,250.00 At least 107,110 but less than 111,573 37,500.00 111,573 or more 43,750.00 3. Q3 '98 (July 1, 1998-September 30, 1998) Quarterly Target(1) Quarterly Bonus - ------------------- --------------- At least 87,229 but less than 92,075 $ 6,250.00 At least 92,075 but less than 96,921 12,500.00 At least 96,921 but less than 101,767 18,750.00 At least 101,767 but less than 106,613 22,500.00 At least 106,613 but less than 111,459 25,000.00 At least 111,459 but less than 116,305 31,250.00 At least 116,305 but less than 121,151 37,500.00 121,151 or more 43,750.00 4. Q4 '98 (October 1, 1998-December 31, 1998) Quarterly Target(1) Quarterly Bonus - ------------------- --------------- At least 94,657 but less than 99,915 $ 6,250.00 At least 99,915 but less than 105,174 12,500.00 At least 105,174 but less than 110,433 18,750.00 At least 110,433 but less than 115,691 22,500.00 At least 115,691 but less than 120,950 25,000.00 At least 120,950 but less than 126,209 31,250.00 At least 126,209 but less than 131,468 37,500.00 131,468 or more 43,750.00 (1) All Quarterly Target figures are expressed in thousands of dollars. EX-10 7 PPD EXHIBIT 10.99 AMENDMENT TO EMPLOYEE AGREEMENT THIS AMENDMENT TO EMPLOYMENT AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc., a North Carolina corporation ("PPD") and Fred B. Davenport, Jr. ("Employee"), amends that certain Employment Agreement dated September 26, 1996 between PPD and Employee (the "Employment Agreement"). WHEREAS, concurrent with the execution of this Amendment Employee has entered into a Severance Agreement with the Company that provides for benefits similar to those provided to Employee under Section 20 of the Employment Agreement; WHEREAS, Employee is required to agree to enter into this Amendment deleting the provisions of Section 20 of the Employment Agreement in order to receive the benefits provided by the Severance Agreement. NOW, THEREFORE, in consideration of the mutual covenants herein contained, the parties hereby agree that Section 20 of the Employment Agreement is deleted effective the date hereof. The Employment Agreement, as amended herein, shall continue in full force and effect. IN WITNESS WHEREOF, the parties have caused this Amendment to be executed as of the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------------ Name: Fredric N. Eshelman Title: Chief Executive Officer /s/ Fred B. Davenport, Jr. ---------------------------(SEAL) Fred B. Davenport, Jr. EX-10 8 PPD - EXHIBIT 10.100 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and Fredric N. Eshelman ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twelve (12) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of one year after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock 2 options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: Fredric N. Eshelman 6814 Towles Road --------------------- Wilmington, NC 28409 --------------------- Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces 3 in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fred B. Davenport, Jr. ------------------------------ Title: Vice President Legal --------------------------- EMPLOYEE /s/ Fredric N. Eshelman ------------------------- (SEAL) Name: Fredric N. Eshelman EX-10 9 PPD - EXHIBIT 10.101 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and Thomas D'Alonzo ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twelve (12) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of one year after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock 2 options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: Thomas D'Alonzo ----------------- 2608 Tatton Drive ----------------- Raleigh, NC 27608 ----------------- Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces 3 in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------ Title: CEO EMPLOYEE /s/ Thomas D'Alonzo ---------------------(SEAL) Name: Thomas D'Alonzo EX-10 10 PPD EXHIBIT 10.102 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and Rudy C. Howard ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twenty-four (24) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of two years after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 2 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: Rudy C. Howard 322 Windchase Lane ------------------ Wilmington NC 28409 ------------------- Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. 3 f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman --------------------------- Title: Chief Executive Officer ------------------------ EMPLOYEE /s/ Rudy C. Howard -------------------------(SEAL) Name: Rudy C. Howard 4 EX-10 11 PPD -EXHIBIT 10.103 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and Fred B. Davenport, Jr. ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twenty-four (24) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of two years after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock 2 options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: Fred B. Davenport, Jr. 6612 Sedgewood Road ------------------- Wilmington NC 28403 -------------------- Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces 3 in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------ Title: CEO -------------------- EMPLOYEE /s/ Fred B. Davenport, Jr. --------------------------(SEAL) Name: Fred B. Davenport, Jr. 4 EX-10 12 PPD - EXHIBIT 10.104 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and Joseph H. Highland ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twelve (12) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of one year after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock 2 options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: Joseph H. Highland 68 Colfax Road ------------------ Skillman, NJ 08558 ------------------ Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces 3 in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric Eshelman ----------------------------- Title: CEO EMPLOYEE /s/ Joseph H. Highland ------------------------(SEAL) Name: Joseph H. Highland EX-10 13 PPD - EXHIBIT 10.105 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and Joshua S. Baker ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twelve (12) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of one year after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 2 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: Joshua S. Baker 3304 Arthur Miami Road ---------------------- Hillsboro, NC 27278 ---------------------- Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. 3 f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------ Title: CEO EMPLOYEE /s/ Joshua s. Baker -------------------------(SEAL) Name: Joshua S. Baker EX-10 14 PPD - EXHIBIT 10.106 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and Patrick C. O'Connor ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twelve (12) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of one year after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock 2 options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: Patrick C. O'Connor /s/ Patrick C. O'Connor ----------------------- Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces 3 in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman --------------------------- Title: CEO EMPLOYEE /s/ Patrick C. O'Connor -----------------------(SEAL) Name: Patrick C. O'Connor EX-10 15 PPD - EXHIBIT 10.107 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and Paul S. Covington ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twelve (12) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of one year after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock 2 options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: Paul S. Covington 3116 Braemar Lane -------------------------- Wilmington, NC 28409-8569 -------------------------- Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces 3 in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------ Title: CEO EMPLOYEE /s/ Paul S. Covington ---------------------(SEAL) Name: Paul S. Covington EX-10 16 PPD - EXHIBIT 10.108 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and Mark A.Sirgo ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twelve (12) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of one year after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 2 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: Mark A. Sirgo /s/ Mark A. Sirgo ----------------- Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. 3 f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fredric N. Eshelman ------------------------ Title: CEO EMPLOYEE /s/ Mark A. Sirgo -----------------(SEAL) Name: Mark A. Sirgo EX-10 17 PPD - EXHIBIT 10.109 SEVERANCE AGREEMENT THIS AGREEMENT, made this 2nd day of February, 1998, by and between Pharmaceutical Product Development, Inc. ("PPD") and William Neilson ("Employee"). WHEREAS, Employee is a valued employee of PPD and in order to induce Employee to remain in the employ of PPD, PPD desires to provide the severance benefits hereinafter described in the event of a "Change in Control", as hereinafter defined, of PPD. NOW, THEREFORE, it is agreed as follows: 1. Definitions a. "Change in Control" means a change of control of a nature that would be required to be reported in response to Item 6(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 50% or more of the combined voting power of PPD's then outstanding securities. b. "Constructive Termination" means a termination of Employee's employment by PPD during the Covered Period initiated by Employee after (i) a substantial diminution or alteration in the duties of Employee, (ii) a reduction by PPD in Employee's base salary in effect on the date of the Change in Control, or (iii) the relocation of Employee's primary work location to a location that is more than twenty-five (25) miles from Employee's primary work location prior to the Change in Control. Constructive Termination specifically does not include termination of Employee by reason of death, Disability or retirement at or after age 65. Employee shall give PPD written notice of a Constructive Termination, which notice shall provide a brief description of the circumstances which Employee asserts gives rise to a right of Constructive Termination, and PPD shall have ten (10) days from receipt of said notice within which to remedy said circumstances. c. "Covered Period" means the time period commencing on the date of and coincident with a Change of Control and ending one year thereafter. d. "Disability" means the inability of Employee to perform his assigned duties for PPD for a period of three (3) months due to Employee's physical or mental illness as determined by a reputable medical doctor. e. "PPD" means Pharmaceutical Product Development, Inc. and all of its subsidiaries and affiliated entities. f. "Termination for Cause" means (i) an act or acts involving fraud, embezzlement or theft from PPD, (ii) Employee's willful and repeated failure to follow directions of the Board of Directors that continues for at least ten (10) days following written notice of the Board of Directors of such failure to follow directions, or (iii) termination for cause as defined in and made pursuant to a then effective employment agreement, if any, between Employee and PPD. 2. Compensation Upon Change of Control. If during the Covered Period (i) PPD terminates Employee's employment for reason other than Termination for Cause or (ii) Employee's employment is terminated by reason of Constructive Termination, Employee shall be entitled to the following compensation and benefits: a. PPD shall pay Employee a lump sum equal to Employee's W-2 compensation for the twelve (12) months ending on the last day of the month preceding the month of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. b. PPD shall pay Employee any bonus or deferred compensation (whether in the form of cash, stock or otherwise) accrued but unpaid as of Employee's termination, said sum to be paid within ten (10) days after Employee's termination of employment. c. For a period of one year after Employee's termination of employment with PPD, PPD shall continue to pay for and provide existing employee welfare benefits which Employee is receiving as of the date of termination of employment, including life insurance, health, medical, dental, vision and wellness, accidental death and dismemberment and disability benefits; provided, however, that PPD's obligations under this clause shall terminate from the date that Employee first becomes eligible after termination of employment with PPD for similar coverage under another employer's plan. d. Notwithstanding anything to the contrary in any award agreement for non-qualified stock options, (i) all unvested shares underlying PPD non-qualified stock options granted more than six months prior to the date of Employee's termination shall become fully vested as of the date of Employee's termination, and (ii) Employee shall continue to be treated under each award agreement as if he was an employee of PPD until the first to occur of (x) the third anniversary of Employee's termination of employment, or (y) the expiration of the exercise period provided for therein; provided, however, in the event of Employee's death or his disability (as disability is defined in the award agreement) after the date of Employee's termination of employment hereunder, the time for exercise after death or such disability prescribed in the award agreement shall apply. The provisions of this subsection shall also apply to any and all substitute stock options granted to Employee in exchange for Employee's PPD non-qualified stock options to which this subsection applies. 2 3. Miscellaneous. a. PPD will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of PPD, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that PPD would be required to perform it if no succession had taken place. b. This Agreement shall inure to the benefit of and be enforceable by Employee's personal or legal representatives, executives, administrators, successors, heirs, distributees, devisees and legatees. c. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be given (i) by certified mail, return receipt requested, postage prepaid, or (ii) by recognized overnight carrier, and shall be deemed received when actually received. Notices shall be addressed as follows: If to PPD: Pharmaceutical Product Development, Inc. 3151 17th Street Extension Wilmington, North Carolina 28412 Attention: Chief Executive Officer If to Employee: William Neilson 15 Mermaid Street ----------------- RYK East Sags Ex ----------------- TN317ET-UK ----------------- Either party hereto may change the notice address by giving notice thereof in the same manner as provided for herein. d. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any provision or condition of this Agreement to be performed by such other party shall be deemed a subsequent waiver of the same or similar provisions or conditions. e. No agreements or representations, oral or otherwise, expressed or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly in this agreement, and this Agreement supersedes and replaces in its entirety all prior agreements and representations, expressed, implied, oral or otherwise, made by PPD to or with Employee. 3 f. This Agreement shall be governed by and interpreted under the laws of the State of North Carolina. g. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. h. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. i. All legal expenses incurred by Employee in the successful enforcement of any of the terms of this Agreement shall be paid by PPD. IN WITNESS WHEREOF, the parties have executed this Agreement effective the date first hereinabove set forth. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: Fredric N. Eshelman ----------------------- Title: Chief Executive Officer EMPLOYEE /s/ William Neilson -------------------(SEAL) Name: William Neilson EX-10 18 PHARMACEUTICAL PRODUCTS DEV - EXHIBIT 10.110 PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. EMPLOYEE STOCK PURCHASE PLAN Instrument of Amendment THIS INSTRUMENT OF AMENDMENT (the "Instrument") is executed this 2nd day of March, 1998 by PHARMACEUTICAL PRODUCT DEVELOPMENT, INC., a North Carolina corporation (the "Company"). Statement of Purpose The Company sponsors the Pharmaceutical Product Development, Inc. Employee Stock Purchase Plan (the "Plan"). The Company desires to amend the Plan to establish certain limits on the purchase of Company stock under the Plan, especially in connection with the availability of cash contributions in addition to payroll deductions. The amendments set forth herein have been approved by the Company's Board of Directors in accordance with Section 7.3 of the Plan. NOW, THEREFORE, the Plan is hereby amended effective as of the date hereof as follows: 1. The following subparagraph (3) is added to the end of Section 3.2(b) of the Plan: "(3) In no event may the total number of shares of Common Stock that may be purchased by Participants for any Offering Period exceed the lesser of (A) an amount that the Board of Directors may, in its sole and exclusive discretion, establish from time to time or (B) the total remaining shares available pursuant to Section 3.1. In the event that the total number of shares of Common Stock to be purchased for an Offering Period would otherwise exceed the limit set forth in the preceding sentence, the Committee shall first reduce shares to be purchased by non-payroll deduction additional cash contributions for such Offering Period proportionately among all Participants who have made such additional cash contributions; and if such limit would still be exceeded, the Committee shall then reduce shares to be purchased by payroll deductions for such Offering Period proportionately among all Participants who have made such payroll deductions." 2. The following additional sentence is added to the end of Section 4.1 of the Plan: "Notwithstanding the foregoing, (i) for the Offering Period beginning on January 1, 1998, the maximum amount of such additional contributions that may be made by any Participant shall not exceed five thousand dollars ($5,000) and (ii) no such additional contributions shall be permitted for Offering Periods beginning on or after July 1, 1998." 3. Except as expressly or by necessary implication amended hereby, the Plan shall continue in full force and effect. IN WITNESS WHEREOF, the Company has caused this Instrument to be executed by its duly authorized officer as of the day and year first above written. PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. By: /s/ Fred Eshelman -------------------------------- Name Fred Eshelman -------------------------- Title: CEO -------------------------- 2 EX-21 19 PHARMACEUTICAL PRODUCTS - EXHIBIT 21 Exhibit 21 Pharmaceutical Product Development, Inc., and Subsidiaries Subsidiaries The subsidiaries of Pharmaceutical Product Development, Inc., as of February 27, 1998, are as follows: Jurisdiction of Incorporation or Name of Subsidiary Organized in ------------------------------------------- ----------------------------- 1. Applied Bioscience International Inc. Delaware 2. PPD Pharmaco, Inc. Texas 3. Pharmaco International Holdings, Inc. Delaware 4. Pharmaco Investments Inc. Delaware 5. PPD Pharmaco International SNC France 6. Pharma Contracts Scandinavia AB Sweden 7. PPD Pharmaco Canada, Ltd. Canada 8. PPD Do Brazil-Suporte Brazil 9. Q & Q Brazil 10. Pharmaco International Holdings GmbH Germany 11. Pharmaco GmbH Germany 12. Pharmaco International Sp.zo.o Poland 13. PI Praha, s.r.o. Czech Republic 14. Trilife GmbH & Co. KG Germany 15. Safe-Trade 41 (Pty) Ltd. South Africa 16. PPD UK Holdings Ltd. United Kingdom 17. Pharmaco International 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. Chelmsford Clinical trials Unit Ltd. (formerly 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. PPD Pharmaco Pty Limited Australia 30. PPD Pharmaco SRL Italy 31. PPD Spain, S.L. Spain 32. Intek Labs, Inc. North Carolina 33. Cambridge Applied Nutrition Toxicology and Bioscience Limited United Kingdom 34. Clinical Technology Centre (International) Limited United Kingdom 35. Technical Assessment Systems, Inc. Maryland 36. Belmont Research, Inc. Massachusetts 37. PPD Discovery, Inc. North Carolina 38. Target Discovery, Inc. North Carolina 39. SARCO, Inc. Delaware Subsidiaries 1, 32, 36 and 37 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, 15, 29, 30, and 31 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, 22 and 23 are wholly owned subsidiaries of Subsidiary 16. Subsidiary 35 is a wholly owned subsidiary of Subsidiary 28. Subsidiaries 33, and 34 are wholly owned subsidiaries of Subsidiary 17. Subsidiaries 38 and 39 are wholly owned subsidiaries of Subsidiary 37. Subsidiary 28 does business under the trade name ENVIRON.
EX-23 20 PHARMACEUTICAL PRODUCTS - EXHIBIT 23.1 EXHIBIT 23.1 CONSENT OF INDEPENDENT ACCOUNTANTS We consent to the incorporation by reference in the registration statement of Pharmaceutical Product Development, Inc. and its subsidiaries of Form S-8 (File No. 333-20925) of our reports dated February 5, 1998, except as to the information presented in Note 20 for which the date is February 27, 1998, on our audits of the consolidated financial statements and financial statement schedules of Pharmaceutical Product Development, Inc. and its subsidiaries as of December 31, 1997 and 1996 and for the years then ended, which report is included in this annual report on Form 10-K. We also consent to the reference to our firm under the caption selected financial data. COOPERS & LYBRAND L.L.P. Raleigh, North Carolina March 20, 1998 EX-23 21 PHARMACEUTICAL PRODUCTS EXHIBIT 23.2 EXHIBIT 23.2 Consent of Independent Public Accountants As independent public accountants, we hereby consent to the incorporation or our report dated February 22, 1996, included in this Form 10-K into the Company's previously filed Registration Statement on Form S-8, File No. 333-20925. /s/ Arthur Andersen LLP Washington, D.C. March 20, 1998 EX-27 22 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-31-1997 Jan-01-1997 Dec-31-1997 15,879 7,994 103,069 1,515 0 136,497 83,960 49,058 197,047 66,547 0 0 0 2,295 125,310 197,047 0 235,272 0 130,199 90,861 0 478 15,676 6,074 9,602 0 0 0 9,602 0.42 0.42
EX-99 23 PHARMACEUTICAL PRODUCTS DEV - EXHIBIT 99 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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