- ------------------------------------------------------------------------------- - ------------------------------------------------------------------------------- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ---------------- FORM 10-K ---------------- ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 1997 COMMISSION FILE NO. 0-27698 CHIREX INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) DELAWARE 04-3296309 (STATE OR OTHER JURISDICTION OF (IRS EMPLOYER IDENTIFICATION NUMBER) INCORPORATION OR ORGANIZATION) 300 ATLANTIC STREET, SUITE 402 STAMFORD, CONNECTICUT 06901 (ADDRESS OF PRINCIPLE EXECUTIVE OFFICE) (ZIP CODE) (203) 351-2300 (REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE) TITLE OF EACH CLASS SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE SECURITIES EXCHANGE ACT NAME OF EXCHANGE OF 1934 ON WHICH REGISTERED ___________________________ __________________________________ COMMON STOCK, $.01 PAR VALUE THE NASDAQ STOCK MARKET'S NATIONAL MARKET SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE SECURITIES EXCHANGE ACT OF 1934: NONE. 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 the registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K [X] The aggregate market value of the voting stock held by non-affiliates of the registrant was approximately $197,632,965 as of March 4, 1998. APPLICABLE ONLY TO CORPORATE REGISTRANTS As of March 4, 1998 there were 11,798,983 shares outstanding (excluding as of such date 1,491,295 shares of common stock issuable upon exercise of options with a weighted average price of $10.78 per share). - ------------------------------------------------------------------------------- - ------------------------------------------------------------------------------- CHIREX INC. TABLE OF CONTENTS PAGE ---- PART I ITEM 1. BUSINESS....................................................... 1 ITEM 2. PROPERTIES..................................................... 11 ITEM 3. LEGAL PROCEEDINGS.............................................. 11 ITEM 4. SUBMISSIONS OF MATTERS TO A VOTE OF SECURITY HOLDERS........... 11 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS........................................................ 12 ITEM 6. SELECTED FINANCIAL DATA........................................ 13 ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS...................................... 15 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.................... 15 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE........................................... 15 PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT............. 15 ITEM 11. EXECUTIVE COMPENSATION......................................... 15 ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS................ 15 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS................. 15 PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS........... 16 PART I ITEM 1. BUSINESS GENERAL ChiRex Inc. (the "Company" or "ChiRex") is a contract manufacturing organization ("CMO") serving the outsourcing needs of the pharmaceutical industry through its extensive pharmaceutical fine chemical manufacturing and process development capabilities and proprietary technologies. The Company supports and supplements the in-house development and manufacturing capabilities of its pharmaceutical and biotechnology customers with a broad range of fully-integrated services, accelerating the time from drug discovery to commercialization. The Company currently manufactures over 50 products at its manufacturing facilities located in Dudley, England and Annan, Scotland. The Company's customers include Glaxo Wellcome plc, SmithKline Beecham plc, Pfizer Inc., Pharmacia & Upjohn Inc., Rohm and Haas Company, ACS Dobfar, Cell Therapeutics Inc., and Sanofi S.A. The Company was created simultaneously with its initial public offering in March 1996 (the "IPO") through the combination of a U.S.-based chiral chemistry business, SepraChem, Inc. and a U.K-based pharmaceutical fine chemical manufacturing business, Sterling Organics Limited. Since the IPO, the Company has integrated these operations, added new core products to the Company's portfolio while phasing out non-core products to release capacity and improve profitability, purchased a new manufacturing facility in Annan, Scotland and further developed its commercial development process and technology base. The Company is engaged in one business segment, the development, manufacture and marketing of pharmaceutical fine chemicals. RECENT DEVELOPMENTS In October 1997, the Company purchased a Glaxo Wellcome plc pharmaceutical production facility located in Annan, Scotland for approximately $69 million, including payment for certain working capital. As part of the transaction, Glaxo Wellcome awarded the Company a five-year contract to supply certain pharmaceutical intermediates and active ingredients with an aggregate sales value of approximately $450 million in revenues. The Company plans to invest approximately $25 million over two years to accommodate newly contracted products and modify the facility for general purpose manufacturing. In April 1997, as part of its strategy to phase out of non-core products, the Company disposed of its acetaminophen (paracetamol) business to Rhone Poulenc Chimie SpA. Although acetaminophen, an OTC analgesic, was the largest volume product manufactured by the Company, representing approximately 31% of the Company's 1996 pro forma revenues, it was not highly profitable at the gross margin level and certain long-term supply arrangements were scheduled to terminate by 1998 year end. In connection with the disposition of the business, the Company implemented measures to partially offset the effect on operating performance, including a 15% headcount reduction and a rebudget of all cost centers. During the spring of 1997 the Company finalized its 1996 agreement with Dabur India Ltd. ("Dabur") to dissolve their joint venture, InNova Pharmaceuticals SRL ("InNova") due to certain changes in the market for semi- synthetic paclitaxel, a compound used in the treatment of breast and ovarian cancer. In January 1997, the Company entered into an exclusive license with Harvard University for the application of kinetic resolution technology ("KR Technology") applicable to the manufacture of single isomer forms of certain chiral intermediates. The Company believes that such technology may be developed to reduce the manufacturing costs and improve purity, potency and efficacy for some single-isomer drugs and intermediates. INDUSTRY CMOs have evolved from providing limited third-party manufacturing services to offering a full range of drug development and manufacturing capabilities. CMOs currently offer research and development and hazard 1 evaluation capabilities, scale-up facilities, state-of-the-art analytical departments, documentation expertise, large, multi-purpose, FDA-inspected current Good Manufacturing Practices ("cGMP") facilities and efficient waste treatment facilities. The development and scale-up of customers' products requires CMOs to interact with their customers on many levels. In many cases, the customers' technical personnel work closely with the CMOs staff to scale- up new products, monitor manufacturing and assist with regulatory compliance. This process necessitates a high degree of confidence in the CMO's technical expertise as well as its ability to safeguard confidential information. Due to the interactive nature of their services, a CMO's success depends on the strength of its relationships with customers. Critical success factors for CMOs in developing outsourcing relationships with major life science companies include: .An established reputation and proven track record .Flexible cGMP manufacturing capacity at clinical, pilot and commercial scale .Technical competence and a broad technology base .Regulatory support at all development stages .Financial stability .Secure management of trade secrets and intellectual property rights According to A.D. Little, in 1996 the global market for the manufacture of pharmaceutical fine chemical intermediates and bulk actives and custom synthesis was approximately $12.0 billion. In recent years, outsourcing of drug development and manufacturing activities by pharmaceutical and biotechnology companies has increased for the following reasons: Cost Containment Pressures. Recently, drug companies have been focusing on more efficient ways of conducting business because of margin pressures stemming from patent expirations, market acceptance of generic drugs and pressure from regulators and payors to reduce drug prices. In addition, managed care organizations are beginning to limit the selection of drugs that affiliated physicians may prescribe, thereby further increasing competition among pharmaceutical and biotechnology companies. The Company believes that the pharmaceutical industry is responding by focusing its resources on new drug discovery, regulatory compliance and sales and marketing while outsourcing information management, clinical trial management, process development and supply of pharmaceutical intermediates and active ingredients. Reducing Drug Development Time. Pharmaceutical and biotechnology companies face increased pressure to deliver new drugs to market in the shortest possible time in order to accelerate realization of revenue, capture market share and obtain the longest possible term of patent protection. By working in collaboration with CMOs like the Company, pharmaceutical and biotechnology companies can focus on their core competencies of drug discovery and marketing activities. The Company believes that CMOs are often able to perform essential services with a higher level of expertise and specialization, and in less time than its customers could perform such services in-house, resulting in reduced new drug development times. Increasingly Complex Drug Manufacturing Processes. An increasing proportion of drugs under development are single-isomer pharmaceuticals, which for certain drugs may have advantages over racemic mixtures, including reduced side effects, increased safety and higher potency. The ability to determine the biological activity of each isomer has led to increasing regulatory pressure to develop drugs in single-isomer form. Current FDA guidelines require a demonstration of biological activity for each isomer, including therapeutic benefits and side effects. As a result, the cost and time of development are significantly greater for compounds developed as racemic mixtures as compared to single-isomers, creating a demand for new processes and process technologies that can produce single- isomer drugs and intermediates cost effectively. Rather than develop complex manufacturing processes in-house, pharmaceutical companies are moving towards outsourcing these functions to CMOs with demonstrated process technology expertise. 2 Growth of Biotechnology Industry. The biotechnology industry and the number of drugs produced by it have grown substantially over the past decade. Many biotechnology companies have chosen not to spend the substantial capital resources, time, competency, personnel and risk necessary to operate a cGMP manufacturing facility, but utilize CMOs to perform these functions both during product development and commercialization. Although these trends will result in increased competition, the Company believes there are significant entry barriers to the high value-added CMO industry, including the need for cGMP commercial scale manufacturing capacity and world-class pilot plant facilities, access to and expertise in leading manufacturing and process technologies and the ability to manage the complex regulatory regime governing new product development. BUSINESS STRATEGY The Company's goal is to be a preferred partner to major pharmaceutical and life sciences companies in the development of manufacturing processes and to supply on a commercial scale pharmaceutical intermediates and active ingredients for leading proprietary and generic drugs. The Company's strategy for achieving this objective is to: . leverage its research and development expertise to develop and maintain its process technologies for the manufacture of a broad spectrum of complex chemicals and extend its relationship with leading academic institutions to capture next generation process technologies; . expand cGMP manufacturing capacity at its Dudley and Annan facilities and explore opportunities to acquire additional facilities or complementary businesses; . provide clinical scale manufacturing capacity with safe, efficient scale up for its customers' products in its state-of-the art pilot plant facility; and . apply its proprietary technologies to the development and manufacture of a range of chiral intermediates which the Company intends to market at higher margins than those achievable using non-proprietary technologies. CORE COMPETENCIES The Company offers a full range of manufacturing and process development services to its clients. These services include process research and development, clinical quantity production capability and commercial-scale manufacturing, as well as hazard evaluation capabilities, sophisticated chemical analysis services and regulatory and documentation expertise. The Company provides all or any portion of its service capabilities to its customers and works with its customers to tailor the range of services provided based on the customer's needs. The Company has developed the following core competencies. Advanced Manufacturing Over the last 30 years, the Company has developed expertise in the synthesis, scale-up and manufacture of complex pharmaceutical intermediates and active ingredients at its Dudley site. This 42-acre site was originally constructed by Sterling Winthrop Inc. in the late 1960's and became its primary pharmaceutical chemical manufacturing facility. With a production capacity of 600 cubic meters (over 160,000 gallons), the Dudley facility is one of the largest independent pharmaceutical chemical manufacturing facilities in the world. Since 1992, the Company has invested over $50 million at the site, including major expenditures on waste water treatment facilities and a new cGMP pilot plant and development center. There are three main production buildings at the Dudley site which have a variety of advanced equipment to provide a flexible FDA-inspected, cGMP and ISO 9002 certified manufacturing base. Two of the buildings provide multi- process facilities (including a segregated bulk pharmaceutical purification suite fitted with reactors, isolation and finishing equipment) capable of performing an extensive range of chemical 3 transformations. The third building is a plant that was dedicated to the manufacture of acetaminophen. The equipment associated with the acetaminophen business was dismantled in 1997 and this plant is now available for future capacity expansion. The combination of the three main production buildings and the state-of-the-art pilot plant and development center enable the Company to manufacture efficiently products in quantities from laboratory samples to commercial scale. The Company has made a significant addition to its manufacturing capacity with the acquisition of a former Glaxo Wellcome facility in Annan, Scotland. This 154 acre site encompasses three main production buildings. Two of the production buildings have operated as a unit since 1980 to produce large volumes of an anti-hypertensive drug. Special features of this unit include computer control and totally enclosed plant with bulk handling systems (for both powders and liquids) to ensure safe processing of chemicals and solvents. The second production unit was opened in 1987 and has manufactured one of the intermediates for an anti-ulcer drug. Under a Supply Agreement with Glaxo Wellcome, the Company will continue to manufacture certain products currently made at the site and plans to invest approximately $25 million over two years to accommodate newly contracted products and modify the facility for general purpose pharmaceutical fine chemical manufacturing. The second production unit comprises nearly half the site capacity and is available for future contract manufacturing demand. The Company's quality assurance department has extensive experience in the analysis, quality assurance, validation and registration of bulk pharmaceutical and fine chemicals. The Company's analytical laboratories contain fully-automated equipment with extensive data handling capabilities, spectroscopic systems and variable wavelength and diode-array UV capabilities designed to ensure that the Company's products comply with all pharmacopeia and regulatory requirements. Process Development The Company possesses significant expertise in manufacturing process research and development. These skills are critical to advancing a product from the laboratory to pilot plant and finally commercial scale manufacturing in a timely and cost effective manner. Following an initial inquiry, the Company provides feasibility studies and cost estimates to the customer. The Company engages in initial process research and development, hazard evaluation and produces laboratory samples. In connection with process development, the Company utilizes computer controlled reaction calorimeters and analytical equipment, and is assisted by its Scientific Advisory Board, which includes leading academics in various fields of chemistry. Ultimately, a pilot plant product which receives regulatory approval and is deemed commercially viable is scaled-up to commercial manufacture. Historically, approximately 80% of products that reach the pilot plant result in full commercial manufacturing arrangements. Process development serves an important marketing function. As a result of the regulatory requirements associated with certifying a new manufacturing source, it is often advantageous for a pharmaceutical company to maintain its relationship with a CMO because the CMO is certified to produce the product by regulatory authorities. Consequently, the Company promotes its process research and development capabilities aggressively in an effort to establish relationships with a customer early in the product development timeline and consequently secures long-term commercial-scale supply arrangements. Technology The Company's expertise in applying a wide range of sophisticated process technologies to large scale classical chemical transformations enables it to provide its customers with safe and cost efficient commercial scale manufacturing capacity. In addition, the Company has a wide spectrum of proprietary synthesis and separation technologies for application in the manufacture of single-isomer products (the "ChiRex Technologies"). In January 1997, the Company added to this technology platform by licensing KR Technology from Harvard University. During 1997, the Company manufactured four products in its pilot plant using its ChiRex Technologies. 4 PRODUCT PORTFOLIO The Company sold over 50 products in 1997. Approximately 90% of the Company's product portfolio are pharmaceutical products with the remaining 10% consisting of fragrance and flavor, agrichemical and polymer products. Nearly all of the products produced or under development by the Company are governed by secrecy agreements which contain, among other things, restrictions on the disclosure of the customer, the product and the therapeutic indication. Core Products During 1996, management identified certain core products which it believes offer superior long-term growth potential, higher margins or strategic customer relationship benefits. In 1997, core products accounted for 72.4% of the Company's revenues. The Company's customers' pharmaceutical products are used in the treatment of, among others, cancer, cardiovascular disease, AIDS, urinary tract infections and high cholesterol. Non-Core Products In 1997, the Company effectively completed the planned phase out of products which do not meet management's criteria regarding profitability, growth profile or customer development potential. There are currently approximately less than five remaining non-core products which the Company plans to eliminate from its product portfolio. In 1997, non-core products (excluding acetaminophen) accounted for 6.4% of the Company's revenues. DEVELOPMENT PRODUCTS The Company has over 30 years of experience collaborating with pharmaceutical companies on the process development of new pharmaceutical products. The Company's work in the development stage of its customers' products provides a strong foundation for securing supply arrangements for full-scale manufacturing upon commercialization. Products are no longer considered development products when they are produced by the Company on a commercial scale. The Company provides development and pilot-scale manufacturing services for its pharmaceutical customers. The following table sets forth 37 products in the Company's development pipeline which the Company believes have significant revenue potential. Sixteen of these products have been identified as core products, of which ten are produced at pilot-scale and had revenues associated with them in 1997 and fifteen incorporate ChiRex Technologies. The remaining products are at an earlier stage in the development cycle and have not been identified as core products. NUMBER OF DEVELOPMENT PHASE OF COMPANY DRUG(1) PRODUCTS REPRESENTATIVE INDICATIONS -------------------- --------- ------------------------------------------------------------- Commercial.............. 18 AIDS, Hypertension, Central Nervous System Disorder, Diabetes Phase III............... 6 Cancer, Pancreatitis, Asthma, Migrane Phase II................ 7 AIDS Preclinical/Phase I/Unknown.............. 6 Various - -------- (1) Based on customer provided or publicly available information. Fourteen of the commercial products listed above have been produced on a commercial scale by manufacturers other than the Company. However, the Company is working with its customers to gain the necessary regulatory approval to participate in the manufacture of these products. 5 TECHNOLOGY The Company has developed expertise in the large-scale operation of many classical chemical transformation technologies and has the exclusive rights to use the ChiRex Technologies in a defined field on a perpetual basis under approximately 45 U.S. patents and several patent applications. In addition, it has accumulated experience in the effective management of the risks inherent in handling toxic or hazardous raw materials and products and in carrying out hazardous chemical reactions. The Company's expertise allows pharmaceutical companies to have complex multi-step procedures carried out at a single site, which increases the ability of such companies to maintain confidentiality, product supervision and management. The Company's ChiRex Technologies consist of a broad platform of proprietary asymmetric synthesis and resolution technologies, which it believes provide multiple manufacturing routes to produce single-isomer chiral pharmaceutical intermediates and active ingredients. The Company selects the most appropriate ChiRex Technology for a particular application based on several factors, including the cost of any required catalyst, the availability and cost of the starting materials and the cost of recovering and recycling by-products. The following table summarizes certain aspects of the ChiRex Technologies: DEVELOPMENT -------------------------------- METHOD OF TECHNOLOGY USE PHASE MANUFACTURE ---------- ------------------------ ----------- -------------------- Kinetic Resolution...... Catalytic ring opening Pilot Plant Asymmetric Synthesis of epoxides to make chiral epoxides and Diols Asymmetric Catalytic asymmetric Commercial Asymmetric Synthesis dihydroxylation........ reaction to make chiral diols using Sharpless catalyst Asymmetric epoxidation.. Catalytic oxidation to Commercial Asymmetric Synthesis make chiral epoxides using Jacobsen Catalyst Enzymatic resolution.... Enzymatic Commercial Resolution Biotransformation Diastereomeric Resolution by Commercial Resolution crystallization........ Crystallization Asymmetric reduction.... Catalytic reduction to Laboratory Asymmetric Synthesis make chiral alcohols Single-isomer chiral chemicals are generally manufactured by asymmetric synthesis or resolution. In asymmetric synthesis, the single-isomer form of the drug or intermediate is synthesized directly from a precursor compound that is achiral. With resolution, the single-isomer is separated from a racemic mixture. Asymmetric synthesis is often the preferred method of producing single-isomer drugs or intermediates due to the potential higher attainable yields. Due to the technical challenges of developing a cost- effective process, however, there are few asymmetric synthesis processes demonstrated at commercial scale. The Company continues to improve its technology position through significant research and development expenditures, licensing third party technology and by maintaining close relationships with its Scientific Advisory Board and institutional research partners. In support of its technologies, the Company maintains a state-of-the-art hazards evaluation laboratory where operating hazards are identified and safe operating parameters established for all processes before they are carried out in the pilot plant. The pilot plant is then used to confirm the safe operation of the process and evaluate scale-up parameters before moving to full-scale operation. In addition, the Company has accumulated extensive in-house experience in the development and application of microprocessor control systems to control process hazards and improve the reproducibility of process performance and product quality. 6 The Company uses a wide range of computer software in its operations. The Company has dedicated internal resources to identify and resolve "year 2000" compliance issues within computer applications utilized by the Company. The Company has also engaged external resources and will purchase necessary computer software and upgrades to become "year 2000" compliant. SALES AND MARKETING, CUSTOMERS The Company markets the majority of its products directly to pharmaceutical and other life science companies. An important component of the Company's strategy is to pursue long-term supply relationships with selected major customers. The Company employs sales and marketing personnel who possess the requisite technical backgrounds to communicate effectively with both prospective customers and the Company's research and development personnel. The Company is dependent on a small number of customers. In 1997, the Company's four largest customers accounted for approximately 76% of total revenues. Sanofi S.A., Glaxo Wellcome plc, Rohm and Haas Company and SmithKline Beecham accounted for approximately 36%, 17%, 13% and 10% of the Company's 1997 revenues respectively. The loss of one or more of these customers could have a material adverse effect on the Company. In addition, in light of the worldwide consolidation of the pharmaceutical market, there is a risk that the Company could lose customers in market consolidations or become more dependent on individual customers as such customers increase their size and market share. The Company, as part of its ongoing commercial development efforts, maintains a presence at important international trade shows and hosts a bi- annual international technical symposium to which selected senior representatives and executives of the research and development organizations of major pharmaceutical companies are invited. In addition, the Company's technical and marketing personnel present papers at symposia on a regular basis. CONTRACTS The Company conducts business on both a purchase order basis and a formal contract basis. Where the company conducts business on a formal contract basis, it has entered into a variety of contractual arrangements with its customers, on both a fixed price and a cost plus basis. In cases where the contracts are fixed price, the Company bears the cost of overruns, with certain exceptions, but benefits if the costs are lower than anticipated. In cases where the contracts are on a cost plus basis, the Company is guaranteed reimbursement for its actual costs of performance and an agreed upon profit, with certain exceptions. Contracts may have terms ranging from a few months to several years depending upon the nature of the work being performed and the approval status of the product in question. Some of the Company's contracts are terminable by the customer upon notice. Contracts may also be terminated for a variety of reasons including unexpected or undesired results of the product, the failure of a product to satisfy safety requirements, the failure of a product to gain regulatory approval or a party's failure to properly discharge its obligations under such agreement. In 1997 the Company bore the cost of overruns on certain contracts with customers which were on a fixed price basis. In response to such losses, management of the Company has initiated discussions with such customers and is attempting to renegotiate these contracts. However, there can be no assurance that any renegotiation will be successful or that any new contractual provisions so negotiated will result in arrangements which will be more favorable to the Company. PATENTS AND PROPRIETARY TECHNOLOGY Proprietary rights relating to the Company's products and processes will generally be protected from unauthorized use by third parties only to the extent that they are covered by valid and enforceable patents or are maintained in confidence as trade secrets. The Company currently has the exclusive, royalty-free perpetual right and license to use and practice the ChiRex Technologies on a worldwide basis in a defined field under 7 approximately 45 U.S. patents and several patent applications. The material patents licensed to the Company expire at various times beginning in 2005. The Company has ongoing research efforts and expects to seek additional patents in the future covering patentable results of such research. Certain of the Company's technology is not covered by any patent or patent application. There can be no assurance that any pending patent applications filed by the Company will result in patents being issued or that any patents now or hereafter owned or licensed by the Company will afford protection against competitors with similar technology, will not be infringed upon or designed around by others or will not be challenged by others and held to be invalid or unenforceable. In the absence of patent protection, the business of the Company may be adversely affected by competitors who independently develop substantially equivalent technology. There may now or in the future be issued third-party patents relating to technology utilized by the Company. The Company may need to acquire licenses to, or to contest the validity of, any such patents. It is likely that significant funds would be required to defend any claim that the Company infringes a third-party patent, and any such claim could adversely affect sales of the challenged product until the claim is resolved. Furthermore, any such dispute could result in a rejection of the Company's patent applications or the invalidation of its patents. There can be no assurance that any license required under any such patent would be made available or, if available, would be available on acceptable terms or that the Company would prevail in any litigation involving such patent. Any of the foregoing adverse results could have a material adverse effect on the Company and its results of operations. The Company also seeks to protect its proprietary technology, including technology which may not be patented nor patentable, in part by confidentiality agreements and, if applicable, inventors' rights agreements with its collaborators, advisors, employees and consultants. There can be no assurance that these agreements will be enforceable and will not be breached, that the Company will have adequate remedies for any breach or that the Company's trade secrets will not otherwise be disclosed to, or discovered by, competitors. COMPETITION Competition in the Company's market is based upon reputation, service, manufacturing capability and expertise, reliability of supply and price. In addition, the Company's success depends to a significant extent on its ability to sell products to potential customers at an early stage of product development. The Company's current competitors include Alusuisse-Lonza Holdings AG, DSM Andeno B.V. and Laporte PLC. In addition, the Company competes with major pharmaceutical manufacturers (including a number of the Company's customers) who develop their own process technologies and manufacture fine chemicals and pharmaceutical intermediates in-house. The Company encounters, and expects to continue to encounter, intense competition in obtaining contracts for the sale of its products. The market in which the Company competes is characterized by extensive research efforts and rapid technological progress. Competition may increase further as a result of advances that may be made in the commercial applicability of the Company's and competitors' technologies and greater availability of capital for investment in these fields. In addition, the Company faces intense competition for scientific, managerial and marketing personnel from other companies, research and academic institutions and governmental entities. The Company also has encountered, and expects to continue to encounter, intense competition for the acquisition of additional manufacturing capacity. The Company's competitors for manufacturing capacity include CMOs and certain pharmaceutical and chemical companies, some of which have substantially greater financial resources than the Company. ENVIRONMENTAL REGULATION The manufacturing and research and development processes of the Company involve the controlled use of hazardous materials. The Company is subject to laws and regulations governing the use, manufacture, storage, 8 handling and disposal of such materials and waste products in the United Kingdom. In the event of contamination or injury from hazardous materials, the Company could be held liable for any resulting damages and any such liability could exceed its resources. Dudley, England Facility The Company's manufacturing plant in Dudley, England is subject to the U.K. Environmental Protection Act 1990 ("EPA 1990"), which requires authorizations for any industrial air and certain water discharges and solid waste disposal. The individual authorizations are contained within several Integrated Pollution Control ("IPC") authorizations under the 1991 Environmental Protection Regulations adopted pursuant to the EPA 1990. The Company's IPC authorizations for its Dudley facility are administered by the U.K.'s Environment Agency ("EA"). In addition, the Dudley plant is also subject to the U.K. Water Resource Act 1991 ("WRA") governing the discharge of liquid waste, and the U.K. Water Industry Act 1991 ("WIA") governing discharges to sewers. The Company believes it is in compliance in all material respects with its IPC authorization conditions, limitations and compliance schedules for Dudley. The Company possesses "envelope" authorizations for its air pollutant emissions, which enable the Company to alter its production lines and processes to a degree without seeking additional authorizations. The Company has committed itself in a plan submitted to the EA to implement certain air pollution emission reduction programs. The Company has a consent to discharge its process waste water in Dudley, following treatment in the Company's biological waste water pretreatment plant, into local sewers for further treatment by the company that owns and operates the local area wastewater treatment facility, which discharges its effluent to the River Tyne. Northumbrian Water ("NW") is the local sewer operator and the EA is the governmental regulatory body responsible for the regulation of NW and the country's rivers. In the past, the Company has had periodic difficulty in meeting its consent limits for suspended solids in waste water. During 1996, the Company reached agreement with NW which resulted in a relaxation of the consent limit for suspended solids. The Company also made certain capital improvements to its biological waste water treatment plant, and it is now generally in compliance with the consent limit. If the consent limit is exceeded, the plant must adhere to certain notice and corrective action procedures. This compliance program was developed in consultation with and has received the approval of the EA. Since the IPO, the Company reached agreement with NW and the EA on a set of contingency measures that would be taken in the event the Company's biological pretreatment plant in Dudley experienced a treatment upset or, due to malfunction or other failure had to be bypassed for a period of time. The procedures are designed to minimize the impact of such occurrences while allowing the Company to continue its production operations, which in the absence of such agreed procedures, would have been subject to potential shutdown. The Environment Act 1995 ("1995 Act") imposes strict, retroactive clean- up liability on persons responsible for creating or contributing to contaminated sites. Landowners are presumptively liable under this statute for conditions existing on their property where a different responsible party can not be found. The Company believes that the limited areas of subsurface contamination presently known to exist at the Dudley site are confined and will not give rise to liability under the 1995 Act. Annan, Scotland Facility The Company's manufacturing plant in Annan, Scotland is also subject to the EPA 1990 and the 1995 Act. The Company's IPC authorizations for Annan are administered by the Scottish Environmental Protection Agency ("SEPA"). In addition, the facility is also subject to the Sewerage (Scotland) Act 1968 and the Control of Pollution Act 1974 providing for the regulation of trade or sewage effluent to streams and other inland waters, as well as certain provisions of The Rivers (Prevention of Pollution) (Scotland) Acts 1951 and 1965. 9 The Company possesses certain IPC authorizations covering existing products at the Annan site. In addition, the Company has also applied for additional IPC authorizations governing other products to be manufactured and is engaged in discussions with SEPA to obtain envelope authorizations. SEPA has approved a two phase, twenty-four month environmental improvement program for the Annan incinerator. Phase one relating to burner modifications is underway and is scheduled to be completed by the end of second quarter 1998. Phase two which involves installation of a baghouse filter to manage particulate emissions, will begin by September 1998 with completion expected by year end. The Company has also agreed with SEPA upon a program to reduce volatile organic compound emissions by fitting the site with new vacuum pumps and scrubber systems. An oil spill following the off-loading of a road tanker occurred on the Annan site in 1992 when Glaxo Wellcome plc owned the facility. Actions to control the oil spill were taken at such time. However, sporadic problems have been encountered since such spill, involving the appearance of fuel in the site's drainage system. To address this issue, the Company has applied for permission to install a land drainage interceptor to capture minor residual oil before it can enter any waterways or the land drainage system. Under the Asset Purchase Agreement between the Company and Glaxo Wellcome,. Glaxo is responsible for remediation costs relating to such oil spill and has agreed to provide the Company with certain indemnities in the event of governmental and other claims. There can be no assurance that the Company will not be required to incur future expenditures for environmental compliance and control at both the Dudley and Annan sites. Such costs, and other unanticipated costs of compliance with environmental laws and regulations in the future, could have a material adverse effect on the Company's results of operations. OTHER GOVERNMENTAL REGULATION The Company's operations, as well as those of its customers, are subject to extensive regulation by numerous governmental authorities in the United States, the United Kingdom and other countries. In particular, the Company's manufacturing operations are required to comply with applicable FDA regulations with respect to cGMP. Similar requirements are imposed by regulatory authorities in other countries. The concept of cGMP encompasses all aspects of the production process, including validation and record keeping, and involves changing and evolving standards. Consequently, continuing compliance with cGMP is a particularly difficult and expensive part of regulatory compliance, especially since the FDA and certain other analogous international governmental agencies have increased the number of regular inspections to determine compliance. Failure to comply with the applicable regulatory requirements can among other things result in fines, suspensions of regulatory approvals, product recalls, operating restrictions and criminal prosecution. Continuing studies of the proper utilization, safety and efficacy of pharmaceutical products are being conducted by government agencies, industry and others. Such studies, which increasingly employ sophisticated methods and techniques, can call into question the utilization, safety and efficacy of previously marketed products and in some cases have resulted, and may in the future result, in the discontinuance of their marketing and, in certain countries, give rise to claims for damages for persons who allege they have been injured as a result of their use. The Company is subject to environmental, labor, health and workplace safety regulation pursuant to a variety of national and local legislation in the United Kingdom. The Company is also subject to FDA regulation under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act and the Toxic Substances Control Act. In addition, numerous other domestic and foreign government regulations govern the Company. The evolving and complex nature of regulatory requirements, the broad authority and discretion of governmental agencies, continuing studies involving the safety of currently marketed pharmaceutical products and the generally high level of regulatory oversight results in a continuing possibility that from time to time the Company will be adversely affected by regulatory actions despite its ongoing efforts and commitment to achieve and maintain compliance with regulatory requirements. 10 In addition, compliance with governmental laws and regulations, including environmental laws and regulations, requires the Company to obtain permits issued by appropriate regulatory agencies. Permits generally require periodic renewal or review of their conditions, and public comment may be solicited in the permitting process. There can be no assurance that the Company will be able to obtain all necessary permits or renew all existing permits, or that material changes in permit conditions will not be imposed or that material public opposition will not surface. Failure to obtain or renew certain permits could result in the shutdown of the Company's facility, the imposition of significant fines or require the Company to incur significant expenditures to comply with the law. FINANCIAL INFORMATION ABOUT FOREIGN AND DOMESTIC OPERATIONS AND EXPORT SALES The Company derives the majority of its revenues and operating income from its foreign operations. The Company's foreign operations are subject to various risks including, in certain countries, currency exchange fluctuations and restrictions, restrictions on imports, government price controls, restrictions on the level of remittance of dividends, interest, royalties and other payments, the need for governmental approval of new operations, the continuation of existing operations and other corporate actions, political instability, the possibility of expropriation and uncertainty as to the enforcement of commercial rights, trademarks and other proprietary rights. In addition, the introduction of the Euro as currency in Europe in 1999 may subject the Company to additional risks including contract termination, computer system application changes, and currency swaps. EMPLOYEES As of December 31, 1997, the Company had 578 full-time employees. Three hundred and seventy-four of the Company's full time employees are unionized. The Company believes its labor relations are satisfactory. ITEM 2. PROPERTIES The Company's production facilities are located in the United Kingdom. The Company's corporate office is located in Stamford, Connecticut. LAND SIZE LOCATION TITLE (ACRES) (SQ. FT) USE -------- ------ ------ ------- ----------------------------------- Stamford, CT Leased -- 4,500 Corporate Office Dudley, England Owned 42 443,108 Manufacturing, Warehousing, Offices Annan, Scotland Owned 154 158,446 Manufacturing, Warehousing, Offices ITEM 3. LEGAL PROCEEDINGS The Company is involved in various legal proceedings incidental to the conduct of its business. While it is not possible to determine the ultimate disposition of these proceedings, the Company believes that the outcome of such proceedings will not have a material adverse effect on the financial position or results of operations of the Company. In late 1996, Phenomenex Inc., of Torrance, California formally opposed the Company's attempt to register the ChiRex name as a trademark for "single isomer chiral intermediate chemical compounds and active ingredients for use in the manufacture of pharmaceuticals" in a proceeding filed in the U.S. Patent and Trademark Office's Trademark Trial and Appeal Board. In December 1997, the Company reached a final agreement with Phenomenex whereby Phenomenex discharged their opposition proceeding on terms favorable to the Company. Under such agreement, the Company also purchased certain Phenomenex trademarks. ITEM 4. SUBMISSIONS OF MATTERS TO A VOTE OF SECURITY HOLDERS None. 11 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS PRICE RANGE OF COMMON STOCK The Common Stock was initially offered to the public on March 5, 1996 at a price of $13.00 per share. The Common Stock is listed and traded on The Nasdaq Stock Market's National Market SM ("Nasdaq") under the symbol "CHRX." The following table sets forth for the periods indicated the high and low sales prices of the Common Stock as reported by Nasdaq. 1997: HIGH LOW ----- ------ ------ First Quarter.............................................. $13.25 $ 9.50 Second Quarter............................................. 12.75 9.88 Third Quarter.............................................. 25.50 11.63 Fourth Quarter............................................. 26.25 16.63 1996: HIGH LOW ----- ------ ------ First Quarter (from March 5)............................... $13.25 $ 9.50 Second Quarter............................................. 13.25 10.00 Third Quarter.............................................. 13.38 7.88 Fourth Quarter............................................. 13.50 9.50 On March 4, 1998, the last reported sale price of the Common Stock as reported by Nasdaq was $16.75. As of March 4, 1998, there were approximately 6,500 holders of record of the Common Stock. DIVIDEND POLICY The Company has never declared or paid cash dividends on its capital stock. The Company currently intends to retain any future earnings for use in the Company's business and, therefore, does not anticipate paying cash dividends in the foreseeable future. 12 ITEM 6. SELECTED HISTORICAL FINANCIAL DATA The following selected historical financial data of ChiRex Inc. as of December 31, 1994 and 1995 and for the years then ended have been derived from the financial statements of ChiRex Inc. which have been audited by Coopers & Lybrand L.L.P., independent public accountants. The selected historical financial data for ChiRex Inc. as of December 31, 1996 and 1997 and for the years then ended, have been derived from the financial statements of ChiRex Inc. which are incorporated by reference elsewhere in this document and which have been audited by Arthur Andersen LLP , independent public accountants. The period from inception (January 1, 1993) to December 31, 1993 is unaudited. This information should be read in conjunction with "Item 8. Financial Statements and Supplementary Data" and "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations." CHIREX INC. YEARS ENDED DECEMBER 31 --------------------------------------------- 1993 1994 1995 1996 1997 ------- ------- ------- -------- -------- (IN THOUSANDS EXCEPT PER-SHARE AMOUNTS) STATEMENT OF OPERATIONS DATA: Revenues........................ $ 4,633 $ 1,810 $ 2,754 $ 74,615 $ 94,100 Cost and expenses: Cost of goods sold............ 1,565 814 1,715 56,508 71,440 Research and development...... 3,458 2,343 595 3,517 3,937 Selling, general and administrative............... 1,999 1,964 2,099 8,876 10,587 Restructruring charge, net of proceeds from disposition of acetaminophen business....... -- -- -- -- 8,069 Write-off of in-process research and development..... -- -- -- 5,790 -- Stock compensation charge..... -- -- -- 5,611 -- ------- ------- ------- -------- -------- Total operating expenses.... 7,022 5,121 4,409 80,302 94,033 ------- ------- ------- -------- -------- Operating income (loss)......... (2,389) (3,311) (1,655) (5,687) 67 Interest expense, net........... -- -- -- 755 1,052 Other expenses.................. -- -- 797 -- -- ------- ------- ------- -------- -------- Loss before income taxes........ (2,389) (3,311) (2,452) (6,442) (985) Benefit (provision) for income taxes.......................... -- -- -- (1,867) 335 ------- ------- ------- -------- -------- Net loss........................ $(2,389) $(3,311) $(2,452) $ (8,309) $ (650) ======= ======= ======= ======== ======== Basic and diluted loss per common share................... $ (0.68) $ (0.94) $ (0.70) $ (0.88) $ (0.06) ======= ======= ======= ======== ======== BALANCE SHEET DATA (AS OF DECEMBER 31): Cash............................ $ -- $ -- $ 1 $ 291 $ 5,347 Total assets.................... 2,531 1,873 2,693 130,806 203,067 Long-term debt.................. -- -- -- 3,933 69,675 Stockholders' equity............ 2,351 1,873 2,693 90,068 93,095 13 The following selected historical financial data of ChiRex (Dudley) Limited (formerly ChiRex Limited or Sterling Organics Limited) as of December 31, 1992, 1993 and 1994 and for the years then ended and for the period from January 1, 1995 to August 10, 1995, have been derived from the financial statements of Sterling Organics Limited which have been audited by Coopers & Lybrand L.L.P., independent public accountants. The following selected historical financial data of ChiRex (Holdings) Limited (formerly Crossco (157) Limited) as of December 31, 1995 and for the period from August 10, 1995 to December 31, 1995, have been derived from the consolidated financial statements of Crossco (157) Limited which have been audited by Coopers & Lybrand L.L.P., independent public accountants. This information should be read in conjunction with "Item 8. Financial Statements and Supplementary Data" and "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations." CHIREX (HOLDINGS) LIMITED AND CHIREX (DUDLEY) LIMITED CHIREX (HOLDINGS) LIMITED(1) ------------------------ CHIREX (DUDLEY) LIMITED PERIOD FROM ----------------------------------- INCEPTION PERIOD (AUGUST 10, (UNAUDITED) YEARS ENDED DECEMBER 31 ENDED 1995) TO PERIOD ------------------------ AUGUST 10, DECEMBER 31, ENDED MARCH 1992 1993 1994 1995(1) 1995 11, 1996(2) ------- ------- ------- ---------- ------------ ----------- (IN THOUSANDS) STATEMENT OF OPERATIONS DATA: Revenues................ $85,609 $74,497 $78,859 $51,375 $34,828 $15,212 Costs and expenses: Cost of goods sold.... 74,245 66,529 68,572 44,220 30,836 12,564 Research and develop- ment expenses........ 1,741 1,564 1,816 1,115 651 558 Selling, general and administrative....... 6,202 4,908 5,598 2,156 2,728 1,300 ------- ------- ------- ------- ------- ------- Total costs and ex- penses............. 82,188 73,001 75,986 47,491 34,215 14,422 ------- ------- ------- ------- ------- ------- Operating income........ 3,421 1,496 2,873 3,884 613 790 Interest income (ex- pense)................. (181) 264 237 16 (1,927) (690) Other income............ 484 379 481 402 5 -- ------- ------- ------- ------- ------- ------- Income before income tax expense................ 3,724 2,139 3,591 4,302 (1,309) 100 Income tax expense...... 1,353 935 1,061 1,327 (351) 33 ------- ------- ------- ------- ------- ------- Net income (loss)... $ 2,371 $ 1,204 $ 2,530 $ 2,975 (958) 67 ======= ======= ======= ======= Dividends on preference shares................. (243) (217) ------- ------- Net loss for ordinary shares................. $(1,201) $ (150) ======= ======= BALANCE SHEET DATA (END OF PERIOD): Cash.................... $ -- $ 3,329 $ -- $ 396 $ 7,845 $ 7,517 Total assets............ 75,552 73,362 77,016 82,727 79,961 78,793 Long-term debt.......... -- -- -- -- 40,304 40,376 Total shareholders' eq- uity................... 49,824 50,502 54,849 59,821 365 322 - -------- (1) On August 10, 1995, ChiRex (Dudley) Limited was acquired by ChiRex (Holdings) Limited. (2) On March 11, 1996, ChiRex (Holdings) Limited was acquired by ChiRex inc. 14 ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION Management's discussion and analysis of results of operations and financial condition as set forth on pages 14 through 17 of the Registrant's 1997 Annual Report to Stockholders is incorporated herein by reference. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Financial statements and supplementary data as set forth on pages 18 through 31 of the Registrant's 1997 Annual Report to Stockholders is incorporated herein by reference. In addition, the following is included herein as Schedule II: SCHEDULE II--VALUATION AND QUALIFYING ACCOUNTS FOR THE YEARS ENDED DECEMBER 31, 1995, 1996 AND 1997 CHARGED BALANCE BALANCE (CREDITED) TO AT END BEGINNING STATEMENTS OF OF OF PERIOD OPERATIONS DEDUCTIONS PERIOD --------- ------------- ---------- -------- Allowance for doubtful accounts: 1995....................... $ -- $ 70,000 $ -- $ 70,000 1996....................... 70,000 434,000 (204,000) 300,000 1997....................... 300,000 (236,000) (42,000) 22,000 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT The required information is hereby incorporated by reference from the Company's Proxy Statement for the 1998 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission by March 17, 1998. ITEM 11. EXECUTIVE COMPENSATION The required information is hereby incorporated by reference from the Company's Proxy Statement for the 1998 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission by March 17, 1998. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The required information is hereby incorporated by reference from the Company's Proxy Statement for the 1998 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission by March 17, 1998. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The required information is hereby incorporated by reference from the Company's Proxy Statement for the 1998 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission by March 17, 1998. 15 PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K (a)(1) Financial Statements. The following financial statements as set forth on pages 18 through 31 of the Registrant's 1997 Annual Report to Stockholders are incorporated herein by reference: . Reports of Independent Public Accountants . Consolidated Balance Sheets as of December 31, 1996 and 1997 . Consolidated Statements of Operations for the years ended December 31, 1995, 1996 and 1997 . Consolidated Statements of Cash Flows for the years ended December 31, 1995, 1996 and 1997 . Consolidated Statements of Stockholder's equity for the years ended December 31, 1995, 1996 and 1997 . Notes to Consolidated Financial Statements. (a)(2) Financial Statement Schedule. Schedules have been omitted as they are not applicable or the required information is shown in the financial statements or notes thereto. (a)(3) Exhibits. The Exhibits listed on the accompanying Index to Exhibits are filed as part of this Annual Report on Form 10-K. (b) Reports on Form 8-K. In 1997 the Company filed the following Reports on Form 8-K: . On April 11, 1997 the Company filed a Report on Form 8-K reporting the sale of its acetaminophen business to Rhone-Poulenc Chimie. . On May 1, 1997 the Company filed Amendment Number 1 to its April 11, 1997 Report on Form 8-K. This Amendment Number 1 included pro forma financial statements relating to the sale of the Company's acetaminophen business to Rhone-Poulenc Chimie which were not filed in the original Report. . On November 17, 1997 the Company filed a Report on Form 8-K reporting its completion of the purchase of a pharmaceutical production facility located in Annan, Scotland from Glaxo Wellcome plc. . On November 26, 1997 the Company filed Amendment Number 1 to its November 17, 1997 Report on Form 8-K. This Amendment Number 1 included audited financial statements for the years ended December 31, 1994, 1995 and 1996 relating to the Annan, Scotland business purchased. 16 CHIREX INC. INDEX TO EXHIBITS ITEM 14 (A) (3) EXHIBIT NO. DESCRIPTION ----------- ----------- 2.1* Agreement for the Sale and Purchase of the Entire Issued Share Capital of Sterling Organics Limited by and among Sanofi Winthrop Limited, Crossco (157) Limited and Sanofi, dated August 10, 1995. 2.2* Contribution Agreement by and among the Registrant, SepraChem Inc. and the shareholders of Crossco (157) Limited listed on Schedule I attached thereto, dated February 7, 1996. 2.3* Agreement and Plan of Merger by and among the Registrant, SepraChem, Sepracor, SepraChem Merger Corporation, Roger B. Pettman and Certain Trusts Affiliated with Victor H. Wooley, dated as of February 6, 1996, as amended. 2.4+**** Asset Purchase Agreement between ChiRex Limited, ChiRex Inc. and Rhone- Poulenc Chimie S.A. 2.5+***** Asset Purchase Agreement between ChiRex Inc. and Glaxo Wellcome plc 3.1* Certificate of Incorporation of the Registrant. 3.2*** Amended and Restated By-Laws of the Registrant. 4.1* Specimen Certificate for Shares of Common Stock, $.01 par value, of the Registrant. 4.2***** Facilities Agreement between ChiRex (Holdings) Limited and Bankers Trust Company. 4.3***** Pledge Agreement between ChiRex Inc. and Bankers Trust Company. 10.1* 1995 Employee Stock Purchase Plan. 10.2*** 1997 Stock Incentive Plan. 10.3*** Amended and Restated 1995 Director Stock Option Plan. 10.4* Employment Agreement with Alan R. Clark. 10.5* Employment Agreement with David F. Raynor. 10.6*** Employment Agreement with John Graham Thorpe. 10.7*** Employment Agreement with John Edward Weir. 10.8*** Settlement Agreement with Robert L. Bratzler. 10.9*** Consulting Agreement with Robert L. Bratzler. 10.10*** ChiRex Pension Scheme. 10.11+*** Supply Agreement dated as of January 21, 1997 between ChiRex Inc. and Cell Therapeutics, Inc. 10.12+*** License Agreement dated as of January 28, 1997 between ChiRex Inc. and President and Fellows of Harvard College. 10.13* Contract Research Agreement by and between the Registrant and Sepracor, dated December 21, 1995. 10.14* Contract Manufacturing Agreement by and between the Registrant and Sepracor, dated December 21, 1995. 10.15* Technology Transfer and License Agreement by and between the Registrant and Sepracor, dated as of January 1, 1995. 10.16* Corporate Services Agreement by and between the Registrant and Sepracor, dated December 21, 1995. 17 EXHIBIT NO. DESCRIPTION ----------- ----------- 10.17* Supply Agreement by and between the Registrant and Sepracor, dated December 21, 1995. 10.18* Technology Development Agreement by and between SepraChem and Sandoz Pharma Ltd., dated October 1, 1995. 10.19* License Agreement by and between Sepracor and Massachusetts Institute of Technology, dated May 5, 1989. 10.20* License Agreement by and between Sepracor and Massachusetts Institute of Technology, dated June 21, 1991. 10.21* License Agreement by and between Sepracor and Research Corporation Technologies, Inc., dated March 13, 1991. 10.22* License Agreement by and between Sepracor and Research Corporation Technologies, Inc., dated September 10, 1992. 10.23* License Agreement by and between Sepracor and Tanabe Seiyaku Co., Ltd., dated October 30, 1990. 10.24* Toll Manufacturing Agreement by and between Sterling Organics and Rohm and Haas (UK) Limited, dated July 4, 1991. 10.25* Toll Manufacturing Agreement by and between Sterling Organics and Rohm and Haas (UK) Limited, dated August 27, 1987. 10.26* Supply Agreement by and between Sterling Organics and Sanofi Winthrop Limited and Sterling Winthrop, Inc. dated June 17, 1994. 10.27* Supply Agreement by and between Sterling Organics and Sanofi S.A., dated August 10, 1995. 10.28* Supply Agreement by and between Sterling Organics and Sanofi S.A., dated August 10, 1995. 10.29*** Sterling/Currency LIBOR Revolving Credit Facility between Midland Bank Plc and ChiRex (Holdings) Limited, executed as of August 10, 1996. 10.30* Procedural Joint Union Agreement by and between Sterling Organics and AEEU, dated July 7, 1975. 10.31* House Agreement by and between Sterling Organics and AEEU, dated February 1976. 10.32* Procedural Agreement by and between Sterling Organics and EESA, dated November 3, 1979. 10.33* Agreement by and between Sterling Organics and ACTS, dated July 19, 1978. 10.34* Escrow Agreement by and between the Registrant, Roger B. Pettman and Broomes Secretarial Services Limited. 10.35* Escrow Agreement by and between Alan R. Clark, David F. Raynor, John E. Weir, J. Graham Thorpe, Hugh F. Ford, William Riddell, Geoff B. Loxham, C. Lyn Chapple, David A. Routledge and Broomes Secretarial Services Limited 10.36+***** Supply Agreement between ChiRex Inc. and Glaxo Wellcome plc. 10.37 Employment Agreement with Michael A. Griffith dated December 22, 1997. 10.38 Employment Agreement with Jon E. Tropsa dated January 1, 1998. 10.39 Employment Agreement with Beth P. Hecht dated December 22, 1997. 10.40 Scientific Advisory Board Consulting Agreement with Eric Jacobsen, Ph.D. dated July 19, 1996. 13 ChiRex Inc. 1997 Annual Report 16** Letter re Change in Certifying Accountant 18 EXHIBIT NO. DESCRIPTION - ------- ----------- 21*** Subsidiaries of the Registrant. 23.1 Consent of Arthur Andersen LLP. 23.2 Consent of Coopers & Lybrand L.L.P. 23.3# Consent of Coopers & Lybrand L.L.P. 27 Financial Data Schedule - -------- * Incorporated by reference to the corresponding exhibits in the Registration Statement on Form S-1 previously filed by the Registrant (File no. 33-80831). ** Incorporated by reference to the Form 8-K previously filed by the Registrant on September 11, 1996. *** Incorporated by reference to the corresponding exhibits in the Registration Statement on Form S-1 previously filed by the Registrant on February 26, 1997 (File no. 333-22401). **** Incorporated by reference to the Form 8-K previously filed by the Registrant on April 11, 1997. ***** Incorporated by reference to the Form 8-K previously filed by the Registrant on November 17, 1997. # Previously filed by the Registrant on the Company's 1996 Annual Report on Form 10-K and is incorporated by reference. + Confidential treatment received as to certain portions. 19 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized, in the Town of Stamford, Connecticut on this 13th day of March, 1998. CHIREX INC. /s/ Alan R. Clark By __________________________________ Alan R. Clark, Chairman and Chief Executive Officer Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, this Annual Report on Form 10-K has been signed below by the following persons in the capacities indicated below on this 13th day of March, 1998. SIGNATURE TITLE /s/ Alan R. Clark Chairman of the Board of Directors and - ------------------------------------- Chief Executive Officer (Principal Alan R. Clark Executive Officer) /s/ Michael A. Griffith Chief Financial Officer, Secretary and - ------------------------------------- Director (Principal Financial and Michael A. Griffith Accounting Officer) /s/ Eric Jacobsen Director - ------------------------------------- Eric A. Jacobsen /s/ Dirk Detert Director - ------------------------------------- Dirk Detert /s/ Elizabeth M. Greetham Director - ------------------------------------- Elizabeth M. Greetham /s/ W. Dieter Zander Director - ------------------------------------- W. Dieter Zander - ------------------------------------- SM 20