UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

Form 10-K

 

 

Commission File Number 000-23019

 

KENDLE INTERNATIONAL INC.

 

 

441 Vine Street, 500 Carew Tower

Cincinnati, Ohio 45202

513-381-5550

 

Securities Registered Pursuant to Section 12(b) of the Act:

 

 

Securities Registered Pursuant to Section 12(g) of the Act:

None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes o     No þ

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  Yes o     No þ

 

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 þ     No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files.) Yes o     No o

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) 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 10-K or any amendment to this Form 10-K.  þ

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes o. No þ

 

The aggregate market value of the Registrant’s Common Stock at June 30, 2010, held by non-affiliates was $163,278,167 (based on the $11.52 closing price of the Company’s Common Stock on The NASDAQ Global Select Market LLC on June 30, 2010).

 

As of March 3, 2011 14,981,841 shares of no par value Common Stock were issued and 14,958,789 shares of no par value Common Stock were outstanding.

 

Documents Incorporated by Reference

 

Portions of the Registrant’s Proxy Statement to be filed with the Commission for the Registrant’s 2010 annual report to shareholders for the fiscal year ended December 31, 2010, are incorporated by reference into Part III. See Exhibit Index on page 45.

 

 

Kendle International Inc.

 

Form 10-K Annual Report
For the Fiscal Year Ended December 31, 2010

 

Table of Contents

 

 

This Annual Report on Form 10-K contains certain statements that are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Kendle International Inc. (the Company or Kendle). See “Item 1A — Risk Factors” for further information.

 

The forward-looking statements speak as of the date made and are not guarantees of future performance. Actual results or developments may differ materially from the expectations expressed or implied in the forward-looking statements, and the Company undertakes no obligation to update any such statements.

 

 

General

 

Kendle International Inc., an Ohio corporation established in 1989, is a global clinical research organization (CRO) that provides a broad range of Phase I-IV global clinical development services to the biopharmaceutical industry. The Company augments the research and development activities of biopharmaceutical companies by offering high-quality, value-added clinical research services and proprietary information technology designed to reduce drug development time and expense. The Company is managed in two reportable segments, Early Stage and Late Stage. The Early Stage business currently focuses on the Company’s Phase I operations, while Late Stage is comprised of clinical development services related to Phases II through IV.

 

Early Stage

 

The Early Stage reportable segment is focused on the high-end scientific exploratory medicine area, from First-in-Human studies through proof-of-concept stages, in the Company’s Toronto, Canada and Utrecht, The Netherlands locations. The Company also provides full support for Phase I studies in established compounds, including bioequivalence and pharmacokinetics studies, at its Morgantown, West Virginia location. In the fourth quarter of 2010 the Company made a decision to close the Early Stage component of operations at its Utrecht location. Please see Note 9 to the Consolidated Financial Statements, as well as the Company’s Form 8-K filed with the Securities and Exchange Commission on February 14, 2011 for further details.

 

Late Stage

 

The Late Stage reportable segment includes four reporting units: Clinical and Data Monitoring; Project Management & Late Phase; Regulatory, Safety, Site and Medical Affairs; and Biostatistics and Statistical Programming. This segment has a global reach that enables the Company to meet its customers’ needs by accessing specific patient populations in large urban areas as well as emerging markets/regions all over the world.

 

The Clinical and Data Monitoring unit (C&DM) conducts Phase II through IV clinical trials worldwide. C&DM provides a wide range of services including clinical monitoring, data management and study reports to assist customers with their drug development efforts.

 

The Project Management & Late Phase (PM & LP) unit oversees all steps of a study, from award through close out of a study. This unit also designs and conducts Phase IIIB and IV studies worldwide.

 

The Regulatory, Safety, Site and Medical Affairs unit provides regulatory expertise and consulting services at every stage of drug and device development, from early development to market and post market. This unit designs, among other things, clinical programs and clinical trial protocols, reviews programs and provides gap analysis to assist sponsors in achieving their clinical development strategies. The unit also provides consulting services for nonclinical development for small molecules, biologicals, vaccines and devices. This unit focuses on health economics, outcome research, scientific events and medical education services. Additionally, this unit has safety experts that assist customers with the collection, analysis and reporting of accurate drug safety data.

The Biostatistics and Statistical Programming unit offers full service statistical support for Phase I to IV clinical trials and submissions. The unit has biostatisticians that can supply comprehensive statistical analysis plans on a turnkey basis or on a consulting basis.

 

The Company believes that the outsourcing of drug development activities by biopharmaceutical companies will increase as these companies strive to grow revenues through an accelerated drug development cycle while responding to cost containment pressures. The CRO industry, by specializing in clinical trial management, often performs the needed services with a higher level of expertise or specialization at a faster pace and at a lower cost than a biopharmaceutical company could perform such services internally.

 

Acquisition Activity

 

In June 2008, the Company completed its acquisition of DecisionLine Clinical Research Corporation (DecisionLine) and its related company. DecisionLine is a clinical research organization located in Toronto, Ontario specializing in the conduct of early phase studies. The acquisition supports the overall goal of strategic business expansion, and, in particular, expansion of Phase I studies.

 

Business Strategy

 

The Company’s strategy is to continue to enhance its reputation as a high-quality, global provider of a full range of CRO services. This year has been a challenging one for the CRO industry, for the Company and for its customers. The Company has been affected by the repercussions of merger and acquisition activity in the global biopharmaceutical industry and the resultant reprioritization of their pipelines, search for cost efficiencies and right sizing of their workforces resulting in lower new business authorizations and higher than historical cancellations. In the near term, the Company’s strategy is to adapt to the current state of flux in the industry and bring stability back to the Company’s operations. The Company’s longer term strategy remains steadfast and consists of the following strategic initiatives:

 

 

Customers and Marketing

 

Net service revenues from the top five customers accounted for approximately 26% and 27% of the Company’s total net service revenues for the years ended December 31, 2010 and 2009. No customer accounted for more than 10% of the Company’s net service revenues in either 2010 or 2009.

 

Segment and geographic information for the Company is contained in Note 13 to the Consolidated Financial Statements.

 

Backlog

 

Backlog consists of anticipated net service revenue from contracts, letters of intent and other forms of commitments (collectively defined as backlog) that either have not started but are anticipated to begin in the near future, or are in process and have not been completed. Amounts included in backlog represent anticipated future net service revenue and exclude net service revenue that has been recognized previously in the Consolidated Statements of Operations. Once contracted work begins, net service revenue is recognized in the Consolidated Statements of

Operations. Backlog at December 31, 2010, was approximately $828 million compared to approximately $830 million at December 31, 2009. The majority of the Company’s backlog is from large established biopharmaceutical firms with annual revenues greater than $1 billion. Backlog arising from contracts with small biotech firms with no revenues or large biopharmaceutical partner are not material to the Company. The Company continues to experience high levels of cancellations and delays between proposals and awards due to budget reductions and pipeline reprioritizations at large pharmaceutical companies, drug failures due to efficacy and safety, and regulatory actions related to drugs in development among other things. The average duration of the contracts in backlog fluctuates from quarter to quarter based on the contracts constituting backlog at any given time. The Company generally experiences a longer period of time between contract award and revenue recognition with respect to large contracts covering global services. Additionally, as a result of biopharmaceutical companies starting to award trials earlier in the cycle than they have historically, we are seeing the time duration between award and revenue recognition elongate as study designs continue to be reviewed and revised. As the Company competes for and enters into large contracts that are global in nature, the Company expects the average duration of the contracts in backlog to increase and may be affected by changes in foreign exchange rates. Fluctuations in foreign exchange rates caused backlog to decrease by approximately $6.6 million as of December 31, 2010, primarily as a result of the weakening of the Euro throughout 2010. Based on its 2010 experience, quarterly revenue as a percentage of the beginning of the quarter backlog averaged approximately 10%.

 

No assurance can be given that the Company will be able to realize the net service revenues that are included in the backlog. Backlog is not necessarily a meaningful indicator of future results for a variety of reasons, including, but not limited to, the following: (i) contracts vary in size and duration, with revenue from some studies realized over a number of years; (ii) the scope of contracts may change, either increasing or decreasing the value of the contract; and (iii) studies may be terminated or delayed at any time by the study’s sponsor or by regulatory authorities due to efficacy, safety or funding concerns, among other reasons.

 

Competition

 

The Company competes primarily against in-house research and development departments of biopharmaceutical companies, universities, teaching hospitals and other full-service CROs, some of which possess substantially greater capital, technical expertise and other resources than the Company. CROs generally compete on the basis of past performance for a customer, medical and scientific expertise in specific therapeutic areas, the quality of services provided, the ability to manage large-scale trials on a global basis, medical database management capabilities, the ability to provide statistical and regulatory services, the ability to recruit investigators, the ability to recruit patients into studies, the ability to integrate information technology with systems to improve the efficiency of clinical research, an international presence with strategically located facilities and financial viability and price.

 

The CRO industry is highly fragmented with hundreds of CROs ranging from small, limited-service providers to full-service, global drug development corporations. Some of the large multi-national full-service CROs competing with the Company include Covance, Inc., PAREXEL International Corporation, Pharmaceutical Product Development, Inc., ICON plc, PRA International, PharmaNet Development Group, Inc. and Quintiles Transnational Corporation.

 

Government Regulation

 

The Company’s clinical services are subject to industry standards for the conduct of clinical research and development studies that are contained in regulations for Good Clinical Practice (GCP). The Food and Drug Administration (FDA) in the United States and the European Agency for the Evaluation of Medicinal Products in Europe (EMEA), along with other regulatory bodies, require that clinical trial test results submitted to the regulatory bodies be based on studies conducted in accordance with GCP.

 

In addition, the International Conference on Harmonization — Good Clinical Practice Guidelines provides guidance on GCP. The Company implements and revises its standard operating procedures to facilitate GCP compliance.

Employees

 

As of December 31, 2010, the Company employed approximately 3,105 associates, about 61% of whom were located outside the United States. None of the Company’s associates are covered by a collective bargaining agreement and the Company believes its overall relations with its associates are good. Associates in certain of the Company’s non-U.S. locations are represented by workers’ councils as required by local laws.

 

Available Information

 

The Company maintains a web site at the address www.kendle.com.  The Company is not including the information contained on its web site as a part of, or incorporating it by reference into, this Annual Report on Form 10-K. The Company makes available free of charge through its web site its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and amendments to these reports, as soon as reasonably practicable after it electronically files such material with, or furnishes such material to, the Securities and Exchange Commission (SEC).

 

Required filings by the Company’s officers and directors with respect to the Company furnished in electronic form are also made available on its web site as is the Company’s Proxy Statement for its annual meeting of shareholders. These filings also may be read or copied at the SEC’s Public Reference Room located in Washington, D.C. The SEC also maintains an Internet site (http://www.SEC.gov) that contains reports, proxy statements and other information regarding issuers that file electronically with the SEC.

 

 

Certain statements contained in this Annual Report on Form 10-K that are not historical facts constitute forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, and are intended to be covered by the safe harbors created by that Act. Reliance should not be placed on forward-looking statements because they involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied. Forward-looking statements generally contain the words “believe”, “expect,” “may,” “anticipate,” “intend,” “estimate,” “project,” “plan,” “assume,” “seek to” or other similar expressions, although not all forward-looking statements contain these identifying words. Any forward-looking statement speaks only as of the date made. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances arising after the date on which they are made.

 

Statements concerning, without limitation, expected financial performance and results, plans and objectives, prospects, on-going business strategies and possible future action which the Company intends to pursue to achieve strategic objectives constitute forward-looking information. Implementation of these strategies and the achievement of such financial performance are each subject to numerous conditions, uncertainties and risk factors. The risk factors listed below are those deemed to be material by the Company. Additional risks and uncertainties not currently known may materially adversely affect the Company’s business, financial condition and/or results of operations.

 

Risks Related to Our Industry

 

The Company depends on the biopharmaceutical industry for most of its revenue.

 

The Company’s revenues depend on the outsourcing trends, size of the drug-development pipeline and research and development expenditures of the biopharmaceutical industry. Economic factors and industry trends that affect companies in the biopharmaceutical industry affect its business. A slowdown in research and development spending or a reprioritization of the drug development pipelines or limited access to capital to fund projects in the biopharmaceutical industry could negatively affect the Company’s net service revenues and results of operations. Mergers and acquisitions in the biopharmaceutical industry and the related rationalization of the drug-development pipelines could result in delay or cancellation of certain existing projects.

The CRO industry is highly competitive.

 

The CRO industry is comprised of a wide range of competitors including small, niche providers as well as large multi-national full-service global clinical research organizations. These companies compete based on a variety of factors, including reputation for quality, performance, price, scope of service offerings and geographic presence. Some of the Company’s competitors have greater financial resources and a wider range of service offerings over a greater geographic area. Additionally, the Company’s customers have in-house capabilities to perform services that are provided by CROs. These factors potentially could have a negative impact on the Company’s ability to win business awards.

 

Revenue and earnings growth rates in the future may not be as robust as in the past.

 

Current economic conditions including pharmaceutical company mergers, drug development pipeline reprioritization, and cost containment efforts by customers including reduction of research and development spending, among other things, have, and may continue to impact the CRO industry and, in particular, the Company’s sales and revenue growth rates. There can be no assurance that growth rates will recover to the level experienced in the past.

 

Change in government regulation or healthcare reform could adversely affect the Company.

 

Government agencies regulate the drug development process utilized by the Company in its work with biopharmaceutical companies. Changes in regulations that simplify the drug approval process or increases in regulatory requirements that lessen the research and development efforts of the Company’s customers could negatively affect the Company. In addition, any failure on the Company’s part to comply with existing regulations or in the adoption of new regulations could impair the value of its services and result in the termination of or additional costs under its contracts with customers.

 

Comprehensive healthcare reform could reduce the demand for services which could reduce revenues. Legislation creating downward pressure on the prices for drugs that pharmaceutical and biotechnology companies can charge or the removal of these drugs from reimbursement formularies could reduce the amount of revenue the Company could earn from projects outsourced to it. Healthcare reform outside the U.S. could also adversely impact the Company’s revenues and profitability.

 

Risks Related to Our Business

 

The Company’s contracts may be delayed, terminated or reduced in scope with little or no notice.

 

Many of the Company’s contracts provide for services on a fixed-price basis and may be terminated or reduced in scope with little or no notice. Cancellations may occur for a variety of reasons, including the failure of the product to satisfy safety requirements, the Customer’s inability to manufacture sufficient quantities of the drug, unexpected results of the product or the customer’s decision to terminate the development of a product.

 

The loss, reduction in scope or delay of a large contract or the delay of multiple contracts could have a material adverse effect on the Company’s results of operations; although its contracts entitle it to receive payments for work performed in the event of a cancellation. Cancellation or delay of a large contract or multiple contracts could leave the Company with under-utilized resources and thereby negatively affect its net service revenues and results of operations. The Company believes its aggregate backlog is not necessarily a meaningful indicator of future net service revenues and financial results.

 

The fixed price nature of many of the Company’s contracts could result in financial losses.

 

Because many of the Company’s contracts are structured as fixed price, it is at financial risk if it initially underbids the contract or overruns the initial cost estimates. Such under-bidding or significant cost overruns could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

The Company’s backlog may not be indicative of future results.

 

The Company includes in backlog anticipated revenues from projects currently in process plus written awards, signed contracts, letters of intent and other awards believed to be firm commitments. These contracts vary in size and duration and may be subject to changes in scope, delays or cancellations. If the Company is successful in securing future contracts that are larger and more global in nature, the rate at which backlog is converted into revenue may be slower than the Company’s historical experience. Additionally, as a result of biopharmaceutical companies starting to award trials earlier in the cycle than they have historically, we are seeing the time duration between award and revenue recognition elongate as study designs continue to be reviewed and revised. The portion of backlog that may be performed in non-U.S. subsidiaries is exposed to fluctuations in the applicable foreign currencies which could affect the amount of revenue ultimately recognized. Fluctuations in foreign exchange rates caused backlog to decrease by approximately $6.6 million at December 31, 2010.

 

The economic climate has caused the Company to rapidly adjust from a robust growth strategy to a cost containment strategy in a short period of time, which has placed, and is expected to continue to place, significant demands on it.

 

The Company has had to adapt to a rapidly changing economic and industry environment. Historically, the Company had grown rapidly, both organically and through acquisitions. In 2009 and continuing through 2010, the Company experienced lower new business authorizations than in its recent past, combined with higher than historical levels of cancellations. This placed significant stress upon the organization to adjust from building toward expected future growth to taking rapid actions to preserve profitability. As a result, the Company embarked on reduction in force and cost containment initiatives which could have an unfavorable impact on the future operations should the environment quickly recover. Additionally, certain geographic regions could grow at faster rates than other geographic regions, resulting in the Company hiring associates in those regions (i.e. Latin America and Asia/Pacific) at a more accelerated pace than in other regions.

 

If the Company is unable to attract suitable investigators and volunteers for clinical trials, the Company’s business may suffer.

 

The clinical research studies the Company operates rely upon the accessibility and willing participation of physician investigators and volunteer subjects. Investigators supervise the administration of study drugs to patients during the course of a clinical trial. Volunteer subjects generally include people from the communities in which the studies are conducted. The Company’s clinical research business could be adversely affected if we are unable to attract suitable investigators or clinical study volunteers on a consistent basis.

 

If the Company is required to write off goodwill or other intangible assets acquired in its business combinations, its financial position and results of operations would be adversely affected.

 

The Company had goodwill and other acquisition-related intangible assets of approximately $248.0 million and $258.8 million as of December 31, 2010 and December 31, 2009, respectively, which constituted approximately 51% and 48%, respectively, of its total assets at these periods. The Company periodically (at least annually unless triggering events occur that cause an interim evaluation), evaluates goodwill and other acquired intangible assets for impairment. Any future determination requiring the write off of a portion of the Company’s goodwill or other acquired intangible assets could adversely affect its results of operations and financial condition. Should current economic conditions continue, the annual or an interim evaluation (if required as indicated above) could result in an impairment of the Company’s goodwill. In connection with its annual evaluation of goodwill for the year ended December 31, 2010, the Company determined that a portion of the goodwill related to its Early Stage segment was impaired and as a result wrote off approximately $7.3 million of the goodwill related to this segment. See Note 5 to the Consolidated Financial Statements for further detail on goodwill and amortizable intangible assets.

 

The Company’s indebtedness could adversely affect its business and financial condition.

 

As of December 31, 2010, the Company had $142.5 million (in par value) of convertible debt outstanding and an additional $35 million of borrowing capacity under a revolving line of credit. The Company also maintains a

$5.0 million multicurrency facility that is renewable annually and used in connection with its European operations. For a description of the Company’s indebtedness and that of its subsidiaries, see Liquidity and Capital Resources section of Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

The Company’s level of indebtedness will have several important effects on its future operations. For example, the Company will be required to use a portion of its cash flow from operations for the payment of principal and interest due on its outstanding indebtedness. In addition, the Company’s outstanding indebtedness and leverage could increase the impact of negative changes in general economic and industry conditions, as well as competitive pressures. The level of the Company’s outstanding indebtedness may affect its ability to obtain additional financing for working capital, capital expenditures or general corporate purposes.

 

General economic conditions as well as conditions affecting the Company’s operations specifically, including, but not limited to, financial and business conditions, many of which are beyond its control, may affect its future performance. As a result, these and other factors may affect the Company’s ability to make principal and interest payments on its indebtedness. The Company’s business might not continue to generate cash flow at or above current levels, including levels required to service its indebtedness. Moreover, if the Company is required to repatriate foreign earnings to fund its debt service, it may not be able to accomplish this in a “tax efficient” manner and may, therefore, incur additional income taxes. If the Company cannot generate sufficient cash flow from operations in the future to service its indebtedness, it may, among other things:

 

 

These measures might not be sufficient to enable the Company to service its indebtedness. In addition, any financing, refinancing or sale of assets might not be available on economically favorable terms, if at all.

 

Furthermore, the Company’s credit facility contains certain restrictive covenants which may affect, and in many respects significantly limit, management’s choices in responding to business, economic, regulatory and other competitive conditions.

 

The Company’s access to funds under the Facility or its money market fund holdings is dependent on the solvency and liquidity of the participating lenders or fund sponsors.

 

The Company draws on its money market fund holdings or uses its revolving credit facility to provide liquidity to fund its operating needs. The balances fluctuate depending on the Company’s needs and cash flows. If a party to the Facility or the sponsors of the money market funds becomes insolvent or unable to honor its commitments, the Company could have insufficient cash to meet its obligations and may be required to seek alternative forms of capital at rates and with terms and conditions not as favorable as those under its current Facility.

 

The Company may be exposed to risk from its various counterparties.

 

The global economy has shown signs of volatility and continues to show signs of fragility; its impact may be far reaching. As a result, the Company may be exposed to risks related to defaults from its suppliers and customers, as well as, from the counterparties to its purchased call options and sold warrants that are beyond the Company’s control. Key suppliers could fail to deliver agreed upon goods or services. Customers may not be able to obtain financing for their clinical trials with the Company, which may result in the delay or cancellation of these trials. Additionally, customers may not be able to pay or may pay receivables more slowly than in the past resulting in bad debt expenses or poor cash flows. The purchasers of the call options and sold warrants could become insolvent resulting in an inability to honor their commitments or in unanticipated dilution should the target conversion price terms be met.

The Company’s international operations are subject to numerous risks.

 

The Company has international operations in many foreign countries, including, but not limited to, South Africa, India and countries in Eastern Europe, the Asia Pacific region and Latin America. These operations are subject to risks and uncertainties inherent in operating in these countries, including government regulations, potential highly inflationary economies, currency restrictions and other restraints, burdensome taxes, government takeovers of assets and political instability. These risks and uncertainties could negatively impact the Company’s ability to, among other things, perform large, global projects for its customers or repatriate cash. Furthermore, the Company’s ability to deal with these issues could be affected by applicable U.S. laws and the need to protect its assets in those locations.

 

The Company’s financial results are exposed to exchange rate fluctuations.

 

The Company’s Consolidated Financial Statements are denominated in U.S. dollars. For the year ended December 31, 2010, approximately 59% of the Company’s net service revenues were derived from operations outside the United States compared to 57% in the same period of 2009. The Company strives for contractual protection to limit the foreign currency fluctuation risk exposure in contracts with its customers where possible, but that protection is not always achievable or adequate to insulate the Company from significant fluctuations. Additionally, due to the uncertainties regarding the timing of and currencies involved, it is impracticable to implement hedging instruments to match the Company’s foreign currency inflows and outflows. As a result, changes in foreign currency exchange rates could significantly affect the Company’s results of operations, financial position and cash flows as well as its ability to finance large acquisitions outside the United States.

 

The Company’s quarterly operating results may vary.

 

The Company’s operating results may vary significantly from quarter to quarter and are influenced by a variety of factors, such as:

 

 

The Company believes that operating results for any particular quarter are not necessarily a meaningful indication of future results. Although fluctuations in quarterly operating results could negatively or positively affect the market price of the Company’s common stock. These fluctuations may not be indicative of future overall operating performance.

 

The Company’s business depends on the continued effectiveness and availability of its information technology infrastructure, and failures of this infrastructure could limit its operations.

 

To remain competitive in the Company’s industry, it must employ information technologies that capture, manage, and analyze the large streams of data generated during the clinical trials we manage in compliance with applicable regulatory requirements. In addition, because the Company provides services on a global basis, it relies extensively on its technology to allow the concurrent conduct of studies and work sharing around the world. As with all information technology, the Company’s systems could become vulnerable to potential damage or interruptions from fires, blackouts, telecommunications failures and other unexpected events, as well as to break-ins, sabotage or intentional acts of vandalism. Given the extensive reliance of the Company’s business on this technology and the substantial investment in new technology infrastructure, any substantial disruption or resulting loss of data that is

not avoided or corrected by its backup measures could harm its business and operations. Although the Company carries property and business interruption insurance, the coverage may not be adequate to compensate for all losses that may occur.

 

The Company’s business depends on the successful implementation and deployment of its enterprise wide reporting solution and failure could harm the Company’s ability to manage its business and obtain accurate financial reporting.

 

The Company made a significant investment in an enterprise resource planning solution implementation of which began in 2010. When fully implemented, this major initiative is intended to integrate pricing, sales, project accounting, time reporting, trial management, human resources, billing and general ledger programs to provide management and financial reporting. The delay in implementation or failure of this project could result in, among other things, an inability to manage our business, bill and collect accounts receivable or accurately report our financial results. This new technology will also rely on third parties for processing and storing of data which exposes the Company to additional risks.

 

The Company’s business could expose it to potential liability for personal injury claims that could affect its financial condition.

 

The Company’s business involves clinical trial management which includes the testing of new drugs on human volunteers. This business 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 a drug or device. Many of these volunteers and patients are already seriously ill and are at risk of further illness or death. Any claim or liability could have a material adverse effect on the Company’s financial position and its reputation if, as a result, it were required to pay damages or incur defense costs in connection with a claim and if: (i) such claim is outside the scope of indemnification agreements the Company has with customers and collaborative partners, (ii) an indemnification agreement is not performed in accordance with its terms or (iii) its liability exceeds the amount of any applicable indemnification limits or available insurance coverage. The Company might also not be able to purchase adequate insurance for these risks at reasonable rates in the future.

 

The nature of the Company’s business exposes it to litigation and regulatory risk.

 

The nature of the Company’s business exposes it to litigation risk, and it is a party to lawsuits in the ordinary course of its business. While the Company does not believe that the resolution of any currently pending lawsuits against it will, individually or in the aggregate, have a material adverse effect on its business, financial condition or results of operations, it is possible that one or more lawsuits to which it is currently a party to or to which it subsequently becomes a party to, could adversely affect it in the future. In addition, failure to comply with applicable regulatory requirements can result in actions that could adversely affect the Company’s business and financial performance.

 

If the Company fails to hire, retain and integrate qualified personnel, it will be difficult for it to achieve its financial and operational goals.

 

The Company’s success depends to a significant extent upon the skills, experience and efforts of its senior management team and its ability to hire qualified personnel in the geographic regions and therapeutic areas in which it operates. The loss of any of the Company’s executive officers or other key employees, without a properly executed transition plan, could have an adverse effect on it. In addition, there has been substantial competition among both CROs and biopharmaceutical companies for qualified personnel. Difficulty recruiting or retaining qualified personnel and/or unexpected recruiting costs could affect the Company’s ability to meet financial and operational goals.

New standards or changes in existing accounting standards issued by the Financial Accounting Standards Board (FASB), SEC or other standard setting bodies may adversely affect the Company’s financial statements and could entail significant expenditures. The application of these standards often requires the use of estimates and assumptions that may materially differ from actual results.

 

The Company’s consolidated financial statements are currently subject to the application of U.S. Generally Accepted Accounting Principles (GAAP), which is periodically revised and/or expanded. Accordingly, the Company is required to adopt new or revised accounting standards issued by recognized authoritative bodies, including the FASB. It is possible that future changes in standards may change the current accounting treatment and that such changes could have a material adverse effect on the Company’s operating results and financial condition. (See Note 1, Critical Accounting Policies, specifically New Accounting Pronouncements for known changes in standards.)

 

The preparation of the Company’s consolidated financial statements in compliance with GAAP often requires management to make estimates and assumptions based on available information at that time. These estimates and assumptions may ultimately differ from actual results and the impact could have a material adverse effect on the Company’s financial position and results of operations.

 

Risks related to our Common Stock

 

Market conditions have caused significant volatility in the Company’s stock price.

 

The market price of the Company’s common stock has historically experienced and is expected to continue to experience some volatility because:

 

 

This volatility and valuation decline has affected securities issued by many companies in many industries, in addition to the Company’s common stock, often for reasons unrelated to their operating performance. Future valuation declines may cause the Company’s total market capitalization to decrease to a level which could result in a potential impairment of the Company’s goodwill.

 

The Company’s convertible note hedge and warrant transactions may affect the trading price of its common stock.

 

In connection with the issuance of the Company’s Convertible Notes (see Note 7), the Company entered into convertible note hedge transactions with the participating Underwriter and JP Morgan Chase (collectively, the counterparties). The convertible note hedge transactions are comprised of purchased call options and sold warrants. The purchased call options are expected to reduce exposure to potential dilution upon the conversion of the Convertible Notes. The Company also entered into warrant transactions with such counterparties. The sold warrants have an exercise price that is approximately 70% higher than the closing price of the Company’s common stock on the date the Convertible Notes were priced. The warrants are expected to provide the Company with some protection against increases in our stock price over the conversion price per share. In connection with these transactions, the counterparties, or their affiliates:

 

 

These activities may have the effect of increasing, or preventing a decline in, the market price of the Company’s common stock. In addition, any hedging transactions by the counterparties, or their affiliates, including during any conversion reference period, may have an adverse impact on the trading price of the Company’s common stock. The counterparties, or their affiliates, are likely to modify their hedge positions from time to time prior to conversion or maturity of the Convertible Notes by purchasing and selling shares of the Company’s common stock or other instruments, including over-the-counter derivative instruments, that they may wish to use in connection with such hedging. In addition, the Company intends to exercise its purchased call options whenever the Convertible Notes are converted, although not required to do so. In order to unwind any hedge positions with respect to the potential exercise of the purchased call options, the counterparties or their affiliates would expect to sell shares of common stock in secondary market transactions or unwind various over-the-counter derivative transactions with respect to the Company’s common stock during the conversion reference period for any Convertible Notes that may be converted.

 

The effect, if any, of any of these transactions and activities in connection with the Convertible Notes on the market price of the Company’s common stock will depend in part on market conditions and cannot be ascertained at this time, but any of these activities could adversely affect the trading price of the Company’s common stock and, as a result, the number of shares and value of the common stock received upon conversion of the Convertible Notes.

 

Anti-takeover provisions in the Company’s charter documents and under Ohio law may make an acquisition of the Company, which may be beneficial to its stockholders, more difficult, which could depress its stock price.

 

Certain provisions of the Company’s Articles of Incorporation and Code of Regulations and of Ohio law make it difficult for a third party to acquire control of it without the consent of its Board of Directors (Board). These anti-takeover defenses may discourage, delay or prevent a transaction involving a change in control of the Company, and, accordingly, could limit the price that investors may be willing to pay for its common stock, including transactions in which holders of common stock might receive a premium for their shares over the market price. In cases where Board approval is not obtained, these provisions could also discourage proxy contests and make it more difficult for existing shareholders to elect directors of their choosing and cause the Company to take other corporate actions they desire.

 

These provisions include:

 

 

In addition, the Company has adopted a shareholder rights plan that may have anti-takeover effects, which will make its acquisition by another company more difficult. The Company’s shareholder rights plan provides that, in the event any person or entity acquires 15% or more of its outstanding common stock, its shareholders will be entitled to purchase shares of common stock, or in certain instances, shares of the acquirer, at a discounted price. The rights are intended to discourage a significant share acquisition, merger or tender offer involving the Company’s common stock by increasing the cost of affecting any such transaction and, accordingly, could have an adverse impact on a takeover attempt that a shareholder might consider to be in the Company’s best interests.

 

 

None.

 

 

The Company leases all of its facilities. The Company’s principal executive offices are located in Cincinnati, Ohio. Early in 2008, the Company entered into a lease extension for these offices which extended the term of the

lease from 2009 to 2019 and increased the amount of space leased from approximately 122,000 square feet to approximately 143,000 square feet. The lease extension also provides the Company with an opportunity to lease additional space in the future.

 

In addition, the Company leases substantial facilities in Durham, North Carolina; Toronto, Canada; Munich, Germany; Camberley, United Kingdom; Edinburgh, United Kingdom; Utrecht, The Netherlands; and Mexico City, Mexico. The Company’s Early Stage operations are located in Morgantown, West Virginia, Toronto, Canada and Utrecht, The Netherlands. The Company has previously announced its intention to close the Utrecht Early Stage location in early 2011. The Company also maintains offices in various other North American, European and Asia-Pacific, including Australian and Indian locations, as well as in Latin America and South Africa.

 

Management believes that such offices are sufficient to meet its current needs and does not anticipate any difficulty in securing additional space, as needed, on terms acceptable to the Company.

 

 

The Company is party to lawsuits and administrative proceedings incidental to the normal course of business. The Company currently is not a party to any pending material litigation, nor, to the Company’s knowledge, is any material litigation currently threatened against the Company.

 

 

 

Shares of the Company’s Common Stock are listed on The NASDAQ Global Select Market LLC^® and are traded under the symbol “KNDL.” The following table sets forth the high and low prices for shares of the Company’s Common Stock for the periods indicated.

 

 

 

The number of holders of record of Kendle International Inc. common stock was 139 as of March 8, 2011. This total excludes shares held under beneficial ownership in nominee name or within clearinghouse positions of brokerage firms or banks. The Company has not paid dividends on its Common Stock since its initial public offering in August 1997. The Company does not currently intend to pay dividends in the foreseeable future and, in any event, is restricted from paying dividends under the terms and conditions of its credit facility.

Performance Graph

 

The following graph compares the five-year cumulative total shareholder returns of the Company’s Common Stock with the NASDAQ Composite Index and the NASDAQ Health Services Index.

 

COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among Kendle International Inc., The NASDAQ Composite Index
And The NASDAQ Health Services Index

 

 

 

Fiscal year ending December 31.

 

 

Securities Authorized Under Equity Compensation Plans:

 

The information required for Securities Authorized Under Equity Compensation Plans can be found in Part III, Item 12, Security Ownership of Certain Beneficial Owners and Management of this Annual Report on Form 10-K.

 

CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

CONSOLIDATED BALANCE SHEET DATA(2)

 

 

 

 

 

Refer to Risk Factors previously discussed in Part 1 Item 1A and the Cautionary Statement for Forward-Looking Information later in this section.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The information set forth and discussed below in Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) is derived from the Company’s Consolidated Financial Statements and the related notes thereto, which are included herein, and should be read in conjunction therewith.

 

Company Overview

 

Kendle International Inc. (the Company or Kendle) is a global clinical research organization (CRO) that delivers integrated clinical development services, including clinical trial management, clinical data management, statistical analysis, medical writing, regulatory consulting and organizational meeting management and publications services, among other things, on a contract basis to the biopharmaceutical industry. The Company operates in North America, Europe, Asia/Pacific, Latin America and Africa. The Company operates its business in two reportable operating segments, Early Stage and Late Stage. The Early Stage business currently focuses on the Company’s Phase I operations while Late Stage is comprised of clinical development services related to Phase II through III clinical trials conducted worldwide, late phase clinical development services related to Phase IIIB and IV clinical trials conducted worldwide, regulatory affairs and biometrics offerings. The Company aggregates its clinical and data monitoring reporting unit, project management and late phase reporting unit, regulatory, site and medical affairs reporting unit, and biostatistics and statistical programming reporting unit into the Late Stage segment under the aggregation criteria in accounting guidance related to segments. The aggregation criteria met includes a similar nature of services provided, a similar type of customer, similar methods used to distribute services, similar economic characteristics and a similar regulatory environment. In addition, the Company reports support functions primarily composed of Human Resources, Information Technology, Sales and Marketing and Finance under the Support and Other category for purposes of segment reporting. A portion of the costs incurred from the support units are allocated to the Early and Late Stage reportable operating segments.

 

The Company’s revenue recognition process is described later in this MD&A under “Critical Accounting Policies and Estimates.”

 

Late Stage Segment Contracts

 

The Company provides services to its customers primarily under “full-service” contracts that include a broad range of services in support of all aspects of a customer’s clinical trial. These services typically include biostatistics, clinical development services for Phase II through IV clinical trials and regulatory affairs. The Company from time to time provides a select number of these services under more narrow contracts focusing on one or more specialty areas, referred to as Functional Service Awards. The Company usually competes for business awards in a competitive bidding process. In the bidding process, the Company submits a bid that includes a price based upon hourly billing rates for billable employees multiplied by task hours the Company estimates will be necessary to achieve the service assumptions. Upon receiving a business award, the Company and its customer negotiate a contract to memorialize these assumptions and the related price.

 

Service contracts usually are long-term arrangements that require Company performance over several years. A contract usually requires a portion of the contract fee to be paid at the time of contract execution, and the balance is received in specified installments or milestones over the contract’s duration. Other methods for receiving payment include units achieved and time and materials incurred. During performance of the services, any of the following events may occur and impact the contract price:

 

 

In each of the foregoing situations, the Company enters into negotiations for a contract amendment to reflect the change in scope or assumptions and the related price. Depending on the complexity of the amendment, the amendment process can take from a few weeks for a simple adjustment, such as a timeline extension, to several months for a complex amendment, such as a change in patient enrollment strategy. Under the Company’s policy, project teams are not authorized to engage in tasks outside the scope of the contract without prior management approval. In limited situations, management may authorize the project team to commence work on activities outside the contract scope while the Company and its customer negotiate and finalize the contract amendment.

 

Contract amendments are commonplace within the industry and occur on the majority of the Company’s contracts. At any point in time, the Company will be in the process of discussing numerous proposed amendments, the scope and value of which can change significantly between time of proposal and final agreement. The total value of these amendments primarily represents future work and revenues.

 

In addition to full-service and functional service arrangements described above, the Company provides consulting services to its customers under contracts that generally are shorter-term in nature than full-service contracts. Net service revenues from these contracts are not material to the Company’s consolidated net service revenues.

 

In connection with providing services, the Company incurs pass-through costs, which include travel-related expenses for Company employees performing services and fees payable to third-party investigators or labs participating in, or supporting, the customer’s clinical trial. The customer agrees to reimburse the Company on a dollar-for-dollar basis for the costs incurred by the Company in accordance with contractually specified parameters. The revenues and costs from these pass-through and third-party costs are reflected in the Company’s Consolidated Statements of Operations under the line items titled “Reimbursable out-of-pocket revenues” and “Reimbursable out-of-pocket costs”, respectively.

 

The customer may terminate the contract at any time with little or no advance notice to the Company. Customers, in particular, may terminate a contract immediately for concerns related to the efficacy or safety of a particular drug. Upon termination, the customer is required to pay the Company for the value of work completed up to termination as well as reimburse the Company for its out-of-pocket costs incurred in accordance with the contract.

 

Historically the majority of the Company’s contracts were fixed-price in nature and net service revenues were calculated on a proportional performance or percentage of completion methodology. However over the recent history the Company and its customers have moved toward a units-based contract methodology in new contracts. It is the Company’s intent to continue to structure its contracts under a units-based methodology. Therefore, the Company expects the percentage of contracts under which net service revenues are recognized using units-based methodology to continue to increase in future periods. Under a units-based contract methodology, amounts recognized as net service revenues are calculated based on units completed in the period multiplied by a unit value or selling price that is outlined in the contract.

 

A contract amendment, which results in revisions to net service revenues and cost estimates, is recognized in revenue calculations beginning in the period in which the parties reach written agreement to the amendment.

 

Early Stage Segment Contracts

 

Early Stage segment business awards are also subject to a competitive bidding process and, upon award, are memorialized in a contract that includes terms and conditions that are substantially similar to the Company’s contracts with its Late Stage segment customers. Most of the revenue for the Early Stage segment is recognized under units-based contracts by multiplying units completed by the applicable contract per-unit price. In general, the Early Stage segment contract duration is substantially less than that of the Late Stage segment. Because the Early Stage business is also subject to the same cancellation risk as the Late Stage contracts, the Company attempts to require the customer to pay a cancellation fee if the customer cancels a project award. Net service revenues from these Early Stage contracts generally represent less than 10% of the Company’s consolidated net service revenues.

Acquisitions

 

In June 2008, the Company completed its acquisition of DecisionLine Clinical Research Corporation (DecisionLine) and its related company. DecisionLine (now Kendle Toronto) is a clinical research organization located in Toronto, Ontario specializing in the conduct of early phase studies.

 

The results of operations for acquisitions are included in the Company’s Consolidated Statements of Operations from the dates of acquisition.

 

Recent Developments and CRO Marketplace

 

The CRO industry in general continues to be dependent on the research and development efforts of the principal pharmaceutical and biotechnology companies as major customers, and the Company believes this dependence will continue. The loss of business from any of its major customers could have a material adverse effect on the Company. The economic conditions have created a very challenging climate causing the Company to rapidly adjust its strategies and align the workforce to match the demand for its services. The business climate has caused customers to re-evaluate priorities resulting in increases in contracts for the more promising projects, scaling back and/or canceling other projects and delaying decisions on others. The biopharmaceutical industry is reducing costs and, often, their workforce. The Company may benefit from increased outsourcing on the part of its customers or it may be harmed by a reduction in spending. The Company views the current conditions as an opportunity to attract well qualified candidates to strengthen and improve its operations and gain penetration and increase market share as less research and development is done in-house by our customers. Another industry trend is the rapidly approaching “patent cliff” for a number of blockbuster drugs within the biopharmaceutical industry and the significant loss of industry revenue from these drugs. The Company’s customers are addressing this situation in two ways: (1) by exploring ways to capture the revenue from these drugs once they move to the “generic” category, and (2) by continuing to identify new uses for the existing drugs which may increase its value by lengthening its patent life, or developing new compounds. This is both an opportunity and a challenge for the Company, as its customers will need to find less costly, more efficient research options often through the establishment of strategic alliances or partnerships. The Company believes it is well positioned for this development.

 

In addition, the volatility of currency exchange rate fluctuations may have a significant impact on the Company as more of its business is earned outside the United States. Fluctuations in exchange rates are not predictable, with any degree of accuracy, or foreseeable.

 

Results of Operations

 

Year Ended December 31, 2010 (2010) Compared with Year Ended December 31, 2009 (2009)

 

Net Service Revenues

 

Information to be discussed regarding segment net service revenues is outlined in the following table:

 

 

 

 

Net service revenues decreased 19.9% to $333.8 million for 2010 from $416.7 million in 2009.

 

Net service revenues in the Late Stage segment decreased 17.4% to $305.9 million in 2010 compared to $370.2 million in 2009. The declines were driven primarily by low new business awards throughout 2009 and the first half of 2010, reductions in the scope of existing projects, cancellations of existing projects and continued delays in the selling cycle, more specifically, advancing contracts from the awarded status to the signed contract status, which prevented the Company from commencing work and revenue generating activities. Additionally, pharmaceutical company mergers as well as uncertainty in the global economy delayed customer decisions on previously awarded contracts and slowed the contract signature process as pharmaceutical companies re-evaluate their pipelines and their plans for future development of products. The Company also experienced a significantly higher than normal cancellation rate on previously awarded studies in 2009 and for at least the first quarter of 2010. In the second quarter of 2010, the Company began to see this rate moderate and in the third and fourth quarters cancellations were lower than the first half of 2010.

 

Net service revenues in the Early Stage segment decreased approximately 30.9%, to approximately $25.9 million in 2010 compared to $37.5 million in 2009, primarily due to lower sales volumes and continued project delays similar to those discussed in the Late Stage segment. Due to the trend of decreased net service revenues at the Phase I unit in the Netherlands, the Company made a decision (in the fourth quarter) to close the Early Stage operations at this location. Please see Note 9 to the financial statements for further details.

 

A summary of net service revenues by geographic region for 2010 and 2009 is presented below:

 

 

In 2010 revenues decreased in all regions from the prior year. This is the result of the same factors as previously mentioned in the analysis of Late Stage and Early Stage revenues. The Company experienced a decline in both demand and volume in all regions, however the decrease in Latin America was not as great as that of the other regions as the Company’s customers continue to look toward accessing the patient populations in lower cost, emerging regions to conduct clinical trials.

 

Net service revenues from the Company’s top five customers accounted for approximately 26% and 27% of net service revenues in 2010 and 2009, respectively. No customer accounted for more than 10% of total net service revenues for 2010 or 2009.

 

Reimbursable Out-of-Pocket Revenues/Expenses

 

Reimbursable out-of-pocket revenues and expenses fluctuate from period to period due primarily to the level of investigator activity in a particular period. Reimbursable out-of-pocket revenues and expenses decreased 15.3% to $114.5 million in 2010 from $135.2 million in 2009. The decrease is due primarily to a decrease in the number of studies in which the Company is procuring investigator services.

Operating Expenses

 

 

Direct costs decreased in 2010 from 2009 by approximately $39.0 million, or 18.5%. The decrease in direct costs is attributable to a full year of cost savings initiatives (that began in the second quarter of 2009) and reduced work volumes as a result of the decline in net service revenues experienced by the Company.

 

Direct costs expressed as a percentage of net service revenues were 51.4% in 2010 compared to 50.5% in 2009. In 2009, direct costs benefitted from insurance proceeds received against an accrual for rework that was originally absorbed by the Company.

 

Selling, general and administrative (SG&A) expenses decreased in 2010 from 2009 by approximately $9.4 million, or 6.5%. The primary reason for the decrease in SG&A costs relates to the full year benefit of the cost savings initiatives undertaken in the second quarter of 2009, which are discussed in detail below along with restructuring expenses, as well as strict cost control measures put into place in 2009 and 2010. Selling, general and administrative expenses expressed as a percentage of net service revenues were 40.5% in 2010 compared to 34.7% in 2009. SG&A as a percent of revenues has increased when compared to the previous period as a significant portion of these costs are more fixed in nature and do not decrease in proportion with net service revenues. Additionally, in the second quarter of 2010, the Company awarded annual salary merit increases to its employees for the first time since 2008, reinstated certain benefits that had previously been suspended, continued on its path to implement its new ERP system, and continued to invest in its new business development and global sales organization, which partially offset the benefits of our cost savings efforts.

 

Beginning in the second quarter of 2009, the Company commenced several initiatives to optimize its workforce, match capacity with demand, and reduce operating expenses. The Company recorded restructuring charges totaling $4.5 million in 2010 and $10.2 million in 2009, for severance-related and other expenses (primarily related to facility closures). These measures resulted in lower costs in 2010 as compared to 2009. Severance charges have been primarily related to the Late Stage and Support and Other reportable segments, with the exception of a $3.0 million severance reserve recorded in the fourth quarter of 2010 related to the announced closing of Early Stage operations at the Company’s Utrecht, Netherlands facility.

 

Depreciation and amortization expense increased by $0.6 million, from $15.7 million in 2009 to $16.3 million in 2010.

 

Due to the inconsistent nature of the Early Stage business, both within the Company and the industry, during the third quarter of 2010 the Company commenced an evaluation of strategic alternatives for the Early Stage segment. Based upon this review and other triggering events, the Company began, but was unable to complete its goodwill impairment analysis, which was completed during the fourth quarter. Also during the fourth quarter, in addition to conducting its annual impairment analysis for both the Early and Late Stage segments, the Company made a decision to close the Early Stage portion of its operations in Utrecht, The Netherlands. As a result of the above events the Company recorded a goodwill impairment charge of $7.3 million for its Early Stage segment in the fourth quarter of 2010. At December 31, 2009, the fair value of the Early Stage segment exceeded the carrying value, resulting in no goodwill impairment charge. At December 31, 2010 and 2009, the fair value of all Late Stage reporting units exceeded the carrying value, resulting in no goodwill impairment charge.

Information to be discussed regarding segment operating income is outlined in the below table:

 

 

The Company experienced a loss from operations in 2010 of $1.2 million, or (0.4%) of net service revenues compared to income from operations of $35.6 million, or 8.5% of net service revenues in 2009. The overall decline in operating income and operating income as a percentage of net service revenues was primarily due to items discussed in more detail in the preceding paragraphs, primarily the reduction in net service revenues, goodwill impairment and restructuring items. Please see section titled Non-GAAP Operating Income and EPS for further discussion.

 

Income from operations from Kendle’s Late Stage segment in 2010 was $63.6 million or 20.8% of net service revenues compared to Late Stage income from operations of $81.1 million, or 21.9% of net service revenues in 2009. The decline in the Late Stage operating margin was due primarily to a decline in net service revenues, felt most heavily in the North American, European and Asia Pacific regions, which was driven by a decline in new business awards and new contracts, increased cancellations and delays in existing studies leading to decreased utilization of billable associates and excess capacity which the Company was able to partially offset by its restructuring efforts.

 

Early Stage operating results declined in 2010 from the same periods in 2009 as a result of the decline in net service revenues, as well as the restructuring costs and goodwill impairment recorded in connection with the closure of Early Stage operations at its Utrecht, The Netherlands facility. Early Stage operations generally have higher fixed costs making a decline in revenues more difficult to absorb. The Early Stage operations for 2010 resulted in operating losses, largely driven by the results of the Utrecht closure. The Early Stage segment incurred net operating loss of $11.5 million or (44.2%) of net service revenues in 2010 compared to Early Stage income from operations of $4.2 million, or 11.2% of net service revenues in 2009.

 

Other Income/(Expense)

 

Total other income (expense) was a net expense of $4.0 million in 2010 compared to expense of $6.9 million in 2009.

 

The components of Other Income/Expense were as follows for the periods presented:

 

Interest Income

 

Interest income decreased by approximately $435,000 in 2010 which is the result of both a decrease in average cash balance and lower returns on invested cash.

 

Interest Expense

 

The primary component of interest expense is related to the Company’s 3.375% Convertible Notes issued in June 2007. For 2010, the amount of interest expense recognized for the contractual interest rate was $5.0 million and the amount recognized for discount amortization was $5.6 million for a total of approximately $10.6 million. Additionally, approximately $1.6 million of interest expense was recognized for amortization of deferred issuance costs related to the Company’s Convertible Notes, the new credit Facility and termination of the Old Facility (as defined in Liquidity and Capital Resources). For 2009, the amount of interest expense recognized for the contractual interest rate was $6.1 million and the amount recognized for discount amortization was $6.5 million for a total of $12.6 million. Additionally, $1.3 million of interest expense was recognized for amortization of deferred issuance costs related to the Convertible Notes and the Company’s credit facility. The decline in interest expense in 2010 is due to a full year of lower outstanding principle on the Convertible Notes purchased by the Company on the open market in 2009 as well as an additional open market purchase in the second quarter of 2010.

 

Gain on Extinguishment of Debt

 

In 2010, the Company repurchased in the open market $12.0 million in par value of its outstanding Convertible Notes for cash in the amount of $11.1 million. The amortized book value of the debt was $10.8 million and a pre-tax net loss of approximately $71,000 was recorded. Debt issuance costs with a carrying value of $154,000 were written off in conjunction with the transaction and were included in the determination of net loss. During 2009, the Company repurchased in several transactions on the open market $45.5 million in par value of Convertible Notes for cash in the amount of $36.5 million. The carrying value of these Convertible Notes at the time of repurchase was approximately $40.0 million and a pre-tax gain on extinguishment of debt of approximately $2.9 million was recorded. As part of the repurchase transaction, the proportionate share of debt issuance costs ($840,000) were included in the determination of the gain amount and were written off.

 

See also the Liquidity and Capital Resources section.

 

Foreign Currency

 

The exchange rate transaction gains and losses typically occur when the Company holds assets and/or liabilities in a currency other than the functional currency of the reporting location. Due to uncertainties regarding the timing of and currencies involved in the majority of the Company’s foreign exchange rate transactions, it is impracticable to implement hedging instruments to match the Company’s foreign currency inflows and outflows. In 2009, the Company implemented procedures intended to mitigate the impact of foreign currency exchange rate fluctuations including an intercompany procedure to allow for regular settlement of intercompany balances. The Company will continue to evaluate ways to mitigate the risk of this impact in the future.

 

For the year ended December 31, 2010, the Company recorded foreign exchange rate gains of $8.7 million dollars, related primarily to strengthening of most currencies against the Euro.

 

In the first quarter of 2009, the Company eliminated a substantial portion of its foreign currency denominated intercompany notes payable between the U.S. subsidiary and the U.K. subsidiary and between the U.S. subsidiary and German subsidiary. The Company maintained foreign currency arrangements in connection with these transactions. The Company also terminated its foreign currency hedge arrangements that were in place to hedge this currency exposure. As a result the Company incurred losses related to the exchange rate fluctuations on the intercompany notes and related derivative instruments (pre-settlement) of approximately $1.0 million for the year ended December 31, 2009. In addition to the losses on the intercompany notes and foreign currency hedge arrangements discussed above, the Company recorded foreign exchange rate gains of approximately $6.3 million in 2009. The foreign exchange gain in 2009 mostly occurred in the first six months of 2009 and was primarily due to

the strengthening of the British pound against the Euro and the strengthening of the U.S. dollar against both the British pound and the Euro during that time period.

 

Income Taxes

 

The Company recorded a tax benefit at an effective rate of approximately 12.9% in 2010 compared to tax expense at an effective rate of approximately 46.8% in 2009. The tax benefit of $674,000 for 2010 includes approximately $90,000 of tax benefit related to the impairment of approximately $7.3 million of goodwill. Additionally, tax benefits were recorded during the year related to the recognition of tax benefits that were previously unrecognized. The tax expense of $13.4 million for 2009 includes $4.4 million in tax expense for the settlement of foreign currency hedges and related intercompany notes and a $1.0 million item for the tax related to the taxable gain from the extinguishment of debt in connection with the open market repurchases. These items are partially offset by a tax benefit recorded in the third quarter of 2009 related to revisions in estimates for certain items related to the Company’s 2008 U.S. federal tax return and an additional tax benefit of approximately $1.0 million recorded during 2009 related to the usage of certain deferred tax assets for which a valuation allowance had been previously recorded.

 

Net Income (Loss)

 

Net loss for 2010 was approximately $4.6 million, or $0.31 per diluted share and basic share, compared with net income of approximately $15.2 million, or $1.02 per diluted share and $1.03 per basic share in 2009.

 

Non-GAAP Operating Income, Net Income and EPS

 

Non-GAAP operating income, non-GAAP net income and non-GAAP EPS are alternative views of the Company’s performance used by management that the Company is providing because management believes this information enhances investors’ understanding of the Company’s results. Non-GAAP measures exclude certain items because of the nature of these items and the impact that they have on the analysis of underlying business performance and trends. The excluded items are restructuring charges and goodwill impairment. The excluded items are significant components in understanding and assessing financial performance. Therefore, the information on non-GAAP operating income, net income and EPS should be considered in addition to, but not in lieu of, operating income, net income and earnings per share prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Additionally, since non-GAAP measures are not determined in accordance with GAAP, they have no standardized meaning prescribed by GAAP and, therefore, may not be comparable to the calculation of similar measures of other companies.

A reconciliation between GAAP financial measures and non-GAAP financial measures is as follows:

 

 

Restructuring Expenses

 

Non-GAAP operating income and non-GAAP net income and EPS exclude restructuring costs, primarily costs related to facility closures and employee severance costs. Restructuring costs have occurred in past periods and may occur in future periods, and therefore should not be considered to be non-recurring. However, management excludes these amounts from non-GAAP operating income and non-GAAP net income and EPS because it believes it is helpful for understanding the Company’s performance.

 

Goodwill Impairment

 

For the year ended December 31, 2010, the Company recorded an impairment loss of $7.3 million in connection with the finalization of the third quarter goodwill impairment analysis, the Company’s annual impairment testing in the fourth quarter and the decision to close the Early Stage operations of its Utrecht, The Netherlands facility. Subsequent to the impairment charge, the Company’s Early Stage segment maintains approximately $11.7 million of goodwill.

Year Ended December 31, 2009 (2009) Compared with Year Ended December 31, 2008 (2008)

 

Net Service Revenues

 

Information to be discussed regarding segment net service revenues is outlined in the following table:

 

Revenues

 

 

 

 

Net service revenues decreased 12% to $416.7 million for 2009 from $475.1 million in 2008. The changes in currency rates reduced net service revenues by approximately 6% for the year 2009.

 

Net service revenues in the Late Stage segment decreased approximately 14% to $370.2 million in 2009 compared to $430.3 million in 2008. The declines were driven primarily by changes in foreign currency exchange rates, reductions in the scope of existing projects, cancellations of existing projects and continued delays in the selling cycle, more specifically, advancing contracts from the awarded status to the signed contract status, which prevented the Company from commencing work and revenue generating activities. As mentioned, the Company also experienced a significantly higher than normal cancellation rate on previously awarded studies. The Company believes this situation is the result of biopharmaceutical industry merger and acquisition activity, weakness in the current global economy and reduced access to capital, among other things. Additionally, recent pharmaceutical company mergers as well as reduced prescription drug sales and uncertainty in the global economy delayed customer decisions on previously awarded contracts and slowed the contract signature process as pharmaceutical companies re-evaluated their pipelines and, in the case of newly merged customers, focused on integration efforts rather than future development of products.

 

Net service revenues in the Early Stage segment increased approximately 6.5%, or $2.3 million to approximately $37.5 million in 2009 compared to $35.2 million in 2008. The majority of this increase is attributable to the Kendle Toronto acquisition as 2009 results contain 12 months of net service revenues from Kendle Toronto compared to 7 months of net service revenues in 2008. This increase was partially offset by the impact of currency rate fluctuations and decreased net service revenues at the Phase I unit in the Netherlands as a result of the previously mentioned project delays and cancellations.

 

A summary of net service revenues by geographic region for 2009 and 2008 is presented below:

 

In 2009, the Company experienced a decline in both demand and volume in North America and Europe as the Company’s customers continue to look toward accessing the patient populations in Latin America, Asia-Pacific and other lower cost emerging regions to conduct clinical trials.

 

Net service revenues from the Company’s top five customers accounted for approximately 27% of net service revenues in both 2009 and 2008. No customer accounted for more than 10% of total net service revenues for 2009 or 2008.

 

Reimbursable Out-of-Pocket Revenues/Expenses

 

Reimbursable out-of-pocket revenues and expenses fluctuate from period to period due primarily to the level of investigator activity in a particular period. Reimbursable out-of-pocket revenues and expenses decreased 33% to $135.2 million in 2009 from $203.5 million in 2008. The decrease is due primarily to a decrease in the number of studies in which the Company is procuring investigator services.

 

Operating Expenses

 

 

Direct costs decreased in 2009 from 2008 by approximately $36.9 million, or 15%. The decrease in direct costs in 2009 is attributable to the decline in net service revenues and headcount reductions and other cost savings initiatives initiated in the second quarter of 2009 as discussed in more detail below.

 

Additionally, in the fourth quarter of 2008, the Company identified a programming issue unique to one study and one customer that required the Company to rework a large portion of the project and additionally, to bear costs that would, under normal circumstances, be absorbed by the customer. The Company accrued $4.9 million related to these costs in the fourth quarter of 2008. In 2009, as a result of ongoing discussions with the customer and the insurance provider, the Company increased the accrual for direct costs by $2.2 million to a total of $7.1 million and received the insurance claim recovery of $5.0 million. The net reduction in direct costs in 2009 related to this programming issue and the insurance claim recovery was approximately $2.8 million.

 

Direct costs expressed as a percentage of net service revenues were 50.5% in 2009 compared to 52.1% in 2008. The decrease in direct costs as a percentage of net service revenues in 2009 is due in large part to the fluctuations in the accrual for rework discussed in the preceding paragraph.

 

Selling, general and administrative (SG&A) expenses decreased in 2009 from 2008 by approximately $10.9 million, or 7%. The primary reason for the decrease in SG&A costs relates to the cost savings initiatives undertaken in 2009, as discussed in more detail below. Selling, general and administrative expenses expressed as a percentage of net service revenues were 34.7% in 2009 compared to 32.7% in 2008.

 

In the second quarter of 2009, the Company commenced several initiatives to optimize its workforce and capacity and to reduce operating expenses. These activities included a reduction of discretionary spending, limiting previously planned headcount additions, delay or elimination of salary merit increases, reduction or elimination of certain other benefits, workforce reductions or furloughs, and other cost savings in an attempt to reduce expenses. The Company recorded a charge in the second quarter of 2009 for severance-related and other expenses (primarily related to facility closures), of approximately $6.0 million. In the third quarter of 2009, the Company revised its estimate of severance costs and expensed an additional $380,000. As a result of these initiatives, the Company realized savings of approximately $20 million in 2009.

In the fourth quarter of 2009, due to continued weakness in new business awards and future net service revenue projections and higher than historical cancellations, the Company committed to additional headcount reductions expected to be initiated during the first quarter of 2010 and recorded a charge in the fourth quarter of 2009 for severance-related expenses of approximately $3.8 million. Because the bulk of the Company’s expenses are typically incurred in the Late Stage and Support and Other reportable segments, the majority of the costs removed from the business also affect those two segments. Headcount was reduced from approximately 4,275 associates at the end of 2008 to 3,640 associates at the end of 2009. This reduction was primarily in the U.S. and Western Europe and is expected to result in savings of approximately $16 to $18 million in 2010. When customer demand increases, the Company will be required to increase staffing to deliver services and all of the estimated savings may not materialize.

 

Depreciation and amortization expense increased by $0.4 million, from $15.3 million in 2008 to $15.7 million in 2009. The increase is primarily due to a full year of amortization expense in 2009 on a customer relationship asset from the Kendle Toronto acquisition versus seven months in 2008.

 

Information to be discussed regarding segment operating income is outlined in the below table:

 

 

 

 

Income from operations in 2009 declined to $35.6 million, or 8.5% of net service revenues, compared to $56.8 million, or 12.0% of net service revenues in 2008. The overall decline in operating income and operating income as a percentage of net service revenues was primarily due to items discussed in more detail in the preceding paragraphs, including the reduction in net service revenues and the restructuring expense. Please see section titled Non-GAAP Operating Income, Net Income and EPS for further discussion.

 

Income from operations from Kendle’s Late Stage segment in 2009 was $81.1 million or 21.9% of net service revenues compared to Late Stage income from operations of $105.1 million, or 24.4% of net service revenues in 2008. The decline in the Late Stage operating margin was due primarily to a decline in net service revenues, primarily in the North American and European regions, driven by the decline in new business awards and new contracts, increased cancellations and delays in existing studies leading to decreased utilization of billable associates and excess capacity. Additionally, in 2009 the decline in Late Stage operating margin was due to the accrual of costs related to the workforce capacity optimization as discussed above.

 

Income from operations from Kendle’s Early Stage segment in 2009 was $4.2 million, or 11.2% of net service revenues compared to Early Stage income from operations of $6.2 million, or 17.5% of net service revenues in 2008. The primary reason for the decline in operating income as a percentage of net service revenues was due to low demand, for reasons previously cited, at the Company’s Phase I unit in the Netherlands.

 

Other Income/(Expense)

 

Total other income (expense) was expense of $6.9 million in 2009 compared to expense of $17.2 million in 2008.

The components of Other Income/Expense were as follows for the periods presented:

 

 

Interest Income

 

Interest income decreased by approximately $181,000 in 2009 due to lower returns on the invested cash.

 

Interest Expense

 

The primary component of interest expense is related to the Company’s 3.375% Convertible Notes issued in June 2007. The Company adopted new accounting guidance related to convertible debt effective January 1, 2009 as it relates to this issuance and as required by the new guidance has retrospectively adjusted the prior periods for the effects of the new guidance.

 

For 2009, the amount of interest expense recognized for the contractual interest rate was $6.1 million and the amount recognized for discount amortization was $6.5 million for a total of $12.6 million. Additionally, $1.3 million of interest expense was recognized for amortization of deferred issuance costs related to the Convertible Notes and the Company’s credit facility. For 2008, the amount of interest expense recognized for the contractual interest rate was $6.8 million and the amount recognized for discount amortization was $6.6 million for a total of $13.4 million. Additionally, $1.2 million of interest expense was recognized for amortization of deferred issuance costs related to the Convertible Notes and the Company’s credit facility. The decline in interest expense in 2009 is due to the open market repurchases during the year of a portion of the convertible notes outstanding.

 

Gain on Extinguishment of Debt

 

During 2009, the Company repurchased in several transactions on the open market $45.5 million in par value of Convertible Notes for cash in the amount of $36.5 million. The carrying value of these Convertible Notes at the time of repurchase was approximately $40.0 million and a pretax gain on extinguishment of debt of approximately $2.9 million was recorded. As part of the repurchase transactions, the proportionate share of debt issuance costs in the amount of $840,000 was included in the determination of the gain amount and was written off.

 

See also the Liquidity and Capital Resources section.

 

Foreign Currency

 

In the first quarter of 2007, the Company entered into foreign currency hedge arrangements to hedge foreign currency exposure related to intercompany notes outstanding. The hedging transactions were designed to mitigate the Company’s exposure related to two intercompany notes between the Company’s U.S. subsidiary, as lender, and the Company’s subsidiary in each of the United Kingdom and Germany. The derivative arrangements were not designated for hedge accounting treatment and mark to market adjustments on these arrangements were recorded in the Company’s Consolidated Statements of Operations.

 

In the first quarter of 2009, the Company eliminated a substantial portion of the note payable between the U.S. subsidiary and the U.K. subsidiary, referenced above, and the entire amount of the note payable between the U.S. subsidiary and German subsidiary. In connection with these transactions, the Company also terminated its foreign currency hedge arrangements referenced in the preceding paragraph.

In 2009, losses related to the exchange rate fluctuations on the intercompany notes and related derivative instruments (pre-settlement) were approximately $1.0 million compared to gains of approximately $2.4 million in 2008 on the intercompany notes and derivatives instruments.

 

In addition to the gains on the intercompany notes and foreign currency hedge arrangements discussed above, the Company recorded foreign exchange rate gains of approximately $6.3 million in 2009 compared to losses of approximately $3.4 million in 2008. The foreign exchange gain in 2009 mostly occurred in the first six months of 2009 and was primarily due to the strengthening of the British pound against the Euro and the strengthening of the U.S. dollar against both the British pound and the Euro during that time period. As mentioned below, the Company has implemented procedures intended to mitigate the impact of foreign currency exchange rate fluctuations and those procedures have helped to reduce the impact in the second half of 2009. The foreign exchange losses in 2008 were due primarily to the weakening of the British pound against the Euro as the Company had a large amount of euro denominated payables in countries that have a functional currency of the British pound.

 

The exchange rate transaction gains and losses typically occur when the Company holds assets and/or liabilities in a currency other than the functional currency of the reporting location. Due to uncertainties regarding the timing of and currencies involved in the majority of the Company’s foreign exchange rate transactions, it is impracticable to implement hedging instruments to match the Company’s foreign currency inflows and outflows. In 2009, the Company implemented procedures intended to mitigate the impact of foreign currency exchange rate fluctuations including an intercompany procedure to allow for regular settlement of intercompany balances. The Company will continue to evaluate ways to mitigate the risk of this impact in the future.

 

Income Taxes

 

The Company recorded tax expense at an effective rate of approximately 46.8% in 2009 compared to approximately 41.6% in 2008. The tax expense of $13.4 million for 2009 includes $4.4 million in tax expense for the settlement of foreign currency hedges and related intercompany notes and a $1.0 million item for the tax related to the taxable gain from the extinguishment of debt in connection with the open market repurchases. These items are partially offset by a tax benefit recorded in the third quarter of 2009 related to revisions in estimates for certain items related to the Company’s 2008 U.S. federal tax return and an additional tax benefit of approximately $1.0 million recorded during 2009 related to the usage of certain deferred tax assets for which a valuation allowance had been previously recorded. In 2008, the Company recorded an additional tax benefit of approximately $3.3 million related to the recognition of tax benefits that were previously unrecognized in accordance with accounting guidance related to accounting for uncertainty in income taxes.

 

Net Income

 

The net income for 2009 was approximately $15.2 million, or $1.02 per diluted share and $1.03 per basic share.

 

The net income for 2008 was approximately $23.1 million, or $1.54 per diluted share and $1.57 per basic share.

 

Liquidity and Capital Resources

 

The Company had cash and cash equivalents of approximately $21.2 million at December 31, 2010 compared to approximately $52.1 million at December 31, 2009. In 2010, cash and cash equivalents decreased by $30.9 million primarily as a result of cash used in investing and financing activities of $19.6 million and $11.8 million, respectively, offset slightly by cash provided from operating activities. Foreign exchange rates negatively impacted cash and cash equivalents by approximately $0.4 million. In addition, the Company has restricted cash of approximately $0.9 million at December 31, 2010 compared with $1.1 million at December 31, 2009, which represents cash received from customers that is held in a separate Company bank account and available for use only for specific project-related expenses, primarily investigator fees, upon authorization from the customer. Because this restricted cash is directly related to operation of the Company’s business, the activity is included in operating cash flows as opposed to financing cash flows.

 

Net cash provided by operating activities for the year consisted primarily of a net loss of $4.6 million adjusted for noncash expenses of $20.6 million primarily related to depreciation and amortization, debt issuance cost

amortization, and goodwill impairment charges, partially offset by the noncash changes in deferred income taxes and unrealized gains in foreign exchange for the year ended December 31, 2010. Additional uses of operating cash resulted from decreases in advanced billings and accrued liabilities primarily as a result of lower revenue volumes in 2010, offset partially by the net collections of accounts receivable. In 2009, changes in operating assets and liabilities provided net cash in the amount of $10.5 million, driven by collections of accounts receivable as well as receipt of cash payments totaling $4.5 million for tenant improvement allowances as per the terms of the lease for the Company’s headquarters. Fluctuations in accounts receivable and advance billings occur on a regular basis as services are performed, milestones or other billing criteria are achieved, invoices are sent to customers and payments for outstanding accounts receivable are collected from customers. Accounts receivable, net of advance billings, decreased from $49.1 million at December 31, 2009, to $48.1 million at December 31, 2010.

 

Cash flows used for investing activities for the year ended December 31, 2010 included the use of approximately $17.3 million for property and equipment additions and $2.4 million for the final payment on a prior acquisition. Cash flows used for investing activities for the year ended December 31, 2009 included the use of $19.0 million for property and equipment additions and $2.9 million for acquisition of businesses (primarily partial payment of accrued contingent consideration) combined with the receipt of $17.3 million from the termination of the existing hedge agreements.

 

Cash flows used in financing activities for the year ended December 31, 2010 were $11.8 million, of which $11.1 million was used to repurchase $12.0 million in par value of the Company’s Convertible Notes on the open market. Cash flows used in financing activities for the year ended December 31, 2009 were $36.9 million, of which $36.5 million was used to repurchase $45.5 million in par value of the Company’s Convertible Notes on the open market.

 

Cash used for capital expenditures of $17.3 million, $19.0 million, $27.1 million in 2010, 2009, and 2008, respectively was primarily related to information technology initiatives.

 

In March 2010, the Company terminated its prior credit agreement and entered into a new credit agreement (the “Facility”). The Facility is comprised of a $35 million revolving loan commitment, with up to $10 million of such commitment available for issuance of letters of credit and up to $5 million of such commitment available for same-day swing line loans. At the Company’s request and with the consent of the current lender or additional lenders, the total commitment may be increased by, or incremental term loans be obtained for, up to an additional $15 million. At the Company’s election, loans under the Facility are available either at (i) an adjusted base rate plus an applicable margin; or (ii) an adjusted LIBOR rate plus an applicable margin. The applicable margin for each interest rate is calculated in accordance with the terms of the Facility.

 

The Facility, as amended on April 27, 2010, matures on March 31, 2015. Before this amendment, the Facility had the potential for accelerated maturity on January 15, 2012 in the event that five percent (5%) or more of the currently outstanding principal amount of the Convertible Notes discussed below had not been redeemed or repaid in full on or prior to January 15, 2012. The Facility was amended again on January 21, 2011 (Amendment No. 2) to increase the “Total Leverage Ratio” for certain periods and also contemplates certain additional add-backs to “Consolidated EBITDA” for certain cash and non-cash charges.

 

Borrowings under the Facility are collateralized by substantially all of the Company’s assets pursuant to the terms of a Pledge and Security Agreement. The Facility contains various affirmative and negative covenants including those regarding limitations on the Company’s ability to incur certain indebtedness, limitations on certain investments, limitations on capital expenditures in any fiscal year and limitations on certain acquisitions and asset sales outside the ordinary course of business as well as financial covenants regarding limitations on the Company’s total leverage ratio, senior secured leverage ratio and interest coverage ratio. The Company is in compliance with the covenants as of December 31, 2010.

 

The Company also maintains an existing $5.0 million Multicurrency Facility that is renewable annually and is used in connection with the Company’s European operations.

 

In July, 2007, the Company issued $200 million of five-year Convertible Notes with a maturity date of July 15, 2012. The Convertible Notes bear interest at an annual rate of 3.375%, payable semi-annually in arrears on January 15 and July 15 of each year. The Convertible Notes are convertible at the option of the holder into cash and, if

applicable, shares of the Company’s common stock at an initial conversion price of $47.71 per share (approximating 20.9585 shares per $1,000 principal amount of the Convertible Notes), upon the occurrence of certain events. In addition, upon events defined as a “fundamental change” under the Convertible Note Indenture, holders of the Convertible Notes may require the Company to repurchase the Convertible Notes. If upon the occurrence of such events in which the holders of the Convertible Notes exercise the conversion provisions of the Convertible Notes, the Company will need to remit the principal balance of the Convertible Notes to the holders in cash. As such, the Company would be required to classify the entire amount outstanding of the Convertible Notes as a current liability in the following quarter. The evaluation of the classification of amounts outstanding associated with the Convertible Notes occurs every quarter. As of December 31, 2010 and 2009, the Convertible Notes are classified as long-term in the accompanying Consolidated Balance Sheets.

 

Concurrent with the sale of the Convertible Notes, the Company purchased convertible bond hedges from two counterparties which are designed to mitigate potential dilution from the conversion of the Convertible Notes in the event that the market value per share of the Company’s common stock at the time of exercise is greater than approximately $47.71. In addition, the Company issued warrants to the counterparties that could require the Company to issue shares of the Company’s common stock at a strike price of $61.22 per share. The Convertible Note hedge and warrant transactions generally have the effect of increasing the conversion price of the Convertible Notes to approximately $61.22 per share of Kendle common stock, representing approximately a 70% premium based on the closing sale price as reported on The NASDAQ Global Market on July 10, 2007, of $36.01 per share.

 

In 2010, the Company repurchased $12.0 million in par value of its Convertible Notes on the open market for cash of $11.1 million. The amortized carrying value of these repurchased notes was $10.8 million and a non-cash net loss of $71,000 was recorded. As part of the repurchase transaction, the proportionate share of debt issuance costs in the amount of $154,000 was written off. This transaction is expected to result in reduced cash interest expense and non-cash discount amortization of $2.0 million over the remaining term of the Convertible Notes. Of the consideration paid to repurchase the Convertible Notes, $348,000 was allocated to the equity component. This is considered to be a reacquisition of a portion of the equity component of the Convertible Notes and as such is recorded as a reduction of additional paid in capital.

 

As of December 31, 2010, $142.5 million in par value was outstanding under the Convertible Notes, no amounts were outstanding under the revolving credit portion of the Facility that the Company maintained and no amounts were outstanding under the Multicurrency Facility. The Company did draw on the Facility for short periods of time in the third and fourth quarters of 2010 to cover operational cash flow needs resulting primarily from temporary billing delays related to the ERP implementation, promptly repaying each advance. The maximum amount outstanding at any point was $3 million and the average daily amount outstanding for the second half of 2010 was $250,000. The weighted average interest rate paid on these advances was 5.76%.

 

The Company’s primary cash needs on both a short-term and long-term basis are for the payment of salaries and fringe benefits, hiring and recruiting expenses, business development costs, capital expenditures, acquisitions and facility-related expenses. The Company believes that its existing capital resources, together with cash flows from operations and borrowing capacity under the Facility and the Multicurrency Facility, will be sufficient to meet its foreseeable cash needs for both the short and long term.

 

The Company has not historically experienced regular liquidity or collections issues with the large majority of its customers. However, the Company does have contracts with biotechnology and small pharmaceutical companies, some of which are dependent upon external financing to fund their contractual commitments. The Company is continuing to monitor the financial status of its customers.

 

As more of the Company’s revenues are generated in locations other than the U.S., repatriation of those cash flows in a tax efficient manner is increasingly challenging. The Company is in the process of revising its internal transfer pricing methodologies to align with its current operational model with the goal of future tax savings as a result of increased utilization of existing tax attributes.

 

In the future, the Company will continue to consider the acquisition of businesses to enhance its service offerings, therapeutic base and global presence. Any such acquisitions may require additional external financings

and the Company may from time to time seek to obtain funds from public or private issuances of equity or debt securities. There can be no assurance that such financings will be available on terms acceptable to the Company.

 

Contractual Obligations

 

Future minimum payments for all contractual obligations for years subsequent to December 31, 2010 are as follows:

 

 

Short-term obligations arising in the ordinary course of business are excluded from the above table.

 

 

 

Critical Accounting Policies and Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make significant estimates and assumptions that affect the reported Consolidated Financial Statements for a particular period. Actual results could differ from those estimates.

 

Revenue Recognition

 

A portion of the Company’s net service revenues are based on fixed-price contracts calculated on a proportional performance basis (also referred to herein as “percentage-of-completion”) based upon assumptions regarding the estimated total costs for each contract. The Company also recognizes revenue under units-based contracts by multiplying units completed by the applicable contract per-unit price. Additionally, work is performed under time-and-materials contracts, recognizing revenue as hours are worked based on the hourly billing rate for each contract.

 

Percentage-of-Completion

 

With respect to certain fixed price contracts, costs are incurred for performance of each contract and compared to the estimated budgeted costs for that contract to determine a percentage of completion on the contract. The percentage of completion is then multiplied by the contract value to determine the amount of revenue recognized. The contract value equals the value of the services to be performed under the contract as determined by aggregating the labor hours estimated to be incurred to perform the tasks in the contract at the agreed rates. Contract value excludes the value of third-party and other pass-through costs. As the work progresses, original estimates might be changed as a result of management’s regular contract review process.

Management regularly reviews the budget on each contract to determine if the budgeted costs accurately reflect the costs that the Company will incur for contract performance. The Company reviews each contract’s performance to date, current cost trends and circumstances specific to each contract. The Company estimates its remaining costs to complete the contract based on a variety of factors, including:

 

 

Examples of factors included in the review process that could change the rate of progress of future contract performance are: patient enrollment rate, changes in the composition of staff on the project or other customer requirements, among other things.

 

Based on these contract reviews, the Company adjusts its cost estimates. Adjustments to net service revenue resulting from changes in cost estimates are recorded on a cumulative basis in the period in which the revisions are made. When estimates indicate a loss, such loss is provided in the current period in its entirety. While the Company routinely adjusts cost estimates on individual contracts, the Company’s estimates and assumptions historically have been accurate in all material respects in the aggregate. The Company expects the estimates and assumptions to remain accurate in all material respects in the aggregate in future periods.

 

A contract amendment, which results in revisions to net service revenues and cost estimates, is recognized in the percentage-of-completion calculations beginning in the period in which the parties reach written agreement to the amendment (see also Company Overview section of MD&A for a description of the contract amendment process). Historically, the aggregate value of contract amendments signed in any year represents approximately 15% to 20% of annual sales. Although the majority of the Company’s contract amendments relate to future services, the Company and its customers may execute contract amendments for services that the Company already has performed. In these circumstances, net service revenue from past services performed is recognized in the current period. Historically, the impact of such amendments on results of operations has not been material.

 

Under the Company’s policy, project teams are not authorized to engage in tasks outside the scope of the contract without prior management approval. In limited situations, management may authorize the project team to commence work on activities outside the contract scope while the Company and its customer negotiate and finalize the contract amendment. When work progresses on unsigned, unprocessed contract amendments, the Company reviews the direct costs incurred, and, where significant defers such costs on the balance sheet. In addition, the impact of such costs on the estimates to complete is considered and, where material, the estimates are adjusted. Historically, neither the deferred costs nor the impact on estimates have been material.

 

The Company believes that total costs constitute the most appropriate indicator of the performance of fixed price contracts because the costs relate primarily to the amount of labor hours incurred to perform the contract. The customer receives the benefit of the work performed throughout the contract term and is obligated to pay for services once performed. Accordingly, the Company believes that an input measure of cost is a reasonable surrogate for an output measure under the proportional performance model and is consistent with the revenue recognition concepts issued by the SEC.

 

Units-Based

 

The Company has seen increasing demand from its customers to move to a units-based contract methodology in new contracts and a majority of the Company’s net service revenues are based on a units methodology. It is the Company’s intent to structure more of its contracts under a units-based methodology for calculating net service revenues so the Company expects the percentage of contracts under which net service revenues are recognized using units-based methodology to continue to increase in future periods. Under a units-based contract methodology, amounts recognized as net service revenues are calculated based on units completed in the period multiplied by a unit value or selling price that is outlined in the contract.

For a units-based contract, a typical unit could include such things as completion of a monitoring visit, monthly site management units or case report form pages entered. The Company tracks the units completed for each unit category included in the contract. Net service revenue is recognized monthly based on the units actually completed in the period at the agreed upon unit value or selling price. Net service revenue is recognized only up to the number of units contained in each contract. If the Company completes or expects to complete units over and above the number of units initially estimated and contained in the contract, a contract amendment is generated to reflect the additional units needed.

 

A contract amendment, which results in revisions to net service revenues and expected units or unit values, is recognized in the unit-based net service revenue calculations beginning in the period in which the parties agree to the amendment (see also Company Overview section of MD&A for a description of the contract amendment process).

 

The Company believes that under certain types of contracts the value of the work performed is best captured by calculating net service revenues using the value of units completed. The Company believes that units-based revenue recognition is consistent with the revenue recognition concepts issued by the SEC.

 

As the Company provides services on projects, it also incurs third-party and other pass-through costs, which are reimbursable by its customers pursuant to the contract. The revenues and costs from these third-party and other pass-through costs are reflected in the Company’s Consolidated Statements of Operations under the line items titled “Reimbursable out-of-pocket revenues” and “Reimbursable out-of-pocket costs”, respectively.

 

Direct Costs

 

Direct costs consist of compensation and related fringe benefits for project-related associates, unreimbursed project-related costs and an allocated portion of indirect costs, which primarily includes facilities-related costs and information systems costs. Labor costs represent over 80% of total direct costs with the allocated portion of indirect costs and other expenses representing the remainder. To determine the allocated portion of indirect costs, the Company calculates an allocation percentage based on the relationship between billable associate salaries and total salaries. The remaining indirect costs are allocated to SG&A.

 

Because the Company’s business is labor intensive, direct costs historically have increased with an increase in net service revenues. The Company, however, has not experienced any material variations in the relationship between direct costs and net service revenues for the fiscal years ended 2010, 2009, and 2008. The following factors, among others, may cause direct costs to decrease as a percentage of net service revenues:

 

 

The following factors, among others, will cause direct costs to increase as a percentage of net service revenues:

 

 

Other Costs

 

Selling, general and administrative expenses consist of compensation and related fringe benefits for sales and administrative employees and professional services, as well as unallocated costs related to facilities, information systems and other costs.

 

Depreciation and amortization expenses consist of depreciation and amortization costs recorded on a straight-line method over the estimated useful life of the property or equipment and internally developed software. Finite-lived intangible assets are generally amortized on an accelerated basis based on the discounted cash flow calculations used in the valuation of the asset.

Accounts Receivable/Allowance for Doubtful Accounts

 

Billed accounts receivable represent amounts for which invoices have been issued to customers. Unbilled accounts receivable are amounts recognized as revenue for which invoices have not yet been issued to customers. Advance billings represent amounts billed or payment received for which revenues have not yet been earned. The Company maintains an allowance for doubtful accounts receivable based on historical evidence of accounts receivable collections and specific identification of accounts receivable that might pose collection problems. The bad debt reserve is monitored on a regular basis and adjusted as circumstances warrant. The Company’s allowance for doubtful accounts has been sufficient to cover any bad debt write-offs. The Company will continue to monitor its bad debt exposure and adjust bad debt reserves as necessary.

 

If the Company is unable to collect all or part of its outstanding receivables, there could be a material impact to the Company’s Consolidated Statements of Operations or financial position.

 

Goodwill and Intangible Assets

 

The Company analyzes goodwill and other finite-lived intangible assets to determine any potential impairment loss annually in the fourth quarter, unless conditions exist that require an updated analysis on an interim basis. A fair value approach is used to test goodwill for impairment. The fair value approach compares estimates related to the fair value of the reporting unit with the unit’s carrying amount, including goodwill. The fair value is determined using both the market approach and the income approach which consists of projected discounted cash flows. If the carrying amount of the reporting unit exceeds the fair value, the amount of the impairment loss must be measured. The Company has five reporting units that are tested for impairment: Early Stage, and the four Late Stage reporting units consisting of: Clinical and Data Monitoring; Project Management and Late Phase Services; Regulatory, Site and Medical Affairs; and Biostatistics and Statistical Programming. Reporting units are defined as the components of operating segments for which discrete financial information is available and regularly reviewed by management.

 

Due to the inconsistent nature of the Early Stage business, both within the Company and the industry, during the third quarter of 2010 the Company commenced an evaluation of strategic alternatives for the Early Stage segment. Based upon this review and other triggering events, the Company began, but was unable to complete its goodwill impairment analysis, this was completed during the fourth quarter. Also during the fourth quarter, in addition to conducting its annual impairment analysis for both the Early and Late Stage segments, the Company made a decision to close the Early Stage portion of its operations in Utrecht, The Netherlands. As a result of the above events the Company recorded a goodwill impairment charge of $7.3 million for its Early Stage segment in the fourth quarter of 2010. At December 31, 2009 the fair value of the Early Stage segment exceeded the carrying value, resulting in no goodwill impairment charge.

 

At December 31, 2010 and 2009, the fair value of all Late Stage reporting units exceeded the carrying value, resulting in no goodwill impairment charge. At December 31, 2010 the fair value of each Late Stage reporting unit exceeded the carrying value by the following approximate percentages: Regulatory, Site and Medical Affairs — greater than 100%; Project Management & Late Phase — 21%; Clinical and Data Monitoring — 2% and Biostatistics and Statistical Programming — 44%.

 

The estimate of fair value is inherently subjective and requires the Company to make a number of assumptions and projections. These assumptions and projections relate to revenue growth rates, profit margin percentages, discount rates, perpetuity growth rates, future capital expenditures and future market conditions, among other things. The most significant assumptions are revenue, and operating margin growth rates, as well as the discount rate. The use of different assumptions could increase or decrease estimated discounted future cash flows and may affect the results of the Company’s impairment analysis. The growth rates are forward looking and by their nature are uncertain. The Company may or may not be able to achieve the estimated growth rates and/or margin rates.

 

Internally Developed Software

 

Pursuant to the accounting guidance related to the capitalization of software developed or obtained for internal use, the Company capitalizes costs incurred to internally develop software used primarily in the Company’s proprietary clinical trial and data management systems, and amortizes these costs over the useful life of the product,

not to exceed five years. Internally developed software represents software in the application development stage, and there is no assurance that the software development process will produce a final product for which the fair value exceeds its carrying value. Internally developed software is an intangible asset subject to impairment write-downs whenever events indicate that the carrying value of the software may not be recoverable. As with other long-lived assets, this asset is reviewed at least annually to determine the appropriateness of the carrying value of the asset and the estimated useful lives. Assessing the fair value of the internally developed software requires estimates and judgment on the part of management. As discussed in Note 1 to the Consolidated Financial Statements, internally developed software is amortized over its estimated useful life of five years. The Company believes the useful life established remains reasonable.

 

Tax Valuation Allowance and Tax Liabilities

 

The Company follows the guidance related to accounting for uncertainties in income taxes. This guidance requires significant judgment in determining what constitutes an individual tax position as well as assessing the outcome of each tax position. Changes in judgments as to recognition or measurement of tax positions can materially affect the estimate of the effective tax rate, and, consequently, the Company’s operating results. The Company considers many factors when evaluating and estimating tax positions and tax benefits, which may require periodic adjustments and which may not accurately anticipate actual outcomes. In addition, the calculation of tax liabilities involves dealing with uncertainties in the application of complex tax regulations in a multitude of jurisdictions. At December 31, 2010, the Company has recorded a gross liability for uncertain income tax positions of $1.1 million (including interest). If events occur and the payment of these amounts ultimately proves to be unnecessary, the reversal of liabilities would result in tax benefits being recognized in the period when it is determined the liabilities are no longer necessary. If the calculation of liability related to uncertain tax positions proves to be more or less than the ultimate assessment, a tax expense or benefit to expense, respectively, would result.

 

The Company provides for income taxes on all transactions that have been recognized in the Consolidated Financial Statements in accordance with accounting guidance related to accounting for income taxes. Specifically, the Company estimates its tax liability based on current tax laws in the statutory jurisdictions in which it operates. Because the Company conducts business on a global basis, its effective tax rate has and will continue to depend upon the geographic distribution of its pre-tax earnings (losses) among jurisdictions with varying tax rates. These estimates include judgments about deferred tax assets and liabilities resulting from temporary differences between assets and liabilities recognized for financial reporting purposes and such amounts recognized for tax purposes. The Company has assessed the realization of deferred tax assets and a valuation allowance has been established based on an assessment that it is more likely than not, that realization cannot be assured. The ultimate realization of this tax benefit is dependent upon the generation of sufficient pretax income in the respective tax jurisdictions. If estimates prove inaccurate or if the tax laws change unfavorably, significant revisions in the valuation allowance may be required in the future.

 

Stock-based Compensation

 

The Company follows the guidance related to accounting for share-based payments. The Company generally uses the straight-line method of recording compensation expense relative to share-based payment, unless awards have graded vesting features and the expense recorded under the straight-line method is not adequate. In those situations, compensation cost is recognized separately over each tranche. Stock-based compensation expense is recorded primarily in general and administrative expenses in the Company’s Consolidated Statements of Operations as the majority of the stock option expense relates to options granted to executives.

 

If factors change and the Company employs different assumptions in the calculation of stock-based compensation in future periods, the compensation expense that the Company records may differ significantly from the expense recorded in the current period.

 

New Accounting Pronouncements

 

For a discussion of New Accounting Pronouncements, see Note 1 to the Company’s Consolidated Financial Statements.

Cautionary Statement for Forward-Looking Information

 

Certain statements contained in this Annual Report on Form 10-K that are not historical facts constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are intended to be covered by the safe harbors created by that Act. Reliance should not be placed on forward-looking statements because they involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied. Any forward-looking statement speaks only as of the date made. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances arising after the date on which they are made.

 

Statements concerning expected financial performance, on-going business strategies and possible future action which the Company intends to pursue to achieve strategic objectives constitute forward-looking information. Implementation of these strategies and the achievement of such financial performance are each subject to numerous conditions, uncertainties and risk factors.

 

Factors that could cause actual performance to differ materially from these forward-looking statements include those Risk Factors set forth in Item 1A of this Annual Report on Form 10-K.

 

 

Interest Rates

 

The Company is exposed to changes in interest rates on any amounts outstanding under the Facility and Multicurrency Facility. At December 31, 2010, no amounts were outstanding under the Facility or the Multicurrency Facility.

 

Foreign Currency

 

The Company operates on a global basis and is therefore exposed to various types of currency risks. Two specific transaction risks arise from the nature of the contracts the Company executes with its customers. From time to time contracts are denominated in a currency different than the particular local currency. This contract currency denomination issue is applicable only to a portion of the contracts executed by the Company. The first risk occurs as revenue recognized for services rendered is denominated in a currency different from the currency in which the subsidiary’s expenses are incurred. As a result, the subsidiary’s net service revenues and resultant net income or loss can be affected by fluctuations in exchange rates.

 

The second risk results from the passage of time between the invoicing of customers under these contracts and the ultimate collection of customer payments against such invoices. Because the contract is denominated in a currency other than the subsidiary’s local currency, the Company recognizes a receivable at the time of invoicing at the local currency equivalent of the foreign currency invoice amount. Changes in exchange rates from the time the invoice is prepared until the payment from the customer is received will result in the Company receiving either more or less in local currency than the local currency equivalent of the invoice amount at the time the invoice was prepared and the receivable established. This difference is recognized by the Company as a foreign currency transaction gain or loss, as applicable, and is reported in Other income (expense) in the Consolidated Statements of Operations.

 

A third type of transaction risk arises from transactions denominated in multiple currencies between any two of the Company’s various subsidiary locations. For each subsidiary, the Company maintains an intercompany receivable and payable, which is denominated in multiple currencies. Changes in exchange rates from the time the intercompany receivable/payable balance arises until the balance is settled or measured for reporting purposes, results in exchange rate gains and losses. This intercompany receivable/payable arises when work is performed by a Kendle location in one country on behalf of a Kendle location in a different country under contract with the customer. Additionally, there are occasions when funds are transferred between subsidiaries for working capital purposes. Where possible, the Company settles these intercompany balances frequently to reduce this exposure. The foreign currency transaction gain or loss is reported in Other Income (Expense) in the Consolidated Statements of Operations.

 

In 2010, the Company recorded total foreign exchange gains of $8.9 million compared to gains of approximately $6.3 million in 2009 related to the risks described above.

The Company’s Consolidated Financial Statements are denominated in U.S. dollars. Accordingly, changes in exchange rates between the applicable foreign currency and the U.S. dollar will affect the translation of each foreign subsidiary’s financial results into U.S. dollars for purposes of reporting the Consolidated Financial Statements. The Company’s foreign subsidiaries’ functional currency is the local currency, accordingly those subsidiaries translate their financial results from local currency into U.S. dollars as follows: income statement accounts are translated at average exchange rates for the period; balance sheet asset and liability accounts are translated at end of period exchange rates; and equity accounts are translated at historical exchange rates. Translation of the balance sheet in this manner affects the shareholders’ equity account referred to as the foreign currency translation adjustment account. This account exists only in the foreign subsidiaries’ U.S. dollar balance sheet and is necessary to keep the foreign subsidiaries’ balance sheet stated in U.S. dollars in balance. Cumulative foreign currency translation adjustments, which are reported as a separate component of Shareholders’ Equity, were approximately $20.8 million and $22.2 million at December 31, 2010 and 2009, respectively.

 

Foreign Currency Hedges

 

In 2007, the Company entered into foreign currency hedging transactions to mitigate exposure in movements between the U.S. dollar and British Pounds Sterling and U.S dollar and Euro. The hedging transactions were designed to mitigate the Company’s exposure related to two intercompany notes between the Company’s U.S. subsidiary, as lender, and the Company’s subsidiaries in each of the United Kingdom and Germany. The hedge agreements were not designated for hedge accounting treatment under accounting guidance related to derivatives and all changes in the fair market value of the hedge were recorded in the Company’s Consolidated Statements of Operations.

 

The note between the Company’s U.S. subsidiary and United Kingdom subsidiary is denominated in Pounds Sterling and was substantially settled in January 2009, at this time the hedge agreement related to this loan was terminated resulting in $17.3 million of cash proceeds. The Company recorded foreign exchange gains of $997,000 related to the Pound Sterling loan in 2009. Prior to the termination of the Pound Sterling hedge in January 2009, the Company recorded foreign exchange losses of $1.3 million.

 

The note between the Company’s U.S. subsidiary and German subsidiary was denominated in Euros and repaid in full in March 2009, and the related hedge agreement was terminated at the same time. Foreign exchange losses of $1.5 million and gains of $741,000 were recorded related to the Euro note and the Euro hedge agreement, respectively, prior to their repayment and termination in March 2009.

 

 

The Financial Statements and Supplementary Data called for by this Item are set forth in pages F-1 to F-32, which are incorporated herein by reference.

 

 

None to report.

 

 

Management’s Evaluation of Disclosure Controls and Procedures

 

Based on the Company’s most recent evaluation, which was completed as of the end of the period covered by this Annual Report on Form 10-K, our CEO/Chairman (principal executive officer) and Chief Financial Officer (principal financial and accounting officer) concluded that the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended) are effective.

 

(a) Management’s Report on Internal Control over Financial Reporting

 

The Company’s management is responsible for establishing and maintaining adequate internal controls designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of

financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The Company’s internal control over financial reporting includes those policies and procedures that:

 

1. pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets of the Company;

 

2. provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with GAAP and that receipts and expenditures of the Company are being made only in accordance with the authorizations of management and the Directors of the Company; and

 

3. provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the Consolidated Financial Statements.

 

All internal control systems, no matter how well designed, have inherent limitations, including the possibility of human error, collusion and the improper overriding of controls by management. Accordingly, even those systems determined to be effective can provide only reasonable, but not absolute assurance with respect to financial statement preparation and presentation. Further, because of changes in conditions, the effectiveness of internal control may vary over time.

 

As required by Section 404 of the Sarbanes Oxley Act of 2002, management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2010. Management’s assessment is based on the criteria established in the Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based upon our assessment, management concludes that the Company maintained effective internal control over financial reporting as of December 31, 2010. Deloitte and Touche LLP, the Company’s independent registered public accounting firm, has issued an attestation report on the Company’s internal control over financial reporting as of December 31, 2010. This report appears below.

 

(b) Changes in Internal Control Over Financial Reporting

 

During the third quarter of 2010, the Company implemented a new enterprise resource planning (ERP) system for a large portion of North America and Latin America. This implementation included modules primarily for general ledger, accounts payable, accounts receivable and revenue recognition. During the fourth quarter of 2010, the Company revised certain internal controls over financial reporting to utilize the new ERP system.

 

The Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, has determined that these revised internal controls over financial reporting provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance with generally accepted accounting principles during the period covered by this report. Management has also determined that there were no changes in the Company’s internal controls over financial reporting related to legacy systems that have materially affected, or are reasonably likely to materially affect, the internal controls over financial reporting for the quarter-ended December 31, 2010.

 

The Company expects the transition from legacy systems to the new ERP system to continue into 2011. The Company will continue to evaluate the impact of the implementation on its internal controls over financial reporting. At this time, the Company does not anticipate any adverse impact from the conversion.

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Shareholders of

Kendle International Inc.

Cincinnati, Ohio

 

We have audited the internal control over financial reporting of Kendle International Inc. and subsidiaries (the “Company”) as of December 31, 2010, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

 

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

 

A company’s internal control over financial reporting is a process designed by, or under the supervision of, the company’s principal executive and principal financial officers, or persons performing similar functions, and effected by the company’s board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

 

Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2010, based on the criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.

 

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statements as of and for the year ended December 31, 2010 of the Company and our report dated March 16, 2011 expressed an unqualified opinion on those financial statements.

 

 

Cincinnati, Ohio

March 16, 2011

 

Nothing to report.

 

DIRECTORS OF THE COMPANY

 

The name, age and background information for each of the Company’s Directors is set forth in the section titled “Election of Directors” contained in the Company’s definitive Proxy Statement to be filed with the SEC and is incorporated herein by reference.

 

AUDIT COMMITTEE

 

Information regarding the members of the audit committee and the audit committee financial expert is set forth in the sections titled “Board of Directors” and “Audit Committee” under the heading “Governance of the Company” in the Company’s definitive Proxy Statement to be filed with the SEC. The information in these sections is incorporated herein by reference.

 

EXECUTIVE OFFICERS OF THE COMPANY

 

The Executive Officers of the Company at March 1, 2011, were as follows:

 

 

Background information regarding Dr. Kendle and Mr. Bergen is set forth in the sections titled “Election of Directors” and “Securities Ownership of Management” in the Company’s definitive Proxy Statement to be filed with the SEC. Background information regarding Mr. Cheesman, Dr. Roseman and Dr. Cutler is set forth in the notes to the table within the section titled “Securities Ownership of Management” contained in the Company’s definitive Proxy Statement to be filed with the SEC. This information is incorporated herein by reference.

 

SECTION 16(A) BENEFICIAL OWNERSHIP REPORTING COMPLIANCE

 

Information on compliance with Section 16(a) of the Exchange Act is set forth in the section titled “Section 16(a) Beneficial Ownership Reporting Compliance” under the heading entitled “Securities Ownership” in the Company’s definitive Proxy Statement to be filed with the SEC and is incorporated herein by reference.

 

CODE OF ETHICS

 

The Company has adopted a Code of Ethics and Conduct, which applies to the Company’s employees, including its Chief Executive Officer and its principal financial and accounting officer. The Code of Ethics and Conduct is available on the Company’s web site at www.kendle.com. Amendments to the Code of Ethics and Conduct will be posted to the Company’s web site. In addition, the Company will make available, free of charge, to

any person, a copy of its Code of Ethics and Conduct upon written request submitted to the Company. This written request should be addressed to the Company’s Secretary at the Company’s principal executive offices.

 

 

Information required by this report is set forth in the following sections under the heading titled “Governance of the Company” in the Company’s definitive Proxy Statement to be filed with the SEC, which information is incorporated herein by reference:

 

 

Information required by this report is set forth in the “Executive Compensation” section in the Company’s definitive Proxy Statement to be filed with the SEC. The “Executive Compensation” section includes information under the following headings, which information is incorporated herein by reference.

 

 

 

Information on the number of shares beneficially owned by each Director and executive officer, and by all Directors and executive officers as a group is set forth in the section titled “Securities Ownership of Management” under the heading titled “Securities Ownership” in the Company’s definitive Proxy Statement to be filed with the SEC. The information set forth in such section is incorporated herein by reference.

 

Information on the number of shares beneficially owned by any person who is known to the Company to be the beneficial owner of more than five percent of the Company’s Common Stock is set forth in the section titled “Principal Shareholders” under the heading titled “Securities Ownership” in the Company’s definitive Proxy Statement to be filed with the SEC. The information set forth in such section is incorporated herein by reference.

The following table presents summary information at December 31, 2010, with respect to all of the Company’s equity compensation plans.

 

Equity Compensation Plan Information

 

 

 

 

 

TRANSACTIONS WITH RELATED PERSONS

 

Information with respect to transactions with related persons, if any, is contained under the caption “Review and Approval of Transactions with Related Persons” under the heading titled “Governance of the Company” in the Company’s definitive Proxy Statement to be filed with the SEC. The information set forth in such section is incorporated herein by reference.

 

REVIEW, APPROVAL OR RATIFICATION OF TRANSACTIONS WITH RELATED PERSONS

 

Information with respect to the review, approval or ratification of transactions with related persons is contained under the caption “Review and Approval of Transactions with Related Persons” under the heading titled “Governance of the Company” in the Company’s definitive Proxy Statement to be filed with the SEC. The information set forth in such section is incorporated herein by reference.

 

PROMOTERS AND CERTAIN CONTROL PERSONS

 

Not applicable.

 

DIRECTOR INDEPENDENCE

 

The name of each Director who is independent is contained in the section titled “Director Independence” under the heading titled “Governance of the Company” in the Company’s definitive Proxy Statement to be filed with the SEC. The information set forth in such section is incorporated herein by reference.

 

 

Information required by this Item is contained in the sections titled “Audit Committee’s Pre-Approval Policies and Procedures” and “Fees Paid to Registered Public Accounting Firm” under the heading titled “Ratification of Appointment of Registered Public Accounting Firm” in the Company’s definitive Proxy Statement to be filed with the SEC and is incorporated herein by reference.

 

 

(a) (1) and (2) — All financial statements and schedules required to be filed by Item 8 of this Annual Report on Form 10-K and included in this report are listed beginning on page F-1. No additional financial statements or schedules are being filed as the required information is not applicable or because the information is required and is included in the respective financial statements or notes thereto.

 

(3) Exhibits — Exhibits set forth below that are on file with the SEC are incorporated by reference as exhibits hereto.

 

Kendle International Inc.

 

Index to Consolidated Financial Statements

 

 

To the Board of Directors and Shareholders of

Kendle International Inc.

Cincinnati, Ohio

 

We have audited the accompanying consolidated balance sheets of Kendle International Inc. and subsidiaries (the “Company”) as of December 31, 2010 and 2009, and the related consolidated statements of operations, shareholders’ equity, and cash flows for each of the three years in the period ended December 31, 2010. 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 the standards of the Public Company Accounting Oversight Board (United States). 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, such consolidated financial statements present fairly, in all material respects, the financial position of Kendle International Inc. and subsidiaries as of December 31, 2010 and 2009, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2010, in conformity with accounting principles generally accepted in the United States of America.

 

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control over financial reporting as of December 31, 2010, based on the criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 16, 2011 expressed an unqualified opinion on the Company’s internal control over financial reporting.

 

Cincinnati, Ohio

March 16, 2011