SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (MARK ONE) |X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934. FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2003 OR |_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _________ TO ___________ Commission file number 000-23019 KENDLE INTERNATIONAL INC. (Exact name of registrant as specified in its charter) Ohio 31-1274091 (State or other jurisdiction (IRS Employer Identification No.) of incorporation or organization) 441 Vine Street, Suite 1200, Cincinnati, Ohio 45202 (Address of principal executive offices) Zip Code Registrant's telephone number, including area code (513) 381-5550 - -------------------------------------------------------------------------------- (Former name or former address, if changed since last report) 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 and Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes |X| No |_| Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes |X| No |_| Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date: 12,939,366 shares of Common Stock, no par value, as of April 30, 2003. 1 KENDLE INTERNATIONAL INC. INDEX Page ---- Part I. Financial Information Item 1. Financial Statements (Unaudited) Condensed Consolidated Balance Sheets -March 31, 2003 and December 31, 2002 3 Condensed Consolidated Statements of Operations - Three Months Ended March 31, 2003 and 2002 4 Condensed Consolidated Statements of Comprehensive Income (Loss) - Three Months Ended March 31, 2003 and 2002 5 Condensed Consolidated Statements of Cash Flows - Three Months Ended March 31, 2003 and 2002 6 Notes to Condensed Consolidated Financial Statements 7 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 14 Item 3. Quantitative and Qualitative Disclosure About Market Risk 25 Item 4. Controls and Procedures 25 Part II. Other Information 26 Item 1. Legal Proceedings 26 Item 2. Changes in Securities and Use of Proceeds 26 Item 3. Defaults upon Senior Securities 26 Item 4. Submission of Matters to a Vote of Security Holders 26 Item 5. Other Information 26 Item 6. Exhibits and Reports on Form 8-K 26 Signatures 27 Exhibit Index 32 2 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) March 31, December 31, 2003 2002 ------------ ------------ (unaudited) (note 1) ASSETS Current assets: Cash and cash equivalents $ 5,811 $ 12,671 Available for sale securities 22,289 17,304 Accounts receivable 44,619 47,050 Other current assets 8,683 7,343 ------------ ------------ Total current assets 81,402 84,368 ------------ ------------ Property and equipment, net 18,903 19,028 Goodwill, net 22,295 22,033 Other indefinite-lived intangible assets 15,000 15,000 Other assets 14,520 14,968 ------------ ------------ Total assets $ 152,120 $ 155,397 ============ ============ LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Current portion of obligations under capital leases $ 893 $ 843 Current portion of amounts outstanding under credit facilities 3,000 3,000 Trade payables 5,678 5,883 Advance billings 19,928 22,313 Other accrued liabilities 12,382 10,878 ------------ ------------ Total current liabilities 41,881 42,917 ------------ ------------ Obligations under capital leases, less current portion 1,436 1,643 Convertible note 6,000 6,000 Long-term debt 9,000 9,750 Other noncurrent liabilities 738 727 ------------ ------------ Total liabilities 59,055 61,037 ------------ ------------ Commitments and contingencies Shareholders' equity: Preferred stock -- no par value; 100,000 shares authorized; no shares issued and outstanding Common stock -- no par value; 45,000,000 shares authorized; 12,951,453 and 12,861,510 shares issued and 12,931,556 and 12,841,613 outstanding at March 31, 2003 and December 31, 2002, respectively 75 75 Additional paid in capital 134,402 134,266 (Accumulated deficit) (39,602) (37,478) Accumulated other comprehensive loss: Net unrealized holding loss on available for sale securities (6) (6) Unrealized loss on interest rate swap (551) (566) Foreign currency translation adjustment (860) (1,538) ------------ ------------ Total accumulated other comprehensive loss (1,417) (2,110) Less: Cost of common stock held in treasury, 19,897 shares at March 31, 2003 and December 31, 2002, respectively (393) (393) ------------ ------------ Total shareholders' equity 93,065 94,360 ------------ ------------ Total liabilities and shareholders' equity $ 152,120 $ 155,397 ============ ============ The accompanying notes are an integral part of these condensed consolidated financial statements. 3 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands, except per share data) For the Three Months Ended March 31, ---------------------------- 2003 2002 ------------ ------------ Net service revenues $ 37,180 $ 43,921 Reimbursable out-of-pocket revenues 11,545 10,029 ------------ ------------ Total revenues 48,725 53,950 ------------ ------------ Costs and expenses: Direct costs 22,689 26,032 Reimbursable out-of-pocket costs 11,545 10,029 Selling, general and administrative expenses 13,142 12,283 Depreciation and amortization 2,185 1,974 Severance and office consolidation costs 682 -- ------------ ------------ 50,243 50,318 ------------ ------------ Income (loss) from operations (1,518) 3,632 Other income (expense): Interest income 103 153 Interest expense (272) (265) Other (438) (34) ------------ ------------ Income (loss) before income taxes (2,125) 3,486 Income tax expense (benefit) (1) 1,369 ------------ ------------ Net income (loss) $ (2,124) $ 2,117 ============ ============ Income (loss) per share data: Basic: Net income (loss) per share $ (0.16) $ 0.17 ============ ============ Weighted average shares 12,877 12,686 Diluted: Net income (loss) per share $ (0.16) $ 0.16 ============ ============ Weighted average shares 12,877 13,470 The accompanying notes are an integral part of these condensed consolidated financial statements. 4 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) (in thousands) For the Three Months Ended March 31, ---------------------------- 2003 2002 ------------ ------------ Net income (loss) $ (2,124) $ 2,117 Other comprehensive income (loss): Foreign currency translation adjustment 678 (281) Net unrealized holding losses on available for sale securities arising during the period, net of tax -- (36) Net unrealized holding gains on interest rate swap agreement 15 -- ------------ ------------ Comprehensive income (loss) $ (1,431) $ 1,800 ============ ============ The accompanying notes are an integral part of these condensed consolidated financial statements. 5 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (in thousands) For the Three Months Ended March 31, ---------------------------- 2003 2002 ------------ ------------ Net cash provided by operating activities $ 944 $ 2,758 ------------ ------------ Cash flows from investing activities: Proceeds from sales and maturities of available for sale securities 18,500 5,397 Purchases of available for sale securities (23,488) (7,428) Acquisitions of property and equipment (1,397) (1,037) Additions to internally developed software (593) (594) Other 4 -- Acquisition of business, less cash acquired -- (7,931) ------------ ------------ Net cash used in investing activities (6,974) (11,593) ------------ ------------ Cash flows from financing activities: Net proceeds (repayments) under credit facilities (750) 6,500 Net proceeds (repayments) - book overdraft (32) 1,900 Proceeds from exercise of stock options 111 128 Payments on capital lease obligations (210) (187) Other -- 58 ------------ ------------ Net cash (used in) provided by financing activities (881) 8,399 ------------ ------------ Effects of exchange rates on cash and cash equivalents 51 (57) Net decrease in cash and cash equivalents (6,860) (493) Cash and cash equivalents: Beginning of period 12,671 6,016 ------------ ------------ End of period $ 5,811 $ 5,523 ============ ============ Supplemental schedule of noncash investing and financing activities: Acquisition of Businesses: Fair value of assets acquired (net of cash acquired) $ -- $ 19,154 Fair value of liabilities assumed -- (1,131) Common stock issued -- (4,092) Convertible debt issued -- (6,000) ------------ ------------ Net cash payments $ -- $ 7,931 ============ ============ The accompanying notes are an integral part of these condensed consolidated financial statements. 6 KENDLE INTERNATIONAL INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three months ended March 31, 2003 are not necessarily indicative of the results that may be expected for the year ending December 31, 2003. For further information, refer to the consolidated financial statements and notes thereto included in the Form 10-K for the year ended December 31, 2002 filed by Kendle International Inc. ("the Company") with the Securities and Exchange Commission. The condensed consolidated balance sheet at December 31, 2002 has been derived from the audited financial statements at that date but does not include all of the information and notes required by accounting principles generally accepted in the United States of America for complete financial statements. Net Income (Loss) Per Share Data Net income (loss) per basic share is computed using the weighted average common shares outstanding. Net income (loss) per diluted share is computed using the weighted average common shares and potential common shares outstanding. The net income (loss) used in computing net income (loss) per diluted share has been calculated as follows: (in thousands) Three Months Ended Three Months Ended March 31, 2003 March 31, 2002 ------------------ ------------------ Net income (loss) per Statements of Operations $ (2,124) $ 2,117 Add: after-tax interest expense on convertible note -- 24 ------------------ ------------------ Net income for diluted EPS calculation $ (2,124) $ 2,141 The weighted average shares used in computing net income (loss) per diluted share have been calculated as follows: 7 (in thousands) Three Months Ended Three Months Ended March 31, 2003 March 31, 2002 ------------------ ------------------ Weighted average common shares Outstanding 12,877 12,686 Stock options -- 568 Convertible note -- 216 ------------------ ------------------ Weighted average shares 12,877 13,470 Options to purchase approximately 2,300,000 shares of common stock were outstanding during the three months ended March 31, 2003 but were not included in the computation of earnings per diluted share because the effect would be antidilutive. Options to purchase approximately 790,000 shares of common stock were outstanding during the three months ended March 31, 2002 but were not included in the computation of earnings per diluted share because the options' exercise price was greater than the average market price of the common shares and, therefore, the effect would be antidilutive. Stock-Based Compensation The Company accounts for stock options issued to associates in accordance with Accounting Principles Board Opinion (APB) No. 25, "Accounting for Stock Issued to Employees." Under APB No. 25, the Company recognizes expense based on the intrinsic value of the options. The Company has adopted the disclosure requirements of Statement of Financial Accounting Standards (SFAS) No. 123, "Accounting for Stock-Based Compensation," as amended by SFAS No. 148, "Accounting for Stock-Based Compensation - Transition and Disclosure" which requires compensation expense to be disclosed based on the fair value of the options granted at the date of grant. Had the Company adopted SFAS No. 123 for expense recognition purposes, the amount of compensation expense that would have been recognized in the first quarter of 2003 and 2002 would have been approximately $1.3 million and $845,000, respectively. The Company's pro-forma net income (loss) per diluted share would have been adjusted to the amounts below: (in thousands, except per share data) Three Months Ended Three Months Ended March 31, 2003 March 31, 2002 ------------------ ------------------ PRO FORMA NET INCOME (LOSS): As reported $ (2,124) $ 2,117 Less: pro forma adjustment for stock- based compensation, net of tax (1,014) (673) ------------------ ------------------ Pro-forma net income (loss) $ (3,138) $ 1,444 PRO-FORMA NET INCOME (LOSS) PER BASIC SHARE: As reported $ (0.16) $ 0.17 Pro forma $ (0.24) $ 0.11 Effect of pro forma expense $ (0.08) $ (0.06) 8 PRO-FORMA NET INCOME (LOSS) PER DILUTED SHARE: As reported $ (0.16) $ 0.16 Pro forma $ (0.24) $ 0.11 Effect of pro forma expense $ (0.08) $ (0.05) New Accounting Pronouncements In January 2003, the Emerging Issues Task Force (EITF) issued EITF Issue 00-21, "Revenue Arrangements with Multiple Deliverables," which requires companies to determine whether an arrangement involving multiple deliverables contains more than one unit of accounting. In applying EITF Issue 00-21, revenue arrangements with multiple deliverables should be divided into separate units of accounting if the deliverables in the arrangement meet certain criteria. Arrangement consideration should be allocated among the separate units of accounting based on their relative fair values. This issue is effective for revenue arrangements entered into in fiscal periods beginning after June 15, 2003. The Company is currently evaluating what impact, if any, the adoption of this issue will have on its results of operations and/or financial position. In January 2003, the Financial Accounting Standards Board (FASB) issued Interpretation No. 46 (FIN 46), "Consolidation of Variable Interest Entities." FIN 46 requires a variable interest entity to be consolidated by a company if that company is subject to a majority of the risk of loss from the variable interest entity's activities or entitled to receive a majority of the entity's residual returns or both. A variable interest entity is a corporation, partnership, trust, or any other legal structure used for business purposes that either (a) does not have equity investors with voting rights or (b) has equity investors that do not provide sufficient financial resources for the entity to support its activities. A variable interest entity often holds financial assets, including loans or receivables, real estate or other property. A variable interest entity may be essentially passive or it may engage in research and development or other activities on behalf of another company. The consolidation requirements of FIN 46 apply immediately to variable interest entities created after January 31, 2003. The consolidation requirements apply to older entities in the first fiscal year or interim period beginning after June 15, 2003. Certain of the disclosure requirements apply to all financial statements issued after January 31, 2003, regardless of when the variable interest entity was established. The Company is currently evaluating the consolidation requirements of FIN 46. In December 2002, the FASB issued SFAS No. 148, "Accounting for Stock-Based Compensation - Transition and Disclosure, an Amendment of SFAS No. 123." SFAS No. 148 provides transition guidance for those companies that elect to voluntarily adopt the accounting provisions of SFAS No. 123, "Accounting for Stock-Based Compensation." SFAS No. 148 also mandates certain new disclosures that are incremental to those required by SFAS No. 123. SFAS No. 148 is effective for fiscal years ending after December 15, 2002. The Company has adopted the disclosure requirements of SFAS No. 148. At this time the Company does not plan to adopt the accounting provisions of SFAS No. 123 and will continue to account for stock options in accordance with APB No. 25, "Accounting for Stock Issued to Employees." In July 2002, the FASB issued SFAS No. 146, "Accounting for Exit or Disposal Activities." SFAS No. 146 addresses the recognition, measurement, and reporting of costs that are associated with exit and disposal activities, including costs related to terminating a contract 9 that is not a capital lease and termination benefits that employees who are involuntarily terminated receive under the terms of a one-time benefit arrangement that is not an ongoing benefit arrangement or an individual deferred-compensation contract. SFAS No. 146 supersedes EITF No. 94-3, "Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring)" and requires liabilities associated with exit and disposal activities to be expensed as incurred. SFAS No. 146 is required for exit or disposal activities of the Company initiated after December 31, 2002, with earlier adoption encouraged. The Company has adopted SFAS No. 146. 2. ACQUISITION: Details of the Company's acquisition in 2002 are listed below. On January 29, 2002, the Company acquired substantially all of the assets of Clinical and Pharmacologic Research, Inc. (CPR) located in Morgantown, West Virginia. CPR specializes in Phase I studies for the generic drug industry, enabling the Company to expand into the generic drug market. Results of CPR are included in the Company's consolidated results from the date of acquisition. The aggregate purchase price was approximately $18.2 million, including approximately $8.1 million in cash (including acquisition costs), 314,243 shares of Common Stock valued at $4.1 million and a $6.0 million convertible subordinated note. The note is convertible at the holders' option into 314,243 shares of the Company's Common Stock at any time before January 29, 2005, the Maturity Date. Valuation of Common Stock issued in the acquisition was based on an appraisal obtained by the Company on previously similarly structured acquisitions, which provided for a discount of the shares due to lock-up restrictions and the lack of registration of the shares. The goodwill and the intangible asset acquired in the acquisition are deductible for income tax purposes over a 15-year period. The following unaudited pro forma results of operations assume the acquisitions occurred at the beginning of 2002: (in thousands) Three Months Ended March 31,2002 ------------------ Net service revenues $ 44,722 Net income $ 2,255 Net income per diluted share $ 0.17 Weighted average shares 13,666 Pro-forma net income per above $ 2,255 Add: after-tax interest expense on convertible note 34 10 Pro-forma net income for diluted EPS $ 2,289 The pro forma financial information is not necessarily indicative of the operating results that would have occurred had the acquisitions been consummated as of January 1, 2002, nor are they necessarily indicative of future operating results. 3. OFFICE CONSOLIDATION AND EMPLOYEE SEVERANCE: In order to bring its cost structure more in line with current revenue projections, in the first quarter of 2003, the Company recorded a charge of approximately $690,000 for severance and outplacement benefits relating to a workforce reduction program which impacted approximately 17 employees, or 1 percent of its total workforce. Approximately $109,000 was paid during the first quarter of 2003, and at March 31, 2003 approximately $581,000 remains accrued and is reflected in Other Accrued Liabilities on the Company's Consolidated Balance Sheet. The remaining $581,000 will be paid over the remaining quarters of 2003. Additional legal and other costs of up to approximately $100,000 are expected to be incurred over the remaining quarters of 2003 and will be expensed as incurred. Costs relating to this program are reflected in the line item entitled "Severance and Office Consolidation Costs" in the Company's Condensed Consolidated Statements of Operations. On August 29, 2002, the Company committed to a plan that consolidated its three New Jersey offices into one central office, located in Cranford, New Jersey. At that time, the Company maintained separate offices in Princeton, Cranford and Ft. Lee, New Jersey. The leases in the Ft. Lee and Princeton offices expired during the fourth quarter of 2002 and the first quarter of 2003, respectively. The Company vacated these offices in the fourth quarter in advance of the expiration of each of the respective office leases. As part of this plan, the Company eliminated approximately 22 full-time positions. In connection with the office consolidation, the Company recorded a pre-tax charge of $321,000 in the third quarter of 2002, consisting primarily of facility lease costs and severance and outplacement costs. As of March 31, 2003, $32,000 remains accrued and is reflected in Other Accrued Liabilities in the Company's Consolidated Balance Sheet. The amounts accrued as office consolidation costs are detailed as follows: (in thousands) Employee Facilities Other Total Severance ---------- ---------- ---------- ---------- Liability at December 31, 2002 $ 73 $ 44 $ 40 $ 157 Amount Paid 37 24 -- 61 Non-cash charge -- 4 -- 4 Adjustment to liability 36 4 20 60 ---------- ---------- ---------- ---------- Liability at March 31, 2003 $ -- $ 12 $ 20 $ 32 11 The $60,000 adjustment to the liability was due to lower than expected outplacement and legal costs associated with the office consolidation program. The Company recorded an additional $53,000 in costs in the first quarter of 2003 primarily related to retention bonuses. The remaining $32,000 will be used primarily for facility-related obligations that will be paid out in the remaining quarters of 2003. 4. GOODWILL AND OTHER INTANGIBLE ASSETS: Identifiable intangible assets as of December 31, 2002 and March 31, 2003 are composed of: (in thousands) Goodwill Indefinite-lived Amortizable Intangible Asset intangibles ---------------- ---------------- ---------------- Balance at 12/31/02 $ 22,033 $ 15,000 $ -- Less: Tax benefit to reduce goodwill (96) -- -- Add: Exchange rate fluctuations 358 -- -- Balance at 3/31/03 $ 22,295 $ 15,000 $ -- 5. DEBT: In June 2002, the Company entered into an Amended and Restated Credit Agreement (the "Facility") that replaced the previous credit facility that would have expired in October 2003. The Facility is composed of a revolving credit loan that expires in three years and a $15.0 million term loan that matures in five years. The Facility is in addition to an existing $5.0 million Multicurrency Facility that is renewable annually and is used in connection with the Company's European operations. The revolving credit loan bears interest at a rate equal to either (a) The Eurodollar Rate plus the Applicable Percentage (as defined) or (b) the higher of the Federal Fund's Rate plus 0.5% or the Bank's Prime Rate. The $15.0 million term loan bears interest at a rate equal to the higher of the Federal Funds Rate plus 0.5% and the Prime Rate or an Adjusted Eurodollar Rate. Under terms of the Facility, revolving loans are convertible into term loans within the Facility if used for acquisitions. The Facility contains various restrictive financial covenants, including the maintenance of certain fixed coverage and leverage ratios. At March 31, 2003 the Company fell below the minimum permitted Fixed Charge coverage ratio. The Company and the banks amended the minimum permitted Fixed Charge coverage ratio for the first quarter of 2003 and future periods. In addition, as part of the amendment: - The amount available under the revolving credit loan is reduced from $23 million to the lesser of $10 million or 50% of the Company's Eligible Receivables, as defined. - Until the Company's Fixed Charge Coverage Ratio returns to levels specified in the original agreement, the applicable percentage applied to the interest rate on the Company's borrowing under the Facility is increased by 0.75%. - The term loan is collateralized by a pledge of the Company's domestic cash and cash equivalents and any amounts outstanding under the revolving credit loan are collateralized by the Company's Eligible Receivables, as defined, and any remaining 12 domestic cash and cash equivalents above the amounts pledged as security under the term loan. - The Company must maintain a ratio of cash and cash equivalents held in the United States to principal amounts outstanding under the Company's term loan of at least 1.1 to 1.0. The $5.0 million Multicurrency Facility is composed of a euro overdraft facility up to the equivalent of $3.0 million and a pound sterling overdraft facility up to the equivalent of $2.0 million. This Multicurrency Facility bears interest at a rate equal to either (a) the rate published by the European Central Bank plus a margin (as defined) or (b) the Bank's Base Rate (as determined by the bank having regard to prevailing market rates) plus a margin (as defined). At March 31, 2003, no amounts were outstanding under the Company's revolving credit loan, $12.0 million was outstanding under the term loan, and no amounts were outstanding under the $5.0 million Multicurrency Facility. Interest is payable on the term loan at a rate of 5.82%. Principal payments of $750,000 are due on the term loan on the last business day of each quarter through March of 2007. 13 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS The information discussed below is derived from the Condensed Consolidated Financial Statements included in this Form 10-Q for the three months ended March 31, 2003 and should be read in conjunction therewith. The Company's results of operations for a particular quarter may not be indicative of results expected during subsequent quarters or for the entire year. COMPANY OVERVIEW Kendle International Inc. (the "Company") is an international contract research organization (CRO) that provides integrated clinical research services including clinical trial management, clinical data management, statistical analysis, medical writing, regulatory consultation and organizational meeting management and publications services on a contract basis to the pharmaceutical and biotechnology industries The Company's contracts are generally fixed price, with some variable components, and range in duration from a few months to several years. A contract typically requires a portion of the contract fee to be paid at the time the contract becomes effective and the balance is received in installments over the contract's duration, in most cases on a milestone achievement basis. Net revenues from contracts are generally recognized on the percentage of completion method, measured principally by the total costs incurred as a percentage of estimated total costs for each contract. The estimated total costs of contracts are reviewed and revised periodically throughout the lives of the contracts with adjustments to revenues resulting from such revisions being recorded on a cumulative basis in the period in which the revisions are made. The Company also performs work under time-and-materials contracts, recognizing revenue as hours are worked based on the hourly billing rates for each contract. Additionally, the Company recognizes revenue under units-based contracts as units are completed multiplied by the contract per-unit price. The Company incurs costs in excess of contract amounts in subcontracting with third-party investigators as well as other out-of-pocket costs. These out-of-pocket costs are reimbursable by the Company's customers. The Company includes amounts paid to investigators and other out-of-pocket costs as reimbursable out-of-pocket revenues and reimbursable out-of-pocket costs in the Consolidated Statements of Operations. In certain contracts, these costs are fixed by the contract terms, so the Company recognizes these costs as part of net service revenues and direct costs. Direct costs consist of compensation and related fringe benefits for project-related associates, unreimbursed project-related costs and indirect costs including facilities, information systems and other costs. Selling, general and administrative expenses consist of compensation and related fringe benefits for sales and administrative associates and professional services, as well as unallocated costs related to facilities, information systems and other costs. The CRO industry in general continues to be dependent on the research and development activities 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 the major customers could have a material adverse affect on the Company. 14 The Company's results are subject to volatility due to a variety of factors. The cancellation or delay of contracts and cost overruns could have immediate adverse effects on the consolidated financial statements. Fluctuations in the Company's sales cycle and the ability to maintain large customer contracts or to enter into new contracts could hinder the Company's long-term growth. In addition, the Company's aggregate backlog, consisting of signed contracts and letters of intent, is not necessarily a meaningful indicator of future results. Accordingly, no assurance can be given that the Company will be able to realize the net service revenues included in the backlog. RESULTS OF OPERATIONS THREE MONTHS ENDED MARCH 31, 2003 COMPARED TO THREE MONTHS ENDED MARCH 31, 2002 Net Service Revenues Net service revenues decreased 15% to $37.2 million in the first quarter of 2003 from $43.9 million in the first quarter of 2002. Foreign currency exchange rate fluctuations accounted for a 4% increase in net service revenues in the first quarter of 2003 compared to 2002. The 15% decrease in net service revenues was composed of growth from acquisitions of 3% and a decline in organic net service revenues of 18%. The decline in net service revenues is due to delays and cancellations affecting net service revenues in the first quarter of 2003 compared to the corresponding period in 2002 as well as an overall slowdown in new business for the Company. In addition, in 2003 net service revenue recorded on contracts where costs paid to investigators and other out-of-pocket costs are fixed by the contract terms and recorded as direct costs and net service revenues decreased by approximately $1.7 million. Approximately 30% of the Company's net service revenues were derived from operations outside the United States in the first quarter of 2003 compared to 28% in the corresponding period in 2002. The top five customers based on net service revenues contributed approximately 49% of net revenues during the first quarter of 2003 compared to 47% of net service revenues during the first quarter of 2002. Net service revenues from Pharmacia Inc. and Pfizer Inc. accounted for approximately 21% and 10%, respectively, of total first quarter 2003 net service revenues compared to approximately 17% and 10%, respectively, of total first quarter 2002 net service revenues. The Company's net service revenues from Pharmacia Inc. and Pfizer Inc. are derived from numerous projects that vary in size, duration and therapeutic indication. Reimbursable Out-of-Pocket Revenues Reimbursable out-of-pocket revenues fluctuate from period to period, primarily due to the level of investigator activity in a particular period. Reimbursable out-of-pocket revenues increased 15.1% to $11.5 million in the first quarter of 2003 from $10.0 million in the corresponding period of 2002. Operating Expenses Direct costs decreased by 13% from $26.0 million in the first quarter 2002 to $22.7 million in the first quarter 2003. The 13% decrease in direct costs is composed of a 14% decrease in organic direct costs and a 1% increase in direct costs due to the impact of acquisitions. The decline in organic direct costs is related to the decline in net service revenues for the period. As a result of the decrease in net service revenues, the Company has decreased the use of outside contractors working on Company projects. In addition, the decrease in organic direct costs is a 15 result of lower investigator and out-of-pocket costs of approximately $1.7 million on contracts where these costs are fixed by the contract terms. Direct costs expressed as a percentage of net service revenues were 61.0% for the three months ended March 31, 2003 compared to 59.3% for the three months ended March 31, 2002. The increase in direct costs as a percentage of net service revenue in the first quarter of 2003 is due to lower utilization of resources in the first quarter of 2003 resulting from temporary delays in certain projects. Reimbursable out-of-pocket costs increased 15.1% to $11.5 million in the first quarter of 2003 from $10.0 million in the corresponding period of 2002. Selling, general and administrative expenses increased from $12.3 million in the first quarter of 2002 to $13.1 million in the same quarter of 2003. The change in selling, general and administrative expenses is composed of a 6% increase in organic SG&A costs and a 1% increase in SG&A costs due to the impact of acquisitions. Foreign currency exchange rate fluctuations accounted for a 5% increase in selling, general and administrative expenses in the first quarter of 2003 compared to 2002. In addition, SG&A increased due to an increase in employee related costs such as salary increases from the first quarter of 2002 to the first quarter of 2003. Selling, general and administrative expenses expressed as a percentage of net service revenues were 35.3% for the three months ended March 31, 2003 compared to 28.0% for the corresponding 2002 period. The increase in SG&A costs as a percentage of net service revenues is due to the decrease in net service revenues resulting from delays in certain projects. Depreciation and amortization expense increased by 11% in the first quarter of 2003 compared to the first quarter of 2002. The increase is primarily due to increased depreciation and amortization relating to the Company's capital expenditures. In the first quarter of 2003, in order to bring its cost structure more in line with current revenue projections, the Company recorded a charge of approximately $690,000 for severance and outplacement benefits relating to a workforce reduction program which impacted approximately 1 percent of its total workforce. At March 31, 2003, approximately $581,000 remains accrued and is reflected in Other Accrued Liabilities on the Company's Consolidated Balance Sheet. The remaining $581,000 will be paid over the remaining quarters of 2003. Other Income (Expense) Other Income (Expense) was an expense of approximately $600,000 in the first quarter of 2003 compared to an expense of approximately $150,000 in the first quarter of 2002. In the first quarter of 2003 the Company incurred foreign currency translation losses of approximately $345,000 primarily as a result of the British pound weakening against the euro. Foreign currency losses in the first quarter of 2002 were insignificant. Income Taxes The Company reported a tax benefit at an effective rate of 0.0% in the quarter ended March 31, 2003 compared to tax expense at an effective rate of 39.3% in the quarter ended March 31, 2002. The Company records a full valuation allowance against net operating losses incurred in certain European subsidiaries of the Company. Since Kendle operates on a global basis, the effective tax rate varies from year to year based on the locations that generate the pre-tax earnings or losses. 16 Net Income (Loss) Including the effect of the severance charge and office consolidation costs (of $548,000 or $0.04 per share), the net loss for the quarter was $2.1 million, or $0.16 per share compared with net income of $2.1 million, or $0.16 per diluted share during the same period a year ago. LIQUIDITY AND CAPITAL RESOURCES Cash and cash equivalents decreased by $6.9 million for the three months ended March 31, 2003 primarily as a result of cash used in investing and financing activities of $7.0 million and $0.9 million, respectively, offset by cash provided by operating activities of $0.9 million. Net cash provided by operating activities primarily resulted from net loss adjusted for non-cash activity. 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. Such activity varies by individual customer and contract. Accounts receivable, net of advance billings was approximately $24.7 million at March 31, 2003 and December 31, 2002. Financing activities for the quarter ended March 31, 2003 consisted primarily of a payment of $750,000 relating to the Company's Facility (defined below). 17 Investing activities for the three months ended March 31, 2003 consisted primarily of net purchases of available for sale securities of $5.0 million and capital expenditures of approximately $2.0 million. The Company had available for sale securities totaling $22.3 million at March 31, 2003. In June 2002, the Company entered into an Amended and Restated Credit Agreement (the "Facility") that replaced the previous credit facility that would have expired in October 2003. The Facility is composed of a revolving credit loan that expires in three years and a $15.0 million term loan that matures in five years. The Facility is in addition to an existing $5.0 million Multicurrency Facility that is renewable annually and is used in connection with the Company's European operations. The revolving credit loan bears interest at a rate equal to either (a) The Eurodollar Rate plus the Applicable Percentage (as defined) or (b) the higher of the Federal Fund's Rate plus 0.5% or the Bank's Prime Rate. The $15.0 million term loan bears interest at a rate equal to the higher of the Federal Funds Rate plus 0.5% and the Prime Rate or an Adjusted Eurodollar Rate. Under terms of the Facility, revolving loans are convertible into term loans within the Facility if used for acquisitions. The Facility contains various restrictive financial covenants, including the maintenance of certain fixed coverage and leverage ratios. At March 31, 2003 the Company fell below the minimum permitted Fixed Charge coverage ratio. The Company and the banks amended the minimum permitted Fixed Charge coverage ratio for the first quarter of 2003 and future periods. In addition, as part of the amendment: - The amount available under the revolving credit loan is reduced from $23 million to the lesser of $10 million or 50% of the Company's Eligible Receivables, as defined. - Until the Company's Fixed Charge Coverage Ratio returns to levels specified in the original agreement, the applicable percentage applied to the interest rate on the Company's borrowing under the Facility is increased by 0.75%. - The term loan is collateralized by a pledge of the Company's domestic cash and cash equivalents and any amounts outstanding under the revolving credit loan are collateralized by the Company's Eligible Receivables, as defined, and any remaining 18 domestic cash and cash equivalents above the amounts pledged as security under the term loan. - The Company must maintain a ratio of cash and cash equivalents held in the United States to principal amounts outstanding under the Company's term loan of at least 1.1 to 1.0. The $5.0 million Multicurrency Facility is composed of a euro overdraft facility up to the equivalent of $3.0 million and a pound sterling overdraft facility up to the equivalent of $2.0 million. This Multicurrency Facility bears interest at a rate equal to either (a) the rate published by the European Central Bank plus a margin (as defined) or (b) the Bank's Base Rate (as determined by the bank having regard to prevailing market rates) plus a margin (as defined). At March 31, 2003, no amounts were outstanding under the Company's revolving credit loan, $12.0 was million was outstanding under the term loan, and no amounts were outstanding under the $5.0 million Multicurrency Facility. Interest is payable on the term loan at a rate of 5.82%. Principal payments of $750,000 are due on the term loan on the last business day of each quarter through March of 2007. Effective July 1, 2002 the Company entered into an interest rate swap agreement to fix the interest rate on the $15.0 million term loan. The swap is designated as a cash flow hedge under the guidelines of SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities." Under the swap agreement the interest rate on the term loan is fixed at 4.32% plus a margin of 1.5%. The swap is in place through the life of the term loan, ending on March 31, 2007. Changes in fair market value of the swap are recorded in Accumulated Other Comprehensive Loss on the Consolidated Balance Sheet. At March 31, 2003 approximately $551,000 has been recorded in Accumulated Other Comprehensive Loss to reflect a decrease in the fair market value of the swap. With the acquisition of CPR the Company entered into a $6,000,000 convertible note payable to the shareholders of CPR. The principal balance is convertible at the holders' option into 314,243 shares of the Company's Common Stock at any time through January 29, 2005 (the Maturity Date). If the note has not been converted at the Maturity Date, the Company has the option to extend the Maturity Date of the note for another three years. The note bears interest at an annual rate of 3.80% from January 29, 2002 through the Maturity Date. Interest is payable semi-annually. If the Maturity Date is extended, the interest rate will be reset on January 29, 2005 at an annual rate of interest equal to the yield of a three-year United States Treasury Note. 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 its Credit Facilities, will be sufficient to meet its foreseeable cash needs. In addition, in the future, the Company will continue to consider acquiring businesses to enhance its service offerings, therapeutic base and global presence. Any such acquisitions may require additional external financing and the Company may from time to time seek to obtain funds from 19 public or private issuance of equity or debt securities. There can be no assurance that such financing will be available on terms acceptable to the Company. ADDITIONAL CONSIDERATIONS On July 15, 2002 two of the Company's major customers, Pharmacia Inc. and Pfizer Inc. announced plans to merge in a stock-for-stock transaction. The merger closed in the second quarter of 2003. Pharmacia and Pfizer combined represent approximately 31% of the Company's net service revenues for the three months ended March 31, 2003 and approximately 34% of the Company's March 31, 2003 backlog. Since the merger announcement, the Company has not noticed a change, as a result of the announced merger, in the levels of business received from either of these companies. The Company is unable to predict what impact, either positive or negative, if any, the merger will have on the current backlog of business or on amount of business the Company will receive from the combined companies in the future. MARKET RISK Interest Rates The Company is exposed to changes in interest rates on its available-for-sale securities and amounts outstanding under its credit facilities. Available-for-sale securities are recorded at fair value in the financial statements. These securities are exposed to market price risk, which also takes into account interest rate risk. At March 31, 2003, the potential loss in fair value resulting from a hypothetical decrease of 10% in quoted market price would be approximately $2.2 million. In July 2002, the Company entered into an interest rate swap agreement with the intent of managing the interest rate risk on its five-year term loan. Interest rate swap agreements are contractual agreements between two parties for the exchange of interest payment streams on a principal amount and an agreed-upon fixed or floating rate, for a defined period of time. See discussion of debt in the Liquidity and Resources section of the Management's Discussion and Analysis of Financial Conditions and Results of Operations. Foreign Currency The Company operates on a global basis and therefore is exposed to various types of currency risks. Two specific transaction risks arise from the nature of the contracts the Company executes with its customers because from time to time contracts are denominated in a currency different than the particular subsidiary's 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 location's expenses are incurred. As a result, the location's net revenues and resultant net income can be affected by fluctuations in exchange rates. Historically, fluctuations in exchange rates from those in effect at the time contracts were executed have not had a material effect upon the Company's consolidated financial results. 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 location's local currency, the Company recognizes a receivable at the time of invoicing at the local currency equivalent of the 20 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. 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 consolidated financial statements. The Company's foreign 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 subsidiary's U.S. dollar balance sheet and is necessary to keep the foreign balance sheet stated in U.S. dollars in balance. Foreign currency translation adjustments, reported as a separate component of Shareholders' Equity were approximately $(900,000) at March 31, 2003 compared to $(1.5) million at December 31, 2002. CRITICAL ACCOUNTING POLICIES AND ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principles 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. The majority of the Company's revenues are based on fixed-price contracts calculated on a percentage-of-completion basis based on assumptions regarding the estimated total costs for each contract. Costs are incurred for each project and compared to the estimated budgeted costs for each contract to determine a percentage of completion on the project. The percentage of completion is multiplied by the total contract value to determine the amount of revenue recognized. Management reviews the budget on each contract to determine if the budgeted amounts are correct, and budgets are adjusted as needed. As the work progresses, original estimates might be changed due to changes in the scope of the work. The Company attempts to negotiate contract amendments with the sponsor to cover these services provided outside the terms of the original contract. However, there can be no guarantee that the sponsor will agree to the proposed amendments, and the Company ultimately bears the risk of cost overruns. In certain instances, the Company may have to commit additional resources to existing projects, resulting in lower gross margins. Similar situations may occur in the future. Historically, the majority of the Company's estimates have been materially correct, but there can be no guarantee that these estimates will continue to be accurate. Amendments to contracts resulting in revisions to revenues and costs are recognized in the period in which the revisions are negotiated. Included in accounts receivable are unbilled accounts receivable, which represent revenue recognized in excess of amounts billed. As the Company works on projects, the Company also incurs third-party and other pass-through costs, which are typically reimbursable by its customers pursuant to the contract. In 21 certain contracts, however, these costs are fixed by the contract terms. In these contracts, the Company is at risk for costs incurred in excess of the amounts fixed by the contract terms. Excess costs incurred above the contract terms would negatively affect the Company's gross margin. The Company accounts for employee stock options under Accounting Principles Board Opinion (APB) No. 25, "Accounting for Stock Issued to Employees," and its related interpretations. Under APB 25, no compensation expense is recognized when the exercise price is equal to the market price of the stock on the date of the grant. If the Company accounted for stock options under SFAS 123, the Company would have to record additional compensation expense relating to stock option grants. If the Company had to account for stock options under SFAS 123, the Company's financial results would be materially adversely affected by the additional compensation expense that would have to be recognized. The compensation expense could vary significantly from period to period based on a number of factors, including the number of stock options granted, the expected holding period, the share price and share price volatility and interest rate fluctuations. Billed accounts receivable represent amounts for which invoices have been sent to customers. Unbilled accounts receivable are amounts recognized as revenue for which bills have not yet been sent 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. 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 results of operations or financial position. The Company analyzes goodwill and other indefinite-lived intangible assets to determine any potential impairment loss on an annual basis, unless conditions exist that require an updated analysis on an interim basis. A fair value approach is used to test goodwill for impairment. An impairment charge is recognized for the amount, if any, by which the carrying amount of the goodwill exceeds the fair value. In the fourth quarter of 2002, the Company recorded a goodwill impairment charge of $67.7 million. The Company has a 50% owned joint-venture investment in Beijing KendleWits Medical Consulting Co., Ltd. (KendleWits), a company located in the People's Republic of China. The Company accounts for this investment under the equity method. To date, the Company has contributed approximately $750,000 for the capitalization of KendleWits and the carrying value recorded as of March 31, 2003 is approximately $400,000. Future capital contributions will be dependent upon the on-going capitalization needs of KendleWits and the Company's willingness to provide additional capital. The Company is not obligated to make any additional investment in KendleWits and currently has no plans to do so. Future results of KendleWits may vary, and are dependent upon the demand for clinical research services in China and the ability of KendleWits to generate additional business. The Company capitalizes costs incurred to internally develop software used primarily in providing proprietary clinical trial and data management services, 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 22 whenever events indicate that the carrying value of the software may not be recoverable. Assessing the fair value of the internally developed software requires estimates and judgement on the part of management. 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 judgements 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 upon an assessment that realization cannot be assured. The ultimate realization of this tax benefit is dependent upon the generation of sufficient operating 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. NEW ACCOUNTING PRONOUNCEMENTS In January 2003, the Emerging Issues Task Force issued EITF Issue 00-21, "Revenue Arrangements with Multiple Deliverables," which requires companies to determine whether an arrangement involving multiple deliverables contains more than one unit of accounting. In applying EITF Issue 00-21, revenue arrangements with multiple deliverables should be divided into separate units of accounting if the deliverables in the arrangement meet certain criteria. Arrangement consideration should be allocated among the separate units of accounting based on their relative fair values. This issue is effective for revenue arrangements entered into in fiscal periods beginning after June 15, 2003. The Company is currently evaluating what impact, if any, the adoption of this issue will have on its results of operations and/or financial position. In January 2003, the Financial Accounting Standards Board (FASB) issued Interpretation No. 46 (FIN 46), "Consolidation of Variable Interest Entities." FIN 46 requires a variable interest entity to be consolidated by a company if that company is subject to a majority of the risk of loss from the variable interest entity's activities or entitled to receive a majority of the entity's residual returns or both. A variable interest entity is a corporation, partnership, trust, or any other legal structures used for business purposes that either (a) does not have equity investors with voting rights or (b) has equity investors that do not provide sufficient financial resources for the entity to support its activities. A variable interest entity often holds financial assets, including loans or receivables, real estate or other property. A variable interest entity may be essentially passive or it may engage in research and development or other activities on behalf of another company. The consolidation requirements of FIN 46 apply immediately to variable interest entities created after January 31, 2003. The consolidation requirements apply to older entities in the first fiscal year or interim period beginning after June 15, 2003. Certain of the disclosure requirements apply to all financial statements issued after January 31, 2003, regardless of when the variable interest entity was established. The Company is currently evaluating the consolidation requirements of FIN 46. In December 2002, the FASB issued SFAS No. 148, Accounting for Stock-Based Compensation - Transition and Disclosure, an Amendment of SFAS No. 123. SFAS No. 148 provides transition guidance for those companies that elect to voluntarily adopt the accounting provisions of SFAS No. 123, Accounting for Stock-Based Compensation. SFAS No. 148 also mandates certain new disclosures that are incremental to those required by SFAS No. 123. SFAS 23 No. 148 is effective for fiscal years ending after December 15, 2002. The Company has adopted the disclosure requirements of SFAS No. 148. At this time the Company does not plan to adopt the accounting provisions of SFAS No. 123 and will continue to account for stock options in accordance with Accounting Principles Board Opinion No. 125, "Accounting for Stock Issued to Employees." In July 2002, the FASB issued SFAS No. 146, "Accounting for Exit or Disposal Activities." SFAS No. 146 addresses the recognition, measurement, and reporting of costs that are associated with exit and disposal activities, including costs related to terminating a contract that is not a capital lease and termination benefits that employees who are involuntarily terminated receive under the terms of a one-time benefit arrangement that is not an ongoing benefit arrangement or an individual deferred-compensation contract. SFAS No. 146 supersedes Emerging Issues Task Force Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring) and requires liabilities associated with exit and disposal activities to be expensed as incurred. SFAS No. 146 is required for exit or disposal activities of the Company initiated after December 31, 2002, with earlier adoption encouraged. The Company has adopted SFAS No. 146. CAUTIONARY STATEMENT FOR FORWARD-LOOKING INFORMATION Certain statements contained in this Form 10-Q 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 which 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 which could cause actual performance to differ materially from these forward-looking statements include, without limitation, factors discussed in conjunction with a forward-looking statement, changes in general economic conditions, competitive factors, outsourcing trends in the pharmaceutical industry, changes in the financial conditions of the Company's customers, potential mergers and acquisitions in the pharmaceutical industry, the Company's ability to manage growth and to continue to attract and retain qualified personnel, the Company's ability to complete additional acquisitions and to integrate newly acquired businesses, the Company's ability to penetrate new markets, competition and consolidation within the industry, the ability of joint venture businesses to be integrated with the Company's operations, the fixed price nature of contracts or the loss of large contracts, cancellation or delay of contracts, the progress of ongoing projects, cost overruns, fluctuations in the Company's sales cycle, the ability to maintain large customer contracts or to enter into new contracts, the effects of exchange rate fluctuations, the carrying value of and impairment of the Company's investments and the other risk factors set forth in the Company's filings with the Securities and Exchange Commission, copies of which are available upon request from the Company's investor relations department. No assurance can be given that the Company will be able to realize the net service 24 revenues included in backlog and verbal awards. The Company believes that its aggregate backlog and verbal awards are not necessarily meaningful indicators of future results. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK See Management's Discussion and Analysis of Financial Conditions and Results of Operations. ITEM 4. CONTROLS AND PROCEDURES (a) Evaluation of disclosure controls and procedures. The Company's chief executive officer and chief financial officer have reviewed and evaluated the effectiveness of the Company's disclosure controls and procedures (as defined in the Exchange Act Rules 13a-14(c) and 15d-14(c)) as of a date within ninety days before the filing date of this quarterly report. Based on that evaluation, the chief executive officer and the chief financial officer have concluded that the Company's disclosure controls and procedures are effective and designed to ensure that material information relating to the Company and the Company's consolidated subsidiaries are made known to them by others within those entities. (b) Changes in internal controls. There were no significant changes in the Company's internal controls or in other factors that could significantly affect those controls subsequent to the date of the evaluation. 25 PART II. OTHER INFORMATION Item 1. Legal Proceedings - None Item 2. Changes in Securities and Use of Proceeds - None Item 3. Defaults upon Senior Securities - Not applicable Item 4. Submission of Matters to a Vote of Security Holders - None Item 5. Other Information - Not applicable Item 6. Exhibits and Reports on Form 8-K -- (a) Exhibits 10.24 Third Amendment to Amended and Restated Credit Agreement 99.1 Statement of Chief Executive Officer 99.2 Statement of Chief Financial Officer (b) Reports filed on Form 8-K during the quarter: On January 3, 2003 the Company filed a Form 8-K to disclose the retirement of Timothy M. Mooney, Executive Vice President and Chief Financial Officer and announce Karl Brenkert III as the Company's new Chief Financial Officer and Senior Vice President. 26 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. KENDLE INTERNATIONAL INC. By: /s/ Candace Kendle ----------------------------------- Date: May 15, 2003 Candace Kendle Chairman of the Board and Chief Executive Officer By: /s/ Karl Brenkert III ----------------------------------- Date: May 15, 2003 Karl Brenkert Vice President - Chief Financial Officer 27 CERTIFICATIONS I, Candace Kendle, certify that: 1. I have reviewed this quarterly report on Form 10-Q of Kendle International Inc. 2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; 3. Based on my knowledge, the financial statements and other financial information included in this quarterly report, fairly present, in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; 4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; b) evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the "Evaluation Date"); and c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent function): a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and 6. The registrant's other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. 28 By: /s/ Candace Kendle ----------------------------------- Date: May 15, 2003 Candace Kendle Chairman of the Board and Chief Executive Officer 29 CERTIFICATIONS I, Karl Brenkert III, certify that: 1. I have reviewed this quarterly report on Form 10-Q of Kendle International Inc. 2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; 3. Based on my knowledge, the financial statements and other financial information included in this quarterly report, fairly present, in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; 4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; b) evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the "Evaluation Date"); and c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent function): a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and 6. The registrant's other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. 30 By: /s/ Karl Brenkert III ----------------------------------- Date: May 15, 2003 Karl Brenkert Vice President - Chief Financial Officer 31 KENDLE INTERNATIONAL INC. EXHIBIT INDEX Exhibits Description -------- ----------- 10.24 Third Amendment to Amended and Restated Credit Agreement 99.1 Statement of Chief Executive Officer 99.2 Statement of Chief Financial Officer 32