UNITED STATES 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 SEPTEMBER 30, 2005 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 of (IRS Employer Identification No.) 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 by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No X ----- ----- Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date: 14,039,587 shares of Common Stock, no par value, as of October 25, 2005. 1 KENDLE INTERNATIONAL INC. INDEX Page ---- Part I. Financial Information Item 1. Financial Statements (Unaudited) Condensed Consolidated Balance Sheets -September 30, 2005 and December 31, 2004 3 Condensed Consolidated Statements of Operations - Three Months Ended September 30, 2005 and 2004; Nine Months Ended September 30, 2005 and 2004 4 Condensed Consolidated Statements of Comprehensive Income (Loss) - Three Months Ended September 30, 2005 and 2004; Nine Months Ended September 30, 2005 and 2004 5 Condensed Consolidated Statements of Cash Flows - Nine Months Ended September 30, 2005 and 2004 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 27 Item 4. Controls and Procedures 27 Part II. Other Information 28 Item 1. Legal Proceedings 28 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 28 Item 3. Defaults upon Senior Securities 28 Item 4. Submission of Matters to a Vote of Security Holders 28 Item 5. Other Information 28 Item 6. Exhibits 28 Signatures 29 Exhibit Index 30 2 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED BALANCE SHEETS September 30, December 31, 2005 2004 ------------- ------------ (in thousands, except share data) (unaudited) (note 1) ASSETS Current assets: Cash and cash equivalents $ 25,510 $ 17,665 Restricted cash 213 971 Available-for-sale securities 10,621 10,271 Accounts receivable 54,814 56,025 Other current assets 11,420 10,243 -------- -------- Total current assets 102,578 95,175 -------- -------- Property and equipment, net 15,441 16,821 Goodwill 24,323 26,003 Other finite-lived intangible assets 549 663 Other indefinite-lived intangible assets 15,000 15,000 Other assets 6,829 9,018 -------- -------- Total assets $164,720 $162,680 ======== ======== LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Current portion of obligations under capital leases $ 392 $ 740 Current portion of amounts outstanding under credit facilities 3,000 3,000 Convertible note -- 1,500 Trade payables 7,055 9,169 Advance billings 19,403 24,924 Other accrued liabilities 15,820 15,128 -------- -------- Total current liabilities 45,670 54,461 -------- -------- Obligations under capital leases, less current portion 526 863 Long-term debt 1,500 3,750 Other noncurrent liabilities 1,139 831 -------- -------- Total liabilities 48,835 59,905 -------- -------- 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; 13,961,379 and 13,262,826 shares issued and 13,941,482 and 13,242,929 outstanding at September 30, 2005 and December 31, 2004, respectively 75 75 Additional paid in capital 144,566 136,111 Accumulated deficit (28,615) (35,596) Accumulated other comprehensive: Net unrealized holding losses on available-for-sale securities (54) (49) Unrealized gains (losses) on interest rate swap 1 (92) Foreign currency translation adjustment 305 2,719 -------- -------- Total accumulated other comprehensive income 252 2,578 Less: Cost of common stock held in treasury, 19,897 shares at September 30, 2005 and December 31, 2004 (393) (393) -------- -------- Total shareholders' equity 115,885 102,775 -------- -------- Total liabilities and shareholders' equity $164,720 $162,680 ======== ======== The accompanying notes are an integral part of these condensed consolidated financial statements. 3 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) For the Three Months For the Nine Months Ended September 30, Ended September 30, -------------------- ------------------- 2005 2004 2005 2004 ------- ------- -------- -------- (in thousands, except per share data) Net service revenues $51,581 $42,920 $149,233 $124,923 Reimbursable out-of-pocket revenues 12,865 8,776 34,936 31,774 ------- ------- -------- -------- Total revenues 64,446 51,696 184,169 156,697 ------- ------- -------- -------- Costs and expenses: Direct costs 27,451 23,794 80,329 71,276 Reimbursable out-of-pocket costs 12,865 8,776 34,936 31,774 Selling, general and administrative expenses 16,738 14,973 50,634 43,640 Depreciation and amortization 1,851 2,237 6,228 6,806 Severance and office consolidation costs -- -- -- 302 ------- ------- -------- -------- 58,905 49,780 172,127 153,798 ------- ------- -------- -------- Income from operations 5,541 1,916 12,042 2,899 Other income (expense): Interest income 234 101 674 265 Interest expense (92) (158) (380) (573) Other (370) (509) (77) (224) Gain on debt extinguishment -- -- 300 597 ------- ------- -------- -------- Income before income taxes 5,313 1,350 12,559 2,964 Income tax expense 1,919 750 5,578 1,480 ------- ------- -------- -------- Net income $ 3,394 $ 600 $ 6,981 $ 1,484 ======= ======= ======== ======== Income per share data: Basic: Net income per share $ 0.25 $ 0.05 $ 0.52 $ 0.11 ======= ======= ======== ======== Weighted average shares 13,633 13,231 13,413 13,141 Diluted: Net income per share $ 0.24 $ 0.04 $ 0.50 $ 0.11 ======= ======= ======== ======== Weighted average shares 14,258 13,413 13,926 13,373 The accompanying notes are an integral part of these condensed consolidated financial statements. 4 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (UNAUDITED) For the Three Months Ended For the Nine Months Ended September 30, September 30, -------------------------- ------------------------- 2005 2004 2005 2004 ------ ------ ------- ------ (in thousands) Net income $3,394 $ 600 $ 6,981 $1,484 ------ ------ ------- ------ Other comprehensive income: Foreign currency translation adjustment 126 549 (2,414) (520) Net unrealized holding gains (losses) on available-for-sale securities arising during the period, net of tax 2 20 (5) (34) Net unrealized holding gains on interest rate swap agreement 16 8 93 190 ------ ------ ------- ------ Comprehensive income $3,538 $1,177 $ 4,655 $1,120 ====== ====== ======= ====== The accompanying notes are an integral part of these condensed consolidated financial statements. 5 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) For the Nine Months Ended September 30, ------------------------- 2005 2004 ------- -------- (in thousands) Net cash provided by (used in) operating activities $10,509 $ (5,783) ------- -------- Cash flows from investing activities: Proceeds from sales and maturities of available-for-sale securities 3,485 7,889 Purchases of available-for-sale securities (3,915) (9,419) Acquisitions of property and equipment (3,579) (2,094) Cash provided by restricted cash 676 1,544 Additions to software costs (158) (1,282) Other 18 15 ------- -------- Net cash used in investing activities (3,473) (3,347) ------- -------- Cash flows from financing activities: Net repayments under credit facilities (2,187) (1,472) Net repayments - book overdraft (389) (75) Repayment of convertible note (1,200) (1,903) Other (31) -- Proceeds from exercise of stock options 5,419 135 Payments on capital lease obligations (597) (668) ------- -------- Net cash provided by (used in) financing activities 1,015 (3,983) ------- -------- Effects of exchange rates on cash and cash equivalents (206) 113 Net increase (decrease) in cash and cash equivalents 7,845 (13,000) Cash and cash equivalents: Beginning of period 17,665 21,750 ------- -------- End of period $25,510 $ 8,750 ======= ======== 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 accounting principles generally accepted in the United States of America 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 accounting principles generally accepted in the United States of America 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. Certain amounts reflected in the prior years Condensed Consolidated Financial Statements have been reclassified to be comparable with the current year. Operating results for the three and nine months ended September 30, 2005 are not necessarily indicative of the results that may be expected for the year ending December 31, 2005. For further information, refer to the Consolidated Financial Statements and notes thereto included in the Form 10-K for the year ended December 31, 2004 filed by Kendle International Inc. ("the Company") with the Securities and Exchange Commission. The condensed consolidated balance sheet at December 31, 2004 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. Cash and Cash Equivalents, Including Restricted Cash In the Company's condensed consolidated statement of cash flows for the nine months ended September 30, 2005, the Company changed the classification of changes in restricted cash balances to present such changes as an investing activity. The Company previously presented such changes as an operating activity. In the accompanying consolidated statements of cash flows for the period from January 01, 2004 to September 30, 2004, the Company reclassified changes in restricted cash balances to be consistent with the Company's 2005 presentation which resulted in a $1.5 million increase in investing cash flows and a corresponding decrease in operating cash flows from the amounts previously reported. Net Income Per Share Data Net income per basic share is computed using the weighted average common shares outstanding. Net income per diluted share is computed using the weighted average common shares and potential common shares outstanding. The net income used in computing net income per diluted share has been calculated as follows: 7 Three Months Ended Three Months Ended September 30, 2005 September 30, 2004 ------------------ ------------------ (in thousands) Net income per Statements of operations $3,394 $600 ------ ---- Net income for diluted earnings per share calculation $3,394 $600 Nine Months Ended Nine Months Ended September 30, 2005 September 30, 2004 ------------------ ------------------ (in thousands) Net income per Statements of operations $6,981 $1,484 ------ ------ Net income for diluted earnings per share calculation $6,981 $1,484 The weighted average shares used in computing net income per diluted share have been calculated as follows: Three Months Ended Three Months Ended September 30, 2005 September 30, 2004 ------------------ ------------------ (in thousands) Weighted average common shares Outstanding 13,633 13,231 Stock options 625 182 ------ ------ Weighted average shares 14,258 13,413 ------ ------ Nine Months Ended Nine Months Ended September 30, 2005 September 30, 2004 ------------------ ------------------ (in thousands) Weighted average common shares Outstanding 13,413 13,141 Stock options 513 232 ------ ------ Weighted average shares 13,926 13,373 ------ ------ Options to purchase approximately 50,000 and 300,000 shares of common stock were outstanding during the three and nine months ended September 30, 2005 but were not included in the computation of earnings per diluted share because the effect would be antidilutive. Options to purchase approximately 1,500,000 and 1,400,000 shares of common stock were outstanding during the three and nine months ended September 30, 2004 but were not included in the computation of earnings per diluted share because the effect would be antidilutive. 8 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. On May 12, 2005, the Compensation Committee amended the vesting schedule of a total of approximately 140,000 options outstanding that met the following criteria: 1) Outstanding/unvested as of May 12, 2005 2) Have an option price greater than $11.73 (fair market value on May 12, 2005) 3) Were granted between May 1, 2001 and May 1, 2002. All unvested shares that met the above criteria, with the exception of options held by any executive officer of the company, were immediately vested as of May 12, 2005. The Compensation Committee decided to accelerate the vesting schedule of these options primarily to enhance employee appreciation of the importance of focusing on increasing shareholder value and to avoid expensing the options upon adoption of SFAS 123(R). Had the Company adopted SFAS No. 123 for expense recognition purposes, the amount of compensation expense that would have been recognized in the third quarter of 2005 and 2004 would have been approximately $0.5 million and $1.0 million, respectively. The amount of compensation expense that would have been recognized in the first nine months of 2005 and 2004 would have been approximately $4.5 million and $3.0 million, respectively. Approximately $2.2 million of the $4.5 million in compensation expense that would have been recognized for the nine months ended September 30, 2005 resulted from the amendment made to the vesting schedule. The Company's pro-forma net income (loss) per diluted share would have been adjusted to the amounts below: Three Months Three Months Ended September Ended September 30, 2005 30, 2004 --------------- --------------- (in thousands, except per share data) PRO FORMA NET INCOME (LOSS): As reported $3,394 $ 600 Less: pro forma adjustment for stock-based compensation, net of tax (363) (759) ------ ------ Pro-forma net income (loss) $3,031 $ (159) PRO-FORMA NET INCOME (LOSS) PER BASIC SHARE: As reported $ 0.25 $ 0.05 Effect of pro forma expense $(0.03) $(0.06) Pro-forma $ 0.22 $(0.01) 9 PRO-FORMA NET INCOME (LOSS) PER DILUTED SHARE: As reported $ 0.24 $ 0.04 Effect of pro forma expense $(0.03) $(0.05) Pro-forma $ 0.21 $(0.01) Nine Months Nine Months Ended September Ended September 30, 2005 30, 2004 --------------- --------------- (in thousands, except per share data) PRO FORMA NET INCOME (LOSS): As reported $ 6,981 $ 1,484 Less: pro forma adjustment for stock-based compensation, net of tax (3,439) (2,302) ------- ------- Pro-forma net income (loss) $ 3,542 $ (818) PRO-FORMA NET INCOME (LOSS) PER BASIC SHARE: As reported $ 0.52 $ 0.11 Effect of pro-forma expense $ (0.26) $ (0.17) Pro-forma $ 0.26 $ (0.06) PRO-FORMA NET INCOME (LOSS) PER DILUTED SHARE: As reported $ 0.50 $ 0.11 Effect of pro-forma expense $ (0.25) $ (0.17) Pro-forma $ 0.25 $ (0.06) New Accounting Pronouncements In December 2004, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards No. 123, "Share-Based Payment" (SFAS 123(R)). SFAS 123(R) requires that compensation costs relating to share-based payment transactions be recognized in the financial statements. The cost will be measured based on the fair value of the equity or liability instruments issued. SFAS 123(R) covers a range of shared-based compensation arrangements, including stock options, restricted stock plans, performance-based awards, stock appreciation rights and employee stock purchase plans. The Company currently uses the Black-Scholes option pricing model to value options and is currently assessing which model may be used in the future under the new statement. In addition to determining the fair value model to be used, the Company will also be required to determine the transition method to be used at the date of adoption. The allowed transition methods include prospective and retroactive adoption options. The prospective method requires that compensation expense be recorded for all unvested stock options at the beginning of the first quarter following the adoption of SFAS 123(R), while the retroactive methods would record compensation expense for all unvested stock options beginning with the first period restated. The Company is in the process of evaluating the impact SFAS 123(R) will have on its Consolidated Financial Statements. 10 In April 2005, the Securities and Exchange Commission announced the adoption of a new rule that amends the effective date of SFAS 123(R). The effective date of the new standard under these new rules for the Company's Consolidated Financial Statements is January 1, 2006. In May 2005, the FASB issued FASB Statement 154, "Accounting Changes and Error Corrections" which replaces APB Opinion No. 20, "Accounting Changes" and FASB Statement 3 "Reporting Accounting Changes in Interim Financial Statements." This statement changes the requirements for the accounting for and reporting of a change in accounting principle. This statement applies to all voluntary changes in accounting principle. It also applies to changes required by an accounting pronouncement in the unusual instances that the pronouncement does not include specific transition provisions. This statement requires voluntary changes in accounting principles be recognized retrospectively to prior periods' financial statements, rather than recognition in the net income of the current period. Retrospective application requires restatements of prior period financial statements as if that accounting principle had always been used. This statement carries forward without change the guidance contained in Opinion 20 for reporting the correction of an error in previously issued financial statements and a change in accounting estimate. The provisions of FASB Statement 154 are effective for accounting changes and corrections of error made in fiscal years beginning after December 15, 2005. Statement No. 153, "Exchanges of Non-monetary Assets", an amendment of APB Opinion No. 29, "Accounting for Non-monetary Transactions" is based on the principle that exchanges of non-monetary assets should be measured based on the fair value of the assets exchanged. Further, the amendments eliminate the narrow exception for non-monetary exchanges of similar productive assets and replace it with a broader exception for exchanges of non-monetary assets that do not have commercial substance. The Statement is effective for non-monetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. Earlier application is permitted for non-monetary asset exchanges occurring in fiscal periods beginning after the date of issuance. The application of FAS-153 did not have any impact on earnings and financial position. In December 2004, the FASB issued FASB Staff Position (FSP) No. 109-2, "Accounting and Disclosure Guidance for the Foreign Earnings Repatriation Provision within the American Jobs Creation Act of 2004." The FSP provides guidance under FAS No. 109, "Accounting for Income Taxes," with respect to recording the potential impact of the repatriation provision of the American Jobs Creation Act of 2004 (the "Jobs Act") on enterprises' income tax expense and deferred tax liability. The Jobs Act, enacted on October 22, 2004, creates a temporary incentive for U.S. corporations to repatriate undistributed income earned abroad by providing an 85 percent dividends received deduction for certain dividends from controlled foreign corporations. FSP No. 109-2 states that companies are allowed time beyond the financial reporting period of enactment to evaluate the effect of the Jobs Act on its plan for reinvestment or repatriation of foreign earnings for purposes of applying FAS No. 109. The Company has evaluated the effects of the repatriation provision and does not plan to repatriate undistributed income earned abroad. Therefore, the provisions of FSP 109-2 have no material effect on the Company's Consolidated Financial Statements. 2. OFFICE CONSOLIDATION AND EMPLOYEE SEVERANCE: In the first quarter of 2004, in order to align its resources to meet customer need and demand projections, the Company implemented a workforce realignment plan which resulted in a pre-tax 11 charge of approximately $254,000 for severance and outplacement benefits. An additional $48,000 in net costs (composed of approximately $80,000 in additional costs offset by a reduction to the liability of approximately $32,000) was incurred in the second quarter of 2004 relating to this plan. The workforce realignment plan impacted approximately 3 percent of the Company's North American workforce. Payments in 2004 totaled $302,000 and no amounts remain accrued at September 30, 2005. In August 2003, the Company initiated a workforce realignment plan which immediately eliminated approximately 65 positions from its global workforce. In the third quarter of 2003, the Company recorded a pre-tax charge of approximately $897,000 for severance and outplacement benefits relating to this workforce realignment. In the third quarter of 2005, the Company recorded an additional $70,000 in costs related to on-going arbitration proceedings for an individual whose position was eliminated as a result of the realignment plan. Approximately $85,000 remains accrued and is reflected in Other Accrued Liabilities on the Company's Condensed Consolidated Balance Sheet. The amounts accrued for the workforce reduction and office consolidation costs are detailed as follows: Employee Severance --------- (in thousands) Liability at December 31, 2004 $15 Amounts accrued 70 Amounts paid -- Adjustment to liability -- Liability at September 30, 2005 $85 3. GOODWILL AND OTHER INTANGIBLE ASSETS: Non-amortizable intangible assets at September 30, 2005 and December 31, 2004 are composed of: Indefinite-lived Goodwill Intangible -------- ---------------- (in thousands) Balance at 12/31/04 $26,003 $15,000 Foreign currency fluctuations (1,388) -- Tax benefit to reduce goodwill (292) -- ------- ------- Balance at 9/30/05 $24,323 $15,000 ======= ======= Amortizable intangible assets at September 30, 2005 and December 31, 2004 are composed of: 12 Customer Non-Compete Internally-Developed Relationships Agreements Software ------------- ----------- -------------------- (in thousands) Balance at 12/31/04 $346 $317 $ 5,097 Additional amounts acquired -- -- 158 Dispositions -- -- (11) 2005 amortization (28) (86) (1,719) ---- ---- ------- Balance at 9/30/05 $318 $231 $ 3,525 ==== ==== ======= Internally-developed software is included in other assets within the condensed consolidated financial statements. Amortization expense for the next five years relating to these amortizable intangible assets is estimated to be as follows: (in thousands) Remainder of 2005: $ 477 2006: $1,511 2007: $1,079 2008: $ 525 2009: $ 257 Thereafter: $ 225 ------ Total $4,074 ====== 4. DEBT: In May 2005, the Company entered into the Second Amended and Restated Credit Agreement (the "Facility") that replaced the previous credit agreement. 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 Facility is composed of a $20.0 million revolving credit loan that expires in May of 2008. The existing term loan is carried over from the previous agreement and matures in March of 2007. The revolving credit loan bears interest at a rate equal to either (a) The LIBOR 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 existing 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 new five year 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. The Company is in compliance with the financial covenants contained in the Facility as of September 30, 2005. 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 13 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 September 30, 2005, no amounts were outstanding under the Company's revolving credit loan, $4.5 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 5.8% and on the Multicurrency Facility at a rate of 6.75%. Principal payments of $750,000 are due on the term loan on the last business day of each quarter through March 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 Statement of Financial Accounting Standards (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 the applicable margin (currently 1.50%). The swap is in place through the life of the term loan, ending on March 31, 2007. Changes in fair value of the swap are recorded in Accumulated Other Comprehensive Loss on the Condensed Consolidated Balance Sheet. At September 30, 2005, approximately $1,000 has been recorded in Accumulated Other Comprehensive Income to reflect the unrealized gain of the swap compared to the unrealized loss of approximately $92,000 at December 31, 2004. With the acquisition of Clinical and Pharmacologic Research, Inc. (CPR) in 2002, the Company entered into a $6.0 million convertible note payable to the shareholders of CPR. The principal balance was 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 had not been converted at the Maturity Date, the Company had the option to extend the Maturity Date of the note for another three years. The note bore interest at an annual rate of 3.80% from January 29, 2002 through the Maturity Date. Interest was payable semi-annually. In June of 2003, the Company and the shareholders of CPR entered into Note Prepayment Agreements. Under the Note Prepayment Agreements, the Company agreed to satisfy its payment obligations under the $6.0 million convertible note by making a series of four payments between June 30, 2003 and January 10, 2005. The four payments were initiated either by the Company through the exercise of a "call" option or by the CPR shareholders through the exercise of a "put" option. Gains resulting from this early extinguishment of debt were recorded when paid as a gain in the Company's Condensed Consolidated Statements of Operations. In the first quarter of 2005, the Company paid approximately $1.2 million to settle the remaining $1.5 million of the convertible note that was outstanding at December 31, 2004. A gain of $300,000 has been recorded in the first quarter of 2005 in the Company's Condensed Consolidated Statements of Operations. No amounts remain outstanding under this convertible note at September 30, 2005. Total gains resulting from early extinguishment of debt under the Note Prepayment Agreement were approximately $1.5 million. ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION 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 and nine months ended September 30, 2005 and should be read in conjunction therewith. The Company's results of operations for a 14 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 consulting and organizational meeting management and publications services on a contract basis to biopharmaceutical companies. The Company is managed in one reportable segment encompassing contract services related to Phase I through IV clinical trials. 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 is entered into and the balance is received in installments over the contract's duration, in most cases on a milestone-achievement basis. Net service 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. When estimates indicate a loss, such loss is provided in the current period in its entirety. 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. Finally, at one of the Company's subsidiaries, the contracts are of a short-term nature and revenue is recognized under the completed contract method of accounting. 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 expenses in the Condensed 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 an allocation of 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. 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. 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. 15 The Company's results of operations are subject to volatility due to a variety of factors. The cancellation or delay of contracts and cost overruns could have short-term adverse affects on the Condensed 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 as well as awarded projects for which the contract is actively being negotiated, 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 SEPTEMBER 30, 2005 COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 2004 Net Service Revenues Net service revenues increased approximately $8.7 million, or 20%, to $51.6 million in the third quarter of 2005 from $42.9 million in the third quarter of 2004. The 20% increase in net service revenues was due entirely to organic revenue growth. Foreign currency exchange rate fluctuations had minimal impact on third quarter 2005 revenue compared to third quarter 2004. In the third quarter of 2005, net service revenues in the North American and European regions increased by approximately $4.5 million or 18% and $4.3 million or 27%, respectively, from the same period of the prior year. The growth in net service revenues is primarily due to the Company's expanding customer base in both North America and Europe. The increase in European revenues includes increased demand for Phase I services at the Company's Phase I unit located in Utrecht, The Netherlands. Approximately 42% of the Company's net service revenues were derived from operations outside of North America in the third quarter of 2005 compared to 41% in the corresponding period in 2004. The top five customers based on net service revenues contributed approximately 34% of net service revenues during the third quarter of 2005 compared to approximately 39% of net service revenues during the third quarter of 2004. Net service revenues from Pfizer Inc. accounted for approximately 13% of total third quarter 2005 net service revenues compared to approximately 21% of total third quarter 2004 net service revenues. The Company's net service revenues from Pfizer Inc. are derived from numerous projects that vary in size, duration and therapeutic indication. No other customer accounted for more than 10% of the net service revenues for the quarter in either period presented. 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 47% to $12.9 million in the third quarter of 2005 from $8.8 million in the corresponding period of 2004. Operating Expenses 16 Direct costs increased approximately $3.7 million, or 15%, to $27.5 million in the third quarter of 2005 from $23.8 million in the third quarter of 2004. Foreign currency exchange rate fluctuations had minimal impact on direct costs in the third quarter of 2005 compared to 2004. The growth in direct costs relates directly to the increase in net service revenues in the third quarter of 2005, including specifically increased use of outside contractors. Direct costs expressed as a percentage of net service revenues were 53.2% for the three months ended September 30, 2005 compared to 55.4% for the three months ended September 30, 2004. The decrease in direct costs as a percentage of net service revenues is attributable to increased utilization of billable associates during the third quarter of 2005 as well as a larger revenue base to absorb fixed costs. Reimbursable out-of-pocket costs increased 47% to $12.9 million in the third quarter of 2005 from $8.8 million in the corresponding period of 2004. Selling, general and administrative expenses increased $1.7 million, or 12%, from $15.0 million in the third quarter of 2004 to $16.7 million in the same quarter of 2005. Foreign currency exchange rate fluctuations had no impact on the increase in selling, general and administrative expenses in the third quarter of 2005 compared to the comparable period of 2004. The increase is primarily due to increases in employee-related costs due to the Company's increase in headcount. The increase in employee-related costs is comprised of general salary increases and corresponding payroll tax and benefit increases as well as an increase in sales commissions and profit-sharing accrual. Selling, general and administrative expenses expressed as a percentage of net service revenues were 32.4% for the three months ended September 30, 2005 compared to 34.9% for the corresponding 2004 period. Depreciation and amortization expense decreased by $386,000 in the third quarter of 2005 compared to the third quarter of 2004. This decrease was due to a reduction in depreciation expense as fixed assets come to the end of their depreciable life as well as a slowdown in additions to fixed assets as compared to prior periods. Other Income (Expense) Other Income (Expense) was expense of approximately $228,000 in the third quarter of 2005 compared to expense of approximately $566,000 in the third quarter of 2004. Interest expense decreased by approximately $66,000 in the third quarter of 2005 compared to the third quarter of 2004 due to decreased debt outstanding in the third quarter of 2005. Interest income increased by approximately $133,000 in the third quarter of 2005 due to larger cash and investment balances in the quarter as well as a general increase in interest rates in the third quarter of 2005 compared to the third quarter of 2004. The available-for-sale securities balance averaged $10.6 million in the third quarter of 2005 compared to $10.3 million in the third quarter of 2004. Foreign exchange rate gains and losses were a loss of approximately $450,000 in the third quarter of 2004 compared to a loss of $346,000 in the third quarter of 2005. Income Taxes The Company reported tax expense at an effective rate of 36.1% in the quarter ended September 30, 2005, compared to tax expense at an effective rate of 55.6% in the quarter ended September 30, 2004. The Company continues to maintain full valuation allowances against the net operating losses incurred in some of its subsidiaries. The primary reason for the drop in the 17 effective rate in 2005 is due to earnings growth in 2005 compared to 2004 in those locations with full valuation allowances. Because Kendle operates on a global basis, the effective tax rate varies from quarter to quarter based on the locations that generate the pre-tax earnings or losses. Net Income The net income for the quarter ended September 30, 2005 was approximately $3.4 million or $0.25 per basic and $0.24 per diluted share compared to net income for the quarter ended September 30, 2004 of approximately $600,000, or $0.05 per basic and $0.04 per diluted share. NINE MONTHS ENDED SEPTEMBER 30, 2005 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30, 2004 Net Service Revenues Net service revenues increased 19% to $149.2 million in the first nine months of 2005 from $124.9 million in the first nine months of 2004. The 19% increase in net service revenues was due entirely to organic growth. Foreign currency exchange rate fluctuations accounted for a 1% increase in net service revenues in the first nine months of 2005 compared to the first nine months of 2004. In the first nine months of 2005, net service revenues in the North American and European regions increased by approximately $10.4 million or 14% and $14.1 million or 31%, respectively, from the same period of the prior year. The growth in net service revenues is primarily due to the Company's expanding customer base in both North America and Europe, including an increased demand for the Company's Phase I services in the Netherlands. Approximately 43% of the Company's net service revenues were derived from operations outside of North America in the first nine months of 2005 compared to 40% in the corresponding period of 2004. The top five customers based on net service revenues contributed approximately 35% of net service revenues during the first nine months of 2005 compared to approximately 41% of net service revenues during the first nine months of 2004. Net service revenues from Pfizer Inc. accounted for approximately 16% of total net service revenues in the nine months ended September 30, 2005 compared to approximately 21% of total net service revenues in the same period of 2004. The Company's net service revenues from Pfizer Inc. are derived from numerous projects that vary in size, duration and therapeutic indication. No other customer accounted for more than 10% of the net service revenues in either the first nine months of 2005 or 2004. 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 10.0% to $34.9 million in the nine months ended September 30, 2005 from $31.8 million in the corresponding period of 2004. Operating Expenses Direct costs increased by 13% from $71.3 million in the first nine months of 2004 to $80.3 million in the first nine months of 2005. Foreign currency exchange rate fluctuations accounted for a 2% increase in direct costs in the first nine months of 2005 compared to 2004. The remaining growth in direct costs relates directly to the increase in net service revenues in the first nine months of 2005, including increased use of outside contractors to support the Company's 18 increased project activity. Direct costs expressed as a percentage of net service revenues were 53.8% for the nine months ended September 30, 2005 compared to 57.1% for the nine months ended September 30, 2004. The decrease in direct costs as a percentage of net service revenues is attributable to increased utilization of billable associates during the nine month period ended September 30, 2005 as well as a larger revenue base to absorb fixed costs. Reimbursable out-of-pocket costs increased 10.0% to $34.9 million in the nine months ended September 30, 2005 from $31.8 million in the corresponding period of 2004. Selling, general and administrative expenses increased from $43.6 million in the first nine months of 2004 to $50.6 million in the first nine months of 2005. Foreign currency exchange rate fluctuations accounted for a 1% increase in selling, general and administrative expenses in the first nine months of 2005 compared to the comparable period of 2004. The increase is primarily due to costs associated with the Company's marketing efforts in 2005 and increases in employee-related costs. The increase in employee-related costs is comprised of general salary increases and corresponding payroll tax increases as well as an increase in sales commissions, profit-sharing accrual and costs for recruiting new associates. Selling, general and administrative expenses expressed as a percentage of net service revenues were 33.9% for the nine months ended September 30, 2005 compared to 34.9% for the corresponding 2004 period. Depreciation and amortization expense decreased by 9% in the nine months ending September 30, 2005 compared to the corresponding period of 2004. This decrease was due to a reduction in depreciation expense as fixed assets come to the end of their depreciable life as well as a slowdown in additions to fixed assets as compared to prior periods. In the first quarter of 2004, in order to align its resources to meet customer need and demand projections, the Company implemented a workforce realignment plan which resulted in a pre-tax charge of approximately $254,000 for severance and outplacement benefits. In the second quarter of 2004, the Company incurred an additional $48,000 in costs related to this workforce realignment plan. This workforce realignment plan impacted approximately 3 percent of the Company's North American workforce. No expenses related to workforce realignment plans were incurred in 2005. No amounts remain accrued at September 30, 2005. Other Income (Expense) Other Income (Expense) was income of $517,000 for the first nine months of 2005 compared to income of approximately $65,000 in the first nine months of 2004. Interest expense decreased by approximately $193,000 in the first nine months of 2005 compared to the first nine months of 2004 due to decreased debt outstanding in the nine months ended September 30, 2005. Interest income increased by approximately $409,000 in the first nine months of September 2005 due to larger cash and investment balances as well as a general increase in interest rates in 2005 compared to 2004. The available-for-sale securities balance averaged $10.2 million for the nine months ended September 30, 2005 compared to $9.3 million for the nine months ended September 30, 2004. In the first nine months of 2004, the Company made partial early repayments on its convertible note and recorded gains from these repayments of approximately $597,000 compared to a gain of $300,000 on partial early repayment of debt in the first nine months of 2005. The convertible note was fully paid as of January 31, 2005. Income Taxes 19 The Company reported tax expense at an effective rate of 44.4% in the nine months ended September 30, 2005 compared to tax expense at an effective rate of 49.9% in the nine months ended September 30, 2004. In the second quarter of 2005, the Company recorded a one-time, non-cash charge of approximately $1.2 million, net of federal income tax effect, to reflect the write-off of deferred state income tax assets due to a change in Ohio state tax law enacted on June 30, 2005. The one-time charge results from adoption of a comprehensive change in Ohio corporate tax laws that provides for the phase-in of a Commercial Activities Tax (CAT) on gross receipts. Concurrent with the phase-in of the CAT, the Ohio income tax, net worth tax, and personal property tax will be phased out. The Company anticipates that the net effect of this tax law change will benefit the Company's earnings in future years. The Company continues to maintain full valuation allowances against net operating losses incurred in certain European subsidiaries of the Company. The primary reason for the drop in the effective rate in 2005 is due to earnings growth in 2005 compared to 2004 in those locations with full valuation allowances. Because Kendle operates on a global basis, the effective tax rate varies from quarter to quarter based on the locations that generate the pre-tax earnings or losses. Net Income Net income for the nine months ended September 30, 2005 was approximately $7.0 million, or $0.50 per diluted share and $0.52 per basic share compared to net income of approximately $1.5 million or $0.11 per basic and diluted share for the nine months ended September 30, 2004. LIQUIDITY AND CAPITAL RESOURCES Cash and cash equivalents increased by $7.8 million for the nine months ended September 30, 2005 as a result of cash provided by operating activities of $10.5 million and cash provided by financing activities of $1.0 million offset by cash used in investing activities of $3.5 million and the negative effects of exchange rates on cash and cash equivalents of $206,000. At September 30, 2005, cash and cash equivalents were $25.5 million. In addition, the Company has approximately $213,000 in restricted cash that represents cash received from customers that is segregated in a separate Company bank account and available for use only for specific project expenses. Net cash provided by operating activities for the period consisted primarily of net income adjusted for non-cash items. The change in net operating assets used approximately $1.2 million in cash during the nine months ended September 30, 2005, primarily due to an increase in net accounts receivable, offset by increases in income tax payable and accrued compensation liabilities. 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 $35.4 million at September 30, 2005, and $31.1 million at December 31, 2004. Investing activities for the nine months ended September 30, 2005 consisted primarily of capital expenditures of approximately $3.7 million, mostly relating to computer equipment and software purchases, including internally developed software. Financing activities for the nine months ended September 30, 2005, consisted primarily of scheduled repayments relating to the Company's credit facility of $2.2 million and partial early repayment of the Company's convertible debt of approximately $1.2 million offset by proceeds from stock option exercises of approximately $5.4 million. 20 The Company had available-for-sale securities totaling $10.6 million at September 30, 2005 compared to $10.3 million at December 31, 2004. In May 2005, the Company entered into the Second Amended and Restated Credit Agreement (the "Facility") that replaced the previous credit agreement. 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 Facility is composed of a $20.0 million revolving credit loan that expires in May of 2008. The existing term loan is carried over from the previous agreement and matures in March of 2007. The revolving credit loan bears interest at a rate equal to either (a) The LIBOR 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 existing 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 new five year 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. The Company is in compliance with the financial covenants contained in the Facility as of September 30, 2005. 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 September 30, 2005 no amounts were outstanding under the Company's revolving credit loan, $4.5 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 5.8% and on the Multicurrency Facility at a rate of 6.75%. Principal payments of $750,000 are due on the term loan on the last business day of each quarter through March 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 Statement of Financial Accounting Standards (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 the applicable margin (currently 1.50%). The swap is in place through the life of the term loan, ending on March 31, 2007. Changes in fair value of the swap are recorded in Accumulated Other Comprehensive Loss on the Condensed Consolidated Balance Sheet. At September 30, 2005, an unrealized gain of approximately $1,000 has been recorded in Accumulated Other Comprehensive Income to reflect the unrealized gain of the swap compared to the unrealized loss of approximately $92,000 at December 31, 2004. With the acquisition of CPR in 2002, the Company entered into a $6.0 million convertible note payable to the shareholders of CPR. The principal balance was 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 had not been converted at the Maturity Date, the Company had the 21 option to extend the Maturity Date of the note for another three years. The note bore interest at an annual rate of 3.80% from January 29, 2002 through the Maturity Date. Interest was payable semi-annually. In June of 2003, the Company and the shareholders of CPR entered into Note Prepayment Agreements. Under the Note Prepayment Agreements, the Company agreed to satisfy its payment obligations under the $6.0 million convertible note by making a series of four payments between June 30, 2003 and January 10, 2005. The four payments were initiated either by the Company through the exercise of a "call" option or by the CPR shareholders through the exercise of a "put" option. Gains resulting from this early extinguishment of debt were recorded in the Company's Condensed Consolidated Statements of Operations when payments were made by the Company. In the first quarter of 2005, the Company paid approximately $1.2 million to settle the remaining $1.5 million of the convertible note that was outstanding at December 31, 2004. A gain of $300,000 has been recorded in the first quarter of 2005 in the Company's Condensed Consolidated Statements of Operations. No amounts remain outstanding under this convertible note at September 30, 2005. Total gains resulting from early extinguishment of debt under the Note Prepayment Agreement were approximately $1.5 million. MARKET RISK Interest Rates The Company is exposed to changes in interest rates on its available-for-sale securities and amounts outstanding under the Facility and Multicurrency Facility. Available-for-sale securities are recorded at fair value in the Condensed Consolidated Financial Statements. These securities are exposed to market price risk, which also takes into account interest rate risk. At September 30, 2005, the potential loss in fair value resulting from a hypothetical decrease of 10% in quoted market price would be approximately $1.1 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 Capital Resources section of Management's Discussion and Analysis of Financial Condition and Results of Operations. 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 22 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 Condensed 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. The foreign currency transaction gain or loss is reported in Other Income (Expense) in the Condensed Consolidated Statements of Operations. The Company's Condensed 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 Condensed 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 subsidiaries' U.S. dollar balance sheet and is necessary to keep the foreign subsidiaries' balance sheet stated in U.S. dollars in balance. Foreign currency translation adjustments, which are reported as a separate component of shareholders' equity, were approximately $305,000 at September 30, 2005 compared to $2.7 million at December 31, 2004. CRITICAL ACCOUNTING POLICIES AND ESTIMATES The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make significant estimates and assumptions that affect the reported Condensed Consolidated Financial Statements for a particular period. Actual results could differ from those estimates. Revenue Recognition The majority of the Company's net service revenues are based on fixed-price contracts calculated on a percentage-of-completion basis based upon 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 23 recognized. Management periodically 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 are subject to change if there are changes in the scope of the work. When estimates indicate a loss, such loss is provided in the current period in its entirety. The Company attempts to negotiate contract amendments with the customer to cover services provided outside the terms of the original contract. However, there can be no guarantee that the customer will agree to proposed amendments, and the Company ultimately bears the risk of cost overruns. 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 provides services on projects, the Company also incurs third-party and other pass-through costs, which are typically reimbursable by its customers pursuant to a contract. In 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. In these instances, the Company recognizes these costs as direct costs with corresponding net service revenues. Excess costs incurred above the contract terms would negatively affect the Company's gross margin. Accounts Receivable/Allowance for Doubtful Accounts Billed accounts receivable represent amounts for which invoices have been sent to customers. Unbilled accounts receivable are amounts recognized as revenue for which invoices 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 Condensed Consolidated Results of Operations or financial position. Intangible Assets 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. The goodwill impairment testing involves the use of estimates related to the fair market value of the reporting unit and is inherently subjective. An impairment charge is recognized for the amount, if any, by which the carrying amount of goodwill exceeds fair value. At December 31, 2003 and 2004 the fair value of the Company exceeded the carrying value, resulting in no goodwill impairment charge. During the first nine months of 2005, no events arose that indicated a need for an interim impairment analysis. In addition to goodwill, the Company has a $15 million indefinite lived intangible asset representing one customer relationship acquired in the Company's acquisition of CPR. The intangible asset is evaluated each reporting period to determine whether events or circumstances continue to support an indefinite useful life. During the first nine months of 2005, no event or events have occurred which would indicate a need to adjust the indefinite useful life of this asset. Internally Developed Software 24 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 estimated useful life of the product, not to exceed five years. Internally developed software includes 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. Assessing the fair value of the internally developed software requires estimates and judgment on the part of management. Tax Valuation Allowance 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 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 December 2004, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards No. 123, "Share-Based Payment" (SFAS 123(R)). SFAS 123(R) requires that compensation costs relating to share-based payment transactions be recognized in the financial statements. The cost will be measured based on the fair value of the equity or liability instruments issued. SFAS 123(R) covers a range of shared-based compensation arrangements, including stock options, restricted stock plans, performance-based awards, stock appreciation rights and employee stock purchase plans. The Company currently uses the Black-Scholes option pricing model to value options and is currently assessing which model may be used in the future under the new statement. In addition to determining the fair value model to be used, the Company will also be required to determine the transition method to be used at the date of adoption. The allowed transition methods include prospective and retroactive adoption options. The prospective method requires that compensation expense be recorded for all unvested stock options at the beginning of the first quarter following the adoption of SFAS 123(R), while the retroactive methods would record compensation expense for all unvested stock options beginning with the first period restated. The Company is in the process of evaluating the impact SFAS 123(R) will have on its Consolidated Financial Statements. In April 2005, the Securities and Exchange Commission announced the adoption of a new rule that amends the effective date of SFAS 123(R). The effective date of the new standard under these new rules for the Company's Consolidated Financial Statements is January 1, 2006. 25 In May 2005, the FASB issued FASB Statement No. 154, "Accounting Changes and Error Corrections" which replaces APB Opinion No. 20, "Accounting Changes" and FASB Statement 3 "Reporting Accounting Changes in Interim Financial Statements." This statement changes the requirements for the accounting for and reporting of a change in accounting principle. This statement applies to all voluntary changes in accounting principle. It also applies to changes required by an accounting pronouncement in the unusual instances that the pronouncement does not include specific transition provisions. This statement requires voluntary changes in accounting principles be recognized retrospectively to prior periods' financial statements, rather than recognition in the net income of the current period. Retrospective application requires restatements of prior period financial statements as if that accounting principle had always been used. This statement carries forward without change the guidance contained in the Opinion 20 for reporting the correction of an error in previously issued financial statements and a change in accounting estimate. The provisions of FASB Statement 154 are effective for accounting changes and corrections of error made in fiscal years beginning after December 15, 2005. Statement No. 153, "Exchanges of Non-monetary Assets", an amendment of APB Opinion No. 29, "Accounting for Non-monetary Transactions" is based on the principle that exchanges of non-monetary assets should be measured based on the fair value of the assets exchanged. Further, the amendments eliminate the narrow exception for non-monetary exchanges of similar productive assets and replace it with a broader exception for exchanges of non-monetary assets that do not have commercial substance. The Statement is effective for non-monetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. Earlier application is permitted for non-monetary asset exchanges occurring in fiscal periods beginning after the date of issuance. The application of FAS-153 did not have any impact on earnings and financial position. In December 2004, the FASB issued FASB Staff Position (FSP) No. 109-2, "Accounting and Disclosure Guidance for the Foreign Earnings Repatriation Provision within the American Jobs Creation Act of 2004." The FSP provides guidance under FAS No. 109, "Accounting for Income Taxes," with respect to recording the potential impact of the repatriation provision of the American Jobs Creation Act of 2004 (the "Jobs Act") on enterprises' income tax expense and deferred tax liability. The Jobs Act, enacted on October 22, 2004, creates a temporary incentive for U.S. corporations to repatriate undistributed income earned abroad by providing an 85 percent dividends received deduction for certain dividends from controlled foreign corporations. FSP No. 109-2 states that companies are allowed time beyond the financial reporting period of enactment to evaluate the effect of the Jobs Act on its plan for reinvestment or repatriation of foreign earnings for purposes of applying FAS No. 109. The Company has evaluated the effects of the repatriation provision and does not plan to repatriate undistributed income earned abroad. Therefore, the provisions of FSP 109-2 have no material effect on the Company's Consolidated Financial Statements. 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 26 statements to reflect events or circumstances arising after the date on which such statements 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 and biotechnology industries, changes in the financial conditions of the Company's customers, potential mergers and acquisitions in the pharmaceutical and biotechnology industries, the Company's ability to manage growth, 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 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 or from the SEC. The Company's growth and ability to achieve operational and financial goals is dependent upon its ability to attract and retain qualified personnel. If the Company fails to hire, retain and integrate qualified personnel, it will be difficult for the Company to achieve its financial and operational goals. No assurance can be given that the Company will be able to realize the net service 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 Condition and Results of Operations. ITEM 4. CONTROLS AND PROCEDURES 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-15(e) and 15d-15(e)) as of the end of the period covered by 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. Changes in Internal Controls - During the fiscal quarter ended September 30, 2005, there were no changes in the Company's internal control over financial reporting that have materially 27 affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting. PART II. OTHER INFORMATION Item 1. Legal Proceedings - None Item 2. Unregistered Sales of Equity 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 - None Item 6. Exhibits Exhibits - Exhibits set forth below that are on file with the Securities and Exchange Commission are incorporated by reference as exhibits thereto. Exhibit Filing Number Description of Exhibit Status - ------- ---------------------- ------ 31.1 Certificate of Chief Executive Officer pursuant to Section 302 of the C Sarbanes-Oxley Act of 2002 31.2 Certificate of Chief Financial Officer pursuant to Section 302 of the C Sarbanes-Oxley Act of 2002 32.1 Certificate of Chief Executive Officer pursuant to Section 906 of the C Sarbanes-Oxley Act of 2002 32.2 Certificate of Chief Financial Officer pursuant to Section 906 of the C Sarbanes-Oxley Act of 2002 Filing Status Description of Filing Status - ------ ---------------------------- C Filed herewith 28 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. Date: November 9, 2005 By: /s/ Candace Kendle ------------------------------------ Candace Kendle Chairman of the Board and Chief Executive Officer Date: November 9, 2005 By: /s/ Karl Brenkert III ------------------------------------ Karl Brenkert III Senior Vice President - Chief Financial Officer 29 KENDLE INTERNATIONAL INC. EXHIBIT INDEX Exhibits Description - -------- ----------- 31.1 Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2 Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1 Certificate of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 32.2 Certificate of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 30