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, 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: 13,060,015 shares of Common Stock, no par value, as of October 31, 2003. 1 KENDLE INTERNATIONAL INC. INDEX Page ---- Part I. Financial Information Item 1. Financial Statements (Unaudited) Condensed Consolidated Balance Sheets -September 30, 2003 and December 31, 2002 3 Condensed Consolidated Statements of Operations - Three Months Ended September 30, 2003 and 2002; Nine Months Ended September 30, 2003 and 2002 4 Condensed Consolidated Statements of Comprehensive Income (Loss) - Three Months Ended September 30, 2003 and 2002; Nine Months Ended September 30, 2003 and 2002 5 Condensed Consolidated Statements of Cash Flows - Nine Months Ended September 30, 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 16 Item 3. Quantitative and Qualitative Disclosure About Market Risk 30 Item 4. Controls and Procedures 30 Part II. Other Information 31 Item 1. Legal Proceedings 31 Item 2. Changes in Securities and Use of Proceeds 31 Item 3. Defaults upon Senior Securities 31 Item 4. Submission of Matters to a Vote of Security Holders 31 Item 5. Other Information 31 Item 6. Exhibits and Reports on Form 8-K 31 Signatures 32 Exhibit Index 33 2 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) September 30, December 31, 2003 2002 --------- --------- (unaudited) (note 1) ASSETS Current assets: Cash and cash equivalents $ 15,339 $ 12,671 Available for sale securities 10,424 17,304 Accounts receivable 44,718 47,050 Other current assets 10,391 7,343 --------- --------- Total current assets 80,872 84,368 --------- --------- Property and equipment, net 17,924 19,028 Goodwill, net 22,794 22,033 Other indefinite-lived intangible assets 15,000 15,000 Other assets 12,649 14,968 --------- --------- Total assets $ 149,239 $ 155,397 ========= ========= LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Current portion of obligations under capital leases $ 874 $ 843 Current portion of amounts outstanding under credit facilities 3,000 3,000 Trade payables 4,508 5,883 Advance billings 17,738 22,313 Other accrued liabilities 14,999 10,878 --------- --------- Total current liabilities 41,119 42,917 --------- --------- Obligations under capital leases, less current portion 1,096 1,643 Convertible note 4,000 6,000 Long-term debt 7,500 9,750 Other noncurrent liabilities 850 727 --------- --------- Total liabilities 54,565 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; 13,070,651 and 12,861,510 shares issued and 13,050,754 and 12,841,613 outstanding at September 30, 2003 and December 31, 2002, respectively 75 75 Additional paid in capital 135,010 134,266 Accumulated deficit (39,681) (37,478) Accumulated other comprehensive loss: Net unrealized holding gain (loss) on available for sale securities 1 (6) Unrealized loss on interest rate swap (458) (566) Foreign currency translation adjustment 120 (1,538) --------- --------- Total accumulated other comprehensive loss (337) (2,110) Less: Cost of common stock held in treasury, 19,897 shares at September 30, 2003 and December 31, 2002, respectively (393) (393) --------- --------- Total shareholders' equity 94,674 94,360 --------- --------- Total liabilities and shareholders' equity $ 149,239 $ 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 For the Nine Months Ended September 30, September 30, ------------------------- ------------------------- 2003 2002 2003 2002 --------- --------- --------- --------- Net service revenues $ 40,424 $ 40,966 $ 116,101 $ 128,581 Reimbursable out-of-pocket revenues 12,716 11,468 38,642 35,997 --------- --------- --------- --------- Total revenues 53,140 52,434 154,743 164,578 --------- --------- --------- --------- Costs and expenses: Direct costs 22,404 23,900 68,573 76,438 Reimbursable out-of-pocket costs 12,716 11,468 38,642 35,997 Selling, general and administrative expenses 13,833 11,321 39,322 36,032 Depreciation and amortization 2,244 2,141 6,656 6,196 Severance and office consolidation costs 897 321 1,473 321 --------- --------- --------- --------- 52,094 49,151 154,666 154,984 --------- --------- --------- --------- Income from operations 1,046 3,283 77 9,594 Other income (expense): Interest income 67 173 266 474 Interest expense (251) (361) (799) (907) Other (162) 128 (586) 186 Investment impairment -- -- (405) (1,938) Gain on debt extinguishment -- -- 558 -- --------- --------- --------- --------- Income (loss) before income taxes 700 3,223 (889) 7,409 Income tax expense 356 1,320 1,314 3,756 --------- --------- --------- --------- Net income (loss) $ 344 $ 1,903 $ (2,203) $ 3,653 ========= ========= ========= ========= Income (loss) per share data: Basic: Net income (loss) per share $ 0.03 $ 0.15 $ (0.17) $ 0.29 ========= ========= ========= ========= Weighted average shares 13,013 12,777 12,943 12,707 Diluted: Net income (loss) per share $ 0.03 $ 0.14 $ (0.17) $ 0.28 ========= ========= ========= ========= Weighted average shares 13,244 13,441 12,943 13,188 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 For the Nine Months Ended September 30, September 30, -------------------------- ------------------------- 2003 2002 2003 2002 ------- ------- ------- ------- Net income (loss) $ 344 $ 1,903 $(2,203) $ 3,653 ------- ------- ------- ------- Other comprehensive income (loss): Foreign currency translation adjustment 243 (63) 1,658 1,411 Net unrealized holding gains (losses) on available for sale securities arising during the period, net of tax 3 (7) 7 (32) Net unrealized holding gains (losses) on interest rate swap agreement 116 (564) 108 (564) ------- ------- ------- ------- Comprehensive income (loss) $ 706 $ 1,269 $ (430) $ 4,468 ======= ======= ======= ======= 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 Nine Months Ended September 30, ----------------------- 2003 2002 -------- -------- Net cash provided by operating activities $ 4,233 $ 17,083 -------- -------- Cash flows from investing activities: Proceeds from sales and maturities of available for sale securities 54,207 28,401 Purchases of available for sale securities (47,341) (31,463) Acquisitions of property and equipment (3,120) (5,441) Additions to software costs (1,428) (1,661) Acquisition of businesses, less cash acquired -- (7,942) Other 10 -- -------- -------- Net cash provided by (used in) investing activities 2,328 (18,106) -------- -------- Cash flows from financing activities: Net proceeds (repayments) under credit facilities (2,250) 2,301 Net repayments - book overdraft (5) (470) Repayment of convertible note (1,442) -- Proceeds from exercise of stock options 192 294 Payments on capital lease obligations (635) (605) Other (65) (32) -------- -------- Net cash (used in) provided by financing activities (4,205) 1,488 -------- -------- Effects of exchange rates on cash and cash equivalents 312 220 Net increase in cash and cash equivalents 2,668 685 Cash and cash equivalents: Beginning of period 12,671 6,016 -------- -------- End of period $ 15,339 $ 6,701 ======== ======== Supplemental schedule of noncash investing and financing activities: Acquisition of Businesses: Fair value of assets acquired (net of cash acquired) $ -- $ 19,165 Fair value of liabilities assumed -- (1,131) Common stock issued -- (4,092) Convertible debt issued -- (6,000) -------- -------- Net cash payments $ -- $ 7,942 ======== ======== 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. Operating results for the three and nine months ended September 30, 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 September 30, 2003 September 30, 2002 ---------------------------- ------------------------ Net income per Statements of Operations $ 344 $1,903 Add: after-tax interest expense on convertible note -- 35 ------ ------ Net income for diluted earnings per share calculation $ 344 $1,938 7 (in thousands) Nine Months Ended Nine Months Ended September 30, 2003 September 30, 2002 ---------------------------- ----------------------- Net income (loss) per Statements of Operations $(2,203) $3,653 The weighted average shares used in computing net income (loss) per diluted share have been calculated as follows: (in thousands) Three Months Ended Three Months Ended September 30, 2003 September 30, 2002 ---------------------------- ------------------------ Weighted average common shares Outstanding 13,013 12,777 Stock options 231 350 Convertible note -- 314 ---------------------------- ------------------------ Weighted average shares 13,244 13,441 ---------------------------- ------------------------ (in thousands) Nine Months Ended Nine Months Ended September 30, 2003 September 30, 2002 ---------------------------- ------------------------ Weighted average common shares Outstanding 12,943 12,707 Stock options -- 481 ---------------------------- ------------------------ Weighted average shares 12,943 13,188 ---------------------------- ------------------------ Options to purchase approximately 1,800,000 and 2,150,000 shares of common stock were outstanding during the three and nine months ended September 30, 2003, respectively, but were not included in the computation of earnings per diluted share because the effect would be antidilutive. Options to purchase approximately 1,338,000 and 907,000 shares of common stock were outstanding during the three and nine months ended September 30, 2002, respectively, but were not included in the computation of earnings per diluted share because 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. 8 Had the Company adopted SFAS No. 123 for expense recognition purposes, the amount of compensation expense that would have been recognized in the first nine months of 2003 and 2002 would have been approximately $3.7 million in both periods. 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 September 30, 2003 September 30, 2002 ------------------ ------------------ PRO FORMA NET INCOME (LOSS): As reported $ 344 $ 1,903 Less: pro forma adjustment for stock-based compensation, net of tax (907) (1,022) --------- --------- Pro-forma net income (loss) $ (563) $ 881 PRO-FORMA NET INCOME (LOSS) PER BASIC SHARE: As reported $ 0.03 $ 0.15 Effect of pro forma expense $ (0.07) $ (0.08) Pro-forma $ (0.04) $ 0.07 PRO-FORMA NET INCOME (LOSS) PER DILUTED SHARE: As reported $ 0.03 $ 0.14 Effect of pro forma expense $ (0.07) $ (0.07) Pro-forma $ (0.04) $ 0.07 (in thousands, except per share data) Nine Months Ended Nine Months Ended September 30, 2003 September 30, 2002 ------------------ ------------------ PRO FORMA NET INCOME (LOSS): As reported $ (2,203) $ 3,653 Less: pro forma adjustment for stock-based compensation, net of tax (2,909) (2,953) --------- --------- Pro-forma net income (loss) $ (5,112) $ 700 PRO-FORMA NET INCOME (LOSS) PER BASIC SHARE: As reported $ (0.17) $ 0.29 Effect of pro-forma expense $ (0.23) $ (0.24) Pro-forma $ (0.40) $ 0.05 PRO-FORMA NET INCOME (LOSS) PER DILUTED SHARE: As reported $ (0.17) $ 0.28 Effect of pro-forma expense $ (0.23) $ (0.22) Pro-forma $ (0.40) $ 0.06 9 New Accounting Pronouncements - ----------------------------- In May 2003, the FASB issued SFAS No. 150, "Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity". This statement establishes standards for how an issuer classifies and measures certain types of financial instruments that have characteristics of both liabilities and equity. It requires that an issuer classify a financial instrument that is within its scope as a liability (or an asset in some circumstances). Many of those instruments were previously classified as equity. SFAS No. 150 is effective for financial instruments entered into or modified after May 31, 2003 and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003. The company adopted the standard on July 1, 2003. The adoption of SFAS No. 150 had no material effect on the Company's consolidated financial position or results of operations. 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 adoption of this statement did not have a material impact on the Company's consolidated financial statements. 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 adoption of this statement did not have a material impact on the Company's consolidated financial statements. 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." 10 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 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: 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 the Company's 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. In June of 2003, the Company and the shareholders of CPR entered into Note Prepayment Agreements. See Note 5, Debt for further discussion regarding these agreements. 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 acquisition occurred at the beginning of 2002: (in thousands, except per share data) Nine Months Ended September 30, 2002 ------------------------- Net service revenues $129,382 Net income $3,791 Net income per diluted share $0.29 Weighted average shares 13,252 11 The pro forma financial information is not necessarily indicative of the operating results that would have occurred had the acquisition been consummated as of January 1, 2002, nor are they necessarily indicative of future operating results. 3. OFFICE CONSOLIDATION AND EMPLOYEE SEVERANCE: 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. Approximately $845,000 was paid during the third quarter and at September 30, 2003 approximately $52,000 remains accrued and is reflected in Other Accrued Liabilities on the Company's Condensed Consolidated Balance Sheet. The remaining $52,000 is expected to be paid out in the fourth quarter of 2003. 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. In order to bring its cost structure more in line with the then current revenue projections, in the first quarter of 2003, the Company recorded a pre-tax charge of approximately $690,000 for severance and outplacement benefits relating to a workforce reduction program which impacted approximately 17 employees. In the second quarter of 2003, the Company recorded an adjustment to reduce this charge by $106,000 as a result of lower than expected severance costs related to the workforce reduction. Approximately $57,000 was paid during the third quarter of 2003 pertaining to this workforce reduction, and at September 30, 2003 approximately $28,000 remains accrued and is reflected in Other Accrued Liabilities on the Company's Condensed Consolidated Balance Sheet. The remaining $28,000 will be paid in the fourth quarter of 2003. 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. In the first quarter of 2003, the Company incurred an additional $52,000 in costs relating to the office consolidation. As of September 30, 2003, $31,000 remains accrued and is reflected in Other Accrued Liabilities in the Company's Condensed Consolidated Balance Sheet. The amounts accrued for the workforce reduction and office consolidation costs are detailed as follows: Employee Facilities Other Total Severance --------- ---------- ----- ----- Liability at December 31, 2002 $ 73 $ 44 $ 40 $ 157 Amounts accrued 1,639 -- -- 1,639 Amounts paid (1,490) (25) -- (1,515) Non-Cash charge -- (4) -- (4) Adjustment to liability (142) (4) (20) (166) Liability at September 30, 2003 $ 80 $ 11 $ 20 $ 111 12 4. GOODWILL AND OTHER INTANGIBLE ASSETS: Identifiable intangible assets as of December 31, 2002 and September 30, 2003 are composed of: (in thousands) Goodwill Indefinite-lived Intangible Asset ---------- ---------------- Balance at 12/31/02 $ 22,033 $ 15,000 Less: Tax benefit to reduce goodwill (291) -- Add: Exchange rate fluctuations 1,052 -- Balance at 9/30/03 $ 22,794 $ 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. 13 - 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 domestic cash and cash equivalents above the amounts pledged as security under the term loan. - The Company must maintain a ratio of cash, cash equivalents and available-for-sale securities held in the United States to principal amounts outstanding under the Company's term loan of at least 1.1 to 1.0. In the third quarter of 2003 the Company reached an agreement in principle with the banks to amend the Fixed Charge Coverage ratio from a rolling four quarters calculation to a calculation based on the results of each individual quarter. The company expects to sign the amendment with the banks in the 4th quarter. 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, 2003, no amounts were outstanding under the Company's revolving credit loan, $10.5 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 6.57%. 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 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 2.25%). 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 Condensed Consolidated Balance Sheet. At September 30, 2003, approximately $458,000 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 $6.0 million 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. 14 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 are to be initiated either by the Company through the exercise of a "call" option or the CPR shareholders through the exercise of a "put" option. If the four put or call options are exercised, the Company would pay $4.5 million to fully settle the $6.0 million note. Gains resulting from this early extinguishment of debt will be recorded when paid as a gain in the Company's Consolidated Statements of Operations. At June 30, 2003 the CPR shareholders exercised their put option and the Company paid $1.4 million to settle $2.0 million of the $6.0 million convertible note. A gain of approximately $558,000 has been recorded in the second quarter of 2003 in the Company's Condensed Consolidated Statements of Operations. 6. SUBSEQUENT EVENT: On October 1, 2003, the Company completed its acquisition of Mexican CRO Estadisticos y Clinicos Asociados, S.A. (ECA). ECA is a Phase I-IV contract research organization located in Mexico City, Mexico. With the acquisition, the Company has expanded its capability to conduct clinical trials in Latin America. The Company acquired substantially all the assets and assumed certain liabilities of ECA for a purchase price of approximately $3.2 million in cash plus acquisition costs. The Company is in the process of finalizing the purchase price allocation. 15 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 and nine months ended September 30, 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 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 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. 16 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 SEPTEMBER 30, 2003 COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 2002 Net Service Revenues -------------------- Net service revenues decreased approximately $542,000, or 1%, to $40.4 million in the third quarter of 2003 from $41.0 million in the third quarter of 2002. Foreign currency exchange rate fluctuations accounted for a 5% increase in net service revenues in the third quarter of 2003 compared to 2002. Net service revenues in North America declined by approximately $4.7 million, or 15.6%, from the third quarter of 2002 to the corresponding period in 2003 due to an overall slowdown in new business in North America and in particular, a slowdown in new business from two of the Company's largest customers which recently merged. The decline in North American net service revenues was offset somewhat by an increase in net service revenues in both the European and Asia-Pacific regions, which increased $3.6 million or 35.9% and $603,000 or 71.2%, respectively, from the same period of the prior year. In addition, in the third quarter of 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 $600,000. Approximately 37% of the Company's net service revenues were derived from operations outside of North America in the third quarter of 2003 compared to 26% in the corresponding period in 2002. The top five customers based on net service revenues contributed approximately 52% of net service revenues during the third quarter of 2003 compared to approximately 50% of net service revenues during the third quarter of 2002. Net service revenues from Pfizer Inc. (including the former Pharmacia Inc.) accounted for approximately 29% of total third quarter 2003 net service revenues compared to approximately 32% of total third quarter 2002 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 year 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 11% to $12.7 million in the third quarter of 2003 from $11.5 million in the corresponding period of 2002. 17 Operating Expenses ------------------ Direct costs decreased approximately $1.5 million, or 6%, from $23.9 million in the third quarter 2002 to $22.4 million in the third quarter 2003. Direct costs expressed as a percentage of net service revenues were 55.4% for the three months ended September 30, 2003 compared to 58.3% for the three months ended September 30, 2002. The improvement in direct costs is due to the lower use of outside contractors working on Company contracts as well as the workforce realignment and other cost containment measures implemented in the third quarter of 2003. In addition, the decrease in direct costs is a result of lower investigator and out-of-pocket costs of approximately $600,000 on contracts where these costs are fixed by the contract terms. Reimbursable out-of-pocket costs increased 11% to $12.7 million in the third quarter of 2003 from $11.5 million in the corresponding period of 2002. Selling, general and administrative expenses increased $2.5 million, or 22%, from $11.3 million in the third quarter of 2002 to $13.8 million in the same quarter of 2003. Foreign currency exchange rate fluctuations accounted for a 3% increase in selling, general and administrative expenses in the third quarter of 2003 compared to the comparable period of 2002. The remaining increase is primarily due to broad-based employee incentive compensation amounts accrued in the third quarter of 2003. Selling, general and administrative expenses expressed as a percentage of net service revenues were 34.2% for the three months ended September 30, 2003 compared to 27.6% for the corresponding 2002 period. The increase in SG&A costs as a percentage of net service revenues is due to the increase in SG&A due to the incentive compensation accrual. Depreciation and amortization expense increased by $103,000 or, 4.8%, in the third quarter of 2003 compared to the third quarter of 2002. The increase is primarily due to increased depreciation and amortization relating to the Company's capital expenditures. In the third quarter of 2003, the Company recorded a charge of approximately $897,000 for severance and outplacement costs in connection with a workforce realignment plan implemented in August. Approximately $845,000 was paid during the quarter in connection with this realignment plan. As of September 30, 2003, approximately $52,000 remains accrued and is expected to be paid in the fourth quarter of 2003. In the third quarter of 2002, the Company recorded a charge of approximately $321,000 for costs associated with consolidating its three New Jersey offices into one central location. Other Income (Expense) ---------------------- Other Income (Expense) was an expense of approximately $346,000 in the third quarter of 2003 compared to an expense of approximately $60,000 in the third quarter of 2002. The decrease in Other Income is primarily due to foreign exchange losses of approximately $116,000 in the third quarter of 2003 compared to exchange rate gains of approximately $77,000 in the corresponding period of 2002 as well as lower interest income in the third quarter of 2003 due to lower worldwide interest rates on investments. Income Taxes ------------ The Company reported tax expense at an effective rate of 50.9% in the quarter ended September 30, 2003, compared to tax expense at an effective rate of 41.0% in the quarter ended 18 September 30, 2002. In the fourth quarter of 2002, the Company recorded 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 quarter to quarter based on the locations that generate the pre-tax earnings or losses. Net Income ---------- Including the effects of the severance and outplacement costs (items totaling an after-tax expense of $547,000, or $0.04 per diluted share) the net income for the quarter ended September 30, 2003, was approximately $344,000, or $0.03 per diluted share. Including the effect of the office consolidation costs (an after-tax expense of $193,000, or $0.02 per diluted share) the net income for the third quarter of 2002 was approximately $1,903,000 or $0.14 per diluted share. NINE MONTHS ENDED SEPTEMBER 30, 2003 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30, 2002 Net Service Revenues -------------------- Net service revenues decreased by approximately $12.5 million or, 10%, to $116.1 million in the first nine months of 2003 from $128.6 million in the first nine months of 2002. Foreign currency exchange rate fluctuations accounted for a 4% increase in net service revenues in the first nine months of 2003 compared to the comparable period of 2002. Net service revenues in North America for the nine months ended September 30, 2003 declined by approximately $17.1 million or 18.1% from the same period of the prior year. This decline has been offset somewhat by increases in net service revenues in both the European and Asia/Pacific regions, which increased by approximately $3.4 million or 10.7% and $1.3 million or 52%, respectively. The decline in North American net service revenues is due to an overall slowdown in new business in North America and in particular, a slowdown in new business from two of the Company's largest customers which recently merged. Additionally, contract delays and cancellations adversely affected net service revenues in the first nine months of 2003, primarily in the first half of 2003 and to a lesser extent the last three months, compared to the corresponding period in 2002. Finally, 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 $3.3 million. Approximately 33% of the Company's net service revenues were derived from operations outside of North America in the first nine months of 2003 compared to 27% in the corresponding period in 2002. The top five customers based on net service revenues contributed approximately 49% of net service revenues during the first nine months of 2003 compared to 46% of net service revenues during the first nine months of 2002. Net service revenues from Pfizer Inc. (including the former Pharmacia Inc.) accounted for approximately 29% of total net service revenues for both the nine months ended September 30, 2003 and 2002. 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 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 19 increased 7.4% to $38.6 million in the nine months ended September 30, 2003 from $36.0 million in the corresponding period of 2002. Operating Expenses ------------------ Direct costs decreased by approximately $7.9 million, or 10%, from $76.4 million in the first nine months of 2002 to $68.6 million in the first nine months of 2003. The change in direct costs is the result of an 11% decrease in organic direct costs. Acquisitions did not have a material impact on direct costs in the period. Foreign currency exchange rate fluctuations accounted for a 5% increase in direct costs in the first nine months of 2003 compared to the comparable period of 2002. The decline in direct costs is due to the lower use of outside contractors working on Company contracts as well as the workforce realignment and other cost containment measures implemented in 2003. In addition, the decrease in organic direct costs is a result of lower investigator and out-of-pocket costs of approximately $3.3 million on contracts where these costs are fixed by the contract terms. Direct costs expressed as a percentage of net service revenues were 59.1% for the nine months ended September 30, 2003 compared to 59.4% for the nine months ended September 30, 2002. Reimbursable out-of-pocket costs increased 7.4% to $38.6 million in the first nine months of 2003 from $36.0 million in the corresponding period of 2002. Selling, general and administrative expenses increased by approximately $3.3 million, or 9.1%, from $36.0 million in the first nine months of 2002 to $39.3 million in the first nine months of 2003. The change in selling, general and administrative expenses is principally the result of a 9% increase in organic SG&A costs. Acquisitions did not have a material impact on SG&A costs in the period. Foreign currency exchange rate fluctuations accounted for a 4% increase in selling, general and administrative expenses in the first nine months of 2003 compared to the comparable period of 2002. The remaining increase is due primarily to broad-based employee incentive compensation amounts accrued in the third quarter of 2003. Selling, general and administrative expenses expressed as a percentage of net service revenues were 33.9% for the nine months ended September 30, 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 increase in SG&A expense as discussed above and a smaller net service revenue base. Depreciation and amortization expense increased by approximately $460,000 or 7% in the nine months ending September 30, 2003 compared to the corresponding period 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 the then 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. In the second quarter of 2003, the Company recorded an adjustment to reduce this charge by approximately $106,000 as a result of lower than expected severance costs related to the workforce reduction. In the third quarter of 2003, the Company recorded a charge of approximately $897,000 for severance and outplacement costs in connection with a workforce realignment plan implemented in August. In the third quarter of 2002, the Company recorded a charge of approximately $321,000 for costs associated with consolidating its three New Jersey offices into one central location. 20 Other Income (Expense) ---------------------- Other Income (Expense) was an expense of approximately $966,000 in the first nine months of 2003 compared to an expense of approximately $2.2 million in the first nine months of 2002. In the second quarter of 2003, the Company made a partial early repayment on its $6 million convertible note and recorded a gain from this early partial debt extinguishment of approximately $558,000. Additionally, during the quarter, the Company determined that its investment in KendleWits, its 50 percent-owned joint venture in the People's Republic of China, was permanently impaired and accordingly recorded a $405,000 non-cash impairment charge to reduce the carrying value of this investment to zero. In addition, in the first nine months of 2003 the Company incurred foreign currency transaction losses of approximately $415,000 primarily as a result of the British pound and United States dollar weakening against the euro. In the second quarter of 2002, the Company recorded a $1.9 million non-cash charge to write-off its investment in Digineer, Inc., a healthcare consulting and software development company that during the quarter adopted a plan to cease operations. In the first nine months of 2002, the Company incurred foreign currency transaction gains of approximately $174,000. Income Taxes ------------ The Company reported tax expense at an effective rate of 147.8% in the nine months ended September 30, 2003, compared to tax expense at an effective rate of 50.7% in the nine months ended September 30, 2002. In the fourth quarter of 2002, the Company recorded 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 quarter to quarter based on the locations that generate the pre-tax earnings or losses. The write-off of the Digineer investment in 2002 is a capital loss for income tax purposes and is deductible only to the extent the Company generates capital gains in the future to offset this loss. The Company recorded a valuation allowance against the deferred tax asset relating to the Digineer loss and no income tax benefit was recorded. Net Income (Loss) ----------------- Including the effect of the severance charges and office consolidation costs, the write-off of the investment in KendleWits and the gain from debt extinguishment (items with an aggregate after-tax effect of approximately $1.1 million or $0.08 per share), the net loss for the nine months in 2003 was $2.2 million, or $0.17 per basic and diluted share compared with net income of $3.7 million, or $0.28 per diluted share including the write-off of the Digineer investment and office consolidation costs (items with an aggregate after-tax effect 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 increased by $2.7 million for the nine months ended September 30, 2003, primarily as a result of cash provided by operating and investing activities of $4.2 million and $2.3 million, respectively, offset by cash used in financing activities of $4.2 million. Net cash provided by operating activities primarily resulted from the net loss adjusted for non-cash expenses and a decrease in accounts receivable offset partially by a decrease in advance billings. In the first nine months of 2002, net cash provided by operating activities was $17.1 million, primarily resulting from net income adjusted for non-cash activity and a decrease in accounts receivable ($9.9 million). 21 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 $27.0 million at September 30, 2003, and $24.7 million at December 31, 2002. Financing activities for the nine months ended September 30, 2003, consisted primarily of scheduled repayments relating to the Company's Facility (defined below) amounting to $2.3 million and a partial early repayment of the Company's convertible debt (see below) of $1.4 million. Investing activities for the nine months ended September 30, 2003, consisted primarily of net proceeds from the sale and maturity of available for sale securities of $6.9 million offset by capital expenditures of approximately $4.5 million. The Company had available for sale securities totaling $10.4 million at September 30, 2003, down from $17.3 million at December 31, 2002. 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, changes as part of the amendment include but are not limited to the following: - 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 22 remaining domestic cash and cash equivalents above the amounts pledged as security under the term loan. - The Company must maintain a ratio of cash, cash equivalents and available-for-sale securities held in the United States to principal amounts outstanding under the Company's term loan of at least 1.1 to 1.0. In the third quarter of 2003 the Company reached an agreement in principle with the banks to amend the Fixed Charge Coverage ratio from a rolling four quarters calculation to a calculation based on the results of each individual quarter. The company expects to sign the amendment with the banks in the 4th quarter. 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, 2003, no amounts were outstanding under the Company's revolving credit loan, $10.5 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 6.57%. 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 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 2.25%). 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 Condensed Consolidated Balance Sheet. At September 30, 2003, approximately $458,000 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 $6.0 million 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. 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 are to be initiated either by the Company through the exercise of a "call" option or by the CPR shareholders through the exercise of a "put" option. If the four put or call options are exercised, the Company would pay $4.5 million to fully settle the $6.0 million note. Gains resulting from this early 23 extinguishment of debt will be recorded when paid as a gain in the Company's Condensed Consolidated Statements of Operations. At June 30, 2003, the CPR shareholders exercised their put option and the Company paid approximately $1.4 million to settle $2.0 million of the $6.0 million convertible note. A gain of $558,000 has been recorded in the second quarter of 2003 in the Company's Condensed Consolidated Statements of Operations. 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, subject to the terms and conditions under its existing credit facilities, 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 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 29% of the Company's net service revenues for both the three and nine months ended September 30, 2003 and approximately 36% of the Company's September 30, 2003, backlog. During the second quarter of 2003, the Company identified a change, coinciding with the completion of the announced merger, in the levels of business received from the combined Pfizer company. Although the level of new business awards from Pfizer increased in the third quarter of 2003 compared to the second quarter of 2003, the level of awards received has not reached pre-merger levels. The Company believes that the level of business from Pfizer will continue to increase in the fourth quarter, but there is no assurance that the level of business received will meet or exceed the business amounts the Company received from Pharmacia Inc. and Pfizer Inc. in periods prior to the merger. If the level of business does not return to levels experienced prior to the merger, failure to replace this business would have a negative impact on the Company's results of operations and financial position in future quarters. On October 1, 2003, the Company completed its acquisition of Mexican CRO Estadisticos y Clinicos Asociados, S.A. (ECA). ECA is a Phase I-IV contract research organization located in Mexico City, Mexico. With the acquisition, the Company has expanded its capability to conduct clinical trials in Latin America. The Company acquired substantially all the assets and assumed certain liabilities of ECA for a purchase price of approximately $3.2 million in cash plus acquisition costs. The Company is in the process of finalizing the purchase price allocation. 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 24 fair value in the financial statements. These securities are exposed to market price risk, which also takes into account interest rate risk. At September 30, 2003, the potential loss in fair value resulting from a hypothetical decrease of 10% in quoted market price would be approximately $1.0 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 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 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 $120,000 at September 30, 2003, compared to $(1.5 million) at December 31, 2002. 25 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 for 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 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 26 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. In the second quarter of 2003, the Company determined that its investment in KendleWits was impaired and as a result recorded a $405,000 non-cash charge to reduce the carrying value of this investment to zero. 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. 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 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 judgment 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 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 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 May 2003, the FASB issued SFAS No. 150, "Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity". This statement establishes standards for how an issuer classifies and measures certain types of financial instruments that have characteristics of both liabilities and equity. It requires that an issuer classify a financial 27 instrument that is within its scope as a liability (or an asset in some circumstances). Many of those instruments were previously classified as equity. SFAS No. 150 is effective for financial instruments entered into or modified after May 31, 2003 and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003. The company adopted the standard on July 1, 2003. The adoption of SFAS No. 150 had no material effect on the Company's consolidated financial position or results of operations. 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 adoption of this statement did not have a material impact on the Company's consolidated financial statements. 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 adoption of this statement did not have a material impact on the Company's consolidated financial statements. 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 Accounting Principles Board Opinion 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 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 28 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, 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. 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. 29 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. 30 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 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 (b) Reports filed on Form 8-K during the quarter: On August 5, 2003 the Company filed a Form 8-K to disclose the non-GAAP financial measures included in its press release announcing its second quarter results of operations and financial condition and the reasons for including the non-GAAP financial measures. 31 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: November 14, 2003 Candace Kendle Chairman of the Board and Chief Executive Officer By: /s/ Karl Brenkert III ------------------------------- Date: November 14, 2003 Karl Brenkert III Senior Vice President - Chief Financial Officer 32 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 33