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, 2001 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 the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date: 12,373,082 shares of Common Stock, no par value, as of October 31, 2001. 1 KENDLE INTERNATIONAL INC. INDEX Page ---- Part I. Financial Information Item 1. Financial Statements (Unaudited) Condensed Consolidated Balance Sheets - September 30, 2001 and December 31, 2000 3 Condensed Consolidated Statements of Operations - Three Months Ended September 30, 2001 and 2000; Nine Months Ended September 30, 2001 and 2000 4 Condensed Consolidated Statements of Comprehensive Income (Loss) - Three Months Ended September 30, 2001 and 2000; Nine Months Ended September 30, 2001 and 2000 5 Condensed Consolidated Statements of Cash Flows - Nine Months Ended September 30, 2001 and 2000 6 Notes to Condensed Consolidated Financial Statements 7 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 12 Item 3. Quantitative and Qualitative Disclosure About Market Risk 19 Part II. Other Information 20 Item 2. Changes in Securities and Use of Proceeds 20 Item 4. Submission of Matters to a Vote of Security Holders 20 Item 6. Exhibits and Reports on Form 8-K 20 Signatures 21 Exhibit Index 22 2 KENDLE INTERNATIONAL INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) September 30, December 31, 2001 2000 --------- --------- (unaudited) (note 1) ASSETS Current assets: Cash and cash equivalents $ 5,726 $ 6,709 Available for sale securities 18,607 17,851 Accounts receivable 49,608 40,817 Unreimbursed investigator and project costs 5,797 5,426 Other current assets 5,237 7,052 --------- --------- Total current assets 84,975 77,855 --------- --------- Property and equipment, net 15,842 15,103 Goodwill, net 84,092 73,077 Other assets 11,116 10,484 --------- --------- Total assets $ 196,025 $ 176,519 ========= ========= LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Current portion of obligations under capital leases $ 555 $ 674 Amounts outstanding under credit facilities 16,079 1,600 Trade payables 4,759 5,268 Advances against investigator and project costs 2,490 1,736 Advance billings 13,679 16,342 Other accrued liabilities 11,286 12,839 --------- --------- Total current liabilities 48,848 38,459 --------- --------- Obligations under capital leases, less current portion 909 472 Other noncurrent liabilities 5,870 4,718 --------- --------- Total liabilities 55,627 43,649 --------- --------- Commitments and contingencies Shareholders' equity: Preferred stock -- no par value; 100,000 shares authorized; no shares issued and outstanding Common stock -- no par value; 45,000,000 shares authorized; 12,379,822 and 11,763,307 shares issued and 12,362,542 and 11,763,307 outstanding at September 30, 2001 and December 31, 2000, respectively 75 75 Additional paid in capital 128,686 122,725 Retained earnings 15,429 13,116 Accumulated other comprehensive income: Net unrealized holding gains (losses) on available for sale securities 42 (117) Foreign currency translation adjustment (3,484) (2,929) --------- --------- Total accumulated other comprehensive loss (3,442) (3,046) Less: Cost of common stock held in treasury, 17,280 and 0 shares at September 30, 2001 and December 31, 2000, respectively (350) -- --------- --------- Total shareholders' equity 140,398 132,870 --------- --------- Total liabilities and shareholders' equity $ 196,025 $ 176,519 ========= ========= 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, ------------------------ ------------------------ 2001 2000 2001 2000 --------- --------- --------- --------- Net revenues $ 39,439 $ 27,153 $ 110,353 $ 91,453 --------- --------- --------- --------- Costs and expenses: Direct costs 23,641 16,851 67,284 55,540 Selling, general and administrative expenses 11,350 9,536 32,008 30,378 Depreciation and amortization 2,535 2,158 7,335 5,749 Employee severance and other costs -- -- -- 2,980 --------- --------- --------- --------- 37,526 28,545 106,627 94,647 --------- --------- --------- --------- Income (loss) from operations 1,913 (1,392) 3,726 (3,194) Other income (expense): Interest income 217 275 721 748 Interest expense (238) (179) (617) (476) Other 215 (88) 253 (14) --------- --------- --------- --------- Income (loss) before income taxes 2,107 (1,384) 4,083 (2,936) Income tax expense (benefit) 934 (540) 1,770 (1,172) --------- --------- --------- --------- Net income (loss) $ 1,173 $ (844) $ 2,313 $ (1,764) ========= ========= ========= ========= Income (loss) per share data: Basic: Net income (loss) per share $ 0.09 $ (0.07) $ 0.19 $ (0.15) ========= ========= ========= ========= Weighted average shares 12,350 11,751 12,210 11,691 Diluted: Net income (loss) per share $ 0.09 $ (0.07) $ 0.18 $ (0.15) ========= ========= ========= ========= Weighted average shares 13,044 11,751 12,803 11,691 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, --------------------------- --------------------------- 2001 2000 2001 2000 ------- ------- ------- ------- Net income (loss) $ 1,173 $ (844) $ 2,313 $(1,764) ------- ------- ------- ------- Other comprehensive income: Foreign currency translation adjustment 943 (1,147) (555) (2,081) Net unrealized holding gains on available for sale securities arising during the period, net of tax 34 84 154 121 Reclassification adjustment for holding (gains) losses included in net income, net of tax (21) 33 5 33 ------- ------- ------- ------- Net change in unrealized holding gains on available for sale securities 13 117 159 154 ------- ------- ------- ------- Comprehensive income (loss) $ 2,129 $(1,874) $ 1,917 $(3,691) ======= ======= ======= ======= 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, ---------------------- 2001 2000 -------- -------- Net cash provided by operating activities $ 3,670 $ 15,188 -------- -------- Cash flows from investing activities: Proceeds from sales and maturities of available for sale securities 34,276 2,100 Purchases of available for sale securities (34,824) -- Acquisitions of property and equipment (3,173) (3,715) Additions to software costs (2,356) (1,567) Other investments (5) (732) Acquisition of business, less cash acquired (10,789) (1,812) Contingent purchase price paid in connection with prior acquisition (2,144) (2,680) -------- -------- Net cash used in investing activities (19,015) (8,406) -------- -------- Cash flows from financing activities: Net proceeds (repayments) under credit facilities 14,450 (4,300) Net proceeds (repayments) - book overdraft 393 (1,420) Proceeds from exercise of stock options 458 20 Payments on capital lease obligations (667) (561) Other (14) -- -------- -------- Net cash provided by (used in) financing activities 14,620 (6,261) -------- -------- Effects of exchange rates on cash and cash equivalents (258) (336) Net increase (decrease) in cash and cash equivalents (983) 185 Cash and cash equivalents: Beginning of period 6,709 5,720 -------- -------- End of period $ 5,726 $ 5,905 ======== ======== SUPPLEMENTAL SCHEDULE OF NONCASH INVESTING AND FINANCING ACTIVITIES: Issuance of Common Stock in connection with contingent purchase price relating to prior acquisition $ 796 $ 1,040 ======== ======== Issuance of Common Stock in connection with Employee Stock Purchase Plan $ 388 $ 313 ======== ======== Acquisition of Businesses: Fair value of assets acquired $ 16,474 $ 3,172 Fair value of liabilities assumed (1,812) (618) Common Stock issued (3,873) (742) -------- -------- Net cash payments $ 10,789 $ 1,812 ======== ======== The accompanying notes are an integral part of these condensed consolidated financial statements. KENDLE INTERNATIONAL INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. BASIS OF PRESENTATION: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three months and nine months ended September 30, 2001 are not necessarily indicative of the results that may be expected for the year ending December 31, 2001. For further information, refer to the consolidated financial statements and notes thereto included in the Form 10-K for the year ended December 31, 2000 filed by Kendle International Inc. ("the Company") with the Securities and Exchange Commission. The condensed consolidated balance sheet at December 31, 2000 has been derived from the audited financial statements at that date but does not include all of the information and notes required by generally accepted accounting principles for complete financial statements. 2. 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 weighted average shares used in computing net income per diluted share have been calculated as follows: (in thousands) Three Months Ended Three Months Ended September 30, 2001 September 30, 2000 ------------------ ------------------- Weighted average common shares outstanding 12,350 11,751 Stock options 663 -- Contingently issuable shares 31 -- ------ ------ Weighted average shares 13,044 11,751 7 (in thousands) Nine Months Ended Nine Months Ended September 30, 2001 September 30, 2000 ---------- ------------------ Weighted average common shares outstanding 12,210 11,691 Stock options 583 Contingently issuable shares 10 -- ------ ------ Weighted average shares 12,803 11,691 Options to purchase approximately 581,000 and 712,000 shares of common stock were outstanding during the three and nine months ended September 30, 2001 respectively, but were not included in the computation of earnings per diluted share because the options' exercise price was greater than the average market price of the common shares and, therefore, the effect would be antidilutive. Options to purchase approximately 1,700,000 shares of common stock (approximately 400,000 shares of common stock equivalents) were outstanding during the three and nine months ended September 30, 2000 but were not included in the computation of earnings per diluted share because the effect would be antidilutive. 3. ACQUISITIONS: Details of the Company's acquisitions in 2000 and 2001 are listed below. The acquisitions have been accounted for using the purchase method of accounting, with goodwill as a result of the transactions being amortized over 30 years. The escrow accounts referred to have been established at acquisition date to provide indemnification of sellers' representations and warranties. Valuation of Common Stock issued in the acquisitions was based on the market price of the shares discounted for lock-up restrictions and lack of registration of the shares. The results of operations are included in the Company's results from the respective dates of acquisition. In February 2001, the Company acquired AAC Consulting Group, Inc., a full service regulatory consulting firm with offices in Rockville, Maryland. Total acquisition costs consisted of approximately $10.9 million in cash and 374,665 shares of the Company's Common Stock. Of the total shares, 124,888 shares were placed in an escrow account, 38,899 of which were released in August 2001 and the remainder to be released in February 2002. In April 2000, the Company acquired SYNERmedica Pty Ltd., a contract research organization with offices in Melbourne and Sydney, Australia. Total acquisition costs consisted of approximately $2.2 million in cash and 78,500 shares of the Company's Common Stock. The shares were placed in an escrow account, 52,595 of which were released in May 2001 and the remainder to be released in April 2002. 8 The following unaudited pro forma results of operations assume the acquisitions occurred at the beginning of 2000: (in thousands) Nine Months Ended Nine Months Ended September 30, 2001 September 30, 2000 ----------------- -------------------- Net revenues $ 112,233 $ 99,658 Net income (loss) $ 2,440 $ (1,498) Net income (loss) per diluted share $ 0.19 $ (0.12) Weighted average shares 13,164 12,108 The pro forma financial information is not necessarily indicative of the operating results that would have occurred had the acquisitions been consummated as of January 1, 2000, nor are they necessarily indicative of future operating results. 4. EMPLOYEE SEVERANCE AND OTHER COSTS: In order to bring its cost structure more in line with revenue projections, in the second quarter of 2000 the Company announced a plan to eliminate approximately 125 full-time positions globally. Through September 30, 2001, the Company has eliminated approximately 120 of these positions. In connection with the workforce reduction, the Company recorded a pre-tax charge of approximately $3.0 million ($1.8 million net of tax) in the second quarter of 2000, consisting primarily of severance, outplacement, other employee benefit costs and facility related charges. As of September 30, 2001, $1.1 million remains accrued and is reflected in Other Accrued Liabilities in the Company's Balance Sheet. The amounts accrued as employee severance and other costs are detailed as follows: (in thousands) Employee Severance and Outplacement Facilities Other Total -------------------- --------------- --------- ------------- Liability at December 31, 2000 $ 443 $ 627 $ 404 $ 1,474 Payments/Write-Offs 47 187 96 330 -------------------- -------------- --------- ------------- Liability at September 30, 2001 $ 396 $440 $ 308 $ 1,144 5. SEGMENT INFORMATION: The Company is managed through two reportable segments, namely, the contract research services group and the medical communications group. The contract research services group constitutes the Company's core business and includes clinical trial management, clinical data management, statistical analysis, medical writing, and regulatory consultation, including current Good Manufacturing Practice compliance and validation services. The medical communications group, which includes only Health Care Communications Inc. (HCC), provides organizational, meeting management and publication services to professional organizations and pharmaceutical companies. Overhead costs are included in the contract research services group and have not been allocated. 9 (in thousands) Contract Research Medical Services Communications Total --------- --------- --------- Three Months Ended September 30, 2001 Net revenues $ 37,955 $ 1,484 $ 39,439 Net income 733 440 1,173 Three Months Ended September 30, 2000 Net revenues $ 25,517 $ 1,636 $ 27,153 Net income (loss) (1,346) 502 (844) Nine Months Ended September 30, 2001 Net revenues $ 105,544 $ 4,809 $ 110,353 Net income 1,099 1,214 2,313 Nine Months Ended September 30, 2000 Net revenues $ 87,115 $ 4,338 $ 91,453 Net income (loss) (3,004) 1,240 (1,764) September 30, 2001 Identifiable Assets $ 172,025 $ 24,000 $ 196,025 6. DEBT: The Company has two Senior Credit Facilities (the Credit Facilities). The Credit Facilities are composed of a $35.0 million revolving credit loan and a $5.0 million Multicurrency Facility that is used in connection with the Company's European operations. The $35.0 million facility bears interest at a rate equal to either (a) LIBOR plus the Applicable Margin (as defined) or (b) the higher of the Bank's prime rate or the Federal Funds rate plus 0.50%, plus the Applicable Margin. The $5.0 million facility is composed of a euro overdraft facility up to the equivalent of $3.0 million and a 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). The facilities contain various restrictive financial covenants, including the maintenance of certain fixed coverage and leverage ratios as well as minimum net worth levels. At September 30, 2001, $11.2 million was outstanding under the Company's $35 million revolving credit loan and $4.9 million was outstanding under the $5.0 million Multicurrency Facility. Interest is payable on the $11.2 million outstanding at a weighted average rate of 4.8% and on the $4.9 million at a weighted average rate of 5.3%. 10 7. NEW ACCOUNTING PRONOUNCEMENTS: In July 2001, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standards ("SFAS") No. 141, "Business Combinations" that requires all business combinations initiated after June 30, 2001 to be accounted for using the purchase method. The Company has adopted SFAS No. 141 and the adoption did not have an impact on the Company's results of operations or its financial position. In July 2001, the FASB issued SFAS No. 142, "Goodwill and Other Intangible Assets" that requires that all intangible assets determined to have an indefinite useful life no longer be amortized but instead be reviewed at least annually for impairment. The Company will adopt SFAS No. 142 as of January 1, 2002, as required. The adoption of SFAS No. 142 is expected to reduce goodwill amortization expense by approximately $3.2 million annually ($2.5 million on an after-tax basis), and result in additional earnings per share of approximately $0.20. The Company is in the process of assessing the impact of any impairment under the new tests prescribed by the standard. In October 2001, the FASB issued SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets." SFAS No. 144 supercedes SFAS No. 121, "Accounting for the Impairment of Long-Lived Assets to be Disposed of" and certain provisions of APB Opinion No. 30, "Reporting the Results of Operations - Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions." The statement is effective for fiscal years beginning after December 15, 2001. The Company is in the process of assessing the provisions of this standard to determine any impact on the Company's results of operations or its financial position. 11 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, 2001 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, and regulatory consultation, including current Good Manufacturing Practice compliance and validation services, on a contract basis to the pharmaceutical and biotechnology industries. Kendle also provides organizational, meeting management and publication services to professional associations and pharmaceutical companies through its subsidiary, Health Care Communications Inc. (HCC). The Company is managed through two reportable segments, the contract research services group and the medical communications group. The medical communications group includes only HCC. The Company's contracts are generally fixed price, with some variable components, and range in duration from a few months to several years. A portion of the contract fee is typically required 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 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 incurs costs, in excess of contract amounts, in subcontracting with third-party investigators. Such costs, which are reimbursable by its customers, are generally excluded from direct costs and net revenues. In certain contracts, however, these costs are fixed by the contract terms. In these instances, the Company recognizes these costs as direct costs with corresponding net revenues. 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 Company's results are subject to volatility due to such factors as the commencement, completion, cancellation or delay of contracts; the progress of ongoing projects; cost overruns; the Company's sales cycle; or the ability to maintain large customer contracts or to enter into new contracts. In addition, the Company's aggregate backlog 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 revenues included in the backlog. 12 ACQUISITIONS In February 2001, the Company acquired AAC Consulting Group, Inc., a regulatory consulting firm based in Rockville, Maryland. Total acquisition costs consisted of approximately $10.9 million in cash and 374,665 shares of the Company's Common Stock. RESULTS OF OPERATIONS THREE MONTHS ENDED SEPTEMBER 30, 2001 COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 2000 Net revenues increased by 45% in the third quarter of 2001 compared to the third quarter of 2000. The increase in net revenues was composed of growth from acquisitions of 10% and growth in organic revenues of 35%. The growth in organic revenues is primarily attributable to the increased level of clinical development activity in 2001. Revenue in the third quarter of 2001 was negatively impacted by approximately $281,000 compared to the same period in 2000 due to the effect of foreign currency fluctuations related to the strengthening of the U.S. dollar. By geographic region, North America accounted for approximately 71% of net revenues during the quarter, Europe 27% and Asia-Pacific 2%, compared to 63%, 35%, and 2%, respectively, in the third quarter of 2000. The top five customers based on net revenues contributed approximately 47% of net revenues during the quarter. Net revenues from Pharmacia Inc. and Pfizer Inc. accounted for approximately 14% and 11%, respectively, of total third quarter 2001 net revenues. Direct costs increased by 40% from the third quarter of 2000 to the third quarter 2001. The 40% increase in direct costs is composed of a 31% increase in organic direct costs and a 9% increase in direct costs due to the impact of acquisitions. The increase in organic direct costs is primarily a result of an increase in certain project-related costs. These project-related costs are normally billed back to the customer as a "pass-through" expense and are excluded from costs and revenues. However, in a small number of the Company's contracts, these costs are fixed by the contract terms and have been recorded as direct costs and net revenues, producing a zero profit margin. Direct costs expressed as a percentage of net revenues were 59.9% for the three months ended September 30, 2001 compared to 62.1% for the three months ended September 30, 2000. The decrease in these costs as a percentage of net revenues is due to a higher level of revenue per billable employee resulting from increased utilization of billable employees. Selling, general and administrative expenses increased by 19% in the third quarter of 2001 compared to 2000. The 19% increase in selling, general and administrative expenses is composed of a 13% increase in organic SG&A costs and a 6% increase in SG&A costs due to the impact of acquisitions. The increase in organic SG&A costs is primarily due to increased employee-related costs such as accrued bonus, recruiting costs and other employee costs incurred to support the larger revenue base. Selling, general and administrative expenses expressed as a percentage of net revenues were 28.8% for the three months ended September 30, 2001 compared to 35.1% for the corresponding 2000 period. The decrease in these costs as a percentage of net revenues is primarily due to efficiencies realized from the workforce reduction program that was implemented in the second quarter of 2000. Depreciation and amortization expense increased by 17% in the third quarter of 2001 compared to the third quarter of 2000. The increase is due to increased amortization of goodwill as a result of the Company's acquisitions and increased depreciation expense as a result of the Company's capital expenditures. 13 Net income for the third quarter of 2001 was $1.2 million compared to a net loss of $844,000 for the corresponding period of 2000. The Company's effective tax rate was 44.3% for the three months ended September 30, 2001 as compared to 39.0% for the three months ended September 30, 2000. The increase in the effective tax rate is primarily due to the larger impact of non-deductible goodwill amortization in 2001 and increased investment in taxable rather than tax-exempt securities in 2001. NINE MONTHS ENDED SEPTEMBER 30, 2001 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30, 2000 Net revenues increased by 21% in the first nine months of 2001 compared to the same period of 2000. The 21% increase in net revenues was composed of organic growth of 12% and growth from acquisitions of 9%. The growth in organic revenues is primarily attributable to the increased level of clinical development activity in 2001. Revenue in the first nine months of 2001 was negatively impacted by approximately $2.4 million due to the effect of foreign currency fluctuations related to the strengthening of the U.S. dollar. By geographic region, North America accounted for approximately 69% of the Company's nine months ended September 30, 2001 net revenues, Europe 29% and Asia-Pacific 2%, compared to 63%, 36%, and 1%, respectively, in the first nine months of 2000. The top five customers based on net revenues accounted for approximately 45% of total nine month 2001 net revenues. Net revenues from Pfizer Inc. and Pharmacia Inc. accounted for approximately 12% and 11%, respectively, of total nine month 2001 net revenues. Direct costs increased by 21% for the nine months ended September 30, 2001 compared to the corresponding period in 2000. The 21% increase in direct costs is composed of a 15% increase in organic direct costs and a 6% increase in direct costs due to the impact of acquisitions. The increase in organic direct costs is primarily a result of an increase in certain project-related costs. These project-related costs are normally billed back to the customer as a "pass-through" expense and are excluded from costs and revenues. However, in a small number of the Company's contracts, these costs are fixed by the contract terms and have been recorded as direct costs and net revenues, producing a zero profit margin. Direct costs expressed as a percentage of net revenues were 61.0% for the nine months ended September 30, 2001 compared to 60.7% for the nine months ended September 30, 2000. Selling, general and administrative expenses increased by 5% in the nine months ended September 30, 2001 compared to the nine months ended September 30, 2000. The 5% increase in SG&A expenses is composed almost entirely of an increase in costs due to the impact of acquired companies. Selling, general and administrative expenses expressed as a percentage of net revenues decreased to 29% for the nine months ended September 30, 2001 from 33% for the nine months ended September 30, 2000. The decrease in these costs as a percentage of net revenues is primarily due to efficiencies realized from the workforce reduction program that was implemented in the second quarter of 2000. Depreciation and amortization expense increased by 28% in the nine months ended September 30, 2001 compared to the nine months ended September 30, 2000. The increase is due to increased amortization of goodwill as a result of the Company's acquisitions and increased depreciation expense as a result of the Company's capital expenditures. 14 Net income for the nine months ended September 30, 2001 was $2.3 million compared to a net loss for the nine months ended September 30, 2000 of $1.8 million, inclusive of the $1.8 million after tax charge relating to the workforce reduction program. Excluding the effect of this charge, net income would have been approximately $56,000 for the nine months of 2000. The Company's effective tax rate was 43.4% for the nine months ended September 30, 2001 as compared to 39.9% for the nine months ended September 30, 2000. The increase in the effective tax rate is primarily due to the larger impact of non-deductible goodwill amortization in 2001 and increased investment in taxable rather than tax-exempt securities in 2001 SEGMENT INFORMATION The Company is managed through two reportable segments, the contract research services group and the medical communications group. The medical communications group includes only HCC. Overhead costs are included in the contract research services group and have not been allocated. Net revenues from the contract research services group increased to $37.9 million for the third quarter of 2001 from $25.6 million for the third quarter of 2000. Net income from the contract research services group was $0.7 million for the third quarter of 2001 compared to a net loss of $1.3 million for the third quarter of 2000. Net revenues from the medical communications group decreased to $1.5 million for the third quarter of 2001 compared to $1.6 million for the third quarter of 2000. Net income from the medical communications group decreased to $0.4 million in the quarter ended September 30, 2001 compared to $0.5 million for the corresponding period of 2000. Net revenues and profitability vary according to the mix of contracts and the timing of work completed in the medical communications group. Net revenues from the contract research services group increased to $105.6 million for the nine months ended September 30, 2001 compared to $87.2 million for the nine months ended September 30, 2000. Net income from the contract research services group was $1.1 million for the nine months ended September 30, 2001 compared to a net loss of $3.0 million for the nine months ended September 30, 2000. Net revenues from the medical communications group increased to $4.8 million for the nine months ended September 30, 2001 compared to $4.3 million for the corresponding period in 2000. Net income from the medical communications group was $1.2 million for each period. LIQUIDITY AND CAPITAL RESOURCES Cash and cash equivalents decreased by $1.0 million for the nine months ended September 30, 2001 primarily as a result of cash provided by operating and financing activities of $3.7 million and $14.6 million, respectively, offset by cash used in investing activities of $19.0 million. Net cash provided by operating activities primarily resulted from net income 15 adjusted for non-cash activity offset by an increase in accounts receivable and a decrease in advance billings. 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. Investing activities for the nine months ended September 30, 2001 consisted primarily of costs incurred related to the Company's acquisition of $10.8 million, net of cash acquired, capital expenditures of approximately $5.5 million, and cash paid for contingent purchase price of $2.1 million. Financing activities for the nine months ended September 30, 2001 consisted primarily of net borrowings of $14.5 million under the Company's credit facilities. The Company had available for sale securities totaling $18.6 million at September 30, 2001. The Company has two Senior Credit Facilities (the Credit Facilities). The Credit Facilities are composed of a $35.0 million revolving credit loan that expires in October 2003 and a $5.0 million Multicurrency Facility that is renewable annually that is used in connection with the Company's European operations. The $35.0 million facility bears interest at a rate equal to either (a) LIBOR plus the Applicable Margin (as defined) or (b) the higher of the Bank's prime rate or the Federal Funds rate plus 0.50%, plus the Applicable Margin. The $5.0 million facility is composed of a euro overdraft facility up to the equivalent of $3.0 million and a 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). The facilities contain various restrictive financial covenants, including the maintenance of certain fixed coverage and leverage ratios as well as minimum net worth levels. At September 30, 2001, $11.2 million was outstanding under the Company's $35 million revolving credit loan and $4.9 million was outstanding under the $5 million Multicurrency Facility. Interest is payable on the $11.2 million outstanding at a weighted average rate of 4.8% and on the $4.9 million at a weighted average rate of 5.3%. 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 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. 16 MARKET RISK Interest Rates The Company is exposed to changes in interest rates on its available for sale securities and amounts outstanding under its Credit Facilities. Available-for-sale securities are recorded at fair value in the financial statements. These securities are exposed to market price risk, which also takes into account interest rate risk. At September 30, 2001, the potential loss in fair value resulting from a hypothetical decrease of 10% in quoted market price would be approximately $1.9 million. The Company is also exposed to interest rate changes on its variable rate borrowings. Based on the Company's September 30, 2001 amounts outstanding under Credit Facilities, a one percent change in the weighted average interest rate would change the Company's annual interest expense by approximately $160,000. 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 since 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's foreign subsidiaries. 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 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 subsidiary's local currency, the Company recognizes a receivable at the time of invoicing at the local currency equivalent of the foreign currency invoice amount. Changes in exchange rates from the time the invoice is prepared until the payment from the customer is received will result in the Company receiving either more or less in local currency than the local currency equivalent of the invoice amount at the time the invoice was prepared and the receivable established. This difference is recognized by the Company as a foreign currency transaction gain or loss, as applicable, and is reported in other income (expense) in the consolidated statements of income. 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 $(3.5) million at September 30, 2001 compared to $(2.9) million at December 31, 2000. 17 NEW ACCOUNTING PRONOUNCEMENTS In July 2001, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standards ("SFAS") No. 141, "Business Combinations" that requires all business combinations initiated after June 30, 2001 to be accounted for using the purchase method. The Company has adopted SFAS No. 141, and the adoption did not have an impact on the Company's results of operations or its financial position. In July 2001, the FASB issued SFAS No. 142, "Goodwill and Other Intangible Assets" that requires that all intangible assets determined to have an indefinite useful life no longer be amortized, but instead be reviewed at least annually for impairment. The Company will adopt SFAS No. 142 as of January 1, 2002, as required. The adoption of SFAS No. 142 is expected to reduce goodwill amortization expense by approximately $3.2 million annually ($2.5 million on an after-tax basis), and result in additional earnings per share of approximately $0.20. The Company is in the process of assessing the impact of any impairment under the new test prescribed by the standard. In October 2001, the FASB issued SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets." SFAS No. 144 supercedes SFAS No. 121, "Accounting for the Impairment of Long-Lived Assets to be Disposed of" and certain provisions of APB Opinion No. 30, "Reporting the Results of Operations - Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions." The statement is effective for fiscal years beginning after December 15, 2001. The Company is in the process of assessing the provisions of this standard to determine any impact on the Company's results of operations or its financial position. 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, the Company's ability to manage growth and to continue to attract and retain qualified personnel, the Company's ability to complete additional acquisitions and to integrate newly acquired businesses, the Company's ability to penetrate new markets, competition and consolidation within the industry, the ability of joint venture businesses to be integrated with the Company's operations, the fixed price nature of contracts or the loss of large contracts, cancellation or delay of contracts, the progress of ongoing projects, cost 18 overruns, the Company's sales cycle, the ability to maintain large customer contracts or to enter into new contracts, the effects of exchange rate fluctuations, and the other risk factors set forth in the Company's SEC filings, copies of which are available upon request from the Company's investor relations department. No assurance can be given that the Company will be able to realize the net revenues included in backlog and verbal awards. The Company believes that its aggregate backlog and verbal awards are not necessarily meaningful indicators of future results. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK See Management's Discussion and Analysis of Financial Conditions and Results of Operations 19 PART II. OTHER INFORMATION Item 1. Legal Proceedings - None Item 2. Changes in Securities and Use of Proceeds - Not applicable 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 -- None (a) Exhibits (b) No reports on Form 8-K were filed during the quarter. 20 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, 2001 Candace Kendle Chairman of the Board and Chief Executive Officer By: /s/ Timothy M. Mooney ------------------------------- Date: November 14, 2001 Timothy M. Mooney Executive Vice President - Chief Financial Officer 21 KENDLE INTERNATIONAL INC. EXHIBIT INDEX Exhibits Description -------- ----------- 22