KENDLE INTERNATIONAL INC
10-Q, 1998-11-16
COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH
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<PAGE>   1



                       SECURITIES AND EXCHANGE COMMISSION
                             Washington, D.C. 20549

                                    FORM 10-Q

       QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
                             EXCHANGE ACT OF 1934.

                FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 1998

                      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 700, 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: 10,951,276 shares of common
stock, no par value, as of October 31, 1998.



                                       1

<PAGE>   2



                            KENDLE INTERNATIONAL INC.

<TABLE>
<CAPTION>
                                                       INDEX


                                                                                                        Page
                                                                                                        ----
<S>                <C>                                                                                   <C>
Part I.            Financial Information


         Item 1.     Financial Statements (Unaudited)

                     Condensed Consolidated Balance Sheets - September 30, 1998
                           and December 31, 1997                                                           3

                     Condensed Consolidated Statements of Operations - Three
                           Months Ended September 30, 1998 and 1997; Nine Months
                           Ended September 30, 1998 and 1997                                               4

                     Condensed Consolidated Statements of Comprehensive
                           Income - Three Months Ended September 30, 1998 and 1997;
                           Nine Months Ended September 30, 1998 and 1997                                   5

                     Condensed Consolidated Statements of Cash Flows - Nine
                           Months Ended September 30, 1998 and 1997                                        6

                     Notes to Condensed Consolidated Financial Statements                                  7

         Item 2.     Management's Discussion and Analysis of Financial Condition
                          and Results of Operations                                                       12


Part II.           Other Information                                                                      19


         Item 6.     Exhibits and Reports on Form 8-K                                                     19


Signatures                                                                                                20

Exhibit Index                                                                                             21
</TABLE>



                                       2

<PAGE>   3




                            KENDLE INTERNATIONAL INC.
                      CONDENSED CONSOLIDATED BALANCE SHEETS

<TABLE>
<CAPTION>
                                                                                 September 30,      December 31,
                                                                                      1998              1997
                                                                                 ------------       ------------
                                                                                  (Unaudited)

                                             ASSETS
<S>                                                                              <C>                <C>
Current assets:
     Cash and cash equivalents                                                   $ 56,104,181       $ 15,766,963
     Available for sale securities                                                     50,041          8,438,650
     Accounts receivable                                                           26,587,785         15,027,791
     Unreimbursed investigator and project costs                                    5,186,448          5,174,967
     Other current assets                                                           2,879,018          1,845,297
                                                                                 ------------       ------------
          Total current assets                                                     90,807,473         46,253,668
                                                                                 ------------       ------------
Property and equipment, net                                                         9,785,780          6,194,692
Excess of purchase price over net assets acquired, net                             48,355,410         25,929,433
Other assets                                                                        2,429,026          1,246,815
                                                                                 ------------       ------------
          Total assets                                                           $151,377,689       $ 79,624,608
                                                                                 ============       ============

                                LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
     Current portion of obligations under capital leases                         $    923,625       $    627,836
     Trade payables                                                                 5,978,284          9,837,358
     Advances against investigator and project costs                                4,083,670          1,303,310
     Advance billings                                                               8,834,820          8,066,286
     Other accrued liabilities                                                      6,721,411          5,708,505
                                                                                 ------------       ------------
          Total current liabilities                                                26,541,810         25,543,295
                                                                                 ------------       ------------
Obligations under capital leases, less current portion                              1,658,652          1,617,256
Note payable -- escrow agreement                                                    1,590,000          1,470,000
Other noncurrent liabilities                                                        1,312,023            645,248
                                                                                 ------------       ------------
          Total liabilities                                                        31,102,485         29,275,799
                                                                                 ------------       ------------
Shareholders' equity:
     Preferred stock -- no par value; 100,000 shares authorized; no shares
       issued and outstanding
     Common stock -- no par value; 15,000,000 shares authorized;
       10,950,756 shares issued and outstanding at September 30, 1998,
       7,582,367 shares issued and outstanding at December 31, 1997                    75,000             75,000
     Additional paid in capital                                                   114,294,069         50,186,639
     Retained earnings                                                              5,364,427            351,970
     Accumulated other comprehensive income                                           541,708           (264,800)
                                                                                 ------------       ------------
          Total shareholders' equity                                              120,275,204         50,348,809
                                                                                 ------------       ------------
               Total liabilities and shareholders' equity                        $151,377,689       $ 79,624,608
                                                                                 ============       ============
</TABLE>



The accompanying notes are an integral part of these condensed consolidated
financial statements.



                                        3





<PAGE>   4


                            KENDLE INTERNATIONAL INC.
                CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                                   (UNAUDITED)

<TABLE>
<CAPTION>
                                                         For the Three Months Ended           For the Nine Months Ended
                                                                 September 30,                     September 30,
                                                        -----------------------------       -----------------------------
                                                           1998              1997              1998            1997
                                                           ----              ----              ----            ----

<S>                                                     <C>               <C>               <C>               <C>        
Net revenues                                            $22,869,484       $12,517,782       $65,168,642       $25,689,492
                                                        -----------       -----------       -----------       -----------

Costs and expenses:
     Direct costs                                        11,550,007         7,115,974        34,726,388        14,463,060
     Selling, general and administrative
       expenses                                           7,303,677         3,360,414        19,456,674         7,360,761
     Depreciation and amortization                        1,261,657           513,741         3,321,001           804,946
                                                        -----------       -----------       -----------       -----------
                                                         20,115,341        10,990,129        57,504,063        22,628,767
                                                        -----------       -----------       -----------       -----------
       Income from operations                             2,754,143         1,527,653         7,664,579         3,060,725

Other income (expense):
     Interest income                                        766,239            94,837         1,063,607           108,092
     Interest expense                                       (69,512)         (284,470)         (211,686)         (355,694)
     Other expense                                          (92,736)          (12,648)          (38,650)          (21,426)
                                                        -----------       -----------       -----------       -----------
Income before income taxes
     and extraordinary item                               3,358,134         1,325,372         8,477,850         2,791,697
 
Income tax expense                                        1,348,708           372,808         3,465,394           372,808
                                                        -----------       -----------       -----------       -----------
Income before extraordinary item                          2,009,426           952,564         5,012,456         2,418,889

Extraordinary loss, net of tax benefit                                     (1,139,823)                         (1,139,823)
                                                        -----------       -----------       -----------       -----------
     Net income (loss)                                  $ 2,009,426         ($187,259)      $ 5,012,456       $ 1,279,066
                                                        ===========       ===========       ===========       ===========
Pro forma income (loss) data:
     Income before extraordinary item                                        $952,564                         $ 2,418,889

     Pro forma adjustment for income taxes                                   (196,435)                           (756,626)
                                                                          -----------                         -----------
     Pro forma income before
       extraordinary item                                                     756,129                           1,662,263

     Extraordinary loss, net of tax benefit                                (1,139,823)                         (1,139,823)
                                                                          -----------                         -----------
     Pro forma net income (loss)                                            ($383,694)                           $522,440
                                                                          ===========                         ===========
Income (loss) per share data (pro forma for 1997):
Basic:
     Income per share before extraordinary
       item                                                   $0.19             $0.14             $0.55             $0.40

     Extraordinary loss per share                                               (0.21)                              (0.28)
                                                        -----------       -----------       -----------       -----------
     Net income (loss) per share                              $0.19            ($0.07)            $0.55             $0.12
                                                        ===========       ===========       ===========       ===========
     Weighted average shares outstanding                 10,750,343         5,250,963         9,187,371         4,206,362

Diluted:
     Income per share before extraordinary
       item                                                   $0.18             $0.13             $0.51             $0.34

     Extraordinary loss per share                                               (0.19)                              (0.23)
                                                        -----------       -----------       -----------       -----------
     Net income (loss) per share                              $0.18            ($0.06)            $0.51             $0.11
                                                        ===========       ===========       ===========       ===========
     Weighted average shares and potential
       shares outstanding                                11,410,455         6,038,441         9,821,955         4,880,722
</TABLE>



The accompanying notes are an integral part of these condensed consolidated 
financial statements.


                                        4


<PAGE>   5


                           KENDLE INTERNATIONAL, INC.
           CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
                                   (UNAUDITED)

<TABLE>
<CAPTION>
                                                               For the Three Months Ended        For the Nine Months Ended
                                                                         Sept. 30,                       Sept. 30,
                                                              ---------------------------       ----------------------------
                                                                  1998              1997          1998              1997
                                                              ----------        ---------       -----------       ----------

<S>                                                           <C>               <C>              <C>              <C>       
Net income (loss)                                             $2,009,426        $(187,259)       $5,012,456       $1,279,066
                                                              ----------        ---------       -----------       ----------
Other comprehensive income, net of tax:

     Foreign currency translation adjustments                    973,237            5,608           805,708            5,608

     Net unrealized holdings gains (losses)
          on available for sale securities arising
          during the period, net of tax                              174            3,953            65,273            3,953
     Reclassification adjustment for holdings
          gains included in net income, net of tax                                                  (64,473)
                                                              ----------        ---------       -----------       ----------
     Net change in unrealized holdings gains
          (losses) on available for sale securities                  174            3,953               800            3,953
                                                              ----------        ---------       -----------       ----------

Comprehensive income                                          $2,982,837        $(177,698)      $ 5,818,964       $1,288,627
                                                              ==========        =========       ===========       ==========
</TABLE>




The accompanying notes are an integral part of these condensed consolidated
financial statements.



                                        5

<PAGE>   6


                           KENDLE INTERNATIONAL INC.
                CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
                                  (UNAUDITED)

<TABLE>
<CAPTION>
                                                                                     For the Nine Months Ended
                                                                                           September 30,
                                                                                --------------------------------
                                                                                    1998                 1997
                                                                                    ----                 ----
<S>                                                                             <C>                 <C>          
Net cash used in operating activities                                           $ (3,650,597)       $   (486,590)
                                                                                ------------        ------------
Cash flows from investing activities:
     Proceeds from sale of available for sale securities                          10,337,102
     Purchase of available for sale securities                                                        (9,804,750)
     Acquisitions of property and equipment                                       (3,410,346)         (1,111,613)
     Additions to software costs                                                  (1,103,390)           (284,894)
     Other investments                                                              (250,000)
     Acquisition of business, less cash acquired                                 (12,675,466)        (22,842,235)
                                                                                ------------        ------------
Net cash used in investing activities                                             (7,102,100)        (34,043,492)
                                                                                ------------        ------------

Cash flows from financing activities:
     Borrowings under line of credit                                                                   3,100,000
     Repayments under line of credit                                                                  (3,100,000)
     Borrowings under senior credit facility                                                          10,745,439
     Repayments of senior credit facility                                                            (10,745,439)
     Proceeds from subordinated debt borrowings                                                        3,500,000
     Proceeds from issuance and conversion of stock purchase warrants                                  1,501,537
     Repayments of subordinated debt borrowings                                                       (5,000,000)
     Net proceeds from sale of common stock                                       51,474,635          45,251,554
     Proceeds from exercise of stock options                                          90,605              15,948
     Debt issue costs                                                                (54,322)           (538,698)
     Payments on capital lease obligations                                          (611,249)           (330,110)
     Distributions to shareholders                                                                    (2,557,819)
                                                                                ------------        ------------
Net cash provided by financing activities                                         50,899,669          41,842,412
                                                                                ------------        ------------

Effects of exchange rates on cash and cash equivalents                               190,246               5,608

Net increase in cash and cash equivalents                                         40,337,218           7,317,938
Cash and cash equivalents:
     Beginning of period                                                          15,766,963           2,047,476
                                                                                ------------        ------------
     End of period                                                              $ 56,104,181        $  9,365,414
                                                                                ============        ============

Supplemental schedule of noncash investing and financing activities:
- --------------------------------------------------------------------

Acquisition of equipment under capital lease obligations                                            $  1,637,056
                                                                                                    ============

Issuance of note payable under escrow agreement for acquisition of U-Gene                           $  1,530,000
                                                                                                    ============

Equipment acquired for note payable                                                                 $    739,684
                                                                                                    ============
Acquisition of Businesses (Note 4):

     Fair value of assets acquired                                              $ 30,193,345        $ 34,072,671
     Fair value of liabilities assumed                                            (4,975,689)         (8,552,180)
     Stock issued                                                                (12,542,190)         (2,678,256)
                                                                                ------------        ------------

     Net cash payments                                                          $ 12,675,466        $ 22,842,235
                                                                                ============        ============
</TABLE>



The accompanying notes are an integral part of these condensed consolidated
financial statements.


                                        6

<PAGE>   7



                            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, 1998 are not necessarily indicative of the results that may
     be expected for the year ending December 31, 1998. For further information,
     refer to the consolidated financial statements and notes thereto included
     in the Form 10-K filed by Kendle International Inc. ("the Company") on
     March 31, 1998 with the Securities and Exchange Commission.

             The balance sheet at December 31, 1997 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.

             Certain amounts reflected in the prior periods' condensed
     consolidated financial statements have been reclassified to be comparable
     with the current periods.

2.   SHAREHOLDER'S EQUITY:

             In June, 1998, the Company completed its follow-on offering of
     2,415,000 shares of common stock at a price to the public of $23.50 per
     share. Of the 2,415,000 shares sold, 2,315,000 were sold by the Company and
     100,000 shares were sold by selling shareholders. Proceeds to the Company
     approximated $51.5 million, net of underwriting commissions and discounts
     and offering expenses of $2.9 million.



                                       7
<PAGE>   8




3.   NET INCOME PER SHARE DATA:

     In accordance with Statement of Financial Accounting Standards ("SFAS") No.
128, "Earnings Per Share," net income per basic share is computed using the
weighted average common shares outstanding for all periods presented. Net income
per diluted share is computed using the weighted average common shares and
potentially dilutive common shares outstanding for all periods presented.

     The weighted average shares and potential shares outstanding used in
computing net income per diluted share have been calculated as follows:

<TABLE>
<CAPTION>
                                                     Three Months Ended     Three Months Ended
                                                     September 30, 1998     September 30, 1997
                                                     -------------------    -------------------
     <S>                                            <C>                    <C>
     Weighted average common shares
         outstanding                                     10,750,343             5,250,963
     Stock purchase warrants                                                      135,289
     Stock options                                          660,112               652,189
                                                     -------------------    -------------------

     Weighted average shares and potential
         shares outstanding                              11,410,455             6,038,441

<CAPTION>
                                                      Nine Months Ended      Nine Months Ended
                                                     September 30, 1998     September 30, 1997
                                                     -------------------    -------------------
     <S>                                            <C>                    <C>
     Weighted average common shares
         outstanding                                      9,187,371             4,206,362
     Stock purchase warrants                                                      130,677
     Stock options                                          634,584               543,683
                                                     -------------------    -------------------

     Weighted average shares and potential
         shares outstanding                               9,821,955             4,880,722
</TABLE>


4.   ACQUISITION:

             On February 12, 1998, the Company completed its acquisition of
     ACER/EXCEL Inc. ("ACER/EXCEL"), headquartered in Cranford, New Jersey.
     Total acquisition costs consisted of $14.4 million in cash and 987,574
     shares of the Company's Common Stock. The total purchase price included
     $6.0 million placed in escrow pending resolution of an issue relating to
     ACER/EXCEL's S corporation tax status. In early 1998, ACER/EXCEL determined
     that, with respect to its tax status as an S corporation, certain
     inadvertent terminating events occurred in 1991. On September 3, 1998,
     ACER/EXCEL was granted a waiver of its inadvertent termination status
     retroactive to the date of the terminating events, and $5.0 million of the
     escrow was paid to the seller, with the remaining $1.0 million being
     transferred to the general escrow as discussed below. As a result of the
     resolution of this matter, the computation of the excess of acquisition
     costs over net assets acquired was increased to include the $6.0 million as
     consideration.


                                       8
<PAGE>   9


             A general escrow, which was established at the acquisition date to
     provide indemnification of sellers' representations and warranties and
     currently consists of 186,336 shares of the Company's Common Stock, will be
     released to the selling shareholders, 50% in February, 1999 and the
     remainder in February, 2000. The value of the stock consideration was
     determined for financial reporting purposes as of December 23, 1997, the
     date the purchase price was agreed to. Valuation of the Common Stock was
     based on an appraisal obtained by the Company which discounted the shares
     due to lock-up restrictions and the lack of registration of the shares.

             The acquisition has been accounted for using the purchase method of
     accounting, with goodwill as a result of the transaction being amortized
     over 30 years. The results of operations are included in the Company's
     results from the date of acquisition.

              The following unaudited pro forma results of operations assume the
     acquisition of ACER/EXCEL occurred at the beginning of each year:

<TABLE>
<CAPTION>
                                                             Nine Months Ended          Nine Months Ended
                                                            September 30, 1998         September 30, 1997
                                                            ------------------         ------------------
     <S>                                                   <C>                        <C>        
     Net revenues                                              $66,432,265                  $35,177,922

     Income before extraordinary item                           $4,880,893                   $4,367,970

     Net income                                                 $4,880,893                   $3,228,147

     Income before extraordinary item
       (assuming the Company was taxed as a
       C corporation throughout 1997)                           $4,880,893                   $2,812,462

     Net income per diluted share                                    $0.48                        $0.55

     Income per diluted share before
       extraordinary item (assuming the
       Company was taxed as a C corporation
       throughout 1997)                                              $0.48                        $0.48

     Weighted average shares and
       potential shares outstanding                             10,139,506                    5,868,296
</TABLE>


             The pro forma financial information is not necessarily indicative
     of the operating results that would have occurred had the ACER/EXCEL
     acquisition been consummated as of January 1, 1997 and 1998, nor are they
     necessarily indicative of future operating results.



                                       9
<PAGE>   10



5.   COMPREHENSIVE INCOME:

             In 1998, the Company adopted SFAS No. 130, "Reporting Comprehensive
     Income." This statement requires display of comprehensive income in a set
     of general purpose financial statements. Comprehensive income is defined as
     changes in equity of a business enterprise during a period from
     transactions and other events from non-owner sources. In accordance with
     SFAS No. 130, the Company has displayed a statement of comprehensive income
     for all periods presented.

             Accumulated other comprehensive income was as follows:

<TABLE>
<CAPTION>
                                                         September 30, 1998        December 31, 1997
                                                         ------------------        -----------------
    <S>                                                 <C>                       <C>
     Net unrealized holdings gains (losses)
          on available for sale securities, net
          of tax                                                $     41              $    (759)
     Cumulative foreign currency translation
         adjustment                                              541,667               (264,041)
                                                         ------------------        ------------------

     Accumulated other comprehensive
         income                                                 $541,708              $(264,800)
</TABLE>


6.   INCOME TAXES:

             The condensed consolidated financial statements of the Company for
     the three and nine months ended September 30, 1997 include a provision for
     income taxes only for the period since the Company's initial public
     offering (IPO) on August 22, 1997 as the taxable income of the Company
     prior to that date was included in the income tax returns of the individual
     shareholders under the S corporation election. Pro forma income data is
     presented to give effect to a tax provision on taxable income for financial
     reporting purposes using statutory federal, state and local rates that
     would have resulted if the Company had filed corporate tax returns during
     the entire period.

7.   NEW ACCOUNTING PRONOUNCEMENTS:

             In June 1997, the Financial Accounting Standards Board ("FASB")
     issued Statement of Financial Accounting Standards ("SFAS") No. 131
     "Disclosures about Segments of an Enterprise and Related Information." This
     statement requires selected information to be reported on the Company's
     operating segments. Operating segments are determined by the way management
     structures the segments in making operating decisions and assessing
     performance. The Company is currently reviewing what changes, if any, this
     will require on the presentation of the financial statements for fiscal
     periods beginning after December 15, 1997.



                                       10
<PAGE>   11

             In March, 1998, the American Institute of Certified Public
     Accountants issued Statement of Position ("SOP") 98-1 "Accounting for the
     Costs of Computer Software Developed or Obtained for Internal Use." This
     statement defines the accounting for computer software developed or
     obtained (purchased) for internal use, including (1) a requirement to
     capitalize specified costs as a long-lived asset, (2) amortization of such
     amounts, and (3) recognition and measurement of impairment of those
     amounts. The Company plans to adopt the SOP January 1, 1999. The Company
     does not believe the adoption of this SOP will have a material impact on
     its financial statements.

             In June, 1998, the FASB issued SFAS No. 133, "Accounting for
     Derivative Instruments and Hedging Activities." SFAS No. 133 is effective
     for all fiscal quarters of all fiscal years beginning after June 15, 1999
     (January 1, 2000 for the Company). SFAS No. 133 requires that all
     derivative instruments be recorded on the balance sheet at their fair
     value. Changes in the fair value of derivatives are recorded each period in
     current earnings or other comprehensive income, depending on whether a
     derivative is designated as part of a hedge transaction and, if it is, the
     type of hedge transaction. Management of the Company anticipates that, due
     to its limited use of derivative instruments, the adoption of SFAS No. 133
     will not have a significant effect on the Company's results of operations
     or its financial position.



                                       11
<PAGE>   12





ITEM 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND 
         RESULTS OF OPERATIONS

         The information set forth and discussed below for the three and nine
months ended September 30, 1998 and 1997, is derived from the Condensed
Consolidated Financial Statements included herein 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 and drug
development services on a contract basis to the pharmaceutical and
biopharmaceutical industries. These services include Phase I through IV clinical
trial management, clinical data management, statistical analysis, medical
writing and regulatory consultation and representation.

         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. 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 excluded from direct costs and net revenues.

         Direct costs consist of compensation and related fringe benefits for
project-related employees, 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 employees, professional services and advertising costs,
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; the ability to
maintain large customer contracts or to enter into new contracts, and other
factors. In recent months, the Company's Phase I unit has experienced a decline
in revenues and a resulting loss from operations. The Phase I unit results are
due in part to the inherent volatility in Phase I revenues due to the nature of
Phase I studies (shorter duration studies with shorter lead time and higher
potential for cancellation) combined with turnover in certain management
personnel. The Company has taken steps to mitigate this volatility with the
hiring of experienced Phase I management personnel and has increased its Phase I
new business development efforts. The Company anticipates these actions will
lead to 


                                       12
<PAGE>   13

improved Phase I unit operating results beginning in late 1998 and early
1999. However, the decline in revenues and resulting loss from operations in the
Phase I unit could continue if the Company's efforts are unsuccessful.

ACQUISITIONS

         In 1997, the Company acquired U-Gene Research B.V. ("U-Gene") and GMI
Gesellschaft fur Angewandte Mathematik und Informatik mbH ("gmi") as of June 
30, 1997 and September 3, 1997, respectively.

         In 1998, the Company acquired ACER/EXCEL Inc. ("ACER/EXCEL")
headquartered in Cranford, New Jersey, as of February 12, 1998. ACER/EXCEL
provides customers with Phase II through IV clinical trial management, data
collection, statistical analysis and regulatory document preparation. It also
provides drug development services to the Pacific Rim, through a joint venture
which operates a CRO headquartered in Beijing, China, and through a limited
partnership in Taiwan.

          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 results of operations are included in the Company's condensed
consolidated statements of operations from the dates of acquisition.

RESULTS OF OPERATIONS

THREE MONTHS ENDED SEPTEMBER 30, 1998 COMPARED TO THREE MONTHS ENDED SEPTEMBER
30, 1997

         Net revenues increased by $10.4 million, or 83%, from $12.5 million for
the three months ended September 30, 1997 to $22.9 million for the three months
ended September 30, 1998. The increase in net revenues was comprised of organic
growth of 45% and growth from acquisitions of 38%. Revenues from G.D. Searle &
Co. accounted for approximately 35% of net revenues for the three months ended
September 30, 1998 and no other customer accounted for more than 10% of the
Company's net revenues for the three months ended September 30, 1998.

         Direct costs increased by $4.5 million, or 62%, from $7.1 million for
the three months ended September 30, 1997 to $11.6 million for the three months
ended September 30, 1998. This increase is primarily comprised of increases in
direct salaries and fringe benefits to support the increases in net revenues for
the period. Direct costs expressed as a percentage of net revenues decreased
from 56.8% for the three months ended September 30, 1997 to 50.5% for the three
months ended September 30, 1998. The decrease in those costs as a percentage of
net revenues is due to (a) the absorption of direct project-related costs over a
larger revenue base, (b) a refinement in the classification of indirect costs,
and (c) a favorable change in the gross profit on certain of the Company's
contracts.

         Selling, general and administrative expenses increased by $3.9 million,
or 117%, from $3.4 million for the three months ended September 30, 1997 to $7.3
million for the three months ended September 30, 1998. The increase is primarily
comprised of (a) an increase in salaries and benefits, which is the result of
the Company's continued efforts to increase its infrastructure in order to
support the growth in business activity, and (b) an increase in rent and other
facilities 


                                       13

<PAGE>   14

expenses, training, contractual services, recruiting, marketing, advertising,
and other expenses for the three months ended September 30, 1998 as compared to
the same period in 1997. Selling, general and administrative expenses as a
percentage of net revenues increased from 26.8% for the three months ended
September 30, 1997 to 31.9% for the three months ended September 30, 1998. The
increase in those costs as a percentage of net revenues is due primarily to a
refinement in the classification of indirect costs.

         Depreciation and amortization expense increased $800,000, or 145%, from
$514,000 for the three months ended September 30, 1997 to $1.3 million for the
three months ended September 30, 1998. The increase was due to capital
expenditures and amortization of goodwill as a result of the Company's
acquisitions.

         Income taxes of $1.3 million, or 40.2% of income before income taxes,
were recorded for the three months ended September 30, 1998 as compared to
$373,000 for the three months ended September 30, 1997. No income taxes were
recorded with respect to periods prior to the Company's August 22, 1997 initial
public offering ("IPO") as the Company was taxed as an S corporation.

NINE MONTHS ENDED SEPTEMBER 30, 1998 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30,
1997

         Net revenues increased by $39.5 million, or 154%, from $25.7 million
for the nine months ended September 30, 1997 to $65.2 million for the nine
months ended September 30, 1998. The increase in net revenues was comprised of
organic growth of 87% and growth from acquisitions of 67%. Revenues from G.D.
Searle & Co. accounted for approximately 39% of net revenues for the nine months
ended September 30, 1998 and no other customer accounted for more than 10% of
the Company's net revenues for the nine months ended September 30, 1998.

         Direct costs increased by $20.2 million, or 140%, from $14.5 million
for the nine months ended September 30, 1997 to $34.7 million for the nine
months ended September 30, 1998. This increase is primarily comprised of
increases in direct salaries and fringe benefits to support the increases in net
revenues for the period. Direct costs expressed as a percentage of net revenues
decreased from 56.3% for the nine months ended September 30, 1997 to 53.3% for
the nine months ended September 30, 1998. The decrease in those costs as a
percentage of net revenues is due to (a) the absorption of direct
project-related costs over a larger revenue base, (b) a refinement in the
classification of indirect costs, and (c) a favorable change in the gross profit
on certain of the Company's contracts.

         Selling, general and administrative expenses increased by $12.1
million, or 164%, from $7.4 million for the nine months ended September 30, 1997
to $19.5 million for the nine months ended September 30, 1998. The increase is
primarily comprised of (a) an increase in salaries and benefits, which is the
result of the Company's continued efforts to increase its infrastructure in
order to support the growth in business activity, and (b) an increase in rent
and other facilities expenses, training, contractual services, recruiting,
marketing, advertising, and other expenses for the nine months ended September
30, 1998 as compared to the same period in 1997. Selling, general and
administrative expenses as a percentage of net revenues increased from 28.7% for
the nine months ended September 30, 1997 to 29.9% for the nine months ended
September 30, 1998. The increase in those costs as a percentage of net revenues
is due primarily to a refinement in the classification of indirect costs.



                                       14
<PAGE>   15

         Depreciation and amortization expense increased $2.5 million, or 313%,
from $805,000 for the nine months ended September 30, 1997 to $3.3 million for
the nine months ended September 30, 1998. The increase was due to capital
expenditures and amortization of goodwill as a result of the Company's
acquisitions.

         Income taxes of $3.5 million, or 40.9% of income before income taxes,
were recorded for the nine months ended September 30, 1998 as compared to
$373,000 for the nine months ended September 30, 1997. No income taxes were
recorded with respect to periods prior to the Company's August 22, 1997 IPO as
the Company was taxed as an S corporation.

LIQUIDITY AND CAPITAL RESOURCES

         Cash and cash equivalents increased by $40.3 million for the nine
months ended September 30, 1998 as a result of cash provided by financing
activities of $50.9 million offset by cash used in operating and investing
activities of $3.7 million and $7.1 million, respectively. Net cash used in
operating activities resulted primarily from net income offset by additional
working capital used to support the Company's growth.

         Investing activities for the nine months ended September 30, 1998
consisted primarily of the costs related to the ACER/EXCEL acquisition of $12.7
million, net of cash acquired. Financing activities for the nine months ended
September 30, 1998 consisted primarily of net proceeds of $51.5 million as a
result of the Company's follow-on offering of common stock.

         Cash and cash equivalents increased by $7.3 million for the nine months
ended September 30, 1997 as a result of cash provided by financing activities of
$41.8 million offset by cash used in operating and investing activities of
$487,000 and $34.0 million, respectively. Net cash used in operating activities
resulted primarily from net income offset by additional working capital used to
support the Company's growth.

         Investing activities for the nine months ended September 30, 1997
consisted primarily of the costs related to the U-Gene and gmi acquisitions of
$22.8 million, net of cash acquired. Financing activities for the nine months
ended September 30, 1997 consisted primarily of $45.3 million of net proceeds
from the Company's IPO.

         The Company has a $30 million credit facility with certain banks. The
credit 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. All amounts
outstanding thereunder become due and payable in June, 2000. The facility
includes various restrictive covenants including the maintenance of certain
fixed coverage and leverage ratios as well as minimum net worth levels. At
September 30, 1998, there were no amounts outstanding under the credit facility.

         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 facility, will be sufficient to meet its foreseeable cash needs. In
the future, the Company will continue to consider acquiring businesses to
enhance its service 


                                       15

<PAGE>   16

offerings, therapeutic base and global presence. Any such acquisitions may
require additional external financings and the Company may from time to time
seek to obtain funds from public or private issuances of equity or debt
securities. There can be no assurance that such financings will be available on
terms acceptable to the Company.

IMPACT OF THE YEAR 2000

         The Year 2000 Issue is the result of computer programs being written
using two digits rather than four to define the applicable year. Any of the
Company's computer programs that have date-sensitive software may recognize a
date using "00" as the year 1900 rather than the year 2000. This could result in
a system failure or miscalculations causing disruptions of operations,
including, among other things, a temporary inability to process transactions,
send invoices, or engage in similar normal business activities.

         The Company has a detailed plan in place to address the Year 2000
Issue. The Company has formed an ongoing internal review team to address the 
Year 2000 Issue that encompasses personnel from various operational and 
administrative areas of the Company and an outside consultant. Progress against
the Year 2000 plan is monitored by this internal review team and reported to 
senior management and the Board of Directors on a regular basis. The project 
has proceeded according to plan thus far.

         The Company's Year 2000 plan encompasses the following: (a) inventory
and assessment, (b) remediation, and (c) validation and implementation. To date,
the Company's key financial and operational systems have been inventoried and
detailed plans are in place for the required systems modifications or
replacements. Implementation of required changes to critical business systems,
including testing of those changes, is expected to be substantially complete by
December 31, 1998. The remainder of the plan is expected to be ongoing in 1999,
with completion by September 30, 1999.

         The Company has initiated formal communications with its suppliers and
customers to determine the extent to which the Company is vulnerable to those 
third parties' failure to remediate their own Year 2000 Issue. These suppliers 
include utility companies, telecommunications companies and business specific 
product suppliers such as software and hardware providers and Phase I unit 
equipment providers. To date, responses have been received from approximately 
46% of the Company's inventory of suppliers. There can be no guarantee that the
systems of other companies on which the Company's systems rely will be 
converted in a timely matter, or that a failure to convert by another company, 
or a conversion that is incompatible with the Company's systems, would not have
a material adverse effect on the Company.

         Incremental costs, which include contractor costs to modify existing
systems and costs of internal resources involved in achieving Year 2000
compliance, are charged to expense as incurred. The Company has utilized both
internal and external resources to reprogram or replace and test the software
for Year 2000 modifications. Costs for the Year 2000 project are estimated to
total $500,000, of which approximately 50% has been spent through October 31,
1998.

         The costs of the project and the date on which the Company plans to
complete the Year 2000 modifications are based on management's best estimates,
which were derived utilizing numerous assumptions of future events including the
continued availability of certain resources, 



                                       16
<PAGE>   17

third party modification plans and other factors. However, there can be no
guarantee that these estimates will be achieved and actual results could differ
materially from those plans. Specific factors that might cause such material
differences include, but are not limited to, the availability and cost of
personnel trained in this area, the ability to locate and correct all relevant
computer codes, and the ability of third parties with whom we have business
relationships to successfully address their own Year 2000 concerns.

         The Company's risk management program includes emergency backup and
recovery procedures to be followed in the event of failure of a business
critical system. These procedures will be expanded to include specific
procedures for potential Year 2000 Issues. Contingency plans to protect the
business from Year 2000 related interruptions are being developed. These plans
will be complete by December 31, 1998 and will include, for example, development
of backup procedures and identification of alternative suppliers.

         Worst-case scenarios resulting from Year 2000 problems could include
the following: loss of electrical, water and other utility services which could
result in disruption of the Company's services, software and embedded technology
failure which could disrupt the Company's equipment, systems and networks
resulting in an inability to perform existing and future studies and/or an
adverse impact on the health and well being of patients; the loss of
telecommunications capabilities (both voice and data), which could result in an
inability of the Company to internally communicate or to communicate with, among
others, its customers and investigational sites; and the inability of the
Company's third party investigational sites to become Year 2000 compliant, which
could result in the loss to the Company of their services. As previously
discussed, the Company is currently in the process of developing contingency
plans to address the consequences of these issues, should they arise. These or 
other events could result in business slowdowns or suspensions and have a 
material adverse effect on the Company's business, financial condition, results
of operations or cash flows.

NEW ACCOUNTING PRONOUNCEMENTS

         In June 1997, the Financial Accounting Standards Board ("FASB") issued
Statement of Financial Accounting Standards ("SFAS") No. 131 "Disclosures about
Segments of an Enterprise and Related Information." This statement requires
selected information to be reported on the Company's operating segments.
Operating segments are determined by the way management structures the segments
in making operating decisions and assessing performance. The Company is
currently reviewing what changes, if any, this will require on the presentation
of the financial statements for fiscal periods beginning after December 15,
1997.

         In March, 1998, the American Institute of Certified Public Accountants
issued Statement of Position ("SOP") 98-1 "Accounting for the Costs of Computer
Software Developed or Obtained for Internal Use." This statement defines the
accounting for computer software developed or obtained (purchased) for internal
use, including (1) a requirement to capitalize specified costs as a long-lived
asset, (2) amortization of such amounts, and (3) recognition and measurement of
impairment of those amounts. The Company plans to adopt the SOP January 1, 1999.
The Company does not believe the adoption of this SOP will have a material
impact on its financial statements.

         In June, 1998, the FASB issued SFAS No. 133, "Accounting for Derivative
Instruments and Hedging Activities." SFAS No. 133 is effective for all fiscal
quarters of all fiscal years beginning after June 15, 1999 (January 1, 2000 for
the Company). SFAS No. 133 requires that 



                                       17
<PAGE>   18

all derivative instruments be recorded on the balance sheet at their fair value.
Changes in the fair value of derivatives are recorded each period in current
earnings or other comprehensive income, depending on whether a derivative is
designated as part of a hedge transaction and, if it is, the type of hedge
transaction. Management of the Company anticipates that, due to its limited use
of derivative instruments, the adoption of SFAS No. 133 will not have a
significant effect 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, the ability of the combined businesses to be integrated with the
Company's operations, the ability to penetrate new markets, the ability of joint
venture businesses to be integrated with the Company's operations, and the
ability to maintain large customer contracts or to enter into new contracts, 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.



                                       18
<PAGE>   19





PART II.          OTHER INFORMATION

Item 1.           Legal Proceedings - None

Item 2.           Changes in Securities - Not applicable

Item 3.           Defaults upon Senior Securities - Not applicable

Item 4.           Submission of Matters to a Vote of Security Holders - Not 
                  applicable

Item 5.           Other Information - Not applicable

Item 6.           Exhibits and Reports on Form 8-K

         (a) Exhibits

         Exhibits                  Description
         --------                  -----------

         27.1                      Financial Data Schedule For the Nine
                                   Months Ended September 30, 1998

         27.2                      Financial Data Schedule For the Three
                                   Months Ended September 30, 1998

         (b) No reports on Form 8-K were filed during the quarter.



                                       19
<PAGE>   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 K. BRYAN
                                        ----------------------------------------
Date:  November 16, 1998                Candace K. Bryan
                                        Chairman of the Board and Chief
                                        Executive Officer



                                    By: /s/ TIMOTHY M. MOONEY
                                        ----------------------------------------
Date:  November 16, 1998                Timothy M. Mooney
                                        Vice President - Chief Financial Officer



                                       20
<PAGE>   21



                            KENDLE INTERNATIONAL INC.

                                  EXHIBIT INDEX

         Exhibits                          Description
         --------                          -----------


         27.1                              Financial Data Schedule For the Nine
                                           Months Ended September 30, 1998

         27.2                              Financial Data Schedule For the Three
                                           Months Ended September 30, 1998



                                       21

<TABLE> <S> <C>

<ARTICLE> 5
<MULTIPLIER> 1,000
<CURRENCY> U.S. DOLLARS
       
<S>                             <C>
<PERIOD-TYPE>                   3-MOS
<FISCAL-YEAR-END>                          DEC-31-1998
<PERIOD-START>                             JUL-01-1998
<PERIOD-END>                               SEP-30-1998
<EXCHANGE-RATE>                                      1
<CASH>                                          56,104
<SECURITIES>                                        50
<RECEIVABLES>                                   26,588
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                90,807
<PP&E>                                          13,970
<DEPRECIATION>                                   4,184
<TOTAL-ASSETS>                                 151,378
<CURRENT-LIABILITIES>                           26,542
<BONDS>                                              0
                                0
                                          0
<COMMON>                                            75
<OTHER-SE>                                     120,200
<TOTAL-LIABILITY-AND-EQUITY>                   151,378
<SALES>                                         22,869
<TOTAL-REVENUES>                                22,869
<CGS>                                           11,550
<TOTAL-COSTS>                                   20,115
<OTHER-EXPENSES>                                 (674)
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                  70
<INCOME-PRETAX>                                  3,358
<INCOME-TAX>                                     1,349
<INCOME-CONTINUING>                              2,009
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                     2,009
<EPS-PRIMARY>                                     0.19
<EPS-DILUTED>                                     0.18
        

</TABLE>

<TABLE> <S> <C>

<ARTICLE> 5
<MULTIPLIER> 1,000
<CURRENCY> U.S. DOLLARS
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1998
<PERIOD-START>                             JAN-01-1998
<PERIOD-END>                               SEP-30-1998
<EXCHANGE-RATE>                                      1
<CASH>                                          56,104
<SECURITIES>                                        50
<RECEIVABLES>                                   26,588
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                90,807
<PP&E>                                          13,970
<DEPRECIATION>                                   4,184
<TOTAL-ASSETS>                                 151,378
<CURRENT-LIABILITIES>                           26,542
<BONDS>                                              0
                                0
                                          0
<COMMON>                                            75
<OTHER-SE>                                     120,200
<TOTAL-LIABILITY-AND-EQUITY>                   151,378
<SALES>                                         65,169
<TOTAL-REVENUES>                                65,169
<CGS>                                           34,726
<TOTAL-COSTS>                                   57,504
<OTHER-EXPENSES>                               (1,025)
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                 212
<INCOME-PRETAX>                                  8,478
<INCOME-TAX>                                     3,465
<INCOME-CONTINUING>                              5,012
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                     5,012
<EPS-PRIMARY>                                     0.55
<EPS-DILUTED>                                     0.51
        

</TABLE>


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