KENDLE INTERNATIONAL INC
10-Q, 1997-11-14
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, 1997

                      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    No X
                                      ---   ---

Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date: 7,574,467 shares of common
stock, no par value, as of November 10, 1997.


                                       1
<PAGE>   2



                            KENDLE INTERNATIONAL INC.

                                      INDEX


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


         Item 1.     Financial Statements (Unaudited)

                     Condensed Consolidated Balance Sheets - September 30, 1997
                         and December 31, 1996                                                  3

                     Condensed Consolidated Statements of Operations - Three
                     Months Ended September 30, 1997 and 1996; Nine Months
                         Ended September 30, 1997 and 1996                                      4

                     Condensed Consolidated Statements of Cash Flows - Nine
                         Months Ended September 30, 1997 and 1996                               5

                     Notes to Condensed Consolidated Financial Statements                       7

         Item 2.     Management's Discussion and Analysis of Financial Condition
                         and Results of Operations                                             11


Part II.           Other Information                                                           17


         Item 2.     Changes in Securities                                                     17

         Item 6.     Exhibits and Reports on Form 8-K                                          18


Signatures                                                                                     19

Exhibit Index                                                                                  20
</TABLE>


                                       2
<PAGE>   3


                            KENDLE INTERNATIONAL INC.
                      CONDENSED CONSOLIDATED BALANCE SHEETS


<TABLE>
<CAPTION>
                                                                                September 30,     December 31,
                                                                                    1997              1996
                                                                                ------------       ----------
                                                                                (Unaudited)

                                              ASSETS
<S>                                                                             <C>                <C>       
Current assets:
     Cash and cash equivalents                                                  $  9,365,414       $2,047,476
     Available for sale securities                                                 9,804,750
     Accounts receivable                                                          16,211,477        3,583,210
     Unreimbursed investigator and project costs                                   3,392,646          980,597
     Other current assets                                                          1,147,494           12,806
                                                                                ------------       ----------
               Total current assets                                               39,921,781        6,624,089
                                                                                ------------       ----------
Property and equipment, net                                                        5,276,055        1,835,001
Excess of purchase price over net assets acquired, net                            26,084,632
Other assets                                                                         862,507          164,020
                                                                                ------------       ----------
               Total assets                                                     $ 72,144,975       $8,623,110
                                                                                ============       ==========

                               LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
     Current portion of obligations under capital leases                        $    549,874       $  360,203
     Trade payables                                                                4,496,537          913,371
     Advances against investigator and project costs                               1,598,823          776,565
     Advance billings                                                              7,768,223        4,303,809
     Other accrued liabilities                                                     4,542,205          563,672
                                                                                ------------       ----------
         Total current liabilities                                                18,955,662        6,917,620
                                                                                ------------       ----------
Obligations under capital leases, less current portion                             1,856,401          761,029
Other noncurrent liabilities                                                         519,416
Note payable -- escrow agreement                                                   1,500,000
                                                                                ------------       ----------
         Total liabilities                                                        22,831,479        7,678,649
                                                                                ------------       ----------
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;
         3,650,000 shares issued and outstanding at December 31, 1996,
         7,552,567 shares issued and outstanding at September 30, 1997                75,000           75,000
     Additional paid in capital                                                   50,168,745          270,396
     Retained earnings                                                              (939,810)         599,065
     Cumulative foreign currency translation adjustment                                5,608
     Unrealized holding gains on available for sale securities, net of tax             3,953
                                                                                ------------       ----------
         Total shareholders' equity                                               49,313,496          944,461
                                                                                ------------       ----------
               Total liabilities and shareholders' equity                       $ 72,144,975       $8,623,110
                                                                                ============       ==========
</TABLE>


The accompanying notes are an integral part of these 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,
                                                 -------------------------------       -------------------------------
                                                     1997               1996               1997               1996
                                                     ----               ----               ----               ----

<S>                                              <C>                <C>                <C>                <C>        
Net revenues                                     $ 12,517,782       $  3,607,427       $ 25,689,492       $ 8,300,819
                                                 ------------       ------------       ------------       -----------

Costs and expenses:
     Direct costs                                   7,115,974          2,441,882         14,463,060         5,617,387
     Selling, general and administrative
        expenses                                    3,360,414            818,099          7,408,884         1,835,594
     Depreciation and amortization                    513,741             50,803            804,946           142,910
                                                 ------------       ------------       ------------       -----------
                                                   10,990,129          3,310,784         22,676,890         7,595,891
                                                 ------------       ------------       ------------       -----------

        Income from operations                      1,527,653            296,643          3,012,602           704,928

Other income (expense):
     Interest income                                   94,837              3,011            108,092             7,706
     Interest expense                                (284,470)            (5,723)          (355,694)          (36,014)
     Other expense                                    (12,648)              (243)           (21,426)             (566)
                                                 ------------       ------------       ------------       -----------

Income before income taxes
     and extraordinary item                         1,325,372            293,688          2,743,574           676,054

Income tax expense                                    372,808                               372,808
                                                 ------------       ------------       ------------       -----------

Income before extraordinary item                      952,564            293,688          2,370,766           676,054

Extraordinary loss, net of tax benefit             (1,139,823)                           (1,139,823)
                                                 ------------       ------------       ------------       -----------

        Net income (loss)                        $   (187,259)      $    293,688       $  1,230,943       $   676,054
                                                 ============       ============       ============       ===========

Pro forma income (loss) data:
     Income before extraordinary item            $    952,564       $    293,688       $  2,370,766       $   676,054

     Pro forma adjustment for income
        taxes                                        (196,435)          (117,595)          (756,626)         (270,422)
                                                 ------------       ------------       ------------       -----------

     Pro forma income before
        extraordinary item                            756,129            176,093          1,614,140           405,632

     Extraordinary loss, net of tax benefit        (1,139,823)                           (1,139,823)
                                                 ------------       ------------       ------------       -----------

     Pro forma net income (loss)                 $   (383,694)      $    176,093       $    474,317       $   405,632
                                                 ============       ============       ============       ===========

Primary pro forma income (loss)
      per share data:
      Pro forma income per share before
         extraordinary item                      $       0.13       $       0.04       $       0.34       $      0.10

      Extraordinary loss per share                      (0.19)                                (0.24)
                                                 ------------       ------------       ------------       -----------

      Pro forma net income (loss) per share      $      (0.06)      $       0.04       $       0.10       $      0.10
                                                 ============       ============       ============       ===========

      Weighted average shares outstanding           6,023,402          3,960,462          4,804,827         3,942,533

Fully diluted pro forma income (loss)
      per share data:
      Pro forma income per share before
         extraordinary item                      $       0.13       $       0.04       $       0.32       $      0.10

      Extraordinary loss per share                      (0.19)                                (0.23)
                                                 ------------       ------------       ------------       -----------

      Pro forma net income (loss) per share      $      (0.06)      $       0.04       $       0.09       $      0.10
                                                 ============       ============       ============       ===========

      Weighted average shares outstanding           6,023,402          3,960,462          5,018,730         3,942,533
</TABLE>



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



                                       4
<PAGE>   5


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



<TABLE>
<CAPTION>
                                                                   For Nine Months Ended
                                                                       September 30,
                                                               -----------------------------
                                                                  1997              1996
                                                                  ----              ----
<S>                                                           <C>                <C>        
Net cash provided by (used in) operating activities           $   (486,590)      $ 1,712,340
                                                              ------------       -----------

Cash flows from investing activities:
     Purchase of available for sale securities                  (9,804,750)
     Acquisitions of property and equipment                     (1,111,613)         (277,389)
     Additions to software costs                                  (284,894)
     Acquisitions of businesses, less cash acquired            (22,842,235)
                                                              ------------       -----------
Net cash used in investing activities                          (34,043,492)         (277,389)
                                                              ------------       -----------

Cash flows from financing activities:
     Borrowings under line of credit                             3,100,000         3,067,000
     Repayments under line of credit                            (3,100,000)       (3,387,000)
     Borrowings under senior credit facility                    10,745,439
     Repayment of senior credit facility                       (10,745,439)
     Proceeds from subordinated debt borrowings                  3,500,000
     Proceeds from issuance of stock purchase warrants           1,500,000
     Repayment of subordinated debt borrowings                  (5,000,000)
     Proceeds from initial public offering, net                 45,251,554
     Proceeds from conversion of stock purchase warrants             1,537
     Proceeds from exercises of stock options                       15,948
     Debt issue costs                                             (538,698)
     Distributions to shareholders                              (2,557,819)         (285,290)
     Payments on capital lease obligations                        (330,110)          (99,271)

                                                              ------------       -----------
Net cash provided by (used in) financing activities             41,842,412          (704,561)
                                                              ------------       -----------

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

Net increase in cash and cash equivalents                        7,317,938           730,390
Cash and cash equivalents:
     Beginning of period                                         2,047,476            15,266
                                                              ------------       -----------
     End of period                                            $  9,365,414       $   745,656
                                                              ============       ===========
</TABLE>


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




                                       5
<PAGE>   6

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



<TABLE>
<CAPTION>
                                                                                    For Nine Months Ended
                                                                                        September 30,
                                                                          -----------------------------------------
                                                                               1997                    1996
                                                                               ----                    ----

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

<S>                                                                       <C>         
Acquisition of equipment under capital lease obligations                  $  1,637,056
                                                                          ============

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

Issuance of common stock in conjunction with gmi acquisition              $  2,678,256
                                                                          ============

Exercise of stock purchase warrants recorded as additional
      paid in capital                                                     $  1,500,000
                                                                          ============



Acquisitions of Businesses (Note 3):

      Fair value of assets acquired                                       $ 34,072,671
      Fair value of liabilities assumed or incurred                         (8,552,180)
      Stock issued                                                          (2,678,256)
                                                                          ------------

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




The accompanying notes are an integral part of these 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, except for the item discussed in Note 6) considered necessary
     for a fair presentation have been included. Operating results for the three
     months and the nine months ended September 30, 1997 are not necessarily
     indicative of the results that may be expected for the year ending December
     31, 1997. For further information, refer to the consolidated financial
     statements and notes thereto included in Kendle International Inc.'s (the
     "Company") Form S-1 filed on August 21, 1997 with the Securities and
     Exchange Commission.

             The balance sheet at December 31, 1996 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.    SHAREHOLDER'S EQUITY

             On August 22, 1997, the Company completed its initial public
     offering ("IPO") of 4,140,000 shares of common stock at a price to the
     public of $14.00 per share. Of the 4,140,000 shares sold, 3,540,000 were
     sold by the Company and 600,000 shares were sold by selling shareholders.
     Net proceeds to the Company approximated $45.3 million.

   
             The net proceeds remaining after the repayment of indebtedness
     incurred with the U-Gene Research B.V. ("U-Gene") acquisition and the cash
     payments relating to the acquisition of GMI Gesellschaft fur Angewandte
     Mathematik und Informatik mbH ("gmi") (See Note 4) have been invested in
     securities with original maturities that do not exceed one year.
     Investments with maturities ranging from three months to one year have been
     classified as available for sale securities and consist of highly 
    




                                       7
<PAGE>   8


     liquid debt securities. In accordance with Statement of Financial
     Accounting Standards (SFAS) No. 115, "Accounting for Certain Investments in
     Debt and Equity Securities," available for sale securities have been
     recorded at fair value, with unrealized gains and losses, net of tax,
     reported as a separate component of shareholders' equity.

3.    EARNINGS PER SHARE

             Primary and fully diluted pro forma income (loss) per share data
     has been computed for the three months ended September 30, 1997 and the
     three and nine months ended September 30, 1996 using primary weighted
     average shares outstanding, as the difference between primary and fully
     diluted weighted average shares outstanding for these periods is not
     material.

             In accordance with Accounting Principles Bulletin No. 15, "Earnings
     Per Share," supplemental net income (loss) per share, after giving effect
     to: (a) the elimination of interest expense on the indebtedness retired
     with the IPO proceeds; and (b) the issuance of common stock whose proceeds
     were used to retire the indebtedness; was $(0.04) and $0.12 for the three
     and nine months ended September 30, 1997, respectively. These per share
     amounts also assume that the Company was taxed as a C corporation for each
     period.

             In February 1997, the Financial Accounting Standards Board issued
     SFAS No. 128, "Earnings Per Share." SFAS No. 128 is designed to simplify
     the existing computational guidelines for computing earnings per share
     (EPS). It provides for the elimination of primary EPS, replacing it with
     basic EPS, with the principal difference being that common stock
     equivalents are not considered in computing basic EPS. SFAS No. 128 is
     effective for the Company for the year ending December 31, 1997. The
     adoption of this statement would have increased the Company's pro forma
     net income per share for the three and nine months ended September 30,
     1997 by 12% and 11%, respectively.

4.   ACQUISITIONS

             Effective September 3, 1997, the Company acquired gmi. Acquisition
     costs of $12.7 million consisted of $10.0 million in cash and the issuance
     of 191,304 shares of the Company's Common Stock at $14 per share or $2.7
     million. The gmi 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 Company acquired U-Gene as of June 30, 1997 for approximately
     $15.9 million. The acquisition was 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.


                                       8
<PAGE>   9




             The following unaudited pro forma results of operations assume the
     acquisitions of U-Gene and gmi occurred as of January 1, 1996:

<TABLE>
<CAPTION>
                                                             Nine Months Ended           Nine Months Ended
                                                            September 30, 1997          September 30, 1996
                                                            ------------------          ------------------
<S>                                                                <C>                         <C>        
       Net revenues                                                $36,734,386                 $22,006,003

       Income before extraordinary  item                            $2,906,249                  $1,285,632

       Net income                                                   $1,766,426                  $1,285,632

       Income before extraordinary item,
            assuming the Company was taxed
           as a C corporation                                       $2,149,623                  $1,015,210

       Income per share before
           extraordinary item                                            $0.58                       $0.31

       Net income per share                                              $0.35                       $0.31

       Income per share before
           extraordinary item, assuming the
           Company was taxed as a
           C corporation                                                 $0.43                       $0.25
</TABLE>


             The pro forma financial information is not necessarily indicative
     of the operating results that would have occurred had the U-Gene and gmi
     acquisitions been consummated as of January 1, 1996, nor are they
     necessarily indicative of future operating results.

5.   INCOME TAXES

             The condensed consolidated financial statements of the Company for
     periods prior to the IPO as discussed in Note 2 do not include a provision
     for income taxes because the taxable income or loss of the Company is
     included in the income tax returns of the individual shareholders under the
     S corporation election. Pro forma income (loss) 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 these
     periods.


                                       9
<PAGE>   10



6.   EXTRAORDINARY ITEM

             During the third quarter of 1997, the Company recorded an
     extraordinary loss on early extinguishment of indebtedness which amounted
     to $1.1 million, net of tax benefits of approximately $426,000. The
     extraordinary loss resulted from the write-off of the debt discount
     recorded in connection with long-term borrowings. Such borrowings were made
     by the Company in connection with the acquisition of U-Gene prior to the
     Company's IPO and were repaid with the proceeds of the IPO.

7.   SUBSEQUENT EVENT

             On October 28, 1997, the Company announced the signing of a
     non-binding letter of intent to acquire 100% of the stock of ACER/EXCEL
     Inc. ("ACER"), headquartered in Cranford, New Jersey. The transaction would
     be effected through an exchange of both cash and stock and would be
     accounted for under the purchase method of accounting. Under the proposed
     agreement, the Company would acquire ACER for approximately $36 million,
     consisting of approximately 1.2 million shares of stock and $17 million in
     cash. The share portion of the consideration is subject to a pricing
     formula based on the stock's fair market value.



                                       10
<PAGE>   11


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

         The information set forth and discussed below for the three months and
nine months ended September 30, 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

         The Company provides integrated clinical research services on a
contract basis to the pharmaceutical and biopharmaceutical industries. These
services include Phase I to IV clinical trial management, clinical drug
management, biostatistical analysis, medical writing and regulatory consultation
and representation.

         Kendle'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 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 clients, 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.

ACQUISITIONS

         During the quarter, the Company acquired two European based contract
research organizations, U-Gene Research BV ("U-Gene"), headquartered in Utrecht,
The Netherlands, and GMI Gesellschaft fur Angewandte Mathematik und Informatik
mbH ("gmi"), headquartered in Munich, Germany. U-Gene provides a full range of
clinical drug development services including Phase II-IV clinical trial design
and management, and Phase I and II(a) research studies at its 38-bed, clinical
pharmacology unit. gmi provides a wide range of clinical drug development
services including Phase II to IV 


                                       11
<PAGE>   12



clinical trials, seminars and in-house training programs and presentations and
specializes in health/pharmocoeconomic studies. Both acquisitions were accounted
for using the purchase method of accounting, with goodwill as a result of the
transaction being amortized over 30 years. The U-Gene acquisition was completed
as of June 30, 1997 and the gmi acquisition was completed on September 3, 1997.
The results of operations are included in the Company's results of operations
from the respective dates of acquisition.

RESULTS OF OPERATIONS

THREE MONTHS ENDED SEPTEMBER 30, 1997 COMPARED TO THREE MONTHS ENDED SEPTEMBER
30, 1996

   
         Net revenues increased by $8.9 million, or 247%, from $3.6 million for
the three months ended September 30, 1996 to $12.5 million for the three months
ended September 30, 1997. The increase in net revenues was due to: (a) 62 new
projects in the three months ended September 30, 1997 as compared to the three
months ended September 30, 1996, which resulted in net revenues of $4.0 million
for the three months ended September 30, 1997; (b) a net increase in revenues
recognized on existing projects of $1.0 million; and (c) an increase of
approximately $3.9 million in net revenues relating to the acquisitions.
Revenues from G.D. Searle & Co. accounted for approximately 49% of net revenues
for the three months ended September 30, 1997. Net revenues from clients other
than G.D. Searle & Co. increased $4.4 million, or 220%, from $2.0 million for
the three months ended September 30, 1996 to $6.4 million for the three months
ended September 30, 1997.
    

         Direct costs increased by $4.7 million, or 191%, from $2.4 million for
the three months ended September 30, 1996 to $7.1 million for the three months
ended September 30, 1997. This increase is primarily comprised of: (a)
approximately $3.8 million in direct salaries and fringe benefits to support the
increases in net revenues for the period; and (b) an increase of approximately
$539,000 in indirect costs in connection with projects, including allocated
facility, unreimbursed project-related and other costs which also increased to
support the growth in business activity. Direct costs expressed as a percentage
of net revenues decreased from 67.7% for the three months ended September 30,
1996 to 56.8% for the three months ended September 30, 1997. The decrease in
those costs as a percentage of net revenues is due primarily to the absorption
of direct project-related costs over a larger revenue base, as net revenues
increased by 247% for the three months ended September 30, 1997 as compared to
the three months ended September 30, 1996, while direct costs increased by 191%
over the same periods.

   
         Selling, general and administrative expenses increased by $2.5 million,
or 311%, from $818,000 for the three months ended September 30, 1996 to $3.4
million for the three months ended September 30, 1997. Selling, general and
administrative expenses as a percentage of net revenues increased from 22.7% for
the three months ended September 30, 1996 to 26.8% for the three months ended
September 30, 1997. The increase is primarily comprised of: (a) an increase of
approximately $1.5 million in salaries and benefits, which is the result of the
Company's continued efforts to increase its infrastructure in 
    


                                       12
<PAGE>   13



order to support the growth in business activity; and (b) increases in training
($168,000), contractual services ($118,000), recruiting ($109,000), and
marketing and advertising ($101,000) expenses for the three months ended
September 30, 1997 as compared to the same period in 1996.

         Depreciation and amortization expense increased $463,000, or 911%, from
$51,000 for the three months ended September 30, 1996 to $514,000 for the three
months ended September 30, 1997. The increase was due to capital expenditures
associated with the three offices opened by the Company in 1996 and amortization
of goodwill as a result of the U-Gene and gmi acquisitions.

         Interest expense, net of interest income, increased by $187,000, from
$3,000 for the three months ended September 30, 1996 to $190,000 for the three
months ended September 30, 1997 due to the Company's borrowings during the three
months ended September 30, 1997 relating to the U-Gene acquisition. This
indebtedness was repaid with the proceeds of the Company's IPO.

         Income taxes of $373,000, or 28.1% of income before income taxes and
extraordinary item, were recorded for the three months ended September 30, 1997
as compared to no income taxes being recorded for the three months ended
September 30, 1996. Income taxes were not provided prior to the Company's IPO as
the Company was taxed as an S corporation.

         Net loss of $(188,000) for the three months ended September 30, 1997
includes a $1.1 million extraordinary loss associated with the early
extinguishment of indebtedness which resulted from long-term borrowings made by
the Company in connection the U-Gene acquisition prior to the Company's IPO,
that were repaid with the proceeds from the IPO.

NINE MONTHS ENDED SEPTEMBER 30, 1997 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30,
1996

   
         Net revenues increased by $17.4 million, or 210%, from $8.3 million for
the nine months ended September 30, 1996 to $25.7 million for the nine months
ended September 30, 1997. The increase in net revenues was due to: (a) 70 new
projects in the nine months ended September 30, 1997, as compared to the nine
months ended September 30, 1996, which resulted in net revenues of $7.9 million
for the nine months ended September 30, 1997; (b) a net increase in revenues
recognized on existing projects of $5.6 million; and (c) an increase of
approximately $3.9 million in net revenues relating to the acquisitions.
Revenues from G.D. Searle & Co. accounted for approximately 56% of net revenues
for the nine months ended September 30, 1997. Net revenues from clients other
than G.D. Searle & Co. increased $6.3 million, or 129%, from $4.9 million for
the nine months ended September 30, 1996 to $11.2 million for the nine months
ended September 30, 1997.
    



                                       13
<PAGE>   14



         Direct costs increased by $8.9 million, or 157%, from $5.6 million for
the nine months ended September 30, 1996 to $14.5 million for the nine months
ended September 30, 1997. This increase is primarily comprised of: (a)
approximately $6.2 million in direct salaries and fringe benefits to support the
increases in net revenues for the period; and (b) an increase of approximately
$2.2 million in indirect costs in connection with projects, including allocated
facility, unreimbursed project-related and other costs which also increased to
support the growth in business activity. Direct costs expressed as a percentage
of net revenues decreased from 67.7% for the nine months ended September 30,
1996 to 56.3% for the nine months ended September 30, 1997. The decrease in
those costs as a percentage of net revenues is due primarily to the absorption
of direct project-related costs over a larger revenue base, as net revenues
increased by 210% for the nine months ended September 30, 1997 as compared to
the nine months ended September 30, 1996, while direct costs increased by 157%
over the same periods.

         Selling, general and administrative expenses increased $5.6 million, or
304%, from $1.8 million for the nine months ended September 30, 1996 to $7.4
million for the nine months ended September 30, 1997. Selling, general and
administrative expenses as a percentage of net revenues increased from 22.1% for
the nine months ended September 30, 1996 to 28.8% for the nine months ended
September 30, 1997. The increase is primarily comprised of: (a) an increase of
approximately $3.4 million 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 for the nine months ended September 30, 1997 as
compared to the same period in 1996; and (b) increases in training ($438,000),
contractual services ($470,000), recruiting ($366,000), conferences and seminars
($218,000) and marketing and advertising ($247,000) expenses for the nine months
ended September 30, 1997 as compared to the same period in 1996.

         Depreciation and amortization expense increased $662,000, or 463%, from
$143,000 for the nine months ended September 30, 1996 to $805,000 for the nine
months ended September 30, 1997. The increase was due to capital expenditures
associated with the three offices opened by the Company in 1996 and amortization
of goodwill as a result of the U-Gene and gmi acquisitions.

         Interest expense, net of interest income, increased by $220,000, from
$28,000 for the nine months ended September 30, 1996 to $248,000 for the nine
months ended September 30, 1997 due to the Company's borrowings during the three
months ended September 30, 1997 relating to the U-Gene acquisition. This
indebtedness was repaid with the proceeds of the Company's IPO.

         Income taxes of $373,000, or 13.6% of income before income taxes and
extraordinary item, were recorded for the nine months ended September 30, 1997
as compared to no income taxes being recorded for the nine months ended
September 30, 1996. Income taxes were not provided prior to the Company's IPO as
the Company was taxed as an S corporation.


                                       14
<PAGE>   15



         Net income of $1.2 million for the nine months ended September 30, 1997
includes a $1.1 million extraordinary loss associated with the early
extinguishment of indebtedness which resulted from long-term borrowings made by
the Company in connection the U-Gene acquisition prior to the Company's IPO,
that were repaid with the proceeds from the IPO.


LIQUIDITY AND CAPITAL RESOURCES

         On August 22, 1997, the Company completed its IPO of 4,140,000 shares
of common stock at a price to the public of $14.00 per share. Of the 4,140,000
shares sold, 3,540,000 were sold by the Company and 600,000 shares were sold by
selling shareholders. Net proceeds to the Company approximated $45.3 million.

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

         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 and the purchase of available for sale securities of $9.8 million.
Financing activities for the nine months ended September 30, 1997 primarily
consisted of $45.3 million of net proceeds from the Company's IPO.

         Cash and cash equivalents increased by $730,000 for the nine months
ended September 30, 1996 as a result of cash provided by operating activities of
$1.7 million, and cash used by investing and financing activities of $277,000
and $705,000, respectively. Net cash used by operating activities resulted
primarily from net income offset by the net change in working capital items.

         Investing activities for the nine months ended September 30, 1996
consisted of property and equipment purchases. Financing activities for the nine
months ended September 30, 1996 consisted primarily of borrowings under the
Company's line of credit and distributions to shareholders.

         The Company has a $20 million credit facility with a U.S. bank. The
credit facility bears interest at a rate equal to either LIBOR plus the
Applicable Margin (as defined), or the higher of the Bank's prime rate or the
Federal Funds rate plus 0.50%. All amounts outstanding thereunder become due and
payable in June, 2000. At September 30, 1997, there were no amounts outstanding
under the credit facility.

         The Company has a $1.9 million computer and a $630,000 furniture lease
line of credit with a bank. Amounts drawn on these lines are payable over a 4-5
year term from 


                                       15
<PAGE>   16


the date of funding. These lines expire on March 31,1998. The monthly
installment payments are equal to 1.80%-2.23% and 1.71%-1.76% of the total
computer and furniture draws, respectively. Amounts drawn on these lines of
credit totaled $2.2 million at September 30, 1997.

         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 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.

RECENT EVENTS

         On October 28, 1997 the Company announced the signing of a non-binding
letter of intent to acquire 100% of the stock of ACER/EXCEL Inc. ("ACER") The
transaction would be effected through an exchange of both cash and stock and
would be accounted for under the purchase method of accounting. Under the
proposed agreement, which is expected to be completed by January 1998, Kendle
would acquire ACER for approximately $36 million, consisting of approximately
1.2 million shares of stock and $17 million in cash. The share portion of the
consideration is subject to a pricing formula based on the stock's fair market
value. The proposed transaction is subject to the negotiation and execution of a
definitive agreement and other approvals.


NEW ACCOUNTING PRONOUNCEMENTS

   
         In February 1997, the Financial Accounting Standards Board ("FASB")
issued SFAS No. 128, "Earnings Per Share." SFAS No. 128 is designed to simplify
the existing computational guidelines for computing earnings per share ("EPS")
and provides for the elimination of primary EPS replacing it with basic EPS,
with the principal difference being that common stock equivalents are not
considered in computing basic EPS. SFAS No. 128 is effective for the Company for
the year ending December 31, 1997. The effect of the adoption of this statement
would have increased the Company's pro forma net income per share for the three
and nine months ended September 30, 1997 by approximately 12% and 11%,
respectively.
    

   
         In June 1997, the FASB issued SFAS No. 130, "Reporting Comprehensive
Income." This standard establishes a requirement for display of Comprehensive
Income in general-purpose financial statements for fiscal periods beginning
after December 15, 1997. The Company does not expect the adoption of the
standard to be material.
    

                                       16
<PAGE>   17



CAUTIONARY STATEMENT FOR FORWARD-LOOKING INFORMATION

         Information set forth in this Form 10-Q, including "Management's
Discussion and Analysis of Financial Condition and Results of Operations"
contains various "forward looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, which statements reflect management's
current view with respect to certain future events and financial performance
that are subject to risks and uncertainties. Such forward looking statements can
be identified by the use of forward looking terminology such as "may," "will,"
"expect," "anticipate," "estimate," "believe," or "continue," or the negative
thereof or other variations thereof or comparable terminology.

         The Company cautions that any such forward looking statements are
further qualified by important factors that could cause the Company's actual
operating results to differ materially from those in the forward looking
statements, including without limitation, the actual operating performance, the
ability of the combined businesses to be integrated with Kendle's operations,
the ability to penetrate new markets, the ability of joint venture businesses to
be integrated with Kendle's operations, and the ability to maintain large client
contracts or to enter into new contracts, and the other risk factors set forth
in the Company's recent SEC filings on Form S-1 and S-8, copies of which are
available upon request from Kendle's investor relations department.

PART II.          OTHER INFORMATION

Item 1.           Legal Proceedings - None

Item 2.           Changes in Securities

         Report of Sales of Securities and Use of Proceeds Therefrom
         -----------------------------------------------------------

         -    Name of Seller--Kendle International Inc.
         -    Effective Date of Registration Statement--August 21, 1997.
         -    SEC File Number Assigned to the Registration Statement--
              333-30581.
         -    CUSIP Number--48880L 10 7
         -    Date the Offering Commenced--August 22, 1997.
         -    The offer did not terminate before any securities were sold.
         -    The offer did not terminate prior to the sale of all securities
              registered.
         -    Managing Underwriters---Lehman Brothers and J.C. Bradford & Co.
              Title of Security--Common Stock, no par value; ISSUER-- Amount
              registered--3,540,000 (includes Underwriters' over-allotment
              option); Aggregate price of offering amount
              registered--$49,560,000; Amount sold--3,540,000; Aggregate
              offering price of amount sold--$49,560,000; SELLING
              SHAREHOLDERS--Amount registered--600,000; Aggregate offering price
              of amount registered--$8,400,000; Amount sold--600,000; Aggregate
              offering price of amount sold--$8,400,000.



                                       17
<PAGE>   18



         -    Offering expenses for the issuer--Underwriting discounts and
              commissions--$3,469,200; Other expenses--$839,246
         -    Net proceeds to the issuer after total expenses--$45,251,554
         -    Use of Proceeds--Acquisition of business--$10.0 million (cash
              portion of gmi acquisition); Repayment of indebtedness--$13.8
              million; S corporation distribution to shareholders--$1.3 million;
              Working capital--$1.0 million.
         -    The use of proceeds described above does not represent a material
              change in the use of proceeds described in the prospectus.


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
         --------                         -----------

         11                               Statement Regarding Computation of
                                               Earnings Per Share
         27.1                             Financial Data Schedule


   
         (b) The Company filed one report during the quarter ended September 30,
1997 on Form 8-K, dated September 18, 1997, in which the Company reported its
acquisition of gmi under Item 2. "Acquisition or Disposition of Assets." No
other reports on Form 8-K were filed during the quarter.
    




                                       18
<PAGE>   19




                                   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 Bryan
                                      -------------------------------------
Date:  November 14, 1997              Candace Kendle Bryan
                                      Chairman of the Board and Chief
                                      Executive Officer
    



                                  By: /s/ Timothy M. Mooney
                                      -------------------------------------
Date:  November 14, 1997              Timothy M. Mooney
                                      Vice President - Chief Financial Officer



                                       19
<PAGE>   20



                            KENDLE INTERNATIONAL INC.

                                  EXHIBIT INDEX

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

         11                           Statement Regarding Computation of
                                               Earnings Per Share
         27.1                         Financial Data Schedule



                                       20





<PAGE>   1
                                   EXHIBIT 11
             COMPUTATION OF PRO FORMA INCOME (LOSS) PER COMMON SHARE



   
<TABLE>
<CAPTION>
                                                       For the Three Months Ended          For the Nine Months Ended
                                                               September 30,                    September 30,
                                                               -------------                    -------------
                                                          1997              1996             1997            1996
                                                          ----              ----             ----            ----
<S>                                                   <C>               <C>               <C>             <C>       
Pro forma income (loss) data for primary
          and fully diluted computation:
     Pro forma income before extraordinary item       $   756,129       $   176,093       $1,614,140      $  405,632
     Extraordinary loss, net of tax benefit            (1,139,823)                        (1,139,823)
                                                      -----------       -----------       ----------      ----------

     Pro forma net income (loss)                      $  (383,694)      $   176,093       $  474,317      $  405,632
                                                      ===========       ===========       ==========      ==========

PRIMARY
Weighted average common shares and dilutive
  common stock equivalents:
        Common stock outstanding                        5,386,252         3,650,000        4,337,039       3,650,000
        Stock purchase warrants                                             153,738                          153,738
        Stock options                                     637,150           156,724          467,788         138,795
                                                      -----------       -----------       ----------      ----------
                                                        6,023,402         3,960,462        4,804,827       3,942,533
                                                      ===========       ===========       ==========      ==========

Primary income (loss) per common share:
     Pro forma income per share before
        extraordinary item                            $      0.13       $      0.04       $     0.34      $     0.10
     Extraordinary loss per share                           (0.19)                             (0.24)
                                                      -----------       -----------       ----------      ----------
     Pro forma net income (loss) per share            $     (0.06)      $      0.04       $     0.10      $     0.10
                                                      ===========       ===========       ==========      ==========


FULLY DILUTED
Weighted average common shares and dilutive
  common stock equivalents:
        Common stock outstanding                        5,386,252         3,650,000        4,337,039       3,650,000
        Stock purchase warrants                                             153,738                          153,738
        Stock options                                     701,075           233,898          681,691         201,540
                                                      -----------       -----------       ----------      ----------
                                                        6,087,327         4,037,636        5,018,730       4,005,278
                                                      ===========       ===========       ==========      ==========

Fully diluted income (loss) per common share:
     Pro forma income per share before
        extraordinary item                            $      0.12       $      0.04       $     0.32      $     0.10
     Extraordinary loss per share                           (0.19)                             (0.23)
                                                      -----------       -----------       ----------      ----------
     Pro forma net income (loss) per share            $     (0.07)      $      0.04       $     0.09      $     0.10
                                                      ===========       ===========       ==========      ==========
</TABLE>
    

Note:   Certain stock options and stock purchase warrants are deemed outstanding
        for all periods presented. Effective with the Company's IPO, the stock
        purchase warrants were exercised and converted to common stock.




<TABLE> <S> <C>

<ARTICLE> 5
<MULTIPLIER> 1
<CURRENCY> US DOLLARS
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1997
<PERIOD-START>                             JAN-01-1997
<PERIOD-END>                               SEP-30-1997
<EXCHANGE-RATE>                                      1
<CASH>                                           9,365
<SECURITIES>                                     9,805
<RECEIVABLES>                                   16,211
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                39,922
<PP&E>                                           6,820
<DEPRECIATION>                                   1,543
<TOTAL-ASSETS>                                  72,145
<CURRENT-LIABILITIES>                           18,956
<BONDS>                                              0
                                0
                                          0
<COMMON>                                            75
<OTHER-SE>                                      49,238
<TOTAL-LIABILITY-AND-EQUITY>                    72,145
<SALES>                                         25,689
<TOTAL-REVENUES>                                25,689
<CGS>                                           14,463
<TOTAL-COSTS>                                   22,677
<OTHER-EXPENSES>                                  (87)
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                 356
<INCOME-PRETAX>                                      0
<INCOME-TAX>                                       373
<INCOME-CONTINUING>                              2,371
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                (1,140)
<CHANGES>                                            0
<NET-INCOME>                                     1,231
<EPS-PRIMARY>                                     0.10
<EPS-DILUTED>                                     0.09
<FN>
EARNINGS PER SHARE PRIMARY AND FULLY DILUTED REFLECTS THE ADJUSTMENT FOR INCOME
TAXES AS IF THE COMPANY WERE A C CORPORATION FOR THE ENTIRE PERIOD.
</FN>
        

</TABLE>


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