MYLAN LABORATORIES INC
10-Q, 1997-08-12
PHARMACEUTICAL PREPARATIONS
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- ------------------------------------------------------------------------------
    
                   UNITED STATES SECURITIES AND EXCHANGE COMMISSION  
                                WASHINGTON, D.C.  20549
                                      FORM 10-Q
              --------------------------------------------------------------
    
    
            [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
                                        OF THE SECURITIES EXCHANGE ACT OF 1934
    
                   For the quarterly period ended June 30, 1997

                                 OR

         [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
                                    OR THE SECURITIES EXCHANGE ACT OF 1934
          For the transition period from          to

              Commission file number 1-9114

                            MYLAN LABORATORIES INC.
              (Exact Name of registrant as specified in its charter)

         Pennsylvania                           25-1211621
(State or other jurisdiction of               (I.R.S. Employer
 incorporation or organization)                Identification No.)

      130 Seventh Street
    1030 Century Building
   Pittsburgh, Pennsylvania                         15222
(Address of principal executive offices)          (Zip Code)

                               412-232-0100
             (Registrant's telephone number, including area code)

                                Not Applicable
        (Former name, former address and former fiscal year, 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 Exchange Act of 1934 during
the preceding  twelve 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

                                                          Outstanding at
   Class of Common Stock                                   July 25, 1997
      $.50 par value                                        121,972,656
- ------------------------------------------------------------------------------




<PAGE>






                    MYLAN LABORATORIES INC. AND SUBSIDIARIES


                                      INDEX




                                                               Page
                                                              Number


PART I. FINANCIAL INFORMATION

        ITEM 1:  Financial Statements

        Consolidated Balance Sheets - June 30, 1997
          and March 31, 1997                                 2A and 2B

        Consolidated Statements of Earnings - Three
      Months Ended June 30, 1997 and 1996                        3

        Consolidated Statements of Cash Flows - Three
      Months Ended June 30, 1997 and 1996                        4

        Notes to Consolidated Financial Statements -
          Three Months Ended June 30, 1997                       5

        ITEM 2:  Management's Discussion and Analysis of
           Financial Condition and Results of
           Operations                                       6 through 8

PART II. OTHER INFORMATION                                       9





















<PAGE>



                    MYLAN LABORATORIES INC. AND SUBSIDIARIES
                           CONSOLIDATED BALANCE SHEETS

                                     ASSETS



                                                       June 30,       March 31,
                                                           1997            1997
                                                      Unaudited         Audited
Current Assets:
    Cash and cash equivalents                      $108,995,000    $126,156,000
    Marketable securities                            15,062,000      13,876,000
    Accounts receivable - net                       107,029,000     115,303,000
    Inventories:
        Raw materials                                66,555,000      51,796,000
        Work in process                              19,718,000      20,843,000
        Finished goods                               35,001,000      28,251,000
                                                   ------------    ------------
                                                    121,274,000     100,890,000
  Prepaid and refundable income tax                  11,893,000               -
    Deferred income tax benefit                       5,571,000      13,532,000
    Other current assets                             10,477,000       9,263,000
                                                   ------------    ------------
           Total Current Assets                     380,301,000     379,020,000


Property, Plant and Equipment - at cost             203,793,000     197,466,000
    Less accumulated depreciation                    64,686,000      61,637,000
                                                   ------------     -----------
                                                    139,107,000     135,829,000
Deferred Income Tax Benefit                           3,892,000               -
Marketable Securities, non-current                   23,460,000      23,668,000
Investment in and Advances to Somerset               24,693,000      25,113,000
Intangible Assets-net of accumulated amortization   135,005,000     137,062,000
Other Assets                                         81,034,000      76,888,000
                                                   ------------    ------------
Total Assets                                       $787,492,000    $777,580,000
                                                   ============    ============

                 See Notes to Consolidated Financial Statements
                                      -2A-



<PAGE>



                      LIABILITIES AND SHAREH0LDERS' EQUITY


                                                        June 30,      March 31,
                                                            1997           1997
                                                       Unaudited        Audited
Current Liabilities:
    Trade accounts payable                          $ 16,856,000   $ 18,039,000
    Current portion of long-term obligations          18,257,000     17,453,000
    Income taxes payable                              18,777,000     13,795,000
    Other current liabilities                         23,146,000     24,566,000
    Cash dividend payable                              4,893,000      4,893,000
                                                    ------------   ------------
           Total Current Liabilities                  81,929,000     78,746,000
Long-Term Obligations                                 32,936,000     32,593,000
Deferred Income Tax Liability                                  -      6,501,000

Shareholders' Equity:
    Preferred stock, par value $.50 per
        share, authorized 5,000,000 shares,
        issued and outstanding - none                          -              -
    Common stock, par value $.50 per share,
        authorized 300,000,000 shares, issued
        122,823,506 shares at June 30, 1997 and
        122,814,956 shares at March 31, 1997
                                                      61,412,000     61,407,000
    Additional paid-in capital                        89,349,000     89,262,000
    Retained earnings                                525,466,000    513,750,000
    Net unrealized gain (loss) on investments            144,000      (947,000)
                                                    ------------
                                                     676,371,000    663,472,000
    Less Treasury stock - at cost, 753,700
        shares at June 30, 1997 and 752,950
        shares at March 31, 1997                       3,744,000      3,732,000
                                                    ------------   ------------
Net Worth                                            672,627,000    659,740,000
                                                    ------------   ------------
Total Liabilities and Shareholders' Equity          $787,492,000   $777,580,000
                                                    ============   ============




                 See Notes to Consolidated Financial Statements
                                      -2B-



<PAGE>



                    MYLAN LABORATORIES INC. AND SUBSIDIARIES
                       CONSOLIDATED STATEMENTS OF EARNINGS
                FOR THE THREE MONTHS ENDED JUNE 30, 1997 AND 1996
                                    UNAUDITED


                                          1997                    1996
                                          ----                    ----
NET SALES                         $109,188,000            $ 98,543,000
COST AND EXPENSES:
    Cost of Sales                   61,379,000              55,779,000
    Research and Development        11,691,000              10,531,000
    Selling and Administrative      19,739,000              21,251,000
                                  ------------            ------------
                                    92,809,000              87,561,000
EQUITY IN EARNINGS OF SOMERSET       4,136,000               5,043,000
OTHER INCOME                         1,826,000               3,992,000
                                  ------------            ------------
EARNINGS BEFORE INCOME TAXES        22,341,000               20,017,00
INCOME TAX RATE                            26%                     30%
INCOME TAXES                         5,743,000               6,006,000
                                  ------------            ------------
NET EARNINGS                      $ 16,598,000            $ 14,011,000
                                  ============            ============

EARNINGS PER SHARE                $        .14            $        .12
                                  ============            ============

WEIGHTED AVERAGE COMMON SHARES     122,065,000             121,868,000
                                  ============            ============


The Company has paid regular  quarterly  cash  dividends of $.04 per share since
October 1995.









                 See Notes to Consolidated Financial Statements
                                       -3-



<PAGE>



                    MYLAN LABORATORIES INC. AND SUBSIDIARIES
                      CONSOLIDATED STATEMENTS OF CASH FLOWS
                FOR THE THREE MONTHS ENDED JUNE 30, 1997 AND 1996

                                    UNAUDITED

                                                          1997          1996
                                                          ----          ----
CASH FLOWS FROM OPERATING ACTIVITIES
    Net Earnings                                     $ 16,598,000  $ 14,011,000
    Adjustments to reconcile net earnings to net
        cash provided from operating activities:
           Depreciation and amortization                5,146,000     4,215,000
           Deferred income taxes                          871,000    (2,836,000)
           Equity in the earnings of Somerset          (4,136,000)   (5,043,000)
           Cash received from Somerset                  4,556,000     2,636,000
           Allowances on accounts receivable           (4,199,000)      (14,000)
           Other non-cash items                         1,538,000      (565,000)
  Changes in operating assets and liabilities:
           Accounts receivable                         12,223,000     7,547,000
           Inventories                                (20,396,000)   (2,236,000)
           Trade accounts payable                      (1,183,000)   (2,657,000)
           Income taxes payable                        (6,911,000)     8,078,000
           Other operating assets and liabilities      (6,526,000)     5,291,000
                                                     ------------   ------------
Net cash (used in) provided from operating activities  (2,419,000)    28,427,000
CASH FLOWS FROM INVESTING ACTIVITIES
    Additions to property, plant and equipment         (6,327,000)   (8,514,000)
    Increase in intangible and other assets            (4,307,000)   (5,345,000)
    Proceeds from investment securities                 3,005,000     5,909,000
    Purchase of investment securities                  (2,303,000)   (6,457,000)
                                                      ------------  ------------
Net cash used in investing activities                  (9,932,000)  (14,407,000)
CASH FLOWS FROM FINANCING ACTIVITIES
    Cash dividend paid                                 (4,882,000)   (4,867,000)
    Payments on long-term obligations                      (8,000)       (7,000)
    Proceeds from exercise of stock options                80,000       584,000
                                                      ------------  ------------
Net cash used in financing activities                  (4,810,000)   (4,290,000)
                                                      ------------  ------------

Net (Decrease) Increase in Cash and Cash Equivalents  (17,161,000)    9,730,000
Cash and Cash Equivalents - Beginning of Period       126,156,000   176,980,000
                                                      ------------  ------------

Cash and Cash Equivalents - End of Period            $108,995,000  $186,710,000
                                                     ============  ============

CASH PAID DURING THE PERIOD FOR:
    Interest                                         $      5,000  $      5,000
    Income Taxes                                     $ 15,698,000  $    761,000

                 See Notes to Consolidated Financial Statements
                                       

                                      -4-



<PAGE>



                    MYLAN LABORATORIES INC. AND SUBSIDIARIES
                   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
                            THREE MONTH PERIOD ENDED
                                  JUNE 30, 1997

                                    Unaudited

A.    In the opinion of management, the accompanying unaudited financial
      statements contain all adjustments (consisting of only normal recurring
      accruals) necessary to present fairly the financial position of the
      Company as of June 30, 1997 and March 31, 1997 together with the results
      of operations and cash flows for the interim periods ended June 30, 1997
      and 1996.  The consolidated results of operations for the three months
      ended June 30, 1997 and 1996 are not necessarily indicative of the results
      to be expected for the full year.

B.    These interim financial  statements should be read in conjunction with the
      consolidated  financial statements and notes thereto in the Company's 1997
      Annual Report and Report on Form 10-K.

C.    Equity in Earnings of Somerset  includes the  Company's 50% portion of the
      net  earnings  of  Somerset  Pharmaceuticals  Inc.  ("Somerset"),  certain
      management fees and  amortization of intangible  assets resulting from the
      acquisition of Somerset. Such intangible assets are being amortized over a
      15 year period using the straight line method.

      Condensed unaudited financial information of Somerset for the three month
      periods ended June 30, 1997 and 1996 are as follows: (in thousands)


                              June 30,            June 30,
                                  1997                1996

        Net Sales              $17,273             $30,143
        Costs and Expenses     (5,247)            (16,295)
        Income Taxes           (4,155)             (4,807)
                              -------             -------
        Net Earnings           $ 7,871             $ 9,041
                               =======             =======

      The above  information  represents 100% of Somerset's  operations of which
      the Company has a 50%  interest.  Somerset  launched its  easy-to-identify
      capsule in the June 30, 1996 period,  this  resulted in higher than normal
      sales and costs and expenses.






                                       -5-



<PAGE>



                         PART 1 - FINANCIAL INFORMATION

                  ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS
                OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Results of Operations
      Net earnings for the quarter ended June 30, 1997 were $16,598,000 or $0.14
per share  representing an 18% increase over last year's first quarter.  For the
same  periods,  net sales  increased  by 11% to  $109,188,000  and gross  profit
dollars increased by 12% to $47,809,000.  Gross profit as a percent of net sales
was 44% for the quarter ended June 30, 1997,  the highest rate since the quarter
ended December 31, 1995.
      These  increases are primarily  attributable to the addition of 13 generic
products  since June 30,  1996,  including 6 products  added  during the current
quarter,  and also to sales of the products  Maxzide(R)  and  Nitrek(TM)  by the
Company's branded division, Bertek Pharmaceuticals Inc.

      New products and increased  sales volume  throughout the Company more than
offset the impact of continued  price  deterioration  in the  Company's  generic
product  line.  Excluding  the 13 products  added in the past year,  the generic
product line realized a 20% decrease in aggregate pricing from the first quarter
of  fiscal  1997 to  this  year's  first  quarter.  The  primary  causes  of the
deterioration  relate to the  consolidation of the Company's  customers  through
mergers and  acquisitions,  the emergence of large buying groups which represent
many independent  pharmacies and increased competition by brand-name competitors
who have entered the generic industry.

      Research and  development  expenses of $11,691,000 are 11% higher than the
first quarter of last year, and consistent  with the steady  quarterly  increase
realized  throughout the fiscal year ended March 31, 1997.  Based on the current
status  of  the  various  research  projects  in  progress,  including  generic,
innovative and  transdermal  patch related  projects,  the Company  expects that
quarterly expenditures for research and development to increase to approximately
$14,000,000 by the quarter ending March 31, 1998.

      Selling and administrative expenses were $19,739,000 for the quarter ended
June  30,  1997,  down 7% from  the same  quarter  a year  ago but in line  with
quarterly  levels  for the last  three  quarters.  The  June  1996  quarter  was
abnormally high due to accruals for certain legal matters.  With the addition of
Maxzide(R)  and  Nitrek(TM),  the Company has begun to expand its branded  sales
initiative through its Bertek  Pharmaceuticals Inc. division resulting in higher
selling and administrative  expenses.  The Company intends to continue to expand
this area in preparation for the addition of new branded products.

      Equity in Earnings of Somerset  includes the  Company's 50% portion of the
net earnings of Somerset Pharmaceuticals, Inc. ("Somerset"), which are generated
exclusively from the sale of Eldepryl(R).  In May of 1996, Somerset withdrew its
tablet  form  of   Eldepryl(R)   from  the  market  and   replaced  it  with  an
easy-to-identify  Eldepryl(R) capsule. Despite the withdrawal of the tablet form
of the  innovator  product,  in  August  1996 the  Food and Drug  Administration
approved several generic versions of Eldepryl(R) in tablet form.

                                       -6-



<PAGE>



      The impact of  generic  competition  has and will  continue  to  adversely
affect Somerset's  contribution to the Company's net earnings.  The reduction in
Somerset's   revenues  resulting  from  generic   competition  may  also  impact
Somerset's  ability  to  continue  research  and  development   expenditures  at
historical levels.

      Other  income is  derived  principally  from  investment  earnings  on the
Company's cash and marketable securities and also includes the impact of certain
strategic  alliances  investments  and gains and  losses  from the  disposal  of
assets.  The amount of other income  recognized by the Company has been affected
by statutory  accounting treatment of strategic alliance investments and changes
in the  amount of and yields on cash and  marketable  securities  available  for
investment.

      The  effective  tax  rate for the  quarter  ended  June  30,  1997 was 26%
compared to 30% for the  quarter  ended June 30, 1996 and 28% for the year ended
March 31, 1997. The lower rate in the current quarter resulted  primarily from a
favorable  settlement  during the  quarter  with the  Internal  Revenue  Service
regarding  an audit of the  Company's  tax  returns  for the  fiscal  years 1992
through  1995.  Under the terms of the  settlement,  the  Company  has agreed to
change the method it employs to  determine  tax credits for  operating in Puerto
Rico for tax years after the audit  period.  This  agreement  coupled with other
changes  in the  Federal  Tax Code will  continue  to reduce  the  amount of tax
credits otherwise available to the Company for operating in Puerto Rico.

Liquidity, Capital Resources and Financial Condition

      The Company's  balance  sheet remains very strong with working  capital of
$298,372,000, total assets of $787,492,000 and total equity of $672,627,000. The
ratio of current assets to current  liabilities was 4.6 to 1 as of June 30, 1997
compared to 4.8 to 1 at March 31, 1997.

      Significant  changes in balance sheet accounts  between March 31, 1997 and
June 30, 1997 relate  principally  to the  settlement  of the  Internal  Revenue
Service audit during the quarter and increased  inventory levels attributable to
continued higher demand for the Company's products.  These timing items are also
responsible for the significant  change in cash flows from operating  activities
between the current quarter and the same period a year ago.


      In March 1997 the Company's  Board of Directors  authorized the repurchase
of up to five million  shares of the Company's  outstanding  common  stock.  The
Company intends to purchase  shares  throughout the remainder of fiscal 1998 and
believes that this use of funds will not have an adverse affect on the Company's
operations.

Other Matters

      In June 1997 the Company's subsidiary Mylan Pharmaceuticals  Inc.("Mylan")
entered in to an  exclusive  supply and  distribution  agreement  with  Genpharm
Inc.("Genpharm") a Canadian corporation,  relating to the sale of ranitidine HCL
tablets ("ranitidine") in the United States subject to the

                                       -7-



<PAGE>



favorable resolution of several legal issues.  Ranitidine is the generic version
of Glaxo's  Zantac(R).  Both Mylan and Genpharm have received tentative approval
from  the FDA to  market  ranitidine;  however,  both  companies  are  currently
involved in separate court actions with Glaxo  regarding  patent related issues,
which prevent either company from marketing the product.

      Under the terms of the  agreement  Mylan and  Genpharm  will  share in the
combined  profits  resulting  from the sale,  by Mylan,  of  ranitidine  tablets
manufactured by either Mylan or Genpharm.  In addition,  the agreement  provides
that Mylan shall be  entitled to share in any benefit  received by Genpharm as a
result of Genpharm entering into any ageement with any third party,  which would
affect  either the  marketing  of  ranitidine  or  Genpharm's  ability to supply
product to Mylan.

      As  announced  by the  Company on July 24,  1997,  after a series of court
decisions,  Genpharm received notice from the FDA on July 23, 1997 that Genpharm
is entitled to generic marketing  exclusivity with regard to ranitidine  tablets
through August 29, 1997.  While Glaxo's initial patent  exclusivity  relating to
the product expired on July 25, 1997,  neither  Genpharm nor Mylan have resolved
their  respective  legal matters with Glaxo and accordingly  both are prohibited
from marketing their respective products.

      On July 31, 1997, Genpharm announced that it had reached an agreement with
Novopharm  Limited and its subsidiary  Granutec Inc.  ("Novopharm"),  a Canadian
corporation,  whereby  Genpharm  has  agreed  to  waive  its  generic  marketing
exclusivity  period in favor of Novopharm.  Novopharm had previously settled its
patent issues with Glaxo. Based on the agreement between Genpharm and Novopharm,
the FDA, on August 1, 1997 approved the Novopharm generic ranitidine product for
sale in the United States.  Presently the FDA will not approve any other generic
ranitidine until after August 29, 1997.

      Under the terms of the agreement between Genpharm and Novopharm,  Genpharm
will  be  entitled  to  receive  compensation  from  Novopharm  predicated  upon
Novopharm's sales of the product. Under the terms of the agreement between Mylan
and  Genpharm,  Mylan  will be  entitled  to  share in the  compensation  due to
Genpharm.

      In terms of branded product sales, ranitidine is recognized as the largest
branded product to encounter generic competition to date. The Company expects to
recognize  earnings as a result of these  aggreements  beginning  in the quarter
ending September 30, 1997.  However,  due to the various legal actions currently
pending,  legal  actions  which may result from the  marketing of the product by
Novopharm,  the complexity of the  contractual  agreements  described  above and
competition  which  will  occur  at  the  expiration  of the  generic  marketing
exclusivity  period,  the  Company  cannot at this time  reasonably  project the
extent, timing or duration of such future earnings.







                                       -8-



<PAGE>



PART II. OTHER INFORMATION


   Item 6. Exhibits and Reports on Form 8-K

   (a)      Exhibit 27 required by Item 601(c) of Regulation S-X filed herewith.

   (b)      Reports  on Form 8-K - There  were no  reports  filed on Form 8-K
               during the three months ended June 30, 1997.









                                   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 thereunto duly authorized.

                                          Mylan Laboratories Inc.
                                               (Registrant)



DATE__08/12/97________________________      _ /s/ Milan Puskar_________________
                                            Milan Puskar
                                            Chairman of the Board, Chief
                                            Executive Officer and President



DATE__08/12/97_______________________       __/s/ Frank A. DeGeorge____________
                                            Frank A. DeGeorge
                                            Director of Corporate Finance
















                                       -9-
WARNING: THE EDGAR SYSTEM ENCOUNTERED ERROR(S) WHILE PROCESSING THIS SCHEDULE.

<TABLE> <S> <C>
                                    
                                          
<ARTICLE>                     5           
<LEGEND>                                  
 
                             Financial Data Schedule
                    Mylan Laboratories Inc. and Subsidiaries
                          Article 5 of Regulation S-X

     The schedule  contains  summary  financial  information  extracted from the
Consolidated  Balance Sheets at June 30, 1997 and the Consolidated  Statement of
Earnings  for the three  months  ended  June 30,  1997 and is  qualified  in its
entirety by reference to such financial statements.
                                          
</LEGEND>                                 
<CIK>                         0000069499  
                                          
<S>                                 <C>       
<PERIOD-TYPE>                       3-MOS            
<FISCAL-YEAR-END>                   MAR-31-1998             

<PERIOD-END>                        JUN-30-1997              
                                               
<CASH>                               108,995,000             
<SECURITIES>                          15,062,000             
<RECEIVABLES>                        117,461,000             
<ALLOWANCES>                          10,432,000             
<INVENTORY>                          121,274,000             
<CURRENT-ASSETS>                     380,301,000             
<PP&E>                               203,793,000             
<DEPRECIATION>                        64,686,000             
<TOTAL-ASSETS>                       787,492,000             
<CURRENT-LIABILITIES>                 81,929,000             
<BONDS>                               39,744,000             
                          0             
                                    0              
<COMMON>                              61,412,000             
<OTHER-SE>                           611,215,000             
<TOTAL-LIABILITY-AND-EQUITY>         787,492,000             
<SALES>                              109,188,000             
<TOTAL-REVENUES>                     109,188,000             
<CGS>                                 61,379,000             
<TOTAL-COSTS>                         61,379,000         
<OTHER-EXPENSES>                      31,429,000         
<LOSS-PROVISION>                               0         
<INTEREST-EXPENSE>                       758,000         
<INCOME-PRETAX>                       22,341,000         
<INCOME-TAX>                           5,743,000         
<INCOME-CONTINUING>                   16,598,000         
<DISCONTINUED>                                 0         
<EXTRAORDINARY>                                0         
<CHANGES>                                      0         
<NET-INCOME>                          16,598,000         
<EPS-PRIMARY>                                .14         
<EPS-DILUTED>                                .14                       
                                     
                                
                                          

</TABLE>


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