MYLAN LABORATORIES INC
10-Q, 1998-11-16
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 September 30, 1998

                                       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                       November 6, 1998
       ---------------------                       ----------------
          $.50 par value                              128,621,728   

<PAGE>




                    MYLAN LABORATORIES INC. AND SUBSIDIARIES


                                      INDEX




                                                                    Page
                                                                   Number
                                                                  --------

PART I. FINANCIAL INFORMATION

        ITEM 1: Financial Statements

          Consolidated Balance Sheets - September 30, 1998
           and March 31, 1998                                     2A - 2B

          Consolidated Statements of Earnings - Three and Six
           Months Ended September 30, 1998 and 1997                  3

          Consolidated Statements of Cash Flows - Six
           Months Ended September 30, 1998 and 1997                  4

          Notes to Consolidated Financial Statements -
           Six Month Period Ended September 30, 1998               5 - 7

        ITEM 2: Management's Discussion and Analysis of
           Financial Condition and Results of
           Operations                                             8 - 11

PART II. OTHER INFORMATION

        ITEM 1: Legal Proceedings                                   12

        ITEM 4: Submission of Matters to a Vote of
                      Security Holders                              12

        ITEM 6:       Exhibits and Reports on Form 8-K              12














<PAGE>



                    MYLAN LABORATORIES INC. AND SUBSIDIARIES
                           CONSOLIDATED BALANCE SHEETS

                                     ASSETS




                                                   September 30,      March 31,
                                                         1998           1998
                                                     Unaudited        Audited
Current Assets:
    Cash and cash equivalents                       $138,223,000   $103,756,000
    Marketable securities                             15,956,000     20,967,000
    Accounts receivable - net                        157,618,000    136,864,000
    Inventories:
        Raw materials                                 67,743,000     63,308,000
        Work in process                               20,095,000     27,858,000
        Finished goods                                63,190,000     54,875,000
                                                    ------------   ------------
                                                     151,028,000    146,041,000
  Deferred income tax benefit                         13,600,000      7,845,000
    Prepaid and refundable income tax                  2,132,000      7,946,000
    Other current assets                               8,355,000      6,679,000
                                                    ------------   ------------
           Total Current Assets                      486,912,000    430,098,000


Property, Plant and Equipment - at cost              234,423,000    226,319,000
    Less accumulated depreciation                     82,119,000     74,907,000
                                                    ------------   ------------
                                                     152,304,000    151,412,000
Marketable Securities, non-current                    20,989,000     20,974,000
Investment in and Advances to Somerset                33,628,000     29,721,000
Intangible Assets-net of accumulated amortization    138,860,000    128,745,000
Other Assets                                          91,735,000     86,803,000
                                                    ------------   ------------
Total Assets                                        $924,428,000   $847,753,000
                                                    ============   ============




                 See Notes to Consolidated Financial Statements
                                      -2A-


<PAGE>



                      LIABILITIES AND SHAREH0LDERS' EQUITY



                                                 September 30,       March 31,
                                                          1998            1998
                                                     Unaudited         Audited
Current Liabilities:
    Trade accounts payable                        $ 13,331,000    $ 15,957,000
    Current portion of long-term obligations        18,414,000       8,477,000
    Income taxes payable                             3,495,000       5,377,000
    Other current liabilities                       45,582,000      36,635,000
    Cash dividends payable                           4,912,000       4,900,000
                                                  ------------    ------------
           Total Current Liabilities                85,734,000      71,346,000
Long-Term Obligations                               25,717,000      26,218,000
Deferred Income Tax Liability                        5,665,000       5,724,000
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
        123,275,067 shares at September 30,
        1998 and 123,050,172 shares at
        March 31, 1998                              61,638,000      61,525,000
    Additional paid-in capital                      95,469,000      92,405,000
    Retained earnings                              656,309,000     594,847,000
    Accumulated other comprehensive
    (expense)income                                  (470,000)       1,570,000
                                                 ------------
                                                   812,946,000     750,347,000
    Less Treasury stock - at cost, 812,828
        shares at September 30, 1998 and
        849,858 shares at March 31, 1998             5,634,000       5,882,000
                                                  ------------    ------------

Net Worth                                          807,312,000     744,465,000
                                                  ------------    ------------
Total Liabilities and Shareholders' Equity        $924,428,000    $847,753,000
                                                  ============    ============




                 See Notes to Consolidated Financial Statements
                                      -2B-


<PAGE>



                    MYLAN LABORATORIES INC. AND SUBSIDIARIES
                       CONSOLIDATED STATEMENTS OF EARNINGS
                                    UNAUDITED

<TABLE>
<S>                              <C>               <C>             <C>              <C>
                                  Three Months Ended September 30,    Six Months Ended September 30,
                                  --------------------------------    ------------------------------
                                           1998           1997            1998             1997
                                           ----           ----            ----             ----
REVENUES:
  Net Sales                           $ 177,592,000  $ 127,133,000   $ 344,310,000    $ 236,321,000
  Other Revenues                              -         26,822,000           -           26,822,000
                                      -------------  -------------   -------------    -------------
                                        177,592,000    153,955,000     344,310,000      263,143,000
COST AND EXPENSES:
    Cost of Sales                        85,548,000     71,201,000     167,112,000      132,580,000
    Research and Development             13,382,000     12,124,000      27,466,000       23,815,000
    Selling and Administrative           28,435,000     31,482,000      53,444,000       51,221,000
                                      -------------  -------------   -------------    -------------
                                        114,808,000     93,556,000     207,617,000      181,117,000
                                        127,365,000    114,807,000     248,022,000      207,616,000
EQUITY IN EARNINGS OF SOMERSET            2,142,000      2,456,000       4,492,000        6,592,000
OTHER INCOME                              4,078,000      4,437,000       8,112,000        6,263,000
                                      -------------  -------------   -------------    -------------
EARNINGS BEFORE INCOME TAXES             56,447,000     46,041,000     108,892,000       68,382,000
INCOME TAX RATE                              34%            34%             34%              31%

INCOME TAXES                             19,232,000     15,650,000      37,495,000       21,393,000
                                      -------------  -------------   -------------    -------------
NET EARNINGS                          $  37,215,000  $  30,391,000   $  71,397,000    $  46,989,000
                                      =============  =============   =============    =============
EARNINGS PER SHARE:
  Basic                               $         .30  $         .25   $         .58    $         .39
                                      =============  =============   =============    =============
  Diluted                             $         .30  $         .25   $         .58    $         .38
                                      =============  =============   =============    =============
WEIGHTED AVERAGE COMMON SHARES:
  Basic                                 122,408,000    122,029,000     122,352,000      122,047,000
                                      =============  =============   =============    =============
  Diluted                               123,809,000    123,102,000     123,943,000      123,071,000
                                      =============  =============   =============    =============

</TABLE>

                       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 SIX MONTHS ENDED SEPTEMBER 30, 1998 AND 1997
                                    UNAUDITED

                                                        1998           1997
                                                        ----           ----
CASH FLOWS FROM OPERATING ACTIVITIES
    Net Earnings                                    $ 71,397,000   $ 46,989,000
    Adjustments to reconcile net earnings to net
        cash provided from(used in)operating activities:
           Depreciation and amortization              11,154,000     10,529,000
           Deferred income taxes                      (4,716,000)    (1,108,000)
           Equity in earnings of Somerset             (4,492,000)    (6,592,000)
           Cash received from Somerset                   585,000      4,989,000
           Allowances on accounts receivable           8,287,000      5,500,000
           Other non-cash items                          323,000        866,000
        Changes in operating assets and liabilities:
           Accounts receivable                       (29,041,000)    (7,982,000)
           Inventories                                (5,181,000)   (31,555,000)
           Trade accounts payable                     (2,626,000)      (817,000)
           Income taxes payable                        3,932,000     (5,115,000)
           Other operating assets and liabilities      7,271,000    (22,682,000)
                                                     ------------  -------------
Net cash provided from(used in)operating activities   56,893,000     (6,978,000)
CASH FLOWS FROM INVESTING ACTIVITIES
    Additions to property, plant and equipment        (8,104,000)   (11,196,000)
    Increase in intangible and other assets           (3,084,000)    (4,465,000)
    Proceeds from investment securities               13,853,000      7,706,000
    Purchase of investment securities                (11,995,000)    (6,776,000)
                                                    -------------   ------------
Net cash used in investing activities                 (9,330,000)   (14,731,000)
CASH FLOWS FROM FINANCING ACTIVITIES
    Payments on long-term obligations                 (6,139,000)    (1,416,000)
    Cash dividends paid                               (9,781,000)    (9,764,000)
    Repurchase of Common Stock                             -         (1,507,000)
    Proceeds from exercise of stock options            2,824,000      1,302,000
                                                     ------------   ------------
Net cash used in financing activities                (13,096,000)   (11,385,000)
                                                    ------------   ------------
Net Increase(Decrease)in Cash and Cash Equivalents    34,467,000    (33,094,000)
Cash and Cash Equivalents - Beginning of Period      126,156,000    176,980,000
                                                    -------------   ------------




Cash and Cash Equivalents - Beginning of Period      103,756,000    126,156,000
                                                     ------------  ------------
Cash and Cash Equivalents - End of Period           $138,223,000   $ 93,062,000
                                                     ============  ============

CASH PAID DURING THE PERIOD FOR:
    Interest                                        $    275,000   $    350,000
    Income Taxes                                    $ 38,329,000   $ 27,640,000





                 See Notes to Consolidated Financial Statements
                                       -4-


<PAGE>



                    MYLAN LABORATORIES INC. AND SUBSIDIARIES
                   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
                             SIX MONTH PERIOD ENDED
                               SEPTEMBER 30, 1998
                                    Unaudited


A.    In the opinion of management, the accompanying unaudited consolidated
      financial statements contain all adjustments (consisting of only normal
      recurring accruals) necessary to present fairly the financial position of
      the Company as of September 30, 1998 and March 31, 1998 together with the
      results of operations and cash flows for the interim periods ended
      September 30, 1998 and 1997.  The consolidated results of operations for
      the three and six months ended September 30, 1998 and 1997 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 1998
      Annual Report and Report on Form 10-K.

C.    Diluted earnings per share is computed by dividing net earnings  available
      to common  shareholders by the weighted average common shares  outstanding
      adjusted for the dilutive  effect of options  granted  under the Company's
      stock option plans.  The effect of dilutive  stock options on the weighted
      average  shares  outstanding  was  1,401,000  and  1,073,000 for the three
      months ending  September 30, 1998 and 1997 and 1,591,000 and 1,024,000 for
      the six months ending September 30, 1998 and 1997.

D.    Total  comprehensive  income for the three and six months ended  September
      30, 1998 and 1997 are as follows: (in thousands)



                                  Three Months Ended      Six Months Ended
                                      September 30,         September 30,
                                      -------------         -------------
                                     1998      1997         1998     1997
                                     ----      ----         ----     ----
Net earnings                       $37,215   $30,391      $71,397   $46,989
Unrealized (loss)gain on
marketable securities, net of tax     (548)    1,625       (2,040)    2,716
                                   -------   -------      -------  -------
Comprehensive Income               $36,667   $32,016      $69,357   $49,705
                                   =======   =======      =======   =======


      Accumulated  other  comprehensive  (expense)income,  as  reflected  on the
      balance sheet,  was comprised  solely of the unrealized  (loss) or gain on
      marketable securities net of income tax.







                                       -5-


<PAGE>



                    MYLAN LABORATORIES INC. AND SUBSIDIARIES
                   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
                             SIX MONTH PERIOD ENDED
                               SEPTEMBER 30, 1998
                                    Unaudited


E.    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 and
      six month periods ended September 30, 1998 and 1997 are as follows: (in
      thousands)


                     Three Months Ended           Six Months Ended
                        September 30,               September 30,
                        -------------               -------------
                       1998      1997             1998      1997
                       ----      ----             ----      ----
Net Sales             $12,998   $15,110          $25,628   $32,383

Costs and Expenses      5,997     8,007           10,899    13,254

Income Taxes            2,904     2,485            6,079     6,640
                      -------   -------          -------   -------
Net Earnings          $ 4,097   $ 4,618          $ 8,650   $12,489
                      =======   =======          =======   =======

      The above  information  represents 100% of Somerset's  operations of which
      the Company has a 50% interest.

F.    On October 2, 1998 the Company acquired all the outstanding shares of
      Penederm Inc. through the issuance of approximately 5,900,000 shares of
      the Company's common stock.  Penederm primarily develops and markets
      patented topical prescription products.  Penederm maintains administrative
      and research and development facilities in Foster City, California.  The
      total purchase price of approximately $205,000,000 included the value of
      the Company's common stock as well as the value assigned to the Company's
      options issued in the exchange for all the outstanding Penederm options.
      The Company plans on recording a one-time charge estimated for the cost of
      acquired in-process research and development of $150,000,000 in the third
      quarter.  The remaining assets acquired, consisting principally of
      intangibles are to be amortized over a period not to exceed 25 years.  The
      amounts recorded will be based on a final independent valuation of the net
      assets acquired.








                                       -6-


<PAGE>



                    MYLAN LABORATORIES INC. AND SUBSIDIARIES
                   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
                             SIX MONTH PERIOD ENDED
                               SEPTEMBER 30, 1998
                                    Unaudited

G.    Under the terms of the Company's  supply and  distribution  agreement with
      Genpharm Inc.  ("Genpharm")  relating to sales of  ranitidine  HCL tablets
      ("ranitidine")  the  Company  is to share  in any  benefit  that  Genpharm
      receives from its agreement  with  Novopharm  Limited  ("Novopharm").  The
      Company  recognized  revenue of $26,822,000 in the quarter ended September
      30, 1997 in connection with the Genpharm Novopharm  arrangement.  However,
      as a result  of a dispute  between  Genpharm  and  Novopharm  relating  to
      contract  interpretation,  the Company has not  recognized  any additional
      revenue  related  to their  agreement.  Based upon an  independent  audit,
      Genpharm  initiated  suit  against  Novopharm  to resolve  and collect any
      additional  funds due. In response to  Genpharm's  suit,  Novopharm  filed
      counterclaims  against both Genpharm and the Company. The Company believes
      the  counterclaims  against Genpharm and the Company are without merit and
      will vigorously defend its position.

H.    As a result of price increases in the generic industry the Company
      received notification from the Federal Trade Commission ("FTC") that it is
      investigating whether the Company and others have engaged in activities
      restricting competition in the manufacture or sale of pharmaceutical
      ingredients or products.  The Company is cooperating fully with the
      inquiry and is providing the information requested by the FTC.  The FTC
      has completed the initial investigative stage of the inquiry.  As with all
      governmental inquiries the duration and outcome is inherently uncertain.
      However, management believes that the Company has acted properly and in
      full compliance with the Federal Trade Commission Act and all other laws
      and regulations governing trade and competition in the marketplace, and
      that the ultimate resolution of this matter will not have a material
      adverse effect on the Company's financial position or results of
      operations.

I.    In August 1997, Key Pharmaceuticals ("Key") filed suit in the United 
      States District Court for the Western District of Pennsylvania against the
      Company and certain subsidiaries alleging patent infringement relating to
      the marketing of its nitroglycerin transdermal system.  The Company
      received FDA approval for its nitroglycerin transdermal system in
      September 1996 and immediately began marketing the product.  The relief
      sought includes a preliminary and permanent injunction, treble damages
      along with interest and attorney's fees and expenses.  On September 25,
      1998 Key's request for a preliminary injunction was denied and the suit is
      currently in the trial stage.  The Company continues to believe the suit
      is without merit and is vigorously defending its position.







                                       -7-


<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  three  months  ended   September  30,  1998  were
$37,215,000,  representing  a 22% increase over the same quarter a year ago. Net
earnings  for the six months  then ended were  $71,397,000,  representing  a 52%
increase over the same period a year ago. Net sales increased 40% from last year
to $177,592,000 for the current quarter and gross profit (net sales less cost of
goods sold) as a  percentage  of net sales  increased  from 44% last year to 52%
this  year.  For the six  month  period  ended  September  30,  1998,  net sales
increased 46% from the same period last year to $344,310,000 and gross profit as
a percentage of net sales increased from 44% last year to 51% this year.

      Improved operating results were realized in all of the Company's operating
divisions including a 29% increase in net sales at Bertek  Pharmaceuticals Inc.,
the Company's branded  division,  due to the addition of five new products and a
similar increase in unit dose sales through the UDL Laboratories  division.  The
most  significant  improvements  came  from  Mylan  Pharmaceuticals,  Inc.,  the
Company's generic division,  primarily as a result of the favorable impact
of selective price increases on 14 products,  seven of which were implemented in
the last half of fiscal  1998 and  seven  more  which  were  implemented  in the
quarter ended June 30, 1998. In addition,  overall shipment volumes increased to
3.9 billion units for this six month period versus 3.5 billion units for the six
month period last year and nine product line additions were made since September
30, 1997.

      The  decision  to  increase  prices was made in light of  continued  price
deterioration  and increased  costs involved in bringing new products to market,
primarily  resulting  from legal  challenges  under the  Hatch-Waxman  Act.  The
products  selected for increases  and the amount of the increases  were based on
numerous factors, including product line contribution, market size, competition,
raw material  suppliers and  manufacturing  capacity.  The Company has chosen to
increase  prices in order to ensure the  Company's  full line of low-cost,
effective,  quality  generic  alternatives  continues  to be  available  to  the
American public.

      While  these  price  increases  have  favorably  impacted  earnings in the
current  periods,  the  extent if any in future  periods  depends  upon  several
factors,  some of which are  beyond  the  Company's  control.  During  the
quarter ended June 30, 1998, the Company  received notice that the FTC, in light
of the price  increases in the generic  market,  was  investigating  whether the
Company  and others had engaged in  activities  restricting  competition  in the
manufacture or sale of pharmaceutical ingredients or products (see note H).






                                       -8-


<PAGE>




      The Company is cooperating fully with this  investigation and is supplying
the documents requested. Management believes that the Company has acted properly
and in full compliance with the Federal Trade  Commission Act and all other laws
and regulations governing trade and competition in the marketplace.  The Company
fully intends to (1) assert its positions  vigorously  with the FTC, (2) fulfill
its contractual  obligations under existing supply agreements for pharmaceutical
ingredients, (3) maintain where possible its current pricing levels for products
for which prices have recently been increased, and (4) continue to examine other
products to determine if price increases are  appropriate.  The Company believes
the ultimate  resolution of this matter will not have a material  adverse effect
on the Company's financial position or results of operations.

      Net  earnings  were  favorably  impacted in the three month  period  ended
September 30, 1997 with the recording of $26,822,000 of "Other Revenue" relating
to an agreement the Company has with Genpharm for the sale of  ranitidine.  This
income  represents  the  Company's  portion  of the  revenue  received  by
Genpharm from Novopharm under a separate agreement between the two companies for
the sale of ranitidine (see note G).

      Research and  development  expenses of $13,382,000 for the current quarter
are 10% higher  than the same  quarter  last year and year to date  expenses  of
$27,466,000  are 15% higher than last year.  The Company is committed to funding
research projects for branded, generic and transdermal products in order to grow
its various product lines.

      The Company is  currently  in  litigation  with  respect to its equity and
funding  investments  in VivoRx,  Inc.  and VivoRx  Diabetes,  Inc.(collectively
"VivoRx"),  certain VivoRx directors and certain of their affiliated  companies.
The Company  initiated this  litigation  based upon  improprieties  which became
apparent  during the quarter ended June 30, 1998. The litigation is in the early
stages of discovery. The Company is continuing to evaluate its options regarding
its  investments  and the future  funding of diabetes  research  pursuant to its
Exclusive License Agreement with VivoRx.

      Selling and administrative expenses for the six months ended September 30,
1998 were $53,444,000,  which represents a 4% increase over the same period last
year.  The increase is  primarily  due to legal  expenditures  related to patent
challenges under the  Hatch-Waxman Act and higher payroll and related  expenses.
These  increases  were  partially  off-set  by a  decrease  in  advertising  and
promotional  programs  which were  unusually  high in the six month period ended
September 30, 1997 due to the launch of ranitidine  and other generic  products.
The decrease in advertising and promotional programs also contributed to the 10%
decrease in selling and  administrative  expenses to  $28,435,000  for the three
month period ended  September 30, 1998,  in spite of a  significant  increase in
legal expenses.

      Other income  increased 30% to  $8,112,000  for the six month period ended
September  30,  1998.  The  improvement  is due to the  increase in cash and the
earnings related to investments, primarily pooled asset funds.




                                       -9-



<PAGE>



      The change in the effective tax rate to 34% for the six month period ended
September  30,  1998  from  31%  over the same  period  last  year is  primarily
attributable  to the increase in domestic  earnings versus Puerto Rican earnings
which are subject to a federal tax credit.

Liquidity and Capital Resources and Financial Condition

      Working  capital   increased  from  $358,752,000  at  March  31,  1998  to
$401,178,000  at  September  30,  1998.  The ratio of current  assets to current
liabilities was 5.7 to 1 at September 30, 1998 compared to 6.0 to 1 at March 31,
1998.

      Net cash provided from operating  activities was  $56,893,000  for the six
months  ended  September  30,  1998  compared  to net  cash  used  in  operating
activities  of  $6,978,000  for the six months ended  September  30, 1997.  This
improvement  resulted  primarily  from  increased net earnings for the six-month
period ended September 30, 1998 compared to the six-month period ended September
30, 1997 as well as the collection of funds  associated  with a receivable  from
Genpharm recorded in "Other current assets" in the prior year.

Year 2000

The  Company  has  completed  an  initial  review  of its  critical  information
technology ("IT") and non-IT operating systems for Year 2000 ("Y2K") compliance.
On the  basis  of this  review,  management  has  concluded  that  the  costs of
remediation  and  potential  losses  related  to issues are  unlikely  to have a
material  effect on the Company's  financial  position,  results of operation or
cash flows.

In assessing  potential  issues,  the Company has taken the  following  steps to
address its IT and non-IT operating systems:

      - Formed a project team across functional departments to complete a review
and identify nonconforming systems.

      - Communicated to employees  throughout the Company to increase  awareness
of issues and activate the identification process.

      - Identified  critical IT and non-IT  nonconforming  operating systems and
developed a plan to bring these systems into compliance.

      - Corresponded  with customers,  vendors,  service suppliers and financial
institutions to verify their readiness.

      -  Established a testing program to ensure that such systems are
compliant.

      -  Developed contingency plans where practical in the event of system
failures.






                                      -10-


<PAGE>



      Because of the continued growth of the Company over the last several years
and prior to the  formation of the project  team,  the Company  initiated  major
system   conversions  to  accommodate  the  physical   expansion  and  increased
transaction  volume  associated  with this growth.  Many factors were considered
during  the  selection  process.  While Y2K  compliance  was one of the  factors
considered, other factors were equally and significantly more important. Any new
systems  selected  were  expected  to  be  Y2K  compliant.  Due  to  the  recent
independent upgrades and replacements of its computer systems to accommodate its
growth,  the  Company  has not been  required  to spend  nor does it  anticipate
spending  significant  incremental funds to become Y2K compliant.  The funds for
system  conversions will be financed through  operating  revenue of the Company.
Such  conversions are currently on schedule and are expected to meet the testing
schedule  established by the project team.  The Company has neither  delayed nor
anticipates  delaying any significant  information  system projects prior to the
year 2000.

      Management believes that the Company has acted with appropriate  diligence
to address  potential Y2K issues and that such issues will not materially affect
its business or operations.  The Company is, however dependent on third parties,
such as its customers, vendors, service suppliers and financial institutions, to
make their own systems Y2K compliant. If these entities fail to remedy their Y2K
issues,  the Company  could  potentially  suffer  interruptions  in its business
operations.  These  interruptions  could  potentially  delay the  Company in its
manufacturing or distribution of its products.  Furthermore, no assurance can be
given that the  efforts  of the  project  team will  successfully  remedy  every
non-compliant system or foresee the consequences of all Y2K issues.

Forward Looking Statements

      The  statements  set forth in this Item 2 under  "Results  of  Operations"
concerning  the  manner in which  the  Company  intends  to  respond  to the FTC
investigation  and to conduct its  operations in the face of this  investigation
are forward-looking  statements.  The Company may be unable to realize the plans
and objectives  described therein due to various important  factors,  including,
but not limited to, the factors described under "Forward Looking  Statements" in
Item 7 of the Company's  Annual Report on Form 10-K for the year ended March 31,
1998,  or if the FTC  concludes,  on the  basis of its  investigation,  that the
Company has acted improperly.

      In addition,  the statements  under  "Liquidity and Capital  Resources and
Financial  Condition-Year  2000"  which  express the  Company's  belief that Y2K
issues  will not have a  material  adverse  effect  on the  Company  may also be
forward-looking  statements.  Factors which could cause the Company to be unable
to avoid any material Y2K issues  include the failure of its Y2K project team to
identify latent or other non-compliant codes or technologies, the failure of any
of the customers,  vendors,  service  suppliers or financial  institutions  with
which the  Company  transacts  business  to address  their own Y2K issues or the
ineffectiveness  of any contingent plans  implemented by the Company to mitigate
the effects of interruptions in its business due to Y2K issues.




                                      -11-


<PAGE>



PART II. OTHER INFORMATION

      Item 1. Legal Proceedings

      There have been no material  developments  to the  information  previously
disclosed in the Company's periodic filings regarding  litigation except for the
Key  Pharmaceutical  ("Key") suit.  On September  25, 1998,  Key's request for a
preliminary  injunction was denied and the case is currently in the trial stage.
The  Company  continues  to  believe  that  this  suit is  without  merit and is
vigorously defending its position at trial.

      Item 4. Submission of Matters to a Vote of Security Holders

      On July  30,  1998  the  shareholders  overwhelmingly  elected  the  seven
directors nominated and the independent  auditors of the Company as described in
the Company's 1998 Proxy Statement.


      Item 6. Exhibits and Reports on Form 8-K


      (a)      27.1 Financial Data Schedule.

      (b)      Reports  on Form  8-K - On  August  26,  1998 the  Company  filed
               reports on Forms 8-K and 8-K/A under Item 5 announcing the filing
               of the Form S-4  registration  statement for the shares  required
               for the acquisition of Penederm Inc.


                                   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
                                     Milan Puskar
                                     Chairman of the Board, Chief
                                     Executive Officer and President
                                     (Principal executive officer)



DATE
                                     Donald C. Schilling
                                     Vice President of Finance
                                     (Principal financial officer)




                                      -12-




<TABLE> <S> <C>


<ARTICLE>             5

<LEGEND>

Exhibit 27
                             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 Sheet at September 30, 1998 and the
Consolidated Statement of Earnings for the six months ended September
30, 1998 and is qualified in its entirety by reference to such
consolidated financial statements.
Item Description
- - ----------------
</LEGEND>

<CIK>                                 0000069499  
<NAME>                                   none
                                          
<S>                                 <C>       
<PERIOD-TYPE>                          6-MOS            
<FISCAL-YEAR-END>                     MAR-31-1999             

<PERIOD-END>                          SEP-30-1998              
                                               
<CASH>                                 138,223,000            
<SECURITIES>                            15,956,000            
<RECEIVABLES>                          189,290,000            
<ALLOWANCES>                            31,672,000            
<INVENTORY>                            151,028,000            
<CURRENT-ASSETS>                       486,912,000            
<PP&E>                                 234,423,000            
<DEPRECIATION>                          82,119,000            
<TOTAL-ASSETS>                         924,428,000            
<CURRENT-LIABILITIES>                   85,734,000            
<BONDS>                                 30,254,000            
                            0            
                                      0             
<COMMON>                                61,638,000            
<OTHER-SE>                             745,674,000            
<TOTAL-LIABILITY-AND-EQUITY>           924,428,000            
<SALES>                                344,310,000            
<TOTAL-REVENUES>                       344,310,000            
<CGS>                                  167,112,000            
<TOTAL-COSTS>                          167,112,000                                         
<OTHER-EXPENSES>                        80,910,000        
<LOSS-PROVISION>                           296,000        
<INTEREST-EXPENSE>                         890,000        
<INCOME-PRETAX>                        108,892,000        
<INCOME-TAX>                            37,495,000        
<INCOME-CONTINUING>                     71,397,000        
<DISCONTINUED>                                   0        
<EXTRAORDINARY>                                  0     
<CHANGES>                                        0     
<NET-INCOME>                            71,397,000     
<EPS-PRIMARY>                                  .58        
<EPS-DILUTED>                                  .58                      
                                                  
                                                  
                                    

</TABLE>


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