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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

For the quarterly period ended December 31, 2004

OR

o     TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____________ to ____________

Commission file number 1-9114

MYLAN LABORATORIES INC.

(Exact name of registrant as specified in its charter)
     
Pennsylvania
(State of incorporation)
  25-1211621
(I.R.S. Employer Identification No.)

1500 Corporate Drive
Canonsburg, Pennsylvania 15317
(Address of principal executive offices)
(Zip Code)

(724) 514-1800
(Registrant’s telephone number, including area code)

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 þ NO o

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). YES þ NO o

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

     
Class of
Common Stock
  Outstanding at
February 3, 2005
     
$0.50 par value   269,241,972
 
 

 


MYLAN LABORATORIES INC. AND SUBSIDIARIES

FORM 10-Q
For the Quarterly Period Ended
December 31, 2004

INDEX

     
    Page
    Number
PART I. FINANCIAL INFORMATION
   
Item 1: Financial Statements
   
  3
  4
  5
  6
  15
  32
  32
   
  33
  34
  36
 EX-10.1
 EX-10.2
 EX-10.3
 EX-10.4
 EX-10.5
 EX-10.6
 EX-10.7
 EX-10.8
 EX-10.9
 EX-10.10
 EX-10.11
 EX-10.12
 EX-10.13
 EX-31.1
 EX-31.2
 EX-32

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MYLAN LABORATORIES INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Earnings
(unaudited; in thousands, except per share amounts)
                                 
    Three Months     Nine Months  
Period Ended December 31,   2004     2003     2004     2003  
Revenues:
                               
Net revenues
  $ 290,972     $ 336,543     $ 936,939     $ 1,027,344  
Other revenue
          13,243             13,910  
 
                       
Total revenues
    290,972       349,786       936,939       1,041,254  
Cost of sales
    155,625       150,602       466,586       456,933  
 
                       
Gross profit
    135,347       199,184       470,353       584,321  
 
                       
 
                               
Operating expenses:
                               
Research & development
    23,167       25,248       66,704       73,933  
Selling & marketing
    19,661       18,027       59,552       53,137  
General & administrative
    43,537       33,096       121,080       95,016  
Litigation settlements, net
          (2,676 )     (25,985 )     (24,345 )
 
                       
Total operating expenses
    86,365       73,695       221,351       197,741  
 
                       
 
                               
Earnings from operations
    48,982       125,489       249,002       386,580  
Other income, net
    3,699       4,194       6,295       14,727  
 
                       
 
                               
Earnings before income taxes
    52,681       129,683       255,297       401,307  
Provision for income taxes
    17,911       45,065       89,840       141,548  
 
                       
Net earnings
  $ 34,770     $ 84,618     $ 165,457     $ 259,759  
 
                       
 
                               
Earnings per common share:
                               
Basic
  $ 0.13     $ 0.32     $ 0.62     $ 0.97  
 
                       
Diluted
  $ 0.13     $ 0.31     $ 0.60     $ 0.94  
 
                       
 
                               
Weighted average common shares:
                               
Basic
    269,165       268,560       268,888       269,141  
 
                       
Diluted
    273,139       276,881       273,826       276,478  
 
                       
 
                               
Cash dividend declared per common share
  $ 0.03     $ 0.03     $ 0.09     $ 0.07  
 
                       

See Notes to Condensed Consolidated Financial Statements

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MYLAN LABORATORIES INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets
(unaudited; in thousands)
                 
    December 31,     March 31,  
    2004     2004  
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 183,313     $ 101,713  
Marketable securities
    651,952       585,445  
Accounts receivable, net
    196,390       191,094  
Inventories
    292,385       320,797  
Deferred income tax benefit
    84,083       78,477  
Other current assets
    31,567       40,315  
 
           
Total current assets
    1,439,690       1,317,841  
 
               
Property, plant and equipment, net
    316,902       273,051  
Intangible assets, net
    123,274       134,601  
Goodwill
    102,579       102,579  
Other assets
    46,149       47,218  
 
           
Total assets
  $ 2,028,594     $ 1,875,290  
 
           
 
               
Liabilities and shareholders’ equity
               
Liabilities
               
Current liabilities:
               
Trade accounts payable
  $ 60,857     $ 40,639  
Income taxes payable
          23,837  
Other current liabilities
    108,742       109,292  
 
           
Total current liabilities
    169,599       173,768  
 
               
Long-term obligations
    18,747       19,130  
Deferred income tax liability
    25,222       22,604  
 
           
 
               
Total liabilities
    213,568       215,502  
 
           
 
               
Shareholders’ equity
               
Common stock
    152,185       151,777  
Additional paid-in capital
    352,533       338,143  
Retained earnings
    1,778,745       1,637,497  
Accumulated other comprehensive earnings
    1,688       2,496  
 
           
 
    2,285,151       2,129,913  
 
               
Less:
               
Treasury stock at cost
    470,125       470,125  
 
           
Total shareholders’ equity
    1,815,026       1,659,788  
 
           
Total liabilities and shareholders’ equity
  $ 2,028,594     $ 1,875,290  
 
           

See Notes to Condensed Consolidated Financial Statements

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MYLAN LABORATORIES INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows
(unaudited; in thousands)
                 
Nine Months Ended December 31,   2004     2003  
Cash flows from operating activities:
               
Net earnings
  $ 165,457     $ 259,759  
Adjustments to reconcile net earnings to net cash provided from operating activities:
               
Depreciation and amortization
    33,426       32,718  
Deferred income tax (benefit) expense
    (1,883 )     25,942  
Net earnings from equity method investees
    2,146       2,774  
Cash received from Somerset
          10,000  
Changes in estimated sales allowances
    2,934       (6,773 )
Gain on sale of building
          (5,000 )
Other non-cash items
    6,558       (1,643 )
Gain from litigation settlements, net
    (25,985 )     (24,345 )
Receipts from (payments for) litigation settlements, net
    42,985       (16,630 )
Changes in operating assets and liabilities:
               
Accounts receivable
    (12,806 )     (13,039 )
Inventories
    28,412       (73,828 )
Trade accounts payable
    20,218       (2,368 )
Income taxes
    (22,009 )     34,328  
Other operating assets and liabilities, net
    (17,230 )     (12,910 )
 
           
Net cash provided from operating activities
    222,223       208,985  
 
           
 
               
Cash flows from investing activities:
               
Capital expenditures
    (63,205 )     (88,979 )
Purchase of marketable securities
    (607,144 )     (581,139 )
Proceeds from sale of marketable securities
    539,345       441,791  
Liquidation of equity investment
          7,269  
Proceeds from sale of building
          12,000  
Other items
    5,204       (1,498 )
 
           
Net cash used in investing activities
    (125,800 )     (210,556 )
 
           
 
               
Cash flows from financing activities:
               
Cash dividends paid
    (24,184 )     (17,980 )
Purchase of common stock
          (133,088 )
Proceeds from exercise of stock options
    9,361       24,369  
 
           
Net cash used in financing activities
    (14,823 )     (126,699 )
 
           
 
               
Net increase (decrease) in cash and cash equivalents
    81,600       (128,270 )
Cash and cash equivalents - beginning of period
    101,713       258,902  
 
           
Cash and cash equivalents - end of period
  $ 183,313     $ 130,632  
 
           
 
               
Additional disclosures:
               
Cash paid for income taxes
  $ 115,192     $ 81,279  
 
           
 
               
Non-cash financing activities:
               
Issuance of restricted stock
  $     $ 11,740  
 
           

See Notes to Condensed Consolidated Financial Statements

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MYLAN LABORATORIES INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements
(unaudited; in thousands, except share and per share amounts)

1. General

     In the opinion of management, the accompanying unaudited condensed consolidated financial statements (interim financial statements) of Mylan Laboratories Inc. and subsidiaries (“Mylan” or “the Company”) were prepared in accordance with accounting principles generally accepted in the United States of America and the rules and regulations of the Securities and Exchange Commission for reporting on Form 10-Q; therefore, as permitted under these rules, certain footnotes and other financial information included in audited financial statements were condensed or omitted. The interim financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the interim results of operations, financial position and cash flows for the periods presented.

     These interim financial statements should be read in conjunction with the Consolidated Financial Statements and Notes thereto in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2004.

     Certain prior year amounts were reclassified to conform to the current year presentation. Such reclassifications had no impact on reported net earnings, earnings per share or shareholders’ equity.

     The interim results of operations for the three and nine months ended December 31, 2004, and the interim cash flows for the nine months ended December 31, 2004, are not necessarily indicative of the results to be expected for the full fiscal year or any other future period.

2. Revenue Recognition and Accounts Receivable

     Revenue is recognized for product sales upon shipment when title and risk of loss transfer to the Company’s customers and when provisions for estimates, including discounts, rebates, price adjustments, returns, chargebacks and other promotional programs are reasonably determinable. No revisions were made to the methodology used in determining these provisions during the three and nine month periods ended December 31, 2004. Accounts receivable are presented net of allowances relating to these provisions. Such allowances were $269,044 and $264,170 as of December 31, 2004, and March 31, 2004. Other current liabilities include $26,238 and $28,178 at December 31, 2004, and March 31, 2004, for certain rebates and other adjustments that are payable to indirect customers.

     The following is a rollforward of the most significant provisions for estimated sales allowances during the nine months ended December 31, 2004:

                                 
            Checks/Credits     Provisions        
    Balance     Issued     Recorded in     Balance  
    March 31, 2004     to Third Parties     Current Period     December 31, 2004  
Chargebacks
  $ 144,121     $ (652,086 )   $ 651,271     $ 143,306  
Customer performance and promotions
  $ 61,058     $ (144,753 )   $ 148,474     $ 64,779  
Returns
  $ 45,311     $ (27,346 )   $ 25,610     $ 43,575  

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3. Recent Accounting Pronouncements

     In December 2004, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 123(R), Share-Based Payment. SFAS 123(R) establishes standards for the accounting for transactions in which an entity exchanges its equity instruments for goods and services. Under SFAS 123(R), companies will no longer be able to account for share-based compensation transactions using the intrinsic method in accordance with Accounting Principles Board Opinion (“APB”) No. 25, Accounting for Stock Issued to Employees. Instead, companies will be required to account for such transactions using a fair-value method and to recognize compensation expense over the period during which an employee is required to provide services in exchange for the award. The provisions of SFAS 123 (R) are effective for periods beginning after June 15, 2005, and apply to all awards that vest after the required effective date and to awards that are granted, modified, repurchased, or cancelled after that date. Management is currently assessing the impact that adoption of this Statement will have on the Company’s Consolidated Financial Statements.

4. Balance Sheet Components

     Selected balance sheet components consist of the following:

                 
    December 31,     March 31,  
    2004     2004  
Inventories:
               
Raw materials
  $ 124,324     $ 149,048  
Work in process
    37,626       34,511  
Finished goods
    130,435       137,238  
 
           
 
  $ 292,385     $ 320,797  
 
           
 
               
Property, plant and equipment:
               
Land and improvements
  $ 9,761     $ 9,704  
Buildings and improvements
    148,118       132,983  
Machinery and equipment
    259,573       240,594  
Construction in progress
    82,178       54,181  
 
           
 
    499,630       437,462  
Less — accumulated depreciation
    182,728       164,411  
 
           
 
  $ 316,902     $ 273,051  
 
           
 
               
Other current liabilities:
               
Accrued rebates
  $ 26,238     $ 28,178  
Payroll and employee benefit plan accruals
    35,913       20,644  
Royalties and product license fees
    9,689       20,493  
Legal and professional
    15,203       13,650  
Cash dividends payable
    8,076       8,052  
Current portion of long-term obligations
    1,604       1,586  
Other
    12,019       16,689  
 
           
 
  $ 108,742     $ 109,292  
 
           

5. Earnings per Common Share

     Basic earnings per common share is computed by dividing net earnings by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed by dividing net earnings by the weighted average number of common shares outstanding during the period adjusted for the dilutive effect of stock options and restricted stock outstanding. The effect of dilutive stock options on the weighted average number of common shares outstanding was 3,974,000 and 8,321,000 for the three months ended December 31, 2004 and 2003 and 4,938,000 and 7,337,000 for the nine months ended December 31, 2004 and 2003.

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     Options to purchase 6,804,000 and 35,000 shares of common stock were outstanding as of December 31, 2004 and 2003, but were not included in the computation of diluted earnings per share for the three months then ended because to do so would have been antidilutive.

6. Intangible Assets

     Intangible assets consist of the following components:

                                 
    Weighted                    
    Average Life     Original     Accumulated     Net Book  
    (years)     Cost     Amortization     Value  
December 31, 2004
                               
 
                               
Amortized intangible assets:
                               
Patents and technologies
    19     $ 117,435     $ 46,934     $ 70,501  
Product rights and licenses
    12       111,433       67,367       44,066  
Other
    20       14,267       6,343       7,924  
 
                         
 
          $ 243,135     $ 120,644       122,491  
 
                           
 
                               
Intangible assets no longer subject to amortization:
                               
Trademarks
                            783  
 
                             
 
                          $ 123,274  
 
                             
 
                               
March 31, 2004
                               
 
                               
Amortized intangible assets:
                               
Patents and technologies
    19     $ 117,435     $ 42,304     $ 75,131  
Product rights and licenses
    12       109,333       59,111       50,222  
Other
    20       14,267       5,802       8,465  
 
                         
 
          $ 241,035     $ 107,217       133,818  
 
                           
 
                               
Intangible assets no longer subject to amortization:
                               
Trademarks
                            783  
 
                             
 
                          $ 134,601  
 
                             

     Amortization expense for the nine months ended December 31, 2004, and 2003 was $13,427 and $15,003 and is expected to be $14,341, $14,063, $13,611, $13,300 and $12,282 for fiscal years 2006 through 2010, respectively.

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7. Comprehensive Earnings

     Comprehensive earnings consist of the following:

                                 
    Three Months     Nine Months  
Period Ended December 31,   2004     2003     2004     2003  
Net earnings
  $ 34,770     $ 84,618     $ 165,457     $ 259,759  
Other comprehensive earnings net of tax:
                             
Net unrealized (loss) gain on marketable securities
  (490 )     (891 )     (893 )     1,722  
Reclassification for (gains) losses included in net earnings
  (29 )     (1,953 )     85       (2,228 )
 
                       
 
    (519 )     (2,844 )     (808 )     (506 )
 
                       
 
                               
Comprehensive earnings
$ 34,251     $ 81,774     $ 164,649     $ 259,253  
 
                       

     Accumulated other comprehensive earnings, as reflected on the balance sheet, is comprised solely of the net unrealized gain on marketable securities, net of deferred income taxes.

8.   Common Stock

     As of December 31, 2004, and March 31, 2004, there were 600,000,000 shares of common stock authorized with 304,369,702 and 303,553,121 shares issued. Treasury shares held as of both December 31, 2004, and March 31, 2004, were 35,129,643.

     In May 2002, the Board of Directors approved a Stock Repurchase Program to purchase up to 22,500,000 shares of the Company’s outstanding common stock. During the nine months ended December 31, 2003, the Company purchased 6,458,700 shares for approximately $133,088. The Stock Repurchase Program was completed on November 18, 2003.

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9. Stock Option Plans

     On July 25, 2003, Mylan shareholders approved the Mylan Laboratories Inc. 2003 Long-Term Incentive Plan (“the 2003 Plan”). Under the 2003 Plan, 22,500,000 shares of common stock are reserved for issuance to key employees, consultants, independent contractors and non-employee directors of Mylan through a variety of incentive awards including: stock options, stock appreciation rights, restricted shares and units, performance awards, other stock based awards and short-term cash awards. Upon approval of the 2003 Plan, the Mylan Laboratories Inc. 1997 Incentive Stock Option Plan was frozen and no further grants of stock options will be made under that plan.

     In accordance with the provisions of SFAS No. 123, Accounting for Stock-Based Compensation and SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, an amendment of FASB Statement No. 123, the Company accounts for stock option plans under the intrinsic-value-based method as defined in APB 25. The following table illustrates the effect on net earnings and earnings per share if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation:

                                 
    Three Months     Nine Months  
Period ended December 31,   2004     2003