Mylan Laboratories, Inc. 10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2005
OR
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o |
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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)
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Pennsylvania
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25-1211621 |
(State of incorporation)
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(I.R.S. Employer Identification No.) |
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1500 Corporate Drive
Canonsburg, Pennsylvania 15317
(Address of principal executive offices)
(Zip Code) |
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(724) 514-1800
(Registrants 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 by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
YES o NO þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as
of the latest practicable date.
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Class of
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Outstanding at |
Common Stock
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October 31, 2005 |
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$0.50 par value
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215,310,557 |
MYLAN LABORATORIES INC. AND SUBSIDIARIES
FORM 10-Q
For the Quarterly Period Ended
September 30, 2005
INDEX
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Page
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Number
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PART I. FINANCIAL INFORMATION |
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Item 1: Financial Statements |
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3 |
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4 |
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5 |
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6 |
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15 |
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31 |
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32 |
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32 |
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34 |
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35 |
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36 |
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EX-31.1 |
EX-31.2 |
EX-32 |
2
MYLAN LABORATORIES INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Earnings
(unaudited; in thousands, except per share amounts)
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Three Months |
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Six Months |
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Period Ended September 30, |
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2005 |
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2004 |
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2005 |
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2004 |
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Net revenues |
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$ |
297,994 |
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$ |
306,955 |
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$ |
621,372 |
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$ |
645,967 |
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Cost of sales |
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154,763 |
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151,702 |
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310,307 |
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310,961 |
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Gross profit |
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143,231 |
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155,253 |
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311,065 |
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335,006 |
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Operating expenses: |
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Research & development |
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28,159 |
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22,042 |
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53,245 |
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43,537 |
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Selling, general & administrative |
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57,089 |
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59,688 |
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128,271 |
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117,434 |
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Litigation settlements, net |
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12,000 |
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(25,985 |
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Total operating expenses |
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85,248 |
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81,730 |
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193,516 |
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134,986 |
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Earnings from operations |
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57,983 |
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73,523 |
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117,549 |
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200,020 |
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Interest expense |
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8,942 |
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8,942 |
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Other income, net |
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4,347 |
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1,910 |
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9,903 |
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2,596 |
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Earnings before income taxes |
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53,388 |
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75,433 |
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118,510 |
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202,616 |
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Provision for income taxes |
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17,618 |
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26,779 |
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39,825 |
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71,929 |
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Net earnings |
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$ |
35,770 |
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$ |
48,654 |
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$ |
78,685 |
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$ |
130,687 |
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Earnings per common share: |
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Basic |
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$ |
0.16 |
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$ |
0.18 |
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$ |
0.32 |
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$ |
0.49 |
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Diluted |
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$ |
0.16 |
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$ |
0.18 |
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$ |
0.31 |
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$ |
0.48 |
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Weighted average common shares: |
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Basic |
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225,042 |
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268,945 |
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247,244 |
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268,749 |
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Diluted |
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229,259 |
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272,930 |
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251,261 |
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274,170 |
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Cash dividend declared
per common share |
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$ |
0.06 |
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$ |
0.03 |
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$ |
0.12 |
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$ |
0.06 |
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See Notes to Condensed Consolidated Financial Statements
3
MYLAN LABORATORIES INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(unaudited; in thousands)
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September 30, |
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March 31, |
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2005 |
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2005 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
182,091 |
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$ |
137,733 |
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Marketable securities |
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449,422 |
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670,348 |
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Accounts receivable, net |
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239,049 |
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297,334 |
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Inventories |
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255,413 |
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286,267 |
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Deferred income tax benefit |
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127,926 |
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119,327 |
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Other current assets |
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12,763 |
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17,443 |
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Total current assets |
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1,266,664 |
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1,528,452 |
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Property, plant and equipment, net |
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371,072 |
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336,719 |
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Intangible assets, net |
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114,308 |
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120,493 |
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Goodwill |
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102,579 |
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102,579 |
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Other assets |
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59,440 |
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47,430 |
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Total assets |
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$ |
1,914,063 |
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$ |
2,135,673 |
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Liabilities and shareholders equity |
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Liabilities |
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Current liabilities: |
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Trade accounts payable |
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$ |
75,451 |
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$ |
78,114 |
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Income taxes payable |
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5,333 |
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44,123 |
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Current portion of long-term obligations & long-term debt |
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4,336 |
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1,586 |
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Cash dividends payable |
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12,905 |
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8,078 |
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Other current liabilities |
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171,231 |
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113,606 |
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Total current liabilities |
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269,256 |
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245,507 |
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Long-term debt |
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772,250 |
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Other long-term obligations |
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19,700 |
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19,325 |
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Deferred income tax liability |
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22,196 |
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24,905 |
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Total liabilities |
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1,083,402 |
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289,737 |
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Shareholders equity
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Common stock |
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152,937 |
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152,217 |
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Additional paid-in capital |
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372,047 |
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354,172 |
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Retained earnings |
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1,858,398 |
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1,808,802 |
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Accumulated other comprehensive earnings |
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3,373 |
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870 |
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2,386,755 |
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2,316,061 |
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Less: |
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Treasury stock at cost |
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1,556,094 |
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470,125 |
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Total shareholders equity |
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830,661 |
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1,845,936 |
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Total liabilities and shareholders equity |
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$ |
1,914,063 |
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$ |
2,135,673 |
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See Notes to Condensed Consolidated Financial Statements
4
MYLAN LABORATORIES INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(unaudited; in thousands)
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Six Months Ended September 30, |
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2005 |
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2004 |
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Cash flows from operating activities: |
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Net earnings |
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$ |
78,685 |
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$ |
130,687 |
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Adjustments to reconcile net earnings to net cash |
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provided from operating activities: |
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Depreciation and amortization |
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23,928 |
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22,049 |
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Deferred income tax benefit |
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(12,657 |
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(5,351 |
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Net loss from equity method investees |
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948 |
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2,334 |
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Changes in estimated sales allowances |
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7,737 |
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6,682 |
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Restructuring provision |
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19,646 |
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Other non-cash items |
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6,456 |
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3,582 |
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Loss (gain) from litigation, net |
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12,000 |
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(25,985 |
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Receipts from litigation settlements |
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2,000 |
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42,985 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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61,383 |
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(28,315 |
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Inventories |
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30,035 |
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24,193 |
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Trade accounts payable |
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(2,604 |
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2,136 |
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Income taxes |
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(38,790 |
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(10,811 |
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Other operating assets and liabilities, net |
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6,311 |
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(6,675 |
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Net cash provided from operating activities |
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195,078 |
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157,511 |
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Cash flows from investing activities: |
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Capital expenditures |
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(51,313 |
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(38,197 |
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Purchase of marketable securities |
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(440,844 |
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(485,781 |
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Proceeds from sale of marketable securities |
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665,458 |
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399,275 |
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Other items, net |
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(1,704 |
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1,653 |
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Net cash provided by (used in) investing activities |
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171,597 |
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(123,050 |
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Cash flows from financing activities: |
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Cash dividends paid |
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(24,262 |
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(16,112 |
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Payment of financing fees |
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(13,900 |
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Proceeds from long-term debt |
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775,000 |
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Purchase of common stock |
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(1,081,011 |
) |
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Proceeds from exercise of stock options |
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16,635 |
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8,050 |
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Increase in outstanding checks in excess of cash in disbursement accounts |
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5,221 |
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Net cash used in financing activities |
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(322,317 |
) |
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(8,062 |
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Net increase in cash and cash equivalents |
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44,358 |
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|
26,399 |
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Cash and cash equivalents beginning of period |
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137,733 |
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|
101,713 |
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Cash and cash equivalents end of period |
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$ |
182,091 |
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$ |
128,112 |
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Additional disclosures: |
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Cash paid for income taxes |
|
$ |
91,272 |
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$ |
88,326 |
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Interest paid |
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$ |
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$ |
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See Notes to Condensed Consolidated Financial Statements
5
MYLAN LABORATORIES INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(unaudited; dollars in thousands, except Note 12 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 Companys Annual Report on Form 10-K for the fiscal
year ended March 31, 2005.
The interim results of operations for the three and six months ended September 30, 2005, and
the interim cash flows for the six months ended September 30, 2005, are not necessarily indicative
of the results to be expected for the full fiscal year or any other future period.
During the first quarter of fiscal 2006, Mylan announced that it was closing Mylan Bertek
Pharmaceuticals Inc. (Mylan Bertek), its branded subsidiary (see Note 4). Mylan had previously
reported its financial results in two reportable segments, Generic and Brand. With the closure of
Mylan Bertek, management now evaluates the business as one segment, pharmaceuticals, and has
reported as such effective with the first quarter of fiscal 2006. In accordance with Statement of
Financial Accounting Standards (SFAS) No. 131, information for earlier periods has been restated
and reported as one segment.
2. Revenue Recognition and Accounts Receivable
Revenue is recognized for product sales upon shipment when title and risk of loss transfer to
the Companys 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
six month periods ended September 30, 2005. Accounts receivable are presented net of allowances
relating to these provisions. Such allowances were $344,920 and $349,355 as of September 30, 2005,
and March 31, 2005. Other current liabilities include $63,944 and $51,772 at September 30, 2005,
and March 31, 2005, for certain rebates and other adjustments that are payable to indirect
customers.
3. Recent Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board issued 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 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. In April 2005, the SEC delayed the effective date of SFAS 123(R) to fiscal years
beginning after June 15, 2005. Management is currently assessing the impact that adoption of this
Statement will have on the Companys Consolidated Financial Statements.
6
4. Restructuring
On June 14, 2005, the Company announced that it was closing its branded subsidiary, Mylan
Bertek, and transferring the responsibility for marketing Mylan Berteks products to other Mylan
subsidiaries. In conjunction with this restructuring, the Company incurred restructuring charges of
$9,443, pre-tax, and $19,646, pre-tax, during the three and six months ended September 30, 2005.
Of the $9,443 recorded in the second quarter, $758 is included in research and development expense,
with the remainder in selling, general and administrative expense. For the six months ended
September 30, 2005, $990 is included in research and development expense, with the remainder in
selling, general and administrative expense. The major components of the restructuring charge and
the remaining accrual balance at September 30, 2005, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash |
|
|
Employee |
|
|
|
|
|
|
|
|
|
Asset |
|
|
Termination & |
|
|
Other |
|
|
|
|
|
|
Write-downs |
|
|
Severance Costs |
|
|
Exit Costs |
|
|
Total |
|
Initial charge quarter ended June 30, 2005 |
|
$ |
970 |
|
|
|
6,953 |
|
|
|
2,280 |
|
|
$ |
10,203 |
|
Amounts utilized quarter ended June 30, 2005 |
|
|
(970 |
) |
|
|
(4,248 |
) |
|
|
|
|
|
|
(5,218 |
) |
|
|
|
Accrued restructuring costs June 30, 2005 |
|
$ |
|
|
|
|
2,705 |
|
|
|
2,280 |
|
|
$ |
4,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional charge quarter ended September 30, 2005 |
|
$ |
667 |
|
|
|
7,754 |
|
|
|
1,022 |
|
|
$ |
9,443 |
|
Amounts utilized quarter ended September 30, 2005 |
|
|
(667 |
) |
|
|
(1,839 |
) |
|
|
(1,260 |
) |
|
|
(3,766 |
) |
|
|
|
Accrued restructuring costs September 30, 2005 |
|
$ |
|
|
|
|
8,620 |
|
|
|
2,042 |
|
|
$ |
10,662 |
|
|
|
|
Employee termination and severance costs are primarily related to involuntary terminations,
most of which were with respect to the Mylan Bertek sales force, and represent cash termination
payments to be paid to the affected employees as a direct result of the restructuring. Exit costs
consist primarily of lease termination costs incurred as a result of the restructuring.
As of September 30, 2005, the Companys restructuring was substantially complete. The
majority of the remaining accrued restructuring costs, most of which relate to employee termination
and severance costs, are expected to be paid during the third quarter of fiscal 2006.
7
5. Balance Sheet Components
Selected balance sheet components consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
|
|
2005 |
|
|
2005 |
|
Inventories: |
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
102,614 |
|
|
$ |
119,654 |
|
Work in process |
|
|
37,790 |
|
|
|
39,589 |
|
Finished goods |
|
|
115,009 |
|
|
|
127,024 |
|
|
|
|
|
|
|
|
|
|
$ |
255,413 |
|
|
$ |
286,267 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment: |
|
|
|
|
|
|
|
|
Land and improvements |
|
$ |
10,639 |
|
|
$ |
9,704 |
|
Buildings and improvements |
|
|
168,913 |
|
|
|
161,050 |
|
Machinery and equipment |
|
|
275,247 |
|
|
|
269,208 |
|
Construction in progress |
|
|
113,513 |
|
|
|
85,324 |
|
|
|
|
|
|
|
|
|
|
|
568,312 |
|
|
|
525,286 |
|
Less accumulated depreciation |
|
|
197,240 |
|
|
|
188,567 |
|
|
|
|
|
|
|
|
|
|
$ |
371,072 |
|
|
$ |
336,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other current liabilities: |
|
|
|
|
|
|
|
|
Accrued rebates |
|
$ |
63,944 |
|
|
$ |
51,772 |
|
Payroll and employee benefit plan accruals |
|
|
34,510 |
|
|
|
21,251 |
|
Royalties and product license fees |
|
|
8,955 |
|
|
|
11,446 |
|
Legal and professional |
|
|
23,900 |
|
|
|
18,148 |
|
Other |
|
|
39,922 |
|
|
|
10,989 |
|
|
|
|
|
|
|
|
|
|
$ |
171,231 |
|
|
$ |
113,606 |
|
|
|
|
|
|
|
|
6. 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 and restricted stock on the weighted average
number of common shares outstanding was 4,217,000 and 3,985,000 for the three months ended
September 30, 2005 and 2004, and 4,017,000 and 5,421,000 for the six months ended September 30,
2005 and 2004.
Options to purchase 5,402,000 and 6,857,000 shares of common stock were outstanding as of
September 30, 2005 and 2004, 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.
8
7. Intangible Assets
Intangible assets consist of the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
Average Life |
|
|
Original |
|
|
Accumulated |
|
|
Net Book |
|
|
|
(years) |
|
|
Cost |
|
|
Amortization |
|
|
Value |
|
September 30, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and technologies |
|
|
19 |
|
|
$ |
118,935 |
|
|
$ |
51,666 |
|
|
$ |
67,269 |
|
Product rights and licenses |
|
|
12 |
|
|
|
112,633 |
|
|
|
73,758 |
|
|
|
38,875 |
|
Other |
|
|
20 |
|
|
|
14,267 |
|
|
|
6,886 |
|
|
|
7,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
245,835 |
|
|
$ |
132,310 |
|
|
|
113,525 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets no longer subject to amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trademarks |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
114,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and technologies |
|
|
19 |
|
|
$ |
118,935 |
|
|
$ |
48,478 |
|
|
$ |
70,457 |
|
Product rights and licenses |
|
|
12 |
|
|
|
111,433 |
|
|
|
69,923 |
|
|
|
41,510 |
|
Other |
|
|
20 |
|
|
|
14,267 |
|
|
|
6,524 |
|
|
|
7,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
244,635 |
|
|
$ |
124,925 |
|
|
|
119,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets no longer subject to amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trademarks |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
120,493 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense for the six months ended September 30, 2005, and 2004, was $7,385 and
$8,989 and is expected to be $14,851, $14,603, $14,151, $13,840 and $12,822 for fiscal years 2006
through 2010, respectively.
8. Long-Term Debt
A summary of long-term debt is as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2005 |
|
|
March 31, 2005 |
|
Senior Notes (A) |
|
$ |
500,000 |
|
|
$ |
|
|
Senior Credit Facility (B) |
|
|
275,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
775,000 |
|
|
|
|
|
Less: current portion |
|
|
2,750 |
|
|
|
|
|
|
|
|
|
|
|
|
Total long term debt |
|
$ |
772,250 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
(A) |
|
On July 21, 2005, the Company issued $500,000 in Senior Notes, which consist of
$150,000 of Senior Notes due August 15, 2010, and bearing interest at 5 3/4 %
per annum and $350,000 of Senior Notes due August 15, 2015 (collectively the Notes), and
bearing interest at 6 3/8% per annum. Interest is payable semi-annually on February 15 and
August 15, commencing February 15, 2006. The proceeds from the Notes were used to finance
a portion of the Dutch Auction self-tender described in Note 10. |
9
|
|
|
|
|
In connection with the Notes offering, the Company entered into a registration rights agreement, as described
below. |
|
|
|
Prior to maturity, the Company may, under certain circumstances, redeem the Notes in whole
or in part at prices specified in the bond indenture governing the notes. Upon a change of
control (as defined in the indenture governing the Notes) of the Company, each holder of the
Notes may require the Company to purchase all or a portion of such holders Notes at 101% of
the principal amount of such Notes, plus accrued and unpaid interest. |
|
|
|
The Notes are senior unsecured obligations of the Company and rank junior to all of the
Companys secured obligations. The Notes are guaranteed jointly and severally on a full and
unconditional senior unsecured basis by all of the Companys wholly owned domestic
subsidiaries except a captive insurance company, which is considered to be a minor
subsidiary. Also, the assest and operations of Mylan Laboratories Inc. (Mylan Labs), the
parent company, are not material, and as such condensed consolidating financial information
for the parent and subsidiaries is not provided. |
|
|
|
The Notes indenture contain covenants that, among other things, (a) limit the ability of the
Company to incur additional secured indebtedness, (b) make investments or other restricted
payments, (c) pay dividends on, redeem or repurchase the Companys capital stock, (d) engage
in sale-leaseback transactions and (e) consolidate, merge or transfer all or substantially
all of its assets. Certain of the covenants contained in the indenture will no longer be
applicable or will be less restrictive if the Company achieves investment grade ratings as
outlined in the indenture. |
|
|
|
In connection with the completion of the Notes offering, the Company entered into a
registration rights agreement (the Registration Rights Agreement), dated July 21, 2005.
The Registration Rights Agreement requires the Company to use its reasonable best efforts
(i) to file with the SEC a registration statement covering an offer to exchange the Notes
for freely tradeable notes with substantially similar terms within 120 days of the issue
date of the Notes (the Closing Date), (ii) to cause such registration statement to be
declared effective by the SEC within 210 days of the Closing Date, (iii) to keep such
registration statement effective until the exchange offer is consummated, (iv) to consummate
the exchange offer within 240 days of the Closing Date and (v) if such registration
statement is not declared effective, or if the exchange offer is not consummated, on the
dates specified for such effectiveness or consummation, or if certain other events occur, to
file a shelf registration statement for the resale of the Notes. If the Company fails to
meet the requirements of the Registration Rights Agreement outlined above, during the
periods specified, the Company will incur additional interest on the Notes until such
registration defaults are cured in an amount equal to 0.25%, per annum of the principal
amount of the Notes for each 90 day period of default up to a maximum increase of 1.0% over
the original interest rates of the Notes. |
|
(B) |
|
On July 21, 2005, the Company entered into a $500,000 senior secured credit facility
(the Credit Facility). The Credit Facility consists of a $225,000 five-year revolving
credit facility (the Revolving Credit Facility), which the Company intends to use for
working capital and general corporate purposes, and a $275,000 five-year term loan (the
Term Loan), the proceeds of which were used to fund a portion of the Dutch Auction
self-tender described in Note 10. Loans under the Revolving Credit Facility bear interest
at a rate equal to either LIBOR plus 1.25% per annum or prime plus 0.25% per annum, at the
Companys option and the Term Loan bears interest at a rate equal to LIBOR plus 1.50% per
annum or
prime plus 0.50% per annum also at the Companys option. The Term Loan interest rate in
effect at September 30, 2005 was 5.40%. The Company is required to pay a fee on the unused
portion of the Revolving Credit Facility of 0.50% per annum. At September 30, 2005, no
borrowings were outstanding under the Revolving Credit Facility. |
|
|
|
The Term Loan will amortize at a rate of 1% per year for the first four years, with the
balance paid in four equal quarterly installments thereafter. Subject to exceptions, the
Credit Facility has mandatory prepayments with respect to certain proceeds of asset sales,
debt issuances, equity issuances and with respect to the Companys excess cash flows. Also,
the Term Loan may be prepaid without penalty at any time in whole or in part at the
Companys option. Because the amount of mandatory prepayment varies from quarter to quarter
and cannot be reasonably estimated, only the 1% per year amortization is included on the
balance sheet as a current liability. |
10
|
|
|
|
|
The Companys obligations under the Credit Facility are guaranteed jointly and severally on
a full and unconditional senior secured basis by all of the Companys wholly owned domestic
subsidiaries except a captive insurance company, which is considered to be a minor
subsidiary. The obligations under the Credit Facility are also collateralized by a first
priority lien on, and pledge of, 100% of the equity interests of certain of the Companys
wholly owned domestic subsidiaries and 65% of the equity interests of each of the Companys
foreign subsidiaries. |
|
|
|
The Credit Facility includes covenants that (a) require the Company to maintain a minimum
interest coverage ratio and a maximum total leverage ratio, (b) place limitations on the
Companys ability to incur debt, grant liens, carry out mergers, acquisitions and asset
sales and make investments and (c) place limitations on the Companys ability to pay
dividends or make other restricted payments. |
All debt issuance costs associated with the Notes and the Credit Facility are being amortized over
the life of the related debt. The total unamortized amounts of $13,994 are included in other
assets in the consolidated balance sheets.
At September 30, 2005, the carrying value of the Companys long-term debt approximated fair value.
Principal maturities of the Notes and Credit Facility for the next five years and thereafter, as of
September 30, 2005, are as follows:
|
|
|
|
|
Year 1 |
|
$ |
2,750 |
|
Year 2 |
|
|
2,750 |
|
Year 3 |
|
|
2,750 |
|
Year 4 |
|
|
2,750 |
|
Year 5 |
|
|
198,000 |
|
Thereafter |
|
|
566,000 |
|
|
|
|
|
|
|
$ |
775,000 |
|
|
|
|
|
9. Comprehensive Earnings
Comprehensive earnings consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
Period Ended September 30, |
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net earnings |
|
$ |
35,770 |
|
|
$ |
48,654 |
|
|
$ |
78,685 |
|
|
$ |
130,687 |
|
Other comprehensive earnings net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain (loss)
on marketable securities |
|
|
900 |
|
|
|
190 |
|
|
|
2,395 |
|
|
|
(403 |
) |
Reclassification for (gains) losses
included in net earnings |
|
|
123 |
|
|
|
(22 |
) |
|
|
108 |
|
|
|
114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,023 |
|
|
|
168 |
|
|
|
2,503 |
|
|
|
(289 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings |
|
$ |
36,793 |
|
|
$ |
48,822 |
|
|
$ |
81,188 |
|
|
$ |
130,398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
10. Common Stock
As of September 30, 2005, and March 31, 2005, there were 600,000,000 shares of common stock
authorized with 305,873,958 and 304,434,724 shares issued. Treasury shares held as of September 30,
2005 were 90,744,394, and 35,129,643 at March 31, 2005.
11
On June 14, 2005, the Company announced a $1,250,000 share buyback, comprised of a modified
Dutch Auction self-tender for up to $1,000,000 (which commenced on June 16, 2005) and a $250,000
follow-on share repurchase program in the open market or otherwise. In the tender offer,
shareholders were given the opportunity to tender some or all of their shares at a price not less
than $18.00 per share or more than $20.50 per share. Based on the number of shares tendered and the
prices specified by the tendering shareholders, the Company determined the lowest per share price
within the range that would enable it to buy up to 48,780,487 shares, or such lesser number of
shares as were properly tendered. Additionally, in the event the final purchase price was less than
the maximum price of $20.50 per share and more than 48,780,487 shares were tendered, the Company
generally would have the right to purchase up to an additional 2% of its outstanding common stock
without extending the tender offer, so that the Company could repurchase up to $1,000,000 of its
common stock.
The tender offer expired on July 15, 2005, and closed on July 21, 2005, at which time the
Company announced that it accepted for payment an aggregate of 51,282,051 shares of its common
stock at a purchase price of $19.50 per share. The 51,282,051 shares are comprised of the
48,780,487 shares the Company offered to purchase and 2,501,564 shares purchased pursuant to the
Companys right to purchase up to an additional 2%.
Additionally, during the three months ended September 30, 2005, the Company purchased
4,332,700 shares for approximately $78,378, on the open market under the follow-on repurchase
program.
11. 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.
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 |
|
|
Six Months |
|
Period ended September 30, |
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net income, as reported |
|
$ |
35,770 |
|
|
$ |
48,654 |
|
|
$ |
78,685 |
|
|
$ |
130,687 |
|
Add: |
|
Stock-based compensation expense included in reported net income, net of
related tax effects |
|
|
981 |
|
|
|
972 |
|
|
|
1,960 |
|
|
|
1,951 |
|
Deduct: |
|
Total compensation expense determined under the fair value based method for all stock
awards, net of related tax effects |
|
|
(2,213 |
) |
|
|
(4,041 |
) |
|
|
(3,146 |
) |
|
|
(8,693 |
) |
|
|
|
|
|
Pro forma net income |
|
$ |
34,538 |
|
|
$ |
45,585 |
|
|
$ |
77,499 |
|
|
$ |
123,945 |
|
|
|
|
|
|
Earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic as reported |
|
$ |
0.16 |
|
|
$ |
0.18 |
|
|
$ |
0.32 |
|
|
$ |
0.49 |
|
|
|
|
|
|
Basic pro forma |
|
$ |
0.15 |
|
|
$ |
0.17 |
|
|
$ |
0.31 |
|
|
$ |
0.46 |
|
|
|
|
|
|
Diluted as reported |
|
$ |
0.16 |
|
|
$ |
0.18 |
|
|
$ |
0.31 |
|
|
$ |
0.48 |
|
|
|
|
|
|
Diluted pro forma |
|
$ |
0.15 |
|
|
$ |
0.17 |
|
|
$ |
0.31 |
|
|
$ |
0.45 |
|
|
|
|
|
|
12
12. Contingencies
Legal Proceedings
While it is not possible to determine with any degree of certainty the ultimate outcome of the
following legal proceedings, the Company believes that it has meritorious defenses with respect to
the claims asserted against it and intends to vigorously defend its position. An adverse outcome in
any of these proceedings could have a material adverse effect on the Companys financial position
and results of operations.
Omeprazole
In fiscal 2001, Mylan Pharmaceuticals Inc. (MPI), a wholly-owned subsidiary of Mylan Labs,
filed an ANDA seeking approval from the Food and Drug Administration (FDA) to manufacture, market
and sell omeprazole delayed-release capsules, and made Paragraph IV certifications to several
patents owned by AstraZeneca PLC (AstraZeneca) that were listed in the FDAs Orange Book. On
September 8, 2000, AstraZeneca filed suit against MPI and Mylan Labs in the U.S. District Court for
the Southern District of New York alleging infringement of several of AstraZenecas patents. MPI
filed multiple motions for summary judgment as to all claims of infringement, and the summary
judgment motions remain pending. On May 29, 2003, the FDA approved MPIs ANDA for the 10 mg and 20
mg strengths of omeprazole delayed-release capsules and, on August 4, 2003, Mylan Labs announced
that MPI had commenced the sale of omeprazole 10 mg and 20 mg delayed-release capsules. AstraZeneca
then amended the pending lawsuit to assert claims against Mylan Labs and MPI, and filed a separate
lawsuit against MPIs supplier, Esteve Quimica S.A., for unspecified money damages and a finding of
willful infringement which could result in treble damages, injunctive relief, attorneys fees,
costs of litigation and such further relief as the court deems just and proper. MPI has certain
indemnity obligations to Esteve in connection with this litigation. MPI, Esteve and the other
generic manufacturers who are co-defendants in the case have filed motions for summary judgment of
non-infringement and patent invalidity. Those motions remain pending before the court.
Lorazepam and Clorazepate
On June 1, 2005, a jury verdict was rendered against Mylan Labs and MPI in the U.S. District
Court for the District of Columbia (D.C.) in the amount of approximately $12.0 million, which has
been accrued for on the Companys balance sheet. The jury found Mylan willfully violated
Massachusetts, Minnesota and Illinois state antitrust laws, meaning the amount of the verdict could
be trebled, and an award of attorneys fees and litigation costs could be made to the plaintiffs.
The case was brought by four health insurers who opted out of earlier class action settlements
agreed to by the Company in 2001, and represents the last remaining claims relating to Mylans 1998
price increases for lorazepam and clorazepate. The Company has filed a motion for judgment as a
matter of law, which remains pending before the court. If the Companys post-verdict motion is
denied, the Company intends to appeal to the U.S. Court of Appeals for the D.C. circuit.
Pricing and Medicaid Litigation
On June 26, 2003, MPI and UDL Laboratories Inc., a subsidiary of Mylan Labs (UDL), received
requests from the U.S. House of Representatives Energy and Commerce
Committee seeking
information about certain products sold by UDL and MPI, in connection with the Committees
investigation into pharmaceutical reimbursement and rebates under Medicaid. UDL and MPI are
cooperating with this inquiry and provided information in response to the Committees requests in
2003. Several states Attorneys General (AGs) have also sent letters to MPI, UDL and Mylan
Bertek, demanding that those companies retain documents relating to Medicaid reimbursement and
rebate calculations pending the outcome of unspecified investigations by those AGs into such
matters. In addition, in July 2004, Mylan Labs received subpoenas from the AGs of California and
Florida in connection with civil investigations purportedly related to price reporting and
marketing practices regarding various drugs. As noted below, both California and Florida
subsequently filed suits against Mylan, and the Company believes any further requests for
information and disclosures will be made as part of that litigation.
13
Beginning in September 2003, Mylan Labs, MPI and/or UDL, together with many other U.S.
pharmaceutical companies, have been named in a series of civil lawsuits filed by State AGs and
municipal bodies within the State of New York alleging generally that the defendants defrauded the
State Medicaid systems by allegedly reporting Average Wholesale Prices (AWP) and/or Wholesale
Acquisition Costs that exceeded the actual selling price of the defendants prescription drugs.
To date, Mylan Labs, MPI and UDL have been named as defendants in substantially similar civil
lawsuits filed by the AGs of Alabama, California, Florida, Illinois, Kentucky, Massachusetts,
Mississippi and Wisconsin, and also by the City of New York and approximately 30 counties across
New York State. Several of these cases have been transferred to the AWP multi-district litigation
proceedings pending in the U.S. District Court for the District of Massachusetts for pretrial
proceedings. Others of these cases will likely be litigated in the state courts in which they were
filed. Each of the cases seeks an unspecified amount in money damages, civil penalties and/or
treble damages, counsel fees and costs and injunctive relief. In each of these matters, Mylan Labs
and its subsidiaries either have not yet been required to respond to the complaints or have motions
to dismiss pending. The Company previously reported that the U.S. District Court for the District
of Massachusetts had dismissed the complaint filed by the Massachusetts AG without prejudice and
with leave to amend. The Massachusetts AG has since filed an amended complaint which has survived
motions to dismiss, and Mylan Labs intends to answer, denying liability. Mylan Labs and its
subsidiaries intend to defend each of these actions vigorously.
In addition by letter dated January 12, 2005, MPI was notified by the U.S. Department of
Justice of an investigation concerning MPIs calculations of Medicaid drug rebates. To the best of
MPIs information, the investigation is in its early stages. MPI is collecting information
requested by the government and is cooperating fully with the governments investigation.
Shareholder Litigation
On November 22, 2004, an individual purporting to be a Mylan Labs shareholder filed a civil
action in the Court of Common Pleas of Allegheny County, Pennsylvania, against Mylan Labs and all
members of its Board of Directors alleging that the Board members had breached their fiduciary
duties by approving the planned acquisition of King Pharmaceuticals, Inc. (King) and by declining to dismantle the Companys
anti-takeover defenses to permit an auction of the Company to Carl Icahn or other potential buyers
of the Company, and also alleging that certain transactions between the Company and its directors
(or their relatives or companies with which they were formerly affiliated) may have been wasteful.
On November 23, 2004, a substantially identical complaint was filed in the same court by another
purported Mylan Labs shareholder. The actions were styled as shareholder derivative suits on behalf
of Mylan Labs and class actions on behalf of all Mylan Labs shareholders, and were consolidated by
the court under the caption In re Mylan Laboratories Inc. Shareholder Litigation. Mylan Labs and
its directors filed preliminary objections seeking dismissal of the complaints. On January 19,
2005, the plaintiffs amended their complaints to add Bear Stearns & Co., Inc., Goldman Sachs & Co.,
Richard C. Perry, Perry Corp., American Stock Transfer & Trust Company, and John Does 1-100 as
additional defendants, and to add claims regarding trading activity by the additional defendants
and the implications on Mylan Labs shareholder rights agreement. On October 26, 2005, the court
approved the voluntary dismissal of these cases by the plaintiffs, with prejudice.
Other Litigation
The Company is involved in various other legal proceedings that are considered normal to its
business. While it is not feasible to predict the ultimate outcome of such other proceedings, the
Company believes that the ultimate outcome of such other proceedings will not have a material
adverse effect on its financial position or results of operations.
13. Subsequent
Event
On
November 4, 2005, the Company announced that it has signed an agreement with
Vernalis plc for the sale of the U.S. and Canadian rights for
Apokyn®, Mylans product for the acute, intermittent
treatment of hypomobility, off episodes associated with
advanced Parkinsons disease. Under the terms of the agreement,
the Company will receive a cash payment of $23,000 and Vernalis will
assume obligations, including completion of certain phase IV studies.
In addition, Mylan has agreed to provide certain transitional
services, including supply chain management and customer service
assistance.
14
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION
The following discussion and analysis addresses material changes in the results of operations
and financial condition of Mylan Laboratories Inc. and Subsidiaries (the Company, Mylan or
we) for the periods presented. This discussion and analysis should be read in conjunction with
the Consolidated Financial Statements, the related Notes to Consolidated Financial Statements and
Managements Discussion and Analysis of Results of Operations and Financial Condition included in
the Companys Annual Report on Form 10-K for the fiscal year ended March 31, 2005, the unaudited
interim Condensed Consolidated Financial Statements and related Notes included in Item 1 of this
Report on Form 10-Q (Form 10-Q) and the Companys other SEC filings and public disclosures.
This Form 10-Q may contain forward-looking statements. These statements are made pursuant to
the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements may include, without limitation, statements about the Companys market
opportunities, strategies, competition and expected activities and expenditures, and at times may
be identified by the use of words such as may, could, should, would, project, believe,
anticipate, expect, plan, estimate, forecast, potential, intend, continue and
variations of these words or comparable words. Forward-looking statements inherently involve risks
and uncertainties. Accordingly, actual results may differ materially from those expressed or
implied by these forward-looking statements. Factors that could cause or contribute to such
differences include, but are not limited to, the risks described below under Risk Factors in this
Item 2. The Company undertakes no obligation to update any forward-looking statements for revisions
or changes after the date of this Form 10-Q.
Overview
Mylans financial results for the three months ended September 30, 2005, included net revenues
of $298.0 million, net earnings of $35.8 million and earnings per diluted share of $0.16.
Comparatively, the three months ended September 30, 2004, included net revenues of $307.0 million,
net earnings of $48.7 million and earnings per diluted share of $0.18. This represents a decrease
of 3% in revenues, 26% in net earnings and 12% in earnings per diluted share when compared to the
same prior year period. The current quarter results include approximately $0.03 per share, net of
tax, of restructuring costs related to the closure of Mylan Bertek Pharmaceuticals Inc. (Mylan
Bertek).
For the six months ended September 30, 2005, Mylan reported net revenues of $621.4 million,
net earnings of $78.7 million and earnings per diluted share of $0.31. For the first six months of
fiscal 2005, net revenues were $646.0 million, net earnings were $130.7 million and earnings per
diluted share were $0.48. This represents a decrease of 4% in revenues, 40% in net earnings and
34% in earnings per diluted share when compared to the prior fiscal year. Included in the current
year results are $0.03 per diluted share, net of tax, with respect to a contingent legal liability
related to previously-disclosed litigation in connection with the Companys lorazepam and
clorazepate products, and $0.05 per diluted share, net of tax, of restructuring costs. Included in
the financial results for the first six months of fiscal 2005 was $0.06 per diluted share, net of
tax, of income from the favorable settlement of other litigation. A more detailed discussion of
the Companys financial results of the three and six month periods ended September 30, 2005, can be
found under the section titled Results of Operations.
Significant developments which have occurred during the second quarter include:
|
|
|
Share Buyback On July 21, 2005, Mylan closed on its modified Dutch Auction self-
tender and accepted for payment, for an aggregate purchase price of approximately $1.0
billion, 51,282,051 shares of its common stock at a price of $19.50 per share. |
Subsequent to the completion of the Dutch Auction self-tender, Mylan repurchased
4,332,700 shares of its common stock on the open market for an aggregate purchase price
of $78.4 million under a previously announced open market follow-on repurchase. In
total, the Company plans to buy back up to $250.0 million of its common stock (inclusive
of the $78.4 million) from time to time on the open market or otherwise.
15
|
|
|
Financing The share buyback described above was financed through Mylans existing
cash reserves as well as $500.0 million in Senior Notes and a $275.0 million borrowing
under a $500.0 million senior credit facility. The Senior Notes, which were issued on
July 21, 2005, consist of $150.0 million of Senior Notes due 2010, and bearing interest
at 5 3/4% per annum, and $350.0 million of Senior Notes due 2015, and bearing interest
at 6 3/8% per annum. The senior credit facility, which was also entered into on July
21, 2005, consists of a $225.0 million five-year revolving credit facility, which the
Company expects to use for working capital and general corporate purposes, and a $275.0
million five-year term loan. The term loan bears interest at LIBOR plus 150 basis
points or prime plus 50 basis points at the Companys option. The interest rate in
effect on the term loan at September 30, 2005, was 5.40%. No borrowings were
outstanding under the revolving credit facility at September 30, 2005. |
|
|
|
|
Recent FDA Approvals Mylan received final approval from the U.S. Food and Drug
Administration (FDA) for its Abbreviated New Drug Application (ANDA) for amlodipine
besylate tablets in the 2.5 mg, 5 mg and 10 mg dosage strengths. Amlodipine besylate
tablets are the generic equivalent of Pfizers Norvasc®
Tablets, which had U.S. sales of approximately 2.6 billion for the
12-month period ended September 30, 2005. The FDA has confirmed
that Mylan was the first generic company to file an ANDA on all strengths of Norvasc
and is therefore eligible for 180 days of market exclusivity, which will begin to run
from the earlier of the commercial launch of the Mylan product or a final court
decision concerning the pending litigation between Pfizer and Mylan. |
Also, during the second quarter, Mylan received tentative FDA approval for its ANDA for
ondansetron hydrochloride tablets, 4 mg, 8 mg, 16 mg, and 24 mg strengths. Ondansetron
HCl tablets are the generic version of GlaxoSmithKlines
Zofran® Tablets, which had sales of approximately $600 million
for the 12-month period ended September 30, 2005.
|
|
|
Oxybutynin Litigation On September 28, 2005, Mylan announced that the federal
district court in the Northern District of West Virginia ruled in favor of Mylan in its
oxybutynin patent litigation with Alza Corporation, a subsidiary of Johnson & Johnson.
Mylan is the first generic company to file ANDAs with the FDA for 5 mg and 10 mg
Ditropan XL®. The Company will be eligible for 180 days of market exclusivity upon
final FDA approval, which has been requested. Ditropan XL® had
U.S. sales of approximately $350 million in the 5 mg and 10 mg
strengths during the 12-month period ended September 30, 2005. |
|
|
|
|
Closure of Mylan Bertek During the first quarter of fiscal 2006, Mylan announced
that it was closing Mylan Bertek, its branded subsidiary and transferring
responsibility for selling Mylan Berteks products to its other subsidiaries, Mylan
Pharmaceuticals, Inc. (MPI) and UDL Laboratories, Inc. (UDL). In connection with
this restructuring, the Company incurred restructuring charges of $9.4 million and
$19.6 million in the second quarter and six-month period, of which $8.6 million and
$18.6 million, respectively, was included in selling, general and administrative
(SG&A) expense. These costs primarily relate to employee termination and severance
costs associated with the Mylan Bertek sales force, along with lease termination costs
and asset write-downs. As of September 30, 2005, the restructuring was substantially
completed. |
Results of Operations
Quarter Ended September 30, 2005, Compared to Quarter Ended September 30, 2004
Total Revenues and Gross Profit
Net revenues for the current quarter decreased by 3% or $9.0 million to $298.0 million from
$307.0 million in the same prior year period. This decrease was the result of overall unfavorable
pricing partially offset by revenue from new products. The pricing pressure on the Companys
product portfolio, most notably on omeprazole and carbidopa/levodopa, was the result of increased
competition, and was the primary factor for the decrease in net revenues. As is the case in the
generic industry, the entrance into the market of additional competition generally has a negative
impact on the volume and pricing of the affected products. In the near term, it is likely that
unfavorable pricing will continue to impact certain products in the Companys portfolio.
16
Products launched subsequent to October 1, 2004, helped to offset some of the impact from the
unfavorable pricing discussed above. New products contributed net revenues of $34.0 million during
the second quarter, substantially all of which was due to the Companys launch of its fentanyl
transdermal system in January 2005.
Doses shipped for the second quarter
increased by approximately 4% to 3.3 billion.
Consolidated gross profit decreased 8% or $12.0 million to $143.2 million and gross margins
decreased to 48.1% from 50.6%. The decrease in gross margins was primarily the result of the
pricing pressure discussed above.
Operating Expenses
Research and development (R&D) expenses for the current quarter increased 28% or $6.1
million to $28.2 million from $22.1 million in the same prior year period. This increase was due
primarily to an increase in the number of ongoing R&D studies, including those with respect to
nebivolol, the Companys next-generation beta blocker.
SG&A expenses decreased by 4% or $2.6 million to $57.1 million from $59.7 million. This
decrease is primarily the result of savings, mostly payroll and payroll related, as a result of the
closure of Mylan Bertek. Partially offsetting these costs savings is $8.6 million in restructuring
charges recorded in the current quarter. The restructuring charge consists primarily of employee
termination and severance costs, mostly associated with the Mylan Bertek sales force.
Interest Expense
During the second quarter of fiscal 2006, Mylan completed the financing of $500.0 million in
Senior Notes and a $500.0 million senior credit facility. Interest expense related to this
financing was $8.9 million in the second quarter. Included in interest expense is a commitment fee
on the unused portion of the revolving credit facility and the amortization of debt issuance costs.
Other Income, net
Other income, net of non-operating expenses, was $4.3 million in the second quarter of fiscal
2006 compared to $1.9 million in the same prior year period. The increase is primarily the result
of higher interest and dividend income on our investments in marketable securities, as well as less
of a loss recorded on our investment in Somerset Pharmaceuticals, Inc. (Somerset).
We own a 50% equity interest in Somerset and account for this investment using the equity
method of accounting. The recorded loss in Somerset in the second quarter of fiscal 2006 was $0.7
million compared to $1.4 million in the same prior year period.
Six Months Ended September 30, 2005, Compared to Six Months Ended September 30, 2004
Total Revenues and Gross Profit
Net revenues for the six months ended September 30, 2005 decreased by 4% or $24.6 million to
$621.4 million from $646.0 million in the same prior year period. This decrease was the result of
overall unfavorable pricing partially offset by increased volume and revenue from new products. As
a result of continued competition, omeprazole, carbidopa/levodopa and Amnesteem were principally
responsible for the price erosion in the Companys product portfolio. As is the case in the
generic industry, the entrance into the market of additional competition generally has a negative
impact on the volume and pricing of the affected products. In the near term, it is likely that
unfavorable pricing will continue to impact certain products in the Companys portfolio.
In total for the
six months ended September 30, 2005, doses shipped
decreased by approximately 3% to 6.2 billion. Despite the decrease in
doses, the impact of volume on revenue was favorable as a result of a more favorable product mix.
17
Also helping to partially offset the unfavorable pricing is revenue from new products. New
products contributed net revenues of $88.1 million in the current fiscal year, substantially all of
which is due to fentanyl.
Consolidated gross profit decreased 7% or $23.9 million to $311.1 million and gross margins
decreased to 50.1% from 51.9%. The decrease in gross margins is primarily the result of the pricing
pressure discussed above, partially offset by the favorable contribution from new products.
Operating Expenses
R&D expenses for the six months ended September 30, 2005 increased 22% or $9.7 million to
$53.2 million from $43.5 million in the same prior year period. This increase was due primarily to
an increase in the number of ongoing R&D studies, including those with respect to nebivolol. Also
included in R&D in the current year was $1.0 million of restructuring costs.
SG&A expenses increased by 9% or $10.8 million to $128.3 million from $117.4 million. This
increase was primarily the result of the restructuring charge of $18.6 million recorded in the
current period. The restructuring charge consists primarily of employee termination and severance
costs, mostly associated with the Mylan Bertek sales force, as well as asset write-downs and lease
termination costs. Savings, primarily payroll and payroll related, realized as a result of the
restructuring partially offset the increase in SG&A in the current year.
Litigation, net
The six months ended September 30, 2005, included a charge of $12.0 million for a contingent
liability with respect to the Companys previously disclosed lorazepam and clorazepate product
litigation. In the same prior year period, net gains of $26.0 million were recorded with respect to
settlement of other litigation.
Interest Expense
During the second quarter of fiscal 2006, Mylan completed the financing of $500.0 million in
Senior Notes and a $500.0 million senior credit facility. Interest expense related to this
financing was $8.9 million for the six months ended September 30, 2005. Included in interest
expense is a commitment fee on the unused portion of the revolving credit facility and the
amortization of debt issuance costs.
Other Income, net
Other income, net of non-operating expenses, was $9.9 million in the first half of fiscal 2006
compared to $2.6 million in the same prior year period. The increase is primarily the result of
higher interest and dividend income on our investments in marketable securities, as well as less of
a loss recorded on our investment in Somerset.
We own a 50% equity interest in Somerset and account for this investment using the equity
method of accounting. The recorded loss in Somerset for the first six months of fiscal 2006 was
$0.9 million compared to $2.8 million in the same prior year period.
Liquidity and Capital Resources
The Companys primary source of liquidity continues to be cash flows from operating
activities, which were $195.1 million for the six months ended September 30, 2005. Changes in
operating assets and liabilities yielded $56.3 million in operating cash, primarily due to a
decrease in accounts receivable, net, and lower inventories, partially offset by a decrease in
accrued income taxes payable.
The decrease in accounts receivable is primarily due to the timing of cash collections since
the end of fiscal 2005, primarily with respect to the fourth quarter sales of fentanyl. Inventory
decreased as the result of normal consumption and lower overall inventory levels. The decrease in
accrued income taxes payable was the result of the timing of tax payments.
18
Cash provided by investing activities for the six months ended September 30, 2005, was $171.6
million. Of the Companys $1.9 billion of total assets at September 30, 2005, $631.5 million was
held in cash, cash equivalents and marketable securities. Investments in marketable securities
consist of a variety of high credit quality debt securities, including U.S. government, state and
local government and corporate obligations. These investments are highly liquid and available for
working capital needs. As these instruments mature, the funds are generally reinvested in
instruments with similar characteristics. During the second quarter, the Company utilized a
portion of its existing cash, along with the proceeds from the issuance of debt, to finance certain
transactions described below.
Capital expenditures during the six months ended September 30, 2005, were $51.3 million. These
expenditures were incurred primarily with respect to the Companys previously announced planned
expansions. The Company expects capital expenditures for fiscal 2006 to approximate $120.0 million.
Cash used in financing activities was $322.3 million for the six months ended September 30,
2005. A total of $1.08 billion was used during the period to repurchase Mylan common stock. Of
this, $1.0 billion was used to repurchase shares as part of the Companys modified Dutch Auction
self- tender, with the remainder used to pay for expenses related to the self-tender and to
repurchase shares under a previously announced open market follow-on repurchase program. During
the second quarter, approximately 4.3 million shares were repurchased under the repurchase program
for approximately $78.4 million. The Company anticipates that it will repurchase the remaining amount of shares
allowable under the follow-on repurchase program, throughout the remainder of fiscal 2006.
Cash
proceeds of $775.0 million from the issuance of debt were received in the current year,
and used to partially finance the stock buybacks described above. Financing fees of $13.9 million
were paid during the six months ended September 30, 2005, in order to obtain this financing.
Also included in cash flows from financing activities are proceeds of $16.6 million from the
exercise of stock options and cash dividends paid of $24.3 million. In the first quarter of fiscal
2006, the Board voted to double the amount of the quarterly dividend to 6.0 cents per share from
3.0 cents per share, effective with the dividend paid for the first quarter of fiscal 2006.
The Company is involved in various legal proceedings that are considered normal to its
business (see Note 12 to Condensed Consolidated Financial Statements). While it is not feasible to
predict the outcome of such proceedings, an adverse outcome in any of these proceedings could
materially affect the Companys financial position and results of operations.
The Company is actively pursuing, and is currently involved in, joint projects related to the
development, distribution and marketing of both generic and brand products. Many of these
arrangements provide for payments by the Company upon the attainment of specified milestones. While
these arrangements help to reduce the financial risk for unsuccessful projects, fulfillment of
specified milestones or the occurrence of other obligations may result in fluctuations in cash
flows.
The Company is continuously evaluating the potential acquisition of products, as well as
companies, as a strategic part of its future growth. Consequently, the Company may utilize current
cash reserves or incur additional indebtedness to finance any such acquisitions, which could impact
future liquidity.
19
Contractual Obligations
The following table summarizes our contractual obligations at September 30, 2005 and the
effect that such obligations are expected to have on our liquidity and cash flows in future
periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than |
|
|
One - Three |
|
|
Three - Five |
|
|
|
|
As of September 30, 2005 |
|
Total |
|
|
One Year |
|
|
Years |
|
|
Years |
|
|
Thereafter |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases |
|
$ |
11,085 |
|
|
$ |
3,629 |
|
|
$ |
6,636 |
|
|
$ |
604 |
|
|
$ |
216 |
|
Long-term debt |
|
|
775,000 |
|
|
|
2,750 |
|
|
|
8,250 |
|
|
|
264,000 |
|
|
|
500,000 |
|
Other long-term obligations |
|
|
19,325 |
|
|
|
1,821 |
|
|
|
5,463 |
|
|
|
3,642 |
|
|
|
8,399 |
|
Revolving credit facility |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Letters of credit |
|
|
775 |
|
|
|
775 |
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$ |
806,185 |
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$ |
8,975 |
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$ |
20,349 |
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$ |
268,246 |
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$ |
508,615 |
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We lease certain real property under various operating lease arrangements that expire
generally over the next four years. These leases generally provide us with the option to renew the
lease at the end of the lease term. We have also entered into agreements to lease vehicles which
are typically 24 to 36 months in length.
Long-term debt consists of $500.0 million in Senior Notes and a $275.0 million borrowing under
a $500.0 million senior credit facility. The Senior Notes, which were issued on July 21, 2005,
consist of $150.0 million of Senior Notes due 2010, and bearing interest at 5 3/4% per annum, and
$350.0 million of Senior Notes due 2015, and bearing interest at 6 3/8% per annum. The senior
credit facility, which was also entered into on July 21, 2005, consists of a $225.0 million
five-year revolving credit facility, which the Company expects to use for working capital and
general corporate purposes, and a $275.0 million five-year term loan. The term loan bears interest
at LIBOR plus 150 basis points or prime plus 50 basis points at the Companys option. The interest
rate in effect on the term loan at September 30, 2005 was 5.40%. No borrowings were outstanding
under the revolving credit facility at September 30, 2005.
Other long-term obligations, primarily deferred compensation, consist of the discounted future
payments under individually negotiated agreements with certain key employees and directors.
In addition to the above, the Company has entered into various product licensing and
development agreements. In some of these arrangements, we provide funding for the development of
the product or to obtain rights to the use of the patent, through milestone payments, in exchange
for marketing and distribution rights to the product. Because milestones represent the completion
of specific contractual events and it is uncertain if and when these milestones will be achieved,
such contingencies have not been recorded on the Companys consolidated balance sheet. In the event
that all projects are successful, milestone and development payments of approximately $9.5 million
would be paid.
The Company periodically enters into licensing agreements with other pharmaceutical companies
for the manufacture, marketing and/or sale of pharmaceutical products. These agreements generally
call for the Company to pay a percentage of amounts earned from the sale of the product as a
royalty.
Other than discussed above the Company does not have material financial guarantees or other
contractual commitments that are reasonably likely to adversely affect liquidity. The Company does
not have any special purpose entities or off-balance sheet financing arrangements.
We have entered into employment and other agreements with certain executives that provide for
compensation and certain other benefits. These agreements provide for severance payments under
certain circumstances.
Recent Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board issued Statement of Financial
Accounting Standards (SFAS) No. 123(R), Share-Based Payment. SFAS No. 123(R) establishes
standards for the accounting for transactions in which an entity exchanges its equity instruments
for goods and services. Under SFAS No. 123(R), companies will no longer be able to account for
share-based compensation transactions using the intrinsic
20
method in accordance with 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. In April 2005, the SEC delayed the effective date of SFAS No.
123(R) to fiscal years beginning after June 15, 2005. Management is currently assessing the impact
that adoption of this Statement will have on the Companys Consolidated Financial Statements.
Risk Factors
The following risk factors could have a material adverse effect on our business, financial
position or results of operations and could cause the market value of our common stock to decline.
These risk factors may not include all of the important factors that could affect our business or
our industry or that could cause our future financial results to differ materially from historic or
expected results or cause the market price of our common stock to fluctuate or decline.
OUR FUTURE REVENUE GROWTH AND PROFITABILITY ARE DEPENDENT UPON OUR ABILITY TO DEVELOP AND/OR
LICENSE, OR OTHERWISE ACQUIRE, AND INTRODUCE NEW PRODUCTS ON A TIMELY BASIS IN RELATION TO OUR
COMPETITORS PRODUCT INTRODUCTIONS. OUR FAILURE TO DO SO SUCCESSFULLY COULD HAVE A MATERIAL ADVERSE
EFFECT ON OUR FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR
COMMON STOCK TO DECLINE.
Our future revenues and profitability will depend, to a significant extent, upon our ability
to successfully develop and/or license, or otherwise acquire, and commercialize new generic and
patent or statutorily protected (usually brand) pharmaceutical products in a timely manner. Product
development is inherently risky, especially for new drugs for which safety and efficacy have not
been established, and the market is not yet proven. Likewise, product licensing involves inherent
risks including uncertainties due to matters that may affect the achievement of milestones, as well
as the possibility of contractual disagreements with regard to terms such as license scope or
termination rights. The development and commercialization process, particularly with regard to new
drugs, also requires substantial time, effort and financial resources. We may not be successful in
commercializing any of the products that we are developing or licensing (including, without
limitation, nebivolol) on a timely basis, if at all, which could adversely affect our product
introduction plans, financial position and results of operations and could cause the market value
of our common stock to decline.
FDA approval is required before any prescription drug product, including generic drug
products, can be marketed. The process of obtaining FDA approval to manufacture and market new and
generic pharmaceutical products is rigorous, time-consuming, costly and largely unpredictable. We
may be unable to obtain requisite FDA approvals on a timely basis for new generic or brand products
that we may develop, license or otherwise acquire. Also, for products pending approval, we may
obtain raw materials or produce batches of inventory to be used in efficacy and bioequivalency
testing, as well as in anticipation of the products launch. In the event that FDA approval is
denied or delayed we could be exposed to the risk of this inventory becoming obsolete. The timing
and cost of obtaining FDA approvals could adversely affect our product introduction plans,
financial position and results of operations and could cause the market value of our common stock
to decline.
The ANDA approval process often results in the FDA granting final approval to a number of
ANDAs for a given product at the time a patent claim for a corresponding brand product or other
market exclusivity expires. This often forces us to face immediate competition when we introduce a
generic product into the market. Additionally, ANDA approvals often continue to be granted for a
given product subsequent to the initial launch of the generic product. These circumstances
generally result in significantly lower prices, as well as reduced margins, for generic products
compared to brand products. New generic market entrants generally cause continued price and margin
erosion over the generic product life cycle.
The Waxman-Hatch Act provides for a period of 180 days of generic marketing exclusivity for
each ANDA applicant that is first to file an ANDA containing a certification of invalidity,
non-infringement or unenforceability related to a patent listed with respect to a reference drug
product, commonly referred to as a Paragraph IV certification. During this exclusivity period,
which under certain circumstances may be required to be shared with
21
other applicable ANDA sponsors with Paragraph IV certifications, the FDA cannot grant final
approval to other ANDA sponsors holding applications for the same generic equivalent. If an ANDA
containing a Paragraph IV certification is successful and the applicant is awarded exclusivity, it
generally results in higher market share, net revenues and gross margin for that applicant. Even if
we obtain FDA approval for our generic drug products, if we are not the first ANDA applicant to
challenge a listed patent for such a product, we may lose significant advantages to a competitor
that filed its ANDA containing such a challenge. The same would be true in situations where we are
required to share our exclusivity period with other ANDA sponsors with Paragraph IV certifications.
Such situations could have a material adverse effect on our ability to market that product
profitably and on our financial position and results of operations, and the market value of our
common stock could decline.
OUR APPROVED PRODUCTS MAY NOT ACHIEVE EXPECTED LEVELS OF MARKET ACCEPTANCE, WHICH COULD HAVE A
MATERIAL ADVERSE EFFECT ON OUR PROFITABILITY, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND
COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
Even if we are able to obtain regulatory approvals for our new pharmaceutical products,
generic or brand, the success of those products is dependent upon market acceptance. Levels of
market acceptance for our new products could be impacted by several factors, including:
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the availability of alternative products from our competitors; |
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the price of our products relative to that of our competitors; |
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the timing of our market entry; |
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the ability to market our products effectively to the retail level; and |
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the acceptance of our products by government and private formularies. |
Some of these factors are not within our control. Our new products may not achieve expected
levels of market acceptance. Additionally, continuing studies of the proper utilization, safety and
efficacy of pharmaceutical products are being conducted by the industry, government agencies and
others. Such studies, which increasingly employ sophisticated methods and techniques, can call into
question the utilization, safety and efficacy of previously marketed products. For example, on July
15, 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl
patches, a product we currently market, the loss of revenues of which could have a significant
impact on our business. In some cases, studies have resulted, and may in the future result, in the
discontinuance of product marketing. These situations, should they occur, could have a material
adverse effect on our profitability, financial position and results of operations, and the market
value of our common stock could decline.
A RELATIVELY SMALL GROUP OF PRODUCTS MAY REPRESENT A SIGNIFICANT PORTION OF OUR NET REVENUES OR NET
EARNINGS FROM TIME TO TIME. IF THE VOLUME OR PRICING OF ANY OF THESE PRODUCTS DECLINES, IT COULD
HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND
COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
Sales of a limited number of our products often represent a significant portion of our net
revenues and net earnings. If the volume or pricing of our largest selling products declines in the
future, our business, financial position and results of operations could be materially adversely
affected, and the market value of our common stock could decline.
22
WE FACE VIGOROUS COMPETITION FROM OTHER PHARMACEUTICAL MANUFACTURERS THAT THREATENS THE COMMERCIAL
ACCEPTANCE AND PRICING OF OUR PRODUCTS, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS,
FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK
TO DECLINE.
Our competitors may be able to develop products and processes competitive with or superior to
our own for many reasons, including that they may have:
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proprietary processes or delivery systems; |
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larger research and development and marketing staffs; |
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larger production capabilities in a particular therapeutic area; |
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more experience in preclinical testing and human clinical trials; |
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more products; or |
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more experience in developing new drugs and financial resources, particularly with
regard to brand manufacturers. |
Any of these factors and others could have a material adverse effect on our business,
financial position and results of operations and could cause the market value of our common stock
to decline.
BECAUSE THE PHARMACEUTICAL INDUSTRY IS HEAVILY REGULATED, WE FACE SIGNIFICANT COSTS AND
UNCERTAINTIES ASSOCIATED WITH OUR EFFORTS TO COMPLY WITH APPLICABLE REGULATIONS. SHOULD WE FAIL TO
COMPLY WE COULD EXPERIENCE MATERIAL ADVERSE EFFECTS ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS
OF OPERATIONS, AND THE MARKET VALUE OF OUR COMMON STOCK COULD DECLINE.
The pharmaceutical industry is subject to regulation by various federal and state governmental
authorities. For instance, we must comply with FDA requirements with respect to the manufacture,
labeling, sale, distribution, marketing, advertising, promotion and development of pharmaceutical
products. Failure to comply with FDA and other governmental regulations can result in fines,
disgorgement, unanticipated compliance expenditures, recall or seizure of products, total or
partial suspension of production and/or distribution, suspension of the FDAs review of NDAs or
ANDAs, enforcement actions, injunctions and criminal prosecution. Under certain circumstances, the
FDA also has the authority to revoke previously granted drug approvals. Although we have internal
regulatory compliance programs and policies and have had a favorable compliance history, there is
no guarantee that these programs, as currently designed, will meet regulatory agency standards in
the future. Additionally, despite our efforts at compliance, there is no guarantee that we may not
be deemed to be deficient in some manner in the future. If we were deemed to be deficient in any
significant way, our business, financial position and results of operations could be materially
affected and the market value of our common stock could decline.
In addition to the new drug approval process, the FDA also regulates the facilities and
operational procedures that we use to manufacture our products. We must register our facilities
with the FDA. All products manufactured in those facilities must be made in a manner consistent
with current good manufacturing practices (cGMP). Compliance with cGMP regulations requires
substantial expenditures of time, money and effort in such areas as production and quality control
to ensure full technical compliance. The FDA periodically inspects our manufacturing facilities for
compliance. FDA approval to manufacture a drug is site-specific. Failure to comply with cGMP
regulations at one of our manufacturing facilities could result in an enforcement action brought by
the FDA which could include withholding the approval of NDAs, ANDAs or other product applications
of that facility. If the FDA were to require one of our manufacturing facilities to cease or limit
production, our business could be adversely affected. Delay and cost in obtaining FDA approval to
manufacture at a different facility also could have a material adverse effect on our business,
financial position and results of operations and could cause the market value of our common stock
to decline.
23
We are subject, as are generally all manufacturers, to various federal, state and local laws
regulating working conditions, as well as environmental protection laws and regulations, including
those governing the discharge of materials into the environment. Although we have not incurred
significant costs associated with complying with environmental provisions in the past, if changes
to such environmental laws and regulations are made in the future that require significant changes
in our operations or if we engage in the development and manufacturing of new products requiring
new or different environmental controls, we may be required to expend significant funds. Such
changes could have a material adverse effect on our business, financial position and results of
operations and could cause the market value of our common stock to decline.
OUR REPORTING AND PAYMENT OBLIGATIONS UNDER THE MEDICAID REBATE PROGRAM AND OTHER GOVERNMENTAL
PURCHASING AND REBATE PROGRAMS ARE COMPLEX AND MAY INVOLVE SUBJECTIVE DECISIONS. ANY DETERMINATION
OF FAILURE TO COMPLY WITH THOSE OBLIGATIONS COULD SUBJECT US TO PENALTIES AND SANCTIONS WHICH COULD
HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS, AND
THE MARKET VALUE OF OUR COMMON STOCK COULD DECLINE.
The regulations regarding reporting and payment obligations with respect to Medicaid
reimbursement and rebates and other governmental programs are complex, and as discussed elsewhere
in this Form 10-Q, we and other pharmaceutical companies are defendants in a number of suits filed
by state attorneys general and have been notified of an investigation by the U.S. Department of
Justice with respect to Medicaid reimbursement and rebates. Our calculations and methodologies are
currently being reviewed internally and likewise are subject to review and challenge by the
applicable governmental agencies, and it is possible that such reviews could result in material
changes. In addition, because our processes for these calculations and the judgments involved in
making these calculations involve, and will continue to involve, subjective decisions and complex
methodologies, these calculations are subject to the risk of errors.
In addition, as also disclosed in this Form 10-Q, a number of state and federal government
agencies are conducting investigations of manufacturers reporting practices with respect to AWP,
in which they have suggested that reporting of inflated AWP has led to excessive payments for
prescription drugs. We and numerous other pharmaceutical companies have been named as defendants in
various actions relating to pharmaceutical pricing issues and whether allegedly improper actions by
pharmaceutical manufacturers led to excessive payments by Medicare and/or Medicaid.
Any governmental agencies that have commenced, or may commence, an investigation of the
Company could impose, based on a claim of violation of fraud and false claims laws or otherwise,
civil and/or criminal sanctions, including fines, penalties and possible exclusion from federal
health care programs (including Medicaid and Medicare). Some of the applicable laws may impose
liability even in the absence of specific intent to defraud. Furthermore, should there be ambiguity
with regard to how to properly calculate and report payments-and even in the absence of any such
ambiguity-a governmental authority may take a position contrary to a position we have taken, and
may impose civil and/or criminal sanctions. Any such penalties or sanctions could have a material
adverse effect on our business, financial position and results of operations and could cause the
market value of our common stock to decline.
WE EXPEND A SIGNIFICANT AMOUNT OF RESOURCES ON RESEARCH AND DEVELOPMENT EFFORTS THAT MAY NOT LEAD
TO SUCCESSFUL PRODUCT INTRODUCTIONS. FAILURE TO SUCCESSFULLY INTRODUCE PRODUCTS INTO THE MARKET
COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS,
AND THE MARKET VALUE OF OUR COMMON STOCK COULD DECLINE.
Much of our development effort is focused on technically difficult-to-formulate products
and/or products that require advanced manufacturing technology. We conduct research and development
primarily to enable us to manufacture and market FDA-approved pharmaceuticals in accordance with
FDA regulations. Typically, research expenses related to the development of innovative compounds
and the filing of NDAs are significantly greater than those expenses associated with ANDAs. As we
continue to develop new products, our research expenses will likely increase. Because of the
inherent risk associated with research and development efforts in our industry, particularly
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with respect to new drugs (including, without limitation, nebivolol), our research and
development expenditures may not result in the successful introduction of FDA approved new
pharmaceutical products. Also, after we submit an NDA or ANDA, the FDA may request that we conduct
additional studies and as a result, we may be unable to reasonably determine the total research and
development costs to develop a particular product. Finally, we cannot be certain that any
investment made in developing products will be recovered, even if we are successful in
commercialization. To the extent that we expend significant resources on research and development
efforts and are not able, ultimately, to introduce successful new products as a result of those
efforts, our business, financial position and results of operations may be materially adversely
affected, and the market value of our common stock could decline.
A SIGNIFICANT PORTION OF OUR NET REVENUES ARE DERIVED FROM SALES TO A LIMITED NUMBER OF CUSTOMERS.
ANY SIGNIFICANT REDUCTION OF BUSINESS WITH ANY OF THESE CUSTOMERS COULD HAVE A MATERIAL ADVERSE
EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS, AND THE MARKET VALUE OF OUR
COMMON STOCK COULD DECLINE.
A significant portion of our net revenues are derived from sales to a limited number of
customers. As such, a reduction in or loss of business with one customer, or if one customer were
to experience difficulty in paying us on a timely basis, our business, financial position and
results of operations could be materially adversely affected, and the market value of our common
stock could decline.
THE USE OF LEGAL, REGULATORY AND LEGISLATIVE STRATEGIES BY COMPETITORS, BOTH BRAND AND GENERIC,
INCLUDING SO-CALLED AUTHORIZED GENERICS AND CITIZENS PETITIONS, AS WELL AS THE POTENTIAL IMPACT
OF PROPOSED LEGISLATION, MAY INCREASE OUR COSTS ASSOCIATED WITH THE INTRODUCTION OR MARKETING OF
OUR GENERIC PRODUCTS, COULD DELAY OR PREVENT SUCH INTRODUCTION AND/OR SIGNIFICANTLY REDUCE OUR
PROFIT POTENTIAL. THESE FACTORS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL
POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
Our competitors, both brand and generic, often pursue strategies to prevent or delay
competition from generic alternatives to brand products. These strategies include, but are not
limited to:
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entering into agreements whereby other generic companies will begin to market a
so-called authorized generic, a generic equivalent of a branded product, at the same time
generic competition initially enters the market; |
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filing citizens petitions with the FDA, including timing the filings so as to thwart
generic competition by causing delays of our product approvals; |
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seeking to establish regulatory and legal obstacles that would make it more difficult
to demonstrate bioequivalence; |
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initiating legislative efforts in various states to limit the substitution of generic
versions of brand pharmaceuticals; |
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filing suits for patent infringement that automatically delay FDA approval of many
generic products; |
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introducing next-generation products prior to the expiration of market exclusivity
for the reference product, which often materially reduces the demand for the first generic
product for which we seek FDA approval; |
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obtaining extensions of market exclusivity by conducting clinical trials of brand drugs
in pediatric populations or by other potential methods as discussed below; |
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persuading the FDA to withdraw the approval of brand name drugs for which the patents
are about to expire, thus allowing the brand name company to obtain new patented products
serving as substitutes for the products withdrawn; and |
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seeking to obtain new patents on drugs for which patent protection is about to expire. |
The Food and Drug Modernization Act of 1997 includes a pediatric exclusivity provision that
may provide an additional six months of market exclusivity for indications of new or currently
marketed drugs if certain agreed upon pediatric studies are completed by the applicant. Brand
companies are utilizing this provision to extend periods of market exclusivity.
Some companies have lobbied Congress for amendments to the Waxman-Hatch legislation that would
give them additional advantages over generic competitors. For example, although the term of a
companys drug patent can be extended to reflect a portion of the time an NDA is under regulatory
review, some companies have proposed extending the patent term by a full year for each year spent
in clinical trials, rather than the one-half year that is currently permitted.
If proposals like these were to become effective, our entry into the market and our ability to
generate revenues associated with new products may be delayed, reduced or eliminated, which could
have a material adverse effect on our business, financial position and results of operations and
could cause the market value of our common stock to decline.
THE INDENTURE FOR OUR SENIOR NOTES AND OUR SENIOR CREDIT FACILITY IMPOSE SIGNIFICANT OPERATING AND
FINANCIAL RESTRICTIONS, WHICH MAY PREVENT US FROM CAPITALIZING ON BUSINESS OPPORTUNITIES AND TAKING
SOME ACTIONS. THESE FACTORS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL
POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
The indenture for our Senior Notes and senior credit facility impose significant operating and
financial restrictions on us. These restrictions will limit the ability of us and our subsidiaries
to, among other things, incur additional indebtedness, make investments, sell assets, incur certain
liens, enter into agreements restricting our subsidiaries ability to pay dividends, or merge or
consolidate. In addition, our senior credit facility requires us to maintain specified financial
ratios. We cannot assure you that these covenants will not adversely affect our ability to finance
our future operations or capital needs or to pursue available business opportunities. A breach of
any of these covenants or our inability to maintain the required financial ratios could result in a
default under the related indebtedness. If a default occurs, the relevant lenders could elect to
declare the indebtedness, together with accrued interest and other fees, to be immediately due and
payable and proceed against any collateral securing that indebtedness. These factors could have a
material adverse effect on our business, financial position and results of operations and could
cause the market value of our common stock to decline.
OUR ABILITY TO SERVICE OUR DEBT AND MEET OUR CASH REQUIREMENTS DEPENDS ON MANY FACTORS, SOME OF
WHICH ARE BEYOND OUR CONTROL. THESE FACTORS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS,
FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK
TO DECLINE.
Our ability to satisfy our obligations, including our Senior Notes and our senior credit
facility, will depend on our future operating performance and financial results, which will be
subject, in part, to factors beyond our control, including interest rates and general economic,
financial and business conditions. If we are unable to generate sufficient cash flow, we may be
required to: refinance all or a portion of our debt, including the notes and our senior credit
facility; obtain additional financing in the future for acquisitions, working capital, capital
expenditures and general corporate or other purposes; redirect a substantial portion of our cash
flow to debt service, which as a result, might not be available for our operations or other
purposes; sell some of our assets or operations; reduce or delay capital expenditures; or revise or
delay our operations or strategic plans. If we are required to take any of these actions, it could
have a material adverse effect on our business, financial condition or results of operations.
26
In addition, we cannot assure you that we would be able to take any of these actions, that these
actions would enable us to continue to satisfy our capital requirements or that these actions would
be permitted under the terms of our senior credit facility and the indenture governing the notes.
The increased leverage resulting from the financing of our Dutch Auction self-tender offer through
our notes offering and our senior credit facility could have certain material adverse effects on
us, including limiting our ability to obtain additional financing and reducing cash available for
our operations and acquisitions. As a result, our ability to withstand competitive pressures may be
decreased and, we may be more vulnerable to economic downturns, which in turn could reduce our
flexibility in responding to changing business, regulatory and economic conditions. These factors
could have a material adverse effect on our business, financial position and results of operations
and could cause the market value of our common stock to decline.
WE DEPEND ON THIRD-PARTY SUPPLIERS AND DISTRIBUTORS FOR THE RAW MATERIALS, PARTICULARLY THE
CHEMICAL COMPOUND(S) COMPRISING THE ACTIVE PHARMACEUTICAL INGREDIENT, THAT WE USE TO MANUFACTURE
OUR PRODUCTS, AS WELL AS CERTAIN FINISHED GOODS. A PROLONGED INTERRUPTION IN THE SUPPLY OF SUCH
PRODUCTS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF
OPERATIONS, AND THE MARKET VALUE OF OUR COMMON STOCK COULD DECLINE.
We typically purchase the active pharmaceutical ingredient (i.e. the chemical compounds that
produce the desired therapeutic effect in our products), and other materials and supplies that we
use in our manufacturing operations, as well as certain finished products, from many different
foreign and domestic suppliers.
Additionally, we maintain safety stocks in our raw materials inventory, and in certain cases
where we have listed only one supplier in our applications with the FDA, have received FDA approval
to use alternative suppliers should the need arise. However, there is no guarantee that we will
always have timely and sufficient access to a critical raw material or finished product. A
prolonged interruption in the supply of a single-sourced raw material, including the active
ingredient, or finished product could cause our financial position and results of operations to be
materially adversely affected, and the market value of our common stock could decline. In addition,
our manufacturing capabilities could be impacted by quality deficiencies in the products which our
suppliers provide, which could have a material adverse effect on our business, financial position
and results of operations, and the market value of our common stock could decline.
WE USE SEVERAL MANUFACTURING FACILITIES TO MANUFACTURE OUR PRODUCTS. HOWEVER, A SIGNIFICANT NUMBER
OF OUR PRODUCTS ARE PRODUCED AT ONE LOCATION. PRODUCTION AT THIS FACILITY COULD BE INTERRUPTED,
WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF
OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
Although we have other facilities, we produce a significant number of our products at our
largest manufacturing facility. A significant disruption at that facility, even on a short-term
basis, could impair our ability to produce and ship products to the market on a timely basis, which
could have a material adverse effect on our business, financial position and results of operations
and could cause the market value of our common stock to decline.
WE MAY EXPERIENCE DECLINES IN THE SALES VOLUME AND PRICES OF OUR PRODUCTS AS THE RESULT OF THE
CONTINUING TREND TOWARD CONSOLIDATION OF CERTAIN CUSTOMER GROUPS, SUCH AS THE WHOLESALE DRUG
DISTRIBUTION AND RETAIL PHARMACY INDUSTRIES, AS WELL AS THE EMERGENCE OF LARGE BUYING GROUPS. THE
RESULT OF SUCH DEVELOPMENTS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL
POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
We make a significant amount of our sales to a relatively small number of drug wholesalers and
retail drug chains. These customers represent an essential part of the distribution chain of
generic pharmaceutical products. Drug wholesalers and retail drug chains have undergone, and are
continuing to undergo, significant consolidation.
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This consolidation may result in these groups gaining additional purchasing leverage and
consequently increasing the product pricing pressures facing our business. Additionally, the
emergence of large buying groups representing independent retail pharmacies and the prevalence and
influence of managed care organizations and similar institutions potentially enable those groups to
attempt to extract price discounts on our products. The result of these developments may have a
material adverse effect on our business, financial position and results of operations and could
cause the market value of our common stock to decline.
WE MAY BE UNABLE TO PROTECT OUR INTELLECTUAL AND OTHER PROPRIETARY PROPERTY IN AN EFFECTIVE MANNER,
WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF
OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
Although our brand products may have patent protection, this may not prevent other companies
from developing functionally equivalent products or from challenging the validity or enforceability
of our patents. If our patents are found to be non-infringed, invalid or not enforceable, we could
experience an adverse effect on our ability to commercially promote patented products. We could be
required to enforce our patent or other intellectual property rights through litigation, which can
be protracted and involve significant expense and an inherently uncertain outcome. Any negative
outcome could have a material adverse effect on our business, financial position and results of
operations and could cause the market value of our common stock to decline.
OUR COMPETITORS INCLUDING BRAND COMPANIES OR OTHER THIRD PARTIES MAY ALLEGE THAT WE ARE INFRINGING THEIR INTELLECTUAL
PROPERTY, FORCING US TO EXPEND SUBSTANTIAL RESOURCES IN RESULTING LITIGATION, THE OUTCOME OF WHICH
IS UNCERTAIN. ANY UNFAVORABLE OUTCOME OF SUCH LITIGATION COULD HAVE A MATERIAL ADVERSE EFFECT ON
OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR
COMMON STOCK TO DECLINE.
Companies that produce brand pharmaceutical products routinely bring litigation against ANDA
applicants that seek FDA approval to manufacture and market generic forms of their branded
products. These companies allege patent infringement or other violations of intellectual property
rights as the basis for filing suit against an ANDA applicant. Likewise, patent holders may bring
patent infringement suits against companies that are currently marketing and selling their approved
generic products. Litigation often involves significant expense and can delay or prevent
introduction or sale of our generic products.
There
may also be situations where the Company uses its business judgment and decides to
market and sell products, notwithstanding the fact that allegations of patent infringement(s)
have not been finally resolved by the courts. The risk involved in doing so can be
substantial because the remedies available to the owner of a patent for infringement include, among
other things, damages measured by the profits lost by the patent owner and not by the profits
earned by the infringer. In the case of a willful infringement, the definition of which is subjective,
such damages may be trebled. Moreover, because of the discount pricing typically involved with
bioequivalent products, patented brand products generally realize a substantially higher profit
margin than bioequivalent products. An adverse decision in a case such as this or in other similar
litigation could have a material adverse effect on our business, financial position and results of
operations and could cause the market value of our common stock to decline.
WE MAY EXPERIENCE REDUCTIONS IN THE LEVELS OF REIMBURSEMENT FOR PHARMACEUTICAL PRODUCTS BY
GOVERNMENTAL AUTHORITIES, HMOS OR OTHER THIRD-PARTY PAYERS. ANY SUCH REDUCTIONS COULD HAVE A
MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD
CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
Various governmental authorities and private health insurers and other organizations, such as
HMOs, provide reimbursement to consumers for the cost of certain pharmaceutical products. Demand
for our products depends in part on the extent to which such reimbursement is available.
Third-party payers increasingly challenge the pricing of pharmaceutical products. This trend and
other trends toward the growth of HMOs, managed health care and legislative health care reform
create significant uncertainties regarding the future levels of reimbursement for
28
pharmaceutical products. Further, any reimbursement may be reduced in the future, perhaps to
the point that market demand for our products declines. Such a decline could have a material
adverse effect on our business, financial position and results of operations and could cause the
market value of our common stock to decline.
LEGISLATIVE OR REGULATORY PROGRAMS THAT MAY INFLUENCE PRICES OF PRESCRIPTION DRUGS COULD HAVE A
MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK
TO DECLINE.
Current or future federal or state laws and regulations may influence the prices of drugs and,
therefore, could adversely affect the prices that we receive for our products. Programs in
existence in certain states seek to set prices of all drugs sold within those states through the
regulation and administration of the sale of prescription drugs. Expansion of these programs, in
particular, state Medicaid programs, or changes required in the way in which Medicaid rebates are
calculated under such programs, could adversely affect the price we receive for our products and
could have a material adverse effect on our business, financial position and results of operations
and could cause the market value of our common stock to decline.
WE ARE INVOLVED IN VARIOUS LEGAL PROCEEDINGS AND CERTAIN GOVERNMENT INQUIRIES AND MAY EXPERIENCE
UNFAVORABLE OUTCOMES OF SUCH PROCEEDINGS OR INQUIRIES, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT
ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF
OUR COMMON STOCK TO DECLINE.
We are involved in various legal proceedings and certain government inquiries, including, but
not limited to, patent infringement, product liability, breach of contract and claims involving
Medicaid and Medicare reimbursements, some of which are described in our periodic reports and
involve claims for, or the possibility of fines and penalties involving, substantial amounts of
money or for other relief. If any of these legal proceedings or inquiries were to result in an
adverse outcome, the impact could have a material adverse effect on our business, financial
position and results of operations and could cause the market value of our common stock to decline.
With respect to product liability, the Company maintains commercial insurance to protect
against and manage a portion of the risks involved in conducting its business. Although we carry
insurance, we believe that no reasonable amount of insurance can fully protect against all such
risks because of the potential liability inherent in the business of producing pharmaceuticals for
human consumption. To the extent that a loss occurs, depending on the nature of the loss and the
level of insurance coverage maintained, it could have a material adverse effect on our business,
financial position and results of operations and could cause the market value of our common stock
to decline.
WE ENTER INTO VARIOUS AGREEMENTS IN THE NORMAL COURSE OF BUSINESS WHICH PERIODICALLY INCORPORATE
PROVISIONS WHEREBY WE INDEMNIFY THE OTHER PARTY TO THE AGREEMENT. IN THE EVENT THAT WE WOULD HAVE
TO PERFORM UNDER THESE INDEMNIFICATION PROVISIONS, IT COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR
BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR
COMMON STOCK TO DECLINE.
In the normal course of business, we periodically enter into employment, legal settlement, and
other agreements which incorporate indemnification provisions. We maintain insurance coverage which
we believe will effectively mitigate our obligations under these indemnification provisions.
However, should our obligation under an indemnification provision exceed our coverage or should
coverage be denied, our business, financial position and results of operations could be materially
affected and the market value of our common stock could decline.
OUR ACQUISITION STRATEGIES IN GENERAL INVOLVE A NUMBER OF INHERENT RISKS. THESE RISKS COULD CAUSE A
MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD
CAUSE A DECLINE IN THE MARKET VALUE OF OUR COMMON STOCK.
29
We continually seek to expand our product line through complementary or strategic acquisitions
of other companies, products and assets, and through joint ventures, licensing agreements or other
arrangements. Acquisitions, joint ventures and other business combinations involve various inherent
risks, such as assessing accurately the values, strengths, weaknesses, contingent and other
liabilities, regulatory compliance and potential profitability of acquisition or other transaction
candidates. Other inherent risks include the potential loss of key personnel of an acquired
business, our inability to achieve identified financial and operating synergies anticipated to
result from an acquisition or other transaction and unanticipated changes in business and economic
conditions affecting an acquisition or other transaction. International acquisitions, and other
transactions, could also be affected by export controls, exchange rate fluctuations, domestic and
foreign political conditions and the deterioration in domestic and foreign economic conditions.
We may be unable to realize synergies or other benefits expected to result from acquisitions,
joint ventures and other transactions or investments we may undertake, or be unable to generate
additional revenue to offset any unanticipated inability to realize these expected synergies or
benefits. Realization of the anticipated benefits of acquisitions or other transactions could take
longer than expected, and implementation difficulties, market factors and the deterioration in
domestic and global economic conditions could alter the anticipated benefits of any such
transactions. These factors could cause a material adverse effect on our business, financial
position and results of operations and could cause a decline in the market value of our common
stock.
OUR FUTURE SUCCESS IS HIGHLY DEPENDENT ON OUR CONTINUED ABILITY TO ATTRACT AND RETAIN KEY
PERSONNEL. ANY FAILURE TO ATTRACT AND RETAIN KEY PERSONNEL COULD HAVE A MATERIAL ADVERSE EFFECT ON
OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR
COMMON STOCK TO DECLINE.
Because our success is largely dependent on the scientific nature of our business, it is
imperative that we attract and retain qualified personnel in order to develop new products and
compete effectively. If we fail to attract and retain key scientific, technical or management
personnel, our business could be affected adversely. Additionally, while we have employment
agreements with certain key employees in place, their employment for the duration of the agreement
is not guaranteed. If we are unsuccessful in retaining all of our key employees, it could have a
material adverse effect on our business, financial position and results of operations and could
cause the market value of our common stock to decline.
RECENT DECISIONS BY THE FDA, CURRENT BRAND TACTICS AND OTHER FACTORS BEYOND OUR CONTROL HAVE PLACED
OUR BUSINESS UNDER INCREASING PRESSURE, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS,
FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK
TO DECLINE.
We believe that
certain recent FDA rulings are contrary to multiple sections of the Federal
Food, Drug, and Cosmetic Act and the Administrative Procedures Act, the FDAs published regulations
and the legal precedent on point. These decisions call into question the rules of engagement in our
industry and have added a level of unpredictability that may materially adversely affect our
business and the generic industry as a whole.
While we continue to challenge these recent decisions as well as current brand tactics that
undermine congressional intent, we cannot guarantee that we will prevail or
predict when or if these matters will be
rectified. If they are not, our business, financial position and results of operations could
suffer and the market value of our common stock could decline.
WE HAVE BEGUN THE IMPLEMENTATION OF AN ENTERPRISE RESOURCE PLANNING SYSTEM. AS WITH ANY
IMPLEMENTATION OF A SIGNIFICANT NEW SYSTEM, DIFFICULTIES ENCOUNTERED COULD RESULT IN BUSINESS
INTERRUPTIONS, AND COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND
RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
We have begun the implementation of an enterprise resource planning (ERP) system to enhance
operating efficiencies and provide more effective management of our business operations.
Implementations of ERP systems and related software carry risks such as cost overruns, project
delays and business interruptions and delays. If we
30
experience a material business interruption as a result of our ERP implementation, it could
have a material adverse effect on our business, financial position and results of operations and
could cause the market value of our common stock to decline.
WE MUST MAINTAIN ADEQUATE INTERNAL CONTROLS AND BE ABLE, ON AN ANNUAL BASIS, TO PROVIDE AN
ASSERTION AS TO THE EFFECTIVENESS OF SUCH CONTROLS. FAILURE TO MAINTAIN ADEQUATE INTERNAL CONTROLS
OR TO IMPLEMENT NEW OR IMPROVED CONTROLS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS,
FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK
TO DECLINE.
Effective internal controls are necessary for the Company to provide reasonable assurance with
respect to its financial reports. We are spending a substantial amount of management time and
resources to comply with changing laws, regulations and standards relating to corporate governance
and public disclosure, including the Sarbanes-Oxley Act of 2002, new Securities and Exchange
Commission (SEC) regulations and the New York Stock Exchange rules. In particular, Section 404 of
the Sarbanes-Oxley Act of 2002 requires managements annual review and evaluation of our internal
control systems, and attestations as to the effectiveness of these systems by our independent
public accounting firm. If we fail to maintain the adequacy of our internal controls, we may not be
able to ensure that we can conclude on an ongoing basis that we have effective internal control
over financial reporting. Additionally, internal control over financial reporting may not prevent
or detect misstatements because of its inherent limitations, including the possibility of human
error, the circumvention or overriding of controls, or fraud. Therefore, even effective internal
controls can provide only reasonable assurance with respect to the preparation and fair
presentation of financial statements. In addition, projections of any evaluation of effectiveness
of internal control over financial reporting to future periods are subject to the risk that the
control may become inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate. If the Company fails to maintain the adequacy of
its internal controls, including any failure to implement required new or improved controls, this
could have a material adverse effect on our business, financial position and results of operations,
and the market value of our common stock could decline.
THERE ARE INHERENT UNCERTAINTIES INVOLVED IN ESTIMATES, JUDGMENTS AND ASSUMPTIONS USED IN THE
PREPARATION OF FINANCIAL STATEMENTS IN ACCORDANCE WITH GAAP. ANY FUTURE CHANGES IN ESTIMATES,
JUDGEMENTS AND ASSUMPTIONS USED OR NECESSARY REVISIONS TO PRIOR ESTIMATES, JUDGMENTS OR ASSUMPTIONS
COULD LEAD TO A RESTATEMENT WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL
POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
The consolidated and condensed consolidated financial statements included in the periodic
reports we file with the SEC are prepared in accordance with accounting principles generally
accepted in the United States of America (GAAP). The preparation of financial statements in
accordance with GAAP involves making estimates, judgments and assumptions that affect reported
amounts of assets (including intangible assets), liabilities, revenues, expenses and income.
Estimates, judgments and assumptions are inherently subject to change in the future and any
necessary revisions to prior estimates, judgements or assumptions could lead to a restatement. Any
such changes could result in corresponding changes to the amounts of assets (including goodwill and
other intangible assets), liabilities, revenues, expenses and income. Any such changes could have a
material adverse effect on our business, financial position and results of operations and could
cause the market value of our common stock to decline.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The Company is subject to market risk from changes in the market values of investments in its
marketable debt securities and interest rate risk from changes in interest rates associated with
its long term debt.
In addition to marketable debt and equity securities, investments are made in overnight
deposits, money market funds and marketable securities with maturities of less than three months.
These instruments are classified as cash equivalents for financial reporting purposes and have
minimal or no interest rate risk due to their short-term nature.
31
The following table summarizes the investments in marketable debt and equity securities which
subject the Company to market risk at September 30, 2005 and March 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
(in thousands) |
|
2005 |
|
|
2005 |
|
Debt securities |
|
$ |
442,761 |
|
|
$ |
667,170 |
|
Equity securities |
|
|
6,661 |
|
|
|
3,178 |
|
|
|
|
|
|
|
|
|
|
$ |
449,422 |
|
|
$ |
670,348 |
|
|
|
|
|
|
|
|
The primary objectives for the marketable debt securities investment portfolio are liquidity
and safety of principal. Investments are made to achieve the highest rate of return while retaining
principal. Our investment policy limits investments to certain types of instruments issued by
institutions and government agencies with investment-grade credit ratings. At September 30, 2005,
the Company had invested $442.8 million in marketable debt securities, of which $116.4 million will
mature within one year and $326.4 million will mature after one year. The short duration to
maturity creates minimal exposure to fluctuations in market values for investments that will mature
within one year. However, a significant change in current interest rates could affect the market
value of the remaining $326.4 million of marketable debt securities that mature after one year. A
5% change in the market value of the marketable debt securities that mature after one year would
result in a $16.3 million change in marketable debt securities.
On July 21, 2005, the Company issued $500.0 million in Senior Notes with fixed interest rates
and borrowed $275.0 million under a term loan as part of a senior credit facility with a variable
interest rate based on the prime rate or LIBOR. Also on July 21, 2005, the Company entered into a
$225.0 million revolving credit facility, any borrowings under which will bear interest at a
variable rate based on the prime rate or LIBOR. At this time no amounts have been drawn under the
revolving credit facility.
Generally, the fair market value of fixed interest rate debt will decrease as interest rates
rise and increase as interest rates fall. As of September 30, 2005, the carrying value of our long
term debt approximated fair value. A 10% change in interest rates on the term loan would result in
a change in interest expense of approximately $1.5 million per year.
ITEM 4. CONTROLS AND PROCEDURES
An evaluation was performed under the supervision and with the participation of the Companys
management, including the Chief Executive Officer and the Chief Financial Officer, of the
effectiveness of the design and operation of the Companys disclosure controls and procedures as of
September 30, 2005. Based upon that evaluation, the Chief Executive Officer and the Chief
Financial Officer concluded that the Companys disclosure controls and procedures were effective.
In addition, during the period covered by this report, there have been no significant changes in
the Companys internal controls or in other factors that could significantly affect these controls,
and no corrective actions taken with regard to significant deficiencies or material weaknesses in
such controls. No change in the Companys internal control over financial reporting occurred during
the last fiscal quarter that has materially affected, or is reasonably likely to materially affect,
the Companys internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
For a description of the material pending legal proceedings to which the Company is a party,
please see our Annual Report on Form 10-K for the year ended March 31, 2005. During the quarter
ended September 30, 2005, there were no new material legal proceedings or material developments
with respect to pending proceedings other than as described below. While it is not possible to
determine with any degree of certainty the ultimate outcome of the following matters, the Company
believes that it has meritorious defenses with respect to the claims asserted against it and
intends to vigorously defend its position. An adverse outcome in any of these proceedings could
have a material adverse effect on the Companys financial position and results of operations.
32
Lorazepam and Clorazepate
On June 1, 2005, a jury verdict was rendered against Mylan Labs and MPI in the U.S. District
Court for the District of Columbia in the amount of approximately $12.0 million, which has been
accrued for on the Companys balance sheet. The jury found Mylan willfully violated Massachusetts,
Minnesota and Illinois state antitrust laws, meaning the amount of the verdict could be trebled,
and an award of attorneys fees and litigation costs could be made to the plaintiffs. The case was
brought by four health insurers who opted out of earlier class action settlements agreed to by the
Company in 2001, and represents the last remaining claims relating to Mylans 1998 price increases
for lorazepam and clorazepate. The Company has filed a motion for judgment as a matter of law,
which remains pending before the court. If the Companys post-verdict motion is denied, the Company
intends to appeal to the U.S. Court of Appeals for the D.C. circuit.
Pricing and Medicaid Litigation
On June 26, 2003, UDL and MPI received requests from the U.S. House of Representatives Energy
and Commerce Committee requesting information about certain drug products sold by UDL and MPI, in
connection with the Committees investigation into pharmaceutical reimbursement and rebates under
Medicaid. UDL and MPI are cooperating with this inquiry and provided information in response to the
Committees requests in 2003. Several states AGs have also sent letters to MPI, UDL and Mylan
Bertek Pharmaceuticals Inc., a wholly-owned subsidiary of Mylan Labs, demanding that those
companies retain documents relating to Medicaid reimbursement and rebate calculations pending the
outcome of unspecified investigations by those AGs into such matters. In addition, in July 2004,
Mylan Labs received subpoenas from the AGs of California and Florida in connection with civil
investigations purportedly related to price reporting and marketing practices regarding various
drugs. As noted below, both California and Florida subsequently filed suits against Mylan, and the
Company believes any further requests for information and disclosures will be made as part of that
litigation.
Beginning in September 2003, Mylan Labs, MPI and/or UDL, together with many other U.S.
pharmaceutical companies, have been named in a series of civil lawsuits filed by State Attorneys
General and municipal bodies within the State of New York alleging generally that the defendants
defrauded the State Medicaid systems by allegedly reporting Average Wholesale Prices (AWP)
and/or Wholesale Acquisition Costs that exceeded the actual selling price of the defendants
prescription drugs. To date, Mylan Labs, MPI and UDL have been named as defendants in
substantially similar civil lawsuits filed by the AGs of Alabama, California, Florida, Illinois,
Kentucky, Massachusetts, Mississippi and Wisconsin, and also by the City of New York and
approximately 30 counties across New York State. Several of these cases have been transferred to
the AWP multi-district litigation proceedings pending in the U.S. District Court for the District
of Massachusetts for pretrial proceedings. Others of these cases will likely be litigated in the
state courts in which they were filed. Each of the cases seeks an unspecified amount in money
damages, civil penalties and/or treble damages, counsel fees and costs and injunctive relief. In
each of these matters, Mylan Labs and its subsidiaries either have not yet been required to respond
to the complaints or have motions to dismiss pending. The Company previously reported that the
U.S. District Court for the District of Massachusetts had dismissed the complaint filed by the
Massachusetts AG without prejudice and with leave to amend. The Massachusetts AG has since filed
an Amended Complaint which has survived motions to dismiss, and Mylan Labs intends to answer,
denying liability. Mylan Labs and its subsidiaries intend to defend each of these actions
vigorously.
In addition by letter dated January 12, 2005, MPI was notified by the U.S. Department of
Justice of an investigation concerning MPIs calculations of Medicaid drug rebates. To the best of
MPIs information, the investigation is in its early stages. MPI is collecting information
requested by the government and is cooperating fully with the governments investigation.
Shareholder Litigation
On November 22, 2004, an individual purporting to be a Mylan Labs shareholder, filed a civil
action in the Court of Common Pleas of Allegheny County, Pennsylvania, against Mylan Labs and all
members of its Board of Directors alleging that the Board members had breached their fiduciary
duties by approving the planned acquisition of King Pharmaceuticals, Inc. (King) and by declining
to dismantle the Companys anti-takeover defenses to
33
permit an auction of the Company to Carl Icahn or other potential buyers of the Company, and
also alleging that certain transactions between the Company and its directors (or their relatives
or companies with which they were formerly affiliated) may have been wasteful. On November 23,
2004, a substantially identical complaint was filed in the same court by another purported Mylan
Labs shareholder. The actions were styled as shareholder derivative suits on behalf of Mylan Labs
and class actions on behalf of all Mylan Labs shareholders, and were consolidated by the court
under the caption In re Mylan Laboratories Inc. Shareholder Litigation. Mylan Labs and its
directors filed preliminary objections seeking dismissal of the complaints. On January 19, 2005,
the plaintiffs amended their complaints to add Bear Stearns & Co., Inc., Goldman Sachs & Co.,
Richard C. Perry, Perry Corp., American Stock Transfer & Trust Company, and John Does 1-100 as
additional defendants, and to add claims regarding trading activity by the additional defendants
and the implications on Mylan Labs shareholder rights agreement. On October 26, 2005, the court
approved the voluntary dismissal of these cases by the plaintiffs, with prejudice.
Other Litigation
The Company is involved in various other legal proceedings that are considered normal to its
business. While it is not feasible to predict the ultimate outcome of such other proceedings at
this time, the Company believes that the ultimate outcome of such other proceedings will not have a
material adverse effect on its financial position or results of operations.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(a) Not applicable.
(b) Not applicable.
(c) Issuer Purchases of Equity Securities:
During the quarter ending September 30, 2005, the Company repurchased 55,614,751 shares of
common stock as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total number of |
|
|
Approximate dollar |
|
|
|
|
|
|
|
|
|
|
|
Shares purchased as |
|
|
value of shares |
|
|
|
|
|
|
|
|
|
|
|
part of publicly |
|
|
that may be |
|
|
|
Total number of |
|
|
Average price paid |
|
|
announced plans or |
|
|
purchased under the |
|
Period |
|
shares purchased |
|
|
per share |
|
|
programs |
|
|
program |
|
July 1,
2005 - July 31, 2005 |
|
|
51,282,051 |
|
|
|
$19.50 |
|
|
|
51,282,051 |
(1) |
|
|
|
|
August 1,
2005 - August 31, 2005 |
|
|
4,182,700 |
|
|
|
$18.05 |
|
|
|
4,182,700 |
(2) |
|
$ |
174,488,534 |
|
September 1,
2005 - September
30, 2005 |
|
|
150,000 |
|
|
|
$18.53 |
|
|
|
150,000 |
(2) |
|
$ |
171,708,914 |
|
|
|
|
(1) |
|
On June 14, 2005, Mylan announced a modified Dutch Auction self-tender for up to
$1.0 billion, which commenced on June 16, 2005. The tender offer expired on July 15, 2005, and
closed on July 21, 2005, at which time the Company announced that it accepted for payment an
aggregate of 51,282,051 shares of its common stock at a purchase price of $19.50 per share. |
|
(2) |
|
On June 14, 2005, in connection with the announcement of the modified Dutch
Auction (see (1) above), Mylan announced a $250 million follow-on share repurchase program in the
open market or otherwise. |
34
ITEM 6. EXHIBITS
|
|
|
3.1
|
|
Amended and Restated Articles of Incorporation of the registrant, as amended to date,
filed as Exhibit 3.1 to the Form 10-Q for the quarterly period ended June 30, 2003,
and incorporated herein by reference. |
|
|
|
3.2
|
|
Bylaws of the registrant, as amended to date, filed as Exhibit 3.1 to the Report of
Form 8-K filed on February 22, 2005, and incorporated herein by reference. |
|
|
|
4.1(a)
|
|
Rights Agreement dated as of August 22, 1996, between the registrant and American
Stock Transfer & Trust Company, filed as Exhibit 4.1 to the Report on Form 8-K filed
with the SEC on September 3, 1996, and incorporated herein by reference. |
|
|
|
4.1(b)
|
|
Amendment to Rights Agreement dated as of November 8, 1999, between the registrant and
American Stock Transfer & Trust Company, filed as Exhibit 1 to Form 8-A/A filed with
the SEC on March 31, 2000, and incorporated herein by reference. |
|
|
|
4.1(c)
|
|
Amendment No. 2 to Rights Agreement dated as of August 13, 2004, between the
registrant and American Stock Transfer & Trust Company, filed as Exhibit 4.1 to the
Report on Form 8-K filed with the SEC on August 16, 2004, and incorporated herein by
reference. |
|
|
|
4.1(d)
|
|
Amendment No. 3 to Rights Agreement dated as of September 8, 2004, between the
registrant and American Stock Transfer & Trust Company, filed as Exhibit 4.1 to the
Report on Form 8-K filed with the SEC on September 9, 2004, and incorporated herein by
reference. |
|
|
|
4.1(e)
|
|
Amendment No. 4 to Rights Agreement dated as of December 2, 2004, between the
registrant and American Stock Transfer & Trust Company, filed as Exhibit 4.1 to the
Report on Form 8-K filed with the SEC on December 3, 2004, and incorporated herein by
reference. |
|
|
|
4.2
|
|
Indenture, dated as of July 21, 2005, between the registrant and The Bank of New York,
as trustee, as filed as Exhibit 4.1 to the Report on Form 8-K filed with the SEC on
July 27, 2005, and incorporated herein by reference. |
|
|
|
4.3
|
|
Registration Rights Agreement, dated as of July 21, 2005, among the registrant, the
Guarantors party thereto and Merrill Lynch, Pierce, Fenner & Smith Incorporated, BNY
Capital Markets, Inc., KeyBanc Capital Markets (a Division of McDonald Investments
Inc.), PNC Capital Markets, Inc. and SunTrust Capital Markets, Inc., as filed as
Exhibit 4.2 to the Report on Form 8-K filed with the SEC on July 27, 2005, and incorporated herein by reference. |
|
|
|
10.1
|
|
Credit Agreement, dated as of July 21, 2005, among the registrant and a syndicate of
bank lenders, including Merrill Lynch & Co., Merrill Lynch, Pierce, Fenner and Smith
Incorporated, as sole lead arranger, sole bookrunner and syndication agent, Keybank
National Association, PNC Bank, National Association, Suntrust Bank and The Bank of
New York, as co-documentation agents, and Merrill Lynch Capital Corporation, as
administrative agent, as filed as Exhibit 99.1 to the Report on Form 8-K filed with
the SEC on July 27, 2005, and incorporated herein by reference. |
|
|
|
31.1
|
|
Certification of CEO pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2
|
|
Certification of CFO pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32
|
|
Certification of CEO and CFO pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
35
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this Report on Form 10-Q for the quarterly period ended September 30, 2005, to be signed on
its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
Mylan Laboratories Inc.
(Registrant)
|
|
November 4, 2005 |
By: |
/s/ Robert J. Coury
|
|
|
|
Robert J. Coury |
|
|
|
Vice Chairman and Chief Executive Officer |
|
|
|
|
|
November 4, 2005 |
|
/s/ Edward J. Borkowski
|
|
|
|
Edward J. Borkowski |
|
|
|
Chief Financial Officer
(Principal financial officer) |
|
|
|
|
|
November 4, 2005 |
|
/s/ Gary E. Sphar
|
|
|
|
Gary E. Sphar |
|
|
|
Vice President, Corporate Controller
(Principal accounting officer) |
|
36
EXHIBIT INDEX
|
|
|
31.1
|
|
Certification of CEO pursuant to Section 302 of the Sarbanes-OxleyAct of 2002. |
|
|
|
31.2
|
|
Certification of CFO pursuant to Section 302 of the Sarbanes-OxleyAct of 2002. |
|
|
|
32
|
|
Certification of CEO and CFO pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
37