MYLAN INC. 10-Q
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-Q
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended
September 30, 2007
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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
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For the transition period
from to
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Commission File Number 1-9114
MYLAN INC.
(Exact name of registrant as
specified in its charter)
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Pennsylvania
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25-1211621
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(State of
incorporation)
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(I.R.S. Employer
Identification No.)
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1500 Corporate Drive
Canonsburg, Pennsylvania
(Address of principal executive offices)
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15317
(Zip
Code)
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(724) 514-1800
(Registrants telephone number, including area code)
Mylan Laboratories Inc.
(Former name, former address or formal fiscal year, if
changed since last report)
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding twelve
months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to
such filing requirements for the past
90 days. YES þ NO o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer or a
non-accelerated
filer. See definition of accelerated filer and large
accelerated filer in
Rule 12b-2
of the Exchange Act.
Large Accelerated
Filer þ Accelerated
Filer o Non-Accelerated
Filer 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 Common Stock
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Outstanding at October 26, 2007
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$0.50 par value
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248,891,625
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MYLAN
INC. AND SUBSIDIARIES
FORM 10-Q
For the Quarterly Period Ended
September 30, 2007
INDEX
2
MYLAN
INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Earnings
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Period Ended September 30,
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Three Months
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Six Months
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2007
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2006
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2007
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2006
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(Unaudited; in thousands, except per share amounts)
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Revenues:
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Net revenues
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$
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472,400
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$
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357,766
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$
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1,015,109
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$
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706,555
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Other revenues
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4,691
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8,891
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8,303
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16,241
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Total revenues
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477,091
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366,657
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1,023,412
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722,796
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Cost of sales
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255,450
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170,567
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505,063
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338,506
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Gross profit
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221,641
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196,090
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518,349
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384,290
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Operating expenses:
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Research and development
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33,577
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22,696
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65,297
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43,921
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Selling, general and administrative
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97,016
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50,348
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173,895
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100,173
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Litigation settlements, net
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(848
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)
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(11,500
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)
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(813
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(11,500
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)
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Total operating expenses
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129,745
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61,544
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238,379
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132,594
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Earnings from operations
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91,896
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134,546
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279,970
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251,696
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Interest expense
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23,107
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10,441
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46,026
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20,801
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Other income (expense), net
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166,832
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(2,222
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)
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130,474
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7,362
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Earnings before income taxes and minority interest
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235,621
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121,883
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364,418
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238,257
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Provision for income taxes
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88,498
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44,342
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137,705
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85,129
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Earnings before minority interest
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147,123
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77,541
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226,713
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153,128
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Minority interest
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(2,704
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)
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(2,841
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Net earnings
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$
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149,827
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$
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77,541
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$
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229,554
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$
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153,128
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Earnings per common share:
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Basic
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$
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0.60
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$
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0.37
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$
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0.92
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$
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0.73
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Diluted
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$
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0.60
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$
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0.36
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$
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0.91
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$
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0.71
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Weighted average common shares outstanding:
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Basic
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248,660
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210,999
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248,569
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210,477
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Diluted
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250,500
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215,077
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251,052
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214,934
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Cash dividend declared per common share:
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$
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$
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0.06
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$
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0.06
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$
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0.12
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See Notes to Condensed Consolidated Financial Statements
3
MYLAN
INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
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September 30, 2007
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March 31, 2007
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(Unaudited; in thousands, except share and per share
amounts)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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1,203,641
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$
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1,252,365
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Marketable securities
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65,953
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174,207
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Accounts receivable, net
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488,107
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350,294
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Inventories
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430,538
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429,111
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Deferred income tax benefit
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141,612
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145,343
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Prepaid expenses and other current assets
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286,704
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60,724
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Total current assets
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2,616,555
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2,412,044
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Property, plant and equipment, net
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725,427
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686,739
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Intangible assets, net
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334,547
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352,780
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Goodwill
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614,770
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612,742
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Deferred income tax benefit
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43,230
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45,779
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Other assets
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142,044
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143,783
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Total assets
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$
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4,476,573
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$
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4,253,867
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LIABILITIES AND SHAREHOLDERS EQUITY
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Current liabilities:
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Trade accounts payable
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$
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179,889
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$
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160,286
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Short-term borrowings
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120,390
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108,259
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Income taxes payable
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89,025
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78,387
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Current portion of other long-term obligations
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29,929
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124,782
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Other current liabilities
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346,956
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228,821
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Total current liabilities
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766,189
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700,535
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Deferred revenue
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100,366
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90,673
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Long-term debt
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1,569,451
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1,654,932
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Other long-term obligations
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41,183
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29,760
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Deferred income tax liability
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78,288
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85,900
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Total liabilities
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2,555,477
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2,561,800
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Minority interest
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34,425
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43,207
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Shareholders equity
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Preferred stock par value $0.50 per share
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Shares authorized: 5,000,000 Shares issued: none
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Common stock par value $0.50 per share
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Shares authorized: 600,000,000 at September 30, 2007 and
March 31, 2007
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169,899
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169,681
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Shares issued: 339,798,357 at September 30, 2007 and
339,361,201 at March 31, 2007
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Additional paid-in capital
|
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986,482
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962,746
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Retained earnings
|
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|
2,306,434
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2,103,282
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Accumulated other comprehensive earnings
|
|
|
12,130
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|
|
|
1,544
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|
|
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|
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|
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|
3,474,945
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3,237,253
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Less: Treasury stock at cost
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Shares: 90,963,658 at September 30, 2007 and 90,948,957 at
March 31, 2007
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1,588,274
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1,588,393
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Total shareholders equity
|
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|
1,886,671
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1,648,860
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Total liabilities and shareholders equity
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$
|
4,476,573
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$
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4,253,867
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See Notes to Condensed Consolidated Financial Statements
4
MYLAN
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
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Six Months Ended September 30,
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2007
|
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2006
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(Unaudited;
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in thousands)
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Cash flows from operating activities:
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|
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Net earnings
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$
|
229,554
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|
$
|
153,128
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Adjustments to reconcile net earnings to net cash provided from
operating activities:
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|
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|
|
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Depreciation and amortization
|
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|
54,209
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23,887
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|
Stock-based compensation expense
|
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|
10,441
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|
|
|
12,835
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|
Minority interest
|
|
|
(2,841
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)
|
|
|
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|
Net income from equity method investees
|
|
|
(2,958
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)
|
|
|
(5,038
|
)
|
Change in estimated sales allowances
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|
56,090
|
|
|
|
19,919
|
|
Deferred income tax benefit (expense)
|
|
|
9,066
|
|
|
|
(7,687
|
)
|
Other non-cash items, net
|
|
|
12,321
|
|
|
|
7,313
|
|
Litigation settlements, net
|
|
|
(813
|
)
|
|
|
(11,500
|
)
|
Receipts from litigation settlements, net
|
|
|
2,795
|
|
|
|
13,508
|
|
Gain on foreign currency option contract
|
|
|
(85,046
|
)
|
|
|
|
|
Cash received from Somerset
|
|
|
|
|
|
|
5,500
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(186,470
|
)
|
|
|
(36,609
|
)
|
Inventories
|
|
|
7,089
|
|
|
|
(24,259
|
)
|
Trade accounts payable
|
|
|
(6,665
|
)
|
|
|
(8,180
|
)
|
Income taxes
|
|
|
(7,806
|
)
|
|
|
7,319
|
|
Deferred revenue
|
|
|
10,986
|
|
|
|
(8,504
|
)
|
Other operating assets and liabilities, net
|
|
|
(11,228
|
)
|
|
|
14,552
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
88,724
|
|
|
|
156,184
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(57,349
|
)
|
|
|
(49,798
|
)
|
Purchase of marketable securities
|
|
|
(185,092
|
)
|
|
|
(403,789
|
)
|
Proceeds from sale of marketable securities
|
|
|
293,014
|
|
|
|
318,482
|
|
Other items, net
|
|
|
(3,347
|
)
|
|
|
(896
|
)
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
47,226
|
|
|
|
(136,001
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Cash dividends paid
|
|
|
(29,825
|
)
|
|
|
(25,253
|
)
|
Payment of financing fees
|
|
|
|
|
|
|
(1,782
|
)
|
Excess tax benefit from stock-based compensation
|
|
|
2,164
|
|
|
|
3,353
|
|
Proceeds from exercise of stock options
|
|
|
7,203
|
|
|
|
21,704
|
|
Proceeds from long-term debt
|
|
|
|
|
|
|
187,000
|
|
Payments on long-term debt
|
|
|
(189,349
|
)
|
|
|
(187,938
|
)
|
Change in short-term borrowings, net
|
|
|
4,210
|
|
|
|
|
|
Change in outstanding checks in excess of cash in
|
|
|
|
|
|
|
|
|
disbursement accounts
|
|
|
18,008
|
|
|
|
(7,605
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in financing activities
|
|
|
(187,589
|
)
|
|
|
(10,521
|
)
|
|
|
|
|
|
|
|
|
|
Effect on cash of changes in exchange rates
|
|
|
2,915
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(48,724
|
)
|
|
|
9,662
|
|
Cash and cash equivalents beginning of period
|
|
|
1,252,365
|
|
|
|
150,124
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents end of period
|
|
$
|
1,203,641
|
|
|
$
|
159,786
|
|
|
|
|
|
|
|
|
|
|
See Notes to Condensed Consolidated Financial Statements
5
MYLAN
INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited;
dollars and euros in thousands, except share and per share
amounts)
In the opinion of management, the accompanying unaudited
condensed consolidated financial statements (interim financial
statements) of Mylan 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, 2007.
The interim results of operations for the three and six months
ended September 30, 2007, and the interim cash flows for
the six months ended September 30, 2007, are not
necessarily indicative of the results to be expected for the
full fiscal year or any other future period.
On October 2, 2007, the Company amended its bylaws, to
change the Companys fiscal year from beginning
April 1st and
ending on
March 31st,
to beginning
January 1st
and ending on
December 31st.
As a result of this change, Mylan will be required to file a
transition report on
Form 10-K
for the nine month period ending December 31, 2007 and will
thereafter report based on its changed fiscal year.
The Company also amended its articles of incorporation to change
its name from Mylan Laboratories Inc. to Mylan Inc., effective
as of October 2, 2007.
Certain prior year amounts were reclassified to conform to the
current year presentation. Such reclassifications had no impact
on reported net earnings, earnings per share or
shareholders equity.
|
|
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, 2007.
At March 31, 2007, as a result of significant uncertainties
surrounding the Food and Drug Administrations
(FDAs) approval of additional abbreviated new
drug applications (ANDAs) with respect to a product
launched by the Company in late March 2007, the Company was not
able to reasonably estimate the amount of potential price
adjustments that would occur as a result of the additional
approvals. As a result, revenues on shipments of this product
were deferred until such uncertainties were resolved. Initially,
such uncertainties were considered to be resolved upon our
customers sale of this product. During the quarter ended
September 30, 2007, as a result of additional competition
entering the market upon companies receiving final FDA approval,
these uncertainties were resolved and the Company now believes
that it is able to reasonably estimate the amount of potential
price adjustments. Accordingly, all revenues on shipments
previously deferred have been recognized and revenue is
currently being recorded at the time of shipment as described
above.
Accounts receivable are presented net of allowances relating to
the provisions noted above. Such allowances were $454,881 and
$404,687 as of September 30, 2007, and March 31, 2007.
Other current liabilities include $57,769 and $51,873 at
September 30, 2007 and March 31, 2007, for certain
rebates and other adjustments that are payable to indirect
customers.
6
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
|
|
3.
|
Recent
Accounting Pronouncements
|
In September 2006, the Financial Accounting Standards Board
(FASB) issued Statement of Financial Accounting
Standards (SFAS) No. 157, Fair Value
Measurements, (SFAS No. 157), which
defines fair value, establishes a framework for measuring fair
value in GAAP and expands disclosure about fair value
measurements. The statement is effective for fiscal years
beginning after November 15, 2007. The Company is currently
evaluating the impact of adopting SFAS No. 157 on its
consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial
Liabilities, (SFAS No. 159), providing
companies with an option to report selected financial assets and
liabilities at fair value. This statement is effective for
fiscal years beginning after November 15, 2007. The Company
is currently evaluating the impact of adopting
SFAS No. 159 on its consolidated financial statements.
In August 2007, the FASB issued an exposure draft of a proposed
FASB Staff Position (the Proposed FSP) reflecting
new rules that would change the accounting treatment for certain
convertible debt instruments, including our Senior Convertible
Notes. Under the proposed new rules for convertible debt
instruments that may be settled entirely or partially in cash
upon conversion, an entity should separately account for the
liability and equity components of the instrument in a manner
that reflects the issuers economic interest cost. The
effect of the proposed new rules for the debentures is that the
equity component would be included in the
paid-in-capital
section of stockholders equity on our balance sheet and
the value of the equity component would be treated as original
issue discount for purposes of accounting for the debt component
of the Senior Convertible Notes. Higher interest expense would
result by recognizing accretion of the discounted carrying value
of the Senior Convertible Notes to their face amount as interest
expense over the term of the Senior Convertible Notes. This
Proposed FSP is expected to be effective for fiscal years
beginning after December 15, 2007, would not permit early
application and would be applied retrospectively to all periods
presented (retrospective application). The Company is currently
evaluating the proposed new rules and the impact of this
Proposed FSP, if it should be adopted. However, if the Proposed
FSP is adopted, we expect to have higher interest expense
starting in 2008 due to the interest expense accretion, and
prior period interest expense associated with the Senior
Convertible Notes would also reflect higher than previously
reported interest expense due to retrospective application.
|
|
4.
|
Acquisition
of Generics Business of Merck KGaA
|
On May 12, 2007, Mylan and Merck KGaA announced the signing
of a definitive agreement under which Mylan agreed to purchase
Mercks generic pharmaceutical business (Merck
Generics) in an all-cash transaction. The definitive
agreement was amended on October 1, 2007 to detail the
final structure of the closing transactions and to identify
certain assets to be transferred in connection with the purchase
of Merck Generics. On October 2, 2007, Mylan completed its
acquisition of Merck Generics and paid a preliminary purchase
price of approximately 4,925,000 (approximately
$6,992,000). The preliminary purchase price is subject to change
as a result of a closing balance sheet audit and certain working
capital and other adjustments. The purchase price is expected to
be finalized by the end of the calendar year. Mylan will account
for this transaction as a purchase under SFAS No. 141,
Business Combinations
(SFAS No. 141) and will consolidate
the results of operations of Merck Generics from October 2,
2007. The final purchase price will be allocated to in-process
research and development, assets acquired, and liabilities
assumed. The Company expects to record a substantial charge in
the quarter ended December 31, 2007 related to the acquired
in-process research and development. In order to finance the
acquisition, the Company used cash on hand and entered into
several new borrowing arrangements subsequent to
September 30, 2007. See Note 9 for further discussion.
In conjunction with the acquisition of Merck Generics, Mylan
entered into a deal-contingent foreign currency option contract
in order to mitigate the risk of foreign currency exposure
related to the Euro-denominated purchase price. The contract was
contingent upon the closing of the acquisition, and included a
premium of $121,892, which was paid upon such closing on
October 2, 2007. This premium was included within other
current liabilities as of September 30, 2007. The value of
the foreign currency option contract fluctuated depending on the
value of the
7
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
U.S. dollar compared to the Euro. The Company accounted for
this instrument under the provisions of SFAS No. 133,
Accounting for Derivative Instruments and Hedging Activities
(SFAS No. 133). This instrument did
not qualify for hedge accounting treatment under
SFAS No. 133 and therefore was required to be adjusted
to fair value with the change in the fair value of the
instrument recorded in current earnings. The Company recorded a
non-cash, unrealized gain of $142,532 and $85,046 (net of the
premium), for the three and six month periods ended
September 30, 2007, respectively, related to the
deal-contingent foreign currency option contract. These amounts
are included in other income (expense), net in the Condensed
Consolidated Statement of Earnings for both periods. The fair
value of this contract at September 30, 2007 is included in
prepaid expenses and other current assets on the Condensed
Consolidated Balance Sheet. In conjunction with the closing on
October 2, 2007 of the acquisition of Merck Generics, this
foreign currency option contract was settled (net of the
premium) and Mylan received a cash payment of $85,046.
|
|
5.
|
Stock-Based
Incentive Plan
|
Mylans shareholders approved the Mylan Laboratories
Inc. 2003 Long-Term Incentive Plan on July 25, 2003,
and approved certain amendments on July 28, 2006 (as
amended, 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. Awards are granted at
the fair value of the shares underlying the options at the date
of the grant and generally become exercisable over periods
ranging from three to four years and generally expire in ten
years.
Upon approval of the 2003 Plan, the Mylan Laboratories Inc.
1997 Incentive Stock Option Plan (the 1997 Plan)
was frozen, and no further grants of stock options will be made
under that plan. However, there are stock options outstanding
from the 1997 Plan, expired plans and other plans assumed
through acquisitions.
The following table summarizes stock option activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
Number of Shares
|
|
|
Exercise Price
|
|
|
|
under Option
|
|
|
per Share
|
|
|
Outstanding at March 31, 2007
|
|
|
17,647,728
|
|
|
$
|
16.17
|
|
Options granted
|
|
|
3,641,792
|
|
|
|
15.91
|
|
Options exercised
|
|
|
(437,838
|
)
|
|
|
13.29
|
|
Options forfeited
|
|
|
(252,399
|
)
|
|
|
17.65
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2007
|
|
|
20,599,283
|
|
|
$
|
16.18
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest at September 30, 2007
|
|
|
20,087,287
|
|
|
$
|
16.15
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30, 2007
|
|
|
12,652,979
|
|
|
$
|
15.31
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2007, options outstanding, options
vested and expected to vest, and options exercisable had average
remaining contractual terms of 6.44 years, 6.38 years
and 5.13 years, respectively. Also at September 30,
2007, options outstanding, options vested and expected to vest
and options exercisable had aggregate intrinsic values of
$25,813, $25,770, and $25,230, respectively.
8
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
A summary of the status of the Companys nonvested
restricted stock and restricted stock unit awards as of
September 30, 2007 and the changes during the six month
period ended September 30, 2007, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
Number of
|
|
|
Grant-Date
|
|
|
|
Restricted
|
|
|
Fair Value
|
|
Restricted Stock Awards
|
|
Stock Awards
|
|
|
per Share
|
|
|
Nonvested at March 31, 2007
|
|
|
211,316
|
|
|
$
|
23.10
|
|
Granted
|
|
|
1,014,404
|
|
|
|
15.80
|
|
Released
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(19,714
|
)
|
|
|
21.37
|
|
|
|
|
|
|
|
|
|
|
Nonvested at September 30, 2007
|
|
|
1,206,006
|
|
|
$
|
16.99
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2007, the Company had $44,982 of total
unrecognized compensation expense, net of estimated forfeitures,
related to all of its stock-based awards, which will be
recognized over the remaining weighted average period of
2.28 years. The total intrinsic value of options exercised
during the three and six month periods ended September 30,
2007 were $782 and $3,160. The total fair value of all options
which vested during the three and six month periods ended
September 30, 2007, was $17 and $21,407.
|
|
6.
|
Balance
Sheet Components
|
Selected balance sheet components consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
March 31,
|
|
|
|
2007
|
|
|
2007
|
|
|
Inventories:
|
|
|
|
|
|
|
|
|
Raw materials
|
|
$
|
161,278
|
|
|
$
|
148,109
|
|
Work in process
|
|
|
90,391
|
|
|
|
95,655
|
|
Finished goods
|
|
|
178,869
|
|
|
|
185,347
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
430,538
|
|
|
$
|
429,111
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment:
|
|
|
|
|
|
|
|
|
Land and improvements
|
|
$
|
30,658
|
|
|
$
|
29,850
|
|
Buildings and improvements
|
|
|
344,728
|
|
|
|
297,505
|
|
Machinery and equipment
|
|
|
544,438
|
|
|
|
471,990
|
|
Construction in progress
|
|
|
90,389
|
|
|
|
141,301
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,010,213
|
|
|
|
940,646
|
|
Less: accumulated depreciation
|
|
|
284,786
|
|
|
|
253,907
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
725,427
|
|
|
$
|
686,739
|
|
|
|
|
|
|
|
|
|
|
9
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
March 31,
|
|
|
|
2007
|
|
|
2007
|
|
|
Other current liabilities:
|
|
|
|
|
|
|
|
|
Payroll and employee benefit plan accruals
|
|
$
|
55,700
|
|
|
$
|
47,282
|
|
Accrued rebates
|
|
|
57,769
|
|
|
|
51,873
|
|
Royalties
|
|
|
11,335
|
|
|
|
15,215
|
|
Deferred revenue
|
|
|
17,806
|
|
|
|
17,675
|
|
Accrued interest
|
|
|
5,258
|
|
|
|
4,575
|
|
Legal and professional
|
|
|
18,217
|
|
|
|
40,095
|
|
Foreign currency option contract
|
|
|
121,892
|
|
|
|
|
|
Other
|
|
|
58,979
|
|
|
|
52,106
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
346,956
|
|
|
$
|
228,821
|
|
|
|
|
|
|
|
|
|
|
|
|
7.
|
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 awards outstanding on the weighted average number of
common shares outstanding was 1,840,000 and 4,078,000 for the
three months ended September 30, 2007 and 2006, and
2,483,000 and 4,457,000 for the six months ended
September 30, 2007 and 2006.
Stock options or restricted stock awards representing 13,821,000
and 2,167,000 shares of common stock were outstanding as of
September 30, 2007 and 2006, 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 anti-dilutive.
|
|
8.
|
Goodwill
and Intangible Assets
|
A rollforward of goodwill from March 31, 2007 to
September 30, 2007 is as follows:
|
|
|
|
|
|
|
Total
|
|
|
Goodwill balance at March 31, 2007
|
|
$
|
612,742
|
|
Foreign currency translation and other
|
|
|
2,028
|
|
|
|
|
|
|
Goodwill balance at September 30, 2007
|
|
$
|
614,770
|
|
|
|
|
|
|
10
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
Intangible assets consist of the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
Average Life
|
|
|
Original
|
|
|
Accumulated
|
|
|
Net Book
|
|
|
|
(years)
|
|
|
Cost
|
|
|
Amortization
|
|
|
Value
|
|
|
September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and technologies
|
|
|
20
|
|
|
$
|
118,926
|
|
|
$
|
64,008
|
|
|
$
|
54,918
|
|
Product rights and licenses
|
|
|
8
|
|
|
|
372,599
|
|
|
|
107,122
|
|
|
|
265,477
|
|
Other
|
|
|
14
|
|
|
|
22,489
|
|
|
|
9,120
|
|
|
|
13,369
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
514,014
|
|
|
$
|
180,250
|
|
|
|
333,764
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets no longer subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trademarks
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
783
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
334,547
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and technologies
|
|
|
20
|
|
|
$
|
118,927
|
|
|
$
|
61,000
|
|
|
$
|
57,927
|
|
Product rights and licenses
|
|
|
8
|
|
|
|
367,805
|
|
|
|
86,349
|
|
|
|
281,456
|
|
Other
|
|
|
14
|
|
|
|
20,821
|
|
|
|
8,207
|
|
|
|
12,614
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
507,553
|
|
|
$
|
155,556
|
|
|
|
351,997
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets no longer subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trademarks
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
783
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
352,780
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense for the six months ended September 30,
2007, and 2006, was $24,234 and $6,703. As discussed in
Note 1, on October 2, 2007, the Company changed its
fiscal year end to December 31. Amortization expense is
expected to be $36,105 for the nine month transition period
ended December 31, 2007 and $46,247, $43,766, $43,320 and
$37,429 for calendar years 2008 through 2011, respectively. This
excludes expected additional amortization expense related to the
Merck Generics acquisition, which has yet to be determined.
A summary of long-term debt is as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30
|
|
|
March 31
|
|
|
|
2007
|
|
|
2007
|
|
|
Senior Notes(A)
|
|
$
|
500,000
|
|
|
$
|
500,000
|
|
Credit Facilities(B)
|
|
|
450,000
|
|
|
|
450,000
|
|
Senior Convertible Notes(C)
|
|
|
600,000
|
|
|
|
600,000
|
|
Matrix Facility Loans(D)
|
|
|
46,028
|
|
|
|
226,362
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,596,028
|
|
|
|
1,776,362
|
|
Less: Current portion
|
|
|
26,577
|
|
|
|
121,430
|
|
|
|
|
|
|
|
|
|
|
Total long-term debt
|
|
$
|
1,569,451
|
|
|
$
|
1,654,932
|
|
|
|
|
|
|
|
|
|
|
11
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
|
|
|
(A) |
|
On August 31, 2007, the
Company launched tender offers to purchase for cash any and all
of its outstanding 5.750% Senior Notes due 2010 (the
2010 Notes) and 6.375% Senior Notes due 2015
(the 2015 Notes and collectively the
Senior Notes) as well as consent solicitations to
eliminate various affirmative and negative covenants and events
of default contained in the indentures for the Senior Notes,
pursuant to the terms of the Offer to Purchase and Consent
Solicitation Statement and related Letter of Instructions (the
Offer to Purchase). The holders of the Senior Notes
could not tender their Senior Notes without delivering their
consent and could not deliver a consent without tendering their
Senior Notes. The tender offers and solicitations were made as
part of a broader strategy to establish its new global capital
structure and in preparation for the consummation of the
acquisition of Merck Generics. |
|
|
|
Each of the tender offers expired
at 10:00 a.m., New York City time, on October 2, 2007, (the
Expiration Time). Holders who validly tendered their
Senior Notes after the Consent Payment Deadline and on or prior
to the Expiration Time received the total consideration
applicable to the Senior Notes tendered less the consent
payment, plus accrued and unpaid interest to, but not including,
the Settlement Date. |
|
|
|
As of the Expiration Time,
approximately $147,500 in aggregate principal amount of the 2010
Notes, representing 98.31% of the outstanding 2010 Notes, and
$349,800 in aggregate principal amount of the 2015 Notes,
representing 99.95% of the outstanding 2015 Notes, were
tendered. On October 2, 2007, $497,300 of the Senior Notes
were accepted for purchase and paid for by Mylan in conjunction
with the acquisition of Merck Generics. In addition, the
amendments that were the subject of the consent solicitations
were adopted, thereby eliminating various affirmative and
negative covenants and events of default contained in the
indentures for the Senior Notes. |
|
(B) |
|
The Credit Facilities were repaid
in conjunction with the closing of the Merck Generics
acquisition. |
|
|
|
On October 2, 2007, the
Company entered into a credit agreement (the Senior Credit
Agreement) among the Company, a
wholly-owned
European subsidiary (the Euro Borrower), certain
lenders and JPMorgan Chase Bank, National Association, as
Administrative Agent, pursuant to which the Company borrowed
$500,000 in Tranche A Term Loans (the
U.S. Tranche A Term Loans) and $2,000,000
in Tranche B Term Loan (the U.S. Tranche B
Term Loans), and the Euro Borrower borrowed
approximately 1,130,702 ($1,600,000) in Euro Term Loans
(the Euro Term Loans and, together with the
U.S. Tranche A Term Loans and the U.S. Tranche B
Term Loans, the Term Loans). The proceeds of the
Term Loans were used (1) to pay a portion of the
consideration for the acquisition of Merck Generics, (2) to
refinance the 2007 credit facility and the 2006 credit facility,
(together the Existing Credit Agreements), by and
among the Company, the lenders party thereto and JPMorgan Chase
Bank, National Association, as administrative agent, (3) to
purchase the Senior Notes tendered pursuant to the cash tender
offers therefore and (4) to pay a portion of the fees and
expenses in respect of the foregoing transactions (collectively,
the Transactions). The termination of the Existing
Credit Agreements was concurrent with, and contingent upon, the
effectiveness of the Senior Credit Agreement. The Senior Credit
Agreement also contains a $750,000 revolving facility (the
Revolving Facility and, together with the Term
Loans, the Senior Credit Facilities) under which
either the Company or the Euro Borrower may obtain extensions of
credit, subject to the satisfaction of specified conditions. In
conjunction with the closing of the Merck Generics acquisition
the Company borrowed $325,000 under the Revolving Facility. The
Revolving Facility includes a $100,000 subfacility for the
issuance of letters of credit and a $50,000 subfacility for
swingline borrowings. Borrowings under the Revolving Facility
are available in U.S. dollars, Euro, Pounds sterling, Yen
or other currencies that may be agreed. The Euro Term Loans are
guaranteed by the Company and the Senior Credit Facilities are
guaranteed by substantially all of the Companys domestic
subsidiaries (the Guarantors). The Senior Credit
Facilities are also secured by a pledge of the capital stock of
substantially all direct subsidiaries of the Company and the
Guarantors (limited to 65% of outstanding voting stock of
foreign holding companies and any foreign subsidiaries) and
substantially all of the other tangible and intangible property
and assets of the Company and the Guarantors. |
12
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
|
|
|
|
|
The U.S. Tranche A Term
Loans and the U.S. Tranche B Term Loans currently bear
interest at LIBOR (determined in accordance with the Senior
Credit Agreement) plus 3.25% per annum, if the Company chooses
to make LIBOR borrowings, or at a base rate (determined in
accordance with the Senior Credit Agreement) plus 2.25% per
annum. The Euro Term Loans currently bear interest at the Euro
Interbank Offered Rate (EURIBO)(determined in
accordance with the Senior Credit Agreement) plus 3.25% per
annum. Borrowings under the Revolving Facility currently bear
interest at LIBOR (or EURIBO, in the case of borrowings
denominated in Euro) plus 2.75% per annum, if the Company
chooses to make LIBOR (or EURIBO, in the case of borrowings
denominated in Euro) borrowings, or at a base rate plus 1.75%
per annum. Under the terms of the Senior Credit Agreement, the
applicable margins over LIBOR, EURIBO or the base rate may be
increased based on the Companys initial corporate rating
following the date of the Senior Credit Agreement. The
applicable margins over LIBOR, EURIBO or the base rate for the
Revolving Facility and the U.S. Tranche A Term Loans
can fluctuate based on a calculation of the Companys
Consolidated Leverage Ratio as defined in the Senior Credit
Agreement. The Company also pays a facility fee on the entire
amount of the Revolving Facility. The facility fee is currently
0.50% per annum, but can decrease to 0.375% per annum based on
the Companys Consolidated Leverage Ratio. |
|
|
|
The Senior Credit Agreement
contains customary affirmative covenants for facilities of this
type, including covenants pertaining to the delivery of
financial statements, notices of default and certain other
information, maintenance of business and insurance, collateral
matters and compliance with laws, as well as customary negative
covenants for facilities of this type, including limitations on
the incurrence of indebtedness and liens, mergers and certain
other fundamental changes, investments and loans, acquisitions,
transactions with affiliates, dispositions of assets, payments
of dividends and other restricted payments, prepayments or
amendments to the terms of specified indebtedness (including the
Interim Credit Agreement described below) and changes in lines
of business. The Senior Credit Agreement contains financial
covenants requiring maintenance of a minimum interest coverage
ratio and a senior leverage ratio, both of which are defined
within the agreement. These financial covenants are not tested
earlier than the quarter ended June 30, 2008. |
|
|
|
The Senior Credit Agreement
contains default provisions customary for facilities of this
type, which are subject to customary grace periods and
materiality thresholds, including, among other things, defaults
related to payment failures, failure to comply with covenants,
misrepresentations, defaults or the occurrence of a change
of control under other material indebtedness, bankruptcy
and related events, material judgments, certain events related
to pension plans, specified changes in control of the Company
and invalidity of guarantee and security agreements. If an event
of default occurs under the Senior Credit Agreement, the lenders
may, among other things, terminate their commitments, declare
immediately payable all borrowings and foreclose on the
collateral. |
|
|
|
The U.S. Tranche A Term
Loans mature on October 2, 2013. The
U.S. Tranche A Term Loans require amortization
payments of $6,250 per quarter in 2008, $12,500 per quarter in
2009, $18,500 per quarter in 2010, $25,000 per quarter in 2011,
$31,250 per quarter in 2012 and $31,250 per quarter in 2013. The
U.S. Tranche B Term Loans and the Euro Term Loans
mature on October 2, 2014. The U.S. Tranche B
Term Loans and the Euro Term Loans amortize quarterly at the
rate of 1.0% per annum beginning in 2008. The Senior Credit
Agreement requires prepayments of the Term Loans with
(1) up to 50% of Excess Cash Flow, as defined within the
Senior Credit Agreement, beginning in 2009, with reductions
based on the Companys Consolidated Leverage Ratio,
(2) the proceeds from certain asset sales and casualty
events, unless the Companys Consolidated Leverage Ratio is
equal to or less than 3.5 to 1.0, and (3) the proceeds from
certain issuances of indebtedness not permitted by the Senior
Credit Agreement. Amounts drawn on the Revolving Facility become
due and payable on October 2, 2013. The Term Loans and
amounts drawn on the Revolving Facility may be voluntarily
prepaid without penalty or premium. |
|
|
|
In addition, on October 2,
2007, the Company entered into a credit agreement (the
Interim Credit Agreement) among the Company, certain
lenders and Merrill Lynch Capital Corporation, as Administrative
Agent, pursuant to which the Company borrowed $2,850,000 in term
loans (the Interim Term Loans). The |
13
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
|
|
|
|
|
proceeds of the Interim Term Loans were used to finance in part
the Transactions. The Interim Term Loans are unsecured and are
guaranteed by substantially all of the Companys domestic
subsidiaries. |
|
|
|
The Interim Term Loans currently
bear interest at LIBOR (determined in accordance with the
Interim Credit Agreement) plus 4.50% per annum. The interest
rate increases by 0.50% per annum on any Interim Term Loans that
remain outstanding six months after the closing date and
thereafter increases by 0.25% per annum every three months (up
to a maximum of 11.25% per annum). |
|
|
|
The Interim Credit Agreement
contains customary affirmative covenants for facilities of this
type, including covenants pertaining to the delivery of
financial statements, notices of default and certain other
information, maintenance of business of insurance and compliance
with laws, as well as customary negative covenants for
facilities of this type, including limitations on the incurrence
of indebtedness and liens, mergers and certain other fundamental
changes, investments and loans, acquisitions, transactions with
affiliates, dispositions of assets, payments of dividends and
other restricted payments, prepayments of any subordinated
indebtedness and changes in our lines of business. In addition,
the arrangers of the Interim Term Loans have the right to
request, on not more than two occasions between six months and
one year after the closing date, that the Company use
commercially reasonable efforts to issue and sell debt
securities that will generate proceeds sufficient to refinance
the Interim Term Loans. |
|
|
|
The Interim Credit Agreement
contains default provisions customary for facilities of this
type, which are subject to customary grace periods and
materiality thresholds, including, among other things, defaults
related to payment failures, failure to comply with covenants,
misrepresentations, acceleration of other indebtedness,
bankruptcy and related events, material judgments and certain
events related to pension plans. If an event of default occurs
under the Interim Credit Agreement, the lenders may, among other
things, declare the Interim Term Loans immediately due and
payable. |
|
|
|
The Interim Term Loans have an
initial maturity date of October 2, 2008; however as long as
there is no bankruptcy or payment event of default as of such
date, the maturity may be extended to October 2, 2017. The
Interim Term Loans do not require amortization payments. The
Interim Credit Agreement requires prepayments of the Interim
Term Loans (1) with the proceeds from certain asset sales
and casualty events, (2) with the proceeds from certain
issuances of equity or indebtedness and (3) upon the
occurrence of specified changes in control of the Company. The
Interim Term Loans may be voluntarily prepaid without penalty or
premium. |
|
|
|
On and after October 2, 2008,
the lenders have the option to convert any remaining outstanding
Interim Term Loans into exchange notes. The exchange notes have
affirmative and negative covenants and events of default which
are similar to those under the Interim Term Loans but include
certain additional exceptions and modifications. In addition,
the exchange notes are not required to be prepaid in all the
circumstances in which prepayments are required on the Interim
Term Loans. The interest rate for exchange notes can be fixed in
connection with a transfer of such notes. The Company is
obligated to provide for registration of the exchange notes
under the securities laws. In addition, on October 2, 2008,
the affirmative and negative covenants, default provisions,
prepayment provisions and certain other provisions in the
Interim Credit Agreement are automatically amended so as to
conform to the provisions for the exchange notes. |
|
(C) |
|
On March 1, 2007, Mylan
entered into a purchase agreement relating to the sale by the
Company of $600,000 aggregate principal amount of the
Companys 1.25% Senior Convertible Notes due 2012 (the
Convertible Notes). The Convertible Notes bear
interest at a rate of 1.25% per year, accruing from
March 7, 2007. Interest is payable semiannually in arrears
on March 15 and September 15 of each year, beginning
September 15, 2007. The Convertible Notes will mature on
March 15, 2012, subject to earlier repurchase or
conversion. Holders may convert their notes subject to certain
conversion provisions determined by, among others, the market
price of the Companys common stock and the trading price
of the Convertible Notes. The Convertible Notes have an initial
conversion rate of 44.5931 shares of common stock per
$1,000 principal amount (equivalent to an initial conversion
price of approximately $22.43 per share), subject to adjustment,
with the principal amount payable in cash and the remainder in
cash or stock at the option of the Company. |
14
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
|
|
|
|
|
On March 1, 2007,
concurrently with the sale of the Convertible Notes, Mylan
entered into a convertible note hedge transaction, comprised of
a purchased call option, and two warrant transactions with each
of Merrill Lynch International, an affiliate of Merrill Lynch,
and JPMorgan Chase Bank, National Association, London Branch, an
affiliate of JPMorgan, each of which the Company refers to as a
counterparty. The net cost of the transactions was approximately
$80,600. The purchased call options will cover approximately
26,755,853 shares of Mylan common stock, subject to
anti-dilution adjustments substantially similar to the
anti-dilution adjustments for the Convertible Notes, which under
most circumstances represents the maximum number of shares that
underlie the Convertible Notes. Concurrently with entering into
the purchased call options, the Company entered into warrant
transactions with the counterparties. Pursuant to the warrant
transactions, the Company will sell to the counterparties
warrants to purchase in the aggregate approximately
26,755,853 shares of Mylan common stock, subject to
customary anti-dilution adjustments. The warrants may not be
exercised prior to the maturity of the Convertible Notes,
subject to certain limited exceptions. |
|
|
|
The purchased call options are
expected to reduce the potential dilution upon conversion of the
Convertible Notes in the event that the market value per share
of Mylan common stock at the time of exercise is greater than
approximately $22.43, which corresponds to the initial
conversion price of the Convertible Notes. The sold warrants
have an exercise price that is 60.0% higher than the price per
share of $19.50 at which the Company offered common stock in a
concurrent equity offering. If the market price per share of
Mylan common stock at the time of conversion of any Convertible
Notes is above the strike price of the purchased call options,
the purchased call options will, in most cases, entitle the
Company to receive from the counterparties in the aggregate the
same number of shares of our common stock as the Company would
be required to issue to the holder of the converted Convertible
Notes. Additionally, if the market price of Mylan common stock
at the time of exercise of the sold warrants exceeds the strike
price of the sold warrants, the Company will owe the
counterparties an aggregate of approximately
26,755,853 shares of Mylan common stock. The purchased call
options and sold warrants may be settled for cash at the
Companys election. |
|
|
|
The purchased call options and
sold warrants are separate transactions entered into by the
Company with the counterparties, are not part of the terms of
the Convertible Notes, and will not affect the holders
rights under the Convertible Notes. Holders of the Convertible
Notes will not have any rights with respect to the purchased
call options or the sold warrants. The purchased call options
and sold warrants meet the definition of derivatives under
SFAS No. 133 (as amended by
SFAS No. 138, Accounting for Certain Derivative
Instruments and Certain Hedging Activities
(SFAS No. 138) and SFAS No. 149,
Amendment of Statement 133 on Derivative Instruments and
Hedging Activities (SFAS No. 149)).
However, because these instruments have been determined to be
indexed to the Companys own stock (in accordance with the
guidance of Emerging Issues Task Force (EITF) Issue
No. 01-6,
The Meaning of Indexed to a Companys Own Stock) and
have been recorded in stockholders equity in the
Companys Condensed Consolidated Balance Sheet (as
determined under EITF Issue
No. 00-19,
Accounting for Derivative Financial Instruments Indexed to,
and Potentially Settled in, a Companys Own Stock) the
instruments are exempted out of the scope of
SFAS No. 133 and are not subject to the mark to market
provisions of that standard. |
|
(D) |
|
Matrixs borrowings consisted
primarily of two
Euro-denominated
Facilities (Facility A and Facility B).
On July 5, 2007, Facility A was repaid in the amount of
82,500. Matrixs effective interest rate for Facility
B was EURIBO plus 129 basis points, or 5.66% at
September 30, 2007. Facility B is payable over three years
in semi-annual installments beginning in October 2007. On
September 30, 2007, Matrix paid 50,000 on
Facility B reducing the principal amount of the loan to
32,500. These loans were collateralized by the pledge of
certain of Matrix subsidiaries shares and by a Matrix
corporate guarantee to ABN Amro Bank NV. |
All financing fees associated with the Companys borrowings
are being amortized over the life of the related debt. The total
unamortized amounts of $23,763 and $26,801 are included in other
assets in the Condensed Consolidated Balance Sheets at
September 30, 2007 and March 31, 2007.
15
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
In conjunction with the refinancing of debt, approximately
$12,100 of deferred financing fees were written off for the
Senior Notes and Credit Facilities on October 2, 2007.
There was also a tender offer premium to the Senior Notes
holders made in the amount of $32,082. In conjunction with the
new financing for the Merck Generics acquisition, Mylan incurred
approximately $129,800 in financing fees. Certain of these fees
incurred for the interim Bridge loan and the Term A and B
loans may be refundable.
At September 30, 2007 and March 31, 2007, the fair
value of the Convertible Notes was approximately $561,000 and
$640,400, respectively.
|
|
10.
|
Comprehensive
Earnings
|
Comprehensive
earnings consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
Net earnings
|
|
|
|
|
|
$
|
149,827
|
|
|
|
|
|
|
$
|
77,541
|
|
Other comprehensive earnings (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
1,148
|
|
|
|
|
|
|
|
|
|
Unrecognized losses and prior service cost related to
post-retirement plans
|
|
|
|
|
|
|
170
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses) on securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain (losses) on marketable securities
|
|
|
870
|
|
|
|
|
|
|
|
(18
|
)
|
|
|
|
|
Less: Reclassification for losses included in net earnings
|
|
|
(344
|
)
|
|
|
526
|
|
|
|
(5
|
)
|
|
|
(23
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive earnings (loss), net of tax:
|
|
|
|
|
|
|
1,844
|
|
|
|
|
|
|
|
(23
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings, net of tax
|
|
|
|
|
|
$
|
151,671
|
|
|
|
|
|
|
$
|
77,518
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
Net earnings
|
|
|
|
|
|
$
|
229,554
|
|
|
|
|
|
|
$
|
153,128
|
|
Other comprehensive earnings (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
11,082
|
|
|
|
|
|
|
|
|
|
Unrecognized losses and prior service cost related to
post-retirement plans
|
|
|
|
|
|
|
340
|
|
|
|
|
|
|
|
|
|
Unrealized losses on securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized losses on marketable securities
|
|
|
(732
|
)
|
|
|
|
|
|
|
(916
|
)
|
|
|
|
|
Less: Reclassification for losses included in net earnings
|
|
|
(104
|
)
|
|
|
(836
|
)
|
|
|
730
|
|
|
|
(186
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive earnings (loss), net of tax:
|
|
|
|
|
|
|
10,586
|
|
|
|
|
|
|
|
(186
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings, net of tax
|
|
|
|
|
|
$
|
240,140
|
|
|
|
|
|
|
$
|
152,942
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
Accumulated other comprehensive earnings, as reflected on the
balance sheet, is comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
March 31,
|
|
|
|
2007
|
|
|
2007
|
|
|
Net unrealized gain on marketable securities
|
|
$
|
714
|
|
|
$
|
1,550
|
|
Change in unrecognized losses and prior service cost related to
post-retirement
plans
|
|
|
(932
|
)
|
|
|
(1,272
|
)
|
Foreign currency translation adjustments
|
|
|
12,348
|
|
|
|
1,266
|
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income
|
|
$
|
12,130
|
|
|
$
|
1,544
|
|
|
|
|
|
|
|
|
|
|
The Company adopted FASB Interpretation No. 48,
Accounting for Uncertainty in Income Taxes an
Interpretation of FASB Statement 109
(FIN 48) effective April 1, 2007.
FIN 48 clarifies the accounting for uncertain tax
positions. This Interpretation provides that the tax effects
from an uncertain tax position be recognized in the
Companys financial statements, only if the position is
more likely than not of being sustained upon audit, based on the
technical merits of the position. As a result of the
implementation of FIN 48, the Company recognized a $16,400
increase in its existing liability for unrecognized tax
benefits, with a corresponding decrease to the April 1,
2007 retained earnings of $11,400 and an increase to deferred
tax assets of $5,000.
As of April 1, 2007, after the implementation of
FIN 48, the Companys liability for unrecognized tax
benefits was $42,900, excluding liabilities for interest and
penalties. If the Company were to recognize these benefits, the
effective tax rate would reflect a favorable net impact of
$33,000. In addition, at April 1, 2007, liabilities for
accrued interest and penalties relating to the unrecognized tax
benefits totaled $6,300. As of September 30, 2007, the
Companys Condensed Consolidated Balance Sheet reflects a
liability for unrecognized tax benefits of $38,329, excluding
liabilities for interest and penalties. Accrued interest and
penalties included in the Condensed Consolidated Balance Sheet
were $6,850 as of September 30, 2007.
The Company recognizes interest and penalties associated with
uncertain tax positions as a component of income tax expense in
the Condensed Consolidated Statement of Earnings.
It is anticipated that the amount of unrecognized tax benefits
will change in the next 12 months; however, these changes
are not expected to have a significant impact on the results of
operations, cash flows or the financial position of the Company.
The tax years 2005 through 2007 remain open to examination by
the Internal Revenue Service. The major state taxing
jurisdictions applicable to the Company remain open from 2004
through 2007.
The Company has two reportable segments, the Mylan
Segment and the Matrix Segment. The Mylan
Segment primarily develops, manufactures, sells and distributes
generic or branded generic pharmaceutical products in tablet,
capsule or transdermal patch form, while the Matrix Segment
engages mainly in the manufacture and sale of active
pharmaceutical ingredients APIs and the distribution
of branded generic products. Additionally, certain general and
administrative expenses, as well as litigation settlements, and
non-operating income and expenses are reported in
Corporate/Other.
The Companys chief operating decision maker evaluates the
performance of its reportable segments based on net revenues and
segment earnings from operations. Items below the earnings from
operations line of the Condensed Consolidated Statements of
Earnings are not presented by segment, since they are excluded
from the measure of segment profitability reviewed by the
Companys chief operating decision maker. The Company does
not report depreciation expense, total assets and capital
expenditures by segment as such information is not used by the
chief operating decision maker.
17
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
The accounting policies of the segments are the same as those
described in the Summary of Significant Accounting
Policies included in the Companys Annual Report on
Form 10-K.
Intersegment revenues are accounted for at current market values.
The table below presents segment information for the three and
six months ended September 30, 2007 and 2006 and provides a
reconciliation of segment information to total consolidated
information. For the Mylan and Matrix Segments, segment earnings
from operations (Segment profitability (loss))
represents segment gross profit less direct research and
development expenses and direct selling, general and
administrative expenses.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mylan
|
|
|
Matrix
|
|
|
Corporate/Other(1)
|
|
|
Consolidated
|
|
|
Three Months Ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intersegment revenues
|
|
$
|
|
|
|
$
|
6,165
|
|
|
$
|
(6,165
|
)
|
|
$
|
|
|
Third-party net revenues
|
|
|
392,353
|
|
|
|
80,047
|
|
|
|
|
|
|
|
472,400
|
|
Segment profitability (loss)
|
|
|
170,174
|
|
|
|
(13,502
|
)
|
|
|
(64,776
|
)
|
|
|
91,896
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mylan
|
|
|
Matrix
|
|
|
Corporate/Other(1)
|
|
|
Consolidated
|
|
|
Six Months Ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intersegment revenues
|
|
$
|
|
|
|
$
|
15,334
|
|
|
$
|
(15,334
|
)
|
|
$
|
|
|
Third-party net revenues
|
|
|
843,759
|
|
|
|
171,350
|
|
|
|
|
|
|
|
1,015,109
|
|
Segment profitability (loss)
|
|
|
421,484
|
|
|
|
(30,785
|
)
|
|
|
(110,729
|
)
|
|
|
279,970
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mylan
|
|
|
Matrix
|
|
|
Corporate/Other(1)
|
|
|
Consolidated
|
|
|
Three Months Ended September 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intersegment revenues
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Third-party net revenues
|
|
|
357,766
|
|
|
|
|
|
|
|
|
|
|
|
357,766
|
|
Segment profitability (loss)
|
|
|
161,630
|
|
|
|
|
|
|
|
(27,084
|
)
|
|
|
134,546
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mylan
|
|
|
Matrix
|
|
|
Corporate/Other(1)
|
|
|
Consolidated
|
|
|
Six Months Ended September 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intersegment revenues
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Third-party net revenues
|
|
|
706,555
|
|
|
|
|
|
|
|
|
|
|
|
706,555
|
|
Segment profitability (loss)
|
|
|
316,928
|
|
|
|
|
|
|
|
(65,232
|
)
|
|
|
251,696
|
|
|
|
|
(1) |
|
Includes corporate overhead, intercompany eliminations and
charges not directly attributable to segments. |
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),
filed an Abbreviated New Drug Application (ANDA)
seeking approval from the U.S. 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
18
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
filed suit against MPI and Mylan Inc. (Mylan) in the
U.S. District Court for the Southern District of New York
alleging infringement of several of AstraZenecas patents.
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
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
and MPI and filed a separate lawsuit against MPIs
supplier, Esteve Quimica S.A. (Esteve), 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 filed motions for summary judgment
of non-infringement and patent invalidity. On January 12,
2006, those motions were denied. On May 31, 2007, the
district court ruled in Mylans and Esteves favor by
finding that the asserted patents were not infringed by
Mylans/Esteves products. On July 18, 2007,
AstraZeneca appealed the decision to the United States Court of
Appeals for the Federal Circuit.
Lorazepam
and Clorazepate
On June 1, 2005, a jury verdict was rendered against Mylan
Inc. and MPI in the U.S. District Court for the District of
Columbia (D.C.) in the amount of approximately
$12,000 which has been accrued for by the Company. The jury
found Mylan willfully violated Massachusetts, Minnesota and
Illinois state antitrust laws in connection with API supply
agreements entered into between the Company and its API supplier
and broker for two drugs, lorazepam and clorazepate, in 1997,
and subsequent price increases on these drugs in 1998. 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. In
post-trial filings, the plaintiffs have requested that the
verdict be trebled. Plaintiffs are also seeking an award of
attorneys fees, litigation costs and interest on the
judgment in unspecified amounts. In total, the plaintiffs have
moved for judgments that could result in a liability of
approximately $69,000 for Mylan (not including the request for
attorneys fees and costs). The Company filed a motion for
judgment as a matter of law, a motion for a new trial, a motion
to dismiss two of the insurers and a motion to reduce the
verdict. On December 20, 2006, the Companys motion
for judgment as a matter of law and motion for a new trial were
denied. A hearing on the pending post-trial motions took place
on February 28, 2007. 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.
(UDL) received requests from the U.S. House of
Representatives Energy and Commerce Committee (the
Committee) seeking information about certain
products sold by MPI and UDL in connection with the
Committees investigation into pharmaceutical reimbursement
and rebates under Medicaid. MPI and UDL cooperated with this
inquiry and provided information in response to the
Committees requests in 2003. Several states
attorneys general (AG) 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
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, MPI
and/or UDL,
together with many other 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, MPI
and/or UDL
have been named as defendants in substantially similar civil
lawsuits filed by the AGs of Alabama, Alaska, California,
Florida, Hawaii, Idaho, Illinois, Iowa,
19
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
Kentucky, Massachusetts, Mississippi, Missouri, South Carolina,
Texas, Utah and Wisconsin and also by the city of New York and
approximately 40 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, with the exception of the Florida,
Iowa, Idaho, South Carolina and Utah AG actions and the actions
brought by various counties in New York, excluding the actions
brought by Erie, Oswego and Schenectady counties, Mylan, MPI
and/or UDL
have answered the respective complaints denying liability. Mylan
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. MPI is cooperating fully with the
governments investigation.
Modafinil
Antitrust Litigation and FTC Inquiry
Beginning in April 2006, Mylan, along with four other drug
manufacturers, has been named in a series of civil lawsuits
filed in the Eastern District of Pennsylvania by a variety of
plaintiffs purportedly representing direct and indirect
purchasers of the drug modafinil and a third party payor and one
action brought by Apotex, Inc., a manufacturer of generic drugs
seeking approval to market a generic modafinil product. These
actions allege violations of federal and state laws in
connection with the defendants settlement of patent
litigation relating to modafinil. These actions are in their
preliminary stages, and motions to dismiss each action are
pending, with the exception of the third party payor action, in
which Mylans response to the complaint is not due until
the motions filed in the other cases have been decided. Mylan
intends to defend each of these actions vigorously. In addition,
by letter dated July 11, 2006, Mylan was notified by the
U.S. Federal Trade Commission (FTC) of an
investigation relating to the settlement of the modafinil patent
litigation. In its letter, the FTC requested certain information
from Mylan, MPI and Mylan Technologies Inc. (MTI) pertaining to
the patent litigation and the settlement thereof. On
March 29, 2007, the FTC issued a subpoena, and on
April 26, 2007, the FTC issued a civil investigative demand
to Mylan requesting additional information from the Company
relating to the investigation. Mylan is cooperating fully with
the governments investigation and its outstanding requests
for information.
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.
|
|
14.
|
Guarantor
Financial Statements
|
Each of the Companys wholly-owned domestic subsidiaries as
of September 30, 2007, except a captive insurance company,
has guaranteed, on a full, unconditional and joint and several
basis, the Companys performance under the Senior Notes
(collectively, the Guarantor Subsidiaries). Matrix
is not a guarantor of the Senior Notes. As of September 30,
2007, there were certain restrictions under the Senior Notes
indenture on the ability of the Company and the Guarantor
Subsidiaries to receive or distribute funds in the form of cash
dividends, loans or advances. As disclosed in Note 9, as a
result of the tender offers substantially all of the Senior
Notes were purchased and such restrictive covenants have been
eliminated. The following combined financial data provides
information regarding the financial position, results of
operations and cash flows of the Guarantor Subsidiaries
(condensed consolidating financial data). Separate financial
statements and other disclosures concerning the Guarantor
Subsidiaries are not presented because management has determined
that such information would not be material to the holders of
the debt.
20
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
GUARANTOR
SUBSIDIARIES
CONDENSED
CONSOLIDATING BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-
|
|
|
Consolidating
|
|
|
|
|
|
|
Mylan
|
|
|
Guarantor
|
|
|
Guarantor
|
|
|
and Eliminatnig
|
|
|
|
|
|
|
Labs
|
|
|
Subs
|
|
|
Subs
|
|
|
Entries
|
|
|
Consolidated
|
|
|
September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
1,169,532
|
|
|
$
|
10,188
|
|
|
$
|
23,921
|
|
|
$
|
|
|
|
$
|
1,203,641
|
|
Marketable securities
|
|
|
35,250
|
|
|
|
|
|
|
|
30,703
|
|
|
|
|
|
|
|
65,953
|
|
Accounts receivable, net
|
|
|
77,838
|
|
|
|
391,516
|
|
|
|
98,264
|
|
|
|
(79,511
|
)
|
|
|
488,107
|
|
Inventories
|
|
|
|
|
|
|
317,442
|
|
|
|
114,054
|
|
|
|
(958
|
)
|
|
|
430,538
|
|
Deferred income tax benefit
|
|
|
(24,210
|
)
|
|
|
163,276
|
|
|
|
2,546
|
|
|
|
|
|
|
|
141,612
|
|
Prepaid expenses and other current assets
|
|
|
346,803
|
|
|
|
11,995
|
|
|
|
48,809
|
|
|
|
(120,903
|
)
|
|
|
286,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
1,605,213
|
|
|
|
894,417
|
|
|
|
318,297
|
|
|
|
(201,372
|
)
|
|
|
2,616,555
|
|
Intercompany receivables, net
|
|
|
(554,484
|
)
|
|
|
1,154,346
|
|
|
|
(776,911
|
)
|
|
|
177,049
|
|
|
|
|
|
Property, plant and equipment, net
|
|
|
78,918
|
|
|
|
468,218
|
|
|
|
178,291
|
|
|
|
|
|
|
|
725,427
|
|
Intangible assets, net
|
|
|
|
|
|
|
82,824
|
|
|
|
251,723
|
|
|
|
|
|
|
|
334,547
|
|
Goodwill
|
|
|
|
|
|
|
102,578
|
|
|
|
512,192
|
|
|
|
|
|
|
|
614,770
|
|
Deferred income tax benefit
|
|
|
42,564
|
|
|
|
|
|
|
|
666
|
|
|
|
|
|
|
|
43,230
|
|
Other assets
|
|
|
66,573
|
|
|
|
8,962
|
|
|
|
66,509
|
|
|
|
|
|
|
|
142,044
|
|
Investments in subsidiaries
|
|
|
2,303,126
|
|
|
|
|
|
|
|
|
|
|
|
(2,303,126
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
3,541,910
|
|
|
$
|
2,711,345
|
|
|
$
|
550,767
|
|
|
$
|
(2,327,449
|
)
|
|
$
|
4,476,573
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and shareholders equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade accounts payable
|
|
$
|
362
|
|
|
$
|
50,444
|
|
|
$
|
129,531
|
|
|
$
|
(448
|
)
|
|
$
|
179,889
|
|
Short-term borrowings
|
|
|
|
|
|
|
|
|
|
|
120,390
|
|
|
|
|
|
|
|
120,390
|
|
Income taxes payable
|
|
|
(82,338
|
)
|
|
|
166,517
|
|
|
|
6,238
|
|
|
|
(1,392
|
)
|
|
|
89,025
|
|
Current portion of other long-term obligations
|
|
|
3,352
|
|
|
|
|
|
|
|
26,577
|
|
|
|
|
|
|
|
29,929
|
|
Other current liabilities
|
|
|
194,415
|
|
|
|
118,941
|
|
|
|
33,600
|
|
|
|
|
|
|
|
346,956
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
115,791
|
|
|
|
335,902
|
|
|
|
316,336
|
|
|
|
(1,840
|
)
|
|
|
766,189
|
|
Deferred revenue
|
|
|
|
|
|
|
100,366
|
|
|
|
|
|
|
|
|
|
|
|
100,366
|
|
Long-term debt
|
|
|
1,550,000
|
|
|
|
|
|
|
|
211,677
|
|
|
|
(192,226
|
)
|
|
|
1,569,451
|
|
Other long-term obligations
|
|
|
20,332
|
|
|
|
4,636
|
|
|
|
16,637
|
|
|
|
(422
|
)
|
|
|
41,183
|
|
Deferred income tax liability
|
|
|
(17,553
|
)
|
|
|
(3,491
|
)
|
|
|
99,332
|
|
|
|
|
|
|
|
78,288
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
1,668,570
|
|
|
|
437,413
|
|
|
|
643,982
|
|
|
|
(194,488
|
)
|
|
|
2,555,477
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minority interest
|
|
|
|
|
|
|
|
|
|
|
34,861
|
|
|
|
(436
|
)
|
|
|
34,425
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity
Preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
169,899
|
|
|
|
7,494
|
|
|
|
210
|
|
|
|
(7,704
|
)
|
|
|
169,899
|
|
Additional paid-in capital
|
|
|
985,351
|
|
|
|
600,175
|
|
|
|
10,849
|
|
|
|
(609,893
|
)
|
|
|
986,482
|
|
Retained earnings
|
|
|
2,306,435
|
|
|
|
1,666,273
|
|
|
|
(151,346
|
)
|
|
|
(1,514,928
|
)
|
|
|
2,306,434
|
|
Accumulated other comprehensive earnings
|
|
|
(71
|
)
|
|
|
(10
|
)
|
|
|
12,211
|
|
|
|
|
|
|
|
12,130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,461,614
|
|
|
|
2,273,932
|
|
|
|
(128,076
|
)
|
|
|
(2,132,525
|
)
|
|
|
3,474,945
|
|
Less treasury stock at cost
|
|
|
1,588,274
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,588,274
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity
|
|
|
1,873,340
|
|
|
|
2,273,932
|
|
|
|
(128,076
|
)
|
|
|
(2,132,525
|
)
|
|
|
1,886,671
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity
|
|
$
|
3,541,910
|
|
|
$
|
2,711,345
|
|
|
$
|
550,767
|
|
|
$
|
(2,327,449
|
)
|
|
$
|
4,476,573
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
GUARANTOR
SUBSIDIARIES
CONDENSED
CONSOLIDATING BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-
|
|
|
Consolidating
|
|
|
|
|
|
|
Mylan
|
|
|
Guarantor
|
|
|
Guarantor
|
|
|
and Eliminating
|
|
|
|
|
|
|
Labs
|
|
|
Subs
|
|
|
Subs
|
|
|
Entries
|
|
|
Consolidated
|
|
|
March 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
1,146,380
|
|
|
$
|
21,689
|
|
|
$
|
84,312
|
|
|
$
|
(16
|
)
|
|
$
|
1,252,365
|
|
Marketable securities
|
|
|
143,220
|
|
|
|
|
|
|
|
30,987
|
|
|
|
|
|
|
|
174,207
|
|
Accounts receivable, net
|
|
|
10,708
|
|
|
|
262,024
|
|
|
|
79,712
|
|
|
|
(2,150
|
)
|
|
|
350,294
|
|
Inventories
|
|
|
|
|
|
|
324,767
|
|
|
|
108,096
|
|
|
|
(3,752
|
)
|
|
|
429,111
|
|
Other current assets
|
|
|
5,400
|
|
|
|
158,488
|
|
|
|
47,129
|
|
|
|
(4,950
|
)
|
|
|
206,067
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
1,305,708
|
|
|
|
766,968
|
|
|
|
350,236
|
|
|
|
(10,868
|
)
|
|
|
2,412,044
|
|
Intercompany receivables, net
|
|
|
(390,417
|
)
|
|
|
1,009,683
|
|
|
|
(776,231
|
)
|
|
|
156,965
|
|
|
|
|
|
Property, plant and equipment, net
|
|
|
16,741
|
|
|
|
510,853
|
|
|
|
159,145
|
|
|
|
|
|
|
|
686,739
|
|
Intangible assets, net
|
|
|
|
|
|
|
89,321
|
|
|
|
263,459
|
|
|
|
|
|
|
|
352,780
|
|
Goodwill
|
|
|
|
|
|
|
102,579
|
|
|
|
510,163
|
|
|
|
|
|
|
|
612,742
|
|
Other assets
|
|
|
162,480
|
|
|
|
12,191
|
|
|
|
64,891
|
|
|
|
(50,000
|
)
|
|
|
189,562
|
|
Investments in subsidiaries
|
|
|
2,007,547
|
|
|
|
|
|
|
|
|
|
|
|
(2,007,547
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
3,102,059
|
|
|
$
|
2,491,595
|
|
|
$
|
571,663
|
|
|
$
|
(1,911,450
|
)
|
|
$
|
4,253,867
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and shareholders equity
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade accounts payable
|
|
$
|
302
|
|
|
$
|
56,617
|
|
|
$
|
105,532
|
|
|
$
|
(2,165
|
)
|
|
$
|
160,286
|
|
Short-term borrowings
|
|
|
|
|
|
|
|
|
|
|
108,259
|
|
|
|
|
|
|
|
108,259
|
|
Income taxes payable
|
|
|
(177,857
|
)
|
|
|
252,404
|
|
|
|
5,464
|
|
|
|
(1,624
|
)
|
|
|
78,387
|
|
Current portion of other long-term obligations
|
|
|
3,352
|
|
|
|
|
|
|
|
121,430
|
|
|
|
|
|
|
|
124,782
|
|
Other current liabilities
|
|
|
76,214
|
|
|
|
114,255
|
|
|
|
40,036
|
|
|
|
(1,684
|
)
|
|
|
228,821
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
(97,989
|
)
|
|
|
423,276
|
|
|
|
380,721
|
|
|
|
(5,473
|
)
|
|
|
700,535
|
|
Deferred revenue
|
|
|
|
|
|
|
90,673
|
|
|
|
|
|
|
|
|
|
|
|
90,673
|
|
Long-term debt
|
|
|
1,550,000
|
|
|
|
|
|
|
|
104,932
|
|
|
|
|
|
|
|
1,654,932
|
|
Other long-term obligations
|
|
|
2,700
|
|
|
|
1,309
|
|
|
|
161,651
|
|
|
|
(50,000
|
)
|
|
|
115,660
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
1,454,711
|
|
|
|
515,258
|
|
|
|
647,304
|
|
|
|
(55,473
|
)
|
|
|
2,561,800
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minority interest
|
|
|
|
|
|
|
|
|
|
|
44,469
|
|
|
|
(1,262
|
)
|
|
|
43,207
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity
Preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
169,681
|
|
|
|
7,494
|
|
|
|
210
|
|
|
|
(7,704
|
)
|
|
|
169,681
|
|
Additional paid-in capital
|
|
|
962,415
|
|
|
|
593,831
|
|
|
|
10,048
|
|
|
|
(603,548
|
)
|
|
|
962,746
|
|
Retained earnings
|
|
|
2,103,282
|
|
|
|
1,375,003
|
|
|
|
(131,540
|
)
|
|
|
(1,243,463
|
)
|
|
|
2,103,282
|
|
Accumulated other comprehensive earnings
|
|
|
363
|
|
|
|
9
|
|
|
|
1,172
|
|
|
|
|
|
|
|
1,544
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,235,741
|
|
|
|
1,976,337
|
|
|
|
(120,110
|
)
|
|
|
(1,854,715
|
)
|
|
|
3,237,253
|
|
Less treasury stock at cost
|
|
|
1,588,393
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,588,393
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity
|
|
|
1,647,348
|
|
|
|
1,976,337
|
|
|
|
(120,110
|
)
|
|
|
(1,854,715
|
)
|
|
|
1,648,860
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity
|
|
$
|
3,102,059
|
|
|
$
|
2,491,595
|
|
|
$
|
571,663
|
|
|
$
|
(1,911,450
|
)
|
|
$
|
4,253,867
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
GUARANTOR
SUBSIDIARIES
CONDENSED
CONSOLIDATING STATEMENTS OF EARNINGS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-
|
|
|
Consolidating
|
|
|
|
|
|
|
Mylan
|
|
|
Guarantor
|
|
|
Guarantor
|
|
|
and Eliminating
|
|
|
|
|
|
|
Labs
|
|
|
Subs
|
|
|
Subs
|
|
|
Entries
|
|
|
Consolidated
|
|
|
Three Months Ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
|
|
|
$
|
392,353
|
|
|
$
|
86,212
|
|
|
$
|
(6,165
|
)
|
|
$
|
472,400
|
|
Other revenues
|
|
|
|
|
|
|
4,691
|
|
|
|
|
|
|
|
|
|
|
|
4,691
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
397,044
|
|
|
|
86,212
|
|
|
|
(6,165
|
)
|
|
|
477,091
|
|
Cost of sales
|
|
|
|
|
|
|
187,989
|
|
|
|
69,784
|
|
|
|
(2,323
|
)
|
|
|
255,450
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
|
|
|
|
209,055
|
|
|
|
16,428
|
|
|
|
(3,842
|
)
|
|
|
221,641
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
2,085
|
|
|
|
28,204
|
|
|
|
9,044
|
|
|
|
(5,756
|
)
|
|
|
33,577
|
|
Selling, general and administrative
|
|
|
57,706
|
|
|
|
23,732
|
|
|
|
15,578
|
|
|
|
|
|
|
|
97,016
|
|
Litigation settlements, net
|
|
|
(1,071
|
)
|
|
|
223
|
|
|
|
|
|
|
|
|
|
|
|
(848
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
58,720
|
|
|
|
52,159
|
|
|
|
24,622
|
|
|
|
(5,756
|
)
|
|
|
129,745
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings from operations
|
|
|
(58,720
|
)
|
|
|
156,896
|
|
|
|
(8,194
|
)
|
|
|
1,914
|
|
|
|
91,896
|
|
Interest expense
|
|
|
16,486
|
|
|
|
257
|
|
|
|
6,364
|
|
|
|
|
|
|
|
23,107
|
|
Other income, net
|
|
|
164,094
|
|
|
|
441
|
|
|
|
2,464
|
|
|
|
(843
|
)
|
|
|
166,156
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) before income taxes, minority interest and
equity in earnings of subsidiaries
|
|
|
88,888
|
|
|
|
157,080
|
|
|
|
(12,094
|
)
|
|
|
1,071
|
|
|
|
234,945
|
|
Provision for income taxes
|
|
|
78,233
|
|
|
|
11,542
|
|
|
|
(1,641
|
)
|
|
|
364
|
|
|
|
88,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) before minority interest and equity in earnings
of subsidiaries
|
|
|
10,655
|
|
|
|
145,538
|
|
|
|
(10,453
|
)
|
|
|
707
|
|
|
|
146,447
|
|
Minority interest
|
|
|
|
|
|
|
|
|
|
|
(2,704
|
)
|
|
|
|
|
|
|
(2,704
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) before equity in earnings of subsidaries
|
|
|
10,655
|
|
|
|
145,538
|
|
|
|
(7,749
|
)
|
|
|
707
|
|
|
|
149,151
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings (loss) of subsidaries
|
|
|
138,465
|
|
|
|
(8,310
|
)
|
|
|
357
|
|
|
|
(129,836
|
)
|
|
|
676
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss)
|
|
$
|
149,120
|
|
|
$
|
137,228
|
|
|
$
|
(7,392
|
)
|
|
$
|
(129,129
|
)
|
|
$
|
149,827
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
GUARANTOR
SUBSIDIARIES
CONDENSED
CONSOLIDATING STATEMENTS OF EARNINGS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-
|
|
|
Consolidating
|
|
|
|
|
|
|
Mylan
|
|
|
Guarantor
|
|
|
Guarantor
|
|
|
and Eliminating
|
|
|
|
|
|
|
Labs
|
|
|
Subs
|
|
|
Subs
|
|
|
Entries
|
|
|
Consolidated
|
|
|
Three Months Ended September 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
|
|
|
$
|
357,766
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
357,766
|
|
Other revenues
|
|
|
|
|
|
|
8,891
|
|
|
|
|
|
|
|
|
|
|
|
8,891
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
366,657
|
|
|
|
|
|
|
|
|
|
|
|
366,657
|
|
Cost of sales
|
|
|
|
|
|
|
171,440
|
|
|
|
|
|
|
|
(873
|
)
|
|
|
170,567
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
|
|
|
|
195,217
|
|
|
|
|
|
|
|
873
|
|
|
|
196,090
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
2,552
|
|
|
|
20,144
|
|
|
|
|
|
|
|
|
|
|
|
22,696
|
|
Selling, general and administrative
|
|
|
32,382
|
|
|
|
17,720
|
|
|
|
246
|
|
|
|
|
|
|
|
50,348
|
|
Litigation settlements, net
|
|
|
(11,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
23,434
|
|
|
|
37,864
|
|
|
|
246
|
|
|
|
|
|
|
|
61,544
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings from operations
|
|
|
(23,434
|
)
|
|
|
157,353
|
|
|
|
(246
|
)
|
|
|
873
|
|
|
|
134,546
|
|
Interest expense
|
|
|
10,185
|
|
|
|
256
|
|
|
|
|
|
|
|
|
|
|
|
10,441
|
|
Other income, net
|
|
|
38,695
|
|
|
|
5,233
|
|
|
|
1,223
|
|
|
|
(47,373
|
)
|
|
|
(2,222
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before income taxes, minority interest and equity in
earnings of subsidiaries
|
|
|
5,076
|
|
|
|
162,330
|
|
|
|
977
|
|
|
|
(46,500
|
)
|
|
|
121,883
|
|
Provision for income taxes
|
|
|
(7,764
|
)
|
|
|
51,764
|
|
|
|
342
|
|
|
|
|
|
|
|
44,342
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before minority interest and equity in earnings of
subsidiaries
|
|
|
12,840
|
|
|
|
110,566
|
|
|
|
635
|
|
|
|
(46,500
|
)
|
|
|
77,541
|
|
Minority interest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before equity in earnings of subsidaries
|
|
|
12,840
|
|
|
|
110,566
|
|
|
|
635
|
|
|
|
(46,500
|
)
|
|
|
77,541
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of subsidaries
|
|
|
111,201
|
|
|
|
|
|
|
|
|
|
|
|
(111,201
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings
|
|
$
|
124,041
|
|
|
$
|
110,566
|
|
|
$
|
635
|
|
|
$
|
(157,701
|
)
|
|
$
|
77,541
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
GUARANTOR
SUBSIDIARIES
CONDENSED
CONSOLIDATING STATEMENTS OF EARNINGS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-
|
|
|
Consolidating
|
|
|
|
|
|
|
Mylan
|
|
|
Guarantor
|
|
|
Guarantor
|
|
|
and Eliminating
|
|
|
|
|
|
|
Labs
|
|
|
Subs
|
|
|
Subs
|
|
|
Entries
|
|
|
Consolidated
|
|
|
Six Months Ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
|
|
|
$
|
843,759
|
|
|
$
|
186,684
|
|
|
$
|
(15,334
|
)
|
|
$
|
1,015,109
|
|
Other revenues
|
|
|
|
|
|
|
8,303
|
|
|
|
|
|
|
|
|
|
|
|
8,303
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
852,062
|
|
|
|
186,684
|
|
|
|
(15,334
|
)
|
|
|
1,023,412
|
|
Cost of sales
|
|
|
|
|
|
|
356,615
|
|
|
|
153,875
|
|
|
|
(5,427
|
)
|
|
|
505,063
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
|
|
|
|
495,447
|
|
|
|
32,809
|
|
|
|
(9,907
|
)
|
|
|
518,349
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
4,641
|
|
|
|
55,614
|
|
|
|
17,317
|
|
|
|
(12,275
|
)
|
|
|
65,297
|
|
Selling, general and administrative
|
|
|
95,664
|
|
|
|
45,782
|
|
|
|
32,449
|
|
|
|
|
|
|
|
173,895
|
|
Litigation settlements, net
|
|
|
(1,036
|
)
|
|
|
223
|
|
|
|
|
|
|
|
|
|
|
|
(813
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
99,269
|
|
|
|
101,619
|
|
|
|
49,766
|
|
|
|
(12,275
|
)
|
|
|
238,379
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings from operations
|
|
|
(99,269
|
)
|
|
|
393,828
|
|
|
|
(16,957
|
)
|
|
|
2,368
|
|
|
|
279,970
|
|
Interest expense
|
|
|
34,157
|
|
|
|
512
|
|
|
|
11,357
|
|
|
|
|
|
|
|
46,026
|
|
Other income, net
|
|
|
122,100
|
|
|
|
1,113
|
|
|
|
5,989
|
|
|
|
(1,686
|
)
|
|
|
127,516
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings before income taxes, minority interest and
equity in earnings of subsidiaries
|
|
|
(11,326
|
)
|
|
|
394,429
|
|
|
|
(22,325
|
)
|
|
|
682
|
|
|
|
361,460
|
|
Provision for income taxes
|
|
|
77,174
|
|
|
|
61,678
|
|
|
|
(1,379
|
)
|
|
|
232
|
|
|
|
137,705
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings before minority interest and equity in earnings
of subsidiaries
|
|
|
(88,500
|
)
|
|
|
332,751
|
|
|
|
(20,946
|
)
|
|
|
450
|
|
|
|
223,755
|
|
Minority interest
|
|
|
|
|
|
|
|
|
|
|
(2,841
|
)
|
|
|
|
|
|
|
(2,841
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings before equity in earnings of subsidaries
|
|
|
(88,500
|
)
|
|
|
332,751
|
|
|
|
(18,105
|
)
|
|
|
450
|
|
|
|
226,596
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings (loss) of subsidaries
|
|
|
317,604
|
|
|
|
(17,954
|
)
|
|
|
1,488
|
|
|
|
(298,180
|
)
|
|
|
2,958
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss)
|
|
$
|
229,104
|
|
|
$
|
314,797
|
|
|
$
|
(16,617
|
)
|
|
$
|
(297,730
|
)
|
|
$
|
229,554
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
GUARANTOR
SUBSIDIARIES
CONDENSED
CONSOLIDATING STATEMENTS OF EARNINGS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-
|
|
|
Consolidating
|
|
|
|
|
|
|
Mylan
|
|
|
Guarantor
|
|
|
Guarantor
|
|
|
and Eliminating
|
|
|
|
|
|
|
Labs
|
|
|
Subs
|
|
|
Subs
|
|
|
Entries
|
|
|
Consolidated
|
|
|
Six Months Ended September 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
|
|
|
$
|
706,555
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
706,555
|
|
Other revenues
|
|
|
|
|
|
|
16,241
|
|
|
|
|
|
|
|
|
|
|
|
16,241
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
722,796
|
|
|
|
|
|
|
|
|
|
|
|
722,796
|
|
Cost of sales
|
|
|
|
|
|
|
340,252
|
|
|
|
|
|
|
|
(1,746
|
)
|
|
|
338,506
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
|
|
|
|
382,544
|
|
|
|
|
|
|
|
1,746
|
|
|
|
384,290
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
5,143
|
|
|
|
38,778
|
|
|
|
|
|
|
|
|
|
|
|
43,921
|
|
Selling, general and administrative
|
|
|
62,046
|
|
|
|
37,366
|
|
|
|
761
|
|
|
|
|
|
|
|
100,173
|
|
Litigation settlements, net
|
|
|
(11,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
55,689
|
|
|
|
76,144
|
|
|
|
761
|
|
|
|
|
|
|
|
132,594
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings from operations
|
|
|
(55,689
|
)
|
|
|
306,400
|
|
|
|
(761
|
)
|
|
|
1,746
|
|
|
|
251,696
|
|
Interest expense
|
|
|
20,288
|
|
|
|
513
|
|
|
|
|
|
|
|
|
|
|
|
20,801
|
|
Other income, net
|
|
|
38,612
|
|
|
|
9,505
|
|
|
|
2,453
|
|
|
|
(48,246
|
)
|
|
|
2,324
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings before income taxes, minority interest and
equity in earnings of subsidiaries
|
|
|
(37,365
|
)
|
|
|
315,392
|
|
|
|
1,692
|
|
|
|
(46,500
|
)
|
|
|
233,219
|
|
Provision for income taxes
|
|
|
(2,396
|
)
|
|
|
86,933
|
|
|
|
592
|
|
|
|
|
|
|
|
85,129
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings before minority interest and equity in earnings
of subsidiaries
|
|
|
(34,969
|
)
|
|
|
228,459
|
|
|
|
1,100
|
|
|
|
(46,500
|
)
|
|
|
148,090
|
|
Minority interest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings before equity in earnings of subsidaries
|
|
|
(34,969
|
)
|
|
|
228,459
|
|
|
|
1,100
|
|
|
|
(46,500
|
)
|
|
|
148,090
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of subsidaries
|
|
|
234,597
|
|
|
|
5,038
|
|
|
|
|
|
|
|
(234,597
|
)
|
|
|
5,038
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings
|
|
$
|
199,628
|
|
|
$
|
233,497
|
|
|
$
|
1,100
|
|
|
$
|
(281,097
|
)
|
|
$
|
153,128
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
GUARANTOR
SUBSIDIARIES
CONDENSED
CONSOLIDATING STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Guarantor
|
|
|
|
|
|
|
|
|
|
Mylan Labs
|
|
|
Subs
|
|
|
Subs
|
|
|
Eliminating
|
|
|
Consolidated
|
|
|
Six Months Ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows provided by (used in) operations:
|
|
$
|
479,301
|
|
|
$
|
(393,045
|
)
|
|
$
|
2,452
|
|
|
$
|
16
|
|
|
$
|
88,724
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(7,208
|
)
|
|
|
(35,010
|
)
|
|
|
(15,131
|
)
|
|
|
|
|
|
|
(57,349
|
)
|
Purchase of marketable securities
|
|
|
(98,927
|
)
|
|
|
|
|
|
|
(86,165
|
)
|
|
|
|
|
|
|
(185,092
|
)
|
Proceeds from sale of marketable securities
|
|
|
156,609
|
|
|
|
|
|
|
|
136,405
|
|
|
|
|
|
|
|
293,014
|
|
Other items, net
|
|
|
|
|
|
|
(849
|
)
|
|
|
(2,498
|
)
|
|
|
|
|
|
|
(3,347
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
50,474
|
|
|
|
(35,859
|
)
|
|
|
32,611
|
|
|
|
|
|
|
|
47,226
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends paid
|
|
|
(29,825
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(29,825
|
)
|
Net change in short-term borrowings
|
|
|
|
|
|
|
|
|
|
|
4,210
|
|
|
|
|
|
|
|
4,210
|
|
Payment on long-term debt
|
|
|
|
|
|
|
|
|
|
|
(189,349
|
)
|
|
|
|
|
|
|
(189,349
|
)
|
Excess tax benefit from stock-based compensation
|
|
|
2,164
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,164
|
|
Proceeds from exercise of stock options
|
|
|
5,809
|
|
|
|
|
|
|
|
1,394
|
|
|
|
|
|
|
|
7,203
|
|
Change in outstanding checks in excess of cash in disbursement
accounts
|
|
|
|
|
|
|
18,008
|
|
|
|
|
|
|
|
|
|
|
|
18,008
|
|
Loans/advances made to affiliates, net
|
|
|
(132,922
|
)
|
|
|
|
|
|
|
132,922
|
|
|
|
|
|
|
|
|
|
Transfer from (to) affiliates
|
|
|
(351,849
|
)
|
|
|
399,395
|
|
|
|
(47,546
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities
|
|
|
(506,623
|
)
|
|
|
417,403
|
|
|
|
(98,369
|
)
|
|
|
|
|
|
|
(187,589
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect on cash of changes in exchange rates
|
|
|
|
|
|
|
|
|
|
|
2,915
|
|
|
|
|
|
|
|
2,915
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
23,152
|
|
|
|
(11,501
|
)
|
|
|
(60,391
|
)
|
|
|
16
|
|
|
|
(48,724
|
)
|
Cash and cash equivalents beginning of period
|
|
|
1,146,380
|
|
|
|
21,689
|
|
|
|
84,312
|
|
|
|
(16
|
)
|
|
|
1,252,365
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents end of period
|
|
$
|
1,169,532
|
|
|
$
|
10,188
|
|
|
$
|
23,921
|
|
|
$
|
|
|
|
$
|
1,203,641
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial
Statements (Continued)
GUARANTOR
SUBSIDIARIES
CONDENSED
CONSOLIDATING STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Guarantor
|
|
|
|
|
|
|
|
|
|
Mylan Labs
|
|
|
Subs
|
|
|
Subs
|
|
|
Eliminating
|
|
|
Consolidated
|
|
|
Six Months ended September 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows (used in) provided by operations:
|
|
$
|
(20,126
|
)
|
|
$
|
180,134
|
|
|
$
|
3,781
|
|
|
$
|
(7,605
|
)
|
|
$
|
156,184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(3,495
|
)
|
|
|
(46,303
|
)
|
|
|
|
|
|
|
|
|
|
|
(49,798
|
)
|
Purchase of marketable securities
|
|
|
|
|
|
|
(376,667
|
)
|
|
|
(27,122
|
)
|
|
|
|
|
|
|
(403,789
|
)
|
Proceeds from sale of marketable securities
|
|
|
|
|
|
|
297,090
|
|
|
|
21,392
|
|
|
|
|
|
|
|
318,482
|
|
Other items, net
|
|
|
|
|
|
|
(896
|
)
|
|
|
|
|
|
|
|
|
|
|
(896
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(3,495
|
)
|
|
|
(126,776
|
)
|
|
|
(5,730
|
)
|
|
|
|
|
|
|
(136,001
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends paid
|
|
|
(25,253
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(25,253
|
)
|
Payment of financing fees
|
|
|
(1,782
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,782
|
)
|
Proceeds from long-term debt
|
|
|
187,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
187,000
|
|
Payment on long-term debt
|
|
|
(187,938
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(187,938
|
)
|
Excess tax benefit from stock-based compensation
|
|
|
3,353
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,353
|
|
Proceeds from exercise of stock options
|
|
|
21,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,704
|
|
Change in outstanding checks in excess of cash in disbursement
accounts
|
|
|
|
|
|
|
(7,605
|
)
|
|
|
|
|
|
|
|
|
|
|
(7,605
|
)
|
Transfer from (to) affiliates
|
|
|
37,873
|
|
|
|
(37,873
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
34,957
|
|
|
|
(45,478
|
)
|
|
|
|
|
|
|
|
|
|
|
(10,521
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
11,336
|
|
|
|
7,880
|
|
|
|
(1,949
|
)
|
|
|
(7,605
|
)
|
|
|
9,662
|
|
Cash and cash equivalents beginning of period
|
|
|
4,911
|
|
|
|
128,191
|
|
|
|
9,417
|
|
|
|
7,605
|
|
|
|
150,124
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents end of period
|
|
$
|
16,247
|
|
|
$
|
136,071
|
|
|
$
|
7,468
|
|
|
$
|
|
|
|
$
|
159,786
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28
|
|
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
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, 2007, the unaudited
interim Condensed Consolidated Financial Statements and related
Notes included in Part I, 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 Part II,
Item 1A. 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, 2007, included total revenues of
$477.1 million, net earnings of $149.8 million and
earnings per diluted share of $0.60. Comparatively, the three
months ended September 30, 2006, included total revenues of
$366.7 million, net earnings of $77.5 million and
earnings per diluted share of $0.36. This represents an increase
of 30% in total revenues, 93% in net earnings and 67% in
earnings per diluted share when compared to the same prior year
period. For the six months ended September 30, 2007, Mylan
reported total revenues of $1.02 billion, net earnings of
$229.6 million and earnings per diluted share of $0.91. For
the six months ended September 30, 2006, total revenues
were $722.8 million, net earnings were $153.1 million
and earnings per diluted share were $0.71. This represents an
increase of 42% in total revenues, 50% in net earnings and 28%
in earnings per diluted share when compared to the prior period.
On October 2, 2007, the Company completed its acquisition
of Merck KGaAs generic business (Merck
Generics) for 4.9 billion (approximately
$6.9 billion) in an all cash transaction. Mylan will
account for this transaction as a purchase under Statement of
Financial Accounting Standards (SFAS) No. 141,
Business Combinations (SFAS No. 141), and
will consolidate the results of operations of Merck Generics as
of October 2, 2007. The final purchase price will be
allocated to in-process research and development, assets
acquired, and liabilities assumed. The Company expects to record
a substantial charge in the quarter ended December 31, 2007
related to the acquired in-process research and development.
In conjunction with this acquisition, the Company entered into a
deal-contingent foreign currency option contract in order to
mitigate the risk of foreign currency exposure on the
Euro-denominated purchase price. The Company accounted for this
instrument under the provisions of SFAS No. 133,
Accounting for Derivative Instruments and Hedging Activities
(SFAS No. 133). This instrument did
not qualify for hedge accounting treatment under
SFAS No. 133 and, therefore, was adjusted to fair
value at each reporting date with the change in the fair value
of the instrument recorded in earnings. Included in diluted
earnings per share for the three and six months ended
September 30, 2007 was a gain of $0.36 and $0.21 per
diluted share, respectively, with respect to this option
contract.
Included in the results for both the three and six months ended
September 30, 2006 are losses of $0.02 per diluted share
with respect to the mark to market of a foreign exchange forward
contract entered into in advance of the Companys
acquisition of Matrix Laboratories Limited (Matrix)
which was completed in the quarter ended March 31, 2007.
Also included in the results for both the three and six months
ended September 30, 2006 is a gain of $0.03 per share
related to the favorable settlement of certain litigation.
29
In the quarter ended March 31, 2007, Mylan issued
26.2 million shares of its common stock in an equity
offering and sold approximately 8.1 million shares to
certain selling shareholders of Matrix as part of that
acquisition.
Mylan now reports as two reportable segments, the Mylan
Segment and the Matrix Segment. Additionally,
certain general and administrative expenses, as well as
litigation settlements, and non-operating income and expenses
are reported in Corporate/Other. In accordance with
SFAS No. 131, Disclosures about Segments of an
Enterprise and Related Information
(SFAS No. 131), information for
earlier periods has been recast.
A more detailed discussion of the Companys financial
results for the three and six month periods ended
September 30, 2007, can be found under the section titled
Results of Operations.
Results
of Operations
Quarter
Ended September 30, 2007, Compared to Quarter Ended
September 30, 2006
Total
Revenues and Gross Profit
Total revenues for the current quarter increased 30% or
$110.4 million to $477.1 million compared to
$366.7 million in the quarter ended September 30,
2006. Mylan Segment total revenues were $397.0 million, and
Matrix Segment total revenues were $80.0 million.
For the Mylan Segment, net revenues for the current quarter
increased by $34.6 million or 10% compared to the three
months ended September 30, 2006, primarily as a result of
the contribution from new products and favorable volume,
partially offset by unfavorable pricing.
New products in the current quarter contributed net revenues of
$66.2 million and consisted primarily of amlodipine and
oxybutynin. Mylan launched amlodipine in March 2007. However,
because of significant uncertainties surrounding the Food and
Drug Administrations (FDAs) approval of
additional amlodipine abbreviated new drug applications
(ANDAs) we were unable to reasonably estimate the
amount of potential price adjustments that would occur as a
result of the additional approvals. As a result, revenues on
shipments of amlodipine were deferred until such uncertainties
were resolved. Initially, such uncertainties were considered
resolved upon our customers sale of this product. During
the quarter ended September 30, 2007, as a result of
additional competition entering the market upon companies
receiving final FDA approval, these uncertainties were resolved
and all revenues on shipments previously deferred have been
recognized and revenue is currently being recorded at the time
of shipment.
Fentanyl, Mylans AB-rated generic alternative to
Duragesic®,
continued to contribute significantly to the quarterly results,
accounting for 15% of Mylan Segment net revenues despite the
entrance into the market of additional generic competition in
August 2007. As expected the additional competition had an
unfavorable impact on fentanyl pricing. Additional generic
competition, as well as the impact of continued consolidation
among retail customers, negatively impacted pricing on other
products in our 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.
For the Mylan Segment, with respect to volume, total doses
shipped increased from the same prior year period by
approximately 18% to 4.1 billion doses.
Net revenues for the Matrix Segment were $86.2 million, of
which $80.0 million represented third-party sales.
Approximately 65% of the Matrix Segments third-party net
revenues come from the sale of API and intermediates and
approximately 25% mainly from the distribution of branded
generic products in Europe. Intersegment revenue was derived
from API sales to the Mylan Segment primarily in conjunction
with the Companys vertical integration strategy, as well
as revenue earned through intersegment product development
agreements.
For the three months ended September 30, 2007, consolidated
gross profit increased 13% or $25.6 million to
$221.6 million from $196.1 million, and gross margins
decreased to 46.5% from 53.5%. Included in gross profit for the
current quarter were purchase accounting related items of
approximately $8.1 million, which consisted
30
primarily of incremental amortization related to the intangible
assets associated with the Matrix acquisition. Excluding such
items, consolidated gross margins were 48.2%.
For the Mylan Segment, gross profit was $210.9 million
compared to $196.1 million, while gross margins decreased
slightly to 53.1% from 53.5%. A significant portion of gross
profit was comprised of fentanyl and new products, including
oxybutynin and amlodipine. Products generally contribute most
significantly to gross margin at the time of their launch and
even more so in periods of market exclusivity or limited generic
competition. The additional competition on fentanyl and multiple
generic market entrants for amlodipine both had a negative
impact on current quarter margins.
Operating
Expenses
Consolidated research and development (R&D)
expense for the current quarter was $33.6 million compared
to $22.7 million for the same period in the prior year,
which represents an increase of $10.9 million or 48%.
Matrix Segment R&D expense was $9.0 million for the
three months ended September 30, 2007, accounting for the
majority of the increase. Mylan Segment R&D expense was
$22.4 million for the current quarter compared to
$20.1 million for the same period in the prior year. This
increase is primarily the result of a higher number of ongoing
clinical studies during the three months ended
September 30, 2007 compared to the prior year.
Selling, general and administrative (SG&A)
expense for the current quarter was $97.0 million compared
to $50.3 million for the same period in the prior year, an
increase of $46.7 million or 93%. The increase was
primarily the result of higher Corporate/Other SG&A which
increased $27.5M or 76% to $63.5 million from
$36.0 million. The increase to Corporate/Other SG&A is
due to integration costs related to our acquisition of Merck
Generics, higher payroll and payroll related costs and increased
costs associated primarily with the Companys recent
implementation of an ERP system. The remainder of the increase
is related to the addition of the Matrix Segment, with SG&A
expense of $15.2 million.
Interest
Expense
Interest expense for the three months ended September 30,
2007 was $23.1 million compared to $10.4 million for
the same period of the prior year. The increase is the result of
additional debt incurred to fund a portion of the Matrix
acquisition, debt assumed in the Matrix acquisition and the
issuance of the Convertible Notes in March 2007.
Other
Income (Expense), net
Other income (expense), net was $166.8 million of income
for the three months ended September 30, 2007, compared to
$2.2 million of expense in the same prior year period. The
increase is primarily the result of an unrealized gain of
$142.5 million recorded in the current quarter on a
deal-contingent foreign currency option contract entered into
with respect to the acquisition of Merck Generics. The purpose
of this foreign currency option contract was to mitigate
exchange rate risk on the Euro-denominated purchase price. In
accordance with SFAS No. 133, this derivative
instrument is marked to market each period with any change in
the fair value reported in current earnings. Additionally, the
increase is the result of higher interest and dividend income on
our investments.
Income
Tax Expense
The Companys effective tax rate increased in the current
quarter to 37.6% from 36.4% in the same period of the prior
year. This increase is due primarily to the impact of losses in
certain entities for which the Company could not recognize a tax
benefit, which is expected to diminish over time.
31
Six
Months Ended September 30, 2007, Compared to Six Months
Ended September 30, 2006
Total
Revenues and Gross Profit
Total revenues for the six months ended September 30, 2007
increased 42% or $300.6 million to $1.02 billion
compared to $722.8 million. Mylan Segment total revenues
were $852.1 million, and Matrix Segment total revenues were
$171.4 million.
For the Mylan Segment, net revenues for the six months ended
September 30, 2007 increased by $137.2 million or 19%
compared to the six months ended September 30, 2006,
primarily as a result of the contribution from new products,
partially offset by unfavorable pricing.
New products for the six month period contributed net revenues
of $189.2 million and consisted primarily of amlodipine and
oxybutynin. Mylan launched amlodipine in March 2007. However,
because of significant uncertainties surrounding the FDAs
approval of additional amlodipine ANDAs we were unable to
reasonably estimate the amount of potential price adjustments
that would occur as a result of the additional approvals. As a
result, revenues on shipments of amlodipine were deferred until
such uncertainties were resolved. Initially, such uncertainties
were considered resolved upon our customers sale of this
product. During the six months ended September 30, 2007, as
a result of additional competition entering the market upon
companies receiving final FDA approval, these uncertainties were
resolved and all revenues previously deferred have been
recognized and revenue is currently being recorded at the time
of shipment.
Fentanyl continued to contribute significantly to the results
for the six month period, accounting for 15% of Mylan Segment
net revenues despite the entrance into the market of additional
generic competition in August 2007. As expected the additional
competition had an unfavorable impact on fentanyl pricing.
Additional generic competition, as well as the impact of
continued consolidation among retail customers, negatively
impacted pricing on other products in our 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.
For the Mylan Segment, total doses shipped increased from the
same prior year period by approximately 11% to 7.6 billion
doses.
Net revenues for the Matrix Segment were $186.7 million, of
which $171.4 million represented third-party sales.
Approximately 65% of the Matrix Segments third-party net
revenues comes from the sale of API and intermediates and
approximately 25% mainly from the distribution of branded
generic products in Europe. Intersegment revenue was derived
from API sales to the Mylan Segment, as well as revenue earned
through intersegment product development agreements.
Consolidated gross profit increased 35% or $134.0 million
to $518.3 million from $384.3 million, and gross
margins decreased to 50.6% from 53.2%. Included in gross profit
for the six months ended September 30, 2007, were purchase
accounting related items of approximately $23.0 million,
which consisted of incremental amortization related to the
intangible assets and the amortization of the inventory
step-up
associated with the Matrix acquisition. Excluding such items,
consolidated gross margins were 52.9%.
For the six months ended September 30, 2007, for the Mylan
Segment, gross profit was $500.1 million compared to
$384.3 million, while gross margins increased to 58.7% from
53.2%. A significant portion of gross profit was comprised of
fentanyl and new products, including oxybutynin and amlodipine.
Products generally contribute most significantly to gross margin
at the time of their launch and even more so in periods of
market exclusivity or limited generic competition. The
additional competition on fentanyl and multiple generic market
entrants for amlodipine both had a negative impact on current
year margins.
Operating
Expenses
Consolidated R&D expense for the six months ended
September 30, 2007 was $65.3 million compared to
$43.9 million for the same period in the prior year, which
represents an increase of $21.4 million or 49%. Matrix
Segment R&D expense was $17.3 million for the six
months ended September 30, 2007. Excluding Matrix, R&D
expense increased by $4.1 million or 9%. The Mylan Segment
had R&D expense of $43.3 million for the six months
ended September 30, 2007 compared to $38.8 million for
the same period in the prior year. This increase is
32
primarily the result of a higher number of ongoing clinical
studies during the six months ended September 30, 2007,
compared to the prior year.
SG&A expense for the current quarter was
$173.9 million compared to $100.2 million for the same
period in the prior year, an increase of $73.7 million or
74%. The Matrix Segment contributed to the increase, with
SG&A expense of $31.7 million. The remainder of the
increase was primarily the result of higher Corporate/Other
SG&A which increased $35.3M or 49% to $106.9 million
from $71.6 million. The increase to Corporate/Other
SG&A is due primarily to integration costs related to our
acquisition of Merck Generics, higher payroll and payroll
related costs and increased costs associated primarily with the
Companys recent implementation of an ERP system.
Litigation,
net
During the six months ended September 30, 2006, the Company
recorded a net gain of $11.5 million as a result of a
favorable settlement with respect to certain outstanding
litigation.
Interest
Expense
Interest expense for the six months ended September 30,
2007 was $46.0 million compared to $20.8 million for
the same period of the prior year. The increase is the result of
additional debt incurred to fund a portion of the Matrix
acquisition, debt assumed in the Matrix acquisition and the
issuance of the Convertible Notes in March of 2007.
Other
Income (Expense), net
Other income (expense), net, was $130.5 million during the
six months ended September 30, 2007 compared to
$7.4 million of income in the same prior year period. The
change is primarily the result of an unrealized gain of
$85.0 million on a deal-contingent foreign currency
contract related to the acquisition of Merck Generics. The cash
was received in conjunction with the closing of the acquisition
subsequent to September 30, 2007. The purpose of this
foreign currency option contract was to mitigate exchange rate
risk on the Euro-denominated purchase price. In accordance with
SFAS No. 133, this derivative instrument is marked to
market each period with any change in the fair value reported in
current earnings. The remaining increase is a result of higher
interest and dividend income on our investments.
During the first quarter of fiscal 2007, Mylan received a cash
payment from Somerset of approximately $5.5 million. The
amount in excess of the carrying value of our investment in
Somerset, approximately $5.0 million, was recorded as
equity income.
Income
Tax Expense
The Companys effective tax rate increased for the six
months ended September 30, 2007 to 37.8% from 35.7% in the
same period of the prior year. This increase is due primarily to
the impact of losses in certain entities for which the Company
could not recognize a tax benefit, which is expected to diminish
over time.
Liquidity
and Capital Resources
Cash flows from operating activities were $88.7 million for
the six months ended September 30, 2007, consisting
primarily of net income plus non-cash addbacks for depreciation
and amortization and the change in sales allowances, partially
offset by the gain on a foreign currency option contract and
the negative impact on cash of changes in working capital. In
total, working capital at September 30, 2007 was
$1.9 billion compared to $1.7 billion at
March 31, 2007. A decrease in marketable securities was
offset by an increase in accounts receivable, which increased as
a result of the timing of payments and higher overall sales,
including previously deferred sales of amlodipine which were
recognized in the current quarter.
Cash provided by investing activities for the six months ended
September 30, 2007, was $47.2 million. Of the
Companys $4.5 billion of total assets at
September 30, 2007, $1.3 billion was held in cash,
cash equivalents and
33
marketable securities. As a result of the Merck acquisition,
cash is expected to be lower as a percentage of total assets.
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 six months ended September 30,
2007, the Company liquidated a portion of its marketable
securities portfolio and used a significant amount of cash on
hand to fund, in part, the acquisition of Merck Generics.
Capital expenditures during the six months ended
September 30, 2007, were $57.3 million. These
expenditures were incurred primarily with respect to the
Companys previously announced planned expansions and the
implementation of an integrated ERP system.
Cash used in financing activities was $187.6 million for
the six months ended September 30, 2007, due primarily to
the repayment of certain Matrix debt.
Also included in cash flows from financing activities are
proceeds of $7.2 million from the exercise of stock options
and cash dividends paid of $29.8 million. The Company does
not anticipate paying dividends for the foreseeable future.
In conjunction with the closing of the Merck Generics
acquisition on October 2, 2007, the Company entered into a
credit agreement (the Senior Credit Agreement) among
the Company, a wholly-owned European subsidiary (the Euro
Borrower), certain lenders and JPMorgan Chase Bank,
National Association, as Administrative Agent, pursuant to which
the Company borrowed $500.0 million in Tranche A Term
Loans (the U.S. Tranche A Term Loans) and
$2.0 billion in Tranche B Term Loan (the
U.S. Tranche B Term Loans), and the Euro
Borrower borrowed approximately 1.1 billion
($1.6 billion) in Euro Term Loans (the Euro Term
Loans and, together with the U.S. Tranche A Term
Loans and the U.S. Tranche B Term Loans, the
Term Loans). The proceeds of the Term Loans were
used (1) to pay a portion of the consideration for the
acquisition of Merck Generics, (2) to refinance the 2007
credit facility and the 2006 credit facility, (together the
Existing Credit Agreements), by and among the
Company, the lenders party thereto and JPMorgan Chase Bank,
National Association, as administrative agent, (3) to
purchase the outstanding 5.750% Senior Notes due 2010 and the
6.375% Senior Notes due 2015, collectively the Senior
Notes, tendered pursuant to the previously announced cash
tender offers therefore and (4) to pay a portion of the
fees and expenses in respect of the foregoing transactions
(collectively, the Transactions). The termination of
the Existing Credit Agreements was concurrent with, and
contingent upon, the effectiveness of the Senior Credit
Agreement. The Senior Credit Agreement also contains a
$750.0 million revolving facility (the Revolving
Facility and, together with the Term Loans, the
Senior Credit Facilities) under which either the
Company or the Euro Borrower may obtain extensions of credit,
subject to the satisfaction of specified conditions. In
conjunction with the closing of the Merck Generics acquisition,
the Company borrowed $325.0 million under the Revolving
Facility. The Revolving Facility includes a $100.0 million
subfacility for the issuance of letters of credit and a
$50.0 million subfacility for swingline borrowings.
Borrowings under the Revolving Facility are available in
U.S. dollars, Euro, Pounds sterling, Yen or other
currencies that may be agreed. The Euro Term Loans are
guaranteed by the Company and the Senior Credit Facilities are
guaranteed by substantially all of the Companys domestic
subsidiaries (the Guarantors). The Senior Credit
Facilities are also secured by a pledge of the capital stock of
substantially all direct subsidiaries of the Company and the
Guarantors (limited to 65% of outstanding voting stock of
foreign holding companies and any foreign subsidiaries) and
substantially all of the other tangible and intangible property
and assets of the Company and the Guarantors.
The U.S. Tranche A Term Loans and the
U.S. Tranche B Term Loans currently bear interest at
LIBOR (determined in accordance with the Senior Credit
Agreement) plus 3.25% per annum, if the Company chooses to make
LIBOR borrowings, or at a base rate (determined in accordance
with the Senior Credit Agreement) plus 2.25% per annum. The Euro
Term Loans currently bear interest at the Euro Interbank Offered
Rate (EURIBO)(determined in accordance with the
Senior Credit Agreement) plus 3.25% per annum. Borrowings under
the Revolving Facility currently bear interest at LIBOR (or
EURIBO, in the case of borrowings denominated in Euro) plus
2.75% per annum, if the Company chooses to make LIBOR (or
EURIBO, in the case of borrowings denominated in Euro)
borrowings, or at a base rate plus 1.75% per annum. Under the
terms of the Senior Credit Agreement, the applicable margins
over LIBOR, EURIBO or the base rate may be increased based on
the Companys initial corporate rating following the date
of the Senior Credit Agreement. The
34
applicable margins over LIBOR, EURIBO or the base rate for the
Revolving Facility and the U.S. Tranche A Term Loans
can fluctuate based on a calculation of the Companys
Consolidated Leverage Ratio as defined in the Senior Credit
Agreement. The Company also pays a facility fee on the entire
amount of the Revolving Facility. The facility fee is currently
0.50% per annum, but can decrease to 0.375% per annum based on
the Companys Consolidated Leverage Ratio.
The Senior Credit Agreement contains customary affirmative
covenants for facilities of this type, including covenants
pertaining to the delivery of financial statements, notices of
default and certain other information, maintenance of business
and insurance, collateral matters and compliance with laws, as
well as customary negative covenants for facilities of this
type, including limitations on the incurrence of indebtedness
and liens, mergers and certain other fundamental changes,
investments and loans, acquisitions, transactions with
affiliates, dispositions of assets, payments of dividends and
other restricted payments, prepayments or amendments to the
terms of specified indebtedness (including the Interim Credit
Agreement described below) and changes in lines of business. The
Senior Credit Agreement contains financial covenants requiring
maintenance of a minimum interest coverage ratio and a senior
leverage ratio, both of which are defined within the agreement.
These financial covenants are not tested earlier than the
quarter ended June 30, 2008.
The Senior Credit Agreement contains default provisions
customary for facilities of this type, which are subject to
customary grace periods and materiality thresholds, including,
among other things, defaults related to payment failures,
failure to comply with covenants, misrepresentations, defaults
or the occurrence of a change of control under other
material indebtedness, bankruptcy and related events, material
judgments, certain events related to pension plans, specified
changes in control of the Company and invalidity of guarantee
and security agreements. If an event of default occurs under the
Senior Credit Agreement, the lenders may, among other things,
terminate their commitments, declare immediately payable all
borrowings and foreclose on the collateral.
The U.S. Tranche A Term Loans mature on
October 2, 2013. The U.S. Tranche A Term Loans
require amortization payments of $6.3 million per quarter
in 2008, $12.5 million per quarter in 2009,
$18.5 million per quarter in 2010, $25.0 million per
quarter in 2011, $31.3 million per quarter in 2012 and
$31.3 million per quarter in 2013. The
U.S. Tranche B Term Loans and the Euro Term Loans
mature on October 2, 2014. The U.S. Tranche B
Term Loans and the Euro Term Loans amortize quarterly at the
rate of 1.0% per annum beginning in 2008. The Senior Credit
Agreement requires prepayments of the Term Loans with
(1) up to 50% of Excess Cash Flow, as defined within the
Senior Credit Agreement, beginning in 2009, with reductions
based on the Companys Consolidated Leverage Ratio,
(2) the proceeds from certain asset sales and casualty
events, unless the Companys Consolidated Leverage Ratio is
equal to or less than 3.5 to 1.0, and (3) the proceeds from
certain issuances of indebtedness not permitted by the Senior
Credit Agreement. Amounts drawn on the Revolving Facility become
due and payable on October 2, 2013. The Term Loans and
amounts drawn on the Revolving Facility may be voluntarily
prepaid without penalty or premium.
In addition, on October 2, 2007, the Company entered into a
credit agreement (the Interim Credit Agreement)
among the Company, certain lenders and Merrill Lynch Capital
Corporation, as Administrative Agent, pursuant to which the
Company borrowed $2.9 billion in term loans (the
Interim Term Loans). The proceeds of the Interim
Term Loans were used to finance in part the Transactions. The
Interim Term Loans are unsecured and are guaranteed by
substantially all of the Companys domestic subsidiaries.
The Interim Term Loans currently bear interest at LIBOR
(determined in accordance with the Interim Credit Agreement)
plus 4.50% per annum. The interest rate increases by 0.50% per
annum on any Interim Term Loans that remain outstanding six
months after the closing date and thereafter increases by 0.25%
per annum every three months (up to a maximum of 11.25% per
annum).
The Interim Credit Agreement contains customary affirmative
covenants for facilities of this type, including covenants
pertaining to the delivery of financial statements, notices of
default and certain other information, maintenance of business
of insurance and compliance with laws, as well as customary
negative covenants for facilities of this type, including
limitations on the incurrence of indebtedness and liens, mergers
and certain other fundamental changes, investments and loans,
acquisitions, transactions with affiliates, dispositions of
assets, payments of dividends and other restricted payments,
prepayments of any subordinated indebtedness and changes in our
lines of business. In addition, the arrangers of the Interim
Term Loans have the right to request, on not more
35
than two occasions between six months and one year after the
closing date, that the Company use commercially reasonable
efforts to issue and sell debt securities that will generate
proceeds sufficient to refinance the Interim Term Loans.
The Interim Credit Agreement contains default provisions
customary for facilities of this type, which are subject to
customary grace periods and materiality thresholds, including,
among other things, defaults related to payment failures,
failure to comply with covenants, misrepresentations,
acceleration of other indebtedness, bankruptcy and related
events, material judgments and certain events related to pension
plans. If an event of default occurs under the Interim Credit
Agreement, the lenders may, among other things, declare the
Interim Term Loans immediately due and payable.
The Interim Term Loans have an initial maturity date of
October 2, 2008; however, as long as there is no bankruptcy
or payment event of default as of such date, the maturity may be
extended to October 2, 2017. The Interim Term Loans do not
require amortization payments. The Interim Credit Agreement
requires prepayments of the Interim Term Loans (1) with the
proceeds from certain asset sales and casualty events,
(2) with the proceeds from certain issuances of equity or
indebtedness and (3) upon the occurrence of specified
changes in control of the Company. The Interim Term Loans may be
voluntarily prepaid without penalty or premium.
On and after October 2, 2008, the lenders have the option
to convert any remaining outstanding Interim Term Loans into
exchange notes. The exchange notes have affirmative and negative
covenants and events of default which are similar to those under
the Interim Term Loans but include certain additional exceptions
and modifications. In addition, the exchange notes are not
required to be prepaid in all the circumstances in which
prepayments are required on the Interim Term Loans. The interest
rate for exchange notes can be fixed in connection with a
transfer of such notes. The Company is obligated to provide for
registration of the exchange notes under the securities laws. In
addition, on October 2, 2008, the affirmative and negative
covenants, default provisions, prepayment provisions and certain
other provisions in the Interim Credit Agreement are
automatically amended so as to conform to the provisions for the
exchange notes.
In conjunction with the refinancing of debt, approximately
$12.1 million of deferred financing fees were written off
for the Senior Notes and Credit Facilities on October 2,
2007. There was also a tender offer premium to the Senior Notes
holders made in the amount of approximately $32.1 million.
In conjunction with the new financing for the Merck Generics
acquisition Mylan incurred approximately $129.8 million in
financing fees. Certain of the fees incurred for the interim
loan and Term A and B loans may be refundable.
The Company is involved in various legal proceedings that are
considered normal to its business (see Note 13 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 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.
Recent
Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board
(FASB) issued SFAS No. 157, Fair Value
Measurements (SFAS No. 157), which defines
fair value, establishes a framework for measuring fair value in
GAAP and expands disclosure about fair value measurements. The
statement is effective for fiscal years beginning after
November 15, 2007. The Company is currently evaluating the
impact of adopting SFAS No. 157 on its consolidated
financial statements.
In February 2007, the FASB issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities
(SFAS No. 159), providing companies with an
option to report selected financial assets and liabilities at
fair value. This statement is effective for fiscal years
beginning after November 15, 2007. The Company is currently
evaluating the impact of adopting SFAS No. 159 on its
consolidated financial statements.
36
In August 2007, the FASB issued an exposure draft of a proposed
FASB Staff Position (the Proposed FSP) reflecting
new rules that would change the accounting treatment for certain
convertible debt instruments, including our Senior Convertible
Notes. Under the proposed new rules for convertible debt
instruments that may be settled entirely or partially in cash
upon conversion, an entity should separately account for the
liability and equity components of the instrument in a manner
that reflects the issuers economic interest cost. The
effect of the proposed new rules for the debentures is that the
equity component would be included in the
paid-in-capital
section of stockholders equity on our balance sheet and
the value of the equity component would be treated as original
issue discount for purposes of accounting for the debt component
of the Senior Convertible Notes. Higher interest expense would
result by recognizing accretion of the discounted carrying value
of the Senior Convertible Notes to their face amount as interest
expense over the term of the Senior Convertible Notes. This
Proposed FSP is expected to be effective for fiscal years
beginning after December 15, 2007, would not permit early
application and would be applied retrospectively to all periods
presented (retrospective application). The Company is currently
evaluating the proposed new rules and the impact of adopting
this Proposed FSP, if it should be adopted. However, if the
Proposed FSP is adopted, we expect to have higher interest
expense starting in 2008 due to the interest expense accretion,
and prior period interest expense associated with the Senior
Convertible Notes would also reflect higher than previously
reported interest expense due to retrospective application.
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ITEM 3.
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QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
The Company is subject to market risk primarily from changes in
the market values of investments in its marketable debt
securities, interest rate risk from changes in interest rates
associated with its long-term debt and foreign currency exchange
rate risk.
In conjunction with the acquisition of Merck Generics, we
incurred substantial indebtedness which has variable interest
rates (see Liquidity and Capital Resources) and are subject to
increased foreign currency exchange rate risk.
The Company is in the process of evaluating the impact of the
Merck Generics acquisition and associated borrowings on its
foreign exchange rate and interest rate exposure, including a
review of hedging strategies to manage these risks. On
October 2, 2007, a wholly-owned subsidiary of Mylan Inc.
borrowed 1.1 billion ($1.6 billion) in Euro Term
Loans. These loans protect against possible declines in the
Euro-denominated net assets acquired pursuant to the purchase of
Merck Generics.
Marketable
Debt Securities
In addition to marketable debt and equity securities,
investments are made in overnight deposits, money market funds
and marketable securities with maturities of less than three
months. These instruments are classified as cash equivalents for
financial reporting purposes and have minimal or no interest
rate risk due to their short-term nature.
The following table summarizes the investments in marketable
debt and equity securities which subject the Company to market
risk at September 30, 2007 and March 31, 2007:
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September 30,
|
|
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March 31,
|
|
|
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2007
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2007
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|
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Marketable debt securities
|
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$
|
62,531
|
|
|
$
|
171,548
|
|
Marketable equity securities
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3,422
|
|
|
|
2,659
|
|
|
|
|
|
|
|
|
|
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$
|
65,953
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|
|
$
|
174,207
|
|
|
|
|
|
|
|
|
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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, 2007, the Company had invested
$62.5 million in marketable debt securities, of which
$7.0 million will mature within one year and
$55.5 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 $62.5 million of
marketable
37
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 $2.8 million change in
marketable debt securities.
Long-Term
Debt
On March 1, 2007, Mylan entered into a Purchase Agreement
(the Convertible Notes Purchase Agreement) relating
to the sale by the Company of $600.0 million aggregate
principal amount of the Companys 1.25% Senior
Convertible Notes due 2012 (the Convertible Notes).
The Convertible Notes bear interest at a rate of 1.25% per year,
accruing from March 7, 2007. Interest is payable
semiannually in arrears on March 15 and September 15 of each
year, beginning September 15, 2007. The Convertible Notes
will mature on March 15, 2012, subject to earlier
repurchase or conversion. The Convertible Notes have an initial
conversion rate of 44.5931 shares of common stock per
$1,000 principal amount (equivalent to an initial conversion
price of approximately $22.43 per share), subject to adjustment.
As of September 30, 2007, the fair value of our Convertible
Notes was approximately $561.0 million.
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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,
2007. Based upon that evaluation, the Chief Executive Officer
and the Chief Financial Officer concluded that the
Companys disclosure controls and procedures were
effective. No change in the Companys internal control over
financial reporting occurred during the quarter ended
September 30, 2007, that has materially affected, or is
reasonably likely to materially affect, the Companys
internal control over financial reporting.
On October 2, 2007, the Company closed on the acquisition
of Merck Generics. Merck Generics will be excluded for the
purposes of managements evaluation of our internal control
over financial reporting as of December 31, 2007. Also
subsequent to quarter end, the Company began implementing a new
consolidation system.
PART II.
OTHER INFORMATION
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ITEM 1.
|
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),
filed an Abbreviated New Drug Application (ANDA)
seeking approval from the U.S. 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 Inc. (Mylan) in the
U.S. District Court for the Southern District of New York
alleging infringement of several of AstraZenecas patents.
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
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
and MPI and filed a separate lawsuit against MPIs
supplier, Esteve Quimica S.A. (Esteve), 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 filed motions for summary judgment
of non-infringement and patent invalidity. On January 12,
2006, those motions were denied. On May 31, 2007, the
district court ruled in Mylans and Esteves favor by
finding that the asserted patents were not infringed by
38
Mylans/Esteves products. On July 18, 2007,
AstraZeneca appealed the decision to the United States Court of
Appeals for the Federal Circuit.
Lorazepam
and Clorazepate
On June 1, 2005, a jury verdict was rendered against Mylan
and MPI in the U.S. District Court for the District of
Columbia (D.C.) in the amount of approximately
$12,000 which has been accrued for by the Company. The jury
found Mylan willfully violated Massachusetts, Minnesota and
Illinois state antitrust laws in connection with API supply
agreements entered into between the Company and its API supplier
and broker for two drugs, lorazepam and clorazepate, in 1997,
and subsequent price increases on these drugs in 1998. 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. In
post-trial filings, the plaintiffs have requested that the
verdict be trebled. Plaintiffs are also seeking an award of
attorneys fees, litigation costs and interest on the
judgment in unspecified amounts. In total, the plaintiffs have
moved for judgments that could result in a liability of
approximately $69,000 for Mylan (not including the request for
attorneys fees and costs). The Company filed a motion for
judgment as a matter of law, a motion for a new trial, a motion
to dismiss two of the insurers and a motion to reduce the
verdict. On December 20, 2006, the Companys motion
for judgment as a matter of law and motion for a new trial were
denied. A hearing on the pending post-trial motions took place
on February 28, 2007. 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.
(UDL) received requests from the U.S. House of
Representatives Energy and Commerce Committee (the
Committee) seeking information about certain
products sold by MPI and UDL in connection with the
Committees investigation into pharmaceutical reimbursement
and rebates under Medicaid. MPI and UDL cooperated with this
inquiry and provided information in response to the
Committees requests in 2003. Several states
attorneys general (AG) 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
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, MPI
and/or UDL,
together with many other 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, MPI
and/or UDL
have been named as defendants in substantially similar civil
lawsuits filed by the AGs of Alabama, Alaska, California,
Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Massachusetts,
Mississippi, Missouri, South Carolina, Texas, Utah and Wisconsin
and also by the city of New York and approximately 40 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, with the exception of the Florida,
Iowa, Idaho, South Carolina and Utah AG actions and the actions
brought by various counties in New York, excluding the actions
brought by Erie, Oswego and Schenectady counties, Mylan, MPI
and/or UDL
have answered the respective complaints denying liability. Mylan
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. MPI is cooperating fully with the
governments investigation.
39
Modafinil
Antitrust Litigation and FTC Inquiry
Beginning in April 2006, Mylan, along with four other drug
manufacturers, has been named in a series of civil lawsuits
filed in the Eastern District of Pennsylvania by a variety of
plaintiffs purportedly representing direct and indirect
purchasers of the drug modafinil and a third party payor and one
action brought by Apotex, Inc., a manufacturer of generic drugs
seeking approval to market a generic modafinil product. These
actions allege violations of federal and state laws in
connection with the defendants settlement of patent
litigation relating to modafinil. These actions are in their
preliminary stages, and motions to dismiss each action are
pending, with the exception of the third party payor action, in
which Mylans response to the complaint is not due until
the motions filed in the other cases have been decided. . Mylan
intends to defend each of these actions vigorously. In addition,
by letter dated July 11, 2006, Mylan was notified by the
U.S. Federal Trade Commission (FTC) of an
investigation relating to the settlement of the modafinil patent
litigation. In its letter, the FTC requested certain information
from Mylan, MPI and Mylan Technologies Inc. (MTI) pertaining to
the patent litigation and the settlement thereof. On
March 29, 2007, the FTC issued a subpoena, and on
April 26, 2007, the FTC issued a civil investigative demand
to Mylan requesting additional information from the Company
relating to the investigation. Mylan is cooperating fully with
the governments investigation and its outstanding requests
for information.
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.
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.
Risks
Relating to Our Business
Our
acquisition of Merck Generics involves a number of integration
risks. These risks could cause 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 acquisition of Merck Generics involves a number of
integration risks, such as:
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difficulties in successfully integrating the facilities,
operations and personnel of Merck Generics with our historical
business and corporate culture;
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difficulties in achieving identified financial and operating
synergies;
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diversion of managements attention from our ongoing
business concerns to integration matters;
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the potential loss of key personnel or customers;
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difficulties in consolidating information technology platforms
and corporate infrastructure;
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difficulties in transitioning the Merck Generics business and
products from the Merck name to achieve a global
brand alignment;
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our substantial indebtedness and assumed liabilities;
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the incurrence of significant additional capital expenditures,
transaction and operating expenses and non-recurring
acquisition-related charges;
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challenges in operating in other markets outside of the United
States that are new to us; and
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40
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unanticipated effects of export controls, exchange rate
fluctuations, domestic and foreign political conditions or
domestic and foreign economic conditions.
|
These factors could impair our growth and ability to compete,
require us to focus additional resources on integration of
operations rather than other profitable areas, or otherwise
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.
We may
fail to realize the expected cost savings, growth opportunities
and other benefits anticipated from the acquisitions of Merck
Generics and a controlling interest in Matrix.
The success of the acquisitions of Merck Generics and a
controlling interest in Matrix will depend, in part, on our
ability to realize anticipated cost savings, revenue synergies
and growth opportunities from integrating the historical
businesses of Mylan, Merck Generics and Matrix. We expect to
benefit from operational cost savings resulting from the
consolidation of capabilities and elimination of redundancies as
well as greater efficiencies from increased scale and market
integration.
There is a risk, however, that the historical businesses of
Mylan, Merck Generics and Matrix may not be combined in a manner
that permits these costs savings or synergies to be realized in
the time currently expected, or at all. This may limit or delay
our ability to integrate the companies manufacturing,
research and development, marketing, organizations, procedures,
policies and operations. In addition, a variety of factors,
including, but not limited to, wage inflation and currency
fluctuations, may adversely affect our anticipated cost savings
and revenues.
Also, we may be unable to achieve our anticipated cost savings
and synergies without adversely affecting our revenues. If we
are not able to successfully achieve these objectives, the
anticipated benefits of these acquisitions may not be realized
fully, or at all, or may take longer to realize than expected.
These factors could impair our growth and ability to compete,
require us to focus additional resources on integration of
operations rather than other profitable areas, or otherwise
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.
We
have grown at a very rapid pace. Our inability to properly
manage or support this growth 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 have grown very rapidly over the past few years, including
with our acquisitions of Merck Generics and a controlling
interest in Matrix. This growth has put significant demands on
our processes, systems and people. We expect to make significant
investments in additional personnel, systems and internal
control processes to help manage our growth. Attracting,
retaining and motivating key employees in various departments
and locations to support our growth is critical to our business,
and competition for these people can be intense. If we are
unable to hire and retain qualified employees and if we do not
continue to invest in systems and processes to manage and
support our rapid growth, there may be a material adverse effect
on our business, financial position and results of operations,
and the market value of our common stock could decline.
Our
global expansion through the acquisitions of Merck Generics and
a controlling interest in Matrix exposes us to additional risks
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.
With our recently completed acquisitions of Merck Generics and a
controlling interest in Matrix, our operations extend to
numerous countries outside the United States. Operating globally
exposes us to certain additional risks including, but not
limited to:
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compliance with a variety of national and local laws of
countries in which we do business, including restrictions on the
import and export of certain intermediates, drugs and
technologies;
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fluctuations in exchange rates for transactions conducted in
currencies other than the U.S. dollar;
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41
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adverse changes in the economies in which we operate as a result
of a slowdown in overall growth, a change in government or
economic liberalization policies, or financial, political or
social instability in such countries that affects the markets in
which we operate, particularly emerging markets;
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wage increases or rising inflation in the countries in which we
operate;
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natural disasters, including drought, floods and earthquakes in
the countries in which we operate; and
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communal disturbances, terrorist attacks, riots or regional
hostilities in the countries in which we operate.
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We also face the risk that some of our competitors have more
experience with operations in such countries or with
international operations generally. Certain of the above factors
could have 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 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 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, or a
partner, may not be successful in commercializing any of such
products on a timely basis, if at all, including, without
limitation, nebivolol, for which we are dependent on our partner
Forest Laboratories, which could adversely affect our product
introduction plans, business, financial position and results of
operations and could cause the market value of our common stock
to decline.
Before any prescription drug product, including generic drug
products, can be marketed, marketing authorization approval is
required by the relevant regulatory authorities (for example the
FDA in the United States and the European Medicines Agency, or
EMA) and/or
national regulatory agencies in the European Union, or EU. The
process of obtaining regulatory approval to manufacture and
market new and generic pharmaceutical products is rigorous, time
consuming, costly and largely unpredictable. Outside the United
States, the approval process may be more or less rigorous, and
the time required for approval may be longer or shorter than
that required in the United States. Bio-equivalency studies
conducted in one country may not be accepted in other countries,
and the approval of a pharmaceutical product in one country does
not necessarily mean that the product will be approved in
another country. We, or a partner, may be unable to obtain
requisite approvals on a timely basis for new generic or branded
products that we may develop, license or otherwise acquire.
Moreover, if we obtain regulatory approval for a drug it may be
limited with respect to the indicated uses and delivery methods
for which the drug may be marketed, which could in turn restrict
our potential market for the drug. Also, for products pending
approval, we may obtain raw materials or produce batches of
inventory to be used in efficacy and bioequivalence testing, as
well as in anticipation of the products launch. In the
event that regulatory approval is denied or delayed, we could be
exposed to the risk of this inventory becoming obsolete. The
timing and cost of obtaining regulatory approvals could
adversely affect our product introduction plans, business,
financial position and results of operations and could cause the
market value of our common stock to decline. See
Business Government Regulation.
The approval process for generic pharmaceutical products often
results in the relevant regulatory agency granting final
approval to a number of generic pharmaceutical products at the
time a patent claim for a corresponding branded product or other
market exclusivity expires. This often forces us to face
immediate competition when we introduce a generic product into
the market. Additionally, further generic approvals often
continue to be granted for a given product subsequent to the
initial launch of the generic product. These
42
circumstances generally result in significantly lower prices, as
well as reduced margins, for generic products compared to
branded products. New generic market entrants generally cause
continued price and margin erosion over the generic product life
cycle.
In the United States, the Drug Price Competition and Patent Term
Restoration Act of 1984, or 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 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, the applicant generally enjoys higher market share,
net revenues and gross margin for that product. 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. For example, DuoNeb, one of
our key products, came off exclusivity in July 2007, and we
expect this to adversely affect our revenues for that product.
Such situations could have a material adverse effect on our
ability to market that product profitably and on our business,
financial position and results of operations, and the market
value of our common stock could decline.
In Europe, there is no exclusivity period for the first generic.
The EMA or national regulatory agencies may grant marketing
authorizations to any number of generics. However, if there are
other relevant patents when the core patent expires, for
example, new formulations, the owner of the original brand
pharmaceutical may be able to obtain preliminary injunctions in
certain European jurisdictions preventing launch of the generic
product, if the generic company did not commence proceedings in
a timely manner to invalidate any relevant patents prior to
launch of its generic.
In addition, in jurisdictions other than the United States we
may face similar regulatory hurdles and constraints. If we are
unable to navigate our products through all of the regulatory
hurdles we face in a timely manner it could adversely affect our
product introduction plans, business, financial position and
results of operations and could cause the market value of our
common stock to decline.
If the
transfer pricing arrangements we have among our subsidiaries are
determined to be inappropriate, our tax liability may increase,
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 have transfer pricing arrangements among our subsidiaries in
relation to various aspects of our business, including
manufacturing, marketing, sales and delivery functions. Transfer
pricing regulations in most of the countries in which we operate
require that any international transaction involving associated
companies be on arms-length terms. If, however, a tax
authority in any jurisdiction reviews any of our tax returns and
determines that the transfer prices and terms we have applied
are not appropriate, or that other income of our affiliates
should be taxed in that jurisdiction, we may incur increased tax
liability, including accrued interest and penalties, which would
cause our tax expense to increase. This 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
approved products may not achieve expected levels of market
acceptance, which could have a material adverse effect on our
profitability, business, 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 branded, 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.
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Some of these factors are not within our control. 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. In some cases, studies have
resulted, and may in the future result, in the discontinuance of
product marketing or other risk management programs such as the
need for a patient registry. These situations, should they
occur, could have a material adverse effect on our
profitability, business, financial position and results of
operations, and could cause the market value of our common stock
to decline.
A
relatively small group of products may represent a significant
portion of our net revenues, gross profit 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, gross profit 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.
We
face vigorous competition from other pharmaceutical
manufacturers that threatens the commercial acceptance and
pricing of our products. Such competition 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 generic pharmaceutical industry is highly competitive. We
face competition from many U.S. and foreign manufacturers, some
of whom are significantly larger than we are. 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 greater financial
resources, particularly with regard to manufacturers of branded
products.
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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
governmental authorities. For instance, we must comply with
requirements of the FDA and similar requirements of similar
agencies in our other markets with respect to the manufacture,
labeling, sale, distribution, marketing, advertising, promotion
and development of pharmaceutical products. Failure to comply
with regulations of the FDA and other regulators can result in
fines,
44
disgorgement, unanticipated compliance expenditures, recall or
seizure of products, total or partial suspension of production
and/or
distribution, suspension of the applicable regulators review of
our submissions, enforcement actions, injunctions and criminal
prosecution. Under certain circumstances, the regulators may
also have 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 Europe we must also comply with regulatory requirements with
respect to the manufacture, labeling, sale, distribution,
marketing, advertising, promotion and development of
pharmaceutical products. Some of these requirements are
contained in EU regulations and governed by the EMA. Other
requirements are set down in national laws and regulations of
the EU Member States. Failure to comply with the regulations can
result in a range of fines, penalties, product
recalls/suspensions or even criminal liability. Similar laws and
regulations exist in most of the markets in which we operate.
In addition to the new drug approval process, government
agencies also regulate the facilities and operational procedures
that we use to manufacture our products. We must register our
facilities with the FDA and other similar regulators. Products
manufactured in our facilities must be made in a manner
consistent with current good manufacturing practices, or 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 and other agencies periodically inspect our
manufacturing facilities for compliance. Regulator 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 or other regulatory
bodies which could include withholding the approval of our
submissions or other product applications of that facility. If
any regulatory body 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 or other
regulatory 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.
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.
We are also required to comply with data protection and data
privacy rules in many countries. 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 Medicare and/or
Medicaid rebate program and other governmental purchasing and
rebate programs are complex and may involve subjective decisions
that could change as a result of new business circumstances, new
regulatory guidance, or advice of legal counsel. 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 Medicare
and/or
Medicaid reimbursement and rebates and other governmental
programs are complex, and as discussed in the reports we file
with the SEC and that are incorporated by reference into this
prospectus supplement, 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 United States
Department of Justice with respect to Medicaid reimbursement and
rebates. While we cannot predict the outcome of the
investigation, possible remedies which the United States
government could seek include treble damages, civil monetary
penalties and exclusion from the Medicare and Medicaid
45
programs. In connection with such an investigation, the United
States government may also seek a Corporate Integrity Agreement
(administered by the Office of Inspector General of HHS) with us
which could include ongoing compliance and reporting
obligations. 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, they are subject to review and challenge by
the applicable governmental agencies, and it is possible that
such reviews could result in material changes. Further,
effective October 1, 2007, the Centers for Medicaid and
Medicare Services, or CMS, adopted new rules for Average
Manufacturers Price, or AMP, based on the provisions of
the Deficit Reduction Act of 2005, or DRA. One significant
change as a result of the DRA is that AMP will be disclosed to
the public. AMP was historically kept confidential by the
government and participants in the Medicaid program. Disclosing
AMP to competitors, customers, and the public at large could
negatively affect our leverage in commercial price negotiations.
In addition, as also disclosed in our SEC filings, a number of
state and federal government agencies are conducting
investigations of manufacturers reporting practices with
respect to Average Wholesale Prices, or 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 Medicare
and/or
Medicaid. 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 paymentsand even in the absence of
any such ambiguitya 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 approved pharmaceuticals in accordance
with applicable regulations. Typically, research expenses
related to the development of innovative compounds and the
filing of marketing authorization applications for innovative
compounds (such as NDAs in the United States) are significantly
greater than those expenses associated with the development of
and filing of marketing authorization applications for, generic
products (such as ANDAs in the United States and abridged
applications in Europe). 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 with respect to new drugs
(including, without limitation, nebivolol), our, or a
partners, research and development expenditures may not
result in the successful introduction of new pharmaceutical
products approved by the relevant regulatory bodies. Also, after
we submit a marketing authorization application for a new
compound or generic product, the relevant regulatory authority
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.
46
A
significant portion of our net revenues is 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 is derived from sales
to a limited number of customers. If we were to experience a
significant reduction in or loss of business with one such
customer, or if one such 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 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 could
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 branded and generic, often pursue
strategies to prevent or delay competition from generic
alternatives to branded products. These strategies include, but
are not limited to:
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entering into agreements whereby other generic companies will
begin to market an 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 or other regulatory
bodies, 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 to limit the substitution of
generic versions of brand pharmaceuticals;
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filing suits for patent infringement that may delay regulatory
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 regulatory 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;
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persuading regulatory bodies 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.
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In the United States, 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 in the United States, Europe or in other
countries where we operate 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.
We
have substantial indebtedness and will be required to apply a
substantial portion of our cash flow from operations to service
our indebtedness. Our substantial indebtedness may have a
material adverse effect on
47
our business, financial position and results of operations
and could cause the market value of our common stock to
decline.
We incurred significant indebtedness to fund a portion of the
consideration for our acquisition of Merck Generics and we will
continue to have significant indebtedness even after this and
the concurrent preferred stock offering.
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increasing our vulnerability to general adverse economic and
industry conditions;
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requiring us to dedicate a substantial portion of our cash flow
from operations and proceeds of any equity issuances to payments
on our indebtedness, thereby reducing the availability of cash
flow to fund working capital, capital expenditures, acquisitions
and investments and other general corporate purposes;
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making it difficult for us to optimally capitalize and manage
the cash flow for our businesses;
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limiting our flexibility in planning for, or reacting to,
changes in our businesses and the markets in which we operate;
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making it difficult for us to meet the leverage and interest
coverage ratios required by our Senior Secured Credit Agreement;
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limiting our ability to borrow money or sell stock to fund our
working capital, capital expenditures, acquisitions and debt
service requirements and other financing needs;
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increasing our vulnerability to increases in interest rates in
general because a substantial portion of our indebtedness bears
interest at floating rates;
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requiring us to sell assets in order to pay down debt; and
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placing us at a competitive disadvantage to our competitors that
have less debt.
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If we do not have sufficient cash flow to service our
indebtedness, we may need to refinance all or part of our
existing indebtedness, borrow more money or sell securities,
some or all of which may not be available to us at acceptable
terms or at all. In addition, we may need to incur additional
indebtedness in the future in the ordinary course of business.
Although the terms of our Senior Secured Credit Agreement and
our Senior Unsecured Interim Loan Agreement allow us to incur
additional debt, this is subject to certain limitations which
may preclude us from incurring the amount of indebtedness we
otherwise desire. In addition, if we incur additional debt, the
risks described above could intensify. Furthermore, if future
debt financing is not available to us when required or is not
available on acceptable terms, we may be unable to grow our
business, take advantage of business opportunities, respond to
competitive pressures or satisfy our obligations under our
indebtedness. Any of the foregoing 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
decide to sell assets which could adversely affect our prospects
and opportunities for growth which could affect our
business.
We may from time to time consider selling certain assets if we
determine that such assets are not critical to our strategy, or
if we believe the opportunity to monetize the asset is
attractive, or in order to reduce indebtedness, or for other
reasons. We have explored and will continue to explore the sale
of certain non-core assets. Although our intention is to engage
in asset sales only if they advance our overall strategy, any
such sale could reduce the size or scope of our business, our
market share in particular markets or our opportunities with
respect to certain markets, products or therapeutic categories.
As a result, any such sale could have an adverse effect on our
business, prospects and opportunities for growth.
48
Our
credit facilities and any additional indebtedness we incur in
the future impose, or may impose, significant operating and
financial restrictions, which may prevent us from capitalizing
on business opportunities. 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 credit facilities and any additional indebtedness we incur
in the future impose, or may impose, significant operating and
financial restrictions on us. These restrictions limit our
ability to, among other things, incur additional indebtedness,
make investments, pay dividends, prepay other indebtedness, sell
assets, incur certain liens, enter into agreements with our
affiliates or restricting our subsidiaries ability to pay
dividends, or merge or consolidate. In addition, our Senior
Secured Credit Agreement 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 our
indebtedness, together with accrued interest and other fees, to
be immediately due and payable. 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 regulatory agencies, have
received regulatory agency 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 utilize controlled substances in certain of its current
products and products in development and therefore must meet the
requirements of the Controlled Substances Act of 1970 and the
related regulations administered by the Drug Enforcement
Administration, or DEA, in the United States as well as similar
laws in other countries where we operate. These laws relate to
the manufacture, shipment, storage, sale and use of controlled
substances. The DEA and other regulatory agencies limit the
availability of the active ingredients used in certain of our
current products and products in development and, as a result,
our procurement quota of these active ingredients may not be
sufficient to meet commercial demand or complete clinical
trials. We must annually apply to the DEA and other regulatory
agencies for procurement quota in order to obtain these
substances. Any delay or refusal by the DEA or such regulatory
agencies in establishing our procurement quota for controlled
substances could delay or stop our clinical trials or product
launches, or could cause trade inventory disruptions for those
products that have already been launched, 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.
49
Our
efforts to transition our Merck Generics subsidiaries away from
the Merck name and away from services being provided by Merck
KGaA may impose inherent risks or result in greater than
expected costs or impediments, 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 have a license from Merck KGaA to continue using the
Merck name in company and product names in respect
of the Merck Generics businesses for a two-year transitional
period. We are engaged in efforts to transition in an orderly
manner away from the Merck name and to achieve global brand
alignment. Re-branding may prove to be costly, especially in
markets where the Merck Generics name has strong dominance or
significant equity locally. In addition, brand migration poses
risks of both business disruption and customer confusion. Our
customer outreach and similar efforts may not mitigate fully the
risks of the name changes, which may lead to reductions in
revenues in some markets. These losses 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.
As part of the Merck Generics acquisition we entered into a
transitional services agreement whereby Merck KGaA agreed to
continue to provide certain services including accounting and
information technology to Merck Generics for certain periods.
The cost of transitioning such services from Merck KGaA to us
during those periods as well as the capital expenditures that
may be required for system upgrades may be greater than we
expect or result in other impediments to our business. Such
costs or impediments 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.
In addition, in limited circumstances, entities we acquired in
the Acquisition are party to litigation and/or subject to
investigation in matters under which we are entitled to
indemnification by Merck KGaA. However, there are risks
inherent in such indemnities and, accordingly, there can be no
assurance that we will receive the full benefits of such
indemnification.
Our
business is highly dependent upon market perceptions of us, our
brands and the safety and quality of our products. Our business
or brands could be subject to negative publicity, 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.
Market perceptions of our business are very important to us,
especially market perceptions of our brands and the safety and
quality of our products. If we, or our brands, suffer from
negative publicity, or if any of our products or similar
products which other companies distribute are proven to be, or
are claimed to be, harmful to consumers then this 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. Also, because we are dependant on
market perceptions, negative publicity associated with illness
or other adverse effects resulting from our products could have
a material adverse impact on our business, financial position
and results of operations and could cause the market value of
our common stock to decline.
We
have a limited number of manufacturing facilities producing a
substantial portion of our products. Production at any one of
these facilities 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.
A substantial portion of our capacity as well as our current
production is attributable to a limited number of manufacturing
facilities. A significant disruption at any one of those
facilities, 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.
50
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.
A significant amount of our sales are 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. 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.
Our
competitors, including branded pharmaceutical 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 or similar applicants that seek
regulatory 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 or similar
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. If patents
are held valid and infringed by our products in a particular
jurisdiction, we would, unless we could obtain a license from
the patent holder, need to cease selling in that jurisdiction
and may need to deliver up or destroy existing stock in that
jurisdiction.
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 necessarily 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 branded 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 (including the UK National
Health Service and the German statutory health insurance scheme)
and private health insurers and other organizations, such as
health maintenance organizations, or HMOs, in the United States,
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. In the
United States, 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 pharmaceutical products.
Further, any reimbursement may be
51
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.
In Germany recent legislative changes have been introduced which
are aimed at reducing costs for the German statutory health
insurance, or SHI, scheme. The measure is likely to have an
impact upon marketing practice and reimbursement of drugs and
may increase pressure on competition and reimbursement margins.
The Act to Increase Competition in the Statutory Health
Insurance Scheme provides, inter alia: (i) in addition to
the existing reference price scheme, SHI funds will impose
reimbursement caps on innovative drugs; (ii) SHI-funds will
receive a rebate for generic drugs corresponding to 10% of the
selling price, excluding VAT (this does not apply to generic
drugs the price of which is at least 30% below the reference
price); (iii) SHI funds will receive a rebate for generic
drugs corresponding to 16% of the selling price, excluding VAT,
for generics which are not listed in the inventory of groups of
pharmaceuticals with a fixed price to be reimbursed by the
statutory health insurance scheme; and (iv) new incentives
for individual rebate contracts between pharmaceutical companies
and single SHI funds. These 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.
In the UK, the Office of Fair Trading produced recommendations
in February 2007 that suggested that the UK should move towards
a value based pricing structure for the reimbursement of
pharmaceutical products from 2010. If these recommendations are
accepted and lead to change in the system of reimbursement, this
could lead to increased pressure on competition and
reimbursement margins. This 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, state or foreign laws and regulations
may influence the prices of drugs and, therefore, could
adversely affect the prices that we receive for our products.
For example, programs in existence in certain states in the
United 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 Medicare
and/or
Medicaid programs, or changes required in the way in which
Medicare
and/or
Medicaid rebates are calculated under such programs, could
adversely affect the prices 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.
In order to control expenditure on pharmaceuticals, most member
states in the EU regulate the pricing of products and, in some
cases, limit the range of different forms of pharmaceuticals
available for prescription by national health services. These
controls can result in considerable price differences between
member states.
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 Medicare
and/or
Medicaid 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
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, we maintain commercial
insurance to protect against and manage a portion of the risks
involved in conducting our 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
52
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 certain of 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
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.
It is important 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
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.
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, or ERP, system in the United States 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 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.
Changing
the fiscal year end involves incremental work and complexities
and results in the acceleration of certain deadlines. Failure to
meet these accelerated deadlines and/or issues resulting from
the additional work and complexities could impact our results of
operations and cause our stock to decline.
On October 2, 2007, we amended our bylaws to change our
fiscal year. Our fiscal year previously commenced April 1 and
ended March 31. Our fiscal year will now begin on January 1
and end on December 31. As a result of this we will be
filing a transition report for the nine-month period ending
December 31, 2007 and thereafter report on the basis of a
fiscal year ending December 31. This change involves
significant incremental work as well as certain complexities and
expedited deadlines. Among them are the need to reconfigure
certain internal processes and systems, the acceleration of
effectiveness testing for certain Sarbanes-Oxley compliance
measures for us and our subsidiaries, and accelerated external
audit timing and reporting, including the impact of the Merck
Generics acquisition. Issues may arise as a result of these
additional complexities or expedited deadlines or we may fail to
meet compliance requirements within these accelerated deadlines
which could adversely affect our business, financial position
and results of operations and could cause the market value of
our common stock to decline.
53
Any
future acquisitions or divestitures would 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 the market value of our common stock
to decline.
We may continue to seek to expand our product line through
complementary or strategic acquisitions of other companies,
products or assets, or through joint ventures, licensing
agreements or other arrangements or may determine to divest
certain products or assets. Any such acquisitions, joint
ventures or other business combinations may involve significant
challenges in integrating the new companys operations and
divestitures could be equally challenging. Either process may
prove to be complex and time consuming and require substantial
resources and effort. It may also disrupt our ongoing
businesses, which may adversely affect our relationships with
customers, employees, regulators and others with whom we have
business or other dealings.
We may be unable to realize synergies or other benefits expected
to result from any acquisitions, joint ventures or 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, unforeseen expenses, complications and delays,
market factors or a deterioration in domestic and global
economic conditions could alter the anticipated benefits of any
such transactions. We may also compete for certain acquisition
targets with companies having greater financial resources than
us or other advantages over us that may prevent us from
acquiring a target. These factors could impair our growth and
ability to compete, require us to focus additional resources on
integration of operations rather than other profitable areas,
otherwise cause 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.
Matrix,
an important part of our business, is located in India and it is
subject to regulatory, economic, social and political
uncertainties in India. These risks could cause 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 recent years, Matrix has benefited from many policies of the
Government of India and the Indian state governments in the
states in which we operate, which are designed to promote
foreign investment generally, including significant tax
incentives, liberalized import and export duties and
preferential rules on foreign investment and repatriation. There
is no assurance that such policies will continue. Various
factors, such as changes in the current federal government,
could trigger significant changes in Indias economic
liberalization and deregulation policies and disrupt business
and economic conditions in India generally and our business in
particular.
In addition, our financial performance and the market price of
our securities may be adversely affected by general economic
conditions and economic and fiscal policy in India, including
changes in exchange rates and controls, interest rates and
taxation policies, as well as social stability and political,
economic or diplomatic developments affecting India in the
future. In particular, India has experienced significant
economic growth over the last several years, but faces major
challenges in sustaining that growth in the years ahead. These
challenges include the need for substantial infrastructure
development and improving access to healthcare and education.
Our ability to recruit, train and retain qualified employees and
develop and operate our manufacturing facilities could be
adversely affected if India does not successfully meet these
challenges.
Southern Asia has, from time to time, experienced instances of
civil unrest and hostilities among neighboring countries,
including India and Pakistan. Such military activity or
terrorist attacks in the future could influence the Indian
economy by disrupting communications and making travel more
difficult. Resulting political tensions could create a greater
perception that investments in companies with Indian operations
involve a high degree of risk, and that there is a risk of
disruption of services provided by companies with Indian
operations, which could have a material adverse effect on our
share price
and/or the
market for Matrixs products. Furthermore, if India were to
become engaged in armed hostilities, particularly hostilities
that were protracted or involved the threat or use of nuclear
weapons, Matrix might not be able to continue its operations. We
generally do not have insurance for losses and interruptions
caused by terrorist attacks, military conflicts and wars. These
risks could cause a material adverse
54
effect on our business, financial position and results of
operations and could cause the market value of our common stock
to decline.
Movements
in foreign currency exchange rates 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.
A significant portion of our revenues, indebtedness and our
costs will be denominated in foreign currencies including the
Australian dollar, the British pound, the Canadian dollar, the
Euro, the Indian rupee and the Japanese Yen. We report our
financial results in U.S. dollars. Our results of
operations could be adversely affected by certain movements in
exchange rates. From time to time, we may implement currency
hedges intended to reduce our exposure to changes in foreign
currency exchange rates. However, our hedging strategies may not
be successful, and any of our unhedged foreign exchange payments
will continue to be subject to market fluctuations. These risks
could cause 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.
If we
fail to adequately protect or enforce our intellectual property
rights, then we could lose revenue under our licensing
agreements or lose sales to generic copies of our branded
products. These risks could cause 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 success, particularly in our specialty business, depends in
large part on our ability to obtain, maintain and enforce
patents, and protect trade secrets, know-how and other
proprietary information. Our ability to commercialize any
branded product successfully will largely depend upon our
ability to obtain and maintain patents of sufficient scope to
prevent third parties from developing substantially equivalent
products. In the absence of patent and trade secret protection,
competitors may adversely affect our branded products business
by independently developing and marketing substantially
equivalent products. It is also possible that we could incur
substantial costs if we are required to initiate litigation
against others to protect or enforce our intellectual property
rights.
We have filed patent applications covering composition of,
methods of making,
and/or
methods of using, our branded products and branded product
candidates. We may not be issued patents based on patent
applications already filed or that we file in the future and if
patents are issued, they may be insufficient in scope to cover
our branded products. The issuance of a patent in one country
does not ensure the issuance of a patent in any other country.
Furthermore, the patent position of companies in the
pharmaceutical industry generally involves complex legal and
factual questions and has been and remains the subject of much
litigation. Legal standards relating to scope and validity of
patent claims are evolving. Any patents we have obtained, or
obtain in the future, may be challenged, invalidated or
circumvented. Moreover, the United States Patent and Trademark
Office may commence interference proceedings involving our
patents or patent applications. Any challenge to, or
invalidation or circumvention of, our patents or patent
applications would be costly, would require significant time and
attention of our management, could cause 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
specialty business develops, formulates, manufactures and
markets branded products that are subject to risks. These risks
could cause 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 branded products, developed, formulated, manufactured and
marketed by our specialty business may be subject to the
following risks:
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|
|
|
|
limited patent life;
|
|
|
|
competition from generic products;
|
|
|
|
reductions in reimbursement rates by third-party payors;
|
|
|
|
importation by consumers;
|
|
|
|
product liability;
|
55
|
|
|
|
|
drug development risks arising from typically greater research
and development investments than generics; and
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|
unpredictability with regard to establishing a market.
|
These risks could cause 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. In the United States such changes include the
Sarbanes-Oxley Act of 2002, new 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 over financial
reporting and attestations as to the effectiveness of these
controls by our independent registered 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.
During fiscal year 2007 we acquired a controlling stake in
Matrix and on October 2, 2007 we acquired Merck Generics.
For purposes of managements evaluation of our internal
control over financial reporting as of March 31, 2007, we
elected to exclude Matrix from the scope of managements
assessment as permitted by guidance provided by the SEC. Matrix
will be included in, but Merck Generics will be excluded from,
managements assessment of the effectiveness of the
Companys internal controls over financial reporting as of
December 31, 2007. If we fail to implement and maintain
adequate internal controls, it 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, judgments
and assumptions used or necessary revisions to prior estimates,
judgments or assumptions or changes in accounting standards
could lead to a restatement or revision to previously
consolidated financial statements 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, or 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 (including acquired in process
research and development) and income. Estimates, judgments and
assumptions are inherently subject to change in the future and
any necessary revisions to prior estimates, judgments or
assumptions could lead to a restatement. Also, any new or
revised accounting standards may require adjustments to
previously issued financial statements. Any such changes could
result in corresponding changes to the amounts of assets
(including goodwill and other intangible assets), liabilities,
revenues, expenses (including acquired in process
56
research and development) 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.
We are
subject to the U.S. Foreign Corrupt Practices Act and similar
worldwide anti-bribery laws, which impose restrictions and may
carry substantial penalties. Any violations of these laws, or
allegations of such violations, 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 U.S. Foreign Corrupt Practices Act and similar
anti-bribery laws in other jurisdictions generally prohibit
companies and their intermediaries from making improper payments
to officials for the purpose of obtaining or retaining business.
Our policies mandate compliance with these anti-bribery laws,
which often carry substantial penalties. We operate in
jurisdictions that have experienced governmental corruption to
some degree, and, in certain circumstances, strict compliance
with anti-bribery laws may conflict with certain local customs
and practices. We cannot assure you that our internal control
policies and procedures always will protect us from reckless or
other inappropriate acts committed by our affiliates, employees
or agents. Violations of these laws, or allegations of such
violations, 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.
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ITEM 4.
|
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
The following provides a summary of votes cast for the proposals
on which our shareholders voted at our Annual Meeting of
Shareholders held on July 27, 2007.
Proposal No. 1 Election of Ten Directors.
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Nominee
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For
|
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Withheld
|
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Milan Puskar
|
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209,365,176
|
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6,783,383
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Robert J. Coury
|
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208,997,206
|
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7,151,353
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Wendy Cameron
|
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166,453,970
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49,694,589
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Neil Dimick, C.P.A.
|
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202,923,681
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13,224,878
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Douglas J. Leech, C.P.A.
|
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210,820,149
|
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5,328,410
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Prasad Nimmagadda
|
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209,521,491
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6,627,068
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Joseph C. Maroon, M.D.
|
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166,516,638
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49,631,921
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Rodney L. Piatt, C.P.A.
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166,598,702
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|
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49,549,857
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C.B. Todd
|
|
|
209,153,354
|
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6,995,205
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Randall L. Vanderveen, Ph.D.
|
|
|
210,853,327
|
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5,295,232
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Proposal No. 2 Ratification of the
selection of Deloitte & Touche LLP as the
Companys independent registered public accounting firm for
the fiscal year ending March 31, 2008.
|
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|
For
|
|
Against
|
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Abstain
|
|
213,179,370
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|
1,274,863
|
|
1,694,327
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|
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3
|
.1(a)
|
|
Amended and Restated Articles of Incorporation of the
registrant, as amended, filed as Exhibit 3.1 to the
Form 10-Q
for the quarterly period ended June 30, 2003, and
incorporated herein by reference.
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3
|
.1(b)
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|
Amendment to Amended and Restated Articles of Incorporation of
the registrant, filed as Exhibit 3.2 to the Report on
Form 8-K
filed with the SEC on October 5, 2007, and incorporated
herein by reference.
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3
|
.2
|
|
Bylaws of the registrant, as amended to date, filed as
Exhibit 3.1 to the Report of
Form 8-K
filed on October 5, 2007, and incorporated herein by
reference.
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57
|
|
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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.
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|
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.
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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.
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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.
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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.
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4
|
.1(f)
|
|
Amendment No. 5 to Rights Agreement dated as of
December 19, 2005, 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 19, 2005, and incorporated
herein by reference.
|
|
4
|
.2(a)
|
|
Indenture, dated as of July 21, 2005, between the
registrant and The Bank of New York, as trustee, 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
|
.2(b)
|
|
Second Supplemental Indenture, dated as of October 1, 2007,
among the registrant, the Subsidiaries of the registrant listed
on the signature page thereto and The Bank of New York, as
trustee, filed as Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on October 5, 2007, 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., 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.
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|
|
|
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|
10
|
.1
|
|
Amendment No. 1 to Share Purchase Agreement by and among
the registrant and Merck Generics Holding GmbH, Merck S.A. Merck
Internationale Beteiligung GmbH and Merck KGaA, filed as
Exhibit 10.1 to the Report on
Form 8-K
filed with the SEC on October 5, 2007, and incorporated
herein by reference.
|
|
10
|
.2
|
|
Credit Agreement dated October 2, 2007, among the
registrant, Mylan Luxembourg 5 S.à r.l., certain lenders
and JPMorgan Chase Bank, National Association, as Administrative
Agent.
|
|
10
|
.3
|
|
Credit Agreement dated October 2, 2007, among the
registrant, certain lenders and Merrill Lynch Capital
Corporation, as Administrative Agent.
|
|
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.
|
58
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, 2007, to be
signed on its behalf by the undersigned thereunto duly
authorized.
Mylan Inc.
(Registrant)
November 1, 2007
Robert J. Coury
Vice Chairman and Chief Executive Officer
November 1, 2007
Edward J. Borkowski
Executive Vice President and Chief Financial Officer (Principal
financial officer)
November 1, 2007
Daniel C. Rizzo, Jr.
Senior Vice President and Corporate Controller
(Principal accounting officer)
59
EXHIBIT INDEX
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|
|
|
|
|
10
|
.2
|
|
Credit Agreement dated October 2, 2007, among the
registrant, Mylan Luxembourg 5 S.à r.l., certain lenders
and JPMorgan Chase Bank, National Association, as Administrative
Agent.
|
|
10
|
.3
|
|
Credit Agreement dated October 2, 2007, among the
registrant, certain lenders and Merrill Lynch Capital
Corporation, as Administrative Agent.
|
|
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.
|
60