e10vq
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, DC
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,
2010
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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
(State or other
jurisdiction
of incorporation or organization)
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25-1211621
(I.R.S. Employer
Identification No.)
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1500 Corporate Drive, Canonsburg, Pennsylvania 15317
(Address of principal executive
offices)
(724) 514-1800
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 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 has submitted
electronically and posted on its corporate Web site, if any,
every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of
Regulation S-T
(§ 232.405 of this chapter) during the preceding
12 months (or for such shorter period that the registrant
was required to submit and post such
files). Yes þ No o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of
large accelerated filer, accelerated
filer and smaller reporting company in
Rule 12b-2
of the Exchange Act. (Check one):
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Large accelerated
filer þ
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Accelerated filer
o
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
o
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Indicate by check mark whether the registrant is a shell company
(as defined in
Rule 12b-2
of the Exchange
Act). Yes o No þ
Indicate the number of shares outstanding of each of the
issuers classes of common stock, as of the latest
practicable date.
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Class of
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Outstanding at
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Common Stock
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October 22, 2010
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$0.50 par value
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309,730,799
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MYLAN
INC. AND SUBSIDIARIES
INDEX TO
FORM 10-Q
For the Quarterly Period Ended
September 30, 2010
2
MYLAN
INC. AND SUBSIDIARIES
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Period Ended September 30,
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Three Months
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Nine Months
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2010
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2009
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2010
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2009
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(Unaudited; in thousands, except per share amounts)
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Revenues:
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Net revenues
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$
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1,344,999
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$
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1,255,708
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$
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3,979,648
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$
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3,679,868
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Other revenues
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10,114
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8,366
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36,375
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61,100
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Total revenues
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1,355,113
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1,264,074
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4,016,023
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3,740,968
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Cost of sales
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775,056
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759,094
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2,377,818
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2,182,488
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Gross profit
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580,057
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504,980
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1,638,205
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1,558,480
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Operating expenses:
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Research and development
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71,992
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69,812
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200,076
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202,665
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Selling, general and administrative
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272,285
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259,609
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796,420
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780,953
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Litigation settlements, net
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1,462
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114,281
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14,299
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111,530
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Total operating expenses
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345,739
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443,702
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1,010,795
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1,095,148
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Earnings from operations
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234,318
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61,278
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627,410
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463,332
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Interest expense
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87,536
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77,034
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239,985
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240,209
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Other (expense) income, net
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(15,269
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)
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243
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(29,437
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)
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29,741
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Earnings (loss) before income taxes and noncontrolling interest
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131,513
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(15,513
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)
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357,988
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252,864
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Income tax (benefit) provision
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(12,026
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)
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(11,092
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)
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33,245
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52,539
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Net earnings (loss)
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143,539
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(4,421
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)
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324,743
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200,325
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Net (earnings) loss attributable to the noncontrolling interest
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(356
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)
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(841
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)
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525
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(6,658
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)
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Net earnings (loss) attributable to Mylan Inc. before preferred
dividends
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143,183
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(5,262
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)
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325,268
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193,667
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Preferred dividends
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34,759
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34,759
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104,276
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104,276
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Net earnings (loss) attributable to Mylan Inc. common
shareholders
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$
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108,424
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$
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(40,021
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)
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$
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220,992
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$
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89,391
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Earnings (loss) per common share attributable to
Mylan Inc. common shareholders:
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Basic
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$
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0.35
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$
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(0.13
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)
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$
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0.72
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$
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0.29
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Diluted
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$
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0.33
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$
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(0.13
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)
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$
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0.71
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$
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0.29
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Weighted average common shares outstanding:
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Basic
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309,446
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305,285
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308,470
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304,951
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Diluted
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437,921
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305,285
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313,014
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306,086
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See Notes to Condensed Consolidated Financial Statements
3
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September 30, 2010
|
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December 31, 2009
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(Unaudited; in thousands,
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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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610,921
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$
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380,516
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Restricted cash
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23,813
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47,965
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Marketable securities
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30,108
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27,559
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Accounts receivable, net
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1,251,862
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1,234,634
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Inventories
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1,221,765
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1,114,219
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Deferred income tax benefit
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247,917
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248,917
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Prepaid expenses and other current assets
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76,899
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231,576
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Total current assets
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3,463,285
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3,285,386
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Property, plant and equipment, net
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1,150,750
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1,122,648
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Intangible assets, net
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2,562,387
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2,384,848
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Goodwill
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3,568,519
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3,331,247
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Deferred income tax benefit
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|
44,204
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36,610
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Other assets
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617,896
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640,995
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Total assets
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|
$
|
11,407,041
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$
|
10,801,734
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LIABILITIES AND EQUITY
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Liabilities
|
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Current liabilities:
|
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Trade accounts payable
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$
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551,329
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$
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518,252
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Short-term borrowings
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|
150,795
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184,352
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Income taxes payable
|
|
|
56,863
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|
|
|
69,122
|
|
Current portion of long-term debt and other long-term obligations
|
|
|
7,741
|
|
|
|
9,522
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Deferred income tax liability
|
|
|
1,335
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|
|
|
1,986
|
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Other current liabilities
|
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|
954,278
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934,913
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Total current liabilities
|
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|
1,722,341
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1,718,147
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Long-term debt
|
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5,212,229
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|
|
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4,984,987
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Other long-term obligations
|
|
|
460,123
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|
|
|
485,905
|
|
Deferred income tax liability
|
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|
469,408
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|
|
|
467,497
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|
|
|
|
|
|
|
|
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|
Total liabilities
|
|
|
7,864,101
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|
|
|
7,656,536
|
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|
|
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Equity
|
|
|
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Mylan Inc. shareholders equity
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|
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Preferred stock par value $0.50 per share
|
|
|
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|
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|
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Shares authorized: 5,000,000
|
|
|
|
|
|
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|
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Shares issued: 2,139,000
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|
|
1,070
|
|
|
|
1,070
|
|
Common stock par value $0.50 per share
|
|
|
|
|
|
|
|
|
Shares authorized: 1,500,000,000
|
|
|
|
|
|
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|
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Shares issued: 399,344,974 and 396,683,892 as of
September 30, 2010 and December 31, 2009
|
|
|
199,672
|
|
|
|
198,342
|
|
Additional paid-in capital
|
|
|
3,890,333
|
|
|
|
3,834,674
|
|
Retained earnings
|
|
|
881,123
|
|
|
|
660,130
|
|
Accumulated other comprehensive earnings
|
|
|
124,268
|
|
|
|
11,807
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,096,466
|
|
|
|
4,706,023
|
|
Noncontrolling interest
|
|
|
12,812
|
|
|
|
14,052
|
|
Less: treasury stock at cost
|
|
|
|
|
|
|
|
|
Shares: 89,718,669 and 90,199,152 as of September 30, 2010
and December 31, 2009
|
|
|
1,566,338
|
|
|
|
1,574,877
|
|
|
|
|
|
|
|
|
|
|
Total equity
|
|
|
3,542,940
|
|
|
|
3,145,198
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
$
|
11,407,041
|
|
|
$
|
10,801,734
|
|
|
|
|
|
|
|
|
|
|
See Notes to Condensed Consolidated Financial Statements
4
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|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(Unaudited; in thousands)
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net earnings
|
|
$
|
324,743
|
|
|
$
|
200,325
|
|
Adjustments to reconcile net earnings to net cash provided by
operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
309,872
|
|
|
|
296,949
|
|
Stock-based compensation expense
|
|
|
24,156
|
|
|
|
23,591
|
|
Change in estimated sales allowances
|
|
|
6,096
|
|
|
|
62,288
|
|
Deferred income tax benefit
|
|
|
(78,450
|
)
|
|
|
(82,036
|
)
|
Other non-cash items
|
|
|
104,486
|
|
|
|
51,284
|
|
Litigation settlements, net
|
|
|
14,299
|
|
|
|
111,530
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
64,721
|
|
|
|
48,390
|
|
Inventories
|
|
|
(69,340
|
)
|
|
|
11,188
|
|
Trade accounts payable
|
|
|
8,365
|
|
|
|
(57,854
|
)
|
Income taxes
|
|
|
80,883
|
|
|
|
(59,038
|
)
|
Deferred revenue
|
|
|
20,602
|
|
|
|
(24,029
|
)
|
Other operating assets and liabilities, net
|
|
|
(73,485
|
)
|
|
|
(36,038
|
)
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
736,948
|
|
|
|
546,550
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(96,270
|
)
|
|
|
(83,135
|
)
|
Change in restricted cash
|
|
|
24,856
|
|
|
|
(22,861
|
)
|
Cash paid for acquisitions, net
|
|
|
(556,112
|
)
|
|
|
(211,209
|
)
|
Proceeds from sale of property, plant and equipment
|
|
|
4,947
|
|
|
|
|
|
Proceeds from sale of equity-method investee
|
|
|
|
|
|
|
23,333
|
|
Purchase of marketable securities
|
|
|
(7,835
|
)
|
|
|
(4,278
|
)
|
Proceeds from sale of marketable securities
|
|
|
4,739
|
|
|
|
14,970
|
|
Other items, net
|
|
|
4,975
|
|
|
|
237
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(620,700
|
)
|
|
|
(282,943
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Cash dividends paid
|
|
|
(104,276
|
)
|
|
|
(104,276
|
)
|
Payment of financing fees
|
|
|
(23,704
|
)
|
|
|
|
|
Change in short-term borrowings, net
|
|
|
(45,036
|
)
|
|
|
(260
|
)
|
Proceeds from issuance of long-term debt
|
|
|
1,569,300
|
|
|
|
6,236
|
|
Payment of long-term debt
|
|
|
(1,305,224
|
)
|
|
|
(153,315
|
)
|
Proceeds from exercise of stock options
|
|
|
37,215
|
|
|
|
8,803
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
128,275
|
|
|
|
(242,812
|
)
|
|
|
|
|
|
|
|
|
|
Effect on cash of changes in exchange rates
|
|
|
(14,118
|
)
|
|
|
6,469
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
230,405
|
|
|
|
27,264
|
|
Cash and cash equivalents beginning of period
|
|
|
380,516
|
|
|
|
557,147
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents end of period
|
|
$
|
610,921
|
|
|
$
|
584,411
|
|
|
|
|
|
|
|
|
|
|
See Notes to Condensed Consolidated Financial Statements
5
MYLAN
INC. AND SUBSIDIARIES
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
(GAAP) and the rules and regulations of the
Securities and Exchange Commission (SEC) 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 year ended December 31, 2009.
The interim results of operations for the three and nine months
ended September 30, 2010 and the interim cash flows for the
nine months ended September 30, 2010 are not necessarily
indicative of the results to be expected for the full fiscal
year or any other future period. The Company computed its
provision for income taxes in the first three quarters of the
year using an estimated effective tax rate for the full year
with consideration to certain discrete tax items which occurred
within the interim periods. In the three months ended
September 30, 2010, the Company realized a tax benefit on
positive earnings as a result of the release of several tax
reserves, due to favorable tax rulings received from certain
taxing authorities, as well as the expiration of certain
statutes of limitations during the three-month period. The
estimated annual effective tax rate for 2010 includes an
estimate of the full-year effect of foreign tax credits that the
Company anticipates it will claim against its 2010 U.S. tax
liabilities. The Company did not claim foreign tax credits
against its 2009 U.S. tax liabilities. Certain
reclassifications of prior year amounts have been made to
conform to the current year presentation.
|
|
2.
|
Revenue
Recognition and Accounts Receivable
|
Mylan recognizes revenue for product sales when title and risk
of loss pass to its customers and when provisions for estimates,
including discounts, sales allowances, price adjustments,
returns, chargebacks and other promotional programs, are
reasonably determinable. Accounts receivable are presented net
of allowances relating to these provisions. No revisions were
made to the methodology used in determining these provisions
during the nine months ended September 30, 2010 except as
discussed below. Such allowances were $586.2 million and
$607.9 million at September 30, 2010 and
December 31, 2009. Other current liabilities include
$266.0 million and $238.2 million at
September 30, 2010 and December 31, 2009, for certain
sales allowances and other adjustments that are paid to indirect
customers.
During the current quarter, Mylan launched minocycline
hydrochloride extended release (minocycline ER)
tablets, the generic version of Medicis Pharmaceuticals
Corporations
Solodyn®
ER. After receiving final approval from the U.S. Food and
Drug Administration on July 20, 2010, Mylan commenced
immediate shipment of the product. Mylan also reached settlement
and license agreements with Medicis Pharmaceuticals Corporation
(Medicis) resolving patent litigation relating to
minocycline ER, and the Company has ceased additional
distribution. Pursuant to the terms of the agreements, Medicis
will release Mylan from any liability related to the prior sales
of the product, and Mylan will have the right to market
minocycline ER in the U.S. beginning in November 2011, or
earlier under certain circumstances.
As a result of significant uncertainties surrounding the pricing
and market conditions with respect to this product, the Company
is not able to reasonably estimate the amount of potential price
adjustments, including product returns. Therefore, revenues on
shipments of this product are currently being deferred until the
resolution of such uncertainties. At the present time, such
uncertainties are resolved upon our customers sale of this
product. As a result, the Company is recognizing revenue only
upon our customers sale of this product.
6
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
3.
|
Recent
Accounting Pronouncements
|
In October 2009, the Financial Accounting Standards Board
(FASB) issued revised accounting guidance for
multiple-deliverable revenue arrangements. The amended guidance
requires that consideration received be allocated at the
inception of the arrangement to all deliverables using the
relative selling price method and provides for expanded
disclosures related to such arrangements. It is effective for
revenue arrangements entered into or materially modified in
fiscal years beginning on or after June 15, 2010. The
Company is currently evaluating the impact of adoption on its
consolidated financial statements.
In April 2010, the FASB issued revised accounting guidance for
the milestone method of revenue recognition. The amended
guidance is effective for fiscal years beginning on or after
June 15, 2010. It provides guidance on defining a milestone
and determining when it may be appropriate to apply the
milestone method of revenue recognition for research and
development transactions. The Company is currently evaluating
the impact of adoption on its consolidated financial statements.
Termination
of Joint Ventures
During the nine months ended September 30, 2009, Matrix and
Aspen Pharmacare Holdings Limited (Aspen) terminated
two joint ventures in which each held a 50% share; Astrix
Laboratories Limited (Astrix) and Fine Chemicals
Corporation (FCC). Under the agreed upon terms,
Matrix sold its 50% interest in FCC to Aspen for
$23.3 million. At the same time, a wholly-owned subsidiary
of Mylan purchased from Aspen its 50% interest in Astrix for
$38.9 million. These transactions resulted in a net gain of
approximately $10.4 million, which is included in other
(expense) income, net, in the Condensed Consolidated Statements
of Operations for the nine months ended September 30, 2009.
As of the date of purchase, June 1, 2009, the results of
Astrix were consolidated with those of Mylan.
The Company accounted for the acquisition of the remaining 50%
of Astrix using the purchase method of accounting. Under the
purchase method of accounting, the assets acquired and
liabilities assumed in the transaction were recorded at their
respective fair values.
Biologics
Agreement
On June 29, 2009, Mylan announced that it has executed a
definitive agreement with Biocon Limited (Biocon), a
publicly traded company on the Indian stock exchanges, for an
exclusive collaboration on the development, manufacturing,
supply and commercialization of multiple, high value generic
biologic compounds for the global marketplace.
As part of this collaboration, Mylan and Biocon will share
development, capital and certain other costs to bring products
to market. Mylan will have exclusive commercialization rights in
the U.S., Canada, Japan, Australia, New Zealand and in the
European Union and European Free Trade Association countries
through a profit sharing arrangement with Biocon. Mylan will
have co-exclusive commercialization rights with Biocon in all
other markets around the world. In conjunction with executing
this agreement, Mylan recorded an $18.0 million research
and development charge in the nine months ended
September 30, 2009 related to its up-front, non-refundable
obligation pursuant to the agreement.
Bioniche
Pharma
On September 7, 2010, the Company completed the acquisition
of 100% of the outstanding equity in Bioniche Pharma Holdings
Limited (Bioniche Pharma), a privately held, global
injectable pharmaceutical company. The Company financed the
transaction using a combination of cash on hand and long-term
borrowings (see Note 10). In accordance with the FASB
accounting guidance regarding business combinations, the Company
used the purchase
7
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
method of accounting to account for this transaction. Under the
purchase method of accounting, the assets acquired and
liabilities assumed in the transaction were recorded at the date
of acquisition at the estimate of their respective fair values.
Bioniche Pharma manufactures and sells a diverse portfolio of
products across several therapeutic areas for the hospital
setting, including analgesics/anesthetics, orthopedics,
oncology, and urology, with most of the companys sales
made to customers in the U.S. The operating results of
Bioniche Pharma from September 7, 2010 are included in the
Condensed Consolidated Financial Statements as part of
Mylans Generics Segment.
The purchase price of $543.7 million has been allocated to
the assets acquired and liabilities assumed for the former
Bioniche Pharma business as of the acquisition date as follows:
|
|
|
|
|
(In thousands)
|
|
|
|
|
Current assets (excluding inventories)
|
|
$
|
41,680
|
|
Inventories
|
|
|
28,500
|
|
Property, plant and equiptment, net
|
|
|
16,211
|
|
Identified intangible assets
|
|
|
186,000
|
|
In-process research and development
|
|
|
143,000
|
|
Goodwill
|
|
|
207,390
|
|
|
|
|
|
|
Total assets acquired
|
|
|
622,781
|
|
Current liabilities
|
|
|
(37,389
|
)
|
Deferred tax liabilities
|
|
|
(36,910
|
)
|
Other non-current liabilities
|
|
|
(4,746
|
)
|
|
|
|
|
|
Net assets acquired
|
|
$
|
543,736
|
|
|
|
|
|
|
The allocation of the purchase price is not yet final, primarily
related to certain income tax-related accounts. The amount
allocated to acquired in-process research and development
represents an estimate of the fair value of purchased in-process
technology for research projects that, as of the closing date of
the acquisition, had not reached technological feasibility and
had no alternative future use. The fair value of the acquired
in-process technology and research projects was based on the
excess earnings method, which utilizes forecasts of expected
cash inflows (including estimates for ongoing costs) and other
contributory charges, on a
project-by-project
basis, and will be tested for impairment in accordance with FASB
accounting guidance.
The identified intangible assets of $186.0 million are comprised
of product rights and licenses that have a weighted average
useful life of approximately nine years. The goodwill of
$207.4 million arising from the acquisition consists
largely of the value of the employee workforce and the value of
products to be developed in the future. All of the goodwill was
assigned to Mylans Generics Segment. None of the goodwill
recognized is expected to be deductible for income tax purposes.
Acquisition costs of $10.9 million and $12.5 million
were expensed in the three and nine months ended
September 30, 2010.
Pro
Forma financial results
The operating results of Bioniche Pharma have been included in
Mylans Condensed Consolidated Statement of Operations
since September 7, 2010. The following table represents
supplemental unaudited pro forma information as if the
acquisition of Bioniche Pharma had occurred on January 1,
2010 for the three and nine months ended September 30, 2010
and on January 1, 2009 for the three and nine months ended
September 30, 2009. This summary of the unaudited pro forma
results of operations is not necessarily indicative of what
Mylans results
8
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
of operations would have been had Bioniche Pharma been acquired
at the beginning of each annual period presented and may not be
indicative of future performance.
The unaudited pro forma financial information for the periods
below includes the following charges directly attributable to
the accounting for the acquisition: amortization of the
step-up of
inventory of $12.0 million for the nine months ended
September 30, 2010 and 2009; amortization on intangibles
of $5.2 million for the quarters ended September 30,
2009 and 2010; and amortization on intangibles of
$15.6 million for the nine-month periods ended
September 30, 2009 and 2010. In addition, the unaudited pro
forma financial information for the periods presented includes
the effects of certain additional borrowings used to purchase
Bioniche Pharma as if they occurred on January 1, 2010 and
2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
|
|
(Unaudited; in thousands, except per share amounts)
|
|
|
Total revenues
|
|
$
|
1,386,730
|
|
|
$
|
1,286,589
|
|
|
$
|
4,127,302
|
|
|
$
|
3,800,616
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss) attributable to Mylan Inc. before preferred
dividends
|
|
|
136,521
|
|
|
|
(7,685
|
)
|
|
|
305,021
|
|
|
|
178,521
|
|
Preferred dividends
|
|
|
34,759
|
|
|
|
34,759
|
|
|
|
104,276
|
|
|
|
104,276
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss) attributable to Mylan Inc. common
shareholders
|
|
$
|
101,762
|
|
|
$
|
(42,444
|
)
|
|
$
|
200,745
|
|
|
$
|
74,245
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per common share attributable to Mylan Inc.
common shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.33
|
|
|
$
|
(0.14
|
)
|
|
$
|
0.65
|
|
|
$
|
0.24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
0.31
|
|
|
$
|
(0.14
|
)
|
|
$
|
0.64
|
|
|
$
|
0.24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
309,446
|
|
|
|
305,285
|
|
|
|
308,470
|
|
|
|
304,951
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
437,921
|
|
|
|
305,285
|
|
|
|
313,014
|
|
|
|
306,086
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matrix
On March 26, 2009, the Company announced plans to buy the
remaining public interest in Matrix Laboratories Limited
(Matrix) from its minority shareholders pursuant to
a voluntary delisting offer. At the time, the Company owned
approximately 71.2% of Matrix through a wholly-owned subsidiary
and controlled more than 76% of its voting rights. During the
calendar year ended December 31, 2009, the Company
completed the purchase of an additional portion of the remaining
interest from minority shareholders of Matrix, bringing both the
Companys total ownership and control to over 96%. During
the nine months ended September 30, 2010, Mylan completed
the purchase of an additional portion of the remaining interest
from minority shareholders of Matrix, for cash of approximately
$5.0 million, bringing both the Companys total
ownership and control to approximately 97%.
In addition, during the three months ended September 30,
2010, approximately $10.0 million was paid as part of the
purchase consideration for a finished dosage form manufacturing
facility in India.
|
|
5.
|
Stock-Based
Incentive Plan
|
Mylans shareholders have approved the 2003 Long-Term
Incentive Plan (as amended, the 2003 Plan).
Under the 2003 Plan, 37,500,000 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
9
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
and short-term cash awards. Stock option awards are granted at
the fair value of the shares underlying the options at the date
of the grant, generally become exercisable over periods ranging
from three to four years, and generally expire in ten years. In
the 2003 Plan, no more than 8,000,000 shares may be issued
as restricted shares, restricted units, performance shares and
other stock-based awards.
Upon approval of the 2003 Plan, no further grants of stock
options have been made under any other plan. However, there are
stock options outstanding from frozen or 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 December 31, 2009
|
|
|
26,268,678
|
|
|
$
|
15.22
|
|
Options granted
|
|
|
2,408,039
|
|
|
|
20.54
|
|
Options exercised
|
|
|
(2,667,422
|
)
|
|
|
14.00
|
|
Options forfeited
|
|
|
(908,190
|
)
|
|
|
14.91
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2010
|
|
|
25,101,105
|
|
|
$
|
15.87
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest at September 30, 2010
|
|
|
24,019,159
|
|
|
$
|
15.89
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30, 2010
|
|
|
17,529,098
|
|
|
$
|
15.88
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2010, options outstanding, options
vested and expected to vest, and options exercisable had average
remaining contractual terms of 5.67 years, 5.55 years
and 4.43 years, respectively. Also at September 30,
2010, options outstanding, options vested and expected to vest
and options exercisable had aggregate intrinsic values of
$83.5 million, $79.4 million and $56.5 million,
respectively.
A summary of the status of the Companys nonvested
restricted stock and restricted stock unit awards as of
September 30, 2010 and the changes during the nine-month
period ended September 30, 2010, are presented below:
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
|
Weighted Average
|
|
|
|
Restricted
|
|
|
Grant-Date
|
|
|
|
Stock Awards
|
|
|
Fair Value per Share
|
|
|
Nonvested at December 31, 2009
|
|
|
2,464,600
|
|
|
$
|
12.78
|
|
Granted
|
|
|
816,359
|
|
|
|
21.20
|
|
Released
|
|
|
(670,557
|
)
|
|
|
13.57
|
|
Forfeited
|
|
|
(133,180
|
)
|
|
|
12.46
|
|
|
|
|
|
|
|
|
|
|
Nonvested at September 30, 2010
|
|
|
2,477,222
|
|
|
$
|
15.37
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2010, the Company had
$39.9 million 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 1.68 years. The total intrinsic value of
stock-based awards exercised and restricted stock units
converted during the nine months ended September 30, 2010
and September 30, 2009 was $32.6 million and
$11.1 million.
10
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
6.
|
Balance
Sheet Components
|
Selected balance sheet components consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010
|
|
|
December 31, 2009
|
|
|
|
(In thousands)
|
|
|
Inventories:
|
|
|
|
|
|
|
|
|
Raw materials
|
|
$
|
317,619
|
|
|
$
|
287,128
|
|
Work in process
|
|
|
235,647
|
|
|
|
198,280
|
|
Finished goods
|
|
|
668,499
|
|
|
|
628,811
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,221,765
|
|
|
$
|
1,114,219
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment:
|
|
|
|
|
|
|
|
|
Land and improvements
|
|
$
|
71,536
|
|
|
$
|
69,614
|
|
Buildings and improvements
|
|
|
651,176
|
|
|
|
625,303
|
|
Machinery and equipment
|
|
|
1,220,804
|
|
|
|
1,145,464
|
|
Construction in progress
|
|
|
135,514
|
|
|
|
118,410
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,079,030
|
|
|
|
1,958,791
|
|
Less accumulated depreciation
|
|
|
928,280
|
|
|
|
836,143
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,150,750
|
|
|
$
|
1,122,648
|
|
|
|
|
|
|
|
|
|
|
Other current liabilities:
|
|
|
|
|
|
|
|
|
Payroll and employee benefit plan accruals
|
|
$
|
176,799
|
|
|
$
|
188,743
|
|
Accrued sales allowances
|
|
|
265,979
|
|
|
|
238,161
|
|
Legal and professional accruals, including litigation reserves
|
|
|
232,896
|
|
|
|
218,813
|
|
Fair value of financial instruments
|
|
|
43,129
|
|
|
|
66,420
|
|
Other
|
|
|
235,475
|
|
|
|
222,776
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
954,278
|
|
|
$
|
934,913
|
|
|
|
|
|
|
|
|
|
|
|
|
7.
|
Earnings
(Loss) per Common Share attributable to Mylan Inc.
|
Basic earnings (loss) per common share is computed by dividing
net earnings attributable to Mylan Inc. common shareholders by
the weighted average number of shares outstanding during the
period. Diluted earnings (loss) per common share is computed by
dividing net earnings attributable to Mylan Inc. common
shareholders by the weighted average number of shares
outstanding during the period increased by the number of
additional shares that would have been outstanding related to
potentially dilutable securities or instruments, if the impact
is dilutive.
With respect to the Companys convertible preferred stock,
the Company considered the effect on diluted earnings per share
of the preferred stock conversion feature using the if-converted
method. The preferred stock is convertible into between
125,234,172 shares and 152,785,775 shares of the
Companys common stock, subject to anti-dilution
adjustments, depending on the average stock price of the
Companys common stock over the 20
trading-day
period ending on the third trading day prior to conversion,
which will occur on November 15, 2010. For the three months
ended September 30, 2010, the if-converted method is
dilutive; therefore, the preferred stock conversion is included
in the computation of diluted earnings per share. For the nine
months ended September 30, 2010 and the three and nine
months ended September 30, 2009, the if-converted method is
anti-dilutive; therefore, the preferred stock conversion is
excluded from the computation of diluted earnings per share.
11
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Basic and diluted earnings (loss) per common share attributable
to Mylan Inc. are calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands, except per share amounts)
|
|
|
Basic earnings (loss) attributable to Mylan Inc. common
shareholders (numerator):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss) attributable to Mylan Inc. before preferred
dividends
|
|
$
|
143,183
|
|
|
$
|
(5,262
|
)
|
|
$
|
325,268
|
|
|
$
|
193,667
|
|
Less: Preferred dividends
|
|
|
34,759
|
|
|
|
34,759
|
|
|
|
104,276
|
|
|
|
104,276
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss) attributable to Mylan Inc. common
shareholders
|
|
$
|
108,424
|
|
|
$
|
(40,021
|
)
|
|
$
|
220,992
|
|
|
$
|
89,391
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares (denominator):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding
|
|
|
309,446
|
|
|
|
305,285
|
|
|
|
308,470
|
|
|
|
304,951
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per common share attributable to
Mylan Inc.
|
|
$
|
0.35
|
|
|
$
|
(0.13
|
)
|
|
$
|
0.72
|
|
|
$
|
0.29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) attributable to Mylan Inc. common
shareholders (numerator):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss) attributable to Mylan Inc. common
shareholders
|
|
$
|
108,424
|
|
|
$
|
(40,021
|
)
|
|
$
|
220,992
|
|
|
$
|
89,391
|
|
Add: Preferred dividends
|
|
|
34,759
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) attributable to Mylan Inc. common shareholders
and assumed conversions
|
|
$
|
143,183
|
|
|
$
|
(40,021
|
)
|
|
$
|
220,992
|
|
|
$
|
89,391
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares (denominator):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding
|
|
|
309,446
|
|
|
|
305,285
|
|
|
|
308,470
|
|
|
|
304,951
|
|
Stock-based awards and warrants
|
|
|
3,241
|
|
|
|
|
|
|
|
4,544
|
|
|
|
1,135
|
|
Preferred stock conversion
|
|
|
125,234
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total dilutive shares outstanding
|
|
|
437,921
|
|
|
|
305,285
|
|
|
|
313,014
|
|
|
|
306,086
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per common share attributable to
Mylan Inc.
|
|
$
|
0.33
|
|
|
$
|
(0.13
|
)
|
|
$
|
0.71
|
|
|
$
|
0.29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional stock options or restricted stock awards representing
7.5 million and 19.2 million shares were outstanding
at September 30, 2010 and 2009 but were not included in the
computation of diluted earnings per share, because the effect
would be anti-dilutive.
During the nine months ended September 30, 2010, the
Company paid dividends of $104.3 million on the preferred
stock. On October 19, 2010, the Company announced that the
last quarterly dividend of $16.25 per share had been declared
(based on the annual dividend rate of 6.5% and a liquidation
preference of $1,000 per share) and is payable on
November 15, 2010, to the holders of preferred stock of
record as of November 1, 2010. The preferred stock will
also automatically convert into common stock on
November 15, 2010.
12
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
8.
|
Goodwill
and Intangible Assets
|
A rollforward of goodwill from December 31, 2009 to
September 30, 2010 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics Segment
|
|
|
Specialty Segment
|
|
|
Total
|
|
|
|
(In thousands)
|
|
|
Goodwill
|
|
$
|
3,009,740
|
|
|
$
|
706,507
|
|
|
$
|
3,716,247
|
|
Accumulated impairment
losses(1)
|
|
|
|
|
|
|
(385,000
|
)
|
|
|
(385,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009
|
|
$
|
3,009,740
|
|
|
$
|
321,507
|
|
|
$
|
3,331,247
|
|
Goodwill acquired during the
year(2)
|
|
|
207,390
|
|
|
|
|
|
|
|
207,390
|
|
Foreign currency translation
|
|
|
29,882
|
|
|
|
|
|
|
|
29,882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2010
|
|
$
|
3,247,012
|
|
|
$
|
321,507
|
|
|
$
|
3,568,519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Represents the only impairment charge recognized by the Company
under the currently effective accounting guidance. |
|
(2) |
|
Allocation of goodwill acquired through the acquisition of
Bioniche Pharma (see Note 4). |
Intangible assets consist of the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
Average Life
|
|
|
Original
|
|
|
Accumulated
|
|
|
Net Book
|
|
|
|
(Years)
|
|
|
Cost
|
|
|
Amortization
|
|
|
Value
|
|
|
|
(Dollars in thousands)
|
|
|
September 30, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and technologies
|
|
|
20
|
|
|
$
|
122,926
|
|
|
$
|
82,150
|
|
|
$
|
40,776
|
|
Product rights and licenses
|
|
|
10
|
|
|
|
3,251,430
|
|
|
|
964,040
|
|
|
|
2,287,390
|
|
Other(1)
|
|
|
8
|
|
|
|
143,716
|
|
|
|
52,495
|
|
|
|
91,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
3,518,072
|
|
|
$
|
1,098,685
|
|
|
|
2,419,387
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
2,562,387
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and technologies
|
|
|
20
|
|
|
$
|
122,926
|
|
|
$
|
77,717
|
|
|
$
|
45,209
|
|
Product rights and licenses
|
|
|
10
|
|
|
|
2,913,475
|
|
|
|
672,999
|
|
|
|
2,240,476
|
|
Other(1)
|
|
|
8
|
|
|
|
158,996
|
|
|
|
59,833
|
|
|
|
99,163
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
3,195,397
|
|
|
$
|
810,549
|
|
|
$
|
2,384,848
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Other intangibles consist principally of customer lists and
contracts. |
Amortization expense, which is classified within cost of sales
on the Companys Condensed Consolidated Statements of
Operations, for the nine months ended September 30, 2010
and 2009 was $209.9 million and $204.3 million, and is
expected to be $76.1 million for the remainder of 2010, and
$292.1 million, $285.4 million, $279.7 million
and $272.1 million for the years ended December 31,
2011 through 2014, respectively.
In conjunction with the acquisition of Bioniche Pharma, we
acquired $143.0 million of in-process research and
development assets. Acquired in-process research and development
assets are not currently being amortized. As
13
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
products in development are approved for sale, amounts will be
allocated to product rights and licenses and will be amortized
over the estimated useful life. Such in-process research and
development will be subject to periodic impairment testing under
FASB guidance.
|
|
9.
|
Financial
Instruments and Risk Management
|
Financial
Risks
The Company is exposed to certain financial risks relating to
its ongoing business operations. The primary financial risks
that are managed by using derivative instruments are foreign
currency risk, interest rate risk and equity risk.
In order to manage foreign currency risk, Mylan enters into
foreign exchange forward contracts to mitigate risk associated
with changes in spot exchange rates of mainly non-functional
currency denominated assets or liabilities. The foreign exchange
forward contracts are measured at fair value and reported as
current assets or current liabilities on the Condensed
Consolidated Balance Sheets. Any gains or losses on the foreign
exchange forward contracts are recognized in earnings in the
period incurred in the Condensed Consolidated Statements of
Operations.
During the nine months ended September 30, 2010, the
Company entered into forecasted forward contracts to hedge
foreign currency denominated sales from certain international
subsidiaries. These contracts are designated as cash flow hedges
to manage foreign currency risk and are measured at fair value
and reported as current assets or current liabilities on the
Condensed Consolidated Balance Sheets. Any changes in fair value
are included in earnings or deferred through accumulated other
comprehensive earnings (loss) (AOCE), depending on
the nature and effectiveness of the offset.
As of September 30, 2010 and December 31, 2009, the
Company had 679.2 million of borrowings under its
senior credit agreement (the Senior Credit
Agreement) that are designated as a hedge of its net
investment in certain Euro-functional currency subsidiaries to
manage foreign currency risk. The U.S. Dollar equivalent of
such amount was $927.6 million at September 30, 2010
and $978.1 million at December 31, 2009. Borrowings
designated as hedges of net investments are marked to market
using the current spot exchange rate as of the end of the
period, with gains and losses included in the foreign currency
translation adjustment component of AOCE on the Condensed
Consolidated Balance Sheet until the sale or substantial
liquidation of the underlying net investments.
The Company enters into interest rate swaps in order to manage
interest rate risk associated with the Companys
floating-rate debt. These interest rate swaps are designated as
cash flow hedges. The Companys interest rate swaps fix the
interest rate on a portion of the Companys variable-rate
U.S. Tranche B Term Loans and Euro Tranche B Term
Loans under the terms of its Senior Credit Agreement. Derivative
contracts designated as hedges to manage interest rate risk are
measured at fair value and reported as current assets or current
liabilities on the Condensed Consolidated Balance Sheets. Any
changes in fair value are included in earnings or deferred
through AOCE, depending on the nature and effectiveness of the
offset.
In conjunction with the notes offering in May 2010 and the
associated prepayment of term debt (see Note 10), the
Company terminated certain interest rate swaps that had
previously fixed the interest rate on a portion of the
Companys variable-rate U.S. Tranche B Term
Loans. As a result, during the nine months ended
September 30, 2010, charges of approximately
$7.4 million that had previously been classified in AOCE
were recognized into other (expense) income, net. As of
September 30, 2010 and December 31, 2009, the total
notional amount of the Companys floating-rate debt
interest rate swaps was $1.27 billion and
$2.29 billion.
Certain derivative contracts entered into by the Company are
governed by Master Agreements, which contain credit-risk-related
contingent features which would allow the counterparties to
terminate the contracts early and request immediate payment
should the Company trigger an event of default on other
specified borrowings. The aggregate fair value of all such
contracts that are in a liability position at September 30,
2010 is $39.6 million. The Company is not subject to any
obligations to post collateral under derivative contracts.
14
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
The Company maintains significant credit exposure arising from
the convertible note hedge on its Cash Convertible Notes. At
September 30, 2010, the convertible note hedge had a total
fair value of $391.1 million, which reflects the maximum
loss that would be incurred should the parties fail to perform
according to the terms of the contract. The counterparties are
highly rated diversified financial institutions with both
commercial and investment banking operations. The counterparties
are required to post collateral against this obligation should
they be downgraded below thresholds specified in the contract.
Eligible collateral is comprised of a wide range of financial
securities with a valuation discount percentage reflecting the
associated risk.
The Company regularly reviews the creditworthiness of its
financial counterparties and does not expect to incur a
significant loss from failure of any counterparties to perform
under any agreements.
Derivatives
Designated as Hedging Instruments
Fair Values of Derivative Instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset Derivatives
|
|
|
|
September 30, 2010
|
|
|
December 31, 2009
|
|
|
|
Balance Sheet
|
|
|
|
|
Balance Sheet
|
|
|
|
|
|
Location
|
|
Fair Value
|
|
|
Location
|
|
Fair Value
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Prepaid expenses and other current assets
|
|
$
|
6,490
|
|
|
Prepaid expenses and other current assets
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
6,490
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability Derivatives
|
|
|
|
September 30, 2010
|
|
|
December 31, 2009
|
|
|
|
Balance Sheet
|
|
|
|
|
Balance Sheet
|
|
|
|
|
|
Location
|
|
Fair Value
|
|
|
Location
|
|
Fair Value
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swaps
|
|
Other current liabilities
|
|
$
|
39,597
|
|
|
Other current liabilities
|
|
$
|
62,607
|
|
Foreign currency borrowings
|
|
Long-term debt
|
|
|
927,594
|
|
|
Long-term debt
|
|
|
978,059
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
967,191
|
|
|
|
|
$
|
1,040,666
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives
Not Designated as Hedging Instruments
Fair Values of Derivative Instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset Derivatives
|
|
|
|
September 30, 2010
|
|
|
December 31, 2009
|
|
|
|
Balance Sheet
|
|
|
|
|
Balance Sheet
|
|
|
|
|
|
Location
|
|
Fair Value
|
|
|
Location
|
|
Fair Value
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Prepaid expenses and other current assets
|
|
$
|
3,690
|
|
|
Prepaid expenses and other current assets
|
|
$
|
8,793
|
|
Purchased cash convertible note hedge
|
|
Other assets
|
|
|
391,100
|
|
|
Other assets
|
|
|
410,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
394,790
|
|
|
|
|
$
|
419,393
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability Derivatives
|
|
|
|
September 30, 2010
|
|
|
December 31, 2009
|
|
|
|
Balance Sheet
|
|
|
|
|
Balance Sheet
|
|
|
|
|
|
Location
|
|
Fair Value
|
|
|
Location
|
|
Fair Value
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Other current liabilities
|
|
$
|
3,532
|
|
|
Other current liabilities
|
|
$
|
5,694
|
|
Cash conversion feature of Cash Convertible Notes
|
|
Long-term debt
|
|
|
391,100
|
|
|
Long-term debt
|
|
|
410,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
394,632
|
|
|
|
|
$
|
416,294
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
Effect of Derivative Instruments on the Condensed Consolidated
Statements of Operations
Derivatives in Cash Flow Hedging Relationships
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of Gain
|
|
|
|
or (Loss) Recognized
|
|
|
|
in AOCE (Net of Tax)
|
|
|
|
on Derivative
|
|
|
|
(Effective Portion)
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
$
|
9,293
|
|
|
$
|
|
|
|
$
|
6,430
|
|
|
$
|
|
|
Interest rate swaps
|
|
|
7,440
|
|
|
|
(5,112
|
)
|
|
|
10,481
|
|
|
|
937
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
16,733
|
|
|
$
|
(5,112
|
)
|
|
$
|
16,911
|
|
|
$
|
937
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of Gain
|
|
|
|
Location of Gain or
|
|
or (Loss) Reclassified
|
|
|
|
(Loss) Reclassifed
|
|
from AOCE into Earnings
|
|
|
|
from AOCE
|
|
(Effective Portion)
|
|
|
|
into Earnings
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
(Effective Portion)
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Net revenues
|
|
$
|
(232
|
)
|
|
$
|
|
|
|
$
|
647
|
|
|
$
|
|
|
Interest rate swaps
|
|
Interest expense
|
|
|
(5,843
|
)
|
|
|
(14,047
|
)
|
|
|
(28,201
|
)
|
|
|
(34,417
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
(6,075
|
)
|
|
$
|
(14,047
|
)
|
|
$
|
(27,554
|
)
|
|
$
|
(34,417
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of Loss
|
|
Amount of Loss
|
|
|
|
Excluded from the
|
|
Excluded from the Assessment of Hedge Effectiveness
|
|
|
|
Assessment of
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
Hedge Effectiveness
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Other
(expense)
income, net
|
|
$
|
(4,971
|
)
|
|
$
|
|
|
|
$
|
(3,721
|
)
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
(4,971
|
)
|
|
$
|
|
|
|
$
|
(3,721
|
)
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
The
Effect of Derivative Instruments on the Condensed Consolidated
Statement of Operations
Derivatives in Net Investment Hedging Relationships
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of Gain
|
|
|
|
|
|
or (Loss) Recognized
|
|
|
|
|
|
in AOCE (Net of Tax)
|
|
|
|
|
|
on Derivative
|
|
|
|
|
|
(Effective Portion)
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency borrowings
|
|
$
|
(58,079
|
)
|
|
$
|
(28,906
|
)
|
|
$
|
30,979
|
|
|
$
|
(31,356
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
(58,079
|
)
|
|
$
|
(28,906
|
)
|
|
$
|
30,979
|
|
|
$
|
(31,356
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There was no gain or loss recognized into earnings on
derivatives with net investment hedging relationships during the
three or nine months ended September 30, 2010 or 2009.
The
Effect of Derivative Instruments on the Condensed Consolidated
Statement of Operations
Derivatives Not Designated as Hedging Instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of Gain or (Loss)
|
|
|
|
Location of Gain or
|
|
Recognized
|
|
|
|
(Loss) Recognized in
|
|
in Earnings on Derivatives
|
|
|
|
Earnings on
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
Derivatives
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Other (expense) income, net
|
|
$
|
(4,590
|
)
|
|
$
|
(15,461
|
)
|
|
$
|
(27,741
|
)
|
|
$
|
(18,003
|
)
|
Cash conversion feature of Cash Convertible Notes
|
|
Other (expense) income, net
|
|
|
(43,200
|
)
|
|
|
90,725
|
|
|
|
19,500
|
|
|
|
113,150
|
|
Purchased cash convertible note hedge
|
|
Other (expense) income, net
|
|
|
43,200
|
|
|
|
(90,725
|
)
|
|
|
(19,500
|
)
|
|
|
(113,150
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
(4,590
|
)
|
|
$
|
(15,461
|
)
|
|
$
|
(27,741
|
)
|
|
$
|
(18,003
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair
Value Measurement
Fair value is based on the price that would be received from the
sale of an identical asset or paid to transfer an identical
liability in an orderly transaction between market participants
at the measurement date. In order to increase consistency and
comparability in fair value measurements, a fair value hierarchy
has been established that prioritizes observable and
unobservable inputs used to measure fair value into three broad
levels, which are described below:
Level 1: Quoted prices (unadjusted) in
active markets that are accessible at the measurement date for
identical assets or liabilities. The fair value hierarchy gives
the highest priority to Level 1 inputs.
Level 2: Observable market-based inputs
other than quoted prices in active markets for identical assets
or liabilities.
Level 3: Unobservable inputs are used
when little or no market data is available. The fair value
hierarchy gives the lowest priority to Level 3 inputs.
In determining fair value, the Company utilizes valuation
techniques that maximize the use of observable inputs and
minimize the use of unobservable inputs to the extent possible,
as well as considers counterparty credit risk in its assessment
of fair value.
17
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Financial assets and liabilities carried at fair value are
classified in the tables below in one of the three categories
described above:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
|
|
|
|
|
(In thousands)
|
|
|
|
|
|
Financial Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trading securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity securities exchange traded funds
|
|
$
|
3,037
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
3,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total trading securities
|
|
$
|
3,037
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
3,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale
fixed income investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasuries
|
|
$
|
|
|
|
$
|
12,704
|
|
|
$
|
|
|
|
$
|
12,704
|
|
Corporate bonds
|
|
|
|
|
|
|
8,722
|
|
|
|
|
|
|
|
8,722
|
|
Agency mortgage-backed securities
|
|
|
|
|
|
|
2,087
|
|
|
|
|
|
|
|
2,087
|
|
Other
|
|
|
|
|
|
|
2,976
|
|
|
|
|
|
|
|
2,976
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
available-for-sale
fixed income investments
|
|
$
|
|
|
|
$
|
26,489
|
|
|
$
|
|
|
|
$
|
26,489
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale
equity securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biosciences industry
|
|
$
|
582
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
582
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
available-for-sale
equity securities
|
|
$
|
582
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
582
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange derivative assets
|
|
$
|
|
|
|
|
10,180
|
|
|
$
|
|
|
|
$
|
10,180
|
|
Purchased cash convertible note hedge
|
|
|
|
|
|
|
391,100
|
|
|
|
|
|
|
|
391,100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets at fair
value(1)
|
|
$
|
3,619
|
|
|
$
|
427,769
|
|
|
$
|
|
|
|
$
|
431,388
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange derivative liabilities
|
|
$
|
|
|
|
$
|
3,532
|
|
|
$
|
|
|
|
$
|
3,532
|
|
Interest rate swap derivative liabilities
|
|
|
|
|
|
|
39,597
|
|
|
|
|
|
|
|
39,597
|
|
Cash conversion feature of cash convertible notes
|
|
|
|
|
|
|
391,100
|
|
|
|
|
|
|
|
391,100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair
value(1)
|
|
$
|
|
|
|
$
|
434,229
|
|
|
$
|
|
|
|
$
|
434,229
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
|
|
|
|
|
(In thousands)
|
|
|
|
|
|
Financial Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale
fixed income investments
|
|
$
|
|
|
|
$
|
26,485
|
|
|
$
|
|
|
|
$
|
26,485
|
|
Available-for-sale
equity securities
|
|
|
1,074
|
|
|
|
|
|
|
|
|
|
|
|
1,074
|
|
Foreign exchange derivative assets
|
|
|
|
|
|
|
8,793
|
|
|
|
|
|
|
|
8,793
|
|
Purchased cash convertible note hedge
|
|
|
|
|
|
|
410,600
|
|
|
|
|
|
|
|
410,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets at fair
value(1)
|
|
$
|
1,074
|
|
|
$
|
445,878
|
|
|
$
|
|
|
|
$
|
446,952
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange derivative liabilities
|
|
$
|
|
|
|
$
|
5,694
|
|
|
$
|
|
|
|
$
|
5,694
|
|
Interest rate swap derivative liabilities
|
|
|
|
|
|
|
62,607
|
|
|
|
|
|
|
|
62,607
|
|
Cash conversion feature of cash convertible notes
|
|
|
|
|
|
|
410,600
|
|
|
|
|
|
|
|
410,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair
value(1)
|
|
$
|
|
|
|
$
|
478,901
|
|
|
$
|
|
|
|
$
|
478,901
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The Company chose not to elect the fair value option for its
financial assets and liabilities that had not been previously
carried at fair value. Therefore, material financial assets and
liabilities not carried at fair value, such as short-term and
long-term debt obligations and trade accounts receivable and
payable, are still reported at their carrying values. |
For financial assets and liabilities that utilize Level 2
inputs, the Company utilizes both direct and indirect observable
price quotes, including the LIBOR yield curve, foreign exchange
forward prices, and bank price quotes. Below is a summary of
valuation techniques for Level 1 and Level 2 financial
assets and liabilities:
|
|
|
|
|
Trading securities valued at the quoted
market price from broker or dealer quotations or transparent
pricing sources at the reporting date.
|
|
|
|
Available-for-sale
fixed income investments valued at the quoted
market price from broker or dealer quotations or transparent
pricing sources at the reporting date.
|
|
|
|
Available-for-sale
equity securities valued using quoted stock
prices from the London Exchange at the reporting date and
translated to U.S. Dollars at prevailing spot exchange
rates.
|
|
|
|
Interest rate swap derivative assets and liabilities
valued using the LIBOR/EURIBOR yield curves at
the reporting date. Counterparties to these contracts are highly
rated financial institutions, none of which experienced any
significant downgrades during the nine months ended
September 30, 2010, that would reduce the receivable amount
owed, if any, to the Company.
|
|
|
|
Foreign exchange derivative assets and liabilities
valued using quoted forward foreign exchange
prices at the reporting date. Counterparties to these contracts
are highly rated financial institutions, none of which
experienced any significant downgrades during the nine months
ended September 30, 2010 that would reduce the receivable
amount owed, if any, to the Company.
|
|
|
|
Cash conversion feature of cash convertible notes and
purchased convertible note hedge valued using
quoted prices for the Companys cash convertible notes, its
implied volatility and the quoted yield on the Companys
other long-term debt at the reporting date. Counterparties to
the purchased convertible note hedge are highly rated financial
institutions, none of which experienced any significant
downgrades during the nine months ended September 30, 2010,
that would reduce the receivable amount owed, if any, to the
Company.
|
19
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Although the Company has not elected the fair value option for
financial assets and liabilities, any future transacted
financial asset or liability will be evaluated for the fair
value election.
On May 19, 2010, the Company issued $550.0 million
aggregate principal amount of 7.625% Senior Notes due 2017
(the 2017 Senior Notes) and $700.0 million
aggregate principal amount of 7.875% Senior Notes due 2020
(the 2020 Senior Notes) in a private offering exempt
from the registration requirements of the Securities Act of 1933
(the Securities Act) to qualified institutional
buyers in accordance with Rule 144A and to persons outside
of the United States pursuant to Regulation S under the
Securities Act. During the quarter ended September 30,
2010, the Company privately placed $300.0 million aggregate
principal amount of senior notes through a reopening of the 2020
Senior Notes. The notes were issued at a price of 105.5%, giving
an effective yield to maturity of 7.087%. The 2017 Senior Notes
and 2020 Senior Notes are the Companys senior unsecured
obligations and are guaranteed on a senior unsecured basis by
certain of the Companys domestic subsidiaries.
The 2017 Senior Notes bear interest at a rate of 7.625% per
year, accruing from May 19, 2010. Interest on the 2017
Senior Notes is payable semiannually in arrears on January 15
and July 15 of each year, beginning on January 15, 2011.
The 2017 Senior Notes will mature on July 15, 2017, subject
to earlier repurchase or redemption in accordance with the terms
of the indenture. The 2020 Senior Notes bear interest at a rate
of 7.875% per year, accruing from May 19, 2010. Interest on
the 2020 Senior Notes is payable semiannually in arrears on
January 15 and July 15 of each year, beginning on
January 15, 2011. The 2020 Senior Notes will mature on
July 15, 2020, subject to earlier repurchase or redemption
in accordance with the terms of the indenture.
The Company may redeem some or all of the 2017 Senior Notes at
any time prior to July 15, 2014, and some or all of the
2020 Senior Notes at any time prior to July 15, 2015, in
each case at a price equal to 100% of the principal amount
redeemed plus accrued and unpaid interest, if any, to the
redemption date and an applicable make-whole premium set forth
in the indenture. On or after July 15, 2014 in the case of
the 2017 Senior Notes, and on or after July 15, 2015 in the
case of the 2020 Senior Notes, the Company may redeem some or
all of the 2017 Senior Notes and 2020 Senior Notes of such
series at redemption prices set forth in the indenture, plus
accrued and unpaid interest, if any, to the redemption date. In
addition, at any time prior to July 15, 2013, the Company
may redeem up to 35% of the aggregate principal amount of either
series of the 2017 Senior Notes and 2020 Senior Notes at a
specified redemption price set forth in the indenture with the
net cash proceeds of certain equity offerings. If the Company
experiences certain change of control events, it must offer to
repurchase the 2017 Senior Notes and 2020 Senior Notes at 101%
of their principal amount, plus accrued and unpaid interest, if
any, to the repurchase date.
The Company used approximately $1.00 billion of the net
proceeds of the initial 2017 Senior Notes and 2020 Senior Notes
offering to repay a portion of the U.S. Tranche B Term
Loans due under the terms of its Senior Credit Agreement. Also,
during the quarter ended September 30, 2010, the Company
repaid approximately $300.0 million of debt under the
Senior Credit Agreement, by repaying the remaining balance of
the U.S. Tranche A Term Loans and a portion of the
U.S. Tranche B Term Loans.
20
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
A summary of long-term debt is as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010
|
|
|
December 31, 2009
|
|
|
|
(In thousands)
|
|
|
U.S. Tranche A Term Loans(A)
|
|
$
|
|
|
|
$
|
156,250
|
|
Euro Tranche A Term Loans(A)
|
|
|
239,281
|
|
|
|
252,299
|
|
U.S. Tranche B Term Loans(A)
|
|
|
1,310,010
|
|
|
|
2,453,760
|
|
Euro Tranche B Term Loans(A)
|
|
|
688,313
|
|
|
|
725,760
|
|
Senior Convertible Notes(B)
|
|
|
558,550
|
|
|
|
538,693
|
|
Cash Convertible Notes(C)
|
|
|
841,906
|
|
|
|
847,136
|
|
2017 Senior Notes
|
|
|
550,000
|
|
|
|
|
|
2020 Senior Notes(D)
|
|
|
1,016,283
|
|
|
|
|
|
Other
|
|
|
12,670
|
|
|
|
17,437
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,217,013
|
|
|
|
4,991,335
|
|
Less: Current portion
|
|
|
4,784
|
|
|
|
6,348
|
|
|
|
|
|
|
|
|
|
|
Total long-term debt
|
|
$
|
5,212,229
|
|
|
$
|
4,984,987
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(A) |
|
All 2010 and 2011 mandatory principal payments due under the
Senior Credit Agreement were prepaid during 2009. During the
nine months ended September 30, 2010, the Company also
prepaid $156.3 million of the outstanding U.S.
Tranche A Term Loans and $1.14 billion of the
outstanding U.S. Tranche B Term Loans, using a portion of
the net proceeds of the 2017 Senior Notes, the 2020 Senior Notes
and cash on hand. |
|
(B) |
|
At September 30, 2010, the $558.6 million of debt is
net of a $41.4 million discount. At December 31, 2009,
the $538.7 million debt is net of a $61.3 million
discount. Currently, the effective conversion rate for the
Senior Convertible Notes is 42.156 shares of common stock
per $1,000 principal amount of notes, representing a stock price
of $23.72 per share, reflecting the Companys suspension of
its cash dividend. |
|
(C) |
|
At September 30, 2010, the $841.9 million consists of
$450.8 million of debt ($575.0 million face amount,
net of $124.2 million discount) and the bifurcated
conversion feature with a fair value of $391.1 million
recorded as a liability within long-term debt in the Condensed
Consolidated Balance Sheet at September 30, 2010.
Additionally, the Company has purchased call options, which are
recorded as assets at their fair value of $391.1 million
within other assets in the Condensed Consolidated Balance Sheet
at September 30, 2010. At December 31, 2009, the
$847.1 million consisted of $436.5 million of debt
($575.0 million face amount, net of $138.5 million
discount) and the bifurcated conversion feature with a fair
value of $410.6 million recorded as a liability within
other long-term obligations in the Condensed Consolidated
Balance Sheet. The purchased call options are assets recorded at
their fair value of $410.6 million within other assets in
the Condensed Consolidated Balance Sheet at December 31,
2009. |
|
|
|
As of September 30, 2010, because the closing price of our
common stock for at least 20 trading days in the period of 30
consecutive trading days ending on the last trading day in the
September 30, 2010 period, was more than 130% of the
applicable conversion reference price of $13.32 at
September 30, 2010, the $575.0 million of Cash
Convertible Notes was currently convertible. Although the
Companys experience is that convertible debentures are not
normally converted by investors until close to their maturity
date, it is possible that debentures could be converted prior to
their maturity date if, for example, a holder perceives the
market for the debentures to be weaker than the market for the
common stock. Upon an investors election to convert, the
Company is required to pay the full conversion value in cash.
The amount payable per $1,000 notional bond would be calculated
as the product of (1) the conversion reference rate
(currently 75.0751) and (2) the average Daily Volume
Weighted Average Price per share of common stock for a specified
period following the conversion date. Any payment above the
principal amount is matched by a convertible note hedge. |
|
(D) |
|
At September 30, 2010, the $1.02 billion of debt
includes a $16.3 million premium. |
21
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Details of the interest rates in effect at September 30,
2010 and December 31, 2009, on the outstanding borrowings
under the Term Loans are in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010
|
|
|
|
Outstanding
|
|
|
Basis
|
|
Rate
|
|
|
|
(In thousands)
|
|
|
Euro Tranche A Term Loans
|
|
$
|
239,281
|
|
|
EURIBO + 2.75%
|
|
|
3.37%
|
|
U.S. Tranche B Term Loans
|
|
|
|
|
|
|
|
|
|
|
Swapped to Fixed Rate December
2010(1)(2)
|
|
$
|
500,000
|
|
|
Fixed
|
|
|
6.03%
|
|
Swapped to Fixed Rate March
2012(1)
|
|
|
500,000
|
|
|
Fixed
|
|
|
5.38%
|
|
Floating Rate
|
|
|
310,010
|
|
|
LIBOR + 3.25%
|
|
|
3.56%
|
|
|
|
|
|
|
|
|
|
|
|
|
Total U.S. Tranche B Term Loans
|
|
$
|
1,310,010
|
|
|
|
|
|
|
|
Euro Tranche B Term Loans
|
|
|
|
|
|
|
|
|
|
|
Swapped to Fixed Rate March
2011(1)
|
|
$
|
273,140
|
|
|
Fixed
|
|
|
5.38%
|
|
Floating Rate
|
|
|
415,173
|
|
|
EURIBO + 3.25%
|
|
|
3.87%
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Euro Tranche B Term Loans
|
|
$
|
688,313
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009
|
|
|
|
Outstanding
|
|
|
Basis
|
|
Rate
|
|
|
|
(In thousands)
|
|
|
U.S. Tranche A Term Loans
|
|
$
|
156,250
|
|
|
LIBOR + 2.75%
|
|
|
3.00%
|
|
Euro Tranche A Term Loans
|
|
$
|
252,299
|
|
|
EURIBO + 2.75%
|
|
|
3.19%
|
|
U.S. Tranche B Term Loans
|
|
|
|
|
|
|
|
|
|
|
Swapped to Fixed Rate December
2010(1)(2)
|
|
$
|
500,000
|
|
|
Fixed
|
|
|
6.03%
|
|
Swapped to Fixed Rate March
2010(1)
|
|
|
500,000
|
|
|
Fixed
|
|
|
5.44%
|
|
Swapped to Fixed Rate December
2010(1)
|
|
|
1,000,000
|
|
|
Fixed
|
|
|
7.37%
|
|
Floating Rate
|
|
|
453,760
|
|
|
LIBOR + 3.25%
|
|
|
3.50%
|
|
|
|
|
|
|
|
|
|
|
|
|
Total U.S. Tranche B Term Loans
|
|
$
|
2,453,760
|
|
|
|
|
|
|
|
Euro Tranche B Term Loans
|
|
|
|
|
|
|
|
|
|
|
Swapped to Fixed Rate March
2011(1)
|
|
$
|
288,000
|
|
|
Fixed
|
|
|
5.38%
|
|
Floating Rate
|
|
|
437,760
|
|
|
EURIBO + 3.25%
|
|
|
3.83%
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Euro Tranche B Term Loans
|
|
$
|
725,760
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
This interest rate swap is designated as a cash flow hedge of
expected future borrowings under the Senior Credit Agreement. |
|
(2) |
|
This interest rate swap has been extended to December 2012 at a
rate of 6.60%, effective January 2011. |
At September 30, 2010 and December 31, 2009, the fair
value of the Senior Convertible Notes was approximately
$624.6 million and $612.8 million. At
September 30, 2010 and December 31, 2009, the fair
value of the Cash Convertible Notes was approximately
$908.6 million and $879.8 million.
22
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Mandatory minimum repayments remaining on the outstanding
borrowings under the term loans and convertible notes at
September 30, 2010, excluding the discounts, premium and
conversion features, are as follows for each of the periods
ending December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Euro
|
|
|
U.S.
|
|
|
Euro
|
|
|
Senior
|
|
|
Cash
|
|
|
2017
|
|
|
2020
|
|
|
|
|
|
|
Tranche A
|
|
|
Tranche B
|
|
|
Tranche B
|
|
|
Convertible
|
|
|
Convertible
|
|
|
Senior
|
|
|
Senior
|
|
|
|
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Notes
|
|
|
Notes
|
|
|
Notes
|
|
|
Notes
|
|
|
Total
|
|
|
|
(In thousands)
|
|
|
2010
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2012
|
|
|
119,640
|
|
|
|
|
|
|
|
7,170
|
|
|
|
600,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
726,810
|
|
2013
|
|
|
119,641
|
|
|
|
|
|
|
|
7,170
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
126,811
|
|
2014
|
|
|
|
|
|
|
1,310,010
|
|
|
|
673,973
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,983,983
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
575,000
|
|
|
|
|
|
|
|
|
|
|
|
575,000
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
550,000
|
|
|
|
1,000,000
|
|
|
|
1,550,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
239,281
|
|
|
$
|
1,310,010
|
|
|
$
|
688,313
|
|
|
$
|
600,000
|
|
|
$
|
575,000
|
|
|
$
|
550,000
|
|
|
$
|
1,000,000
|
|
|
$
|
4,962,604
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11.
|
Comprehensive
Earnings
|
Comprehensive earnings consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Net earnings (loss)
|
|
|
|
|
|
$
|
143,539
|
|
|
|
|
|
|
$
|
(4,421
|
)
|
Other comprehensive earnings, net of tax, as applicable:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
424,463
|
|
|
|
|
|
|
|
230,791
|
|
Change in unrecognized gains (losses) and prior service cost
related to post-retirement plans
|
|
|
|
|
|
|
8
|
|
|
|
|
|
|
|
(974
|
)
|
Net unrecognized gain (loss) on derivatives
|
|
|
|
|
|
|
16,965
|
|
|
|
|
|
|
|
(5,112
|
)
|
Unrealized gains on
available-for-sale
securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on
available-for-sale
securities
|
|
$
|
176
|
|
|
|
|
|
|
$
|
685
|
|
|
|
|
|
Less: Reclassification for gains included in net earnings
|
|
|
14
|
|
|
|
190
|
|
|
|
12
|
|
|
|
697
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive earnings, net of tax, as applicable:
|
|
|
|
|
|
|
441,626
|
|
|
|
|
|
|
|
225,402
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings
|
|
|
|
|
|
|
585,165
|
|
|
|
|
|
|
|
220,981
|
|
Comprehensive earnings attributable to the noncontrolling
interest
|
|
|
|
|
|
|
(356
|
)
|
|
|
|
|
|
|
(827
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings attributable to Mylan Inc.
|
|
|
|
|
|
$
|
584,809
|
|
|
|
|
|
|
$
|
220,154
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Net earnings
|
|
|
|
|
|
$
|
324,743
|
|
|
|
|
|
|
$
|
200,325
|
|
Other comprehensive earnings, net of tax, as applicable:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
90,206
|
|
|
|
|
|
|
|
334,084
|
|
Change in unrecognized gains (losses) and prior service cost
related to post-retirement plans
|
|
|
|
|
|
|
4,452
|
|
|
|
|
|
|
|
(754
|
)
|
Net unrecognized gain on derivatives
|
|
|
|
|
|
|
17,143
|
|
|
|
|
|
|
|
937
|
|
Unrealized gains on
available-for-sale
securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on
available-for-sale
securities
|
|
$
|
489
|
|
|
|
|
|
|
$
|
1,062
|
|
|
|
|
|
Less: Reclassification for gains included in net earnings
|
|
|
171
|
|
|
|
660
|
|
|
|
173
|
|
|
|
1,235
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive earnings, net of tax, as applicable:
|
|
|
|
|
|
|
112,461
|
|
|
|
|
|
|
|
335,502
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings
|
|
|
|
|
|
|
437,204
|
|
|
|
|
|
|
|
535,827
|
|
Comprehensive loss (earnings) attributable to the noncontrolling
interest
|
|
|
|
|
|
|
525
|
|
|
|
|
|
|
|
(6,693
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings attributable to Mylan Inc.
|
|
|
|
|
|
$
|
437,729
|
|
|
|
|
|
|
$
|
529,134
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive earnings, as reflected on the
Condensed Consolidated Balance Sheets, is comprised of the
following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010
|
|
|
December 31, 2009
|
|
|
|
(In thousands)
|
|
|
Net unrealized gain on
available-for-sale
securities, net of tax
|
|
$
|
1,535
|
|
|
$
|
875
|
|
Net unrecognized gains (losses) and prior service cost related
|
|
|
|
|
|
|
|
|
to post-retirement plans, net of tax
|
|
|
1,039
|
|
|
|
(3,413
|
)
|
Net unrecognized losses on derivatives, net of tax
|
|
|
(22,138
|
)
|
|
|
(39,281
|
)
|
Foreign currency translation adjustment
|
|
|
143,832
|
|
|
|
53,626
|
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive earnings
|
|
$
|
124,268
|
|
|
$
|
11,807
|
|
|
|
|
|
|
|
|
|
|
24
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
A summary of the change in shareholders equity for the
nine months ended September 30, 2010 and 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Mylan Inc.
|
|
|
Noncontrolling
|
|
|
|
|
|
|
Shareholders Equity
|
|
|
Interest
|
|
|
Total
|
|
|
|
(In thousands)
|
|
|
December 31, 2009
|
|
$
|
3,131,146
|
|
|
$
|
14,052
|
|
|
$
|
3,145,198
|
|
Net earnings (loss)
|
|
|
325,268
|
|
|
|
(525
|
)
|
|
|
324,743
|
|
Other comprehensive earnings
|
|
|
112,461
|
|
|
|
|
|
|
|
112,461
|
|
Dividends paid on preferred stock
|
|
|
(104,276
|
)
|
|
|
|
|
|
|
(104,276
|
)
|
Stock option activity
|
|
|
37,215
|
|
|
|
|
|
|
|
37,215
|
|
Stock compensation expense
|
|
|
24,156
|
|
|
|
|
|
|
|
24,156
|
|
Purchase of subsidiary shares from noncontrolling interest
|
|
|
(4,376
|
)
|
|
|
(623
|
)
|
|
|
(4,999
|
)
|
Tax benefit of stock option plans
|
|
|
4,863
|
|
|
|
|
|
|
|
4,863
|
|
Other
|
|
|
3,671
|
|
|
|
(92
|
)
|
|
|
3,579
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010
|
|
$
|
3,530,128
|
|
|
$
|
12,812
|
|
|
$
|
3,542,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008
|
|
$
|
2,757,733
|
|
|
$
|
29,108
|
|
|
$
|
2,786,841
|
|
Net earnings
|
|
|
193,667
|
|
|
|
6,658
|
|
|
|
200,325
|
|
Other comprehensive income
|
|
|
335,467
|
|
|
|
35
|
|
|
|
335,502
|
|
Dividends paid on preferred stock
|
|
|
(104,276
|
)
|
|
|
|
|
|
|
(104,276
|
)
|
Stock option activity
|
|
|
8,803
|
|
|
|
|
|
|
|
8,803
|
|
Stock compensation expense
|
|
|
23,591
|
|
|
|
|
|
|
|
23,591
|
|
Impact on additional paid-in capital of equity transaction
|
|
|
(154,033
|
)
|
|
|
|
|
|
|
(154,033
|
)
|
Purchase of subsidiary shares from noncontrolling interest
|
|
|
|
|
|
|
(21,626
|
)
|
|
|
(21,626
|
)
|
Other
|
|
|
(2,117
|
)
|
|
|
(1,118
|
)
|
|
|
(3,235
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009
|
|
$
|
3,058,835
|
|
|
$
|
13,057
|
|
|
$
|
3,071,892
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mylan previously had three reportable segments,
Generics, Specialty and
Matrix. The Matrix Segment consisted of Matrix,
which was previously a publicly traded company in India, in
which Mylan held a 71.2% ownership stake. Following the
acquisition of additional interests in Matrix and its related
delisting from the Indian stock exchanges, Mylan has two
reportable segments, Generics and
Specialty. Mylan changed its segment disclosure to
align with how the business is being managed after those
changes. The former Matrix Segment is included within the
Generics Segment. Information for earlier periods has been
recast.
The Generics Segment primarily develops, manufactures, sells and
distributes generic or branded generic pharmaceutical products
in tablet, capsule, injectable or transdermal patch form, as
well as active pharmaceutical ingredients (API). The
Specialty Segment engages mainly in the manufacture and sale of
branded specialty nebulized and injectable products.
The Companys chief operating decision maker evaluates the
performance of its reportable segments based on total revenues
and segment profitability. For the Generics and Specialty
Segments, segment profitability represents
25
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
segment gross profit less direct research and development
expenses and direct selling, general and administrative
expenses. Certain general and administrative and research and
development expenses not allocated to the segments, as well as
reserves for litigation settlements, impairment charges and
other expenses not directly attributable to the segments, are
reported in Corporate/Other. Additionally, amortization of
intangible assets, and other purchase accounting related items,
as well as any other significant special items, are included in
Corporate/Other. Items below the earnings from operations line
on the Companys Condensed Consolidated Statements of
Operations 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.
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
for the year ended December 31, 2009. Intersegment revenues
are accounted for at current market values.
Presented in the table below is segment information for the
periods identified and a reconciliation of segment information
to total consolidated information.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics
|
|
|
Specialty
|
|
|
Corporate /
|
|
|
|
|
|
|
Segment
|
|
|
Segment
|
|
|
Other(1)
|
|
|
Consolidated
|
|
|
|
(In thousands)
|
|
|
Three Months Ended September 30, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third party
|
|
$
|
1,213,216
|
|
|
$
|
141,897
|
|
|
$
|
|
|
|
$
|
1,355,113
|
|
Intersegment
|
|
|
2,392
|
|
|
|
13,689
|
|
|
|
(16,081
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,215,608
|
|
|
$
|
155,586
|
|
|
$
|
(16,081
|
)
|
|
$
|
1,355,113
|
|
Segment profitability
|
|
$
|
357,393
|
|
|
$
|
49,761
|
|
|
$
|
(172,836
|
)
|
|
$
|
234,318
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics
|
|
|
Specialty
|
|
|
Corporate /
|
|
|
|
|
|
|
Segment
|
|
|
Segment
|
|
|
Other(1)
|
|
|
Consolidated
|
|
|
Nine Months Ended September 30, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third party
|
|
$
|
3,663,733
|
|
|
$
|
352,290
|
|
|
$
|
|
|
|
$
|
4,016,023
|
|
Intersegment
|
|
|
34,314
|
|
|
|
47,419
|
|
|
|
(81,733
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,698,047
|
|
|
$
|
399,709
|
|
|
$
|
(81,733
|
)
|
|
$
|
4,016,023
|
|
Segment profitability
|
|
$
|
1,015,980
|
|
|
$
|
104,881
|
|
|
$
|
(493,451
|
)
|
|
$
|
627,410
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics
|
|
|
Specialty
|
|
|
Corporate /
|
|
|
|
|
|
|
Segment
|
|
|
Segment
|
|
|
Other(1)
|
|
|
Consolidated
|
|
|
Three Months Ended September 30, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third party
|
|
$
|
1,113,199
|
|
|
$
|
150,875
|
|
|
$
|
|
|
|
$
|
1,264,074
|
|
Intersegment
|
|
|
2,608
|
|
|
|
3,776
|
|
|
|
(6,384
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,115,807
|
|
|
$
|
154,651
|
|
|
$
|
(6,384
|
)
|
|
$
|
1,264,074
|
|
Segment profitability
|
|
$
|
295,190
|
|
|
$
|
39,799
|
|
|
$
|
(273,711
|
)
|
|
$
|
61,278
|
|
26
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics
|
|
|
Specialty
|
|
|
Corporate /
|
|
|
|
|
|
|
Segment
|
|
|
Segment
|
|
|
Other(1)
|
|
|
Consolidated
|
|
|
Nine Months Ended September 30, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third party
|
|
$
|
3,387,921
|
|
|
$
|
353,047
|
|
|
$
|
|
|
|
$
|
3,740,968
|
|
Intersegment
|
|
|
20,836
|
|
|
|
15,196
|
|
|
|
(36,032
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,408,757
|
|
|
$
|
368,243
|
|
|
$
|
(36,032
|
)
|
|
$
|
3,740,968
|
|
Segment profitability
|
|
$
|
995,207
|
|
|
$
|
71,494
|
|
|
$
|
(603,369
|
)
|
|
$
|
463,332
|
|
|
|
|
(1) |
|
Includes certain corporate general and administrative and
research and development expenses; reserves for litigation
settlements; certain intercompany transactions, including
eliminations; amortization of intangible assets and certain
purchase-accounting items; impairment charges; and other
expenses not directly attributable to segments. |
Included in other current liabilities in the Companys
Condensed Consolidated Balance Sheets as of September 30,
2010 and December 31, 2009 are restructuring reserves
totaling $16.6 million and $39.3 million. Of these
amounts, $10.9 million and $27.0 million, as of
September 30, 2010 and December 31, 2009, relate to
certain estimated exit costs associated with the acquisition of
the former Merck Generics business, and the remainder of each
balance relates to the Companys intention to restructure
certain other activities and incur certain related exit costs.
The plans related to the exit activities associated with the
former Merck Generics business were finalized during calendar
year 2008. During the nine months ended September 30, 2010,
payments of $16.1 million were made against the reserve, of
which $6.7 million was for severance costs and the
remaining $9.4 million was for other exit costs. The
majority of the remaining accrual relates to additional
severance and related costs, and the remainder consists of other
exit costs.
In addition, the Company has announced its intent to restructure
certain activities and incur certain related exit costs,
including costs related to the realignment of the Dey business
and the right-sizing of certain businesses in markets outside of
the U.S. Accordingly, the Company has recorded a reserve
for such activities, of which approximately $5.8 million
remains at September 30, 2010. During the nine months ended
September 30, 2010, the Company recorded restructuring
charges of approximately $4.9 million, nearly all of which
relates to severance and related costs. Spending during the nine
months, primarily related to severance, amounted to
approximately $11.4 million.
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. The Company is also
party to certain litigation matters, some of which are described
below, for which Merck KGaA has agreed to indemnify the Company,
under the terms by which Mylan acquired the former Merck
Generics business. An adverse outcome in any of these
proceedings, or the inability or denial of Merck KGaA to pay an
indemnified claim, could have a material adverse effect on the
Companys financial position, results of operations and
cash flows.
Lorazepam
and Clorazepate
On June 1, 2005, a jury verdict was rendered against Mylan,
Mylan Pharmaceuticals Inc. (MPI), and co-defendants
Cambrex Corporation and Gyma Laboratories in the
U.S. District Court for the District of Columbia in
27
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
the amount of approximately $12.0 million, which has been
accrued for by the Company. The jury found that Mylan and its
co-defendants willfully violated Massachusetts, Minnesota and
Illinois state antitrust laws in connection with API supply
agreements entered into between the Company and its API supplier
(Cambrex) and broker (Gyma) 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 antitrust
claims relating to Mylans 1998 price increases for
lorazepam and clorazepate. Following the verdict, 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 and the remaining motions were
denied on January 24, 2008. In post-trial filings, the
plaintiffs requested that the verdict be trebled and that
request was granted on January 24, 2008. On
February 6, 2008, a judgment was issued against Mylan and
its co-defendants in the total amount of approximately
$69.0 million, which, in the case of three of the
plaintiffs, reflects trebling of the compensatory damages in the
original verdict (approximately $11 million in total) and,
in the case of the fourth plaintiff, reflects their amount of
the compensatory damages in the original jury verdict plus
doubling this compensatory damage award as punitive damages
assessed against each of the defendants (approximately
$58 million in total), some or all of which may be subject
to indemnification obligations by Mylan. Plaintiffs are also
seeking an award of attorneys fees and litigation costs in
unspecified amounts and prejudgment interest of approximately
$8.0 million. The Company and its co-defendants have
appealed to the U.S. Court of Appeals for the D.C. Circuit
and have challenged the verdict as legally erroneous on multiple
grounds. The appeals were held in abeyance pending a ruling on
the motion for prejudgment interest, which has been granted.
Mylan intends to contest this ruling along with the liability
finding and other damages awards as part of its pending appeal,
which is proceeding in the Court of Appeals for the D.C.
Circuit, with oral argument having been held on October 8,
2010. In connection with the Companys appeal of the
lorazepam judgment, the Company submitted a surety bond
underwritten by a third-party insurance company in the amount of
$74.5 million. This surety bond is secured by a pledge of a
$15.0 million cash deposit (which is included as restricted
cash on the Companys Condensed Consolidated Balance
Sheets) and an irrevocable letter of credit for
$34.5 million issued under the Senior Credit Agreement.
Pricing
and Medicaid Litigation
Beginning in September 2003, Mylan, MPI
and/or UDL
Laboratories Inc. (UDL), together with many other
pharmaceutical companies, have been named in civil lawsuits
filed by state attorneys general (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
and/or
Wholesale Acquisition Costs that exceeded the actual
selling price of the defendants prescription drugs,
causing state programs to overpay pharmacies and other
providers. 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, Kansas, Kentucky,
Massachusetts, Mississippi, Missouri, Oklahoma, 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 money
damages, civil penalties
and/or
double, treble or punitive damages, counsel fees and costs,
equitable relief
and/or
injunctive relief. Certain of these cases may go to trial in
2010. Mylan and its subsidiaries have denied liability and
intend to defend each of these actions vigorously. On
January 27, 2010, in the New York Counties cases, the
U.S. District Court for the District of Massachusetts
granted the plaintiffs motion for partial summary judgment
as to liability under New York Social Services Law
§ 145-b against Mylan and several other defendants.
The District Court has not ruled on the remaining issues of
liability and damages. On February 8, 2010, Mylan, and a
majority of the other defendants, filed a motion to amend the
courts decision, requesting the court to certify a
question of New York state law pertaining to the courts
finding of requisite causation under the Social Services Law to
the First Circuit Court of Appeals, so that the defendants could
in turn request that the First Circuit
28
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Court of Appeals certify the question to the New York Court of
Appeals. The District Court denied this motion on May 4,
2010.
In May 2008, an amended complaint was filed in the
U.S. District Court for the District of Massachusetts by a
private plaintiff on behalf of the United States of America,
against Mylan, MPI, UDL and several other generic manufacturers.
The original complaint was filed under seal in April 2000, and
Mylan, MPI and UDL were added as parties in February 2001. The
claims against Mylan, MPI, UDL and the other generic
manufacturers were severed from the April 2000 complaint (which
remains under seal) as a result of the federal governments
decision not to intervene in the action as to those defendants.
The complaint alleges violations of the False Claims Act and
sets forth allegations substantially similar to those alleged in
the state AG cases mentioned in the preceding paragraph and
purports to seek nationwide recovery of any and all alleged
overpayment of the federal share under the Medicaid
program, as well as treble damages and civil penalties. In
February 2010, the Company reached an agreement in principle to
settle this case (except for the claims related to the
California federal share) and the Texas state action mentioned
above. This settlement is contingent upon the execution of
definitive settlement documents and court approval. The
settlement would resolve a significant portion of the damages
claims asserted against Mylan, MPI and UDL in the various
pending pricing litigations. In addition, Mylan has reached
agreement in principle to settle the Hawaii state action, and
the Massachusetts state action, which settlements are contingent
upon the execution of definitive settlement documents. With
regard to the remaining state actions, the Company continues to
believe that it has meritorious defenses and will continue to
vigorously defend itself in those actions. The Company has
accrued $160 million in connection with the above-mentioned
settlement in principle and the remaining state actions. The
Company reviews the status of these actions on an ongoing basis,
and from time to time, the Company may settle or otherwise
resolve these matters on terms and conditions that management
believes are in the best interests of the Company. There are no
assurances that settlements can be reached on acceptable terms
or that adverse judgments, if any, in the remaining litigation
will not exceed the amounts reserved.
In addition, by letter dated January 12, 2005, MPI was
notified by the U.S. Department of Justice of an
investigation concerning calculations of Medicaid drug rebates.
The investigation involved whether MPI and UDL may have violated
the False Claims Act by classifying certain authorized generics
as non-innovator rather than innovator drugs for purposes of
Medicaid and other federal healthcare programs on sales from
2000 through 2004. MPI and UDL denied the governments
allegations and denied that they engaged in any wrongful
conduct. On October 19, 2009, a lawsuit, filed in March
2004 by a private relator, in which the federal government
subsequently intervened, was unsealed by the U.S. District
Court for the District of New Hampshire. That same day, MPI and
UDL announced that they had entered into a settlement agreement
with the federal government, relevant states and the relator for
approximately $121.0 million, resolving both the lawsuit
and the U.S. Department of Justice investigation. A
stipulation of dismissal with prejudice has been filed with the
court. The resolution of the matter did not include any
admission or finding of wrongdoing on the part of either MPI or
UDL. The Company has recovered approximately $50 million of
the settlement amount based on overpayments resulting from
adjusted net sales during the relevant timeframe.
Dey is a defendant currently in lawsuits brought by the state
AGs of California, Illinois, Kentucky, and Pennsylvania, as well
as three New York counties. Dey is also named as a defendant in
several class actions brought by consumers and third-party
payors. Dey has reached a settlement of these class actions,
which has been preliminarily approved by the court.
Additionally, a complaint was filed under seal by a plaintiff on
behalf of the United States of America against Dey in August
1997. In August 2006, the Government filed its
complaint-in-intervention
and the case was unsealed in September 2006. The Government has
asserted that Dey is jointly liable with a codefendant and seeks
recovery of alleged overpayments, together with treble damages,
civil penalties and equitable relief. These cases all generally
allege that Dey falsely reported certain price information
concerning certain drugs marketed by Dey, that Dey caused false
claims to be made to Medicaid and to Medicare, and that Dey
caused Medicaid and Medicare to make overpayments on those
claims. Certain of these cases may go to trial in 2010. Dey
intends to defend each of these actions vigorously. The Company
has approximately $96 million recorded in other liabilities
related to the price-related litigation involving Dey. As
29
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
stated above, in conjunction with the acquisition of the former
Merck Generics business, Mylan is entitled to indemnification
from Merck KGaA. As a result, the Company has recorded
approximately $96 million in other assets.
Modafinil
Antitrust Litigation and FTC Inquiry
Beginning in April 2006, Mylan, along with four other drug
manufacturers, has been named as a defendant in civil lawsuits
filed in or transferred to 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. On March 29, 2010,
the Court in the Eastern District of Pennsylvania denied the
defendants motions to dismiss. 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. 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 has cooperated fully with the governments
investigation and completed all requests for information. On
February 13, 2008, the FTC filed a lawsuit against Cephalon
in the U.S. District Court for the District of Columbia and
the case has subsequently been transferred to the
U.S. District Court for the Eastern District of
Pennsylvania. On July 1, 2010, the FTC issued a third party
subpoena to Mylan requesting documents in connection with its
lawsuit against Cephalon. Mylan is in the process of responding
to the subpoena. Mylan is not named as a defendant in the
FTCs lawsuit, although the complaint includes certain
allegations pertaining to the Mylan/Cephalon settlement.
Digitek®
Recall
On April 25, 2008, Actavis Totowa LLC, a division of
Actavis Group, announced a voluntary, nationwide recall of all
lots and all strengths of Digitek (digoxin tablets USP). Digitek
was manufactured by Actavis and distributed in the United States
by MPI and UDL. The Company has tendered its defense and
indemnity in all lawsuits and claims arising from this event to
Actavis, and Actavis has accepted that tender, subject to a
reservation of rights. While the Company is unable to estimate
total potential costs with any degree of certainty, such costs
could be significant. As of October 15, 2010, there are
approximately 1,039 cases pending against Mylan, UDL and Actavis
pertaining to the recall. Most of these cases have been
transferred to the multi-district litigation proceedings pending
in the U.S. District Court for the Southern District of
West Virginia for pretrial proceedings. The remainder of these
cases will likely be litigated in the state courts in which they
were filed. In September 2010, Actavis entered into a Settlement
Agreement with the plaintiffs in a majority of the claims and
lawsuits. Mylan and UDL will not contribute monetarily to the
settlement, but will be dismissed with prejudice from any
settled cases. Any lawsuits in which the plaintiffs choose to
opt out of this settlement will continue to be litigated. An
adverse outcome in these lawsuits or the inability or denial of
Actavis to pay on an indemnified claim could have a materially
negative impact on the Companys financial position,
results of operations or cash flows.
EU
Commission Proceedings
On or around July 3, 2009, the European Commission (the
EU Commission or the Commission) stated
that it had initiated antitrust proceedings pursuant to
Article 11(6) of Regulation No. 1/2003 and
Article 2(1) of Regulation No. 773/2004 to
explore possible infringement of Articles 81 and 82 EC and
Articles 53 and 54 of the EEA Agreement by Les Laboratoires
Servier (Servier) as well as possible infringement
of Article 81 EC by Matrix and four other companies, each
of which entered into agreements with Servier relating to the
product perindopril. Matrix is cooperating with the EU
Commission in connection with the investigation. The EU
Commission stated that the initiation of proceedings does
not imply that the Commission has conclusive proof of an
infringement but
30
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
merely signifies that the Commission will deal with the case as
a matter of priority. No statement of objections has been
filed against Matrix in connection with its investigation. On
August 5, 2009, Matrix and Generics [U.K.] Ltd. received
requests for information from the EU Commission in connection
with this matter, and both companies have responded. By letters
dated February 17, 2010, the EU Commission served
additional requests for information on Matrix and Mylan S.A.S.
The companies responded to these requests. On August 13,
2010, Matrix received an additional request for information.
Matrix has responded to this request. Matrix is cooperating with
the Commission in this investigation.
In addition, the EU Commission is conducting a pharmaceutical
sector inquiry involving approximately 100 companies
concerning the introduction of innovative and generic medicines.
Mylan S.A.S. has responded to the questionnaires received in
connection with the sector inquiry and has produced documents
and other information in connection with the inquiry.
On October 6, 2009, the Company received notice that the EU
Commission was initiating an investigation pursuant to
Article 20(4) of Regulation No. 1/2003 to explore
possible infringement of Articles 81 and 82 EC by the
Company and its affiliates. Mylan S.A.S., acting on behalf of
its Mylan affiliates, has produced documents and other
information in connection with the inquiry. The Company and
Mylan S.A.S. received an additional request for information with
the same case reference on December 18, 2009 and have
responded to the questionnaire. Additional requests were
received on March 18, 2010 and July 29, 2010. Mylan
S.A.S. has responded to these requests. Mylan is cooperating
with the Commission in connection with the investigation. No
statement of objections has been filed against Mylan in
connection with the investigation.
On March 19, 2010, Mylan Inc. and Generics [U.K.] Ltd.
received notice that the EU Commission had opened proceedings
against Lundbeck with respect to alleged unilateral practices
and/or
agreements related to citalopram in the European Economic Area.
On this same date, Mylan Inc. and Generics [U.K.] Ltd. received
requests for information from the EU Commission in connection
with any agreements between Lundbeck and Generics [U.K.] Ltd.
concerning citalopram. Both companies are cooperating with the
EU Commission. Generics [U.K.] Ltd. responded to the request for
information on May 10, 2010 and September 30, 2010. No
statement of objections has been filed in connection with this
investigation.
Other
Litigation
The Company is involved in various other legal proceedings that
are considered normal to its business, including certain
proceedings assumed as a result of the acquisition of the former
Merck Generics business. While it is not feasible to predict the
ultimate outcome of such other proceedings, the ultimate outcome
of any such proceeding is not expected to have a material
adverse effect on its financial position, results of operations
or cash flows.
31
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ITEM 2.
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MANAGEMENTS
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
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The following discussion and analysis addresses material changes
in the financial condition and results of operations 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 Financial Condition and Results of
Operations included in the Companys Annual Report on
Form 10-K
for the year ended December 31, 2009, the unaudited interim
Condensed Consolidated Financial Statements and related Notes
included in Part I ITEM 1 of this
Quarterly Report on
Form 10-Q
(Form 10-Q)
and our other Securities and Exchange Commission
(SEC) filings and public disclosures. The interim
results of operations for the three and nine months ended
September 30, 2010 and the interim cash flows for the nine
months ended September 30, 2010 are not necessarily
indicative of the results to be expected for the full fiscal
year or any other future period.
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 our 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
filing date of this
Form 10-Q.
Executive
Overview
Mylan is the worlds third largest producer of generic and
specialty pharmaceuticals, offering one of the industrys
broadest and highest quality product portfolios, a robust
pipeline and a global commercial footprint that spans more than
140 countries and territories. Employing over
15,500 people, Mylan has attained leading positions in key
international markets through its wide array of dosage forms and
delivery systems, significant manufacturing capacity, global
scale and commitment to customer service. Through our Matrix
Laboratories Limited (Matrix) subsidiary, Mylan
controls one of the worlds largest active pharmaceutical
ingredient (API) manufacturers with respect to the
number of drug master files filed with regulatory agencies. This
relationship makes Mylan one of only two global generics
companies with a comprehensive, vertically integrated supply
chain.
Mylan previously had three reportable segments,
Generics, Specialty and
Matrix. The Matrix Segment consisted of Matrix,
which was previously a publicly traded company in India, in
which Mylan held a 71.2% ownership stake. Following the
acquisition of additional interests in Matrix, beginning in
2009, and its related delisting from the Indian stock exchanges,
Mylan now has two reportable segments, Generics and
Specialty. Mylan revised its segment disclosure to
align with how the business is being managed after those
changes. The former Matrix Segment is included within the
Generics Segment. Information for earlier periods has been
recast.
Generics primarily develops, manufactures, sells and distributes
generic or branded generic pharmaceutical products in tablet,
capsule, injectable or transdermal patch form, as well as API.
Specialty engages mainly in the manufacture and sale of branded
specialty nebulized and injectable products. We also report in
Corporate/Other certain research and development expenses,
general and administrative expenses, litigation settlements,
amortization of intangible assets and certain
purchase-accounting items, impairment charges, and other items
not directly attributable to the segments.
Issuance
of Senior Notes and Loan Repayment
In May 2010, we issued $550.0 million of 7.625% Senior
Notes due 2017 (the 2017 Senior Notes) and
$700.0 million of 7.875% Senior Notes due 2020 (the
2020 Senior Notes). These notes were issued in a
private offering exempt from the registration requirements of
the Securities Act of 1933 to qualified institutional buyers in
accordance with Rule 144A and to persons outside of the
United States pursuant to Regulation S under the
32
Securities Act. During the quarter ended September 30,
2010, we privately placed $300.0 million aggregate
principal amount of senior notes through a reopening of our 2020
Senior Notes. The 2017 Senior Notes and 2020 Senior Notes are
Mylans senior unsecured obligations and are guaranteed on
a senior unsecured basis by certain of our domestic subsidiaries.
The 2017 Senior Notes bear interest at a rate of 7.625% per
year, accruing from May 19, 2010. Interest on the 2017
Senior Notes is payable semiannually in arrears on January 15
and July 15 of each year, beginning on January 15, 2011.
The 2017 Senior Notes will mature on July 15, 2017, subject
to earlier repurchase or redemption in accordance with the terms
of the indenture. The 2020 Senior Notes bear interest at a rate
of 7.875% per year, accruing from May 19, 2010. Interest on
the 2020 Senior Notes is payable semiannually in arrears on
January 15 and July 15 of each year, beginning on
January 15, 2011. The 2020 Senior Notes will mature on
July 15, 2020, subject to earlier repurchase or redemption
in accordance with the terms of the indenture.
We used approximately $1.00 billion of the net proceeds of
the initial 2017 Senior Notes and 2020 Senior Notes offering to
repay a portion of the U.S. Tranche B Term Loans due
under the terms of its Senior Credit Agreement. Also, during the
quarter ended September 30, 2010, we repaid approximately
$300.0 million of debt under the Senior Credit Agreement,
by repaying the remaining balance of the
U.S. Tranche A Term Loans and a portion of the
U.S. Tranche B Term Loans.
Acquisition
of Bioniche Pharma Holdings Limited
On September 7, 2010, we acquired 100% of the outstanding
equity in Bioniche Pharma, a privately held, global injectable
pharmaceutical company, for a purchase price of
$543.7 million in cash. Mylan did not assume any of
Bioniche Pharmas outstanding long-term debt or acquire any
of its cash as part of the transaction. We financed this
transaction using a combination of cash on hand and long-term
borrowings.
Bioniche Pharma manufactures and sells a diverse portfolio of
products across several therapeutic areas for the hospital
setting, including analgesics/anesthetics, orthopedics,
oncology, and urology, and most of its sales are made to
customers in the U.S. The results for Bioniche Pharma from
the date of the acquisition through September 30, 2010 are
included in the Condensed Consolidated Results of Operations and
disclosed as part of the North American region of our Generics
Segment.
Financial
Summary
For the three months ended September 30, 2010, Mylan
reported total revenues of $1.36 billion compared to
$1.26 billion for the three months ended September 30,
2009. This represents an increase in revenues of
$91.0 million, or 7.2%. Consolidated gross profit for the
current quarter was $580.1 million compared to
$505.0 million in the comparable prior year period, an
increase of $75.1 million, or 14.9%. For the current
quarter, earnings from operations of $234.3 million were
realized compared to $61.3 million for the three months
ended September 30, 2009.
The net earnings attributable to Mylan Inc. before preferred
dividends for the three months ended September 30, 2010
were $143.2 million and earnings per diluted share were
$0.33. In the same prior year period, the net loss attributable
to Mylan Inc. common shareholders was $40.0 million, which
translates into a loss per diluted share of $0.13. A more
detailed discussion of the companys financial statements
can be found below in the section titled Results of
Operations.
Included in the results for the three months ended
September 30, 2010 and 2009 are the following items of note:
Three months ended September 30, 2010:
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Amortization, primarily related to purchased intangible assets
associated with acquisitions, of $74.6 million;
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Interest of $17.6 million, primarily related to the
accretion of the discounts on our convertible debt instruments,
net of amortization of the premium on our 2020 Senior Notes;
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Net unfavorable litigation settlement charges of
$1.5 million;
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33
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Costs related to the acquisition of Bioniche Pharma of
$10.9 million;
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A loss on the sale of certain non-operating assets of
$4.9 million;
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Additional costs, primarily restructuring, totaling
$16.0 million; and
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A tax effect of $79.7 million related to the above items
and other income tax-related items.
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Three months ended September 2009:
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Amortization, primarily related to purchased intangible assets
associated with acquisitions, of $71.8 million;
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Interest of $10.8 million relating to the accretion of the
discounts on our convertible debt instruments;
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Net unfavorable litigation settlement charges of
$114.3 million (pre-tax), primarily related to the
settlement of an investigation by the U.S. Department of
Justice, concerning calculations of Medicaid drug rebates;
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Additional costs, primarily restructuring, related to the
integration of acquired entities, and other costs, totaling
$15.8 million; and
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A tax effect of $65.3 million related to the above items
and other income tax-related items.
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Mylans financial results for the nine months ended
September 30, 2010 include total revenues of
$4.02 billion compared to $3.74 billion for the nine
months ended September 30, 2009, representing an increase
of $275.1 million, or 7.4%. Consolidated gross profit for
the nine months ended September 30, 2010 was
$1.64 billion compared to $1.56 billion in the same
prior year period. For the nine months ended September 30,
2010, earnings from operations of $627.4 million were
realized compared to $463.3 million for the same prior year
period.
The net earnings attributable to Mylan Inc. common shareholders
for the nine months ended September 30, 2010 were
$221.0 million, which translates into earnings per diluted
share of $0.71. In the same prior year period, net earnings
attributable to Mylan Inc. common shareholders were
$89.4 million, which translates into earnings per diluted
share of $0.29. A more detailed discussion of the Companys
financial statements can be found below in the section titled
Results of Operations.
Included in the results for the nine months ended
September 30, 2010 and 2009 are the following items of note:
Nine months ended September 30, 2010:
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Amortization, primarily related to purchased intangible assets
associated with acquisitions, of $217.6 million;
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Interest of $42.0 million, primarily related to the
accretion of discounts on our convertible debt instruments, net
of amortization of the premium on our 2020 Senior Notes;
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Net unfavorable litigation charges of $14.3 million;
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Charges, related to the refinancing, of $15.0 million,
primarily swap termination fees and the write-off of deferred
financing costs included in other (expense) income, net;
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Costs related to the acquisition of Bioniche Pharma of
$12.5 million;
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A loss on the sale of certain non-operating assets of
$4.9 million;
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Additional costs, primarily restructuring, totaling
$44.9 million; and
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A tax effect of $165.9 million related to the above items
and other income tax-related items.
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Nine months ended September 30, 2009:
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Amortization, primarily related to purchased intangible assets
associated with acquisitions, of $210.9 million;
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Other revenues of approximately $28.5 million resulting
from the cancellation of product development agreements for
which the revenue had been previously deferred;
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34
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Interest of $31.7 million relating to the accretion of the
discounts on our convertible debt instruments;
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Net unfavorable litigation settlement charges of
$111.5 million (pre-tax), primarily related to the
settlement of an investigation by the U.S. Department of
Justice, concerning calculations of Medicaid drug rebates;
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A charge of $18.0 million related to an up-front payment
made with respect to the Companys execution of a
co-development agreement;
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A net gain of approximately $10.4 million on the
termination of two joint ventures;
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Additional costs, primarily restructuring, related to the
integration of acquired entities, and other costs, totaling
$51.0 million; and
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A tax effect of $137.7 million related to the above items
and other income tax-related items.
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Results
of Operations
Three
Months Ended September 30, 2010, Compared to Three Months
Ended September 30, 2009
Total
Revenues and Gross Profit
For the current quarter, Mylan reported total revenues of
$1.36 billion compared to $1.26 billion in the
comparable prior year period. Total revenues include both net
revenues and other revenues from third parties. Third party net
revenues for the current quarter were $1.34 billion
compared to $1.26 billion for the same prior year period,
representing an increase of $89.3 million, or 7.1%. Other
third party revenues for the current quarter were
$10.1 million compared to $8.4 million in the same
prior year period, an increase of $1.7 million.
Total revenues were negatively impacted by the effect of foreign
currency translation, primarily reflecting a stronger
U.S. dollar in comparison to the functional currencies of
Mylans Euro-denominated subsidiaries, partially offset by
the strengthening against the U.S. dollar of the currencies
of Mylans subsidiaries in Australia, Japan and India.
Translating current year revenues at prior year exchange rates
would have resulted in
year-over-year
growth in total revenues excluding foreign currency of
approximately $109 million, or approximately 9%.
Gross profit for the three months ended September 30, 2010
was $580.1 million and gross margins were 42.8%. For the
three months ended September 30, 2009, gross profit was
$505.0 million, and gross margins were 39.9%. Gross profit
for the current quarter is impacted by certain purchase
accounting related items recorded during the three months ended
September 30, 2010, of approximately $74.6 million,
which consisted primarily of amortization related to purchased
intangible assets associated with acquisitions. Excluding such
items, gross margins would have been approximately 48.3%. Prior
year gross profit is also impacted by similar purchase
accounting related items in the amount of $71.8 million.
Excluding such items, gross margins in the prior year would have
been approximately 45.6%.
The increase in gross margins, excluding the items noted above,
can primarily be attributed to both Generics, mainly the North
America region, and Specialty. In North America, favorable gross
margins were primarily the result of new product introductions,
while Specialty benefitted from favorable pricing, mainly on the
EpiPen®
Auto-injector.
Generics
Segment
For the current quarter, Generics third party net revenues were
$1.20 billion compared to $1.11 billion in the
comparable prior year period, an increase of $96.1 million,
or 8.7%. Translating Generics third party net revenues for the
current quarter at prior year comparative period exchange rates
would have resulted in
year-over-year
growth of approximately $114 million, or 10%. Generics
sales are derived primarily in or from the U.S. and Canada
(collectively North America), Europe, Middle East
and Africa (collectively, EMEA) and India,
Australia, Japan, and New Zealand (collectively, Asia
Pacific).
Third party net revenues from North America were
$572.5 million for the current quarter, compared to
$487.9 million for the comparable prior year period,
representing an increase of $84.6 million, or 17.3%. The
effect of foreign currency is insignificant within North
America. New products launched in the U.S. and Canada
35
contributed sales of $106.5 million, which drove the growth
in revenue year over year. Partially offsetting the impact of
new products was unfavorable pricing on certain other existing
products, including divalproex sodium
extended-release
(divalproex ER) tablets, the generic version of
Abbott Laboratories
Depakote®
ER. Additional generic competition on divalproex ER entered the
market in August 2009. As such, sales of divalproex ER in the
current quarter were significantly lower than the comparable
prior year quarter.
Sales volumes for Fentanyl, our AB-rated generic alternative to
Duragesic®,
have remained relatively constant primarily due to Mylans
ability to continue to be a stable and reliable source of supply
to the market, and as a result fentanyl continues to contribute
to both net revenues and gross profit. 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. Competition on fentanyl in the
future could have an unfavorable impact on pricing and market
share.
During the current quarter, Mylan launched minocycline
hydrochloride extended release (minocycline ER)
tablets, the generic version of Medicis Pharmaceuticals
Corporations
Solodyn®
ER. After receiving final approval from the U.S. Food and
Drug Administration on July 20, 2010, Mylan commenced
immediate shipment of the product. Mylan also reached settlement
and license agreements with Medicis Pharmaceuticals Corporation
(Medicis) resolving patent litigation relating to
minocycline ER, and the Company has ceased additional
distribution. Pursuant to the terms of the agreements, Medicis
will release Mylan from any liability related to the prior sales
of the product, and Mylan will have the right to market
minocycline ER in the U.S. beginning in November 2011, or
earlier under certain circumstances.
As a result of significant uncertainties surrounding the pricing
and market conditions with respect to this product, the Company
is not able to reasonably estimate the amount of potential price
adjustments, including product returns. Therefore, revenues on
shipments of this product are currently being deferred until the
resolution of such uncertainties. At the present time, such
uncertainties are resolved upon our customers sale of this
product. As a result, the Company is recognizing revenue only
upon our customers sale of this product.
Third party net revenues from EMEA were $363.5 million for
the three-month period ended September 30, 2010, compared
to $413.8 million for the comparable prior year period, a
decrease of $50.3 million, or 12.2%. However, translating
current quarter third party net revenues from EMEA at prior year
exchange rates would have reduced the
year-over-year
decrease in third party net revenues excluding the effect of
foreign currency to approximately $14 million, or 3%. This
decrease was mainly the result of unfavorable pricing in many of
the European markets in which Mylan operates, partially offset
by new product launches in several markets totaling
approximately $25.3 million.
Certain markets in which we do business have recently undergone
government-imposed price reductions. Such measures, along with
the tender systems discussed below, are likely to have a
negative impact on sales and gross profit in these markets.
However, some pro-generic government initiatives in certain
markets could help to offset some of this unfavorability by
potentially increasing generic substitution.
In the current quarter, the most significant impact of
government-imposed price reductions was felt by our subsidiaries
in Portugal and Spain. Spain, however, realized year over year
growth in net revenues mainly as a result of new product
launches which more than offset the impact of the pricing reform.
New product launches were also the driving force behind year
over year local currency growth by Mylans largest European
subsidiary in France. In addition to new products, France
realized increased volumes on existing products. Partially
offsetting these drivers were pricing pressures resulting from
increased competition in the French market.
In Italy, excluding the effect of foreign currency, third party
sales increased as a result of successful new product launches
and increased market penetration, which resulted in increased
volume. In addition, our Italian subsidiary benefitted from
certain regulatory changes which resulted in an overall positive
pricing effect. In June 2010, additional regulatory changes
were introduced which decreased prices on certain products, and
which may offset these positive pricing impacts in future
periods.
36
A number of markets in which we operate have implemented or may
implement tender systems for generic pharmaceuticals in an
effort to lower prices. Generally speaking, tender systems can
have an unfavorable impact on revenue and profitability. Under
such tender systems, manufacturers submit bids which establish
prices for generic pharmaceutical products. Upon winning the
tender, the winning company will receive a preferential
reimbursement for a period of time. The tender system often
results in companies underbidding one another by proposing low
pricing in order to win the tender. While certain of our
subsidiaries, in particular, the Netherlands, have benefited
from recent tenders, sales in Germany continue to be negatively
affected by the implementation of tender systems in that country.
In Asia Pacific, third party net revenues were
$267.9 million for the three-month period ended
September 30, 2010, compared to $206.1 million for the
comparable prior year period, an increase of $61.8 million,
or 30.0%. Excluding the effect of foreign currency, calculated
as described above, the increase was approximately
$44 million, or 22%. This increase is primarily driven by
higher third party sales by our Matrix subsidiary in India, with
growth in third party sales in Australia and Japan also
contributing.
At our Matrix subsidiary, the increase in third party net
revenues is due to double-digit growth, excluding the effect of
foreign currency, in sales of both anti-retroviral
(ARV) finished dosage form (FDF) generic
products, which are used in the treatment of HIV/AIDS, and API.
In addition to third party sales, the Asia Pacific region also
supplies both FDF generic products and API to Mylan subsidiaries
in conjunction with Mylans vertical integration strategy.
Intercompany revenues recognized by the Asia Pacific region were
$46.6 million for the three months ended September 30,
2010, compared to $21.3 million in the comparable prior
year period. These intercompany sales eliminate within, and
therefore are not included in, Generics or consolidated net
revenues.
As in EMEA, both Japan and Australia have undergone
government-imposed price reductions which have had, and could
continue to have, a negative impact on sales and gross profit in
these markets. In the current quarter, these price reductions
offset the positive contribution from new products, mainly those
launched in Japan.
Specialty
Segment
For the current quarter, Specialty reported third party net
revenues of $141.1 million, a decrease of
$6.8 million, or 4.6%, from the comparable prior year
period of $147.9 million. Intercompany sales by Specialty
totaled $13.7 million in the current quarter compared to
$3.8 million in the same prior year period. The increase is
due to the fact that certain generic products previously sold to
third parties by Specialty are now sold to Mylan subsidiaries in
North America who, in turn, sell the products to third parties.
Excluding the sale of such products from 2009 third party net
revenues would have resulted in an increase in third party net
revenues in the current quarter of $7.8 million or 5.9%.
The most significant contributor to Specialty Segment revenues
continues to be the EpiPen Auto-injector, which is used in the
treatment of severe allergic reactions. Globally, the EpiPen
Auto-injector is the number one epinephrine auto-injector for
the treatment of severe allergic reactions with world-wide
market share of approximately 91%. In the U.S., the EpiPen
Auto-injector is the number one prescribed treatment for severe
allergic reactions with market share of approximately 96%.
Specialty realized increased sales of the EpiPen Auto-injector,
mainly as a result of favorable pricing.
Operating
Expenses
Research and development (R&D) expense for the
three months ended September 30, 2010 was
$72.0 million, compared to $69.8 million in the same
prior year period, an increase of $2.2 million. The
increase is due primarily to costs associated with higher
volumes of internal and external product development.
Selling, general and administrative (SG&A)
expense for the current quarter was $272.3 million,
compared to $259.6 million for the same prior year period,
an increase of $12.7 million, which includes a favorable
impact from foreign currency of approximately $5 million.
Excluding the impact of foreign currency, SG&A increased
approximately $18 million compared to the same prior year
period. This increase is primarily the result of professional
fees, including those incurred in connection with the Bioniche
Pharma acquisition, as well as increased payroll and payroll
related costs.
37
Litigation
Settlements, net
During the three months ended September 30, 2010, we
recorded net unfavorable litigation charges of
$1.5 million, compared to $114.3 million during the
prior year quarter. The prior year amount is made up primarily
of a charge for $121.0 million, pre-tax (approximately
$83.0 million, after-tax), related to the settlement of an
investigation by the U.S. Department of Justice concerning
calculations of Medicaid drug rebates.
Interest
Expense
Interest expense for the three months ended September 2010,
totaled $87.5 million, compared to $77.0 million for
the three months ended September 30, 2009. The increase is
primarily due to interest associated with the 2017 and 2020
Senior Notes debt offerings in May 2010 and July 2010, partially
offset by lower overall debt balances on the Companys
Senior Credit Facility. Included in interest expense for the
current quarter and the comparable prior year period are
$17.6 million and $10.8 million, primarily related to
the accretion of the discounts on our convertible debt
instruments, net of accretion of the premium on our 2020 Senior
Notes.
Other
(Expense) Income, net
Other (expense) income, net, was expense of $15.3 million
in the current quarter compared to income of $0.2 million
in the comparable prior year period. Generally included in other
(expense) income are interest and dividend income and foreign
exchange gains and losses. Additionally, included in the current
quarter is a $4.9 million loss on the sale of certain
non-operating assets and certain non-income-based taxes related
to our acquisition of Bioniche Pharma.
Income
Tax Expense
We recorded an income tax benefit of $12.0 million in the
current quarter compared to a benefit of $11.1 million in
the prior year quarter. In the current quarter, the Company
realized a tax benefit on positive earnings as a result of the
release of several tax reserves, due to favorable tax rulings
received from certain taxing authorities, as well as the
expiration of certain statutes of limitations during the
three-month period.
Nine
Months Ended September 30, 2010, Compared to Nine Months
Ended September 30, 2009
Total
Revenues and Gross Profit
For the current nine-month period, Mylan reported total revenues
of $4.02 billion compared to $3.74 billion in the
comparable prior year period. Total revenues include both net
revenues and other revenues from third parties. Third party net
revenues for the current nine months were $3.98 billion
compared to $3.68 billion for the same prior year period,
representing an increase of $299.8 million, or 8.1%.
Other revenues from third parties for the nine months ended
September 30, 2010, were $36.4 million compared to
$61.1 million in the same prior year period, a decrease of
$24.7 million, or 40.5%. During the nine months ended
September 30, 2009, within Generics, we recognized
$28.5 million of incremental revenue resulting from the
cancellation of product development agreements for which the
revenue had been previously deferred. There was no such revenue
recognized during the current year period.
Total revenues were positively impacted by the effect of foreign
currency translation, primarily reflecting a weaker
U.S. dollar in comparison to the functional currencies of
Mylans subsidiaries in Australia, Japan and India,
partially offset by the impact of a stronger U.S. dollar in
comparison to the functional currencies of certain of our
subsidiaries in Europe. Translating current year third party
total revenues at prior year exchange rates would have resulted
in
year-over-year
growth excluding foreign currency of approximately
$229 million, or 6%.
Gross profit for the nine months ended September 30, 2010
was $1.64 billion and gross margins were 40.8%. For the
nine months ended September 30, 2009, gross profit was
$1.56 billion, and gross margins were 41.7%. Gross profit
for the current year to date period is impacted by certain
purchase accounting related items recorded during the nine
months ended September 30, 2010, of approximately
$217.6 million, which consisted primarily of amortization
related to purchased intangible assets associated with
acquisitions. Excluding such items, gross
38
margins would have been approximately 46.2%. Prior year gross
profit is also impacted by similar purchase accounting related
items in the amount of $210.9 million. Excluding such
items, gross margins in the prior year would have been
approximately 47.3%.
The decrease in gross margins, excluding the items noted above,
can generally be attributed to pricing pressure across the EMEA
region of Generics and the impact of the timing of significant
product launches in the North America region, partially offset
by favorable pricing on Specialtys EpiPen Auto-injector.
During the first quarter of 2009, Mylan launched divalproex ER.
Products generally contribute most significantly to gross margin
at the time of their launch and even more so in periods of
market exclusivity, as was the case with divalproex ER until
August 2009, or in periods of limited generic competition.
Generics
Segment
For the nine months ended September 30, 2010, Generics
reported third party net revenues of $3.63 billion,
compared to $3.33 billion in the comparable prior year
period, an increase of $300.9 million, or 9.0%. Excluding
the effect of foreign currency, calculated as described above,
the increase was approximately $255.0 million, or 7.7%.
Third party net revenues from North America were
$1.71 billion for the nine-month period, compared to
$1.56 billion for the comparable prior year period,
representing an increase of $150.9 million, or 9.7%.
Excluding the effect of foreign currency, calculated as
described above, the increase was approximately
$139 million, or 9%. This increase was driven by sales
contributed from new products in the U.S. and Canada
totaling approximately $255.0 million, and, to a lesser
extent, increased revenues on certain products as a result of
Mylans ability to remain a source of stable supply as
certain competitors experienced regulatory and supply issues.
Partially offsetting these increases were decreases in certain
other existing products, mainly divalproex ER. Additional
generic competition on divalproex ER entered the market upon
expiration of Mylans market exclusivity in August 2009. As
such, sales of divalproex ER in the current year were
significantly lower than in the prior year.
Third party net revenues from EMEA were $1.15 billion for
the nine-month period ended September 30, 2010, compared to
$1.16 billion for the comparable prior year period, a
decrease of $11.3 million, or 1.0%. Translating current
year third party net revenues from EMEA at prior year exchange
rates would have resulted in
year-over-year
increase in third party net revenues excluding the effect of
foreign currency of approximately $25 million, or 2%.
The most significant revenue growth was realized in Italy, as a
result of higher volumes driven by increased market penetration,
and certain regulatory changes which had a positive impact on
pricing. In June 2010, new regulatory changes were introduced
which decreased prices on certain products, and which may offset
the positive pricing impacts in future periods. Italys
strong third party net revenues for the nine months ended
September 30, 2010, were also bolstered by sales of new
products.
New products were also primarily responsible for a year over
year increase in third party net revenues realized in France.
This increase was partially offset by unfavorable pricing as a
result of increased competition in the French market.
Unfavorable pricing, as a result of government-imposed price
reductions, had a significant impact in the current year in
certain markets in which Mylan operates, most notably in
Portugal and Spain. Spain, however, realized year over year
growth in net revenues mainly as a result of new product
launches which more than offset the impact of the pricing
reform. In total for EMEA, new products contributed net revenues
of approximately $86.4 million during the nine months ended
September 30, 2010.
Sales in Germany continue to be negatively affected by the
implementation of tender systems in that country. Current year
to date revenues were negatively impacted by the price
reductions as a result of these tenders, and by the loss of
sales related to tenders which Mylan did not win. Conversely,
sales in the Netherlands were favorably impacted as a result of
tenders won by Mylan.
In Asia Pacific, third party net revenues were
$769.1 million for the nine-month period ended
September 30, 2010, compared to $607.9 million for the
comparable prior year period, an increase of
$161.2 million, or 26.5%. Excluding the effect of foreign
currency, calculated as described above, the increase was
approximately $91 million, or 15%. This increase is
primarily driven by higher third party sales from our operations
in India and Japan.
39
At our Matrix subsidiary, the increase in third party net
revenues is due to double-digit growth, excluding the effect of
foreign currency, in sales of both ARV FDF generic products and
API. In addition to third party sales, the Asia Pacific region
also supplies both FDF generic products and API to Mylan
subsidiaries in conjunction with Mylans vertical
integration strategy. Intercompany revenues recognized by the
Asia Pacific region were $110.6 million for the nine months
ended September 30, 2010, compared to $41.6 million in
the comparable prior year period. These intercompany sales
eliminate within, and therefore are not included in, Generics or
consolidated net revenues.
In Japan, third party net revenues were favorably impacted by
new product launches, as well as a full nine months of revenues
from products launched mid-way through 2009. Partially
offsetting this new product revenue were unfavorable price
variances as a result of government-imposed price reductions.
Third party net revenues in Australia were flat as compared to
the prior year to date period as a result of unfavorable pricing
due to both government-imposed price reductions and increased
competition. Partially offsetting the unfavorable pricing were
favorable volume on existing products and revenue from the
launch of new products.
Specialty
Segment
For the nine months ended September 30, 2010, Specialty
reported third party net revenues of $347.8 million, a
decrease of $1.1 million, or 0.3% over the comparable prior
year period of $348.9 million. Intercompany sales of
product by Specialty totaled $47.4 million in the current
nine-month period compared to $15.2 million in the same
prior year period. As in the quarter, the increase is due to the
fact that certain generic products previously sold to third
parties by Specialty are now sold to Mylan subsidiaries in North
America who, in turn, sell the products to third parties.
Excluding the sale of such products from 2009 third party net
revenues would have resulted in an increase in third party net
revenues in the current year of $44.7 million or 14.8%.
The most significant contributor to Specialty revenues continues
to be the EpiPen Auto-injector, which is used in the treatment
of severe allergic reactions. Globally, the EpiPen Auto-injector
is the number one epinephrine auto-injector for the treatment of
severe allergic reactions with world-wide market share of
approximately 91%. In the U.S., the EpiPen Auto-injector is the
number one prescribed treatment for severe allergic reactions
with market share of approximately 96%.
In addition to the continued strong sales of the EpiPen
Auto-injector, the increase in third-party sales included
increased sales of
Perforomist®
Solution, Deys maintenance therapy for patients with
moderate to severe chronic obstructive pulmonary disease.
Operating
Expenses
R&D expense for the nine months ended September 30,
2010 was $200.1 million, compared to $202.7 million in
the same prior year period, a decrease of $2.6 million,
which includes an unfavorable impact from foreign currency of
approximately $3 million. Excluding the impact of foreign
currency, R&D decreased approximately $5 million
compared to the same prior year period. Included in R&D for
the nine months ended September 30, 2009, was an up-front
payment of $18 million related to our execution of a
co-development agreement. Excluding this payment, R&D is
higher in the current year mainly as a result of costs
associated with higher volumes of internal and external product
development.
SG&A expense for the nine months ended September 30,
2010 was $796.4 million, compared to $781.0 million
for the same prior year period, an increase of
$15.5 million, which includes an unfavorable impact from
foreign currency of approximately $9 million. Excluding the
impact of foreign currency, SG&A increased approximately
$7 million compared to the same prior year period. This
increase is not considered to be significant.
Litigation
Settlements, net
During the nine months ended September 30, 2010, we
recorded net unfavorable litigation charges of
$14.3 million related to the potential settlement of
certain ongoing matters. During the nine months ended
September 30, 2009, we recorded net unfavorable litigation
charges of $111.5 million. The prior year amount
40
consists primarily of a charge for $121.0 million, pre-tax
(approximately $83.0 million, after-tax), related to the
settlement of an investigation by the U.S. Department of
Justice concerning calculations of Medicaid drug rebates.
Interest
Expense
Interest expense for the nine months ended September 30,
2010, totaled $240.0 million, compared to
$240.2 million for the nine months ended September 30,
2009. Incremental interest in the current year associated with
the 2017 and 2020 Senior Notes offerings in May 2010 and July
2010, was offset by less interest on our Senior Credit Facility
as a result of prepayments made in March 2009 and December 2009.
Included in interest expense for the current nine months and the
comparable prior year period are $42.0 million and
$31.7 million, primarily related to the accretion of the
discounts on our convertible debt instruments, net of accretion
of the premium on our 2020 Senior Notes.
Other
(Expense) Income, net
Other (expense) income, net was expense of $29.4 million in
the current nine-month period compared to income of
$29.7 million in the comparable prior year period.
Generally included in other (expense) income are interest and
dividend income and foreign exchange gains and losses.
Additionally, included in the current year is a
$4.9 million loss on the sale of certain non-operating
assets, charges associated with the termination of certain
interest rate swaps totaling $7.4 million, the write-off of
previously deferred financing fees of $7.6 million, in
conjunction with the debt offering during the current period,
and certain non-income-based taxes related to our acquisition of
Bioniche Pharma. The prior year period includes a favorable
adjustment of $13.9 million to the restructuring reserve as
a result of a reduction in the estimated remaining spending on
accrued projects, as well as a net gain of $10.4 million
realized on the termination of two joint ventures.
Income
Tax Expense
We recorded income tax expense of $33.2 million in the nine
months ended September 30, 2010 compared to
$52.5 million in the comparable prior year period. The
decrease in tax expense is driven by a decrease in the effective
tax rate. The effective rate for the current year period was
9.3%, versus 20.8% in the comparable prior year period. The
decrease in the effective rate was mainly due to the release of
certain tax reserves due to favorable tax rulings from taxing
authorities and expirations of statutes of limitations.
Liquidity
and Capital Resources
Our primary source of liquidity is cash provided by operations,
which was $736.9 million for the nine months ended
September 30, 2010. We believe that cash provided by
operating activities will continue to allow us to meet our needs
for working capital, capital expenditures, interest and
principal payments on debt obligations and other cash needs over
the next several years. Nevertheless, our ability to satisfy our
working capital requirements and debt service obligations, or
fund planned capital expenditures, will substantially depend
upon our future operating performance (which will be affected by
prevailing economic conditions), and financial, business and
other factors, some of which are beyond our control. During the
nine months ended September 30, 2010, changes in operating
assets and liabilities resulted in a net cash inflow of
$31.7 million, primarily due to the receipt of
approximately $98.8 million, representing a tax refund
received in the first quarter, and cash collections on accounts
receivable, partially offset by an increase in our inventory
balances.
Cash used in investing activities for the nine months ended
September 30, 2010 was $620.7 million, consisting
primarily of cash paid for acquisitions and capital
expenditures. On September 7, 2010, we acquired Bioniche
Pharma, a privately held, global injectable pharmaceutical
company, for $543.7 million. We believe Bioniche Pharma
will provide Mylan not only an immediate entry into the North
American injectables market but also a platform for future
growth opportunities. In addition, cash of approximately
$10.0 million was paid as part of the purchase
consideration for an FDF manufacturing facility in India.
Capital expenditures were $96.3 million, and were made
primarily for equipment, including a portion related to our
previously announced planned expansions and integration plans.
Capital expenditures for the year 2010 are expected to be
approximately $200.0 to $250.0 million.
41
Cash provided by financing activities was $128.3 million
for the nine months ended September 30, 2010. During the
nine months ended September 30, 2010, we completed a
private placement of $550.0 million aggregate principal
amount of 7.625% Senior Notes due 2017 and
$700.0 million aggregate principal amount of
7.875% Senior Notes due 2020. Through a reopening of the
2020 Senior Notes during the quarter ended September 30,
2010, the Company privately placed $300.0 million aggregate
principal amount of senior notes, which were issued at a price
of 105.5%, giving an effective yield to maturity of 7.087%. We
used approximately $1.30 billion of the net proceeds from
the private placement to repay a portion of our outstanding term
loans. Additionally, we paid cash dividends of
$104.3 million on our 6.5% mandatory convertible preferred
stock.
As of September 30, 2010, because the closing price of our
common stock for at least 20 trading days in the period of 30
consecutive trading days ending on the last trading day in the
September 30, 2010 period was more than 130% of the
applicable conversion reference price of $13.32 at
September 30, 2010, the $575.0 million of Cash
Convertible Notes were currently convertible. Although the
Companys experience is that convertible debentures are not
normally converted by investors until close to their maturity
date, it is possible that debentures could be converted prior to
their maturity date if, for example, a holder perceives the
market for the debentures to be weaker than the market for the
common stock. Upon an investors election to convert, the
Company is required to pay the full conversion value in cash.
The amount payable per $1,000 notional bond would be calculated
as the product of (1) the conversion reference rate and
(2) the average Daily Volume Weighted Average Price per
share of common stock for a specified period following the
conversion date. Any payment above the principal amount is
matched by a convertible note hedge.
We are involved in various legal proceedings that are considered
normal to our business. While it is not possible to predict the
outcome of such proceedings, an adverse outcome in any of these
proceedings could materially affect our financial position and
results of operations. Additionally, for certain contingencies
assumed in conjunction with the acquisition of the former Merck
Generics business, Merck KGaA, the seller, has indemnified
Mylan. The inability or denial of Merck KGaA to pay on an
indemnified claim could have a material adverse effect on our
financial position, results of operations or cash flows.
Our Condensed Consolidated Balance Sheet as of
September 30, 2010 includes restructuring reserves of
$16.6 million. Spending against this balance, which
consists primarily of severance and related costs and costs
associated with the previously announced rationalization and
optimization of our global manufacturing and research and
development platforms, is expected to occur during 2010 and 2011.
On October 19, 2010, the Company announced that the last
quarterly dividend of $16.25 per share had been declared, based
on the annual dividend rate of 6.5% and a liquidation preference
of $1,000 per share, payable on November 15, 2010, to the
holders of preferred stock of record as of November 1,
2010. All outstanding shares of preferred stock will also
automatically convert to common stock on November 15, 2010.
We are actively pursuing, and are currently involved in, joint
projects related to the development, distribution and marketing
of both generic and branded products. Many of these arrangements
provide for payments by us 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.
We are continuously evaluating the potential acquisition of
products, as well as companies, as a strategic part of our
future growth. Consequently, we may utilize current cash
reserves or incur additional indebtedness to finance any such
acquisitions, which could impact future liquidity. In addition,
on an ongoing basis, we review our operations including the
evaluation of potential divestitures of products and businesses
as part of our future strategy. Any divestitures could impact
future liquidity.
At September 30, 2010 and December 31, 2009, we had
$85.2 million and $77.5 million, respectively,
outstanding under existing letters of credit. Additionally, as
of September 30, 2010, we had $44.6 million available
under the $100.0 million subfacility on our Senior Credit
Agreement for the issuance of letters of credit.
42
Mandatory minimum repayments remaining on the outstanding
borrowings under the term loans and notes at September 30,
2010, excluding the discounts, premium and conversion features,
are as follows for each of the periods ending December 31:
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|
Tranche B
|
|
|
Tranche B
|
|
|
Convertible
|
|
|
Convertible
|
|
|
Senior
|
|
|
Senior
|
|
|
|
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Notes
|
|
|
Notes
|
|
|
Notes
|
|
|
Notes
|
|
|
Total
|
|
|
|
(In thousands)
|
|
2010
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2012
|
|
|
119,640
|
|
|
|
|
|
|
|
7,170
|
|
|
|
600,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
726,810
|
|
2013
|
|
|
119,641
|
|
|
|
|
|
|
|
7,170
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
126,811
|
|
2014
|
|
|
|
|
|
|
1,310,010
|
|
|
|
673,973
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,983,983
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
575,000
|
|
|
|
|
|
|
|
|
|
|
|
575,000
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
550,000
|
|
|
|
1,000,000
|
|
|
|
1,550,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
239,281
|
|
|
$
|
1,310,010
|
|
|
$
|
688,313
|
|
|
$
|
600,000
|
|
|
$
|
575,000
|
|
|
$
|
550,000
|
|
|
$
|
1,000,000
|
|
|
$
|
4,962,604
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 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. We have been compliant with the financial
covenants during the nine months ended September 30, 2010.
Recent
Accounting Pronouncements
In October 2009, the FASB issued revised accounting guidance for
multiple-deliverable revenue arrangements. The amended guidance
requires that consideration received be allocated at the
inception of the arrangement to all deliverables using the
relative selling price method and provides for expanded
disclosures related to such arrangements. It is effective for
revenue arrangements entered into or materially modified in
fiscal years beginning on or after June 15, 2010. Mylan is
currently evaluating the impact of adoption on its consolidated
financial statements.
In April 2010, the FASB issued revised accounting guidance for
the milestone method of revenue recognition. The amended
guidance is effective for fiscal years beginning on or after
June 15, 2010. It provides guidance on defining a milestone
and determining when it may be appropriate to apply the
milestone method of revenue recognition for research and
development transactions. Mylan is currently evaluating the
impact of adoption on its consolidated financial statements.
|
|
ITEM 3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
For a discussion of the Companys market risk, see
Item 7A. Quantitative and Qualitative Disclosures
about Market Risk in the Companys Annual Report
filed on
Form 10-K.
|
|
ITEM 4.
|
CONTROLS
AND PROCEDURES
|
An evaluation was performed under the supervision and with the
participation of the Companys management, including the
Principal Executive Officer and the Principal Financial Officer,
of the effectiveness of the design and operation of the
Companys disclosure controls and procedures as of
September 30, 2010. Based upon that evaluation, the
Principal Executive Officer and the Principal Financial Officer
concluded that the Companys disclosure controls and
procedures were effective.
During the quarter ended September 30, 2010, the Company
completed its acquisition of Bioniche Pharma. Bioniche Pharma
will be excluded for the purposes of managements
evaluation of the Companys internal control over financial
reporting as of December 31, 2010.
Management has not identified any other changes in the
Companys internal control over financial reporting that
occurred during the quarter that have materially affected, or
are reasonably likely to materially affect, the Companys
internal control over financial reporting.
43
|
|
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. The Company is also
party to certain litigation matters, some of which are described
below, for which Merck KGaA has agreed to indemnify the Company,
under the terms by which Mylan acquired the former Merck
Generics business. An adverse outcome in any of these
proceedings, or the inability or denial of Merck KGaA to pay an
indemnified claim, could have a material adverse effect on the
Companys financial position, results of operations and
cash flows.
Lorazepam
and Clorazepate
On June 1, 2005, a jury verdict was rendered against Mylan,
Mylan Pharmaceuticals Inc. (MPI), and co-defendants
Cambrex Corporation and Gyma Laboratories in the
U.S. District Court for the District of Columbia in the
amount of approximately $12.0 million, which has been
accrued for by the Company. The jury found that Mylan and its
co-defendants willfully violated Massachusetts, Minnesota and
Illinois state antitrust laws in connection with API supply
agreements entered into between the Company and its API supplier
(Cambrex) and broker (Gyma) 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 antitrust
claims relating to Mylans 1998 price increases for
lorazepam and clorazepate. Following the verdict, 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 and the remaining motions were
denied on January 24, 2008. In post-trial filings, the
plaintiffs requested that the verdict be trebled and that
request was granted on January 24, 2008. On
February 6, 2008, a judgment was issued against Mylan and
its co-defendants in the total amount of approximately
$69.0 million, which, in the case of three of the
plaintiffs, reflects trebling of the compensatory damages in the
original verdict (approximately $11 million in total) and,
in the case of the fourth plaintiff, reflects their amount of
the compensatory damages in the original jury verdict plus
doubling this compensatory damage award as punitive damages
assessed against each of the defendants (approximately
$58 million in total), some or all of which may be subject
to indemnification obligations by Mylan. Plaintiffs are also
seeking an award of attorneys fees and litigation costs in
unspecified amounts and prejudgment interest of approximately
$8.0 million. The Company and its co-defendants have
appealed to the U.S. Court of Appeals for the D.C. Circuit
and have challenged the verdict as legally erroneous on multiple
grounds. The appeals were held in abeyance pending a ruling on
the motion for prejudgment interest, which has been granted.
Mylan intends to contest this ruling along with the liability
finding and other damages awards as part of its pending appeal,
which is proceeding in the Court of Appeals for the D.C.
Circuit, with oral argument having been held on October 8,
2010. In connection with the Companys appeal of the
lorazepam judgment, the Company submitted a surety bond
underwritten by a third-party insurance company in the amount of
$74.5 million. This surety bond is secured by a pledge of a
$15.0 million cash deposit (which is included as restricted
cash on the Companys Condensed Consolidated Balance
Sheets) and an irrevocable letter of credit for
$34.5 million issued under the Senior Credit Agreement.
Pricing
and Medicaid Litigation
Beginning in September 2003, Mylan, MPI
and/or UDL
Laboratories Inc. (UDL), together with many other
pharmaceutical companies, have been named in civil lawsuits
filed by state attorneys general (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
and/or
Wholesale Acquisition Costs that exceeded the actual
selling price of the defendants prescription drugs,
causing state programs to overpay pharmacies and other
providers. 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, Kansas, Kentucky,
Massachusetts, Mississippi, Missouri, Oklahoma, South Carolina,
Texas, Utah and Wisconsin and also by the city
44
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 money damages, civil penalties
and/or
double, treble or punitive damages, counsel fees and costs,
equitable relief
and/or
injunctive relief. Certain of these cases may go to trial in
2010. Mylan and its subsidiaries have denied liability and
intend to defend each of these actions vigorously. On
January 27, 2010, in the New York Counties cases, the
U.S. District Court for the District of Massachusetts
granted the plaintiffs motion for partial summary judgment
as to liability under New York Social Services Law
§ 145-b against Mylan and several other defendants.
The District Court has not ruled on the remaining issues of
liability and damages. On February 8, 2010, Mylan, and a
majority of the other defendants, filed a motion to amend the
courts decision, requesting the court to certify a
question of New York state law pertaining to the courts
finding of requisite causation under the Social Services Law to
the First Circuit Court of Appeals, so that the defendants could
in turn request that the First Circuit Court of Appeals certify
the question to the New York Court of Appeals. The District
Court denied this motion on May 4, 2010.
In May 2008, an amended complaint was filed in the
U.S. District Court for the District of Massachusetts by a
private plaintiff on behalf of the United States of America,
against Mylan, MPI, UDL and several other generic manufacturers.
The original complaint was filed under seal in April 2000, and
Mylan, MPI and UDL were added as parties in February 2001. The
claims against Mylan, MPI, UDL and the other generic
manufacturers were severed from the April 2000 complaint (which
remains under seal) as a result of the federal governments
decision not to intervene in the action as to those defendants.
The complaint alleges violations of the False Claims Act and
sets forth allegations substantially similar to those alleged in
the state AG cases mentioned in the preceding paragraph and
purports to seek nationwide recovery of any and all alleged
overpayment of the federal share under the Medicaid
program, as well as treble damages and civil penalties. In
February 2010, the Company reached an agreement in principle to
settle this case (except for the claims related to the
California federal share) and the Texas state action mentioned
above. This settlement is contingent upon the execution of
definitive settlement documents and court approval. The
settlement would resolve a significant portion of the damages
claims asserted against Mylan, MPI and UDL in the various
pending pricing litigations. In addition, Mylan has reached
agreement in principle to settle the Hawaii state action, and
the Massachusetts state action, which settlements are contingent
upon the execution of definitive settlement documents. With
regard to the remaining state actions, the Company continues to
believe that it has meritorious defenses and will continue to
vigorously defend itself in those actions. The Company has
accrued $160 million in connection with the above-mentioned
settlement in principle and the remaining state actions. The
Company reviews the status of these actions on an ongoing basis,
and from time to time, the Company may settle or otherwise
resolve these matters on terms and conditions that management
believes are in the best interests of the Company. There are no
assurances that settlements can be reached on acceptable terms
or that adverse judgments, if any, in the remaining litigation
will not exceed the amounts reserved.
In addition, by letter dated January 12, 2005, MPI was
notified by the U.S. Department of Justice of an
investigation concerning calculations of Medicaid drug rebates.
The investigation involved whether MPI and UDL may have violated
the False Claims Act by classifying certain authorized generics
as non-innovator rather than innovator drugs for purposes of
Medicaid and other federal healthcare programs on sales from
2000 through 2004. MPI and UDL denied the governments
allegations and denied that they engaged in any wrongful
conduct. On October 19, 2009, a lawsuit, filed in March
2004 by a private relator, in which the federal government
subsequently intervened, was unsealed by the U.S. District
Court for the District of New Hampshire. That same day, MPI and
UDL announced that they had entered into a settlement agreement
with the federal government, relevant states and the relator for
approximately $121.0 million, resolving both the lawsuit
and the U.S. Department of Justice investigation. A
stipulation of dismissal with prejudice has been filed with the
court. The resolution of the matter did not include any
admission or finding of wrongdoing on the part of either MPI or
UDL. The Company has recovered approximately $50 million of
the settlement amount based on overpayments resulting from
adjusted net sales during the relevant timeframe.
Dey is a defendant currently in lawsuits brought by the state
AGs of California, Illinois, Kentucky, and Pennsylvania, as well
as three New York counties. Dey is also named as a defendant in
several class actions brought by consumers and third-party
payors. Dey has reached a settlement of these class actions,
which has been
45
preliminarily approved by the court. Additionally, a complaint
was filed under seal by a plaintiff on behalf of the United
States of America against Dey in August 1997. In August 2006,
the Government filed its
complaint-in-intervention
and the case was unsealed in September 2006. The Government has
asserted that Dey is jointly liable with a codefendant and seeks
recovery of alleged overpayments, together with treble damages,
civil penalties and equitable relief. These cases all generally
allege that Dey falsely reported certain price information
concerning certain drugs marketed by Dey, that Dey caused false
claims to be made to Medicaid and to Medicare, and that Dey
caused Medicaid and Medicare to make overpayments on those
claims. Certain of these cases may go to trial in 2010. Dey
intends to defend each of these actions vigorously. The Company
has approximately $96 million recorded in other liabilities
related to the price-related litigation involving Dey. As stated
above, in conjunction with the acquisition of the former Merck
Generics business, Mylan is entitled to indemnification from
Merck KGaA. As a result, the Company has recorded approximately
$96 million in other assets.
Modafinil
Antitrust Litigation and FTC Inquiry
Beginning in April 2006, Mylan, along with four other drug
manufacturers, has been named as a defendant in civil lawsuits
filed in or transferred to 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. On March 29, 2010,
the Court in the Eastern District of Pennsylvania denied the
defendants motions to dismiss. 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. 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 has cooperated fully with the governments
investigation and completed all requests for information. On
February 13, 2008, the FTC filed a lawsuit against Cephalon
in the U.S. District Court for the District of Columbia and
the case has subsequently been transferred to the
U.S. District Court for the Eastern District of
Pennsylvania. On July 1, 2010, the FTC issued a third party
subpoena to Mylan requesting documents in connection with its
lawsuit against Cephalon. Mylan is in the process of responding
to the subpoena. Mylan is not named as a defendant in the
FTCs lawsuit, although the complaint includes certain
allegations pertaining to the Mylan/Cephalon settlement.
Digitek®
Recall
On April 25, 2008, Actavis Totowa LLC, a division of
Actavis Group, announced a voluntary, nationwide recall of all
lots and all strengths of Digitek (digoxin tablets USP). Digitek
was manufactured by Actavis and distributed in the United States
by MPI and UDL. The Company has tendered its defense and
indemnity in all lawsuits and claims arising from this event to
Actavis, and Actavis has accepted that tender, subject to a
reservation of rights. While the Company is unable to estimate
total potential costs with any degree of certainty, such costs
could be significant. As of October 15, 2010, there are
approximately 1,039 cases pending against Mylan, UDL and Actavis
pertaining to the recall. Most of these cases have been
transferred to the multi-district litigation proceedings pending
in the U.S. District Court for the Southern District of
West Virginia for pretrial proceedings. The remainder of these
cases will likely be litigated in the state courts in which they
were filed. In September 2010, Actavis entered into a Settlement
Agreement with the plaintiffs in a majority of the claims and
lawsuits. Mylan and UDL will not contribute monetarily to the
settlement, but will be dismissed with prejudice from any
settled cases. Any lawsuits in which the plaintiffs choose to
opt out of this settlement will continue to be litigated. An
adverse outcome in these lawsuits or the inability or denial of
Actavis to pay on an indemnified claim could have a materially
negative impact on the Companys financial position,
results of operations or cash flows.
46
EU
Commission Proceedings
On or around July 3, 2009, the European Commission (the
EU Commission or the Commission) stated
that it had initiated antitrust proceedings pursuant to
Article 11(6) of Regulation No. 1/2003 and
Article 2(1) of Regulation No. 773/2004 to
explore possible infringement of Articles 81 and 82 EC and
Articles 53 and 54 of the EEA Agreement by Les Laboratoires
Servier (Servier) as well as possible infringement
of Article 81 EC by Matrix and four other companies, each
of which entered into agreements with Servier relating to the
product perindopril. Matrix is cooperating with the EU
Commission in connection with the investigation. The
EU Commission stated that the initiation of
proceedings does not imply that the Commission has conclusive
proof of an infringement but merely signifies that the
Commission will deal with the case as a matter of
priority. No statement of objections has been filed
against Matrix in connection with its investigation. On
August 5, 2009, Matrix and Generics [U.K.] Ltd. received
requests for information from the EU Commission in connection
with this matter, and both companies have responded. By letters
dated February 17, 2010, the EU Commission served
additional requests for information on Matrix and Mylan S.A.S.
The companies responded to these requests. On August 13,
2010, Matrix received an additional request for information.
Matrix has responded to this request. Matrix is cooperating with
the Commission in this investigation.
In addition, the EU Commission is conducting a pharmaceutical
sector inquiry involving approximately 100 companies
concerning the introduction of innovative and generic medicines.
Mylan S.A.S. has responded to the questionnaires received in
connection with the sector inquiry and has produced documents
and other information in connection with the inquiry.
On October 6, 2009, the Company received notice that the EU
Commission was initiating an investigation pursuant to
Article 20(4) of Regulation No. 1/2003 to explore
possible infringement of Articles 81 and 82 EC by the
Company and its affiliates. Mylan S.A.S., acting on behalf of
its Mylan affiliates, has produced documents and other
information in connection with the inquiry. The Company and
Mylan S.A.S. received an additional request for information with
the same case reference on December 18, 2009 and have
responded to the questionnaire. Additional requests were
received on March 18, 2010 and July 29, 2010. Mylan
S.A.S. has responded to these requests. Mylan is cooperating
with the Commission in connection with the investigation. No
statement of objections has been filed against Mylan in
connection with the investigation.
On March 19, 2010, Mylan Inc. and Generics [U.K.] Ltd.
received notice that the EU Commission had opened proceedings
against Lundbeck with respect to alleged unilateral practices
and/or
agreements related to citalopram in the European Economic Area.
On this same date, Mylan Inc. and Generics [U.K.] Ltd. received
requests for information from the EU Commission in connection
with any agreements between Lundbeck and Generics [U.K.] Ltd.
concerning citalopram. Both companies are cooperating with the
EU Commission. Generics [U.K.] Ltd. responded to the request for
information on May 10, 2010 and September 30, 2010. No
statement of objections has been filed in connection with this
investigation.
Other
Litigation
The Company is involved in various other legal proceedings that
are considered normal to its business, including certain
proceedings assumed as a result of the acquisition of the former
Merck Generics business. While it is not feasible to predict the
ultimate outcome of such other proceedings, the ultimate outcome
of any such proceeding is not expected to have a material
adverse effect on its financial position, results of operations
or cash flows.
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.
47
CURRENT
ECONOMIC CONDITIONS MAY ADVERSELY AFFECT OUR INDUSTRY, BUSINESS,
FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE
MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
Over the past few years, the global economy has undergone a
period of unprecedented volatility, and the economic environment
may continue to be less favorable than that of past years. This
has led, and could further lead, to reduced consumer spending in
the foreseeable future, and this may include spending on
healthcare. While generic drugs present an ideal alternative to
higher-priced branded products, our sales could be negatively
impacted if patients forego obtaining healthcare. In addition,
reduced consumer spending may drive us and our competitors to
decrease prices. These conditions may adversely affect our
industry, business, financial position and results of operations
and may cause the market value of our common stock to decline.
OUR
INTEGRATION OF ACQUIRED BUSINESSES INVOLVES A NUMBER OF 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.
There are a number of operational risks associated with the
integration of acquired businesses, including Bioniche Pharma.
These risks include, but are not limited to, difficulties in
achieving identified financial and operating synergies, cost
savings, revenue synergies and growth opportunities;
difficulties in consolidating information technology platforms,
business applications and corporate infrastructure; our
substantial indebtedness and assumed liabilities; challenges in
operating in other markets outside of the U.S. that are new
to us; and the 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
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, through our
acquisitions of the former Merck Generics business and Matrix,
as well as the recent acquisition of Bioniche Pharma. This
growth has put significant demands on our processes, systems and
people. We expect to make further 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 are
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 FOOTPRINT 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.
Our operations extend to numerous countries outside the
U.S. Operating globally exposes us to certain additional
risks including, but not limited to:
|
|
|
|
|
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;
|
|
|
|
changes in laws, regulations, and practices affecting the
pharmaceutical industry and the healthcare system, including but
not limited to imports, exports, manufacturing, cost, pricing,
reimbursement, approval, inspection, and delivery of healthcare;
|
48
|
|
|
|
|
fluctuations in exchange rates for transactions conducted in
currencies other than the functional currency;
|
|
|
|
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;
|
|
|
|
wage increases or rising inflation in the countries in which we
operate;
|
|
|
|
supply disruptions, and increases in energy and transportation
costs;
|
|
|
|
natural disasters, including droughts, floods and earthquakes in
the countries in which we operate;
|
|
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communal disturbances, terrorist attacks, riots or regional
hostilities in the countries in which we operate; and
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government uncertainty, including as a result of new or changed
laws and regulations.
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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. Any 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.
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 UNCERTAINTIES CREATE RISKS WHICH
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 it operates, 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 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 in India 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, and within the countries
themselves. Rioting, 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 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 effect on our business,
financial position and results of operations and could cause the
market value of our common stock to decline.
49
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 are 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 and, in some cases, cash flows, 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.
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.
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
BUSINESS, 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, which could adversely
affect our 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
and/or
national regulatory agencies (for example the Food and Drug
Administration (FDA) in the U.S. and the
European Medicines Agency (EMA) in the 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 U.S.,
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 U.S. Bioequivalency studies conducted in
one country may not be accepted in other countries, and the
approval
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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.
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 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 U.S., the Drug Price Competition and Patent Term
Restoration Act of 1984, or the Hatch-Waxman Act, provides for a
period of 180 days of generic marketing exclusivity for
each abbreviated new drug application (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. 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 other jurisdictions outside the U.S., 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.
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. We also partner with
51
third parties to develop products. Typically, research expenses
related to the development of innovative compounds and the
filing of marketing authorization applications for innovative
compounds (such as new drug applications (NDAs) in
the U.S.) 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 U.S. and abridged applications in Europe). As we and
our partners 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, 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.
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 but not limited to:
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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.
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.
52
THE
ILLEGAL DISTRIBUTION AND SALE BY THIRD PARTIES OF COUNTERFEIT
VERSIONS OF OUR PRODUCTS OR OF STOLEN PRODUCTS COULD HAVE A
NEGATIVE IMPACT ON OUR REPUTATION AND 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 drug supply has been increasingly challenged by the
vulnerability of distribution channels to illegal counterfeiting
and the presence of counterfeit products in a growing number of
markets and over the Internet. The World Health Organization
estimates that more than 10% of medications being sold globally
are counterfeit.
Third parties may illegally distribute and sell counterfeit
versions of our products, which do not meet the rigorous
manufacturing and testing standards that our products undergo.
Counterfeit products are frequently unsafe or ineffective, and
can be potentially life-threatening. Counterfeit medicines may
contain harmful substances, the wrong dose of the active
pharmaceutical ingredient (API) or no API at all.
However, to distributors and users, counterfeit products may be
visually indistinguishable from the authentic version.
Reports of adverse reactions to counterfeit drugs or increased
levels of counterfeiting could materially affect patient
confidence in the authentic product. It is possible that adverse
events caused by unsafe counterfeit products will mistakenly be
attributed to the authentic product. In addition, thefts of
inventory at warehouses, plants or while in-transit which are
not properly stored and which are sold through unauthorized
channels could adversely impact patient safety, our reputation
and our business.
Public loss of confidence in the integrity of pharmaceutical
products as a result of counterfeiting or theft 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.
IF WE
OR ANY PARTNER 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
part on our or any partners 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 or any
partners 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 U.S. Patent and Trademark
Office or any other governmental agency 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.
53
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 but not limited to the possibility 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.
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 U.S., some companies have lobbied Congress for amendments
to the Hatch-Waxman 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 U.S., 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.
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, INCLUDING
IN AN AT-RISK LAUNCH SITUATION, 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
(i.e., an at-risk launch situation). The risk
involved in doing so can be substantial because the remedies
available to the owner of a patent for infringement may 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.
OUR
SPECIALTY BUSINESS DEVELOPS, FORMULATES, MANUFACTURES OR
IN-LICENSES 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 (or
alternatively, in-licensed) and marketed by our specialty
business may be subject to the following risks, among others:
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limited patent life, or the loss of patent protection;
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competition from generic products;
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reductions in reimbursement rates by third-party payors;
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importation by consumers;
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product liability;
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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.
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In addition, developing and commercializing branded products is
generally more costly than generic products. If such business
expenditures do not ultimately result in the launch of
commercially successful brand products, or if any of the risks
above were to occur, there could be a material adverse effect on
our business, financial position and results of operations and
the market value of our common stock could decline.
A
RELATIVELY SMALL GROUP OF PRODUCTS MAY REPRESENT A SIGNIFICANT
PORTION OF OUR NET REVENUES, 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 from time to time
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.
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.
WE
DEPEND TO A LARGE EXTENT 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 COULD CAUSE THE
MARKET VALUE OF OUR COMMON STOCK TO 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 business,
financial position and results of operations to be materially
adversely affected, and the market value of our common stock
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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 our 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 (DEA) in the U.S. 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.
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.
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.
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
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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, 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 similar
standards in each territory in which we manufacture. Compliance
with such 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. Regulatory approval to manufacture a drug is
site-specific. Failure to comply with good manufacturing
practices 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. Because our processes for these
calculations and the judgments involved in making these
calculations involve, and will continue to involve,
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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 (AMP) based on the
provisions of the Deficit Reduction Act of 2005
(DRA). While the matter remains subject to
litigation and proposed legislation, one potential significant
change as a result of the DRA is that AMP would need to 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 herein, a number of state and
federal government agencies are conducting investigations of
manufacturers reporting practices with respect to Average
Wholesale Prices (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 payments and even in the
absence of any such ambiguity a governmental
authority may take a position contrary to a position we have
taken, and may impose civil
and/or
criminal sanctions. Any such penalties or sanctions could have a
material adverse effect on our business, financial position and
results of operations and could cause the market value of our
common stock to decline.
WE MAY
EXPERIENCE REDUCTIONS IN THE LEVELS OF REIMBURSEMENT FOR
PHARMACEUTICAL PRODUCTS BY GOVERNMENTAL AUTHORITIES, HMOS OR
OTHER THIRD-PARTY PAYORS. IN ADDITION, THE USE OF TENDER SYSTEMS
COULD REDUCE PRICES FOR OUR PRODUCTS OR REDUCE OUR MARKET
OPPORTUNITIES. 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 U.K. National
Health Service and the German statutory health insurance scheme)
and private health insurers and other organizations, such as
health maintenance organizations (HMOs) in the U.S.,
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
U.S., third-party payors 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 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 addition, a number of markets in which we operate have
implemented or may implement tender systems for generic
pharmaceuticals in an effort to lower prices. Under such tender
systems, manufacturers submit bids which establish prices for
generic pharmaceutical products. Upon winning the tender, the
winning company will receive a preferential reimbursement for a
period of time. The tender system often results in companies
underbidding one another by proposing low pricing in order to
win the tender.
Certain other countries may consider the implementation of a
tender system. Even if a tender system is ultimately not
implemented, the anticipation of such could result in price
reductions. Failing to win tenders, or the implementation of
similar systems in other markets leading to further price
declines, 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.
59
LEGISLATIVE
OR REGULATORY PROGRAMS THAT MAY INFLUENCE PRICES OF
PHARMACEUTICAL PRODUCTS 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
U.S. 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.
Several countries in which we operate have implemented, or plan
to implement, government mandated price reductions, including
but not limited to Spain, Portugal, Italy, Australia, Japan and
Canada. When such price cuts occur, pharmaceutical companies
have generally experienced significant declines in revenues and
profitability and uncertainties continue to exist within the
market. Such price reductions could have an adverse effect on
our business, and as uncertainties are resolved or if other
countries in which we operate enact similar measures, they could
have a further material adverse effect on our business,
financial position and results of operations and could cause the
market value of our common stock to decline.
HEALTHCARE
REFORM LEGISLATION 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 recent years, there have been numerous initiatives on the
federal and state levels for comprehensive reforms affecting the
payment for, the availability of and reimbursement for
healthcare services in the U.S., and it is likely that federal
and state legislatures and health agencies will continue to
focus on health care reform in the future. The Patient
Protection and Affordable Care Act (H.R. 3590; Public Law
111-148)
(PPACA) and The Health Care and Education and
Reconciliation Act of 2010 (H.R. 4872), which amends the PPACA
(collectively the Health Reform Laws), were signed
into law in March 2010. While the Health Reform Laws may
increase the number of patients who have insurance coverage for
our products, they also include provisions such as the
assessment of a pharmaceutical manufacturer fee and an increase
in the amount of rebates that manufacturers pay for coverage of
their drugs by Medicaid programs.
We are unable to predict the future course of federal or state
healthcare legislation. The Health Reform Laws and further
changes in the law or regulatory framework that reduce our
revenues or increase our costs could also have a material
adverse effect on our business, financial condition and results
of operations and cash flows, and could cause the market value
of our common stock to decline.
Additionally, we encounter similar regulatory and legislative
issues in most other countries. In the EU and some other
international markets, the government provides health care at
low cost to consumers and regulates pharmaceutical prices,
patient eligibility or reimbursement levels to control costs for
the government-sponsored health care system. This international
system of price regulations may lead to inconsistent prices.
Within the EU and in other countries, the availability of our
products in some markets at lower prices undermines our sales in
some markets with higher prices. Additionally, certain countries
set prices by reference to the prices in other countries where
our products are marketed. Thus, our inability to secure
adequate prices in a particular country may also impair our
ability to obtain acceptable prices in existing and potential
new markets, and may create the opportunity for third party
cross border trade.
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If significant additional reforms are made to the
U.S. healthcare system, or to the healthcare systems of
other markets in which we operate, those reforms could have a
material adverse effect on our business, financial position and
results of operations and could cause the market value of our
common stock to decline.
WE ARE
INVOLVED IN VARIOUS LEGAL PROCEEDINGS AND CERTAIN GOVERNMENT
INQUIRIES AND MAY EXPERIENCE UNFAVORABLE OUTCOMES OF SUCH
PROCEEDINGS OR INQUIRIES, WHICH COULD HAVE A MATERIAL ADVERSE
EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF
OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK
TO DECLINE.
We are involved in various legal proceedings and certain
government inquiries, including, but not limited to, patent
infringement, product liability, breach of contract and claims
involving Medicare
and/or
Medicaid reimbursements, some of which are described in our
periodic reports, that 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 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.
In addition, in limited circumstances, entities we acquired in
the acquisition of the former Merck Generics business are party
to litigation 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,
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.
IF THE
INTERCOMPANY TERMS OF CROSS BORDER 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 potential tax exposures resulting from the varying
application of statutes, regulations and interpretations which
include exposures on intercompany terms of cross border
arrangements among our subsidiaries in relation to various
aspects of our business, including manufacturing, marketing,
sales and delivery functions. Although our cross border
arrangements between affiliates are based upon internationally
accepted standards, tax authorities in various jurisdictions may
disagree with and subsequently challenge the amount of profits
taxed in their country, which may result in 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.
UNANTICIPATED
CHANGES IN OUR TAX PROVISIONS OR EXPOSURE TO ADDITIONAL INCOME
TAX LIABILITIES 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 income taxes in the U.S. and many foreign
jurisdictions. Significant judgment is required in determining
our worldwide provision for income taxes. In the ordinary course
of business, there are many transactions and calculations where
the ultimate tax determination is uncertain. The final
determination of any tax audits or related litigation could be
materially different from our historical income tax provisions
and accruals.
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Additionally, changes in the effective tax rate as a result of a
change in the mix of earnings in countries with differing
statutory tax rates, changes in our overall profitability,
changes in the valuation of deferred tax assets and liabilities,
the results of audits and the examination of previously filed
tax returns by taxing authorities and continuing assessments of
our tax exposures could impact our tax liabilities and affect
our income tax expense, 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.
CHANGES
IN INCOME TAX LAWS AND TAX RULINGS MAY HAVE A SIGNIFICANTLY
ADVERSE IMPACT ON OUR EFFECTIVE TAX RATE AND INCOME TAX EXPENSE,
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 Education, Jobs and Medicaid Assistance Act was passed on
August 5, 2010 and contained several provisions meant to
limit the ability of corporations to claim foreign tax credits
in reduction of their U.S. tax liability. We do not
anticipate that the enactment of these provisions will
materially impact our overall effective tax rate and income tax
expense. Other proposals to change the U.S. income tax
rules were proposed by the Obama administration in their fiscal
year 2011 budget. The proposals would, among other things, limit
the use of foreign tax credits to reduce residual
U.S. income tax on
non-U.S. source
income and defer the deduction of interest attributable to
non-U.S. source
income of foreign subsidiaries. Each of these proposals would be
effective only for taxable years beginning after
December 31, 2010. We cannot determine whether these
proposals will be enacted into law or what, if any, changes will
be made to such proposals prior to their being enacted into law.
If enacted, and depending on its precise terms, such legislation
could materially increase our overall effective income tax rate
and income tax expense. 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.
The Tax Extenders Act of 2009 includes legislation which would
extend, for one year, 49 expiring tax provisions. On
May 20, 2010, a new tax extenders bill, the American Jobs
and Tax Loophole Closing Act of 2010, was introduced. This bill
was passed by the House on May 28, 2010 and is now pending
action in the Senate. The total impact to the Company of an
extension of these expiring tax provisions is currently unknown
due to the potential impact of revenue offsets, which may be
included in the final version of this legislation, if enacted.
If enacted, and depending on its precise terms, such legislation
could materially increase our overall effective income tax rate
and income tax expense. 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.
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 COULD LEAD TO
ADVERSE CONSEQUENCES THAT 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 high level of indebtedness could have important
consequences, including but not limited to:
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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 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;
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restricting us from exploiting business opportunities;
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increasing our cost of borrowings; and
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placing us at a competitive disadvantage to our competitors that
have less debt.
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Our ability to service our indebtedness will depend on our
future operating performance and financial results, which will
be subject, in part, to factors beyond our control, including
interest rates and general economic, financial and business
conditions. If we 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 Credit 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, the global credit markets
are currently experiencing an unprecedented contraction. If
current pressures on credit continue or worsen, future debt
financing may not be available to us when required or may not be
available on acceptable terms, and as a result 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, AND WHICH COULD HAVE A
MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND
RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR
COMMON STOCK TO DECLINE.
We may from time to time consider selling certain assets if
(a) we determine that such assets are not critical to our
strategy, or (b) we believe the opportunity to monetize the
asset is attractive or for various reasons including we want to
reduce indebtedness. 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. We also continue to review the carrying
value of manufacturing and intangible assets for indications of
impairment as circumstances require. Future events and decisions
may lead to asset impairments
and/or
related costs. As a result, any such sale or impairment could
have an adverse effect on our business, prospects and
opportunities for growth, financial position and results of
operations and could cause the market value of our common stock
to decline.
OUR
CREDIT FACILITIES, SENIOR UNSECURED NOTES, OTHER OUTSTANDING
INDEBTEDNESS 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, senior unsecured notes, other outstanding
indebtedness and any additional indebtedness we incur in the
future impose, or may impose, significant operating and
financial restrictions on us. These
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restrictions limit our ability to, among other things, incur
additional indebtedness, make investments, pay certain
dividends, prepay other indebtedness, sell assets, incur certain
liens, enter into agreements with our affiliates or restricting
our subsidiaries ability to pay dividends, merge or
consolidate. In addition, our Senior 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.
THE
TOTAL AMOUNT OF INDEBTEDNESS RELATED TO OUR OUTSTANDING CASH
CONVERTIBLE NOTES DUE 2015 (THE CASH CONVERTIBLE
NOTES) WILL INCREASE IF OUR STOCK PRICE INCREASES. IN
ADDITION, OUR OUTSTANDING SENIOR NOTES SETTLEMENT VALUE
INCREASES AS OUR STOCK PRICE INCREASES, ALTHOUGH WE DO NOT
ACCOUNT FOR THIS AS AN INCREASE IN INDEBTEDNESS. ALSO, WE HAVE
ENTERED INTO NOTE HEDGES AND WARRANT TRANSACTIONS IN
CONNECTION WITH THE 1.25% SENIOR CONVERTIBLE NOTES DUE 2012
(THE SENIOR CONVERTIBLE NOTES) AND CASH CONVERTIBLE
NOTES IN ORDER TO HEDGE SOME OF THE RISK ASSOCIATED WITH
THE POTENTIAL INCREASE OF INDEBTEDNESS AND SETTLEMENT VALUE.
SUCH TRANSACTIONS HAVE BEEN CONSUMMATED WITH CERTAIN
COUNTERPARTIES, MAINLY HIGHLY RATED FINANCIAL INSTITUTIONS. ANY
INCREASE IN INDEBTEDNESS, NET EXPOSURE RELATED TO THE RISK OR
FAILURE OF ANY COUNTERPARTIES TO PERFORM THEIR OBLIGATIONS,
COULD HAVE ADVERSE EFFECTS ON US, INCLUDING UNDER OUR DEBT
AGREEMENTS, 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.
Under applicable accounting rules, the cash conversion feature
that is a term of the Cash Convertible Notes must be recorded as
a liability on our balance sheet and periodically marked to fair
value. If our stock price increases, the liability associated
with the cash conversion feature would increase and, because
this liability must be periodically marked to fair value on our
balance sheet, the total amount of indebtedness related to the
notes that is shown on our balance sheet would also increase.
This could have adverse effects on us, including under our
existing and any future debt agreements. For example, our senior
credit facilities contain covenants that restrict our ability to
incur debt, make capital expenditures, pay dividends and make
investments if, among other things, our leverage ratio, exceeds
certain levels. In addition, the interest rate we pay under our
senior credit facilities increases if our leverage ratio
increases. Because the leverage ratio under our senior credit
facilities is calculated based on a definition of total
indebtedness as defined under accounting principles generally
accepted in the United States of America (GAAP), if
the amount of our total indebtedness were to increase, our
leverage ratio would also increase. As a result, we may not be
able to comply with such covenants in the future, which could,
among other things, restrict our ability to grow our business,
take advantage of business opportunities or respond to
competitive pressures. 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 the
notes and our common stock to decline.
Although the conversion feature under our Senior Convertible
Notes is not marked to market, the conversion feature also
increases as the price of our common stock increases. If our
stock price increases, the settlement value of the conversion
feature increases.
In connection with the issuance of the Cash Convertible Notes
and Senior Convertible Notes, we entered into note hedge and
warrant transactions with certain financial institutions, each
of which we refer to as a counterparty. The Cash Convertible
Note hedge is comprised of purchased cash-settled call options
that are expected to reduce our exposure to potential cash
payments required to be made by us upon the cash conversion of
the notes. The Senior Convertible Notes hedge is comprised of
call options that are expected to reduce our exposure to the
settlement value (issuance of common stock) upon the conversion
of the notes. We have also entered into respective warrant
transactions with the counterparties pursuant to which we will
have sold to each counterparty warrants for the
64
purchase of shares of our common stock. Together, each of the
note hedges and warrant transactions are expected to provide us
with some protection against increases in our stock price over
the conversion price per share. However, there is no assurance
that these transactions will remain in effect at all times.
Also, although we believe the counterparties are highly rated
financial institutions, there are no assurances that the
counterparties will be able to perform their respective
obligations under the agreement we have with each of them. Any
net exposure related to conversion of the notes or any failure
of the counterparties to perform their obligations under the
agreements we have with them 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.
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, including those in rapidly developing
economies, 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,
including tax savings, 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, or 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.
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 adversely affected and the market value of our common
stock could decline.
65
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 ARE
IN THE PROCESS OF ENHANCING AND FURTHER DEVELOPING OUR GLOBAL
ENTERPRISE RESOURCE PLANNING SYSTEMS AND ASSOCIATED BUSINESS
APPLICATIONS. AS WITH ANY ENHANCEMENTS OF SIGNIFICANT SYSTEMS,
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 are enhancing and further developing our global enterprise
resource planning (ERP) systems and associated
applications to provide more operating efficiencies and
effective management of our business operations. Such changes to
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 enhancements, it could have a material adverse effect on
our business, financial position and results of operations and
could cause the market value of our common stock to decline.
WE
MUST MAINTAIN ADEQUATE INTERNAL CONTROLS AND BE ABLE, ON AN
ANNUAL BASIS, TO PROVIDE AN ASSERTION AS TO THE EFFECTIVENESS OF
SUCH CONTROLS. FAILURE TO MAINTAIN ADEQUATE INTERNAL CONTROLS OR
TO IMPLEMENT NEW OR IMPROVED CONTROLS COULD HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS
OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON
STOCK TO DECLINE.
Effective internal controls are necessary for the Company to
provide reasonable assurance with respect to its financial
reports. We are spending a substantial amount of management time
and resources to comply with changing laws, regulations and
standards relating to corporate governance and public
disclosure. In the U.S. such changes include the
Sarbanes-Oxley Act of 2002, Securities and Exchange Commission
(SEC) regulations and the NASDAQ listing standards.
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.
66
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 OR CHARGES, INCLUDING
IMPAIRMENT CHARGES, 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 GAAP. The preparation of financial
statements in accordance with GAAP involves making estimates,
judgments and assumptions that affect reported amounts of
assets, liabilities, revenues, expenses and income. Estimates,
judgments and assumptions are inherently subject to change in
the future and any necessary revisions to prior estimates,
judgments or assumptions could lead to a restatement.
Furthermore, although we have recorded reserves for lawsuits
based on estimates of probable future costs, such lawsuits could
result in substantial further costs. 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 liabilities, revenues,
expenses and income. Any such changes could have a material
adverse effect on our business, financial position and results
of operations and could cause the market value of our common
stock to decline.
In addition, a significant amount of our total assets are
related to acquired intangible assets and goodwill. Such assets
require impairment testing periodically
and/or under
certain circumstances. Impairment testing requires the use of
significant estimates, judgments and assumptions, which involve
inherent uncertainty. Any future changes to estimates, judgments
and assumptions used in impairment testing could lead to
impairment charges, 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.
|
|
ITEM 5.
|
OTHER
INFORMATION
|
None.
|
|
|
|
|
|
3
|
.1
|
|
Amended and Restated Articles of Incorporation of the
registrant, as amended to date, filed as Exhibit 3.1 to the
Report on
Form 10-Q
for the quarter ended June 30, 2009, and incorporated
herein by reference.
|
|
3
|
.2
|
|
Bylaws of the registrant, as amended to date, filed as
Exhibit 3.2 to the Report on
Form 10-Q
for the quarter ended June 30, 2009, and incorporated
herein by reference.
|
|
4
|
.1(a)
|
|
Rights Agreement dated as of August 22, 1996, between the
registrant and American Stock Transfer &
Trust Company, filed as Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on September 3, 1996, and incorporated
herein by reference.
|
|
4
|
.1(b)
|
|
Amendment to Rights Agreement dated as of November 8, 1999,
between the registrant and American Stock Transfer &
Trust Company, filed as Exhibit 1 to
Form 8-A/A
filed with the SEC on March 31, 2000, and incorporated
herein by reference.
|
|
4
|
.1(c)
|
|
Amendment No. 2 to Rights Agreement dated as of
August 13, 2004, between the registrant and American Stock
Transfer & Trust Company, filed as
Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on August 16, 2004, and incorporated
herein by reference.
|
|
4
|
.1(d)
|
|
Amendment No. 3 to Rights Agreement dated as of
September 8, 2004, between the registrant and American
Stock Transfer & Trust Company, filed as
Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on September 9, 2004, and incorporated
herein by reference.
|
|
4
|
.1(e)
|
|
Amendment No. 4 to Rights Agreement dated as of
December 2, 2004, between the registrant and American Stock
Transfer & Trust Company, filed as
Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on December 3, 2004, and incorporated
herein by reference.
|
67
|
|
|
|
|
|
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.
|
|
4
|
.4
|
|
Indenture, dated as of September 15, 2008, among the
registrant, the guarantors named therein and Bank of New York
Mellon as trustee, filed as Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on September 15, 2008, and incorporated
herein by reference.
|
|
4
|
.5
|
|
Indenture, dated as of May 19, 2010, among the registrant,
the guarantors named therein and The Bank of New York Mellon as
trustee, filed as Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on May 19, 2010, and incorporated herein
by reference.
|
|
10
|
.1
|
|
Purchase Agreement, dated as of July 30, 2010, among the
registrant, the guarantors named therein and Goldman,
Sachs & Co.
|
|
31
|
.1
|
|
Certification of Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
31
|
.2
|
|
Certification of Principal Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
32
|
|
|
Certification of Principal Executive Officer and Principal
Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
|
101
|
.INS
|
|
XBRL Instance Document
|
|
101
|
.SCH
|
|
XBRL Taxonomy Extension Schema
|
|
101
|
.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
101
|
.LAB
|
|
XBRL Taxonomy Extension Label Linkbase
|
|
101
|
.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase
|
68
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly authorized.
Robert J. Coury
Chairman and Chief Executive Officer
(Principal Executive Officer)
October 27, 2010
John D. Sheehan
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
October 27, 2010
Daniel C. Rizzo, Jr.
Senior Vice President, Chief Accounting Officer and
Corporate Controller
(Principal Accounting Officer)
October 27, 2010
69
EXHIBIT INDEX
|
|
|
|
|
|
10
|
.1
|
|
Purchase Agreement, dated as of July 30, 2010, among the
registrant, the guarantors named therein and Goldman,
Sachs & Co.
|
|
31
|
.1
|
|
Certification of Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
31
|
.2
|
|
Certification of Principal Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
32
|
|
|
Certification of Principal Executive Officer and Principal
Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
|
101
|
.INS
|
|
XBRL Instance Document
|
|
101
|
.SCH
|
|
XBRL Taxonomy Extension Schema
|
|
101
|
.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
101
|
.LAB
|
|
XBRL Taxonomy Extension Label Linkbase
|
|
101
|
.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase
|
70
exv10w1
Exhibit 10.1
MYLAN INC.
7.875% Senior Notes due 2020
Purchase Agreement
July 30, 2010
Goldman, Sachs & Co.
200 West Street,
New York, New York 10282-2198
Ladies and Gentlemen:
Mylan Inc., a Pennsylvania corporation (the Company), proposes, subject to the terms and
conditions stated herein, to issue and sell to Goldman, Sachs & Co. (the Purchaser) an aggregate
of $300,000,000 principal amount of its 7.875% Senior Notes due 2020 (the Securities). The
Securities will be issued pursuant to that certain indenture, dated as of May 19, 2010 (the
Indenture), that was entered into among the Company, the Guarantors (as defined below) and The
Bank of New York Mellon, as trustee (the Trustee). The Companys obligations under the
Securities will be irrevocably and unconditionally guaranteed (the Guarantees) as to the payment
of principal, premium and interest on a senior basis, jointly and severally, initially by each of
the subsidiary guarantors listed on the signature pages of this Agreement (each a Guarantor and,
collectively, the Guarantors). This Agreement, the Securities, the Guarantees and the Indenture
are collectively referred to herein as the Transaction Documents.
1. |
|
The Company and each Guarantor represent and warrant to, and agree with, you that: |
(a) A preliminary offering circular, dated July 29, 2010 (the Preliminary Offering Circular)
and an offering circular, dated July 30, 2010 (the Offering Circular), have been prepared in
connection with the offering of the Securities. The Preliminary Offering Circular, as amended and
supplemented immediately prior to the Applicable Time (as defined in Section 1(b)), is hereinafter
referred to the Pricing Circular. Any reference to the Preliminary Offering Circular, the
Pricing Circular or the Offering Circular shall be deemed to refer to and include the Companys
most recent Annual Report on Form 10-K and all subsequent documents filed with the United States
Securities and Exchange Commission (the Commission) pursuant to Section 13(a), 13(c) or 15(d) of
the United States Securities Exchange Act of 1934, as amended (the Exchange Act) on or prior to
the date of such circular and any reference to the Preliminary Offering Circular or the Offering
Circular, as the case may be, as amended or supplemented, as of any specified date, shall be deemed
to include (i) any documents filed with the Commission pursuant to Section 13(a), 13(c) or 15(d) of
the Exchange Act after the date of the Preliminary Offering Circular or the Offering Circular, as
the case may be, and prior to such specified date and (ii) any Additional Issuer Information (as
defined in Section 5(f)) furnished by the Company prior to the completion of the distribution of
the Securities; and all
documents filed under the Exchange Act and so deemed to be included in the Preliminary
Offering Circular, the Pricing Circular or the Offering Circular, as the case may be, or any
amendment or supplement thereto are hereinafter called the Exchange Act Reports. The Exchange
Act Reports, when they were or are filed with the Commission, conformed or will conform in all
material respects to the applicable requirements of the Exchange Act and the applicable rules and
regulations of the Commission thereunder; and no such documents were filed with the Commission
since the Commissions close of business on the business day immediately prior to the date of this
Agreement and prior to the execution of this Agreement, except as set forth on Schedule
I(a) hereof. The Preliminary Offering Circular or the Offering Circular and any amendments or
supplements thereto and the Exchange Act Reports did not and will not, as of their respective
dates, contain an untrue statement of a material fact or omit to state a material fact necessary in
order to make the statements therein, in the light of the circumstances under which they were made,
not misleading; provided, however, that this representation and warranty shall not apply to any
statements or omissions made in reliance upon and in conformity with information furnished in
writing to the Company by you expressly for use therein;
(b) For the purposes of this Agreement, the Applicable Time is 12:00 pm (Eastern time) on
the date of this Agreement; the Pricing Circular as supplemented by the information set forth in
Schedule II hereto, taken together (collectively, the Pricing Disclosure Package) as of
the Applicable Time, did not include any untrue statement of a material fact or omit to state any
material fact necessary in order to make the statements therein, in the light of the circumstances
under which they were made, not misleading; and each Company Supplemental Disclosure Document (as
defined in Section 6(a)) listed on Schedule I(b) hereto does not conflict with the
information contained in the Pricing Circular or the Offering Circular and each such Company
Supplemental Disclosure Document, as supplemented by and taken together with the Pricing Disclosure
Package as of the Applicable Time, did not include any untrue statement of a material fact or omit
to state any material fact necessary in order to make the statements therein, in the light of the
circumstances under which they were made, not misleading; provided, however, that this
representation and warranty shall not apply to statements or omissions made in a Company
Supplemental Disclosure Document in reliance upon and in conformity with information furnished in
writing to the Company by you expressly for use therein;
(c) Deloitte & Touche LLP, the accountants who certified the financial statements and
supporting schedules included or incorporated by reference in the Offering Circular and the Pricing
Circular are independent public accountants with respect to the Company and its subsidiaries within
the meaning of the United States Securities Act of 1933, as amended (the Securities Act) and the
rules and regulations thereunder;
(d) The financial statements of the Company included in the Pricing Circular and the Offering
Circular, together with the related schedules and notes, present fairly the financial position of
the Company and its consolidated subsidiaries at the dates indicated and the results of operations,
stockholders equity and cash flows of the Company and its consolidated subsidiaries for the
periods specified; said financial statements have been prepared in conformity with generally
accepted accounting principles (GAAP) applied on a consistent basis throughout the periods
involved. The supporting schedules, if any, included in the Pricing Circular and the Offering
Circular present fairly in accordance with GAAP the information required to be stated therein. The
selected financial data and the summary financial information of the Company included in the
Pricing Circular and the Offering Circular present fairly the information shown therein and have
been compiled on a basis consistent
2
with that of the audited financial statements of the Company incorporated by reference in the
Pricing Circular and the Offering Circular;
(e) Since the respective dates as of which information is given in the Pricing Circular and
the Offering Circular, except as otherwise stated therein, (i) there has not been any change in the
capital stock or long-term debt of the Company or any of its subsidiaries, or any material adverse
change in the condition, financial or otherwise, results of operations, business affairs or
business prospects of the Company and its subsidiaries considered as one enterprise, whether or not
arising in the ordinary course of business (a Material Adverse Effect), and (ii) there have been
no transactions entered into by the Company or any of its subsidiaries, other than those in the
ordinary course of business, which are material with respect to the Company and its subsidiaries
considered as one enterprise;
(f) The Company has been duly organized and is validly existing as a corporation in good
standing under the laws of the Commonwealth of Pennsylvania and has corporate power and authority
to own, lease and operate its properties and to conduct its business as described in the Pricing
Circular and the Offering Circular and to enter into and perform its obligations under this
Agreement; and the Company is duly qualified as a foreign corporation to transact business and is
in good standing in each other jurisdiction in which such qualification is required, whether by
reason of the ownership or leasing of property or the conduct of business, except where the failure
to so qualify would not, individually or in the aggregate, reasonably be expected to result in a
Material Adverse Effect;
(g) Each Designated Subsidiary (as defined below) has been duly organized and is validly
existing as a corporation, limited partnership or limited liability company in good standing under
the laws of the jurisdiction of its formation, has corporate or other power and authority to own,
lease and operate its properties and to conduct its business as described in the Pricing Circular
and the Offering Circular and is duly qualified as a foreign corporation or limited liability
company to transact business and is in good standing in each jurisdiction in which such
qualification is required, whether by reason of the ownership or leasing of property or the conduct
of business, except where the failure to so qualify would not, individually or in the aggregate,
reasonably be expected to result in a Material Adverse Effect; except as otherwise disclosed in the
Pricing Circular and the Offering Circular, all of the issued and outstanding capital stock of each
Designated Subsidiary has been duly authorized and validly issued, is fully paid and non-assessable
and is owned by the Company, directly or through subsidiaries, free and clear of any security
interest, mortgage, pledge, lien, encumbrance, claim or equity; none of the outstanding shares of
capital stock of the Designated Subsidiaries was issued in violation of any preemptive or similar
rights of any securityholder of such Designated Subsidiary. Designated Subsidiary means (a) each
Guarantor and (b) each other direct or indirect subsidiary of the Company that holds at least 5% of
the consolidated total assets of the Company or accounts for at least 5% of the consolidated total
revenues of the Company;
(h) The authorized, issued and outstanding capital stock of the Company is as set forth in the
Pricing Circular and the Offering Circular. The shares of issued and outstanding capital stock of
the Company have been duly authorized and validly issued and are fully paid and non-assessable; and
none of the outstanding shares of capital stock of the Company was issued in violation of the
preemptive or other similar rights of any securityholder of the Company;
(i) This Agreement has been duly authorized, executed and delivered by the Company and each of
the Guarantors;
3
(j) The Indenture has been duly authorized, executed and delivered by the Company and each of
the Guarantors and constitutes a valid and binding agreement of the Company and each of the
Guarantors, enforceable against the Company and each of the Guarantors in accordance with its
terms, except as the enforcement thereof may be limited by bankruptcy, insolvency (including,
without limitation, all laws relating to fraudulent transfers), reorganization, moratorium or
similar laws affecting enforcement of creditors rights generally and except as enforcement thereof
is subject to general principles of equity (regardless of whether enforcement is considered in a
proceeding in equity or at law);
(k) The Securities have been duly authorized and, when the notes representing the Securities
are executed and authenticated in the manner provided for in the Indenture and delivered against
payment of the purchase price therefor as provided in this Agreement, will constitute valid and
binding obligations of the Company, enforceable against the Company in accordance with their terms,
except as the enforcement thereof may be limited by bankruptcy, insolvency (including, without
limitation, all laws relating to fraudulent transfers) reorganization, moratorium or similar laws
affecting enforcement of creditors rights generally and except as enforcement thereof is subject
to general principles of equity (regardless of whether enforcement is considered in a proceeding in
equity or at law), and will be in the form contemplated by, and entitled to the benefits of, the
Indenture;
(l) The Guarantees have been duly authorized and, when executed in the manner provided for in
the Indenture as provided in this Agreement, will constitute valid and binding obligations of the
Guarantors, enforceable against the Guarantors in accordance with their terms, except as the
enforcement thereof may be limited by bankruptcy, insolvency (including, without limitation, all
laws relating to fraudulent transfers) reorganization, moratorium or similar laws affecting
enforcement of creditors rights generally and except as enforcement thereof is subject to general
principles of equity (regardless of whether enforcement is considered in a proceeding in equity or
at law), and will be in the form contemplated by, and entitled to the benefits of, the Indenture;
(m) The Securities and the Guarantees will conform in all material respects to the respective
statements relating thereto contained in the Pricing Circular and the Offering Circular and will be
in substantially the respective forms last delivered to you prior to the date of this Agreement;
the Indenture conforms in all material respects to the statements relating thereto contained in the
Pricing Circular and the Offering Circular;
(n) Neither the Company nor any of its subsidiaries is (a) in violation of its charter or
by-laws or (b) in default in the performance or observance of any obligation, agreement, covenant
or condition contained in any contract, indenture, mortgage, deed of trust, loan or credit
agreement, note, lease or other agreement or instrument to which the Company or any of its
subsidiaries is a party or by which it or any of them may be bound, or to which any of the property
or assets of the Company or any of its subsidiaries is subject (collectively, Agreements and
Instruments) except in the case of this clause (b) for defaults that would not, individually or in
the aggregate, reasonably be expected to result in a Material Adverse Effect;
(o) The execution, delivery and performance of this Agreement, the Indenture and the
Securities and any other agreement or instrument entered into or issued or to be entered into or
issued by the Company or the Guarantors in connection with the transactions contemplated hereby or
thereby or in the Pricing Circular and the Offering Circular and the consummation of the
transactions contemplated herein and in the Pricing Circular and the Offering Circular (including
the issuance and
4
sale of the Securities and the use of the proceeds from the sale of the Securities as
described in the Pricing Circular and the Offering Circular under the caption Use of Proceeds)
and compliance by the Company and the Guarantors with their obligations hereunder have been duly
authorized by all necessary corporate or other action and do not and will not, whether with or
without the giving of notice or passage of time or both, conflict with or constitute a breach of,
or default or Repayment Event (as defined below) under, or result in the creation or imposition of
any lien, charge or encumbrance upon any property or assets of the Company or any of its
subsidiaries pursuant to, the Agreements and Instruments except for such conflicts, breaches or
defaults or Repayment Events or liens, charges or encumbrances that would not, individually or in
the aggregate, reasonably be expected to result in a Material Adverse Effect, nor will such action
result in any violation of (x) the provisions of the charter or by-laws of the Company or any of
its subsidiaries or (y) any applicable law, statute, rule, regulation, judgment, order, writ or
decree of any government, government instrumentality or court, domestic or foreign, having
jurisdiction over the Company or any of its subsidiaries or any of their assets, properties or
operations, except in the case of clause (y) above, any such violations that would not,
individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.
As used herein, a Repayment Event means any event or condition which gives the holder of any
note, debenture or other evidence of indebtedness (or any person acting on such holders behalf)
the right to require the repurchase, redemption or repayment of all or a portion of such
indebtedness by the Company or any of its subsidiaries;
(p) No labor dispute with the employees of the Company or any of its subsidiaries exists or,
to the knowledge of the Company, is imminent, and the Company is not aware of any existing or
imminent labor disturbance by the employees of any of its or any subsidiarys principal suppliers,
manufacturers, customers or contractors, except such disputes or disturbances that would not,
individually or in the aggregate, reasonably be expected to have a Material Adverse Effect;
(q) Except as described in the Pricing Circular and the Offering Circular and except such
matters as would not, individually or in the aggregate, reasonably be expected to result in a
Material Adverse Effect, neither the Company nor any of its subsidiaries is in violation of any
federal, state, local or foreign statute, law, rule, regulation, ordinance, code, policy or rule of
common law or any judicial or administrative interpretation thereof, including any judicial or
administrative order, consent, decree or judgment. Except as described in the Pricing Circular and
the Offering Circular, there is no action, suit, proceeding, inquiry or investigation before or
brought by any court or governmental agency or body, domestic or foreign, now pending, or, to the
knowledge of the Company, threatened or contemplated, against or affecting the Company or any of
its subsidiaries that would, individually or in the aggregate, reasonably be expected to result in
a Material Adverse Effect, or which might materially and adversely affect the consummation of the
transactions contemplated by this Agreement or the performance by the Company of its obligations
hereunder. The aggregate of all pending legal or governmental proceedings to which the Company or
any of its subsidiaries is a party or of which any of their respective property or assets is the
subject which are not described in the Pricing Circular and the Offering Circular, including
ordinary routine litigation incidental to the business, could not reasonably be expected to result
in a Material Adverse Effect;
(r) All United States federal income tax returns of the Company and its subsidiaries required
by law to be filed have been filed or extensions thereof have been duly requested and all taxes
shown by such returns or otherwise assessed, which are due and payable, have been paid, except
assessments against which appeals have been or will be promptly taken and as to which adequate
reserves have been provided or where the failure to pay would not, individually or in the
aggregate,
5
reasonably be expected to result in a Material Adverse Effect. The Company and its
subsidiaries have filed all other tax returns that are required to have been filed by them pursuant
to applicable foreign, state, local or other law except insofar as the failure to file such returns
would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse
Effect, and have paid all taxes due pursuant to such returns or pursuant to any assessment received
by the Company and its subsidiaries, except for such taxes, if any, as are being contested in good
faith and as to which adequate reserves have been provided or where the failure to pay would not,
individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.
The charges, accruals and reserves on the books of the Company in respect of any income and
corporation tax liability for any years not finally determined are adequate to meet any assessments
or re-assessments for additional income tax for any years not finally determined, except to the
extent of any inadequacy that would not, individually or in the aggregate, reasonably be expected
to result in a Material Adverse Effect;
(s) The Company and its subsidiaries maintain a system of internal control over financial
reporting (as such term is defined in Rule 13a15(f) of the Exchange Act) that complies with the
requirements of the Exchange Act, designed by, or under the supervision of, the Companys principal
executive officer and principal financial officer, or persons performing similar functions,
sufficient to provide reasonable assurances that (A) transactions are executed in accordance with
managements general or specific authorization, (B) transactions are recorded as necessary to
permit preparation of financial statements for external purposes in conformity with GAAP and to
maintain accountability for assets, (C) access to assets is permitted only in accordance with
managements general or specific authorization and (D) the recorded accountability for assets is
compared with the existing assets at reasonable intervals and appropriate action is taken with
respect to any differences. The Companys internal control over financial reporting is effective
and the Company is not aware of any material weaknesses in its internal control over financial
reporting. Since the date of the latest audited financial statements included or incorporated by
reference in the Pricing Circular, there has been no change in the Companys internal control over
financial reporting that has materially affected, or is reasonably likely to materially affect, the
Companys internal control over financial reporting;
(t) The Company maintains disclosure controls and procedures (as such term is defined in Rule
13a-15(e) under the Exchange Act) that comply with the requirements of the Exchange Act; such
disclosure controls and procedures have been designed to ensure that material information relating
to the Company and its subsidiaries is made known to the Companys principal executive officer and
principal financial officer by others within those entities; and such disclosure controls and
procedures are effective;
(u) The Company and its subsidiaries carry or are entitled to the benefits of insurance, with
financially sound and reputable insurers, in such amounts and covering such risks as is generally
maintained by companies of established repute engaged in the same or similar business, and all such
insurance is in full force and effect;
(v) The Company is, and immediately after the Time of Delivery will be, Solvent. As used
herein, the term Solvent means, with respect to the Company on a particular date, that on such
date (A) the fair market value of the assets of the Company is greater than the total amount of
liabilities (including contingent liabilities) of the Company, (B) the present fair salable value
of the assets of the Company is greater than the amount that will be required to pay the probable
liabilities of the Company on its debts as they become absolute and matured, (C) the Company is
able to realize upon
6
its assets and pay its debts and other liabilities, including contingent obligations, as they
mature, and (D) the Company does not have unreasonably small capital;
(w) Neither the Company nor any affiliate of the Company has taken, nor will the Company or
any affiliate take, directly or indirectly, any action which is designed to or which has
constituted or which would be expected to cause or result in stabilization or manipulation of the
price of any security of the Company to facilitate the sale or resale of the Securities;
(x) Except as described in the Pricing Disclosure Package and the Offering Circular, the
Company and its subsidiaries own or possess, or can acquire on reasonable terms, adequate patents,
patent rights, licenses, inventions, copyrights, know-how (including trade secrets and other
unpatented and/or unpatentable proprietary or confidential information, systems or procedures),
trademarks, service marks, trade names or other intellectual property (collectively, Intellectual
Property) necessary to carry on the business now operated by them, and neither the Company nor any
of its subsidiaries has received any notice or is otherwise aware of any infringement of or
conflict with asserted rights of others with respect to any Intellectual Property or of any facts
or circumstances which would render any Intellectual Property invalid or inadequate to protect the
interest of the Company or any of its subsidiaries therein, and which infringement or conflict (if
the subject of any unfavorable decision, ruling or finding) or invalidity or inadequacy would,
individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect;
(y) Except as disclosed in the Pricing Circular and the Offering Circular and other than
registration or qualification under state securities or blue sky laws in connection with the offer
and sale of the Securities, no filing with, or authorization, approval, consent, license, order,
registration, qualification or decree of, any court or governmental authority or agency is
necessary or required for the performance by the Company of its obligations hereunder, in
connection with the offering, issuance or sale of the Securities hereunder or the consummation of
the transactions contemplated by this Agreement or for the due execution, delivery or performance
of the Indenture by the Company and the Guarantors, except such as have been already obtained;
(z) Except as described in the Pricing Circular and the Offering Circular, the Company and its
subsidiaries possess such permits, licenses, approvals, consents and other authorizations
(collectively, Governmental Licenses) issued by the appropriate federal, state, local or foreign
regulatory agencies or bodies necessary to conduct the business now operated by them, except where
the failure to so possess would not, individually or in the aggregate, reasonably be expected to
result in a Material Adverse Effect; the Company and its subsidiaries are in compliance with the
terms and conditions of all such Governmental Licenses, except where the failure to so comply would
not, individually or in the aggregate, reasonably be expected to result in a Material Adverse
Effect; all of the Governmental Licenses are valid and in full force and effect, except where the
invalidity of such Governmental Licenses or the failure of such Governmental Licenses to be in full
force and effect would not, individually or in the aggregate, reasonably be expected to result in a
Material Adverse Effect; and neither the Company nor any of its subsidiaries has received any
notice of proceedings relating to the revocation or modification of any such Governmental Licenses
which, individually or in the aggregate, if the subject of an unfavorable decision, ruling or
finding, would reasonably be expected to result in a Material Adverse Effect;
(aa) The Company and its subsidiaries have good and marketable title to all real property
owned by the Company and its subsidiaries and good and marketable title to all other properties
7
owned by them, in each case, free and clear of all mortgages, pledges, liens, security
interests, claims, restrictions or encumbrances of any kind except such as (a) are described in the
Pricing Circular and the Offering Circular or (b) do not, individually or in the aggregate,
materially affect the value of such property and do not interfere with the use made and proposed to
be made of such property by the Company or any of its subsidiaries; and all of the leases and
subleases under which the Company or any of its subsidiaries holds properties described in the
Pricing Circular and the Offering Circular, are in full force and effect, except where the failure
of such lease or sublease to be in full force and effect would not, individually or in the
aggregate, reasonably be expected to result in a Material Adverse Effect, and neither the Company
nor any of its subsidiaries has any notice of any material claim of any sort that has been asserted
by anyone adverse to the rights of the Company or any of its subsidiaries under any of the leases
or subleases mentioned above, or affecting or questioning the rights of the Company or any
subsidiary thereof to the continued possession of the leased or subleased premises under any such
lease or sublease;
(bb) Except as would not, individually or in the aggregate, reasonably be expected to result
in a Material Adverse Effect, no supplier of merchandise to the Company or any of its subsidiaries
has ceased shipments of merchandise to the Company;
(cc) Except as described in the Pricing Circular and the Offering Circular and except such
matters as would not, individually or in the aggregate, reasonably be expected to result in a
Material Adverse Effect, (A) neither the Company nor any of its subsidiaries is in violation of any
federal, state, local or foreign statute, law, rule, regulation, ordinance, code, policy or rule of
common law or any judicial or administrative interpretation thereof, including any judicial or
administrative order, consent, decree or judgment, relating to pollution or protection of human
health, the environment (including, without limitation, ambient air, surface water, groundwater,
land surface or subsurface strata) or wildlife, including, without limitation, laws and regulations
relating to the release or threatened release of chemicals, pollutants, contaminants, wastes, toxic
substances, hazardous substances, petroleum or petroleum products, asbestos-containing materials or
mold (collectively, Hazardous Materials) or to the manufacture, processing, distribution, use,
treatment, storage, disposal, transport or handling of Hazardous Materials (collectively,
Environmental Laws), (B) the Company and its subsidiaries have all permits, authorizations and
approvals required under any applicable Environmental Laws and are each in compliance with their
requirements, (C) there are no pending or, to the Companys knowledge, threatened administrative,
regulatory or judicial actions, suits, demands, demand letters, claims, liens, notices of
noncompliance or violation, investigation or proceedings relating to any Environmental Law against
the Company or any of its subsidiaries and (D) there are no events or circumstances that would
reasonably be expected to form the basis of an order for clean-up or remediation, or any action,
suit or proceeding by any private party or governmental body or agency, against or affecting the
Company or any of its subsidiaries relating to Hazardous Materials or Environmental Laws;
(dd) The Company is not required, and upon the issuance and sale of the Securities as herein
contemplated and the application of the net proceeds therefrom as described in the Pricing Circular
and the Offering Circular will not be required, to register as an investment company under the
Investment Company Act of 1940, as amended (the Investment Company Act);
(ee) Neither the Company nor any of its affiliates, as such term is defined in Rule 501(b) of
Regulation D under the Securities Act (Regulation D) (each, an Affiliate), has, directly or
indirectly, solicited any offer to buy, sold or offered to sell or otherwise negotiated in respect
of, nor will, directly
8
or indirectly, solicit any offer to buy, sell or offer to sell or otherwise negotiate in
respect of, in the United States or to any United States citizen or resident, any security which is
or would be integrated with the sale of the Securities or the Guarantees in a manner that would
require the Securities or the Guarantees to be registered under the Securities Act;
(ff) The Securities are eligible for resale pursuant to Rule 144A and will not be, at the Time
of Delivery, of the same class (within the meaning of Rule 144A of the Securities Act) as
securities listed on a national securities exchange registered under Section 6 of the Exchange Act
or quoted in a U.S. automated interdealer quotation system;
(gg) None of the Company, its Affiliates or any person acting on its or any of their behalf
(other than you, as to whom the Company makes no representation) has engaged or will engage, in
connection with the offering of the Securities, in any form of general solicitation or general
advertising within the meaning of Rule 502(c) under the Securities Act, or, with respect to
Securities sold outside the United States to non-U.S. persons (as defined in Rule 902 under the
Securities Act), by means of any directed selling efforts within the meaning of Rule 902 under the
Securities Act and the Company, any Affiliate of the Company and any person acting on its or any of
their behalf (other than you, as to whom the Company makes no representation) has complied with and
will implement the offering restrictions within the meaning of such Rule 902;
(hh) Subject to compliance by (i) you with the representations and warranties set forth in
Section 3 and (ii) the Purchasers under and as defined in that certain purchase agreement, dated
as of May 12, 2010, among the Company, the Guarantors and you, as representative of the several
Purchasers named therein (the May Purchase Agreement), with the representations, warranties and
covenants set forth in Section 3 of the May Purchase Agreement, it is not necessary in connection
with the offer, sale and delivery of the Securities to you and to each subsequent purchaser in the
manner contemplated by this Agreement, the Pricing Circular and the Offering Circular to register
the Securities under the Securities Act or to qualify the Indenture under the Trust Indenture Act
of 1939, as amended;
(ii) The statements set forth in the Pricing Circular and Offering Circular under the caption
Description of Notes, insofar as they purport to constitute a summary of the terms of the
Securities, are accurate, complete and fair in all material respects;
(jj) The Company is subject to Section 13 or 15(d) of the Exchange Act;
(kk) Except as would not, individually or in the aggregate, reasonably be expected to result
in a Material Adverse Effect, (a) none of the Company, any of its subsidiaries or, to the knowledge
of the Company, any director, officer, agent, employee or affiliate is aware of or has taken any
action, directly or indirectly, that would result in a violation by such persons of the Foreign
Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (the FCPA);
and (b) the Company and, to the knowledge of the Company, its affiliates have conducted their
businesses in compliance with the FCPA and have instituted and maintain policies and procedures
designed to ensure, and which are reasonably expected to continue to ensure, continued compliance
therewith; and
(ll) None of the Company, any of its subsidiaries or, to the knowledge of the Company, any
director, officer, agent, employee or affiliate is currently subject to any U.S. sanctions
administered by
9
the Office of Foreign Assets Control of the U.S. Treasury Department (OFAC) except as would
not, individually or in the aggregate, reasonably be expected to result in a Material Adverse
Effect; and the Company will not directly or indirectly use the proceeds of the sale of the
Securities, or lend, contribute or otherwise make available such proceeds to any of its
subsidiaries, joint venture partners or other person, for the purpose of financing the activities
of any person currently subject to any U.S. sanctions administered by OFAC.
2. |
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Subject to the terms and conditions herein set forth, the Company agrees to issue and sell to
you, and you agree to purchase from the Company, at a purchase price of 104.600% of the principal
amount thereof, $300,000,000 principal amount of the 2020 Notes. |
3. |
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Upon the authorization by you of the release of the Securities, you propose to offer the
Securities for sale upon the terms and conditions set forth in this Agreement and the Offering
Circular and you hereby represent and warrant to, and agree with the Company and each
Guarantor that: |
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(a) |
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You will offer and sell the Securities only to: (i) persons who you reasonably believe
are qualified institutional buyers (QIBs) within the meaning of Rule 144A under the
Securities Act in transactions meeting the requirements of Rule 144A or (ii) upon the terms
and conditions set forth in Annex I to this Agreement; |
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(b) |
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You are an Institutional Accredited Investor within the meaning of Rule 501(a) under
the Securities Act; and |
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(c) |
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You will not offer or sell the Securities by any form of general solicitation or
general advertising, including but not limited to the methods described in Rule 502(c)
under the Securities Act. |
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4. |
(a) |
The Securities to be purchased by you hereunder will be represented by one or more
definitive global Securities in book-entry form which will be deposited by or on behalf of the
Company with The Depository Trust Company (DTC) or its designated custodian. The Company
will deliver the Securities to you, for your account, against payment by or on behalf of you
of the purchase price therefor by wire transfer in Federal (same day) funds, by causing DTC to
credit the Securities to your account at DTC. The Company will cause the certificates
representing the Securities to be made available to you for checking at least twenty-four
hours prior to the Time of Delivery (as defined below) at the office of Latham & Watkins LLP,
885 Third Avenue, New York, NY 10022-4834 (the Closing Location). The time and date of such
delivery and payment shall be 9:30 a.m., New York City time, on August 13, 2010 or such other
time and date as you and the Company may agree upon in writing. Such time and date are herein
called the Time of Delivery. |
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(b) |
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The documents to be delivered at the Time of Delivery by or on behalf of the parties
hereto pursuant to Section 8 hereof, including the cross-receipt for the Securities and any
additional documents requested by you pursuant to Section 8(g) hereof, will be delivered at
such time and date at the Closing Location, and the Securities will be delivered at DTC or
its designated custodian, all at the Time of Delivery. A meeting will be held at the
Closing Location at 5:00 p.m., New York City time, on the New York Business Day next
preceding the Time of Delivery, at which meeting the final drafts of the documents to be
delivered pursuant to the preceding sentence will be available for review by the parties
hereto. For the
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10
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purposes of this Section 4, New York Business Day shall mean each Monday, Tuesday,
Wednesday, Thursday and Friday which is not a day on which banking institutions in New
York are generally authorized or obligated by law or executive order to close. |
5. |
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The Company and each Guarantor agree, jointly and severally, with you: |
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(a) |
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To prepare the Offering Circular in a form approved by you; to make no amendment or any
supplement to the Offering Circular which shall be disapproved by you promptly after
reasonable notice thereof; and to furnish you with copies thereof; |
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(b) |
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Promptly from time to time to take such action as you may reasonably request to qualify
the Securities for offering and sale under the securities laws of such jurisdictions as you
may request and to comply with such laws so as to permit the continuance of sales and
dealings therein in such jurisdictions for as long as may be necessary to complete the
distribution of the Securities, provided that in connection therewith the Company shall not
be required to qualify as a foreign corporation or to file a general consent to service of
process in any jurisdiction or to subject itself to taxation as a foreign corporation in
such jurisdiction if it is not otherwise so subject; |
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(c) |
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To furnish you with written and electronic copies thereof in such quantities as you may
from time to time reasonably request, and if, at any time prior to the expiration of nine
months after the date of the Offering Circular, any event shall have occurred as a result
of which the Offering Circular as then amended or supplemented would include an untrue
statement of a material fact or omit to state any material fact necessary in order to make
the statements therein, in the light of the circumstances under which they were made when
such Offering Circular is delivered, not misleading, or, if for any other reason it shall
be necessary or desirable during such same period to amend or supplement the Offering
Circular, to notify you and upon your request to prepare and furnish without charge to you
and to any dealer in securities as many written and electronic copies as you may from time
to time reasonably request of an amended Offering Circular or a supplement to the Offering
Circular which will correct such statement or omission or effect such compliance; |
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(d) |
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During the period beginning from the date hereof and continuing until the date 90 days
after the Time of Delivery, not to offer, sell, contract to sell or otherwise dispose of,
except as provided hereunder any securities of the Company that are substantially similar
to the Securities without your prior written consent; |
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(e) |
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Not to be or become, at any time prior to the expiration of two years after the Time of
Delivery, an open-end investment company, unit investment trust, closed-end investment
company or face-amount certificate company that is or is required to be registered under
Section 8 of the Investment Company Act; |
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(f) |
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At any time when the Company is not subject to Section 13 or 15(d) of the Exchange Act,
for the benefit of holders from time to time of Securities, to furnish at its expense, upon
request, to holders of Securities and prospective purchasers of securities information (the
Additional Issuer Information) satisfying the requirements of subsection (d)(4)(i) of
Rule 144A under the Securities Act; |
11
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(g) |
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Until the offering of the Securities is complete, the Company will file all documents
required to be filed with the Commission pursuant to the Exchange Act within the time
periods required by the Exchange Act; |
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(h) |
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During the one year period after the Time of Delivery, the Company will not, and will
not permit any of its affiliates (as defined in Rule 144 under the Securities Act) to,
resell any of the Securities which constitute restricted securities under Rule 144 that
have been reacquired by any of them; and |
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(i) |
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To use the net proceeds received by it from the sale of the Securities pursuant to this
Agreement in the manner specified in the Pricing Circular under the caption Use of
Proceeds. |
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(a) |
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The Company and each Guarantor represent and agree that, without your prior consent, it
has not made and will not make any offer relating to the Securities that, if the offering
of the Securities contemplated by this Agreement were conducted as a public offering
pursuant to a registration statement filed under the Securities Act with the Commission,
would constitute an issuer free writing prospectus, as defined in Rule 433 under the
Securities Act (any such offer is hereinafter referred to as a Company Supplemental
Disclosure Document); |
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(b) |
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You represent and agree that, without the prior consent of the Company, other than one
or more term sheets relating to the Securities containing customary information and
conveyed to purchasers of securities, you have not made and will not make any offer
relating to the Securities that, if the offering of the Securities contemplated by this
Agreement were conducted as a public offering pursuant to a registration statement filed
under the Securities Act with the Commission, would constitute a free writing prospectus,
as defined in Rule 405 under the Securities Act (any such offer (other than any such term
sheets), is hereinafter referred to as a Purchaser Supplemental Disclosure Document); and |
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(c) |
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Any Company Supplemental Disclosure Document or Purchaser Supplemental Disclosure
Document, the use of which has been consented to by the Company and you, is listed on
Schedule I(b) hereto. |
7. |
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The Company and each Guarantor, jointly and severally, covenant and agree with you that the
Company will pay or cause to be paid the following: (i) the fees, disbursements and expenses
of the Companys and the Guarantors counsel and accountants in connection with the issue of
the Securities and all other expenses in connection with the preparation, printing,
reproduction and filing of the Preliminary Offering Circular and the Offering Circular and any
amendments and supplements thereto and the mailing and delivering of copies thereof to you and
the dealers; (ii) the cost of printing or producing, this Agreement, the Indenture, the Blue
Sky Memorandum, closing documents (including any compilations thereof) and any other documents
in connection with the offering, purchase, sale and delivery of the Securities; (iii) all
expenses in connection with the qualification of the Securities for offering and sale under
state securities laws as provided in Section 5(b) hereof, including the reasonable fees and
disbursements of counsel for you in connection with such qualification and in connection with
the Blue Sky and legal investment surveys; (iv) any fees charged by securities rating services
for rating the Securities; (v) the cost of preparing the Securities; (vi) the fees and
expenses of the Trustee and any agent
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of the Trustee and the fees and disbursements of counsel for the Trustee in connection with
the Indenture and the Securities; and (vii) all other costs and expenses incident to the
performance of its obligations hereunder which are not otherwise specifically provided for in
this Section. It is understood, however, that, except as provided in this Section, and
Sections 9 and 11 hereof, you will pay all of your own costs and expenses, including the fees
of your counsel, transfer taxes on resale of any of the Securities by you, and any advertising
expenses connected with any offers you may make. |
8. |
|
Your obligations hereunder shall be subject, in your discretion, to the condition that all
representations and warranties and other statements of the Company and each Guarantor herein
are, at and as of the Time of Delivery, true and correct, the condition that the Company and
each Guarantor shall have performed all of its obligations hereunder theretofore to be
performed, and the following additional conditions: |
|
(a) |
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Latham & Watkins LLP, counsel for you, shall have furnished to you its opinion and
negative assurance letter, in each case dated the Time of Delivery, in form and substance
acceptable to you, and such counsel shall have received such papers and information as they
may reasonably request to enable them to pass upon such matters; |
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(b) |
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(i) Skadden, Arps, Slate, Meagher & Flom LLP, counsel for the Company and the
Guarantors, shall have furnished to you their written opinions and negative assurance
letter, dated the Time of Delivery, satisfactory to you and substantially in the form set
forth in Exhibit A hereto; and (ii) Kristin Kolesar, Senior Vice President and
Global General Counsel, Operations of the Company shall have furnished to you her written
opinion, dated the Time of Delivery, satisfactory to you and substantially in the form set
forth in Exhibit B hereto; |
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(c) |
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On the date of the Offering Circular prior to the execution of this Agreement and also
at the Time of Delivery, Deloitte & Touche LLP shall have furnished to you a letter or
letters, dated the respective dates of delivery thereof, in form and substance satisfactory
to you; |
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(d) |
|
(i) Neither the Company nor any of its subsidiaries shall have sustained since the date
of the latest audited financial statements included in the Pricing Circular any loss or
interference with its business from fire, explosion, flood or other calamity, whether or
not covered by insurance, or from any labor dispute or court or governmental action, order
or decree, otherwise than as set forth or contemplated in the Pricing Circular and the
Offering Circular, and (ii) since the respective dates as of which information is given in
the Pricing Circular and the Offering Circular there shall not have been any change in the
capital stock or long-term debt of the Company or any of its subsidiaries or any change, or
any development involving a prospective change, in or affecting the general affairs,
management, financial position, stockholders equity or results of operations of the
Company and its subsidiaries, otherwise than as set forth or contemplated in the Pricing
Circular and the Offering Circular, the effect of which, in any such case described in
clause (i) or (ii), is in your judgment so material and adverse as to make it impracticable
or inadvisable to proceed with the offering or the delivery of the Securities on the terms
and in the manner contemplated in this Agreement and in the Offering Circular; |
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(e) |
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On or after the Applicable Time (i) no downgrading shall have occurred in the rating
accorded the Companys outstanding indebtedness by any nationally recognized statistical
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rating organization, as that term is defined by the Commission for purposes of Rule
436(g)(2) under the Securities Act, and (ii) no such organization shall have publicly
announced that it has under surveillance or review, with possible negative implications,
its rating of any of the Companys outstanding indebtedness; |
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(f) |
|
On or after the Applicable Time there shall not have occurred any of the following: (i)
a suspension or material limitation in trading in securities generally on the New York
Stock Exchange or on NASDAQ; (ii) a suspension or material limitation in trading in the
Companys securities on NASDAQ; (iii) a general moratorium on commercial banking activities
declared by either Federal or New York State authorities or a material disruption in
commercial banking or securities settlement or clearance services in the United States;
(iv) the outbreak or escalation of hostilities involving the United States or the
declaration by the United States of a national emergency or war or (v) the occurrence of
any other calamity or crisis or any change in financial, political or economic conditions
in the United States or elsewhere, if the effect of any such event specified in clause (iv)
or (v) in your judgment makes it impracticable or inadvisable to proceed with the offering
or the delivery of the Securities on the terms and in the manner contemplated in the
Offering Circular; and |
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(g) |
|
The Company and the Guarantors shall have furnished or caused to be furnished to you at
the Time of Delivery certificates of officers of the Company and the Guarantors
satisfactory to you as to the accuracy of the representations and warranties of the Company
and the Guarantors herein at and as of such Time of Delivery, as to the performance by the
Company and the Guarantors of all of their obligations hereunder to be performed at or
prior to such Time of Delivery, as to the matters set forth in subsection (d) of this
Section and as to such other matters as you may reasonably request. |
|
9. |
(a) |
The Company and the Guarantors will, jointly and severally, indemnify you and hold you
harmless against any losses, claims, damages or liabilities, joint or several, to which you
may become subject, under the Securities Act or otherwise, insofar as such losses, claims,
damages or liabilities (or actions in respect thereof) arise out of or are based upon an
untrue statement or alleged untrue statement of a material fact contained in any Preliminary
Offering Circular, the Pricing Circular, the Offering Circular, or any amendment or supplement
thereto, any Company Supplemental Disclosure Document, or arise out of or are based upon the
omission or alleged omission to state therein a material fact necessary to make the statements
therein not misleading, and will reimburse you for any legal or other expenses reasonably
incurred by you in connection with investigating or defending any such action or claim as such
expenses are incurred; provided, however, that the Company shall not be liable in any such
case to the extent that any such loss, claim, damage or liability arises out of or is based
upon an untrue statement or alleged untrue statement or omission or alleged omission made in
any Preliminary Offering Circular, the Pricing Circular, the Offering Circular or any such
amendment or supplement, or any Company Supplemental Disclosure Document, in reliance upon and
in conformity with written information furnished to the Company by you expressly for use
therein. |
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(b) |
|
You will indemnify and hold harmless the Company and the Guarantors against any losses,
claims, damages or liabilities to which such parties may become subject, under the
Securities Act or otherwise, insofar as such losses, claims, damages or liabilities (or
actions in respect thereof) arise out of or are based upon an untrue statement or alleged
untrue
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14
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statement of a material fact contained in any Preliminary Offering Circular, the Pricing
Circular, the Offering Circular, or any amendment or supplement thereto, or any Company
Supplemental Disclosure Document, or arise out of or are based upon the omission or
alleged omission to state therein a material fact or necessary to make the statements
therein not misleading, in each case to the extent, but only to the extent, that such
untrue statement or alleged untrue statement or omission or alleged omission was made in
any Preliminary Offering Circular, the Pricing Circular, the Offering Circular or any such
amendment or supplement, or any Company Supplemental Disclosure Document in reliance upon
and in conformity with written information furnished to the Company or any Guarantor by
you expressly for use therein; and you will reimburse the Company and the Guarantors for
any legal or other expenses reasonably incurred by the Company or the Guarantors in
connection with investigating or defending any such action or claim as such expenses are
incurred. |
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(c) |
|
Promptly after receipt by an indemnified party under subsection (a) or (b) above of
notice of the commencement of any action, such indemnified party shall, if a claim in
respect thereof is to be made against the indemnifying party under such subsection, notify
the indemnifying party in writing of the commencement thereof; but the omission so to
notify the indemnifying party shall not relieve it from any liability which it may have to
any indemnified party otherwise than under such subsection. In case any such action shall
be brought against any indemnified party and it shall notify the indemnifying party of the
commencement thereof, the indemnifying party shall be entitled to participate therein and,
to the extent that it shall wish, jointly with any other indemnifying party similarly
notified, to assume the defense thereof, with counsel satisfactory to such indemnified
party (who shall not, except with the consent of the indemnified party, be counsel to the
indemnifying party), and, after notice from the indemnifying party to such indemnified
party of its election so to assume the defense thereof, the indemnifying party shall not be
liable to such indemnified party under such subsection for any legal expenses of other
counsel or any other expenses, in each case subsequently incurred by such indemnified
party, in connection with the defense thereof other than reasonable costs of investigation.
No indemnifying party shall, without the written consent of the indemnified party, effect
the settlement or compromise of, or consent to the entry of any judgment with respect to,
any pending or threatened action or claim in respect of which indemnification or
contribution may be sought hereunder (whether or not the indemnified party is an actual or
potential party to such action or claim) unless such settlement, compromise or judgment (i)
includes an unconditional release of the indemnified party from all liability arising out
of such action or claim and (ii) does not include a statement as to, or an admission of,
fault, culpability or a failure to act, by or on behalf of any indemnified party. |
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(d) |
|
If the indemnification provided for in this Section 9 is unavailable to or insufficient
to hold harmless an indemnified party under subsection (a) or (b) above in respect of any
losses, claims, damages or liabilities (or actions in respect thereof) referred to therein,
then each indemnifying party shall contribute to the amount paid or payable by such
indemnified party as a result of such losses, claims, damages or liabilities (or actions in
respect thereof) in such proportion as is appropriate to reflect the relative benefits
received by the Company and the Guarantors on the one hand you on the other from the
offering of the Securities. If, however, the allocation provided by the immediately
preceding sentence is not permitted by applicable law or if the indemnified party failed to
give the notice required under subsection (c) above, then each indemnifying party shall
contribute to such amount paid or payable by
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such indemnified party in such proportion as is appropriate to reflect not only such
relative benefits but also the relative fault of the Company and the Guarantors on the one
hand and you on the other in connection with the statements or omissions which resulted in
such losses, claims, damages or liabilities (or actions in respect thereof), as well as
any other relevant equitable considerations. The relative benefits received by the
Company and the Guarantors on the one hand and you on the other shall be deemed to be in
the same proportion as the total net proceeds from the offering (before deducting
expenses) received by the Company and the Guarantors bear to the total underwriting
discounts and commissions received by you, in each case as set forth in the Offering
Circular. The relative fault shall be determined by reference to, among other things,
whether the untrue or alleged untrue statement of a material fact or the omission or
alleged omission to state a material fact relates to information supplied by the Company
and the Guarantors on the one hand or you on the other and the parties relative intent,
knowledge, access to information and opportunity to correct or prevent such statement or
omission. The Company, the Guarantors and you agree that it would not be just and
equitable if contribution pursuant to this subsection (d) were determined by pro rata
allocation or by any other method of allocation which does not take account of the
equitable considerations referred to above in this subsection (d). The amount paid or
payable by an indemnified party as a result of the losses, claims, damages or liabilities
(or actions in respect thereof) referred to above in this subsection (d) shall be deemed
to include any legal or other expenses reasonably incurred by such indemnified party in
connection with investigating or defending any such action or claim. Notwithstanding the
provisions of this subsection (d), you shall not be required to contribute any amount in
excess of the amount by which the total price at which the Securities underwritten by you
and distributed to investors were offered to investors exceeds the amount of any damages
which you have otherwise been required to pay by reason of such untrue or alleged untrue
statement or omission or alleged omission. |
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(e) |
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The obligations of the Company and the Guarantors under this Section 9 shall be in
addition to any liability which the Company and the Guarantors may otherwise have and shall
extend, upon the same terms and conditions, to any of your affiliates and each person, if
any, who controls you within the meaning of the Securities Act; and your obligations under
this Section 9 shall be in addition to any liability which you may otherwise have and shall
extend, upon the same terms and conditions, to each officer and director of the Company or
any Guarantor and to each person, if any, who controls the Company or any Guarantor within
the meaning of the Securities Act. |
10. |
|
The respective indemnities, agreements, representations, warranties and other statements of
the Company, the Guarantors and you, set forth in this Agreement or made by or on behalf of
them, respectively, pursuant to this Agreement, shall remain in full force and effect,
regardless of any investigation (or any statement as to the results thereof) made by or on
behalf of you or any controlling person of you, or the Company or any Guarantor, or any
officer or director or controlling person of the Company or any Guarantor, and shall survive
delivery of and payment for the Securities. |
11. |
|
If this Agreement shall be terminated for any reason and the Securities are not delivered by
or on behalf of the Company and the Guarantors as provided herein, the Company and the
Guarantors will reimburse you for all expenses approved in writing by you, including fees and
disbursements of counsel, reasonably incurred by you in making preparations for the purchase,
sale and delivery
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of the Securities, but the Company and the Guarantors shall then be under no further liability
to you except as provided in Sections 7 and 9 hereof. |
12. |
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All statements, requests, notices and agreements hereunder shall be in writing, and if to you
shall be delivered or sent by mail, telex or facsimile transmission to Goldman, Sachs & Co. at
200 West Street, New York, New York 10282-2198, Attention: Registration Department;
and if to the Company shall be delivered or sent by mail, telex or facsimile transmission to
the address of the Company set forth in the Offering Circular, Attention: Secretary. Any such
statements, requests, notices or agreements shall take effect upon receipt thereof. |
In accordance with the requirements of the USA Patriot Act (Title III of Pub. L. 107-56 (signed
into law October 26, 2001)), you are required to obtain, verify and record information that
identifies your clients, including the Company, which information may include the name and address
of your clients, as well as other information that will allow you to properly identify your
clients.
13. |
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This Agreement shall be binding upon, and inure solely to the benefit of, you, the Company,
the Guarantors and, to the extent provided in Sections 9 and 10 hereof, the officers and
directors of the Company and the Guarantors and each person who controls the Company, any
Guarantor or you, and their respective heirs, executors, administrators, successors and
assigns, and no other person shall acquire or have any right under or by virtue of this
Agreement. No purchaser of any of the Securities from you shall be deemed a successor or
assign by reason merely of such purchase. |
14. |
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Time shall be of the essence of this Agreement. |
15. |
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The Company and each Guarantor acknowledge and agree that (i) the purchase and sale of the
Securities pursuant to this Agreement is an arms-length commercial transaction between the
Company and the Guarantors, on the one hand, and you, on the other, (ii) in connection
therewith and with the process leading to such transaction you are acting solely as a
principal and not the agent or fiduciary of the Company or any Guarantor, (iii) you have not
assumed an advisory or fiduciary responsibility in favor of the Company or any Guarantor with
respect to the offering contemplated hereby or the process leading thereto (irrespective of
whether you have advised or are currently advising the Company or any Guarantor on other
matters) or any other obligation to the Company or any Guarantor except the obligations
expressly set forth in this Agreement and (iv) the Company and the Guarantors have consulted
their own legal and financial advisors to the extent they have deemed appropriate. The
Company and the Guarantors agree that they will not claim that you, or any of them, have
rendered advisory services of any nature or respect, or owe a fiduciary or similar duty to the
Company or any Guarantor, in connection with such transaction or the process leading thereto. |
16. |
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This Agreement supersedes all prior agreements and understandings (whether written or oral)
between the Company, the Guarantors and you, or any of them, with respect to the subject
matter hereof. |
17. |
|
THIS AGREEMENT AND ANY MATTERS RELATED TO THIS TRANSACTION SHALL BE GOVERNED BY AND CONSTRUED
IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK WITHOUT REGARD TO PRINCIPLES OF CONFLICT
OF LAWS THAT WOULD RESULT IN THE APPLICATION OF ANY LAW OTHER THAN THE LAWS OF THE STATE OF
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NEW YORK. The Company and the Guarantors agree that any suit or proceeding arising in respect
of this agreement or our engagement will be tried exclusively in the U.S. District Court for the
Southern District of New York or, if that court does not have subject matter jurisdiction, in
any state court located in The City and County of New York and the Company agrees to submit to
the jurisdiction of, and to venue in, such courts. |
18. |
|
The Company, the Guarantors and you hereby irrevocably waive, to the fullest extent permitted
by applicable law, any and all right to trial by jury in any legal proceeding arising out of
or relating to this Agreement or the transactions contemplated hereby. |
19. |
|
This Agreement may be executed by any one or more of the parties hereto in any number of
counterparts, each of which shall be deemed to be an original, but all such respective
counterparts shall together constitute one and the same instrument. |
20. |
|
Notwithstanding anything herein to the contrary, the Company (and the Companys employees,
representatives, and other agents) are authorized to disclose to any and all persons, the tax
treatment and tax structure of the potential transaction and all materials of any kind
(including tax opinions and other tax analyses) provided to the Company relating to that
treatment and structure, without your imposing any limitation of any kind. However, any
information relating to the tax treatment and tax structure shall remain confidential (and the
foregoing sentence shall not apply) to the extent necessary to enable any person to comply
with securities laws. For this purpose, tax treatment means US federal and state income tax
treatment, and tax structure is limited to any facts that may be relevant to that treatment. |
[Remainder of page intentionally left blank]
18
If the foregoing is in accordance with your understanding, please sign and return to us
counterparts hereof, and upon the acceptance hereof by you, this letter and such acceptance hereof
shall constitute a binding agreement among you and the Company and each Guarantor.
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Very truly yours,
MYLAN INC.
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By: |
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Name: |
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Title: |
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BERTEK INTERNATIONAL, INC.
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By: |
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Name: |
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Title: |
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DEY, INC.
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By: |
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Name: |
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DEY PHARMA, L.P.
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By: |
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Title: |
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DEY LIMITED PARTNER, INC.
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By: |
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Name: |
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Title: |
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EMD, INC.
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By: |
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Name: |
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MLRE LLC
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By: |
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Title: |
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MP AIR INC.
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MYLAN BERTEK PHARMACEUTICALS INC.
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MYLAN CARIBE, INC.
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MYLAN DELAWARE INC.
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MYLAN LLC
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MYLAN LHC INC.
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MYLAN PHARMACEUTICALS INC.
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MYLAN TECHNOLOGIES INC.
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UDL LABORATORIES, INC.
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Accepted as of the date hereof:
GOLDMAN, SACHS & CO.
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By: |
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(Goldman, Sachs & Co.) |
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21
exv31w1
Exhibit 31.1
Certification
of Principal Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
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I,
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Robert J.
Coury, certify that:
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1. I have reviewed this quarterly report on
Form 10-Q
of Mylan Inc.;
2. Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and
other financial information included in this report, fairly
present in all material respects the financial condition,
results of operations and cash flows of the registrant as of,
and for, the period[s] presented in this report;
4. The registrants other certifying officer and I are
responsible for establishing and maintaining disclosure controls
and procedures (as defined in Exchange Act
Rules 13a-15(e)
and
15d-15(e))
and internal control over financial reporting (as defined in
Exchange Act
Rules 13a-15(f)
and
15d-15(f))
for the registrant and have:
a) designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information
relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being prepared;
b) designed such internal control over financial reporting,
or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrants
disclosure controls and procedures and presented in this report
our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d) disclosed in this report any change in the
registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably
likely to materially affect, the registrants internal
control over financial reporting;
5. The registrants other certifying officer and I
have disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrants
auditors and the audit committee of registrants board of
directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in
the design or operation of internal controls over financial
reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and
report financial information; and
b) any fraud, whether or not material, that involves
management or other employees who have a significant role in the
registrants internal control over financial reporting.
Robert J. Coury
Chairman and Chief Executive Officer
(Principal Executive Officer)
Date: October 27, 2010
exv31w2
Exhibit 31.2
Certification
of Principal Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
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I,
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John D.
Sheehan, certify that:
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1. I have reviewed this quarterly report on
Form 10-Q
of Mylan Inc.;
2. Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and
other financial information included in this report, fairly
present in all material respects the financial condition,
results of operations and cash flows of the registrant as of,
and for, the period[s] presented in this report;
4. The registrants other certifying officer and I are
responsible for establishing and maintaining disclosure controls
and procedures (as defined in Exchange Act
Rules 13a-15(e)
and
15d-15(e))
and internal control over financial reporting (as defined in
Exchange Act
Rules 13a-15(f)
and
15d-15(f))
for the registrant and have:
a) designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information
relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being prepared;
b) designed such internal control over financial reporting,
or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrants
disclosure controls and procedures and presented in this report
our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d) disclosed in this report any change in the
registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably
likely to materially affect, the registrants internal
control over financial reporting;
5. The registrants other certifying officer and I
have disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrants
auditors and the audit committee of registrants board of
directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in
the design or operation of internal controls over financial
reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and
report financial information; and
b) any fraud, whether or not material, that involves
management or other employees who have a significant role in the
registrants internal control over financial reporting.
John D. Sheehan
Executive Vice President and
Chief Financial Officer
(Principal Financial Officer)
Date: October 27, 2010
exv32
Exhibit 32
Certification
of Principal Executive Officer and Principal Financial Officer
Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report on
Form 10-Q
of Mylan Inc. (the Company) for the period ended
September 30, 2010 as filed with the Securities and
Exchange Commission on the date hereof (the Report),
each of the undersigned, in the capacities and on the date
indicated below, hereby certifies pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002, that to his knowledge:
1. The Report fully complies with the requirements of
Section 13(a) or 15(d) of the Securities Exchange Act of
1934; and
2. The information contained in the Report fairly presents,
in all material respects, the financial condition and results of
operations of the Company.
Robert J. Coury
Chief Executive Officer
(Principal Executive Officer)
John D. Sheehan
Executive Vice President and
Chief Financial Officer
(Principal Financial Officer)
Date: October 27, 2010
A signed original of this written statement required by
Section 906 has been provided to the Company and will be
retained by the Company and furnished to the Securities and
Exchange Commission or its staff upon request.
The foregoing certification is being furnished in accordance
with Securities and Exchange Commission Release
No. 34-47551
and shall not be considered filed as part of the
Form 10-Q.