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,
2009
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OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period
from to
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Commission file number 1-9114
MYLAN INC.
(Exact name of registrant as
specified in its charter)
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Pennsylvania
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25-1211621
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(State or other jurisdiction
of incorporation or organization)
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(I.R.S. Employer
Identification No.)
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1500 Corporate Drive, Canonsburg, Pennsylvania 15317
(Address of principal executive
offices)
(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
o 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 28, 2009
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$0.50 par value
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305,584,189
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* |
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The registrant has not yet been phased into the interactive data
requirements. |
MYLAN
INC. AND SUBSIDIARIES
FORM 10-Q
For the Quarterly Period Ended
September 30, 2009
INDEX
2
MYLAN
INC. AND SUBSIDIARIES
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Period Ended September 30,
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Three Months
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Nine Months
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2009
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2008
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2009
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2008
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(Unaudited; in thousands, except per share amounts)
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Revenues:
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Net revenues
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$
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1,255,708
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$
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1,191,010
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$
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3,679,868
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$
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3,440,680
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Other revenues
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8,366
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|
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465,838
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61,100
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493,750
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Total revenues
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1,264,074
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1,656,848
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3,740,968
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3,934,430
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Cost of sales
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759,094
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745,711
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2,182,488
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2,258,863
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Gross profit
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504,980
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911,137
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1,558,480
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1,675,567
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Operating expenses:
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Research and development
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69,812
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74,721
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202,665
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239,320
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Impairment loss on goodwill
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385,000
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Selling, general and administrative
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259,609
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275,584
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780,953
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787,953
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Litigation settlements, net
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114,281
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|
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111,530
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Total operating expenses
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443,702
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350,305
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1,095,148
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1,412,273
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Earnings from operations
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61,278
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560,832
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463,332
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263,294
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Interest expense
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77,034
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93,540
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240,209
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|
282,405
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Other income, net
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|
243
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|
|
|
5,766
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|
|
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29,741
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20,583
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|
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|
|
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(Loss) earnings before income taxes and noncontrolling interest
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(15,513
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)
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473,058
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252,864
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1,472
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Income tax (benefit) provision
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(11,092
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)
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256,088
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52,539
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180,062
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Net (loss) earnings
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(4,421
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)
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216,970
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200,325
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(178,590
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)
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Net (earnings) loss attributable to the noncontrolling interest
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(841
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)
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|
151
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(6,658
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)
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2,266
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Net (loss) earnings attributable to Mylan Inc. before preferred
dividends
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(5,262
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)
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217,121
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193,667
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(176,324
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)
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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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104,236
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Net (loss) earnings attributable to Mylan Inc. common
shareholders
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$
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(40,021
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)
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$
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182,362
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$
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89,391
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$
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(280,560
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)
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(Loss) earnings per common share attributable to Mylan Inc.
common shareholders:
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Basic
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$
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(0.13
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)
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$
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0.60
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|
$
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0.29
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|
$
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(0.92
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)
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Diluted
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$
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(0.13
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)
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$
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0.47
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$
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0.29
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|
$
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(0.92
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)
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Weighted average common shares outstanding:
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Basic
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305,285
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304,449
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304,951
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304,305
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Diluted
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305,285
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458,350
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306,086
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304,305
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See Notes to Condensed Consolidated Financial Statements
3
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September 30, 2009
|
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December 31, 2008
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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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$
|
584,411
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|
|
$
|
557,147
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Restricted cash
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63,346
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40,309
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Available-for-sale
securities
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34,034
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42,260
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Accounts receivable, net
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1,102,380
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1,164,613
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Inventories
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1,119,042
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|
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1,065,990
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Deferred income tax benefit
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|
|
247,755
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|
|
199,278
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Prepaid expenses and other current assets
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110,961
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|
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105,076
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|
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Total current assets
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3,261,929
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|
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3,174,673
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Property, plant and equipment, net
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1,085,174
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|
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1,063,996
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Intangible assets, net
|
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2,465,869
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|
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2,453,161
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|
Goodwill
|
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|
3,316,654
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|
|
3,161,580
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Deferred income tax benefit
|
|
|
46,130
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|
|
|
16,493
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|
Other assets
|
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|
586,812
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|
|
|
539,956
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|
|
|
|
|
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Total assets
|
|
$
|
10,762,568
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|
$
|
10,409,859
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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
|
|
$
|
476,605
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|
$
|
498,815
|
|
Short-term borrowings
|
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|
167,074
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|
151,109
|
|
Income taxes payable
|
|
|
59,882
|
|
|
|
92,158
|
|
Current portion of long-term debt and other long-term obligations
|
|
|
7,727
|
|
|
|
5,099
|
|
Deferred income tax liability
|
|
|
3,280
|
|
|
|
1,935
|
|
Other current liabilities
|
|
|
868,768
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|
|
795,534
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|
|
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|
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Total current liabilities
|
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|
1,583,336
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|
|
|
1,544,650
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Long-term debt
|
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|
5,128,827
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|
|
|
5,078,937
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|
Other long-term obligations
|
|
|
405,298
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|
|
|
422,052
|
|
Deferred income tax liability
|
|
|
573,215
|
|
|
|
577,379
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|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
7,690,676
|
|
|
|
7,623,018
|
|
|
|
|
|
|
|
|
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|
Equity
|
|
|
|
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Mylan Inc. shareholders equity
|
|
|
|
|
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Preferred stock par value $0.50 per share
|
|
|
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|
|
|
|
|
Shares authorized: 5,000,000
|
|
|
|
|
|
|
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|
Shares issued: 2,139,000
|
|
|
1,070
|
|
|
|
1,070
|
|
Common stock par value $0.50 per share
|
|
|
|
|
|
|
|
|
Shares authorized: 1,500,000,000 and 600,000,000 as of
September 30, 2009 and December 31, 2008
|
|
|
|
|
|
|
|
|
Shares issued: 395,767,460 and 395,368,062 as of
September 30, 2009 and December 31, 2008
|
|
|
197,884
|
|
|
|
197,684
|
|
Additional paid-in capital
|
|
|
3,824,302
|
|
|
|
3,955,725
|
|
Retained earnings
|
|
|
655,985
|
|
|
|
566,594
|
|
Accumulated other comprehensive loss
|
|
|
(45,335
|
)
|
|
|
(380,802
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
4,633,906
|
|
|
|
4,340,271
|
|
Noncontrolling interest
|
|
|
13,057
|
|
|
|
29,108
|
|
Less treasury stock at cost
|
|
|
|
|
|
|
|
|
Shares: 90,220,543 and 90,635,441 as of September 30, 2009
and December 31, 2008
|
|
|
1,575,071
|
|
|
|
1,582,538
|
|
|
|
|
|
|
|
|
|
|
Total equity
|
|
|
3,071,892
|
|
|
|
2,786,841
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
$
|
10,762,568
|
|
|
$
|
10,409,859
|
|
|
|
|
|
|
|
|
|
|
See Notes to Condensed Consolidated Financial Statements
4
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited; in thousands)
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net earnings (loss)
|
|
$
|
200,325
|
|
|
$
|
(178,590
|
)
|
Adjustments to reconcile net earnings (loss) to net cash
provided by operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
296,949
|
|
|
|
327,791
|
|
Stock-based compensation expense
|
|
|
23,591
|
|
|
|
23,188
|
|
Net earnings from equity method investees
|
|
|
(1,231
|
)
|
|
|
(3,165
|
)
|
Change in estimated sales allowances
|
|
|
62,288
|
|
|
|
22,115
|
|
Deferred income tax benefit
|
|
|
(82,036
|
)
|
|
|
(76,154
|
)
|
Impairment loss on goodwill
|
|
|
|
|
|
|
385,000
|
|
Other non-cash items
|
|
|
52,515
|
|
|
|
24,812
|
|
Litigation settlements, net
|
|
|
111,530
|
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
48,390
|
|
|
|
(135,293
|
)
|
Inventories
|
|
|
11,188
|
|
|
|
(98,812
|
)
|
Trade accounts payable
|
|
|
(57,854
|
)
|
|
|
(35
|
)
|
Income taxes
|
|
|
(59,038
|
)
|
|
|
92,346
|
|
Deferred revenue
|
|
|
(24,029
|
)
|
|
|
(110,021
|
)
|
Other operating assets and liabilities, net
|
|
|
(36,038
|
)
|
|
|
(24,009
|
)
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
546,550
|
|
|
|
249,173
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(83,135
|
)
|
|
|
(101,699
|
)
|
Increase in restricted cash
|
|
|
(22,861
|
)
|
|
|
(44,828
|
)
|
Cash paid for acquisitions
|
|
|
(211,209
|
)
|
|
|
|
|
Proceeds from sale of equity-method investee
|
|
|
23,333
|
|
|
|
|
|
Purchase of
available-for-sale
securities
|
|
|
(4,278
|
)
|
|
|
(17,509
|
)
|
Proceeds from sale of
available-for-sale
securities
|
|
|
14,970
|
|
|
|
60,109
|
|
Other items, net
|
|
|
237
|
|
|
|
4,716
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(282,943
|
)
|
|
|
(99,211
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Cash dividends paid
|
|
|
(104,276
|
)
|
|
|
(102,736
|
)
|
Payment of financing fees
|
|
|
|
|
|
|
(13,954
|
)
|
Purchase of bond hedge
|
|
|
|
|
|
|
(161,173
|
)
|
Proceeds from issuance of warrants
|
|
|
|
|
|
|
62,560
|
|
Change in short-term borrowings, net
|
|
|
(260
|
)
|
|
|
46,054
|
|
Proceeds from long-term debt
|
|
|
6,236
|
|
|
|
581,547
|
|
Payment of long-term debt
|
|
|
(153,315
|
)
|
|
|
(392,213
|
)
|
Proceeds from exercise of stock options
|
|
|
8,803
|
|
|
|
1,098
|
|
Other items, net
|
|
|
|
|
|
|
(260
|
)
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities
|
|
|
(242,812
|
)
|
|
|
20,923
|
|
|
|
|
|
|
|
|
|
|
Effect on cash of changes in exchange rates
|
|
|
6,469
|
|
|
|
579
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
27,264
|
|
|
|
171,464
|
|
Cash and cash equivalents beginning of period
|
|
|
557,147
|
|
|
|
484,202
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents end of period
|
|
$
|
584,411
|
|
|
$
|
655,666
|
|
|
|
|
|
|
|
|
|
|
See Notes to Condensed Consolidated Financial Statements
5
MYLAN
INC. AND SUBSIDIARIES
In the opinion of management, the accompanying unaudited
Condensed Consolidated Financial Statements (interim
financial statements) of Mylan Inc. and subsidiaries
(Mylan or the Company) were prepared in
accordance with accounting principles generally accepted in the
United States of America (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,
as amended, for the fiscal year ended December 31, 2008.
The interim results of operations for the three and nine months
ended September 30, 2009 and the interim cash flows for the
nine months ended September 30, 2009 are not necessarily
indicative of the results to be expected for the full fiscal
year or any other future period.
Management evaluated all activity of Mylan through
October 30, 2009 (the issue date of the interim financial
statements) and concluded that no subsequent events have
occurred that would require recognition in the interim financial
statements or disclosure in the notes to the interim financial
statements, other than as discussed elsewhere in the Notes to
Condensed Consolidated Financial Statements.
|
|
2.
|
Revenue
Recognition and Accounts Receivable
|
Revenue is recognized for product sales when title and risk of
loss pass to the Companys customers and when provisions
for estimates, including discounts, rebates, price adjustments,
returns, chargebacks and other promotional programs are
reasonably determinable. No revisions were made to the
methodology used in determining these provisions during the nine
months ended September 30, 2009. Accounts receivable are
presented net of allowances relating to these provisions. Such
allowances were $546.8 million and $496.5 million as
of September 30, 2009 and December 31, 2008. Other
current liabilities include $250.9 million and
$238.9 million at September 30, 2009 and
December 31, 2008, for certain rebates and other
adjustments that are payable to indirect customers.
|
|
3.
|
Recent
Accounting Pronouncements
|
In June 2009, the Financial Accounting Standards Board
(FASB) issued Statement of Financial Accounting
Standards (SFAS) No. 168, The FASB
Accounting Standards Codification and the Hierarchy of Generally
Accepted Accounting Principles A Replacement of FASB
Statement No. 162 (as codified in the FASB
Accounting Standards
Codificationtm
(ASC or Codification) topic 105,
Generally Accepted Accounting Principles
(ASC 105)). This update to ASC 105
establishes the Codification as the single source of
authoritative GAAP recognized by the FASB to be applied by
nongovernmental entities. Rules and interpretive releases of the
SEC under authority of federal securities laws are also sources
of authoritative GAAP for SEC registrants. This update to ASC
105 and the Codification are effective for financial statements
issued for interim and annual periods ending after
September 15, 2009. The Codification supersedes all
existing non-SEC accounting and reporting standards. All other
non-grandfathered non-SEC accounting literature not included in
the Codification has become non-authoritative. Following this
update to ASC 105, the FASB will not issue new standards in the
form of Statements, FASB Staff Positions (FSP), or
Emerging Issues Task Force (EITF) Abstracts.
Instead, the FASB will issue Accounting Standards Updates, which
will serve only to: (a) update the Codification;
(b) provide background information about the guidance;
and (c) provide the basis for conclusions on the
change(s) in the Codification. The Company adopted the
requirements of this standard for the quarter ended
September 30, 2009. The adoption of this
6
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
update to ASC 105 did not have a material impact on the
Companys Condensed Consolidated Financial Statements. All
accounting references have been updated, and therefore SFAS
references have been augmented with ASC references. In future
filings all accounting references will refer to the Codification
only.
In June 2009, the FASB issued SFAS No. 166,
Accounting for Transfers of Financial Assets an
amendment of SFAS No. 140 (as codified in ASC
topic 860, Transfers and Servicing (ASC
860)). This update to ASC 860 is a revision to FASB
Statement No. 140, Accounting for Transfers and
Servicing of Financial Assets and Extinguishments of
Liabilities (which is codified in ASC 860), and will
require more disclosures about transfers of financial assets,
including securitization transactions and where entities have
continuing exposure to the risks related to transferred
financial assets. It eliminates the concept of a
qualifying special-purpose entity, changes the
requirements for derecognizing financial assets, and requires
additional disclosures. This update to ASC 860 enhances
disclosures reported to users of financial statements by
providing greater transparency about transfers of financial
assets and an entitys continuing involvement in
transferred financial assets. This update to ASC 860 is
effective for fiscal years beginning after November 15,
2009. Early application is not permitted. The Company is
currently evaluating the impact on its consolidated financial
statements of adopting this update to ASC 860.
In May 2009, the FASB issued SFAS No. 165,
Subsequent Events (as codified in ASC topic 855,
Subsequent Events (ASC 855)). This update to
ASC 855 sets forth the period after the balance sheet date
during which management of a reporting entity should evaluate
events or transactions that may occur for potential recognition
or disclosure in the financial statements, the circumstances
under which an entity should recognize events or transactions
occurring after the balance sheet date in its financial
statements and the disclosures that an entity should make about
events or transactions that occurred after the balance sheet
date. The Company adopted the requirements of this standard as
of June 30, 2009. The adoption of this update to
ASC 855 did not have a material impact on the
Companys Condensed Consolidated Financial Statements.
In April 2009, the FASB issued FSP
FAS 115-2
and
FAS 124-2,
Recognition and Presentation of
Other-Than-Temporary
Impairments (as codified in ASC topic 320,
Investments Debt and Equity Securities (ASC
320)). This update to ASC 320 amends
SFAS 115, Accounting for Certain Investments in Debt and
Equity Securities, SFAS 124, Accounting for Certain
Investments Held by
Not-for-Profit
Organizations, and EITF Issue
99-20,
Recognition of Interest Income and Impairment on Purchased
Beneficial Interests and Beneficial Interests That Continue to
Be Held by a Transferor in Securitized Financial Assets (all
of which are codified in ASC 320), to make the
other-than-temporary
impairments guidance more operational and to improve the
presentation of
other-than-temporary
impairments in the financial statements. This standard replaces
the existing requirement that the entitys management
assert it has both the intent and ability to hold an impaired
debt security until recovery with a requirement that management
assert it does not have the intent to sell the security, and it
is more likely than not it will not have to sell the security
before recovery of its cost basis. The Company adopted the
requirements of this standard as of June 30, 2009. The
adoption of this update to ASC 320 did not have a material
impact on the Companys Condensed Consolidated Financial
Statements.
In April 2009, the FASB issued FSP
FAS 107-1
and APB
28-1,
Interim Disclosures about Fair Value of Financial
Instruments (as codified in ASC topic 825, Financial
Instruments (ASC 825)). This update to
ASC 825 requires companies to disclose in interim financial
statements the fair value of financial instruments within the
scope of ASC 825. However, companies are not required to provide
in interim periods the disclosures about the concentration of
credit risk of all financial instruments that are currently
required in annual financial statements. The fair-value
information disclosed in the footnotes must be presented
together with the related carrying amount, making it clear
whether the fair value and carrying amount represent assets or
liabilities and how the carrying amount relates to what is
reported in the balance sheet. This update to ASC 825 also
requires that companies disclose the method or methods and
significant assumptions used to estimate the fair value of
financial instruments and a discussion of changes, if any, in
the method or methods and significant assumptions during the
period. The
7
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Company adopted the requirements of this standard as of
June 30, 2009. The adoption of this update to ASC 825
did not have a material impact on the Companys Condensed
Consolidated Financial Statements.
On January 1, 2009, the Company adopted FSP APB
14-1,
Accounting for Convertible Debt Instruments That May Be
Settled in Cash Upon Conversion (Including Partial Cash
Settlement) (as codified in ASC topic 470, Debt
(ASC 470)). Under the new rules, for convertible
debt instruments (including the Companys Senior
Convertible Notes) that may be settled entirely or partially in
cash upon conversion, entities now separately account for the
liability and equity components of the instrument in a manner
that reflects the issuers economic interest cost. The
effect of the new rules, as they apply to the Companys
Senior Convertible Notes, is that the equity component is
included in the additional paid-in capital section of
shareholders equity on the Companys consolidated
balance sheet and the value of the equity component is treated
as an original issue discount for purposes of accounting for the
debt component. Higher interest expense results through the
accretion of the discounted carrying value of the Senior
Convertible Notes to their face amount over their term. This
update to ASC 470 requires retrospective application as
disclosed below.
On January 1, 2009, the Company adopted
SFAS No. 160, Noncontrolling Interests in
Consolidated Financial Statements an amendment of
ARB 51 (as codified in ASC topic 810, Consolidation
(ASC 810)). This update to ASC 810
amends Accounting Research Bulletin No. 51,
Consolidated Financial Statements (which is codified in
ASC 810), to establish accounting and reporting standards for
the noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary. This standard defines a
noncontrolling interest, sometimes called a minority interest,
as the portion of equity in a subsidiary not attributable,
directly or indirectly, to a parent. This update to ASC 810
requires, among other items, that a noncontrolling interest be
included in the consolidated balance sheet within equity
separate from the parents equity; consolidated net income
to be reported at amounts inclusive of both the parents
and noncontrolling interests shares and, separately, the
amounts of consolidated net income attributable to the parent
and noncontrolling interest all on the consolidated statement of
operations; and if a subsidiary is deconsolidated, any retained
noncontrolling equity investment in the former subsidiary be
measured at fair value and a gain or loss be recognized in net
income based on such fair value.
The Companys Condensed Consolidated Statements of
Operations for the three and nine months ended
September 30, 2008, as originally reported and as adjusted
for the adoption of the aforementioned updates to ASC 470
and ASC 810, are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2008
|
|
|
|
|
|
|
As Adjusted
|
|
|
|
(In thousands, except per share amounts)
|
|
|
Interest expense
|
|
$
|
87,553
|
|
|
$
|
93,540
|
|
Earnings before income taxes and noncontrolling interest
|
|
|
479,045
|
|
|
|
473,058
|
|
Income tax provision
|
|
|
272,438
|
|
|
|
256,088
|
|
Net earnings
|
|
|
206,607
|
|
|
|
216,970
|
|
Net earnings attributable to the noncontrolling interest
|
|
|
151
|
|
|
|
151
|
|
Net earnings attributable to Mylan Inc. common shareholders
|
|
|
171,999
|
|
|
|
182,362
|
|
Loss per common share attributable to Mylan Inc.:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.56
|
|
|
$
|
0.60
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
0.45
|
|
|
$
|
0.47
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
304,449
|
|
|
|
304,449
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
458,350
|
|
|
|
458,350
|
|
|
|
|
|
|
|
|
|
|
8
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2008
|
|
|
|
|
|
|
As Adjusted
|
|
|
|
(In thousands, except per share amounts)
|
|
|
Interest expense
|
|
$
|
264,789
|
|
|
$
|
282,405
|
|
Earnings before income taxes and noncontrolling interest
|
|
|
19,088
|
|
|
|
1,472
|
|
Income tax provision
|
|
|
197,378
|
|
|
|
180,062
|
|
Net loss
|
|
|
(178,290
|
)
|
|
|
(178,590
|
)
|
Net earnings attributable to the noncontrolling interest
|
|
|
2,266
|
|
|
|
2,266
|
|
Net loss attributable to Mylan Inc. common shareholders
|
|
|
(280,260
|
)
|
|
|
(280,560
|
)
|
Loss per common share attributable to Mylan Inc.:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.92
|
)
|
|
$
|
(0.92
|
)
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
(0.92
|
)
|
|
$
|
(0.92
|
)
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
304,305
|
|
|
|
304,305
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
304,305
|
|
|
|
304,305
|
|
|
|
|
|
|
|
|
|
|
The Companys Condensed Consolidated Balance Sheet as
originally reported and as adjusted for the adoption of the
aforementioned updates to ASC 470 and ASC 810, is as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008
|
|
|
December 31, 2008
|
|
|
|
|
|
|
As Adjusted
|
|
|
|
(In thousands)
|
|
|
Liabilities and equity
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
Long-term debt
|
|
$
|
5,165,419
|
|
|
$
|
5,078,937
|
|
Deferred income tax liability
|
|
|
545,121
|
|
|
|
577,379
|
|
Total liabilities
|
|
|
7,677,242
|
|
|
|
7,623,018
|
|
Minority interest
|
|
|
29,108
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
Mylan Inc. shareholders equity
|
|
|
|
|
|
|
|
|
Additional paid-in capital
|
|
|
3,873,743
|
|
|
|
3,955,725
|
|
Retained earnings
|
|
|
594,352
|
|
|
|
566,594
|
|
Noncontrolling interest
|
|
|
|
|
|
|
29,108
|
|
Total equity
|
|
|
2,703,509
|
|
|
|
2,786,841
|
|
|
|
4.
|
Acquisitions
and Other Transactions
|
Acquisition
of the Remaining Interest in Matrix Laboratories
Limited
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. On
June 1, 2009, Mylan announced that it had successfully
completed the delisting offer and accepted the discovered price
of 211 Rupees per share, which was established by the reverse
book building process prescribed by Indian regulations. During
the nine months ended September 30, 2009, the Company
completed the
9
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
purchase of an additional portion of the remaining interest from
minority shareholders of Matrix, for cash of approximately
$172.3 million, bringing both the Companys total
ownership and control to approximately 95%.
Matrixs stock was delisted effective August 21, 2009.
Minority shareholders who have not yet tendered their shares may
do so during the six-month period following the delisting. The
purchase was treated as an equity transaction as required by ASC
topic 805, Business Combinations (ASC 805).
Under ASC 805, subsequent increases or decreases of ownership
that do not result in a change in control are accounted for as
equity transactions. As such, upon purchase of the additional
interest in Matrix, both the noncontrolling interest and
additional paid in capital on the Condensed Consolidated Balance
Sheet were reduced by $21.6 million and
$154.0 million, respectively.
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
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 the date
of acquisition at the preliminary estimate of 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 a non-recurring research and
development charge in the nine months ended September 30,
2009 related to its up-front, non-refundable obligation pursuant
to the agreement.
|
|
5.
|
Impairment
of Long-lived Assets Including Goodwill
|
On February 27, 2008, the Company announced that it was
reviewing strategic alternatives for its specialty business,
Dey, L.P. (Dey), including the potential sale of the
business. This decision was based upon several factors,
including a strategic review of the business and the expected
performance of the
Perforomist®
Solution product, where anticipated growth was determined to be
slower than expected and the timeframe to reach peak sales was
determined to be longer than was originally anticipated.
As a result of the Companys ongoing review of strategic
alternatives, the Company determined that it was more likely
than not that the business would be sold or otherwise disposed
of significantly before the end of its previously estimated
useful life. Accordingly, a recoverability test of Deys
long-lived assets was performed during the three months ended
March 31, 2008 in accordance with ASC topic 360,
Property, Plant, and Equipment (ASC
10
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
360). The Company evaluated both cash flow projections and
estimated proceeds from the eventual disposition of the
long-lived assets. The estimated undiscounted future cash flows
exceeded the book values of the long-lived assets and, as a
result, no impairment charge was recorded.
Upon the closing of the former Merck Generics business
transaction, Dey was defined as the Specialty Segment under the
provisions of ASC topic 280, Segment Reporting. Dey is
also considered a reporting unit under the provisions of ASC
topic 350, Intangibles Goodwill and Other
(ASC 350). Upon closing of the transaction, the
Company allocated $711.2 million of goodwill to Dey.
The Company tests goodwill for possible impairment on an annual
basis and at any other time events occur or circumstances
indicate that the carrying amount of goodwill may be impaired.
As the Company had determined that it was more likely than not
that the business would be sold or otherwise disposed of
significantly before the end of its previously estimated useful
life, the Company was required, during the three months ended
March 31, 2008, to assess whether any portion of its
recorded goodwill balance was impaired.
The first step of the ASC 350 impairment analysis consisted of a
comparison of the fair value of the reporting unit with its
carrying amount, including the goodwill. The Company performed
extensive valuation analyses, utilizing both income and
market-based approaches, in its goodwill assessment process. The
following describes the valuation methodologies used to derive
the estimated fair value of the reporting unit.
Income Approach: To determine fair value, the
Company discounted the expected future cash flows of the
reporting unit, using a discount rate, which reflected the
overall level of inherent risk and the rate of return an outside
investor would have expected to earn. To estimate cash flows
beyond the final year of its model, the Company used a terminal
value approach. Under this approach, the Company used estimated
operating income before interest, taxes, depreciation and
amortization in the final year of its model, adjusted to
estimate a normalized cash flow, applied a perpetuity growth
assumption, and discounted by a perpetuity discount factor to
determine the terminal value. The Company incorporated the
present value of the resulting terminal value into its estimate
of fair value.
Market-Based Approach: To corroborate the
results of the income approach described above, Mylan estimated
the fair value of its reporting unit using several market-based
approaches, including the guideline company method which focused
on comparing its risk profile and growth prospects to a select
group of publicly traded companies with reasonably similar
guidelines.
Based on the ASC 350 step one analysis that was
performed for Dey, the Company determined that the carrying
amount of the net assets of the reporting unit was in excess of
its estimated fair value. As such, the Company was required to
perform the step two analysis for Dey, in order to
determine the amount of any goodwill impairment. The step
two analysis consisted of comparing the implied fair value
of the goodwill with the carrying amount of the goodwill, with
an impairment charge resulting from any excess of the carrying
value of the goodwill over the implied fair value of the
goodwill based on a hypothetical allocation of the estimated
fair value to the net assets. Based on the second step analysis,
the Company concluded that $385.0 million of the goodwill
recorded at Dey was impaired. As a result, the Company recorded
a non-cash goodwill impairment charge of $385.0 million
during the three months ended March 31, 2008, which
represented the Companys best estimate as of
March 31, 2008. The allocation discussed above was
performed only for purposes of assessing goodwill for
impairment; accordingly, Mylan did not adjust the net book value
of the assets and liabilities on the Companys Condensed
Consolidated Balance Sheet, other than goodwill, as a result of
this process.
The determination of the fair value of the reporting unit
required the Company to make significant estimates and
assumptions that affect the reporting units expected
future cash flows. These estimates and assumptions primarily
include, but are not limited to, the discount rate, terminal
growth rates, operating income before depreciation and
amortization, and capital expenditures forecasts. Due to the
inherent uncertainty involved in making these estimates, actual
results could differ from those estimates. In addition, changes
in underlying
11
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
assumptions could have a significant impact on either the fair
value of the reporting unit or the goodwill impairment charge.
The hypothetical allocation of the fair value of the reporting
unit to individual assets and liabilities within the reporting
unit also required the Company to make significant estimates and
assumptions. The hypothetical allocation required several
analyses to determine the estimate of the fair value of assets
and liabilities of the reporting unit.
In September 2008, following the completion of the comprehensive
review of strategic alternatives for Dey, the Company announced
its decision to retain the Dey business. This decision included
a plan to realign the business, and as a result, the Company
expects to incur severance and other exit costs (see
Note 14). In addition, the comprehensive review resulted in
the impairment of intangible assets related to certain non-core,
insignificant, third-party products in December 2008.
|
|
6.
|
Stock-Based
Incentive Plan
|
Mylans shareholders approved the 2003 Long-Term
Incentive Plan on July 25, 2003, and approved certain
amendments on July 28, 2006, April 25, 2008 and
May 7, 2009 (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 and short-term cash awards.
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, the 1997 Incentive Stock
Option Plan (the 1997 Plan) was frozen, and no
further grants of stock options will be made under that plan.
However, there are stock options outstanding from the 1997 Plan,
expired plans and other plans assumed through acquisitions.
The following table summarizes stock option activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
Number of Shares
|
|
|
Exercise Price
|
|
|
|
Under Option
|
|
|
per Share
|
|
|
Outstanding at December 31, 2008
|
|
|
23,423,041
|
|
|
$
|
15.32
|
|
Options granted
|
|
|
5,226,254
|
|
|
|
13.60
|
|
Options exercised
|
|
|
(435,987
|
)
|
|
|
11.17
|
|
Options forfeited
|
|
|
(1,016,932
|
)
|
|
|
14.33
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2009
|
|
|
27,196,376
|
|
|
$
|
15.09
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest at September 30, 2009
|
|
|
25,938,815
|
|
|
$
|
15.14
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30, 2009
|
|
|
17,844,466
|
|
|
$
|
15.82
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2009, options outstanding, options
vested and expected to vest and options exercisable had average
remaining contractual terms of 5.97 years, 5.82 years
and 4.38 years, respectively. Also at September 30,
2009, options outstanding, options vested and expected to vest
and options exercisable had aggregate intrinsic values of
$51.2 million, $48.3 million and $27.9 million,
respectively.
12
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
A summary of the status of the Companys nonvested
restricted stock and restricted stock unit awards as of
September 30, 2009 and the changes during the nine months
ended September 30, 2009, are presented below:
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
|
Weighted Average
|
|
|
|
Restricted
|
|
|
Grant-Date
|
|
Restricted Stock Awards
|
|
Stock Awards
|
|
|
Fair Value per Share
|
|
|
Nonvested at December 31, 2008
|
|
|
2,543,348
|
|
|
$
|
13.46
|
|
Granted
|
|
|
884,163
|
|
|
|
12.74
|
|
Released
|
|
|
(756,873
|
)
|
|
|
15.22
|
|
Forfeited
|
|
|
(179,829
|
)
|
|
|
11.97
|
|
|
|
|
|
|
|
|
|
|
Nonvested at September 30, 2009
|
|
|
2,490,809
|
|
|
$
|
12.79
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2009, the Company had
$47.2 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 1.82 years. The total intrinsic value of
stock-based awards exercised and restricted stock units
converted during the nine months ended September 30, 2009
and September 30, 2008 was $11.1 million and
$4.6 million.
|
|
7.
|
Balance
Sheet Components
|
Selected balance sheet components consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
|
|
(In thousands)
|
|
|
Inventories:
|
|
|
|
|
|
|
|
|
Raw materials
|
|
$
|
287,993
|
|
|
$
|
273,232
|
|
Work in process
|
|
|
184,063
|
|
|
|
157,473
|
|
Finished goods
|
|
|
646,986
|
|
|
|
635,285
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,119,042
|
|
|
$
|
1,065,990
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment:
|
|
|
|
|
|
|
|
|
Land and improvements
|
|
$
|
64,303
|
|
|
$
|
56,945
|
|
Buildings and improvements
|
|
|
620,790
|
|
|
|
577,182
|
|
Machinery and equipment
|
|
|
1,109,765
|
|
|
|
1,012,748
|
|
Construction in progress
|
|
|
95,890
|
|
|
|
110,721
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,890,748
|
|
|
|
1,757,596
|
|
Less accumulated depreciation
|
|
|
805,574
|
|
|
|
693,600
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,085,174
|
|
|
$
|
1,063,996
|
|
|
|
|
|
|
|
|
|
|
Other current liabilities:
|
|
|
|
|
|
|
|
|
Payroll and employee benefit plan accruals
|
|
$
|
198,097
|
|
|
$
|
181,316
|
|
Accrued rebates
|
|
|
250,855
|
|
|
|
238,886
|
|
Fair value of financial instruments
|
|
|
76,193
|
|
|
|
91,797
|
|
Legal and professional accruals
|
|
|
181,095
|
|
|
|
71,813
|
|
Restructuring reserves
|
|
|
55,600
|
|
|
|
75,100
|
|
Other
|
|
|
106,928
|
|
|
|
136,622
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
868,768
|
|
|
$
|
795,534
|
|
|
|
|
|
|
|
|
|
|
13
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
8.
|
(Loss)
Earnings per Common Share attributable to Mylan Inc.
|
Basic (loss) earnings per common share is computed by dividing
net (loss) earnings attributable to Mylan Inc. common
shareholders by the weighted average number of shares
outstanding during the period. Diluted (loss) earnings per
common share is computed by dividing net (loss) 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. For
the three and nine months ended September 30, 2009, and for
the nine months ended September 30, 2008, the if-converted
method is anti-dilutive; therefore, the preferred stock
conversion is excluded from the computation of diluted earnings
per share. For the three months ended September 30, 2008,
the preferred stock conversion is dilutive; therefore, under the
provisions of the if-converted method, the conversion of the
preferred stock is included in the denominator of the
computation of diluted earnings per share, and the preferred
share dividend is added back to the numerator.
Basic and diluted (loss) earnings per common share attributable
to Mylan Inc. are calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
(In thousands, except per share amounts)
|
|
|
Basic (loss) earnings attributable to Mylan Inc. common
shareholders (numerator):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) earnings attributable to Mylan Inc. before preferred
dividends
|
|
$
|
(5,262
|
)
|
|
$
|
217,121
|
|
|
$
|
193,667
|
|
|
$
|
(176,324
|
)
|
Less: Preferred dividends
|
|
|
34,759
|
|
|
|
34,759
|
|
|
|
104,276
|
|
|
|
104,236
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) earnings attributable to Mylan Inc. common
shareholders
|
|
$
|
(40,021
|
)
|
|
$
|
182,362
|
|
|
$
|
89,391
|
|
|
$
|
(280,560
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares (denominator):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding
|
|
|
305,285
|
|
|
|
304,449
|
|
|
|
304,951
|
|
|
|
304,305
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic (loss) earnings per common share attributable to Mylan
Inc.
|
|
$
|
(0.13
|
)
|
|
$
|
0.60
|
|
|
$
|
0.29
|
|
|
$
|
(0.92
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted (loss) earnings attributable to Mylan Inc. common
shareholders (numerator):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) earnings attributable to Mylan Inc. common
shareholders
|
|
$
|
(40,021
|
)
|
|
$
|
182,362
|
|
|
$
|
89,391
|
|
|
$
|
(280,560
|
)
|
Add: Preferred dividends
|
|
|
|
|
|
|
34,759
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings attributable to Mylan Inc. common shareholders
and assumed conversions
|
|
$
|
(40,021
|
)
|
|
$
|
217,121
|
|
|
$
|
89,391
|
|
|
$
|
(280,560
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares (denominator):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based awards
|
|
|
|
|
|
|
1,115
|
|
|
|
1,135
|
|
|
|
|
|
Preferred stock conversion
|
|
|
|
|
|
|
152,786
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total dilutive shares outstanding
|
|
|
305,285
|
|
|
|
458,350
|
|
|
|
306,086
|
|
|
|
304,305
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted (loss) earnings per common share attributable to Mylan
Inc.
|
|
$
|
(0.13
|
)
|
|
$
|
0.47
|
|
|
$
|
0.29
|
|
|
$
|
(0.92
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Additional stock options or restricted stock awards representing
19.2 million and 18.6 million shares were outstanding
for the nine months ended September 30, 2009 and 2008, but
were not included in the computation of diluted earnings per
share because the effect would be anti-dilutive.
On October 20, 2009, the Company announced that a quarterly
dividend of $16.25 per share was declared (based on the annual
dividend rate of 6.5% and a liquidation preference of $1,000 per
share) payable on November 16, 2009, to the holders of
preferred stock of record as of November 1, 2009.
|
|
9.
|
Goodwill
and Intangible Assets
|
A rollforward of goodwill from December 31, 2008 to
September 30, 2009 is as follows:
|
|
|
|
|
|
|
Total
|
|
|
|
(In thousands)
|
|
|
Goodwill balance at December 31, 2008
|
|
$
|
3,161,580
|
|
Foreign currency translation
|
|
|
155,074
|
|
|
|
|
|
|
Goodwill balance at September 30, 2009
|
|
$
|
3,316,654
|
|
|
|
|
|
|
Intangible assets consist of the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
Average Life
|
|
|
Original
|
|
|
Accumulated
|
|
|
Net Book
|
|
|
|
(Years)
|
|
|
Cost
|
|
|
Amortization
|
|
|
Value
|
|
|
|
(In thousands)
|
|
|
September 30, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and technologies
|
|
|
20
|
|
|
$
|
118,926
|
|
|
$
|
76,146
|
|
|
$
|
42,780
|
|
Product rights and licenses
|
|
|
10
|
|
|
|
2,925,260
|
|
|
|
607,684
|
|
|
|
2,317,576
|
|
Other
|
|
|
8
|
|
|
|
169,108
|
|
|
|
63,595
|
|
|
|
105,513
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
3,213,294
|
|
|
$
|
747,425
|
|
|
$
|
2,465,869
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and technologies
|
|
|
20
|
|
|
$
|
118,926
|
|
|
$
|
71,631
|
|
|
$
|
47,295
|
|
Product rights and licenses
|
|
|
10
|
|
|
|
2,738,191
|
|
|
|
433,169
|
|
|
|
2,305,022
|
|
Other
|
|
|
8
|
|
|
|
129,563
|
|
|
|
28,719
|
|
|
|
100,844
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
2,986,680
|
|
|
$
|
533,519
|
|
|
$
|
2,453,161
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense, which is primarily classified within cost
of sales on the Companys Condensed Consolidated Statements
of Operations, for the nine months ended September 30, 2009
and 2008 was $204.3 million and $235.0 million and is
expected to be $69.7 million for the remainder of 2009, and
$277.8 million, $272.3 million, $271.9 million
and $259.8 million for the years ended December 31,
2010 through 2013, respectively.
|
|
10.
|
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 interest
rate risk, equity risk and foreign currency risk.
15
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
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 statement of operations.
The Company has 754.5 million ($1.10 billion) of
borrowings under the Senior Credit Agreement that are designated
as a hedge of its net investment in certain Euro-functional
currency subsidiaries. In accordance with ASC topic 830,
Foreign Currency Matters, and ASC topic 815,
Derivatives and Hedging (ASC 815), borrowings
designated as hedges of net investments are measured at fair
value using the current spot exchange rate at the end of the
period, with gains and losses included in the foreign currency
translation adjustment component of accumulated other
comprehensive income (loss) (AOCI) on the 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 in accordance with ASC 815. 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 Senior Credit Agreement. In accordance with ASC
815, 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
reported in earnings or deferred, depending on the nature and
effectiveness of the offset. Any ineffectiveness in a hedging
relationship is recognized immediately in earnings in the
Condensed Consolidated Statements of Operations. As of
September 30, 2009, the total notional amount of the
Companys floating-rate debt interest rate swaps was
$2.3 billion.
As described in Note 11 to Condensed Consolidated Financial
Statements, a total of $1.0 billion of the Companys
floating-rate
debt interest rate swaps have been extended through additional
forward starting swaps. In July 2009, the Company entered into
$500.0 million of notional value forward-starting
interest-rate swaps to fix the interest rate on a portion of the
Companys variable-rate U.S. Tranche B Term Loans
under the Senior Credit Agreement. These swaps are designated as
cash flow hedges of expected future borrowings under the Senior
Credit Agreement. The swaps extend previously executed swaps
maturing in December 2010 and fix a rate of 6.60% from December
2010 to December 2012.
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 derivative
instruments with credit-risk-related contingent features that
are in a liability position at September 30, 2009 is
$70.9 million. The Company is not subject to any
obligations to post collateral under derivative contracts.
In September 2008, the Company issued $575.0 million in
Cash Convertible Notes whereby holders may convert their Cash
Convertible Notes subject to certain conversion provisions
determined by a) the market price of the Companys
common stock, b) specified distributions to common
shareholders, c) a fundamental change, as defined in the
purchase agreement, or d) certain time periods specified in
the purchase agreement. The conversion feature can only be
settled in cash and, therefore, it is bifurcated from the Cash
Convertible Notes and treated as a separate derivative
instrument. In order to offset the cash flow risk associated
with the cash conversion feature, the Company entered into a
convertible note hedge with certain counterparties. Both the
cash conversion feature and the purchased convertible note hedge
are measured at fair value with gains and losses recorded in the
Companys Condensed Consolidated Statements of Operations.
Also, in conjunction with the issuance of the Cash Convertible
Notes, the Company entered into several warrant transactions
with certain counterparties. The warrants meet the definition of
derivatives under ASC 815; however, because these instruments
have been determined to be indexed to the Companys own
stock, and have been recorded in shareholders equity in
the Companys Condensed
16
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Consolidated Balance Sheet (in accordance with the guidance of
ASC 815), the instruments are exempt from the scope of ASC 815
and are not subject to the fair value provisions set forth
therein.
The Companys most significant credit exposure arises from
the convertible note hedge on its Cash Convertible Notes. At
September 30, 2009, the convertible note hedge had a total
fair value of $348.9 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 under ASC 815
Fair Values of Derivative Instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability Derivatives
|
|
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
|
|
Balance Sheet Location
|
|
Fair Value
|
|
|
Balance Sheet Location
|
|
Fair Value
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swaps
|
|
Other current liabilities
|
|
$
|
70,890
|
|
|
Other current liabilities
|
|
$
|
72,395
|
|
Foreign currency borrowings
|
|
Long-term debt
|
|
|
1,103,130
|
|
|
Long-term debt
|
|
|
1,128,267
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
1,174,020
|
|
|
|
|
$
|
1,200,662
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives
Not Designated as Hedging Instruments under ASC 815
Fair Values of Derivative Instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset Derivatives
|
|
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
|
|
Balance Sheet Location
|
|
Fair Value
|
|
|
Balance Sheet Location
|
|
Fair Value
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Prepaid expenses and other current assets
|
|
$
|
2,276
|
|
|
Prepaid expenses and other current assets
|
|
$
|
14,632
|
|
Purchased cash convertible note hedge
|
|
Other assets
|
|
|
348,900
|
|
|
Other assets
|
|
|
235,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
351,176
|
|
|
|
|
$
|
250,382
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability Derivatives
|
|
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
|
|
Balance Sheet Location
|
|
Fair Value
|
|
|
Balance Sheet Location
|
|
Fair Value
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Other current liabilities
|
|
$
|
4,827
|
|
|
Other current liabilities
|
|
$
|
19,402
|
|
Cash conversion feature of Cash Convertible Notes
|
|
Long-term debt
|
|
|
348,900
|
|
|
Long-term debt
|
|
|
235,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
353,727
|
|
|
|
|
$
|
255,152
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
The
Effect of Derivative Instruments on the Condensed Consolidated
Statement of Operations
for the Three Months Ended September 30, 2009
Derivatives in ASC 815 Cash Flow Hedging Relationships
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of Gain or
|
|
|
|
|
|
Amount of Gain
|
|
|
(Loss) Reclassified
|
|
Amount of Gain
|
|
|
|
or (Loss) Recognized
|
|
|
from AOCI
|
|
or (Loss) Reclassified
|
|
|
|
in AOCI on Derivative
|
|
|
into Earnings
|
|
from AOCI into Earnings
|
|
|
|
(Effective Portion)
|
|
|
(Effective Portion)
|
|
(Effective Portion)
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
Interest rate swaps
|
|
$
|
(5,112
|
)
|
|
Interest expense
|
|
$
|
(14,047
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
(5,112
|
)
|
|
Total
|
|
$
|
(14,047
|
)
|
|
|
|
|
|
|
|
|
|
|
|
The
Effect of Derivative Instruments on the Condensed Consolidated
Statement of Operations
for the Nine Months Ended September 30, 2009
Derivatives in ASC 815 Cash Flow Hedging Relationships
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of Gain or
|
|
|
|
|
|
Amount of Gain
|
|
|
(Loss) Reclassified
|
|
Amount of Gain
|
|
|
|
or (Loss) Recognized
|
|
|
from AOCI
|
|
or (Loss) Reclassified
|
|
|
|
in AOCI on Derivative
|
|
|
into Earnings
|
|
from AOCI into Earnings
|
|
|
|
(Effective Portion)
|
|
|
(Effective Portion)
|
|
(Effective Portion)
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
Interest rate swaps
|
|
$
|
937
|
|
|
Interest expense
|
|
$
|
(34,417
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
937
|
|
|
Total
|
|
$
|
(34,417
|
)
|
|
|
|
|
|
|
|
|
|
|
|
There was no gain or loss recognized into earnings on
derivatives with cash flow hedging relationships for
ineffectiveness during the three and nine months ended
September 30, 2009.
The
Effect of Derivative Instruments on the Condensed Consolidated
Statement of Operations
for the Three Months Ended September 30, 2009
Derivatives in ASC 815 Net Investment Hedging
Relationships
|
|
|
|
|
|
|
Amount of Gain
|
|
|
|
or (Loss) Recognized
|
|
|
|
in AOCI on Derivative
|
|
|
|
(Effective Portion)
|
|
(In thousands)
|
|
|
|
|
Foreign currency borrowings
|
|
$
|
(28,906
|
)
|
|
|
|
|
|
Total
|
|
$
|
(28,906
|
)
|
|
|
|
|
|
The
Effect of Derivative Instruments on the Condensed Consolidated
Statement of Operations
for the Nine Months Ended September 30, 2009
Derivatives in ASC 815 Net Investment Hedging
Relationships
|
|
|
|
|
|
|
Amount of Gain
|
|
|
|
or (Loss) Recognized
|
|
|
|
in AOCI on Derivative
|
|
|
|
(Effective Portion)
|
|
(In thousands)
|
|
|
|
|
Foreign currency borrowings
|
|
$
|
(31,356
|
)
|
|
|
|
|
|
Total
|
|
$
|
(31,356
|
)
|
|
|
|
|
|
18
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
There was no gain or loss recognized into earnings on
derivatives with net investment hedging relationships during the
three and nine months ended September 30, 2009.
The
Effect of Derivative Instruments on the Condensed Consolidated
Statement of Operations
for the Three Months Ended September 30, 2009
Derivatives Not Designated as Hedging Instruments under ASC
815
|
|
|
|
|
|
|
|
|
Location of Gain or
|
|
|
|
|
|
(Loss) Recognized in
|
|
Amount of Gain or (Loss)
|
|
|
|
Earnings on
|
|
Recognized
|
|
|
|
Derivatives
|
|
in Earnings on Derivatives
|
|
(In thousands)
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Other income, net
|
|
$
|
(15,461
|
)
|
Cash conversion feature of Cash Convertible Notes
|
|
Other income, net
|
|
|
90,725
|
|
Purchased cash convertible note hedge
|
|
Other income, net
|
|
|
(90,725
|
)
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
(15,461
|
)
|
|
|
|
|
|
|
|
The
Effect of Derivative Instruments on the Condensed Consolidated
Statement of Operations
for the Nine Months Ended September 30, 2009
Derivatives Not Designated as Hedging Instruments under ASC
815
|
|
|
|
|
|
|
|
|
Location of Gain or
|
|
Amount of Gain or (Loss)
|
|
|
|
(Loss) Recognized in
|
|
Recognized
|
|
|
|
Earnings on Derivatives
|
|
in Earnings on Derivatives
|
|
(In thousands)
|
|
|
|
|
|
|
Foreign currency forward contracts
|
|
Other income, net
|
|
$
|
(18,003
|
)
|
Cash conversion feature of Cash Convertible Notes
|
|
Other income, net
|
|
|
113,150
|
|
Purchased cash convertible note hedge
|
|
Other income, net
|
|
|
(113,150
|
)
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
(18,003
|
)
|
|
|
|
|
|
|
|
Fair
Value Measurement
As defined in ASC topic 820, Fair Value Measurements and
Disclosures (ASC 820), 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, ASC 820 establishes a fair value hierarchy 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
assets or liabilities. The fair value hierarchy gives the
highest priority to Level 1 inputs.
Level 2: Observable prices that are based
on inputs not quoted in active markets, but corroborated by
market data.
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.
19
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Financial assets and liabilities carried at fair value as of
September 30, 2009 are classified in the table below in one
of the three categories described above:
Financial Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
|
|
(In thousands)
|
|
|
Available-for-sale
fixed income investments
|
|
$
|
|
|
|
$
|
32,439
|
|
|
$
|
|
|
|
$
|
32,439
|
|
Available-for-sale
equity securities
|
|
|
1,595
|
|
|
|
|
|
|
|
|
|
|
|
1,595
|
|
Foreign exchange derivative assets
|
|
|
|
|
|
|
2,276
|
|
|
|
|
|
|
|
2,276
|
|
Purchased cash convertible note hedge
|
|
|
|
|
|
|
348,900
|
|
|
|
|
|
|
|
348,900
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets at fair
value(1)
|
|
$
|
1,595
|
|
|
$
|
383,615
|
|
|
$
|
|
|
|
$
|
385,210
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
|
Foreign exchange derivative liabilities
|
|
$
|
|
|
|
$
|
4,827
|
|
|
$
|
|
|
|
$
|
4,827
|
|
Interest rate swap derivative liabilities
|
|
|
|
|
|
|
70,890
|
|
|
|
|
|
|
|
70,890
|
|
Cash conversion feature of cash convertible notes
|
|
|
|
|
|
|
348,900
|
|
|
|
|
|
|
|
348,900
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair
value(1)
|
|
$
|
|
|
|
|
424,617
|
|
|
$
|
|
|
|
$
|
424,617
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The Company chose not to elect the fair value option as
prescribed by ASC topic 825, Financial Instruments, 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:
|
|
|
|
|
Municipal bonds valued at the quoted market
price from broker or dealer quotations or transparent pricing
sources at the reporting date.
|
|
|
|
Other
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.
|
|
|
|
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, 2009, 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, 2009 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
|
20
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
|
|
|
Hedge are highly rated financial institutions, none of which
experienced any significant downgrades during the nine months
ended September 30, 2009, that would reduce the receivable
amount owed, if any, to the Company.
|
A summary of long-term debt at September 30, 2009 and
December 31, 2008, is as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
|
|
(In thousands)
|
|
|
U.S. Tranche A Term Loans(A)
|
|
$
|
218,750
|
|
|
$
|
265,625
|
|
Euro Tranche A Term Loans(A)
|
|
|
358,612
|
|
|
|
413,684
|
|
U.S. Tranche B Term Loans(A)
|
|
|
2,479,320
|
|
|
|
2,504,880
|
|
Euro Tranche B Term Loans(A)
|
|
|
744,518
|
|
|
|
714,583
|
|
Senior Convertible Notes(B)
|
|
|
532,183
|
|
|
|
513,518
|
|
Cash Convertible Notes(C)
|
|
|
780,744
|
|
|
|
655,442
|
|
Other
|
|
|
18,416
|
|
|
|
14,586
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,132,543
|
|
|
|
5,082,318
|
|
Less: Current portion
|
|
|
3,716
|
|
|
|
3,381
|
|
|
|
|
|
|
|
|
|
|
Total long-term debt
|
|
$
|
5,128,827
|
|
|
$
|
5,078,937
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(A) |
|
All 2009 payments due under the Senior Credit Agreement were
prepaid in December 2008. During the three months ended
March 31, 2009, the Company prepaid the 2010 payments due
under the Senior Credit Agreement, as follows:
$46.9 million on the U.S. Tranche A Term loans,
52.6 ($71.2) million on the Euro Tranche A Term
Loans, $25.6 million on the U.S. Tranche B Term Loans,
and 5.3 ($7.1) million on the Euro Tranche B
Term Loans. |
|
(B) |
|
At September 30, 2009, the $532.2 million of debt is
net of a $67.8 million discount. During the three and nine
months ended September 30, 2009, the Company recognized
non-cash interest expense of $6.4 million and
$18.7 million in the Condensed Consolidated Statements of
Operations. At December 31, 2008, the $513.5 million
of debt is net of an $86.5 million discount. |
|
(C) |
|
At September 30, 2009, the $780.7 million consists of
$431.8 million of debt ($575.0 million face amount,
net of $143.2 million discount) and the bifurcated
conversion feature with a fair value of $348.9 million
recorded as a liability within long-term debt in the Condensed
Consolidated Balance Sheet at September 30, 2009. The
purchased call options are assets recorded at their fair value
of $348.9 million within other assets in the Condensed
Consolidated Balance Sheet at September 30, 2009. At
December 31, 2008, the $655.4 million consisted of
$419.7 million of debt ($575.0 million face amount,
net of $155.3 million discount) and the bifurcated
conversion feature with a fair value of $235.7 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
$235.7 million within other assets in the Condensed
Consolidated Balance Sheet at December 31, 2008. |
21
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
Details of the interest rates in effect at September 30,
2009 and December 31, 2008, on the outstanding borrowings
under the Term Loans are in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009
|
|
|
|
Outstanding
|
|
|
Basis
|
|
Rate
|
|
|
|
(Dollars in thousands)
|
|
|
U.S. Tranche A Term Loans
|
|
$
|
218,750
|
|
|
LIBOR + 2.75%
|
|
|
3.00
|
%
|
Euro Tranche A Term Loans
|
|
$
|
358,612
|
|
|
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)(3)
|
|
|
500,000
|
|
|
Fixed
|
|
|
5.44
|
%
|
Swapped to Fixed Rate December
2010(1)
|
|
|
1,000,000
|
|
|
Fixed
|
|
|
7.37
|
%
|
Floating Rate
|
|
|
479,320
|
|
|
LIBOR + 3.25%
|
|
|
3.50
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Total U.S. Tranche B Term Loans
|
|
$
|
2,479,320
|
|
|
|
|
|
|
|
Euro Tranche B Term Loans
|
|
|
|
|
|
|
|
|
|
|
Swapped to Fixed Rate March
2011(1)
|
|
$
|
292,398
|
|
|
Fixed
|
|
|
5.38
|
%
|
Floating Rate
|
|
|
452,120
|
|
|
EURIBO + 3.25%
|
|
|
3.69
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Total Euro Tranche B Term Loans
|
|
$
|
744,518
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008
|
|
|
|
Outstanding
|
|
|
Basis
|
|
Rate
|
|
|
|
(Dollars in thousands)
|
|
|
U.S. Tranche A Term Loans
|
|
$
|
265,625
|
|
|
LIBOR + 3%
|
|
|
6.50
|
%
|
Euro Tranche A Term Loans
|
|
$
|
413,684
|
|
|
EURIBO + 3%
|
|
|
7.86
|
%
|
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)(3)
|
|
|
500,000
|
|
|
Fixed
|
|
|
5.44
|
%
|
Swapped to Fixed Rate December
2010(1)
|
|
|
1,000,000
|
|
|
Fixed
|
|
|
7.37
|
%
|
Floating Rate
|
|
|
504,880
|
|
|
LIBOR + 3.25%
|
|
|
5.79
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Total U.S. Tranche B Term Loans
|
|
$
|
2,504,880
|
|
|
|
|
|
|
|
Euro Tranche B Term Loans
|
|
$
|
714,583
|
|
|
EURIBO + 3.25%
|
|
|
8.11
|
%
|
|
|
|
(1) |
|
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 December 2010 |
|
(3) |
|
This interest rate swap has been extended to March 2012 at a
rate of 5.38%, effective March 2010 |
At September 30, 2009 and December 31, 2008, the fair
value of the Senior Convertible Notes was approximately
$588.5 million and $444.0 million. At
September 30, 2009 and December 31, 2008, the fair
value of the Cash Convertible Notes was approximately
$802.0 million and $524.4 million.
At September 30, 2009 and December 31, 2008, the
Company had $84.0 million and $83.6 million in letters
of credit outstanding.
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, 2009, excluding the discount and conversion
feature, are as follows for each of the periods ending December
31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
Euro
|
|
|
U.S.
|
|
|
Euro
|
|
|
Senior
|
|
|
Cash
|
|
|
|
|
|
|
Tranche A
|
|
|
Tranche A
|
|
|
Tranche B
|
|
|
Tranche B
|
|
|
Convertible
|
|
|
Convertible
|
|
|
|
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Notes
|
|
|
Notes
|
|
|
Total
|
|
|
|
(In thousands)
|
|
|
2009
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011
|
|
|
62,500
|
|
|
|
102,460
|
|
|
|
25,560
|
|
|
|
7,675
|
|
|
|
|
|
|
|
|
|
|
|
198,195
|
|
2012
|
|
|
78,125
|
|
|
|
128,076
|
|
|
|
25,560
|
|
|
|
7,675
|
|
|
|
600,000
|
|
|
|
|
|
|
|
839,436
|
|
2013
|
|
|
78,125
|
|
|
|
128,076
|
|
|
|
25,560
|
|
|
|
7,675
|
|
|
|
|
|
|
|
|
|
|
|
239,436
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
2,402,640
|
|
|
|
721,493
|
|
|
|
|
|
|
|
|
|
|
|
3,124,133
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
575,000
|
|
|
|
575,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
218,750
|
|
|
$
|
358,612
|
|
|
$
|
2,479,320
|
|
|
$
|
744,518
|
|
|
$
|
600,000
|
|
|
$
|
575,000
|
|
|
$
|
4,976,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12.
|
Comprehensive
Earnings (Loss)
|
Comprehensive earnings (loss) consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(In thousands)
|
|
|
Net (loss) earnings
|
|
|
|
|
|
$
|
(4,421
|
)
|
|
|
|
|
|
$
|
216,970
|
|
Other comprehensive earnings (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
230,791
|
|
|
|
|
|
|
|
(388,308
|
)
|
Change in unrecognized gains and prior service cost
related to post-retirement plans
|
|
|
|
|
|
|
(974
|
)
|
|
|
|
|
|
|
791
|
|
Net unrecognized loss on derivatives
|
|
|
|
|
|
|
(5,112
|
)
|
|
|
|
|
|
|
(3,562
|
)
|
Unrealized gains (losses) on
available-for-sale
securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains (losses) on
available-for-sale
securities
|
|
|
685
|
|
|
|
|
|
|
|
(695
|
)
|
|
|
|
|
Less: Reclassification for gains included in net earnings
|
|
|
12
|
|
|
|
697
|
|
|
|
8
|
|
|
|
(687
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive earnings (loss), net of tax:
|
|
|
|
|
|
|
225,402
|
|
|
|
|
|
|
|
(391,766
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings (loss)
|
|
|
|
|
|
|
220,981
|
|
|
|
|
|
|
|
(174,796
|
)
|
Comprehensive (earnings) loss attributable to the noncontrolling
interest
|
|
|
|
|
|
|
(827
|
)
|
|
|
|
|
|
|
25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings (loss) attributable to Mylan Inc.
|
|
|
|
|
|
$
|
220,154
|
|
|
|
|
|
|
$
|
(174,771
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(In thousands)
|
|
|
Net earnings (loss)
|
|
|
|
|
|
$
|
200,325
|
|
|
|
|
|
|
$
|
(178,590
|
)
|
Other comprehensive earnings (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
334,084
|
|
|
|
|
|
|
|
(223,480
|
)
|
Change in unrecognized gains and prior service cost
related to post-retirement plans
|
|
|
|
|
|
|
(754
|
)
|
|
|
|
|
|
|
1,568
|
|
Net unrecognized gain on derivatives
|
|
|
|
|
|
|
937
|
|
|
|
|
|
|
|
1,061
|
|
Unrealized gains on
available-for-sale
securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on
available-for-sale
securities
|
|
|
1,062
|
|
|
|
|
|
|
|
(616
|
)
|
|
|
|
|
Less: Reclassification for gains included in net earnings
|
|
|
173
|
|
|
|
1,235
|
|
|
|
74
|
|
|
|
(542
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive earnings (loss), net of tax:
|
|
|
|
|
|
|
335,502
|
|
|
|
|
|
|
|
(221,393
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings (loss)
|
|
|
|
|
|
|
535,827
|
|
|
|
|
|
|
|
(399,983
|
)
|
Comprehensive (earnings) loss attributable to the noncontrolling
interest
|
|
|
|
|
|
|
(6,693
|
)
|
|
|
|
|
|
|
2,273
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive earnings (loss) attributable to Mylan Inc.
|
|
|
|
|
|
$
|
529,134
|
|
|
|
|
|
|
$
|
(397,710
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive loss, as reflected on the
Condensed Consolidated Balance Sheets, is comprised of the
following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
|
|
(In thousands)
|
|
|
Net unrealized gain in
available-for-sale
securities
|
|
$
|
1,326
|
|
|
$
|
91
|
|
Change in unrecognized losses and prior service cost related to
post-retirement plans
|
|
|
(9,738
|
)
|
|
|
(8,984
|
)
|
Net unrecognized losses on derivatives
|
|
|
(44,478
|
)
|
|
|
(45,415
|
)
|
Foreign currency translation adjustments
|
|
|
7,555
|
|
|
|
(326,494
|
)
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive loss
|
|
$
|
(45,335
|
)
|
|
$
|
(380,802
|
)
|
|
|
|
|
|
|
|
|
|
Mylan previously had three reportable segments in accordance
with ASC topic 280, Segment Reporting
(ASC 280); the Generics Segment, Specialty
Segment and the Matrix Segment. The Matrix Segment had consisted
of Matrix, which had been a publicly traded Indian Company, in
which Mylan held a 71.2% ownership stake. Beginning this
quarter, the Company has changed its segment disclosure to
better align with how the business is now being managed.
Following the acquisition of approximately 24% of the remaining
interest in Matrix and its related de-listing, Mylan has two
reportable segments, Generics and Specialty. The former Matrix
Segment is included within the Generics Segment. Under the
provisions of ASC 280, 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 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
24
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
litigation settlements, non-cash 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, including
the inventory
step-up, as
well as any non-cash impairment charges and other significant,
non-recurring items (such as the revenue related to the sale of
Bystolic product rights in 2008), 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,
as amended, for the fiscal year ended December 31, 2008.
Intersegment revenues are accounted for at current market values.
The table below presents segment information for the periods
identified and provides a reconciliation of segment information
to total consolidated information.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics
|
|
|
Specialty
|
|
|
Corporate/
|
|
|
|
|
Three Months Ended September 30, 2009
|
|
Segment
|
|
|
Segment
|
|
|
Other(1)
|
|
|
Consolidated
|
|
|
|
(In thousands)
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics
|
|
|
Specialty
|
|
|
Corporate/
|
|
|
|
|
Nine Months Ended September 30, 2009
|
|
Segment
|
|
|
Segment
|
|
|
Other(1)
|
|
|
Consolidated
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics
|
|
|
Specialty
|
|
|
Corporate/
|
|
|
|
|
Three Months Ended September 30, 2008
|
|
Segment
|
|
|
Segment
|
|
|
Other(1)
|
|
|
Consolidated
|
|
|
Total revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third party
|
|
$
|
1,076,362
|
|
|
$
|
125,444
|
|
|
$
|
455,042
|
|
|
$
|
1,656,848
|
|
Intersegment
|
|
|
394
|
|
|
|
5,151
|
|
|
|
(5,545
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,076,756
|
|
|
$
|
130,595
|
|
|
$
|
449,497
|
|
|
$
|
1,656,848
|
|
Segment profitability
|
|
$
|
273,897
|
|
|
$
|
28,177
|
|
|
$
|
258,758
|
|
|
$
|
560,832
|
|
25
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics
|
|
|
Specialty
|
|
|
Corporate/
|
|
|
|
|
Nine Months Ended September 30, 2008
|
|
Segment
|
|
|
Segment
|
|
|
Other(1)
|
|
|
Consolidated
|
|
|
Total revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third party
|
|
$
|
3,157,853
|
|
|
$
|
308,482
|
|
|
$
|
468,095
|
|
|
$
|
3,934,430
|
|
Intersegment
|
|
|
838
|
|
|
|
27,547
|
|
|
|
(28,385
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,158,691
|
|
|
$
|
336,029
|
|
|
$
|
439,710
|
|
|
$
|
3,934,430
|
|
Segment profitability
|
|
$
|
703,723
|
|
|
$
|
50,396
|
|
|
$
|
(490,825
|
)
|
|
$
|
263,294
|
|
|
|
|
(1) |
|
Includes certain corporate general and administrative and
research and development expenses; a non-recurring, up-front
payment of $18.0 million made with respect to the
Companys execution of a co-development agreement that was
entered into during the nine months ended September 30,
2009; litigation settlements; intercompany eliminations; revenue
related to the 2008 sale of Bystolic product rights;
amortization of intangible assets and certain
purchase-accounting items (such as the inventory
step-up);
non-cash impairment charges; and other expenses not directly
attributable to segments. |
Included in other current liabilities in the Companys
Condensed Consolidated Balance Sheet as of September 30,
2009 are restructuring reserves totaling $55.6 million. Of
this amount, $39.6 million relates to certain estimated
exit costs associated with the acquisition of the former Merck
Generics business, and the remainder 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, 2009,
payments of $13.0 million were made against the reserve, of
which $3.9 million were severance costs and the remaining
$9.1 million were other exit costs. In addition, during the
nine months ended September 30, 2009, the Company reversed
$13.9 million of the reserve to other income as a result of
a reduction in the estimated remaining spending on accrued
projects. Of the remaining accrual, approximately
$22.1 million relates to additional severance and related
costs, $14.3 million relates to costs associated with the
previously announced rationalization and optimization of the
Companys global manufacturing and research and development
platforms, and the remainder consists of other exit costs.
In addition to the activities associated with the acquisition of
the former Merck Generics business, 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 the Companys
sales force in certain markets outside of the
U.S. Accordingly, the Company has recorded a reserve for
such activities, of which approximately $16.0 million
remains at September 30, 2009. During the nine months ended
September 30, 2009, the Company recorded restructuring
charges of approximately $16.4 million, nearly all of which
relates to severance and related costs. The majority of this
amount was charged to selling, general and administrative
expense, with the remainder to cost of sales. Spending during
the nine months, primarily related to severance, amounted to
approximately $8.6 million. Of the accrual balance at
September 30, 2009, $7.7 million is recorded in the
Specialty Segment with the remainder in the Generics Segment.
As finalization of certain of these plans is still in progress,
the Company has not yet estimated the total amount expected to
be incurred in connection with such activities. However, Mylan
expects that the majority of such costs will relate to one-time
termination benefits and certain asset write-downs, which could
be significant. Spending against the balance of the
restructuring reserves as of September 30, 2009 is expected
to occur over the next two to three years.
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
26
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
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 of the Share Purchase Agreement 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 and results of
operations.
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 intend to challenge 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 will now proceed in the Court of Appeals
for the D.C. Circuit. 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 $40.0 million cash deposit (which is included
as restricted cash on the Companys Consolidated Balance
Sheet as of September 30, 2009) 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. 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, 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 or treble damages,
27
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
counsel fees and costs,
and/or
injunctive relief. Mylan and its subsidiaries have denied
liability and intend to defend each of these actions vigorously.
In May 2008, an amended complaint was filed in the
U.S. District Court for the District of Massachusetts by a
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 recovery of any and all alleged overpayment of
the federal share under the Medicaid program. Mylan
intends to answer the complaint denying liability and to defend
the action vigorously.
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. Mylan
has recorded a one time, non-recurring, after-tax charge of
approximately $83.0 million ($121.0 million pre-tax)
in the quarter ended September 30, 2009, as a result of
this settlement. Additionally, the Company intends to seek
recovery of a substantial portion of the settlement amount from
any party that received overpayments resulting from adjusted net
sales during the relevant timeframe.
Dey is a defendant currently in lawsuits brought by the state
AGs of Arizona, California, Florida, Illinois, Iowa, Kansas,
Kentucky, Pennsylvania and Wisconsin, as well as the city of New
York and approximately 40 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. Deys motion
for partial summary judgment is pending. These cases all
generally allege that Dey falsely reported certain price
information concerning certain drugs marketed by Dey. Dey
intends to defend each of these actions vigorously. The Company
has approximately $114.6 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 under the Share Purchase
Agreement. As a result, the Company has recorded approximately
$114.6 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 the Eastern District of Pennsylvania by a variety of
plaintiffs purportedly representing direct and indirect
purchasers of the drug modafinil and a third-party payor and one
action brought by Apotex, Inc., a manufacturer of generic drugs,
seeking approval to market a generic modafinil product. These
actions allege violations of federal and state laws in
connection with the defendants settlement of patent
litigation relating to modafinil. These actions are in their
preliminary stages, and motions to dismiss each action are
pending. Mylan intends to defend each of these actions
vigorously. In addition, by letter dated July 11, 2006,
Mylan was notified by
28
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
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. Mylan is not named as a defendant in
the FTCs lawsuit, although the complaint includes certain
allegations pertaining to the Mylan/Cephalon settlement.
Levetiracetam
By letter dated November 19, 2007, Mylan was notified by
the FTC of an investigation brought against Mylan and
Dr. Reddys Laboratories, Inc. by UCB Society Anonyme
and UCB Pharma, Inc. relating to the settlement in October 2007
of the levetiracetam patent litigation. In its letter, the FTC
requested certain information from Mylan pertaining to the
litigation and the settlement. On April 9, 2008, the FTC
issued a civil investigative demand requesting additional
information from Mylan relating to the investigation. Mylan
cooperated fully with the governments investigation and
complied with all requests for information. By letter dated
March 10, 2009, the FTC notified Mylan that it has closed
its investigation and that it intends to take no additional
action at this time.
Digitek
(R) 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. To date, an estimated 710 lawsuits have
been filed against Mylan, UDL and Actavis pertaining to the
recall. 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 and results of operations.
Pioglitazone
On February 21, 2006, a district court in the
U.S. District Court for the Southern District of New York
held that Mylan, MPI and UDLs pioglitazone abbreviated new
drug application (ANDA) product infringed a patent
asserted against them by Takeda Pharmaceuticals North America,
Inc. and Takeda Chemical Industries, Ltd (Takeda)
and that the patent was enforceable. That same court also held
that Alphapharm Pty, Ltd and Genpharm ULCs pioglitazone
ANDA product infringed the Takeda patent and that the patent was
valid. Subsequently, the district court granted Takedas
motion to find the cases to be exceptional and to award
attorneys fees and costs in the amounts of $11.4 million
from Mylan and $5.4 million from Alphapharm/Genpharm, with
interest, which amounts were paid in 2009. Mylan and
Alphapharm/Genpharm both separately appealed the underlying
patent validity and enforceability determinations and the
exceptional case findings to the Court of Appeals for the
Federal Circuit, but the findings were affirmed. Mylans
and Alphapharms petitions to the U.S. Supreme Court
were rejected on October 5, 2009.
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
29
MYLAN
INC. AND SUBSIDIARIES
Notes to
Condensed Consolidated Financial Statements
(Unaudited) (Continued)
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 [UK] Ltd received
requests for information from the EU Commission in connection
with this matter, and both companies have responded.
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. 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.
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 Company believes
that the ultimate outcome of such other proceedings will not
have a material adverse effect on its financial position or
results of operations.
30
|
|
ITEM 2.
|
MANAGEMENTS
DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL
CONDITION
|
The following discussion and analysis addresses material changes
in the results of operations and financial condition of Mylan
Inc. and subsidiaries (the Company,
Mylan or we) for the periods presented.
This discussion and analysis should be read in conjunction with
the Consolidated Financial Statements, the related Notes to
Consolidated Financial Statements and Managements
Discussion and Analysis of Results of Operations and Financial
Condition included in the Companys Annual Report on
Form 10-K,
as amended, for the year ended December 31, 2008, 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 the Companys other Securities and Exchange Commission
(SEC) filings and public disclosures.
This
Form 10-Q
may contain forward-looking statements. These
statements are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements may include, without limitation,
statements about the Companys market opportunities,
strategies, competition and expected activities and
expenditures, and at times may be identified by the use of words
such as may, will, 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 approximately
15,000 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 its Matrix
Laboratories Limited (Matrix) subsidiary, Mylan
controls the third-largest active pharmaceutical ingredient
(API) manufacturer in the world. 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, as determined in accordance with the
Financial Accounting Standards Board (FASB)
Accounting Standards
CodificationTM
(ASC or Codification) topic 280,
Segment Reporting (ASC 280). The Matrix
Segment had consisted of Matrix, which had been a publicly
traded Indian Company, in which Mylan held a 71.2% ownership
stake. Beginning this quarter the Company has changed its
segment disclosure to better align with how the business is now
being managed. Following the acquisition of approximately 24% of
the remaining interest in Matrix and its related de-listing,
Mylan has two reportable segments, Generics and
Specialty. The former Matrix Segment is included
within the Generics Segment. Under the provisions of ASC 280,
information for earlier periods has been recast.
Generics primarily develops, manufactures, sells and distributes
generic or branded generic pharmaceutical products in tablet,
capsule or transdermal patch form, as well as API. Specialty
engages mainly in the manufacture and sale of branded specialty
nebulized and injectable products. The Company also reports in
Corporate/Other certain general and administrative expenses;
litigation settlements; amortization of intangible assets and
certain purchase-accounting items (such as the inventory
step-up);
non-cash impairment charges; and other items not directly
attributable to the segments. The measure of profitability used
by the Company with respect to its segments is gross profit,
less direct research and development (R&D) and
direct selling, general and administrative
(SG&A) expenses.
31
Acquisition
of the Remaining Interest in Matrix Laboratories
Limited
On March 26, 2009, the Company announced plans to buy the
remaining public interest in 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. On June 1, 2009, Mylan announced that it had
successfully completed the delisting offer and accepted the
discovered price of 211 Rupees per share, which was established
by the reverse book building process prescribed by Indian
regulations. During the nine months ended September 30,
2009, the Company completed the purchase of an additional
portion of the remaining interest from minority shareholders of
Matrix, for cash of approximately $172.3 million, bringing
both the Companys total ownership and control to
approximately 95%.
Matrixs stock was delisted effective August 21, 2009.
Minority shareholders who have not yet tendered their shares may
do so during the six-month period following the delisting. The
purchase was treated as an equity transaction as required by ASC
topic 805, Business Combinations (ASC 805).
Under ASC 805, subsequent increases or decreases of ownership
that do not result in a change in control are accounted for as
equity transactions.
Termination
of Joint Ventures
During the quarter ended June 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
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 the date
of acquisition at the preliminary estimate of 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 a non-recurring research and
development charge related to its up-front, non-refundable
obligation pursuant to the agreement.
Financial
Summary
Mylans financial results for the three months ended
September 30, 2009, included total revenues of
$1.26 billion compared to $1.66 billion for the three
months ended September 30, 2008. Included in total revenues
for the three months ended September 30, 2008, was
$455.0 million of previously deferred revenue related to
the Companys sale of the product rights of
Bystolictm.
Excluding this, total revenues increased by $62.2 million
over the same prior year period. Consolidated gross profit for
the current quarter was $505.0 million compared to
$911.1 million in the same prior year period, a decrease of
44.6%. Excluding Bystolic, gross profit for the current quarter
increased by 10.7%. For the current quarter, operating earnings
of $61.3 million were realized compared to
$560.8 million for the three months ended
September 30, 2008, or $105.8 million, excluding
Bystolic.
32
The net loss attributable to Mylan Inc. common shareholders for
the three months ended September 30, 2009 was
$40.0 million, which translates into a loss per diluted
share of $0.13. In the same prior year period, the net earnings
attributable to Mylan Inc. common shareholders were
$182.4 million, which translates into earnings per diluted
share of $0.47. A more detailed discussion of the Companys
financial results can be found below in the section titled
Results of Operations.
In addition to the revenue from the sale of the product rights
of Bystolic, the comparability of results between the two
periods is affected by the following:
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Charges consisting primarily of incremental amortization related
to purchased intangible assets and the amortization of the
inventory
step-up
associated with the acquisition of the former Merck Generics
business of $71.8 million (pre-tax) during the three months
ended September 30, 2009, compared to $105.4 million
(pre-tax) in the comparable prior year period; and
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A charge of $121.0 million (pre-tax) related to the
settlement of an investigation by the U.S. Department of
Justice, concerning calculations of Medicaid drug rebates.
|
Mylans financial results for the nine months ended
September 30, 2009, include total revenues of
$3.74 billion compared to $3.93 billion for the nine
months ended September 30, 2008. This represents a decrease
in revenues of $193.5 million. Revenues related to the sale
of the product rights of Bystolic totaled $468.1 million
during the nine months ended September 30, 2008. Excluding
this, total revenues in the current year increased by
$274.6 million or 7.9%. Consolidated gross profit for the
nine months ended September 30, 2009 was $1.56 billion
compared to $1.68 billion in the same prior year period, a
decrease of 7.0%. Excluding Bystolic, gross profit for the
current year increased by 29.1%. For the nine months ended
September 30, 2009, operating earnings of
$463.3 million was realized compared to $263.3 million
for the same prior year period.
The net earnings attributable to Mylan Inc. common shareholders
for the nine months ended September 30, 2009 were
$89.4 million, which translates into earnings per diluted
share of $0.29. In the same prior year period, the net loss
attributable to Mylan Inc. common shareholders was
$280.6 million, which translates into a loss per diluted
share of $0.92. A more detailed discussion of the Companys
financial results can be found below in the section titled
Results of Operations.
In addition to the revenue from the sale of the product rights
of Bystolic, the comparability of results between the two
periods is affected by the following:
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Charges consisting primarily of incremental amortization related
to purchased intangible assets and the amortization of the
inventory
step-up
associated with the acquisition of the former Merck Generics
business of $210.2 million (pre-tax) during the nine months
ended September 30, 2009, compared to $335.7 million
(pre-tax) in the comparable prior year period;
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A charge of $121.0 million (pre-tax) related to the
settlement of an investigation by the U.S. Department of
Justice, concerning calculations of Medicaid drug
rebates; and
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A non-cash impairment loss on the goodwill of the Dey, L.P.
(Dey) business of $385.0 million (pre-tax and
after-tax) recorded during the three months ended March 31,
2008. The operating results of Dey are included in the Specialty
Segment, however this non-cash impairment charge has been
included in the Corporate/Other results for the nine months
ended September 30, 2008.
|
Results
of Operations
Three
Months Ended September 30, 2009, Compared to Three Months
Ended September 30, 2008
Total
Revenues and Gross Profit
For the current quarter, Mylan reported total revenues of
$1.26 billion compared to $1.66 billion in the
comparable prior year period. Net revenues increased
$64.7 million or 5.4% from $1.19 billion to
$1.26 billion, while other revenues decreased
$457.5 million, mainly due to the sale of the product
rights of Bystolic in the prior year. Foreign exchange
translation had an unfavorable impact on net revenues, due
primarily to the strengthening of the U.S. Dollar in
comparison to the functional currencies of Mylans other
subsidiaries, primarily those in Europe,
33
Australia and India. On a constant currency basis, net revenues
increased by approximately 9%. The increase in net revenues is
due to higher third-party sales in both of the Companys
segments. The Generics Segment accounted for the majority of the
increase ($42.2 million) followed by the Specialty Segment
($22.4 million). See below for a more detailed discussion
of each segment.
Gross profit for the three months ended September 30, 2009
was $505.0 million, and gross margins were 39.9%. For the
three months ended September 30, 2008, gross profit was
$911.1 million, and gross margins were 55.0%. Excluding the
impact of the Bystolic revenue, gross profit in the prior year
was $456.1 million and gross margins were 38.0%.
Additionally, gross profit for both quarters is impacted by
certain purchase accounting related items which consisted
primarily of incremental amortization related to purchased
intangible assets and the inventory
step-up
associated with the acquisition of the former Merck Generics
business. Excluding such items from both periods and the
Bystolic revenue from the prior year, gross margins would have
been approximately 45.6% in the current quarter compared to
46.7% in the same prior year period. The decrease in margins was
realized by the Generics Segment, due mainly to an unfavorable
product mix, as Specialty Segment margins remained constant.
Generics
Segment
For the current quarter, the Generics Segment reported total
revenues of $1.12 billion, compared to $1.08 billion
for the comparable prior year period. Generics Segment total
revenues are derived from sales primarily in or from the
U.S. and Canada (collectively, North America),
Europe, the Middle East and Africa (collectively,
EMEA) and Australia, Japan, India and New Zealand
(collectively, Asia Pacific).
Total revenues from North America were $502.5 million for
the three-month period ended September 30, 2009, compared
to $460.3 million for the three months ended
September 30, 2008, an increase of $42.1 million or
9.2%. The increase in revenues is the result of products
launched subsequent to September 30, 2008, and favorable
volume, partially offset by unfavorable pricing. New products
contributed net revenues of approximately $60.0 million.
Products generally contribute most significantly to sales and
gross margin at the time of their launch, when there is limited
generic competition and even more so in periods of market
exclusivity.
Fentanyl, Mylans AB-rated generic alternative to
Duragesic®,
continued to contribute to both revenue and gross profit despite
the entrance into the market of additional generic competition.
Sales of fentanyl have remained relatively strong primarily due
to Mylans ability to continue to be a stable and reliable
source of supply to the market. 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
continue to have an unfavorable impact on pricing and market
share.
Total revenues from EMEA were $417.6 million for the
three-month period ended September 30, 2009, compared to
$422.1 million for the comparable prior year period, which
represents a slight decrease. However, on a constant currency
basis, EMEA revenues increased by approximately 7%, driven
mainly by France and the U.K., partially offset by lower sales
in Germany.
Revenues in France increased as a result of new product launches
and higher volumes. In the U.K., prior year revenues were
negatively impacted by excess supply in the market at that time.
The increase in the current year is the result of such excess
supply issues having since been resolved.
The German market was affected by recently implemented
tender systems. A number of markets in which we
operate have implemented or may implement such tender systems
for generic pharmaceuticals in an effort to lower prices. These
measures have a negative impact on sales and gross profit in the
affected markets. In Germany, current quarter revenues were
negatively impacted by the price reductions as a result of these
tenders, as well as general pricing pressure on its non-tender
business and the loss of exclusivity on certain Statutory Health
Insurance contracts.
Total revenues from Asia Pacific were $237.0 million for
the three-month period ended September 30, 2009, compared
to $226.6 million for the three months ended
September 30, 2008, representing an increase of
$10.4 million or 4.6%. Sales in Asia Pacific are derived
from the sale of generic pharmaceuticals in Australia, India,
Japan and New Zealand.
34
On a constant currency basis, Asia Pacific revenues increased
approximately 10%. In Australia, sales decreased as new products
were offset by lower volume. The third quarter of 2008 was an
unusually strong quarter in terms of volume as many Australian
customers re-stocked their inventory following the government
mandated pricing reform that took place in July of 2008. Japan
sales increased as Mylan continues to gain footing in the
continually expanding Japanese generics market. In India,
revenues increased primarily due to higher sales of first-line
anti-retroviral (ARV) products. Also contributing to
the increase in Asia Pacific revenues are higher third party
sales of API. API is also sold to Mylan subsidiaries in
conjunction with the Companys vertical integration
strategy.
In addition to net revenue, total revenues in Asia Pacific
included other revenue of $9.6 million in the current
quarter through intercompany product development agreements,
compared to $13.9 million in the same prior year period.
Certain markets in which the Company does business have recently
undergone government-imposed price reductions, thereby
increasing pricing pressures on pharmaceutical products. This is
true in Australia as well as several European countries. Such
measures, along with the tender systems discussed above, 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.
For the three months ended September 30, 2009, the segment
profitability for the Generics Segment was $295.2 million
compared to $273.9 million in the prior year comparable
period. This increase is the result of higher revenues and gross
profit, mainly from North America and Asia Pacific, as well as
lower operating expenses as discussed below.
Specialty
Segment
For the current quarter, the Specialty Segment reported total
revenues of $154.7 million, of which $150.9 million
represented third-party sales, compared to total revenues of
$130.6 million in the same prior year period, of which
$125.4 million represented third-party sales. The Specialty
Segment consists of Dey, which focuses on the development,
manufacturing and marketing of specialty pharmaceuticals in the
respiratory and severe allergy markets. The most significant
contributor to Specialty Segment revenues and profitability is
the
EpiPen®
Auto-Injector, which is used in the treatment of severe allergic
reactions. The EpiPen Auto-Injector is the number one prescribed
treatment for severe allergic reactions with a U.S. market
share of over 95%.
Segment profitability for the current quarter was
$39.8 million compared to $28.2 million in the
comparable three-month period. The increase is the result of
increased revenue and gross profit as operating expenses were
consistent when comparing the periods.
Operating
Expenses
R&D expense for the three months ended September 30,
2009, was $69.8 million compared to $74.7 million in
the same prior year period, a decrease of $4.9 million. The
decrease was primarily realized by the Generics Segment and is
reflective of certain restructuring activities undertaken by the
Company with respect to the previously announced rationalization
and optimization of the global manufacturing and research and
development platforms.
SG&A expense for the current quarter was
$259.6 million compared to $275.6 million for the same
period in the prior year, a decrease of $16.0 million. This
decrease was primarily recognized in Corporate/Other and is due
to lower costs, including temporary staffing and consulting
costs related to the integration of the former Merck Generics
business, the majority of which were incurred in prior periods.
Lower selling expenses, resulting from right-sizing of the sales
force in certain
non-U.S. markets,
and the favorable impact of foreign currency also contributed to
the overall decrease in the current quarter.
Litigation
Settlements, net
During the three months ended September 30, 2009, the
Company recorded net unfavorable litigation charges of
$114.3 million. The majority of this amount,
$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.
35
Interest
Expense
Interest expense for the three months ended September 30,
2009, totaled $77.0 million compared to $93.5 million
for the three months ended September 30, 2008. The decrease
is due to the reduction in the Companys outstanding debt
balance, through repayments made in December 2008 and March
2009, as well as lower overall interest rates.
Other
Income, net
Other income, net was $0.2 million in the current quarter
compared to $5.8 million in the comparable three-month
period.
Income
Tax Expense
The Company recorded an income tax benefit of $11.1 million
for the three-month period ending September 30, 2009
compared to a provision of $256.1 million in the comparable
prior year quarter. The fluctuation in the effective tax rate is
due to different levels of income, the deductibility of certain
foreign attributes, changes in unrecognized losses of certain
foreign subsidiaries, and changes to the reserves required by
ASC topic 740, Income Taxes (ASC 740).
Nine
Months Ended September 30, 2009, Compared to Nine Months
Ended September 30, 2008
Total
Revenues and Gross Profit
For the nine months ended September 30, 2009, Mylan
reported total revenues of $3.74 billion compared to
$3.93 billion in the same prior year period. Net revenues
increased $239.2 million or 7% from $3.44 billion to
$3.68 billion, while other revenues decreased
$432.7 million. On a constant currency basis, net revenues
increased by approximately 14%. The increase in net revenues is
due to higher third-party sales in both of the Companys
segments. The Generics Segment accounted for the majority of the
increase ($198.7 million) in third-party sales followed by
the Specialty Segment ($40.5 million). See below for a more
detailed discussion of each segment.
The decrease in other revenues of $432.7 million in the
nine-month period was primarily the result of approximately
$468.1 million recognized in the prior year of previously
deferred revenue related to the sale of the Companys
rights of Bystolic. This decrease is partially offset by an
increase in incremental revenue in the current year resulting
from the cancellation of product development agreements for
which the revenue had been previously deferred. Prior to the
termination of these agreements, Mylan had been amortizing the
previously received non-refundable, upfront payments over a
period of several years.
Gross profit for the nine months ended September 30, 2009
was $1.56 billion, and gross margins were 41.7%. For the
nine months ended September 30, 2008, gross profit was
$1.68 billion, and gross margins were 42.6%. Gross profit
for both periods is impacted by certain purchase accounting
related items which consisted primarily of incremental
amortization related to purchased intangible assets and the
inventory
step-up
associated with the acquisition of the former Merck Generics
business. Excluding such items from both periods, and the
Bystolic revenue from the prior year, gross margins would have
been approximately 47.3% in the current year period compared to
44.5% in the prior year period. This increase in gross margins
was realized by the Generics Segment, due primarily to the
launch of new products in North America, as gross margins in the
Specialty Segment remained constant.
Generics
Segment
For the nine months ended September 30, 2009, the Generics
Segment reported total revenues of $3.41 billion, compared
to $3.16 billion for the comparable prior year period.
Total revenues from North America were $1.64 billion for
the nine-month period ended September 30, 2009, compared to
$1.31 billion for the nine months ended September 30,
2008. Included in total revenues are other revenues of
$48.3 million in the current year period compared to
$17.0 million in the prior year period. This increase is
the result of approximately $26.0 million of incremental
revenue resulting from the cancellation of product development
agreements.
36
North America net revenues were $1.59 billion in the
nine-month period ended September 30, 2009, compared to
$1.30 billion in the prior year period, an increase of
$293.3 million or 22.6%. The increase in net revenues is
the result of revenue from new products and favorable volume,
partially offset by unfavorable pricing. New products
contributed net revenues of approximately $297.0 million,
the majority of which were divalproex ER, Mylans version
of Abbott Laboratories
Depakote®
ER, and levetiracetam, Mylans version of UCB Pharmas
Keppra®.
Fentanyl continued to contribute significantly to both revenue
and gross profit despite the entrance into the market of
additional generic competition. Sales of fentanyl have remained
relatively strong primarily due to Mylans ability to
continue to be a stable and reliable source of supply to the
market. 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.
Total revenues from EMEA were $1.18 billion for the
nine-month period ended September 30, 2009, compared to
$1.27 billion for the comparable prior year period. On a
constant currency basis, EMEA revenues increased by
approximately 5% over the prior year.
Increased revenues in France, driven mainly by market share gain
and new product launches, strong development in Italy where we
have recently achieved market leadership, and a full nine months
of revenue contribution from the Central and Eastern European
businesses acquired in June 2008, served to offset lower
revenues brought about by continued pricing pressures in certain
European markets, primarily in Germany. A number of markets in
which we operate have implemented or may implement tender
systems for generic pharmaceuticals in an effort to lower
prices. Such measures are likely to have a further negative
impact on sales and gross profit in these markets.
Total revenues from Asia Pacific were $692.2 million for
the nine-month period ended September 30, 2009, compared to
$678.8 million for the nine months ended September 30,
2008, representing an increase of $13.4 million or 2.0%.
However, on a constant currency basis, Asia Pacific sales
increased by approximately 15%, primarily realized by
Mylans Japanese and Indian subsidiaries, and higher sales
of API. The increase in Japan was driven by favorable product
mix, as well as the continued impact of certain pro-generic
measures implemented by the Japanese government. In India,
revenues increased due to higher sales of first-line ARV
products. These increases were offset by lower sales in
Australia, which have been impacted by unfavorable pricing
following the government price reduction of 25% that took place
in the third quarter of 2008 and the competitive pressure that
resulted.
In addition to net revenue, total revenues in Asia Pacific
included other revenue of $42.7 million in the nine months
ended September 30, 2009, realized primarily through
intercompany product development agreements, compared to
$37.0 million in the same prior year period.
Certain markets in which the Company does business have recently
undergone government-imposed price reductions, thereby
increasing pricing pressures on pharmaceutical products. This is
true in Australia as well as several European countries. Such
measures, along with the tender systems discussed above, 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.
For the nine months ended September 30, 2009, the segment
profitability for the Generics Segment was $995.2 million
compared to $703.7 million in the prior year comparable
period. This increase is the result of higher revenues and gross
profit, as well as lower operating expenses, as discussed below.
Specialty
Segment
For the nine months ended September 30, 2009, the Specialty
Segment reported total revenues of $368.2 million, of which
$353.0 million represented third-party sales, compared to
total revenues of $336.0 million in the same prior year
period, of which $308.5 million represented third-party sales.
The EpiPen Auto-Injector continued to be the most significant
contributor to Specialty Segment revenues and profitability.
37
In addition to the continued strong sales of the EpiPen
Auto-Injector, the increase in third-party revenues is due
primarily to increased sales of
Perforomist®
Solution, Deys maintenance therapy for patients with
moderate to severe chronic obstructive pulmonary disease.
Increased sales of the EpiPen Auto-Injector and Perforomist
Solution in the current year were partially offset by lower
revenue from
DuoNeb®
for which patent protection was lost in late 2007. The
additional competition which followed the loss of patent
protection has not only affected Deys sales of the branded
product, but also impacted the profit share received from sales
of the licensed generic.
Segment profitability for the nine months ended
September 30, 2009 was $71.5 million compared to
$50.4 million in the comparable nine-month period. This
increase is the result of increased sales volume as discussed
above, as well as lower operating expenses resulting from
certain restructuring initiatives.
Operating
Expenses
R&D expense for the nine months ended September 30,
2009, was $202.7 million compared to $239.3 million in
the same prior year period, a decrease of $36.7 million.
The decrease was realized by the Generics Segment and to a
lesser degree the Specialty Segment, and is reflective of
certain restructuring activities undertaken by the Company with
respect to the previously announced rationalization and
optimization of the global manufacturing and research and
development platforms. These decreases were partially offset by
a non-recurring, up-front payment of $18.0 million made
with respect to the Companys execution of a co-development
agreement that was entered into during the nine months ended
September 30, 2009.
SG&A expense for the nine months ended September 30,
2009 was $781.0 million compared to $788.0 million for
the same period in the prior year, a decrease of
$7.0 million. This decrease resulted from lower SG&A
realized by both segments, due to the favorable impact of
foreign exchange and cost savings resulting from certain
restructuring initiatives. This decrease was partially offset by
an increase in Corporate/Other SG&A activities due
primarily to an increase in legal and professional fees, as well
as higher payroll and payroll related costs.
Litigation
Settlements, net
During the nine months ended September 30, 2009, the
Company recorded net unfavorable litigation charges of
$111.5 million. The majority of this amount,
$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,
2009, totaled $240.2 million compared to
$282.4 million for the nine months ended September 30,
2008. The decrease is due to the reduction in the Companys
outstanding debt balance, through repayments made in December
2008 and March 2009, as well as lower overall interest rates.
Other
Income, net
Other income, net was $29.7 million in the current
nine-month period compared to $20.6 million in the
comparable nine-month period. Included in the current year is a
favorable adjustment in the current year 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
The Company recorded income tax expense of $52.5 million
for the nine-month period ending September 30, 2009
compared to $180.1 million in the comparable prior year
period. The fluctuation in the tax provision is due to different
levels of income, the deductibility of certain foreign
attributes, changes in unrecognized losses of certain foreign
subsidiaries, and changes to the reserves required by ASC 740.
In the nine-month period ending September 30, 2008, a
pre-tax operating loss was offset by the non-deductible goodwill
impairment charge related to Dey. The effective tax rate in the
prior year was largely influenced by the gain on the sale of
Bystolic as well.
38
Liquidity
and Capital Resources
Cash provided by operating activities were $546.6 million
for the nine months ended September 30, 2009. The amount
consists primarily of net earnings and non-cash addbacks for
depreciation and amortization and litigation settlements,
partially offset by a decrease in cash from net changes in
operating assets and liabilities and the deferred income tax
benefit.
Cash used in investing activities for the nine months ended
September 30, 2009 was $282.9 million, consisting
primarily of approximately $172.3 million which was spent
to acquire additional shares of Matrix and $38.9 million
which was used to acquire the additional 50% interest in Astrix.
Partially offsetting these cash outflows was the receipt of
$23.3 million consisting of the proceeds from Matrixs
sale of its 50% in the FCC joint venture.
Also included in cash used in investing activities were capital
expenditures of $83.1 million. These expenditures were
primarily for equipment, including a portion related to the
Companys previously announced planned expansions and
integration plans surrounding the acquisition of the former
Merck Generics business.
Cash used in financing activities was $242.8 million for
the nine months ended September 30, 2009. Cash dividends of
$104.3 million were paid on the Companys 6.50%
mandatory convertible preferred stock. Additionally, the Company
made repayments on its long-term debt in the amount of
$153.3 million. These payments primarily consist of the
prepayment of amounts due in 2010 under the Companys
Senior Credit Agreement.
The Company is involved in various legal proceedings that are
considered normal to its business. While it is not feasible to
predict the outcome of such proceedings, an adverse outcome in
any of these proceedings could materially affect the
Companys financial position and results of operations.
Additionally, for certain contingencies assumed in conjunction
with the acquisition of the former Merck Generics business,
Merck KGaA, the seller, has indemnified Mylan under the
provisions of the Share Purchase Agreement. The inability or
denial of Merck KGaA to pay on an indemnified claim, could have
a material adverse effect on the Companys financial
position or results of operations.
The Companys Condensed Consolidated Balance Sheet as of
September 30, 2009 includes restructuring reserves of
$55.6 million. Spending against this balance, which
consists primarily of severance and related costs and costs
associated with the previously announced rationalization and
optimization of the Companys global manufacturing and
research and development platforms, is expected to occur over
the next two to three years.
Additionally, as finalization of these plans is still in
progress, the Company has not yet estimated the total amount
expected to be incurred in connection with such activities.
However, Mylan expects that the majority of such costs will
relate to one-time termination benefits and certain asset
write-downs, which could be significant.
On May 7, 2009, at the annual shareholders meeting,
Mylans shareholders approved an increase in the number of
authorized shares of Mylans common stock from 600,000,000
to 1,500,000,000. In addition, the shareholders approved an
increase in shares that may be issued under the Companys
2003 Long-Term Incentive Plan as restricted shares, restricted
units, performance shares and other stock-based awards from
5,000,000 to 8,000,000.
On October 20, 2009, the Company announced that a quarterly
dividend of $16.25 per share was declared (based on the annual
dividend rate of 6.5% and a liquidation preference of $1,000 per
share) payable on November 16, 2009, to the holders of
preferred stock of record as of November 1, 2009.
The Company is actively pursuing, and is 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 to be made by the Company upon
the attainment of specified milestones. While these arrangements
help to reduce the financial risk for unsuccessful projects,
fulfillment of specified milestones or the occurrence of other
obligations may result in fluctuations in cash flows.
The Company is continuously evaluating the potential acquisition
of products, as well as companies, as a strategic part of its
future growth. Consequently, the Company may utilize current
cash reserves or incur additional indebtedness to finance any
such acquisitions, which could impact future liquidity. In
addition, on an ongoing basis,
39
the Company reviews its operations including the evaluation of
potential divestures of products and businesses as part of its
future strategy. Any divestitures could impact future liquidity.
At September 30, 2009 and December 31, 2008, the
Company had $84.0 million and $83.6 million in letters
of credit outstanding.
Mandatory minimum repayments remaining on the outstanding
borrowings under the term loans and convertible notes at
September 30, 2009, excluding the discount and conversion
feature, are as follows for each of the periods ending December
31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
Euro
|
|
|
U.S.
|
|
|
Euro
|
|
|
Senior
|
|
|
Cash
|
|
|
|
|
|
|
Tranche A
|
|
|
Tranche A
|
|
|
Tranche B
|
|
|
Tranche B
|
|
|
Convertible
|
|
|
Convertible
|
|
|
|
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Term Loans
|
|
|
Notes
|
|
|
Notes
|
|
|
Total
|
|
|
|
(In thousands)
|
|
|
2009
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011
|
|
|
62,500
|
|
|
|
102,460
|
|
|
|
25,560
|
|
|
|
7,675
|
|
|
|
|
|
|
|
|
|
|
|
198,195
|
|
2012
|
|
|
78,125
|
|
|
|
128,076
|
|
|
|
25,560
|
|
|
|
7,675
|
|
|
|
600,000
|
|
|
|
|
|
|
|
839,436
|
|
2013
|
|
|
78,125
|
|
|
|
128,076
|
|
|
|
25,560
|
|
|
|
7,675
|
|
|
|
|
|
|
|
|
|
|
|
239,436
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
2,402,640
|
|
|
|
721,493
|
|
|
|
|
|
|
|
|
|
|
|
3,124,133
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
575,000
|
|
|
|
575,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
218,750
|
|
|
$
|
358,612
|
|
|
$
|
2,479,320
|
|
|
$
|
744,518
|
|
|
$
|
600,000
|
|
|
$
|
575,000
|
|
|
$
|
4,976,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recent
Accounting Pronouncements
In June 2009, the FASB issued SFAS No. 168, The
FASB Accounting Standards Codification and the Hierarchy of
Generally Accepted Accounting Principles A
Replacement of FASB Statement No. 162 (as codified in
ASC topic 105, Generally Accepted Accounting Principles
(ASC 105)). This update to ASC 105
establishes the Codification as the single source of
authoritative accounting principles generally accepted in the
United States of America (GAAP) recognized by the
FASB to be applied by nongovernmental entities. Rules and
interpretive releases of the SEC under authority of federal
securities laws are also sources of authoritative GAAP for SEC
registrants. ASC 105 and the Codification are effective for
financial statements issued for interim and annual periods
ending after September 15, 2009. The Codification
supersedes all existing non-SEC accounting and reporting
standards. All other non-grandfathered non-SEC accounting
literature not included in the Codification has become
non-authoritative. Following this update to ASC 105, the
FASB will not issue new standards in the form of Statements,
FASB Staff Positions (FSP), or Emerging Issues Task
Force (EITF) Abstracts. Instead, the FASB will issue
Accounting Standards Updates, which will serve only to:
(a) update the Codification; (b) provide
background information about the guidance; and (c)
provide the bases for conclusions on the change(s) in the
Codification. The Company adopted the requirements of this
standard for the quarter ended September 30, 2009. The
adoption of this update to ASC 105 did not have a material
impact on the Companys Condensed Consolidated Financial
Statements. All accounting references have been updated, and
therefore SFAS references have been replaced with ASC references.
In June 2009, the FASB issued SFAS No. 166,
Accounting for Transfers of Financial Assets an
amendment of SFAS No. 140 (as codified in ASC
topic 860, Transfers and Servicing
(ASC 860)). This update to ASC 860 is a
revision to FASB Statement No. 140, Accounting for
Transfers and Servicing of Financial Assets and Extinguishments
of Liabilities (which is codified in ASC 860), and will
require more disclosures about transfers of financial assets,
including securitization transactions and where entities have
continuing exposure to the risks related to transferred
financial assets. It eliminates the concept of a
qualifying special-purpose entity, changes the
requirements for derecognizing financial assets, and requires
additional disclosures. This update to ASC 860 enhances
disclosures reported to users of financial statements by
providing greater transparency about transfers of financial
assets and an entitys continuing involvement in
transferred financial assets. This update to ASC 860 is
effective for fiscal years beginning after November 15,
2009. Early application is not permitted. The Company is
currently evaluating the impact on its consolidated financial
statements of adopting this update to ASC 860.
40
In May 2009, the FASB issued SFAS No. 165,
Subsequent Events (as codified in ASC topic 855,
Subsequent Events (ASC 855)). This
update to ASC 855 sets forth the period after the balance
sheet date during which management of a reporting entity should
evaluate events or transactions that may occur for potential
recognition or disclosure in the financial statements, the
circumstances under which an entity should recognize events or
transactions occurring after the balance sheet date in its
financial statements and the disclosures that an entity should
make about events or transactions that occurred after the
balance sheet date. The Company adopted the requirements of this
standard for the quarter ended June 30, 2009. The adoption
of this update to ASC 855 did not have a material impact on
the Companys Condensed Consolidated Financial Statements.
In April 2009, the FASB issued FSP
FAS 115-2
and
FAS 124-2,
Recognition and Presentation of Other-Than-Temporary
Impairments (as codified in ASC topic 320,
Investments Debt and Equity Securities
(ASC 320)). This update to ASC 320
amends SFAS No. 115, Accounting for Certain
Investments in Debt and Equity Securities,
SFAS No. 124, Accounting for Certain Investments
Held by Not-for-Profit Organizations, and EITF Issue
No. 99-20,
Recognition of Interest Income and Impairment on Purchased
Beneficial Interests and Beneficial Interests That Continue to
Be Held by a Transferor in Securitized Financial Assets (all
of which are codified in ASC 320), to make the
other-than-temporary impairments guidance more operational and
to improve the presentation of other-than-temporary impairments
in the financial statements. This standard replaces the existing
requirement that the entitys management assert it has both
the intent and ability to hold an impaired debt security until
recovery with a requirement that management assert it does not
have the intent to sell the security, and it is more likely than
not it will not have to sell the security before recovery of its
cost basis. The Company adopted the requirements of this
standard as of June 30, 2009. The adoption of this update
to ASC 320 did not have a material impact on the
Companys Condensed Consolidated Financial Statements.
In April 2009, the FASB issued FSP
FAS 107-1
and APB
28-1,
Interim Disclosures about Fair Value of Financial Instruments
(as codified in ASC topic 825, Financial Instruments
(ASC 825)). This update to ASC 825
requires companies to disclose in interim financial statements
the fair value of financial instruments within the scope of
ASC 825. However, companies are not required to provide in
interim periods the disclosures about the concentration of
credit risk of all financial instruments that are currently
required in annual financial statements. The fair-value
information disclosed in the footnotes must be presented
together with the related carrying amount, making it clear
whether the fair value and carrying amount represent assets or
liabilities and how the carrying amount relates to what is
reported in the balance sheet. This update to ASC 825 also
requires that companies disclose the method or methods and
significant assumptions used to estimate the fair value of
financial instruments and a discussion of changes, if any, in
the method or methods and significant assumptions during the
period. The Company adopted the requirements of this standard as
of June 30, 2009. The adoption of this update to
ASC 825 did not have a material impact on the
Companys Condensed Consolidated Financial Statements.
On January 1, 2009, the Company adopted FSP APB
14-1,
Accounting for Convertible Debt Instruments That May Be
Settled in Cash Upon Conversion (Including Partial Cash
Settlement) (as codified in ASC topic 470, Debt
(ASC 470)). Under the new rules, for convertible
debt instruments (including the Companys Senior
Convertible Notes) that may be settled entirely or partially in
cash upon conversion, entities now separately account for the
liability and equity components of the instrument in a manner
that reflects the issuers economic interest cost. The
effect of the new rules, as they apply to the Companys
Senior Convertible Notes, is that the equity component is
included in the additional paid-in capital section of
shareholders equity on the Companys consolidated
balance sheet and the value of the equity component is treated
as an original issue discount for purposes of accounting for the
debt component. Higher interest expense results through the
accretion of the discounted carrying value of the Senior
Convertible Notes to their face amount over their term. This
update to ASC 470 requires retrospective application as
disclosed below.
On January 1, 2009, the Company adopted
SFAS No. 160, Noncontrolling Interests in
Consolidated Financial Statements an amendment of
ARB No. 51 (as codified in ASC topic 810,
Consolidation (ASC 810)). This update to
ASC 810 amends Accounting Research
Bulletin No. 51, Consolidated Financial
Statements (which is codified in ASC 810), to establish
accounting and reporting standards for the noncontrolling
interest in a subsidiary and for the deconsolidation of a
subsidiary. This standard defines a noncontrolling interest,
sometimes called a minority interest, as the portion of equity
in a subsidiary not attributable, directly or indirectly, to a
parent. This update to ASC 810 requires, among other items,
that a noncontrolling interest be included in the consolidated
41
balance sheet within equity separate from the parents
equity; consolidated net income to be reported at amounts
inclusive of both the parents and noncontrolling
interests shares and, separately, the amounts of
consolidated net income attributable to the parent and
noncontrolling interest all on the consolidated statement of
operations; and if a subsidiary is deconsolidated, any retained
noncontrolling equity investment in the former subsidiary be
measured at fair value and a gain or loss be recognized in net
income based on such fair value.
The Companys Condensed Consolidated Statements of
Operations for the three and nine months ended
September 30, 2008, as originally reported and as adjusted
for the adoption of the aforementioned updates to ASC
470 and ASC 810, are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2008
|
|
|
|
|
|
|
As Adjusted
|
|
|
|
(In thousands, except per share amounts)
|
|
|
Interest expense
|
|
$
|
87,553
|
|
|
$
|
93,540
|
|
Earnings before income taxes and noncontrolling interest
|
|
|
479,045
|
|
|
|
473,058
|
|
Income tax provision
|
|
|
272,438
|
|
|
|
256,088
|
|
Net earnings
|
|
|
206,607
|
|
|
|
216,970
|
|
Net earnings attributable to the noncontrolling interest
|
|
|
151
|
|
|
|
151
|
|
Net earnings attributable to Mylan Inc. common shareholders
|
|
|
171,999
|
|
|
|
182,362
|
|
Loss per common share attributable to Mylan Inc.:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.56
|
|
|
$
|
0.60
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
0.45
|
|
|
$
|
0.47
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
304,449
|
|
|
|
304,449
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
458,350
|
|
|
|
458,350
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2008
|
|
|
|
|
|
|
As Adjusted
|
|
|
|
(In thousands, except per share amounts)
|
|
|
Interest expense
|
|
$
|
264,789
|
|
|
$
|
282,405
|
|
Earnings before income taxes and noncontrolling interest
|
|
|
19,088
|
|
|
|
1,472
|
|
Income tax provision
|
|
|
197,378
|
|
|
|
180,062
|
|
Net loss
|
|
|
(178,290
|
)
|
|
|
(178,590
|
)
|
Net earnings attributable to the noncontrolling interest
|
|
|
2,266
|
|
|
|
2,266
|
|
Net loss attributable to Mylan Inc. common shareholders
|
|
|
(280,260
|
)
|
|
|
(280,560
|
)
|
Loss per common share attributable to Mylan Inc.:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.92
|
)
|
|
$
|
(0.92
|
)
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
(0.92
|
)
|
|
$
|
(0.92
|
)
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
304,305
|
|
|
|
304,305
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
304,305
|
|
|
|
304,305
|
|
|
|
|
|
|
|
|
|
|
42
The Companys Condensed Consolidated Balance Sheet as
originally reported and as adjusted for the adoption of the
aforementioned updates to ASC 470 and ASC 810, is as
follows:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008
|
|
|
December 31, 2008
|
|
|
|
|
|
|
As Adjusted
|
|
|
|
(In thousands)
|
|
|
Liabilities and equity
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
Long-term debt
|
|
$
|
5,165,419
|
|
|
$
|
5,078,937
|
|
Deferred income tax liability
|
|
|
545,121
|
|
|
|
577,379
|
|
Total liabilities
|
|
|
7,677,242
|
|
|
|
7,623,018
|
|
Minority interest
|
|
|
29,108
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
Mylan Inc. shareholders equity
|
|
|
|
|
|
|
|
|
Additional paid-in capital
|
|
|
3,873,743
|
|
|
|
3,955,725
|
|
Retained earnings
|
|
|
594,352
|
|
|
|
566,594
|
|
Noncontrolling interest
|
|
|
|
|
|
|
29,108
|
|
Total equity
|
|
|
2,703,509
|
|
|
|
2,786,841
|
|
|
|
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,
as amended.
|
|
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, 2009. Based upon that evaluation, the
Principal Executive Officer and the Principal Financial Officer
concluded that the Companys disclosure controls and
procedures were effective. No change in the Companys
internal control over financial reporting occurred during the
nine months ended September 30, 2009, that has materially
affected, or is reasonably likely to materially affect, the
Companys internal control over financial reporting.
PART II.
OTHER INFORMATION
|
|
ITEM 1.
|
LEGAL
PROCEEDINGS
|
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 of the Share Purchase Agreement 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 and results of
operations.
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
43
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 intend to challenge 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 will now proceed in the Court of Appeals
for the D.C. Circuit. 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 $40.0 million cash deposit (which is included
as restricted cash on the Companys Consolidated Balance
Sheet as of September 30, 2009) 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. 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, 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 or treble damages, counsel fees and costs,
and/or
injunctive relief. Mylan and its subsidiaries have denied
liability and intend to defend each of these actions vigorously.
In May 2008, an amended complaint was filed in the
U.S. District Court for the District of Massachusetts by a
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 recovery of any and all alleged overpayment of
the federal share under the Medicaid program. Mylan
intends to answer the complaint denying liability and to defend
the action vigorously.
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
44
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. Mylan
has recorded a one time, non-recurring, after-tax charge of
approximately $83.0 million ($121.0 million pre-tax)
in the quarter ended September 30, 2009, as a result of
this settlement. Additionally, the Company intends to seek
recovery of a substantial portion of the settlement amount from
any party that received overpayments resulting from adjusted net
sales during the relevant timeframe.
Dey is a defendant currently in lawsuits brought by the state
AGs of Arizona, California, Florida, Illinois, Iowa, Kansas,
Kentucky, Pennsylvania and Wisconsin, as well as the city of New
York and approximately 40 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. Deys motion
for partial summary judgment is pending. These cases all
generally allege that Dey falsely reported certain price
information concerning certain drugs marketed by Dey. Dey
intends to defend each of these actions vigorously. The Company
has approximately $114.6 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 under the Share Purchase
Agreement. As a result, the Company has recorded approximately
$114.6 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 the Eastern District of Pennsylvania by a variety of
plaintiffs purportedly representing direct and indirect
purchasers of the drug modafinil and a third-party payor and one
action brought by Apotex, Inc., a manufacturer of generic drugs,
seeking approval to market a generic modafinil product. These
actions allege violations of federal and state laws in
connection with the defendants settlement of patent
litigation relating to modafinil. These actions are in their
preliminary stages, and motions to dismiss each action are
pending. 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. Mylan is not
named as a defendant in the FTCs lawsuit, although the
complaint includes certain allegations pertaining to the
Mylan/Cephalon settlement.
Levetiracetam
By letter dated November 19, 2007, Mylan was notified by
the FTC of an investigation brought against Mylan and
Dr. Reddys Laboratories, Inc. by UCB Society Anonyme
and UCB Pharma, Inc. relating to the settlement in October 2007
of the levetiracetam patent litigation. In its letter, the FTC
requested certain information from Mylan pertaining to the
litigation and the settlement. On April 9, 2008, the FTC
issued a civil investigative demand requesting additional
information from Mylan relating to the investigation. Mylan
cooperated fully with the governments investigation and
complied with all requests for information. By letter dated
March 10, 2009, the FTC notified Mylan that it has closed
its investigation and that it intends to take no additional
action at this time.
45
Digitek
(R) 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. To date, an estimated 710 lawsuits have
been filed against Mylan, UDL and Actavis pertaining to the
recall. 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 and results of operations.
Pioglitazone
On February 21, 2006, a district court in the
U.S. District Court for the Southern District of New York
held that Mylan, MPI and UDLs pioglitazone abbreviated new
drug application (ANDA) product infringed a patent
asserted against them by Takeda Pharmaceuticals North America,
Inc. and Takeda Chemical Industries, Ltd (Takeda)
and that the patent was enforceable. That same court also held
that Alphapharm Pty, Ltd and Genpharm ULCs pioglitazone
ANDA product infringed the Takeda patent and that the patent was
valid. Subsequently, the district court granted Takedas
motion to find the cases to be exceptional and to award
attorneys fees and costs in the amounts of $11.4 million
from Mylan and $5.4 million from Alphapharm/Genpharm, with
interest, which amounts were paid in 2009. Mylan and
Alphapharm/Genpharm both separately appealed the underlying
patent validity and enforceability determinations and the
exceptional case findings to the Court of Appeals for the
Federal Circuit, but the findings were affirmed. Mylans
and Alphapharms petitions to the U.S. Supreme Court
were rejected on October 5, 2009.
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 Laboratories Limited
(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 [UK] Ltd received
requests for information from the EU Commission in connection
with this matter, and both companies have responded.
In addition, the European 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. 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.
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 Company believes
that the ultimate
46
outcome of such other proceedings will not have a material
adverse effect on its financial position or results of
operations.
The following risk factors could have a material adverse effect
on our business, financial position or results of operations and
could cause the market value of our common stock to decline.
These risk factors may not include all of the important factors
that could affect our business or our industry or that could
cause our future financial results to differ materially from
historic or expected results or cause the market price of our
common stock to fluctuate or decline.
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.
The global economy is currently undergoing a period of
unprecedented volatility, and the future economic environment
may continue to be less favorable than that of recent 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
CONTINUING INTEGRATION OF THE FORMER MERCK GENERICS BUSINESS
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.
We acquired the former Merck Generics business in October 2007.
There continue to be a number of operational risks associated
with the acquisition and related integration, including but not
limited to:
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difficulties in successfully integrating the operations and
personnel of the former Merck Generics business with our
historical business and corporate culture;
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difficulties in achieving identified financial and operating
synergies;
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diversion of managements attention from our ongoing
business concerns to integration matters;
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the potential loss of key personnel or customers;
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difficulties in consolidating information technology platforms,
business applications and corporate infrastructure;
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our substantial indebtedness and assumed liabilities;
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the incurrence of significant additional capital expenditures,
operating expenses and non-recurring acquisition-related charges;
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challenges in operating in other markets outside of the United
States that are new to us; and
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unanticipated effects of export controls, exchange rate
fluctuations, domestic and foreign political conditions or
domestic and foreign economic conditions.
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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.
47
WE MAY
FAIL TO REALIZE THE EXPECTED COST SAVINGS, GROWTH OPPORTUNITIES
AND OTHER BENEFITS ANTICIPATED FROM THE ACQUISITIONS OF THE
FORMER MERCK GENERICS BUSINESS AND MATRIX, 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 success of the acquisitions of the former Merck Generics
business and Matrix will depend, in part, on our ability to
realize anticipated cost savings, revenue synergies and growth
opportunities from integrating the businesses. We expect to
benefit from operational cost savings resulting from the
consolidation of capabilities and elimination of redundancies as
well as greater efficiencies from increased scale and market
integration.
There is a risk, however, that the businesses may not be
combined in a manner that permits these costs savings or
synergies to be realized in the time currently expected, or at
all. This may limit or delay our ability to integrate the
companies manufacturing, research and development,
marketing, organizations, procedures, policies and operations.
In addition, a variety of factors, including, but not limited
to, wage inflation and currency fluctuations, may adversely
affect our anticipated cost savings and revenues.
Also, we may be unable to achieve our anticipated cost savings
and synergies without adversely affecting our revenues. If we
are not able to successfully achieve these objectives, the
anticipated benefits of these acquisitions may not be realized
fully, or at all, or may take longer to realize than expected.
These factors could impair our growth and ability to compete,
require us to focus additional resources on integration of
operations rather than other profitable areas, or otherwise
cause a material adverse effect on our business, financial
position and results of operations and could cause a decline in
the market value of our common stock.
WE
HAVE GROWN AT A VERY RAPID PACE. OUR INABILITY TO PROPERLY
MANAGE OR SUPPORT THIS GROWTH MAY HAVE A MATERIAL ADVERSE EFFECT
ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS
AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO
DECLINE.
We have grown very rapidly over the past few years, through our
acquisitions of the former Merck Generics business and Matrix.
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 EXPANSION THROUGH THE ACQUISITIONS OF THE FORMER MERCK
GENERICS BUSINESS AND MATRIX EXPOSES US TO ADDITIONAL RISKS
WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS,
FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE
MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
With our acquisitions of the former Merck Generics business and
Matrix, our operations extend to numerous countries outside the
United States. Operating globally exposes us to certain
additional risks including, but not limited to:
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compliance with a variety of national and local laws of
countries in which we do business, including restrictions on the
import and export of certain intermediates, drugs and
technologies;
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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;
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fluctuations in exchange rates for transactions conducted in
currencies other than the functional currency;
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48
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adverse changes in the economies in which we operate as a result
of a slowdown in overall growth, a change in government or
economic liberalization policies, or financial, political or
social instability in such countries that affects the markets in
which we operate, particularly emerging markets;
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wage increases or rising inflation in the countries in which we
operate;
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supply disruptions, and increases in energy and transportation
costs;
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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. Certain of the above factors
could have a material adverse effect on our business, financial
position and results of operations and could cause a decline in
the market value of our common stock.
OUR
FUTURE REVENUE GROWTH AND PROFITABILITY ARE DEPENDENT UPON OUR
ABILITY TO DEVELOP AND/OR LICENSE, OR OTHERWISE ACQUIRE, AND
INTRODUCE NEW PRODUCTS ON A TIMELY BASIS IN RELATION TO OUR
COMPETITORS PRODUCT INTRODUCTIONS. OUR FAILURE TO DO SO
SUCCESSFULLY COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR
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 United States 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 United
States, the approval process may be more or less rigorous, and
the time required for approval may be longer or shorter than
that required in the United States. Bioequivalency studies
conducted in one country may not be accepted in other countries,
and the approval of a pharmaceutical product in one country does
not necessarily mean that the product will be approved in
another country. We, or a partner, may be unable to obtain
requisite approvals on a timely basis for new generic or branded
products that we may develop, license or otherwise acquire.
Moreover, if we obtain regulatory approval for a drug it may be
limited with respect to the indicated uses and delivery methods
for which the drug may be marketed, which could in turn restrict
our potential market for the drug. Also, for products pending
approval, we may obtain raw materials or produce batches of
inventory to be used in efficacy and bioequivalence testing, as
well as in anticipation of the products launch. In the
event that regulatory approval is denied or delayed, we could be
exposed to the risk of this inventory becoming obsolete. The
timing and cost of obtaining regulatory approvals could
adversely affect our product introduction plans, business,
financial position and results of operations and could cause the
market value of our common stock to decline.
49
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 United States, 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 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 jurisdictions other than the United States, we
may face similar regulatory hurdles and constraints. If we are
unable to navigate our products through all of the regulatory
hurdles we face in a timely manner it could adversely affect our
product introduction plans, business, financial position and
results of operations and could cause the market value of our
common stock to decline.
IF THE
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.
50
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 current U.S. presidential administration recently
announced several proposals to change U.S. income tax
rules, including proposals for U.S. international tax
reform. 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, limit the deferral of U.S. income tax on
non-U.S. source
income, and defer the deduction of interest and certain other
expenses 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.
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.
A
RELATIVELY SMALL GROUP OF PRODUCTS MAY REPRESENT A SIGNIFICANT
PORTION OF OUR NET REVENUES, GROSS PROFIT OR NET EARNINGS FROM
TIME TO TIME. IF THE VOLUME OR PRICING OF ANY OF THESE PRODUCTS
DECLINES, IT COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR
BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD
CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO
DECLINE.
Sales of a limited number of our products often represent a
significant portion of our net revenues, gross profit and net
earnings. If the volume or pricing of our largest selling
products declines in the future, our business, financial
position and results of operations could be materially adversely
affected, and the market value of our common stock could decline.
51
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.
BECAUSE
THE PHARMACEUTICAL INDUSTRY IS HEAVILY REGULATED, WE FACE
SIGNIFICANT COSTS AND UNCERTAINTIES ASSOCIATED WITH OUR EFFORTS
TO COMPLY WITH APPLICABLE REGULATIONS. SHOULD WE FAIL TO COMPLY,
WE COULD EXPERIENCE MATERIAL ADVERSE EFFECTS ON OUR BUSINESS,
FINANCIAL POSITION AND RESULTS OF OPERATIONS, AND THE MARKET
VALUE OF OUR COMMON STOCK COULD DECLINE.
The pharmaceutical industry is subject to regulation by various
governmental authorities. For instance, we must comply with
requirements of the FDA and similar requirements of similar
agencies in our other markets with respect to the manufacture,
labeling, sale, distribution, marketing, advertising, promotion
and development of pharmaceutical products. Failure to comply
with regulations of the FDA and other regulators can result in
fines, 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
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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. As discussed elsewhere in this
Form 10-Q
and other reports we file with the SEC, we and other
pharmaceutical companies are defendants in a number of suits
filed by state attorneys general and had been notified of an
investigation by the United States Department of Justice with
respect to Medicaid reimbursement and rebates, which has since
been settled. Because our processes for these calculations and
the judgments involved in making these calculations involve, and
will continue to involve, subjective decisions and complex
methodologies, these calculations are subject to the risk of
errors. In addition, they are subject to review and challenge by
the applicable governmental agencies, and it is possible that
such reviews could result in material changes. Further,
effective October 1, 2007, the Centers for Medicaid and
Medicare Services, or CMS, adopted new rules for Average
Manufacturers Price (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.
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Some of the applicable laws may impose liability even in the
absence of specific intent to defraud. Furthermore, should there
be ambiguity with regard to how to properly calculate and report
payments and even in the absence of any such
ambiguity a governmental authority may take a
position contrary to a position we have taken, and may impose
civil and/or
criminal sanctions. Any such penalties or sanctions could have a
material adverse effect on our business, financial position and
results of operations and could cause the market value of our
common stock to decline.
WE
EXPEND A SIGNIFICANT AMOUNT OF RESOURCES ON RESEARCH AND
DEVELOPMENT EFFORTS THAT MAY NOT LEAD TO SUCCESSFUL PRODUCT
INTRODUCTIONS. FAILURE TO SUCCESSFULLY INTRODUCE PRODUCTS INTO
THE MARKET COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS,
FINANCIAL POSITION AND RESULTS OF OPERATIONS, AND THE MARKET
VALUE OF OUR COMMON STOCK COULD DECLINE.
Much of our development effort is focused on technically
difficult-to-formulate
products
and/or
products that require advanced manufacturing technology. We
conduct research and development primarily to enable us to
manufacture and market approved pharmaceuticals in accordance
with applicable regulations. Typically, research expenses
related to the development of innovative compounds and the
filing of marketing authorization applications for innovative
compounds (such as New Drug Applications (NDA) in
the United States) are significantly greater than those expenses
associated with the development of and filing of marketing
authorization applications for generic products (such as ANDAs
in the United States and abridged applications in Europe). As we
continue to develop new products, our research expenses will
likely increase. Because of the inherent risk associated with
research and development efforts in our industry, particularly
with respect to new drugs 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.
A
SIGNIFICANT PORTION OF OUR NET REVENUES IS DERIVED FROM SALES TO
A LIMITED NUMBER OF CUSTOMERS. ANY SIGNIFICANT REDUCTION OF
BUSINESS WITH ANY OF THESE CUSTOMERS COULD HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS
OF OPERATIONS, AND THE MARKET VALUE OF OUR COMMON STOCK COULD
DECLINE.
A significant portion of our net revenues is derived from sales
to a limited number of customers. If we were to experience a
significant reduction in or loss of business with one such
customer, or if one such customer were to experience difficulty
in paying us on a timely basis, our business, financial position
and results of operations could be materially adversely
affected, and the market value of our common stock could decline.
THE
USE OF LEGAL, REGULATORY AND LEGISLATIVE STRATEGIES BY
COMPETITORS, BOTH BRAND AND GENERIC, INCLUDING AUTHORIZED
GENERICS AND CITIZENS PETITIONS, AS WELL AS THE
POTENTIAL IMPACT OF PROPOSED LEGISLATION, MAY INCREASE OUR COSTS
ASSOCIATED WITH THE INTRODUCTION OR MARKETING OF OUR GENERIC
PRODUCTS, COULD DELAY OR PREVENT SUCH INTRODUCTION AND/OR COULD
SIGNIFICANTLY REDUCE OUR PROFIT POTENTIAL. THESE FACTORS COULD
HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL
POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET
VALUE OF OUR COMMON STOCK TO DECLINE.
Our competitors, both branded and generic, often pursue
strategies to prevent or delay competition from generic
alternatives to branded products. These strategies include, but
are not limited to:
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entering into agreements whereby other generic companies will
begin to market an authorized generic, a generic equivalent of a
branded product, at the same time generic competition initially
enters the market;
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filing citizens petitions with the FDA or other regulatory
bodies, including timing the filings so as to thwart generic
competition by causing delays of our product approvals;
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seeking to establish regulatory and legal obstacles that would
make it more difficult to demonstrate bioequivalence;
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initiating legislative efforts to limit the substitution of
generic versions of brand pharmaceuticals;
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filing suits for patent infringement that may delay regulatory
approval of many generic products;
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introducing next-generation products prior to the
expiration of market exclusivity for the reference product,
which often materially reduces the demand for the first generic
product for which we seek regulatory approval;
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obtaining extensions of market exclusivity by conducting
clinical trials of brand drugs in pediatric populations or by
other potential methods;
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persuading regulatory bodies to withdraw the approval of brand
name drugs for which the patents are about to expire, thus
allowing the brand name company to obtain new patented products
serving as substitutes for the products withdrawn; and
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seeking to obtain new patents on drugs for which patent
protection is about to expire.
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In the United States, some companies have lobbied Congress for
amendments to the 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 United States, Europe or in other
countries where we operate were to become effective, our entry
into the market and our ability to generate revenues associated
with new products may be delayed, reduced or eliminated, which
could have a material adverse effect on our business, financial
position and results of operations and could cause the market
value of our common stock to decline.
WE
HAVE SUBSTANTIAL INDEBTEDNESS AND WILL BE REQUIRED TO APPLY A
SUBSTANTIAL PORTION OF OUR CASH FLOW FROM OPERATIONS TO SERVICE
OUR INDEBTEDNESS. OUR SUBSTANTIAL INDEBTEDNESS MAY HAVE A
MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND
RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR
COMMON STOCK TO DECLINE.
We incurred significant indebtedness to fund a portion of the
consideration for our acquisition of the former Merck Generics
business. 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; and
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placing us at a competitive disadvantage to our competitors that
have less debt.
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If we do not have sufficient cash flow to service our
indebtedness, we may need to refinance all or part of our
existing indebtedness, borrow more money or sell securities,
some or all of which may not be available to us at acceptable
terms or at all. In addition, we may need to incur additional
indebtedness in the future in the ordinary course of business.
Although the terms of our Senior 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 AFFECT 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 AND ANY ADDITIONAL INDEBTEDNESS WE INCUR IN
THE FUTURE IMPOSE, OR MAY IMPOSE, SIGNIFICANT OPERATING AND
FINANCIAL RESTRICTIONS, WHICH MAY PREVENT US FROM CAPITALIZING
ON BUSINESS OPPORTUNITIES. THESE FACTORS COULD HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS
OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON
STOCK TO DECLINE.
Our credit facilities and any additional indebtedness we incur
in the future impose, or may impose, significant operating and
financial restrictions on us. These restrictions limit our
ability to, among other things, incur additional indebtedness,
make investments, pay 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.
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WE
DEPEND ON THIRD-PARTY SUPPLIERS AND DISTRIBUTORS FOR THE RAW
MATERIALS, PARTICULARLY THE CHEMICAL COMPOUND(S) COMPRISING THE
ACTIVE PHARMACEUTICAL INGREDIENT, THAT WE USE TO MANUFACTURE OUR
PRODUCTS AS WELL AS CERTAIN FINISHED GOODS. A PROLONGED
INTERRUPTION IN THE SUPPLY OF SUCH PRODUCTS COULD HAVE A
MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND
RESULTS OF OPERATIONS, AND THE MARKET VALUE OF OUR COMMON STOCK
COULD DECLINE.
We typically purchase the active pharmaceutical ingredient
(i.e., the chemical compounds that produce the desired
therapeutic effect in our products) and other materials and
supplies that we use in our manufacturing operations, as well as
certain finished products, from many different foreign and
domestic suppliers.
Additionally, we maintain safety stocks in our raw materials
inventory and, in certain cases where we have listed only one
supplier in our applications with regulatory agencies, have
received regulatory agency approval to use alternative suppliers
should the need arise. However, there is no guarantee that we
will always have timely and sufficient access to a critical raw
material or finished product. A prolonged interruption in the
supply of a single-sourced raw material, including the active
ingredient, or finished product could cause our business,
financial position and results of operations to be materially
adversely affected, and the market value of our common stock
could decline. In addition, our manufacturing capabilities could
be impacted by quality deficiencies in the products which our
suppliers provide, which could have a material adverse effect on
our business, financial position and results of operations, and
the market value of our common stock could decline.
We utilize controlled substances in certain of 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 United States as well as
similar laws in other countries where we operate. These laws
relate to the manufacture, shipment, storage, sale and use of
controlled substances. The DEA and other regulatory agencies
limit the availability of the active ingredients used in certain
of our current products and products in development and, as a
result, our procurement quota of these active ingredients may
not be sufficient to meet commercial demand or complete clinical
trials. We must annually apply to the DEA and other regulatory
agencies for procurement quota in order to obtain these
substances. Any delay or refusal by the DEA or such regulatory
agencies in establishing our procurement quota for controlled
substances could delay or stop our clinical trials or product
launches, or could cause trade inventory disruptions for those
products that have already been launched, which could have a
material adverse effect on our business, financial position and
results of operations and could cause the market value of our
common stock to decline.
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.
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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.
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
58
higher profit margin than bioequivalent products. An adverse
decision in a case such as this or in other similar litigation
could have a material adverse effect on our business, financial
position and results of operations and could cause the market
value of our common stock to decline.
WE MAY
EXPERIENCE REDUCTIONS IN THE LEVELS OF REIMBURSEMENT FOR
PHARMACEUTICAL PRODUCTS BY GOVERNMENTAL AUTHORITIES, HMOS OR
OTHER THIRD-PARTY PAYERS. 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
United States, provide reimbursement to consumers for the cost
of certain pharmaceutical products. Demand for our products
depends in part on the extent to which such reimbursement is
available. In the United States, third-party payers increasingly
challenge the pricing of pharmaceutical products. This trend and
other trends toward the growth of HMOs, managed health care and
legislative health care reform create significant uncertainties
regarding the future levels of reimbursement for pharmaceutical
products. Further, any reimbursement may be 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 (including,
most recently, the Netherlands) 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.
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
United States seek to set prices of all drugs sold within those
states through the regulation and administration of the sale of
prescription drugs. Expansion of these programs, in particular
state Medicare
and/or
Medicaid programs, or changes required in the way in which
Medicare
and/or
Medicaid rebates are calculated under such programs, could
adversely affect the prices we receive for our products and
could have a material adverse effect on our business, financial
position and results of operations and could cause the market
value of our common stock to decline.
In order to control expenditure on pharmaceuticals, most member
states in the EU regulate the pricing of products and, in some
cases, limit the range of different forms of pharmaceuticals
available for prescription by national health services. These
controls can result in considerable price differences between
member states.
On July 18, 2008, the Australian government mandated a 25%
price reduction on generic pharmaceutical products sold in
Australia. Such a widespread price reduction of this magnitude
is unprecedented in Australia. As a result, pharmaceutical
companies have generally experienced significant declines in
revenues and profitability and
59
uncertainties continue to exist within the market. This price
reduction has had an adverse effect on our business in
Australia, and as uncertainties are resolved or if other
countries in which we operate enact similar measures, they 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
and/or
subject to investigation in matters under which we are entitled
to indemnification by Merck KGaA. However, there are risks
inherent in such indemnities and, accordingly, there can be no
assurance that we will receive the full benefits of such
indemnification. This 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.
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.
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
60
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.
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 expected
to result from any acquisitions, joint ventures or other
transactions or investments we may undertake, or be unable to
generate additional revenue to offset any unanticipated
inability to realize these expected synergies or benefits.
Realization of the anticipated benefits of acquisitions or other
transactions could take longer than expected, and implementation
difficulties, unforeseen expenses, complications and delays,
market factors or a deterioration in domestic and global
economic conditions could alter the anticipated benefits of any
such transactions. We may also compete for certain acquisition
targets with companies having greater financial resources than
us or other advantages over us that may prevent us from
acquiring a target. These factors could impair our growth and
ability to compete, require us to focus additional resources on
integration of operations rather than other profitable areas,
otherwise cause a material adverse effect on our business,
financial position and results of operations and could cause the
market value of our common stock to decline.
MATRIX,
AN IMPORTANT PART OF OUR BUSINESS, IS LOCATED IN INDIA AND
IT IS SUBJECT TO REGULATORY, ECONOMIC, SOCIAL AND POLITICAL
UNCERTAINTIES IN INDIA. THESE RISKS COULD CAUSE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS
OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON
STOCK TO DECLINE.
In recent years, Matrix has benefited from many policies of the
Government of India and the Indian state governments in the
states in which 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
61
changes in the current federal government, could trigger
significant changes in Indias economic liberalization and
deregulation policies and disrupt business and economic
conditions in India generally and our business in particular.
In addition, our financial performance and the market price of
our securities may be adversely affected by general economic
conditions and economic and fiscal policy in India, including
changes in exchange rates and controls, interest rates and
taxation policies, as well as social stability and political,
economic or diplomatic developments affecting India in the
future. In particular, India has experienced significant
economic growth over the last several years, but faces major
challenges in sustaining that growth in the years ahead. These
challenges include the need for substantial infrastructure
development and improving access to healthcare and education.
Our ability to recruit, train and retain qualified employees and
develop and operate our manufacturing facilities 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. Such military activity or
terrorist attacks in the future could influence the Indian
economy by disrupting communications and making travel more
difficult. Resulting political tensions could create a greater
perception that investments in companies with Indian operations
involve a high degree of risk, and that there is a risk of
disruption of services provided by companies with Indian
operations, which could have a material adverse effect on our
share price
and/or the
market for Matrixs products. Furthermore, if India were to
become engaged in armed hostilities, particularly hostilities
that were protracted or involved the threat or use of nuclear
weapons, Matrix might not be able to continue its operations. We
generally do not have insurance for losses and interruptions
caused by terrorist attacks, military conflicts and wars. These
risks could cause a material adverse effect on our business,
financial position and results of operations and could cause the
market value of our common stock to decline.
MOVEMENTS
IN FOREIGN CURRENCY EXCHANGE RATES COULD HAVE A MATERIAL ADVERSE
EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF
OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK
TO DECLINE.
A significant portion of our revenues, indebtedness and our
costs 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.
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
62
already filed or that we file in the future and if patents are
issued, they may be insufficient in scope to cover our branded
products. The issuance of a patent in one country does not
ensure the issuance of a patent in any other country.
Furthermore, the patent position of companies in the
pharmaceutical industry generally involves complex legal and
factual questions and has been and remains the subject of much
litigation. Legal standards relating to scope and validity of
patent claims are evolving. Any patents we have obtained, or
obtain in the future, may be challenged, invalidated or
circumvented. Moreover, the United States Patent and Trademark
Office 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.
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.
WE
MUST MAINTAIN ADEQUATE INTERNAL CONTROLS AND BE ABLE, ON AN
ANNUAL BASIS, TO PROVIDE AN ASSERTION AS TO THE EFFECTIVENESS OF
SUCH CONTROLS. FAILURE TO MAINTAIN ADEQUATE INTERNAL CONTROLS OR
TO IMPLEMENT NEW OR IMPROVED CONTROLS COULD HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS
OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON
STOCK TO DECLINE.
Effective internal controls are necessary for the Company to
provide reasonable assurance with respect to its financial
reports. We are spending a substantial amount of management time
and resources to comply with changing laws, regulations and
standards relating to corporate governance and public
disclosure. In the United States such changes include the
Sarbanes-Oxley Act of 2002, 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
63
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.
THE
TOTAL AMOUNT OF INDEBTEDNESS RELATED TO OUR OUTSTANDING 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 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 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 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
64
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.
THERE
ARE INHERENT UNCERTAINTIES INVOLVED IN ESTIMATES, JUDGMENTS AND
ASSUMPTIONS USED IN THE PREPARATION OF FINANCIAL STATEMENTS IN
ACCORDANCE WITH GAAP. ANY FUTURE CHANGES IN ESTIMATES, JUDGMENTS
AND ASSUMPTIONS USED OR NECESSARY REVISIONS TO PRIOR ESTIMATES,
JUDGMENTS OR ASSUMPTIONS OR CHANGES IN ACCOUNTING STANDARDS
COULD LEAD TO A RESTATEMENT OR REVISION TO PREVIOUSLY
CONSOLIDATED FINANCIAL STATEMENTS WHICH COULD HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS
OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON
STOCK TO DECLINE.
The Consolidated and Condensed Consolidated Financial Statements
included in the periodic reports we file with the SEC are
prepared in accordance with accounting principles generally
accepted in the United States of America (GAAP). The
preparation of financial statements in accordance with GAAP
involves making estimates, judgments and assumptions that affect
reported amounts of assets (including intangible assets),
liabilities, revenues, expenses (including acquired in-process
research and development) and income. Estimates, judgments and
assumptions are inherently subject to change in the future and
any necessary revisions to prior estimates, judgments or
assumptions could lead to a restatement. Also, any new or
revised accounting standards may require adjustments to
previously issued financial statements. Any such changes could
result in corresponding changes to the amounts of assets
(including goodwill and other intangible assets), liabilities,
revenues, expenses (including acquired in-process research and
development) and income. Any such changes could have a material
adverse effect on our business, financial position and results
of operations and could cause the market value of our common
stock to decline.
WE ARE
SUBJECT TO THE U.S. FOREIGN CORRUPT PRACTICES ACT AND SIMILAR
WORLDWIDE ANTI-BRIBERY LAWS, WHICH IMPOSE RESTRICTIONS AND MAY
CARRY SUBSTANTIAL PENALTIES. ANY VIOLATIONS OF THESE LAWS, OR
ALLEGATIONS OF SUCH VIOLATIONS, COULD HAVE A MATERIAL ADVERSE
EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF
OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK
TO DECLINE.
The U.S. Foreign Corrupt Practices Act and similar
anti-bribery laws in other jurisdictions generally prohibit
companies and their intermediaries from making improper payments
to officials for the purpose of obtaining or retaining business.
Our policies mandate compliance with these anti-bribery laws,
which often carry substantial penalties. We operate in
jurisdictions that have experienced governmental corruption to
some degree, and, in certain circumstances, strict compliance
with anti-bribery laws may conflict with certain local customs
and practices. We cannot assure you that our internal control
policies and procedures always will protect us from reckless or
other inappropriate acts committed by our affiliates, employees
or agents. Violations of these laws, or allegations of such
violations, could have a material adverse effect on our
business, financial position and results of operations and could
cause the market value of our common stock to decline.
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ITEM 5.
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OTHER
INFORMATION
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On October 27, 2009, Mylan named Daniel C. Rizzo, Jr.
its principal financial officer. Rizzo, age 47, serves as
the Companys Senior Vice President, Chief Accounting
Officer and Corporate Controller. He joined the Company in June
2006, as Vice President and Corporate Controller (principal
accounting officer), prior to which he served as Vice President
and General Controller of Hexion Specialty Chemicals, Inc. from
October 2005 to May 2006, before which he was Vice President,
Corporate Controller and principal accounting officer at Gardner
Denver, Inc. since 1998.
Mr. Rizzo is party to an Executive Employment Agreement
(Employment Agreement) and a Transition and
Succession Agreement (T&S Agreement), in each
case dated February 8, 2008.
65
Employment
Agreement
The Employment Agreement has an initial term of three years
(i.e., through February 28, 2011) and may be extended
or renewed upon mutual agreement of the parties. Mr. Rizzo
has an annual base salary of $350,000 and is eligible for a
discretionary annual bonus targeted at 60% of base salary.
In the event of Mr. Rizzos termination of employment
without cause (as defined in the Employment
Agreement), Mr. Rizzo will be entitled to receive, in
addition to his accrued benefits, a lump sum equal to the sum of
his then-current annual base salary. Mr. Rizzo would also
be entitled to continuation of employee benefits for up to
12 months following termination of employment with the
Company. During the term of the Employment Agreement and for a
period of one year following termination of employment for any
reason, Mr. Rizzo may not engage in activities that are
competitive with the Companys activities and may not
solicit the Companys customers or employees.
T&S
Agreement
Mr. Rizzos T&S Agreement governs the terms of
his employment commencing on the occurrence of a change of
control (as defined in the T&S Agreement), and
continues for the two year period following which a change of
control occurs.
The agreement provides that upon a termination without
cause or for good reason or by reason of
Mr. Rizzos death or disability (each as defined in
the T&S Agreement), the Company shall pay to Mr. Rizzo
a lump sum in cash equal to three times the sum of: (i)
his then current annual base salary, plus (ii) an amount
equal to the highest bonus determined under the Employment
Agreement or paid to him under the T&S Agreement (in the
case of Mr. Rizzos death or disability, reduced by
any disability or death benefits that he or his estate or
beneficiaries are entitled to pursuant to plans or arrangements
of the Company). Under the T&S Agreement, Mr. Rizzo
also would be entitled to continuation of employee benefits for
a period of three years following termination of employment with
the Company.
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3
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.1
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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.
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3
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.2
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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.
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4
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.1(a)
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Rights Agreement dated as of August 22, 1996, between the
registrant and American Stock Transfer &
Trust Company, filed as Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on September 3, 1996, and incorporated
herein by reference.
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4
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.1(b)
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Amendment to Rights Agreement dated as of November 8, 1999,
between the registrant and American Stock Transfer &
Trust Company, filed as Exhibit 1 to
Form 8-A/A
filed with the SEC on March 31, 2000, and incorporated
herein by reference.
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4
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.1(c)
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Amendment No. 2 to Rights Agreement dated as of
August 13, 2004, between the registrant and American Stock
Transfer & Trust Company, filed as
Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on August 16, 2004, and incorporated
herein by reference.
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4
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.1(d)
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Amendment No. 3 to Rights Agreement dated as of
September 8, 2004, between the registrant and American
Stock Transfer & Trust Company, filed as
Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on September 9, 2004, and incorporated
herein by reference.
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.1(e)
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|
Amendment No. 4 to Rights Agreement dated as of
December 2, 2004, between the registrant and American Stock
Transfer & Trust Company, filed as
Exhibit 4.1 to the Report on
Form 8-K
filed with the SEC on December 3, 2004, and incorporated
herein by reference.
|
|
4
|
.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.
|
66
|
|
|
|
|
|
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.
|
|
10
|
.1
|
|
Amendment No. 3 to Executive Employment Agreement dated as
of August 31, 2009, by and between the registrant and
Heather Bresch.
|
|
10
|
.2
|
|
Amendment No. 3 to Executive Employment Agreement dated as
of August 31, 2009, by and between the registrant and Rajiv
Malik.
|
|
10
|
.3
|
|
Retirement Benefit Agreement dated as of August 31, 2009,
by and between the registrant and Heather Bresch.
|
|
10
|
.4
|
|
Retirement Benefit Agreement dated as of August 31, 2009,
by and between the registrant and Rajiv Malik.
|
|
10
|
.5
|
|
Agreement dated as of September 22, 2009, by and between
the registrant and Milan Puskar.
|
|
10
|
.6
|
|
Severance Plan, as amended to date.
|
|
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.
|
67
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly authorized.
Mylan Inc.
(Registrant)
Robert J. Coury
Chairman and Chief Executive Officer
October 30, 2009
Heather Bresch
President
October 30, 2009
Daniel C. Rizzo, Jr.
Senior Vice President, Chief Accounting Officer
and Corporate Controller
(Principal financial and accounting officer)
October 30, 2009
68
EXHIBIT INDEX
|
|
|
|
|
|
10
|
.1
|
|
Amendment No. 3 to Executive Employment Agreement dated as
of August 31, 2009, by and between the registrant and
Heather Bresch.
|
|
10
|
.2
|
|
Amendment No. 3 to Executive Employment Agreement dated as
of August 31, 2009, by and between the registrant and Rajiv
Malik.
|
|
10
|
.3
|
|
Retirement Benefit Agreement dated as of August 31, 2009,
by and between the registrant and Heather Bresch.
|
|
10
|
.4
|
|
Retirement Benefit Agreement dated as of August 31, 2009,
by and between the registrant and Rajiv Malik.
|
|
10
|
.5
|
|
Agreement dated as of September 22, 2009, by and between
the registrant and Milan Puskar.
|
|
10
|
.6
|
|
Severance Plan, as amended to date.
|
|
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.
|