e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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 |
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2008
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 001-13305
WATSON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Nevada
(State or other jurisdiction of
incorporation or organization)
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95-3872914
(I.R.S. Employer Identification No.) |
311 Bonnie Circle
Corona, CA 92880-2882
(Address of principal executive offices, including zip code)
(951) 493-5300
(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 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 |
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
The number of shares outstanding of the Registrants only class of common stock as of October 24, 2008 was approximately 104,608,000.
WATSON PHARMACEUTICALS, INC.
TABLE
OF CONTENTS
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2008
WATSON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited; in thousands)
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September 30, |
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December 31, |
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2008 |
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2007 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
339,354 |
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$ |
204,554 |
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Marketable securities |
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12,683 |
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11,799 |
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Accounts receivable, net |
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314,475 |
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267,117 |
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Inventories |
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481,559 |
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490,601 |
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Prepaid expenses and other current assets |
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68,883 |
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86,072 |
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Deferred tax assets |
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106,311 |
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113,633 |
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Total current assets |
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1,323,265 |
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1,173,776 |
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Property and equipment, net |
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660,549 |
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688,185 |
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Investments and other assets |
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73,204 |
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68,034 |
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Deferred tax assets |
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76,360 |
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61,886 |
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Product rights and other intangibles, net |
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543,891 |
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603,697 |
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Goodwill |
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868,085 |
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876,449 |
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Total assets |
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$ |
3,545,354 |
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$ |
3,472,027 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
353,745 |
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$ |
398,154 |
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Income taxes payable |
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|
777 |
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Short-term debt and current portion of long-term debt |
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3,217 |
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6,241 |
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Deferred revenue |
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16,281 |
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21,754 |
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Deferred tax liabilities |
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24,080 |
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18,778 |
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Total current liabilities |
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398,100 |
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444,927 |
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Long-term debt |
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824,609 |
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899,408 |
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Deferred revenue |
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33,786 |
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39,535 |
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Other long-term liabilities |
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4,848 |
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7,333 |
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Other taxes payable |
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51,983 |
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52,619 |
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Deferred tax liabilities |
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181,745 |
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178,740 |
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Total liabilities |
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1,495,071 |
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1,622,562 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock |
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Common stock |
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376 |
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373 |
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Additional paid-in capital |
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991,409 |
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968,739 |
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Retained earnings |
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1,361,730 |
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1,179,737 |
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Accumulated other comprehensive (loss) income |
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|
(619 |
) |
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2,392 |
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Treasury stock, at cost |
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|
(302,613 |
) |
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(301,776 |
) |
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Total stockholders equity |
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2,050,283 |
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1,849,465 |
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Total liabilities and stockholders equity |
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$ |
3,545,354 |
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$ |
3,472,027 |
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See accompanying Notes to Condensed Consolidated Financial Statements.
- 1 -
WATSON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in thousands, except per share amounts)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Net revenues |
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$ |
640,691 |
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$ |
594,706 |
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$ |
1,890,276 |
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$ |
1,869,316 |
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Cost of sales (excludes amortization, presented below) |
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386,655 |
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346,420 |
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1,126,655 |
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1,131,578 |
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Gross profit |
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254,036 |
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248,286 |
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763,621 |
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737,738 |
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Operating expenses: |
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Research and development |
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45,322 |
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35,657 |
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122,553 |
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108,968 |
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Selling and marketing |
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58,572 |
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53,347 |
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172,156 |
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160,407 |
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General and administrative |
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42,697 |
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59,144 |
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140,041 |
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152,460 |
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Amortization |
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20,200 |
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|
44,159 |
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60,569 |
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|
132,251 |
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Loss (gain)
on asset sales and impairments |
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|
303 |
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(6,118 |
) |
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303 |
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|
(6,118 |
) |
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|
|
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|
|
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Total
operating expenses |
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|
167,094 |
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|
186,189 |
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|
495,622 |
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|
547,968 |
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Operating income |
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|
86,942 |
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|
62,097 |
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|
267,999 |
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|
189,770 |
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Other income (expense): |
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|
|
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|
|
|
|
|
|
|
|
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Loss on
early extinguishment of debt |
|
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|
|
|
|
|
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|
(1,095 |
) |
|
|
(4,410 |
) |
Interest income |
|
|
2,157 |
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|
1,964 |
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|
6,151 |
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|
6,696 |
|
Interest expense |
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|
(7,005 |
) |
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|
(10,125 |
) |
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|
(20,732 |
) |
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|
(35,476 |
) |
Other income |
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|
11,942 |
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|
1,449 |
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|
19,375 |
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|
|
7,886 |
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|
|
|
|
|
|
|
|
|
|
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Total other
income (expense), net |
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|
7,094 |
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|
(6,712 |
) |
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|
3,699 |
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|
(25,304 |
) |
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|
|
|
|
|
|
|
|
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|
Income before income taxes |
|
|
94,036 |
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|
55,385 |
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|
|
271,698 |
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|
|
164,466 |
|
Provision for income taxes |
|
|
22,975 |
|
|
|
20,779 |
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|
|
89,705 |
|
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|
61,839 |
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|
|
|
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|
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Net income |
|
$ |
71,061 |
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|
$ |
34,606 |
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|
$ |
181,993 |
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|
$ |
102,627 |
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|
|
|
|
|
|
|
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Earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.69 |
|
|
$ |
0.34 |
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|
$ |
1.77 |
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|
$ |
1.00 |
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Diluted |
|
$ |
0.62 |
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|
$ |
0.31 |
|
|
$ |
1.60 |
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|
$ |
0.93 |
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|
|
|
|
|
|
|
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|
Weighted average shares outstanding: |
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|
|
|
|
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|
|
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|
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|
|
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Basic |
|
|
102,893 |
|
|
|
102,453 |
|
|
|
102,749 |
|
|
|
102,266 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
117,995 |
|
|
|
117,421 |
|
|
|
117,661 |
|
|
|
117,042 |
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|
|
|
|
|
|
|
|
|
|
|
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|
See accompanying Notes to Condensed Consolidated Financial Statements.
- 2 -
WATSON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; in thousands)
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Nine Months Ended |
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September 30, |
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2008 |
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2007 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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|
|
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|
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Net income |
|
$ |
181,993 |
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|
$ |
102,627 |
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|
|
|
|
|
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|
Reconciliation to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
67,392 |
|
|
|
56,935 |
|
Amortization |
|
|
60,569 |
|
|
|
132,250 |
|
Charge for asset impairment |
|
|
303 |
|
|
|
4,499 |
|
Deferred income tax provision (benefit) |
|
|
16,980 |
|
|
|
(15,509 |
) |
Provision for inventory reserve |
|
|
35,940 |
|
|
|
36,908 |
|
Restricted stock and stock option compensation |
|
|
14,055 |
|
|
|
10,337 |
|
Earnings on equity method investments |
|
|
(9,561 |
) |
|
|
(5,409 |
) |
Gain on sale of securities |
|
|
(9,605 |
) |
|
|
(2,131 |
) |
Loss on early extinguishment of debt |
|
|
1,095 |
|
|
|
4,410 |
|
Loss (gain) on sale of fixed assets |
|
|
1,697 |
|
|
|
(10,221 |
) |
Other |
|
|
(4,344 |
) |
|
|
4,541 |
|
Changes in assets and liabilities: |
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|
|
|
|
|
|
|
Accounts receivable, net |
|
|
(47,358 |
) |
|
|
111,852 |
|
Inventories |
|
|
(26,898 |
) |
|
|
(48,654 |
) |
Prepaid expenses and other current assets |
|
|
12,942 |
|
|
|
20,945 |
|
Accounts payable and accrued expenses |
|
|
(45,789 |
) |
|
|
(142,957 |
) |
Deferred revenue |
|
|
(10,703 |
) |
|
|
(10,712 |
) |
Income taxes payable |
|
|
9,933 |
|
|
|
2,967 |
|
Other assets |
|
|
(8,419 |
) |
|
|
3,047 |
|
|
|
|
|
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Total adjustments |
|
|
58,229 |
|
|
|
153,098 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
240,222 |
|
|
|
255,725 |
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|
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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|
|
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|
Additions to property and equipment |
|
|
(42,545 |
) |
|
|
(49,812 |
) |
Acquisition of product rights and other intangibles |
|
|
(763 |
) |
|
|
(492 |
) |
Additions to goodwill |
|
|
(1,441 |
) |
|
|
|
|
Proceeds from sale of marketable equity securities |
|
|
4,793 |
|
|
|
3,223 |
|
Proceeds from sale of investments |
|
|
8,250 |
|
|
|
|
|
Additions to marketable securities |
|
|
(5,407 |
) |
|
|
(5,624 |
) |
Additions to long-term investments |
|
|
|
|
|
|
(1,152 |
) |
Distribution from joint venture |
|
|
1,052 |
|
|
|
715 |
|
Proceeds from sale of property, plant and equipment |
|
|
789 |
|
|
|
14,385 |
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(35,272 |
) |
|
|
(38,757 |
) |
|
|
|
|
|
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|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Principal payments on debt |
|
|
(95,633 |
) |
|
|
(252,910 |
) |
Repurchase of common stock |
|
|
(837 |
) |
|
|
(1,731 |
) |
Borrowings on short-term debt and other long-term liabilities |
|
|
17,909 |
|
|
|
1,655 |
|
Proceeds from stock plans |
|
|
8,411 |
|
|
|
15,195 |
|
|
|
|
|
|
|
|
Net cash used in financing activities |
|
|
(70,150 |
) |
|
|
(237,791 |
) |
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
134,800 |
|
|
|
(20,823 |
) |
Cash and cash equivalents at beginning of period |
|
|
204,554 |
|
|
|
154,171 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
339,354 |
|
|
$ |
133,348 |
|
|
|
|
|
|
|
|
See accompanying Notes to Condensed Consolidated Financial Statements.
- 3 -
WATSON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 GENERAL
Watson Pharmaceuticals, Inc. (Watson or the Company) is primarily engaged in the
development, manufacturing, marketing, sale and distribution of brand and off-patent (generic)
pharmaceutical products. Watson was incorporated in 1985 and began operations as a manufacturer
and marketer of off-patent pharmaceuticals. Through internal product development and synergistic
acquisitions of products and businesses, the Company has grown into a diversified specialty
pharmaceutical company. Watson operates manufacturing, distribution, research and development
(R&D) and administrative facilities predominantly in the United States of America (U.S.) and
India with our key commercial market being the U.S.
The accompanying condensed consolidated financial statements should be read in conjunction
with the Companys Annual Report on Form 10-K for the year ended December 31, 2007. Certain
information and footnote disclosures normally included in annual financial statements prepared in
accordance with generally accepted accounting principles have been condensed or omitted from the
accompanying condensed consolidated financial statements. The year end condensed consolidated
balance sheet was derived from the audited financial statements. The accompanying interim
financial statements are unaudited, but reflect all adjustments which are, in the opinion of
management, necessary to present fairly Watsons consolidated financial position, results of
operations and cash flows for the periods presented. Unless otherwise noted, all such adjustments
are of a normal, recurring nature. The Companys results of operations and cash flows for the
interim periods are not necessarily indicative of the results of operations and cash flows that it
may achieve in future periods.
Comprehensive Income
Comprehensive income includes all changes in equity during a period except those that
resulted from investments by or distributions to the Companys stockholders. Other comprehensive
income refers to revenues, expenses, gains and losses that, under generally accepted accounting
principles, are included in comprehensive income, but excluded from net income. The components of
comprehensive income including attributable income taxes consisted of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net income |
|
$ |
71,061 |
|
|
$ |
34,606 |
|
|
$ |
181,993 |
|
|
$ |
102,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation (loss) gain |
|
|
(1,964 |
) |
|
|
1,676 |
|
|
|
(2,899 |
) |
|
|
2,761 |
|
Unrealized (loss) gain on securities, net of tax |
|
|
(543 |
) |
|
|
122 |
|
|
|
(745 |
) |
|
|
(395 |
) |
Unrealized gain (loss) on cash flow hedge, net
of tax |
|
|
878 |
|
|
|
(249 |
) |
|
|
633 |
|
|
|
(249 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive (loss) income |
|
|
(1,629 |
) |
|
|
1,549 |
|
|
|
(3,011 |
) |
|
|
2,117 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
$ |
69,432 |
|
|
$ |
36,155 |
|
|
$ |
178,982 |
|
|
$ |
104,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- 4 -
Preferred and Common Stock
As of September 30, 2008 and December 31, 2007 there were 2,500,000 shares of no par value
per share preferred stock authorized, with none issued. As of September 30, 2008 and December 31,
2007, there were 500,000,000 shares of $0.0033 par value per share common stock authorized, with
114,093,000 and 113,115,000 shares issued and 104,608,000 and 103,658,000 shares outstanding,
respectively. Of the issued shares, 9,485,000 and 9,457,000 shares were held as treasury shares
as of September 30, 2008 and December 31, 2007, respectively.
Provisions for Sales Returns and Allowances
As customary in the pharmaceutical industry, the Companys gross product sales are subject to
a variety of deductions in arriving at reported net product sales. When the Company recognizes
revenue from the sale of its products, an estimate of sales returns and allowances (SRA) is
recorded which reduces product sales. These adjustments include estimates for chargebacks, rebates,
cash discounts and returns and other allowances. These provisions are estimated based on historical
payment experience, historical relationship to revenues, estimated customer inventory levels and
current contract sales terms with direct and indirect customers. The estimation process used to
determine our SRA provision has been applied on a consistent basis and no material adjustments have
been necessary to increase or decrease our reserves for SRA as a result of a significant change in
underlying estimates. The Company uses a variety of methods to assess the adequacy of our SRA
reserves to ensure that our condensed consolidated financial statements are fairly stated. This
includes periodic reviews of customer inventory data, customer contract programs and product
pricing trends to analyze and validate the SRA reserves.
The provision for chargebacks is our most significant sales allowance. A chargeback represents
an amount payable in the future to a wholesaler for the difference between the invoice price paid
to the Company by our wholesale customer for a particular product and the negotiated contract price
that the wholesalers customer pays for that product. The Companys chargeback provision and
related reserve vary with changes in product mix, changes in customer pricing and changes to
estimated wholesaler inventories. The provision for chargebacks also takes into account an estimate
of the expected wholesaler sell-through levels to indirect customers at contract prices. The
Company validates the chargeback accrual quarterly through a review of the inventory reports
obtained from our largest wholesale customers. This customer inventory information is used to
verify the estimated liability for future chargeback claims based on historical chargeback and
contract rates. These large wholesalers represent 85% 90% of the Companys chargeback payments.
The Company continually monitors current pricing trends and wholesaler inventory levels to ensure
the liability for future chargebacks is fairly stated.
Net revenues and accounts receivable balances in the Companys condensed consolidated
financial statements are presented net of SRA estimates. Certain SRA balances are included in
accounts payable and accrued liabilities. Accounts receivable are presented net of SRA balances of
$288.2 million and $341.0 million at September 30, 2008 and December 31, 2007, respectively.
Accounts payable and accrued liabilities include $40.1 million and $46.7 million at September 30,
2008 and December 31, 2007, respectively, for certain rebates and other amounts due to indirect
customers.
- 5 -
The following table summarizes the activity in the Companys major categories of SRA (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
Cash |
|
|
|
|
|
|
Chargebacks |
|
|
Rebates |
|
|
Allowances |
|
|
Discounts |
|
|
Total |
|
Balance at December 31, 2006 |
|
$ |
164,480 |
|
|
$ |
180,538 |
|
|
$ |
42,489 |
|
|
$ |
14,072 |
|
|
$ |
401,579 |
|
Provision related to sales in nine months
ended September 30, 2007 |
|
|
909,497 |
|
|
|
296,333 |
|
|
|
122,717 |
|
|
|
51,001 |
|
|
|
1,379,548 |
|
Credits and payments |
|
|
(925,744 |
) |
|
|
(323,243 |
) |
|
|
(114,244 |
) |
|
|
(51,968 |
) |
|
|
(1,415,199 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
|
148,233 |
|
|
|
153,628 |
|
|
|
50,962 |
|
|
|
13,105 |
|
|
|
365,928 |
|
Provision related to sales in three months
ended December 31, 2007 |
|
|
325,400 |
|
|
|
80,165 |
|
|
|
44,706 |
|
|
|
17,060 |
|
|
|
467,331 |
|
Credits and payments |
|
|
(309,190 |
) |
|
|
(79,476 |
) |
|
|
(39,624 |
) |
|
|
(17,253 |
) |
|
|
(445,543 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
164,443 |
|
|
|
154,317 |
|
|
|
56,044 |
|
|
|
12,912 |
|
|
|
387,716 |
|
Provision related to sales in nine months
ended September 30, 2008 |
|
|
919,990 |
|
|
|
228,722 |
|
|
|
133,362 |
|
|
|
49,860 |
|
|
|
1,331,934 |
|
Credits and payments |
|
|
(967,379 |
) |
|
|
(250,595 |
) |
|
|
(123,460 |
) |
|
|
(49,954 |
) |
|
|
(1,391,388 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2008 |
|
$ |
117,054 |
|
|
$ |
132,444 |
|
|
$ |
65,946 |
|
|
$ |
12,818 |
|
|
$ |
328,262 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings Per Share (EPS)
Basic EPS is computed by dividing net income by the weighted average common shares
outstanding during a period. Diluted EPS is based on the treasury stock method and includes the
effect from potential issuance of common stock, such as shares issuable upon conversion of the
$575 million convertible contingent senior debentures (CODES), and the dilutive effect of
share-based compensation arrangements outstanding during the period. Common share equivalents
have been excluded where their inclusion would be anti-dilutive. In accordance with Emerging
Issues Task Force (EITF) Issue No. 04-8, The Effect of Contingently Convertible Debt on Diluted
Earnings per Share, the Company is required to add approximately 14.4 million shares associated
with the conversion of the CODES to the number of shares outstanding for the calculation of
diluted EPS for all periods in which the securities were outstanding. A reconciliation of the
numerators and denominators of basic and diluted EPS consisted of the following (in thousands,
except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
EPS basic |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
71,061 |
|
|
$ |
34,606 |
|
|
$ |
181,993 |
|
|
$ |
102,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average common shares
outstanding |
|
|
102,893 |
|
|
|
102,453 |
|
|
|
102,749 |
|
|
|
102,266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPS basic |
|
$ |
0.69 |
|
|
$ |
0.34 |
|
|
$ |
1.77 |
|
|
$ |
1.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPS diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
71,061 |
|
|
$ |
34,606 |
|
|
$ |
181,993 |
|
|
$ |
102,627 |
|
Add: Interest expense on CODES, net of tax |
|
|
1,988 |
|
|
|
1,905 |
|
|
|
5,919 |
|
|
|
5,906 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income, adjusted |
|
$ |
73,049 |
|
|
$ |
36,511 |
|
|
$ |
187,912 |
|
|
$ |
108,533 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average common shares
outstanding |
|
|
102,893 |
|
|
|
102,453 |
|
|
|
102,749 |
|
|
|
102,266 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of CODES |
|
|
14,357 |
|
|
|
14,357 |
|
|
|
14,357 |
|
|
|
14,357 |
|
Dilutive share-based compensation
arrangements |
|
|
745 |
|
|
|
611 |
|
|
|
555 |
|
|
|
419 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted average common shares
outstanding |
|
|
117,995 |
|
|
|
117,421 |
|
|
|
117,661 |
|
|
|
117,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPS diluted |
|
$ |
0.62 |
|
|
$ |
0.31 |
|
|
$ |
1.60 |
|
|
$ |
0.93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- 6 -
Stock awards to purchase 5.6 million and 5.9 million common shares for the three month
periods ended September 30, 2008 and 2007, respectively, were outstanding but were not included in
the computation of diluted earnings per share because the options were antidilutive. Stock awards
to purchase 6.8 million and 7.9 million common shares for the nine month periods ended September
30, 2008 and 2007, respectively, were outstanding but were not included in the computation of
diluted earnings per share because the options were antidilutive.
Derivatives
During the year ended December 31, 2007, the Company entered into an interest rate swap
derivative to convert floating-rate debt to fixed-rate debt. The Companys interest rate swap
agreements involve agreements to pay a fixed rate and receive a floating rate, at specified
intervals, calculated on an agreed upon notional amount. As of September 30, 2008, all of the
derivative instruments entered into are designated as hedges of underlying exposures. The Company
does not use any of these instruments for trading or speculative purposes.
At September 30, 2008 and December 31, 2007, the notional amount of interest rate swaps
entered into by the Company was $200.0 million. The fair value of the interest rate swap at
September 30, 2008 and December 31, 2007 was a liability of $0.5 million and $1.6 million,
respectively. The liability is presented within other long-term liabilities on the balance sheet
at December 31, 2007 and within accounts payable and accrued expenses at September 30, 2008 as the
interest rate swap expires in January 2009.
Share-Based Compensation
The Company accounts for share-based compensation under Statement of Financial Accounting
Standards (SFAS) No. 123 (revised 2004), Share-Based Payment (SFAS 123R) which requires the
measurement and recognition of compensation expense for all share-based compensation awards made to
employees and directors based on estimated fair values.
As of September 30, 2008, the Company had $4.3 million of total unrecognized compensation
expense, net of estimated forfeitures, related to stock option grants, which will be recognized
over the remaining weighted average period of 1.8 years. As of September 30, 2008, the Company had
$21.3 million of total unrecognized compensation expense, net of estimated forfeitures, related to
restricted stock grants, which will be recognized over the remaining weighted average period of 2.0
years. During the nine months ended September 30, 2008, the Company issued approximately 864,000
restricted stock grants with an aggregate intrinsic value of $24.0 million. No stock option grants
were issued during the nine months ended September 30, 2008.
Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board (FASB) issued SFAS No. 157,
Fair-Value Measurements, (SFAS 157) which defines fair value, establishes a framework for
measuring fair value in generally accepted accounting principles and expands disclosures about
fair-value measurements. The Company adopted SFAS 157 effective January 1, 2008 for all financial
assets and liabilities and any other assets and liabilities that are recognized or disclosed at
fair value on a recurring basis (see NOTE 10 FAIR VALUE
MEASUREMENT). For nonfinancial assets and liabilities measured at fair value on a
non-recurring basis, SFAS 157 is effective for financial statements issued for fiscal years
beginning after November 15, 2008. The Company is currently reviewing the application of SFAS 157
for nonfinancial assets and liabilities measured at fair value on a non-recurring basis and has not
yet determined how the adoption of SFAS 157 will impact its condensed consolidated financial
statements.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities Including an Amendment of FASB Statement No. 115, (SFAS 159) which
is effective for fiscal years beginning after November 15, 2007. SFAS 159 is an elective standard
which permits an entity to choose to measure many financial instruments and certain other items at
fair value at specified election dates.
- 7 -
Subsequent unrealized gains and losses on items for which
the fair value option has been elected will be reported in earnings. The Company has not elected
the fair value option of SFAS 159 for any specific assets or liabilities.
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations, (SFAS
141R) which replaces SFAS No. 141, Business Combinations. SFAS 141R establishes principles and
requirements for recognizing and measuring identifiable assets and goodwill acquired, liabilities
assumed and any noncontrolling interest in a business combination at their fair value at
acquisition date. SFAS 141R alters the treatment of acquisition-related costs, business
combinations achieved in stages (referred to as a step acquisition), the treatment of gains from a
bargain purchase, the recognition of contingencies in business combinations, the treatment of
in-process research and development in a business combination as well as the treatment of
recognizable deferred tax benefits. SFAS 141R is effective for business combinations closed in
fiscal years beginning after December 15, 2008. Early adoption is prohibited.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements an amendment of Accounting Research Bulletin No. 51, (SFAS 160). SFAS
160 establishes accounting and reporting standards for the noncontrolling interest (minority
interest) in a subsidiary and for the deconsolidation of a subsidiary. SFAS 160 is effective for
financial statements issued for fiscal years beginning after December 15, 2008. Early adoption is
prohibited. The Company currently has no minority interests and therefore expects the adoption of
SFAS 160 will not have a material impact on its consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities, an amendment of FASB Statement No. 133, (SFAS 161). SFAS 161 requires
enhanced disclosures about a companys derivative and hedging activities. SFAS 161 is effective
for financial statements issued for fiscal years beginning after December 15, 2008. The Company is
currently evaluating the impact of the adoption of the enhanced disclosures requirements of SFAS
161 and does not expect the adoption to have a material impact on its consolidated financial
statements.
In April 2008, the FASB issued FASB Staff Position (FSP) No. FAS 142-3, Determination of
the Useful Life of Intangible Assets, (FSP 142-3). FSP 142-3 amends the factors that should be
considered in developing renewal or extension assumptions used to determine the useful life of a
recognized intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets and also
requires expanded disclosure related to the determination of intangible asset useful lives. FSP
142-3 is effective for fiscal years beginning after December 15, 2008. Early adoption is
prohibited. The Company is currently evaluating the impact the adoption of FSP 142-3 will have on
its consolidated financial statements.
- 8 -
NOTE 2 OTHER INCOME
Other income (expense) consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Earnings on equity method investments |
|
$ |
3,733 |
|
|
$ |
1,686 |
|
|
$ |
9,561 |
|
|
$ |
5,409 |
|
Gain on sale of securities |
|
|
8,250 |
|
|
|
|
|
|
|
9,605 |
|
|
|
2,472 |
|
Other (expense) income |
|
|
(41 |
) |
|
|
(237 |
) |
|
|
209 |
|
|
|
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
11,942 |
|
|
$ |
1,449 |
|
|
$ |
19,375 |
|
|
$ |
7,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 3 OPERATING SEGMENTS
Watson has three reportable operating segments: Generic, Brand and Distribution. The Generic
segment includes off-patent pharmaceutical products that are therapeutically equivalent to
proprietary products. The Brand segment includes the Companys lines of Specialty Products and
Nephrology products. Watson has aggregated its brand product lines in a single segment because of
similarities in regulatory environment, methods of distribution and types of customer. This
segment includes patent-protected products and certain trademarked off-patent products that Watson
sells and markets as brand pharmaceutical products. The Company sells its brand and generic
products primarily to pharmaceutical wholesalers, drug distributors and chain drug stores in the
U.S. The Distribution segment distributes generic pharmaceutical products and select brand
pharmaceutical products manufactured by third parties to independent pharmacies, pharmacy chains,
pharmacy buying groups and physicians offices in the U.S. Sales are principally generated
through an in-house telemarketing staff and through internally developed ordering systems. The
Distribution segment operating results exclude sales of Watson products, which are included in
their respective Generic and Brand segment results.
Segment net revenues, segment gross profit and segment contribution information for the
Companys Generic, Brand and Distribution segments consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2008 |
|
|
Three Months Ended September 30, 2007 |
|
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
Product sales |
|
$ |
352,190 |
|
|
$ |
94,298 |
|
|
$ |
170,933 |
|
|
$ |
617,421 |
|
|
$ |
326,231 |
|
|
$ |
93,534 |
|
|
$ |
129,875 |
|
|
$ |
549,640 |
|
Other |
|
|
11,593 |
|
|
|
11,677 |
|
|
|
|
|
|
|
23,270 |
|
|
|
31,489 |
|
|
|
13,577 |
|
|
|
|
|
|
|
45,066 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
363,783 |
|
|
|
105,975 |
|
|
|
170,933 |
|
|
|
640,691 |
|
|
|
357,720 |
|
|
|
107,111 |
|
|
|
129,875 |
|
|
|
594,706 |
|
Cost of sales(1) |
|
|
212,367 |
|
|
|
30,224 |
|
|
|
144,064 |
|
|
|
386,655 |
|
|
|
210,931 |
|
|
|
22,089 |
|
|
|
113,400 |
|
|
|
346,420 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit(1) |
|
|
151,416 |
|
|
|
75,751 |
|
|
|
26,869 |
|
|
|
254,036 |
|
|
|
146,789 |
|
|
|
85,022 |
|
|
|
16,475 |
|
|
|
248,286 |
|
Gross margin(1) |
|
|
41.6 |
% |
|
|
71.5 |
% |
|
|
15.7 |
% |
|
|
39.7 |
% |
|
|
41.0 |
% |
|
|
79.4 |
% |
|
|
12.7 |
% |
|
|
41.7 |
% |
Research and
development |
|
|
31,736 |
|
|
|
13,586 |
|
|
|
|
|
|
|
45,322 |
|
|
|
26,555 |
|
|
|
9,102 |
|
|
|
|
|
|
|
35,657 |
|
Selling and
marketing |
|
|
13,990 |
|
|
|
29,024 |
|
|
|
15,558 |
|
|
|
58,572 |
|
|
|
14,018 |
|
|
|
26,613 |
|
|
|
12,716 |
|
|
|
53,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contribution |
|
$ |
105,690 |
|
|
$ |
33,141 |
|
|
$ |
11,311 |
|
|
|
150,142 |
|
|
$ |
106,216 |
|
|
$ |
49,307 |
|
|
$ |
3,759 |
|
|
|
159,282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contibution margin |
|
|
29.1 |
% |
|
|
31.3 |
% |
|
|
6.6 |
% |
|
|
23.4 |
% |
|
|
29.7 |
% |
|
|
46.0 |
% |
|
|
2.9 |
% |
|
|
26.8 |
% |
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,697 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59,144 |
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
44,159 |
|
Loss (gain) on asset sales and impairments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
86,942 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
62,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.4 |
% |
- 9 -
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2008 |
|
|
Nine Months Ended September 30, 2007 |
|
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
Product sales |
|
$ |
1,038,938 |
|
|
$ |
294,756 |
|
|
$ |
443,822 |
|
|
$ |
1,777,516 |
|
|
$ |
1,065,152 |
|
|
$ |
281,096 |
|
|
$ |
421,946 |
|
|
$ |
1,768,194 |
|
Other |
|
|
68,249 |
|
|
|
44,511 |
|
|
|
|
|
|
|
112,760 |
|
|
|
62,834 |
|
|
|
38,288 |
|
|
|
|
|
|
|
101,122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
1,107,187 |
|
|
|
339,267 |
|
|
|
443,822 |
|
|
|
1,890,276 |
|
|
|
1,127,986 |
|
|
|
319,384 |
|
|
|
421,946 |
|
|
|
1,869,316 |
|
Cost of sales(1) |
|
|
669,676 |
|
|
|
82,167 |
|
|
|
374,812 |
|
|
|
1,126,655 |
|
|
|
693,896 |
|
|
|
74,099 |
|
|
|
363,583 |
|
|
|
1,131,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit(1) |
|
|
437,511 |
|
|
|
257,100 |
|
|
|
69,010 |
|
|
|
763,621 |
|
|
|
434,090 |
|
|
|
245,285 |
|
|
|
58,363 |
|
|
|
737,738 |
|
Gross margin(1) |
|
|
39.5 |
% |
|
|
75.8 |
% |
|
|
15.5 |
% |
|
|
40.4 |
% |
|
|
38.5 |
% |
|
|
76.8 |
% |
|
|
13.8 |
% |
|
|
39.5 |
% |
Research and
development |
|
|
83,458 |
|
|
|
39,095 |
|
|
|
|
|
|
|
122,553 |
|
|
|
77,036 |
|
|
|
31,932 |
|
|
|
|
|
|
|
108,968 |
|
Selling and
marketing |
|
|
41,868 |
|
|
|
86,593 |
|
|
|
43,695 |
|
|
|
172,156 |
|
|
|
41,764 |
|
|
|
79,397 |
|
|
|
39,246 |
|
|
|
160,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contribution |
|
$ |
312,185 |
|
|
$ |
131,412 |
|
|
$ |
25,315 |
|
|
|
468,912 |
|
|
$ |
315,290 |
|
|
$ |
133,956 |
|
|
$ |
19,117 |
|
|
|
468,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contibution margin |
|
|
28.2 |
% |
|
|
38.7 |
% |
|
|
5.7 |
% |
|
|
24.8 |
% |
|
|
28.0 |
% |
|
|
41.9 |
% |
|
|
4.5 |
% |
|
|
25.1 |
% |
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
140,041 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
152,460 |
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60,569 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
132,251 |
|
Loss (gain) on asset sales and impairments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
267,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
189,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.2 |
% |
|
|
|
(1) |
|
Excludes amortization of acquired intangibles including product rights. |
NOTE 4 INVENTORIES
Inventories consist of finished goods held for sale and distribution, raw materials and
work-in-process. Included in inventory at September 30, 2008 and December 31, 2007 is
approximately $16.6 million and $15.1 million, respectively, of inventory that is pending approval
by the U.S. Food and Drug Administration (FDA) or has not been launched due to contractual
restrictions. This inventory consists of generic pharmaceutical products that are capitalized
only when the bioequivalence of the product is demonstrated or the product is already FDA approved
and is awaiting a contractual triggering event to enter the marketplace.
Inventories are stated at the lower of cost (first-in, first-out method) or market (net
realizable value) and consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
102,958 |
|
|
$ |
102,607 |
|
Work-in-process |
|
|
48,073 |
|
|
|
45,851 |
|
Finished goods |
|
|
330,528 |
|
|
|
342,143 |
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
481,559 |
|
|
$ |
490,601 |
|
|
|
|
|
|
|
|
- 10 -
NOTE 5 LONG-TERM DEBT
Long-term debt consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Senior Credit Facility, due 2011, bearing interest
at LIBOR plus 0.75% (2006 Credit Facility) |
|
$ |
250,000 |
|
|
$ |
325,000 |
|
CODES, face amount of $575 million,
due 2023, net of unamortized discount |
|
|
574,609 |
|
|
|
574,402 |
|
Other notes payable |
|
|
3,217 |
|
|
|
6,247 |
|
|
|
|
|
|
|
|
|
|
|
827,826 |
|
|
|
905,649 |
|
Less: Current portion |
|
|
3,217 |
|
|
|
6,241 |
|
|
|
|
|
|
|
|
Total long-term debt |
|
$ |
824,609 |
|
|
$ |
899,408 |
|
|
|
|
|
|
|
|
Senior Credit Facility
During the nine months ended September 30, 2008 and 2007, the Company made prepayments of the
2006 Credit Facility totaling $75.0 million and $250.0 million, respectively. As a result of these
pre-payments, the Companys results for the nine months ended September 30, 2008 and 2007 reflect a
$1.1 million and $4.4 million charge for losses on the early extinguishment of debt, respectively.
As of September 30, 2008, $250.0 million is outstanding under the 2006 Credit Facility. The full
amount outstanding on the 2006 Credit Facility is due November 2011.
NOTE 6
BUSINESS RESTRUCTURING CHARGES
During the first quarter of 2008, the Company announced efforts to reduce its cost structure
with the planned closure of its manufacturing facilities in Carmel, New York and its distribution
center in Brewster, New York. While the final closing date will depend on a number of factors, we
anticipate these facilities will close by the end of 2010. Activity related to our business
restructuring and facility rationalization activities for the nine months ended September 30, 2008
consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrual |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
|
Charged |
|
|
Cash |
|
|
Non-cash |
|
|
September 30, |
|
(in thousands) |
|
to Expense |
|
|
Payments |
|
|
Adjustments |
|
|
2008 |
|
Cost of sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Severance and retention |
|
$ |
13,909 |
|
|
$ |
(1,570 |
) |
|
$ |
|
|
|
$ |
12,339 |
|
Product transfer costs |
|
|
1,907 |
|
|
|
(1,393 |
) |
|
|
|
|
|
|
514 |
|
Facility decommission costs |
|
|
588 |
|
|
|
(409 |
) |
|
|
|
|
|
|
179 |
|
Accelerated depreciation |
|
|
5,600 |
|
|
|
|
|
|
|
(5,600 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,004 |
|
|
|
(3,372 |
) |
|
|
(5,600 |
) |
|
|
13,032 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,019 |
|
|
|
(752 |
) |
|
|
|
|
|
|
267 |
|
Selling, general and
administrative |
|
|
880 |
|
|
|
(28 |
) |
|
|
|
|
|
|
852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,899 |
|
|
|
(780 |
) |
|
|
|
|
|
|
1,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total restructuring charges |
|
$ |
23,903 |
|
|
$ |
(4,152 |
) |
|
$ |
(5,600 |
) |
|
$ |
14,151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product transfer costs consist of documentation, testing and shipping costs to transfer
product to other facilities. Operating expenses include severance and retention. Retention is
expensed only to the extent earned
- 11 -
by employees. Activity related to our business restructuring
and facility rationalization activities is primarily attributable to our Generic segment.
NOTE 7 INCOME TAXES
As of September 30, 2008, the Company reached agreement with Internal Revenue Service (the
IRS) related to the examination of its federal income tax returns for the years ended December
31, 2000 to 2003 (the Exam). The resolution of the Exam represents substantially all of the
changes in the amount of the liability for uncertain tax benefits including the amount of the
liability that would impact the effective rate and the amount accrued for interest and penalties.
As a result, the tax provision for the three months ended September 30, 2008 reflects a
non-recurring benefit of $5.6 million for taxes and interest.
At September 30, 2008, the liability for income taxes associated with uncertain tax positions
decreased to $59.0 million. This liability can be reduced by $28.1 million of offsetting tax
benefits associated with the effects of timing differences, state income tax effects, and amounts
arising from business combinations, which if recognized, would be recorded to goodwill. The net
amount of $31.0 million, if recognized, would favorably affect the Companys effective tax rate.
The liability for income taxes associated with uncertain tax positions was $71.2 million at
December 31, 2007 and $94.0 million at June 30, 2008. These liabilities can be reduced by $28.7
million and $50.8 million, respectively, of offsetting tax benefits. The net amount of $42.5
million and $43.2 million, respectively, if recognized, would favorably affect the Companys
effective tax rate.
At December 31, 2007 the Company had accrued $6.2 million of interest and penalties (net of
tax benefit of $3.6 million) related to uncertain tax positions. Changes in prior periods were
immaterial. At September 30, 2008, the Company had accrued $4.5 million of interest and penalties
(net of tax benefit of $2.6 million) related to uncertain tax positions.
The Federal Research and Development Credit expired at the end of 2007 but was extended
retroactively to January 1, 2008 after the close of the period. Accordingly, no tax benefit
related to the Federal Research and Development Credit has been recorded in the nine months ended
September 30, 2008.
NOTE 8 GOODWILL
Changes in our goodwill balances for the nine months ended September 30, 2008 were as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
Goodwill |
|
|
September 30, |
|
|
|
2007 |
|
|
Adjustment |
|
|
2008 |
|
Brand segment |
|
$ |
356,998 |
|
|
$ |
(8,825 |
) |
|
$ |
348,173 |
|
Generic segment |
|
|
433,451 |
|
|
|
149 |
|
|
|
433,600 |
|
Distribution segment |
|
|
86,000 |
|
|
|
312 |
|
|
|
86,312 |
|
|
|
|
|
|
|
|
|
|
|
Total goodwill |
|
$ |
876,449 |
|
|
$ |
(8,364 |
) |
|
$ |
868,085 |
|
|
|
|
|
|
|
|
|
|
|
The $8.4 million net decrease in goodwill represents a $9.8 million reduction to goodwill
initially recognized upon acquisition of Schein Pharmaceutical, Inc. in 2000 for the settlement of
income tax contingencies related to the IRS examination for the years 2000 to 2003 which was
partially offset by a $1.4 million payment to the IRS related to the Companys acquisition of
Andrx Corporation in November 2006 for the settlement of pre-acquisition income tax liabilities.
- 12 -
NOTE 9 STOCKHOLDERS EQUITY
A summary of the changes in stockholders equity for the nine months ended September 30, 2008
consisted of the following (in thousands):
|
|
|
|
|
Stockholders equity, December 31, 2007 |
|
$ |
1,849,465 |
|
Common stock issued under employee plans |
|
|
8,411 |
|
Increase in additional paid-in capital for share-based compensation plans |
|
|
14,055 |
|
Net income |
|
|
181,993 |
|
Other comprehensive loss |
|
|
(3,011 |
) |
Tax benefit from employee stock plans |
|
|
207 |
|
Repurchase of common stock |
|
|
(837 |
) |
|
|
|
|
Stockholders equity, September 30, 2008 |
|
$ |
2,050,283 |
|
|
|
|
|
NOTE 10 FAIR VALUE MEASUREMENT
In September 2006, the FASB issued SFAS 157 which defines fair value, establishes a framework
for measuring fair value in generally accepted accounting principles and expands disclosures about
fair-value measurements. The Company adopted SFAS 157 effective January 1, 2008 for all financial
assets and liabilities and any other assets and liabilities that are recognized or disclosed at
fair value on a recurring basis. Although the adoption of SFAS 157 did not materially impact the
Companys financial condition, results of operations or cash flows, we are required to provide
additional disclosures within our condensed consolidated financial statements.
SFAS 157 defines fair value as the price that would be received to sell an asset or paid to
transfer the liability (an exit price) in an orderly transaction between market participants and
also establishes a fair value hierarchy which requires an entity to maximize the use of observable
inputs and minimize the use of unobservable inputs when measuring fair value. The fair value
hierarchy within SFAS 157 distinguishes three levels of inputs that may be utilized when measuring
fair value including level 1 inputs (using quoted prices in active markets for identical assets or
liabilities), level 2 inputs (using inputs other than level 1 prices such as quoted prices for
similar assets and liabilities in active markets or inputs that are observable for the asset or
liability) and level 3 inputs (unobservable inputs supported by little or no market activity based
on our own assumptions used to measure assets and liabilities). A financial asset or liabilitys
classification within the above hierarchy is determined based on the lowest level input that is
significant to the fair value measurement.
Financial assets and liabilities measured at fair value or disclosed at fair value on a
recurring basis as at September 30, 2008 consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as at September 30, 2008 Using: |
|
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
Marketable securities |
|
$ |
12,683 |
|
|
$ |
12,683 |
|
|
$ |
|
|
|
$ |
|
|
Investments |
|
|
106 |
|
|
|
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative liabilities |
|
|
594 |
|
|
|
|
|
|
|
594 |
|
|
|
|
|
Marketable securities and investments consist of available-for-sale investments in U.S.
Treasury and agency securities and publicly traded equity securities for which market prices are
readily available. The fair value of derivative liabilities, consisting of interest rate swaps
and an embedded derivative related to the CODES, are
determined based on inputs that can be derived from information available in publicly quoted
markets. Unrealized gains or losses on marketable securities, investments and interest rate swaps
are recorded in
- 13 -
accumulated other comprehensive (loss) income. Changes in the fair value of the
embedded derivative related to the CODES are reflected as an adjustment to interest expense.
NOTE 11 CONTINGENCIES
Legal Matters
Watson and its affiliates are involved in various disputes, governmental and/or regulatory
inspections, inquires, investigations and proceedings, and litigation matters that arise from time
to time in the ordinary course of business. The process of resolving matters through litigation or
other means is inherently uncertain and it is possible that an unfavorable resolution of these
matters will adversely affect the Company, its results of operations, financial condition and cash
flows. The Companys regular practice is to expense legal fees as services are rendered in
connection with legal matters, and to accrue for liabilities when losses are probable and
reasonably estimable.
Cipro® Litigation. Beginning in July 2000, a number of suits were filed against Watson, The
Rugby Group, Inc. (Rugby) and other company affiliates in various state and federal courts
alleging claims under various federal and state competition and consumer protection laws. Several
plaintiffs have filed amended complaints and motions seeking class certification. Approximately 42
cases had been filed against Watson, Rugby and other Watson entities. Twenty-two of these actions
have been consolidated in the U.S. District Court for the Eastern District of New York (In re:
Ciprofloxacin Hydrochloride Antitrust Litigation, MDL Docket No. 001383 ). On May 20, 2003, the
court hearing the consolidated action granted Watsons motion to dismiss and made rulings limiting
the theories under which plaintiffs can seek recovery against Rugby and the other defendants. On
March 31, 2005, the court hearing the consolidated action granted summary judgment in favor of the
defendants on all of plaintiffs claims, denied the plaintiffs motions for class certification,
and directed the clerk of the court to close the case. On May 7, 2005, three groups of plaintiffs
from the consolidated action (the direct purchaser plaintiffs, the indirect purchaser plaintiffs
and plaintiffs Rite Aid and CVS) filed notices of appeal in the United States Court of Appeals for
the Second Circuit, appealing, among other things, the May 20, 2003 order dismissing Watson and the
March 31, 2005 order granting summary judgment in favor of the defendants. The three appeals were
consolidated by the appellate court. On August 25, 2005, the defendants moved to transfer the
appeals to the United States Court of Appeals for the Federal Circuit on the ground that patent
issues are involved in the appeal. On November 7, 2007, the motions panel of the U.S. Court of
Appeals for the Second Circuit granted the motion in part, and ordered the appeal by the indirect
purchaser plaintiffs transferred to the United States Court of Appeals for the Federal Circuit. On
October 15, 2008, the United States Court of Appeals for the Federal Circuit affirmed the
dismissal. The appeal in the United States Court of Appeals for the Second Circuit remains pending.
Other actions are pending in various state courts, including New York, California, Kansas,
Tennessee, Florida and Wisconsin. The actions generally allege that the defendants engaged in
unlawful, anticompetitive conduct in connection with alleged agreements, entered into prior to
Watsons acquisition of Rugby from Sanofi Aventis (Aventis), related to the development,
manufacture and sale of the drug substance ciprofloxacin hydrochloride, the generic version of
Bayers brand drug, Cipro ®. The actions generally seek declaratory judgment, damages,
injunctive relief, restitution and other relief on behalf of certain purported classes of
individuals and other entities. The courts hearing the cases in New York have dismissed the
actions. Appellants have sought leave to appeal the dismissal of the New York action to the New
York Court of Appeals. On April 18, 2006, the New York Supreme Court, Appellate Division, denied
the appellants motion. In Wisconsin, the plaintiffs appealed and on May 9, 2006, the appellate
court reversed the order of dismissal. On June 8, 2006, the defendants filed a petition for review
in the Wisconsin Supreme Court. On July 13, 2007, the Wisconsin Supreme Court affirmed the decision
of the appellate court, and remanded the case for further proceedings. On October 25, 2007, the
circuit court stayed the matter pending the outcome of the appeals in the consolidated action. In
the action pending in Kansas, the court has stayed the matter pending the outcome of the appeal in
the consolidated case. In the action pending in the California
Superior Court for the County of San Diego (In re: Cipro Cases I & II, JCCP Proceeding Nos.
4154 & 4220), on July 21, 2004, the California Court of Appeal granted in part and denied in part
the defendants petition for a writ of mandate seeking to reverse the trial courts order granting
the plaintiffs motion for class certification. Pursuant to the appellate courts ruling, the
majority of the plaintiffs will be permitted to pursue their
- 14 -
claims as a class. On April 13, 2005,
the Superior Court granted the parties joint application to stay the California case pending the
outcome of the appeal of the consolidated case. In August 2007 the plaintiffs moved to lift the
stay. The court denied the motion to lift the stay, but agreed to consider the matter again at a
status conference to be scheduled in 2008. A status conference was held on May 16, 2008, at which
the court scheduled a further status conference for December 12, 2008. The court subsequently
ordered the parties to submit a briefing schedule for summary judgment within thirty days of the
Federal Circuits ruling. Accordingly, the parties will submit a proposed briefing schedule by
November 14, 2008. In addition to the pending actions, Watson understands that various state and
federal agencies are investigating the allegations made in these actions. Aventis has agreed to
defend and indemnify Watson and its affiliates in connection with the claims and investigations
arising from the conduct and agreements allegedly undertaken by Rugby and its affiliates prior to
Watsons acquisition of Rugby, and is currently controlling the defense of these actions.
Governmental Reimbursement Investigations and Drug Pricing Litigation In November 1999, Schein
Pharmaceutical, Inc., now known as Watson Pharma, Inc. (Watson Pharma) was informed by the U.S.
Department of Justice that Watson Pharma, along with numerous other pharmaceutical companies, is a
defendant in a qui tam action brought in 1995 under the U.S. False Claims Act currently pending in
the U.S. District Court for the Southern District of Florida. Watson Pharma has not been served in
the qui tam action. A qui tam action is a civil lawsuit brought by an individual for an alleged
violation of a federal statute, in which the U.S. Department of Justice has the right to intervene
and take over the prosecution of the lawsuit at its option. Pursuant to applicable federal law, the
qui tam action is under seal as to Watson Pharma. The Company believes that the qui tam action
relates to whether allegedly improper price reporting by pharmaceutical manufacturers led to
increased payments by Medicare and/or Medicaid. The qui tam action may seek to recover damages from
Watson Pharma based on its price reporting practices. Watson Pharma subsequently also received and
responded to notices or subpoenas from the Attorneys General of various states, including Florida,
Nevada, New York, California and Texas, relating to pharmaceutical pricing issues and whether
allegedly improper actions by pharmaceutical manufacturers led to excessive payments by Medicare
and/or Medicaid. On June 26, 2003, the Company received a request for records and information from
the U.S. House Committee on Energy and Commerce in connection with that committees investigation
into pharmaceutical reimbursements and rebates under Medicaid. The Company produced documents in
response to the request. Other state and federal inquiries regarding pricing and reimbursement
issues are anticipated.
Beginning in July 2002, the Company and certain of its subsidiaries, as well as numerous other
pharmaceutical companies, were named as defendants in various state and federal court actions
alleging improper or fraudulent reporting practices related to the reporting of average wholesale
prices and wholesale acquisition costs of certain products, and that the defendants committed other
improper acts in order to increase prices and market shares. Some of these actions have been
consolidated in the U.S. District Court for the District of Massachusetts (In re: Pharmaceutical
Industry Average Wholesale Price Litigation, MDL Docket No. 1456). The consolidated amended Class
Action complaint in that case alleges that the defendants acts improperly inflated the
reimbursement amounts paid by various public and private plans and programs. The amended complaint
alleges claims on behalf of a purported class of plaintiffs that paid any portion of the price of
certain drugs, which price was calculated based on its average wholesale price, or contracted with
a pharmacy benefit manager to provide others with such drugs. The Company filed an Answer to the
Amended Consolidated Class Action Complaint on April 9, 2004. Defendants in the consolidated
litigation have been divided into two groups. The Company and its named subsidiaries are contained
in a large group of defendants that is currently awaiting a ruling on the plaintiffs request for
certification of classes of plaintiffs to maintain a class action against the drug company
defendants. Certain other defendants, referred to as the Track One defendants, have proceeded on
a more expedited basis. Classes were certified against these defendants, a trial has been completed
with respect to some of the claims against this group of defendants, the
presiding judge has issued a ruling granting judgment to the plaintiffs, that judgment is
being appealed, and many of the claims have been settled. The Track Two Defendants, including the
Company, have entered into a settlement agreement resolving all claims of the Track Two Defendants
in the Consolidated Class Action. The total amount of the settlement for all of the Track Two
Defendants is $125 million. On July 2, 2008, the United States District Court for the District of
Massachusetts preliminarily approved the Track Two settlement. A hearing on final approval of the
settlement is scheduled for
- 15 -
December 16, 2008. The amount to be paid by each Track Two Defendant is
confidential. The settlement is not expected to materially adversely affect the Companys business,
results of operations, financial condition and cash flows.
The Company and certain of its subsidiaries also are named as defendants in various lawsuits
filed by numerous states, including Texas, Nevada, Montana, Massachusetts, Wisconsin, Kentucky,
Alabama, Illinois, Mississippi, Florida, Arizona, Missouri, Alaska, Idaho, South Carolina, Hawaii,
Utah, and Iowa captioned as follows: State of Nevada v. American Home Products, et al., Civil
Action No. 02-CV-12086-PBS, United States District Court for the District of Massachusetts; State
of Montana v. Abbott Laboratories, et al., Civil Action No. 02-CV-12084-PBS, United States District
Court for the District of Massachusetts; Commonwealth of Massachusetts v. Mylan Laboratories, et
al., Civil Action No. 03-CV-11865-PBS, United States District Court for the District of
Massachusetts; State of Wisconsin v. Abbott Laboratories, et al., Case No. 04-cv-1709, Wisconsin
Circuit Court for Dane County; Commonwealth of Kentucky v. Alpharma, Inc., et al., Case Number
04-CI-1487, Kentucky Circuit Court for Franklin County; State of Alabama v. Abbott Laboratories,
Inc. et al., Civil Action No. CV05-219, Alabama Circuit Court for Montgomery County; State of
Illinois v. Abbott Laboratories, Inc. et al., Civil Action No. 05-CH-02474, Illinois Circuit Court
for Cook County; State of Mississippi v. Abbott Laboratories, Inc. et al., Civil Action No.
G2005-2021 S/2, Mississippi Chancery Court of Hinds County; State of Florida ex rel. Ven-A-Care,
Civil Action No 98-3032G, Florida Circuit Court in Leon County; State of Arizona ex rel. Terry
Goddard, No. CV 2005-18711, Arizona Superior Court for Maricopa County; State of Missouri ex rel.
Jeremiah W. (Jay) Nixon v. Mylan Laboratories, et al, Case No. 054-2486, Missouri Circuit Court of
St. Louis; State of Alaska v. Alpharma Branded Products Division Inc., et al., In the Superior
Court for the State of Alaska Third Judicial District at Anchorage, C.A. No. 3AN-06-12026 CI; State
of Idaho v. Alpharma USPD Inc. et al., In the District Court of the Fourth Judicial District of the
State of Idaho, in and for the County of Ada, C.A. No. CV0C-0701847; State of South Carolina and
Henry D. McMaster v. Watson Pharmaceuticals (New Jersey), Inc., In the Court of Common Pleas for
the Fifth Judicial Circuit, State of South Carolina, County of Richland, C.A. No. 2006-CP-40-7152;
State of South Carolina and Henry D. McMaster v. Watson Pharmaceuticals (New Jersey), Inc., In the
Court of Common Pleas for the Fifth Judicial Circuit, State of South Carolina, County of Richland,
C.A. No. 2006-CP-40-7155; State of Hawaii v. Abbott Laboratories, Inc. et al., In the Circuit Court
of the First Circuit, State of Hawaii, C.A. No. 06-1-0720-04 EEH; State of Utah v. Actavis U.S.,
Inc., et al., In the Third Judicial District Court of Salt Lake County, Civil No. 07-0913719; State
of Iowa v. Abbott Laboratories, Inc., et al., In the U.S. District Court for the Southern District
of Iowa, Central Division, Case No. 07-CV-00461; State of Texas ex rel. Ven-A-Care of the Florida
Keys, Inc. v. Alpharma Inc., et al, Case No. 08-001565, in the District Court of Travis County,
Texas; and United States of America ex rel. Ven-A-Care of the Florida Keys, Inc., Civil Action No.
08-10852, in the U.S. District Court for the District of Massachussetts.
These cases generally allege that the defendants caused the states to overpay pharmacies and
other providers for prescription drugs under state Medicaid Programs by inflating the reported
Average Wholesale Price or Wholesale Acquisition Cost, and by reporting false prices to the United
States government under the Best Prices rebate program. Several of these cases also allege that
state residents were required to make inflated copayments for drug purchases under the federal
Medicare program, and companies were required to make inflated payments on prescription drug
purchases for their employees. Most of these cases, some of which have been removed to federal
court, are in the early stages of pleading or are proceeding through pretrial discovery. On January
20, 2006, the Company was dismissed without prejudice from the actions brought by the States of
Montana and Nevada because the Company was not timely served. The case brought on behalf of the
Commonwealth of Massachusetts has passed its factual discovery deadline as to the Company and the
parties are currently awaiting rulings on cross-
motions for summary judgment as to some or all of the claims. The case brought against the
Company on behalf of Alabama has been set for trial scheduled to begin in June of 2009.
The City of New York filed an action in the United States District Court for the Southern
District of New York on August 4, 2004, against the Company and numerous other pharmaceutical
defendants alleging similar claims. The case was transferred to the United States District Court
for the District of Massachusetts, and was consolidated with several similar cases filed by
individual New York counties. A corrected Consolidated Complaint was filed on June 22, 2005 (City
of New York v. Abbott Laboratories, Inc., et al., Civil Action No. 01-
- 16 -
CV-12257-PBS, United States
District Court for the District of Massachusetts). The Consolidated Complaint included as
plaintiffs the City of New York and 30 New York counties. Since the filing of the Consolidated
Complaint, cases brought by a total of 14 additional New York counties have been transferred to the
District of Massachusetts. In February 2007, three of the New York counties cases were sent back
to New York state court (Erie, Oswego and Schenectady counties). On April 5, 2007, an additional
action raising similar allegations was filed by Orange County, New York (County of Orange v. Abbott
Laboratories, Inc., et al. , United States District Court for the Southern District of New York,
Case No. 07-CV-2777). The Company is therefore named as a defendant by the City of New York and 41
New York counties, consolidated in the District of Massachusetts case, as well as by four
additional New York counties, with these cases pending in New York state court. Many of the state
and county cases are included in consolidated or single-case mediation proceedings, and the Company
is participating in these proceedings.
Additional actions by other states, cities and/or counties are anticipated. These actions
and/or the actions described above, if successful, could adversely affect the Company and may have
a material adverse effect on the Companys business, results of operations, financial condition and
cash flows.
FDA Matters. In May 2002, Watson reached an agreement with the FDA on the terms of a consent
decree with respect to its Corona, California manufacturing facility. The court approved the
consent decree on May 13, 2002 (United States of America v. Watson Laboratories, Inc., and Allen Y.
Chao , United States District Court for the Central District of California, EDCV-02-412-VAP). The
consent decree with the FDA does not require any fine, a facility shutdown, product recalls or any
reduction in production or service at the Companys Corona facility. The consent decree applies
only to the Corona facility and not other manufacturing sites. On July 9, 2008, the court entered
an order dismissing Allen Y. Chao, the Companys former President and Chief Executive Officer, from
the action and from the consent decree. The decree requires Watson to ensure that its Corona,
California facility complies with the FDAs current Good Manufacturing Practices (cGMP)
regulations.
Pursuant to the agreement, Watson hired an independent expert to conduct inspections of the
Corona facility at least once each year. In February 2003, February 2004, January 2005, January
2006, January 2007 and January-February 2008, respectively, the first, second, third, fourth, fifth
and sixth annual inspections were completed and the independent expert submitted its report of the
inspection to the FDA. In each instance, the independent expert reported its opinion that, based on
the findings of the audit of the facility, the FDAs applicable cGMP requirements, applicable FDA
regulatory guidance, and the collective knowledge, education, qualifications and experience of the
experts auditors and reviewers, the systems at Watsons Corona facility audited and evaluated by
the expert are in compliance with the FDAs cGMP regulations. However, the FDA is not required to
accept or agree with the independent experts opinion. The FDA conducted an inspection of that
facility from March 31, 2004 until May 6, 2004. At the conclusion of the inspection, the FDA issued
a Form 483 listing the observations made during the inspection, including observations related to
certain laboratory test methods and other procedures in place at the facility. In June 2004 the
Company submitted its response to the FDA Form 483 inspectional observations and met with FDA
officials to discuss its response, including the corrective actions the Company had taken, and
intended to take, to address the inspectional observations. The FDA conducted another inspection of
the facility from April 5, 2005 through April 13, 2005. At the conclusion of the inspection no
formal observations were made and no FDA Form 483 was issued. The FDA conducted another inspection
of the facility from July 9, 2006 through July 21, 2006. At the conclusion of the inspection no
formal observations were made and no FDA Form 483 was issued. From February 20, 2007 through March
9, 2007, the FDA conducted another inspection of the
facility. At the conclusion of the inspection, the FDA issued a Form 483 listing the
observations made during the inspection. In April 2007 the Company submitted its response to the
FDA Form 483 inspectional observations, including the corrective actions the Company has taken to
address the inspectional observations. The FDA conducted another inspection of the facility from
October 18, 2007 through October 26, 2007. At the conclusion of the inspection, the FDA issued a
Form 483 listing two observations made during the pre-approval portion of the inspection related to
two pending Abbreviated New Drug Applications (ANDAs). No formal observations were made
concerning the Companys compliance with cGMP. The FDA conducted another inspection of the facility
from June 16, 2008 through June 27, 2008. At the conclusion of the inspection no formal
observations were made and no FDA Form 483 was issued. However, if in the future, the
- 17 -
FDA determines that, with respect to its Corona facility, Watson has failed to comply with the consent
decree or FDA regulations, including cGMPs, or has failed to adequately address the observations in
the Form 483, the consent decree allows the FDA to order Watson to take a variety of actions to
remedy the deficiencies. These actions could include ceasing manufacturing and related operations
at the Corona facility, and recalling affected products. Such actions, if taken by the FDA, could
have a material adverse effect on the Company, its results of operations, financial position and/or
cash flows.
Naproxen Sodium (Naprelan). In October 1998, Elan Corporation Plc sued Andrx Pharmaceuticals,
Inc. (Andrx) in the United States District Court for the Southern District of Florida, alleging
that Andrxs pending ANDA for a generic version of Elans Naprelan ® infringed Elans
patent No. 5,637,320 (Elan Corporation PLC v. Andrx Pharmaceuticals, Inc., Case No. 98-7164). In
March 2002, the District Court issued an order that Elans patent was invalid, and in September
2002, Andrx commenced selling the 500mg strength of naproxen sodium, its generic version of
Naprelan ®. In March 2003, the District Court issued an order denying, among other
things, (i) Elans motion for consideration of the March 2002 order invalidating its patent, and
(ii) Andrxs motion asking the District Court for a ruling on its non-infringement defenses. Both
parties appealed that March 2003 decision (Elan Corporation PLC v. Andrx Pharmaceuticals, Inc.,
Case No. 03-1354). On May 5, 2004, the Federal Circuit Court of Appeals reversed the District
Courts determination that the Elan patent was invalid, and remanded the case back to the District
Court for a determination as to whether Andrxs product infringes the Elan patent. On July 12,
2005, the Federal Circuit Court of Appeals issued a decision, in an unrelated case, on how a court
should address issues of claim construction, and the District Court instructed the parties to file
briefs on how the District Court should proceed in this matter in light of the Federal Circuit
Court of Appeals decision. On August 13, 2008, the District Court ruled that the Companys naproxen
sodium product infringes Elans patent No. 5,637,320, and that the infringement was willful. The
company voluntarily discontinued sales of its naproxen sodium product on August 13, 2008, and
intends to appeal the District Courts decision.
In January 2005, Elan filed a complaint in the U.S. District Court for the Southern District
of Florida seeking willful damages as a result of Andrxs sale of its generic version of
Naprelan ® (Elan Corporation PLC v. Andrx Pharmaceuticals, Inc., Case No. 058-60158). In
February 2005, Andrx filed its answer to Elans January 2005 complaint and filed a counterclaim for
declaratory relief for unenforceability due to inequitable conduct and for non-infringement and
invalidity of the applicable patent. The trial of this matter has been scheduled for April 27,
2009. Discovery is ongoing. The Company sold its 500mg strength naproxen sodium product from
September 2002 until August 13, 2008. The Company is unable to estimate the ultimate amount of
liability or financial impact, if any, of these matters as of the filing of this Quarterly Report.
A final adverse determination of either of these matters could have a material adverse effect on
the Companys business, results of operations, financial condition and cash flows.
Federal Trade Commission Investigations. The Company has received Civil Investigative Demands
or requests for information from the Federal Trade Commission seeking information and documents
related to the terms on which the Company has settled lawsuits initiated by patentees under the
Hatch-Waxman Act. These investigations relate to the Companys August 2006 settlement with
Cephalon, Inc. related to the Companys generic version of Provigil ® (modafinil) and
its September 2006 settlement with Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of
Solvay Pharmaceuticals, Inc. and Laboratories Besins Isovesco related to the Companys generic
version of AndroGel ® (testosterone gel). Additionally, the Company has received a
request for information related
to the Companys April 2007 agreement with Sandoz, Inc. related to the Companys forfeiture of
its entitlement to 180 days of marketing exclusivity for its 50 milligram dosage strength of its
generic version of Toprol XL ® (metoprolol xl). The Company believes these agreements
comply with applicable laws and rules. However, if the Federal Trade Commission concludes that any
of these agreements violate applicable antitrust laws or rules, it could initiate legal action
against the Company. These actions, if successful, could have a material adverse effect on the
Companys business, results of operations, financial condition and cash flows.
Department of Health and Human Services Subpoena. In December 2003, the Companys subsidiary,
Watson Pharma, received a subpoena from the Office of the Inspector General (OIG) of the
Department of Health and Human Services. The subpoena requested documents relating to physician
meetings conducted during 2002 and
- 18 -
2003 related to Watson Pharmas Ferrlecit ®
intravenous iron product. Watson Pharma provided the requested documents and has not been contacted
again by the OIG for several years. However, the Company cannot predict what additional actions, if
any, may be taken by the OIG, Department of Health and Human Services, or other governmental
entities.
Hormone Replacement Therapy Litigation. Beginning in early 2004, a number of product liability
suits were filed against the Company and certain Company affiliates, for personal injuries
allegedly arising out of the use of hormone replacement therapy products, including but not limited
to estropipate and estradiol. These complaints also name numerous other pharmaceutical companies as
defendants, and allege various injuries, including ovarian cancer, breast cancer and blood clots.
Approximately 117 cases are pending against Watson and/or its affiliates in state and federal
courts representing claims by approximately 180 plaintiffs. Many of the cases involve multiple
plaintiffs. The majority of the cases have been transferred to and consolidated in the United
States District Court for the Eastern District of Arkansas (In re: Prempro Products Liability
Litigation, MDL Docket No. 1507). Discovery in these cases is ongoing. The Company maintains
product liability insurance against such claims. However, these actions, if successful, or if
insurance does not provide sufficient coverage against the claims, could adversely affect the
Company and could have a material adverse effect on the Companys business, results of operations,
financial condition and cash flows.
Levonorgestrel/Ethinyl Estradiol Tablets (Seasonale®). On December 13, 2007,
Duramed Pharmaceuticals, Inc. sued the Company and certain of its subsidiaries in the United States
District Court for the District of New Jersey, alleging that sales of the Companys Quasense
TM (levonorgestrel/ethinyl estradiol) tablets, the generic version of Durameds
Seasonale ® tablets, infringes Durameds U.S. Patent No. RE 39,861 (Duramed
Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., et. al., Case No. 07cv05941). The complaint
seeks damages and injunctive relief. On March 3, 2008, the Company answered the complaint.
Discovery is ongoing. The Company believes it has substantial meritorious defenses to the case.
However, the Company has sold and is continuing to sell its generic version of Seasonale
®. Therefore, an adverse determination could have a material adverse effect on the Companys
business, results of operations, financial condition and cash flows.
Ferrlecit®. On March 28, 2008, we received a notice from Aventis contending that
the distribution agreement for Ferrlecit ® between certain affiliates of Aventis and the
Company expires on February 18, 2009. The letter also acknowledged the Companys position that the
distribution agreement expires on December 31, 2009, and requested to conduct an expedited
arbitration proceeding to resolve the dispute. By its terms, the distribution agreement, as
amended, has a duration of ten (10) full calendar years after FDA market approval. Ferrlecit
received FDA market approval on February 18, 1999. On April 9, 2008, the Company responded to
Aventis, agreeing to arbitrate the disputes related to Ferrlecit ® on an expedited
basis. The arbitration is pending. Additionally, the parties are continuing to discuss a possible
extension of the distribution agreement and related agreements beyond 2009. However, there can be
no assurance that we will be able to negotiate extensions of these agreements on commercially
reasonable terms, or at all. Our inability to negotiate extensions of these agreements on
commercially reasonable terms, or an adverse finding in an arbitration proceeding, could have a
material adverse effect on our business, results of operations, financial condition and cash flows.
Oxytrol®
Litigation. (Watson Laboratories, Inc. v. Barr Laboratories,
Inc., et al. Case No. 08-793) In September 2008, the Company
received a notice letter from Barr Laboratories, Inc. (Barr) stating that Barr had filed an ANDA
with the FDA seeking approval of a generic version of the Companys Oxytrol (oxybutynin transdermal system) product. Barrs notice letter included a certification under the Hatch-Waxman Act contending that patents listed in the FDA Orange Book for the Companys Oxytrol product are
invalid or not infringed by Barrs ANDA. On October 23, 2008, the Companys subsidiary, Watson Laboratories, Inc., filed suit against Barr and its parent company, Barr Pharmaceuticals, Inc., in the United States District Court for the District of Delaware, alleging that Barrs generic version of Oxytrol infringes the Companys patents. Under applicable law, the filing of the lawsuit stays any FDA approval of Barrs ANDA until the earlier of a District Court judgment
in Barrs favor, or thirty months from the date the Company received Barrs notice letter. The Company believes it has substantial, meritorious claims against Barr. However, if Barr succeeds in obtaining final FDA approval of a generic version of Oxytrol and commences sales of its product, it could have a material adverse effect on the Companys business, results of operations, financial condition and cash flows.
- 19 -
Watson and its affiliates are involved in various other disputes, governmental and/or
regulatory inspections, inquires, investigations and proceedings that could result in litigation,
and other litigation matters that arise from time to time.
The process of resolving matters through litigation or other means is inherently uncertain and
it is possible that an unfavorable resolution of these matters will adversely affect the Company,
its results of operations, financial condition and cash flows.
- 20 -
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and the results of operations should be
read in conjunction with the Condensed Consolidated Financial Statements and notes thereto
included elsewhere in this Quarterly Report on Form 10-Q (Quarterly Report). This discussion
contains forward-looking statements that are subject to known and unknown risks, uncertainties and
other factors that may cause our actual results to differ materially from those expressed or
implied by such forward-looking statements. These risks, uncertainties and other factors include,
among others, those identified under Cautionary Note Regarding Forward-Looking Statements under
Risks Related to our Business in our Annual Report on Form 10-K for the year ended December 31,
2007 and elsewhere in this Quarterly Report and our Annual Report on Form 10-K.
Overview
Watson Pharmaceuticals, Inc. (Watson, the Company we, us or our) was incorporated
in 1985 and is engaged in the development, manufacturing, marketing, sale and distribution of
brand and off-patent (generic) pharmaceutical products. Watson operates manufacturing,
distribution, research and development (R&D) and administrative facilities predominantly in the
United States (U.S.) and India with our key commercial market being the U.S.
Results of Operations
Prescription pharmaceutical products in the U.S. are generally marketed as either generic or
brand pharmaceuticals. Generic pharmaceutical products are bioequivalents of their respective brand
products and provide a cost-efficient alternative to brand products. Brand pharmaceutical products
are marketed under brand names through programs that are designed to generate physician and
consumer loyalty.
Watson has three reportable operating segments: Generic, Brand and Distribution. The Generic
segment includes off-patent pharmaceutical products that are therapeutically equivalent to
proprietary products. The Brand segment includes the Companys Specialty Products and Nephrology
product lines. Watson has aggregated its brand product lines in a single segment because of
similarities in regulatory environment, methods of distribution and types of customer. This segment
includes patent-protected products and certain trademarked off-patent products that Watson sells
and markets as brand pharmaceutical products. The Company sells its brand and generic products
primarily to pharmaceutical wholesalers, drug distributors and chain drug stores. The Distribution
segment mainly distributes generic pharmaceutical products manufactured by third parties, as well
as by Watson, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and
physicians offices under the Anda trade name. Sales are principally generated through an
in-house telemarketing staff and through internally developed ordering systems. The Distribution
segment operating results exclude sales of Watson products, which are included in their respective
Generic and Brand segment results.
The Company evaluates segment performance based on segment net revenues, gross profit and
contribution. Segment contribution represents segment gross profit less direct R&D expenses and
selling and marketing expenses. The Company has not allocated corporate general and administrative
expenses or amortization as such information has not been used by management, or has not been
accounted for at the segment level.
- 21 -
Three Months Ended September 30, 2008 Compared to Three Months Ended September 30, 2007
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|
|
Three Months Ended September 30, 2007 |
|
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
Product sales |
|
$ |
352,190 |
|
|
$ |
94,298 |
|
|
$ |
170,933 |
|
|
$ |
617,421 |
|
|
$ |
326,231 |
|
|
$ |
93,534 |
|
|
$ |
129,875 |
|
|
$ |
549,640 |
|
Other |
|
|
11,593 |
|
|
|
11,677 |
|
|
|
|
|
|
|
23,270 |
|
|
|
31,489 |
|
|
|
13,577 |
|
|
|
|
|
|
|
45,066 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
363,783 |
|
|
|
105,975 |
|
|
|
170,933 |
|
|
|
640,691 |
|
|
|
357,720 |
|
|
|
107,111 |
|
|
|
129,875 |
|
|
|
594,706 |
|
Cost of sales(1) |
|
|
212,367 |
|
|
|
30,224 |
|
|
|
144,064 |
|
|
|
386,655 |
|
|
|
210,931 |
|
|
|
22,089 |
|
|
|
113,400 |
|
|
|
346,420 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit(1) |
|
|
151,416 |
|
|
|
75,751 |
|
|
|
26,869 |
|
|
|
254,036 |
|
|
|
146,789 |
|
|
|
85,022 |
|
|
|
16,475 |
|
|
|
248,286 |
|
Gross margin(1) |
|
|
41.6 |
% |
|
|
71.5 |
% |
|
|
15.7 |
% |
|
|
39.7 |
% |
|
|
41.0 |
% |
|
|
79.4 |
% |
|
|
12.7 |
% |
|
|
41.7 |
% |
Research and
development |
|
|
31,736 |
|
|
|
13,586 |
|
|
|
|
|
|
|
45,322 |
|
|
|
26,555 |
|
|
|
9,102 |
|
|
|
|
|
|
|
35,657 |
|
Selling and
marketing |
|
|
13,990 |
|
|
|
29,024 |
|
|
|
15,558 |
|
|
|
58,572 |
|
|
|
14,018 |
|
|
|
26,613 |
|
|
|
12,716 |
|
|
|
53,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contribution |
|
$ |
105,690 |
|
|
$ |
33,141 |
|
|
$ |
11,311 |
|
|
|
150,142 |
|
|
$ |
106,216 |
|
|
$ |
49,307 |
|
|
$ |
3,759 |
|
|
|
159,282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contibution margin |
|
|
29.1 |
% |
|
|
31.3 |
% |
|
|
6.6 |
% |
|
|
23.4 |
% |
|
|
29.7 |
% |
|
|
46.0 |
% |
|
|
2.9 |
% |
|
|
26.8 |
% |
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,697 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59,144 |
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
44,159 |
|
Loss (gain) on asset sales and impairments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
86,942 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
62,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.4 |
% |
|
|
|
(1) |
|
Excludes amortization of acquired intangibles including product rights. |
Generic Segment
Net Revenues
Our Generic segment develops, manufactures, markets, sells and distributes generic products
that are the therapeutic equivalent to their brand name counterparts and are generally sold at
prices significantly less than the brand product. As such, generic products provide an effective
and cost-efficient alternative to brand products. When patents or other regulatory exclusivity no
longer protect a brand product, opportunities exist to introduce off-patent or generic counterparts
to the brand product. Additionally, we distribute generic versions of third parties brand products
(sometimes known as Authorized Generics) to the extent such arrangements are complementary to our
core business. Our portfolio of generic products includes products we have internally developed,
products we have licensed from third parties, and products we distribute for third parties.
Net revenues in our Generic segment include product sales and other revenue. Our Generic
segment product line includes a variety of products and dosage forms. Indications for this line
include pregnancy prevention, pain management, depression, hypertension and smoking cessation.
Dosage forms include oral solids, transdermals, injectables and transmucosals.
Other revenue consists primarily of royalties and commission revenue.
Net revenues from our Generic segment for the three months ended September 30, 2008 increased
1.7% or $6.1 million to $363.8 million compared to net revenues of $357.7 million from the prior
year period. This increase in net revenues was mainly attributable to new product launches ($42.0
million), including fentanyl transdermal patch (launched at the end of the third quarter of 2007),
omeprazole delayed-release capsules 40 mg (launched in the third quarter of 2008) and clarithromycin
extended-release tablets (launched in the first quarter of 2008) as well as net revenues from
recently launched Authorized Generics ($19.0 million) in the three months ended September 30, 2008,
including TiliaTM Fe and balsalazide disodium (both launched in the fourth quarter of
2007), alendronate sodium tablets (launched in the first quarter of 2008) and dronabinol (launched
in the second quarter of 2008).
Increases in net revenues from new product launches were partially offset by a decrease in
other revenue ($19.9 million), a decrease in net revenues from the sale of oral contraceptives and
price erosion within our base business.
- 22 -
The decrease in other revenue in the three months ended September 30, 2008 compared to the
prior year period for the Generic segment was primarily related to reduced royalties on sales by
Sandoz, Inc. of metoprolol succinate 50 mg extended release tablets (which commenced during the
third quarter of 2007) and reduced royalties on sales by GlaxoSmithkline of Wellbutrin XL® 150 mg due to increased
competition. Both items combined resulted in a reduction in royalties
in the quarter totaling $18.9
million.
Gross Profit
Gross profit represents net revenues less cost of sales. Cost of sales includes production and
packaging costs for the products we manufacture, third party acquisition costs for products
manufactured by others, profit-sharing or royalty payments for products sold pursuant to licensing
agreements, inventory reserve charges and excess capacity utilization charges, where applicable.
Cost of sales does not include amortization costs for acquired product rights or other acquired
intangibles.
Gross profit for our Generic segment increased $4.6 million to $151.4 million in the three
months ended September 30, 2008 compared to $146.8 million in the prior year period. The increase
in gross profit was primarily due to gross profit contribution from new product launches and
recently launched Authorized Generics ($35.9 million) partially offset by a decrease in other
revenue ($19.9 million), a decrease in gross profit from the sale of oral contraceptives and costs
associated with our Global Supply Chain Initiative ($4.4 million).
Research and Development Expenses
Generic segment R&D expenses consist predominantly of personnel-related costs, active
pharmaceutical ingredient costs, contract research, biostudy and facilities costs associated with
the development of our products.
Generic segment R&D expenses increased 19.5% or $5.2 million to $31.7 million in the three
months ended September 30, 2008 compared to $26.6 million in the prior year period primarily due to
higher biostudy and test chemical costs ($2.0 million) and increased R&D expenditures in India
($2.0 million).
Selling and Marketing Expenses
Selling and marketing expenses consist mainly of personnel costs, facilities costs, insurance
and professional services costs.
Generic segment selling and marketing expenses were $14.0 million in the three months ended
September 30, 2008 compared to $14.0 million in the prior year period.
Brand Segment
Net Revenues
Our Brand segment develops, manufactures, markets, sells and distributes products within two
sales and marketing groups: Specialty Products and Nephrology.
Our Specialty Products product line includes urology products such as Trelstar® and Oxytrol®
and a number of non-promoted products.
Our Nephrology product line consists of products for the treatment of iron deficiency anemia
and is generally marketed to nephrologists and dialysis centers. The major products of the
Nephrology group are Ferrlecit® and
INFeD®, which are used to treat low iron levels in patients undergoing hemodialysis in
conjunction with erythropoietin therapy.
- 23 -
Other revenue in the Brand segment consists primarily of co-promotion revenue, royalties and
the recognition of deferred revenue relating to our obligation to manufacture and supply brand
products to third parties. Other revenue also includes revenue recognized from R&D and licensing
agreements.
Net revenues from our Brand segment for the three months ended September 30, 2008 decreased
1.1% or $1.1 million to $106.0 million compared to net revenues of $107.1 million in the prior year
period. The decrease was primarily attributable to a decrease in product revenue, royalties and
deferred revenue relating to our obligation to manufacture and supply certain brand products to
third parties ($3.8 million) which was partially offset by higher sales within the Specialty
Products group.
Gross Profit (Gross Margin)
Gross profit for our Brand segment decreased $9.3 million to $75.8 million in the three months
ended September 30, 2008 compared to $85.0 million in the prior year period. Gross margin decreased
to 71.5% during the three months ended September 30, 2008 compared to 79.4% in the prior year
period. The decrease in gross profit and gross margin was primarily due to the recording of a $7.7
million reserve against inventory for INFeD® pending the resolution of potential quality issues
with certain batches of active pharmaceutical ingredient received from a supplier.
Research and Development Expenses
Brand segment R&D expenses consist predominantly of personnel-related costs, contract
research, clinical costs and facilities costs associated with the development of our products.
Brand segment R&D expenses increased 49.3% or $4.5 million to $13.6 million in the three
months ended September 30, 2008 compared to $9.1 million in the prior year period primarily due to
higher license and filing fees ($2.3 million) and increased clinical study costs ($0.7 million)
related to the development of RAPAFLOTM (silodosin) and oxybutynin topical gel and
higher labor costs.
Selling and Marketing Expenses
Brand segment selling and marketing expenses consist mainly of personnel-related costs,
product promotion costs, distribution costs, professional services costs, insurance and
depreciation.
Brand segment selling and marketing expenses increased 9.1% or $2.4 million to $29.0 million
in the three months ended September 30, 2008 as compared to $26.6 million in the prior year period
primarily related to expenditures to support pre-launch activities related to RAPAFLOTM
and oxybutynin topical gel.
Distribution Segment
Net Revenues
Our Distribution segment mainly distributes generic pharmaceutical products manufactured by
third parties, as well as by Watson, primarily to independent pharmacies, pharmacy chains, pharmacy
buying groups and physicians offices. Sales are principally generated through an in-house
telemarketing staff and through internally developed ordering systems. The Distribution segment
operating results exclude Watson products, which are included in their respective Generic and Brand
segment results.
Net revenues from our Distribution segment for the three months ended September 30, 2008
increased 31.6% or $41.1 million to $170.9 million compared to net revenues of $129.9 million in
the prior year period primarily due to an increase in net revenues from new products launched since
the third quarter of 2007 ($56.4 million) which was partially offset by lower levels of sales in
the current period from 2007 product launches ($5.8 million) and reduced net revenues due to price
erosion.
- 24 -
Gross Profit (Gross Margin)
Gross profit for our Distribution segment increased $10.4 million to $26.9 million in the
three months ended September 30, 2008 compared to $16.5 million in the prior year period primarily
due to higher product sales. Gross margin increased to 15.7% during the three months ended
September 30, 2008 compared to 12.7% in the prior year period primarily due to lower product
acquisition costs.
Selling and Marketing Expenses
Selling and marketing expenses consist mainly of personnel costs, facilities costs, insurance
and freight costs, which support the Distribution segment sales and marketing functions.
Distribution segment selling and marketing expenses increased 22.3% or $2.8 million to $15.6
million in the three months ended September 30, 2008 as compared to $12.7 million in the prior
year period primarily due to higher freight costs related to the increased level of net revenues
and higher fuel surcharges ($1.6 million) and higher commissions ($0.6 million) on the increased
level of net revenues.
Segment Contribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Change |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
Dollars |
|
|
% |
|
Segment contribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic |
|
$ |
105,690 |
|
|
$ |
106,216 |
|
|
$ |
(526 |
) |
|
|
(0.5 |
)% |
Brand |
|
|
33,141 |
|
|
|
49,307 |
|
|
|
(16,166 |
) |
|
|
(32.8 |
)% |
Distribution |
|
|
11,311 |
|
|
|
3,759 |
|
|
|
7,552 |
|
|
|
200.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
150,142 |
|
|
$ |
159,282 |
|
|
$ |
(9,140 |
) |
|
|
(5.7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
as a % of net revenues |
|
|
23.4 |
% |
|
|
26.8 |
% |
|
|
|
|
|
|
|
|
For more information on segment contribution, refer to above Managements Discussion and
Analysis of Financial Condition and Results of Operations.
Corporate General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Corporate general and
administrative expenses |
|
$ |
42,697 |
|
|
$ |
59,144 |
|
|
$ |
(16,447 |
) |
|
|
(27.8 |
)% |
as a % of net revenues |
|
|
6.7 |
% |
|
|
9.9 |
% |
|
|
|
|
|
|
|
|
Corporate general and administrative expenses consist mainly of personnel costs, facilities
costs, insurance and professional services costs, which are general in nature and not directly
related to specific segment operations.
Corporate general and administrative expenses decreased during the three months ended
September 30, 2008 as compared to the same period of the prior year as a result of a
favorable settlement of a tax-related liability due to the resolution of the Internal Revenue
Service (IRS) audit for the Companys 2000 to 2003 tax years ($5.9 million) in the current
year period. In addition, the prior year period was negatively impacted by higher levels of
legal accruals ($8.5 million) and severance accruals ($4.5 million).
- 25 -
Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Amortization |
|
$ |
20,200 |
|
|
$ |
44,159 |
|
|
$ |
(23,959 |
) |
|
|
(54.3 |
)% |
as a % of net revenues |
|
|
3.2 |
% |
|
|
7.4 |
% |
|
|
|
|
|
|
|
|
The Companys amortizable assets consist primarily of acquired product rights. For the three
months ended September 30, 2008 amortization expense decreased 54.3% or $24.0 million as our
Ferrlecit® product rights were fully amortized as of December 2007.
Loss (Gain) on Asset Sales and Impairments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Loss (gain) on asset sales and
impairments |
|
$ |
303 |
|
|
$ |
(6,118 |
) |
|
$ |
6,421 |
|
|
|
(105.0 |
)% |
as a % of net revenues |
|
|
0.0 |
% |
|
|
(1.0 |
)% |
|
|
|
|
|
|
|
|
For the three months ended September 30, 2007, we recorded a gain on sale of our Phoenix
facility in the amount of $10.6 million and also recorded an additional impairment of our Puerto
Rico facility in the amount of $4.5 million. For the three months ended September 30, 2008, we
recorded a loss on disposal of idle property, plant and equipment related to our current and former
manufacturing facilities in Florida and Puerto Rico.
Interest Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Interest income |
|
$ |
2,157 |
|
|
$ |
1,964 |
|
|
$ |
193 |
|
|
|
9.8 |
% |
as a % of net revenues |
|
|
0.3 |
% |
|
|
0.3 |
% |
|
|
|
|
|
|
|
|
Interest income increased for the three months ended September 30, 2008 due to an increase in
invested cash balances over the prior year period.
- 26 -
Interest Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Change |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
Dollars |
|
|
% |
|
Interest expense 2006 Credit Facility |
|
$ |
3,709 |
|
|
$ |
6,889 |
|
|
$ |
(3,180 |
) |
|
|
|
|
Interest expense convertible contingent
senior debentures due 2023 (CODES) |
|
|
3,151 |
|
|
|
3,151 |
|
|
|
|
|
|
|
|
|
Change in derivative value |
|
|
|
|
|
|
(103 |
) |
|
|
103 |
|
|
|
|
|
Interest expense other |
|
|
145 |
|
|
|
188 |
|
|
|
(43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,005 |
|
|
$ |
10,125 |
|
|
$ |
(3,120 |
) |
|
|
(30.8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
as a % of net revenues |
|
|
1.1 |
% |
|
|
1.7 |
% |
|
|
|
|
|
|
|
|
Interest expense decreased for the three months ended September 30, 2008 primarily due to
reduced levels of debt on the 2006 Credit Facility from prepayments made during the fourth quarter
of 2007 and the first quarter of 2008.
Other Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Change |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
Dollars |
|
|
% |
|
Earnings on equity method investments |
|
$ |
3,733 |
|
|
$ |
1,686 |
|
|
$ |
2,047 |
|
|
|
121.4 |
% |
Gain on sale of securities |
|
|
8,250 |
|
|
|
|
|
|
|
8,250 |
|
|
|
N/A |
|
Other expense |
|
|
(41 |
) |
|
|
(237 |
) |
|
|
196 |
|
|
|
(82.7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
11,942 |
|
|
$ |
1,449 |
|
|
$ |
10,493 |
|
|
|
724.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
as a % of net revenues |
|
|
1.9 |
% |
|
|
0.2 |
% |
|
|
|
|
|
|
|
|
Earnings on Equity Method Investments
The Companys equity investments are accounted for under the equity method when the Companys
ownership does not exceed 50% and when the Company can exert significant influence over the
management of the investee.
Earnings on equity method investments during the three months ended September 30, 2008
primarily represents our share of equity earnings in Scinopharm Taiwan, Ltd. (Scinopharm).
Earnings on equity method investments for the three months ended September 30, 2007 primarily
represented our share of earnings in Somerset Pharmaceuticals, Inc. (Somerset), our joint
venture with Mylan Inc. (Mylan).
Gain on Sale of Securities
On July 28, 2008 the Company sold its fifty percent interest in Somerset to Mylan.
- 27 -
Provision for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Provision for income taxes |
|
$ |
22,975 |
|
|
$ |
20,779 |
|
|
$ |
2,196 |
|
|
|
10.6 |
% |
Effective tax rate |
|
|
24.4 |
% |
|
|
37.5 |
% |
|
|
|
|
|
|
|
|
The lower effective tax rate for the three months ended September 30, 2008, as compared to
the same period of the prior year, is primarily due to the resolution
of the Companys federal income tax return examination
(theExam) with the IRS for the years ended December 31, 2000 to 2003 (8.8%)
and a tax benefit related to the sale of Somerset (4.3%).
Nine Months Ended September 30, 2008 Compared to Nine Months Ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2008 |
|
|
Nine Months Ended September 30, 2007 |
|
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
Product sales |
|
$ |
1,038,938 |
|
|
$ |
294,756 |
|
|
$ |
443,822 |
|
|
$ |
1,777,516 |
|
|
$ |
1,065,152 |
|
|
$ |
281,096 |
|
|
$ |
421,946 |
|
|
$ |
1,768,194 |
|
Other |
|
|
68,249 |
|
|
|
44,511 |
|
|
|
|
|
|
|
112,760 |
|
|
|
62,834 |
|
|
|
38,288 |
|
|
|
|
|
|
|
101,122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
1,107,187 |
|
|
|
339,267 |
|
|
|
443,822 |
|
|
|
1,890,276 |
|
|
|
1,127,986 |
|
|
|
319,384 |
|
|
|
421,946 |
|
|
|
1,869,316 |
|
Cost of sales(1) |
|
|
669,676 |
|
|
|
82,167 |
|
|
|
374,812 |
|
|
|
1,126,655 |
|
|
|
693,896 |
|
|
|
74,099 |
|
|
|
363,583 |
|
|
|
1,131,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit(1) |
|
|
437,511 |
|
|
|
257,100 |
|
|
|
69,010 |
|
|
|
763,621 |
|
|
|
434,090 |
|
|
|
245,285 |
|
|
|
58,363 |
|
|
|
737,738 |
|
Gross margin(1) |
|
|
39.5 |
% |
|
|
75.8 |
% |
|
|
15.5 |
% |
|
|
40.4 |
% |
|
|
38.5 |
% |
|
|
76.8 |
% |
|
|
13.8 |
% |
|
|
39.5 |
% |
Research and
development |
|
|
83,458 |
|
|
|
39,095 |
|
|
|
|
|
|
|
122,553 |
|
|
|
77,036 |
|
|
|
31,932 |
|
|
|
|
|
|
|
108,968 |
|
Selling and
marketing |
|
|
41,868 |
|
|
|
86,593 |
|
|
|
43,695 |
|
|
|
172,156 |
|
|
|
41,764 |
|
|
|
79,397 |
|
|
|
39,246 |
|
|
|
160,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contribution |
|
$ |
312,185 |
|
|
$ |
131,412 |
|
|
$ |
25,315 |
|
|
|
468,912 |
|
|
$ |
315,290 |
|
|
$ |
133,956 |
|
|
$ |
19,117 |
|
|
|
468,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contibution margin |
|
|
28.2 |
% |
|
|
38.7 |
% |
|
|
5.7 |
% |
|
|
24.8 |
% |
|
|
28.0 |
% |
|
|
41.9 |
% |
|
|
4.5 |
% |
|
|
25.1 |
% |
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
140,041 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
152,460 |
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60,569 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
132,251 |
|
Loss (gain) on asset sales and impairments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
267,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
189,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.2 |
% |
|
|
|
(1) |
|
Excludes amortization of acquired intangibles including product rights. |
Generic Segment
Net Revenues
Net revenues from our Generic segment for the nine months ended September 30, 2008 decreased
1.8% or $20.8 million to $1,107.2 million compared to net revenues of $1,128.0 million from the
prior year period. Sales of certain Authorized Generics declined $49.0 million to $54.1 million
compared to $103.1 million from the prior year period. Sales of Authorized Generics in the prior
year period included oxycodone HCl controlled release
- 28 -
tablets and pravastatin sodium tablets.
Sales of Authorized Generics in the current year period included TiliaTM Fe and
balsalazide disodium (both launched in the fourth quarter of 2007), alendronate sodium tablets
(launched in the first quarter of 2008), dronabinol (launched in the second quarter of 2008) and
pravastatin sodium tablets. In addition, net revenues from the sale of oral contraceptives
(excluding TiliaTM Fe) declined $30.3 million and price erosion within our base business
resulted in lower net revenues compared to the prior year period. The decrease in net product
sales was partially offset by an increase in net revenues from other new product launches ($93.1
million), including fentanyl transdermal patch (launched at the end of the third quarter of 2007),
albuterol sulfate (launched in the fourth quarter of 2007), clarithromycin extended-release tablets
(launched in the first quarter of 2008) and omeprazole
delayed-release capsules 40 mg (launched in the
third quarter of 2008) and an increase in other revenue ($5.4 million).
Gross Profit
Gross profit for our Generic segment increased $3.4 million to $437.5 million in the nine
months ended September 30, 2008 compared to $434.1 million in the prior year period. Gross profit
was higher in the current year period due to gross profit contribution from new product launches
($59.1 million) including fentanyl transdermal patch, albuterol sulfate, clarithromycin and
omeprazole and higher other revenue ($5.4 million). The prior year period was also negatively
impacted by $6.6 million of excess capacity utilization charges from our Puerto Rico and Phoenix
facilities. Our Puerto Rico manufacturing facility was closed in the first quarter of 2007 and our
Phoenix manufacturing facility was closed in the second quarter of 2007. These increases to gross
profit in the current year period were partially offset by lower gross profit contribution from
certain Authorized Generics ($16.7 million), lower gross profit contribution from oral
contraceptives (excluding TiliaTM Fe) ($25.0 million) and costs associated with our
Global Supply Chain Initiative ($22.0 million).
Research and Development Expenses
Generic segment R&D expenses increased 8.3% or $6.4 million to $83.5 million in the nine
months ended September 30, 2008 compared to $77.0 million in the prior year period due to higher
pre-launch validation costs ($4.0 million), increased R&D expenditures in India ($3.0 million),
higher facility costs ($3.0 million) and costs associated with our Global Supply Chain Initiative
($0.8 million) which were partly offset in part by lower biostudy costs ($4.0 million).
Selling and Marketing Expenses
Generic segment selling and marketing expenses were $41.9 million in the nine months ended
September 30, 2008 compared to $41.8 million in the prior year period.
Brand Segment
Net Revenues
Net revenues from our Brand segment for the nine months ended September 30, 2008 increased
6.2% or $19.9 million to $339.3 million compared to net revenues of $319.4 million in the prior
year period. The increase was primarily attributable to higher other revenues ($6.2 million),
higher sales within the Specialty Products group ($8.8 million) and higher sales within the
Nephrology group ($4.8 million). The increase in the Specialty Products group was primarily
attributable to higher unit sales of Trelstar® as a result of promotional efforts and the
introduction of the MixjectTM delivery system. The increase within the Nephrology
group was primarily attributable to customer buying patterns and lower sales in the prior year
period due to the loss of a customer.
- 29 -
Gross Profit (Gross Margin)
Gross profit for our Brand segment increased $11.8 million to $257.1 million in the nine
months ended September 30, 2008 compared to $245.3 million in the prior year period. The increase
in gross profit was primarily due to an increase in other revenues ($6.2 million) and higher
product sales within both the Specialty Products group and the Nephrology group partially offset
by a $7.7 million inventory reserve for INFeD® pending the resolution of potential quality issues
with certain batches of active pharmaceutical ingredient received from a supplier.
Gross margins for our Brand segment decreased to 75.8% during the nine months ended September
30, 2008 from 76.8% in the prior year period primarily due to the impact of the $7.7 million
inventory reserve recorded in the current period which was partially offset by an increase in
other revenues and favorable changes to product mix during the current year period.
Research and Development Expenses
Brand segment R&D expenses increased 22.4% or $7.2 million to $39.1 million in the nine
months ended September 30, 2008 compared to $31.9 million in the prior year period primarily due
to higher license and filing fees ($9.1 million), higher payroll costs ($1.6 million) which was
partially offset by reduced clinical study costs during the current period related to the
development of RAPAFLOTM and oxybutynin topical gel ($4.9 million).
Selling and Marketing Expenses
Brand segment selling and marketing expenses increased 9.1% or $7.2 million to $86.6 million
in the nine months ended September 30, 2008 as compared to $79.4 million in the prior year period
primarily related to expenditures in the current year period to support pre-launch activities
related to RAPAFLOTM and oxybutynin topical gel.
Distribution Segment
Net Revenues
Net revenues from our Distribution segment for the nine months ended September 30, 2008
increased 5.2% or $21.9 million to $443.8 million compared to net revenues of $421.9 million in
the prior year period primarily due to an increase in net revenues from new products launched
since the third quarter of 2007 ($108.7 million) which was partially offset by lower levels of net
revenues in the current period from 2007 product launches ($28.3 million) and reduced net revenue
levels in the current year period due to reduced volume and price erosion ($58.0 million).
Gross Profit (Gross Margin)
Gross profit for our Distribution segment increased to $69.0 million in the nine months ended
September 30, 2008 compared to $58.4 million in the prior year period. Distribution segment gross
profit improved in the current year period due to higher product sales and due to the prior year
period being negatively impacted by a $2.5 million acquisition-related inventory charge and a $2.0
million product-related inventory charge.
Gross margins also improved for our Distribution segment increasing to 15.6% during the nine
months ended September 30, 2008 from 13.8% in the prior year period due to lower product
acquisition costs in the current period and due to the prior year period being negatively impacted
by inventory charges totaling $4.5 million.
- 30 -
Selling and Marketing Expenses
Distribution segment selling and marketing expenses increased 11.3% or $4.4 million to $43.7
million in the nine months ended September 30, 2008 as compared to $39.2 million in the prior year
period primarily related to higher fuel surcharges ($2.6 million) and higher commissions and other
selling expenses on the increased level of net revenues ($1.2 million).
Segment Contribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
Change |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
Dollars |
|
|
% |
|
Segment contribution |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic |
|
$ |
312,185 |
|
|
$ |
315,290 |
|
|
$ |
(3,105 |
) |
|
|
(1.0 |
)% |
Brand |
|
|
131,412 |
|
|
|
133,956 |
|
|
|
(2,544 |
) |
|
|
(1.9 |
)% |
Distribution |
|
|
25,315 |
|
|
|
19,117 |
|
|
|
6,198 |
|
|
|
32.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
468,912 |
|
|
$ |
468,363 |
|
|
$ |
549 |
|
|
|
0.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
as a % of net revenues |
|
|
24.8 |
% |
|
|
25.1 |
% |
|
|
|
|
|
|
|
|
For more information on segment contribution, refer to above Managements Discussion and
Analysis of Financial Condition and Results of Operations.
Corporate General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Corporate general and administrative expenses |
|
$ |
140,041 |
|
|
$ |
152,460 |
|
|
$ |
(12,419 |
) |
|
|
(8.1 |
)% |
as a % of net revenues |
|
|
7.4 |
% |
|
|
8.2 |
% |
|
|
|
|
|
|
|
|
Corporate general and administrative expenses decreased during the nine months ended
September 30, 2008 as compared to the same period of the prior year due to a favorable tax-related adjustment of a liability due to the settlement of an IRS audit during
the current year period ($5.9 million) which was partially offset by an increase in costs
incurred in the implementation of a new enterprise resource planning
system at certain sites. In addition, the prior year period was
negatively impacted by higher levels of legal accruals ($8.6 million)
and severance accruals ($4.5 million).
Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Amortization |
|
$ |
60,569 |
|
|
$ |
132,251 |
|
|
$ |
(71,682 |
) |
|
|
(54.2 |
)% |
as a % of net revenues |
|
|
3.2 |
% |
|
|
7.1 |
% |
|
|
|
|
|
|
|
|
For the nine months ended September 30, 2008 amortization expense decreased 54.2% or $71.7
million as our Ferrlecit® product rights were fully amortized as of December 2007.
- 31 -
Loss (Gain) on Asset Sales and Impairments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Loss (gain) on asset sales and
impairments |
|
$ |
303 |
|
|
$ |
(6,118 |
) |
|
$ |
6,421 |
|
|
|
(105.0 |
)% |
as a % of net revenues |
|
|
0.0 |
% |
|
|
(1.0 |
)% |
|
|
|
|
|
|
|
|
For the nine months ended September 30, 2007, we recorded a gain on sale of our Phoenix
facility in the amount of $10.6 million and also recorded an additional impairment of our Puerto
Rico facility in the amount of $4.5 million. For the nine months ended September 30, 2008, we
recorded a loss on disposal of idle property, plant and equipment related to our current and former
manufacturing facilities in Florida and Puerto Rico.
Loss on Early Extinguishment of Debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Loss on early extinguishment
of debt |
|
$ |
1,095 |
|
|
$ |
4,410 |
|
|
$ |
(3,315 |
) |
|
|
(75.2 |
)% |
as a % of net revenues |
|
|
0.1 |
% |
|
|
0.2 |
% |
|
|
|
|
|
|
|
|
During the nine months ended September 30, 2008, the Company prepaid $75.0 million of
outstanding debt on the 2006 Credit Facility. As a result of this prepayment, our results for the
nine months ended September 30, 2008 reflect debt repurchase charges of $1.1 million representing
unamortized debt issue costs associated with the repurchased amount.
During the nine months ended September 30, 2007, the Company prepaid $250.0 million on the
2006 Credit Facility. As a result of this prepayment, our results for the nine months ended
September 30, 2007 reflect a $4.4 million charge for debt repurchase charges.
Interest Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Interest income |
|
$ |
6,151 |
|
|
$ |
6,696 |
|
|
$ |
(545 |
) |
|
|
(8.1 |
)% |
as a % of net revenues |
|
|
0.3 |
% |
|
|
0.4 |
% |
|
|
|
|
|
|
|
|
Interest income decreased for the nine months ended September 30, 2008 due to a decrease in
interest rates over the prior year period.
- 32 -
Interest Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
Change |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
Dollars |
|
|
% |
|
Interest expense 2006 Credit Facility |
|
$ |
11,319 |
|
|
$ |
25,339 |
|
|
$ |
(14,020 |
) |
|
|
|
|
Interest expense CODES |
|
|
9,453 |
|
|
|
9,453 |
|
|
|
|
|
|
|
|
|
Change in derivative value |
|
|
(3 |
) |
|
|
15 |
|
|
|
(18 |
) |
|
|
|
|
Interest expense other |
|
|
(37 |
) |
|
|
669 |
|
|
|
(706 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
20,732 |
|
|
$ |
35,476 |
|
|
$ |
(14,744 |
) |
|
|
(41.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
as a % of net revenues |
|
|
1.1 |
% |
|
|
1.9 |
% |
|
|
|
|
|
|
|
|
Interest expense decreased for the nine months ended September 30, 2008 primarily due to
reduced levels of debt on the 2006 Credit Facility from prepayments made during 2007 and the first
quarter of 2008.
Other Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
Change |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
Dollars |
|
|
% |
|
Earnings on equity method investments |
|
$ |
9,561 |
|
|
$ |
5,409 |
|
|
$ |
4,152 |
|
|
|
76.8 |
% |
Gain on sale of securities |
|
|
9,605 |
|
|
|
2,472 |
|
|
|
7,133 |
|
|
|
288.6 |
% |
Other income |
|
|
209 |
|
|
|
5 |
|
|
|
204 |
|
|
|
4080.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
19,375 |
|
|
$ |
7,886 |
|
|
$ |
11,489 |
|
|
|
145.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
as a % of net revenues |
|
|
1.0 |
% |
|
|
0.4 |
% |
|
|
|
|
|
|
|
|
Earnings on Equity Method Investments
The increase in earnings on equity method investments during the nine months ended September
30, 2008 primarily represents our share of equity earnings in Scinopharm. Scinopharm results for
the nine months ended September 30, 2008 increased over the prior year period due to new product
launches during 2008. Earnings on equity method investments for the nine months ended September
30, 2007 primarily represented our share of earnings in Somerset.
Gain on Sale of Securities
The 2008 gain on sale of securities primarily related to the Companys sale of our fifty
percent interest in Somerset to Mylan. The 2007 gain on sale of securities resulted from the sale
of our investment in Adheris, Inc. Contingencies were removed relating to additional
consideration on the Companys sale of its investment in Adheris, Inc. Accordingly, the Company
received common shares of inVentiv Health, Inc. and cash as proceeds on its sale of our investment
in Adheris, Inc.
- 33 -
Provision for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
Provision for income taxes |
|
$ |
89,705 |
|
|
$ |
61,839 |
|
|
$ |
27,866 |
|
|
|
45.1 |
% |
Effective tax rate |
|
|
33.0 |
% |
|
|
37.6 |
% |
|
|
|
|
|
|
|
|
The lower effective tax rate for the nine months ended September 30, 2008, as compared to the
same period of the prior year, is primarily due to the tax benefit related to the resolution of
the Companys Exam with the IRS for the years ended December 31, 2000 to 2003 (3.1%) and a tax
benefit related to the sale of Somerset (1.5%).
Liquidity and Capital Resources
Working Capital Position
Working capital at September 30, 2008 and December 31, 2007 is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
Increase |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
339,354 |
|
|
$ |
204,554 |
|
|
$ |
134,800 |
|
Marketable securities |
|
|
12,683 |
|
|
|
11,799 |
|
|
|
884 |
|
Accounts receivable, net of allowances |
|
|
314,475 |
|
|
|
267,117 |
|
|
|
47,358 |
|
Inventories |
|
|
481,559 |
|
|
|
490,601 |
|
|
|
(9,042 |
) |
Other |
|
|
175,194 |
|
|
|
199,705 |
|
|
|
(24,511 |
) |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
1,323,265 |
|
|
|
1,173,776 |
|
|
|
149,489 |
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
353,745 |
|
|
|
398,154 |
|
|
|
(44,409 |
) |
Income taxes payable |
|
|
777 |
|
|
|
|
|
|
|
777 |
|
Current portion of long-term debt |
|
|
3,217 |
|
|
|
6,241 |
|
|
|
(3,024 |
) |
Other |
|
|
40,361 |
|
|
|
40,532 |
|
|
|
(171 |
) |
|
|
|
|
|
|
|
|
|
|
Total
current liabilities |
|
|
398,100 |
|
|
|
444,927 |
|
|
|
(46,827 |
) |
|
|
|
|
|
|
|
|
|
|
Working Capital |
|
$ |
925,165 |
|
|
$ |
728,849 |
|
|
$ |
196,316 |
|
|
|
|
|
|
|
|
|
|
|
Current Ratio |
|
|
3.32 |
|
|
|
2.64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Watsons primary source of liquidity is cash from operations. Net working capital at
September 30, 2008 was $925.2 million, compared to $728.8 million at December 31, 2007.
We expect that 2008 cash flows from operating activities will continue to exceed net income.
In addition, management expects that 2008 cash flows from operating activities and available cash
balances will be sufficient to fund our operating liquidity needs.
- 34 -
Cash Flows from Operations
Summarized cash flows from operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, |
($ in thousands): |
|
2008 |
|
2007 |
Net cash provided by operating activities
|
|
$ |
240,222 |
|
|
$ |
255,725 |
|
Cash flows from operations represents net income adjusted for certain operations related
non-cash items and changes in certain assets and liabilities. For the nine months ended September
30, 2008, cash provided by operating activities was $240.2 million, compared to $255.7 million in
the nine months ended September 30, 2007. The Company has generated cash flows from operating
activities primarily driven by net income adjusted for amortization of our acquired product rights
and depreciation. Net cash provided by operations was lower in the nine months ended September
30, 2008 compared to the nine months ended September 30, 2007 primarily due to the higher
contribution from net changes in non-cash working capital balances in the 2007 period compared to
the 2008 period.
Investing Cash Flows
Our cash flows from investing activities are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, |
($ in thousands): |
|
2008 |
|
2007 |
Net cash used in investing activities
|
|
$ |
35,272 |
|
|
$ |
38,757 |
|
Investing cash flows consist primarily of expenditures related to additions to property and
equipment, investment and marketable security additions as well as proceeds from the sale of
property, plant and equipment, investments and marketable securities. Net cash used in investing
activities for the nine months ended September 30, 2008 was lower than 2007 levels due primarily
to lower capital expenditures in 2008 as the 2007 period included the completion of certain
projects at our newly acquired Florida facility. Lower comparative capital expenditure levels in
2008 were partially offset by higher proceeds from the sale of investments and property, plant and
equipment during the 2007 period.
Financing Cash Flows
Our cash flows from financing activities are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, |
($ in thousands): |
|
2008 |
|
2007 |
Net cash used in financing activities
|
|
$ |
70,150 |
|
|
$ |
237,791 |
|
Financing cash flows consist primarily of borrowings and repayments of debt, repurchases of
common stock and proceeds from exercising of stock options. For the nine months ended September
30, 2008, net cash used in financing activities was $70.2 million compared to $237.8 million used
in financing activities during the nine
months ended September 30, 2007. Prepayments of the 2006 Credit Facility for the nine months
ended September 30, 2008 were $75.0 million compared to $250.0 million in the prior year period.
- 35 -
Debt and Borrowing Capacity
Our outstanding debt obligations are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
Increase |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
Current portion of long-term debt |
|
$ |
3,217 |
|
|
$ |
6,241 |
|
|
$ |
(3,024 |
) |
Long-term debt |
|
|
824,609 |
|
|
|
899,408 |
|
|
|
(74,799 |
) |
|
|
|
|
|
|
|
|
|
|
Total debt |
|
$ |
827,826 |
|
|
$ |
905,649 |
|
|
$ |
(77,823 |
) |
|
|
|
|
|
|
|
|
|
|
Debt to capital ratio |
|
|
28.8 |
% |
|
|
32.9 |
% |
|
|
|
|
During the nine months ended September 30, 2008, we prepaid $75.0 million of the amount
outstanding under the term loan facility of the 2006 Credit Facility. As a result of this
prepayment, our results for the nine months ended September 30, 2008 reflect a $1.1 million charge
for losses on early extinguishment of debt. No principal payments are required on the term loan
facility in 2008. As of September 30, 2008, we had not drawn any funds from the revolving credit
facility of the 2006 Credit Facility and $250.0 million was outstanding on the term loan facility.
The full amount outstanding on the 2006 Credit Facility is due November 2011.
Under the terms of the 2006 Credit Facility, each of our subsidiaries, other than minor
subsidiaries, entered into a full and unconditional guarantee on a joint and several basis. We
are subject to, and, as of September 30, 2008, were in compliance with financial and operation
covenants under the terms of the 2006 Credit Facility. The agreement currently contains the
following financial covenants:
|
|
|
maintenance of a minimum net worth of at least $1.48 billion; |
|
|
|
|
maintenance of a maximum leverage ratio not greater than 3.0 to 1.0; and |
|
|
|
|
maintenance of a minimum interest coverage ratio of at least 5.0 to 1.0. |
At September 30, 2008, our net worth was $2.05 billion, and our leverage ratio was 1.48 to
1.0. Our interest coverage ratio for the nine months ended September 30, 2008 was 18.9 to 1.0.
Under the 2006 Credit Facility, interest coverage ratio, with respect to any financial
covenant period, is defined as the ratio of EBITDA for such period to interest expense for such
period. The leverage ratio, for any financial covenant period, is defined as the ratio of the
outstanding principal amount of funded debt for the borrower and its subsidiaries at the end of
such period, to EBITDA for such period. EBITDA under the 2006 Credit Facility, for any covenant
period, is defined as net income plus (1) depreciation and amortization, (2) interest expense, (3)
provision for income taxes, (4) extraordinary or unusual losses, (5) non-cash portion of
nonrecurring losses and charges, (6) other non-operating, non-cash losses, (7) minority interest
expense in respect of equity holdings in affiliates, (8) non-cash expenses relating to stock-based
compensation expense and (9) any one-time charges related to the Andrx Acquisition; minus (1)
extraordinary gains, (2) interest income and (3) other non-operating, non-cash income.
Long-term Obligations
At September 30, 2008, there have been no material changes in the Companys enforceable and
legally binding obligations, contractual obligations and commitments from those disclosed in our
Annual Report on Form 10-K for the period ended December 31, 2007.
- 36 -
Recent accounting pronouncements
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 157, Fair-Value Measurements, (SFAS 157) which
defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles and expands disclosures about fair-value measurements. The Company adopted
SFAS 157 effective January 1, 2008 for all financial assets and liabilities and any other assets
and liabilities that are recognized or disclosed at fair value on a recurring basis (refer to NOTE
10 FAIR VALUE MEASUREMENT in the accompanying Notes to Condensed Consolidated Financial
Statements in this Quarterly Report). For nonfinancial assets and liabilities measured at fair
value on a non-recurring basis, SFAS 157 is effective for financial statements issued for fiscal
years beginning after November 15, 2008. The Company is currently reviewing the application of
SFAS 157 for nonfinancial assets and liabilities measured at fair value on a non-recurring basis
and has not yet determined how the adoption of SFAS 157 will impact its condensed consolidated
financial statements.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities Including an Amendment of FASB Statement No. 115, (SFAS 159) which
is effective for fiscal years beginning after November 15, 2007. SFAS 159 is an elective standard
which permits an entity to choose to measure many financial instruments and certain other items at
fair value at specified election dates. Subsequent unrealized gains and losses on items for which
the fair value option has been elected will be reported in earnings. The Company has not elected
the fair value option of SFAS 159 for any specific assets or liabilities.
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations, (SFAS
141R) which replaces SFAS No. 141, Business Combinations. SFAS 141R establishes principles and
requirements for recognizing and measuring identifiable assets and goodwill acquired, liabilities
assumed and any noncontrolling interest in a business combination at their fair value at
acquisition date. SFAS 141R alters the treatment of acquisition-related costs, business
combinations achieved in stages (referred to as a step acquisition), the treatment of gains from a
bargain purchase, the recognition of contingencies in business combinations, the treatment of
in-process research and development in a business combination as well as the treatment of
recognizable deferred tax benefits. SFAS 141R is effective for business combinations closed in
fiscal years beginning after December 15, 2008. Early adoption is prohibited.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements an amendment of Accounting Research Bulletin No. 51, (SFAS 160). SFAS
160 establishes accounting and reporting standards for the noncontrolling interest (minority
interest) in a subsidiary and for the deconsolidation of a subsidiary. SFAS 160 is effective for
financial statements issued for fiscal years beginning after December 15, 2008. Early adoption is
prohibited. The Company currently has no minority interests and therefore expects the adoption of
SFAS 160 will not have a material impact on its consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities, an amendment of FASB Statement No. 133, (SFAS 161). SFAS 161 requires
enhanced disclosures about a companys derivative and hedging activities. SFAS 161 is effective
for financial statements issued for fiscal years beginning after December 15, 2008. The Company is
currently evaluating the impact of the adoption of the enhanced disclosures requirements of SFAS
161 and does not expect the adoption to have a material impact on its consolidated financial
statements.
In April 2008, the FASB issued FASB Staff Position (FSP) No. FAS 142-3, Determination of
the Useful Life of Intangible Assets, (FSP 142-3). FSP 142-3 amends the factors that should be
considered in developing renewal or extension assumptions used to determine the useful life of a
recognized intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets and also
requires expanded disclosure related to the determination of intangible asset useful lives. FSP
142-3 is effective for fiscal years beginning after December 15, 2008. Early adoption is
prohibited. The Company is currently evaluating the impact the adoption of FSP 142-3 will have on
its consolidated financial statements.
- 37 -
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
We are exposed to market risk for changes in the market values of our investments
(Investment Risk) and the impact of interest rate changes (Interest Rate Risk). We have not
used derivative financial instruments in our investment portfolio. The quantitative and
qualitative disclosures about market risk are set forth below.
Investment Risk
As of September 30, 2008, our total holdings in equity securities of other companies,
including equity-method investments and available-for-sale securities, were $61.2 million. Of
this amount, we had equity-method investments of $59.4 million and publicly traded equity
securities (available-for-sale securities) at fair value totaling $1.5 million (included in
marketable securities and investments and other assets). The fair values of these investments are
subject to significant fluctuations due to volatility of the stock market and changes in general
economic conditions. Based on the fair value of the publicly traded equity securities we held at
September 30, 2008, an assumed 25%, 40% and 50% adverse change in the market prices of these
securities would result in a corresponding decline in total fair value of approximately $0.4
million, $0.6 million and $0.8 million, respectively.
We regularly review the carrying value of our investments and identify and recognize losses,
for income statement purposes, when events and circumstances indicate that any declines in the
fair values of such investments, below our accounting basis, are other than temporary.
Interest Rate Risk
Our exposure to interest rate risk relates primarily to our non-equity investment portfolio
and our floating rate debt. Our cash is invested in A-rated money market mutual funds.
Our portfolio of marketable securities include U.S. Treasury and agency securities classified
as available-for-sale securities, with no security having a maturity in excess of two years. These
securities are exposed to interest rate fluctuations. Because of the short-term nature of these
investments, we are subject to minimal interest rate risk and do not believe an increase in market
rates would have a significant negative impact on the realized value of our portfolio.
During the year ended December 31, 2007, the Company entered into an interest rate swap
derivative to convert floating-rate debt to fixed rate debt on a notional amount of $200.0
million. The interest rate swap instruments involve agreements to receive a floating rate and pay
a fixed rate, at specified intervals, calculated on the agreed-upon notional amount. The
differentials paid or received on interest rate swap agreements are recognized as adjustments to
interest expense in the period. These interest rate swap agreements are set to expire in January
2009. For additional information on our interest rate swap derivatives, refer to NOTE 1GENERAL
in the accompanying Notes to Condensed Consolidated Financial Statements in this Quarterly
Report.
Based on quoted market rates of interest and maturity schedules for similar debt issues, we
estimate that the fair values of our 2006 Credit Facility and our other notes payable approximated
their carrying values on September 30, 2008. As of September 30, 2008, the fair value of our CODES
was $57.1 million less than the carrying value. The fair value of the embedded derivative related
to the CODES and our interest rate swap derivative is based on net present value techniques using
discounted expected future cash flows. While changes in market interest rates may affect the fair
value of our fixed-rate debt, we believe the effect, if any, of reasonably possible near-term
changes in the fair value of such debt on our financial condition, results of operations or cash
flows will not be material.
At this time, we have no material foreign exchange or commodity price risks.
- 38 -
We do not believe that inflation has had a significant impact on our revenues or operations.
ITEM 4. CONTROLS AND PROCEDURES
The Company maintains disclosure controls and procedures that are designed to ensure that
information required to be disclosed in the Companys Exchange Act reports is recorded, processed,
summarized and reported within the time periods specified in the SECs rules and forms, and that
such information is accumulated and communicated to the Companys management, including its
Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely
decisions regarding required disclosure. In designing and evaluating the disclosure controls and
procedures, management recognized that any controls and procedures, no matter how well designed
and operated, can provide only reasonable assurance of achieving the desired control objectives,
and management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Also, the Company has investments in certain
unconsolidated entities. As the Company does not control or manage these entities, its disclosure
controls and procedures with respect to such entities are necessarily substantially more limited
than those it maintains with respect to its consolidated subsidiaries.
As required by SEC Rule 13a-15(b), the Company carried out an evaluation, under the
supervision and with the participation of the Companys management, including the Companys
Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design
and operation of the Companys disclosure controls and procedures as of the end of the quarter
covered by this Quarterly Report. Based on the foregoing, the Companys Principal Executive
Officer and Principal Financial Officer concluded that the Companys disclosure controls and
procedures were effective.
There have been no changes in the Companys internal control over financial reporting, during
the three months ended September 30, 2008, that has materially affected, or is reasonably likely
to materially affect, the Companys internal control over financial reporting.
- 39 -
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
For information regarding legal proceedings, refer to PART I, ITEM 3. LEGAL PROCEEDINGS, of
our Annual Report on Form 10-K for the year ended December 31, 2007 and Legal Matters in NOTE
11 CONTINGENCIES in the accompanying Notes to Condensed Consolidated Financial Statements in
this Quarterly Report.
ITEM 1A. RISK FACTORS
In addition to the other information set forth in this report, you should carefully consider
the risk factors previously disclosed in Item 1A. to Part 1 of our Annual Report on Form 10-K
for the year ended December 31, 2007. There were no material changes from these risk factors
during the nine months ended September 30, 2008.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(a) Recent Sales of Unregistered Securities
There were no unregistered sales of equity securities.
(b) Use of Proceeds
N/A.
(c) Issuer Purchases of Equity Securities
During the quarter ended September 30, 2008, the Company repurchased approximately
24,000 shares surrendered to the Company to satisfy tax withholding obligations in connection
with the vesting of restricted stock issued to employees for total consideration of $729,000.
ITEM 6. EXHIBITS
(a) Exhibits:
Reference is hereby made to the Exhibit Index on page 42.
- 40 -
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.
|
|
|
|
|
|
|
|
|
|
|
WATSON PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
(Registrant) |
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ Mark W. Durand |
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark W. Durand |
|
|
|
|
|
|
Senior Vice President Chief Financial Officer |
|
|
|
|
|
|
(Principal Financial Officer) |
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ R. Todd Joyce |
|
|
|
|
|
|
|
|
|
|
|
|
|
R. Todd Joyce |
|
|
|
|
|
|
Vice President Corporate Controller and Treasurer |
|
|
|
|
|
|
(Principal Accounting Officer) |
|
|
Date: October 31, 2008
- 41 -
WATSON PHARMACEUTICALS, INC.
EXHIBIT INDEX TO FORM 10-Q
For the Quarterly Period Ended September 30, 2008
|
|
|
Exhibit |
|
|
No. |
|
Description |
|
10.1
|
|
First Amendment to Distribution Agreement between Amphastar
Pharmaceuticals, Inc. and Andrx Pharmaceuticals, Inc. d/b/a Watson
Laboratories Florida dated August 15, 2008. |
|
|
|
10.2
|
|
Amendment to the Arbitration Provisions of the Ferrlecit
Agreements between R&D Ferrlecit Capital Resources, Inc., A.
Nattermann & CIE. GmbH and May & Baker Limited, trading as
sanofi-aventis dated August 25, 2008. |
|
|
|
31.1
|
|
Certification of President and Chief Executive Officer pursuant to
Rule 13a-14a of the Securities Exchange Act of 1934. |
|
|
|
31.2
|
|
Certification of Senior Vice President and Chief Financial Officer
pursuant to Rule 13a-14a of the Securities Exchange Act of 1934. |
|
|
|
32.1
|
|
Certification of President and Chief Executive Officer pursuant to
Rule 13a-14(d) of the Securities Exchange Act of 1934. |
|
|
|
32.2
|
|
Certification of Senior Vice President and Chief Financial Officer
pursuant to Rule 13a-14(d) of the Securities Exchange Act of 1934. |
|
|
|
|
|
Confidential treatment has been requested for portions of this exhibit.
The confidential portions have been separately filed with the Securities and Exchange Commission.
|
- 42 -