e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 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
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95-3872914 |
(State or other jurisdiction of
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(I.R.S. Employer Identification No.) |
incorporation or organization) |
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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
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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 April 30, 2008 was approximately 104,441,000.
WATSON PHARMACEUTICALS, INC.
TABLE OF CONTENTS
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2008
WATSON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited; in thousands)
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March 31, |
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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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$ |
173,998 |
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$ |
204,554 |
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Marketable securities |
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12,711 |
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11,799 |
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Accounts receivable, net |
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273,305 |
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267,117 |
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Inventories |
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521,322 |
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490,601 |
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Prepaid expenses and other current assets |
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69,039 |
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86,072 |
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Deferred tax assets |
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113,252 |
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113,633 |
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Total current assets |
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1,163,627 |
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1,173,776 |
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Property and equipment, net |
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684,507 |
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688,185 |
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Investments and other assets |
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70,512 |
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68,034 |
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Deferred tax assets |
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60,773 |
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61,886 |
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Product rights and other intangibles, net |
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583,776 |
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603,697 |
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Goodwill |
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876,449 |
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876,449 |
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Total assets |
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$ |
3,439,644 |
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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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$ |
376,545 |
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$ |
398,154 |
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Income taxes payable |
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20,006 |
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Short-term debt and current portion of long-term debt |
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2,851 |
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6,241 |
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Current deferred tax liabilities |
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18,709 |
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18,778 |
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Deferred revenue |
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17,610 |
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21,754 |
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Total current liabilities |
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435,721 |
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444,927 |
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Long-term debt |
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824,473 |
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899,408 |
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Deferred revenue |
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35,117 |
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39,535 |
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Other long-term liabilities |
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5,442 |
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7,333 |
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Other taxes payable |
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55,050 |
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52,619 |
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Deferred tax liabilities |
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180,474 |
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178,740 |
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Total liabilities |
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1,536,277 |
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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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375 |
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373 |
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Additional paid-in capital |
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973,134 |
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968,739 |
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Retained earnings |
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1,230,366 |
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1,179,737 |
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Accumulated other comprehensive income |
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1,352 |
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2,392 |
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Treasury stock, at cost |
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(301,860 |
) |
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(301,776 |
) |
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Total stockholders equity |
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1,903,367 |
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1,849,465 |
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Total liabilities and stockholders equity |
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$ |
3,439,644 |
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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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March 31, |
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2008 |
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2007 |
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Net revenues |
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$ |
626,949 |
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$ |
671,605 |
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Cost of sales (excludes amortization, presented below) |
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380,102 |
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424,720 |
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Gross profit |
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246,847 |
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246,885 |
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Operating expenses: |
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Research and development |
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38,015 |
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37,808 |
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Selling and marketing |
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56,080 |
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55,163 |
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General and administrative |
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50,553 |
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48,055 |
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Amortization |
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20,179 |
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43,933 |
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Total operating expenses |
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164,827 |
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184,959 |
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Operating income |
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82,020 |
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61,926 |
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Other income (expense): |
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Loss on early extinguishment of debt |
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(1,095 |
) |
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(2,729 |
) |
Interest income |
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2,309 |
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2,929 |
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Interest expense |
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(6,796 |
) |
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(13,876 |
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Other income |
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5,353 |
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3,403 |
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Total other (expense) income, net |
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(229 |
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(10,273 |
) |
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Income before income taxes |
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81,791 |
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51,653 |
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Provision for income taxes |
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31,162 |
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20,041 |
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Net income |
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$ |
50,629 |
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$ |
31,612 |
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Earnings per share: |
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Basic |
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$ |
0.49 |
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$ |
0.31 |
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Diluted |
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$ |
0.45 |
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$ |
0.29 |
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Weighted average shares outstanding: |
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Basic |
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102,625 |
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101,927 |
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Diluted |
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117,380 |
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116,612 |
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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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Three Months Ended |
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March 31, |
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2008 |
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2007 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net income |
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$ |
50,629 |
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$ |
31,612 |
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Reconciliation to net cash provided by operating activities: |
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Depreciation |
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21,805 |
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18,029 |
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Amortization |
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20,179 |
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43,933 |
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Deferred income tax provision |
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6,443 |
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250 |
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Provision for inventory reserve |
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9,082 |
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11,427 |
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Restricted stock and stock option compensation |
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4,322 |
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3,402 |
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Earnings on equity method investments |
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(3,983 |
) |
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(1,439 |
) |
Gain on sale of securities |
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(1,355 |
) |
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|
(1,789 |
) |
Loss on early extinguishment of debt |
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|
1,095 |
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|
2,729 |
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Other |
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|
1,567 |
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|
458 |
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Changes in assets and liabilities (net of acquisition of business): |
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Accounts receivable, net |
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(6,188 |
) |
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|
12,083 |
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Inventories |
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(39,803 |
) |
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|
9,063 |
|
Prepaid expenses and other current assets |
|
|
12,786 |
|
|
|
32,222 |
|
Accounts payable and accrued expenses |
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|
(26,151 |
) |
|
|
(83,596 |
) |
Deferred revenue |
|
|
(8,562 |
) |
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|
(1,792 |
) |
Income taxes payable |
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|
24,253 |
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|
|
10,319 |
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Other assets |
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513 |
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|
1,328 |
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Total adjustments |
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16,003 |
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|
56,627 |
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Net cash provided by operating activities |
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66,632 |
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|
88,239 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Additions to property and equipment |
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(18,277 |
) |
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(16,744 |
) |
Acquisition of product rights |
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(258 |
) |
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(153 |
) |
Proceeds from sale of marketable equity securities |
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|
1,628 |
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|
699 |
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Additions to marketable securities |
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(1,288 |
) |
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(1,099 |
) |
Additions to long-term investments |
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(1,144 |
) |
Other investing activities, net |
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|
115 |
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Net cash used in investing activities |
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(18,195 |
) |
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(18,326 |
) |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Principal payments on debt and other long-term liabilities |
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(88,058 |
) |
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(151,661 |
) |
Proceeds from issuance of short-term debt and other long-term liabilities |
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9,076 |
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Repurchase of common stock |
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(84 |
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Proceeds from stock plans |
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73 |
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1,127 |
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Net cash provided by (used in) financing activities |
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(78,993 |
) |
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(150,534 |
) |
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Net decrease in cash and cash equivalents |
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(30,556 |
) |
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(80,621 |
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Cash and cash equivalents at beginning of period |
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204,554 |
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154,171 |
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Cash and cash equivalents at end of period |
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$ |
173,998 |
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$ |
73,550 |
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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, manufacture, 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 March 31, |
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2008 |
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2007 |
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Net income |
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$ |
50,629 |
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$ |
31,612 |
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Other comprehensive (loss) income: |
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Translation gains |
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|
320 |
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|
218 |
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Unrealized loss on securities, net of tax |
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(48 |
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(6 |
) |
Unrealized loss on cash flow hedge, net of tax |
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(1,312 |
) |
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Total other comprehensive (loss) income |
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(1,040 |
) |
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|
212 |
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Total comprehensive income |
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$ |
49,589 |
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$ |
31,824 |
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-4-
Preferred and Common Stock
As of March 31, 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 March 31, 2008 and December 31, 2007,
there were 500,000,000 shares of $0.0033 par value per share common stock authorized, with
113,846,000 and 113,115,000 shares issued and 104,386,000 and 103,658,000 outstanding,
respectively. Of the issued shares, 9,460,000 and 9,457,000 shares were held as treasury shares
as of March 31, 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
$334.7 million and $341.0 million at March 31, 2008 and December 31, 2007, respectively. Accounts
payable and accrued liabilities include $45.3 million and $46.7 million at March 31, 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):
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Returns and |
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Other |
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Chargebacks |
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Rebates |
|
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Allowances |
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Cash Discounts |
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Total |
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|
Balance at December 31, 2006 |
|
$ |
164,480 |
|
|
$ |
180,538 |
|
|
$ |
42,489 |
|
|
$ |
14,072 |
|
|
$ |
401,579 |
|
Provision related to sales in three months
ended March 31, 2007 |
|
|
291,831 |
|
|
|
122,766 |
|
|
|
56,133 |
|
|
|
18,436 |
|
|
|
489,166 |
|
Credits and payments |
|
|
(321,751 |
) |
|
|
(124,215 |
) |
|
|
(33,960 |
) |
|
|
(16,894 |
) |
|
|
(496,820 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2007 |
|
|
134,560 |
|
|
|
179,089 |
|
|
|
64,662 |
|
|
|
15,614 |
|
|
|
393,925 |
|
Provision related to sales in three quarters
ended December 31, 2007 |
|
|
943,066 |
|
|
|
253,732 |
|
|
|
111,290 |
|
|
|
49,625 |
|
|
|
1,357,713 |
|
Credits and payments |
|
|
(913,183 |
) |
|
|
(278,504 |
) |
|
|
(119,908 |
) |
|
|
(52,327 |
) |
|
|
(1,363,922 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
164,443 |
|
|
|
154,317 |
|
|
|
56,044 |
|
|
|
12,912 |
|
|
|
387,716 |
|
Provision related to sales in three months
ended March 31, 2008 |
|
|
313,888 |
|
|
|
78,454 |
|
|
|
45,136 |
|
|
|
16,640 |
|
|
|
454,118 |
|
Credits and payments |
|
|
(323,196 |
) |
|
|
(85,978 |
) |
|
|
(38,409 |
) |
|
|
(14,295 |
) |
|
|
(461,878 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2008 |
|
$ |
155,135 |
|
|
$ |
146,793 |
|
|
$ |
62,771 |
|
|
$ |
15,257 |
|
|
$ |
379,956 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 stock
options and restricted stock awards 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 |
|
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
EPS basic |
|
|
|
|
|
|
|
|
Net income |
|
$ |
50,629 |
|
|
$ |
31,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average common shares outstanding |
|
|
102,625 |
|
|
|
101,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPS basic |
|
$ |
0.49 |
|
|
$ |
0.31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPS diluted |
|
|
|
|
|
|
|
|
Net income |
|
$ |
50,629 |
|
|
$ |
31,612 |
|
Add: Interest expense on CODES, net of tax |
|
|
1,986 |
|
|
|
1,943 |
|
|
|
|
|
|
|
|
Net income, adjusted |
|
$ |
52,615 |
|
|
$ |
33,555 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average common shares outstanding |
|
|
102,625 |
|
|
|
101,928 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
Conversion of CODES |
|
|
14,357 |
|
|
|
14,357 |
|
Dilutive stock options |
|
|
398 |
|
|
|
327 |
|
|
|
|
|
|
|
|
Diluted weighted average common shares outstanding |
|
|
117,380 |
|
|
|
116,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPS diluted |
|
$ |
0.45 |
|
|
$ |
0.29 |
|
|
|
|
|
|
|
|
-6-
Stock awards to purchase 9.0 million and 10.1 million common shares for the three month
periods ended March 31, 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 March 31, 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 March 31, 2008 and December 31, 2007, the notional amount of interest rate swaps entered
into by the Company was $200 million. The fair value of the interest rate swap at March 31, 2008
and December 31, 2007 was a liability of $3.7 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 March 31, 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 March 31, 2008, the Company had $6.5 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 1.6 years. As of March 31, 2008, the Company had $26.4
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 2.3
years. During the quarter ended March 31, 2008, the Company issued approximately 750,000
restricted stock grants with an aggregate intrinsic value of $20.7 million. No stock option grants
were issued during the quarter ended March 31, 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 9 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. 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 to
adopt the fair value option of SFAS 159.
-7-
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. The Companys
consolidated financial statements will be impacted by SFAS 141R only in relation to future business
combination activities.
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.
NOTE 2 OTHER INCOME
Other income consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Earnings on equity method investments |
|
$ |
3,983 |
|
|
$ |
1,439 |
|
Gain on sale of securities |
|
|
1,355 |
|
|
|
1,789 |
|
Other income |
|
|
15 |
|
|
|
175 |
|
|
|
|
|
|
|
|
|
|
$ |
5,353 |
|
|
$ |
3,403 |
|
|
|
|
|
|
|
|
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
-8-
results exclude sales of Watson generic and brand products, which are included in their
respective 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 March 31, 2008 |
|
|
Three Months Ended March 31, 2007 |
|
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
342,459 |
|
|
$ |
98,992 |
|
|
$ |
144,902 |
|
|
$ |
586,353 |
|
|
$ |
411,475 |
|
|
$ |
90,638 |
|
|
$ |
145,440 |
|
|
$ |
647,553 |
|
Other |
|
|
24,297 |
|
|
|
16,299 |
|
|
|
|
|
|
|
40,596 |
|
|
|
13,150 |
|
|
|
10,902 |
|
|
|
|
|
|
|
24,052 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
366,756 |
|
|
|
115,291 |
|
|
|
144,902 |
|
|
|
626,949 |
|
|
|
424,625 |
|
|
|
101,540 |
|
|
|
145,440 |
|
|
|
671,605 |
|
Cost of sales(1) |
|
|
229,723 |
|
|
|
27,526 |
|
|
|
122,853 |
|
|
|
380,102 |
|
|
|
272,623 |
|
|
|
25,215 |
|
|
|
126,882 |
|
|
|
424,720 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit(1) |
|
|
137,033 |
|
|
|
87,765 |
|
|
|
22,049 |
|
|
|
246,847 |
|
|
|
152,002 |
|
|
|
76,325 |
|
|
|
18,558 |
|
|
|
246,885 |
|
Gross margin(1) |
|
|
37.4 |
% |
|
|
76.1 |
% |
|
|
15.2 |
% |
|
|
39.4 |
% |
|
|
35.8 |
% |
|
|
75.2 |
% |
|
|
12.8 |
% |
|
|
36.8 |
% |
Research and
development |
|
|
22,597 |
|
|
|
15,418 |
|
|
|
|
|
|
|
38,015 |
|
|
|
26,513 |
|
|
|
11,295 |
|
|
|
|
|
|
|
37,808 |
|
Selling and
marketing |
|
|
14,053 |
|
|
|
27,995 |
|
|
|
14,032 |
|
|
|
56,080 |
|
|
|
14,549 |
|
|
|
26,411 |
|
|
|
14,203 |
|
|
|
55,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contribution |
|
$ |
100,383 |
|
|
$ |
44,352 |
|
|
$ |
8,017 |
|
|
|
152,752 |
|
|
$ |
110,940 |
|
|
$ |
38,619 |
|
|
$ |
4,355 |
|
|
|
153,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contibution margin |
|
|
27.4 |
% |
|
|
38.5 |
% |
|
|
5.5 |
% |
|
|
24.4 |
% |
|
|
26.1 |
% |
|
|
38.0 |
% |
|
|
3.0 |
% |
|
|
22.9 |
% |
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,553 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,055 |
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
82,020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
61,926 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9.2 |
% |
|
|
|
(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 March 31, 2008 and December 31, 2007 is approximately
$10.6 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):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
113,219 |
|
|
$ |
102,607 |
|
Work-in-process |
|
|
43,014 |
|
|
|
45,851 |
|
Finished goods |
|
|
365,089 |
|
|
|
342,143 |
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
521,322 |
|
|
$ |
490,601 |
|
|
|
|
|
|
|
|
-9-
NOTE 5 LONG-TERM DEBT
Long-term debt consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
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 |
|
|
574,471 |
|
|
|
574,402 |
|
Other notes payable |
|
|
2,853 |
|
|
|
6,247 |
|
|
|
|
|
|
|
|
|
|
|
827,324 |
|
|
|
905,649 |
|
Less: Current portion |
|
|
2,851 |
|
|
|
6,241 |
|
|
|
|
|
|
|
|
Total long-term debt |
|
$ |
824,473 |
|
|
$ |
899,408 |
|
|
|
|
|
|
|
|
Senior Credit Facility
During the three months ended March 31, 2008 and 2007, the Company made prepayments of the
2006 Credit Facility totaling $75.0 million and $150.0 million, respectively. As a result of these
pre-payments, the Companys results for the three months ended March 31, 2008 and 2007 reflect a
$1.1 million and $2.7 million non-cash charge for debt repurchases, respectively. As of March 31,
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 2010. Activity related to our business restructuring
and facility rationalization activities for the three months ended March 31, 2008 consisted of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
|
Costs |
|
|
Cash |
|
|
Non-cash |
|
|
March 31, |
|
(in thousands) |
|
Incurred |
|
|
Payments |
|
|
Adjustments |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Severence and retention |
|
$ |
11,235 |
|
|
$ |
(718 |
) |
|
$ |
|
|
|
$ |
10,517 |
|
Product transfer costs |
|
|
104 |
|
|
|
|
|
|
|
|
|
|
|
104 |
|
Accelerated depreciation |
|
|
1,757 |
|
|
|
|
|
|
|
(1,757 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,096 |
|
|
|
(718 |
) |
|
|
(1,757 |
) |
|
|
10,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
38 |
|
Selling and marketing |
|
|
606 |
|
|
|
|
|
|
|
|
|
|
|
606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
644 |
|
|
|
|
|
|
|
|
|
|
|
644 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total restructuring charges |
|
$ |
13,740 |
|
|
$ |
(718 |
) |
|
$ |
(1,757 |
) |
|
$ |
11,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 by employees. Activity related to our business restructuring
and facility rationalization activities is primarily attributable to our Generic segment.
-10-
NOTE 7 INCOME TAXES
As of December 31, 2007, the balance of unrecognized tax benefits was $71.2 million. The net
amount of unrecognized tax benefits which, if recognized, would favorably affect the effective tax
rate was $42.5 million as of December 31, 2007 and accrued penalties and interest was $6.2 million
(net of tax benefit of $3.6 million) as of December 31, 2007. None of these balances have changed
materially during the quarter ended March 31, 2008.
The Internal Revenue Service (the IRS) continues its examination of the Companys tax
returns for the years 2000 to 2003. As part of this exam, the IRS has raised issues regarding
transfer pricing, deductions relating to investments, certain transactions costs and certain timing
differences. As a result, the Company anticipates the amount of liability for unrecognized tax
benefits may change in the next twelve months due to the final resolution and settlement of these
audits and the expiration of the statute of limitations. Discussions are currently continuing with
the IRS to resolve these matters. However, we are unable to quantify the impact of the resolution at this time.
The Federal Research and Development Credit expired at the end of 2007 and has not been
extended into 2008. No tax benefit related to the Federal Research and Development Credit has been
recorded in the quarter ended March 31, 2008. Should this credit be extended through 2008, the
Companys effective tax rate will be reduced.
NOTE 8 STOCKHOLDERS EQUITY
A summary of the changes in stockholders equity for the three months ended March 31, 2008
consisted of the following (in thousands):
|
|
|
|
|
Stockholders equity, December 31, 2007 |
|
$ |
1,849,465 |
|
Common stock issued under employee plans |
|
|
73 |
|
Increase in additional paid-in capital for restricted stock and stock option compensation |
|
|
4,322 |
|
Net income |
|
|
50,629 |
|
Other comprehensive loss |
|
|
(1,040 |
) |
Tax benefit from employee stock plans |
|
|
2 |
|
Repurchase of common stock |
|
|
(84 |
) |
|
|
|
|
Stockholders equity, March 31, 2008 |
|
$ |
1,903,367 |
|
|
|
|
|
NOTE 9 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 between 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
-11-
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 on a recurring basis as at March 31,
2008 consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as at March 31, 2008 Using: |
|
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Marketable securities |
|
$ |
12,711 |
|
|
$ |
12,711 |
|
|
$ |
|
|
|
$ |
|
|
Investments |
|
|
222 |
|
|
|
222 |
|
|
|
|
|
|
|
|
|
Derivative liabilities |
|
|
3,815 |
|
|
|
|
|
|
|
3,815 |
|
|
|
|
|
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 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 10 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
-12-
appeal by the indirect
purchaser plaintiffs transferred to the United States Court of Appeals for the Federal Circuit.
Both of the appeals remain 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 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
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 early 2008. A status
conference is scheduled for June 13, 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 and, at this time, no details are
available concerning, among other things, the various theories of liability against Watson Pharma
or the amount of damages sought from it. 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
-13-
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. 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 the Attorneys General of numerous states, including Nevada, Montana, Massachusetts,
Wisconsin, Kentucky, Alabama, Illinois, Mississippi, Florida, Arizona, Missouri, Alaska, Idaho,
South Carolina, Hawaii, Utah, and Iowa. 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; and 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.
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
-14-
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 is currently involved in Court-ordered mediation. The case brought on behalf of Alabama is
approaching trial as to some other defendants; the case brought on behalf of Kentucky has a
scheduled discovery deadline of May 15, 2008. Several of the cases have trials scheduled before
the end of 2008, although it is not clear which defendants those trials will involve.
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-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. 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
-15-
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. However, if in the
future, the 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.
Securities Litigation Against Andrx Corporation. On October 11, 2005, Jerry Lowry filed a
class action complaint on behalf of purchasers of the Andrxs common stock during the class period
(March 9, 2005 through September 5, 2005) in the U.S. District Court for the Southern District of
Florida against Andrx Corporation and its then Chief Executive Officer, Thomas Rice (Jerry Lowry v.
Andrx Corporation, et al., Case No. 05-61640). The complaint seeks damages under the Securities
Exchange Act of 1934, and alleges that during the class period, Andrx failed to disclose that its
manufacturing facilities were not in compliance with cGMP. The complaint further alleges that
Andrxs failure to be cGMP compliant led to the FDA placing Andrx on Official Action Indicated
status, which resulted in not being eligible for approvals of Andrxs ANDAs. On July 24, 2006, the defendants moved to dismiss the action. On December 8, 2006,
the court granted in part and denied in part the defendants motion to dismiss. On April 18, 2007,
plaintiffs filed a motion seeking class certification. On December 17, 2007, the parties entered
into an agreement settling all outstanding claims, subject to obtaining the courts approval of the
settlement. On March 19, 2008, the court approved the settlement. The settlement did not
materially adversely affect the Companys business, results of operations, financial condition and
cash flows.
Naproxen Sodium (Naprelan). In October 1998, Elan Corporation Plc sued 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. The parties filed their briefs and are
awaiting the 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
-16-
complaint and filed a counterclaim for declaratory relief
for unenforceability due to inequitable conduct and for non-infringement and invalidity of the
applicable patent. This matter has been stayed pending resolution of the infringement action. Andrx
has sold and is continuing to sell its generic version of the 500mg strength of Naprelan
®. Therefore, an adverse determination 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
related to the Companys generic version of Provigil® (modafinil) and its September 2006 settlement
with Unimed and Laboratories Besins 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 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 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 80 cases are pending against Watson and/or its affiliates in state and federal courts
representing claims by approximately 100 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
QuasenseTM (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 Sanofi-Aventis (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
-17-
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 parties are currently in discussions concerning the appropriate procedures to conduct an
expedited arbitration proceeding, as well as 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.
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.
NOTE 11 SUBSEQUENT EVENT
On April 29, 2008, the Company announced that the FDA has completed the inspection of the
Companys Florida manufacturing facilities and has informed the Company that it has removed the
Official Action Indicated status at the Davie, Florida site. As a result of this action, and
subject to satisfying other FDA approval criteria, ANDAs for products at this site are now
eligible for FDA approval. The FDA completed the onsite portion of its inspection on April 10,
2008, at which time it issued a Form 483 List of Inspectional Observations. The Company responded
to the Form 483 Inspectional Observations on April 17, 2008.
-18-
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, manufacture, 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.
Acquisition of Andrx Corporation
On November 3, 2006, we acquired all the outstanding shares of common stock of Andrx
Corporation (Andrx) in an all-cash transaction for $25 per share, or total consideration of
approximately $1.9 billion (the Andrx Acquisition). The Andrx Acquisition augmented our existing
formulation development capability by providing technology for difficult-to-replicate
controlled-release pharmaceutical products and selective immediate-release products.
In conjunction with the Andrx Acquisition, we recorded a $497.8 million charge to operations
in the year ended December 31, 2006 for in-process research and development (IPR&D) assets
acquired that we determined had no alternative future use in their current state. Our valuation of
IPR&D projects included over thirty controlled- or immediate-release products at various stages of
R&D. These IPR&D projects were valued through discounted cash flow analysis utilizing the income
approach at rates commensurate with their perceived risks, which for these IPR&D projects ranged
between 19%-20%. A partial list of cash flow considerations utilized for each of the IPR&D projects
included an evaluation of a projects estimated cost to complete, future product prospects and
competition, product lifecycles, expected date of market introduction and expected pricing and cost
structure. The major risks and uncertainties associated with the timely and successful completion
of these IPR&D projects include delays caused by legal actions brought by our competitors and the
timing of the receipt of necessary regulatory approvals. No assurances can be given that the
underlying assumptions used to prepare the discounted cash flow analysis will not change or the
timely completion of each project to commercial success will occur. For these and other reasons,
actual results may vary significantly from estimated results.
The charge for IPR&D in the year ended December 31, 2006 related primarily to the acquisition
of the following six IPR&D projects:
Actos® and Extended-Release Metformin Combination Product
In December 2003, Andrx entered into an agreement with Takeda Chemical Industries, Ltd.
(Takeda) to develop and market a combination product consisting of Andrxs approved 505(b)(2) New
Drug Application (NDA) extended-release metformin and Takedas Actos® (pioglitazone), each of
which is administered once a day for the treatment of type 2 diabetes. The Company is responsible
for obtaining regulatory approval of its extended-release metformin in countries that Takeda
determines it will market the combination product. In addition, the Company is responsible for the
formulation and manufacture of the combination product and
Takeda is responsible for obtaining regulatory approval of and marketing the combination
product, both in the U.S. and in certain other countries.
-19-
In March 2006, Takeda filed an NDA for this combination product and the NDA is under review by
the U.S. Food and Drug Administration (FDA). If approved and launched, we are eligible to
receive future milestone payments and royalties from Takedas sale of this product.
Our valuation of this IPR&D project at the Andrx Acquisition date was $133 million.
Enoxaparin Sodium (generic version of Lovenox®)
On May 2, 2005, Andrx entered into an agreement to obtain certain exclusive marketing rights
for Amphastar Pharmaceuticals, Inc.s (Amphastars) generic version of Sanofi-Aventis
(Aventis) Lovenox® injectable product. Amphastar submitted its Abbreviated New Drug Application
(ANDA) for generic Lovenox® to the FDA in March 2003. Amphastars ANDA is the subject of a patent
infringement lawsuit filed by Aventis. On February 8, 2007, the District Court ruled that Aventis
patent was unenforceable due to inequitable conduct. Final judgment in favor of Amphastar was
entered on March 9, 2007. Aventis has appealed and the matter remains pending in the United States
Court of Appeals for the Federal Circuit. Amphastar has not obtained FDA approval for its product
and the product continues to be delayed by a Citizen Petition, including two supplements, and other
factors. Amphastar has submitted comments to Aventis Citizen Petition and supplements.
Additionally, in November 2007, the FDA requested Amphastar to provide additional data regarding
the potential immunogenicity of the product. Amphastar has responded to the FDAs request for
additional information. Our marketing rights for this product generally extend to the U.S. retail
pharmacy market, and we will receive up to 50% of the net profits, as defined, generated from such
sales. The launch of this product is dependent upon Amphastar obtaining FDA approval.
Our valuation of this IPR&D project at the Andrx Acquisition date was $33 million.
Metoprolol Succinate (generic version of Toprol-XL®)
In 2003 and 2004, Andrx filed ANDAs seeking FDA approval to market metoprolol succinate
extended-release tablets in the 25mg, 50mg, 100mg and 200mg strengths. Andrx was awarded 180-days
of market exclusivity for the 50mg strength. During the second quarter of this year, we announced
that pursuant to an agreement with Sandoz Pharmaceutical Corporation, a subsidiary of Novartis AG
(Sandoz), we relinquished our rights to a 180-day period of marketing exclusivity for our 50mg
strength product. As a result of our agreement to relinquish our marketing exclusivity, Sandoz
obtained final approval of its ANDA for metoprolol succinate extended-release 50 mg tablets. We are
entitled to a share of Sandozs profits on sales of the product, which began in the third quarter
of 2007.
We continue to pursue approval of our own pending ANDAs for metoprolol succinate
extended-release tablets.
Our valuation of this IPR&D project at the Andrx Acquisition date was $85 million.
Methylphenidate Hydrochloride (generic version of Concerta®)
Andrx has pending ANDAs for the generic versions of Concerta® (methylphenidate hydrochloride
extended-release tablets) in the 18mg, 27mg, 36mg and 54mg strengths.
In September 2005, ALZA Corporation and McNeil-PPC, Inc. sued Andrx for patent infringement
related to the generic version of Concerta®. In December 2007, the United States District Court for
the District of Delaware completed the trial of this matter. No decision has been issued to date.
The ANDAs remain under review by the FDA and a Citizen Petition has been filed by McNeil-PPC, Inc.
relating to approval criteria for generic versions of Concerta®. Final approval may be subject to
obtaining a waiver or expiration of a third partys 180 days of market exclusivity.
Our valuation of this IPR&D project at the Andrx Acquisition date was $94 million.
-20-
Omeprazole (generic version of Prilosec®)
Andrx has pending ANDAs for omeprazole delayed-release capsules, 10mg, 20mg and 40 mg
strengths, which are bioequivalent to Prilosec®. In 2001, AstraZeneca filed suit against Andrx
alleging infringement of a patent (patent no. 6,013,281) (the 281 patent) directed to a process
for making an omeprazole formulation. Andrx filed counterclaims of non-infringement, invalidity and
unenforceability. In May 2004, the district court ruled that the 281 patent was invalid due to
obviousness. In April 2007, the U.S. Court of Appeals for the Federal Circuit affirmed the 2004
District Court decision that the 281 patent is invalid.
The ANDAs remain under review by the FDA. Upon approval and launch, we believe that we are
entitled to the 180-day period of market exclusivity with respect to the generic version of the
40mg strength of Prilosec®.
Our valuation of this IPR&D project at the acquisition date was $57 million.
Diltiazem HCl ER (Cardizem® LA)
Andrx Corporation has pending ANDAs with the FDA for generic versions of Cardizem® LA
(diltiazem HCl extended-release tablets), 120mg, 180mg, 240mg, 300mg, 360mg and 420mg strengths.
Andrx initially filed its ANDA for the 420mg strength on April 25, 2005, with a Paragraph IV
certification and notification to the patent holder. On August 10, 2005, Biovail Laboratories Intl
SRL (Biovail), which is the holder of the NDA for Cardizem® LA, initiated a patent infringement
lawsuit against Andrx for the 420mg strength in the U.S. District Court for the District of
Delaware. Andrx subsequently amended its initial ANDA submission to include the 120mg, 180mg,
240mg, 300mg and 360mg strengths, along with a related Paragraph IV certification and notice
letter. On October 14, 2005, Biovail initiated a patent infringement lawsuit on the remaining
strengths. On December 4, 2007, we announced that we settled the litigation with Biovail. Under
the terms of the settlement, Biovail has granted us an exclusive license to its U.S. patents
covering Cardizem® LA for a generic version of Cardizem® LA. The agreement generally provides
that we that will not commence marketing our generic equivalent product until April 1, 2009.
The ANDAs remain under review by the FDA.
Our valuation of this IPR&D project at the Andrx Acquisition date was $12 million.
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 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 Generics 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 generic and brand products, which are included in their respective 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 March 31, 2008 Compared to Three Months Ended March 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2008 |
|
|
Three Months Ended March 31, 2007 |
|
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
|
Generic |
|
|
Brand |
|
|
Distribution |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
342,459 |
|
|
$ |
98,992 |
|
|
$ |
144,902 |
|
|
$ |
586,353 |
|
|
$ |
411,475 |
|
|
$ |
90,638 |
|
|
$ |
145,440 |
|
|
$ |
647,553 |
|
Other |
|
|
24,297 |
|
|
|
16,299 |
|
|
|
|
|
|
|
40,596 |
|
|
|
13,150 |
|
|
|
10,902 |
|
|
|
|
|
|
|
24,052 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
366,756 |
|
|
|
115,291 |
|
|
|
144,902 |
|
|
|
626,949 |
|
|
|
424,625 |
|
|
|
101,540 |
|
|
|
145,440 |
|
|
|
671,605 |
|
Cost of sales(1) |
|
|
229,723 |
|
|
|
27,526 |
|
|
|
122,853 |
|
|
|
380,102 |
|
|
|
272,623 |
|
|
|
25,215 |
|
|
|
126,882 |
|
|
|
424,720 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit(1) |
|
|
137,033 |
|
|
|
87,765 |
|
|
|
22,049 |
|
|
|
246,847 |
|
|
|
152,002 |
|
|
|
76,325 |
|
|
|
18,558 |
|
|
|
246,885 |
|
Gross margin(1) |
|
|
37.4 |
% |
|
|
76.1 |
% |
|
|
15.2 |
% |
|
|
39.4 |
% |
|
|
35.8 |
% |
|
|
75.2 |
% |
|
|
12.8 |
% |
|
|
36.8 |
% |
Research and
development |
|
|
22,597 |
|
|
|
15,418 |
|
|
|
|
|
|
|
38,015 |
|
|
|
26,513 |
|
|
|
11,295 |
|
|
|
|
|
|
|
37,808 |
|
Selling and
marketing |
|
|
14,053 |
|
|
|
27,995 |
|
|
|
14,032 |
|
|
|
56,080 |
|
|
|
14,549 |
|
|
|
26,411 |
|
|
|
14,203 |
|
|
|
55,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contribution |
|
$ |
100,383 |
|
|
$ |
44,352 |
|
|
$ |
8,017 |
|
|
|
152,752 |
|
|
$ |
110,940 |
|
|
$ |
38,619 |
|
|
$ |
4,355 |
|
|
|
153,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contibution margin |
|
|
27.4 |
% |
|
|
38.5 |
% |
|
|
5.5 |
% |
|
|
24.4 |
% |
|
|
26.1 |
% |
|
|
38.0 |
% |
|
|
3.0 |
% |
|
|
22.9 |
% |
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,553 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,055 |
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
82,020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
61,926 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9.2 |
% |
|
|
|
(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 includes 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 revenues consist primarily of royalties and commission revenue.
Net revenues from our Generic segment for the three months ended March 31, 2008 decreased
13.6% or $57.9 million to $366.8 million compared to net revenues of $424.6 million from the prior
year period. This decrease in sales was mainly attributable to higher net sales of Authorized
Generics ($72.4 million) in the prior year period including oxycodone HCl controlled release
tablets and pravastatin sodium tablets offset in part by sales of alendronate sodium tablets
launched in the current quarter. The decrease in sales was offset in part by an increase in other
revenue ($11.1 million). Increases in net revenues from new product launches were offset by price
erosion within our base business.
-22-
The increase in other revenues in the three months ended March 31, 2008 for the Generic
segment was primarily related to royalties on sales by Sandoz, Inc. of metoprolol succinate 50 mg
extended release tablets (which commenced during the third quarter of 2007).
Gross Profit (Gross Margin)
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 decreased $15.0 million to $137.0 million in the three
months ended March 31, 2008 compared to $152.0 million in the prior year period. The decrease in
gross profit was primarily due to reduced gross profit contribution from lower sales of Authorized
Generics in the current period ($20.2 million) and facility rationalization costs ($12.9 million)
offset by an increase in other revenue ($11.1 million). Increases in gross profit from new
product launches were offset by price erosion within our base business.
Gross margins for our Generic segment increased 1.6 percentage points to 37.4% for the three
months ended March 31, 2008 from 35.8% in the prior year period. This increase in gross margin
was primarily related to the increase in other revenue in the current quarter.
Research and Development Expenses
Generic segment R&D expenses consist predominantly of personnel-related costs, contract
research, biostudy and facilities costs associated with the development of our products.
Generic segment R&D expenses decreased 14.8% or $3.9 million to $22.6 million in the three
months ended March 31, 2008 compared to $26.5 million in the prior year period due to reduced
spending on biostudy costs in the current period.
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 decreased 3.4% or $0.5 million to $14.1
million in the three months ended March 31, 2008 compared to $14.5 million in the prior year
period.
Brand Segment
Net Revenues
Our brand pharmaceutical business 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 revenues in the Brand segment consist 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 revenues also include revenue recognized from R&D and licensing
agreements.
Net revenues from our Brand segment for the three months ended March 31, 2008 increased 13.5%
or $13.8 million to $115.3 million compared to net revenues of $101.5 million in the prior year
period. The increase was primarily attributable to higher sales within the Nephrology group ($5.5
million), higher other revenues ($5.4 million) and higher sales within the Specialty Products
group ($2.8 million). 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.
The increase within the Specialty Products group was primarily attributable to higher unit sales
of Trelstar® as a result of promotional efforts.
Gross Profit (Gross Margin)
Gross profit for our Brand segment increased $11.4 million to $87.8 million in the three
months ended March 31, 2008 compared to $76.3 million in the prior year period. The increase in
gross profit was primarily due to an increase in other revenues ($5.4 million) and higher product
sales.
Gross margins for our Brand segment increased to 76.1% during the three months ended March
31, 2008 from 75.2% in the prior year period primarily due to the increase in other revenues.
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 36.5% or $4.1 million to $15.4 million in the three
months ended March 31, 2008 compared to $11.3 million in the prior year period primarily due to a
$5.0 million milestone payment related to the filing of an NDA for silodosin with the FDA.
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 6.0% or $1.6 million to $28.0 million
in the three months ended March 31, 2008 as compared to $26.4 million in the prior year period.
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 generic and brand products, which are included in their
respective segment results.
Net revenues from our Distribution segment for the three months ended March 31, 2008
decreased 0.4% or $0.5 million to $144.9 million compared to net revenues of $145.4 million in the
prior year period.
-24-
Gross Profit (Gross Margin)
Gross profit for our Distribution segment increased $3.5 million to $22.0 million in the
three months ended March 31, 2008 compared to $18.6 million in the prior year period. Gross
margins also improved for our Distribution segment increasing to 15.2% during the three months
ended March 31, 2008 from 12.8% in the prior year period. Distribution segment gross profit and
gross margin improved in the current quarter as the prior year period was negatively impacted by a
$2.5 million acquisition-related inventory charge.
Selling and Marketing Expenses
Selling and marketing expenses consist mainly of personnel costs, facilities costs, insurance
and freight costs, which support the Distribution segment sales and marketing functions.
Segment Contribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Change |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
Dollars |
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment contribution |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic |
|
$ |
100,383 |
|
|
$ |
110,940 |
|
|
$ |
(10,557 |
) |
|
|
(9.5 |
)% |
Brand |
|
|
44,352 |
|
|
|
38,619 |
|
|
|
5,733 |
|
|
|
14.8 |
% |
Distribution |
|
|
8,017 |
|
|
|
4,355 |
|
|
|
3,662 |
|
|
|
84.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
152,752 |
|
|
$ |
153,914 |
|
|
$ |
(1,162 |
) |
|
|
(0.8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
as % of net revenues |
|
|
24.4 |
% |
|
|
22.9 |
% |
|
|
|
|
|
|
|
|
For more information on segment contribution, refer to above Managements Discussion and
Analysis of Financial Condition and Results of Operations and NOTE 3 OPERATING SEGMENTS in
the accompanying Notes to Condensed Consolidated Financial Statements in this Quarterly Report.
Corporate General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate general and
administrative expenses |
|
$ |
50,553 |
|
|
$ |
48,055 |
|
|
$ |
2,498 |
|
|
|
5.2 |
% |
as a % of net revenues |
|
|
8.1 |
% |
|
|
7.2 |
% |
|
|
|
|
|
|
|
|
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 increased during the three months ended March
31, 2008 as compared to the same period of the prior year primarily due to costs incurred in the
implementation of a new enterprise resource planning system at certain sites.
-25-
Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization |
|
$ |
20,179 |
|
|
$ |
43,933 |
|
|
$ |
(23,754 |
) |
|
|
(54.1 |
)% |
as a % of net revenues |
|
|
3.2 |
% |
|
|
6.5 |
% |
|
|
|
|
|
|
|
|
The Companys amortizable assets consist primarily of acquired product rights. For the
three months ended March 31, 2008 amortization expense decreased 54.1% or $23.8 million as our
Ferrlecit® product rights were fully amortized as of December 2007.
Loss on Early Extinguishment of Debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on early extinguishment
of debt |
|
$ |
1,095 |
|
|
$ |
2,729 |
|
|
$ |
(1,634 |
) |
|
|
(59.9 |
)% |
as a % of net revenues |
|
|
0.2 |
% |
|
|
0.4 |
% |
|
|
|
|
|
|
|
|
In November 2006, we entered into a Senior Credit Facility with Canadian Imperial Bank of
Commerce, acting through its New York agency, as Administrative Agent, Wachovia Capital Markets,
LLC, as Syndication Agent, and a syndicate of banks (the 2006 Credit Facility). The 2006 Credit
Facility was entered into in connection with the Andrx Acquisition.
During the quarter ended March 31, 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 quarter ended
March 31, 2008 reflect debt repurchase charges of $1.1 million which consist of unamortized debt
issue costs associated with the repurchased amount.
On February 15, 2007 and March 30, 2007, the Company made a $100.0 million and $50.0 million
prepayment, respectively, on the 2006 Credit Facility. As a result of this prepayment, our
results for the first quarter of 2007 reflect a $2.7 million non-cash charge for debt repurchase
charges.
Interest Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
2,309 |
|
|
$ |
2,929 |
|
|
$ |
(620 |
) |
|
|
(21.2 |
)% |
as a % of net revenues |
|
|
0.4 |
% |
|
|
0.4 |
% |
|
|
|
|
|
|
|
|
Interest income decreased for the three months ended March 31, 2008 due to a decrease in
interest rates over the prior year period.
-26-
Interest Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Change |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
Dollars |
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense 2006 Credit Facility |
|
$ |
3,912 |
|
|
$ |
10,374 |
|
|
$ |
(6,462 |
) |
|
|
|
|
Interest expense convertible contingent
senior debentures due 2023 (CODES) |
|
|
3,151 |
|
|
|
3,151 |
|
|
|
|
|
|
|
|
|
Change in derivative value |
|
|
57 |
|
|
|
24 |
|
|
|
33 |
|
|
|
|
|
Interest expense other |
|
|
(324 |
) |
|
|
327 |
|
|
|
(651 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
$ |
6,796 |
|
|
$ |
13,876 |
|
|
$ |
(7,080 |
) |
|
|
(51.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
as a % of net revenues |
|
|
1.1 |
% |
|
|
2.1 |
% |
|
|
|
|
|
|
|
|
Interest expense decreased for the three months ended March 31, 2008 due to reduced levels
of debt on the 2006 Credit Facility from prepayments made during 2007 and the first quarter of
2008.
Other Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Change |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
Dollars |
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings on equity method investments |
|
$ |
3,983 |
|
|
$ |
1,439 |
|
|
$ |
2,544 |
|
|
|
176.8 |
% |
Gain on sale of securities |
|
|
1,355 |
|
|
|
1,789 |
|
|
|
(434 |
) |
|
|
(24.3 |
)% |
Other income |
|
|
15 |
|
|
|
175 |
|
|
|
(160 |
) |
|
|
(91.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,353 |
|
|
$ |
3,403 |
|
|
$ |
1,950 |
|
|
|
57.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
as a % of net revenues |
|
|
0.9 |
% |
|
|
0.5 |
% |
|
|
|
|
|
|
|
|
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.
The increase in earnings on equity method investments during the three months ended March
31, 2008 primarily represents our share of equity earnings in Scinopharm Taiwan Ltd.
(Scinopharm). Scinopharm results for the three months ended March 31, 2008 increased over the
prior year period due to new product launches.
Gain on Sale of Securities
The 2008 and 2007 gain on sale of securities resulted from the sale of our investment in
Adheris, Inc. During both periods, contingencies were removed relating to additional
consideration on our sale of our investment in Adheris, Inc. Accordingly, the Company received
common shares of inVentiv Health, Inc. (inVentiv) and cash as additional proceeds on our sale
of our investment in Adheris, Inc. which was recorded as a gain on sale of securities in the
quarter ended March 31, 2008 and 2007, respectively.
-27-
Provision for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
($ in thousands): |
|
2008 |
|
2007 |
|
Dollars |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
$ |
31,162 |
|
|
$ |
20,041 |
|
|
$ |
11,121 |
|
|
|
55.5 |
% |
as a % of net revenues |
|
|
5.0 |
% |
|
|
3.0 |
% |
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
38.1 |
% |
|
|
38.8 |
% |
|
|
|
|
|
|
|
|
The provision for income taxes differs from the amount computed by applying the statutory
U.S. federal income tax rate primarily due to state taxes and other factors which, combined,
increases the effective tax rate.
The provision for income taxes increased in the three months ended March 31, 2008 due to
higher pre-tax earnings. The lower effective tax rate for the three months ended March 31, 2008,
as compared to the same period of the prior year, primarily reflects a decrease in the state tax
rate and certain permanent items which were partially offset by the loss of the R&D tax credit
which has not been extended in 2008.
Liquidity and Capital Resources
Working Capital Position
Working capital at March 31, 2008 and December 31, 2007 is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
Increase |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
Current Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
173,998 |
|
|
$ |
204,554 |
|
|
$ |
(30,556 |
) |
Marketable securities |
|
|
12,711 |
|
|
|
11,799 |
|
|
|
912 |
|
Accounts receivable, net of allowances |
|
|
273,305 |
|
|
|
267,117 |
|
|
|
6,188 |
|
Inventories |
|
|
521,322 |
|
|
|
490,601 |
|
|
|
30,721 |
|
Other |
|
|
182,291 |
|
|
|
199,705 |
|
|
|
(17,414 |
) |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
1,163,627 |
|
|
|
1,173,776 |
|
|
|
(10,149 |
) |
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
376,545 |
|
|
|
398,154 |
|
|
|
(21,609 |
) |
Income taxes payable |
|
|
20,006 |
|
|
|
|
|
|
|
20,006 |
|
Current portion of long-term debt |
|
|
2,851 |
|
|
|
6,241 |
|
|
|
(3,390 |
) |
Other |
|
|
36,319 |
|
|
|
40,532 |
|
|
|
(4,213 |
) |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
435,721 |
|
|
|
444,927 |
|
|
|
(9,206 |
) |
|
|
|
|
|
|
|
|
|
|
Working Capital |
|
$ |
727,906 |
|
|
$ |
728,849 |
|
|
$ |
(943 |
) |
|
|
|
|
|
|
|
|
|
|
Current Ratio |
|
|
2.67 |
|
|
|
2.64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Watsons primary source of liquidity is cash from operations. Net working capital at March
31, 2008 was $727.9 million, compared to $728.8 million at December 31, 2007.
We expect that 2008 cash flows from operating activities will continue to exceed net income.
In addition, management expects that 2008 cash flows from operating activities and available
cash balances will be sufficient to fund our operating liquidity needs.
-28-
Cash Flows from Operations
Summarized cash flow from operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
($ in thousands): |
|
2008 |
|
2007 |
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
$ |
66,632 |
|
|
$ |
88,239 |
|
Cash flows from operations represent net income adjusted for certain operations related
non-cash items and changes in certain assets and liabilities. For the three months ended March
31, 2008, cash provided by operating activities was $66.6 million, compared to $88.2 million in
the three months ended March 31, 2007. The Company has generated cash flows from operating
activities primarily driven by net income adjusted for amortization of our acquired product
rights and depreciation. Net cash provided by operations was lower in the three months ended
March 31, 2008 compared to the three months ended March 31, 2007 primarily due to first quarter
2008 increases in accounts receivable and inventory levels relative to first quarter 2007
decreases in these same items. These first quarter 2008 reductions to
cash flow from operations were partly offset by higher net income and higher uses of cash from
operations in the first quarter 2007 period for payments of accounts payable and accrued
expenses.
Investing Cash Flows
Our cash flows from investing activities are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
($ in thousands): |
|
2008 |
|
2007 |
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
$ |
18,195 |
|
|
$ |
18,326 |
|
Investing cash flows consist primarily of expenditures related to acquisitions, capital
expenditures, investment and marketable security additions as well as proceeds from investment
and marketable security sales. Net cash used in investing activities for the three months ended
March 31, 2008 was relatively unchanged from 2007 levels.
Financing Cash Flows
Our cash flows from financing activities are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
($ in thousands): |
|
2008 |
|
2007 |
|
|
|
|
|
|
|
|
|
Net cash used in financing activities |
|
$ |
78,993 |
|
|
$ |
150,534 |
|
Financing cash flows consist primarily of borrowings and repayments of debt, repurchases of
common stock and proceeds from exercising of stock awards. For the three months ended March 31,
2008, net cash used in financing activities was $79.0 million compared to $150.5 million used in
financing activities during the three months ended March 31, 2007. Prepayments of the 2006 Credit
Facility for the three months ended March 31, 2008 were $75.0 million compared to $150.0 million
in the prior year period.
-29-
Debt and Borrowing Capacity
Our outstanding debt obligations are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
Increase |
|
($ in thousands): |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of long-term debt |
|
$ |
2,851 |
|
|
$ |
6,241 |
|
|
$ |
(3,390 |
) |
Long-term debt |
|
|
824,473 |
|
|
|
899,408 |
|
|
|
(74,935 |
) |
|
|
|
|
|
|
|
|
|
|
Total debt |
|
$ |
827,324 |
|
|
$ |
905,649 |
|
|
$ |
(78,325 |
) |
|
|
|
|
|
|
|
|
|
|
Debt to capital ratio |
|
|
30.3 |
% |
|
|
32.9 |
% |
|
|
|
|
During the quarter ended March 31, 2008, we prepaid $75.0 million of the amount outstanding
under the Term Facility. As a result of this prepayment, our results for the first quarter of
2008 reflect a $1.1 million non-cash charge for debt repurchase charges. No principal payments
are required on the Term Facility in 2008. As of March 31, 2008, we had not drawn any funds from
the Revolving Facility and $250.0 million was outstanding on the Term Facility. The full amount outstanding on the 2006 Credit Facility is due November 2011.
Under the terms of the Senior 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 March 31, 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 $1.41 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 March 31, 2008, our net worth was $1.90 billion, and our leverage ratio was 1.48 to 1.0.
Our interest coverage ratio for the three months ended March 31, 2008 was 14.9 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 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 March 31, 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.
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
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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 9 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 to
adopt the fair value option of SFAS 159.
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. The Companys
consolidated financial statements will be impacted by SFAS 141R only in relation to future business
combination activities.
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.
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 March 31, 2008, our total holdings in equity securities of other companies, including
equity-method investments and available-for-sale securities, were $57.2 million. Of this amount,
we had equity-method investments of $54.4 million and publicly traded equity securities
(available-for-sale securities) at fair value totaling $2.5 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 March
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31, 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 $0.6 million, $1.0
million and $1.3 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, short-term
commercial paper and short-term certificates of deposit.
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 that
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 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 March 31, 2008. As of March 31, 2008, the fair value of our CODES was
$23.0 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.
We do not believe that inflation has had a significant impact on our revenues or operations.
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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 March 31, 2008, that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
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PART II. OTHER INFORMATION AND SIGNATURES
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
10 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 three months ended March 31, 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 March 31, 2008, the Company repurchased approximately 3,000
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 $84,000.
ITEM 6. EXHIBITS
(a) Exhibits:
Reference is hereby made to the Exhibit Index on page 36.
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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.
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WATSON PHARMACEUTICALS, INC.
(Registrant)
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By: |
/s/ Mark W. Durand
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Mark W. Durand |
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Senior Vice PresidentChief Financial Officer
(Principal Financial Officer) |
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By: |
/s/ R. Todd Joyce
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R. Todd Joyce |
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Vice President Corporate Controller and Treasurer
(Principal Accounting Officer) |
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Date: May 2, 2008
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WATSON PHARMACEUTICALS, INC.
EXHIBIT INDEX TO FORM 10-Q
For the Quarterly Period Ended March 31, 2008
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Exhibit |
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No. |
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Description |
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31.1
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Certification of President and Chief Executive Officer pursuant to
Rule 13a-14a of the Securities Exchange Act of 1934. |
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31.2
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Certification of Senior Vice President and Chief Financial Officer
pursuant to Rule 13a-14a of the Securities Exchange Act of 1934. |
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32.1
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Certification of President and Chief Executive Officer pursuant to
Rule 13a-14(d) of the Securities Exchange Act of 1934. |
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32.2
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Certification of Senior Vice President and Chief Financial Officer
pursuant to Rule 13a-14(d) of the Securities Exchange Act of 1934. |
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