10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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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 quarterly period ended December 31, 2005 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 1-9860
BARR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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Delaware
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42-1612474 |
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.) |
400 Chestnut Ridge Road, Woodcliff Lake, New Jersey 07677-7668
(Address of principal executive offices)
201-930-3300
(Registrants telephone number)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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 or
a non-accelerated filer. See definition of accelerated filer and
Large accelerated filer 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 |
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
As of January 27, 2006 the registrant had 105,759,365 shares of $0.01 par value common stock
outstanding.
BARR PHARMACEUTICALS, INC.
INDEX TO FORM 10-Q
2
Part 1. FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
Barr Pharmaceuticals, Inc. and subsidiaries
Consolidated Balance Sheets
(in thousands, except per share amounts)
(unaudited)
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December 31, |
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June 30, |
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2005 |
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2005 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
30,010 |
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$ |
115,793 |
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Marketable securities |
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391,745 |
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527,462 |
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Accounts receivable, net of reserves of $139,690 and $150,000, at
December 31, 2005 and June 30, 2005, respectively |
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192,720 |
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152,599 |
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Other receivables |
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56,452 |
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21,411 |
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Inventories, net |
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144,038 |
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137,638 |
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Deferred income taxes |
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25,759 |
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30,224 |
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Prepaid expenses and other current assets |
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18,565 |
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8,229 |
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Total current assets |
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859,289 |
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993,356 |
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Property, plant and equipment, net of accumulated depreciation of $145,889
and $129,617, at December 31, 2005 and June 30, 2005, respectively |
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269,899 |
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249,485 |
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Deferred income taxes |
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36,712 |
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60,504 |
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Marketable securities |
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26,635 |
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53,793 |
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Other intangible assets |
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434,770 |
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98,343 |
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Goodwill |
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47,617 |
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17,998 |
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Other assets |
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11,675 |
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9,367 |
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Total assets |
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$ |
1,686,597 |
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$ |
1,482,846 |
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Liabilities and Shareholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
28,697 |
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$ |
49,743 |
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Accrued liabilities |
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113,333 |
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144,428 |
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Current portion of long-term debt and capital lease obligations |
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5,462 |
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5,446 |
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Income taxes payable |
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13,353 |
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Total current liabilities |
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147,492 |
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212,970 |
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Long-term debt and captial lease obligations |
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11,520 |
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15,493 |
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Other liabilities |
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34,507 |
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20,413 |
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Commitments & Contingencies |
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Shareholders equity: |
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Preferred stock, $1 par value per share; authorized 2,000,000; none issued |
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Common stock, $.01 par value per share; authorized 200,000,000;
issued 108,340,964 and 106,340,470, at December 31, 2005
and June 30, 2005, respectively |
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1,083 |
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1,063 |
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Additional paid-in capital |
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535,544 |
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454,489 |
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Retained earnings |
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1,057,796 |
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879,669 |
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Accumulated other comprehensive loss |
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(655 |
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(561 |
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1,593,768 |
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1,334,660 |
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Treasury stock at cost: 2,972,997 shares, at
December 31, 2005 and June 30, 2005 |
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(100,690 |
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(100,690 |
) |
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Total shareholders equity |
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1,493,078 |
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1,233,970 |
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Total liabilities and shareholders equity |
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$ |
1,686,597 |
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$ |
1,482,846 |
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SEE ACCOMPANYING NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
3
Barr Pharmaceuticals, Inc. and subsidiaries
Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
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Three Months Ended |
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Six Months Ended |
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December 31, |
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December 31, |
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2005 |
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2004 |
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2005 |
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2004 |
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Revenues: |
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Product sales |
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$ |
289,386 |
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$ |
255,793 |
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$ |
556,179 |
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$ |
498,792 |
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Alliance, development and other revenue |
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36,131 |
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1,576 |
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79,777 |
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3,085 |
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Total revenues |
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325,517 |
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257,369 |
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635,956 |
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501,877 |
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Costs and expenses: |
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Cost of sales |
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83,732 |
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78,059 |
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163,794 |
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147,697 |
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Selling, general and administrative |
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66,114 |
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58,385 |
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134,686 |
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122,715 |
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Research and development |
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30,940 |
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31,137 |
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66,006 |
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59,651 |
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Earnings from operations |
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144,731 |
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89,788 |
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271,470 |
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171,814 |
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Interest income |
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4,429 |
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2,197 |
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8,904 |
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3,977 |
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Interest expense |
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68 |
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484 |
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147 |
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1,064 |
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Other (expense) income |
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(138 |
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278 |
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(593 |
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268 |
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Earnings before income taxes |
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148,954 |
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91,779 |
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279,634 |
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174,995 |
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Income tax expense |
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54,070 |
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32,392 |
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101,507 |
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63,473 |
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Net earnings |
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$ |
94,884 |
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$ |
59,387 |
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$ |
178,127 |
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$ |
111,522 |
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Earnings per common share basic |
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$ |
0.91 |
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$ |
0.58 |
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$ |
1.71 |
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$ |
1.08 |
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Earnings per common share diluted |
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$ |
0.88 |
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$ |
0.56 |
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$ |
1.66 |
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$ |
1.05 |
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Weighted average shares |
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104,714 |
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102,526 |
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104,219 |
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103,409 |
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Weighted average shares diluted |
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107,410 |
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105,144 |
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106,984 |
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106,028 |
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SEE ACCOMPANYING NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
4
Barr Pharmaceuticals, Inc. and subsidiaries
Consolidated Statements of Cash Flows
For the Six Months Ended December 31, 2005 and 2004
(in thousands of dollars)
(unaudited)
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2005 |
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2004 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net earnings |
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$ |
178,127 |
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$ |
111,522 |
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Adjustments to reconcile net earnings to net cash provided by operating activities: |
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Depreciation and amortization |
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25,455 |
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21,210 |
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Stock-based compensation expense |
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13,894 |
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Deferred tax income tax expense |
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28,311 |
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Other |
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(647 |
) |
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(156 |
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Tax benefit of stock incentive plans |
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20,195 |
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Changes in assets and liabilities (net of business acquired): |
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(Increase) decrease in: |
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Accounts receivable and other receivables, net |
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(66,024 |
) |
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75,160 |
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Inventories |
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14,825 |
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(884 |
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Prepaid expenses |
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(4,513 |
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(738 |
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Other assets |
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(79 |
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6,523 |
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Increase (decrease) in: |
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Accounts payable, accrued liabilities and
other liabilities |
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(71,240 |
) |
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(54,753 |
) |
Income taxes payable |
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(13,353 |
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36,796 |
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Net cash provided by operating activities |
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104,756 |
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214,875 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchases of property, plant and equipment |
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(36,045 |
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(24,875 |
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Buy-out of product royalty |
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(19,250 |
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Purchases of marketable securities |
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(960,438 |
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(617,939 |
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Sales of marketable securities |
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1,124,641 |
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566,235 |
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Acquisitions, net of cash acquired |
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(378,128 |
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(27,000 |
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Investment in venture funds |
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(3,000 |
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(4,470 |
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Other |
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(17 |
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(700 |
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Net cash used in investing activities |
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(252,987 |
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(127,999 |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Principal payments on long-term debt and capital leases |
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(4,733 |
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(6,961 |
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Purchase of treasury stock |
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(99,982 |
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Tax benefit of stock incentives |
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24,622 |
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Proceeds from exercise of stock options and employee stock purchases |
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42,559 |
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7,389 |
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Net cash provided by (used in) financing activities |
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62,448 |
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(99,554 |
) |
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Decrease in cash and cash equivalents |
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(85,783 |
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(12,678 |
) |
Cash and cash equivalents at beginning of period |
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115,793 |
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28,508 |
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Cash and cash equivalents at end of period |
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$ |
30,010 |
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$ |
15,830 |
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SEE ACCOMPANYING NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
5
BARR PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(in thousands of dollars, except per share amounts)
(unaudited)
1. Basis of Presentation
The accompanying unaudited interim financial statements included in this Form 10-Q should be
read in conjunction with the consolidated financial statements of Barr Pharmaceuticals, Inc. and
its subsidiaries (the Company) and accompanying notes that are included in our Annual Report on
Form 10-K for the fiscal year ended June 30, 2005.
In our opinion, the unaudited financial statements reflect all adjustments (including those
that are normal and recurring) that are necessary in the judgment of management for a fair
presentation of such statements in conformity with accounting principles generally accepted in the
United States (GAAP). In preparing financial statements in conformity with GAAP, we must make
estimates and assumptions that affect the reported amounts of assets, liabilities, revenues,
expenses, and related disclosures at the date of the financial statements and during the reporting
period. Actual results could differ from those estimates. Certain amounts in the consolidated
statement of cash flows for the six months ended December 31, 2004 have been reclassified to
conform to our consolidated statement of cash flows for the six months ended December 31, 2005.
There is no effect on our statement of operations.
2. Recent Accounting Pronouncements
In March 2005, the Financial Accounting Standards Board (FASB) published Interpretation No.
47, Accounting for Conditional Asset Retirement Obligations, which clarifies that the term
conditional asset retirement obligation, as used in Statement of Financial Accounting Standards
(SFAS) No. 143, Accounting for Asset Retirement Obligations, that refers to a legal obligation to
perform an asset retirement activity in which the timing and (or) method of settlement are
conditional on a future event that may or may not be within the control of the entity. The
uncertainty about the timing and (or) method of settlement of a conditional asset retirement
obligation should be factored into the measurement of the liability when sufficient information
exists. The interpretation also clarifies when an entity would have sufficient information to
reasonably estimate the fair value of an asset retirement obligation. The adoption of this
Interpretation during the second quarter of fiscal year 2006 did not have a material effect on the
Companys consolidated financial position, results of operations or cash flows.
In June 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections. SFAS
No. 154 replaces APB (Accounting Principles Board) Opinion No. 20, Accounting Changes, and SFAS
No. 3, Reporting Accounting Changes in Interim Financial Statements, and changes the requirements
for the accounting for and reporting of a change in accounting principle. This Statement applies to
all voluntary changes in accounting principle. It also applies to changes required by an accounting
pronouncement in the unusual instance that the pronouncement does not include specific transition
provisions. When a pronouncement includes specific transition provisions, those provisions should
be followed. This Statement shall be effective for accounting changes and corrections of errors
made in fiscal years beginning after December 15, 2005. The Company does not believe that the
adoption of SFAS No. 154 will have a material impact on its results of operations or financial
position.
3. Stock-Based Compensation
The Company adopted SFAS No. 123 (revised 2004), Share-Based Payment (SFAS 123R),
effective July 1, 2005. SFAS 123R requires the recognition of the fair value of stock-based
compensation in net earnings.
The Company has three stock-based employee compensation plans, two stock-based non-employee
director compensation plans and an employee stock purchase plan. Stock-based compensation consists
of stock options,
6
stock appreciation rights and the employee stock purchase plan. Stock options
and stock appreciation rights are granted to employees at exercise prices equal to the fair market
value of the Companys stock at the dates of grant. Generally, stock options and stock
appreciation rights granted to employees fully vest three years from the grant date and have a term
of 10 years. Stock options and stock appreciation rights granted to directors are generally
exercisable on the date of the first annual shareholders meeting immediately following the date of
grant. The Company recognizes stock-based compensation expense over the requisite service period
of the individual grants, which generally equals the vesting period.
Prior to July 1, 2005, the Company accounted for these plans under the intrinsic value method
described in Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to
Employees, and related Interpretations. The Company, applying the intrinsic value method, did not
record stock-based compensation cost in net earnings because the exercise price of its stock
options equaled the market price of the underlying stock on the date of grant. The Company has
elected to utilize the modified prospective transition method for adopting SFAS 123R. Under this
method, the provisions of SFAS 123R apply to all awards granted or modified after the date of
adoption. In addition, the unrecognized expense of awards not yet vested at the date of adoption,
determined under the original provisions of SFAS 123, shall be recognized in net earnings in the
periods after the date of adoption. The Company recognized stock-based compensation expense for
the three and six months ended December 31, 2005 in the amount of $7,124 and $13,894, respectively.
The Company also recorded tax related benefits for the three and six months ended December 31, 2005
in the amount of $1,826 and $3,383, respectively.
SFAS 123R requires the Company to present pro forma information for periods prior to the
adoption as if it had accounted for all stock-based compensation under the fair value method of
that statement. For purposes of pro forma disclosure, the estimated fair value of the options at
the date of grant is amortized to expense over the requisite service period, which generally equals
the vesting period. The following table illustrates the effect on net earnings and earnings per
share as if the Company had applied the fair value recognition provisions of SFAS 123R to its
stock-based employee compensation for the periods indicated.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
December 31, 2004 |
|
|
December 31, 2004 |
|
Net earnings, as reported |
|
$ |
59,387 |
|
|
$ |
111,522 |
|
Deduct: |
|
|
|
|
|
|
|
|
Total stock-based
employee compensation
expense determined
under fair value based
methods for all
awards, net of related
tax effects |
|
|
5,214 |
|
|
|
11,609 |
|
|
|
|
|
|
|
|
Pro forma net earnings |
|
$ |
54,173 |
|
|
$ |
99,913 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share: |
|
|
|
|
|
|
|
|
Basic as reported |
|
$ |
0.58 |
|
|
$ |
1.08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic pro forma |
|
$ |
0.53 |
|
|
$ |
0.97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted as reported |
|
$ |
0.56 |
|
|
$ |
1.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted pro forma |
|
$ |
0.52 |
|
|
$ |
0.94 |
|
|
|
|
|
|
|
|
For all of the Companys stock-based compensation plans, the fair value of each grant was
estimated at the date of grant using the Black-Scholes option-pricing model. Black-Scholes utilizes
assumptions related to volatility, the risk-free interest rate, the dividend yield (which is assumed to be zero, as
the Company has not paid cash dividends recently) and employee exercise behavior. Expected
volatilities utilized in the model are based mainly on the historical volatility of the Companys
stock price and other factors. The risk-free interest rate is derived from the U.S. Treasury yield
curve in effect in the period of grant. The model incorporates exercise and
7
post-vesting
forfeiture assumptions based on an analysis of historical data. The expected life of the fiscal
2006 grants is derived from historical and other factors.
The weighted-average fair value of the stock appreciation rights granted in the three and six
months ended December 31, 2005 was $21.94 and $18.18 per right, respectively, determined using the
following assumptions:
|
|
|
|
|
Average expected term (years) |
|
|
5.0 |
|
Risk-free interest rate |
|
|
3.72 |
% |
Dividend yield |
|
|
0.00 |
% |
Expected volatility |
|
|
36.85 |
% |
As of December 31, 2005, the total remaining unrecognized compensation cost related to
non-vested stock options and stock appreciation rights amounted to $39,530. There were no
unrecognized compensation costs related to the employee stock purchase plan at December 31, 2005.
The weighted average remaining requisite service period of the non-vested stock options and stock
appreciation rights was 24 months.
4. Acquisitions and Business Combinations
FEI Acquisition
On November 9, 2005, the Company completed the acquisition of all of the outstanding equity
interests of FEI Womens Health, LLC (FEI). FEI is the owner of ParaGard® T 380A
(Intrauterine Copper Contraceptive) IUD, which is approved for continuous use for the prevention of
pregnancy for up to 10 years. With this transaction the Company expanded its commitment of
contraception beyond oral contraceptive products into a new arena and further strengthened its
commitment to leadership in female healthcare by offering enhanced contraceptive options.
In
accordance with SFAS No. 141, Business Combinations, the Company used the purchase method
to account for this transaction. Under the purchase method of accounting, the assets acquired and
liabilities assumed from FEI are recorded at the date of acquisition, at their respective fair
values. In connection with the acquisition the Company engaged a valuation firm to evaluate certain
assets and liabilities of FEI. The purchase price plus acquisition costs exceeded the fair values
of acquired assets and assumed liabilities. This resulted in the recognition of goodwill in the
amount of $29,619. The total purchase price, including acquisition costs of $4,810 less cash
acquired of $4,372, was $289,428. The consolidated financial statements issued after completion of
the acquisition reflect these values, but are not restated retroactively to reflect the historical
financial position or results of operations of FEI. The operating results of FEI are included in
the consolidated financial statements subsequent to the November 9, 2005 acquisition date.
The fair values of the assets acquired and liabilities assumed on November 9, 2005 were
as follows:
|
|
|
|
|
|
|
$(000s) |
|
Current assets (excluding cash) |
|
$ |
30,876 |
|
Property and equipment |
|
|
1,955 |
|
Intangible assets |
|
|
256,000 |
|
Goodwill |
|
|
29,619 |
|
Other assets |
|
|
4,677 |
|
|
|
|
|
Total assets acquired |
|
$ |
323,127 |
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
10,780 |
|
|
|
|
|
Other liabilities |
|
|
22,919 |
|
Total liabilities assumed |
|
|
33,699 |
|
|
|
|
|
Net assets acquired |
|
$ |
289,428 |
|
|
|
|
|
|
|
|
|
|
Cash paid net of cash acquired |
|
$ |
289,428 |
|
|
|
|
|
8
The purchase price has been allocated based on an estimate of the fair value of assets
acquired and liabilities assumed as of the date of acquisition. The final valuation of net assets
is expected to be completed no later than one year from the acquisition date in accordance with
GAAP. To the extent that the estimates need to be adjusted, the Company will do so.
In accordance with the requirements of SFAS No. 142, Goodwill and Other Intangible Assets,
the goodwill associated with the acquisition will not be amortized. The intangible asset will have
a 20-year life and will be amortized over that period. Goodwill and the intangible assets resulting
from this acquisition have been allocated to our Proprietary reporting unit.
The following unaudited pro forma financial information presents the combined results of
operations of the Company and FEI as if the acquisition had occurred as of the beginning of the
periods presented. The unaudited pro forma financial information is not necessarily indicative of
what our consolidated results of operations actually would have been had we completed the
acquisition at the dates indicated. In addition, the unaudited pro forma financial information
does not purport to project the future results of operations of the combined company.
Barr Pharmaceuticals, Inc. and subsidiaries
Pro Forma Condensed Combined Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Revenues |
|
$ |
334,206 |
|
|
$ |
270,791 |
|
|
$ |
659,094 |
|
|
$ |
527,240 |
|
Earnings from operations |
|
|
143,287 |
(1) |
|
|
83,110 |
(2) |
|
|
271,939 |
(3) |
|
|
161,399 |
(4) |
Net income |
|
|
93,435 |
(1) |
|
|
52,714 |
(2) |
|
|
178,591 |
(3) |
|
|
101,114 |
(4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share basic |
|
$ |
0.89 |
|
|
$ |
0.51 |
|
|
$ |
1.71 |
|
|
$ |
0.98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share -
diluted |
|
$ |
0.87 |
|
|
$ |
0.50 |
|
|
$ |
1.67 |
|
|
$ |
0.95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares |
|
|
104,714 |
|
|
|
102,526 |
|
|
|
104,219 |
|
|
|
103,409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares diluted |
|
|
107,410 |
|
|
|
105,144 |
|
|
|
106,984 |
|
|
|
106,028 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The unaudited pro forma financial information above reflects the following:
|
|
|
(1) |
|
This amount includes amortization of $3,200 for the intangible asset that was acquired and an
add back of interest expense for the debt that was paid off before the closing of $265. |
|
(2) |
|
This amount includes amortization of $3,200 for the intangible asset that was acquired, an
add back of interest expense for the debt that was paid off before the closing of $836 and a
charge for the amount of the step-up in inventory to fair value of $5,469. |
9
|
|
|
(3) |
|
This amount includes amortization of $6,400 for the intangible asset that was acquired and an
add back of interest expense for the debt that was paid off before the closing of $671. |
|
(4) |
|
This amount includes amortization of $6,400 for the intangible asset that was acquired, an
add back of interest expense for the debt that was paid off before the closing of $1,655 and
a charge for the amount of the step-up in inventory to fair value of $10,335. |
Mircette® Acquisition
On June 15, 2005, the Company entered into a non-binding Letter of Intent with Organon
(Ireland) Ltd., Organon USA Inc. (Organon) and Savient Pharmaceuticals, Inc. (Savient) to
acquire the New Drug Application (NDA) for Mircette®, obtain a royalty-free patent license to
promote Mircette in the United States and dismiss all pending litigation between the parties in
exchange for a payment by the Company of up to $155,000. At the time of the signing of the Letter
of Intent, because the proposed transaction included, as one of its components, a payment in
settlement of litigation, it was presumed under GAAP to give rise to a probable loss, as defined
in SFAS No. 5, Accounting for Contingencies. In consultation with outside advisors and based on
preliminary valuations of the assets the Company would acquire if the transaction closed on the
terms then contemplated, the Company recorded a charge of $63,238 as of June 30, 2005 to reflect
the proposed litigation settlement.
On December 2, 2005, the Company and Organon finalized an agreement that gave the Company
exclusive rights for Organons Mircette product. The agreement also terminated the ongoing patent
litigation regarding the Companys generic version of Mircette, which is marketed under the trade
name Kariva®. The agreement called for the Company to pay Organon $139,000 and Savient $13,750.
Based on final valuations of the asset, the Company has recorded an intangible asset in the amount
of $88,700 and recorded an additional charge of $813 for the difference between amounts recorded as
a probable loss at June 30, 2005 and the final loss amount. The Company also incurred approximately
$1,800 of additional legal and accounting costs related to the transaction during the first half of
fiscal 2006. Additionally, the Company was reimbursed $11,000 from a third party for partial
reimbursement of the Companys recorded charge on this transaction. This reimbursement is reflected
as a reduction of selling, general and administrative expenses.
5. Inventories, net
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
June 30, |
|
|
|
2005 |
|
|
2005 |
|
Raw materials and supplies |
|
$ |
75,015 |
|
|
$ |
79,120 |
|
Work-in-process |
|
|
31,855 |
|
|
|
16,405 |
|
Finished goods |
|
|
37,168 |
|
|
|
42,113 |
|
|
|
|
|
|
|
|
Total |
|
$ |
144,038 |
|
|
$ |
137,638 |
|
|
|
|
|
|
|
|
Inventories are presented net of reserves of $20,900 and $13,415 at December 31, 2005 and June
30, 2005, respectively. The work-in-process and finished goods amounts include inventory acquired
in the FEI transaction that is stated at fair value. The amount included in these line items
related to the acquired inventory was $16,501 as of December 31, 2005 including $16,083 for the
step-up to fair value. Based on units sold from the closing date through December 31, 2005, the
Company charged cost of sales for $4,658 of the initial $20,741 step-up adjustment.
10
6. Goodwill and Other Intangible Assets
As a result of the acquisition of FEI the Company has recorded goodwill in the amount of
$29,619. The changes in the carrying amount of goodwill for the six months ended December 31, 2005
were due to the FEI acquisition.
Intangible assets, excluding goodwill, which are comprised primarily of product licenses and
product rights and related intangibles, consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
June 30, |
|
|
|
2005 |
|
|
2005 |
|
Product licenses |
|
$ |
45,600 |
|
|
$ |
45,600 |
|
Product rights and related intangibles |
|
|
415,496 |
|
|
|
70,796 |
|
|
|
|
|
|
|
|
|
|
|
461,096 |
|
|
|
116,396 |
|
Less: accumulated amortization |
|
|
(26,326 |
) |
|
|
(18,053 |
) |
|
|
|
|
|
|
|
Other intangible assets, net |
|
$ |
434,770 |
|
|
$ |
98,343 |
|
|
|
|
|
|
|
|
On November 9, 2005, the Company acquired the product rights to ParaGard T 380A IUD through
the acquisition of FEI. These product rights had a fair value of $256,000 at the date of
acquisition. On December 2, 2005 the Company also acquired the product rights to Mircette. The
Company recorded an intangible asset of $88,700 for this acquisition. These amounts are contained
in the table listed above.
Estimated amortization expense on product licenses and product rights and related intangibles
for the years ending June 30, 2006 through 2010 is as follows:
|
|
|
|
|
2006 |
|
$ |
25,773 |
|
2007 |
|
$ |
34,133 |
|
2008 |
|
$ |
32,240 |
|
2009 |
|
$ |
24,082 |
|
2010 |
|
$ |
22,431 |
|
The Companys product licenses and product rights and related intangibles have
weighted-average useful lives of approximately 10 and 18 years, respectively.
7. Income taxes payable
Income taxes payable decreased by $13,353 from June 30, 2005 due to the tax benefits relating
to stock-based compensation and the reversal of certain deferred tax assets. The benefits related
to these items combined with our normal tax provision and estimated tax payments created an income
tax receivable of $13,247 that has been reclassified into other receivables.
11
8. Segment Reporting
The Company operates in two reportable business segments: Generic Pharmaceuticals and
Proprietary Pharmaceuticals. Product sales and gross profit information for the Companys
operating segments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
|
|
|
|
|
|
|
Six Months Ended December 31, |
|
|
|
|
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
|
|
|
|
|
% of |
|
|
|
|
|
% of |
|
|
|
|
|
% of |
|
|
|
|
|
% of |
|
|
$s |
|
sales |
|
$s |
|
sales |
|
$s |
|
sales |
|
$s |
|
sales |
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic |
|
$ |
209,093 |
|
|
|
72 |
% |
|
$ |
191,616 |
|
|
|
75 |
% |
|
$ |
416,262 |
|
|
|
75 |
% |
|
$ |
371,858 |
|
|
|
75 |
% |
Proprietary |
|
|
80,293 |
|
|
|
28 |
% |
|
|
64,177 |
|
|
|
25 |
% |
|
|
139,917 |
|
|
|
25 |
% |
|
|
126,934 |
|
|
|
25 |
% |
|
|
|
|
|
Total product sales |
|
$ |
289,386 |
|
|
|
100 |
% |
|
$ |
255,793 |
|
|
|
100 |
% |
|
$ |
556,179 |
|
|
|
100 |
% |
|
$ |
498,792 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$s |
|
Margin % |
|
$s |
|
Margin % |
|
$s |
|
Margin % |
|
$s |
|
Margin % |
Gross profit: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic |
|
$ |
140,494 |
|
|
|
67 |
% |
|
$ |
123,452 |
|
|
|
64 |
% |
|
$ |
278,014 |
|
|
|
67 |
% |
|
$ |
242,207 |
|
|
|
65 |
% |
Proprietary |
|
|
65,160 |
|
|
|
81 |
% |
|
|
54,282 |
|
|
|
85 |
% |
|
|
114,371 |
|
|
|
82 |
% |
|
|
108,888 |
|
|
|
86 |
% |
|
|
|
|
|
Total gross profit |
|
$ |
205,654 |
|
|
|
71 |
% |
|
$ |
177,734 |
|
|
|
69 |
% |
|
$ |
392,385 |
|
|
|
71 |
% |
|
$ |
351,095 |
|
|
|
70 |
% |
|
|
|
|
|
9. Earnings Per Share
The following is a reconciliation of the numerators and denominators used to calculate
earnings per share (EPS) in the consolidated statements of operations:
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(in thousands, except per share amounts) |
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Earnings per common share basic: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (numerator) |
|
$ |
94,884 |
|
|
$ |
59,387 |
|
|
$ |
178,127 |
|
|
$ |
111,522 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares (denominator) |
|
|
104,714 |
|
|
|
102,526 |
|
|
|
104,219 |
|
|
|
103,409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share-basic |
|
$ |
0.91 |
|
|
$ |
0.58 |
|
|
$ |
1.71 |
|
|
$ |
1.08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (numerator) |
|
$ |
94,884 |
|
|
$ |
59,387 |
|
|
$ |
178,127 |
|
|
$ |
111,522 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares |
|
|
104,714 |
|
|
|
102,526 |
|
|
|
104,219 |
|
|
|
103,409 |
|
Effect of dilutive options and warrants |
|
|
2,696 |
|
|
|
2,618 |
|
|
|
2,765 |
|
|
|
2,619 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares diluted (denominator) |
|
|
107,410 |
|
|
|
105,144 |
|
|
|
106,984 |
|
|
|
106,028 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share-diluted |
|
$ |
0.88 |
|
|
$ |
0.56 |
|
|
$ |
1.66 |
|
|
$ |
1.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Not included in the calculation of diluted earnings
per share because their impact is antidilutive: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options outstanding |
|
|
1 |
|
|
|
1,830 |
|
|
|
23 |
|
|
|
1,795 |
|
10. Comprehensive Income
Comprehensive income is defined as the total change in shareholders equity during the period
other than from transactions with shareholders. For the Company, comprehensive income is comprised
of net earnings and the net changes in unrealized gains and losses on securities classified for
SFAS No. 115 purposes as available for sale. Total comprehensive income for the three months
ended December 31, 2005 and 2004 was $94,884 and $58,935, respectively, and for the six months
ended December 31, 2005 and 2004 was $178,033 and $110,717, respectively.
11. Commitments and Contingencies
Leases
The Company is party to various leases that relate to the rental of office facilities and
equipment. The table below shows the future minimum rental payments, exclusive of taxes, insurance
and other costs, under noncancellable long-term leases.
For fiscal years ending June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2008 |
|
|
2009 |
|
|
2010 |
|
|
Thereafter |
|
Operating leases |
|
$ |
4,459 |
|
|
$ |
4,125 |
|
|
$ |
3,528 |
|
|
$ |
3,436 |
|
|
$ |
3,345 |
|
|
$ |
16,165 |
|
Capital leases |
|
|
1,690 |
|
|
|
856 |
|
|
|
204 |
|
|
|
95 |
|
|
|
32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum lease payments |
|
$ |
6,149 |
|
|
$ |
4,981 |
|
|
$ |
3,732 |
|
|
$ |
3,531 |
|
|
$ |
3,377 |
|
|
$ |
16,165 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
Product Liability Insurance
The Company uses a combination of self-insurance and traditional third-party insurance
policies to cover product liability claims.
The Company maintains third-party insurance that provides coverage, subject to specified
co-insurance requirements, for the cost of product liability claims arising during the current
policy period, which began on
October 1, 2005 and ends on September 30, 2006, between an aggregate amount of $25,000 and
$75,000. The Company is self-insured for up to the first $25,000 of costs incurred relating to
product liability claims arising during the current policy period. In addition, the Company has
obtained extended reporting periods under previous policies for claims arising prior to the
current policy period. The current period and extended reporting period policies exclude certain
products; the Company is responsible for all product liability costs arising from these excluded
products.
The Company continues to incur significant legal costs associated with its hormone therapy
litigation (see below). As of December 31, 2005, these costs have been covered under extended
reporting period policies that provide up to $25,000 of coverage. As of December 31, 2005, there
was approximately $9,700 of coverage remaining under these policies. The Company has recorded a
receivable for legal costs incurred and expected to be recovered under these policies. Once the
coverage from these extended reporting period policies has been exhausted, future legal and
settlement costs will be covered by a combination of self-insurance and other third-party insurance
layers.
Indemnity Provisions
From time-to-time, in the normal course of business, the Company agrees to indemnify its
suppliers, customers and employees concerning product liability and other matters. For certain
product liability matters, the Company has incurred legal defense costs on behalf of certain of its
customers under these agreements. Except as described below, no amounts have been recorded in the
financial statements for probable losses with respect to the Companys obligations under such
agreements.
In June 2005, the Company entered into an agreement with Teva Pharmaceuticals USA, Inc. which
allowed Teva to manufacture and launch Tevas generic version of Aventis Allegra® product during
the Companys 180 day exclusivity period, in exchange for Tevas obligation to pay the Company a
specified percentage of Tevas operating profit, as defined, on sales of the product. The
agreement also provides that each company will indemnify the other for the portion of any patent
infringement damages they might incur as a result of the underlying litigation, described below, so
that the parties will share any such damage liability in proportion to their respective share of
Tevas operating profit. On September 1, 2005, Teva launched its generic version of Allegra and
the Company, in accordance with Financial Accounting Standards Board Interpretation No. 45
Guarantors Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees
of Indebtedness of Others, recorded a $4,057 liability to reflect the fair value of the
indemnification obligation it has undertaken. This amount is included in other liabilities on the
consolidated balance sheet as of December 31, 2005.
Litigation Settlement
On October 22, 1999, the Company entered into a settlement agreement with Schein
Pharmaceutical, Inc. (now part of Watson Pharmaceuticals, Inc.) relating to a 1992 agreement
regarding the pursuit of a generic conjugated estrogens product. Under the terms of the settlement,
Schein relinquished any claim to rights in Cenestin in exchange for a payment of $15,000 made to
Schein in 1999. An additional $15,000 payment is required under the terms of the settlement if
Cenestin achieves total profits (product sales less product-specific cost of goods sold, sales and
marketing and other relevant expenses) of greater than $100,000 over any five-year period prior to
October 22, 2014. As of December 31, 2005, no amounts have been recorded related to this
settlement.
14
Litigation Matters
The Company is involved in various legal proceedings incidental to its business, including
product liability, intellectual property and other commercial litigation and antitrust actions.
The Company records accruals for such contingencies to the extent that it concludes a loss is
probable and the amount can be reasonably estimated. Additionally, the Company records insurance
receivable amounts from third party insurers when appropriate.
Many claims involve highly complex issues relating to patent rights, causation, label
warnings, scientific evidence and other matters. Often these issues are subject to substantial
uncertainties and therefore, the probability of loss and an estimate of the amount of the loss are
difficult to determine. The Companys assessments are based on estimates that the Company, in
consultation with outside advisors, believes are reasonable. Although the Company believes it has
substantial defenses in these matters, litigation is inherently unpredictable. Consequently, the
Company could in the future incur judgments or enter into settlements that could have a material
adverse effect on its consolidated financial statements in a particular period.
Summarized below are the more significant matters pending to which the Company is a party. As
of December 31, 2005, the Companys reserve for the liability associated with claims or related
defense costs for these matters is not material.
Patent Matters
Desogestrel/Ethinyl Estradiol Suit
This matter was previously disclosed in the Companys Form 10-K filed in September 2005.
On December 2, 2005, the Company entered into a final settlement with Organon (Ireland) Ltd.,
Organon USA Inc. and Savient Pharmaceuticals, Inc., in which the Company acquired the New Drug
Application (NDA) for Mircette, obtained a royalty-free patent license to promote Mircette in the
United States and dismissed all pending litigation between the parties in exchange for a payment by
the Company of $139,000 to Organon and $13,750 to Savient.
Desmopressin Acetate Suit
In July 2002, the Company filed an Abbreviated New Drug Application (ANDA) seeking approval
from the U.S. Food and Drug Administration (FDA) to market desmopressin acetate tablets, the
generic equivalent of Aventis DDAVP® product. The Company notified Ferring AB, the patent holder,
and Aventis pursuant to the provisions of the Hatch-Waxman Act in October 2002. Ferring AB and
Aventis filed a suit in the U.S. District Court for the Southern District of New York in December
2002 for infringement of one of the four patents listed in the Orange Book for desmopressin acetate
tablets, seeking to prevent the Company from marketing desmopressin acetate tablets until the
patent expires in 2008. In January 2003, the Company filed an answer and counterclaim asserting
non-infringement and invalidity of all four listed patents. In January 2004, Ferring AB amended
their complaint to add a claim of willful infringement.
On February 7, 2005, the court granted summary judgment in the Companys favor. Ferring AB
and Aventis have appealed. On July 5, 2005, the Company launched its generic product. If Ferring
AB and Aventis are successful in reversing the grant of summary judgment and ultimately prevail in
the case, the Company could be liable for damages for patent infringement that could exceed the
Companys profit on the sale of desmopressin acetate. In addition, depending on when the
litigation is ultimately resolved, an adverse ruling likely would prohibit the Company from
continuing to sell its desmopressin acetate product.
Fexofenadine Hydrochloride Suit
In June 2001, the Company filed an ANDA seeking approval from the FDA to market fexofenadine
hydrochloride tablets in 30 mg, 60 mg and 180 mg strengths, the generic equivalent of Aventis
Allegra® tablet products for allergy relief. The Company notified Aventis pursuant to the
provisions of the Hatch-Waxman Act
15
and, in September 2001, Aventis filed a patent infringement
action in the U.S. District Court for the District of New Jersey-Newark Division, seeking to
prevent the Company from marketing this product until after the expiration of various U.S. patents,
the last of which is alleged to expire in 2017.
After the filing of the Companys ANDAs, Aventis listed an additional patent on Allegra in the
Orange Book. The Company filed appropriate amendments to its ANDAs to address the newly listed
patent and, in November 2002, notified Merrell Pharmaceuticals, Inc., the patent holder, and
Aventis pursuant to the provisions of the Hatch-Waxman Act. Aventis filed an amended complaint in November 2002 claiming that the
Companys ANDAs infringe the newly listed patent.
On March 5, 2004, Aventis and AMR Technology, Inc., the holder of certain patents licensed to
Aventis, filed an additional patent infringement action in the U.S. District Court for the District
of New Jersey Newark Division, based on two patents that are not listed in the Orange Book.
In June 2004, the court granted the Company summary judgment of non-infringement as to two
patents. On March 31, 2005, the court granted the Company summary judgment of invalidity as to a
third patent. Discovery is proceeding on the five remaining patents at issue in the case. No trial
date has been scheduled.
On August 31, 2005, the Company received final FDA approval for its fexofenadine tablet
products. As referenced above, pursuant to an agreement between the Company and Teva, the Company
selectively waived its 180 days of generic exclusivity to Teva, and Teva launched its generic
product on September 1, 2005.
On September 21, 2005, Aventis filed a motion for a preliminary injunction or expedited trial.
The motion asked the court to enjoin the Company and Teva from marketing their generic versions of
Allegra tablets, 30 mg, 60 mg and 180 mg, or to expedite the trial in the case. The motion also
asked the court to enjoin Ranbaxy Laboratories, Ltd. and Amino Chemicals, Ltd. from the commercial
production of generic fexofenadine raw material. The preliminary injunction hearing concluded on
November 3, 2005. On January 30, 2006, the Court denied the motion by Aventis for a preliminary
injunction or expedited trial.
Aventis also has brought a patent infringement suit against Teva in Israel, seeking to have
Teva enjoined from manufacturing generic versions of Allegra tablets and requesting damages for
patent infringement.
If the Company and Teva are unsuccessful in the litigation, the Company and Teva could be
liable for Aventis lost profits on the sale of Allegra, which could potentially exceed the Company
and Tevas profits on the sale of the generic product.
Product Liability Matters
Hormone Therapy Litigation
The Company has been named as a defendant in approximately 3,400 personal injury product
liability cases brought against the Company and other manufacturers by plaintiffs claiming that
they suffered injuries resulting from the use of certain estrogen and progestin medications
prescribed to treat the symptoms of menopause. The cases against the Company involve either or
both of the Companys Cenestin products or the use of the Companys medroxyprogesterone acetate
product, which typically has been prescribed for use in conjunction with Premarin or other hormone
therapy products. All of these products remain approved by the FDA and continue to be marketed and
sold to customers. While the Company has been named as a defendant in these cases, fewer than a
third of the complaints actually allege the plaintiffs took a product manufactured by the Company,
and the Companys experience to date suggests that, even in these cases, a high percentage of the
plaintiffs will be unable to demonstrate actual use of a Company product. For that reason,
approximately 2,400 of the 3,400 cases have been dismissed and, based on discussions with the
Companys outside counsel, several hundred more are expected to be dismissed in the near future.
The Company believes it has viable defenses to the allegations in the complaints and is
defending the actions vigorously.
16
Antitrust Matters
Invamed, Inc./Apothecon, Inc.
In February 1998, Invamed, Inc. and Apothecon, Inc., both of which have since been acquired by
Sandoz, Inc., which is a subsidiary of Novartis AG, named the Company and several others as
defendants in lawsuits filed in the U.S. District Court for the Southern District of New York,
alleging violations of antitrust laws and also
charging that the Company unlawfully blocked access to the raw material source for warfarin
sodium. The two actions have been consolidated. On May 10, 2002, the District Court granted
summary judgment in the Companys favor on all antitrust claims in the case, but found that the
plaintiffs could proceed to trial on their allegations that the Company interfered with an alleged
raw material supply contract between Invamed and the Companys raw material supplier. Invamed and
Apothecon appealed the District Courts decision to the U. S. Court of Appeals for the Second
Circuit. Trial on the merits was stayed pending the outcome of the appeal.
On October 18, 2004, the Court of Appeals reversed the District Courts grant of summary
judgment and held that the plaintiffs have raised triable issues of material fact on their
antitrust claims. Discovery is ongoing in the District Court. The case is scheduled to be ready
for trial by June 2006.
The Company believes that the suits filed by Invamed and Apothecon are without merit and is
vigorously defending its position. The plaintiffs were seeking damages of approximately $120,000
as of December 31, 2000, and if successful on their underlying claims may seek to obtain treble
damages.
Ciprofloxacin (Cipro®) Antitrust Class Actions
The Company has been named as a co-defendant with Bayer Corporation, The Rugby Group, Inc. and
others in approximately 38 class action complaints filed in state and federal courts by direct and
indirect purchasers of Ciprofloxacin (Cipro) from 1997 to the present. The complaints alleged that
the 1997 Bayer-Barr patent litigation settlement agreement was anti-competitive and violated
federal antitrust laws and/or state antitrust and consumer protection laws. A prior investigation
of this agreement by the Texas Attorney Generals Office on behalf of a group of state Attorneys
General was closed without further action in December 2001.
The lawsuits included nine consolidated in California state court, one in Kansas state court,
one in Wisconsin state court, one in Florida state court, and two consolidated in New York state
court, with the remainder of the actions pending in the U.S. District Court for the Eastern
District of New York for coordinated or consolidated pre-trial proceedings (the MDL Case). On
March 31, 2005, the Court in the MDL Case granted summary judgment in the Companys favor and
dismissed all of the federal actions before it. On June 7, 2005, plaintiffs filed notices of
appeal to the U.S. Court of Appeals for the Second Circuit. The Court of Appeals has stayed
consideration of the merits pending consideration of the Companys motion to transfer the appeal to
the United States Court of Appeals for the Federal Circuit.
On September 19, 2003, the Circuit Court for the County of Milwaukee dismissed the Wisconsin
state class action for failure to state a claim for relief under Wisconsin law. Plaintiffs
appealed, and briefing is currently underway. On October 17, 2003, the Supreme Court of the State
of New York for New York County dismissed the consolidated New York state class action for failure
to state a claim upon which relief could be granted and denied the plaintiffs motion for class
certification. Plaintiffs have appealed that decision and briefing is complete. On April 13, 2005,
the Superior Court of San Diego, California ordered a stay of the California state class actions
until after the resolution of any appeal in the MDL Case. On April 22, 2005, the District Court of
Johnson County, Kansas similarly stayed the action before it, until after any appeal in the MDL
Case. The Florida state class action remains at a very early stage, with no status hearings,
dispositive motions, pre-trial schedules, or a trial date set as of yet.
The Company believes that its agreement with Bayer Corporation reflects a valid settlement to
a patent suit and cannot form the basis of an antitrust claim. Based on this belief, the Company
is vigorously defending itself in these matters.
17
Tamoxifen Antitrust Class Actions
To date approximately 31 consumer or third-party payor class action complaints have been
filed in state and federal courts against Zeneca, Inc., AstraZeneca Pharmaceuticals L.P. and the
Company alleging, among other things, that the 1993 settlement of patent litigation between Zeneca
and the Company violated the antitrust laws, insulated Zeneca and the Company from generic
competition and enabled Zeneca and the Company to charge artificially inflated prices for
tamoxifen citrate. A prior investigation of this agreement by the U.S. Department of
Justice was closed without further action. On May 19, 2003, the U.S. District Court
dismissed the complaints for failure to state a viable antitrust claim. On November 2, 2005, the
United States Court of Appeals for the Second Circuit affirmed the District Courts order
dismissing the cases for failure to state a viable antitrust claim. On November 30, 2005,
Plaintiffs petitioned the United States Court of Appeals for the Second Circuit for a rehearing en
banc. The Court of Appeals directed the Company to file a response to Plaintiffs petition, which
the Company submitted on January 26, 2006. The Court has not yet ruled on the merits of the
petition.
The Company believes that its agreement with Zeneca reflects a valid settlement to a patent
suit and cannot form the basis of an antitrust claim. Based on this belief, the Company is
vigorously defending itself in these matters.
Ovcon Antitrust Proceedings
To date, the Company has been named as a co-defendant with Warner Chilcott Holdings, Co. III,
Ltd., and others in complaints filed in federal courts by the Federal Trade Commission, 34 State
Attorneys General and nine private class action plaintiffs claiming to be direct and indirect
purchasers of Ovcon-35®. These actions allege, among other things, that a March 24, 2004 Option
and License Agreement between the Company and Galen Holdings PLC (known since January 2005 as
Warner Chilcott Holdings Company, Limited) constitutes an unfair method of competition, is
anticompetitive and restrains trade in the market for Ovcon-35® and its generic equivalents. These
cases, the first of which was filed by the FTC on or about December 2, 2005, remain at a very early
stage, with no status hearings, dispositive motions, pre-trial schedules, or trial dates set as
of yet.
The Company believes that it has not engaged in any improper conduct and is vigorously
defending itself in these matters.
Medicaid Reimbursement Cases
The Company, along with numerous other pharmaceutical companies, has been named as a defendant
in separate actions brought by the states of Alabama, Kentucky, Illinois, Mississippi, the
Commonwealth of Massachusetts, the City of New York, and numerous counties in New York. In each of
these matters, the plaintiffs seek to recover damages and other relief for alleged overcharges for
prescription medications paid for or reimbursed by their respective Medicaid programs.
The Commonwealth of Massachusetts case and the New York cases, with the exception of the
action filed by Erie County, are currently pending in the U.S. District Court for the District of
Massachusetts. Those actions are at an early stage with no trial dates set. The Erie County case
was recently remanded from federal court in Massachusetts to state court in New York, and is also
at an early stage with no trial date set.
The Alabama case was filed in Alabama state court, removed to the U.S. District Court for the
Middle District of Alabama, and returned to state court with no trial date currently set. The
Illinois and Kentucky cases were filed in Illinois and Kentucky state courts, removed to federal
court, and transferred to the United States District Court for the District of Massachusetts.
Illinois and Kentucky have filed motions to have those cases returned to state court. The
defendants have filed motions to dismiss, which have not yet been decided.
The State of Mississippi case was filed in state court on October 20, 2005. This matter is at
a very early stage with no trial date set.
18
The Company believes that it has not engaged in any improper conduct and is vigorously
defending itself in these matters.
Breach of Contract Action
On October 6, 2005, plaintiffs Agvar Chemicals Inc., Ranbaxy Laboratories, Inc. and Ranbaxy
Pharmaceuticals, Inc. filed suit against the Company and Teva Pharmaceuticals USA, Inc. in the
Superior Court of New Jersey. In their complaint, plaintiffs seek to recover damages and other
relief, based on an alleged breach of an alleged contract requiring the Company to purchase raw
material for the Companys generic Allegra product from Ranbaxy, prohibiting the Company from
launching its generic Allegra product without Ranbaxys consent and prohibiting the Company from
entering into an agreement authorizing Teva to launch Tevas generic Allegra product. This matter
is at a very early stage, with no status hearings, dispositive motions, pre-trial schedules, or a
trial date set as of yet. The Company believes there was no such contract and is vigorously
defending itself.
Other Litigation
As of December 31, 2005, the Company was involved with other lawsuits incidental to its
business, including patent infringement actions, product liability, and personal injury claims.
Management, based on the advice of legal counsel, believes that the ultimate outcome of these other
matters will not have a material adverse effect on the Companys consolidated financial statements.
19
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis addresses material changes in the results of operations
and financial condition of Barr Pharmaceuticals, Inc. and subsidiaries for the periods presented.
This discussion and analysis should be read in conjunction with the consolidated financial
statements, the related notes to consolidated financial statements and Managements Discussion and
Analysis of Results of Operations and Financial Condition included in the Companys Annual Report
on Form 10-K for the fiscal year ended June 30, 2005, and the unaudited interim consolidated
financial statements and related notes included in Item 1 of this report on Form 10-Q.
Business Development Activities
On June 15, 2005, we entered into a non-binding Letter of Intent with Organon (Ireland) Ltd.,
Organon USA Inc. (Organon) and Savient Pharmaceuticals, Inc. (Savient) to acquire the New Drug
Application (NDA) for the oral contraceptive product, Mircette®, obtain a royalty-free patent
license to promote Mircette in the United States and dismiss all pending litigation between the
parties in exchange for a payment by us of up to $155.0 million. At the time of the signing of the
Letter of Intent, because the proposed transaction included, as one of its components, a payment in
settlement of litigation, it was presumed under GAAP to give rise to a probable loss, as defined
in SFAS No. 5, Accounting for Contingencies. In consultation with outside advisors and based on
preliminary valuations of the assets we would acquire if the transaction closed on the terms then
contemplated, we recorded a charge of $63.2 million as of June 30, 2005 to reflect the proposed
litigation settlement.
On December 2, 2005, we finalized an agreement with Organon and Savient to acquire the
exclusive rights to Mircette. The agreement terminated the ongoing patent litigation regarding our
generic version of Mircette, which we market under the trade name Kariva. The agreement called for
us to pay Organon $139.0 million and Savient $13.8 million. Based on final valuations of the assets
acquired, we recorded an additional charge of $0.8 million for the difference between amounts
recorded as a probable loss at June 30, 2005 and the final loss amount. We also incurred
transaction costs (primarily legal and accounting fees) for the three and six months ended December
31, 2005 of $0.6 million and $1.8 million, respectively. Additionally, we received $11.0 million
from a third party as partial reimbursement of the $64.0 million charge recorded in conjunction
with this transaction. The $11.0 million reimbursement, together with the additional settlement
charge of $0.8 million and the transactions costs for the three and six months of $0.6 million and
$1.8 million, have all been classified in the selling, general and administrative expense line and
result in a net benefit to selling, general and administrative expenses of $9.5 million for the
three months ended December 31, 2005 and $8.4 million for the six months ended December 31, 2005.
On November 9, 2005, we completed the acquisition of FEI Womens Health, LLC (FEI). FEI is
the owner of ParaGard® T 380A (Intrauterine Copper Contraceptive) IUD (Paragard IUD),
which is approved for continuous use for the prevention of pregnancy for up to 10 years. FEIs
results are included in our financial statements subsequent to November 9, 2005. In conjunction
with this transaction, we recorded an intangible asset of $256 million, increased the cost of the
acquired inventory by $20.7 million to state it at fair value and recorded goodwill of $29.6
million. The intangible asset is being amortized over 20 years while the $20.7 million adjustment
to inventory is being charged to cost of sales as the acquired inventory is sold.
20
Results of Operations
Comparison of the Three and Six Months Ended December 31, 2005 and December 31, 2004
The following table sets forth revenue data for the three and six months ended December 31,
2005 and 2004 (dollars in millions).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Six Months Ended December 31, |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
Generic products: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral contraceptives |
|
$ |
95.9 |
|
|
$ |
102.2 |
|
|
$ |
(6.3 |
) |
|
|
-6 |
% |
|
$ |
191.2 |
|
|
$ |
202.2 |
|
|
$ |
(11.0 |
) |
|
|
-5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other generic |
|
|
113.2 |
|
|
|
89.4 |
|
|
|
23.8 |
|
|
|
27 |
% |
|
|
225.1 |
|
|
|
169.7 |
|
|
|
55.4 |
|
|
|
33 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total generic products |
|
|
209.1 |
|
|
|
191.6 |
|
|
|
17.5 |
|
|
|
9 |
% |
|
|
416.3 |
|
|
|
371.9 |
|
|
|
44.4 |
|
|
|
12 |
% |
Proprietary products |
|
|
80.3 |
|
|
|
64.2 |
|
|
|
16.1 |
|
|
|
25 |
% |
|
|
139.9 |
|
|
|
126.9 |
|
|
|
13.0 |
|
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Product Sales |
|
|
289.4 |
|
|
|
255.8 |
|
|
|
33.6 |
|
|
|
13 |
% |
|
|
556.2 |
|
|
|
498.8 |
|
|
|
57.4 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alliance, development and other revenue |
|
|
36.1 |
|
|
|
1.6 |
|
|
|
34.5 |
|
|
|
2156 |
% |
|
|
79.8 |
|
|
|
3.1 |
|
|
|
76.7 |
|
|
|
2474 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
325.5 |
|
|
$ |
257.4 |
|
|
$ |
68.1 |
|
|
|
26 |
% |
|
$ |
636.0 |
|
|
$ |
501.9 |
|
|
$ |
134.1 |
|
|
|
27 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues Product Sales
Generic Products
Total generic product sales for the three and six months ended December 31, 2005 increased
due to a significant increase in our sales of other generic products, as described below, slightly
offset by lower sales of our generic oral contraceptive products.
Oral Contraceptives
For the three and six months ended December 31, 2005, sales of generic oral contraceptives
declined 6% and 5%, respectively, over the prior year periods. The decline in our generic oral
contraceptives reflects the continued decline in demand for many of these non-promoted products and lower
pricing and fewer units sold due to the impact of competition especially on certain larger oral
contraceptives, such as Aviane and Apri. These factors more than offset higher year-over-year
generic substitution rates and the impact of customer buying patterns
on certain other products, including Kariva.
Other Generic Products
For the three and six months ended December 31, 2005, other generic product sales increased
27% and 33%, respectively over the prior year periods due mainly to the July 2005 launch of
Desmopressin and, to a lesser extent, contributions from Didanosine, which we launched in December
2004. We expect Desmopressin sales, which have been favorably impacted in the first half of the
year by rapid generic substitution, to decline sharply in the third quarter (and thereafter) due
to the launch of a competing product in January 2006. Partially offsetting the strong sales from
Desmopressin and Didanosine were lower sales of Mirtazapine and Metformin XR 750mg due to increased
competition for these products, and reduced demand for Claravis. Lower sales volumes of Claravis,
which is indicated for the treatment of severe acne, are in large part the result of lower
customer demand as
certain customers reduced inventory in anticipation of new labeling requirements.
Manufacturers and marketers of isotrentinoin products, including Claravis, in cooperation with the
FDA, are currently implementing an enhanced risk management program, iPledge, which is designed to
minimize fetal exposure to isotrentinion. iPledge, which
21
is being implemented in stages over the
next few months, is expected to replace the existing risk management program.
Proprietary Products
For the three and six months ended December 31, 2005 proprietary products sales increased 25%
and 10%, respectively, over the prior year periods, primarily the result of (1) an increase in
sales of Seasonale, (2) sales of the Paragard IUD and Mircette oral contraceptive, which we
acquired in November 2005 and December 2005, respectively, (3) modest increases in sales of
Prefest and Nordette, which we acquired in November 2004 and December 2004, respectively, and (4)
increased sales of Plan B. These increases more than offset lower sales of Cenestin and
Loestrin/Loestrin FE due to volume declines reflecting lower year-over-year prescriptions.
Seasonale sales totaled $29.5 million for the quarter and $51.6 million for the six months
ended December 31, 2005, a 43% and 40% increase, respectively, over the comparable prior year
periods. The significant increase for the current periods resulted
from higher unit sales
Seasonale prescriptions increased from 193,000 in the prior year quarter to 255,000 in the current
quarter as well as higher pricing. Based on current prescription levels and a continued
commitment to consumer advertising, we continue to expect our fiscal 2006 sales of Seasonale to
exceed $100 million.
Revenues
Alliance, Development and Other Revenue
Alliance, development and other revenue consists mainly of revenue from profit-sharing
arrangements, co-promotion agreements, standby manufacturing fees and reimbursements and fees we
receive in conjunction with our agreement with the U.S. Department of Defense for the development
of the Adenovirus vaccine. Alliance, development and other revenue increased substantially from
the prior year primarily due to (1) our profit-sharing arrangement with Teva on sales of their
generic Allegra® product and (2) royalty payments and other fees under our
Co-Promotion Agreement and License and Manufacturing Agreement with Kos Pharmaceuticals, Inc.
(Kos) on Niaspan® and Advicorâ which we began receiving in the
fourth quarter of fiscal 2005.
The last day of the 180-day exclusivity period on generic Allegra
tablets is February 26, 2006. Our agreement with Teva provides
for a reduced profit-sharing percentage for product sold after the
expiration of the 180-day exclusivity period. In addition, we are
aware of competitors that have filed ANDAs with a Paragraph IV
certification for generic Allegra tablets. With respect to one such
competitor, the 30-month stay of final FDA approval has expired, so
that it may be eligible for final approval from the FDA after
February 26, 2006. Another competitors 30-month stay
expires in early June 2006, at which time it may be eligible to
receive FDA approval on its ANDA for generic Allegra. If, upon
receipt of FDA approval, either of these or any other competitors
decide to launch their generic Allegra product at risk,
Tevas Allegra revenues and our royalties from Teva could decrease
significantly.
Cost of Sales
Cost of sales includes the cost of products we purchase from third parties, our manufacturing
and packaging costs for products we manufacture, our profit-sharing or royalty payments made to
third parties, including raw material suppliers, changes to our inventory reserves and stock-based
compensation expense of certain departments. Amortization costs arising from the acquisition of
product rights are included in selling, general and administrative expense.
The following table sets forth cost of sales data, in dollars, as well as the resulting gross
margins expressed as a percentage of product sales, for the three and six months ended December
31, 2005 and 2004 (dollars in millions):
22
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Six Months Ended December 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
Generic products |
|
$ |
68.6 |
|
|
$ |
68.2 |
|
|
$ |
0.4 |
|
|
|
0.6 |
% |
|
$ |
138.3 |
|
|
$ |
129.7 |
|
|
$ |
8.6 |
|
|
|
6.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
67.2 |
% |
|
|
64.4 |
% |
|
|
|
|
|
|
|
|
|
|
66.8 |
% |
|
|
65.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proprietary products |
|
$ |
15.1 |
|
|
$ |
9.9 |
|
|
$ |
5.2 |
|
|
|
52.5 |
% |
|
$ |
25.5 |
|
|
$ |
18.0 |
|
|
$ |
7.5 |
|
|
|
41.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
81.2 |
% |
|
|
84.6 |
% |
|
|
|
|
|
|
|
|
|
|
81.7 |
% |
|
|
85.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of sales |
|
$ |
83.7 |
|
|
$ |
78.1 |
|
|
$ |
5.6 |
|
|
|
7.2 |
% |
|
$ |
163.8 |
|
|
$ |
147.7 |
|
|
$ |
16.1 |
|
|
|
10.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
71.1 |
% |
|
|
69.5 |
% |
|
|
|
|
|
|
|
|
|
|
70.6 |
% |
|
|
70.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charges
included in proprietary products cost of sales for step-up inventory |
|
$ |
4.7 |
|
|
$ |
|
|
|
$ |
4.7 |
|
|
|
100.0 |
% |
|
$ |
4.7 |
|
|
$ |
|
|
|
$ |
4.7 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proprietary Gross margin effect |
|
|
5.8 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
3.4 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
Total Gross margin effect |
|
|
1.6 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
0.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Overall gross margins increased for the three and six months ended December 31, 2005 compared
to the prior year due to higher margins on our generic products and a higher mix of proprietary
products as a percentage of total product sales, partially offset by lower margins on our
proprietary products due to product mix and stock-based compensation expense being included in the
current year amounts.
Generic margins increased for the three and six months ended December 31, 2005 due mainly to
the launches of new products, specifically Desmopressin and full-period contribution from
Didanosine, which carry higher margins than the average of our other generic products. The margin
increase related to these products was slightly offset by stock-based compensation expense.
Proprietary margins declined for the three and six months ended December 31, 2005 due
primarily to (a) an additional charge of $4.7 million to cost of sales as described earlier
related to the inventory purchased in the FEI acquisition, (b) the inclusion of stock-based
compensation expense in the current year and (c) a slight change in the mix of products, as
sales of higher margin products declined as a percentage of total proprietary sales.
Selling, General and Administrative Expense
The following table sets forth selling, general and administrative expense for the three and
six months ended December 31, 2005 and 2004 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
|
|
|
|
Six Months Ended December 31, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
Selling, general
and administrative |
|
$ |
66.1 |
|
|
$ |
58.4 |
|
|
$ |
7.7 |
|
|
|
13.2 |
% |
|
$ |
134.7 |
|
|
$ |
122.7 |
|
|
$ |
12.0 |
|
|
|
9.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit included in
selling, general
and admin. |
|
$ |
(9.5 |
) |
|
$ |
|
|
|
$ |
(9.5 |
) |
|
|
(100 |
%) |
|
$ |
(8.4 |
) |
|
$ |
|
|
|
$ |
(8.4 |
) |
|
|
(100 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23
Selling, general and administrative expenses for the current quarter increased by 13% over the
prior year period and reflect the net benefit of $9.5 million relating to the Mircette transaction,
as discussed above. The quarter-over-quarter increase reflects (1) higher selling and marketing
costs of $6.9 million, (2) higher information technology costs of $3.4 million, (3) $2.6 million of
stock based compensation which we did not have in the prior year period and (4) an increase in
legal expenses of $2.9 million. Higher sales and marketing costs are primarily attributable to
higher marketing costs for Seasonale as well as costs for Enjuvia, which we expect to launch in
late fiscal 2006. The increase also includes higher sales force costs primarily related to the
additional sales force acquired in the acquisition of FEI. Higher information technology costs are
primarily related to consulting and training costs related to the implementation of our new SAP
enterprise resource planning system. Higher legal spending is attributable higher spending on
current litigation matters associated with certain antitrust cases and patent challenge matters.
Selling, general and administrative expenses for the six month period increased by 10% over
the prior year period and reflect the net benefit of $8.4 million relating to the Mircette
transaction, as discussed above. The period-over-period increase reflects (1) higher selling and
marketing costs of $5.5 million, for the reasons discussed in connection with the quarterly
comparison above, (2) higher information technology costs of $4.1 million, for the reasons
discussed in connection with the quarterly comparison above, and (3) $5.0 million of stock based
compensation which we did not have in the prior year period.
Research and Development
The following table sets forth research and development expenses for the three and six months
ended December 31, 2005 and 2004 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
|
|
|
|
Six Months Ended December 31, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
Research and development |
|
$ |
30.9 |
|
|
$ |
31.1 |
|
|
$ |
(0.2 |
) |
|
|
-0.6 |
% |
|
$ |
66.0 |
|
|
$ |
59.7 |
|
|
$ |
6.3 |
|
|
|
10.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses for the current three and six month periods includes a
reimbursement of $5.0 million for previously incurred costs under a third party development
agreement. Excluding this reimbursement the remaining increase for the three month period included
$1.7 million in higher clinical trial costs and $1.5 million in stock-based compensation, which we
did not have in the prior year. The net increase for the six month period was primarily from $3.0
million in higher clinical trial costs, $2.9 million in stock-based compensation expenses which we
did not have in the prior year, $1.3 million in higher raw material costs and $1.3 million in
higher third party development costs.
Income Taxes
The following table sets forth income tax expense and the resulting effective tax rate stated
as a percentage of pre-tax income for the three and six months ended December 31, 2005 and 2004
(dollars in millions):
24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Six Months Ended December 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
|
2005 |
|
|
2004 |
|
|
$ |
|
|
% |
|
Income tax expense |
|
$ |
54.1 |
|
|
$ |
32.4 |
|
|
$ |
21.7 |
|
|
|
67.0 |
% |
|
$ |
101.5 |
|
|
$ |
63.5 |
|
|
$ |
38.0 |
|
|
|
59.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
36.3 |
% |
|
|
35.3 |
% |
|
|
|
|
|
|
|
|
|
|
36.3 |
% |
|
|
36.3 |
% |
|
|
|
|
|
|
|
|
The effective tax rate in the prior year quarter was favorably impacted by the
retroactive reinstatement on October 4, 2004, of the federal research tax credit which had
temporarily expired on June 30, 2004.
The tax rate for the current quarter was favorably impacted by the benefit of new tax
legislation, Section 199 (Manufacturers Deduction, effective July 1, 2005), partially offset by
the unfavorable tax effect of SFAS 123R which prohibits the tax deductibility of certain
stockbased compensation until the options are exercised in a disqualifying manner. We expect our
effective tax rate for the remainder of the year to be commensurate with the rate recorded in the
current quarter.
Liquidity and Capital Resources
Our primary source of cash is the collection of accounts and other receivables primarily
related to product sales and our alliance, development and other revenues. Our primary uses of cash
include financing inventory, research and development, marketing, capital projects and business
development activities.
Within the past 12 months cash flows from operations have been more than sufficient to fund
our cash needs. At December 31, 2005, our cash, cash equivalents and short-term marketable
securities totaled $421.8 million, a decrease of $221.5 million from our position at June 30, 2005.
The reduction is primarily due to the acquisitions made during the first half of fiscal 2006.
Operating Activities
Our operating cash flows for the first half of fiscal 2006 were $104.8 million, compared with
$214.9 million for the prior year period. The decline compared to last year reflects an increase in
working capital due to the timing of certain accounts receivable collections and the timing of
certain liability payments. For example, the prior years total
included the receipt of $47.7 million from
Aventis related to Ciprofloxacin price adjustments which were not repeated
during the first half of fiscal 2006. In addition, certain tax benefits which totaled $24.6 million
for the six months ended December 31, 2005 were reclassified from operating activities to financing
activities in fiscal 2006 as described below.
Components of the $104.8 million of operating cash flows in the first six months of fiscal
year 2006 include: (1) net earnings of $178.1 million, (2) a $66.0 million increase in accounts
receivable and other receivables due to the revenue recognized under our agreement with Teva for
the sale of generic Allegra and an overall increase in revenues, (3) a decrease in accounts payable
and accrued liabilities of $71.2 million due mainly to the payment of the legal settlement with
Organon for the Mircette acquisition, (4) the recording of stock-based compensation expense of
$13.9 million, and (5) the recording of $28.3 million in deferred taxes primarily related to the
Mircette acquisition.
Investing Activities
Net cash used in investing activities totaled $253.0 million for the first six months of
fiscal 2006 compared with $128.0 million in the prior year period. The cash used in investing
activities in the current period consisted of our acquisitions of FEI and Mircette for a total of
$378.1 million (net of cash acquired) and capital expenditures of
$36.0 million, partially offset by net sales of marketable securities of
$164.2 million. The prior year included net purchases of marketable securities of $51.7 million,
capital expenditures of $24.9 million,
25
buyout of product royalty of $19.3 million and acquisitions
of $27.0 million. We expect capital expenditures to be approximately $50-60 million for the fiscal
year ending June 30, 2006.
Financing Activities
Net cash provided by financing activities during the first half of fiscal 2006 was $62.4
million compared with net cash used of $99.6 million in the prior year period. The net cash
provided in the current fiscal year primarily reflects proceeds from the exercise of stock options
and employee stock purchases of $42.6 million and the tax benefit of stock incentive plans of
$24.6 million which was included as a component of operating cash flows in the prior year. The
cash generated by options exercised and employee stock purchases is heavily dependent on the
Companys stock price, which increased during the first half of the fiscal year. The level of
proceeds from stock option exercises realized in the first six months of fiscal 2006 may or may
not be repeated in subsequent periods. The net cash used in the prior year primarily reflected the
use of $100.0 million to repurchase shares of our common stock under our share repurchase.
Sufficiency of Cash Resources
We believe our current cash and cash equivalents, marketable securities, investment balances,
cash flows from operations and un-drawn amounts under our revolving credit facility are adequate
to fund our operations and planned capital expenditures and to capitalize on strategic
opportunities as they arise. We have and will continue to evaluate our capital structure as part
of our goal to promote long-term shareholder value. To the extent that additional capital
resources are required, we believe that such capital may be raised by additional bank borrowings,
debt or equity offerings or other means.
Critical Accounting Policies
The methods, estimates and judgments we use in applying the accounting policies most critical
to our financial statements have a significant impact on our reported results. The Securities and
Exchange Commission has defined the most critical accounting policies as the ones that are most
important to the portrayal of our financial condition and results, and/or require us to make our
most difficult and subjective judgments. Based on this definition, our most critical policies are
the following: (1) revenue recognition and related provisions for estimated reductions to gross
revenues (2) inventories and related inventory reserves; (3) income taxes; (4) contingencies; and
(5) accounting for acquisitions. Although we believe that our estimates and assumptions are
reasonable, they are based upon information available at the time the estimates and assumptions
were made. We review the factors that influence our estimates and, if necessary, adjust them.
Actual results may differ significantly from our estimates.
There are no updates to our Critical Accounting Policies from those described in our Annual
Report on Form 10-K for the fiscal year ended June 30, 2005, as modified in our Quarterly Report
on Form 10-Q for the quarter ended September 30, 2005. Please see the Critical Accounting
Policies sections of those reports for a comprehensive discussion of our critical accounting
policies.
Recent Accounting Pronouncements
In March 2005, the FASB published Interpretation No. 47, Accounting for Conditional Asset
Retirement Obligations, which clarifies that the term conditional asset retirement obligation,
as used in SFAS No. 143, Accounting for Asset Retirement Obligations, refers to a legal
obligation to perform an asset retirement activity in which the timing and (or) method of
settlement are conditional on a future event that may or may not be within the control of the
entity. The uncertainty about the timing and (or) method of settlement of a conditional asset
retirement obligation should be factored into the measurement of the liability when sufficient
information exists. The interpretation also clarifies when an entity would have sufficient
information to reasonably estimate the fair value of an asset retirement obligation. The adoption
of this Interpretation during the second quarter of fiscal year 2006 did not have a material effect
on our consolidated financial position, results of operations or cash flows.
26
In June 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections. SFAS
No. 154 replaces APB (Accounting Principles Board) Opinion No. 20, Accounting Changes, and SFAS
No. 3, Reporting Accounting Changes in Interim Financial Statements, and changes the requirements
for the accounting for and reporting of a change in accounting principle. This Statement applies to
all voluntary changes in accounting principle. It also applies to changes required by an accounting
pronouncement in the unusual instance that the pronouncement does not include specific transition
provisions. When a pronouncement includes specific transition provisions, those provisions should
be followed. This Statement will be effective for accounting changes and corrections of errors made
in fiscal years beginning after December 15, 2005. We do not believe that the adoption of SFAS No.
154 will have a material impact on our results of operations or financial position.
Forward-Looking Statements
Except for the historical information contained herein, the
statements made in this report constitute forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words
such as expects, plans, will, may, anticipates, believes, should, intends,
estimates and other words of similar meaning. These statements are subject to risks and
uncertainties that cannot be predicted or quantified and, consequently, actual results may differ
materially from those expressed or implied by such forward-looking statements. Such risks and
uncertainties include, in no particular order:
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the difficulty in predicting the timing and outcome of legal proceedings, including
patent-related matters such as patent challenge settlements and patent infringement cases; |
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the difficulty of predicting the timing of FDA approvals; |
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court and FDA decisions on exclusivity periods; |
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the ability of competitors to extend exclusivity periods for their products; |
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our ability to complete product development activities in the timeframes and for the costs we expect; |
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market and customer acceptance and demand for our pharmaceutical products; |
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our dependence on revenues from significant customers; |
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reimbursement policies of third party payors; |
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our dependence on revenues from significant products including royalties on products
manufactured and marketed by third parties; |
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the use of estimates in the preparation of our financial statements; |
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the impact of competitive products and pricing on products, including the launch of
authorized generics; |
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the ability to launch new products in the timeframes we expect; |
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the availability of raw materials; |
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the availability of any product we purchase and sell as a distributor; |
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the regulatory environment; |
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our exposure to product liability and other lawsuits and contingencies; |
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the cost of insurance and the availability of product liability insurance coverage; |
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our timely and successful completion of strategic initiatives, including integrating
companies and products we acquire and implementing our new enterprise resource planning
system; |
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fluctuations in operating results, including the effects on such results from spending
for research and development, sales and marketing activities and patent challenge
activities; and |
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other risks detailed from time-to-time in our filings with the Securities and Exchange
Commission. |
We wish to caution each reader of this report to consider carefully these factors as well as
specific factors that may be discussed with each forward-looking statement in this report or
disclosed in our filings with the SEC, as such factors, in some cases, could affect our ability to
implement our business strategies and may cause actual results to differ materially from those
contemplated by the statements expressed herein. Readers are urged to carefully review and
consider these factors. We undertake no duty to update the forward-looking statements even though
our situation may change in the future.
27
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our exposure to market risk for a change in interest rates relates primarily to our investment
portfolio of approximately $441.1 million. We do not use derivative financial instruments.
Our investment portfolio consists of cash and cash equivalents and market auction debt
securities primarily classified as available for sale. The primary objective of our investment
activities is to preserve principal while at the same time maximizing yields without significantly
increasing risk. To achieve this objective, we maintain our portfolio in a variety of high credit
quality debt securities, including U.S., state and local government and corporate obligations,
certificates of deposit and money market funds. Over 76% of our portfolio matures in less than
three months, or is subject to an interest-rate reset date that occurs within that time. The
carrying value of the investment portfolio approximates the market value at December 31, 2005 and
the value at maturity. Because our investments consist of cash equivalents and market auction debt
securities, a hypothetical 100 basis point change in interest rates is not likely to have a
material effect on our consolidated financial statements.
None of our outstanding debt at December 31, 2005 bears interest at a variable rate. Any
borrowings under our $175 million unsecured revolving credit facility will bear interest at a
variable rate based on the prime rate, the Federal Funds rate or LIBOR. At December 31, 2005, no
amounts were drawn under this facility.
Item 4. Controls and Procedures
Evaluation of disclosure controls and procedures
The Company maintains disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our 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 our management, including the Companys Chairman and
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions
regarding required disclosures. Management necessarily applied its judgment in assessing the costs
and benefits of such controls and procedures, which, by their nature, can provide only reasonable
assurance regarding managements control objectives.
At the conclusion of the period ended December 31, 2005, the Company carried out an
evaluation, under the supervision and with the participation of its management, including the
Chairman and Chief Executive Officer and Chief Financial Officer, of the effectiveness of the
design and operation of the Companys disclosure controls and procedures. Based upon that
evaluation, the Chairman and Chief Executive Officer and Chief Financial Officer concluded that the
disclosure controls and procedures were effective in alerting them in a timely manner to
information relating to the Company required to be disclosed in this report.
Changes in internal controls
In October 2005, the Company began migrating certain financial and sales processing systems to
SAP, a new enterprise resource planning (ERP) platform. The migration of the Companys remaining
financial, operational, and inventory processes will be implemented in two phases during the second
half of the fiscal year. In addition to expanding and improving access to information, the new ERP
system will provide a standard scalable information platform to accommodate business growth plans.
In connection with the ERP system implementation, the Company is updating its internal controls
over financial reporting, as necessary, to accommodate modifications to its business processes and
to take advantage of enhanced automated controls provided by the system. During the implementation
process to date, the Company believes it has taken the necessary steps to maintain internal control
systems that provide reasonable assurance of the accuracy of financial information.
28
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Litigation Matters
The disclosure under Note 11-Commitments and Contingencies-Litigation Matters included in
Part 1 of this report is incorporated in this Part II, Item 1 by reference.
Item 4. Submissions of Matters to a Vote of Security Holders
The Annual Meeting of the Shareholders of Barr Pharmaceuticals, Inc. was held on November 3,
2005. Of the 106,623,333 shares entitled to vote, 96,967,548 shares were represented at
the meeting or by proxy or present in person. The meeting was held for the following purposes:
1. To elect nine directors. All nine nominees were elected based on the following votes cast:
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For |
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Shares |
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Carole Ben-Maimon |
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93,285,190 |
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Paul M. Bisaro |
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93,344,373 |
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Harold Chefitz |
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96,546,032 |
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Bruce L. Downey |
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93,561,024 |
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Richard Frankovic |
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96,750,309 |
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James Gilmore |
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96,755,960 |
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Jacob M. Kay |
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93,709,399 |
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Peter Seaver |
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96,749,591 |
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George P. Stephan |
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93,487,772 |
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2. |
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To ratify the Audit Committees selection of Deloitte & Touche LLP, an independent registered
public accounting firm, as independent auditors for the fiscal year ending June 30, 2006, and
the result of such vote was as follows: |
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For: |
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Against: |
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Abstain: |
92,754,362
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4,149,943 |
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63,243 |
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3. |
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To increase the number of shares authorized for issuance under the Barr Pharmaceuticals, Inc.
Employee Stock Purchase Plan, and the result of such vote was as follows: |
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For: |
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Against: |
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Abstain: |
73,318,744
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1,448,736 |
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105,336 |
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4. |
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To eliminate animal-based test methods, as set forth in the shareholder proposal, and the
result of such vote was as follows: |
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For: |
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Against: |
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Abstain: |
1,123,688
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71,709,367 |
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7,039,761 |
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Item 6. Exhibits
(a) Exhibits.
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Exhibit No. |
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Description |
2.1
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Purchase Agreement dated as of October 14, 2005, by and among
Duramed Pharmaceuticals, Inc., Copper 380T, FEI Womens
Health, LLC and the individuals listed on the signature pages
thereto. |
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31.1
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Certification of Bruce L. Downey pursuant to Exchange Act
Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002 |
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31.2
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Certification of William T. McKee pursuant to Exchange Act
Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
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32.0
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Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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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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BARR PHARMACEUTICALS, INC. |
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Dated:
February 8, 2006
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/s/ Bruce L. Downey
Bruce L. Downey
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Chairman of the Board and Chief Executive Officer |
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/s/ William T. McKee |
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William T. McKee |
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Vice President, Chief |
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Financial Officer, and
Treasurer |
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(Principal Financial Officer
and Principal Accounting
Officer) |
31