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 March 31, 2006 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
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(I.R.S. Employer |
Incorporation or Organization)
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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.
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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 April 14, 2006 the registrant had 106,168,772 shares of $0.01 par value common stock
outstanding.
BARR PHARMACEUTICALS, INC.
INDEX TO FORM 10-Q
2
Part 1. FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
Barr Pharmaceuticals, Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except share amounts)
(unaudited)
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March 31, |
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June 30, |
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2006 |
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2005 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
14,726 |
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$ |
115,793 |
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Marketable securities |
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577,499 |
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527,462 |
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Accounts receivable, net of reserves of $138,565 and $150,000, at |
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March 31, 2006 and June 30, 2005, respectively |
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188,052 |
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152,599 |
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Other receivables |
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36,474 |
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21,411 |
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Inventories, net |
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139,353 |
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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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12,803 |
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8,229 |
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Total current assets |
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994,666 |
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993,356 |
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Property, plant and equipment, net of accumulated depreciation of $154,433 |
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and $129,617, at March 31, 2006 and June 30, 2005, respectively |
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274,444 |
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249,485 |
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Deferred income taxes |
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37,485 |
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60,504 |
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Marketable securities |
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20,585 |
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53,793 |
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Other intangible assets |
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425,905 |
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98,343 |
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Goodwill |
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47,929 |
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17,998 |
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Other assets |
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10,626 |
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9,367 |
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Total assets |
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$ |
1,811,640 |
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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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$ |
40,558 |
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$ |
49,743 |
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Accrued liabilities |
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109,251 |
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144,428 |
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Current portion of long-term debt and capital lease obligations |
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5,136 |
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5,446 |
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Income taxes payable |
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13,039 |
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13,353 |
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Total current liabilities |
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167,984 |
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212,970 |
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Long-term debt and captial lease obligations |
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11,480 |
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15,493 |
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Other liabilities |
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33,132 |
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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, $.01 par value per share; authorized 200,000,000;
issued 109,135,216 and 106,340,470, at March 31, 2006
and June 30, 2005, respectively |
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1,091 |
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1,063 |
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Additional paid-in capital |
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565,209 |
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454,489 |
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Retained earnings |
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1,133,892 |
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879,669 |
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Accumulated other comprehensive loss |
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(458 |
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(561 |
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1,699,734 |
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1,334,660 |
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Treasury stock at cost: 2,972,997 shares, at |
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March 31, 2006 and June 30, 2005 |
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(100,690 |
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(100,690 |
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Total shareholders equity |
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1,599,044 |
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1,233,970 |
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Total liabilities and shareholders equity |
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$ |
1,811,640 |
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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 March 31, |
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Nine Months Ended March 31, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenues: |
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Product sales |
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$ |
293,157 |
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$ |
261,258 |
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$ |
849,336 |
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$ |
760,050 |
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Alliance, development and other revenue |
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33,684 |
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3,749 |
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113,461 |
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6,834 |
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Total revenues |
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326,841 |
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265,007 |
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962,797 |
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766,884 |
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Costs and expenses: |
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Cost of sales |
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89,642 |
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77,653 |
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253,436 |
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225,350 |
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Selling, general and administrative |
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87,079 |
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59,124 |
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221,765 |
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181,839 |
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Research and development |
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37,705 |
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35,488 |
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103,711 |
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95,139 |
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Earnings from operations |
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112,415 |
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92,742 |
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383,885 |
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264,556 |
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Interest income |
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4,213 |
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2,825 |
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13,117 |
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7,219 |
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Interest expense |
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110 |
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287 |
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257 |
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1,351 |
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Other income (expense) |
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1,071 |
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(260 |
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478 |
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(409 |
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Earnings before income taxes |
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117,589 |
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95,020 |
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397,223 |
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270,015 |
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Income tax expense |
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41,493 |
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33,675 |
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143,000 |
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97,148 |
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Net earnings |
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$ |
76,096 |
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$ |
61,345 |
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$ |
254,223 |
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$ |
172,867 |
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Earnings per common share basic |
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$ |
0.72 |
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$ |
0.60 |
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$ |
2.43 |
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$ |
1.68 |
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Earnings per common share diluted |
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$ |
0.70 |
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$ |
0.58 |
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$ |
2.36 |
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$ |
1.63 |
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Weighted average shares |
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105,924 |
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102,717 |
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104,779 |
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103,180 |
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Weighted average shares diluted |
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108,547 |
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105,892 |
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107,607 |
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105,962 |
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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 Nine Months Ended March 31, 2006 and 2005
(in thousands of dollars)
(unaudited)
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2006 |
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2005 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net earnings |
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$ |
254,223 |
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$ |
172,867 |
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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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43,469 |
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32,761 |
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Stock-based compensation expense |
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20,827 |
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Deferred income tax expense |
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27,425 |
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Other |
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(915 |
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(327 |
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Tax benefit of stock incentive plans |
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33,516 |
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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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(41,375 |
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34,145 |
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Inventories |
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19,511 |
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5,757 |
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Prepaid expenses |
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(3,030 |
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3,642 |
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Other assets |
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(62 |
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6,560 |
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Increase (decrease) in: |
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Accounts payable, accrued liabilities and
other liabilities |
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(59,958 |
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(50,429 |
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Income taxes payable |
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(314 |
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18,417 |
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Net cash provided by operating activities |
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259,801 |
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256,909 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchases of property, plant and equipment |
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(49,684 |
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(42,863 |
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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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(1,601,541 |
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(871,227 |
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Sales of marketable securities |
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1,587,071 |
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803,480 |
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Acquisitions, net of cash acquired |
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(378,440 |
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(27,250 |
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Investment in venture funds and other |
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(3,096 |
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(6,990 |
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Net cash used in investing activities |
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(445,690 |
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(164,100 |
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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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(5,098 |
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(19,712 |
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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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26,983 |
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Proceeds from exercise of stock options and employee stock purchases |
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62,937 |
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13,098 |
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Net cash provided by (used in) financing activities |
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84,822 |
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(106,596 |
) |
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Decrease in cash and cash equivalents |
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(101,067 |
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(13,787 |
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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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$ |
14,726 |
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$ |
14,721 |
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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 the Companys Annual
Report on Form 10-K for the fiscal year ended June 30, 2005.
In managements 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,
the Company 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 nine months ended March 31, 2005 have
been reclassified to conform to the Companys consolidated statement of cash flows for the nine
months ended March 31, 2006. This reclassification has not had any effect on the Companys
consolidated statement of operations.
2. Recent Accounting Pronouncements
In November 2005, the Financial Accounting Standards Board issued FASB Staff Position (FSP)
FASB 115-1 and FASB 124-1, The Meaning of Other-Than-Temporary Impairment and Its Application to
Certain Investments. This FSP provides guidance on determining if an investment is considered to
be impaired, if the impairment is other-than-temporary, and the measurement of an impairment loss.
It also includes accounting considerations subsequent to the recognition of an other-than-temporary
impairment and requires certain disclosures about unrealized losses that have not been recognized
as other-than-temporary impairments. The guidance in this FSP amends Statement of Financial
Accounting Standards (SFAS) No. 115, Accounting for Certain Investments in Debt and Equity
Securities and is effective for reporting periods beginning after December 15, 2005. The adoption
of this FSP has not had a material impact on the Companys consolidated financial statements.
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, 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 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
6
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 nine months
ended March 31, 2006 in the amount of $6,933 and $20,827
respectively. The Company also recorded
related tax benefits for the three and nine months ended March 31, 2006 in the amount of $2,254 and
$5,637, 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 awards 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.
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|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
March 31, 2005 |
|
|
March 31, 2005 |
|
Net earnings, as reported |
|
$ |
61,345 |
|
|
$ |
172,867 |
|
Deduct: |
|
|
|
|
|
|
|
|
Total stock-based employee
compensation expense
determined under fair value
based methods for all awards,
net of related tax effects |
|
|
4,331 |
|
|
|
15,940 |
|
|
|
|
|
|
|
|
Pro forma net earnings |
|
$ |
57,014 |
|
|
$ |
156,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share: |
|
|
|
|
|
|
|
|
Basic as reported |
|
$ |
0.60 |
|
|
$ |
1.68 |
|
|
|
|
|
|
|
|
Basic pro forma |
|
$ |
0.56 |
|
|
$ |
1.52 |
|
|
|
|
|
|
|
|
Diluted as reported |
|
$ |
0.58 |
|
|
$ |
1.63 |
|
|
|
|
|
|
|
|
Diluted pro forma |
|
$ |
0.54 |
|
|
$ |
1.48 |
|
|
|
|
|
|
|
|
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 any cash dividends) 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
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 awards granted in the three and nine months ended March
31, 2006 was $26.21 and $18.55 per right, respectively, determined using the following assumptions:
7
|
|
|
|
|
|
|
|
|
|
|
3 Months |
|
|
9 Months |
|
Average expected term (years) |
|
|
5.0 |
|
|
|
5.0 |
|
Risk-free interest rate |
|
|
4.35 |
% |
|
|
3.75 |
% |
Dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected volatility |
|
|
36.85 |
% |
|
|
36.85 |
% |
As
of March 31, 2006, the aggregate intrinsic value of awards outstanding and
exercisable was $215,411 and $158,166, respectively. In addition, the aggregate intrinsic value of awards
exercised during the three and nine months ended March 31, 2006
was $30,873 and $98,089,
respectively. The total remaining unrecognized compensation
cost related to unvested awards amounted to $34,913. Unrecognized compensation costs related to the
employee stock purchase plan amounted to $301 at March 31, 2006. The weighted average remaining
requisite service period of the unvested awards was 24 months.
The total fair value of awards vested during the three and nine
months ended March 31, 2006 was $3,807 and $24,708,
respectively.
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 assist
management in its determination of the fair value of 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 preliminary fair values of the assets acquired and liabilities assumed on November 9,
2005 were as follows:
8
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
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 has a
20-year life and will be amortized over that period. Goodwill and the intangible asset 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.
9
Barr Pharmaceuticals, Inc. and Subsidiaries
Pro Forma Condensed Combined Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
277,122 |
|
|
$ |
985,935 |
|
|
$ |
804,362 |
|
Earnings from operations |
|
|
87,937 |
(1) |
|
|
391,365 |
(2) |
|
|
247,744 |
(3) |
Net earnings |
|
|
57,375 |
(1) |
|
|
250,470 |
(2) |
|
|
159,830 |
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share basic |
|
$ |
0.56 |
|
|
$ |
2.39 |
|
|
$ |
1.55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per
common share diluted |
|
$ |
0.54 |
|
|
$ |
2.33 |
|
|
$ |
1.51 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares |
|
|
102,717 |
|
|
|
104,779 |
|
|
|
103,180 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares diluted |
|
|
105,892 |
|
|
|
107,607 |
|
|
|
105,962 |
|
|
|
|
|
|
|
|
|
|
|
The unaudited pro forma financial information above reflects the following:
(1) |
|
This amount includes amortization of $1,386 for the intangible asset that was acquired, an add back of $507
for interest expense paid before the acquisition, a
charge for the amount of the step-up in inventory to fair value of $7,778, and a charge for reduced interest income of
$1,348 relating to the reduction of available funds to be invested due to the acquisition. |
|
(2) |
|
This amount includes amortization of $4,274 for the intangible asset that was acquired, an
add back of $671 for interest expense paid before the acquisition, a charge for the amount of
the step-up in inventory to fair value of $20,741, and a charge for reduced interest income of
$2,379 relating to the reduction of available funds to be invested due to the acquisition. |
|
(3) |
|
This amount includes amortization of $4,158 for the intangible asset that was acquired, an
add back of $2,162 for interest expense paid before the acquisition, a charge for the amount
of the step-up in inventory to fair value of $23,333 and a charge for reduced interest income
of $3,562 relating to the reduction of available funds to be invested due to the acquisition. |
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 $152,800. 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
10
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:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
Raw materials and supplies |
|
$ |
74,333 |
|
|
$ |
79,120 |
|
Work-in-process |
|
|
27,752 |
|
|
|
16,405 |
|
Finished goods |
|
|
37,268 |
|
|
|
42,113 |
|
|
|
|
|
|
|
|
Total |
|
$ |
139,353 |
|
|
$ |
137,638 |
|
|
|
|
|
|
|
|
Inventories are presented net of reserves of $25,700 and $13,415 at March 31, 2006 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 $8,882 as of March 31, 2006, including $8,289 for the step-up
to fair value. Based on units sold from the closing date through March 31, 2006, the Company
charged cost of sales for $12,452 of the initial $20,741 step-up adjustment.
6. Goodwill and Other Intangible Assets
As a result of the FEI acquisition during the second quarter of fiscal 2006, the Company had
recorded goodwill in the amount of $29,619. Additional transaction costs relating to employee
severance were incurred during the three months ended March 31, 2006. Goodwill associated with the
acquisition reflects these additional costs and is now stated at $29,931. Total goodwill at March
31, 2006 was $47,929.
Intangible assets, excluding goodwill, which are comprised primarily of product licenses and
product rights and related intangibles, consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
Product licenses |
|
$ |
45,600 |
|
|
$ |
45,600 |
|
Product rights and related intangibles |
|
|
415,496 |
|
|
|
70,796 |
|
|
|
|
|
|
|
|
|
|
|
461,096 |
|
|
|
116,396 |
|
Less: accumulated amortization |
|
|
(35,191 |
) |
|
|
(18,053 |
) |
|
|
|
|
|
|
|
Other intangible assets, net |
|
$ |
425,905 |
|
|
$ |
98,343 |
|
|
|
|
|
|
|
|
11
Amortization expense for the three and nine months ended March 31, 2006 was $8,865 and
$17,137. These amounts were recorded as selling, general and administrative expenses.
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. 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 March 31, |
|
|
Nine Months Ended March 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
$s |
|
|
sales |
|
|
$s |
|
|
sales |
|
|
$s |
|
|
sales |
|
|
$s |
|
|
sales |
|
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic |
|
$ |
200,370 |
|
|
|
68 |
% |
|
$ |
189,418 |
|
|
|
73 |
% |
|
$ |
616,632 |
|
|
|
73 |
% |
|
$ |
561,276 |
|
|
|
74 |
% |
Proprietary |
|
|
92,787 |
|
|
|
32 |
% |
|
|
71,840 |
|
|
|
27 |
% |
|
|
232,704 |
|
|
|
27 |
% |
|
|
198,774 |
|
|
|
26 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
293,157 |
|
|
|
100 |
% |
|
$ |
261,258 |
|
|
|
100 |
% |
|
$ |
849,336 |
|
|
|
100 |
% |
|
$ |
760,050 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Margin |
|
|
|
|
|
|
Margin |
|
|
|
|
|
|
Margin |
|
|
|
|
|
|
Margin |
|
|
|
$s |
|
|
% |
|
|
$s |
|
|
% |
|
|
$s |
|
|
% |
|
|
$s |
|
|
% |
|
Gross profit: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic |
|
$ |
129,443 |
|
|
|
65 |
% |
|
$ |
121,996 |
|
|
|
64 |
% |
|
$ |
407,457 |
|
|
|
66 |
% |
|
$ |
364,203 |
|
|
|
65 |
% |
Proprietary |
|
|
74,072 |
|
|
|
80 |
% |
|
|
61,609 |
|
|
|
86 |
% |
|
|
188,443 |
|
|
|
81 |
% |
|
|
170,497 |
|
|
|
86 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total gross profit |
|
$ |
203,515 |
|
|
|
69 |
% |
|
$ |
183,605 |
|
|
|
70 |
% |
|
$ |
595,900 |
|
|
|
70 |
% |
|
$ |
534,700 |
|
|
|
70 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8. 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 |
|
|
Nine Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Earnings per common share basic: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (numerator) |
|
$ |
76,096 |
|
|
$ |
61,345 |
|
|
$ |
254,223 |
|
|
$ |
172,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares (denominator) |
|
|
105,924 |
|
|
|
102,717 |
|
|
|
104,779 |
|
|
|
103,180 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share-basic |
|
$ |
0.72 |
|
|
$ |
0.60 |
|
|
$ |
2.43 |
|
|
$ |
1.68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (numerator) |
|
$ |
76,096 |
|
|
$ |
61,345 |
|
|
$ |
254,223 |
|
|
$ |
172,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares |
|
|
105,924 |
|
|
|
102,717 |
|
|
|
104,779 |
|
|
|
103,180 |
|
Effect of dilutive options and warrants |
|
|
2,623 |
|
|
|
3,175 |
|
|
|
2,828 |
|
|
|
2,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares diluted (denominator) |
|
|
108,547 |
|
|
|
105,892 |
|
|
|
107,607 |
|
|
|
105,962 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share-diluted |
|
$ |
0.70 |
|
|
$ |
0.58 |
|
|
$ |
2.36 |
|
|
$ |
1.63 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Not included in the calculation of diluted earnings
per share because their impact is antidilutive: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options outstanding |
|
|
22 |
|
|
|
76 |
|
|
|
41 |
|
|
|
1,749 |
|
9. 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 March 31, 2006 and 2005 was $76,293 and $60,959, respectively, and for the nine months ended
March 31, 2006 and 2005 was $254,326 and $171,676, respectively.
10. Commitments and Contingencies
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 March 31, 2006, these costs have been covered under extended
reporting period policies that provide up to $25,000 of coverage. As of March 31, 2006, there was
approximately $8,700 of coverage remaining under these policies. The Company has recorded a
receivable for legal costs incurred and expected to
13
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 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 March 31, 2006.
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, as defined, of greater than $100,000 over any five-year period
prior to October 22, 2014. As of March 31, 2006, no liability has been accrued related to this
settlement.
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 March 31, 2006, the Companys reserve for the liability associated with claims or related
defense costs for these matters is not material.
14
Patent Matters
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. On February
15, 2006, the Court of Appeals for the Federal Circuit denied the appeal by Ferring AB and Aventis
of the courts granting of summary judgment in favor of the Company. Ferring AB and Aventis
subsequently filed a petition for rehearing and rehearing en banc, which was denied on April 10,
2006.
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 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 in favor of 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 has appealed the Courts denial of its motion to the United
States Court of Appeals for the Federal Circuit. Briefing in the appeal is scheduled to be
completed by June 30, 2006, but no date for argument has been set.
15
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 is 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 3,500 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 2,800 of the 3,500 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.
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 has been completed and pre-trial motions have been filed. The trial is
scheduled to begin on June 12, 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
16
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 as well as plaintiffs request for the
appeal to be considered en banc. Merits briefing has not yet been completed because the
proceedings are stayed pending en banc consideration of a similar case.
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.
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
17
early stage, with discovery cut-off dates of December 22, 2006 for the FTC and state cases and March 2,
2007 for the private cases. No trial dates have been set.
The Company believes that it has not engaged in any improper conduct and is vigorously
defending itself in these matters.
Provigil
Antitrust Proceedings
To
date, the Company has been named as a co-defendant with Cephalon,
Inc., Mylan Laboratories, Inc., Teva Pharmaceutical Industries, Ltd.,
Teva Pharmaceuticals USA, Inc., Ranbaxy Laboratories, Ltd., and
Ranbaxy Pharmaceuticals, Inc. (the Defendants) in two
separate complaints filed in the United States District Court for the
Eastern District of Pennsylvania. These actions allege, among other
things, that the agreements between Cephalon and the other individual
Defendants to settle patent litigation relating to Provigil®
constitute an unfair method of competition, are anticompetitive and
restrain trade in the market for Provigil and its AB-rated generics
in violation of the antitrust laws. These cases remain at a very
early stage and no trial dates have been set.
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, Hawaii, Illinois, Kentucky and 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
Company believes that it has not engaged in any improper conduct and is vigorously defending itself
in these matters.
The Commonwealth of Massachusetts case and the New York cases, with the exception of the
action filed by Erie County, New York, are currently pending in the U.S. District Court for the
District of Massachusetts. Discovery is underway in the Massachusetts cases, but no trial dates
have been set. In the New York cases, as well as the Erie County case, which is pending in state
court in New York, briefing is underway on defendants motions to dismiss, with no trial dates 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. Discovery is underway, but no trial date
has been set. The State of Hawaii case was filed in state court in Hawaii on April 26, 2006. This
matter is at a very early stage with no trial date set as of yet. The Illinois and Kentucky cases
were filed in Illinois and Kentucky state courts, removed to federal court, and then remanded back
to their respective state courts. The defendants have filed motions to dismiss in both actions and
no trial dates have been set. The State of Mississippi case was filed in state court and is at a
very early stage with no trial date set.
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. The court has
entered a scheduling order providing for the completion of discovery by March 7, 2007 but has not
yet set a date for trial. The Company believes there was no such contract and is vigorously
defending itself in this matter.
Other Litigation
As of March 31, 2006, 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.
18
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 nine months ended March 31, 2006 of
$1.8 million. 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 of $1.8 million, have all been classified as selling, general and administrative expenses and
have resulted in a net benefit of $8.4 million to selling, general and administrative expenses for
the nine months ended March 31, 2006.
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, 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 related to the rights to market and sell ParaGard,
increased the cost of the acquired inventory by $20.7 million to state it at fair value and
recorded goodwill of $29.9 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.
19
Results of Operations
Comparison of the Three and Nine Months Ended March 31, 2006 and March 31, 2005
The following table sets forth revenue data for the three and nine months ended March 31, 2006
and 2005 (dollars in millions).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Nine Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Generic products: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral contraceptives |
|
$ |
101.2 |
|
|
$ |
93.6 |
|
|
$ |
7.6 |
|
|
|
8 |
% |
|
$ |
292.4 |
|
|
$ |
295.7 |
|
|
$ |
(3.3 |
) |
|
|
-1 |
% |
Other generic |
|
|
99.1 |
|
|
|
95.9 |
|
|
|
3.2 |
|
|
|
3 |
% |
|
|
324.2 |
|
|
|
265.6 |
|
|
|
58.6 |
|
|
|
22 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total generic products |
|
|
200.3 |
|
|
|
189.5 |
|
|
|
10.8 |
|
|
|
6 |
% |
|
|
616.6 |
|
|
|
561.3 |
|
|
|
55.3 |
|
|
|
10 |
% |
Proprietary products |
|
|
92.8 |
|
|
|
71.8 |
|
|
|
21.0 |
|
|
|
29 |
% |
|
|
232.7 |
|
|
|
198.8 |
|
|
|
33.9 |
|
|
|
17 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Product Sales |
|
|
293.1 |
|
|
|
261.3 |
|
|
|
31.8 |
|
|
|
12 |
% |
|
|
849.3 |
|
|
|
760.1 |
|
|
|
89.2 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alliance, development
and other revenue |
|
|
33.7 |
|
|
|
3.7 |
|
|
|
30.0 |
|
|
|
811 |
% |
|
|
113.5 |
|
|
|
6.8 |
|
|
|
106.7 |
|
|
|
1569 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
326.8 |
|
|
$ |
265.0 |
|
|
$ |
61.8 |
|
|
|
23 |
% |
|
$ |
962.8 |
|
|
$ |
766.9 |
|
|
$ |
195.9 |
|
|
|
26 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues Product Sales
Generic Products
Total generic product sales for the three months ended March 31, 2006 increased due to
increases in sales of both our generic oral contraceptive products and our other generic products.
For the nine months ended March 31, 2006, total generic products sales increased due to a
significant increase in sales of our other generic products, which was slightly offset by lower
sales of generic oral contraceptive products.
Oral Contraceptives
For the three months ended March 31, 2006, sales of generic oral contraceptives increased 8%
over the prior year period. This increase was primarily attributable to an increase in market
share of Tri-Sprintec during the quarter combined with continued strong sales of Kariva due to
higher pricing and an increase in market share. We believe that the increase in market share of
Tri-Sprintec was primarily related to temporary supply shortages encountered by one of our
competitors. We understand that these supply shortages have been resolved and therefore expect our
Tri-Sprintec market share and sales to decline in our fiscal fourth quarter as compared to the
quarter ended March 31, 2006.
For the nine months ended March 31, 2006, sales of generic oral contraceptives showed a
slight decline of 1% compared to the prior year period. This decrease resulted from the continued
impact of competition on certain of our larger generic oral contraceptive products, such as Aviane
and Apri, resulting in lower pricing and reduced market share, as well as the continued decline in
demand for several of these products. This decrease more than offset higher sales of Kariva and
Tri-Sprintec due to reasons discussed above.
Other Generic Products
For the three months ended March 31, 2006, sales of other generic products increased 3% to
$99.1 million from $95.9 million in the prior year period. This increase resulted from sales of
Desmopressin, which we launched in July 2005, partially offset by lower sales of Mirtazapine,
Didanosine, Warfarin Sodium and Claravis, and the continued decline in demand for certain of our
other generic products. Mirtazapine sales were lower due to further price and volume erosion from
competition. Revenues from Didanosine were lower during the period due to a decline in unit sales,
while sales of Warfarin Sodium declined due to continued pricing pressure even as our market share
has consistently increased. Claravis sales were lower during this three-month period in large part
due to the decline in the overall compound usage and lower market share. As discussed in our prior
Form 10-Q, sales of Claravis and other isotrentinoin products indicated for the treatment of
severe acne have been negatively impacted by the implementation of iPledge, an enhanced risk
management program that is designed to minimize fetal exposure to isotrentinoin which took effect
on December 31, 2005.
20
For the nine months ended March 31, 2006, sales of other generic products increased 22% to
$324.2 million from $265.6 million in the prior year. The significant growth during the
nine-month period was due primarily to sales of Desmopressin, which we launched in July 2005 and
to a lesser extent, contributions from Didanosine, which we launched in December 2004. Desmopressin sales, which were favorably impacted in the
first half of the fiscal year by rapid generic substitution, declined sharply in the quarter ended
March 31, 2006 due to the launch of a competing product in January 2006. We expect further sales
declines in our fiscal fourth quarter as a result of this competition as well as new competition
from a competing product that was approved and launched in April 2006. Partially offsetting the
strong sales from Desmopressin and Didanosine during this nine-month period were lower sales of
Mirtazapine, as discussed above, as well as reduced demand for Claravis for the reasons discussed
above.
Proprietary Products
For the three months ended March 31, 2006, proprietary product sales increased 29% over the
prior year period, primarily the result of (1) higher sales of Seasonale®, (2) sales of the
ParaGard IUD and Mircette oral contraceptive, which we acquired in November 2005 and December
2005, respectively, (3) higher sales of Cenestin due largely to customer buying patterns and (4)
higher unit sales of our Plan B emergency contraceptive product. These increases more than offset
decreases in revenues attributable to Loestrin/Loestrin FE, which experienced significant volume
declines due to lower market share, and Nordette, which also experienced lower unit sales due to
lower market share despite an increase in pricing.
For the nine months ended March 31, 2006, proprietary product sales increased 17% over the
prior year period. This increase is a result of significant increase in sales of Seasonale,
combined with contributions from acquired products noted above and higher unit sales of Plan B.
Partially offsetting these increases were lower sales of
Loestrin/Loestrin FE due to decreasing market share
and Cenestin due to customer buying patterns.
Seasonale sales totaled $27.1 million for the three-month period ended March 31, 2006 and
$78.8 million for the nine-month period then ended, representing 12% and 29% increases,
respectively, over the comparable prior year periods. The significant increase in sales during the
current periods resulted from higher unit sales due to higher prescriptions, which increased 27%
over the prior year quarter and 33% over the prior year nine-month period, as well as higher
pricing. Based on current prescription levels, we expect our fiscal 2006 sales of Seasonale to
exceed $100 million.
In June 2004, we received notification that a competitor had filed an ANDA containing a
paragraph IV certification asserting that the patent covering Seasonale is invalid, unenforceable
or would not be infringed by the competitors generic product. We did not initiate patent
infringement litigation with respect to the competitors ANDA, and we do not expect to receive
pediatric exclusivity with respect to Seasonale. As a result, the competitors application could
receive FDA approval following the expiration of our New Product Exclusivity in September 2006.
In July 2004, we submitted the patent covering Seasonale for reissue with the Patent and
Trademark Office (PTO). We have not received a determination from the PTO regarding the
reissuance but expect that the PTO will make a determination before the end of the current calendar
year, however the patent covering Seasonale will remain in effect and continue to be listed in the
FDAs Orange Book while the PTO reviews the request for reissuance. If the patent covering
Seasonale is reissued, it will have the same remaining term as the existing patent that expires in
2017.
In addition to Seasonale our extended cycle oral contraceptive franchise includes Seasonique.
We have filed with the FDA an NDA for Seasonique and in August 2005 received an approvable letter.
In March 2006, the FDA notified us that it had determined that additional clinical studies would
not be required to support the approval of Seasonique. Following this notification, we submitted
product labeling that we expect to be approved in late May 2006. If Seasonique gains final FDA
approval in late May, we expect to launch the product in the first quarter of fiscal 2007.
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 Allegraâ product and (2) royalty payments and other fees under our
Co-Promotion Agreement and License and Manufacturing Agreement with Kos Pharmaceuticals, Inc.
(Kos) on Niaspanâ and Advicorâ, which we began receiving in the
fourth quarter of fiscal 2005.
Our 180-day exclusivity period on generic Allegra ended on February 28, 2006. As
discussed above, pursuant to an agreement between the Company and Teva, we selectively waived our
180 days of generic exclusivity in favor of Teva, and Teva launched its generic Allegra product on
September 1, 2005. By the end of April 2006, one competitor had received final approval from the
FDA for their generic Allegra product. We are aware of several other companies that have filed ANDAs
with Paragraph IV certifications for generic Allegra.
Competition for generic Allegra has caused, and will continue to cause, Tevas Allegra revenues to decrease and in
turn, our royalties to decline. Additionally, our profit-sharing percentage in our arrangement with
Teva decreased following the expiration of the exclusivity period on February 28, 2006, further
reducing the amount of royalties we receive from Teva. As a result, our revenues from our
profit-sharing arrangement with Teva are expected to decrease in our fiscal fourth quarter and
thereafter.
21
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 nine months ended March 31,
2006 and 2005 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Nine Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Generic products |
|
$ |
70.9 |
|
|
$ |
67.4 |
|
|
$ |
3.5 |
|
|
|
5 |
% |
|
$ |
209.2 |
|
|
$ |
197.1 |
|
|
$ |
12.1 |
|
|
|
6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
64.6 |
% |
|
|
64.4 |
% |
|
|
|
|
|
|
|
|
|
|
66.1 |
% |
|
|
64.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proprietary products |
|
$ |
18.7 |
|
|
$ |
10.2 |
|
|
$ |
8.5 |
|
|
|
83 |
% |
|
$ |
44.2 |
|
|
$ |
28.3 |
|
|
$ |
15.9 |
|
|
|
56 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
79.8 |
% |
|
|
85.8 |
% |
|
|
|
|
|
|
|
|
|
|
81.0 |
% |
|
|
85.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of sales |
|
$ |
89.6 |
|
|
$ |
77.6 |
|
|
$ |
12.0 |
|
|
|
15 |
% |
|
$ |
253.4 |
|
|
$ |
225.4 |
|
|
$ |
28.0 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
69.4 |
% |
|
|
70.3 |
% |
|
|
|
|
|
|
|
|
|
|
70.2 |
% |
|
|
70.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charges inclued in proprietary
products cost of sales
for step-up inventory |
|
$ |
7.8 |
|
|
$ |
|
|
|
$ |
7.8 |
|
|
|
100 |
% |
|
$ |
12.5 |
|
|
$ |
|
|
|
$ |
12.5 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proprietary Gross margin effect |
|
|
8.4 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
5.4 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
Total Gross margin effect |
|
|
2.7 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
1.5 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
Overall gross margins decreased for the three and nine months ended March 31, 2006 compared to
the prior year periods due to the cost of sales charge associated with the acquisition of FEI and the
inclusion of stock-based compensation expense in the current periods. As discussed above under
Business Development Activities, in connection with acquiring FEI in November 2005, a $20.7
million adjustment to inventory is being charged to cost of sales as the acquired inventory is
sold.
Margins on our generic products increased for the three and nine months ended March 31, 2006
due mainly to the launches of new products, specifically Desmopressin and full period contributions
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. We expect gross
margins on our generic products to decline in our fiscal fourth quarter primarily due to lower
pricing for Desmopressin resulting from the launch of an additional competing product in April
2006.
Proprietary margins declined for the three and nine months ended March 31, 2006 due primarily
to charges of $7.8 million and $12.5 million in the three and nine-month periods, respectively, to
cost of sales as described above related to the FEI acquisition, and the inclusion of stock-based
compensation expense in the current period. The remaining $8.2 million adjustment to inventory
related to the FEI acquisition is expected to be amortized to cost of sales over the next two
quarters.
22
Selling, General and Administrative Expense
The following table sets forth selling, general and administrative expense for the three and
nine months ended March 31, 2006 and 2005 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Nine Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Selling, general and
administrative |
|
$ |
87.1 |
|
|
$ |
59.1 |
|
|
$ |
28.0 |
|
|
|
47 |
% |
|
$ |
221.8 |
|
|
$ |
181.8 |
|
|
$ |
40.0 |
|
|
|
22 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit included in
selling, general
and admin. |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
0 |
% |
|
$ |
(8.4 |
) |
|
$ |
|
|
|
$ |
(8.4 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses for the current quarter increased by 47% over the
prior year period. This increase reflects (1) higher selling and marketing costs of $12.1 million,
(2) higher amortization expenses of $3.8 million, (3) stock-based compensation costs of $3.5
million which we did not have in the prior year period and (4) higher information technology costs
of $3.5 million. Higher selling and marketing costs are primarily attributable to higher marketing
costs for Seasonale as well as costs associated with the launch of Enjuvia®, during our fiscal
fourth quarter. The increase also includes higher sales force costs primarily related to the
additional sales representatives acquired in the FEI acquisition. Higher amortization expenses are attributable to the
increase in our intangible assets relating to the FEI and Mircette acquisitions that took place
during the first half of fiscal 2006. Higher information technology
costs are primarily related to consulting and training costs related to the implementation of our
new SAP enterprise resource planning system.
Selling, general and administrative expenses for the nine-month period increased by 22% over
the prior year period. This increase reflects, for reasons discussed in connection with the
quarterly comparison above, (1) higher selling and marketing costs of $16.1 million, (2)
stock-based compensation costs of $10.1 million which we did not have in the prior year period, (3)
higher information technology costs of $7.6 million and (4) higher amortization expenses of $5.3
million. Offsetting those increases was a net benefit of $8.4 million relating to the Mircette
transaction as described in Business Development Activities above.
Research and Development
The following table sets forth research and development expenses for the three and nine months
ended March 31, 2006 and 2005 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Nine Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Research and
development |
|
$ |
37.7 |
|
|
$ |
35.5 |
|
|
$ |
2.2 |
|
|
|
6 |
% |
|
$ |
103.7 |
|
|
$ |
95.1 |
|
|
$ |
8.6 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The 6% increase in the three-month period resulted from $2.8 million in higher clinical
studies, a $2.5 million write-off of acquired in-process research and development related to the
purchase price of four ANDAs from Teva and Ivax (resulting from Tevas acquisition of Ivax) and
$1.4 million in stock-based compensation which we did not have in the prior year. These increases
were partially offset by a decrease in third party development costs of $6.2 million.
The 9% increase in the nine-month period resulted from a $6.1 million increase in clinical
trial costs, $4.4 million in stock-based compensation which we did not have in the prior year, a
$2.5 million write-off of acquired in-process research and development as discussed above and an
increase of $2.2 million in raw materials expense. Offsetting these increases is a reimbursement
of $5.0 million for previously incurred costs under a third party development agreement.
23
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 nine months ended March 31, 2006 and 2005
(dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Nine Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Income tax expense |
|
$ |
41.5 |
|
|
$ |
33.7 |
|
|
$ |
7.8 |
|
|
|
23 |
% |
|
$ |
143.0 |
|
|
$ |
97.1 |
|
|
$ |
45.9 |
|
|
|
47 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
35.3 |
% |
|
|
35.5 |
% |
|
|
|
|
|
|
|
|
|
|
36.0 |
% |
|
|
36.0 |
% |
|
|
|
|
|
|
|
|
The effective tax rate for the current quarter, which decreased to 35.3% from 35.5% in the
prior year period, was favorably impacted by a combination of (1) a tax deduction related to the
disqualifying exercise of incentive stock options that were previously expensed in our financial
statements for which no tax benefit was taken, (2) the application of the revised tax rate expected
for our fiscal year applied to the prior quarters and (3) a change in the mix of income among the
states where the Company has manufacturing facilities. These drivers were partially offset by the
expiration on December 31, 2005 of the federal tax credit for research and development activities.
Our
federal income tax return for fiscal year 2004 is currently under audit by the IRS. Prior
periods have either been audited or are no longer subject to audit by the IRS.
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 March 31, 2006, our cash, cash equivalents and short-term marketable securities
totaled $592.2 million, a decrease of $51.0 million from our position at June 30, 2005.
Operating Activities
Our
operating cash flows for the nine months ended March 31, 2006
were $259.8 million,
compared with $256.9 million for the prior year period.
Components of the $259.8 million of
operating cash flows in the first nine months of fiscal year 2006 include (1) net earnings of
$254.2 million, (2) a $41.4 million increase in accounts receivable and other receivables due in
part 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 $60.0
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 $20.8 million, and (5) the
reversal of $27.4 million in deferred taxes primarily related to the $64 million charge recorded in
conjunction with the Mircette transaction. In addition, certain tax benefits, which totaled $27.0
million for the nine months ended March 31, 2006, were classified in operating activities prior to
fiscal 2006 but are now classified in financing activities with the
adoption of SFAS 123R as
described in Note 3 to our consolidated financial statements above.
Investing Activities
Net
cash used in investing activities totaled $445.7 million for the first nine months of
fiscal 2006 compared with $164.1 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
$378.4 million (net of cash acquired), capital expenditures of $49.7 million and the net purchase
of marketable securities of $14.5 million. The prior year included net purchases of marketable
securities of $67.7 million, capital expenditures of
$42.9 million, buyout of a product
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royalty of $19.3 million and acquisitions of $27.3 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 nine months of 2006 was $84.8
million compared with net cash used of $106.6 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 $62.9 million and the tax benefit of stock incentive plans of
$27.0 million which was included as a component of operating cash flows in the prior year. The
cash generated by option exercises and employee stock purchases is dependent on the Companys
stock price, which generally increased during the first nine months of the fiscal year. The level
of proceeds from stock option exercises realized in the first nine 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
plan.
Sufficiency of Cash Resources
We believe our current cash and cash equivalents, marketable securities, investment balances,
cash flows from operations and un-drawn amounts of $175 million 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 November 2005, the FASB issued FSP FASB 115-1 and FASB 124-1, The Meaning of
Other-Than-Temporary Impairment and Its Application to Certain Investments. This FSP provides
guidance on determining if an investment is considered to be impaired, if the impairment is
other-than-temporary, and the measurement of an impairment loss. It also includes accounting
considerations subsequent to the recognition of an other-than-temporary impairment and requires certain disclosures about unrealized losses that have not
been recognized as other-than-temporary impairments. The guidance in this FSP amends SFAS No. 115,
Accounting for Certain Investments in Debt and Equity Securities and is effective for reporting
periods beginning after December 15, 2005. We are currently accounting for investments in
accordance with this guidance, and therefore, the adoption of this FSP has not had a material
impact on our consolidated financial statements.
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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. To the extent that any statements made
in this report contain information that is not historical, these statements are essentially
forward-looking. 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.
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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 $605.0 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 87% 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 March 31, 2006 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 March 31, 2006 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 March 31, 2006, 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 March 31, 2006, 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 is on schedule to be completed by June 30, 2006.
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.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Litigation Matters
The disclosure under Note 10 Commitments and Contingencies Litigation Matters
included in Part I of this report is incorporated in this Part II, Item 1 by reference.
Item 6. Exhibits
(a) Exhibits.
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Exhibit No. |
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Description |
10.1
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Employment Agreement, dated as of
January 5, 2006, among Barr Pharmaceuticals, Inc., Duramed
Pharmaceuticals Inc. and G. Frederick Wilkinson. |
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. |
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. |
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: May 8, 2006 |
/s/ Bruce L. Downey
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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 Financial
Officer, and Treasurer
(Principal Financial Officer and
Principal Accounting Officer) |
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