FORM 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2008
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-9860
BARR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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Delaware
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42-1612474 |
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. - Employer
Identification No.) |
225 Summit Ave, Montvale, New Jersey 07645-1523
(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, a
non-accelerated filer, or a smaller reporting company. See the definitions of accelerated filer,
large accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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(Do not check if a smaller reporting company)
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Smaller reporting company
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of April 28, 2008, the registrant had 108,063,358 shares of $0.01 par value common stock
outstanding.
BARR PHARMACEUTICALS, INC.
INDEX TO FORM 10-Q
2
Part I. CONDENSED FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
BARR PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in millions, except share and per share data)
(unaudited)
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March 31, |
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December 31, |
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2008 |
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2007 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
484 |
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$ |
246 |
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Marketable securities |
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21 |
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288 |
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Accounts receivable, net |
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462 |
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497 |
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Other receivables |
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88 |
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86 |
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Inventories |
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481 |
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454 |
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Deferred income taxes |
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81 |
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74 |
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Prepaid expenses and other current assets |
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51 |
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58 |
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Total current assets |
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1,668 |
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1,703 |
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Property, plant and equipment, net |
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1,170 |
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1,112 |
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Deferred income taxes |
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41 |
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40 |
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Marketable securities |
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52 |
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17 |
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Other intangible assets, net |
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1,517 |
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1,483 |
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Goodwill |
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305 |
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286 |
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Other assets |
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129 |
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117 |
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Long-term assets held for sale |
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4 |
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4 |
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Total assets |
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$ |
4,886 |
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$ |
4,762 |
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Liabilities and Shareholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
138 |
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$ |
152 |
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Accrued liabilities |
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285 |
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291 |
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Current portion of long-term debt and capital lease obligations |
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299 |
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298 |
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Income taxes payable |
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34 |
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37 |
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Deferred tax liabilities |
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3 |
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2 |
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Total current liabilities |
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759 |
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780 |
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Long-term debt and capital lease obligations |
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1,743 |
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1,782 |
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Deferred tax liabilities |
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195 |
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193 |
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Other liabilities |
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104 |
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103 |
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Commitments & contingencies (Note 16) |
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Minority interest |
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32 |
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38 |
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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, $.01 par value per share; authorized 200,000,000;
issued 110,943,653 and 110,783,167 at March 31, 2008
and December 31, 2007 |
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1 |
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1 |
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Additional paid-in capital |
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695 |
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682 |
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Retained earnings |
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1,029 |
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1,006 |
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Accumulated other comprehensive income |
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429 |
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278 |
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Treasury
stock at cost: 2,972,997 shares at March 31, 2008 and
December 31, 2007 |
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(101 |
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(101 |
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Total shareholders equity |
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2,053 |
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1,866 |
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Total liabilities, minority interest and shareholders equity |
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$ |
4,886 |
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$ |
4,762 |
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SEE ACCOMPANYING NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
3
BARR PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in millions, except per share data)
(unaudited)
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Three Months Ended |
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March 31, |
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2008 |
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2007 |
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Revenues: |
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Product sales |
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$ |
565 |
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$ |
560 |
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Alliance and development revenue |
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32 |
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25 |
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Other revenue |
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11 |
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12 |
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Total revenues |
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608 |
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597 |
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Costs and expenses: |
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Cost of sales |
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275 |
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300 |
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Selling, general and administrative |
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194 |
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179 |
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Research and development |
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64 |
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62 |
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Write-off of acquired in-process research and development |
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2 |
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Earnings from operations |
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75 |
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54 |
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Interest income |
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5 |
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11 |
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Interest expense |
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32 |
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42 |
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Other (expense) income, net |
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(8 |
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1 |
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Earnings before income taxes and minority interest |
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40 |
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24 |
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Income tax expense |
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17 |
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10 |
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Minority
interest loss, net of taxes |
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(1 |
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Net earnings from continuing operations |
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23 |
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13 |
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Net loss from discontinued operations, net of taxes |
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(1 |
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Net earnings |
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$ |
23 |
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$ |
12 |
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Basic: |
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Earnings per common share continuing operations |
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$ |
0.21 |
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$ |
0.12 |
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Loss per common share discontinued operations |
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(0.01 |
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Net earnings per common share basic |
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$ |
0.21 |
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$ |
0.11 |
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Diluted: |
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Earnings per common share continuing operations |
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$ |
0.21 |
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$ |
0.12 |
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Loss per common share discontinued operations |
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(0.01 |
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Net earnings per common share diluted |
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$ |
0.21 |
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$ |
0.11 |
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Weighted average shares basic |
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108 |
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107 |
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Weighted average shares diluted |
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109 |
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108 |
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SEE ACCOMPANYING NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
4
BARR PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in millions)
(unaudited)
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Three Months Ended |
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March 31, |
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2008 |
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2007 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net earnings |
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$ |
23 |
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$ |
12 |
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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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78 |
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71 |
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Deferred revenue |
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(1 |
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Minority interest |
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1 |
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Stock-based compensation expense |
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7 |
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7 |
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Excess tax benefits from stock-based compensation |
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(1 |
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(3 |
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Deferred income tax (benefit) expense |
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(13 |
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2 |
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Loss on derivative instruments, net |
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1 |
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1 |
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Other |
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5 |
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(5 |
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Write-off of in-process research and development associated with acquisitions |
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2 |
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Changes in assets and liabilities: |
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(Increase) decrease in: |
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Accounts receivable and other receivables, net |
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55 |
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74 |
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Inventories |
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(15 |
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3 |
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Prepaid expenses |
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8 |
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(4 |
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Other assets |
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1 |
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Increase (decrease) in: |
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Accounts payable, accrued liabilities and other liabilities |
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(42 |
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(14 |
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Income taxes payable |
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(5 |
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(15 |
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Net cash provided by operating activities |
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101 |
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132 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchases of property, plant and equipment |
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(29 |
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(23 |
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Proceeds from sales of property, plant and equipment |
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4 |
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Proceeds from sale of discontinued operations |
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3 |
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Acquisitions, net of cash acquired |
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(10 |
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(33 |
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Settlement of derivative instruments |
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(12 |
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2 |
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Purchases of marketable securities |
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(149 |
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(600 |
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Sales of marketable securities |
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379 |
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626 |
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Investment in debt securities |
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(2 |
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Other |
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1 |
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Net cash provided by (used in) investing activities |
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187 |
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(30 |
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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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(57 |
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(151 |
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Excess tax benefits from stock based compensation |
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1 |
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3 |
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Dividends paid to minority interest shareholders |
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(6 |
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Proceeds from exercise of stock options, employee stock purchases and warrants |
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6 |
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5 |
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Net cash used in financing activities |
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(56 |
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(143 |
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Effect of exchange-rate changes on cash and cash equivalents |
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6 |
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4 |
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Increase (decrease) in cash and cash equivalents |
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238 |
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(37 |
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Cash and cash equivalents at beginning of period |
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246 |
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232 |
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Cash and cash equivalents at end of period |
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$ |
484 |
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$ |
195 |
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SEE ACCOMPANYING NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
5
BARR PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Basis of Presentation
Barr Pharmaceuticals, Inc. (Barr or the Company) is a Delaware holding company whose
principal subsidiaries are Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. (Duramed) and
PLIVA d.d. (PLIVA). The accompanying unaudited interim condensed consolidated 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 and the accompanying notes
that are included in the Companys Annual Report on Form 10-K for the year ended December 31,
2007. The Company prepared these condensed consolidated financial statements following the
requirements of the Securities and Exchange Commission and generally accepted accounting
principles in the United States (GAAP) for interim reporting. In managements opinion, the
unaudited condensed consolidated financial statements reflect all
adjustments (consisting of those
that are normal and recurring) that are necessary in the judgment of management for a fair
presentation of such statements in conformity with GAAP.
The condensed consolidated financial statements include all companies that Barr directly or
indirectly controls (meaning it has more than 50% of voting rights in those companies). Investments
in companies where Barr owns between 20% and 50% of a companys voting rights are accounted for by
using the equity method, with Barr recording its proportionate share of net income or loss for such
investments in its results for that period. The condensed consolidated financial statements include
the accounts of the Company and its majority-owned subsidiaries, after elimination of inter-company
accounts and transactions. Non-controlling interests in the Companys subsidiaries are recorded net
of tax as minority interest.
In preparing the condensed consolidated 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 Companys prior-period condensed consolidated financial statements have
been reclassified to conform to the presentation for the three months ended March 31, 2008. Such
amounts include the Companys reclassification of assets held for sale and discontinued operations.
See Note 5.
2. Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standard (SFAS) No. 157 (SFAS 157), Fair Value Measurements, which defines
fair value, establishes a framework for measuring fair value under GAAP and expands disclosure
about fair value measurements. However, in February 2008, the FASB issued FASB Staff Position
(FSP) 157-2 (FSP 157-2) which delays the effective date of SFAS 157 for all nonfinancial assets
and nonfinancial liabilities, except those that are recognized or disclosed at fair value in the
financial statements on a recurring basis. FSP 157-2 defers the effective date of SFAS 157 to
fiscal years beginning after November 15, 2008 for items within the scope of FSP 157-2. Effective
for 2008, the Company has adopted SFAS 157 in accordance with FSP 157-2. The partial adoption of
SFAS 157 did not have a material impact on its condensed consolidated financial statements but
additional disclosures were required. See Note 7.
In February 2007, the FASB issued SFAS No. 159 (SFAS 159), The Fair Value Option for
Financial Assets and Financial Liabilities, providing companies with an option to report selected
financial assets and liabilities at fair value. The objective of SFAS 159 is to reduce both
complexity in accounting for financial instruments and the volatility in earnings caused by
measuring related assets and liabilities differently. GAAP has required different measurement
attributes for different assets and liabilities that can create artificial volatility in earnings.
SFAS 159 helps to mitigate this type of accounting-induced volatility by enabling companies to
report related assets and liabilities at fair value, which would likely reduce the need for
companies to comply with detailed rules for hedge accounting. SFAS 159 also establishes
presentation and disclosure requirements designed to facilitate comparisons between companies that
choose different measurement attributes for similar types of assets and liabilities. SFAS 159
requires companies to provide additional information that will help investors and other users of
financial statements
6
to more easily understand the effect of a companys choice to use fair value on its earnings.
It also requires entities to display the fair value of those assets and liabilities for which a
company has chosen to use fair value on the face of the balance sheet. SFAS 159 is effective for
fiscal years beginning after November 15, 2007. The Company did not elect to adopt the fair value
option under SFAS 159.
In June 2007, the Emerging Issues Task Force (EITF) reached a consensus on EITF Issue
No. 07-3 (EITF 07-3), Accounting for Advance Payments for Goods or Services to be Received for
Use in Future Research and Development Activities. EITF 07-3 provides clarification surrounding the
accounting for nonrefundable research and development advance payments, whereby such payments
should be recorded as an asset when the advance payment is made and recognized as an expense when
the research and development activities are performed. EITF 07-3 is effective for interim and
annual reporting periods beginning after December 15, 2007. The adoption of EITF 07-3 did not have
a material effect on the Companys condensed consolidated financial statements.
In December 2007, the FASB issued SFAS No. 141(R) (SFAS 141(R)), Business Combinations
(revised), replacing SFAS No. 141 (SFAS 141) Business Combinations. This new statement requires
additional assets and assumed liabilities to be measured at fair value when acquired in a business
combination as compared to the original pronouncement. SFAS 141(R) also requires liabilities
related to contingent consideration to be re-measured to fair value each reporting period,
acquisition-related costs to be expensed and not capitalized and acquired in-process research and
development to be capitalized as an indefinite lived intangible asset until completion of project
or abandonment of project. SFAS 141(R) requires prospective application for business combinations
consummated in fiscal years beginning on or after December 15, 2008. This statement does not allow
for early adoption. The Company is currently evaluating the impact of the adoption of this
statement on its condensed consolidated financial statements.
In December 2007, the FASB issued SFAS No. 160 (SFAS 160), Noncontrolling Interests in
Consolidated Financial Statements an amendment of Accounting
Research Bulletin No. 51 ( ARB No.
51). This amendment of ARB No. 51 requires noncontrolling interest in subsidiaries initially to be
measured at fair value and then to be classified as a separate component of equity. This statement
is effective for fiscal years and interim periods within those fiscal years beginning on or after
December 15, 2008. This statement does not allow for early adoption, however, application of SFAS
160 disclosure and presentation requirements is retroactive. The Company is currently evaluating
the impact of the adoption of this statement on its condensed consolidated financial statements.
In December 2007, the EITF issued EITF Issue No. 07-1 (EITF 07-1), Accounting for
Collaborative Arrangements. EITF 07-1 affects entities that participate in collaborative
arrangements for the development and commercialization of intellectual property. The EITF affirmed
the tentative conclusions reached on (1) what constitutes a collaborative arrangement, (2) how the
parties should present costs and revenues in their respective income statements, (3) how the
parties should present cost-sharing payments, profit-sharing payments, or both in their respective
income statements, and (4) disclosure in the annual financial statements of the partners. EITF 07-1
should be applied as a change in accounting principle through retrospective application to all
periods presented for collaborative arrangements existing as of the date of adoption. EITF 07-1 is
effective for financial statements issued for fiscal years beginning after December 15, 2008. The
Company is currently evaluating the impact of the adoption of this statement on its condensed
consolidated financial statements.
On March 19, 2008, the FASB issued SFAS No. 161 (SFAS 161), Disclosures about Derivative
Instruments and Hedging Activities an Amendment of FASB Statement 133. SFAS 161 enhances required
disclosures regarding derivatives and hedging activities, including enhanced disclosures regarding
how: (a) an entity uses derivative instruments; (b) derivative instruments and related hedged items
are accounted for under SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities;
and (c) derivative instruments and related hedged items affect an entitys financial position,
financial performance, and cash flows. Specifically, SFAS 161 requires: disclosure of the
objectives for using derivative instruments be disclosed in terms of underlying risk and accounting
designation; disclosure of the fair values of derivative instruments and their gains and losses in
a tabular format; disclosure of information about credit-risk-related contingent features; and
cross-reference from the derivative footnote to other footnotes in which derivative-related
information is disclosed. SFAS 161 is effective for fiscal years and interim periods beginning
after November 15, 2008. Early application is encouraged. The Company is currently evaluating the
impact of the adoption of this statement on its condensed consolidated financial statements.
7
3. Earnings Per Share
The following is a reconciliation of the numerators and denominators used to calculate
earnings per common share (EPS) as presented in the condensed consolidated statements of
operations:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
(table in millions, except per share data) |
|
|
|
|
|
|
|
|
Numerator for basic and diluted earnings (loss) per share |
|
|
|
|
|
|
|
|
Net earnings from continuing operations |
|
$ |
23 |
|
|
$ |
13 |
|
Net loss from discontinued operations |
|
|
|
|
|
|
(1 |
) |
|
|
|
|
|
|
|
Net earnings |
|
$ |
23 |
|
|
$ |
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: Weighted average shares basic |
|
|
108 |
|
|
|
107 |
|
|
|
|
|
|
|
|
|
|
Earnings per common share continuing operations |
|
$ |
0.21 |
|
|
$ |
0.12 |
|
Loss per common share discontinued operations |
|
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
|
|
Earnings per common share basic |
|
$ |
0.21 |
|
|
$ |
0.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: Weighted average shares diluted |
|
|
109 |
|
|
|
108 |
|
|
|
|
|
|
|
|
|
|
Earnings per common share continuing operations |
|
$ |
0.21 |
|
|
$ |
0.12 |
|
Loss per common share discontinued operations |
|
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
|
|
Earnings per common share diluted |
|
$ |
0.21 |
|
|
$ |
0.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Calculation of weighted average common shares diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares basic |
|
|
108 |
|
|
|
107 |
|
Effect of dilutive options |
|
|
1 |
|
|
|
1 |
|
|
|
|
|
|
|
|
Weighted average shares diluted |
|
|
109 |
|
|
|
108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Not included in the calculation of diluted earnings
per-share because their impact is antidilutive: |
|
|
|
|
|
|
|
|
Stock options outstanding (amounts in thousands) |
|
|
835 |
|
|
|
151 |
|
4. Acquisitions and Business Combinations
O.R.C.A.pharm GmbH
On September 5, 2007, the Company acquired 100% of the outstanding shares of O.R.C.A. pharm
GmbH (ORCA), a privately-owned specialty pharmaceutical company focused on the oncology market in
Germany. In accordance with SFAS No. 141 (SFAS 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 ORCA are recorded at the date of acquisition, at their
respective fair values. The purchase price at September 5, 2007 was approximately
$44 million, including minimum future payments due in 2008 and 2009. The Company may also be required to pay up
to an additional $7 million based on the achievement of defined performance milestones for 2008.
The operating results of ORCA are included in the condensed consolidated financial statements
subsequent to the September 5, 2007 acquisition date. The fair value of the assets and liabilities
acquired on September 5, 2007, including adjustments made during the purchase price allocation
period are as follows:
8
|
|
|
|
|
$ in millions |
|
|
|
|
|
Inventory |
|
$ |
3 |
|
Products acquired |
|
|
29 |
|
Goodwill |
|
|
10 |
|
Other assets |
|
|
6 |
|
Liabilities |
|
|
(4 |
) |
|
|
|
|
Total |
|
$ |
44 |
|
|
|
|
|
The above purchase price allocation is preliminary and is based on the information that was
available as of the acquisition date to estimate the fair value of assets acquired and liabilities
assumed. Management believes the available information provides a reasonable basis for allocating
the purchase price but the Company is awaiting additional information necessary to finalize the
purchase price allocation. The Company expects to finalize the valuation and complete the purchase
price allocation as soon as possible but no later than one year from the acquisition date. Under
the guidance of SFAS 141, this acquisition is being treated as an immaterial acquisition. As an
immaterial acquisition, pro-forma financial statements are not required to be presented.
5. Assets Held for Sale and Discontinued Operations
The Company has decided to divest or exit its operations in Goa, India. As a result, as of
March 31, 2008, the assets and liabilities relating to the Goa operations met the held for sale
criteria of SFAS No. 144 (SFAS 144), Accounting for the Impairment or Disposal of Long Lived
Assets. The Company expects to sell these assets and the related liabilities held for sale within
one year. Following the divestiture, the cash flows and operations of the divested operations will
be eliminated from the Companys ongoing operations, and the Company will cease to have continuing
involvement with these operations. The Companys operations in Goa are part of the generic
pharmaceuticals segment.
The following combined amounts of assets for Goa have been segregated and included in assets
held for sale on the Companys condensed consolidated balance sheet as of March 31, 2008 and
December 31, 2007, as shown below:
|
|
|
|
|
|
|
|
|
$ in millions |
|
March 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Property, plant and equipment, net |
|
$ |
4 |
|
|
$ |
4 |
|
|
|
|
|
|
|
|
Long-term assets held for sale |
|
$ |
4 |
|
|
$ |
4 |
|
|
|
|
|
|
|
|
During 2007, the Company sold its operations in Spain and Italy, and its Veterina business.
For the three months ended March 31, 2007, the Company has segregated from continuing operations
and included in discontinued operations, net of taxes, in the condensed consolidated statement of
operations, the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ in millions |
|
Three Months Ended |
|
|
|
March 31, 2007 |
|
|
|
Italy |
|
|
Spain |
|
|
Veterina |
|
|
Total |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics |
|
$ |
3 |
|
|
$ |
8 |
|
|
$ |
- |
|
|
$ |
11 |
|
Other |
|
|
- |
|
|
|
- |
|
|
|
7 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues of discontinued operations |
|
$ |
3 |
|
|
$ |
8 |
|
|
$ |
7 |
|
|
$ |
18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes and minority interest |
|
$ |
(1 |
) |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(1 |
) |
Loss from discontinued operations- net of tax |
|
$ |
(1 |
) |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(1 |
) |
9
6. Investments in Marketable Securities
Investments in Marketable Securities and Debt
Trading Securities
The fair value of marketable securities classified as trading at each of March 31, 2008 and
December 31, 2007 was $4 million, which is included as a component of current marketable
securities. Net (losses) gains for the three-month periods ended March 31, 2008 and March 31, 2007 were $(0.1) million and $1 million, respectively. These
amounts are included as a component of other (expense) income.
Available-for-Sale Securities
Available-for-sale equity securities include amounts invested in connection with the Companys
excess 401(k) and other deferred compensation plans of $10 million and $12 million at March 31,
2008 and December 31, 2007, respectively.
Available-for-sale debt securities at March 31, 2008 includes $41 million in market auction
debt securities and $16 million in municipal bonds. The market auction debt securities have auction
rate reset dates ranging from April 1, 2008 to April 25, 2008 with underlying maturity dates
ranging January 1, 2016 to August 15, 2034. The municipal bonds have maturity dates ranging from
June 1, 2008 to February 1, 2010.
The Companys holdings of market auction debt securities are restricted to highly rated
municipal securities. The Companys typical practice has been to continue to own the respective
securities or liquidate the holdings by selling those securities at par value at the next auction,
which generally ranges from 7 to 35 days after purchase. The market auction debt securities
investments are investment grade (A rated and above) municipal securities and are insured against
loss of principal and interest by bond insurers whose AAA ratings are under review.
The recent uncertainties in the credit markets have prevented the Company and other investors
from liquidating holdings of market auction debt securities in recent auctions because the amount
of market auction debt securities submitted for sale has exceeded the amount of purchase orders. In
2008, the Company decided to liquidate its holdings in market auction debt securities and not
reinvest in market auction debt securities in order to intentionally reduce exposure to these
instruments. At March 31, 2008, the Company held $41 million in market auction debt securities as
these securities have not been liquidated due to failed auctions. Accordingly, the Company
reclassified these securities as long-term as of March 31, 2008 on the condensed consolidated
balance sheet.
Despite these failed auctions, there have been no defaults on the underlying securities, and
interest income on these holdings continues to be received on scheduled interest payment dates. As
a result, the Company now earns premium interest rates on the failed auction investments (currently
earning 2.75% to 5% on a tax-free basis). If the issuers of these securities are unable to
successfully close future auctions and their credit ratings deteriorate, the Company may be
required to adjust the carrying value of these investments to reflect other than temporary declines
in their value.
The Company has historically valued these securities at par because this is the value it
receives when trading them in the established market. In assessing the fair value of these
securities, the Company determined market input comparability based on an analysis of similar
security current market data factors. As a result of such assessment the Company believes that the
fair value of these securities continues to be par. Therefore, the Company has not adjusted the
recorded value of theses securities. The Company will re-evaluate these securities each quarter for
any possible temporary or permanent adjustments to their value.
Based on the Companys ability to access its cash and other short-term investments, its
expected operating cash flows and its other sources of cash, the Company does not anticipate that
the lack of liquidity in its holdings of market auction debt securities will affect its ability to
operate the business as usual.
10
The amortized cost, gross unrealized gains, and losses recorded as a component of other
comprehensive income, and estimated market values for available-for-sale securities at March 31,
2008 and December 31, 2007 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ in millions |
|
Available for Sale |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Market |
|
|
|
Cost |
|
|
Gains |
|
|
(Losses) |
|
|
Value |
|
March 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt securities |
|
$ |
57 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
57 |
|
Equity securities |
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
69 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
69 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt securities |
|
$ |
288 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
288 |
|
Equity securities |
|
|
12 |
|
|
|
1 |
|
|
|
|
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
300 |
|
|
$ |
1 |
|
|
$ |
|
|
|
$ |
301 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7. Fair Value Measures
On January 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements. SFAS 157
applies to all financial instruments that are measured and reported on a fair value basis. This
includes items currently reported in marketable securities (current and long-term) on the condensed
consolidated balance sheet as well as financial instruments reported in other assets and other
liabilities that are reported at fair value.
As defined in SFAS 157, fair value is the price that would be received to sell an asset or
paid to transfer a liability in an orderly transaction between market participants at the
measurement date. In determining fair value, the Company uses various methods including market,
income, and cost approaches. Based on these approaches, the Company often utilizes certain
assumptions that market participants would use in pricing the asset or liability, including
assumptions about risk and the risks inherent in the inputs to the valuation technique. These
inputs can be readily observable, market corroborated, or generally unobservable firm inputs. The
Company utilizes valuation techniques that maximize the use of observable inputs and minimize the
use of unobservable inputs. Based on the observability of the inputs used in the valuation
techniques the Company is required to provide the following information according to the fair value
hierarchy. The fair value hierarchy ranks the quality and reliability of the information used to
determine fair values. Financial assets and liabilities carried at fair value will be classified
and disclosed in one of the following three categories:
Level 1: Quoted market prices in active markets for identical assets or liabilities.
Level 2: Observable market based inputs or unobservable inputs that are corroborated by market
data.
Level 3: Unobservable inputs that are not corroborated by market data.
|
|
|
Level 1 primarily consists of financial assets and liabilities whose values are
based on unadjusted quoted prices for identical assets or liabilities in an active market
that the Company has the ability to access (examples include active exchange-traded equity
securities, exchange-traded derivatives, most U.S. Government and agency securities, and
certain other sovereign government obligations). |
|
|
|
|
Level 2 includes financial instruments that are valued using models or other
valuation methodologies. These models are primarily industry-standard models that consider
various assumptions, including time value, yield curve, volatility factors, prepayment
speeds, default rates, loss severity, current market, and contractual prices for the
underlying financial instruments, as well as other relevant economic measures.
Substantially all of these assumptions are observable in the marketplace, can be derived
from observable data, or are supported by observable levels at which transactions are
executed in the marketplace. Financial instruments in this category include certain
corporate debt, certain U.S. agency and non-agency mortgage-backed securities and
non-exchange-traded derivatives such as interest rate swaps. |
|
|
|
|
Level 3 is comprised of financial assets and liabilities whose values are based
on prices or valuation techniques that require inputs that are both unobservable and
significant to the overall fair value measurement. These inputs reflect managements own
assumptions about the assumptions a market participant would use in pricing the asset or
liability. |
11
In determining the appropriate levels, the Company performs a detailed analysis of the assets
and liabilities that are subject to SFAS 157. At each reporting period all assets and liabilities
for which the fair value measurement is based on significant unobservable inputs are classified as
Level 3.
The following table presents the Companys fair value hierarchy for those financial assets and
financial liabilities measured at fair value on a recurring basis as of March 31, 2008.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ in millions |
|
Fair Value Measurements on a Recurring Basis |
|
|
|
as of March 31, 2008 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
|
|
|
|
Quoted prices |
|
|
Significant |
|
|
|
|
|
|
|
|
|
in Active |
|
|
Other |
|
|
Significant |
|
|
Balance at |
|
|
|
Markets for |
|
|
Observable |
|
|
Unobservable |
|
|
March 31, |
|
|
|
Identical Items |
|
|
Inputs |
|
|
Inputs |
|
|
2008 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. T-Bills (1) |
|
$ |
115 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
115 |
|
Marketable securities trading (2) |
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
4 |
|
Marketable securities available for sale (3) |
|
|
28 |
|
|
|
41 |
|
|
|
|
|
|
|
69 |
|
Venture fund
investments (4) |
|
|
|
|
|
|
|
|
|
|
20 |
|
|
|
20 |
|
Derivative instruments (5) |
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets at fair value |
|
$ |
147 |
|
|
$ |
42 |
|
|
$ |
20 |
|
|
$ |
209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative instruments (5) |
|
$ |
|
|
|
$ |
39 |
|
|
$ |
|
|
|
$ |
39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Represents quoted market prices from broker or dealer quotations. |
|
(2) |
|
Represents trading investments, which are included as a component of current
marketable securities. |
|
(3) |
|
Represents available-for-sale securities that are at par value, which is
equivalent to fair value. |
|
(4) |
|
Represents investments that are accounted for under the equity method including
investments in venture funds. |
|
(5) |
|
Represents financial instrument assets or liabilities used in hedging
activities. |
The following table represents the Level 3 significant unobservable input components:
|
|
|
|
|
$ in millions |
|
Fair value Measurements |
|
|
|
Using Significant Unobservable Inputs |
|
|
|
(Level 3) |
|
|
|
Venture Fund |
|
|
|
Investments |
|
Beginning balance January 1, 2008 |
|
$ |
20 |
|
Total gains or losses (realized/unrealized) |
|
|
1 |
|
Included in earnings (or changes in net assets) |
|
|
1 |
|
Included in other comprehensive income |
|
|
|
|
Purchase issuance or settlements |
|
|
1 |
|
Distribution |
|
|
(2 |
) |
|
|
|
|
Ending balance March 31, 2008 |
|
$ |
20 |
|
|
|
|
|
The
level 3 fair value disclosure above relates to the
Companys equity interest in venture funds, which are
recorded at fair value. The venture funds value their underlying investments based on a
combination of recent trading activity and discounted cash flow valuations.
12
8. Derivative Instruments
Interest Rate Risk
The Companys interest-bearing investments, loans, and borrowings are subject to interest rate
risk. The Company invests and borrows primarily on a variable-rate basis. Depending upon market
conditions, the Company may fix the interest rate it either pays or receives by entering into
fixed-rate investments and borrowings or through the use of derivative financial instruments.
During 2007, as reflected in the table below, the Company entered into pay-fixed,
receive-floating interest rate swap agreements effectively converting $800 million of variable-rate
debt under unsecured senior credit facilities to fixed-rate debt. The objective of the hedge is to
manage the variability of cash flows in the interest payments related to the portion of the
variable-rate debt designated as being hedged. With the hedge in place, the sole source of
variability to the Company is the interest payments it receives based on changes in LIBOR. The
swaps are accounted for in accordance with SFAS No. 133 (SFAS 133), Accounting for Derivative
Instruments and Hedging Activities as amended and interpreted as amended.
Derivative financial instruments are measured at fair value, are recognized as assets or
liabilities on the condensed consolidated balance sheet, with changes in the fair value of the
derivatives recognized in either net income (loss) or other comprehensive income (loss), depending
on the timing, and designated purpose of the derivative. When the Company pays interest on the
portion of the debt designated as hedged, the gain or loss on the swap designated as hedging the
interest payment will be reclassified from accumulated other comprehensive income into interest
expense.
These derivative instruments are designated as cash flow hedges with the related gains or
losses recorded in other comprehensive income (net of tax) with an offsetting amount included in
other non-current liabilities. The losses are $20 million and $11 million for the three months
ended March 31, 2008 and the year ended December 31, 2007, respectively.
The Company estimates that approximately $11 million of the net losses at March 31, 2008 will
be realized into earnings over the next twelve months for the transactions that are expected to
occur over that period.
The terms of the interest rate swap agreements that are still in effect as of March 31, 2008
are shown in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ in millions |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notional |
|
|
|
|
|
|
|
|
|
|
Principal Amount |
|
|
|
Start Date |
|
Maturity Date |
|
Receive Variable Rate |
|
Pay Fixed Rate |
$ |
175 |
|
|
|
|
Mar-30-07 |
|
Jun-30-08 |
|
90 day LIBOR |
|
|
5.253 |
% |
$ |
125 |
|
|
|
|
Jun-30-07 |
|
Jun-30-10 |
|
90 day LIBOR |
|
|
5.4735 |
% |
$ |
100 |
|
|
|
|
Jun-30-07 |
|
Jun-30-10 |
|
90 day LIBOR |
|
|
5.3225 |
% |
$ |
100 |
|
|
|
|
Sept-30-07 |
|
Sept-30-10 |
|
90 day LIBOR |
|
|
4.985 |
% |
$ |
100 |
|
|
|
|
Sept-30-07 |
|
Sept-30-09 |
|
90 day LIBOR |
|
|
4.92875 |
% |
$ |
100 |
|
|
|
|
Sept-30-07 |
|
Mar-31-09 |
|
90 day LIBOR |
|
|
4.755 |
% |
$ |
100 |
|
|
|
|
Sept-30-07 |
|
Sept-30-09 |
|
90 day LIBOR |
|
|
4.83 |
% |
Foreign Exchange Risk
The Company seeks to manage potential foreign exchange risk from foreign subsidiaries by
matching each such subsidiarys revenues and costs in its functional currency. Similarly, the
Company seeks to manage the foreign exchange risk relating to assets and liabilities of its foreign
subsidiaries by matching the assets and liabilities in the subsidiarys functional currency. When
this is not practical, the Company uses foreign exchange forward contracts or options to manage its
foreign exchange risk, as described below.
The Company entered into foreign exchange forward contracts that serve as economic hedges of
certain forecast foreign currency transactions occurring at various dates through 2008. At March
31, 2008, none of the Companys remaining foreign exchange derivatives were eligible for hedge
accounting, resulting in their changes in fair value
13
being reported in other (expense) income as a loss of $18 million which is partially offset by
the change in the mark-to-market value of the underlying exposure that it is hedging.
All foreign exchange derivative instruments described above are measured at fair value and are
reported as assets or liabilities on the condensed consolidated balance sheet. Changes in fair
value are reported in earnings or other comprehensive income depending upon whether the
risk-management instrument is classified as a formal hedge pursuant to the guidelines outlined by
SFAS 133. Economically, the gains or losses realized on these instruments at maturity are intended
to offset the losses or gains of the transactions, which they are hedging.
The table below summarizes the respective fair values of the derivative instruments described
above at March 31, 2008 and December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ in millions |
|
March 31, 2008 |
|
|
December 31, 2007 |
|
|
|
Assets |
|
|
Liabilities |
|
|
Assets |
|
|
Liabilities |
|
Interest rate swap |
|
$ |
|
|
|
$ |
(32 |
) |
|
$ |
|
|
|
$ |
(17 |
) |
Foreign exchange forward contracts |
|
|
1 |
|
|
|
(7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1 |
|
|
$ |
(39 |
) |
|
$ |
|
|
|
$ |
(17 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
9. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
$ in millions |
|
March 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials and supplies |
|
$ |
157 |
|
|
$ |
166 |
|
Work-in-process |
|
|
108 |
|
|
|
77 |
|
Finished goods |
|
|
216 |
|
|
|
211 |
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
481 |
|
|
$ |
454 |
|
|
|
|
|
|
|
|
At
March 31, 2008 and December 31, 2007, $60 million and
$47 million, respectively, of inventory is classified as other
assets as such inventory is not expected to be sold within 12
months of the applicable period. Included in inventory is
$25 million and $27 million at March 31, 2008 and
December 31, 2007, respectively, of prelaunch
inventory related to products that have not yet received the requisite regulatory approvals for commercial launch.
10. Goodwill and Other Intangible Assets
Goodwill at March 31, 2008 and December 31, 2007 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
$ in millions |
|
Generic |
|
|
Proprietary |
|
|
|
|
|
|
Pharmaceuticals |
|
|
Pharmaceuticals |
|
|
Total |
|
Goodwill balance at December 31, 2007 |
|
$ |
238 |
|
|
$ |
48 |
|
|
$ |
286 |
|
|
Currency translation effect |
|
|
18 |
|
|
|
|
|
|
|
18 |
|
ORCA goodwill adjustments |
|
|
1 |
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
Goodwill balance at March 31, 2008 |
|
$ |
257 |
|
|
$ |
48 |
|
|
$ |
305 |
|
|
|
|
|
|
|
|
|
|
|
14
Intangible assets at March 31, 2008 and December 31, 2007 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ in millions |
|
March 31, |
|
December 31, |
|
|
2008 |
|
2007 |
|
|
Gross |
|
|
|
|
|
Net |
|
Gross |
|
|
|
|
|
Net |
|
|
Carrying |
|
Accumulated |
|
Carrying |
|
Carrying |
|
Accumulated |
|
Carrying |
|
|
Amount |
|
Amortization |
|
Amount |
|
Amount |
|
Amortization |
|
Amount |
|
|
|
|
|
Finite-lived intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product licenses |
|
$ |
45 |
|
|
$ |
21 |
|
|
$ |
24 |
|
|
$ |
45 |
|
|
$ |
21 |
|
|
$ |
24 |
|
Product rights |
|
|
1,524 |
|
|
|
268 |
|
|
|
1,256 |
|
|
|
1,456 |
|
|
|
218 |
|
|
|
1,238 |
|
Land use rights |
|
|
116 |
|
|
|
1 |
|
|
|
115 |
|
|
|
106 |
|
|
|
1 |
|
|
|
105 |
|
Other |
|
|
42 |
|
|
|
16 |
|
|
|
26 |
|
|
|
43 |
|
|
|
16 |
|
|
|
27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total amortized finite-lived
intangible assets |
|
|
1,727 |
|
|
|
306 |
|
|
|
1,421 |
|
|
|
1,650 |
|
|
|
256 |
|
|
|
1,394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indefinite-lived intangible assets
- tradenames: |
|
|
96 |
|
|
|
|
|
|
|
96 |
|
|
|
89 |
|
|
|
|
|
|
|
89 |
|
|
|
|
|
|
Total identifiable intangible assets |
|
$ |
1,823 |
|
|
$ |
306 |
|
|
$ |
1,517 |
|
|
$ |
1,739 |
|
|
$ |
256 |
|
|
$ |
1,483 |
|
|
|
|
|
|
The Companys product licenses, product rights, land use rights and other finite lived
intangible assets have weighted average useful lives of approximately 10, 17, 99 and 10 years,
respectively. Amortization expense associated with these acquired intangibles was $44 million and
$41 million for the three months ended March 31, 2008 and 2007, respectively.
The Company reviews the carrying value of its goodwill and indefinite lived intangible assets
for impairment annually and whenever events and circumstances indicate that the carrying value of
an asset may not be recoverable from the estimated future cash flows expected to result from its
use and eventual disposition. In cases where undiscounted expected future cash flows are less than
the carrying value, an impairment loss is recognized equal to an amount by which the carrying value
exceeds the fair value of assets. Fair value is defined as the market price. If the market price is
not available, fair value is estimated based on the present value of future cash flows. Such
evaluation last took place as of July 1, 2007, with no impairment deemed required.
The annual estimated amortization expense for the next five calendar years on finite-lived
intangible assets is as follows:
|
|
|
|
|
$ in millions |
|
|
|
|
|
Years Ending December 31, |
|
|
|
|
2009 |
|
$ |
148 |
|
2010 |
|
$ |
151 |
|
2011 |
|
$ |
142 |
|
2012 |
|
$ |
132 |
|
2013 |
|
$ |
118 |
|
Included in the finite-lived intangible assets table above are product rights to over 200
intangible assets acquired by the Company over the past five years. The following table
disaggregates the values of these product rights into therapeutic categories as of March 31, 2008:
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ in millions |
|
March 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Gross |
|
|
|
|
|
|
Net |
|
|
Average |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
Amortization |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
Period |
|
Therapeutic Category |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contraception |
|
$ |
384 |
|
|
$ |
78 |
|
|
$ |
306 |
|
|
|
18 |
|
Antibiotics, antiviral & anti-infectives |
|
|
254 |
|
|
|
46 |
|
|
|
208 |
|
|
|
10 |
|
Cardiovascular |
|
|
242 |
|
|
|
44 |
|
|
|
198 |
|
|
|
10 |
|
Psychotherapeutics |
|
|
192 |
|
|
|
31 |
|
|
|
161 |
|
|
|
12 |
|
Other (1) |
|
|
452 |
|
|
|
69 |
|
|
|
383 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product rights |
|
$ |
1,524 |
|
|
$ |
268 |
|
|
$ |
1,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Other includes numerous therapeutic categories, none of which exceeds 10% of the
aggregate net book value of product rights. |
11. Debt
A summary of outstanding debt is as follows:
|
|
|
|
|
|
|
|
|
$ in millions |
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Credit facilities (a) |
|
$ |
1,750 |
|
|
$ |
1,800 |
|
Note due to WCC shareholders (b) |
|
|
|
|
|
|
7 |
|
Obligation under capital leases (c) |
|
|
3 |
|
|
|
2 |
|
Fixed rate bonds (d) |
|
|
120 |
|
|
|
113 |
|
Dual-currency syndicated credit facility (d) |
|
|
24 |
|
|
|
24 |
|
Euro commercial paper program (d) |
|
|
87 |
|
|
|
78 |
|
Dual-currency term loan facility (d) |
|
|
25 |
|
|
|
25 |
|
Multi-currency revolving credit facility (d) |
|
|
32 |
|
|
|
29 |
|
Other |
|
|
1 |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
2,042 |
|
|
|
2,080 |
|
|
|
|
|
|
|
|
|
|
Less: current installments of debt and capital
lease obligations |
|
|
299 |
|
|
|
298 |
|
|
|
|
|
|
|
|
Total long-term debt |
|
$ |
1,743 |
|
|
$ |
1,782 |
|
|
|
|
|
|
|
|
Principal maturities of existing long-term debt and amounts due on capital leases for the
period set forth in the table below are as follows:
16
|
|
|
|
|
$ in millions |
|
|
|
Twelve Months Ending March 31, |
|
Total |
|
2010 |
|
$ |
269 |
|
2011 |
|
|
200 |
|
2012 |
|
|
1,269 |
|
2013 |
|
|
1 |
|
2014 |
|
|
1 |
|
Thereafter |
|
|
|
|
|
|
|
|
Total
principal maturities and amounts due on long term debt and capital obligations |
|
$ |
1,740 |
|
Premium on fixed rate bond |
|
|
3 |
|
|
|
|
|
Total long term debt and capital lease
obligations |
|
$ |
1,743 |
|
|
|
|
|
|
|
|
(a) |
|
In connection with the closing of the PLIVA acquisition, on October 24, 2006, the Company
entered into unsecured senior credit facilities (the Credit Facilities) and drew $2 billion under
a five-year term facility and $416 million under a 364-day term facility, both of which bear
interest at variable rates of LIBOR plus 75 basis points (3.446% at March 31, 2008). The Company is
obligated to repay the outstanding principal amount of the five-year term facility in 18
consecutive quarterly installments of $50 million, with the balance of $1.1 billion due at maturity
in October 2011. The five-year term facility had an outstanding principal balance of $1.75 billion
at March 31, 2008. The Company also has a $300 million revolving credit facility available, which
bears interest at variable rates of LIBOR plus 60 basis points and a facility fee of 15 basis
points. No amounts were drawn at March 31, 2008. Any outstanding borrowings under the revolving credit facility would be payable in
October 2011. The 364-day term facility was repaid in full during 2007. The Credit Facilities
include customary covenants, including financial covenants limiting the total indebtedness of the
Company on a consolidated basis. |
|
(b) |
|
In February 2004, the Company acquired all of the outstanding shares of Womens Capital
Corporation (WCC). In connection with that acquisition, the Company issued a four-year, $7
million promissory note to WCCs former shareholders. The note bears a fixed interest rate of 2%.
The entire principal amount and all accrued interest was due and paid in full on February 25, 2008. |
|
(c) |
|
The Company has certain capital lease obligations for machinery, equipment, and buildings in
the United States and the Czech Republic. |
|
(d) |
|
On April 17, 2008, the Company drew down $285 million from its $300 million revolving credit
facility (noted in (a) above) to use as a bridge to refinance these debt instruments of PLIVA d.d.
and its subsidiaries. These PLIVA d.d. debt instruments were all repaid in April 2008. |
12. Accumulated Other 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 income, unrealized gains (losses) on securities classified for SFAS No.
115 Accounting for Certain Investments in Debt and Equity Securities purposes as available
for sale, unrealized gains (losses) on pension and other post employment benefits and foreign
currency translation adjustments.
17
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
$ in millions |
|
March 31, |
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
Net income |
|
$ |
23 |
|
|
$ |
12 |
|
Net unrealized gain on marketable securities,
net of tax |
|
|
|
|
|
|
1 |
|
Net (loss) on derivative financial instruments
designated as cash flow hedges, net of tax |
|
|
(9 |
) |
|
|
(2 |
) |
Net unrealized gain on
currency translation adjustments |
|
|
160 |
|
|
|
9 |
|
|
|
|
|
|
|
|
Total comprehensive income |
|
$ |
174 |
|
|
$ |
20 |
|
|
|
|
|
|
|
|
Accumulated other comprehensive income, as reflected on the condensed consolidated balance
sheet, is comprised of the following:
|
|
|
|
|
|
|
|
|
$ in millions |
|
March 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Cumulative net (loss) on derivative financial
instruments designated as cash flow hedges, net of tax |
|
$ |
(20 |
) |
|
$ |
(11 |
) |
Cumulative net unrealized gain on pension and other
post employment benefits, net of tax |
|
|
1 |
|
|
|
1 |
|
Cumulative net unrealized gain on
currency translation adjustments |
|
|
448 |
|
|
|
288 |
|
|
|
|
|
|
|
|
Accumulated other comprehensive income |
|
$ |
429 |
|
|
$ |
278 |
|
|
|
|
|
|
|
|
13. Income Taxes
The
Companys effective tax rate increased in the current quarter to
42.0% from 41.7% in the
same period for 2007. The rate was negatively impacted by the expiration of the U.S. research and
development tax credit at December 31, 2007, a shift in the Companys investment portfolio from
tax-exempt securities to taxable securities due to market conditions and a change of the mix of
income in certain U.S. and foreign taxing jurisdictions. The rate was favorably impacted by a
reduction of the tax rates in Germany and the Czech Republic.
The total amount of gross unrecognized tax benefits as of December 31, 2007 was $26 million
and did not change materially as of March 31, 2008. Included in the balance at March 31, 2008 was
$16 million of tax positions that, if recognized, would positively affect the Companys effective
tax rate. The Company estimates that during the next 52-week period the amount of its liability for
unrecognized tax benefits may decrease by $1 million to $5 million from the completion of certain
audits and the expiration of the statute of limitations in certain U.S. and foreign taxing
jurisdictions. It is also possible that tax authorities could raise new issues requiring
increases to the balance of unrecognized tax benefits. However, such potential increases cannot
reasonably be estimated at this time. The Company had $2 million accrued for interest and penalties
at December 31, 2007, which did not change materially as of March 31, 2008.
The
Company is currently being examined by the IRS for its six-month transition period ended
December 31, 2006 and subsequent tax years. Prior periods have either been examined or are no
longer subject to examination. Examinations in several state jurisdictions are currently in
progress for tax years 2004 to 2006. The Companys significant foreign operations remain subject to
examination for tax years 2002 through 2007, with examinations currently in process for tax years
2003 through 2006.
18
14. Stock-based Compensation
The Company recognized stock-based compensation expense, related tax benefits and the effect
on net income from recognizing stock-based compensation for the three months ended March 31, 2008
and 2007 in the following amounts:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
$ in million except per share data |
|
March 31, |
|
|
2008 |
|
2007 |
Stock-based compensation expense |
|
$ |
7 |
|
|
$ |
7 |
|
Related tax benefits |
|
$ |
3 |
|
|
$ |
2 |
|
Effect on net income |
|
$ |
4 |
|
|
$ |
5 |
|
Per share basic |
|
$ |
0.04 |
|
|
$ |
0.05 |
|
Per share diluted |
|
$ |
0.04 |
|
|
$ |
0.04 |
|
The total number of shares of common stock issuable upon the exercise of stock options and
stock-settled appreciation rights granted during the three months ended March 31, 2008 and 2007 was
2,572,520 and 928,950 respectively, with weighted-average exercise prices of $49.26 and $49.46,
respectively.
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 option holder 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 average expected
term is derived from historical and other factors. The stock-based compensation for the awards
issued in the respective periods was determined using the following assumptions and calculated
average fair values:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2008 |
|
2007 |
Average expected term (years) |
|
|
4.0 |
|
|
|
4.0 |
|
Weighted average risk-free interest rate |
|
|
1.86% |
|
|
|
4.43% |
|
Dividend yield |
|
|
0% |
|
|
|
0% |
|
Volatility |
|
|
23.10% |
|
|
|
26.95% |
|
Weighted average grant date fair value |
|
$ |
10.54 |
|
|
$ |
14.08 |
|
As of March 31, 2008, the aggregate intrinsic value of awards outstanding and exercisable was
$65 million. In addition, the aggregate intrinsic value of awards exercised during
the three months ended March 31, 2008 and 2007 was $2 million and $6 million, respectively. The
total remaining unrecognized compensation cost related to unvested awards amounted to $61 million
at March 31, 2008 and is expected to be recognized over the next three years. The weighted average
remaining requisite service period of the unvested awards was 27 months.
15. Restructuring
Managements plans for the restructuring of the Companys operations as a result of its
acquisition of PLIVA are completed. As of March 31, 2008, certain elements of the restructuring
plan have been recorded as a cost of the acquisition.
Through March 31, 2008, the Company has recorded restructuring costs primarily associated with
severance costs and the costs of vacating certain duplicative PLIVA facilities in the U.S. Certain
of these costs were recognized as liabilities assumed in the acquisition. The components of the
restructuring costs capitalized as a cost of the acquisition are as follows and are included in the
generic pharmaceuticals segment:
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ in millions |
|
December 31, |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2007 |
|
|
Payments |
|
|
Additions |
|
|
2008 |
|
Involuntary termination of
PLIVA employees |
|
$ |
1 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1 |
|
Lease termination costs |
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
11 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lease termination costs represent costs incurred to exit duplicative activities of PLIVA.
Severance includes accrued severance benefits and costs associated with change-in-control
provisions of certain PLIVA employment contracts.
In addition, in connection with its restructuring of PLIVAs U.S. operations, the Company
incurred $1 million of severance and retention bonus expense in the three months ended March 31,
2008 that was charged primarily to cost of sales and selling, general and administrative expenses.
16. Commitments and Contingencies
Commitments and Contingencies
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. No amounts have been recorded in the financial statements for
probable losses with respect to the Companys obligations under such agreements.
In September 2001, Barr filed an ANDA for the generic version of Sanofi-Aventis Allegra®
tablets. Sanofi-Aventis has filed a lawsuit against Barr claiming patent infringement. A trial date
for the patent litigation has not been scheduled. 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 Allegra 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, earned
on sales of the product. The agreement between Barr and Teva also provides that each company will
indemnify the other for a portion of any patent infringement damages they might incur, so that the
parties will share any such damage liability in proportion to their respective share of Tevas
operating profit on generic Allegra.
On September 1, 2005, Teva launched its generic version of Allegra. The Company, in
accordance with FASB Interpretation No. 45, Guarantors Accounting and Disclosure Requirements for
Guarantees, Including Indirect Guarantees of Indebtedness to
Others, recorded a liability of $4
million to reflect the fair value of the indemnification obligation it has undertaken.
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 million made
to Schein in 1999. An additional $15 million payment is required under the terms of the settlement
if Cenestin achieves total profits, as defined, of greater than $100 million over any rolling
five-year period prior to October 22, 2014. The Company believes that it is probable that this
payment will be earned during 2008. As a
result, the Company has recorded a contingent liability as of March 31, 2008 in the amount of
$14 million, representing an estimated pro-rata amount of the liability incurred as of March 31,
2008.
20
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. The Company also records accruals for litigation
settlement offers made by the Company, whether or not the settlement offers have been accepted.
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 it, in consultation
with outside advisors, believe 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 results of operations, cash flows, or financial condition in a particular period.
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
Sanofi-Aventis Allegra tablet products for allergy relief. The Company notified Sanofi-Aventis
pursuant to the provisions of the Hatch-Waxman Act and, in September 2001, Sanofi-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 ANDA, Sanofi-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
Sanofi-Aventis pursuant to the provisions of the Hatch-Waxman Act. Sanofi-Aventis filed an amended
complaint in November 2002 claiming that the Companys ANDA infringes the newly listed patent.
On March 5, 2004, Sanofi-Aventis and AMR Technology, Inc., the holder of certain patents
licensed to Sanofi-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 the 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.
21
On September 21, 2005, Sanofi-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 Sanofi-Aventis
for a preliminary injunction or expedited trial. Sanofi-Aventis appealed the courts denial of its
motion to the United States Court of Appeals for the Federal Circuit. On November 8, 2006, the
Federal Circuit affirmed the District Courts denial of the motion for preliminary injunction.
On May 8, 2006, Sanofi-Aventis and AMR Technology, Inc. served a Second Amended and
Supplemental Complaint based on U.S. Patent Nos. 5,581,011 and 5,750,703 (collectively, the API
patents), asserting claims against the Company for infringement of the API (active pharmaceutical
ingredient) patents based on the sale of the Companys fexofenadine product and for inducement of
infringement of the API patents based on the sale of Tevas fexofenadine product. On June 22, 2006,
the Company answered the complaint, denied the allegations, and asserted counterclaims for
declaratory judgment that the asserted patents are invalid and/or not infringed and for damages for
violations of the Sherman Act, 15 U.S.C. §§ 1.2.
On November 14, 2006, Sanofi-Aventis sued the Company and Teva in the U.S. District Court for
the Eastern District of Texas, alleging that Tevas fexofenadine hydrochloride tablets infringe a
patent directed to a certain crystal form of fexofenadine hydrochloride, and that the Company
induced Tevas allegedly infringing sales. On November 21, 2006, Sanofi-Aventis filed an amended
complaint in the same court, asserting that the Companys fexofenadine hydrochloride tablets
infringe a different patent directed to a different crystal form of fexofenadine hydrochloride. On
January 12, 2007, the Company moved to dismiss the suit against Barr Pharmaceuticals, answered the
complaint on behalf of Barr Laboratories, denied the allegations against it, and moved to transfer
the action to the U.S. District Court for New Jersey. On September 27, 2007, the U.S. District
Court for the Eastern District of Texas granted the Companys motion to transfer the case to the
U.S. District for New Jersey and denied Barr Pharmaceutical, Inc.s motion to dismiss as moot.
Sanofi-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 seeking damages.
If the Company and/or Teva are unsuccessful in the Allegra litigation, the Company potentially
could be liable for a portion of Sanofi-Aventis lost profits on the sale of Allegra, which could
potentially exceed the Companys profits earned from its arrangement with Teva on generic Allegra.
Product Liability Matters
Hormone Therapy Litigation
The Company has been named as a defendant in approximately 5,095 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 its Cenestin
products and/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 4,636 of such
cases have been dismissed (leaving approximately 459 pending) and, based on discussions with the
Companys outside counsel, more are expected to be dismissed.
The Company believes it has viable defenses to the allegations in the complaints and is
defending the actions vigorously.
22
Antitrust Matters
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 allege that
the 1997 Bayer-Barr patent litigation settlement agreement was anti-competitive and violated
federal antitrust laws and/or state antitrust and consumer protection laws. A prior investigation
of this agreement by the Texas Attorney Generals Office on behalf of a group of state Attorneys
General was closed without further action in December 2001.
The lawsuits include 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. On November 7, 2007, the Second Circuit
transferred the appeal involving the indirect purchaser plaintiffs to the United States Court of
Appeals for the Federal Circuit, while retaining jurisdiction over the appeals of the direct
purchaser plaintiffs in the case. Briefing on the merits is now complete in the Federal Circuit,
and an oral argument has been scheduled for June 4, 2008. Merits briefing in the Second Circuit is
scheduled to take place in May and June 2008.
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. The Court of
Appeals reinstated the complaint on May 9, 2006 and the Wisconsin Supreme Court affirmed that
decision on July 13, 2007, while not addressing the underlying merits of the plaintiffs case. The
matter was returned to the trial court for further proceedings, and the trial court has stayed the
case.
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. An intermediate appellate
court affirmed that decision, and plaintiffs have sought leave to appeal to the New York Court of
Appeals.
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. Plaintiffs
have moved to lift the stay. The court has not ruled on the motion but has scheduled a further
status hearing for May 16, 2008.
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, although a status hearing is currently scheduled
for May 19, 2008.
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.
Ovcon Antitrust Proceedings
The Company has entered into settlements with the FTC, the State Attorneys General (as
described below) and the class representatives of the indirect purchasers. Only the claims of the
direct purchasers remain active in the litigation.
Under the FTC settlement, the FTC agreed to dismiss its case against the Company, and the
Company agreed to refrain from entering into exclusive supply agreements in certain non-patent
challenge situations where the Company is an ANDA holder and the party being supplied is the NDA
holder. The settlement was entered and the FTCs lawsuit against the Company was dismissed with
prejudice on November 27, 2007.
23
Under
the State Attorneys General settlement, the states agreed to dismiss their claims
against the Company in exchange for a cash payment of $6 million and commitments by the Company not to
engage in certain future conduct similar to the commitments contained in the FTC settlement. The
State Attorneys General settlement was finalized on February 25, 2008.
In the actions brought on behalf of the indirect purchasers, the Company reached
court-approved settlements with the class representatives of the certified class of indirect
purchasers on behalf of the class. The settlements require the
Company to pay $2 million to funds
established by plaintiffs counsel and to donate branded drug products to, among others, charitable
organizations and university health centers.
In the actions brought on behalf of the direct purchasers, on October 22, 2007, the U.S. District Court
for the District of Columbia granted plaintiffs motion to certify a class on behalf of all entities that purchased
Ovcon-35 directly from Warner Chilcott (or its affiliated companies) from April 22,
2004. In November 2007, the Company and the direct purchasers filed cross motions for summary
judgment. No ruling has been made on the motions and no trial date has been set.
Through
March 31, 2008, the Company recorded charges in the amount of $16 million related to
these settlements and other settlement offers in the Ovcon litigation.
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 Provigil Defendants) in ten separate complaints
filed in the U.S. District Court for the Eastern District of Pennsylvania. These actions allege,
among other things, that the agreements between Cephalon and the other individual Provigil
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 generic
equivalents in violation of the antitrust laws. These cases remain at a very early stage and no
trial dates have been set.
The Company was also named as a co-defendant with the Provigil Defendants in an action filed
in the U.S. District Court for the Eastern District of Pennsylvania by Apotex, Inc. The lawsuit
alleges, among other things, that Apotex sought to market its own generic version of Provigil and that the settlement agreements entered into between Cephalon and the other individual
Provigil Defendants constituted an unfair method of competition, are anticompetitive, and restrain
trade in the market for Provigil and its generic equivalents in violation of the antitrust laws.
The Provigil Defendants have filed motions to dismiss, and briefing has taken place with respect to
these motions.
The Company believes that it has not engaged in any improper conduct and is vigorously
defending 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, Alaska, Hawaii, Idaho, Illinois,
Iowa, Kentucky, Massachusetts, Mississippi, South Carolina and Utah, 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, with some states also pursuing similar allegations based on the
reimbursement of drugs under Medicare Part B or the purchase of drugs by a state health plan (for
example, South Carolina).
24
The Iowa and New York cases, with the exception of the actions filed by Erie, Oswego, and
Schenectady Counties in New York, are currently pending in the U.S. District Court for the District
of Massachusetts. In the Iowa case, briefing on the defendants motions to dismiss is underway. In
the consolidated New York cases, discovery is underway, but no trial dates have been set. The Erie,
Oswego, and Schenectady County cases were filed in state courts in New York, again with no trial
dates set.
The Alabama, Illinois, and Kentucky cases were filed in state courts, removed to federal
court, and then remanded back to their respective state courts. On April 11, 2008, the Illinois
trial court dismissed all allegations against generic-drug-manufacturer defendants including the
Company, but with leave for the State to replead. Discovery is underway in the Alabama and
Kentucky actions. The Alabama trial court completed the trial of a different defendant, and has
scheduled two others, but with the sequencing for all remaining defendants not yet known. The
Kentucky trial court has scheduled the trials of three other defendants to take place next year,
with the first one starting on May 19, 2009, but has not yet determined the trial schedule
thereafter.
The State of Mississippi case was filed in Mississippi state court on October 25, 2005.
Discovery was underway, but that case, along with the Illinois case and the actions brought by
Erie, Oswego, and Schenectady Counties in New York, were removed to federal court on the motion of
a co-defendant. Remand motions were granted on September 17, 2007, and thus the cases have returned
to their respective state courts of origin, with discovery underway but again with no trial dates
set.
The State of Hawaii case was filed in state court in Hawaii on April 27, 2007, removed to the
United States District Court for the District of Hawaii, and remanded to state court. Discovery is
underway. No trial date has been set.
The State of Alaska case was filed in state court in Alaska on October 6, 2006. Discovery is
underway. No trial date has been set.
The State of South Carolina cases consist of two complaints, one brought on behalf of the
South Carolina Medicaid Agency and the other brought on behalf of the South Carolina State Health
Plan. Both cases were filed in state court in South Carolina on January 16, 2007. Briefing on the
defendants motions to dismiss is complete. No trial date has been set.
The State of Idaho case was filed in state court in Idaho on January 26, 2007. Discovery is
underway. No trial date has been set. The State of Utah case was filed in state court in Utah on
September 21, 2007. Defendants removed the case to federal court, and the Judicial Panel on
Multidistrict Litigation is transferring the action to the U.S. District Court for the District of
Massachusetts. The States motion to remand the case to state court remains pending. No trial date
has been set.
The Company believes that it has not engaged in any improper conduct and is vigorously
defending 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 its 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. In an amended complaint,
plaintiffs further asserted claims for fraud and negligent misrepresentation. The court has entered
a scheduling order providing for the completion of discovery by December 8, 2008, but has not yet
set a date for trial. The Company believes there was no such contract, fraud or negligent
misrepresentation and is vigorously defending this matter.
Other Litigation
As of March 31, 2008, 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 condensed consolidated financial statements.
Government Inquiries
On October 3, 2006, the FTC notified the Company it was investigating a patent litigation
settlement reached in matters pending in the U.S. District Court for the Southern District of New
York between Barr and Shire PLC concerning Shires Adderall XR product. On June 20, 2007, the
Company received a Civil Investigative Demand, seeking documents and data. The Company is complying
with this Civil Investigative Demand and is cooperating with the agency in its investigation.
Commitments
On January 15, 2008, the Company made a commitment to invest up to $30 million in a new
venture fund, NewSpring Health Capital II L.P. Investments made will also be accounted for under
the equity method. Payments related to this commitment are payable when capital calls are made. The
first capital call payment was made in January 2008 in the amount of $1 million.
17. Segment Reporting
The Company operates in two reportable business segments: generic pharmaceuticals and
proprietary pharmaceuticals. The Company evaluates the performance of its operating segments based
on net revenues and gross profit. The Company does not report depreciation expense, total assets or
capital expenditures by segment as such information is neither used by management nor accounted for
at the segment level. Net product sales and gross profit information for the Companys operating
segments consisted of the following:
25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
$ in millions |
|
Generic |
|
% |
|
Proprietary |
|
% |
|
Other (1) |
|
% |
|
Consolidated |
|
revenue |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
469 |
|
|
|
77 |
% |
|
$ |
96 |
|
|
|
16 |
% |
|
$ |
|
|
|
|
0 |
% |
|
$ |
565 |
|
|
|
93 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
32 |
|
|
|
5 |
% |
|
|
32 |
|
|
|
5 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
11 |
|
|
|
2 |
% |
|
|
11 |
|
|
|
2 |
% |
|
Total revenues |
|
$ |
469 |
|
|
|
77 |
% |
|
$ |
96 |
|
|
|
16 |
% |
|
$ |
43 |
|
|
|
7 |
% |
|
$ |
608 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
Gross Profit: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
233 |
|
|
|
50 |
% |
|
$ |
66 |
|
|
|
68 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
299 |
|
|
|
53 |
% |
Alliance and
development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
32 |
|
|
|
100 |
% |
|
|
32 |
|
|
|
100 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
2 |
|
|
|
23 |
% |
|
|
2 |
|
|
|
23 |
% |
|
Total gross profit |
|
$ |
233 |
|
|
|
50 |
% |
|
$ |
66 |
|
|
|
68 |
% |
|
$ |
34 |
|
|
|
80 |
% |
|
$ |
333 |
|
|
|
55 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
$ in millions |
|
Generic |
|
% |
|
Proprietary |
|
% |
|
Other (1) |
|
% |
|
Consolidated |
|
revenue |
|
Revenues: (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
471 |
|
|
|
79 |
% |
|
$ |
89 |
|
|
|
15 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
560 |
|
|
|
94 |
% |
Alliance and
development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
25 |
|
|
|
4 |
% |
|
|
25 |
|
|
|
4 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
12 |
|
|
|
2 |
% |
|
|
12 |
|
|
|
2 |
% |
|
Total revenues |
|
$ |
471 |
|
|
|
79 |
% |
|
$ |
89 |
|
|
|
15 |
% |
|
$ |
37 |
|
|
|
6 |
% |
|
$ |
597 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
Gross Profit: (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
208 |
|
|
|
44 |
% |
|
$ |
59 |
|
|
|
66 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
267 |
|
|
|
48 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
25 |
|
|
|
100 |
% |
|
|
25 |
|
|
|
100 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
5 |
|
|
|
37 |
% |
|
|
5 |
|
|
|
37 |
% |
|
Total gross profit |
|
$ |
208 |
|
|
|
44 |
% |
|
$ |
59 |
|
|
|
66 |
% |
|
$ |
30 |
|
|
|
80 |
% |
|
$ |
297 |
|
|
|
50 |
% |
|
(1) |
|
The other category includes alliance and development revenues
and revenues from certain non-core operations. |
(2) |
|
Prior period amounts have been reclassified to include the effect of discontinued
operations. |
Product sales by therapeutic category
The Companys generic and proprietary pharmaceutical segment net product sales are represented
in the following therapeutic categories for the following periods:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
$ in millions |
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
Contraception |
|
$ |
153 |
|
|
$ |
165 |
|
Psychotherapeutics |
|
|
63 |
|
|
|
67 |
|
Cardiovascular |
|
|
61 |
|
|
|
66 |
|
Antibiotics, antiviral & anti-infectives |
|
|
69 |
|
|
|
67 |
|
Other (1) |
|
|
219 |
|
|
|
195 |
|
|
|
|
|
|
|
|
Total |
|
$ |
565 |
|
|
$ |
560 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Other includes numerous therapeutic categories, none of which individually exceeds 10% of
consolidated product sales. |
18. Subsequent Events
On May 5, 2008, the Company entered into an agreement with Allergan Inc. related to
Allergans Sanctura® product that PLIVA divested in 2005 to Esprit Pharma, which has
since been acquired by Allergan. Under the terms of this agreement, Allergan paid the Company $53
million, extinguishing any future contingent royalty payments, if
earned, related to Sanctura®.
26
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 the 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 year ended December 31, 2007, and the unaudited
interim condensed consolidated financial statements and related notes included in Item 1 of this
report on Form 10-Q.
Executive Overview
We are a global specialty pharmaceutical company that operates in more than 30 countries. Our
operations are based primarily in North America and Europe, with our key markets being the United
States, Croatia, Germany, Poland and Russia. We are primarily engaged in the development,
manufacture and marketing of generic and proprietary pharmaceuticals. During the three months ended
March 31, 2008, we recorded $564.6 million of product sales and $608.0 million of total revenues.
During the three months ended March 31, 2008, sales of our generic products were $468.9
million, accounting for 83% of our total product sales. North America accounted for $261.2 million
of our generic product sales while the Rest of World (ROW) accounted for $207.7 million. Sales of
our proprietary products were $95.7 million, accounting for 17% of our total product sales. In
addition, we recorded $32.3 million of alliance and development revenues during the quarter and
$11.1 million of other revenues. Alliance and development revenues are derived mainly from
profit-sharing arrangements, co-promotion agreements, and standby manufacturing fees and other
reimbursements and fees we received from third parties, including marketing partners. Other
revenues primarily are derived from our non-core operations which include our diagnostics,
disinfectants, dialysis and infusions (DDD&I) business.
During
the three months ended March 31, 2008, we generated $101 million of operating cash
flows. Our operating cash flows are a significant source of liquidity, and we expect to utilize a
significant portion of these operating cash flows to service our debt obligations as well as fund
our capital needs during 2008.
We recorded earnings of $0.21 per share for our first quarter of 2008. We
expect higher product sales in our second quarter as compared to our first
quarter, but we believe that incremental earnings from these higher sales will
be more than offset by higher operating expenses. Nevertheless, we expect our
earnings per share in the second quarter to be approximately double our
earnings per share in the first quarter due to the $53 million (approximately
$0.30 per share) payment we received in May 2008 from our agreement with
Allergan Inc., as described in the discussion of alliance and development
revenues below. We expect our earnings per share in each of the third and
fourth quarters to be higher than our earnings per share in the second quarter.
Foreign currency exchange rate fluctuations
Our international revenues and expenses are subject to foreign currency exchange rate
fluctuations. These results are first converted from local currencies into Croatian Kuna (HRK),
and then converted from HRK into U.S. dollars (USD). In general, the HRK exchange rate follows
the exchange rate fluctuations between the USD and the Euro. Depending on the direction of change
relative to the USD, foreign currency values can increase or decrease the reported dollar value of
our net assets and results of operations. While we cannot predict with certainty changes in foreign
exchange rates or the effect they will have on us, we attempt to mitigate their impact through
operational means and by using various foreign exchange financial instruments. We use foreign
exchange financial instruments to hedge a portion of forecasted transactions even though none of
the instruments are eligible for hedge accounting. Since our derivatives do not qualify for hedge
accounting, the changes in fair value of these instruments are being measured each period and
reported in other income (expense), which could lead to volatility of our reported net earnings.
Despite the potential for increased earnings volatility, we still use such instruments to offset
the economic risk from foreign exchange rate fluctuations.
For purposes of discussing results on a comparable basis below, we will refer to all total
increases and decreases in US dollars, and often quantify the amount of those changes that are due
to changes in foreign currency exchange rate fluctuations.
Generic Products
For many years, we have successfully utilized a strategy of developing the generic versions of
branded products that possess a combination of unique factors that we believe have the effect of
limiting competition for generics. Such factors include difficult formulation, complex and costly
manufacturing requirements or limited raw material availability. By targeting products with some
combination of these unique factors, we believe that our generic products will, in general, be less
affected by the intense and rapid pricing pressure often associated with more
27
commodity-type generic products. As a result of this focused strategy, we have been able to
successfully identify, develop and market generic products that generally have few competitors or
that are able to enjoy longer periods of limited competition, and thus generate profit margins
higher than those often associated with commodity-type generic products. The development and launch
of our generic oral contraceptive products is an example of our generic development strategy.
Until our acquisition of PLIVA, the execution of this strategy was focused predominantly on
developing solid oral dosage forms of products. While we believe there are more tablet and capsule
products that may fit our barrier-to-entry criteria, we have recently expanded our development
activities, both internally through our acquisition of PLIVA and through collaboration with third
parties, to develop non-tablet and non-capsule products such as injectables, patches, creams,
ointments, sterile ophthalmics and nasal sprays.
We also develop and manufacture active pharmaceutical ingredients (API), primarily for use
internally and, to a lesser extent, for sale to third parties. We manufacture 23 different APIs for
use in pharmaceuticals through our facilities located in Croatia and the Czech Republic. We believe
that our ability to produce API for internal use may provide us with a strategic advantage over
competitors that lack such ability, particularly as to the timeliness of obtaining API for our
products.
Challenging the patents covering certain brand products continues to be an integral part of
our generics business. For many products, the patent provides the unique barrier that we seek to
identify in our product selection process. We try to be the first company to initiate a patent
challenge because, in certain cases, we may be able to obtain 180 days of exclusivity for selling
the generic version of the product. Upon receiving exclusivity for a product, we often experience
significant revenues and profitability associated with that product for the 180-day exclusivity
period, but, at the end of that period, we experience significant decreases in our revenues and
market share associated with the product as other generic competitors enter the market. Our record
of successfully resolving patent challenges has made a recurring contribution to our operating
results, but has created periods of revenue and earnings volatility and will likely continue to do
so in the future. While earnings and cash flow volatility may result from the launch of products
subject to patent challenges, we remain committed to this part of our business.
Proprietary Products
To help diversify our generic product revenue base, we initiated a program in 2001 to develop
and market proprietary pharmaceutical products. We formalized this program through our acquisition
of Duramed Pharmaceuticals in October 2001, and thereafter by establishing Duramed Research as our
proprietary research and development subsidiary. Today, Duramed is recognized as a leader in the
area of womens healthcare. We implement our womens healthcare platform through a substantial
number of employees dedicated to the development and marketing of our proprietary products,
including approximately 354 sales representatives that promote directly to physicians six of our
products SEASONIQUE®, Enjuvia, Mircette®, ParaGard®, Plan B and Amniscreen and two products
under our co-promotion agreement with Kos Pharmaceuticals Niaspan® and Advicor®. We have
accomplished significant growth in proprietary product sales over the last several years through
both internally-developed products, such as SEASONALE®, which was the first and largest selling
extended-cycle oral contraceptive, in the U.S., and SEASONIQUE, also an extended-cycle oral
contraceptive, and through product acquisitions, including ParaGard, the only non-drug loaded IUC
currently on the market in the U.S., in November 2005; Mircette, a well established 28-day oral
contraceptive, in December 2005; Amniscreen, an at home amniotic fluid detection liner, in 2008; and
Adderall IR, an immediate-release, mixed salt amphetamine product that is indicated for the
treatment of attention deficit hyperactivity disorder and narcolepsy, in October 2006.
28
Results of Operations
Comparison of the Three Months Ended March 31, 2008 and March 31, 2007
The following table sets forth revenue data for the three months ended March 31, 2008 and
2007 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic products: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral contraceptives |
|
$ |
92.5 |
|
|
$ |
113.2 |
|
|
$ |
(20.7 |
) |
|
|
18 |
% |
Other generics |
|
|
376.4 |
|
|
|
358.0 |
|
|
|
18.4 |
|
|
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total generic products |
|
|
468.9 |
|
|
|
471.2 |
|
|
|
(2.3 |
) |
|
|
0 |
% |
Proprietary products |
|
|
95.7 |
|
|
|
89.0 |
|
|
|
6.7 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
|
564.6 |
|
|
|
560.2 |
|
|
|
4.4 |
|
|
|
1 |
% |
Alliance and development revenue |
|
|
32.3 |
|
|
|
25.1 |
|
|
|
7.2 |
|
|
|
29 |
% |
Other revenue |
|
|
11.1 |
|
|
|
11.5 |
|
|
|
(0.4 |
) |
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
608.0 |
|
|
$ |
596.8 |
|
|
$ |
11.2 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Sales
Generic Oral Contraceptives
During the three months ended March 31, 2008, sales of our generic oral contraceptives
(Generic OCs) were $92.5 million, down $20.7 million, or 18% as compared to the prior year
period. The year over year decline primarily reflects lower volume on several OCs due to lower
market share and lower pricing. These factors resulted in lower sales of
Aviane of $6.3 million, Tri-Sprintec of $4.2 million and
Sprintec of $3.5 million. These decreases were partially offset by higher sales of Kariva of $1.5 million due to
higher prices, and contributions from Trilegest of $1.8 million, which was launched in October
2007.
Looking ahead to the balance of 2008, we continue to expect sales from our
current portfolio of Generic OCs to remain below 2007 levels due to both lower
market share on many of those products, and lower pricing on several of those
products, principally Tri-Sprintec and Sprintec. These declines are greater
than declines we projected at the beginning of the year. We also continue to
expect that sales of Kariva, the generic version of our proprietary Mircette
product, will decline when the patent on Mircette expires in October 2008. We
do anticipate, however, that the expected launch of our generic version of
Yasmin in the third quarter of 2008 will more than offset those expected
declines. As a result, we now expect 2008 revenues from our Generic OC
franchise will be 10-15% higher than in 2007.
Other Generic Products
During
the three months ended March 31, 2008, sales of our other
generic products (Other Generics) were $376.4 million, up from $358.0 million in the prior year period, an increase of
$18.4 million, or 5%. The increase includes $28 million as a result of changes in foreign
currency exchange rates. In addition, higher sales of Fentanyl of $11.5 million due to volume,
contributions of $5.8 million from products acquired through our September 2007 acquisition of ORCA
in Germany, and the February 2008 launch of Alendronate, which generated $5.3 million of sales in
the quarter, also contributed to this total increase. Partially offsetting these increases were
lower sales of Ondansetron of $10.4 million due to lower volume and lower prices due to new
competition, in addition to lower sales of Desmopressin of $7.8 million and Warfarin of $4.1
million due to lower pricing. The remaining net decrease across our Other Generics is generally
due to smaller declines in price and/or volume.
At the beginning of the year, we projected that sales of Other Generics
would increase year-over-year. We now expect sales of our Other Generics to
remain relatively consistent with 2007 levels. The primary reason for our
revised expectation is a change in the timing of anticipated new product
launches. Certain launches that we had expected to occur in the early part of
the second half of 2008 are now expected to occur later in the year, while
other launches originally expected to occur later in the second half of 2008
are now expected to occur in 2009.
Proprietary Products
During the three months ended March 31, 2008, sales of our proprietary products were $95.7
million, an increase of $6.7 million, or 8%, as compared to the prior year period. This increase
was primarily due to an $11.6 million increase in sales of SEASONIQUE due to higher volume, a $7.0
million increase in sales of Plan B OTC/Rx and a $3.3 million increase in sales of ParaGard, both due to
price and volume. These increases combined with other increases of our proprietary products more
than offset a $6.8 million decrease in sales of SEASONALE due to lower volume resulting from
generic competition, a $4.5 million decrease in sales of Adderall IR due to volume, and a $2.9
million decrease in sales of Mircette due to lower volume.
Despite the fact that Plan B sales were higher during the three months
ended March 31, 2008 as compared to the same period last year, they were below
our internal expectations. We expect that sales of Plan B in our second quarter
will be in line with first quarter sales despite projected demand growth. We
anticipate significant sales growth in our proprietary segment during the
second half of 2008 reflecting increases in demand for Plan B, SEASONIQUE and
ParaGard. Overall, we currently expect our proprietary revenues to be
approximately 10% higher than the prior year.
29
Alliance and Development Revenue
During the three months ended March 31, 2008, we recorded $32.3 million of alliance and
development revenue, up from $25.1 million in the prior year period. This increase was
primarily due to a $5.5 million increase in revenues from our profit-sharing arrangement with Teva
on generic Allegra, a $2.0 million increase in
revenues earned under our license and development agreement with Shire and a $0.5 million
increase in revenues relating to our agreements with Kos Pharmaceuticals (Kos) relating to
Niaspan and Advicor. Offsetting these increases was a $0.9 million decrease in fees associated with
the development of the Adenovirus vaccine for the U.S. Department of Defense.
In 2005, our PLIVA subsidiary sold its Sanctura® product to Esprit Pharma
which subsequently sold the product to Allergan Inc. As part of the original
sale, PLIVA retained a right to milestone payments based on sales levels of
Sanctura over a number of years. In May 2008, we entered into an agreement with
Allergan under which Allergan paid us $53 million in settlement of all future
milestone obligations. We expect to record this payment as alliance and
development revenue in the second quarter.
Other Revenue
We recorded $11.1 million and $11.5 million of other revenue during the three months ended
March 31, 2008 and 2007, respectively. This revenue is primarily attributable to non-core
operations, which includes our diagnostics, disinfectants, dialysis and infusions business.
Cost of Sales
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 (except other, which is expressed as a
percentage of our other revenue line item), for the three months ended March 31, 2008 and 2007
(dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Generic products |
|
$ |
236.4 |
|
|
$ |
262.8 |
|
|
$ |
(26.4 |
) |
|
|
-10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
49.6 |
% |
|
|
44.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proprietary products |
|
$ |
30.5 |
|
|
$ |
29.9 |
|
|
$ |
0.6 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
68.1 |
% |
|
|
66.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenue |
|
$ |
8.5 |
|
|
$ |
7.2 |
|
|
$ |
1.3 |
|
|
|
18 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
23.4 |
% |
|
|
37.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of sales |
|
$ |
275.4 |
|
|
$ |
299.9 |
|
|
$ |
(24.5 |
) |
|
|
-8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
52.2 |
% |
|
|
47.5 |
% |
|
|
|
|
|
|
|
|
Cost of sales components include the following:
|
|
|
our manufacturing and packaging costs for products we manufacture; |
|
|
|
|
amortization expense; |
|
|
|
|
the write-off of the step-up in inventory arising from acquisitions, including
PLIVA; |
|
|
|
|
profit-sharing or royalty payments we make to third parties, including raw material
suppliers; |
|
|
|
|
the cost of products we purchase from third parties; |
|
|
|
|
lower of cost or market adjustments to our inventories; and |
|
|
|
|
stock-based compensation expense relating to employees within certain departments
that we allocate to cost of sales. |
Overall:
During the three months ended March 31, 2008 our cost of sales
decreased by $24.5
million as compared to the prior year period. This decrease was primarily due to the $32.4 million
charge taken in the prior year period for the stepped-up value of inventory acquired from PLIVA,
which we sold during the quarter ended March 31, 2007; we did not have a similar charge in the
current period. In addition, our royalty expense charged to cost of sales decreased by $11.5
million in the current period primarily due to lower revenues of products that result in royalty
obligations to third parties. Offsetting these reductions in overall cost of sales were an $18.6
million increase in material and production costs and a $4.8 million increase in product
amortization expense.
30
Generics: During the three months ended March 31, 2008, our generics segment cost of sales
decreased by $26.4 million compared to the three months ended March 31, 2007. The decrease in our
generics cost of sales and related improvement in our margins was
primarily due to the $32.4 million charge taken in the prior year period
for the stepped-up value of inventory acquired from PLIVA.
Proprietary: During the three months ended March 31, 2008, the cost of sales in our
proprietary segment increased by $0.6 million over the three months ended March 31, 2007. Margins
for our proprietary products increased from 66.4% to 68.1% period-over-period, resulting from a
favorable mix of higher margin products during the current quarter.
Selling, General and Administrative Expense
The following table sets forth selling, general and administrative expense for the three
months ended March 31, 2008 and 2007 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Selling, general and administrative |
|
$ |
194.0 |
|
|
$ |
179.0 |
|
|
$ |
15.0 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charge included in general and administrative |
|
$ |
1.2 |
|
|
$ |
6.5 |
|
|
$ |
(5.3 |
) |
|
|
-82 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (SG&A) expenses increased by $15.0 million in the three
months ended March 31, 2008 as compared to the prior year
period. The increase includes $13 million as a result of changes
in foreign currency rates.
SG&A expenses during the current quarter reflected increased legal fees of $4.3 million,
information technology expenses of $4.3 million, expenses related to the September 2007 acquisition
of ORCA of $2.0 million, and investment in sales and marketing in Russia and Germany of
approximately $3.0. These increases were offset by reduced consulting expenses of $5.6 million and
reduced settlement charges of $5.3 million.
The charges of $1.2 million and $6.5 million for the three months ended March 31, 2008 and
2007, respectively, relate to proposed settlements of anti-trust litigation.
Looking ahead, we expect that our SG&A expense during our second quarter
will be significantly higher than in the first quarter. This anticipated
increase is driven in large part by the expected launch of a direct to consumer
marketing program for SEASONIQUE in the second quarter, as well as higher
promotional and marketing programs expected to be initiated in our key ROW
markets. We expect that SG&A expense will be slightly lower in our third and
fourth quarters as compared to the planned increases in our second quarter.
Research and Development
The following table sets forth research and development expenses and the write-off of acquired
in-process research and development (IPR&D) for the three months ended March 31, 2008 and 2007
(dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Research and development |
|
$ |
64.0 |
|
|
$ |
62.0 |
|
|
$ |
2.0 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Write-off of acquired in-process research and development |
|
$ |
|
|
|
$ |
1.5 |
|
|
$ |
(1.5 |
) |
|
|
-100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses increased by $2.0 million in the three months ended March
31, 2008 as compared to the prior year period. This increase
includes approximately $3.6 million as a result of changes in
foreign currency rates.
Research and development expenses for the current quarter reflect increases of $2.5 million
in development costs which was more than offset by $3.1 million
of lower proprietary clinical trial costs and $1.0 million of
lower generic biostudy costs.
31
During the three months ended March 31, 2007, we wrote-off acquired IPR&D associated with the
PLIVA acquisition of $1.5 million.
We expect that our research and development expenses will increase in our
second quarter as compared to our first quarter, before leveling off in the
second half of 2008. The expected second quarter increase is due primarily to
the timing of clinical programs in our proprietary segment.
Interest Income
The following table sets forth interest income for the three months ended March 31, 2008 and
2007 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Interest income |
|
$ |
5.0 |
|
|
$ |
11.0 |
|
|
$ |
(6.0 |
) |
|
|
-55 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in interest income for the three months ended March 31, 2008 is due to lower
interest rates and lower average daily cash and marketable securities balances. The lower interest
rates being earned reflect a decline in market rates and our decision to shift investments towards
lower yielding and more conservative investments in the recent volatile markets.
Interest Expense
The following table sets forth interest expense for the three months ended March 31, 2008 and
2007 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Interest expense |
|
$ |
32.0 |
|
|
$ |
42.0 |
|
|
$ |
(10.0 |
) |
|
|
-24 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in interest expense for the three months ended March 31, 2008 as compared to the
three months ended March 31, 2007 is due primarily to lower debt balance levels and an
approximate 10% decline in LIBOR rates since last year.
Other (Expense) Income
The following table sets forth other (expense) income for the three months ended March 31,
2008 and 2007 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Other (expense) income |
|
$ |
(8.0 |
) |
|
$ |
1.0 |
|
|
$ |
(9.0 |
) |
|
|
-900 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense) income decreased by $9.0 million for the three months ended March 31, 2008 as
compared to the three months ended March 31, 2007. The decrease was primarily related to net
foreign currency losses, including hedging activities.
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 months ended March 31, 2008 and 2007 (dollars in
millions):
32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Income tax expense |
|
$ |
17.0 |
|
|
$ |
10.0 |
|
|
$ |
7.0 |
|
|
|
70 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
42 |
% |
|
|
41.7 |
% |
|
|
|
|
|
|
|
|
The Companys effective tax rate increased in the current quarter to 42% from 41.7% in the
same period for 2007. The rate was negatively impacted by the expiration of the U.S. research and
development tax credit at December 31, 2007, a shift in the Companys investment portfolio from
tax-exempt securities to taxable securities due to market conditions and a change of the mix of
income in certain U.S. and foreign taxing jurisdictions. The rate was favorably impacted by a
reduction of the tax rates in Germany and the Czech Republic.
33
Liquidity and Capital Resources
Overview
Our primary source of liquidity is cash from operations, which entails the collection of
accounts and other receivables related to product sales, and royalty and other payments we receive
from third parties in various ventures, such as Teva with respect to generic Allegra and Kos
Pharmaceuticals, Inc., a subsidiary of Abbott Laboratories, with respect to Niaspan and Advicor.
Our primary uses of cash include repayment of our senior credit facilities, financing inventory,
research and development programs, marketing and selling, capital projects and investing in
business development activities.
Operating Activities
Our operating cash flow for the three months ended March 31, 2008 was $101 million down from
$132 million in the prior year period. This decline is primarily
attributable to the timing of payments to third parties on accounts payable and other accrued expenses. In addition, lower cash receipts from trade accounts receivable
and higher inventories were partially offset by changes in other working capital items.
Investing Activities
Our net cash provided by investing activities was $187 million for the three months ended
March 31, 2008 as compared to a $30 million net use of cash
in the prior year. The major components of our investing activities that generated positive cash flow
were higher net proceeds from sales of marketable securities in the current period of $230 million
as compared to net sales of marketable securities of $26 million
during the prior year period. This reflects our decision to shift
investments towards lower yielding and more conservative investments
in the recent volatile markets.
Our investing activities also reflected cash expended in connection with investments in
capital expenditures of $29 million, settlement of derivative instruments of $12 million relating
to hedging activities, and minimum required contingent purchase price payments relating to our ORCA
acquisition of $9 million. Offsetting these expenditures were proceeds of $4 million received
from the sale of land and buildings and $3 million of proceeds received representing an installment
payment relating to the December 2007 sale of our Spanish subsidiary. Our investments in capital
include upgrades and expansions to our property, plant and equipment and technology investments.
These investments will expand our production, laboratory, warehouse and distribution capacity in
our facilities and were designed to help ensure that we have the facilities necessary to
manufacture, test, package and distribute our current and future products.
We expect that our capital investments in 2008 will be between $150 million and $175 million,
and possibly increase further during 2009. A significant amount of these investments will be in
support of a new biopharmaceutical manufacturing facility in Croatia, as well as other investments
in our manufacturing facilities in Europe. In addition, we expect continued investment in
facilities and information technology projects supporting global quality initiatives to ensure that
we have a platform to properly manage and grow our global business.
Financing Activities
Net cash used in financing activities during the three months ended March 31, 2008 was $56
million compared to net cash used by financing activities of $143 million in the prior year period.
The decrease in net cash used in financing activities in the current period primarily reflects
lower debt repayments. In the quarter ended March 31, 2008 we made the scheduled $50 million
principal payment on our $1.75 billion five-year term facility and plan to make the same quarterly
payments (totaling $150 million) for this term facility in the remainder of 2008.
On April 17, 2008, we drew down $285 million from our $300 million revolving credit facility
to use as a bridge to refinance all existing debt instruments of PLIVA d.d. and its subsidiaries.
These PLIVA d.d. debt instruments were repaid in full by the end of April 2008.
We are seeking to raise new funds through a five-year term loan facility (new term loan) to
restore our liquidity under our revolving credit facility. Repaying PLIVAs debt and centralizing
our debt in the United States allows us to have greater operating flexibility, increased tax
efficiency and extended debt maturity. We expect to close the new term loan and secure the
funding during the second quarter of 2008. Given the current market environment, however, there can be
no assurance we will obtain the financing.
34
Sufficiency of Cash Resources
We believe our current cash and cash equivalents, marketable securities, investment balances,
cash flows from operations and remaining undrawn amounts under our $300 million revolving credit
facility are adequate to fund our operations, service our debt requirements, make planned capital
expenditures and to capitalize on strategic opportunities as they arise.
Off-Balance Sheet Arrangements
The Company does not have any material off-balance sheet arrangements that have had, or are
expected to have, an effect on our financial statements.
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 provisions for estimated reductions to gross product
sales; (2) revenue recognition and provisions of alliance and development revenue; (3) inventories;
(4) income taxes; (5) contingencies; (6) acquisitions and amortization of intangible assets; (7)
derivative instruments; and (8) foreign currency translation and transactions. 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 year ended December 31, 2007. Please see the Critical Accounting
Policies sections of that report for a comprehensive discussion of our critical accounting
policies.
Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standard (SFAS) No. 157 (SFAS 157), Fair Value Measurements, which defines
fair value, establishes a framework for measuring fair value under GAAP and expands disclosure
about fair value measurements. However, in February 2008, the FASB issued FASB Staff Position
(FSP) 157-2 (FSP 157-2) which delays the effective date of SFAS 157 for all nonfinancial assets
and nonfinancial liabilities, except those that are recognized or disclosed at fair value in the
financial statements on a recurring basis. FSP 157-2 defers the effective date of SFAS 157 to
fiscal years beginning after November 15, 2008 for items within the scope of FSP 157-2. Effective
for 2008, we have adopted SFAS 157 in accordance with FSP 157-2. The partial adoption of SFAS 157
did not have a material impact on our condensed consolidated financial statements but additional
disclosures were required.
In February 2007, the FASB issued SFAS No. 159 (SFAS 159), The Fair Value Option for
Financial Assets and Financial Liabilities, providing companies with an option to report selected
financial assets and liabilities at fair value. The objective of SFAS 159 is to reduce both
complexity in accounting for financial instruments and the volatility in earnings caused by
measuring related assets and liabilities differently. GAAP has required different measurement
attributes for different assets and liabilities that can create artificial volatility in earnings.
SFAS 159 helps to mitigate this type of accounting-induced volatility by enabling companies to
report related assets and liabilities at fair value, which would likely reduce the need for
companies to comply with detailed rules for hedge accounting. SFAS 159 also establishes
presentation and disclosure requirements designed to facilitate comparisons between companies that
choose different measurement attributes for similar types of assets and liabilities. SFAS 159
requires companies to provide additional information that will help investors and other users of
financial statements to more easily understand the effect of a companys choice to use fair value
on its earnings. It also requires entities to display the fair value of those assets and
liabilities for which a company has chosen to use fair value on the face of the balance sheet.
SFAS 159 is effective for fiscal years beginning after November 15, 2007. We did not elect to adopt
the fair value option under SFAS 159.
35
In June 2007, the Emerging Issues Task Force (EITF) reached a consensus on EITF Issue
No. 07-3 (EITF 07-3), Accounting for Advance Payments for Goods or Services to be Received for
Use in Future Research and Development Activities. EITF 07-3 provides clarification surrounding the
accounting for nonrefundable research and development advance payments, whereby such payments
should be recorded as an asset when the advance payment is made and recognized as an expense when
the research and development activities are performed. EITF 07-3 is effective for interim and
annual reporting periods beginning after December 15, 2007. The adoption of EITF 07-3 did not have
a material effect on our condensed consolidated financial statements.
In December 2007, the FASB issued SFAS No. 141(R) (SFAS 141(R)), Business Combinations
(revised), replacing SFAS No. 141 (SFAS 141) Business Combinations. This new statement requires
additional assets and assumed liabilities to be measured at fair value when acquired in a business
combination as compared to the original pronouncement. SFAS 141(R) also requires liabilities
related to contingent consideration to be re-measured to fair value each reporting period,
acquisition-related costs to be expensed and not capitalized and acquired in-process research and
development to be capitalized as an indefinite lived intangible asset until completion of project
or abandonment of project. SFAS 141(R) requires prospective application for business combinations
consummated in fiscal years beginning on or after December 15, 2008. This statement does not allow
for early adoption. We are currently evaluating the impact of the adoption of this statement on our
condensed consolidated financial statements.
In December 2007, the FASB issued SFAS No. 160 (SFAS 160), Noncontrolling Interests in
Consolidated Financial Statements an amendment of Accounting Research Bulletin No. 51(ARB No.
51). This amendment of ARB No. 51 requires noncontrolling interest in subsidiaries initially to be
measured at fair value and then to be classified as a separate component of equity. This statement
is effective for fiscal years and interim periods within those fiscal years beginning on or after
December 15, 2008. This statement does not allow for early adoption, however, application of SFAS
160 disclosure and presentation requirements is retroactive. We are currently evaluating the impact
of the adoption of this statement on our condensed consolidated financial statements.
In December 2007, the EITF issued EITF Issue No. 07-1 (EITF 07-1), Accounting for
Collaborative Arrangements. EITF 07-1 affects entities that participate in collaborative
arrangements for the development and commercialization of intellectual property. The EITF affirmed
the tentative conclusions reached on (1) what constitutes a collaborative arrangement, (2) how the
parties should present costs and revenues in their respective income statements, (3) how the
parties should present cost-sharing payments, profit-sharing payments, or both in their respective
income statements, and (4) disclosure in the annual financial statements of the partners. EITF 07-1
should be applied as a change in accounting principle through retrospective application to all
periods presented for collaborative arrangements existing as of the date of adoption. EITF 07-1 is
effective for financial statements issued for fiscal years beginning after December 15, 2008. We
are currently evaluating the impact of the adoption of this statement on our condensed consolidated
financial statements.
On March 19, 2008, the FASB issued SFAS No. 161 (SFAS 161), Disclosures about Derivative
Instruments and Hedging Activities an Amendment of FASB Statement 133. SFAS 161 enhances required
disclosures regarding derivatives and hedging activities, including enhanced disclosures regarding
how: (a) an entity uses derivative instruments; (b) derivative instruments and related hedged items
are accounted for under SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities;
and (c) derivative instruments and related hedged items affect an entitys financial position,
financial performance, and cash flows. Specifically, SFAS 161 requires: disclosure of the
objectives for using derivative instruments be disclosed in terms of underlying risk and accounting
designation; disclosure of the fair values of derivative instruments and their gains and losses in
a tabular format; disclosure of information about credit-risk-related contingent features; and
cross-reference from the derivative footnote to other footnotes in which derivative-related
information is disclosed. SFAS 161 is effective for fiscal years and interim periods beginning
after November 15, 2008. Early application is encouraged. We are currently evaluating the impact of
the adoption of this statement on our condensed consolidated financial statements.
Forward-Looking Statements
The preceding sections contain a number of forward-looking statements. 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
36
from those expressed or implied by such forward-looking statements. Such risks and
uncertainties include, in no particular order:
|
|
|
the difficulty in predicting the timing and outcome of legal proceedings, including
patent-related matters such as patent challenge settlements and patent infringement cases; |
|
|
|
|
the difficulty of predicting the timing of product approvals under NDAs, ANDA and
marketing authorizations; |
|
|
|
|
court and regulatory authorities decisions on exclusivity periods; |
|
|
|
|
the ability of competitors to extend exclusivity periods for their products; |
|
|
|
|
our ability to complete product development activities in the timeframes and for the
costs we expect; |
|
|
|
|
market and customer acceptance and demand for our pharmaceutical products; |
|
|
|
|
our dependence on revenues from significant customers; |
|
|
|
|
reimbursement policies of third party payors; |
|
|
|
|
our dependence on revenues from significant products; |
|
|
|
|
the use of estimates in the preparation of our financial statements; |
|
|
|
|
the impact of competitive products and pricing on products, including the launch of
authorized generics; |
|
|
|
|
the ability to launch new products in the timeframes we expect; |
|
|
|
|
the availability of raw materials; |
|
|
|
|
the availability of any product we purchase and sell as a distributor; |
|
|
|
|
the regulatory environment in the markets where we operate; |
|
|
|
|
our exposure to product liability and other lawsuits and contingencies; |
|
|
|
|
the increasing cost of insurance and the availability of product liability insurance
coverage; |
|
|
|
|
our timely and successful completion of strategic initiatives, including integrating
companies (such as PLIVA) and products we acquire; |
|
|
|
|
fluctuations in operating results, including the effects on such results from spending
for research and development, sales and marketing activities and patent challenge
activities; |
|
|
|
|
the inherent uncertainty associated with financial projections; |
|
|
|
|
our expansion into international markets through our PLIVA acquisition, and the
resulting currency, governmental, regulatory and other risks involved with international
operations; |
|
|
|
|
our ability to service our significantly increased debt obligations as a result of the
PLIVA acquisition; |
|
|
|
|
changes in generally accepted accounting principles; and |
|
|
|
|
other risks detailed in our SEC filings from time to time, including in our Annual
Report on Form 10-K for the year ended December 31, 2007. |
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.
37
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to market risk for changes in interest rates and foreign currency exchange
rates. We manage these exposures through operational means and, when appropriate, through the use
of derivative financial instruments.
Interest Rate Risk
Our exposure to interest rate risk relates primarily to our investment portfolio of
approximately $536 million and borrowings under our credit facilities of approximately $2 billion.
Our investment portfolio consists principally 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,
commercial paper and money market funds. Over 90% of our portfolio matures in less than three
months. In the case of market auction rate securities, is subject to an interest-rate reset date
that occurs within 90 days. The recent uncertainty in the credit markets has prevented us and other
investors from liquidating holdings of market auction debt securities in recent auctions because
the amount of market auction debt securities submitted for sale has exceeded the amount of purchase
orders. In January 2008, we began liquidating our holdings in market auction debt securities and
not reinvesting proceeds in those securities in order to reduce our exposure to these instruments.
However, we were not able to liquidate all our market auction debt securities because the auctions
failed. As a result, on March 31, 2008, we held $41 million in market auction debt securities as
these securities have not been liquidated due to failed auctions. We reclassified these securities
as long-term as of March 31, 2008 on the condensed consolidated balance sheet to reflect the uncertainty about our ability
to liquidate the investments over the next twelve months. Despite these failed auctions, there have
been no defaults on the underlying securities, and interest income on these holdings continues to
be received on scheduled interest payment dates. As a result, we now earn premium interest rates on
the failed auction investments (currently earning 2.75% to 5% on a tax-free basis). If the issuers of
these securities are unable to successfully close future auctions and their credit ratings
deteriorate, we may be required to adjust the carrying value of these investments to reflect other
than temporary declines in their value. We have historically valued these securities at par,
because this is the value we received when trading them in the established market. In assessing the
fair value of these securities, we determined market input comparability based on an analysis of
similar security current market data factors. As a result of such assessment, we believe that the
fair value of these securities continues to be par. Therefore, we have not adjusted the recorded
value of theses securities. We will re-evaluate these securities each quarter for any possible
temporary or permanent adjustments to their value.
We manage the interest rate risk of our net portfolio of investments and debt with the use of
financial risk management instruments or derivatives, including interest rate swaps and forward
rate agreements.
As of March 31, 2008, a 10% increase in interest rates would have increased the net interest
expense of our combined investment, debt and financial risk management portfolios by $4 million.
Foreign Exchange Rate Risk
A significant portion of our revenues and earnings are generated internationally in various
currencies. We also have a number of investments in foreign subsidiaries whose net assets are
exposed to currency translation risk. We seek to manage these exposures through operational means,
to the extent possible, by matching functional currency revenues and costs and functional currency
assets and liabilities. Exposures that cannot be managed operationally are hedged using foreign
exchange forwards, swaps and option contracts.
As of March 31, 2008, a 10% depreciation in the value of the U.S. dollar would have resulted
in a decrease of $10 million in the fair value of the Companys foreign exchange risk management
instruments. These movements would have been offset by movements in the fair value in the opposite
direction of the underlying transactions and balance sheet items being hedged.
In addition to the information set forth above, the disclosure under Note 8 Derivative
Instruments, included in Part I of this report is incorporated in this Part I, Item 3 by reference.
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Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls (as defined in Rule 13a-15(e) of the Securities Exchange Act
of 1934 as amended (the Exchange Act)) 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 appropriately communicated to our management, including our Chairman
and Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions
regarding required disclosure. 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 three-month period ended March 31, 2008, we carried out an
evaluation, under the supervision and with the participation of our management, including the
Chairman and Chief Executive Officer and Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures. Based upon that evaluation, the
Chairman and Chief Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures were effective to ensure that information required to be disclosed by us in
the reports that we file or submit under the Exchange Act is recorded, processed, summarized and
reported, within the time periods specified in the Commissions rules and forms and to ensure that
information required to be disclosed by us in the reports that we file or submit under the Exchange
Act is accumulated and communicated to our management, to allow timely decisions regarding required
disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in the Companys internal control over financial reporting during the
three months ended March 31, 2008 that have materially affected, or are reasonably likely to
materially affect, its internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
The disclosure under Note 16 Commitments and Contingencies Litigation Matters included in
Part I of this report is incorporated in this Part II, Item 1 by reference.
Item 1A. Risk Factors
In addition to the other information set forth in this report, you should carefully consider
the factors discussed in the Risk Factors section in our Annual Report on Form 10-K for the year
ended December 31, 2007, which could materially affect our business, results of operations,
financial condition or liquidity. The risks described in our Annual Report are not the only risks
facing us. Additional risks and uncertainties not currently known to us or that we currently
believe are immaterial also may materially adversely affect our business, results of operations,
financial condition or liquidity. The risks described in our Annual Report have not materially
changed.
Item 6. Exhibits
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Exhibit No. |
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Description |
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31.1
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Certification of Bruce L. Downey pursuant to Exchange Act
Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
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31.2
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Certification of William T. McKee pursuant to Exchange Act
Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
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32.0
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Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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BARR PHARMACEUTICALS, INC.
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Dated: May 9, 2008 |
/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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Executive Vice President and Chief
Financial Officer
(Principal Financial Officer) |
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/s/ Sigurd Kirk
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Sigurd Kirk |
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Senior Vice President and Chief
Accounting Officer
(Principal Accounting Officer) |
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40